United States Prevention, Pesticides EPA 738-R-93-020
Environmental Protection And Toxic Substances September 1993
Agency (7S08W)
<&EPA Reregistration
Eligibility Decision (RE
Tris(hydroxymethyl)
nitromethane
Recycled/Recyclable
Printad with Soy/Canola Ink on paparthat
contains at toast SQ% recycled tibar
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-93-016
September 1993
R.E.D. FACTS
Tris(hydroxymethyl)-
nitromethane
Pesticide
Reregistration
Use Profile
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 the
reregistration case Tris(hydroxymethyl) nitromethane, which contains the
active ingredient 2-(hydroxymethyl)-2-nitro-l,3-propanediol.
2-{tydroxymethyl)-2-nitro-l,3-propanediol is used as a microbicide
and bacteriostat in disinfectants and industrial preservatives. Specifically.
it is used as an industrial preservative in metalworking fluids, secondary nil
field recovery waters, paper mills and commercial/industrial water cooling
systems; as an in-can preservative in latex paints, polishes and detergents;
and as a disinfectant to control disease organisms in livestock and poultry
areas on farm premises and equipment. It is formulated as a soluble liquid
concentrate, powder or pellets, and is applied through use of a metering
pump in industrial water systems, by pouring into paints and polishes, and
as a spray to farm areas and equipment.
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Regulatory
History
2-(hydroxymethyI)-2-nitro-l,3-propanediol was first registered in the
U.S. in 1955, as an industrial bactericide and slimicide. EPA has issued
three relevant Data Call-In (DCI) Notices: the Antimicrobial DCI in March
1987, the comprehensive reregistration Phase 4 DCI in September 1992,
and a third DCI in August 1993, the latter for residue data. Currently,
nine pesticide products are registered which contain this active ingredient.
Human Health
Assessment
ToKicity
Studies using laboratory animals indicate that 2-(hydroxymethyl)-2-
nitro-l,3-propanediol is of low to moderate acute toxiciry to mammals. It
has been placed in Toxicity Category III for acute oral, dermal and
inhalation effects (Toxiciry Category I indicates the greatest degree of acute
toxicity and Category IV the lowest). It has been placed in Category IV
for eye and skin irritation effects. Since these studies were not conducted
with the technical grade (100%) powder, additional confirmatory acute
inhalation and eye irritation studies are required using that formulation.
In a subchronic dermal toxicity study using rats, there were no
treatment-related effects observed at any dose level. In developmental
toxicity studies using rats and rabbits, treatment-related maternal effects
were observed in the high-dose groups. No mutagenic effects were seen in
a battery of studies.
2-(hydroxymethyl)-2-nitro-l,3-propanediol decomposes to
formaldehyde under alkaline, warm conditions. Formaldehyde has been
classified by EPA as a Group Bl "probable" human carcinogen. The
toxicity of formaldehyde has been a. primary consideration in evaluating the
risks of 2-(hydroxymetliyl)-2-nitro-l,3-propanediol.
Dietary Exposure
No dietary exposure is expected as a result of the registered uses of
2-(hydroxymethyl)-2-nitro-l,3-propanedioL Its one potential food use, as a
disinfectant in or on livestock premises and equipment, has been modified
to delete milk house and milking equipment uses, and to add restrictions to
poultry house uses which eliminate the means of exposure of edible
livestock tissue or eggs. Therefore, no tolerances (rnaximum residue
limits) or exemptions from tolerances are required.
Occupational and Residential Exposure
2-(hydroxymethyl)-2-nitro-l,3-propanediol has many uses that may
involve exposure to workers, and exposure monitoring data were required
to estimate combined inhalation and dermal exposure of mixers, loaders
and applicators in various use sites.
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Worker exposure is considered significant for preservative and pulp
and paper mill uses, which involve open pouring methods. However,
associated risks will be mitigated ten-fold by requiring use of a respirator
and personal protective equipment (PPE) including a long-sleeved shirt and
long pants, and shoes plus socks,
Worker exposure is considered low for the poultry/livestock
disinfectant use, but is of concern since formaldehyde is an active
ingredient in the product, and since a spray method of application is
involved. Use of PPE and a respirator are required, and will reduce any
exposure ten-fold.
Worker exposure during cooling tower and metal working fluid uses
is considered very low. Again, PPE is required to reduce possible
exposure to formaldehyde.
While post-application worker exposure to formaldehyde is minimal
for most uses of 2-{hydroxymethyl)-2-nitro-l,3-propanediol, the
disinfectant spray used in livestock/poultry premises, which contains the
active ingredient formaldehyde, causes post-application exposure of
concern. However, EPA's exposure estimate represents the worst case
scenario, and OSHA requires monitoring for formaldehyde before workers
may reenter treated premises. Therefore, post-application worker exposure
is likely the same or less than exposure during mixing, loading or applying
the pesticide.
Similarly, post-application worker exposure to formaldehyde from
use of the parent chemical in pulp and paper mills is of some concern.
Since the Agency's exposure estimate is very conservative, a post-
application inhalation exposure monitoring study is required only as
confirmatory data.
Human Risk Assessment
Since 2-(hydrosymethyl)-2-nitro-l,3-propanediol has no food uses, no
dietary risk exists. Overall, minimal risk and exposure are associated with
the use of this active ingredient. The risks associated are due to its
degradation product, formaldehyde.
EPA has examined the cancer risks of formaldehyde extensively.
Using the most widely accepted risk assessment methodology, the Agency
has estimated the refined upper bound cancer risk to mixers, loaders and
applicators from exposure to formaldehyde through use of 2-
(hydroxymethyl)-2-nitro-l,3-propanediol. With PPE and respirators, these
risks range from 1.1 in 100,000 for preservative uses to 2.5 in 1,000,000
for poultry/livestock disinfectant uses.
Post-application worker exposure to formaldehyde following the
livestock/poultry premise spray use is of concern; the upper bound risk to
workers is estimated to be 2.5 in 1,000,000. However, the Agency's
exposure estimate represents the worst case scenario. Actual risks to
workers should be lower considering OSHA's formaldehyde monitoring
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requirements. Post-application exposure of pulp and paper mill workers is
conservatively estimated to be 2.7 in 100,000. A post-application
inhalation exposure monitoring study is required for this use, as
confirmatory information,
Environmental In evaluating environmental effects, EPA focused on 2-
Assessment (hydroxymethyl)-2-nitro-l,3-propanediol rather than its degradation
product, formaldehyde. In the aquatic environment, the active ingredient is
relatively stable. As it breaks down to formaldehyde, the latter chemical is
rapidly dissipated. Therefore, the parent compound is of greater interest.
Environmental Fate
Based on the results of an exposure assessment model, the Agency
expects that 2-(hydroxymethyl)-2-nitro-l,3-propanediol used according to
the label will result in minimal exposure to the environment. Concern
would arise only from its discharge into receiving waters from the
industrial uses or in the case of spills, accidents or misuse, A hydrolysis
study is required to confirm the chemical's degradation in the environment.
Ecological Effects
2-(hydroxymethyl)-2-nitro-l,3-propanediol has a low order of acute
oral and dermal toxicity to terrestrial mammals. It may be slightly toxic to
upland game birds, but is practically non-toxic to waterfowl. It also is
practically non-toxic to freshwater fish species on an acute basis. It is
slightly toxic to freshwater aquatic invertebrates and mollusks, and
practically non-toxic to crustaceans.
Ecological Effects Risk Assessment
EPA conducted a Tier Ic Estimated Environmental Concentration
(EEC) model to assess the residue levels of 2-(hydroxymethyl)-2-nitro-l,3-
propanediol in the receiving stream from several use sites. This model
provides a reasonable worst case estimate of the maximum concentration
that may occur immediately downstream from an industrial point source
discharge site. The typical EEC values for all uses of this active ingredient
are below the levels of concern for fish and invertebrates. Therefore, the
pesticide can be used at typical use sites without producing effluent above
levels of concern. Under a high exposure scenario, a high degree of risk
would be posed to aquatic organisms. However, discharge of the pesticide
is regulated by the National Pollutant Discharge Elimination System
(NPDES) permit program administered by EPA. Through this program,
the Agency is able to control the discharge of this pesticide and other
chemicals so that toxic levels are avoided.
Endangered Species
The high exposure scenarios described above exceed the levels of
concern for endangered aquatic organisms. In addition, the typical EEC
value for pulp and paper mills exceeds the level of concern for eiicaugered
aquatic invertebrates. Effluent containing this active ingredient should not
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be discharged into streams or waterways where endangered aquatic
organisms are known to reside. EPA is working with the U.S. Fish and
Wildlife Service to develop a program to avoid jeopardizing the continued
existence of identified species by .the use of pesticides, When this program
goes into effect, endangered species labeling will be required.
Additional Data
Required
The generic data base for 2-(hydroxymethyl)-2~nitro-l,3-propanediol
is substantially complete. However, for confirmatory purposes, EPA is
requiring acute inhalation and eye irritation studies using the technical
grade powder formulation, a post-application inhalation exposure worker
monitoring study, and a hydrolysis study. EPA also is requiring product-
specific data, including chemistry, acute toxicology and efficacy studies, as
well as revised labeling for reregistration.
Product Labeling
Changes Required
All end-use products containing 2-(hydroxymethyl)-2-nitro-l,3-
propanediol must comply with EPA's current pesticide product labeling
requirements. In addition;
» Effluent Discharge Statement - All end-use products for indoor non-
food uses (industrial uses which discharge effluent), aquatic non-food
industrial uses, or terrestrial non-food uses must bear the following effluent
discharge statement:
"Do not discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans or public waters unless in
accordance with the requirements of a National Pollutant Discharge
Elimination System (NPDES) permit and the permitting authority has
been notified in writing prior to discharge. Do not discharge effluent
containing this product to sewer systems without previously notifying
the local sewage treatment plant authority. For guidance contact
your State Water Board or Regional Office of EPA."
* Use Site PPE Requirements and Entry Restrictions
* In poultry/livestock premises, preservative and pulp and paper
mills, the PPE requirement for mixer/loader/applicators is:
"Pesticide handlers must wear:
-Long-sleeved shirt and long pants
—Chemical-resistant gloves
--Shoes plus socks
In addition, when engaged in pouring this product,
-A respirator with either an orgamc-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),"
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• For metal working fluids and cooling tower water uses, the PPE
requirement for mixer/loader/applicators is:
"Pesticide handlers must wear:
—Long-sleeved shirt and long pants
—Chemical-resistant gloves
—Shoes plus socks"
• In poultry/livestock premises, post-application workers must
observe the following use restriction on the labeling in the directions
describing use as a disinfectant spray:
"Entry by any person—other than a correctly equipped handler-is
PROHIBITED in the entire enclosed building/structure from the start
of application until aeration reduces the air concentration level of
formaldehyde in the working area to less than 0.75 ppm. The air
level concentration of formaldehyde must be measured before entry is
permitted. (OSHA issued a final rule for the PEL for formaldehyde
as 0.75 pprn, May 27, 1992, Federal Register, Vol. 57, p. 22290.)
Any handler who enters the treated area during this entry-restricted
period must wear;
—Long-sleeved shirt and long pants
—Shoes plus socks
—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)."
