United States Prevention, Pesticides EPA 738-R-94-026
Environmental Protection And Toxic Substances September 1994
Agency (7508W)
&EPA1 Reregistration
Eligibility Decision (RED)
2,2-dibromo-3-
nitrilopropionamide
(DBNPA) 738R94026
Sri.
Recycled/Recyclable
Printed with Soy/Canola Ink on paper that
contains at toast 50% recycled fiber
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1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
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 covering the
active ingredient 2,2-dibromo-3-nitrilopropionamide (DBNPA). 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 regarding conditions under which these uses and products will be
eligible for reregistration. The RED includes the data and labeling requirements for products
for reregistration.
From its assessment of DBNPA the Agency has concluded that one use—single
flow-through cooling towers, presents an unreasonable adverse risk to aquatic organisms.
Products labeled with this use are therefore ineligible for reregistration. The Agency plans to
take regulatory action against continued.registration of DBNPA products for this use.
Nevertheless, registrants of such products are required to comply with labeling and data
requirements as described in the enclosed document.
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.
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 represei
Franklin Gee at (703) 308-8008. ^
is P/True, Jr., Acting Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) 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. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER 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 to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
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limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S 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.
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REREGISTRATION ELIGIBILITY DECISION
2,2-dibromo-3-nitrilopropionamide (DBNPA)
LISTC
CASE 3056
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
2,2-DIBROMO-3-NITRILOPROPIONAMIDE (DBNPA) REREGISTRATION
ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Regulatory History 5
m. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment 6
B. Human Health Assessment 7
1. Toxicology Assessment 7
a. Acute Toxicity 7
b. Subchronic Toxicity 8
c. Developmental Toxicity 8
d. Mutagenicity 9
e. Other Toxic Endpoints 9
2. Exposure Assessment 9
a. Dietary Exposure 9
b. Occupational and Residential 9
3. Risk Assessment 12
a. Dietary 12
b. Occupational and Residential 12
C. Environmental Assessment 13
1. Environmental Fate 13
a. Environmental Chemistry, Fate and Transport 13
b. Environmental Fate Assessment 15
2. Ecological Effects 16
a. Ecological Effects Data 16
(1) Terrestrial Data 16
(2) Aquatic Data 17
b. Ecological Effects Risk Assessment 18
3. Mitigation of Risk to Aquatic Organisms 21
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 22
A. Determination of Eligibility 22
B. Eligibility Decision 23
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C. Regulatory Position 23
1. Secondary Biological Effluent Treatment Statement 23
2. Endangered Species Statement 24
3. Risk Mitigation to Handlers 24
V. ACTIONS REQUIRED BY REGISTRANTS 25
A. Manufacturing-Use Products 25
1. Additional Generic Data Requirements 25
2. Labeling Requirements for Manufacturing-Use Products 25
B. End-Use Products 28
1. Additional Product-Specific Data Requirements 28
2. Labeling Requirements for End-Use Products 28
C. Existing Stocks 29
VI. APPENDICES 31
APPENDIX A. Table of Use Patterns Subject to Registration ' . . 33
APPENDIX B. Table of the Generic Data Requirements and Studies Used to Make
the Reregistration Decision 51
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of DBNPA 61
APPENDIX D. List of Available Related Documents '.'.'/.'.'.'.'.'' 73
APPENDIX E. PR Notices 86-5 and 91-2 ',[ 77
PR Notice 86-5 79
PR Notice 91-2 97
APPENDIX F. Product Specific Data Call-in '.'.'.'.'103
Attachment 1. Chemical Status Sheet 115
Attachment 2. Product Specific Data Call-In Response Forms (Form A
inserts) Plus Instructions 117
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 123
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 127
Attachment 5. EPA Acceptance Criteria 133
Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
147
Attachment 7. Cost Share Data Compensation Forms, Confidential State-
ment of Formula Form and Instructions 149
APPENDIX G FACT SHEET ! ] ] 159
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2,2-DIBROMO-3-NITRILOPROPIONAMIDE
ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
(DBNPA) REREGISTRATION
Rafael A. Prieto
Frank Hernandez
Phyllis Johnson
Robert Torla
Environmental Fate and Effects Division
Brian Montague
Kevin Poff
David Jones
Jean Holmes
Health Effects Division
Flora Chow
Nguyen Thoa
Pat McLaughlin
Winston Dang
Registration Division
Bipin Gandhi
Robert Travaglini
Van Seabaugh
Special Review and Reregistration Division
Richard Gebken
Bruce Sidwell
Carol Stangel
Office of Enforcement and Compliance
Victoria Mattison
Biological Analysis Branch
Economic Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Science Analysis and Coordination Staff
Chemical Coordination Branch
Chemical Coordination Branch
Toxicology Branch II
Occupational and Residential Exposure Branch
Registration Support Branch
Antimicrobial Program Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Product Reregistration Branch
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Office of General Counsel:
Pesticides and Toxic Substances Division
Kevin Lee Pesticides Branch
Office of Water:
Permits Division
Donna Reed Water Quality and Industrial Permits Branch
Office of Pesticides and Toxic Substances:
Sidney Abel
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
(»
a.i. Active Ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated pesticide concentration in
an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually expressed
as the weight of substance per weight or volume of water, air or feed, e.g., mg/1,
mg/kg or ppm.
LD50 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.
LD,0 Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOEL Lowest Observed Effect Level
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
in
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MOE
MRID
N/A
NPDES
NOEL
OPP
ppm
RED
TD
TC
TGAI
GLOSSARY OF TERMS AND ABBREVIATIONS
Margin Of Exposure
Master Record Identification (number). The EPA's system of recording and
tracking studies submitted.
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
Parts Per Million
Reregistration Eligibility Decision
Toxic Dose. The dose at which a substance produces a toxic effect.
Toxic Concentration. The concentration at which a substance produces a toxic
effect.
Technical Grade Active Ingredient
IV
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EXECUTIVE SUMMARY
This Reregistration Eligibility Decision (RED) addresses pesticide uses of 2,2-dibromo-3-
nitrilopropionamide (DBNPA). Products containing this active ingredient are used to control
microorganisms including algae, bacteria, and fungi in various industrial processes.
The Agency has completed its review of the target database for DBNPA and has concluded
that most uses of DBNPA as labeled and used as specified in this Reregistration Eligibility
Decision will not pose unreasonable risks or adverse effects to humans or the environment.
However, because the risk to non-target aquatic organisms from the discharge of industrial
effluent containing DBNPA outweighs the potential benefits of the pesticidal use of DBNPA in
single flow-through cooling towers, the Agency has concluded that this use is ineligible for
reregistration. The Agency intends to take appropriate regulatory steps to adequately address the
potential risk of this use.
After evaluation of all available ecotoxicological and environmental data and subsequent
consultation with the Agency's Offices (Office of Water and the Office of Toxic Substances), it
was determined that aquatic risk concerns for all currently registered uses except single flow-
through cooling systems may be adequately mitigated by secondary biological treatment of
industrial effluent. Ecotoxicological and environmental fate data indicate that DBNPA degrades
rapidly by anaerobic and aerobic aquatic metabolism into less toxic degradates. Secondary
biological treatment is required for all aquatic industrial uses except, 1) waste water treatment
systems, 2) secondary oil recovery systems, and 3) single flow-through cooling tower systems
(ineligible for reregistration). Biological treatment is not required for waste water treatment
systems because biological degradation readily occurs in these systems. Although secondary
biological treatment is not feasible for secondary oil recovery systems, an evaluation of the
secondary oil recovery use pattern as it relates to DBNPA sufficiently reduces the Agency's
concern with this use pattern. However, aquatic risk concerns for the single flow-through cooling
system use of DBNPA cannot be mitigated. Single flow-through cooling systems represent a
direct surface water discharge situation and a potential adverse risk to aquatic species remains.
Additionally, the Agency has a concern for the potential effect of DBNPA on human
developmental toxicity. In an oral developmental toxicity study in rabbits, DBNPA was observed
to produce fetal structural alterations at a dose (30 mg/kg/day) which was not maternally toxic.
The NOEL for developmental effects was 10 mg/kg/day and the maternal NOEL was 30
mg/kg/day. There is a potential for mixer/loader/applicator exposure from use. Margin of
Exposures (MOE) are acceptable (greater than 100) for all uses regulated by the EPA except one,
that of the handler using an open pouring method to add DBNPA to cooling towers (MOE = 28).
The Agency is therefore requiring use of personal protective equipment for open pouring for
recirculating cooling water tower uses. The potential for post-application acute exposure is
minimal. A food tolerance has been established for DBNPA for food contact with food grade
paper and paperboard (21 CFR 176.300). The use of DBNPA for this purpose is regulated under
the-jurisdiction of the U.S. Food and Drug Administration.
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The Agency is requiring that product specific data, revised Confidential Statements of
Formula (CSF) and revised labeling be submitted within eight months of the issuance of this
document for all products containing DBNPA. These data include product chemistry for each
registration and acute toxicity testing. After reviewing these data and any revised labels and
finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister
a product. However, those products which bear uses of this or any other active ingredients which
have not been determined to be eligible for reregistration will be registered only when such uses
and active ingredients are determined to be eligible for reregistration.
VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific database underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of 2,2-dibromo-3-nitrilopropionamide (DBNPA). The document consists of
six sections. Section I is the introduction. Section II describes DBNPA, 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 DBNPA. Section V discusses the reregistration requirements for DBNPA. Finally,
Section VI is the Appendices which support this Reregistration Eligibility Decision. Additional
details concerning the Agency's review of applicable data are available on request.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
• Common Name: DBNPA
• Chemical Name: 2,2-dibromo-3-nitrilopropionamide
• Chemical Family: Dibromo-3-nitrilopropionamide
• CAS Registry Number: 10222-01-2
• OPP Chemical Code: 101801
• Empirical Formula: C3H2Br2N2O
• Molecular Weight: 242
• Trade and Other Names: DBNPA
Slimicide 508
XD-7287L Antimicrobial
XD-1603
2,2-dibromo-2-carbamoylacetonitrile
2,2-dibromo-2-cyano-acetamide
• Basic Manufacturers: Dow Chemical Company
Ameribrom, Inc
B. Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of these uses of DBNPA is in
Appendix A.
Type of Pesticide: Algicide, bactericide and fungicide (slime-forming algae,
bacteria and fungi); preservative (additive); fungicide (mold and
mildew).
Use Sites: AQUATIC NON-FOOD INDUSTRIAL:
* pulp, paper and paperboard mill water systems
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*• air washer water systems
> commercial/industrial water cooling systems (single flow-
through cooling tower systems and recirculating cooling
tower systems): influent systems, flow through filters,
cooling ponds, canals and lagoons
> evaporative condenser water systems
*• secondary oil recovery injection water, underground
flood water, non-marine underground flood water
>• sewage systems
* heat exchanger water systems
»• industrial auxiliary water systems
»• laboratory equipment water baths
»• industrial scrubbing systems
INDOOR NON-FOOD
»• pasteurizer/warmer/cannery cooling water systems,
brewery pasteurizers
»• industrial adhesives, animal glues
> industrial and paper mill coatings
»• metalworking cutting fluids
*• oil recovery drilling muds, packer fluids and gypsum
mud
*• latex paints (in-can)
> paper/paper products
* resin/latex/polymer emulsions: emulsions, polymers and
defoamers
+ latex/oil/varnish paints (applied film)
> specialty industrial products (waxes, polishes and ink)
*• wet-end additives/industrial (pigment slurries and sizing)
INDOOR FOOD
»• food packaging (regulated by FDA)
Target Pests: Coliform bacteria; slime-forming and odor-causing algae,
bacteria and fungi; yeasts; sulfide producing bacteria (enhanced
oil recovery)
Formulation Types TYPE:
Registered:
End-use, manufacturing use
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FORM:
Tablets, solid soluble concentrate, liquid soluble concentrate.
Method and Rates of
Application:
Aquatic non-food Water treatment, water recirculating system treatment, water
industrial: once-through system treatment.
Indoor non-food:
Equipment:
Timing:
Water treatment, water recirculating system treatment, industrial
preservative treatment (added during manufacture), preservative
treatment.
Metering pump and not specified.
Intermittent (slug initial and subsequent), continuous feed (initial
and subsequent), during manufacture (industrial preservative
treatment) and not specified.
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Table 1: Rates of Application
t*^IH!*^" <
Pulp/paper mills
Air washers
Cooling water systems
Evaporative condensers
Heat exchangers
Lab equipment (water bath)
Scrubbing system
Oil recovery injection water
s u^^^^^^^K^^^ lad^r%eb*i
Preservative uses:
Industrial adhesives; Industrial coatings; Metalworking
cutting fluids; Latex/oil/varnish paints (applied film);
Paper/paper products; Specialty industrial products; Wet-
end additives /industrial (processing chemicals)
Industrial preservative uses:
Industrial adhesives; Industrial coatings;
Resin/latex/polymer emulsions; Metalworking cutting
fluids; Oil recovery drilling (muds/packer fluids); Latex
paints (in-can); Latex/oil/varnish paints (applied film).;
Specialty industrial products; Wet-end additives/industrial
(processing chemicals)
2 to 200 ppm of active ingredient by weight
less than 1 ppm of active ingredient by volume
to 24 ppm by weight
less than 1 ppm of active ingredient by volume
to 24 ppm by weight
6 ppm of active ingredient by volume to 24 ppm
by weight
7 to 24 ppm of active ingredient by weight
20 ppm by weight
6 ppm of active ingredient by weight to 24 ppm
by weight
less than 1 ppm of active ingredient by volume
to 100 ppm by weight
owTT^^V w>^;;;^$bj,.
20 to 2000 ppm of active ingredient by weight
10 to 2000 ppm of active ingredient by weight
Use Practice Limitations:
An NPDES permit is required for discharges to waterways.
C. Regulatory History
Pesticide products containing DBNPA as an active ingredient were first registered
in the United States in 1972 as a microbicide. There are currently 44 products registered
by the EPA to 27 companies containing DBNPA as an active ingredient. There is also
one Special Local Need, FIFRA 24(c) registration for this chemical's use in Missouri to
control bacteria in a specified industrial water system.
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m. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
• Chemical name 2,2-Dibromo-3-nitrilopropionamide
Br
Chemical Structure: N-C-C-C
Color
Physical State
Odor
Melting point
Boiling point
Density
Solubility at 25° C.
Vapor Pressure
Octanol/Water
Partition Coefficient
pH at 25°C
Oxidizing or Reducing
Reaction
Flammability
Br NH2
white to "off white" color
crystalline solid
mild "medicinal antiseptic"
123-126° C.
decomposes at 190° C.
2.375 at 21° C., 0.934-1.370 g/ml.
Solvent Solubility gms/lOOml
Acetone 35
Ethanol 25
Water 1.5
9.0 X ID'4 mm @ 25°C
Kow 6.24 ±0.173 at pH 5.0
K^ 6.31 ±0.075 at pH 7.0
Kow 6.61 ±0.126 at pH 9.0
6.61 in 0.01% aqueous solution
Incompatible with bases, reducing substances
and nucleophiles
Cannot support combustion
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Explodability
Storage Stability
Non-explosive, non combustible
Stable under normal conditions, decomposition
accelerated by light and heat
Corrosion Characteristics Corrosive to mild steel, iron and aluminum
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base for DBNPA is adequate and will support
reregistration eligibility as a non-food use pesticide. The data are reported below.
a. Acute Toxicity
Acute toxicology on DBNPA are summarized below.
Table 2; Acute toxicity values for DBNPA.
--- -"- •• "met
(81-1) Oral LDM- rat
(81-2) Dermal ID,, - rabbit
(81-3) Inhalation LCM - rat
(81-4) Eye Irritation - rabbit
(81-5) Skin Irritation - rabbit
(81-6) Dermal sensitization - guinea pig
RESOLT
235 mg/kg (M); 178 mg/kg (F)
>2g/kg
0.32 mg/L
corrosive
moderate dermal irritant
a weak dermal sensitizer
CATEGORY
n
m
n
i
m
N/A
Acute oral toxicity studies resulted in an LD50 of 235 mg/kg for
male rats and 178 mg/kg for females (MRID# 00136724). The LD50 for
female guinea pigs was 118 mg/kg and for both sexes of rabbits was 118
mg/kg. The animals showed depression, prostration, and labored
breathing, along with weight loss in some cases (MRID#s 00136724).
Another acute oral toxicity study in rats showed the LD50 to be 375 mg/kg
for males and 284 mg/kg for females (MRID# 00143642).
In male rabbits, an acute dermal toxicity test had no deaths and the
LDjo was greater than 2 g/kg (only dose tested; 24-hr exposure). Dermal
irritation (moderate to severe hyperemia/edema and slight to marked
necrosis), however was observed in all treated animals (MRID#s
00136724). Another acute dermal test with rabbits of both sexes also
resulted in an LD^ greater than 2 g/kg (only dose tested; 24-hr exposure).
