United States Office of Prevention, Pesticides EPA 738-R-93-024
Environmental Protection And Toxic Substances December 1993
Agency (7508W)
oEPA Reregistration
Eligibility Decision (RED)
Barium Metaborate
Recycled/Re cyclabt*
Printed with Soy/Caixia ink on paper thai
contains at least 50% recycled fiber
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
JAN 2 5BM
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case barium
metaborate monohydrate. The enclosed Reregistration Eligibility Decision (RED) contains
the Agency's evaluation of the data base of this chemical, its conclusions of the potential
human health and environmental risks of the current product uses, and its decisions and
conditions under which these uses and products will be eligible for reregistration. The RED
includes the data and labeling requirements for products for reregistration. It may also
include requirements for additional data (generic) on the active ingredient(s) to confirm the
risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
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If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative Mr.
Franklin Gee at (703) 308-8008. If you have any questions on the generic data, please
contact Ms. Brigid Lowery at (703) 308-8053.
Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Enclosures
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United States Prevention, Pesticides EPA-738-F-93-019
Environmental Protection And Toxic Substances December 1993
Agency (7508W)
SEPA R.E.D. FACTS
Barium Metaborate
Pesticide All pesticides sold or used in the United States must be registered by
Reregistration EPA, based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment. Because of advances in
scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any regu-
latory controls that are needed to effectively manage each pesticide's risks.
EPA then reregisters pesticides that can be used without posing undue hazards
to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for barium
metaborate monohydrate, referred to as barium metaborate.
Use Profile Barium metaborate is a microbiocide/microbiostat used as an industrial
preservative in the manufacturing process of paints, paper/paper products,
industrial adhesives and coatings. Barium metaborate products are formulated
as soluble concentrates and ready-to-use solutions. They are added to paints,
paper/paper products, adhesives and coatings during the manufacturing
process using a method that involves open pouring into a metering pump.
A newly registered product which contains a mixture of barium
metaborate and another pesticide active ingredient, and is used as a fungicide
to protect walls, ceilings and pipes from mold and bacteria using a brush or
airless spray, is not subject to this RED.
Barium metaborate is a compound of boron, which is ubiquitous in the
environment and occurs naturally in soils, water, food and forage crops.
Boron is an essential nutrient for plants as well as an essential element for
many organisms.
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Regulatory Barium metaborate was first registered in the United States in 1960 as
History broad spectrum bactericide and fungicide. Currently, four end use products
(three of which are covered by this RED) and no technical or manufacturing
use pesticide products are registered which contain barium metaborate as an
active ingredient.
In April 1983, EPA issued a Registration Standard for barium
metaborate (NTIS #PB84-168376). In February 1991, EPA issued a Data
Call-in (DCI) for this chemical, requiring product chemistry, ecological
effects and toxicity data.
Initially, the barium metaborate reregistration case also contained the
active ingredient sodium metaborate. Since sodium metaborate is more
similar to boric acid, however, it was included in the Boric Acid RED,
completed in September 1993.
Human Health Human Toxicity
Assessment Since only indoor, non-food uses are covered by this RED, EPA did not
require the submission of chronic toxicity, carcinogenicity or reproductive
toxicity studies.
Barium metaborate generally is of moderate to low acute toxicity, and
has been placed in Toxicity Category III for most acute effects including oral
and dermal toxicity, acute inhalation, and eye irritation. It has been placed
in Toxicity Category IV (indicating the lowest degree of acute toxicity) for
dermal irritation.
An acute neurotoxicity study using rats showed no treatment-related
effects. A combined subchronic toxicity and neurotoxicity study using rats
showed a treatment-related decrease in forelimb grip strength in high dose
males, and increased ambulatory activity in high dose males and mid- and
high dose females.
A developmental toxicity study using rabbits showed a maternal toxicity
no observed effect level (NOEL) of 10 mg/kg/day, and a lowest observed
effect level (LOEL) of 20 mg/kg/day. The NOEL for developmental toxicity
was 20 mg/kg/day, the highest dose tested. Barium metaborate shows no
evidence of mutagenicity.
Dietary Exposure
Barium metaborate has no registered food or feed uses. Therefore, no
dietary exposure is expected to occur as a result of its pesticide uses.
Occupational and Residential Exposure
The barium metaborate products subject to this RED are added to
paints, paper/paper products, adhesives and coatings during the manufacturing
process, using a method that involves open pouring into a metering pump.
During this process, dermal exposure to mixers, loaders and applicators could
be significant. However, EPA's assessment indicates that the margin of
exposure (MOE) for factory workers involved in these activities is 190, which
2
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is well over the 100-fold acceptable margin. The risk to mixers/loaders/
applicators is considered minimal. Post-application exposure also is expected
to pose minimal risks.
Human Risk Assessment
No food uses of barium metaborate are registered; therefore no dietary
risks are posed. The industrial preservative uses, which involve open pouring
application methods, could involve significant worker exposure. However,
the risks posed are minimal.
Environmental Environmental Fate
Assessment Barium metaborate is one of the boron-containing salts (borates), which
are ubiquitous in the environment. Surface soil, unpolluted waterways and
seawater all typically contain significant amounts of boron as borate. In some
areas such as the American Southwest, boron occurs naturally in surface
waters in concentrations that have been shown to be toxic to commercially
important plants.
EPA is not requiring any environmental fate data for barium metaborate.
The Agency does not believe that the pesticide uses covered by this RED add
significantly to the amount of boron already present in, or pose any
unreasonable risk to, the environment.
Ecological Effects
Barium metaborate is slightly toxic to bobwhite quail on an acute oral
toxicity basis, but is practically non-toxic to birds on a subacute basis. It is
practically non-toxic to bluegill sunlish but slightly toxic to rainbow trout and
aquatic invertebrates.
Ecological Effects Risk Assessment
Barium metaborate applied indoors is not likely to be released to the
environment in significant amounts in effluent. Any minor amounts that are
released would dissociate rapidly to naturally-occurring ionic components.
Any exposure to fish, wildlife or endangered species would be regulated
under the National Pollutant Discharge Elimination System (NPDES) permit
program. Therefore, risk to fish, wildlife and endangered species is minimal.
Additional Data EPA is requiring product-specific data including product chemistry and
Required acute toxicity studies, revised Confidential Statements of Formula (CSF), and
revised product labeling for reregistration of barium metaborate industrial
preservative products.
Product Labeling The labeling of all end-use products containing barium metaborate must
Changes Required comply with EPA's current pesticide labeling requirements. In addition:
3
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• Personal Protective Equipment (PPE) Requirements
Since exposure to mixers/loaders/applicators during open pouring
methods could be significant, the following PPE is required for all
industrial preservative end-use products:
• Long-sleeved shirt and long pants;
• Socks and shoes;
• Chemical-resistant gloves.
• Environmental Hazard Statement
The following effluent discharge statement must appear on the labels of
all end-use products:
"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."
Regulatory The use of microbiocide industrial preservative products containing
Conclusion barium metaborate, registered prior to July 1, 1993, will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration. These
products will be reregistered once the required product-specific data,
Confidential Statements of Formula and revised labeling are received and
accepted by EPA.
The newly registered barium metaborate product, which also contains
another active ingredient, will be reregistered after the other active ingredient
is determined to be eligible for reregistration.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for barium metaborate during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED document or to submit written
comments, please contact the Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Following the comment period, the barium metaborate RED document
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
4
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iDITION DATE: MARCH 31, 1998 PAGE: 202
DSR0 13 - RSPOR? OF PESTICIDE DATA SUBMITTERS IN EPA FILES BY CHEMICAL
:HE111CAL CHEMICAL NAME
063C03 Pentachlcrophenol, sodium salt
COMPANY# 000453 KOPPERS COMPANY, INC.
* DATA TYPES * 1201 KOPPERS BUILDING
EU AT EC FW EF OT PITTSBURGH PA
XX 15219
DOW CHEMICAL CO.
2030 DOW CENTER
COMPANY# 000464
* DATA TYPES *
EU AT EC FW EF OT MIDLAND MI
XX XX 48674
THE
COMPANY# 001022 IBC MANUFACTURING CO
* DATA TYPES * 5966 HEISLEY RD
EU AT EC FW EF OT MENTOR OH
XX
44060
COMPANY# 003090 SANITIZED INC
* DATA TYPES * 57 LITCHFIELD ROAD BOX 2211
EU AT EC FW EF OT NEW PRESTON CT
XX
06777
COMPANY# 003876 BETZDEARBORN INC (ATTN: KEVIN MANNING)
* DATA TYPES * 4 6 36 SOMEP.TON ROAD
EU AT EC FW EF OT TREVOSE PA
XX
XX XX
1 9053
COMPANY* 004643 BETZDEARBORN, INC.
* DATA TYPES * 300 GENESEE ST
EU AT EC FW EF OT LAKE ZURICH IL
XX
XX XX
60047
COMPANY# 0 09573 HARBOR CHEMICAL £ ENGR CORP
* DATA TYPES * 100 WEST MONROE ST SUITE 706
EU AT EC FW EF OT CHICAGO, IL
XX
60603
COMPANY#
* DATA
EU AT EC
XX
0 1 0445
TYPES *
FW EF. OT
CALGON CORP.