Regulatory The currently registered uses of 2-(hydroxymethyl)-2-nitro-l,3-
Conclusion propanediol may pose low level cancer risks to workers from the degradate
formaldehyde, and could pose risks to aquatic organisms under certain
conditions as industrial effluent containing the parent chemical is released
into receiving waters. However, the uses will not cause unreasonable
adverse effects to humans or the environment, and are eligible for
reregistration.
Products containing 2-(nydroxymethyI)-2-nitro-l,3-propanedioi as the
sole active ingredient will be reregistered once the required product-
specific data and revised labeling are received and accepted by EPA,
Products also containing other active ingredients will be reregistered only
after the other active ingredients also are determined to be eligible for
reregistration.
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For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for Tris(hydroxymethyl)nittomethane 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 (75Q6C), Office
of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805,
Following the comment period, the Tris(hydroxymethyl)nitromethane
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 Tris(hydroxymethyl)nitromethane RED, or reregistration of individual
products containing the active ingredient 2-(hydroxymethyl)-2-nitro-lf3-
propanediol, 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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REREGISTRATION ELIGIBILITY DECISION
TRIS(HYDROXYMETHYL)NITROMETHANE
LISTC
CASE 3149
ENVmONMENTAL-PROTECTION-AGENCY
OFFICE-OF PESTICIDE-PROGRAMS
SPECIAL-REVIEW AND'REREGISTRATHM-DmSION
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TABLE OF CONTENTS
2-(HYDROXYMETHYL)-2-NITRO-l ,3-PROPANEDIOL REREGISTRATION
ELIGIBILITY TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS iii
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
IL CASE OVERVIEW 2
A. Chemical Overview , 2
B. Use Profile 2
C. Regulatory History 5
III. SCIENCE ASSESSMENT 5
A, Physical Chemistry Assessment 5
1. Toxicology Assessment 6
a. Acute Toxicity 6
b. Subchronic Toxicity . . 7
c. Developmental Toxicity . , 8
d, Mutagenicity 8
e. Other Toxicity Considerations 9
f. Reference Dose 9
2. Exposure Assessment 10
a. Dietary 10
b. Occupational and Residential 10
3. Risk Assessment 18
a. Dietary 18
b. Occupational and Residential 18
C. Environmental Assessment 22
1. Environmental Fate 22
2. Ecological Effects 22
a. Ecological Effects Risk Assessment 23
b. Endangered Species 25
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 26
A. Determination of Eligibility , . 26
1. Eligibility Decision . . , 26
2. Eligible and Ineligible Uses 27
B. Regulatory Position 27
I, Labeling Rationale 27
V. ACTIONS REQUIRED BY REGISTRANTS 28
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A, Manufacturing-Use Products 28
1. Additional Generic Data Requirements 28
2, Labeling Requirements for Manufacturing-Use Products 28
B. End-Use Products 29
1. Additional Product-Specific Data Requirements 29
2. Labeling Requirements for End-Use Products 29
C. Existing Stocks 31
VI. APPENDICES , 33
APPENDIX A. Table of Use Patterns Subject to Reregistration 35
APPENDIX B. Table of the Generic Data Requirements and Studies Used
to Make the Reregistration Decision 49
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of 3149 57
APPENDIX D. List of Available Related Documents 65
APPENDIX E. 69
PR Notice 86-5 71
PR Notice 91-2 , 91
APPENDIX F. Generic Data Call-in 97
Attachment 1. Chemical Status Sheet 117
Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
Instructions 121
Attachment 3. Requirements Status and Registrants' Response Forms
Inserts (Form B) plus Instructions 126
Attachment 4. List of Registrant(s) sent this DCI (Insert) ........ 133
APPENDIX G. Product Specific Data Call-in , 135
Attachment 1, Chemical Status Sheet 151
Attachment 2. Product Specific Data Call-in Response Forms (Form
A inserts) Plus Instructions , 153
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 157
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 163
Attachment 5, EPA Acceptance Criteria 167
Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice , 181
Attachment 7. Cost Share Data Compensation Form, and Confidential
Statement of Formula Form 183
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2-(HYDROXYMETHYL)-2-NITRO-l»3-PROPANEDIOL
ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
REREGISTRATION
Gabe Patrick
Michele Pethel
Cynthia Szymanski
Environmental Fate and Effects Division
Jose Luis Melendez
Richard Lee
Jean Holmes
Health Effects Division
Winston Dang
Jane Smith
Flora Chow
Edwin Budd
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Occupational and Residential Exposure Branch
Chemical Coordination Branch
Chemical Coordination Branch
Toxicology Branch I
Registration Division
Doreen Aviado
Valdis Goncarovs
Bipin Gandhi
Mark Perry
Special Review and Rereglstration Division
Ernestine Dobbins
Kathy Davis
Policy and Special Projects Staff
Brian Hirsh
Office of General Counsel:
Antimicrobial Program Branch
Antimicrobial Program Branch
Registration Support Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Debbie Mack
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Office of Compliance Monitoring:
Beverly Updike
Office of Research and Development:
Elaine Francis
Office of Water:
Donna Reed
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, Drag, and Cosmetic Act
GRAS Generally Recognized As Safe as designated by FDA
HOT Highest Dose Tested
LCSO Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death hi 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.
LDto Lethal Dose-low, Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOEL Lowest Observed Effect Level
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
in
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GLOSSARY OF TERMS AND ABBREVIATIONS
MOE Margin Of Exposure (PAD)
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
Q*i The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RED Reregistration Eligibility Decision
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance produces a toxic effect.
TMRC Theoretical Maximum Residue Contribution.
IV
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EXECUTIVE SUMMARY
The U.S. Environmental Protection Agency (hereafter referred to as "the Agency") has
conducted a review of the available scientific data and other relevant information supporting the
reregistration of the pesticide active ingredient 2-(hydroxymethyl)-2-nitro-l,3-propanedioI.
This Reregistration Eligibility Decision (RED) addresses the reregistration of products
containing 2-(hydroxymethyl)-2-nitro-l,3-propanediol for currently registered uses. Pesticide
products containing this active ingredient are used as a rnicrobicide and bacteriostat in
disinfectants and preservatives. It is formulated as a powder, as pellets and as a soluble liquid
concentrate. It is applied to livestock and poultry premises by using a spray application method,
and to metalworking cutting fluids, latex paints, drilling muds and packer fluids, pulp/paper mill
systems, and evaporative condenser water systems by using metering pump or pouring
application methods. The Agency has determined that the uses of 2-(hydroxymethyl)-2-nitro-1,3-
propanediol as currently registered may pose low carcinogenic risks to workers from the
degradate formaldehyde and could pose risks to aquatic organisms under certain conditions from
the release of 2-(hydroxymethyI)-2-nitro-l,3-propanediol in industrial effluent into receiving
waters. However, the Agency concludes that the uses will not cause unreasonable risk to human
health or the environment and these uses are eligible for reregistration.
Accordingly, the Agency has determined that all products containing the single active
ingredient 2-(hydroxymethyl)-2-nitro-l,3-propanediol are eligible for reregistration and will be
reregistered when acceptable labeling and product-specific data are submitted and/or cited.
Before reregistering each product, the Agency is requiring that product-specific data be
submitted by the registrants within eight months of the issuance of this document. Additionally,
in order to remain in compliance with FIFRA, it is the Agency *s position that revised labeling
must be submitted by the registrants within that same time period. After reviewing these data
the Agency will determine whether the conditions and requirements of FIFRA section 3(c)5 have
been met for the reregistration of these products. Products containing other active ingredients
subject to reregistration will be reregistered only after each active ingredient has been
reregistered.
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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 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 reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying
a pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of 2-(hydroxymethyl)-2-nitro-1,3-propanediol. The document consists of six
sections. Section I is the introduction. Section II describes 2-(hydroxymethyl)-2-nitro-l,3-
propanediol, 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 2-hydroxymethyl-2-nitro-l,3-propanediol. Section V
discusses the reregistration requirements for products containing this active ingredient. Finally,
Section VI is the Appendices which support this Reregistration Eligibility Decision. Additional
details concerning the Agency's review of applicable data are available on request.'
1 EPA's reviews of data on the set of registered uses considered for EPA's analysis may
be obtained from the OPP Public Docket, Field Operations Division (H7506C), Office of
Pesticide Programs, EPA, Washington, DC 20460.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision document:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Structural Formula:
Trade and Other Names:
B.
Basic Manufacturer:
Use Profile
2-(hydroxymethyl)-2-nitro-1,3-propanediol
Tris(HOCH2-)nitromethane
126-11-4
083902
C4H9N05
N02
HO-CH2-C-CH2-OH
CHrOH
Tris-Nitro; Cimcool wafers;
Tris{hydroxymethyl)nitromethane;
Nitroisobuty Iglycerol; Trimethylolnitromethane;
Nitrotris(hydroxymethyl)methane
Angus Chemical Company
The following is information on the current registered uses with an overview of
use sites and application methods. A detailed table of the use of 2-(hydroxymethyl)~2-
nitro-l,3-propanediol is in Appendix A.
Type of Pesticide:
Use Sites:
Disinfectant (general);
microbieide/microMostat (slime-forming bacteria and
fungi); fungieide/ftmgistat; fungicide; industrial
preservative/preservative (bacteriostat).
Terrestrial non-food:
oil recovery drilling muds/packer fluids (preservatives)
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Aquatic non-food industrial:
pulp/paperrnill water systems; commercial/industrial water
cooling systems; evaporative condenser water systems;
secondary oil recovery injection water; oil recovery drilling
muds/packer fluids (preservatives)
Indoor non-food:
metalworking cutting fluids; oil recovery drilling
muds/packing fluids (preservatives); latex paints (in-can
preservative); specialty industrial products-packaged;
resin/latex/polymer emulsions, (emulsions, solutions, or
suspensions such as detergents and polishes containing
water); livestock premises and poultry premises.
Target Pests: Disinfectant for disease organisms found on farm premises
and equipment. Bacteriostat, microbicide/microbiostat for
the following organisms: aerobic slime-forming bacteria
(Pseudomonas spp,), anaerobic sulfate-reducing bacteria,
such as Desuifovibrio desulfuricans.
Formulation Types Registered:
Technical grade active ingredient, manufacturing use, end use
Soluble concentrate/liquid, soluble concentrate/solid, pelleted/tableted,
crystalline
(19.2 - 100% active ingredient)
Method and Rates of Application:
Types of Treatment-
Industrial preservative treatment, water treatment, water recirculating
system treatment, premise treatment, transportation vehicle treatment,
animal equipment treatment
Equipment - sprayer, metering pump
Method and Rate - Indoor Non-food;
Metalworking cutting fluids: 313-2500 ppm a.i. by volume
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Latex paints: 1000-5000 ppm a.L by weight
Resin/latex/poiymer emulsions: 100-5000 ppm a.i. by weight
Specialty industrial products: 500-1000 ppm a.i. by weight
Livestock and poultry premises: 1500 ppm a.i. by volume
Method and Rate - Aquatic non-food industrial:
Commercial/industrial water cooling systems and evaporative condenser
water systems: 8-500 ppm a.i. by volume; 10 to 609 ppm by weight
Pulp and paper mill water systems: 570 to 2540 ppm a.i, by weight
Oil recovery drilling muds/packer fluids: 63-500 ppm a.i. by volume
Secondary oil recovery injection water: 476-952 ppm a.i. by volume; 580
ppm to 1159 ppm by weight
Timing - As needed; during manufacture; initial, continuous and
intermittent feed
Use Practices Limitations:
The following use practice limitations are currently on labeling for these
products:
"Decomposition occurs in the presence of alkaline materials. Protect from
vapors of ammonia and amine during handling and storage to prevent
deterioration and release of formaldehyde. All treated animal feed
appliances must be thoroughly scrubbed with detergent and rinsed with
potable water prior to reuse. Ventilate building, vehicles, and other
closed spaces. Not for use in California in one, two, or all of the
following systems (depending on the label): in industrial recirculating
water systems, in pulp and paper mill process water systems, or as a
preservative in packaged emulsion, solutions, or suspensions such as
detergents and polishes containing water."