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Dermal irritation (encrustation and exfoliation of the skin) also was
observed in this study (MRID# 00143639).
An acute inhalation study in rats gave an LC50 of 0.32 mg/L for
a four-hour exposure; corneal opacity was present in some surviving rats
(MRID# 41026502). A primary eye irritation study in rabbits resulted
in severe corneal damage, which was considered permanent, in all treated
eyes (MRID#s 00136724, 00143640). In another eye irritation study in
rabbits DBNPA was corrosive to the eyes, with maximum opacity within
one hour (MRID# 00143641). Rabbits treated with DBNPA in a primary
dermal irritation study (4-hr exposure to 0.5 g) experienced erythema and
edema, with exfoliation after five days (MRID# 00143641). Two dermal
sensitization studies with guinea pigs found DBNPA to be a weak
sensitizer (MRID#s 00143641, 00148622).
b. Subchronic Toxicity
In a subchronic toxicity study, rats were given DBNPA for 90 days
by gavage at doses of 0, 5, 13, or 30 mg/kg/day. The NOEL was 5
mg/kg/day. The LOEL was 13 mg/kg/day based on dyspnea at this dose
and higher. The animals with dyspnea also had weight loss and some of
them died (GL# 82-1; MRID#s 41026504; 41310001).
Doses of 0, 103, 309, or 1031 mg/kg/day of DBNPA were applied
to the skin of rats (6 hrs/day; 5 days/week) for 90 days. The systemic
NOEL was 309 mg/kg/day. The systemic LOEL was 1031 mg/kg/day
based on clinical chemistry findings of reduced triglyceride levels in
males, reduced cholesterol as well as elevated alkaline phosphatase and
chloride in females, and urine pH at or above 9 in some males. The
dermal irritation NOEL was 103 mg/kg/day. Dermal irritation (erythema
and/or edema) was transient in several rats of both sexes at the two
highest doses (GL# 82-3; MRID# 41662201).
c. Developmental Toxicity
Rabbits were given DBNPA doses of 0, 2, 10, 30, or 60
mg/kg/day, by gavage, on gestation days 7-19 in a developmental toxicity
study. The maternal NOEL was 30 mg/kg/day. At the maternal LOEL
of 60 mg/kg/day, there were deaths, decreased body weight gain, and
reduced food intake. The developmental NOEL was 10 mg/kg/day.
Retarded ossification of several fetal skeletal elements was observed both
at the LOEL (30 mg/kg/day) and the high dose (60 mg/kg/day). The
occurrence of structural alterations at a maternally non-toxic dose indicates
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that DBNPA is a developmental toxicant in rabbits (GL# 83-3; MRID#
41508301).
d. Mutagenicity
In a Sfl//n0/ie//a/mammalian-microsome mutagenicity assay,
DBNPA did not induce a mutagenic effect in S. typhimurium strains
TA1535, TA1537, TA1538, TA98, or TA100, either with or without
metabolic activation (MRID# 00148623). A mutation assay involving the
HGPRT locus in Chinese hamster ovary cells was negative, with and
without metabolic activation (MRID# 00157756). In a study with human
lymphocytes, DBNPA showed a weak positive response for chromosomal
aberrations, with and without metabolic activation (MRID# 41034701).
Two separate studies showed no evidence of unscheduled DNA synthesis
in rat hepatocytes tested with DBNPA (MRID# 41125801, 157755).
e. Other Toxic Endpoints
Several human incident reports concerning DBNPA are on file with
the Agency. These include eye, throat and respiratory irritation, runny
nose, and headache. Generally the effects arose with spills or misuse.
2. Exposure Assessment
a. Dietary Exposure
A food additive tolerance has been established for DBNPA from
food contact with food grade paper and paperboard (see 21 CFR
176.300). The use of DBNPA as a slimicide in the manufacture of paper
and paperboard that contact food, is regulated under the jurisdiction of the
U.S. Food and Drug Administration and is not directly regulated by EPA.
Another food tolerance has been established for sugar from the
use of DBNPA in sugar beet processing (see 21 CFR 173.320). This use
is no longer registered and is not supported for reregistration.
b. Occupational and Residential
DBNPA is used in a variety of industrial applications as described
in Section II.B. above. DBNPA is formulated as liquid and soluble solid
concentrates. Treatments typically are made using a variety of industrial
equipment (e.g., metering pumps, drip feed devices) and can be of several
varieties including shock/slug, initial, intermittent, maintenance, during
manufacture, and continuous feed.
-------
c.. Mixer/Loader/Applicator Exposure (Handlers):
The formulated DBNPA products are liquids and soluble solid
concentrates. The potential for exposure exists, particularly to those
workers ("handlers") loading DBNPA products by open delivery or
pouring methods. Potential exposure is via the dermal and inhalation
routes as suggested by an exposure study submitted by the Chemical
Manufacturers Association (CMA) to fulfill the data requirements.
DBNPA meets both toxicity (as a developmental toxicant) and exposure
criteria for requiring mixer/loader/applicator data.
Dermal and inhalation exposure to handlers via either an open
pouring system (Table 4.) or a closed system (Table 5.) may be estimated
using the CMA exposure data, maximum application rates based on
information from use patterns in Agency files, and assumptions discussed
below.
Estimates of daily exposure are calculated with the following
equation:
MC5XU>.a,i. used „
— Daify apostre
Brv
Where:
MCS = maximum credible sum is the maximum exposure (dermal + inhalation) per
pound of a.i. handled
lb. a.i. used = application rates from labels of currently registered DBNPA products
BW = 60 kg. for an adult female worker, since the lexicological endpoint is
developmental effects.
(1) Assume 100 gallons of paint are treated with 20%
a.i. end-use product (final diluted concentration is 1%). A
total of 1.80'lb of a.i. is added.
(2) For a pulp and paper mill system, assume 0.5 lb of
end-use product with 20% a.i. is added to one ton of dry
pulp, and 100 tons of pulp are treated. A total of 10 Ibs of
a.i. is added.
(3) For a water recirculating cooling system, assume 12
fl.oz. of 20% a.i. end-use product is added into 1000
gallons of water and a total of 5000 gallons of water is
treated. A total of 60 fl. oz of end-use product (= 0.78 lb
of a.i.) is added.
10
-------
(4) For metalworking fluid, assume 8.48 Ib of 5% a.i.
end-use product is added to 1000 gallons of oil. A total of
0.42 Ib of a.i. is added.
Table 4. Daily Exposure Estimates from Open Delivery System
FOUR LIQUID (OPEN DELIVERY SYSTEM)
Exposure Site
Preservative
WoodP&P
Cooling Tower
Metal Fluid
MCS*(ug/lba.i.)
130
130
27130.00
100
Ib a.i. used
1.80
10
0.78
0.42
BW**(kg)
60
60
60
60
Daily Exposure
(ug/kg/day)
3.90
21.67
352.69
0.67
* MCS = Maximum Credible Sum was derived from CMA Study (worst-case scenario).
** BW = Body Weight [female average body weight (60 kg) is used since the lexicological end-
point is developmental toxicity].
Table 5. Daily Exposure Estimates from Closed Delivery System
FL1MP LIQUID {CLOSED DELIVERY SYSTEM)
Exposure Site
Wood P&P
Preservative
Cooling Tower
Metal Fluid
MCS*(ug/lb a.i.)
10
10
930
470
Ib a.i. used
10
1.80
0.78
0.40
BW**(kg)
60
60
60
60
Daily
Exposure(ug/kg/day)
1.67
0.30
12.09
3.13
MCS = Maximum Credible Sum was derived from CMA Study (worst-case scenario).
** BW = Body Weight [female average body weight (60 kg) is used since the toxicologies! end-
point is developmental toxicity].
Estimates of Daily Exposure are low for all uses of DBNPA, based
on the above study and assumptions, except for a handler using an open
pouring method to add DBNPA to cooling towers (exposure =352.69
ug/kg/day). With appropriate Personal Protective Equipment (PPE) the
estimated daily exposure from open pouring in cooling towers would be
significantly reduced.
Residential exposure is not expected since DBNPA has no
residential use.
11
-------
d.. Post-application Exposure (Workers)
Post-application (dermal and inhalation) acute exposure is expected
to be minimal since workers are not exposed to the DBNPA concentrates
but potentially only to highly diluted levels in manufactured products such
as paints.
3. Risk Assessment
The data available on the potential toxicological effects of DBNPA and
exposure to workers are sufficient for assessing human risks. In acute toxicity
studies described above, DBNPA is moderately, systemically toxic by the oral and
inhalation routes (Toxicity Category II) and slightly toxic by the dermal route
(Toxicity Category III). DBNPA is corrosive to the eye (Toxicity Category I).
Although classified in Toxicity Category III for primary dermal irritation,
DBNPA can produce necrosis of rabbit skin when administered at higher doses
for a more prolonged time period. DBNPA is a dermal sensitizer. DBNPA
appears to be a developmental toxicant in rabbits; structural alterations were
observed at a maternally non-toxic dose. Several human incidents concerning
acute exposure to DBNPA after spills or misuse report eye, throat and respiratory
irritation, and runny nose or headache.
a. Dietary
The one potential food use for DBNPA in paper and paperboard
is regulated by FDA.
b. Occupational and Residential
Handlers may be at risk for acute toxicity effects. They may also
be at risk for developmental effects from acute exposure to DBNPA. The
margin of exposure (MOE) for developmental toxicity may be estimated
by the following equation:
NOEL
Exposure (pig/kg/dcy)
Where the NOEL = 10 mg/kg/day, based on the
developmental study in rabbits (MRID# 41508301). Exposure
estimates are from Tables 4 and 5.
12
-------
Table 6; Estimates of Margins of Exposure for Developmental Toxicity
APPLIED
BY
EXPOSURE
SITE
Wood P & P
Preservative
Cooling
Tower
Metal Fluid
SWEW
Daily Exposure
(ug/kg/day)*
3.90
21.67
352.69
0.67
MOE
2564
461
28
14925
PUMP LIQUID (CLOSED
SYsna®
Daily Exposure
(ug/kg/day)*
1.67
0.30
12.09
3.13
MOE
5988
33333
827
3195
* 100% absorption by the dermal and inhalation routes is assumed.
MOEs are greater than 100 for all uses except for a handler using
an open pouring method to add DBNPA to cooling towers (MOE = 28).
With appropriate personal protective equipment, the exposure from open
pouring in cooling towers would be significantly reduced and the MOE
would be greater than 100.
Developmental and acute toxicity risks for post-application/reentry
workers are not expected because their potential for exposure is expected
to be much lower than for handlers.
C. Environmental Assessment
1. Environmental Fate
a. Environmental Chemistry, Fate and Transport
The Agency required a hydrolysis study for the uses of DBNPA to
determine if and under what conditions the pesticide degrades in aqueous
solution. Any significant environmental degradation products are identified
if degradation occurs. Although hydrolysis were the only required
environmental fate data for DBNPA given its current use patterns,
additional environmental fate data were submitted to the Agency. These
include aqueous photolysis and aerobic and anaerobic aquatic metabolism
studies.
The hydrolysis and aqueous photolysis studies show that DBNPA
degrades to an array of products: dibromoacetonitrile; dibromoacetamide;
dibromoacetic acid; monobromoacetamide; monobromonitrilopropion-
amide; monobromoacetic acid; cyanoacetic acid; cyanoacetamide;
13
-------
oxoacetic acid; oxalic acid and malonic acid. The various pathways that
generate these degradation products depend upon pH and the presence of
light and nucleophiles.
As the pH increases from neutral the half-life of DBNPA
decreases. For instance, at pH 5 the half-life of DBNPA is 67 days as
opposed to 63 hours at pH 7 and 73 minutes at pH 9. Hydrolysis
produces dibromoacetic acid (30.6% of applied) as the major degradate
at pH 5, dibromoacetonitrile (54.5%) as the major degradate at pH 7, and
dibromoacetonitrile (38.6%) as the major degradate at pH 9. Aqueous
photolysis produces dibromoacetic acid (63.7%) as the major degradate at
pH 5 (t!/2 = 14.8 hrs.) in exposed solutions and dibromoacetic acid
(31.4%) in the dark control, and dibromoacetic acid as the major
degradate in the exposed (66.5%) and unexposed (74.9%) solutions at pH
7 (t!/2= 6.9 hrs.). Additionally, the aqueous photolysis study indicate
that:
1) at pH 9 (tlA= 0.4 hrs.) in the solutions exposed to
light, bromoacetamide was present at 14.6% and an
unknown degradate at 61.4%;
2) in the unexposed solutions an unknown (possibly
dibromoacetonitrile from retention times) was present at
51.7% and oxalic acid at 29.9%.
In the aerobic and anaerobic aquatic metabolism studies DBNPA
degraded with a half-life of
-------
Three degradates were identified in the sediment phase: 2-
cyanoacetamide; dibromoacetonitrile; and bromoacetamide. The major
degradate was 2-cyanoacetamide which reached 15.3% of applied by day
seven, and decreased to 2.8% by day 48. Dibromoacetonitrile was
detected once at 0.3% on day two. Bromoacetamide was detected once
at 0.2% on day 30.
In the aerobic aquatic metabolism study, the degradate found in
highest concentration was dibromoacetic acid. This degradate reached
66.45% of applied at 0 hr, fell to 9.0% at hr five, and was not detected
at day two. 2-cyanoacetamide was present at 56.5% at hr five and fell to
2.3% at day 30. Oxalic acid was present at 7.9% at hr five and remained
relatively constant throughout the experiment. Bromoacetic acid was
detected once at 2.3% on day 14. Bromoacetamide was detected twice at
1.1% at hr five and 1.4% on day seven. Dibromoacetonitrile was
detected at 1.8% at day zero, and 5.6% at day five. Unknowns were
detected at a maximum of 10.9% on day 15.
Three degradates were identified in the sediment layer: oxalic acid;
2- cyanoacetamide; and bromoacetamide. The degradate found in highest
concentration in the sediment was 2-cyanoacetamide which reached 16%
of the applied at day two and fell to 1.1% by day 30. Bromoacetamide
was present at 0.2% at 0 hr, rose to 2.1% by day two, and was not
detected by day 30. Oxalic acid reached 4.5% at hr five, then fell to
0.2% by day 30. Unknowns were detected during various times at 0.2%.
b. Environmental Fate Assessment
Because of its use pattern, DBNPA would not generally
contaminate ground water, but would likely contaminate surface waters by
discharge or spill. In general, DBNPA hydrolyses rapidly (t'/2=
-------
various pathways that generate these degradation products depend upon
pH, and the presence of light and nucleophiles. As the pH increases from
neutral the half-life of the parent decreases.
In the aerobic and anaerobic aquatic metabolism studies the parent
degraded with a half-life of less than four hours. The parent and
degradate concentrations decreased rapidly during the metabolism studies
and most of the residues were found in the aqueous layer.
2. Ecological Effects
a. Ecological Effects Data
There are sufficient ecotoxicological data submitted to characterize
the toxicity of DBNPA to nontarget terrestrial and aquatic organisms.
Results of these studies are summarized below.
(1) Terrestrial Data
Results from toxicology studies suggest that DBNPA is
highly toxic to mammals and avian species on an acute oral basis,
but has low toxicity to avian species on a dietary basis. A study
(described above in Section III. B.) with female laboratory rats
using 95% a. i. resulted in an estimated LD50 of 178 mg/kg on an
acute oral basis. Three acute oral avian toxicity studies on mallard
ducks and bobwhite quail resulted in LD50s for combined sexes
ranging from 150-354 mg/kg. The subacute dietary data on
mallard ducks and bobwhite quail using 95% and 100% a.i.
resulted in an LC50 > 10,000 ppm and an LC50 > 5620 ppm,
respectively. Table 7 below summarizes these results.
16
-------
Table 7; Results from Acute and Subacute Avian Toxicology Studies with DBNPA
Species
Mallard
Bobwhite
Bobwhite
% La.
technical grade
technical grade
100%
Acute U>sos
205(160-262)mg/kg
150(1 18-190)mg/kg
354(250-500)mg/kg
MKJU
00025586
00025586
00151654
Species
Mallard
Mallard
Bobwhite
Mallard
% La*
95%
100%
95%
100%
Subacttte LC&s
> 10,000 ppm
>5620 ppm
> 10,000 ppm
> 5620 ppm
wm
00123205
00151656
00123205
00151656
(2) Aquatic Data
Many aquatic toxicological studies have been reviewed by
the Agency. The study results are summarized below. DBNPA
appears to be moderately toxic to freshwater fish species and
moderately to highly toxic to freshwater Crustacea. In addition,
study results suggest that DBNPA is moderately toxic to estuarine
fish and shrimp, highly toxic to estuarine mysids and very highly
toxic to estuarine shellfish and larvae. Acute effects to estuarine
oyster (Eastern Oyster) were seen at levels below the analytical
detection limit, 0.070 mg/L. Therefore, actual levels at which
effects begin for shellfish have not been established. It must be
noted that, due to chemical degradation, many toxic effects to
aquatic organisms occurred within 24 hours of exposure. Some
degradates of DBNPA are highly (dibromoacetonotrile),
moderately (monobromonitrilo-propionamide), and slightly
(dibromoacetamide) toxic to fathead minnow.