CALGON CENTER
PITTSBURGH PA
15230
- P.O. BOX 1346
COMPANY# 010836 NOPCO CHEMICAL DIV DIAMOND SHAMROCK CHEM CO
* DATA TYPES * 60 PARK PL
EU AT EC FW EF OT NEWARK NJ
XX
XX
07 101
COMPANY# 017664 BAROID DIVISION
* DATA TYPES * 3000 N. SAM HOUSTON PKWY E
E'J AT EC FW EF OT HOUSTON TX
XX
XX XX XX 77032
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REREGISTRATION ELIGIBILITY DECISION
BARIUM METABORATE
LIST A
CASE 0632
ENVIRONMENTAL niOTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
BARIUM METABORATE REREGISTRATION ELIGIBILITY DECISION
TEAM iii
GLOSSARY OF TERMS AND ABBREVIATIONS iv
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
n. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements and Regulatory History 3
HI. SCIENCE ASSESSMENT 4
A. Physical Chemistry Assessment 4
B. Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Toxicity 5
b. Subchronic Toxicity S
c. Developmental Toxicity 6
d. Mutagenicity 6
e. Neurotoxicity 7
f. Reference Dose 7
2. Exposure Assessment 7
a. Dietary Exposure 7
b. Occupational and Residential 7
3. Risk Assessment 9
a. Dietary 9
b. Occupational and Residential 9
C. Environmental Assessment 10
1. Environmental Fate 10
a. Environmental Chemistry, Fate and Transport 10
b. Environmental Fate Assessment 11
2. Ecological Effects 11
a. Ecological Effects Data 11
(1) Terrestrial Data 11
(2) Aquatic Data 12
b. Ecological Effects Risk Assessment 13
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 14
A. Determination of Eligibility 14
1. Eligibility Decision 14
2. Eligible and Ineligible Uses 15
i
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B. Regulatory Position 15
1. Tolerance Reassessment 15
2. Restricted Use Classification 15
3. Labeling Rationale 15
V. ACTIONS REQUIRED BY REGISTRANTS 16
A. Manufacturing-Use Products 16
1. Additional Generic Data Requirements 16
2. Labeling Requirements for Manufacturing-Use Products 16
B. End-Use Products 16
1. Additional Product-Specific Data Requirements 16
2. Labeling Requirements for End-Use Products 17
C. Existing Stocks 18
VI. APPENDICES
Appendix A - Use Patterns Subject to Reregistration
Appendix B - Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision
Appendix C - Citations Considered to be Part of the Data Base Supporting the
Reregistration of Barium Metaborate
Appendix D - List of Available Related Documents
Appendix E - Summary of Instructions for Responding to the RED;
- Instructions for the Confidential Statement of Formula
Appendix F - Product Specific Data Call-In
Attachment 1 -
Chemical Status Sheet
Attachment 2 -
Product Specific DCI Response Forms (Form A) plus
Instructions
Attachment 3 -
Requirements Status and Registrants' Response Forms
(Form B) plus Instructions
Attachment 4 -
EPA Batching of End Use Products for meeting Acute
Toxicology Data Requirements.
Attachment 5 -
EPA Acceptance Criteria
Attachment 6 -
List of all Registrant(s) sent this DCI
Attachment 7 -
Cost Share/Data Compensation Forms
ii
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BARIUM METABORATE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Rafael Prieto
Phyllis Johnson
Environmental Fate and Effects Division
Brinson Conerly-Perks
Richard Lee
Mary Frankenberry
Health Effects Division
Pat McLaughlin
Winston Dang
Jane Smith
Policy and Special Projects Staff
Kennan Garvey
Registration Division
Biological Analysis Branch
Biological Analysis Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Toxicology Branch I
Occupational and Residential Exposure Branch
Chemical Coordination Branch
Mary Waller
Theresa Stowe
Shyam Mathur
Special Review and Reregistration Division
Brigid Lowery
Barry O'Keefe
Carol Stangel
Office of General Counsel:
Pesticides and Toxic Substances Division
Jim Curtin
Office of Compliance Monitoring:
Policy and Grants Division
Shruti Sanghavi
Registration Support Branch
Fungicide-Herbicide Branch
Registration Support Branch
Reregistration Branch
Reregistration Branch
Planning and Reregistration Branch
Pesticide Branch
Pesticides Enforcement Policy Branch
iii
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
HDT Highest Dose Tested
LCjq 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 or
feed, e.g., mg/1 or ppm.
LDjq 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.
LDjo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOEL Lowest Observed Effect Level
MOE Margin of Exposure. A numerical value that characterizes the amount of
safety to a toxic chemical - a ratio of exposure to a toxicological endpoint,
usually a NOEL.
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
iv
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GLOSSARY OF TERMS AND ABBREVIATIONS
MRID Master Record Identification (number). EPA's system of recording and
tracking studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
Q"j 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.
v
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executive summary
This Reregistration Eligibility Decision (RED) addresses the eligibility for
reregistration of products containing barium metaborate monohydrate, referred to in this
document as barium metaborate, registered prior to July 1, 1993.
Barium metaborate was originally registered in the United States in November 1960.
Barium metaborate is a fungicide, bacteriostat, microbiocide/microbiostat and is used as an
industrial preservative in the manufacturing process of paints, paper/paper products,
adhesives, and coatings to protect against slime-forming bacteria and fungi. It is used as a
preservative in paper formulation to protect paper products from microbiological degradation
during storage. At higher concentrations it is used to impart mold resistance in paints,
coatings, latex/oil/vaniish paints (applied film), and paper/paper products. Use has been
permitted as a component in the manufacture of paper and paperboard under U.S. Food and
Drug Administration Regulations 21 CFR 176.180, "components of paper and paperboard in
contact with dry food." Since U.S. FDA regulates this use, there is no need for EPA
regulation in this area. Furthermore, barium metaborate may be applied by brush or airless
spray to walls, ceilings, pipes, etc. as a fungicide to protect against molds and bacteria. The
product that contains this use is a mixture of barium metaborate and another active ingredient
and was registered after July 1, 1993; therefore, it is not included in this RED.
A Registration Standard for barium metaborate was issued in April 1983 (NTIS
#PB84-168376) which evaluated the studies available to the Agency. Product chemistry data
and an acute rat inhalation study were required in the April 1983 Registration Standard.
Subsequently, a Data Call-In (DCI) was issued February 1991 for this chemical. The DCI
required submittal of product chemistry data, ecological effects data, and toxicology data.
This Reregistration Eligibility Decision reflects a reassessment of all data which were
submitted in response to the Registration Standard and DCI. Appendix B includes all data
requirements identified by the Agency to support the reregistration of all barium metaborate
uses registered prior to July 1, 1993.
Sodium metaborate was included in the same case as barium metaborate when the lists
of the active ingredients undergoing reregistration were published in 1989. The Agency,
however, determined that sodium metaborate should be reregistered with boric acid since it is
the sodium salt of boric acid. Sodium metaborate was included in the Boric Acid RED
which was issued in September 1993.
The Agency has determined that the uses of barium metaborate registered prior to
July 1, 1993 will not cause unreasonable risk to humans or the environment and are eligible
for reregistration.
Before reregistering the products containing barium metaborate, 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
vi
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data include product chemistry for each registration and acute toxicity testing. After
reviewing these data and any revised labels and finding them acceptable in accordance with
Section 3(c)(5) of FIFRA, the Agency will reregister a product. Those products which
contain other active ingredients will be eligible for reregistration only when the other active
ingredients are determined to be eligible for reregistration.
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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 S "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 uses of barium metaborate monohydrate, referred to in this document as barium
metaborate, which were registered prior to July 1, 1993. The document consists of six
sections. Section I is the introduction. Section II describes barium metaborate, its uses, data
requirements and regulatory history. Section III discusses the human health and
environmental assessment based on the data available to the Agency. Section IV presents the
reregistration decision for barium metaborate. Section V discusses the product reregistration
requirements for barium metaborate. Finally, Section VI is the Appendices which support
this Reregistration Eligibility Decision. Additional details concerning the Agency's review of
applicable data are available on request.
1
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n. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Document:
Common Name:
Barium metaborate
Chemical Name: Barium metaborate monohydrate
CAS Registry Number: 13701-59-2
OPP Chemical Code: 011101
Case:
Empirical Molecular
Formula:
0632
BaBA.H20
241
Molecular Weight:
TGAI: Barium metaborate monohydrate
Trade and Other Names: Busan 11-M1
Basic Manufacturer:
Buckman Laboratories International Inc., U.S.A
B. Use Profile
The following is information on the uses registered prior to July 1, 1993 with
an overview of use sites and application methods. A detailed table of these uses is
provided in Appendix A.
Barium metaborate is a fungicide, bacteriostat, microbiocide/microbiostat and
is used as an industrial preservative in the manufacturing process of paints,
paper/paper products, adhesives, and coatings to protect against slime-forming
bacteria and fungi. It is used as a preservative in paper formulation to protect paper
products from microbiological degradation during storage. At higher concentrations it
is used to impart mold resistance in paints, coatings, latex/oil/varnish paints (applied
film), and paper/paper products. Use has been permitted for the manufacture of
paper and paperboard under U.S. Food and Drug Administration Regulations 21 CFR
176.180, "components of paper and paperboard in contact with dry food." There is
2
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no need for EPA regulation in this area. Furthermore, barium metaborate may be
applied by brush or airless spray to walls, ceilings, pipes, etc. as a fungicide to
protect against molds and bacteria. The product that contains this use is a mixture of
barium metaborate and another active ingredient and was registered after July 1,
1993; therefore, it is not covered in this RED.
Use group/sites:
Indoor non-food: industrial adhesives, industrial coatings, latex/oil/varnish (applied
film) paints, paper/paper products, wet-end additives/industrial processing chemicals.