"Do not use in milking stalls, milking parlors, or milk houses. Remove
all animals, poultry, eggs, or chicks and feeds from buildings, vehicles,
coops, crates, and enclosures. Do not house poultry or livestock,
introduce eggs or chicks, or employ equipment until treatment has been
absorbed, set, or dried. Do not discharge effluent containing this
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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)."
C. Regulatory History
2-(hydroxymethyl)-2-nitro-l,3-propanediol was first registered in the
United States in 1955 as an active ingredient for use in industrial bacteriocide and
slimicide products. Currently, nine products are registered for use in
metalworking fluids systems, oil field systems, cooling water systems, papermills,
and livestock areas as a preservative, as a disinfectant and as a formulating
technical material. Three Data Call-in Notices for 2-(hydroxymethyl)-2~nitro~ 1,3-
propanediol have been issued. The Antimicrobial Data Call-in of March 4, 1987,
required toxicology data and data on applicator exposure to antimicrobial pesticide
active ingredients in a variety of industrial, commercial, consumer, and other
applications and settings. An industry consortium generated a single exposure
study to cover multiple use patterns for a group of chemicals for consortium
members. This applicator exposure study (M1ID 41412201) was commissioned
by the Chemical Manufacturers Association and the study has fulfilled this data
requirement The second Data Call-In was the comprehensive reregistration Phase
4 Data Call-In of September 30, 1992, in which chemistry, ecotox data,
hydrolysis and residue data were required. The third Data Call-In was issued
August 9, 1993 for residue data in edible livestock tissues or, in lieu of data,
label changes could be made to eliminate all possible means of exposure from this
use. This Reregistration Eligibility Decision reflects a reassessment of all data
which were submitted in response to reregistration.
III. SCIENCE ASSESSMENT
A, Physical Chemistry Assessment
2-(hydroxymethyl)-2-nitro-1,3-propanediol is an odorless, white solid which melts
at 175-176' C with decomposition. It is soluble in polar solvents such as water,
inethanoi, ethanol, and isopropanol, but insoluble in non-polar solvents like aliphatic and
aromatic hydrocarbons. This chemical is stable only under acidic conditions of pH 5.0
and below, and is unstable and decomposes to formaldehyde under alkaline conditions
and at temperatures above 49° C.
-------
B. Human Health Assessment
1. Toxicology Assessment
The toxicology data base for 2-(hydroxymemyl)-2-nitro-l,3-propanediol is
adequate for reregistration eligibility. Toxicity studies indicate 2-(hydroxymethyl)-2-
nitro-l,3-propanediol has low acute toxicity and that there are no toxicologicai concerns
associated with this active ingredient oer se that lead to significant concerns. The
Agency has also determined, however, that the degradate of the active ingredient,
formaldehyde, poses a concern.
Other than the acute inhalation and eye irritation studies using the 100% technical
grade powder, the Tier I studies (guidelines 82-3, 90-day dermal; 83-3, developmental
toxicity; and 84-2, mutagenicity battery) required for antimicrobial type active ingredients
have been satisfied. The acute inhalation (rat) and eye irritation (rabbit) studies using
the technical grade powder (100%) are required as confirmatory data for the reasons
discussed below.
a. Acute Toxicity
The acute studies were conducted on the 53,1 - 56.8% 2-
(hydroxymethyl)-2-nitro-l,3-propanediol aqueous concentrate solution.
The table presented below summarizes the results of the acute studies and
is intended for general reference only.
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TABLE I. Acute Toxicity
Test
Result
Category
Acute Oral LD50 (rat)1
1890 mg/kg (m)
1860 mg/kg (f)
III
Acute Dermal LD50
(rabbit)2
Acute Inhalation LCSO
(rat)3
Eye Irritation (rabbit)4
Dermal Irritation (rabbit) s
Skin Sensitization
(guinea pig) 6
> 2000 mg/kg
2,4 mg/liter
slight irritation
non-irritating
negative
III
III
IV
IV
n/a
I MRID 094711
2 00043222/00094713
3 00094711
4 00094711
5 00094715/00109228
6 00094715
n/a = not applicable
Acute toxicity studies were not conducted using the technical grade
powder (100%). Additional acute inhalation (rat) and the eye irritation
(rabbit) studies are required using the 2-(hydroxymethyl)-2-nitro-i»3-
propanediol technical grade powder form since this form may present the
greater potential exposure, hence risk, as compared with the wafer or
pellet forms. The aqueous solution is not an appropriate dosage form for
these studies. These two studies, although required by the Agency, are
considered to be confirmatory because the acute toxicology data base
suggest 2-(hydroxymethyl)-2-nitro-l,3-propanediol has low acute toxicity
to mammals.
b. Subchronic Toxicity
In a 90-day subchronic dermal toxicity study, male and female
Crl;CD BR rats were treated dermally for 6 hours per day, 5 days per
week with a paste of 2-(hydroxymethyl)-2-nitro-l,3-propanediol in
deionhed water. Dosage levels were 0, 250, 500 and 1000 mg/kg/day.
The test material was essentially non-irritating to the skin, although
yellowish discoloration was noted at test sites. There were no treatment-
related effects observed at any dosage level. The NOEL for systemic
toxicity is >_ 1000 mg/kg/day. (MRID 41021101)
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c. Developmental Toxicity
A developmental toxicity study was conducted with pregnant
Sprague Dawley Crl;CD BR rats which were administered daily doses of
0, 50, 375 or 750 mg/kg/day of 2-(hydroxymethyl)-2-nitro-lf3-
propanediol by gavage on days 6 through 15 of gestation. Treatment-
related maternal effects were observed only in the high-dose group and
included: (1) increased mortality (7/25 or 28% of the group), (2)
decreased mean body weight gain, and (3) clinical signs of toxicity
(including head bobbing, tremors, and circling motions). A treatment-
related developmental effect, observed at 375 mg/kg/day and 750
mg/kg/day, was increased mean number of resorptions per dam. At 750
mg/kg/day, fetal body weights were also reduced. Therefore, the NOEL
and LOEL for maternal toxicity are 375 mg/kg//day and 750 mg/kg/day,
respectively. The NOEL and LOEL for developmental toxicity are 50
mg/kg/day and 375 mg/kg/day, respectively. A slightly increased
incidence of omphalocele in the 750 mg/kg/day fetuses in this study, when
compared to historical control data, suggested the possibility of an
additional developmental effect. (MRID 41021102/41089301)
In a second developmental toxicity study, pregnant New Zealand
white rabbits were administered daily doses of 0, 10, 30 or 75 mg/kg/day
of 2-(hydroxymethyl)-2-mtro-lf3-propanediolby gavage on days 7 through
19 of gestation. Treatment-related maternal effects were observed only
in the high-dose group and included: (1) decreased mean body weight
gain, and (2) decreased mean food consumption. No treatment-related
developmental effects were observed in the study. One omphalocele was
observed in the control group and one in the 75 mg/kg/day group. This
finding was not considered to be treatment-related. Therefore, the NOEL
and LOEL for maternal toxicity are 30 mg/kg/day and 75 mg/kg/day
respectively. The NOEL for developmental toxicity is _>_ 75 mg/kg/day.
(MRID 42303501)
d. Mutagenicity
A Salmonella tvphimurium reverse mutation assay (Ames assay)
was conducted using 2-(hydroxymethyl)-2-nitro-l ,3-propanediol as the test
material. Strains TA98, TA100, TA1535, TA1537 and TA1538 were
tested without and with S9 metabolic activation. No increases in reverse
mutations were observed at concentrations up to 1000 ug/plate. (MRID
41058101)
2-(hydroxymethyl)-2-nitro-l,3-propanediol was tested in a
chromosomal aberration assay using Chinese Hamster Ovary (CHO) cells
8
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in vitro without and with metabolic activation up to a cytotoxic level of
2000 ug/ml. The study was negative for induction of chromosomal
aberrations. (MRID 41944301)
2-(hydroxymethyl)-2-nitro-l,3-propanediol was also tested in an
unscheduled DNA damage/repair in vitro study using primary rat
hepatocytes at concentrations up to 10,000 ug/mi. The test was negative
for inducing unscheduled DNA synthesis. (MRID 41944302)
e. Other Toxicity Considerations
The rat oral developmental toxicity study (MRID 41021102/
41089301) has not been selected as an endpoint for assessing acute dermal
worker exposure to the parent compound 2-(hydroxymethyl)-2-mtro-l,3-
propanediol because the NOEL for developmental toxicity via the oral
route likely overstates the actual hazard. This conclusion is based on the
large gap between the developmental NOEL in the study of 50 mg/kg/day
and the LOEL of 375 mg/kg/day for resorptions which were observed at
an incidence only slightly higher than that of control values. In addition,
the lack of toxicity of 2-(hydroxymethyl)-2-nitro-l,3-propanediol when
administered to the rat by the dermal route (the most likely route of
worker exposure or human exposure since there are no food uses for this
chemical) at a dose of 1000 mg/kg/day (limit dose) for 90 days (MRID
41021101, 932200211) strongly suggests that the dermal absorption of the
test material is limited. In contrast, the test material was maternally toxic
by the oral route in the developmental toxicity study (NOEL of 375
mg/kg/day and LOEL of 750 mg/kg/day) which incorporated a much
shorter dosing period.
The antimicrobial properties of 2-(hydroxymethyl)-2-nitro-l,3-
propanediol are due hi large part to the slow release over time of
formaldehyde (HCHO) from the active ingredient under alkaline
conditions. The rate of release is highly dependent on the pH of the
solution and on the temperature (the higher the pH of the solution and/or
the higher the temperature, the faster the release). Since formaldehyde
has significant toxic effects of its own, and has also been classified by the
Agency as a Group Bl (probable human) carcinogen, the toxicity of
formaldehyde is a primary consideration in evaluating the toxicity of 2-
(hydroxymethyl)-2-nitro-l,3-propanediol and performing the risk
assessment.
f. Reference Dose
The Agency has not established a Reference Dose (RfD) for 2-
-------
(hydroxymethyl)-2~ratro-l ,3-propanedioI, because it has no food/feed uses
and no subehronic or chronic oral toxicity studies other than
developmental toxicity studies in rats and rabbits are available from which
to derive an RfD,
2. Exposure Assessment
a. Dietary
No dietary exposure is expected as a result of registered uses.