17
-------
Table 8; Results from Acute and Chronic Aquatic Toxicology Studies with DBNPA
Species Tested: Acute
Bluegill sunfish
Bluegill sunfish
Rainbow trout
Rainbow trout
Fathead minnow
Sheepshead minnow
Sheepshead minnow
Daphnia magna
Daphnia magna
Mysidopsis bahia
Eastern oyster
Eastern oyster larvae
Pink shrimp
Fiddler crab
€hfftnic
Rainbow trout
Daphnia magna
M.%
100
tech
tech
100
99.1
99.5
95
95
100
99.5
99.5
95
95
95
98
98
I£* (ECW) |0 rag/I
2.3(1.8-3.2)
1.3(1-1.6)
1.0(0.61-0.5)
2.3(1.8-3.2)
1.8(1.5-2.1)
3.4(3-4.9)
1.7
0.9(0.87-0.93)
0.86(0.56-1)
0.72(0.5-1.3)
<0.07*
0.74(0.56-1), 48 hr. study
2.4(1.8-3.2)
13.9(10-32)
MATC
> 0.47 < 0.98
NOEL < 0.02
MRH>#
00151657
00104507
00104507
00151658
00118432
41669702
00096362
00073951
00151659
41669701
41711701
00025605
00025605
00025605
40195701
40195702
1 0.070 mg/L stated to be the limit of detection in this study
b. Ecological Effects Risk Assessment
Sufficient information exists to suggest that DBNPA will display
moderate toxicity to terrestrial mammals and avian species if they are
exposed to oral doses of concentrated residues of DBNPA. This might
occur under such conditions as an accidental spill or excessive discharge of
the chemical into a static pool. This information will be used for product
hazard labeling purposes. However, based on submitted avian dietary
studies, dietary toxicity to avian species is low. Median lethal
concentrations were above 5620 ppm for both mallard duck and bobwhite
quail.
The available data suggests, however, that DBNPA, without any
mitigation measures, poses a high risk to aquatic organisms. These data
include environmental fate data, ecotoxicological data on aquatic
organisms, and an exposure screening model.
18
-------
To aid in the aquatic risk assessment of DBNPA, the Agency used
a screening model. This model provides the estimated environmental
concentrations of DBNPA residues in receiving streams from effluent of
pulp/paper mills, cooling towers, oil well/drilling muds, and metal
finishing uses. The model, Tier Ic EEC, determines the maximum
concentration that occurs immediately downstream from an industrial (point
source) discharge site. The calculated EECs are those for a high exposure
site with a return frequency of one in 10 years and for a typical site at
mean stream flow. The high exposure site represents a site mat would be
expected to produce larger EECs than 90% of all sites with the specified
use pattern. A one in 10 year EEC has a 10% probability of being equaled
or exceeded in any single year at a given site or, would be equalled or
exceeded once every ten years at that site on a long term average. This is
similar to the site and frequency assumptions that are generally being used
for agricultural pesticides. These EECs are presented for 50% of the
industries as high (low stream flow) and typical (mean stream flow)
exposure scenarios in Table 9 below.
Table 9; Tier Ic EECs of DBNPA at Discharge Sites
of D1NFA
Metal Finishing (all uses)
0.200
2.000
Metal Finishing (direct
discharge)
0.004
0.070
Pulp and Paper Mills
0.050
0.400
Cooling Water Systems
0.030
0.400
Secondary Oil Recovery
Systems
0.100
3.000
The EECs range from 0.004 to 0.200 ppm of DBNPA for typical
exposure scenarios and from 0.070 to 3.000 ppm for high exposure
scenarios. For both scenarios the model suggests DBNPA EECs will be
higher in receiving streams from effluent discharged from secondary oil
recovery systems and metal finishing plants, than from the other three uses.
To compare these EECs to DBNPA's aquatic toxicity profile the
Agency has calculated levels of concern (LOG) for aquatic organisms
including endangered species potentially exposed to DBNPA. These LOCs
are derived from the toxic potency indicated from the studies summarized
in Table 8. The LOCs of four indicator species are shown in Table 10.
below.
19
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Table 10. LOCs for DBNPA and Indicator Aquatic Species
Afsafiic J&dicatajf Speoi«$
Daphnia magna
Freshwater fish (Rainbow Trout)
Mysid shrimp
Shellfish (Eastern Oyster)
T^fcalSpi^tLaC
{*lA.fe*&
0.43
0.50
0.36
< 0.035
iB»&«$emf Speetesi
LOC^lCjfr&jfca))
0.04
0.05
0.04
< 0.004
Half the LC^ for DBNPA for four types of aquatic indicator species
are -0.43 ppm for Daphnia; 0.5 ppm for freshwater fish (rainbow trout);
~ 0.36 for Mysid shrimp; and <0.035 ppm for shellfish (Eastern Oyster).
An LOG is met or exceeded when the EEC value equals or exceeds
!/2 the LC50 values for non-endangered aquatic organisms (Table 11). The
EEC values (Table 9.) are approximately equal to or greater than the LOG
value for shellfish for typical and high scenarios except for metal finishing
at typical exposure scenarios. Therefore, if the receiving streams have a
flow rate below their mean flow condition, there potentially is a high risk
to shellfish in these waters under direct discharge.
If an EEC is less than the LOG that suggests a high likelihood the
chemical can be discharged into receiving waters without causing adverse
effects. If the EEC equals or exceeds the LOG, it may indicate that the
pesticide can have a potential adverse impact on non-target organisms.
The LOCs for endangered aquatic species are 1/20 the LC50 values,
which for DBNPA are 0.04 ppm for Daphnia; 0.05 ppm for freshwater
fish (rainbow trout); 0.04 ppm for Mysid shrimp; and < 0.004 for shellfish
(Eastern Oyster). The EECs for the high and typical exposure scenarios
for all uses of DBNPA exceed the LOCs for endangered aquatic
invertebrates. The EECs for the high exposure scenario for all uses of
DBNPA exceed the level of concern for freshwater fish. In addition, the
typical exposure scenario EEC values for metal finishing, pulp and paper,
and secondary oil recovery systems exceed the LOG for endangered
freshwater fish. As DBNPA will be discharged at several different sites,
it is reasonable to assume that endangered species are located in some of
these aquatic habitats and are likely to be adversely affected.
20
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Table 11; Non-endangered Indicator Species Which Meet or Exceed LOCs
$»*&te,1$p8
Metal Finishing (all)
Metal Finishing (direct
discharge)
Pulp and Paper Mills
Cooling Water
Systems
Secondary Oil
Recovery Systems
fypsal!3$Q$!iire
S&ti&fog
shellfish
none
shellfish
shellfish
shellfish
M|fr j^osui^ Scenario
Daphnia, fresh water fish, Mysid shrimp
, and shellfish
shellfish
Daphnia, Mysid shrimp and shellfish
Daphnia, Mysid shrimp and shellfish
Daphnia, freshwater fish, Mysid shrimp,
and shellfish
3. Mitigation of Risk to Aquatic Organisms
After evaluating available data and consultations between Agency Offices
(Office of Pesticide Programs, Office of Water, and the Office of Pollution
Prevention and Toxics), the Agency has determined that aquatic risk concerns for
all uses of DBNPA, except single flow-through cooling systems, may be
adequately mitigated by secondary biological treatment of waste water.
Factors considered in the consultation include:
1) DBNPA's use sites;
2) available environmental fate and ecotoxicological
information;
3) information regarding waste water treatments.
The recommended mitigation measure is secondary biological effluent
treatment. Environmental fate data suggest that DBNPA degrades rapidly by
anaerobic and aerobic aquatic metabolism into less toxic degradates.
Secondary biological effluent treatment is required for all aquatic industrial
uses of DBNPA except:
1) waste water treatment systems;
2) secondary oil recovery systems;
3) single flow-through cooling systems.
Biological effluent treatment is not needed for waste water treatment
systems because biological degradation readily occurs in these systems. Secondary
biological treatment is not feasible for secondary oil recovery systems. An
evaluation of the secondary oil recovery use pattern for DBNPA adequately
reduces the Agency's concern with this use pattern. However, aquatic risk
21
-------
concerns (Table 11) for the single flow-through cooling system use of DBNPA
remains since secondary biological effluent treatment is not practical for this use.
The Agency has determined that based on expected "end-of-pipe" effluent
concentrations from single flow-through cooling towers, unacceptable risk to
aquatic organisms may occur with presently labeled rates. Without some type of
mitigatory measure before direct release of the effluent, present environmental
concerns are expected to remain high for the single flow-through cooling tower use
of DBNPA.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing DBNPA. The Agency has completed its
review of these generic data, and has determined that the data and measures stipulated in
this document are sufficient to support reregistration of products containing DBNPA
except for those labeled with the single flow-through cooling tower use. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of DBNPA, and lists the submitted studies that
the Agency found acceptable or supplemental.
The data identified in Appendix B are sufficient to allow the Agency to assess the
registered uses of DBNPA and to determine that DBNPA, as labeled and specified in this
document, can be used in most applications without resulting in unreasonable adverse
effects to humans and the environment. The Agency has determined that the use of
DBNPA in single flow-through cooling towers is ineligible for reregistration due to the
potential high risks of toxicity to nontarget aquatic organisms and its relatively low
benefits. This decision is further discussed in sections B and C below.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration-and benefits information for the single flow-through
cooling tower use. The current guidelines for conducting acceptable studies to generate
such data and the data are identified in Appendix B. Although the Agency has found that
all uses but the single flow-through cooling tower use of DBNPA are eligible for
reregistration, it should be understood that the Agency may take appropriate regulatory
action, and/or require the submission of additional data to support the registration of
products containing DBNPA, if new information comes to the Agency's attention or if the
data requirements for registration (or the guidelines for generating such data) change.
22
-------
B. Eligibility Decision
Based on the reviews of the generic data for the active ingredient DBNPA the
Agency has sufficient information on the health effects of DBNPA and on its potential for
causing adverse effects in fish and wildlife and the environment. Therefore, the Agency
concludes that specific products containing DBNPA for all uses except single flow-
through cooling tower uses are eligible for reregistration when labeled and used as
specified in this Reregistration Eligibility Decision, since they will not pose unreasonable
risks or adverse effects to humans or the environment.
As described in Section HI. C. above, available information indicates that DBNPA
without any mitigation measures poses a high risk to aquatic organisms when released to
bodies of water during normal use. However, when secondary biological treatment is
performed, data suggest DBNPA and its degradates would be sufficiently degraded to
adequately mitigate the risk. While this remedy is available for most current uses of
DBNPA products, it is not considered practical for release of DBNPA treated water from
single flow-through cooling towers. This is primarily because of the typical large size of
these single flow-through cooling tower systems and the high volume of water which
passes through them.
Information provided by the principal registrants of DBNPA indicate that current
usage of this pesticide in single flow-through cooling towers in the U.S. is negligible. The
registrants contend that this is because, while DBNPA is effective at pest control in this
site, it is more costly than currently registered alternative pesticides. Consequently, since
the current benefits of DBNPA for this use are low or non-existent, and the potential risk
to aquatic organisms is potentially high when used, the Agency, as required by Section
4(g)(2)(A) of FIFRA, concludes this use is unreasonable as described in Section 3(c)5.
Therefore, the Agency will take appropriate regulatory action against DBNPA products
labeled for this use.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for DBNPA.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Secondary Biological Effluent Treatment Statement
The required aquatic risk mitigation measure is secondary biological
effluent treatment. Environmental fate data indicates that DBNPA degrades
rapidly by anaerobic and aerobic aquatic metabolism into less toxic degradates.
23
-------
Therefore, DBNPA residues from treatment sites would be reduced before release
into surface waters.
2. Endangered Species Statement
The Agency has concerns about the exposure of threatened and endangered
shellfish (mollusk) species to DBNPA as discussed above in the science assessment
chapter (Section III.). Currently, the Agency is developing a program ("The
Endangered Species Protection Program") to identify all pesticides whose use may
cause adverse impacts on endangered and threatened species and to implement
mitigation measures that will eliminate the adverse impacts. The program would
require use modifications or a generic product label statement, requiring users to
consult county-specific bulletins. These bulletins would provide information about
specific use restrictions to protect endangered and threatened species in the county.
Consultations with the Fish and Wildlife Service will be necessary to assess risks
to newly listed species or from proposed new uses.
The Agency plans to publish a description of the Endangered Species
Program in the Federal Register by 1995 and have enforceable county-specific
bulletins available. Because the Agency is taking this approach for protecting
endangered and threatened species, it is not imposing label modifications at this
time through the RED. Any requirements for product use modifications will occur
in the future under the Endangered Species Protection Program.
3. Risk Mitigation to Handlers
Personal Protective Equipment (PPE) for Handlers (Mixer/Loader/
Applicators)
For each end-use product, PPE requirements for pesticide handlers will be
set during reregistration in one of two ways:
(a) If EPA has no special concerns about the acute or other
adverse effects of an active ingredient, the PPE for pesticide
handlers will be based on the acute toxicity of the end-use product.
For occupational-use products, PPE will be established using the
process described in PR Notice 93-7 or more recent EPA
guidelines.
(b) If EPA has special concerns about an active ingredient due
to very high acute toxicity or to certain other adverse effects, such
as allergic effects or delayed effects (cancer, developmental
toxicity, reproductive effects, etc):
24
-------
*• In the RED for that active ingredient, EPA may establish minimum
or "baseline" handler PPE requirements that pertain to all or most
occupational end-use products containing that active ingredient.
> These minimum PPE requirements must be compared with the PPE
that would be designated on the basis of the acute toxicity of each
end-use product.
> The more stringent choice for each type of PPE (i.e., bodywear,
hand protection, footwear, eyewear, etc.) must be placed on the
label of the end-use product.
There are special toxicological concerns about DBNPA
(developmental toxicity). However, the risk assessment indicates that only
one use warrants the establishment of active-ingredient-based PPE
requirements for handlers. The MOE's were calculated as being acceptable
for all uses, except open pouring into cooling towers. For that use, the
MOE is acceptable only when handlers were wearing long-sleeved shirt,
long pants, chemical-resistant apron, chemical-resistant gloves and shoes
plus socks. Therefore, that suite of PPE is required for handlers engaged
in open pouring into cooling towers. If a closed (metering) system is used
to add DBNPA to cooling towers, the handler only must wear long sleeved
shirt, long pants, shoes, and socks.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregistration of DBNPA for the above
eligible uses has been reviewed and determined to be substantially complete. No
additional generic data are required to support the current uses.
2. Labeling Requirements for Manufacturing-Use Products
25
-------
Personal Protective Equipment and Engineering Controls
Handler PPE for Occupational-Use Products
The minimum (baseline) PPE for handlers engaged in open pouring of
DBNPA into cooling towers is: long sleeve shirt, long pants, shoes plus socks,
chemical-resistant gloves, and a chemical-resistant apron.
Other Labeling Requirements
The Agency is requiring the following labeling statements to be located on
all end-use products containing DBNPA that are intended primarily for
occupational use:
Application Restrictions:
"Do not apply this product in a way that will contact
workers or other persons, either directly or through drift.
Only protected handlers may be in the area during
application."
Engineering Controls:
"When handlers use closed metering systems the handler
requirements may be reduced or modified to long-sleeve
shirt, long pants, shoes and socks."
User Safety Requirements:
"Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions for
washables exist, use detergent and hot water. Keep and
wash PPE separately from other laundry."
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing
gum, using tobacco, or using the toilet"
"Users should remove clothing immediately if pesticide gets
inside. Then wash thoroughly and put on clean clothing."
26
-------
"Users should remove PPE immediately after handling this
product. Wash the outside of gloves before removing. As
soon as possible, wash thoroughly and change into clean
clothing."
Sensitization Statement:
The following statement is required in the "Hazards to Humans (and
Domestic Animals)" section of the Precautionary Statements oh the labeling
of all end-use products containing DBNPA, because it \s classified as a skin
sensitizer:
"This product may cause skin sensitization reactions in some
people."
Type of Respirator:
If the acute inhalation toxicity of the end-use product is in category
I or II and, therefore, a respirator is required for pesticide handlers, the
following type of respirator is appropriate to mitigate DBNPA inhalation
concerns:
"A respirator with either an organic-vapor-removing
cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or a
canister approved for pesticides (MSHA/NIOSH approval
number prefix TC-14G)."