Target pests:
Slime-forming bacteria and fungi
Application type:
Industrial preservative treatment
Application timing:
During manufacture
Rates of Application:
Adhesives:
0.05 to 0.5 percent based on the weight of the solution
Industrial coatings:
1 to 3 percent based on total weight of coating
Latex/oiiyvarnish (applied film) paints
5 to 20 percent based on the total weight of the coating
Paper/paper products:
0.05 to 0.5 percent based on the weight of the solution
Wet-end additives/industrial processing chemicals:
0.05 to 0.5 percent based on the weight of the solution
C. Data Requirements and Regulatory History
Barium metaborate was originally registered in the United States in November
1960 for use as a broad spectrum bactericide and fungicide. A Registration Standard
for barium metaborate was issued in April 1983 (NTIS #PB84-168376) which
evaluated the studies available to the Agency. Product chemistry data and an acute
rat inhalation study were required to support the uses listed in the Registration
Standard. A Data Call-In Notice was issued in February 1991 which required product
3
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chemistry data, ecological effects data, and toxicology data. This Reregistration
Eligibility Decision reflects a reassessment of all data which were submitted in
response to the Registration Standard and Data Call-In. Appendix B includes all data
requirements identified by the Agency to support the reregistration of all uses of
barium metaborate registered prior to July 1, 1993.
Sodium metaborate was included in the same case as barium metaborate when
the lists of the active ingredients undergoing reregistration were published in 1989.
The Agency, however, determined that sodium metaborate should be reregistered with
boric acid; therefore, it was included in the Boric Acid RED which was issued in
September 1993.
m. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The physical and chemical characteristics of the TGAI of barium metaborate are
described below (MRID numbers 00137047 and 42173701):
Color:
White
Physical state:
Powder
Odor:
None
Melting Point:
Fused between 1367.5°C to 1482.5°C
Density:
1.07 g/cm3 at 25 °C
Vapor Pressure:
8.1 x 10"7 Torr
Dissociation Constant:
r
ii
oo
\o
Octanol/Water Partition
Coefficient:
less than 2
pH:
9.76 (concentration 100 ppm in water)
Stability: Barium metaborate is stable at ambient temperature and
elevated temperature (S4°C). It is also stable to
galvanized steel and stainless steel and is stable in the
presence of ferric oxide and zinc acetate for 14 days.
4
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B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base on barium metaborate is adequate;
therefore, the Agency is not requiring any additional toxicological data. The
uses of barium metaborate fall under the use group "indoor non-food." The
Agency does not routinely require the submittal of chronic toxicity,
carcinogencity, and reproductive toxicity data to support the indoor non-food
use group. The results of the studies the Agency required for barium
metaborate do not trigger the need for the additional toxicological testing. The
results of the required studies are summarized below.
a. Acute Toxicity
The results of the acute testing are found in the table below.
ACUTE MAMMALIAN TOXICITY DATA FOR BARIUM METABORATE
(90% MATERIAL)
GDLN
#
TEST
RESULT
TOXICITY
CATEGORY
MRU)
81-1
Acute oral LDW (rat)
530 mg/kg (9)
850 mg/kg (c?)
m
00139192 1
81-2
Acute dermal LDjo
(rabbit)
> 2000 mg/kg
m
00139216
81-3
Acute inhalation LC50
(rat)
> 3.54 mg/L
ni
00137048
81-4
Eye irritation (rabbit)
reversible
irritation
in
00139192
81-5
Dermal irritation
(rabbit)
no irritation
IV
00139192
j 81-6
Skin sensitization
(guinea pig)
negative
N/A
41396401
40898401
b. Subchronic Toxicity
In a combined oral subchronic toxicity and neurotoxicity study,
rats were given 0, 1000, 5000, or 10000 ppm barium metaborate in the
diet for 90 days. The NOEL was 1000 ppm (70 mg/kg/day in males
5
-------
and 80 mg/kg/day in females) and the LOEL was 5000 ppm (349
mg/kg/day in males and 406 mg/kg/day in females). At the high dose,
there were reduced body weight gains in both sexes and decreased food
consumption, red blood cells, hemoglobin, hematocrit, and liver
weights. There were increased relative brain weights. High dose
males also had decreased total protein, cholesterol, globulin, testes
weights, and small or soft testes with aspermatogenesis. At the mid-
dose (LOEL), there were reduced body weight gains and reduced
relative brain weights in females, as well as decreased total protein,
cholesterol and globulin in males. There was an apparent treatment-
related decrease in one of the functional neurological observations,
forelimb grip strength, for the high dose males and increased
ambulatory activity in mid-dose females and in both sexes at the high
dose. (MRU) 42747801) (preliminary notification MRIDS 42310501,
42663401; range finding report MRID 42724201).
c. Developmental Toxicity
In a developmental toxicity study, rabbits were given 0, 2, 10,
or 20 mg/kg/day of barium metaborate. The doses were given by
gavage on gestation days 7 through 19. The NOEL for maternal
toxicity was 10 mg/kg/day. The maternal LOEL was 20 mg/kg/day
based on death of one animal at this dose along with impaired mobility
and hypoactivity of another one. The NOEL for developmental toxicity
was 20 mg/kg/day, the highest dose tested. (MRID 42720502)
(preliminary information MRID 42314301; range finding report MRID
42720501).
d. Mutagenicity
The Agency reviewed three genotoxicity tests to support the
reregistration of barium metaborate: i) Salmonella assay ("Ames"
assay); ii) mammalian cells in culture forward gene mutation assay; and
iii) in vivo cytogenetics. In an Ames assay with strains, TA98, TA100,
TA1535, TA1537, and TA1538 of Salmonella typhimurium, barium
metaborate did not cause a positive response with or without metabolic
activation (MRID 42132601). An in vivo micronucleus assay in mice
was negative for chromosomal aberrations (MRID 42207501).
Furthermore, a mouse lymphoma study with barium metaborate did not
show any mutagenicity. (MRIDS 42151401 and 42873201).
6
-------
e. Neurotoxicity
In an acute neurotoxicity study, rats were administered a single
dose of barium metaborate via gavage at levels of 0, 25, SO, 100, and
200 mg/kg. The NOEL for acute neurotoxicity was 25 mg/kg and the
LOEL was 50 mg/kg based on impairment of gait in males at this and
the higher doses. In females there was impairment of gait at the 200
mg/kg on day 0. There were no adverse effects on survival, body
weight/gain, brain weight or dimensions, and no clinical signs,
locomotor activity changes, or neuropathological lesions were observed
in either sex of rat that were treatment related. No signs of toxicity
were apparent on days 7 and 14 in either sex. (MRID 42734701) (range
finding reports MRIDS 42343601 and 42501201) Furthermore, the
Agency required a 90-day mammal neurotoxicity study. In response
the registrant combined the 90-day neurotoxicty study with the 90-day
oral toxicity study (see section m.B.l.b).
f. Reference Dose
A Reference Dose has not been determined for barium
metaborate since there are no registered food uses.
2. Exposure Assessment
a. Dietary Exposure
Barium metaborate has no food uses; therefore, no dietary
exposure is expected to occur.
b. Occupational and Residential
The barium metaborate products covered in this RED were
registered prior to July 1, 1993. These products can be added into
paints, paper/paper products, and coating material during the
manufacturing process. During the manufacturing process, barium
metaborate is used as a preservative (e.g., as a starch slurry
preservative) in paper coating formulations to protect paper products
from microbiological degradation during storage. At higher
concentrations it is used to impart mold resistance to coated paper and
paper board. Use has been permitted for the manufacture of paper and
paperboard under U.S. Food and Drug Administration Regulations 21
CFR 176.180, "components of paper and paperboard in contact with
dry food." It is also used in latex paints (in-can), oil/vamish (applied
7
-------
film), and coatings to impart resistance to mold. From these uses, the
potential for mixer/loader/applicator exposure exists during the pouring
or pumping of barium metaborate into the product for preservation (i.e.
paint, etc.). The Agency expects the "pour liquid" for the preservative
use to provide the highest potential for exposure to barium metaborate.
The exposure assessment for this use is found below (Section m.B.2.b-
1).
b-1. Mixer/Loader/Applicator Exposure from Pour Liquid Use of
Barium Metaborate during Manufacturing
Barium metaborate products can be formulated as soluble
concentrates and ready to use solutions (e.g., 90%, 52%, 50%) and
added into the paints, paper/paper products, and coating material during
the manufacturing process. The method of open pouring into a
metering pump is used as a general industrial practice and provides the
highest potential for mixer/loader/applicator exposure to barium
metaborate. While conducting open pouring operations of barium
metaborate the potential dermal exposure could be significant, however,
the potential inhalation exposure is considered minimal because of the
low vapor pressure of barium metaborate. After reviewing the entire
toxicological data base the Agency determined that barium metaborate
should be regulated on the basis of a Margin of Exposure (MOE)
instead of a RfD. The lowest NOEL is 10 mg/kg/day based on
maternal toxicity in a developmental study. This compound meets the
Agency's toxicity and exposure criteria for requiring exposure
monitoring data. These data requirements for mixer/loader/applicator
are met by the Chemical Manufacturers Association (CMA) exposure
assessment database (MRID 41412201). The registrant is a participant
in the CMA exposure study. This database was used to estimate
mixer/loader/applicator combined inhalation and dermal exposure based
on the type of application, in this case, the pour liquid for the
preservative use (see table below). The estimated combined dermal and
inhalation daily exposure of barium metaborate to the handler is 52.6
ug/kg/day under the use scenario as preservative.