There is one disinfectant use that was identified as a food use during the
reregistration process: treatments in/on livestock premises/equipment,
No tolerances exist for residues of 2-(hydroxymethyI)-2-nitro-l,3-
propanediol in meat, milk, eggs, or poultry. Presently, this disinfectant
use has been modified on the label by the registrant deleting the milk
house and milking equipment uses. The poultry house uses are maintained
with explicit label restrictions reflecting established Agency nonfood use
policies eliminating the means of exposure of edible livestock tissues or
eggs to 2-(hydroxymethyl)-2-nitro-l ,3-propanediol; therefore, no residue
data, tolerances or exemptions from tolerances are required.
b. Occupational and Residential
2-(hydroxymethyl)-2-nitro-l,3-propanediol is formulated as a
powder, as solid pellets or as a soluble concentrate liquid. It is applied
to livestock/poultry equipment by using a spray application method. It is
used in metal cutting fluids, drilling muds and packer fluids, pulp/paper
mill systems, and evaporative condenser water systems by using metering
pump or pouring application methods. The active is used as a
preservative in paints, emulsions, and thickeners, Under alkaline
conditions, this, compound degrades to form formaldehyde which enhances
its antimicrobial properties.
2-(hydroxymethyi)-2-njtro-i ,3-propanediol has many uses that may
involve exposure to workers. This compound meets the Agency's
exposure criteria for requiring exposure monitoring data due to the
presence of, or degradation to formaldehyde. These data requirements for
mixer/loader/applicator can be met by the Chemical Manufacturers
Association (CMA) exposure assessment database (MRID 41412201). The
exposure to this compound by workers can be represented by five of the
uses: paint preservative, pulp and paper mill, cooling tower water, metal
cutting fluids and livestock/poultry premises disinfectant. This database
was used to estimate mbcer/loader/applicator combined inhalation and
dermal exposure based on the type of application (e.g., pour solids, low
10
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pressure spray) and the uses in pulp and paper mill water, in cooling
tower water, in metal cutting fluids, as a preservative in paints and in
livestock/poultry premises as a disinfectant. These exposure estimates are
provided in Tables II. and III. below.
For the poultry/livestock disinfectant use, the total exposure was
determined for formaldehyde as a result of the degradation of 2-(hydroxy
methyl)-2-nitro-l,3-propanediol to formaldehyde and from the
formaldehyde present as an active ingredient.
Mixers/Loaders/Applicators Exposure Assessment - 2-(hydroxymethyl)-2-
nitro-1,3-propanediol
Preservative and pulp and paper mill use - The
mixer/loader/applicator exposure is considered significant for these uses
(see Table n). The exposure concern associated with using open pouring
methods (of this solid material) for pulp and paper systems and paint
preservatives can be reduced ten-fold by using a respirator and personal
protective equipment (PPE),
Poultry/livestock disinfectant - The mixer/ioader/applicator
exposure is considered low for this low pressure disinfectant spray use
(see Table III); however, PPE and a respirator would reduce potential
exposure to mixer/loader/appHcators from formaldehyde.
Cooling tower and metal cutting fluids - The
mixer/loader/applicator exposure is considered very low for these uses
(see Table II); however, PPE would reduce potential exposure from
formaldehyde.
11
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TABLE II. Average Daily Dose (or Exposure) Using the Pure Solid (100% active
ingredient [a.L]) 2-(hydroxymethyl)-2-nitro-l,3-propanediol
POUR SOLIDS
Setting
Preser-
vative
P&P Mills
Cooling
Tower
Metal Fluid
MCS1
(ug/lb ai)
14310
14310
630
14310
Ibai
used
2
50.8
25.4
7.6
Ib ai/
yr
500
1321
660
92
BW2
(kg)
70
70
70
70
Daily
Exp.3
408.86
10,385
228.6
1,554
Annual
Exp,4
102,214
270,009
5,940
18,807
ADD5
280.04
739.75
16,27
51.53
i MCS = Maximum Credible Sum was derived from CMA Study,
2 BW = Body Weight
3 Daily Exposure (ug/kg/day) = (MCS X Ib ai/used)/BW
4 Annual Exposure (ug/kg/yr) = (MCS X Ib ai used/yr)/BW
s ADD (ug/kg/day) = Annual Exposure / 365 days
= Amortized Average Daily Dose
Assumptions for Table II include the following maximum use rates:
(1). Use as preservative: 0.4 Ibs of pure solid is added per 100 gallons of the
formulation. Assume a total of 500 gallons per treatment and 250
treatments per year.
(2). Use for pulp and paper mill systems: 5.08 Ibs of pure solid per ton of pulp
or paper (dry basis). Assume a total of 10 tons of pulp or paper per
treatment and 26 treatments per year.
(3). Use for cooling water tower systems: 5.08 Ibs of pure solid is added per
1000 gallons of water. Assume a total of 5000 gallons of water per
treatment and 26 treatments per year.
(4), Use for metal working fluids: 2.54 Ibs of pure solid is added per 100
gallons of oil. Assume a total of 300 gallons of oil per treatment and 12
treatments per year.
12
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TABLE III. Average Daily Dose using the Disinfectant Soluble Concentrate Liquid
containing Two Active ingredients: 19.2% 2-(hydroxymethyI)-2-nitro-1,3-propanediol
and 2.28% Formaldehyde
LOW PRESSURE SPRAY
Setting
Disinfectant
2-(hydroxymethyI)-2-
nitio- 1 3-propanedio!
Formaldehyde
MCS1
(ug/lb ai)
24870
24870
Ibai
used
0,67
0.08
Ibai/
yr
17.5
2.08
BW2
(kg)
70
70
Daily
Exp.3
238.04
28.42
Annual
Exp.4
6217,5
738.99
ADD5
17.03
2.02
i MCS = Maximum Credible Sum was derived from CM A Study.
2 BW = Body Weight
3 Daily Exposure (ug/kg/day) = (MCS X Ib ai used)/BW
4 Annual Exposure (ug/kg/yr) = (MCS X Ib ai used/yr)/BW
s ADD (ug/kg/day) = Annual Exposure / 365 days
= Amortized Average Daily Dose
Assumptions for Table III;
(I) the density is 9 Ib/gal for the 19.2 % a.i. solution.
(2) one ounce of this disinfectant solution is diluted by 128 oz (one gallon) of water.
(3) assume 50 gallons of such diluted solution per treatment and 26 treatments per year.
the maximum use rate.
Post-Applicator Exposure Assessment - 2-(hydroxymethyl)-2-nitro-l,3-
propanediol
Post-application worker exposure to the active ingredient. 2-
(hydroxymethyl)-2-nitro-l, 3-propanediol, is minimal for all uses
However, given its degradation to formaldehyde this must be considered
13
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Mixers/Loaders/Applicators Exposure Assessment - Formaldehyde
Based on the available information from the literature, at 25°C and
pH 7.5, the dissociation rate of 2-(hydroxymethyI)-2~nitro-l ,3-propanediol
in aqueous phosphate solution is less than 10% in the first 5 days. Higher
alkalinity and temperature increase the rate of conversion to and percent
of formaldehyde. The release of 2 moles of formaldehyde from one mole
of 2-(hydroxymethyl)-2-nitro-l,3-propanediol is shown below:
(CH2OH)3CN02 OH" 2 CH2O + unidentified products
(unidentified products could be, e.g., nitroethanol is unstable and
could decompose to nitroethene and water).
The mixer/loader/applicator exposure to formaldehyde was
estimated using the average daily dose (ADD), or exposure, estimated for
mixers/loaders/applicators for 2-(hydroxymethyl)-2-nitro-l ,3-propanediol
and assuming a 10% degradation to formaldehyde (see Table IV).
14
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TABLE IV. The Average Daily Dose of Formaldehyde Based on a 10% Conversion
from 2-(hydroxymemyl)-2-nitro-i,3-propanediol and the Exposures from Tables II, and
III for AH Uses
Setting
Preservative
P & P Mills
Cooling Tower
Metal Fluid
Disinfectant
(two actives)
ADD
2-(hydraxpr*tiiyl)-2-nkrol,3-
ppopanedktl
(ug/kg/day)
280.04
739,75
16.27
51.53
17.03
-
10% ADD
2-(hydroxymethyt)-2-niiro- 1 .3-
piopaaedio!
(ug/kg/day)
28,0
73.97
1.63
5.15
1.7
-
ADD
FormaIdehydeA
{ug/kg/day)
12
31.8
0.69
2.2
0.70 +
2,Q2B = 2.72
A As discussed above, \ mole of 2-(hytSrojtyfnethy]}-2-niTO-l,3-prop8nediol forms 2 moles of formaldehyde- The ADD for Formaldehyde is
calculated as follows, e.g. (28,0 ug/kg/day / molecular weight of formaldehyde) X 2 moles of formaldehyde = 12 ug/fcg/day formaldehyde for
the preservative use.
B The ADD for formaldehyde from Table III.
Preservative, pulp and paper mills - The mixer/loader/applicator
exposure to formaldehyde for these uses should be brief (e.g., less than
one hour for each treatment) since only a small amount, if any,
degradation from 2-(hydr0xymethyl)-2-mtro-l,3-pK>panediol to
formaldehyde should occur in that short interval. However, the exposure
to 2-(hydroxymethyi)-2-nitrG-l,3-propanediol is considered significant for
these uses. Thus, personal protective equipment is required as well as a
respirator. Therefore, what exposure to formaldehyde that might have
occurred is reduced ten-fold by using personal protective equipment and
a respirator.
Cooling towers and metal cutting fluids - Since the time needed for
loading 2-(hydroxymethyl)-2-nitro-l ,3-propanediol products for these uses
should be brief (e.g. less than an hour for each treatment), the potential
exposure to the mixer/loader/applicator to 2-(hydroxymethyl)-2-nitro-l,3-
propanediol and formaldehyde will be of relatively short duration.
Additionally, only a small amount, if any, of degradation from 2-
(hydroxymethyl)-2-nitro-l,3-propanedioI to formaldehyde should occur in
that short interval. For these reasons, the use of a respirator would not
15
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be an advantage.
Poultry/livestock disinfectant - The Agency is concerned about
potential exposure of mixer/loader/applicator to formaldehyde for this use
since formaldehyde is already present as an active ingredient in the
product and the application involves a spray method. These workers are
also exposed to the concentrated active ingredients during mixing of the
diluted spray solution. Use of a respirator and PPE would result in a. ten-
fold reduction in the exposure.
Post-Application Worker Exposure - Formaldehyde
Preservative use, cooling tower, and metal cutting fluids - Post-
application worker exposure to formaldehyde from the degradation of 2-
(hydr0xymethyl)-2-nitro-l,3-propanediol is minimal for the cooling tower
use, the preservative use, and the cutting fluid use because the degradation
conditions, i.e. the very alkaline conditions in combination with high
temperature, are not likely to occur in these use situations.
Poultry/livestock disinfectant - Post-application worker exposure
to formaldehyde can be expected as a result of the use of the disinfectant
spray in livestock/poultry premises, because formaldehyde is an active
ingredient in this disinfectant spray and the 2-(hydroxymethyl)-2-nitro-l ,3-
propanediol will slowly degrade to formaldehyde. Therefore, post-
application inhalation exposure is of particular concern. Post-application
monitoring data requirements for formaldehyde are being addressed for
poultry houses under the reregistration data call-in for formaldehyde.
Although the post-application worker exposure is of concern for
the poultry/livestock disinfectant use, the mixer/loader/applicator estimate
actually represents the worst case scenario of exposure. The post-
application worker in the poultry/livestock building is not exposed to the
concentrated product (used for mixing) or the spray application of the
formaldehyde. In addition, part of the application process is to rinse all
treated surfaces with potable water approximately 10 minutes following
spray application. Products containing formaldehyde as the active
ingredient for this use are also regulated by the Occupational Safety and
Health Administration (OSHA) which requires monitoring for
formaldehyde before workers enter the premises following treatment. The
OSHA Permissible Exposure Limit (PEL) for formaldehyde is 0.75 ppm.