Effluent Discharge Labeling Statements
All DBNPA manufacturing-use or end-use pesticide products that may be
contained in an effluent discharged to the waters of the United States or municipal
sewer systems must bear the following effluent discharge labeling statement.
27
-------
"This product is toxic to fish and invertebrates. 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. Secondary biological treatment of
DBNPA effluent is required for all uses except for use in secondary
oil recovery systems. 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 pesticide products distributed or sold by registrants and
distributors (supplemental registrants) must bear the above labeling by October 1,
1995. All products distributed or sold by persons other than registrants or
supplemental registrants after October 1, 1997 must bear the correct labeling.
Refer to PR Notice 93-10 or 40 CFR 152.46(a)(l) for additional information.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific data requirements and instructions are listed in
Appendix G, the Product Specific Data Call-In Notice.
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. Please follow the
instructions in the Pesticide Reregistration Handbook with respect to labels and
labeling.
Protective Equipment and Engineering Controls
Refer to subsection "A" above for labelling requirements and controls.
Effluent Discharge Labeling Statements
Refer to subsection A. above for labeling requirements for effluent
discharge.
28
-------
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products for
50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell DBNPA
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 50 months from
the date of the issuance of this RED. Registrants and persons other than registrants remain
obligated to meet preexisting Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
29
-------
30
-------
VI. APPENDICES
31
-------
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
-------
-------
APPFNDix A- Case 3056, [Dibromo-3-nitrilopropionamidel Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Application Application Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
Minimum
Application
Rate
(ppma.i.)
Maximum
Application
Rate
(ppma.i.)
Max.*
Apps.
Max.*
Apps. ®
Max. Rate
Min. Interval
Between Apps.
& Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
Site: Adhesives, Industrial (Use Group: INDOOR NON-FOOD)
Industrial preservative treatment, During manufacture,
NOL, NA
EIF: Not applicable for th s use
Industrial preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
Preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
Site: Air Washer Water Systems
Water treatment, Continuous feed (initial), Metering pump,
NA
EIF: Not applicable for this use
Water treatment, Continuous feed (initial), NOL, NA
EIF: Not applicable for this use
Water treatment, Continuous feed (subsequent), Metering
pump, NA
EIF: Not applicable for this use
Water treatment, Continuous feed (subsequent), NOL,
NA
EIF: Not applicable for this use
SC/L
SC/L
SC/L
NC
NC
40 W
NC
NC
160W
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NPDES license restriction.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction).
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). NPDES license restriction.
(Use Group: AQUATIC NON-FOOD INDUSTRIAL)
SC/L
SC/L
SC/L
SC/L
1V
1 W
<1 V
<1 W
19V
24 W
10V
12W
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NA
NA
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction). Preclean claim.
NPDES license restriction. Preclean claim. Do not discharge
effluent containing this pesticide into sewage systems without
notifying the sewage treatment plant authority. Do net
discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or public water (NPDES license
restriction). Proper ventilation required.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction). Preclean claim. NPDES license
restriction.
Preclean claim. NPDES license restriction. Proper ventilation
required. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction).
-------
APPENDIX A- Case 3056, [Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Application Application Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
Minimum
Application
Rate
(ppma.i.)
Maximum
Application
Rate
(ppma.i.)
Max.*
Apps.
Max.*
Apps. O
Max. Rate
Min. Interval
Between Apps.
O Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
USES ELIGIBLE FOR R E RE Gl STR AT ION
Site: Air Washer Water Systems (Use Group: AQUATIC NON-FOOD INDUSTRIAL) (Continued from previous
Water treatment, Intermittent (slug) (initial), Metering
pump, NA
EIF: Not applicable for this use
Water treatment, Intermittent (slug) (initial), NOL, NA
EIF: Not applicable for this use
Water treatment, Intermittent (slug) (subsequent),
Metering pump, NA
EIF: Not applicable for this use
Water treatment, Intermittent (slug) (subsequent), NOL,
NA
EIF: Not applicable for this use
Water treatment, NOL, NA, NA
EIF: Not applicable for this use
SC/L
SC/L
SC/L
SC/L
SC/S
1V
1 W
<1 V
<1 W
NC
19V
24 W
9V
12W
NC
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
page)
NA
NA
NA
NA
NA
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction). Preclean claim.
NPDES license restriction. Preclean claim. Do not discharge
effluent containing this pesticide into sewage systems without
notifying the sewage treatment plant authority. Do not
discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or public water (NPDES license
restriction). Proper ventilation required.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction). Preclean claim.
Preclean claim. NPDES license restriction. Proper ventilation
required. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction).
NPDES license restriction. Preclean claim.
Site: Coatings, Industrial (Use Group: INDOOR NON-FOOD)
Industrial preservative treatment, During manufacture,
NOL, NA
EIF: Not applicable for this use
Industrial preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
Preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
SC/L
SC/L
SC/L
NC
NC
40 W
NC
NC
160W
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NPDES license restriction.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction).
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction) NPDES license restriction
36
-------
APPENDIX A- Case 3056
Application Application Application Surface
Tvpe Timing Equipment Type
Efficacy Influencing Factor
Form
[Dibromo-3-nitriloDroDionamidel Chemical 101801 r2.2-Dibromo-3-nitrilopropionamide]
Minimum
Application
Rate
(ppm a.i.)
Maximum
Application
Rate
(ppm a.i.)
Max.*
Apps.
Max.*
Apps. »
Max. Rate
Min. Interval
Between Apps.
O Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Atowed
Disallowed
Use Pattern Limitations
Site- Commercial/Industrial Water Cooling Systems (Use Group: AQUATIC NON-FOOD INDUSTRIAL)
Water once-through system treatment, Continuous feed
(initial), Metering pump, NA
EIF: Not applicable for this use
Water once-through system treatment, Continuous feed
(subsequent), Metering pump, NA
EIF: Not applicable for this use
Water once-through system treatment, Intermittent (slug)
(initial), Metering pump, NA
EIF: Not applicable for this use
Water once-through system treatment, Intermittent (slug)
(subsequent), Metering pump, NA
EIF: Not applicable for this use
Water recirculating system treatment, Continuous feed
(initial), Metering pump, NA
EIF: Not applicable for this use
Water recirculating system treatment, Continuous feed
(initial), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Continuous feed
(subsequent), Metering pump, NA
EIF: Not applicable for this use
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
1 W
<1 W
1 W
<1 W
1 V
1 W
<1 V
24 W
24 W
24 W
24 W
20V
24 W
20V
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Preclean claim. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent containing
his product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). NPDES license
restriction.
Preclean claim. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). NPDES license
restriction.
Preclean claim. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage
treatment plant authority.Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). NPDES license
restriction. Proper ventilation required.
Preclean claim. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). NPDES license
restriction. Proper ventilation required.
Preclean claim. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). NPDES license
restriction. Proper ventilation required.
Preclean claim. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). NPDES license
restriction. Proper ventilation required.
Preclean claim. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). NPDES license
restriction. Proper ventilation required. ,
37
-------
APPENDIX A- Case 3056, [Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Application Application Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
Minimum
Application
Rate
(ppma.i.)
Maximum
Application
Rate
(ppma.i.)
Max.*
Apps.
Max. #
Apps. O
Max. Rate
Min. Interval
Between Apps.
a Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
USES ELIGIBLE FOR R E R E G 1 S T R A T I ON
Site: Commercial/Industrial Water Cooling Systems (Use Group: AQUATIC NON-FOOD INDUSTRIAL) (Continued from previous
Water recirculating system treatment, Continuous feed
(subsequent), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(initial), Metering pump, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(initial), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(subsequent), Metering pump, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(subsequent), NOL, NA
EIF: Not applicable for this use
Water treatment, Continuous feed (initial), Metering pump,
NA
EIF: Not applicable for this use
Water treatment, Continuous feed (initial), NOL, NA
EIF: Not applicable for this use
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
<1 V
1V
1 W
<1 V
1 W
1 W
1V
24V
20V
24 W
20V
24 W
2W
19V
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NA
page)
NA
NA
NA
NA
NA
NA
NA
Preclean claim. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). NPDES license
restriction. Proper ventilation required. Do not apply in
marine and/or estuarine oil fields.
Preclean claim. Proper ventilation required. NPDES license
restriction. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction).
Preclean claim. Proper ventilation required. NPDES license
restriction. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). Do not apply in
marine and/or estuarine oil fields.
Preclean claim. Proper ventilation required. NPDES license
restriction. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction).
Preclean claim. Proper ventilation required. NPDES license
restriction. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). Do not apply in
marine and/or estuarine oil fields.
Proper ventilation required. Preclean claim.
NPDES license restriction. Preclean claim.
38
-------
APPFNPIX A - <>« -MSB, rnihromo-3-nitrilopropionamidel Chemical 101801 r2,2-Dibromo-3-nitrilopropionamide]
Application Application Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
Minimum
Application
Rate
(ppma.i.)
Maximum
Application
Rate
(ppma.i.)
Max.*
Apps.
Max.*
Apps. ®
Max. Rate
Min. Interval
Between Apps.
O Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
USES ELIGIBLE FOR R E R E G I ST R ATIO N •
Site- Commercial/industrial Water Cooling Systems (Use Grouo: AQUATIC NON-FOOD INDUSTRIAL) (Continued from previous
Water treatment, Continuous feed (subsequent), Metering
pump, NA
EIF' Not applicable for this use
Water treatment, Continuous feed (subsequent), NOL,
NA
EIF' Not applicable for this use
Water treatment, Intermittent (slug) (initial), Metering
pump, NA
EIF' Not applicable for this use
Water treatment, Intermittent (slug) (initial), NOL, NA
EIF' Not applicable for this use
Water treatment, Intermittent (slug) (subsequent),
Metering pump, NA
EIF' Not applicable for this use
Water treatment, Intermittent (slug) (subsequent), NOL,
NA
EIF' Not applicable for this use
Water treatment, NOL, NA, NA
EIF' Not applicable for this use
Site- Emulsions, Resin/Latex/Polymer
Industrial preservative treatment, During manufacture,
NOL, NA
EIF' Not applicable for this use
Industrial preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
Site- Evaporative Condenser Water Systems
Water recirculating system treatment, Continuous feed
(initial), Metering pump, NA
sc/s
SC/L
SC/S
SC/L
SC/S
SC/L
SC/S
<1 W
<1 V
1 W
1 V
1 W
<1 V
NC
1 W
19V
2W
19V
2W
19V
NC
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NA
ape)
NA
NA
NA
NA
NA
NA
NA
Proper ventilation required. Preclean claim.
NPDES license restriction. Preclean claim.
Proper ventilation required. Preclean claim.
NPDES license restriction. Preclean claim.
Proper ventilation required. Preclean claim.
NPDES license restriction. Preclean claim.
NPDES license restriction.
(Use Group: INDOOR NON-FOOD)
SC/Ly
SC/L
NC
NC
NC
NC
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NPDES license restriction.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction).
(Use Group: AQUATIC NON-FOOD INDUSTRIAL) .
SC/L
1 V
19V
NS
NS
NS
NS
NA
NA
NPDES license restriction. Preclean claim.
39
-------
APPENDIX A- Case 3056 [Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamidel
Application Application Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
Minimum
Application
Rate
(ppm a.i.)
Maximum
Application
Rate
(ppma.i.)
Max.*
Apps.
Max.*
Apps. 0
Max. Rate
Min. Interval
Between Apps.
O Max. Rate
(Days)
Restricted
Entry
Interval
USES ELIGIBLE FOR R E R E G I ST R ATI ON
Site: Evaporative Condenser Water Systems
Water recirculating system treatment, Continuous feed
(initial), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Continuous feed
(subsequent), Metering pump, NA
EIF: Not applicable for this use
Water recirculating system treatment, Continuous feed
(subsequent), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(initial), Metering pump, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(initial), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(subsequent), Metering pump, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(subsequent), NOL, NA
EIF: Not applicable for this use
Geographic
Limitations
Allowed
(Use Group: AQUATIC NON-FOOD INDUSTRIAL) (Continued from previous
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
1 W
<1 V
<1 W
1 V
1 W
<1 V
1 W
24 W
19V
24 W
19V
24 W
19V
24 W
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NA
Disallowed
Use Pattern Limitations
page)
NA
NA
NA
NA
NA
NA
NA
NPDES license restriction. Prectean claim. Proper ventilation
required. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). Do not apply in
NPDES license restriction. Predean claim.
NPDES license restriction. Prectean claim. Proper ventilation
required. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). Do not apply in
NPDES license restriction. Predean claim.
NPDES license restriction. Prectean claim. Proper ventilation
required. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this.
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). Do not apply in
NPDES license restriction. Predean claim.
NPDES license restriction. Predean claim. Proper ventilation
required. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction). Do not apply in
40
-------
APPENDIX A- Case 3056
Application Application Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
[Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Minimum
Application
Rate
(ppma.i)
Maximum
Application
Plate
(ppm a.i.)
Max.*
Apps.
Max.*
Apps. O
Max. Rate
Min. Interval
Between Apps.
O Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
USES ELIGIBLE FOR R E RE G 1ST R ATI ON
Site: Heat Exchanger Water Systems (Use Group: AQUATIC NON-FOOD INDUSTRIAL)
Water recirculating system treatment, Continuous feed
(initial), NOL, NA
EIF: Not applicable for this use
Water recircualting system treatment, Continuous feed
(subsequent), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(initial), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(subsequent), NOL, NA
EIF: Not applicable for this use
SC/L
SC/L
SC/L
SC/L
1 W
<1 W
1 W
1 W
24 W
24 W
24 W
24 W
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
Site: Industrial Auxiliary Water Systems (Use Group: AQUATIC NON-FOOD INDUSTRIAL)
Water treatment, NOL, NA, NA
SC/S
NC
NC
NS
NS
NS
NS
NA
NA
NA
NA
NA
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim. Do not apply in marine and/or
estuarine oil fields. NPDES license restriction.
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim. Do not apply in marine and/or
estuarine oil fields. NPDES license restriction.
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim. Do not apply in marine and/or
estuarine oil fields. NPDES license restriction.
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim. Do not apply in marine and/or
estuarine oil fields. NPDES license restriction.
NA
NPDES license restriction.
Site: Industrial Processing Water (Use Group: AQUATIC NON-FOOD INDUSTRIAL)
Water treatment, Continuou feed (initial), Metering pump,
NA
Water treatment, Continuous feed (subsequent), Metering
pump, NA
EIF: Not applicable for this use
SC/L
SC/L
1 V
<1 V
19V
19V
NS
NS
NS
NS
NS
NS
NS
NS
MO
MO
NS
NS
Preclean claim. NPDES license restriction.
Preclean claim. NPDES license restriction.
41
-------
APPENDIX A- Case 3056 [Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Application Application Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
Minimum
Application
Rate
(ppma.i.)
Maximum
Application
Rate
(ppma.i.)
Max. #
Apps.
Max.*
Apps. @
Max. Rate
Min. Interval
Between Apps.
& Max. Rate
(Days)
USES ELIGIBLE FOR R E R E G I S T R ATI O N
Site: Industrial Processing Water
Water treatment, Intermittent (slug) (initial), Metering
pump, NA
EIF: Not applicable for this use
Water treatment, Intermittent (slug) (subsequent),
Metering pump, NA
EIF: Not applicable for this use
Site: Industrial Scrubbing System
Water recirculating system treatment, Continuous feed
(initial), Metering pump, NA
EIF: Not applicable for this use
Water recirculating system treatment, Continuous feed
(initial), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Continuous feed
(subsequent), Metering pump, NA
EIF: Not applicable for this use
Water recirculating system treatment, Continuous feed
(subsequent), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(initial), Metering pump, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(initial), NOL, NA
EIF: Not applicable for this use
Restricted
Entry
Interval
Geographic
Limitations
Allowed
(Use Group: AQUATIC NON-FOOD INDUSTRIAL) (Continued from previous
SC/L
SC/L
1 V
<1 V
19V
19V
NS
NS
NS
NS
NS
NS
NS
NS
MO
MO
Disallowed
Use Pattern Limitations
page)
NS
NS
Preclean claim. NPDES license restriction.
Predean claim. NPDES license restriction.
(Use Group: AQUATIC NON-FOOD INDUSTRIAL)
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
1 V
1 W
<1 V
<1 W
1V
1 W
19V
24 W
19V
24 W
19V
24 W
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NPDES license restriction. Preclean claim.
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Do not apply in marine and/or estuarine oil fields.
NPDES license restriction. Preclean claim.
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim. Do not apply in marine and/or
estuarine oil fields. NPDES license restriction.
NPDES license restriction. Preclean claim.
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim. Do not apply in marine and/or
estuarine oil fields. NPDES license restriction.