8
-------
Daily Exposure to Barium Metaborate for Mixers/Loaders/Applicator
from use during manufacturing
SCENARIO: Pour Liquid
Setting
MCS»
lb ai used
Body Weight
Daily
(ug/lb ai)
Exposure
-------
maternal toxicity observed in the developmental study on rabbits at
20 mg/kg/day in the form of mortality, impaired mobility and
hypoactivity. The NOEL for the study is 10 mg/kg/day. The potential
exposure based on the worst-case scenario is 0.0526 mg/kg/day.
Therefore, the MOE for factory workers involved in
mixer/loader/applicator activities is 190. An MOE of 100 or greater is
considered acceptable. The risk to mixers/loaders/applicators is
considered to be minimal.
b-2. Post-application workers
The risk associated with post application exposure to workers is
considered minimal since exposure is limited by the low vapor pressure
of barium metaborate.
Environmental Assessment
1. Environmental Fate
a. Environmental Chemistry, Fate and Transport
In nature, boron does not occur in its elemental (uncombined)
form. However, boron compounds are widely found in soil and water.
Much of the naturally occurring boron is present in inorganic species
where the boron is bound to oxygen. These form a variety of "borate"
compounds, which have similar properties, and include barium
metaborate, BaB^.HzO, the subject of this document. These borate
ions are combined with various metallic ions also occurring naturally,
and dissociate into the respective borate and metallic ions when
dissolved in water. A common form of borate is the negatively
charged ion BO33" which occurs in association with positively charged
metal ions such as sodium and barium. An additional example is the
compound known as borax, which has the formula Na2B407 and in the
solid state is associated with ten molecules of water of crystallization.
In these forms, boron serves as an essential micronutrient for
microorganisms, thereby becoming bound to an organic component in
plants or microorganisms.
In soil the concentration of boron (expressed as elemental boron)
can range from 5-150 ppm. A typical surface soil might contain 50
ppm boron. Boron salts (combinations of borates with metal ions) also
occur naturally in low concentrations in lakes, ponds, rivers, and
oceans. In some geographical areas such as the American Southwest,
boron occurs in concentrations in surface waters that have been shown
10
-------
to be toxic to plants of commercial importance. Seawater boron
concentrations average 4.5 mg/liter. The average concentration for
boron in surface waters has been reported to range from 0.001 mg/liter
to 0.1 mg/liter.
b. Environmental Fate Assessment
The Agency is not requiring any environmental fate data at this
time. No studies have been submitted regarding the environmental fate
of boron salts, and none have been reviewed. It is doubtful that the
information which would be developed by performing standard
environmental fate studies would justify the effort. Since soils are
naturally rich in these boron compounds, high background levels would
make analyses unusually difficult. Analytical procedures could not
distinguish between native and added boron compounds without the use
of isotopic labeling. Moreover, the normal degradative processes
would only produce compounds which are already present in the
environment, such as the metaborate salts with different hydration
states.
2. Ecological Effects
a. Ecological Effects Data
The ecological effects data base on barium metaborate is
adequate; therefore, the Agency is not requiring any additional
ecological effects data. The results of the ecological toxicity testing are
summarized in this section.
(1) Terrestrial Data
In September 1991, the Agency received notification of
potential adverse effects from preliminary results of the acute
avian oral study being conducted on the bobwhite quail (MRID
42033601). The information was submitted because of possible
neurotoxicity in quail treated with barium metaborate at doses
ranging from 486 to 2250 mg/kg. This study was not designed
to address the neurotoxic potential of barium metaborate. The
Agency has reviewed data from an acute neurotoxicity study in
rats and combined rat subchronic oral toxicity and neurotoxicity
study (see section HI.B.l.e).
The terrestrial data indicate that barium metaborate is
slightly toxic to bobwhite quail on an acute oral toxicity basis.
11
-------
A single dose oral toxicity study administered to bob white quail
resulted in an LD^ value of 1254 mg/kg [MRID 42339501 and
MRID 42546001 (final amended report)]. However, barium
metaborate is practically non-toxic to birds, both an upland
species (bobwhite quail) and a waterfowl species (mallard duck)
on a subacute dietary toxicity basis. Avian subacute dietary
toxicity studies demonstrate LCso's > 5620 ppm for both
bobwhite quail [MRID 42338701 and MRID 42546701
(amended final report)] and mallard duck [MRID 42338702 and
MRID 42546702 (amended final report)].
(2) Aquatic Data
Three studies were conducted on the 90% material for
aquatic toxicity, two on fish and one on an aquatic invertebrate.
Data on end-use products are not required for the registered uses
of barium metaborate. The available acute toxicity data indicate
that barium metaborate is practically non-toxic to bluegill
sunfish with a LC^lSl ppm (MRID 42338601) but slightly
toxic to rainbow trout with a LC50=62 ppm (MRID 42338602).
It is also slightly toxic to Daphnia magna with a ECK= 19 ppm
based on a 48 hour acute toxicity test (MRID 42338603).
12
-------
II
SUMMARY OF ECOLOGICAL EFFECTS TOXICITY TESTS
(TERRESTRIAL AND AQUATIC DATA)
GUIDELINE
SPECIES
%
A.I.
LCt* or LDM
(mg/kg)/
NOEL (mg/kg)
AUTHOR
DATE
MRID
Avian Single-Dose Oral Toxicity Test
71-la
bobwhite
quail
90%
LDjo - 12S4
NOEL = 292
Campbell &
Lynn
1992
42546001
Avian Subacute Dietary To
xkity 1
ests
71-2a
bobwhite
quail
90%
LC» > 5620
NOEL = 1780
Campbell el
al.
1992
42546701
71-2b
mallard
duck
90%
LCjo > 5620
NOEL = 5620
Campbell et
al.
1992
42546702
Acute Freshwater Fish Toxicity Tests
72-la
bluegill
sunfish
90%
LCj, = 151 ppm
NOEL = 42.8
Linott
1992
42338601
72-lc
rainbow
trout
90%
LCjo = 62 ppm
NOEL = 14.9
Linott
1992
42338602
Non-target Aquatic Invertebrate Toxicity Test
72-2a
Daphnia
magna
90%
19 ppm
Linott
1992
42338603
b. Ecological Effects Risk Assessment
Barium metaborate is registered as a microbiocide for indoor
non-food end-use. Because of the indoor, in-product nature of the use
of this chemical, it is not expected that barium metaborate will be
released to the environment in significant amounts through the effluent
from a manufacturing plant. Furthermore, any minor amount of the
chemical that would be released in this manner would be expected to
dissociate rapidly to its naturally occurring ionic components. Little
direct exposure to fish, wildlife, and endangered species is expected
from the use of this chemical and any potential exposure would be
regulated under permit by the National Pollutant Discharge Systems;
therefore, risk to fish, wildlife, and endangered species will be minimal
from the microbiocidal use of this chemical.
13
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredients are eligible for reregistration. The Agency has
previously identified and required the submission of the generic (i.e. active ingredient
specific) data required to support reregistration of products containing barium
inelaborate active ingredient. The Agency has completed its review of these generic
data, and has determined that the data are sufficient to support reregistration of
products containing barium metaborate registered prior to July 1, 1993. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of barium metaborate, 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 uses of barium metaborate registered prior to July 1, 1993 and to determine
that these uses will not result in unreasonable adverse effects to humans and the
environment. The Agency finds that all products registered prior to July 1, 1993
which contain barium metaborate as the sole active ingredient are eligible for
reregistration. The reregistration of particular products is addressed in Section V of
this document. Those products that contain other active ingredients will be eligible
for reregistration only when the other active ingredients are determined to be eligible
for reregistration.
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. 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 barium metaborate, 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 ingredient
barium metaborate, the Agency has sufficient information on the health effects
of barium metaborate products subject to this RED and on its potential for
causing adverse effects in fish and wildlife and the environment. Therefore,
the Agency concludes that products containing barium metaborate registered
prior to July 1, 1993 are eligible for reregistration. Those products that
contain other active ingredients will be eligible for reregistration only when the
14
-------
other active ingredients are determined to be eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of barium metaborate products
registered prior to July 1, 1993 are eligible for reregistration.
B. Regulatory Position
The Agency has determined that the uses of barium metaborate registered prior
to July 1, 1993 will not cause unreasonable risk to humans or the environment and
are eligible for reregistration. The following is a summary of the regulatory positions
and rationales for barium metaborate. Where labeling revisions are imposed, specific
language is set forth in Section V of this document.
1. Tolerance Reassessment
There are no registered food or feed uses for barium metaborate;
therefore, no tolerances or exemptions from the requirement of a tolerance are
established for this chemical.
2. Restricted Use Classification
Barium metaborate does not meet the criteria for a Restricted Use
Pesticide.
3. Labeling Rationale
a. Since the mixers/loaders/applicators exposure for barium
metaborate by using open pouring methods could be significant the Agency is
now requiring PPE (Personal Protective Equipment) (i.e. long-sleeved shirt,
long pants, socks, shoes, chemical-resistant gloves) for
mixers/loaders/applicators of end-use products.
b. Although the Agency does not expect effluent from the
microbiocidal use of these products to contain more than minimal amounts of
barium metaborate, the Agency requires an environmental hazard statement on
end-use products registered for industrial preservative uses. The
environmental hazard statement currently on product labels must be revised
according to PR Notice 93-10, issued July 29, 1993. The specific language is
set forth in section V.