Therefore, the post-application worker exposure is the same as (or less
than) that of the mixers/loaders/applicators for the disinfectant use. PPE
and respirators are required for workers entering the treated areas before
air level concentrations for formaldehyde have bees measured.
16
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Pulp and paper mills - Post-application worker exposure to
formaldehyde can be expected as a result of the use of 2-(hydroxymethyl)-
2-nitro-l,3-propanedioI products in pulp and paper mills. The post-
application worker exposure to formaldehyde can be estimated for a
lifetime based on the average daily dose; ADD X work years/years (life
expectancy); or, 0,0029 mg/kg/day X 35 work years/70 years (life
expectancy) = 0.00145 mg/kg/day = LADD.
In calculating the ADD, the Agency considered converting 10% of
the active to formaldehyde; the concentration in pulp mixture; determining
the vapor concentration of formaldehyde (if all of the formaldehyde
converted to the vapor phase); the inhalation rate for an average worker;
the total formaldehyde inhaled during an 8 hour work day; and the
lifetime working exposure. These and other assumptions include:
1) the temperature is 25°C and the pH is 7.5,
2) the slow degradation for 2-(hydroxymethyl)-2-nitro-l,3-propanediol.
i.e. only 10% in water is converted into the formaldehyde,
3) a total of 50.8 pounds of 2-(hydroxymethyl)-2-nitro-i,3-propanediol
is added into the pulp mills,
4) 10 tons of pulp was treated with this compound and approximately 10
million gallons of water (37.8 million liters) are used,
5) the molecular weight of 2-(hydroxymethyl)-2-nitro-l,3-propanediol is
151 and the molecular weight of formaldehyde is 30,
6) an alkaline solution where one mole of 2-(hydroxymethyl)-2-m"tro-l ,3-
propanediol is converted to 2 moles of formaldehyde,
7) the partial vapor pressure of formaldehyde at 760 rnmHg, 25 °C, and
a concentration of 0.02419 mg/L in water can be converted to vapor
concentration at 0.0177 mg/m3,
8) the worker body weight of 70 kg, working at the area for 8 hours/day,
5 days a week, 250 days/year, at an inhalation rate of 16.8 m3 of air were
inhaled/day, and
9) lifetime exposure is 35 years in a lifetime of 70 years.
This determination of post-application exposure is conservative
since factors resulting in dilution of the formaldehyde concentration were
not considered; e.g., the pulp mixture is generally not stationary and there
are ventilation systems in mills. Since this is a very conservative estimate
of the post-application worker exposure and the Agency may have
overestimated worker exposure, a post-application inhalation exposure
monitoring study is required for uses in pulp and paper mill systems.
These data are considered confirmatory by the Agency. This study will
provide the Agency with a more accurate estimation of potential post-
application exposure to workers.
17
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The labeling to protect workers is contained in Section V at the end
of this document,
3. Risk Assessment
a. Dietary
There are no food uses associated with the use of 2-
(hydroxymethyl)-2-nitro-l,3-propanediol; therefore, no dietary risk
assessment was conducted by the Agency.
b. Occupational and Residential
Overall, there is minimal risk associated with the active ingredient,
2-(hydroxymethyl)-2-rutro-l,3-propanedioL The exposure to this active
ingredient for mixers/loaders/applicators is minimal and there are no
toxicological concerns associated with this chemical that lead to significant
risk concerns.
The risk of concern associated with the use of products containing
2-(hydroxymethyl)-2-nitro-l,3-propanediol is due to the degradation
product, formaldehyde, which is slowly released from the active
ingredient under alkaline conditions and the presence of formaldehyde as
an active ingredient in one product.
For details on the effects and risks associated with formaldehyde.
the following EPA documents should be consulted:
Assessment of Health Risks to Garment Workers and Certain Home
Residents from Exposure to Formaldehyde. Office of Pesticides and Toxic
Substances, U.S.E.P.A., April, 1987, pp. 7-1 to 7-11.
Formaldehyde Risk Assessment Update, Final Draft, Office of Toxic
Substances, U.S.E.P.A., June 11, 1991.
Guidance for the Registration of Pesticide Products Containing
Formaldehyde and Paraformaldehvde as the Active Ingredient, Office of
Pesticides and Toxic Substances, Office of Pesticide Programs (OPP).
U.S,E.P,A,,May31» 1988.
In the 1987 risk assessment, the administered dose was expressed
as ambient air concentration (formaldehyde concentration in ppm) and was
used directly as the measure of dose in the risk assessment. In the !99!
risk assessment, the administered dose was expressed as an intracellular
18
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dose, which was derived from a measurement of the amount of DNA-
protein crosslinking (DPX) in the nasal target cells themselves. The 1991
document presented scientific evidence derived from studies in rats and
monkeys and a rationale which suggested that use of the DPX data would
provide a more meaningful measure of dose to the target tissue than the
ambient air concentration and, in turn, would lead to a more accurate risk
estimate. Also, die 1987 assessment utilized a lifetime average daily
exposure adjustment, whereas the 1991 assessment did not,
For the purpose of estimating carcinogenic risks to humans, the
1987 document derived an airborne upper bound incremental unit risk of
1.6 x 1Q~2 per ppm (lifetime individual risk, based on continuous exposure
for 70 years). The 1991 document derived comparable unit risks of 2.8
x 10"3 per ppm and 3.3 x 1O4 per ppm based on the rat and monkey DPX
data, respectively (for formaldehyde concentrations below 0.3 ppm).
These unit risks are 6 to 50 times lower than those calculated in 1987.
The Agency believed the risk for humans most likely was between that for
rats and monkeys.
In 1991, the EPA Science Advisory Board (SAB) was asked to
comment on the novel 1991 DPX methodology for calculating
carcinogenic risks for formaldehyde. The SAB response (in 1992)
expressed reservations regarding the use of the 1991 methodology and
particularly use of the monkey DPX data for this purpose. Consequently,
there is considerable uncertainty at this time regarding the use of the 1991
risk assessment methodology and the 1991 document; a "final draft", has
not yet been "finalized." In the interim, prudence dictates that the 1987
methodology should be used for formaldehyde risk assessments.
IE 1988, EPA published a Registration Standard for pesticide
products containing formaldehyde and paraformaldehyde. In that
Registration Standard, carcinogenic risks to agricultural workers were
calculated based on the risk assessment methodology presented in the 1987
OPTS document referenced previously in this chapter. In the 1988
Registration Standard, a Qf of 1.87 x 10'2 (mg/kg/day)4 was used to
calculate carcinogenic risks for agricultural workers. Using this same Qf
and methodology, the estimate of carcinogenic risks associated with the
five use patterns for 2-(hydroxymethyl)-2-nitro-l,3-propanediol are
calculated as follows:
Carcinogenic Risk = Q(* x LADD
The LADD is determined for the five representative uses by
multiplying the Average Daily Dose (ADD) for formaldehyde for each use
19
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times the fraction of lifetime exposed, i.e. 35 work years / 70 years (life
expectancy). The LADDs for the five use patterns of 2-(hydroxymethyl)-
2-nitro-l,3-propanedioI are provided in Table V. below.
TABLE V. Lifetime Average Daily Dose (LADD) of Formaldehyde
for Five Representative Use Patterns for Mixers/Loaders/Applicators
Representative
Use Pattern
Preservative
Wood P & P
Cooling Tower
Metal Fluid
Disinfectant
(poultry/livestock)
ADD
Formaldehyde
(mg/kg/day)1
0.012
0.032
0.00069
0.0022
0.0027
LADD
Formaldehyde
(mg/kg/day)
0.006
0,016
0.00035
0.0011
0.0014
derived from the 1055 conversion of Uie active ingredient w formaldehyde.
Using these LADD estimates and the Q,,* cited above, the upper bound
increase in carcinogenic risk for each representative use pattern, based on
mixer/loader/applicator exposure to formaldehyde, is derived. These estimated
excess carcinogenic risks are presented below (Table VI),
TABLE VI. Upper bound Excess Carcinogenic Risk Estimates for
Mixers/Loaders/Applicators from Exposure to Formaldehyde
without PPE and respirators
Use Pattern Excess Carcinogenic Risk
Preservative 1.1 x 10^
Wood Pulp & Paper 3.0 x IQ-4
Cooling Tower 6.5 x 10"6
Metal Cutting Fluids 2.1 x 10~5
Disinfectant 2.5 x 10"5
(poultry/livestock)
20
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The actual exposure to formaldehyde is expected to be less than the values used
to calculate the carcinogenic risk estimates presented in Table VI since the conversion
rate of the active ingredient to formaldehyde probably would be less than 10%. In
addition, mixer/loader/applicator exposure will be further mitigated by the use of
personal protective equipment and respirators, which could reduce dermal and primarily
inhalation exposure to airborne formaldehyde at least ten-fold. With the use of personal
protective equipment and respirators for the pulp and paper mill use, the preservative use
and the disinfectant use, the refined estimate of the upper bound increase in carcinogenic
risk for each of these three representative use patterns, based on mixer/loader/applicator
exposure to formaldehyde, is reduced ten-fold. See Table VII below. The metal cutting
fluid uses and the cooling tower uses involve minimal exposure of
mixer/loader/applicators to formaldehyde as described above in the section on exposure.
If PPE, not including respirators, were used, the upperbound excess carcinogenic risk
to formaldehyde would be unchanged from the risk estimates in Table VI, Respirators
would not be useful in reducing exposure and risk for these two uses because of the short
duration of handling the products under these use conditions, resulting in little time
available for formaldehyde formation.
TABLE VII. Refined Upper bound Excess Carcinogenic Risk Estimates for
Mixers/Loaders/Applicators from Exposure to Formaldehyde with PPE and Respirators
Use Pattern Excess Carcinogenic Risk
Preservative 1,1 x 1Q~5
Wood Pulp & Paper 3.0 x 1G'5
Disinfectant 2.5 x 10"6
(poultry/livestock)
Post-application worker exposure to the active ingredient, 2-(hydroxymethyl)-2-
nitro-l,3-propanediol, is minimal for all uses as described above. There are no
significant lexicological concerns specifically with this active ingredient or exposure
concerns. The toxicological concerns and the post-application worker exposure risks are
associated with formaldehyde. The risk associated with formaldehyde for post-
application workers as a result of the cooling tower use, the preservative use, and the
cutting fluid use is minimal, because the degradation conditions, i.e. the very alkaline
conditions in combination with high temperature, are not likely.
Post-application worker exposure to formaldehyde following the livestock/poultry
premise use is of some concern; however, the mixer/loader/appiicator exposure estimate
actually represents the worst case scenario of exposure. The post-application worker is
not exposed to the concentrated product or the spray application of the formaldehyde.