42
-------
APPENDIX A- Case 3056
Application Applcation Application Surface
Type Tinning Equipment Type
Efficacy Influencing Factor
Form
[Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Minimum
Application
Rate
(ppma.i.)
Maximum
Application
Rate
(ppma.i.)
Max.*
Apps.
Max.*
Apps. O
Max. Rate
Min. Interval
Between Apps.
O Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
USES ELIGIBLE FOR R E R E GISTR AT 1 ON
Site- Industrial Scrubbing System (Use Group: AQUATIC NON-FOOD INDUSTRIAL) (Continued from previous
Water recirculating system treatment, Intermittent (slug)
(subsequent), Metering pump, NA
Water recirculating system treatment, Intermittent (slug)
(subsequent), NOL, NA
EIF: Not applicable for this use
Wtare recirculating system treatment, NOL, NOL, NA
SC/L
SC/L
<1 V
1 W
19V
1 W
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
oage)
NA
NA
NPDES license restriction. Preclean claim.
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim. Do not apply in marine and/or
estuarine oil fields. NPDES license restriction.
(Use Group: AQUATIC NON-FOOD INDUSTRIAL)
SC/L
20 v
20V
NS
NS
NS
NS
NA
NA
NPDES license restriction.
Site: Metalworking Cutting Fluids (Use Group: INDOOR NON-FOOD) _
Industrial preservative treatment, During manufacture,
NOL, NA
Preservative treatment, Continuous feed (initial), Metering
pump, NA
Preservative treatment, Continuous feed (subsequent),
Metering pump, NA
EIF: Not applicable for this use
Preservative treatment, Intermittent (slug) (initial),
Metering pump, NA
EIF: Not applicable for this use
SC/L
SC/L
SC/L
SC/L
NC
50V
20V
50V
NC
50V
44V
220V
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NA
NA
NPDES license restriction.
NPDES license restriction.
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Do not apply in marine and/or estuarine oil fields.
NPDES license restriction. Preclean claim.
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Do not apply in marine and/or estuarine oil fields.
43
-------
APPENDIX A- Case 3056, [Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Application Application Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
Minimum
Application
Rate
(ppm a.i.)
Maximum
Application
Rate
(ppm a.i.)
Max. #
Apps.
Max.*
Apps. O
Max. Rate
USES ELIGIBLE FOR R E RE Gl ST R AT ION
Min. Interval
Between Apps.
® Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
Site: Metalworking Cutting Fluids (Use Group: INDOOR NON-FOOD) (Continued from previous page)
Preservative treatment, Intermittent (slug) (subsequent),
Metering pump, NA
EIF: Not applicable for this use
Site: Oil Recovery Drilling Muds/Packer Fluids
Industrial preservative treatment, During manufacture,
NOL, NA
EIF: Not applicable for this use
Site: Paints, Latex (In-Can)
Industrial preservative treatment, During manufacture,
NOL, NA
EIF: Not applicable for this use
Site: Paints, Latex/Oil/Vamish (Applied Film)
Industrial preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
Preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
Site: Paper/Paper Products
Preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
SC/L
20V
176V
NS
NS
NS
NS
NA
NA
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Do not apply in marine and/or estuarine oil fields.
NPDES license restriction. Preclean claim.
(Use Group: INDOOR NON-FOOD)
SC/L
NC
NC
NS
NS
NS
NS
NA
NA
NPDES license restriction.
(Use Group: INDOOR NON-FOOD)
SC/L
NC
NC
NS
NS
NS
NS
.NA
NA
NPDES license restriction.
(Use Group: INDOOR NON-FOOD)
SC/L
SC/L
NC
20V
NC
20V
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction).
NPDES license restriction.
(Use Group: INDOOR NON-FOOD)
SC/L
Site: Pasteurizer/Warmer/Cannery Cooling Water Systems
Water rectrculating system treatment, Continuous feed
(initial), Metering pump, NA
EIF' Not applicable for this use
SC/L
40 W
160W
NS
NS
NS
NS
NA
NA
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction).
(Use Group: INDOOR NON-FOOD)
1V
19V
NS
NS
NS
NS
NA
NA
NPDES license restriction. Preclean claim.
44
-------
APPENDIX A- Case 3056, [Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Application Application Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
Minimum
Application
Plate
(ppm a.i.)
Maximum
Application
Plate
(ppm a.i.)
Max.*
Apps.
Max.*
Apps. 0
Max. Rate
Min. Interval
Between Apps.
O Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
USES ELIGIBLE FOR R E RE G 1ST RATIO N
Site: Pasteurizer/Warmer/Cannery Cooling Water Systems (Use Group: INDOOR NON-FOOD) (Continued from previous page)
Water recirculating system treatment, Continuous feed
(initial), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Continuous feed
(subsequent), Metering pump, NA
Water recirculating system treatment, Continuous feed
(subsequent), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(initial), Metering pump, NA
Water recirculating system treatment, Intermittent (slug)
(initial), NOL, NA
EIF: Not applicable for this use
Water recirculating system treatment, Intermittent (slug)
(subsequent), Metering pump, NA
Water recirculating system treatment, Intermittent (slug)
(subsequent), NOL, NA
EIF: Not applicable for this use
Water treatment, Continuous feed (initial), NOL, NA
EIF: Not applicable for this use
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
1 W
<1 V
< 1 W
1V
1 W
< 1 V
1 W
1 V
24 W
19V
24 W
19V
24 W
19V
24 W
7V
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Proper ventilation required. Do not apply in marine and/or
estuarine oil fields. NPDES license restriction. Do not
discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction). Preclean claim.
NPDES license restriction. Preclean claim.
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim. Do not apply in marine and/or
estuarine oil fields. NPDES license restriction.
NPDES license restriction. Preclean claim.
NPDES license restriction. Proper ventilation required. Do
not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction). Preclean claim. Do not apply in
marine and/or estuarine oil fields.
NPDES license restriction. Preclean claim.
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim. Do not apply in marine and/or
estuarine oil fields. NPDES license restriction.
Preclean claim. NPDES license restriction.
-------
APPENDIX A- Case 3056, [Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Application Application Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
Minimum
Application
Rate
(ppma.i.)
Maximum
Application
Rate
(ppma.i.)
Max.*
Apps.
Max.*
Apps. ®
Max. Rate
Min. Interval
Between Apps.
& Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Lim tations
Allowed
Disallowed
Use Pattern Limitations
USES ELIGIBLE FOR R E R E G I ST R AT I O N
Site: Pasteurizer/Warmer/Cannery Cooling Water Systems (Use Group: INDOOR NON-FOOD) (Continued from previous page)
Water treatment, Intermittent (slug) (initial), NOL, NA
Water treatment, Intermittent (slug) (subsequent), NOL,
NA
SC/L
SC/L
1 V
<1 V
7V
2V
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
Site: Pulp/Paper Mill Water Systems (Use Group: AQUATIC NON-FOOD INDUSTRIAL)
Water treatment, Continuous feed (initial), Drip-feed
device, NA
Water treatment, Continuous feed (initial), Metering pump,
NA
EIF: Not applicable for this use
Water treatment, Continuous feed (initial), NOL, NA
EIF: Not applicable for this use
Water treatment, Continuous feed (subsequent), Metering
pump, NA
EIF: Not applicable for this use
Water treatment, Continuous feed (subsequent), NOL,
NA
EIF: Not applicable for this use
Water treatment, Intermittent (slug) (initial), Metering
pump, NA
EIF: Not applicable for this use
SC/L
SC/L
SC/S
SC/L
SC/L
SC/S
SC/L
SC/L
NC
NC
12V
NC
2.4V
NC
NC
NC
96V
NC
36V
NC
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Preclean claim. NPDES license restriction.
Preclean claim.
NPDES license restriction.
Preclean claim. Proper ventilation required. NPDES license
restriction. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction).
Preclean claim. Proper ventilation required. NPDES license
restriction. Do not discharge effluent containing this pesticide
into sewage systems without notifying the sewage treatment
plant authority. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction).
Proper ventilation required. NPDES license restriction.
Preclean claim. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction).
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction). Preclean claim.
46
-------
APPENDIX A- Case 3056, [Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Application Application Application Surface
Type Timing Equipment ' Type
Efficacy Influencing Factor
Form
Minimum
Application
Rate
(ppma.i.)
Maximum
Application
Rate
(ppma.i.)
Max.*
Apps.
Max.*
Apps. ®
Max. Rate
Min. Interval
Between Apps.
® Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
USES ELIGIBLE FOR R E R E Gl ST R AT IO N
Site: Pulp/Paper Mill Water Systems (Use Group: AQUATIC NON-FOOD INDUSTRIAL) (Continued from previous
Water treatment, Intermittent (slug) (initial), NOL, NA
EIF: Not applicable for this use
Water treatment, Intermittent (slug) (subsequent),
Metering pump, NA
EIF: Not applicable for this use
Water treatment, Intermittent (slug) (subsequent), NOL,
NA
EIF: Not applicable for this use
Site: Secondary Oil Recovery Injection Water
Water treatment, Continuous feed (initial), Metering pump,
NA
EIF: Not applicable for this use
Water treatment, Continuous feed (subsequent), Metering
pump, NA
EIF: Not applicable for this use
Water treatment, Intermittent (slug) (initial), Metering
pump, NA
EIF: Not applicable for this use
SC/L
SC/L
SC/S
SC/L
12V
NC
6V
96V
NC
48V
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
page)
NA
NA
NA
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim. NPDES license restriction.
Proper ventilation required. NPDES license restriction.
Preclean claim. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or
public water (NPDES license restriction).
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Preclean claim.
(Use Group: AQUATIC NON-FOOD INDUSTRIAL)
SC/L
SC/L
SC/L
2W
<1 W
2W
16W
3W
16W
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NPDES license restriction. Preclean claim. Proper ventilation
required. Do not apply in marine and/or estuarine oil fields.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction).
NPDES license restriction. Preclean claim. Proper ventilation
required. Do not apply in marine and/or estuarine oil fields.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction).
NPDES license restriction. Prectean claim. Proper ventilation
required. Do not apply in marine and/or estuarine oil fields.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction).
47
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APPENDIX A - Case 3056, [Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Application Application Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
Minimum
Application
Rate
(ppma.i.)
Maximum
Application
Rate
(ppma.i.)
Max.*
Apps.
Max.*
Apps. 0
Max. Rate
Min. Interval
Between Apps.
& Max. Rate
(Days)
Restricted
Entry
Interval
USES ELIGIBLE FOR R E R EG ISTR ATION
Geographic
Limitations
Allowed
Site: Secondary Oil Recovery Injection Water (Use Group: AQUATIC NON-FOOD INDUSTRIAL) (Continued from previous
Water treatment, Intermittent (slug) (subsequent),
Metering pump, NA
EIF: Not applicable for this use
Water treatment, NOL, NOL, NA
EIF: Not applicable for this use
SC/L
SC/L
2W
2W
16 W
100 W
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
Disallowed
Use Pattern Limitations
page)
NA
NA
Proper ventilation required. NPDES license restriction. Do
not apply in marine and/or estuarine oil fields.
NPDES license restriction.
Site: Sewage Systems (Use Group: AQUATIC NON-FOOD INDUSTRIAL)
Water treatment, Continuous feed (initial), Metering pump,
NA
EIF: Not applicable for this use
Water treatment, NOL, NA, NA
EIF: Not applicable for this use
SC/L
SC/S
<1 W
NC
2W
NC
NS
NS
NS
NS
Site: Specialty Industrial Products (Use Group: INDOOR NON-FOOD)
Industrial preservative treatment, During manufacture,
NOL, NA
EIF: Not applicable for this use
Industrial preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
Preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
SC/L
SC/L
SC/L
NC
NC
40 W
NC
NC
160W
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NPDES license restriction.
NPDES license restriction.
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NPDES license restriction.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction).
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction).
Site: Wet-End Additives/Industrial Processing Chemicals (Use Group: INDOOR NON-FOOD)
Industrial preservative treatment, During manufacture,
NOL, NA
EIF: Not applicable for this use
Industrial preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
SC/L
SC/L
NC
NC
NC
NC
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NPDES license restriction.
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage treatment plant
authority. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
(NPDES license restriction).
48
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APPENDIX A- Case 3056
Application Applcation Application Surface
Type Timing Equipment Type
Efficacy Influencing Factor
Form
[Dibromo-3-nitrilopropionamide] Chemical 101801 [2,2-Dibromo-3-nitrilopropionamide]
Minimum
Application
Rate
(ppma.i.)
Maximum
Application
Rate
(ppma.i.)
Max.*
Apps.
Max.*
Apps. O
Max. Rate
Min. Interval
Between Apps.
& Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
USES ELIGIBLE FOR R E R E G 1 ST R AT 1 O N
Site: Wet-End Additives/Industrial Processing Chemicals (Use Group: INDOOR NON-FOOD) (Continued from previous page)
Preservative treatment, NOL, NOL, NA
EIF: Not applicable for this use
SC/L
40 W
160W
NS
NS
NS
NS
NA
NA
Proper ventilation required. Do not discharge effluent
containing this pesticide into sewage systems without notifying
the sewage treatment plant authority. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction).
Abbreviations used
Header:
Form:
Rate:
Geographic limitations:
In general:
ppm a.i. = parts per million of active ingredient; Max. # Apps. = maximum number of applications
Max. # Apps. @ Max. Rate = maximum number of applications at maximum rate
Min. Interval Between Apps. © Max. Rate (Days) = minimum interval between applications at maximum rate (in days)
SC/S = Soluble Concentrate/Solid; SC/L = Soluble Concentrate/Liquid
W = calculated by weight; V = calculated by volume; NC = not calculated
MO = Missouri
NOL = not on the label; NA = not applicable; NS = not specified
49
-------
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
51
-------
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case covered by this Reregistration Eligibility Decision Document. It
contains generic data requirements that apply to in all products, including data requirements for
which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been assigned.
Refer to the Bibliography appendix for a complete citation of the study.
53
-------
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of DBNPA
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
152342
143344
152342
143344
152342
143344
152342
143344
152342
143344
152342
143344
152342
143344
152342
143344
152342
143344
152342
143344
WAIVED
152342
143344
55
' Indicates study has been classifed by the Agency as supplemental.
-------
Data Supporting Guideline Requirements for the Rereeistration of DBNPA
REQUIREMENT
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
Oxidizing/Reducing Action
Flanunability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion characteristics
Dielectric breakdown volt
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
152342
143344
41711703
152342
143344
42358601
41711702
152342
143344
41733301
152342
42158801
152342
143344
143344
Required as part of Product Specific DCI
WAIVED
Required as part of Product Specific DCI
143344
Required as part of Product Specific DCI
Required as part of Product Specific DCI
Required as part of Product Specific DCI
Required as part of Product Specific DCI
143344
Required as part of Product Specific DCI
Required as part of Product Specific DCI
56
* Indicates study has been daoUed by the Agency as supplemental.
-------
Data Supporting Guideline Requirements for the Reregistration of DBNPA
REQUIREMENT
64-1
71-1A
71-1B
71-2A
71-2B
72-1A
72-1B
72-1C
72-2A
72-2B
72-3A
72-3B
72-3C
Submittal of Samples
Acute Avian Oral - Quail/Duck
Acute Avian Oral - Quail/Duck TEP
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Bluegill - TEP
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Invertebrate Toxicity - TEP
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
Estuarine/Marine Toxicity • Shrimp
USE PATTERN
ALL
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
CITATION(S)
151654
25586
151656
123204
25586
151656
123204
25586
123205
151657
104507
104507
151658
104507
151659
73951*
73951
96362*
41669702
41711701*
25605
41669702
25605*
57
* Indkates study has been classifed by the Agency as supplemental.
-------
Data Supporting Guideline Requirements for the Reregistration of DBNPA
REQUIREMENT
72-3F
72-4A
Estuarine/Marine Toxicity Shrimp - TEP
Early Life Stage Fish
USE PATTERN
FM
FM
CITATION(S)
25605
40195701
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-3
83-3B
84-2A
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Feeding - Rodent
90-Day Dermal - Rodent
Developmental Toxicity - Rabbit
Gene Mutation (Ames Test)
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
143642
136724
143639
136724
41026502
143640
136724
143641
118427
136724
148622
118427
88180
41026503
41662201
41508301
157754
157756
148623
118425
118426
42387101
58
* Indkates study has been classifed by the Agency as supplemental.
-------
Data Supporting Guideline Requirements for the Reregistration of DBNPA
REQUIREMENT USE PATTERN
84-2B
84-4
Structural Chromosomal Aberration FM
Other Genotoxic Effects FM
CITATION(S)
41034701
157754
118425
41565001
41125801
41034701
157755
118425
ENVIRONMENTAL FATE
160-5
161-1
161-2
162-3
162-4
Chemical Identity FM
Hydrolysis FM
Photodegradation - Water FM
Anaerobic Aquatic Metabolism FM
Aerobic Aquatic Metabolism FM
152342
127730
127730
41924901
127730
41924902
42358602
41828301
42358603
163-1
Leaching/Adsorption/Desorption
FM
41828301
59
* Indkales study has been classifed by the Agency as supplemental.