15
-------
c. Due to the indoor and in-product nature of its use, minimal
direct exposure to endangered species is expected from the use of this
chemical; therefore, the effect on endangered species from the reregistered
uses of this chemical is considered minimal. Accordingly, the Agency is not
requiring any endangered species labeling at this time.
At the present time, EPA 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.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregistration of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The Agency is not requiring additional data to support the reregistration
of the active ingredient barium metaborate.
2. Labeling Requirements for Manufacturing-Use Products
There are no registered technical or manufacturing-use products for
barium metaborate. In the future, if any are registered, they will be required
to meet the requirements of 40 CFR 156.10, this RED, and other current
policies.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix
F, the Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they
16
-------
meet current EPA acceptance criteria (Appendix F; Attachment E) and if not,
commit to conduct new studies. If a registrant believes that previously
submitted data meet current testing standards, then study MRED numbers
should be cited according to the instructions for 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.
a. Personal Protective Equipment
Since the mixer/loader/applicator exposure for barium
metaborate by using open pouring methods could be significant, the
Agency is now requiring the following PPE (Personal Protective
Equipment) for mixers/loaders/applicators of end-use products:
• long-sleeved shirt and long pants;
• socks and shoes; and
• chemical-resistant gloves.
b. Environmental Hazard Statement
The following revised effluent discharge labeling statement must
appear on all manufacturing and end-use products subject to this RED:
"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)(1)
for additional information.
17
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C. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of a 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 a RED.
However, existing stocks time frames will be established case-by-case, depending on
the number of products involved, the number of label changes, and other factors.
Refer to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal
Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell barium
metaborate 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.
18
-------
APPENDIX A
USE PATTERNS SUBJECT TO REREGISTRATION
19
-------
APPENDIX A - CASE 0632, (Barium metaborate] Chemical 011101 (Barium metaborate]
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
Form Hinimun
Application
Rate
Maximun Soil Max. Maximun Dose Min. Restr. Geographic
Application Text Apps /crop cycle, lnterv Entry Allowed
Rates (Max 8 Max or /year (days) lnterv
Dse) Rate (days)
Geographic
Disallowed
Use
Limitations
Codes
NON-FOOD/NON-FEED
Industrial preservative treatment.. During
manufacture.. Not on label., Not on the
Label., Not applicable for this use.
Industrial preservative treatment., During
manufacture.. Not on label.. Not on the
Label., Not applicable for this use.
frAWSAAtft/O'ft/WMSH
Industrial preservative treatment.. During
manufacture., Not on label.. Not on the
Label., Not applicable for this use.
PAPER/PAPER/PRODUCTS
Industrial preservative treatment., During
manufacture.. Not on label., tyot on the
Label., Not applicable for this use.
wrr> €*«>: aoo i r f«j/u:. i «b c«bm i
Industrial preservative treatment., During FH?
manufacture.. Not on label., Not on the
Label., Not applicable for this use.
FH? No Calc
FH? No Calc
FH? No Calc
FH? No Calc
No Calc
Use Group: INDOOR NON-FOOD
NA * MS NS NS NS
Use Group: INDOOR NON-FOOD
NA * NS NS NS NS
Use Group: INDOOR NON-FOOD
NA * NS NS NS NS
Use Group: INDOOR NON-FOOO
NA * NS NS NS NS
Use Group: INDOOR NON-FOOO
NA * NS NS NS NS
C23
C23
C23
C23
C23
21
-------
APPENDIX A - CASE 0632, IBariun metaborate] Chemical 011101 (Barium metaborate]
LEGEND
HEADER ABBREVIATIONS
Max. Apps S Max Rate : Maximum number of Applications at Maximum Dosage Rate
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* s Non-specific
C : Coarse
M : Mediun
F : Fine
0 : Others
FORMULATION CODES
FM? : FORM NOT IDENTIFIED
RTU : LIQUID-READY TO USE
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label)
APPLICATION RATE
DCNC : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS COOES
AOS : Preclean claim.
C04 : Proper ventilation required.
C23 : NPDES license restriction.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
22
-------
APPENDIX B
Data Supporting Guideline Requirements
for the Reregist ration of Barium Metaborate
23
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Barium Metaborate
REQUIREMENT USE PATTERN' CITATION(S)
PRODUCT CHEMISTRY
61-1
Chemical Identity
all
00137047
61-2A
Start. Mat. & Mnfg. Process
all
00137047
61-2B
Formation of Impurities
all
00137047
62-1
Preliminary Analysis
all
00137047
62-2
Certification of limits
all
CSF
62-3
Analytical Method
all
00137047
63-2
Color
all
42173701
63-3
Physical State
all
42173701
63-4
Odor
all
42173701
63-5
Melting Point
all
42173701
63-7
Density
all
42173701
63-8
Solubility
all
42173701
63-9
Vapor Pressure
all
42173701
63-10
Dissociation Constant
all
42173701
63-11
Octanol/Water Partition
all
42173701
63-12
pH
all
facsimile dated 4/29/93
63-13
Stability
all
42173701
25
-------
Data Supporting Guideline Requirements for the Reregistration of Barium Metaborate
REQUIREMENT USE PATTERN1 CITATION(S)
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
72-1A Fish Toxicity Bluegill
72-1C Fish Toxicity Rainbow Trout
72-2A Invertebrate Toxicity
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation • Rabbit
81-6 Dermal Sensitization - Guinea Pig
81-8-ss Acute Neurotoxicity - rat
82-1A 90-Day Feeding - Rodent
82-5B 90-Day Neurotoxicity - Mammal
83-3B Developmental Toxicity - Rabbit
84-2A Gene Mutation (Ames Test)
M
M
M
M
M
M
M
M
M
M
M
M
M
M
M
M
M
42546001, 42339501, 42033601
42338701, 42546701
42338702, 42546702
42338601
42338602
42338603
00139192
00139216
00137048
00139192
00139192
41396401, 40898401
42734701, 42343601, 42501201
42747801, 42310501, 42663401,
42724201
42747801, 42310501, 42663401,
42724201
42720502, 42314301, 42720501
42132601
26
-------
Data Supporting Guideline Requirements for the Reregistration of Barium Metaborate
——1 1 —MgML-l-J- ¦ —¦. ¦ . ¦ - 1— ..III Ul i11 '' ^
REQUIREMENT use pattern' CITATION(S)
84-2B
Structural Chromosomal
Aberration
M
42207501
84-4
Other Genotoxic Effects
M
42151401, 42873201
OCCUPATIONAL AND RESIDENTIAL EXPOSURE
233
Estimation of Dermal Exposure
and Indoor Sites
M
41412201
234
Estimation of Inhalation Exposure
at Indoor Sites
M
41412201
1 Use Patterns: e« terrestrial food; b «= terrestrial feed; c a terrestrial non-food; d = aquatic food; • = 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 outdoor; I = indoor food; m = indoor non-food; n = indoor medical; o = indoor residential
27
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APPENDIX C
BIBLIOGRAPHY
Citations considered to be Part of the Data Base
Supporting Reregistration of Barium Metaborate
29
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all
studies considered relevant by the Agency in arriving at the positions and conclusions
stated elsewhere in the Reregistration Eligibility Decision. Primary sources for
studies in this bibliography have been the body of data submitted to the Agency and
its predecessor agencies in support of past regulatory decisions. Selections from other
sources including published literature, in those instances where they have been
considered, are included.
2. 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 EPA, the Agency has sought to identify documents
at a level parallel to the published article from within the typically larger volumes in
which they were submitted. The resulting "studies" generally have a distinct title (or
at least a single subject), can stand alone for purposes of review and can be described
with a conventional bibliographic citation. The Agency has also attempted to unite
basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID Number". This number is
unique to the citation, and should be used whenever a specific reference is required.
It is not related to the six-digit "Accession Number" which has been used to identify
volumes of submitted studies (see paragraph 4(d)(4) below for further explanation).
In a few cases, entries added to the bibliography late in the review may be preceded
by a nine character temporary identifying number which is also to be used whenever
specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to the Agency, 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 a identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document Date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. WTien the date appears
31
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as (19??), the Agency was unable to determine or estimate the date of the
document.
Title. In some cases, it has been necessary for the Agency's bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
Trailing Parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known submission appears
immediately following the word "received".
(2) Administrative Number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is de-
faulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers'). The final element in the
trailing parentheses identifies the Agency 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.
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00137047 Buckman Laboratories, Inc. (1983) CChemistry: Barium Metaborate
Monohydiate & Others | . (Compilation; unpublished study received Dec 27,
1983 under 1448-17; CDL:252065-A)
00137048 Coate, W.; Zoetis, T.; Hardy, R. (1983) Acute Inhalation Toxicity Study in
Rats—Busan 11-Ml—Project No. 197-178. Final rept. (Unpublished study
received Dec 27, 1983 under 1448-17; prepared by Hazleton Laboratories
America, Inc., submitted by Buckman Laboratories, Inc., Memphis, TN;
CDL:252065-B)
00139192 Raltech Scientific Services, Inc. (1979) Busan 11-M1, Lot No. 47601, Nov.
17, 1978: CAcute Oral LD50/Prim Skin Irritation on Rats &. Rabbits | : Lab.
No. 709240.
00139216 Boynton, B.; Angevine, D. (1979) Acute Dermal Toxicity—Male and Female
Rabbits: CBusan 11-M1 | : RT No. 709240. (Prepared by Raltech Scientific
Services, Inc.).
40898401 Kreuzmann, J. (1988) Delayed Contact Hypersensitivity Study in Guinea Pigs:
Busan 11 Ml: Study No. 88-3288-21. Unpublished study prepared by Hill
Top Biolabs, Inc. 28 p.