In addition, part of the application process is to rinse all treated surfaces with potable
water approximately 10 minutes following spray application. Products containing
21
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formaldehyde as the active ingredient for this use are also regulated by the Occupational
Safety and Health Administration (OSHA) which requires monitoring for formaldehyde
before workers enter the premises following treatment. The OSHA Permissible Exposure
Limit (PEL) for formaldehyde is 0.75 ppm. Therefore, the post-application worker
exposure and risk is the same (or less) than that of the mixers/loaders/applicators for the
disinfectant use. The post-application worker upperbound excess carcinogenic risk is <_
2.5 X 10~6.
Post-application worker exposure to formaldehyde can be expected as a result of
the use in pulp and paper mills. The LADD is 0.00145 mg/kg/day; therefore, the upper
bound excess carcinogenic risk is estimated to be 0.00145 mg/kg/day X Q*1 (1.87 X 10~2
mg/kg/day) = 2.7 x 10"5. This carcinogenic risk determination is considered
conservative since this exposure (LADD) does not consider dilution of the formaldehyde
air concentration, the pulp mixture is generally not stationary, and there are ventilation
systems in mills. A post-application inhalation exposure monitoring study is required for
uses in pulp and paper mill systems, but these data are considered confirmatory.
C. Environmental Assessment
Above, in subsection B., the Agency discusses the degradation of 2-
(hydroxymemyl)~2-nitro-l,3-propanediol to formaldehyde and its concerns for
carcinogenic risks to workers. The Agency does not have a similar concern for
environmental exposure. Although formaldehyde is slightly more toxic to aquatic
organisms than is 2-(hydroxymethyl)-2-mtro-l,3-propanediol (the parent compound), the
parent compound is relatively stable in the aquatic environment. As it breaks down to
formaldehyde, the latter compound is rapidly dissipated. Therefore, the Agency focused
its environmental risk assessment on the parent compound.
1. Environmental Fate
The Agency has assessed a hydrolysis study for 2-(hydroxymethyl)-2-nitro-
1,3-propanediol, but it is not adequate to characterize the hydrolysis of this
chemical. A new study is being required to confirm the rate of degradation of
the active ingredient and products formed during hydrolysis. It is expected, as
a result of a model exposure assessment, that this chemical when used according
to the label, will pose minimal risk to the environment. The only concerns for
environmental exposure, therefore, would be in the case of spills, accidents,
misuse or when it may be discharged in industrial effluent under a National
Pollution Discharge Effluent System (NPDES) permit. This type of discharge is
discussed further below.
2. Ecological Effects
There are sufficient ecotoxicological data to characterize the toxicity of
-------
2-(hydroxymemyl)-2-nitro-l,3-propanediol to nontarget terrestrial and aquatic
organisms. The rat and rabbit lexicological data discussed above in subsection
B. suggest that 2-(hydroxymethyl)-2-nitro-1,3-propanediol (53,1 -56.8 %) has a low
order of acute oral and dermal toxicity to terrestrial mammals (acute oral LDSO
= 1860-1890 mg/kg for rats and > 2000 mg/kg for rabbit dermal toxicity test).
The avian toxicity of the technical grade (TGAJ) of 2-(hydroxymethyl)-2-
nitro-1,3-propanediol, when extrapolated from the results of subacute dietary
toxicity data using 50% a.i. formulated product, was found to be slightly toxic
to upland game birds (>2,500 pprn) and practically non-toxic to waterfowl
(> 40,000 ppm). The subacute dietary data using 2~(hydroxymethyl)-2-mtro-1,3-
propanediol TEP (50%), indicate that this pesticide is practically non-toxic to
upland game bird species (bobwhite quail, LC50 greater than 5,000 ppm, (MRID
00094706)) and waterfowl species (mallard duck, LC50 greater than 80,000 ppm
(MRID 00094707)) on a subacute dietary basis.
The available data indicate that 2-(hydroxymethyl)-2-nitro-i, 3-propanediol
is practically non-toxic to rainbow trout (TGAI LC50 = 414 ppm; TEP LC50 >
300 ppm (MRID 00094708)), fathead minnow (TGAI LC50 = 280 ppm (MRID
42205203)), and bluegill sunfish (TEP LC50 > 300 ppm (MRID 00094709)).
Therefore, 2-(hydroxymethyl)-2-nitro-l,3-propanediol can be characterized as
practically non-toxic to freshwater fish species based on acute toxicity. Data
using Daphnia magna as the test species indicate that 2-(hydroxymethyl)-2-nitro-
1,3-propanediol is slightly toxic to freshwater aquatic invertebrates (TGAI LC30
= 80 ppm (MRID 42205204)). The results of two studies indicate that 2-
(hydroxymethyl)-2-nitro-l,3-propanediol is slightly toxic to molluscs (TGAI LC50
22.8 ppm (MRID 42099001)) and practically non-toxic to crustaceans (TGAI LCM
>95.5 ppm (MRID 42099002)). The estuarine/marine fish study was waived
based on the low toxicity of 2-(hydroxymethyI)-2-nitro-l,3-propanediol to
freshwater fish.
a. Ecological Effects Risk Assessment
A Tier Ic EEC (estimated environmental concentration) model was
conducted by the Agency to assess the estimated environmental
concentration of residue levels of 2-(hydroxymethyl)-2-nitro-l.3-
propanediol in the receiving stream from the pulp/paper mills, cooling
towers, oil recovery/drilling muds and metal finishing uses. This model
provides an estimate of the maximum concentration that may occur
immediately downstream from an industrial (point source) discharge site.
The EECs are reasonable worst case, one in ten year EECs. For the high
exposure case site, it would be expected that the EEC would be equaled
or exceeded once every ten years, i.e., there is a 10% chance in any given
year that the EEC will be equaled or exceeded. The difference in the
23
-------
scenarios is the flow rate of the receiving waters. This is similar to the
site and frequency assumptions that are generally being used for
agricultural pesticides.
Below, in Table VIII, EEC values are given for high exposure and
typical exposure scenarios from the different use patterns of 2-
(hydroxymethyl)-2-nitro~ 1,3-propanediol.
Table VIII. Tier Ic EECs for 2-(hydroxymethyl)-2-nitro-l ,3-propanediol
Use Site, Type
Metal Working, Group 1*
Metal Working, Group 2",
recovery rate
Metal Working, Group 2**
maintenance rate
Pulp and Paper Mills
Water Cooling Towers,
Evaporative Condensers,
recovery
Water Cooling Towers,
Evaporative Condensers,
maintenance
Secondary Oil Recovery
Injection Water, Drilling
Muds, recovery
Secondary Oil Recovery
Injection Water, Drilling
Muds, maintenance
High exposure
68 ppm
533 ppm
133 ppm
2540 ppm
609 ppm
152 ppm
1000 ppm
1000 ppm
Typical exposure
0.054 ppm
0.422 ppm
0. 105 ppm
7. 100 ppm
0.978 ppm
0.243 ppm
1 .400 ppm
0.703 ppm
* "OO" Wafers, "OO" Powder, S.SX Sump Saver
** "Tris-Nitro 50% Aqueous, Tris-Nitro 25% Aqueous, Tris-Nilro Solid
A level of concern (LOG) is exceeded when the EEC value equals
or exceeds 1/2 the LC^, values for aquatic organisms. The LOCs for 2-
(hydroxymethyI)-2-nitro-i,3-propanediol are40 ppm forDaphnia and 207
ppm for fish. The typical EEC values are below the LOC values for fish
and invertebrates for all uses. Therefore, if the receiving streams never
24
-------
have a flow rate below their mean flow condition, there is minima! risk
to aquatic organisms in these waters under those conditions. However,
the following table indicates a high risk to aquatic organisms from the
high exposure scenario.
Industrial Appl.
Metal Finishing
Pulp/Paper Mills
Cooling Towers
Oil Well Operations
Type of LOC Exceeded for High Exposure
(Indicates High Risk)
Daphnia for all types, including maintenance
operations
Fish only for the recovery operation
Scenario
and recovery
Daphnia and fish
Daphnia for maintenance and recovery
operations
Fish for recovery operation
Daphnia and fish for maintenance and recovery operations
b. Endangered Species
The LOC for endangered aquatic species is 1/20 the LCSO values,
which for 2-(hydroxymethyl)-2-nitro-l,3-propanediol is 4 ppm for
invertebrates and 20.7 ppm for fish. The high exposure scenarios for all
uses of 2-(hydroxymethyl)-2-nitro-l,3-propanediol exceed the LOC for
endangered aquatic organisms. In addition, the typical EEC value for
pulp and paper mills exceeds the LOC for endangered aquatic
invertebrates. As 2~(hydroxymethyl)-2-nitro-l,3-propanediol will be
discharged at a number of different sites, it is reasonable to assume that
endangered species are located in some of these aquatic habitats.
Therefore, effluent containing 2-(hydroxymethyl)-2-nitro-l ,3-propanediol
should not be discharged into streams and other waterways where
endangered aquatic organisms are known to reside.
Since the discharge of 2-(hydroxymethyl)-2-nitro-l,3-propanediol
is limited by the National Pollutant Discharge Elimination System
(NPDES) permit program of the Office of Water, the Agency would be
able to control the discharge of 2-(hydroxymethyl)-2-niiro-l ,3-propanediol
so that toxic levels are avoided. Results from modeling indicate that 2-
(hydroxymethyl)-2-nitro-l ,3-propanediol can be used at use sites without
producing effluents above concern levels.
25
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing 2-(hydroxymethyl)-2-nitro-l,3~propanediol
as the active ingredient. The Agency has completed its review of these generic data, and
has determined that the data are sufficient to support reregistration of all products
containing 2-(hydroxymethyl)-2-nitro-l,3-propanediol. However, the Agency is
requesting confirmatory data for post-application exposure of the degradate formaldehyde
to workers and hydrolysis of 2-(hydroxymetiiyl)-2-nitro~l,3-propanediol. It is also
requiring product specific efficacy, chemistry and acute toxicity data for labeling
purposes. Appendix B identifies the generic data that the Agency reviewed as part of its
determination of reregistration eligibility of 2-(hydroxymethyl)-2-nitro-l,3-propanediol,
and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of 2-(hydroxymethyl)-2-nitro-l,3-propanediol and to determine that
2-(hydroxymethyl)-2-nitro-l ,3-propanediol can be used without resulting in unreasonable
adverse effects to human health and the environment. The Agency therefore finds that
all products containing 2-{hydroxymethyl)-2-nitro-l ,3-propanediol as the active ingredient
are eligible for reregistration. The reregistration of particular products is addressed in
Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data and the data identified in Appendix B. Although the
Agency has found that all uses of 2-(hydroxymethyl)-2-nitro-l ,3-propanediol 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 2-(hydroxymethyl)-2-nitro-l,3-propanediol, if new
information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change,
1. Eligibility Decision
Based on the review of the generic data for the active ingredient 2-
(hydroxymethyl)-2-nitro-l,3-propanediol, the Agency has sufficient information on the
potential health effects of 2-(hydroxymethyl)-2-nitro-l,3-propaaediol, and its degradate
formaldehyde, and on its potential for causing adverse effects in fish and wildlife and the
environment. The Agency has determined that 2-(hydroxymethyl)-2-nitro-l,3-
26
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propanediol products, labeled and used as specified in this Reregistration Eligibility
Decision, will not pose unreasonable risks or adverse effects to human health or the
environment as long as label restrictions prescribed in this RED are followed.
Therefore, the Agency concludes that products containing 2-(hydroxymethyl)-2-nitro-l ,3-
propanediol for all uses are eligible for reregistration.
2, Eligible and Ineligible Uses
The Agency has determined that all uses of 2-(hydroxymethyl)-2-nitro-l ,3-
propanediol are eligible for reregistration.