-------
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of DBNPA
61
-------
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Decision document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
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 the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
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 identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the first
submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced the
date from the evidence contained in the document. When the date appears as
(19??), the Agency was unable to determine or estimate the date of the document.
63
-------
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume 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.
64
-------
BIBLIOGRAPHY
MRID
CITATION
00025586 Norris, J.M.; Kociba, R.; Bourne, I.E. (1971) Acute Oral Lethality of
Dibromonitrilopropionamide in Mallard Duck and Bobwhite Quail.
(Unpublished study received Jun 11,1974 under 464-426; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:241465-E)
00025605 Heitmuller, T. (1976) Acute Toxicity of XD- 1603L to Embryos of Eastern
Oysters (Crassostrea virginica), to Pink Shrimp (Penaeus duorarum), and to
Fiddler Crabs (Uca pugilator): GH-RC-78. (Unpublished study received Jun 17,
1976 under 464-426; prepared by EG&G, Bionomics, submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:241465-AF)
00073951 Batchelder, T.L.; McCarty, W.M. (1977) Toxicity of
2,2-Dibromo-3nitrilopropionamide (DBNPA) to Daphnids. (Unpublished study
received Oct 5,1977 under 464-426; submitted by Dow Chemical U.S.A.,
Midland, Mich.; CDL:231982-A)
00088180 Rampy, L.W.; Hefner, R.E. (1972) Guinea Pig Skin Sensitization Study
Conducted on Dibromonitrilopropionamide: NB Tl 1.10-7814111. (Unpublished
study received Nov 4, 1981 under 464-426; submitted by Dow Chemical U.S.A.,
Midland, Mich.; CDL:246329-A)
00096362 Heitmuller, T. (1980) Acute Toxicity of XD-1603L to Sheepshead Minnows
(Cyprinodon variegatus): Report No. BP-80-11-216. (Unpublished study received
Feb 5, 1981 under 464-389; prepared by EG & G Bionomics, submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:244284-A)
00104507 Sterner, P. (1971) Acute Toxicity of DBNPA to Bluegill... and Rainbow Trout
(Salmo gairdneri). (Unpublished study received Feb 1, 1972 under 464-426;
submitted by Dow Chemical U.S.A., Midland, MI; CDL:003657-D)
00118425 Davis, P. (1982) An Investigation into the Induction of Sisterchromatid
Exchanges by Slimicide XD 7287: GHE-T-060-K-078141. (Unpublished study
received Nov 23, 1982 under 464-426; prepared by Netherlands Organization for
Applied Scientific Research, submitted by Dow Chemical U.S.A., Midland, MI;
CDL:248895-A)
00118426 De Raat, W. (1982) The Mutagenicity of DBNPA Dissolved in Polyethylene
Glycol in the Ames-test: GHE-T-063-K-78141. (Unpublished study received
Nov 23, 1982 under 464-426; prepared by Netherlands Organization for Applied
65
-------
BIBLIOGRAPHY
MRID
CITATION
Scientific Research, submitted by Dow Chemical U.S.A., Midland, MI;
CDL:248895-B)
00118427 McCartay, L. (1982) Skin Irritation and Skin Sensitization Potential of
Dibromonitrilopropionamide (DBNPA) in Human Volunteers:
HEB-DR-0076-4669-1. (Unpublished study received Nov 23,1982 under
464-426; submitted by Dow Chemical U.S.A., Midland, MI; CDL:248895-C)
00118432 Mayes, M.; Blanchard, F.; Hopkins, D.; et al. (1982) The Static Acute Toxicity of
Dibromonitrilopropionamide (DBNPA) and Its Degradation Products to the
Fathead Minnow (Pimephales promelas Rafinesque): ES-559. (Unpublished
study received Nov 23, 1982 under 464-426; submitted by Dow Chemical
U.S.A., Midland, MI; CDL:248896-E)
00123204 Fink, R. (1975) Eight-day Dietary LC50-Bobwhite Quail: XD-1603L: Project
No. 103-139. Final rept. (Unpublished study received 1975 under 464-426;
prepared by Truslow Farms, Inc., submitted by Dow Chemical U.S.A., Midland,
MI; CDL:241463-D)
00123205 Fink, R. (1975) Eight-day Dietary LC50-Mallard Ducks: XD-1603L: Project No.
103-140. Final rept. (Unpublished study received 1975 under 464-426; prepared
by Truslow Farms, Inc., submitted by Dow Chemical U.S.A., Midland, MI;
CDL:241463-E)
00127730 Exner, I; Kyriacou, D.; Burk, G.; et al. (1971) Rates and Products of
Decomposition of... DBNPA: BP-5120-9. (Unpublished study received Sep 10,
1975 under 464-426; submitted by Dow Chemical U.S.A., Midland, MI;
CDL:224079-C)
00136724 Norris, J.; Dunn, F. (1970) Acute Toxicological Properties of NC1603, an
Industrial Antimicrobial: Eye and Skin Toxicity on Rabbits. (Unpublished study
received May 21,1970 under 464389; submitted by Dow Chemical U.S.A.,
Midland, MI; CDL: 003604-B)
00143344 Eldan, M. (1985) Biobrom C-103 Product Chemistry Data Submitted in Support
of Registration. Unpublished compilation prepared by Dead Sea Bromine Co.
Ltd. 93 p.
00143639 Nissimov, S. (1984) C-103 TECH: Acute Dermal Toxicity in Rabbits: LSRI
66
-------
BIBLIOGRAPHY
MRID
CITATION
Report No. DSB/039/C-103 TECH. Unpublished study prepared by Life
Sciences Research Isreal Ltd. 13 p.
00143640 Nissimov, S. (1983) C-103 TECH: Acute Eye Irritation/Corrosion Study in
Rabbits: LSRI Report No. DSB/040/C-103 TECH. Unpublished study prepared
by Life Science Research Isreal Ltd. 13 p.
00143641 Nissimov, S. (1983) C-103 TECH: Primary Dermal Irritation Study in Rabbits:
LSRI Report No. DSB/037/C-103 TECH. Unpublished study prepared by Life
Science Research Israel Ltd. lip.
00143642 Nissimov, S. (1983) C-103 TECH: Acute Oral Toxicity in the Rat: LSRI Report
No. DSB/036/C-103 TECH. Unpublished study prepared by Life Science
Research Israel Ltd. 19 p.
00148622 Nissimov, S. (1984) Delayed Contact Hypersensitivity Study in Guinea Pigs:
C-103 Tech: Report No. DSB/043/C-103 TECH. Unpublished study prepared by
Life Science Research Israel Ltd. 16 p.
00148623 Evenchik, Z. (1985) Assessment of Mutagenic Potential in Histidine Auxotrophs
of Salmonella typhimurium (The Ames Test): C-103: LSRI Report No.
DSB/062/C-103. Unpublished study prepared by Life Science Research Israel
Ltd. 22 p.
00151654 Beavers, J. (1984) An Acute Oral Toxicity Study in the Bobwhite with Biobrom
C-103: Final Report: Project No. 191-103. Unpublished study prepared by
Wildlife International, Inc. 16 p.
00151656 Beavers, J. (1984) A Dietary LC50 Study in the Bobwhite with Biobrom C-103:
Final Report: Project No.: 191-101. Unpublished study prepared by Wildlife
International Ltd. 15 p.
00151657 Forbis, A.; Burgess, D. (1984) Acute Toxicity of C-103 to Bluegill Sunfish
(Lepomis macrochirus): Static Bioassay Report #31365. Unpublished study
prepared by Analytical Bio-chemistry Laboratories, Inc. 52 p.
00151658 Forbis, A.; Burgess, D. (1984) Acute Toxicity of C-103 to Rainbow Trout: Static
Acute Toxicity Report #31366. Unpublished study prepared by Analytical
Bio-chemistry Laboratories, Inc. 54 p.
67
-------
BIBLIOGRAPHY
MRID
CITATION
00151659
00152342
00157754
00157755
00157756
40195701
40195702
41034701
41026502
Forbis, A.; Burgess, D. (1984) Acute Toxicity of C-103 to Daphnia magna: Static
Acute Bioassay Report #31367. Unpublished study prepared by Analytical
Bio-chemistry Laboratories, Inc. 33 p.
Dow Chemical Co. (1985) Product Chemistry Data for
2,2-Dibromo3-nitrilopropionamide. Unpublished compilation. 152 p.
Bruce, R.; Gollapudi, B.; Wilkerson, J. (1985) Evaluation of
2,2-Dibromo-3-nitrilopropionamide (DBNPA) in the Mouse Bone Marrow Test:
TXT:K-078141-020. Unpublished study prepared by Dow Chemical Co. 28 p.
Mendrala, A. (1985) The Evaluation of 2,2-Dibromo-3-nitrilopropionamide in the
Rat Hepatocyte Unscheduled DNA Synthesis Assay: HET K-078141-021.
Unpublished study prepared by Dow Chemical U.S.A. 23 p.
Mendrala, A. (1985) Evaluation of 2,2-Dibromo-3-nitrilopropionamide in the
Chinese Hamster Ovary Cell/Hypoxanthine (Guanine) Phosphoribosyl
Transferase (CHO/HGPRT) Forward Mutation Assay: HET K-078141-022.
Unpublished study prepared by Dow Chemical U.S.A. 17 p.
Surprenant, D. (1986) The Toxicity of Biobrom C-103 to Rainbow Trout (Salmo
gairdneri) Embryos and Larvae: Report #BW-86-l 12195: Study
#11192-0585-6100-121. Unpublished study prepared by Springborn Bionomics,
Inc. 45 p.
Surprenant, D. (1986) The Chronic Toxicity of Biobrom C-103 to Daphnia
magna Under Flow-through Conditions: Report #BW-86-122250: Study
#11192.0585.6100.130. Unpublished study prepared by Springborn Bionomics,
Inc. 49 p.
Enninga, I. (1989) Evaluation of the Ability of 2,2-dibromo-3nitrilpropionamide
to Induce Chromosome Aberrations in Cultured Peripheral Human Lymphocytes:
Study No. 008459. Unpublished study prepared by RCC Notox B.V. 23 p.
American Biogenics Corporation (1987) Four Hour Acute Dust Aerosol
Inhalation Toxicity Study in Rats of Biobrom C-103: Study 420-883.
Unpublished study. 37 p.
41026503 Life Science Research Israel Ltd. (1986) Biobrom C-103: Repeated Dose Oral
68
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BIBLIOGRAPHY
MRID
CITATION
Toxicity in the Rat: A 13-week Subchronic Study: DSB/087/BBR. Unpublished
study. 208 p.
41125801 Fautz, R. (1989) CCR Project 145405: Unscheduled DNA Synthesis in Primary
Hepatocytes of Male Rats in vitro with Biobrom C-103: Report. Unpublished
study prepared by Laboratory for Mutagenicity Testing. 25 p.
41508301 Rubin, Y.; Nyska, A. (1990) Biobrom C-103 Teratology Study in the Rabbit:
Lab Project Number: LSRIDSB/089/BBR. Unpublished study prepared by Life
Science Research Israel, Ltd. 187 p.
41565001 Bromine Compounds Ltd. (1990) Unscheduled DNA Synthesis in Primary
Hepatocytes of Male Rats in vitro ; Study No. 145405-MRID 41125 801:
Identification of the Test Material: Lab Project Number: 83 41/90. Unpublished
study prepared by Bromine Compounds Ltd. 4 p.
41662201 Mitzell, M.; Firchau, H.; Kociba, R. (1990) 2,2-Dibromo-3-nitrilopropionamide
(DBNPA): 13 Week Dermal Toxicity Study in Fischer 344 Rats: Lab Project
Number: K/078141/028. Unpublished study prepared by The Toxicology
Research Laboratory. 391 p.
41669701 Sousa, J. (1990) DBNPA-Acute Toxicity to Mysid Shrimp (Mysidopsis bahia)
under Flow-Through Conditions: Lab Project Number: 90-83450:
11192.0590.6107.515. Unpublished study prepared by Springborn Labs, Inc. 45
P-
41669702 Sousa, J. (1990) DBNPA-Acute Toxicity to Sheepshead Minnow (Cyprinodon
variegatus) under Flow-Through Conditions: Lab Project Number: 90-08-3441:
11192.0590.6107.505. Unpublished study prepared by Springborn Labs, Inc. 45
P-
41711701 Dionne, E. (1990) Biobrom C-103
(DBNPA,2,2-DIbromo-3-Nitrilopropionamide) Acute Toxicity to Eastern Oysters
(Crassostrea Virginica) Under Flow-through Conditions: Lab Project Number:
SLI 9010-3509: 11192.0590.6107.504. Unpublished study prepared by
Springborn Laboratories, Inc. 41 p.
41711702 Smith, A. (1990) Biobrom C-103 (DBNPA,
2,2-Dibromo-3-Nitrilopropionamide)-Determination of the Dissociation Constant:
69
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BIBLIOGRAPHY
MRID
CITATION
Lab Project Number: SLI 90-10-3523: 11192-0590-6106-795. Unpublished
study prepared by Springborn Laboratories, Inc. 27 p.
41711703 Fackler, P. (1990) Biobrom C-103 (DBNPA, 2,2-Dibromo-3-Nitrilopropi
onamide): Determination of Water Solubility: Lab Project Number: SLI
90-10-3501: 11192-0590-6106-700. Unpublished study prepared by Springborn
Laboratories, Inc. 36 p.
41733301 Weeden, D. (1990) Biobrom C-103 (DBNPA,
2,2-Dibromo-3-Nitrilopropionamide)-Determination of the N-Octanol/Water
Parttion Coefficient: Lab Project Number: 90-10-3520: 11192.0590.6106.705.
Unpublished study prepared by Springborn Laboratories, Inc. 33 p.
41828301 Weeden, D. (1991) Biobrom C-103: (DBNPA,
2,2-dibromo-3-nitrilopropionamide): Determination of the Adsorption and
Desorption Coeffcients: SLI Report: 90-10-3524; SLI Study No.
11192-0590-6110-710: Final Report. Unpublished study prepared by Springborn
Laboratories, Inc. 51 p.
41924901 Fackler, P. (1991) Biobrom C-103
(DBNPA,2,2-Dibromo-3-Nitrilopropionamide) Hydrolysis Study: Final Report:
Lab Project Number: SLI 90-12-3595; 11192.0590.6108.715. Unpublished study
prepared by Springborn Labs, Inc. 82 p.
41924902 Smith, A. (1991) Biobrom C-103 (DBNPA,2,2-Dibromo-3-Nitrilopropionamide)
Photodegradation in Water: Final Report: Lab Project Number: SLI 90-10-3522:
11192.0990.6109.720. Unpublished study prepared by Springborn Labs, Inc. 96
P-
42358602 Smith, A. (1992) Biobrom C-103 (DBNPA, 2,2-dibromo-3-nitrilopropionamide)
Determination of the Anaerobic Aquatic Metabolism: Final Report: Lab Project
Number: 91-10-3952: 11192. 0590. 6111. 755. Unpublished study prepared by
Springborn Laboratories, Inc. 54 p.
42358603 Smith, A. (1992) Biobrom C-103 (DBNPA, 2, 2-dibromo-3-nitrilopropionamide)
Determination of the Aerobic Aquatic Metabolism: Final Report: Lab Project
Number: 91-10-3951: 11192.0590.6111.750. Unpublished study prepared by
Springborn Laboratoris, Inc. 55 p.
70
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BIBLIOGRAPHY
MRID CITATION
42387101 Lehrer, S. (1992) Biobrom C-103 (DBPNA)...Assessment of Mutagenic Potential
in Histidine Auxotrophs of Salmonella Typhimurium (The Ames Test): Revised
Final Report: Lab Project Number: DSB/135/BIO. Unpublished study prepared
by Life Science Research Israel Ltd. 38 p.