42033601 Campbell, S.; Lynn, S. (1991) Busan 11-M1: An Acute Oral Toxicity Study
with the Northern Bobwhite: Lab Project Number: 210/117. Unpublished
study prepared by Wildlife International Ltd. 21 p.
42132601 San, R.; Olson, S. (1991) Salmonella/Mammalian-Microsome Plate
Incorporation Mutagenicity Assay (Ames Test) with a Confirmatory Assay:
Busan 11-M1: Lab Project Number: TA081.501014. Unpublished study
prepared by Microbiological Associates, Inc. 52 p.
42151401 Bigger, C.; Clarke, J. (1991) L5178Y TKCplus | /-Mouse Lymphoma
Mutagenesis Assay with a Confirmatory Assay CBusan 11-M1: Final Report [ :
Lab Project Number: TA081.701020. Unpublished study pre pared by
Microbiological Assoc., Inc. 35 p.
42173701 Siemann, L. (1992) Product Chemistry for Busan 11-M1: Lab Project
Number: 9929-F. Unpublished study prepared by Midwest Research Institute.
42 p.
42207501 Putman, D.; Young, R. (1992) Micronucleus Cytogenetic Assay in Mice: Lab
Project Number: TA081.122. Unpublished study prepared by Microbiological
Associates, Inc. 28 p.
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42310501 Lamb, I. (1992) 28-Day Dietary Range-finding Study of Busan 11-M1 in Rats:
Lab Project Number: WIL-94043. Unpublished study prepared by WIL
Research Labs. Inc. 6 p.
42314301 Drake, K. (1992) Developmental Toxicity Study of Busan 11-M1 in Rabbits:
Lab Project Number: WIL/94042. Unpublished study prepared by Buckman
Laboratories International, Inc. 31 p.
42338601 Lintott, D. (1992) Busan 11-M1: Acute Toxicity to Bluegill, Lepomis
macrochirus, under Static Test Conditions: Lab Project Number: J9107001C.
Unpublished study prepared by Toxikon Environmental Sciences. 47 p.
42338602 Lintott, D. (1992) Busan 11-M1: Acute Toxicity to Rainbow Trout,
Oncorhynchus mykiss, under Static Test Conditions: Lab Project Number:
J9107001D. Unpublished study prepared by Toxikon Environmental Sciences.
47 p.
42338603 Lintott, D. (1992) Busan 11-M1: Acute Toxicity to the Water Flea, Daphnia
magna, under Static Test Conditions: Lab Project Number: J9107001B.
Unpublished study prepared by Toxikon Environmental Sciences. 46 p.
42338701 Cambell, S.; Grimes, J.; Lynn, S. (1992) Busan 11-M1: A Dietary LC50
Study with the Northern Bobwhite: Lab Project Number: 210-115.
Unpublished study prepared by Wildlife International Ltd. 18 p.
42338702 Campbell, S.; Grimes, J.; Lynn, S. (1992) Busan 11-M1: A Dietary LC50
Study with the Mallard: Lab Project Number: 210-116. Unpublished study
prepared by Wildlife International Ltd. 18 p.
42339501 Campbell, S.; Lynn, S. (1992) Busan 11-M1: An Acute Oral Toxicity Study
with the Northern Bobwhite: Lab Project Number: 210-117. Unpublished
study prepared by Wildlife Intl., Ltd. 23 p.
42343601 Lamb, I. (1991) A Range-Finding Acute Study of Busan 11-M1 in Rats:
Audited Draft: Lab Project Number: WIL-94045. Unpublished study prepared
by WIL Research Labs., Inc. 194 p.
42501201 Lamb, I. (1992) A Range-finding Acute Study of Busan 11-M1 in Rats: Final
Report: Lab Project Number: WIL-94045. Unpublished study prepared by
WIL Research Labs, Inc. 192 p.
42546001 Campbell, S.; Lynn, S. (1992) Busan 11-Ml: An Acute Oral Toxicity Study
with the Northern Bobwhite: Amended Final Report: Lab Project Number:
210-117. Unpublished study prepared by Wildlife International Ltd. 35 p.
34
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42546701 Campbell, S.; Grimes, J.; Lynn, S. (1992) Busan 11-M1: A Dietary LC50
Study with the Northern Bobwhite: Amended Final Report: Lab Project
Number: 210-115. Unpublished study prepared by Wilflife International Ltd.
33 p.
42546702 Campbell, S.; Grimes, J.; Lynn, S. (1992) Busan 11-M1: A Dietary LC50
Study with the Mallard: Amended Final Report: Lab Project Number:
210-116. Unpublished study prepared by Wilflife International Ltd. 33 p.
42663401 Drake, K. (1993) Letter Sent to Office of Pesticide Programs dated Feb. 10,
1993: Interim data from a 90 day dietary subchronic/neurotoxicity study:
barium metaborate. Prepared by Buckman Labs., International, Inc. 50 p.
42720501 Lamb, I. (1993) A Range-Finding Developmental Toxicity Study of BUSAN
11-M1 in Rabbits: Final Report: Lab Project Number: WIL-94041.
Unpublished study prepared by WIL Research Laboratories, Inc. 276 p.
42720502 Lamb, I. (1993) A Developmental Toxicity Study of BUSAN 11-M1 in
Rabbits: Final Report: Lab Project Number: WIL-94042. Unpublished study
prepared by WIL Research Laboratories, Inc. 334 p.
42724201 Lamb, I. (1993) A 28-day Dietary Range-finding Study of Busan 11-Ml in
Rats: Final Report: Lab Project Number: WIL-94043. Unpublished study
prepared by WIL Research Labs, Inc. 381 p.
42734701 Lamb, I. (1993) An Acute Neurotoxicity Study of Busan 11-M1 in Rats: Final
Report: Lab Project Number: WIL-94038. Unpublished study prepared by
WIL Research Laboratories, Inc. 1096 p.
42747801 Lamb, I. (1993) A Combined Oral Subchronic (13 Week) Toxicity and
Neurotoxicity Study of Busan 11-M1 in Rats: Final Report: Lab Project
Number: WIL-94044. Unpublished study prepared by WIL Research
Laboratories, Inc. 1253 p.
42873201 Martin, T.; Drake, K. (1993) Supplemental Data to Mouse Lymphoma Assay
with Busan 11-M1 (MRID No. 42151401) Analysis of Dosing Solutions.
Unpublished study prepared by Buckman Laboratories International, Inc. 22
P-
35
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APPENDIX D
LIST OF AVAILABLE DOCUMENTS
37
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APPENDIX D
The following is a list of available documents related to barium metaborate. Its
purpose is to provide a path to more detailed information if it is requried. These
accompanying documents are part of the Administrative Record for Barium Metaborate and
are included in the Agency's Office of Pesticide Programs Public Docket.
1. Health and Environmental Science Chapters
2. Detailed Label Usage Information System (LUIS) Reports
3. Barium Metaborate Fact Sheet (included in this RED)
4. PR Notice 91-2 pertains to the Label Ingredient Statement
Federal publications on barium metaborate are available and may be purchased from
the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA
22161.
1. Guidance for the Reregistration of Pesticide Products Containing Barium
Metaborate as the Active Ingredient: NTIS tt PB84-168376
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APPENDIX E
Instructions for Responding to the RED and
Instructions for the Confidential Statement of Formula
39
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (BCD OR "90-DAY RESPONSE"~If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. Complete the
two response forms provided with each DCI letter by following the instructions contained in
each DCI. You must submit the response forms for each product and for each DCI
within 90 days of the date of this letter (RED issuance date); otherwise, your product
may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS—No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only
with respect to actual data submissions. Requests for data waivers must be submitted as part
of the 90-day response. Requests for time extensions should be submitted in the 90-day
response, but certainly no later than the 8-month response date. All data waiver and time
extension requests must be accompanied by a full justification. All waivers and time
extensions must be granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current
regulations and requirements. Only make labeling changes which are required by the RED
and current regulations (40 CFR 156.10) and policies. Submit any other amendments (such
as formulation changes, or labeling changes not related to reregistration) separately. You
may delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National
Technical Information Service, publication #PB92-221811; 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
40
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concentration. You have two options for submitting a CSF: (1) accept the standard
certified limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by
the analysis of five batches. If you choose the second option, you must submit or cite the
data for the five batches along with a certification statement as described in 40 CFR
§158.175(e). A copy of the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Citation of Data. Complete and sign this form
(EPA form 8570-29) for each product. Cite-all is not a valid option for reregistration.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
Bv U.S. Mail:
Document Processing Desk (RED-SRRD-PRB-XXXX) *
(XXXX = the case code for the RED)
Office of Pesticide Programs (H7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
Bv express:
Document Processing Desk (RED-SRRD-PRB-XXXX)*
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are
not complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
41
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INSTRUCTIONS FOR THE CONFIDENTIAL STATEMENT OF FORMULA
Two copies of the Confidential Statement of Formula (CSF) (EPA Form 8570-4) are
required to be signed and completed for each basic and each alternate formulation. When
new CSFs are submitted and approved, all previously submitted CSFs become obsolete for
that specific formulation.
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product-specific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source product's
label.
j. All the weights in columns 13.a. must be in pounds, kilograms, or grams. In no
case will volumes be accepted. Do not mix English and metric system units (i.e.,
pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
m. The lower certified limits in pure active forms must not fall below the efficacious
level per P.R. Notice 91-2.
42
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n. The upper and lower certified limits for all 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.