B, Regulatory Position
The following is a summary of the regulatory positions and rationales for 2-
(hydroxymethyl)-2-nitro-l ,3-propanediol. Where Labeling revisions are imposed, specific
language is set forth in Section V of this document.
1. Labeling Rationale
Because use of 2-(hydroxymethyl)-2-nitro-1,3-propanediol products
can result in carcinogenic risk to workers, the Agency is requiring the use
of certain protective clothing and equipment while handling and applying
end-use products.
Also, because certain uses can result in discharge of 2-
(hydroxymethyl)-2-nitro-1,3-propanediol into receiving waters, the Agency
is requiring labeling that restricts effluent discharge unless it is under a
NPDES permit.
21
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2. Confirmatory Data Rationale
The Agency is requiring, through a Data Call-in Notice as a part
of this document, registrants to submit additional data to confirm the acute
toxicity and exposure estimated from the current data base. Acute
inhalation and eye irritation studies on powdered technical grade 2-
(hydroxymethyl)-2-nitro-l ,3-propanediol are required, A monitoring study
is required to measure post-application inhalation exposure of
formaldehyde to workers in pulp and paper mills. Under separate and
pre¥ious Data Call-in Notice the Agency has required a similar study for
the use of formaldehyde products in poultry houses. With these data for
these exposure studies, the Agency will either confirm the exposure and
upper bound carcinogenic risk estimates or take further regulatory action
to mitigate exposure, if necessary.
Additionally, the Agency is requiring a hydrolysis study on 2-
(hydroxymethyl)-2-nitro-l,3-propanediol to confirm its degradation in the
environment, and especially as it is discharged in effluent into receiving
waters from the industrial uses of the products.
Based on its review of these additional confirmatory data, the
Agency will determine whether the risk reduction measures required in
this document were sufficient or whether further measures are necessary.
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
As discussed above the Agency is requiring as confirmatory data additional
studies on post-application worker inhalation to formaldehyde from the pulp and
paper mill use and the poultry house use (under separate Data Call-in Notice).
Acute inhalation and eye irritation data on 2-(hydroxymethyl)-2-nitro-l,3-
propanediol are also required as confirmatory data. A new hydrolysis study is
also required to confirm the degradation of 2-(hydroxpaethyl)-2-nitro-l,3-
propanediol. These generic data requirements are listed in Appendix F.
2. Labeling Requirements for Manufacturing-Use Products
"Do not discharge effluent containing this product into lakes, streams,
28
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ponds, estuaries, oceans, or public waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System (NPDES)
permit and the permitting authority has been notified in writing prior to discharge.
Do not discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office of EPA,"
B. End-Use Products
1, Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific data requirements are listed in Appendix G, the
Product Specific Data Call-in Notice. These requirements include efficacy,
product chemistry, and acute toxicology studies.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix G; Attachment 5) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then study MRID numbers should be cited
according to the instructions in the Requirement Status and Registrants Response
Form provided for each product,
2. Labeling Requirements for End-Use Products
For end-use products labeled for indoor non-food (industrial use with
effluent), aquatic non-food industrial and terrestrial non-food uses:
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or public waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment
plant authority. For guidance contact your State Water Board or Regional
Office of EPA."
Mixer/loader/applicators
Uses: Poultry/livestock premises, Preservative, and Pulp and paper mills
The personal protective equipment (PPE) requirement for such products is:
"Pesticide handlers must wear:
29
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—Long-sleeved shirt and long pants
—Chemical-resistant gloves
—Shoes plus socks
—In addition: when engaged in open pouring of this product:
-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)
Mixer/loader/applicators
Uses: Metal cutting fluids. Cooling tower water
The personal protective equipment (PPE) requirement for such products is:
"Pesticide handlers must wear:
-Long-sleeved shirt and long pants
—Chemical-resistant gloves
—Shoes plus socks
Post-application workers
Uses: Poultry/livestock premises
End-use products that contain 2-(hydroxymethyl)-2-nitro-l,3-propanediol
must be revised to adopt the entry restrictions set forth in mis section.
Place the following use restriction on the labeling in the directions
describing use as a disinfectant spray in livestock and/or poultry premises:
"Entry by any person — other than a correctly equipped handler —
is PROHIBITED in the entire enclosed building/strucaire from the
start of-application until aeration reduces the air concentration level
of formaldehyde in the working area to less than 0.75 ppm. The
air level concentration of formaldehyde must be measured before
entry is permitted. (OSHA issued a final rule for the PEL for
formaldehyde as 0.75 ppm, May 27, 1992, Federal Register, Vol.
57, p.22290.) Any handler who enters the treated area during this
entry-restricted period must wear:
-Long-sleeved shirt and long pants
—Shoes plus socks
—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
30
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number prefix TO14G).
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.
C, Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the data of issuance of this RED. Persons other than the registrant
may generally distribute or sell such products for 50 months from the data 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"; Federal Register.
Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell 2-
(hydroxymethyl)-2-nitro-l»3-propanediol products bearing old labels/labeling for 26
months from the data of issuance of this RED, Persons other than the registrant may
distribute or sell such products for 50 months from the date of issuance of this RED.
31
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VI. APPENDICES
33
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APPENDIX A. Table of Use Patterns Subject to
Reregistration
35
-------
-------
APPENDIXA- CASE 3149, (Tris(HOCH2-)nitromethane] Chemical 083902 I2-(Hydroxymethyl)-2-n!tro-1,3-propanediol)
SITE Application Type, Application
Timing, Application Equiprrwnt
Form
Minimum
Application
Rate
Maximum
Application
Rata
Max.
*
Apps,
Max.
#
Apps.
@
Max.
Ruta
Win,
tntsrval
Appe.
Max,
(Dayo)
Restricted
Entry
Interval
iDoys!
Geographic
Limitations
A Ho wed
Dis-
allowed
Use Pattern Limitations
NONFOOO/NONFEED USES
Comma reialllnduetrtal Watar Cooling Systems Ua» Groyp(i): Aquatic Non-Food IndUBtrwl
Water feoirouJoflng eyetem traatmsnt,
Initial, Not on labsl
Surfaco Typai na
Efficacy Influencing Factor na
sen
23 ppm by
Vol
50O ppm
by Vol
not
spec
not
spec
not spec
not apec
Do not discharge affluent containing thie pesticide
into Bflwtiyu ey«tems without notifyme the sewage
treatment plant authority. Do not diachargo effluent
containing this product into lakM, etroame, ponds,
astuarioe, oooone. or public water {NPDES licansa
restriotlonj. Pcoclonn claim.
Watar raoireulating system treatment,
Subsequerrtftneintenanee, Not on tabs!
Sytfaoa Type: na
Efficacy Influencing Factor: na
SC1L
8 ppm by
Vol
126 ppm
by Vol
not
not
spac
not ep«o
not epec
Do not diachargs affluent contairang thi» p»aticide
into sewage eyslams without notifyinfl Itn «iwag»
treatment plant authority^ Do not diBehftigfl affluent
containina thia product into 1»k»», ttraBmi, pondi.
aetuariat, oooans, or public water INPDES licnnie
rBalrictionK Preclaan claim.
Water reciroutating system troatmont,
Initial, Not on label
Surface Typo: na
Efficacy Influencing Factor; ns
sen.
23 ppm by
Vol
GOO ppm
by Vo!
not
spec
not
spec
not spec
not epec
Oo not discharge affluent containing this pesticide
into aewaga syetems without notifying the sewage
treatment plant authority. Do not discharge affluent
containing thia product into lakes, streams, ponde,
tstuariat, oceans, or public watar (NPDES license
r«*tfiotten), Preolean claim.
Water recrreulating system treatment",
Subsaquent/mainlenanca, Not on tab»l
Surface Type; na
Efficacy Influenoinfl Factor; na
SCtL
8 ppm by
Vol
1 25 ppm
by Vol
not
spac
not
spec
not apse
not epec
Do not dwoharge affluent containing this paeticida
into aawaga ayitema without notifying ths sewage
treatment plant authority. Do not discharge efflyent
oontaining thie product into lakes, Btreams, ponds,
estuaries, ooeana, or public water WPDES licenae
rnstrtctirnl. Praclaan claim.
Watar rcctreulating eystem treatment,
Initial, Not on label
Surface Typa: na
Efficacy Influencing Factor: na
Cf
30 ppm by
Wt
609 ppm
by Wt
not
not
sp»e
not spec
not spec
CA
Do not discharge affluent containing thie yaaticido
into sewage evsteme without notifying the sewage
treatment plant authority. Do not discharge effluent
contninirg this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction). Precleanfor heavily soilod araas.
37
-------
APPENDIX A- CASi 3149, [Tris(HOCH2-)nitromethane] Chemical 083902 [2-(Hydroxymethy()-2-nitro-1,3-propanediotl
SITE Application Type, Application
Timing, Application Equipment
Water reeircufrtinfj eyatsm treatment,
Subsequent/Maintenance, Not on label
SurfaoeTypa: na
Efficacy Influencing Factor: na
Form
Cr
Minimum
Application
Rate
1 0 ppm by
Wt
Maximum
Application
Rate
152 ppm
byWt
Max.
1
Apps.
not
spec
Max.
#
Apps.
ft
Max,
Rale
not
epoc
Min.
Interval
Between
Apps.
-------
APPENDIX A- CASE 3149, [Tris(HOCH2-}nitromethane] Chemical 083902 [2-(Hydroxymethyl)-2-nitro-1,3-propanedioI]
SITE Application Typa, Application
Timing, Application Equipment
Water racirculating system treatment,
Subsequent/Maintenance, Not on tabat
Surf«e«Type; m
Efficacy Influancing Factor; na
Water faeireulating system treatment,
Initial, Not on label
Surface Type: na
Efficacy fnfluanerng Factor: na
Wator reciroulatmg systam treatmont,
Subsequent/Maintenance, Not on label
Surface Type: na
Efficacy Influencing Factor: na
Form
SC/L
Cr
Cr
Minimum
Application
Rat»
8 ppm by
Vol
30 ppm by
Wt
10 ppm by
Wt
Maximum
Application
Rate
125 ppm
by Vol
809 ppm
by Wt
1 52 ppm
by Wt
Max,
*
Appe.
not
spec
not
spec
not
spac
Max.
t
Apps,
@
Max.
Rate
not
«pao
not
spec
not
apac
Min.
Interval
Between
Apps. (§>
Max,
Rats
(Days)
not ipec
not spac
not sp«c
Restricted
Entry
tntsrwal
(DaysJ
not epec
not spec
not apec
Geographic
Limitations
Allowed
Dis-
allowed
CA
CA
Use Pattern Limitations
Do not discharga afflusnt containing this pesticide
into sewage *y*tema without notify! ng the sewage
treaimant plant authority. Do not discharge effluent
containing thi« product into lakes, stream*, ponds,
• atusriss, oceans, or public water {NPDES license
rettrictiont. Pracfesn claim.
Do not discharge effluent containing this pa»tieide
into sewage systems without notifying th® townyi>
treatment plant authority. Do not dinoharge effluent
containing this product into lakes, atraeme, ponds,
estuaries, aoosne, or public water (NPDES licenea
restriction), Prstbnn for heavily soiled arsae.