71
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APPENDIX D. List of Available Related Documents
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The following is a list of available documents related to DBNPA. It's purpose is to provide
a path to more detailed information if it is needed. These accompanying documents are part of the
Administrative Record for and are included in the EPA's Office of Pesticide Programs Public
Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
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APPENDIX E. PR Notices 86-5 and 91-2
77
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PR Notice 86-5
79
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Pers9ns responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements f9r granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d)(l). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the
submitter for necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
81
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entire proposed regulation becomes final. Adequate lead time is
being provided for. submitters to comply with the new
requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be cpmpatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional costs and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting intp the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list of all applicable
data requirements and an indication of how each is satisfied—the
statement of the method of support f9r the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements
follows the index on the next page, and samples of some of the
requirements are attached. Except for the language of the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page . ., „„..„„.. 7 12
82
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D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(l)) 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(D) 8 14
D. 5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies .... 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time for review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted—i.e., a registration application,
petition, experimental use permit (EUPj, §3(c)(2)(B) data
call-in, §6(a)(2) submittal, 9r a special review; the transmittal
date; and a list of all individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
83
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application for an EUP should be subdivided into sections A B
';Ti'coio£ne Petition or application, as defined in 40 CFR 180.7
on£fj- ••I25' (Petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and
an application for a registration or an EUP, list the petition"
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study.slKmld be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C.I. Each study included in a submittal
Eackage must.be bound as a separate entity. (See comments on
inding studies on page 9.)
^t. *.Ea?h studV must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250) .
- Include a company name or mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies
When a single study is extremely long, binding it in mul-
tiple V9lumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical C9ntrol data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
. , .b- Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
84
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produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
C9nventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second W9uld cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A), (B), or (C), and if so must be handled as described
in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
iKwever, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single cr9p or from processing a
single crop. When more than one commodity is derived from a
single crop (such as beet tops and beet roots) residue data on
all such C9mmodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element When Required Example
Study Title Page Always Page 12
Statement of Data One of the two alternative Page 13
Confidentiality forms of this statement
Claims is always required
Certification of Good If study reports laboratory Page 16
Laboratory Practice work subject to GLP require-
ments
Flagging statements For certain toxicology studies (When
flagging requirements are finalized.)
Body of Study Always - with an English language
translation if required.
Study Appendices At submitter's option
Cover Sheet to Confi- If CBI is claimed under FIFRA
dential Attachment §10(d)(1)(A), (B), or (C)
CBI Attachment If CBI is claimed under FIFRA
§10(d)(1)(A), (B), or (C) Page 15
Supplemental Statement Only if confidentiality is Page 14
of Data Confidentiality claimed on a basis other than
Claims FIFRA §10(d)(1)(A), (B), or (C)
85
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D.I. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number(s)of the specific requirement(s) addressed by
the study.
c. Auth9r(s). Cite only individuals with primary intellectual
responsibility for the C9ntent 9f the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study.If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory IdentificatJ9n. If the study reports
work done by one or more laboratories,Include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the W9rk. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include 9n the title page elements a. through d. for the
previ9usly submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number 9f the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary study. Do not include supplements to more than one
study under a single title page).
Facts of Publication. If the study is a reprint of a pub-
ished d9cument, identity on the title page all relevant facts of
publication, such as the J9urnal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d)(1).
Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3). These statements apply only to claims of data
confidentiality based on FIFRA §10(d)(1)(A), (B), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or
to waive such a claim (§158.33(c)). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. 09 not make CBI
claims with respect to analytical methods associated with pet-
86
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itions for tolerances or emergency exemptions (see NOTE Pg 13).
D.3. Confidential Attachment
If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
§10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body 9f the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5).
The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page. Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d)(1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10(d)
(1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement 9f Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the'points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it.- A copy
of the title page plus the MRID number (if known) is sufficient
to allow us t9 retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies srKmld not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
F. Physical Format Recruirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black ink, with high contrast and good res9lution. Bindings for
individual studies' must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
87
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any medium
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not.include carbon copies, or copies in other than
black ink.
• Make sure that photocopies are clear, complete, and
• Do not include oversize computer printouts or fold-out
pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
... Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The prop9sed regulations specified two copies; three
are now.being required to expedite and reduce the cost of
processing data.into the OPP Pesticide Document Management System
and getting it into review.)
G- Special Requirements for Submitting Data to the Docket
j j Data submittal Packages associated with a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data
Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d)(1)(A), (B), or (C). Do not
close up or paraphrase text remaining after this
excision.
Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential"
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V.
For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1
Attachment 2
Attachment 3
Attachment 4
Attachment 5
Attachment 6
Attachment 7
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality
Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
Name and address of submitter (or all joint submitters**)
£?\£°<5P°ra£iasi * Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 cSvingtSn? K? 56789
+Smith Chemical Corp will act as sole agent for all submitters.
2- Regulatory action in support of which this package is
Ufe fc£e EPA .identification number (e.g. 359-EUP-67) if you know
^ n2S3EW1S!;i-desCTftb? the ^YPS °f rec3uest ^.g. experimental
use permit, data call-in - of xx-xx-xx date) .
3 . Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No . )
Vol n Title of nth study in the submittal (Guideline
No . )
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:
Name Signature
Company Name
Company Contact:
Name Phone
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Reoruirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Proiect ID
ABC 47-79
Page 1 of X
(X 'is the total number of pages in the study)
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10 (d) (1) (A), (B), or (C) .
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d) (1) (A), (B), or (C) .
Company
Company Agent: Typed Name Date:.
Title ' Sionature
2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:.
Title . Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical
Meth9ds Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1) (A) , (B), or (C), but for which you claim
C9nfidential treatment 9n another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
• Identify specifically by page and line number(s) each
portion of the study for which you claim
confidentiality.
*
• Cite the reasons why the cited passage qualifies for
confidential treatment.
• Indicate the length of time—until a specific date or
event, or permanently--for which the information should
be treated as confidential.
• Identify the measures taken to guard against undesired
disclosure of this information.
• Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
• Encl9se C9pies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
• If y9u assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe ttupse harmful effects and explain why
they should be viewed as substantial.
• If you assert that the informati9n in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED WORDS OR PHRASE: Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED PARAGRAPH(S):
( )
( Reproduce the deleted paragraph(s) here )
( )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process §10(d)(l)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process §10(d)(l)(A)
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Ex
Submitter
am
Sponsor
5le
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1..
2..
3.
Submitter,
Sponsor
Study Director.
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmtttal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submrttal
(e.g., summaries of groups of studies
v to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
•Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
LEGEND
Pa9e of *• Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
* When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
96
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PR Notice 91-2
97
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98
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Pr9gram's pplicy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient{s), as that term
is defined in 40 CFR 158.153(i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
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section 12(a)(l)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used tor
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is imp9rtant for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(l)(C).
Ill. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. C9pies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to pr9vide certified limits
f9r each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) 9nly) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may n9t be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to C9ntrol pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
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requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) above will have until July 1, 1997, to
comply with this N9tice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Product Specific Data Call-In
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DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth 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 01 all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
(expiration date 12-31-92).
This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section n - Data Required By This Notice
Section IE - 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
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The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - rroauct-speciric Data L'all-ln Response Form
3 - Kequiremenis status and Registrant's Response Form
4 - zrA uroupmg or ^no-Use Products for Meeting Acute Toxicology Data
Kequiremenis for Keregistration - - — -
5 - EPA Acceptance untena
6 - MSI ot Registrants Receiving This Notice
7 ' t-;ost snare ana uata uompensation forms, and Product Specific Data Report
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 tms Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided. ~ " -
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
~™^. ~PA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
oc,ols aPProved by the Organization for Economic Cooperation and Development
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)].
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II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
die requirements of any previous Data Call-lnCs). 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 or 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.
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 vanous options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-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 6. 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 horm unless the voluntary
cancellation option is selectea or unless theproduct 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 sausry 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
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Requirements Status and Registrant s Response Form and item numbers 7a and 7b on the Data
uau-in Response horm. Deletion ot a use(s) ana me low volume/minor use option are not vaM
options lor rumiimg product specific data requirements.
.. 3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in section iii-u or tms 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 wen as any otner mtormation/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 pffers 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 witn 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 tor me submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
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Option 2, Agreement to Share in Cost to Develop Data - Registrants may only choose
this option tor acute toxicity data and certain etiicacy 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 optiormf 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 devebping 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 9ther 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 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 suoject 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 tms Notice, you must determine mat the study satisfies the requirements imposed by
this Notice. Y9u 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:
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a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160
As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments "
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
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 oelieves 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
upgradeaoie, 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
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specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number or 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 m>A, 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 whp 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 etticacy (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.
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:
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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 ni-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
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,
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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 referencecf 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 st9cks" provisi9n is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any~additional time to sell, distribute, or use
existing stocks beyond a year from die 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
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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 /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. It the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated-in-response to this Notice.
xely yours/'
v
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-In Chemical Status Sheet
2 - Froduct-Specitic Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
tef
Requirements tor Keregistration
4 - fcFA Grouping ot End-Use Products for Meeting Acute Toxicology Data
1
5 - bsFA Acceptance Criteria
6 - List ot Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
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Attachment 1. Chemical Status Sheet
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DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing DBNPA.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by tms notice, and point ot contact tor inquiries pertaining to the rereeistration of . 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 are contained in the
Requirements Status and Registrant's Response, Attachment 3. The Agency has concluded that
additional data on are needed lor 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 products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of , please contact at (703) 308-.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Franklin Gee at (703) 308-8008. or Veronica Dutch at
(703) 308-8585.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Attn: Veronica Dutch,
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: DBNPA 3056, 101801
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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DRAFT COPY
Page 1 of
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case # and Name
SAMPLE COMPANY 3056 Dibromo-3-nitrilopropionami
NO STREET ADDRESS
NO CITY, XX 00000
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a. I am claimimg a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
Data
7a. My product is a MUP and
I agree to satisfy the MUP
requirements on the attached
form . entitled "Requirements
Status and Registrant's
Response."
8. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both undar applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
9. Date
11.
Phone Number
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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 or 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 registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes. If you are
requesting a data waiver, answer yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with Option
7 (Waiver Request) for each study for which you are requesting a waiver. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-in Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, SubpartC.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-in Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a cppy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
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"Certification of Offer to Cost Share in the Development Data" form. I am
including a copy of my offer and proof of the other registrant's receipt of that offer.
I am identifying the party which is committing to submit or provide the required data;
if the required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-In Notice
(Section III-C.l.) apply as well. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (z) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
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. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
6. By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Studv). If I am citing another registrant's study, I
understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number(s) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5]. I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request, I
will not be required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If
the Agency denies my waiver request, I must choose a method of meeting the data
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requirements of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a revised
Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original
data call-in notice will not change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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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 19 support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, Subpartc.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/ or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9.
Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed 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 optipn. 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).
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 nave 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 Develppment 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.
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4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anypne (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 informati9n 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 mat the conditions for
this Option outlined Option 5 in the Data Call-In Notice (Section in-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. Nptice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request. If the Agency approves my waiver
request, I will not be 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.
126
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u * A r x u u v x Page i Of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
Use additional sheet (s) if necessary.
1. Company name and Address 2. Case t and Name 3. Date mA y^ of DCI
SAMPLE COMPANY 3056 Dibromo-3-nitrilopropionami PRODUCT SPECIFIC
NO STREET ADDRESS ID# NNNNNN-RD-NNNN
NO CITY, XX
4. Guideline
Requirement
Number
61-1
61-2(a)
61-2(b)
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
00000 EPA Reg. No. NNNNNN-NNNNN
5. Study Title
Prod Che* - Regular rhtwlml
Product identity £ composition (1)
Dascriptn starting materials, (1,2)
productn S formulatn
process
Discussion of formation of (1,3)
impurities
Preliminary analysis (1/4)
Certification of limits (1.5)
Analytical method (1)
Color
Physical state
Odor
Melting point (6)
Boiling point (7)
Density
R
0
T
O
C
O
I,
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNQ
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCUEFGRIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCOEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test
Substance
MP/EP
MP/EJ* an
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DRAFT COPY
Page 2 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
81-1
81-2
81-3
5. Study Title
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition (8)
coefficient
pH (9)
Stability
Oxidizing or reducing action (10)
Plammaisiiity (11)
Explodability (12)
Storage stability
Viscosity (13)
Miscibility 114}
Corrosion characteristics
Dielectric breakdown voltage (15)
the attached instructions and supply the
2. Case # and Name
information requested
3056 Dibromo-3-nitrilopropionami
EPA Reg. No. NNNNNN-NNNNN
Acute oral toxicity-rat (1,36,37)
Acute dermal (1,2,37)
toxieity-rabbiVrat
Acute inhalation toxicity-rat (3)
Initial to indicate certification as to information on this page
(full text of certification is on page one).
p
R
0
T
0
C
o
L
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDE FGH I JKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGH I JKLMNO
ABCDEFGHIJKLMNO
ABCDEFGH I JKLMNO
ABCDEFGHIJKLMNO
ABCJ3EFGHI JKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
Substance
TGAI/PAI
TGAI/PAI
TGAI/PAI
PAI
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
and TGAI
and TGAI
and TGAI
and TGAI
8. Time
Frame
8 mos.
8 mos .
8 mos.
8 mos.
8 mos .
8 mos .
8 mos .
8 mos.
8 mos.
8 mos.
8 mos .
8 mos.
8 mos .
8 mos.
8 mos.
8 mos .
8 mos.
9. Registrant
Response
Date
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DRAFT COPY
Page 3 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet (s) if necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
81»4
81-5
81-6
the attached instructions and supply the information requested
2. Case # and Name
3056 Dibromo-3-nitrilopropionami
EPA Reg. No. NNNNNN-NNNNN
5. Study Title
Primary eye irtitatian-rabfcit {2}
Primary dermal irritation (1.2)
Derail sens! tizat ion <4)
F
R
O
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGH I JKLMNO
ABCDEFGHIJKLMNO
Initial to indicate certification as to information on this page
(full text of certification is on page one).
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
7. Test
Substance
m/W?
MP/EP
MP/EP
8. Time
Frame
8 mos.
8 mos.
8 mos.
9. Registrant
Response
Date
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DRAFT COPY
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 3056 Dibromo-3-nitrilopropionami
Key: MP = manufacturing-use product; EP = end-use product; provided formulators purchase their active ingredient(s) 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;
TGAI = technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA - "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical
E - Aquatic nonfood outdoor
J - Forestry
O - Indoor residential
[The following notes are referenced in column two 15. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Prod Che» - Regular Chemical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed further in the following sections: *158.155 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 is 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 ingredients 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 analyzed. If the technical
grade of Active Ingredient cannot be isolated, a statement of composition of the practical equivalent of the technical grade of Active Ingredient must be submitted.
Data 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.
6 Required if technical chemical is solid at room temperature.
7 Required if technical chemical is liquid at room temperature.
8 Required if technical chemical is organic and non-polar.
9 Required if test substances are dispersible with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
14 Required if product is an emulsifiable liquid and is to be diluted with petroleum 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 material 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.
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DRAFT COPY
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 3056 Dibromo-3-nitrilopropionami
Footnotes (cont.):
3 Required if the product consists of, or under conditions of use will result in, an inhalable material (e. g., gas, volatile substances, or aerosol/particulate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
36 Special testing (acute, subchronic, and/or chronic) is required for organophospates, and may be required for other cholinesterase 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)(l).
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
127
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EPA'S BATCHING OF PRODUCTS CONTAINING 2.2-DIBROMO-3-NITRILO-
PROPIONAMIDE (DBNPA) 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 DBNPA, the Agency has batched
products which can be considered similar for purposes of acute toxicity. Factors considered in the
S9rting process include each product's active and inert ingredients (identity, percent composition and
biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettaole 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 accpmplished by the process described in the
preceding paragraph. Frequently acute toxicity data on individual products has been found to be
incomplete. Notwithstanding the batching process, the Agency reserves the right to require, at any
time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit, or cite
a single battery of six acute lexicological studies to represent afl the products within that
batch. It is the registrants' option to participate in the process with an other registrants, only some
of the other registrants, or only their own products within a batch, or to generate all the
required acute lexicological studies for each of Iheir own producls. If a registrant chooses to
generate the dala for a balch, he/she must use one of the products wilhin ihe balch as Ihe lesl
material. If a regislranl chooses to rely upon previously submitted acute loxicity data, he/she may
do so provided thai the dala 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 loxicity, and
the formulation has nol been significanlly altered since submission and acceptance of the acute
loxicily dala. Regardless of whelher new data is generated or existing data is cited, the regislranl
musl clearly identify Ihe material tested by its EPA registration number. If more than one
Confidential Statement Of Formula (CSF) exists for a producl regislration, the registranl musl
indicate Ihe formulation actually test ed by identifying ihe corresponding CSF.