43
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APPENDIX F
Product Specific Data Call-In
45
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£% \ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
^$02. ? WASHINGTON, D.C. 20460
feC^
DATA CALL-IN NOTICE « c fiQA
# M 25 w
OFFICE OF
PREVENTION, PESTICIDES AND
. TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your product(s) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section m 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
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
(expiration date 3-31-96).
47
Recycled/Recydabto
r\ Primed with Soy/Canota Ink on paper tfiaj
XJC7 contains tf least 50% recycled fiber
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This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - 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:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
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You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will satisfy
the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for complying
with data requirements when the studies were not conducted in accordance with acceptable
standards. The OECD protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(W2^re> NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of anv previous Data Call-InCs). 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 III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
49
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III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is presented
below. A discussion of the various options available for satisfying the product specific data
requirements of this Notice is contained in Section m-C. A discussion of options relating to
requests for data waivers is contained in Section m-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form. Attachment 2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to this
Notice. In addition, one copy of the Requirements Status and Registrant's Response Form must
be submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-in Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do not
alter the printed material. If you have questions or need assistance in preparing your response, call
or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions
of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options 1 through 6 on the Requirements
Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response
Form. Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements.
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3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the product
specific data requirements (i.e. you select item number 7a or 7b), then you must select one of the
six options on the Requirements Status and Registrant's Response Form related to data production
for each data requirement. Your option selection should be entered under item number 9,
"Registrant Response." The six options related to data production are the first six options discussed
under item 9 in the instructions for completing the Requirements Status and Registrant's Response
Form. These six options are listed immediately below with information in parentheses to guide
registrants to additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an 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
51
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including alternative dates for meeting such requirements on a step-by-step basis. You must explain
any technical or laboratory difficulties and provide documentation from the laboratory performing
the testing. While EPA is considering your request, the original deadline remains. The Agency
will respond to your request in writing. If EPA does not grant your request, the original deadline
remains. Normally, extensions can be requested only in cases of extraordinary testing problems
beyond the expectation or control of the registrant. Extensions will not be given in submitting the
90-day responses. Extensions will not be considered if the request for extension is not made in a
timely fashion; in no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data - Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
data tables that your product and at least one other product are similar for purposes of depending
on the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted in
the agreement to cost share by the registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data. You must
also provide EPA with documentary evidence that an agreement has been formed. Such evidence
may be your letter offering to join in an agreement and the other registrant's acceptance of your
offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development -- This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has in good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share in the burden
of developing that data. You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data, Attachment 7. In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to
anything else, offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must
not qualify this offer. The other registrant must also inform EPA of its election of an option to
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develop and submit the data required by this Notice by submitting a Data Call-In Response Form
and a Requirements Status and Registrant's Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4. Submitting an Existing Study -- If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to
be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements
of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in
40 CFR 160.3(j) M '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
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requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the
Agency for consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the
Agency's policy regarding acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG are met by the study,
clearly articulate the rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data are usually not available for such
studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study -- If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must
satisfy or supply information to correct all deficiencies in the study identified by EPA. You must
provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
why the study should be rated as acceptable to EPA. Your submission must also specify the MRID
numbers) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.
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Do not submit additional data for the purpose of upgrading a study classified as unacceptable
and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRD number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those criteria
as well as a certification regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies - If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you wish
to select this option you must provide the MRID number of the study you are citing and, if the
study has been reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical reasons,
data and references to relevant EPA regulations, guidelines or policies. (Note: any supplemental
data must be submitted in the format required by PR Notice 86-5). This will be the only
opportunity to state the reasons or provide information in support of your request. If the Agency
approves your waiver request, you will not be required to supply the data pursuant to section
3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an option for
meeting the data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the Requirements Status and Registrant's
Response Form. Product specific data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products and the Agency would grant a waiver only
under extraordinary circumstances. You should also be aware that submitting a waiver request will
not automatically extend the due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in force.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure
of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-In Response Form and a Requirements Status and Registrant's
Response Form:
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
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Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary
report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing "stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
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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.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Registration Division
Attachments
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report Form
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Attachment 1. Chemical Status Sheet
61
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BARIUM METABORATE: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing barium metaborate.
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
barium metaborate. This attachment is to be used in conjunction with (1) the Product Specific
Data Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3)
the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Product Specific Data
Call-in (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for barium metaborate
are contained in the Requirements Status and Registrant's Response. Attachment 3. The
Agency has concluded that additional data on barium metaborate 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 barium metaborate
products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Mr. Franklin Gee at (703) 308-8008.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Mr. C. P. Moran
Special Review and Reregistration Division (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Barium Metaborate
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes". If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the
Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA reregistration numbers of your source (s); you would not complete the
requirements status and registrant's response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." if you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option
7 (Waiver Request) for each study for which you are requesting a waiver. See item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
Note:You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another that you have already voluntarily cancelled this product.
For these cases, please supply all relevant details so that EPA can ensure that its records
are correct.
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SAMPLE
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
For* Approved
0MB No. 2070-0107
2070-0057
Approval Expires 03-31-96
INSTRUCTIONS: Please type or print In Ink. Please read carefully the attached Instructions and supply the Information requested on this for*.
Use additional sheet(s) If necessary.
1. Company name and Address
BUCKMAN LABS INC
1256 MCLEAN BLVD
MEMPHIS TN 38108
2. Case # and Name
0632 Barium metaborate
3. Data and Type of DCI
PRODUCT SPECIFIC
JAN 2 5 1994
0
4. EPA Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
7. Product Specific Data
6a. I am claimimg a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a. My product is • HUP and
1 agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product Is an EUP and
1 agree to satisfy the EUP
requirements on the attached
for* entitled "RequlraiaanU
Status and Registrant's
Response."
1448-105
N.A.
N.A.
8. Certification
1 certify that the statements made on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Sianature and Title of Ccnoanv's Authorized Reoresentatlve
9. Date
10. Name of Company Contact
11. Phone Nunber
fe>7
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3. Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. The guidelines reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart c.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/ or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed 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).
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I understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-In Notice that my
product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that data. I am also submitting a
completed " Certification of offer to Cost Share in the Development Data" form.
I am including a copy of my offer and proof of the other registrant's receipt of that
offer. I am identifying the party which is committing to submit or provide the
require data; if the required study is not submitted on time, my product may be
subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section III-C.l.) apply as well.
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in option 4 in the Data Call-In Notice (Section III-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify that
I have determined that this study will fill the data requirement for which I have
indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (upgrading a study).
I will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study). If I am citing another registrant's study,
I understand that this option is available only for acute toxicity or certain efficacy
data and only if the cited study was conducted on my product, an identical product
or a product which EPA has "grouped" with one or more other products for
purposes of depending on the same data. I may also choose this option if I am citing
my own data. In either case, I will provide the MRID or Accession number (s)
number (s) for the cited data on a "Product Specific Data Report" form or in a
similar format. If I cite another registratrant's data, I will submit a completed
"Certification With Respect To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must be submitted in the format required by
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request. If the Agency approves my waiver
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request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
FIFRA. If the Agency denies my waiver request, I must choose a method of
meeting the data requirements of this Notice by the due date stated by this Notice.
In this case, I must, within 30 days of my receipt of the Agency's written decision,
submit a revised "Requirements Status chosen. I also understand that the deadline
for submission of data as specified by the original data cal-in notice will not change.
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your product has
already been transferred to another company or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure that its records
are correct.
73
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SAMPLK
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
For* Approved
ONB No. 2070-0107
2070-0057
Approval Expire* 03-31-96
INSTRUCTIONS: Please type or print In ink. Please read carefully the attached instructions and supply the Information requested on thla form.
Use additional sheet(s) if necessary.
1. Company name and Address
BUCKMAN LABS INC
1256 MCLEAN BLVD
MEMPHIS TN 38108
2. Case # and Name
0632 Barium metaborate
EPA Reg. No. 1448-105
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# "jwTPS'SM
•
4. Guideline
Requirement
Nuiiber
5. Study Title
1
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
1
2
3
61-1
61-2(a)
61-2(b)
62-1
62-2
62-3
63-2
63-3
63-4
63-7
63-11
Prod Chen - Regular Chastest
Product identity ft conposltion (1)
Oeserlptn starting materials, .• V\v«(Kr>5
<- •. *
10. Certification
1 certify that the statements made on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, inprisorment
or both under applicable law.
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company Contact
13. Phone Nuifcer
75
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SAMPLE
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
For* Approved
0MB No. 2070-0107
2070-0057
Approval Expires 03*31*96
INSTRUCTIONS: Please type or print In ink. Please read carefully the attached Instructions and supply the Information requested on this form.
Use additional sheet(s) If necessary.
1. Company name and Address
BUCKMAN LABS INC
1256 MCLEAN BLVD
MEMPHIS TN 38108
Case # and Name
0632 Barium metaborate
EPA Reg. No. 1448-105
3. Date and Type of DCI
PRODUCT SPECIFIC
ID' i44gAT«3i&i
4. Guideline
5. Sturfy Title
Progress
6. Use
7. Test
8. Time
9. Registrant
Requlrement
Reports
Pattern
Substance
Frame
Response
Number
f
1
2
3
63-12
pH
<*>
ABCDEFGHIJKLMNO
MP/EP
6 mos.
¦¦
63-13
StabiIIty
ABCDEFGHIJKLMNO
MP
8 mos.
63-14
Oxidising or reducing action
<10)
ABCDEFGHIJKLMNO
MP/fiP
;
63-15
Flanmabillty
(11)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-16
Explodablllty
(12)
ABCDlPGHlJKtHKd
MP/fiPs '
6 taoa»
ilMOT
63-17
Storage stability
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-18
Viscosity .
(13)
ABCDEFGHlJKLMNG
MP/EP ~—r>
*-B mos .
63-19
Mtrfcibflity
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SAMPLE
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case / and Name: 0632 Barium metaborate
Key: MP ¦ manufacturing-use product; EP ¦ end-use product; provided formulatora purchase their active Ingredlent(a) from a registered source, they need not submit or cite
data pertaining to the purchased product.(NOTE: If a product Is a 100 percent repackage of another registered product that Is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements Identified In the tables.]; TEP ¦ typical end-use product;
TGA1 ¦ technical grade of the active Ingredient; PAI ¦ "pure" active Ingredient; PAIRA « "pure" active Ingredient, radiolabeled.
Us* Categories Key:
A - Terrestrial food crop 8 • Terrestrial food feed crop C - Terrestrial nonfood crop 0 - Asiatic food crop E - Aquatic nonfood outdoor
f - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced In colum two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE for*.]
Prod Chem - Regular Chemical
1 Requirements pertaining to product identity, composition, analysis, and certification of Ingredients are detailed further In the following sections! *158.1SS for
product Identity and composition (61-1); *158.160, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); *158.167 for
discussion of formation of Impurities (61-3); *158.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice If the pesticide la not already under full scale production and an experimental
use permit Is being sought.
3 If the pesticide Is not already under full scale production and an experimental use permit Is sought, a discussion of unintentional Ingredient* shall be submitted to
the extent this Information Is available.
4 To support registration of an MP or EP, whether produced by an Integrated system or not, the technical grade of Active Ingredient must be analysed. If the technical
grade of Active Ingredient cannot be Isolated, a statement of conposltlon of the practical equivalent of tha technical grade of Active Ingredient must be submitted.
Dete on EPs or MPs will be required on a case-by-case basis.
5 Certified limits are not required for Inert Ingredients In products proposed for experimental use.
8 Required If technical chemical Is organic and non-polar.
9 Required If test substences ere dlsperslble with water.
10 Required If product contains an oxidizing or reducing agent.
11 Required If product contains combustible liquids.
12 Required If product Is potentlelly explosive.
13 Required If product Is a liquid.
14 Required If product Is an emulslflable liquid and Is to be diluted with petroleu* solvents.
15 Required If end-use product Is liquid and Is to be used around electrical equipment.
Acute Toxic - Regular Chemical
1 Not required If test materiel Is a gas or highly volatile.
2 Not required If test material Is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
of potential eye and dermal Irritation effects.
3 Required If the product consists of, or under conditions of use will result In, an inhalable material (e. g., gas, volatile siiiatance*, or aerosol/pertlculate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
77
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SAMPLE
Page 2 of 2
United States Environmental Protection Agency
Washington, D. c. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0632 Barium metaborate
Footnotes (cont.):
36 Special testing (acute, subchronlc, and/or chronic) la required for organophospates, and may be required for other chotfnesterase Inhibitors and other pesticides
which have demonstrated a potential to adversely affect the visual system. Registrants should consult with the agency for development of protocols and methodology
prior to Initiation of studies.
37 Testing of the EP dilution Is required If It can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
applicators specified In 40 CFR 152.170(b) or the criteria for Initiation of special review specified In 40 CFR 154.7 (a)(1).
78
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
79
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EPA'S BATCHING OF BARIUM METABORATE PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing the active ingredient
barium metaborate, the Agency has batched products which can be considered similar for
purposes of acute toxicity. Factors considered in the sorting process include each product's
active and inert ingredients (identity, percent composition and biological activity), type of
formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially similar" since some products within
a batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described
in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see acceptance
criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity,
and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than
one confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant
supplies the data to support a batch of products, he/she must select one of the following options:
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
81
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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.
The table below shows the three products which were batched together.
BATCH NO.
EPA REG. NO.
% of Barium Melaborate
Formulation Type
1
1448-105
52.00% - Barium Metaborate
Ready-to-Use Solution
1448-106
50.00% - Barium Metaborate
Ready-to-Use Solution
1448-17
90.00% - Barium Metaborate
Soluble Concentrate
82
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ATTACHMENT 6 - LIST OF ALI, REGISTRANTS SENT THIS DCI
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
LIST OP ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0632 Barium metaborate
Co. Nr. Company Name Additional Name Address City & State Zip
001448 BUCKMAN LABS INC
1256 MCLEAN BLVD
MEMPHIS TN
36108
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SEPA
United States Environmental
Washington, OC
CERTIFICATION WITH
DATA COMPENSATION
Protection
20460
Agtney Form Appro***
RESPECT TO
REQUIREMENTS
OtIB No. 3070-0107
J070-00S7
AMrtvil Explr** 3-Sl-M
Pub Be reporting burden tor this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect o1 this collection of information, induting suggestions for reducing this burden, to Chief, Information Policy
Branch. PM-223, U.S. Environmental Protection Agency. 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please All in blanks below.
Company Item*
Company Number
Chemical Mam*
EPA Chemical Number
I Certify that:
1. For each study cited in support of registration or registration under the Federal insecticide. Fungicide and
Rodenticide Ad (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to ette that study.
2. That for each study dted in support of registration or ^registration under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter, or I
have notified m writing the oompany(ies) that submitted data l have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(c)(1)(D) and 3(c)(2)(D) of FIFRA: and (b) Commence
negotiation to determine which data are subject to the compensation requirement ot FIFRA and the amount of
compensation due, if any. The companies I have notified are: (check one)
(] All companies on the data submitters' fist for the active ingredient listed on this form (Cite-All
Method or Cite-All Option under the Selective Method). (Also sign the General Offer to Pay
below.)
[ ] The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form,"
3. That l have previously complied with section 3(c)(i )(D) of FIFRA for the studies l have cited in support of
registration or ^registration under FIFRA.
Signature
Oat*
Nam* and Till* (Mom* Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or ^registration of my products, to the extent required by FIFRA sections 3(c)(1)(D) and 3(c)(2)(D).
Slgnatur*
Oat*
Nam* and Title (Picas* Typ* or Print)
EPA Form SS70>31 (4*90)
-------
United States Environmental Protection Agency
gfr Jt Washington, DC 20460
CERTIFICATION OF OFFER TO COST
^#BhbI share in the development of data
Fm
out Mo. 8070-0107
2070-0057
Approval txplfM S-3X-M
PubBc reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the needed, and
completing and reviewing the collection of information. Send comments regarding the burden estipiate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please flfl In blanks below.
Company Htm*
Company Number
Chemical Nam*
EPA Chemical Number
I Certify that:
My company is willing to develp and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), If necessary. However, my oompany would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA If final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Nun* el Rnn(s)
Date ot Otter
Certification'
1 certify that 1 am duly authorized to represent the oompany name above, and that the statements that 1 have made on
this form and all attachments therein are true, accurate, and complete. 1 acknowledge that any knowingly false or
misleading tiatement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Repreaentatlve
Oaie
Nam* and Title (Pteaae Type or Print)
EPA Fana SC70-32 (Mt) Replaces EPA Form UK4, which la obeoleta
-------
REPORT DOCUMENTATION >- "tPO,rr *¦
PAGE
3.
4. THU and SubtKt*
Reregistration Eligibility Document (RED) - O 4 i" i J
V\ b 6> f
%. Alport Oat*
Dec. 1 *7 3
4-
7. Authorti)
EPA, Office of Pesticide Proarams. Special Review & FeRea. Div.
«. Parformirif OrgjnJtattOA Rapt. No
£PAn3t
V. P«Hormlog Organiiation Nam* and Addrata
U.S. Environmental Protection Agency
Offioe of Pesticide Programs
Special Review and Reregistration Division
401 M Street, S.W.
Washington, D.C. 20460
10. Protoct/Tatk/Wsrii Unrt No.
11. CwitiacUC) or Grant(G) No.
(O
IG)
12. Sponioftnc Organisation Nam« and AMmi
same as #9
1L Type of ftapert 4 ^arlod rmrarart
14.
IS. Suppl«m«M»ry Hot**
14. Ab«tr»ct (Umtt. 100 worm)
EPA is directed by the Federal Insecticide, Fungicide, and
Rodenticide Act as amended in 1988 (FIFRA *88) to review all
pesticide products containing active ingredients initially
registered before November 1, 1984, and to reregister those
products that have a substantially complete data base and do not
pose unreasonable adverse effects to people or the environment.'-
This pesticide reregistration program is to be completed by the
late 1990's.
The Reregistration Eligibility Document (or RED) discusses ;
the scientific data and other information supporting EPA's j
regulatory conclusion that products containing a pesticide do not
pose unreasonable risks when used as directed by Agency-approved
labeling, and are eligible for reregistration.
17. Oocumom Analyvlt a. DMcrtptort
Pesticides, standards regulations, manufacturing, chemistry, toxicology,
residues, ecology, path of pollutants.
b. idintlfWn/OpiA^Adtd T«rmi
C. COSAT1 Ftald/Grovp
11. Availability tUHnwn
Publicly Available
)i Security Clats (Thra fitpoH)
unclassified
21. No. o< Pi|"
to
20. Sacu'lty Cla» (Thl> Piji)
unclassified
22. Prica
(Sa* ANSI-ZJ918) $*« lfl|!/vcNooi on Aavarp* OPTIONAL FORM 272 (4-77)
(formerly NTIS-3S)
Dapartmant of Commt
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