In deciding how lo meel Ihe producl specific dala requiremenls, regislranis musl follow Ihe
directions given in ihe Dala Call-In Notice and ils attachment appended lo Ihe RED. The DCI
Notice conlains iwo response forms which are lo be completed and submitted to the Agency within
90 days of receipt The firsl form, "Dala Call-In Response," asks whelher ihe registrant will meet
Ihe dala requiremenls for each producl. The second form, "Requiremenls Slatus and Regislranl's
Response," lists the product specific data required for each producl, including ihe standard six acute
loxicily lesls. A regislranl who wishes lo participate in a balch musl decide whelher he/she will
provide Ihe dala or depend on someone else lo do so. If a regislrant supplies the dala lo supporl a
balch of producls, he/she musl selecl one of the following options: Developing Dala (Option 1)
Submitting an Existing Study (Option 4), Upgrading an Existing Sludy (Option 5) or Citing an
Existing Sludy (Option 6). If a regislranl depends on anolher's dala, he/she must choose among: Cost
Sharing (Option 2), Offers lo Cosl Share (Option 3) or Citing an Existing Sludy (Option 6). If a
regislranl does nol want to participate in a balch, ihe choices are Options 1,
4, 5 or 6. However, a regislranl should know lhal choosing nol lo participate in a balch does nol
preclude olher regislrants in the batch from citing his/her sludies and offering lo cosl share (Option
3) Ihose sludies.
Table I lisls 37 producls conlaining ihe active ingredienl DBNPA (4 batches).
129
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Table I.
1
IM&J&&H&, *
•l "•
' " <
•* -• S V % f^ ff ,
464-426
464-628
1448-72
1706-137
1706-138
1757-71
1757-72
3876-95
4643-25
5009-24
8540-21
8591-17
10349-16
10445-18
10485-32
10707-31
10932-14
11659-13
15300-16
35378-13
45017-32
48525-1
s v. s s
%
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
FgrmislslkHi
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Soluble Concentrate
Ready-to-Use Solution
Ready-to-Use Solution
130
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Batch
MEK
2
3
B£A jfai. Ho.
464-3899
8622-189
59106-1
464-496
1448-73
1757-66
8249-10
10445-17
10707-30
10932-13
11541-13
11659-12
33355-13
34571-10
53128-1
4875-132
8591-23
| %mmA
5.0
8.0
98.0
5.0
5.0
5.0
5.0
5.0
5.0
5.0
5.0
5.0
5.0
5.0
5.0
5.0
5.0
Fomttjiation
H
Ready-to-Use Solution
Formulation Intermediate
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
Table II lists 5 products containing DBNPA as an active ingredient, which were not considered
to be similar for purposes of acute toxicity or the Agency lacked sufficient information for
decision making and were not placed in any batch. Registrants of these products are responsible for
meeting the acute toxicity data requirements for each product.
131
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Table II.
EPA Registration
Number
464-500
464-624
1448-71
8622-20
10707-36
%
DBNPA
10.0
40.0
10.0
20.0
20.0
Formulation
Ready-to-Use Solution
Pelleted/tableted
Ready-to-Use Solution
Ready-to-Use Solution
Ready-to-Use Solution
132
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Attachment 5. EPA Acceptance Criteria
133
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and C9mposition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
135
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at £ 0.1 % by weight and
for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at <0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Npmenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned
experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the
parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
which may be present at ^ 0.1% or was found at £ 0.1% by product analyses and (2) certain lexicologically
significant impurities (see #3).
136
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1 • Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and
all impurities present at ^ 0.1 %.
2. Degree of accountability or closure ^ ca 98%.
3 • Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the case
of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dib.enzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and
stored samples must be analyzed.].
4. Complete and detailed descnption of each step in analytical method used to analyze above samples.
5- Statement of precision and accuracy of analytical method used to analyze above samples.
o. Identities ana quantities (including mean and standard deviation) provided for each analyzed ingredient.
Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
explanation of hpw the limits were determined.
8.
.
Upper certified limit proposed for each impurity present at ^ 0.1 % and for certain lexicologically significant
impurities at <0.1 % along with explanation of now limit determined.
9- Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if
exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
137
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of C9loration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml QT the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3 or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if pressure
too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25°C)
63-11 Octanol/water Partition Coefficient
. Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
138
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81 -3 Acute Inhalation Toxicity in the Rat
81 -4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
139
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3. Dosing, single oral may be administered over 24 hrs.
4. Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
140
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.* Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours oefore dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * arc supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2- Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or
contains particles of inhalable size for man (aerodynamic diameter 15 um or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (±2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
142
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of <2 or ^11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24,48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
143
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1- - Identify material tested (technical, end-use product, etc).
2- - Study not required if material is corrosive or has a pH of <2 or >1 1 5
3. _ 6 adult animals. ' '
4. _ Dosing, single dermal.
5. _ Dosing duration 4 hours.
£• - Application site shaved or clipped at least 24 hours prior to dosine
/. _ Application site approximately 6 cm2.
°- - Application site covered with a gauze patch held in place with nonirritating tape.
Material removed, washed with water, without trauma to application site.
, - , , .
— (wffihfve? issshoSlined and graded for irritation at l> 24> 48 and 72 *• thcn daily until normal or
1 1.* _ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study
144
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pH of <2- or ^11.5.
3. One of the following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.* Reference for test.
6. Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * arc supplemental and may not be required for every study.
145
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Attachment 7. Cost Share Data Compensation Forms, Confidential
State-ment of Formula Form and Instructions
149
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Confidential Business Information: Does Not Contain National Securit]
United SUM* Eiwironmentel Protection Agency
A _ Office of Pesticide Programs (TS-767)
J^ C DA Wellington. DC 20460
v C. rr\ Confidential Statement of Formula
1 . Name and Address of Applicant/Registrant (Include ZIP Codt)
3. Product Name
EPA USE ONLY
10. Components in Formulation (List tt tctiotty introduced
into f/M lotmulttion. Gttt commontf icctptfd etnmictl
ntm*. mo* name. indCAS numbtr.l
f Information (£.0. 12065)
*• m
l_l Basic Formulation
I—I Alternate Formulation
Form Approved. OMB No. 2070-0060. Approval Expires 2/28/941
B.
Pege
of
See Instructions on Back
2. Name and Address of Producer (Include ZIP Code)
4. Registration No./File Symbol
7. Pounds/Gsl or Bulk Density
11. Supplier Name & Address
5. EPA Product Mgr/Teem No.
8.pH
12. EPA Reg. No.
1 6. Typed Name of Approving Official
1 8. Signature of Approving Official
13. Eech Component
in Formulation
«. Amount b. % by Wkigh
1 7. Total Weight
19. Title
100%
6. Country Where Formulated
9. Flash Point/Flame Extension
14. Cinifod Lunili
% by Wnghl
i Upper Limn b LnMtUM
1 S PurpoM in
FormulMion
20 Phone No. /Include Area Code/
21. Date
EPA Form 6570-4 (Rev. 12-90) Previous editions are obsolete. If you can photocopy this, please submit an additional copy. White- EPA File Copy (original)
Yellow - Applicant copy
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.
d. All applicable information which is on the product specific data submission must also be reported on the
CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet for
solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered source products
must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for the
trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported under column 10
and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will
volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
instructions. An explanation must be provided if the proposed limits are different than standard certified
limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that
specific formulation.
153
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch. PM-223. U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
! Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Nam* of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
155
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SEPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OUS NO. 2070-0107
2070-0057
3-31-96
Public reporting burden for ihis coUtctton of Information is estimated to average IS minutes per response, including
t.me tor rev.ew.ng instructions, searching existing data sources, gathering andrnaintaining trJdataneeded, and
"USfW* 1?vie.winQ.t.ht ****** of formation. Send comments regarding the burden estimate or any other
aspect of this coltedipn of information, incfciding suggestions for reducing this burden, to Chief, Information Policy
Branch. PM-223, U.S. Environmental Protection Agency, 401 M St.. S.W.. Washington. DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106), Washington. DC 20503.
Please fill In blanks below.
Company
OK R*g
Nurnbtr
. Mo.
I Certify that:
1. For each study cited in support of registration or reregistration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) that is an exdusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
2. That for each study died in support of registration or reregistration under RFRA 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 in writing the company(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(c)d)(D) and 3(c)(2)(D) of FIFHA: and (b) Commence
negotiation to determine which data are subjed to the compensation requirement of FIFRA and the amount of
compensation due. if any. The companies I have notified are: (check one)
(] The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached •Requirements Status and Registrants' Response Form.'
3. That I have previously complied wfth section 3(c)(i )(D) of FIFRA for the studies I have died in support of
registration or reregistration under FIFRA.
HUM «« Til* <*•••• Typo or PrbM|
Date
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or reregistration of my products, to the extent required by FIFRA sections 3(c)(i)(D) and 3{c)(2)(D).
Signature
Date
NMM mtf Till* (PIMM Typo or Print)
EPA Form •170-91 (4-10)
157
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APPENDIX G FACT SHEET
159
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-94-023
September 1994
4>EPA R.E.D. FACTS
Pesticide
Use Profile
2,2-dibromo-3-nitrilo-
propionamide
(DBNPA)
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 3056; 2,2-dibromo-3-nitrilopropionamide or DBNPA.
DBNPA is a biocide used in a variety of industrial processes to control
algae, bacteria, fungi and yeasts. Formulations include tablets and both
solid and liquid soluble concentrates. DBNPA is applied through
shock/slug, initial, intermittent, maintenance, during manufacture and
continuous feed treatments, using metering pumps, drip feed devices and
other types of industrial equipment. A National Pollutant Discharge
Elimination System (NPDES) permit is required for discharges to
waterways.
Regulatory DBNPA was first registered as a pesticide in the U.S. in 1972.
Hfotorv Currentiy, 44 products are registered that contain this active ingredient.
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Human Health Toxicity
Assessment DBNPA is corrosive to the eyes and has been placed in toxicity
category I (the highest of four acute toxicity categories) for this effect. It is
moderately, systemically toxic by oral or inhalation routes (toxicity category
II), and slightly toxic by the dermal route (toxicity category IE). Although
classified in toxicity category III for primary dermal irritation, DBNPA can
kill skin tissue in rabbits when administered at high doses for a prolonged
period of time. DBNPA also is a skin sensitizer.
In a subchronic toxicity study using rats, DBNPA caused breathing
difficulty associated with lung or heart disease, as well as weight loss and
several deaths at the higher doses. When applied to the skin of rats in
another subchronic study, DBNPA caused changes in body chemistry and
dermal irritation at the higher doses.
DBNPA is a developmental toxicant in rabbits. It was shown to cause
structural alterations (retarded ossification of several fetal skeleton elements)
at a maternally non-toxic dose level. DBNPA is not mutagenic.
EPA has received several human incident reports in which eye, throat
and respiratory irritation, runny nose and headache resulted from spills or
misuse of DBNPA.
Dietary Exposure
A food additive tolerance, or maximum pesticide residue limit for
processed food, has been established for food grade paper or paperboard
manufactured by processes using DBNPA (please see 21 CFR 176.300).
This tolerance is under the regulatory purview of the Food and Drug
Administration (FDA), and EPA defers to FDA regarding the safety of
dietary exposure to DBNPA.
Occupational and Residential Exposure
The potential for occupational exposure exists, particularly among
those workers or "handlers" loading DBNPA products by open delivery or
pouring methods. Handlers may be at risk for acute or developmental
toxicity effects via dermal or inhalation exposure.
EPA estimated the Margins of Exposure (MOE) to handlers using
open pouring systems and closed systems. All the MOEs are acceptable
except for the scenario in which a handler uses an open pouring method to
add DBNPA to cooling. With appropriate personal protective equipment
(PPE), however, this handler's exposure would be significantly reduced and
the MOE would be acceptable.
Risks to post-application/reentry workers are not anticipated because
their potential for exposure is much less than handlers'. Residential
exposure is not expected since DBNPA has no residential uses.
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Human Risk Assessment
DBNPA is corrosive to the eyes, can kill skin tissue exposed to the
chemical at high levels for a prolonged period of time, and is a
developmental toxicant in rabbits. Several human incidents have been
reported involving acute exposure to DBNPA after spills or misuse.
Handlers of DBNPA may be at risk for acute or developmental
toxicity effects, particularly those using open pouring methods to add the
pesticide to cooling towers. EPA is requiring use of appropriate PPE or a
closed application system through this RED to mitigate these risks to
workers.
Environmental
Assessment
Environmental Fate
Because of its use pattern, DBNPA would not generally contaminate
ground water, but could contaminate surface waters through discharge or
spill. DBNPA generally hydrolyses rapidly in natural waters to many
degradates which continue to degrade rapidly by aerobic and anaerobic
aquatic metabolism. This decreases their threat to surface water
contamination. The primary degradation pathway is through aerobic and
anaerobic metabolism.
Ecological Effects
DBNPA is highly toxic to mammals and birds on an acute oral basis,
but has low toxicity to birds on a dietary basis. The pesticide is moderately
toxic to freshwater fish, estuarine fish and shrimp; moderately to highly
toxic to freshwater crustaceans; and highly to very highly toxic to estuarine
shellfish and larvae. Levels at which acute effects begin for shellfish have
not been established, but are less than the analytical detection limit. Many
effects to aquatic organisms occur within 24 hours of exposure.
Ecological Effects Risk Assessment
DBNPA will be of moderate toxicity to terrestrial mammals and birds
if they are exposed orally to concentrated doses of the pesticide in situations
such as an accidental spill or excessive discharge of the pesticide into a static
pool. Under usual circumstances, however, dietary toxicity to birds is low.
Without any mitigation measures, DBNPA poses a high risk to aquatic
organisms. To mitigate these risks, EPA is requiring secondary biological
treatment of waste water for all uses of DBNPA except use in waste water
treatment systems (since biological degradation readily occurs there,
anyway); in secondary oil recovery systems (where biological treatment is
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not feasible, but EPA is less concerned about this use pattern due to the
potential for only limited exposure); and in single flow-through cooling
tower systems.
The use of DBNPA in single flow-through cooling tower systems
poses an unacceptable risk to aquatic organisms. Secondary biological
effluent treatment is not practical for this use; thus, the risks it poses to
aquatic organisms cannot be mitigated. Meanwhile, the benefits it affords
are low or non-existent-tile amount of DBNPA used for this purpose is
negligible and registered alternatives are less costly. Therefore, the use of
DBNPA in single flow-through cooling tower systems is not eligible for
reregistration, and EPA will take appropriate regulatory action against
DBNPA products labeled for this use.
Product Labeling
Changes Required
Additional Data No additional generic data are required to support current uses of
Reauired DBNPA. Tne Agency is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs) and revised labeling for reregistration.
All DBNPA end-use products must comply with EPA's current
pesticide product labeling requirements, and with the following:
Personal Protective Equipment (PPE), Engineering Controls, and Safety
Requirements
The minimum (baseline) PPE for handlers engaged in open pouring of
DBNPA into cooling towers is: long sleeve shirt, long pants, shoes plus
socks, chemical-resistant gloves, and a chemical-resistant apron.
The following labeling statements are required on all DBNPA end-use
products intended primarily for occupational use:
Application Restrictions:
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may
be in the area during application."
Engineering Controls:
"When handlers use closed metering systems the handler requirements
may be reduced or modified to long-sleeve shirt, long pants, shoes and
socks. "
User Safety Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
no such instructions for washables exist, use detergent and hot water.
Keep and wash PPE separately from other laundry. "
User Safety Recommendations:
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"Users should wash hands before eating, drinking, chewing gum,
using tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing. As soon as possible,
wash thoroughly and change into clean clothing."
Sensitization Statement:
Required in the "Hazards to Humans (and Domestic Animals)" section
of the Precautionary Statements on labeling of all end-use products:
"This product may cause skin sensitization reactions in some people."
Type of Respirator:
If the acute inhalation toxicity of the end-use product is in category I
or II and, therefore, a respirator is required for pesticide handlers, the
following type of respirator is appropriate to mitigate DBNPA
inhalation concerns:
"A respirator with either an organic-vapor-removing cartridge with a
prefilter approved for pesticides (MSHA/NIOSH approval number
prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH
approval number prefix TC-14G)."
Effluent Discharge Labeling Statement
All DBNPA manufacturing-use or end-use pesticide products that may
be contained in an effluent discharged to the waters of the U.S. or municipal
sewer systems must bear the following statement:
"This product is toxic to fish and invertebrates. 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. Secondary biological treatment of DBNPA effluent is
required for all uses except for use in secondary oil recovery systems.
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 Most uses °f currently registered pesticide products containing DBNPA
Conclusion *n accor(kncewitn approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, most DBNPA uses
are eligible for reregistration, and pertinent products will be reregistered once
product-specific data, revised Confidential Statements of Formula and revised
labeling are received and accepted by EPA.
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Because the risk to non-target organisms outweighs the potential
benefits associated with the use of DBNPA in single flow-through cooling
towers, this use is ineligible for reregistration. EPA will take appropriate
regulatory action against DBNPA products labeled for this use.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for DBNPA 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 DBNPA RED document will be
available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program, the
DBNPA RED, or reregistration of individual products containing DBNPA,
please contact the Special Review and Reregistration Division (7508W), OPP,
US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-free
1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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United States
Environmental Protection Agency
(7508W)
Washington, DC 20460
Official Business
Penalty for Private Use
$300
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