Da not discharge effluent containing this pesticide
into sewage eystamo without notifying the sewage
treatment plant authority. Do not discharge effluent
containing this product into lakes, etraams, ponds,
actuaries, oceans, or public water (NPDES lioenee
restriction). Prsclean for heavily soiled areas.
Industrial Processing Water Use Group! si: Aquatic Nan-Food Industrial
Water reeireulsting system treatmant.
Initial, Not on label
Surface Type: na
Efficacy Influencing Factor: na
Water lecirculating system treatment,
Stlbsequantrmainlanflnce, Hot on label
Surface Type: n*
Efficacy Influencing Factor: na
Watar recirculatirtg system treatment,
Initial, Not on labol
Surface Type: na
Efficacy Influencing Factor: na
SC/L
sen
SC/L
23 ppm by
Vol
8 ppm by
Vol
23 ppm by
Vol
500 ppm
by Vol
1 2S ppm
by Vol
500 ppm
by Vol
not
specs
not
spec
not
spec
not
spec
not
epoc
not
spoc
not spec
not spec
not spac
not spec
not vpao
not spec
CA
CA
Do not discharge effluent conltining this pesticide
into (sewage systems without notifying the sewage
treatment plant authority. Do not discharge affluent
containing this product into lakes, 8tream», ponds,
actuaries, oce«n«, or public water- (NPDES Noenee
reatriction), Preclean claim.
Do not discharge affluent containing this pesticide
into sewage systems without roti'ytno the sawaga
treatrnsnt plant authority. Do not discharge offiuent
containing this product into lakes, streams, ponds,
actuaries, oceans, or public water (NPDES license
restriction!. Preclean claim.
Do not discharge of flu ant containing thie pesticide
into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent
containing this product into lakes, etraams, ponds,
estuaries, oceans, or public watar (NPDES license
restriction). Preclean claim.
39
-------
APPENDIX A- CASE 3149, [Tris(HOCH2-)nitramethan0J Chemical 083902 [2-(HydrGxymethyl)-2-nitra-1,3-propanedioI]
SITE Application Type, Application
Timing, Application Equipment
Water rseirculating ayetem treatment,
Subsequatrt/mainWna-ncB, Mot on label
Sutfao* Typs; na
Etfioaey Influencing Factor: na
Form
SC/L
Minimum
Application
Raw
8 ppm by
Vol
Maximum
Application
Rat*
1 25 ppm
by Vol
Mem,
f
Apps,
not
epae
Max.
*
Appi.
9
Max.
Rate
not
Rpnc
Min.
Interval
Between
App». @
Max,
Rate
IDaye)
not »p«c
Restriotecl
Entry
Intarval
(Days)
not spac
Geographic
Limitations
Allowed
Dis-
allowed
USB Pattat n Limitations
Do not discharge effluent containing this poBtteida
into snwaga systems without notifying the sowugs
trnaimont plant suthority. Do not discharge effluant
containing this product mta lakss, stream*, ponda,
e«tuaries, ooeann, or public water (NPOES licanso
wrtrlctiont. Piecloan claim.
Liveitoek U»»6wupt«): Indoor Non-Food
Animal equipment treatment. Not on
labs). Sprayer
Surface Typo: ns
Efficacy Influencing Factor; na
Animal aquipmant treatnwnt, Not on
label. Not on label
Surface Type; na
Efficacy Influencing Factor: na
Equipment treatment, Not on label,
Sprayar
Surface Type; rid
Efficacy Influencing Factor na
Equipmont treatment. Not on labal. Not
on label
Surface Typa: na
Efficacy Influencing Factor; na
Premiss treatment, Not ort label,
Sprayor
Surface Type: Iwd
Efficacy Influencing Factor: na
Transportation vehicle trsaimerw, Not
on labs), Sprayar
Surface Typo; hard
Efficacy Influencing Factor: na
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
1 500 ppm
by Vol
1 SOO ppm
by Vol
1 SOO ppm
by Vol
1500 ppm
byVol
! 500 ppm
byVoi
1 500 ppm
by Vol
1 500 ppm
by Voi
1 SOO ppm
by Vol
1 600 ppm
by Vol
1 SOO ppm
by Vol
1 SOO ppm
by Vol
1 500 ppm
by Vol
not
Bpee
not
spec
not
•pec
not
spec
not
spec
not
spec
not
•pec
not
spec
not
tpee
not
•pec
not
spec
not
epoc
not spec
not «p«c
not epac
not spec
not apso
not spec
not spac
not spso
not spec
not spec
not spac
not spec
Preclean claim. Propar ventilation required. Remove
aniimla prior to treatment, Remova fead and water
prior to treatment. 10 minutes contact time. Pofabla
water rinse !non-t«Bidual claim).
Praetaan claim. Proper ventilation rsquiiad. Ramove
animnls prior to trsatmerit. Ftomove faed and water
prior to treatment. 10 mirurta* contact lima, Potabls
water rinea (non-residual claim).
Preclaan claim. Proper vantilation required. Remova
ammalB prior to treatmtnt. Removo feed and water
prior to treatment. 10 minutes contact lima. Potable
water rinse (non-rmdual claim).
Preelaen claim. Propnr vantilation roquirad. Remove
animals prior to treatment, Rornova feed and water
prior to trnntment. 10 minutas corrtaot time. Potable
watar rinaa (nrm-ratidual claim!.
Practean claim. Proper ventilation required. Ramove
animal* prior to treatmtnt. Remova feed and water
prior to tr»atm«nt, 10 minutes contact time. Potable
watar rinse (non-residual claim).
Pwcleiin claim. Proper vantilation required. Remove
animal 8 prior to traatrrwnt. Remove fead and water
prior to treatment. 10 mlnutea contact lime. Potabla
water rinee (non-reaidual claim).
Motalworking Cutting Fluids Use QfoupfsS: Aquatic Non-Food Industrial
40
-------
APPENDIX A CASE 3149, (Tris(HQCH2-Jnitromethane] Chemical 083902 [2-(Hydroxymethyl)-2-mtro-1,3-propaneciio!J
SITE Application Type, Application
Timing, Application Equipment
PrBBarvativB treatment. Initial, Not on
label
Surface Typa: na
Efficacy Influencing Factor: na
PresetvBtitffl treatment,
Subsequont/mamtenanot, Not on label
Surface Typ»: na
Efficacy Influencing factor; na
Preservative treatment. Initial, Not on
label
Surface Typa; na
Efficacy Influ»ncing Factor: na
Preservative treatment,
Subsequent/maintenance, Not on label
Surface Type: na
Efficacy Influencing Factor: na
Preservative treatmant. Initial, Not on
label
Surface Typo: na
Efficacy Influencing Factor: na
Industrial preservative treatment.
During manufacture. Not on label
Surface Type: na
Efficacy Influencing Factor; na
Preservative treatment. Initial, Not on
labal
Surface Type: na
Efficacy Influencing Factor; na
Preservative treatment,
Subsequent/maintenance, Not on label
Surface Type: na
Efficacy Influencing Factor: no
Form
sc/s
sc/s
sc/s
sere
PfT
SC/L
SC/L
SC/L
Minimum
Application
Rate
pprn
cannot be
calculated
ppm
cannot be
ealculatad
ppm
cannot ba
calculated
ppm
cannot ba
calculated
ppm
cannot bo
calculated
1000 pprn
(from label)
1 2SO ppm
by Vol
313 ppm
by Vol
Maximum
Application
Rat*
ppm
cannot be
calculated
ppm
cannot ba
calculated
ppm
cannot ba
calculated
pprn
cannot bo
calculated
ppm
cannot be
calculated
2000 ppm
(from label!
2500 ppm
by Vol
625 ppm
by Vol
Max.
#
Apps,
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
apac
Max.
»
App«.
@
Max.
Rate
not
upnc
not
epdo
not
spec
not
spec
not
ap««
not
spue
not
spec
not
epac
Min.
Interval
Between
Appe. @
Max,
Rate
(Days)
not apec
not spec
not spec
not spec
not apoc
not spei;
not apes
not tpeo
ReBtrictad
Entry
Intervnt
(Day«|
not apse
not apeo
not epoc
not spec
not spec
not apec
not ep«c
not spec
Geographic
Limitstioni
Allowed
Dis-
allowed
Use Patlarn Limitations
Do not discharge affluent containing this pesticide
into Bnwage aystams without notifying thi sawage
treatment plant authority. Do not discharge affluent
containing this product into lake*, etreams, ponds,
sstuariee, ocaane, or public water (NPDES licenao
r«»trioticn). 6.0 pH frninimum), 8.0 pH (maximum).
Do not discharge effluent containing this pesticide
into Bewafle aysteme without notifying the oownge
treatment plant authority. Do not discharge sfflusnt
containing this product into lakes, atroarm, ponds,
astuariea, ocaanB, or public water (NPD6S licenge
restriction).
Do not discharge affluent containing this pasticide
into aewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent
containing this product Into lakes, streams, ponds,
estuaries, oceans, or public water (NPQES licensa
restriction}.
41
-------
APPENDIXA- CASE 3149, [Tris(HOCH2-)nitromethane] Chemical 083902 t2-(Hydroxymethyl}-2-nitro-1 ,3-propanediol]
SITE Application Type, Application
Timing, Application Equipment
Industrial preservative treatment.
During manufacture. Not on label
Surface Type: na
Efficacy Influencing Factor; rw
Prase rvattvo treatment, Initial, Not on
tabs!
Surface Type: na
Efficacy Influencing FsotOf; na
Preservative treatment,
Sub8«qu«nt/mnintsnHHC9, Not on labal
Surface Type: na
Efficacy Influencing Factor: na
Industrial preservative treatmant. Not
on label, Not on label
Surface Type; na
Efficacy Influencing Factor; ne
PraoBrvalive treatment, Initial, Not on
lahul
Surface Type: na
Efficacy Influencing Factor; na
Preservative trsatrmnt.
Subsequent/maintenance, Mot on label
Surfaea Type: na
Efficacy Influencing Factor; na
Form
SC/L
SC/L
SC/L
Cr
Cr
Cr
Minimum
Application
Rate
1000 ppm
(from lab oil
1 250 ppm
by Vol
313 ppm
by Vol
1000 ppm
{from label)
tOOO ppnn
(from label)
250 ppm
(from label)
Maximum
Application
Rate
2000 ppm
(from laball
2500 ppm
by Vol
626 ppm
by Vol
2000 ppm
(from label)
2000 ppm
{from labell
500 pprn
(from labelj
Max,
#
Apps,
not
spec
not
spec
not
spac
not
spec
not
spec
not
spec
Max,
*
Apps,
@
Max.
Rate
not
apec
not
spec
not
spec
not
spec
not
spec
not
spec
Min.
Interval
Between
Appe, @
Max.
Rats
(Days)
not *pac
not spec
not apec
not spec
not spec
not spac
ftostrictod
Entry
Intarval
(Daysl
not opec
not spec
not apec
not »pac
not apae
not spftc
Gaographic
Limitations
Allowed
Die-
allowed
Usa Pattern Limitations
Do not discharge efflunnt containing thig paeticide
Into eewago nvstoms without notifying the oawogo
treatmant plant authority. Do not discharge affluent
containing this product into InkeF, Btraatnt, ponds,
eatunriBS, ocsans, or public water (NPDES lioariB*
raetrlotion). 6.0 pH (minimum). 8.O pH |ma»muinS.
Do not discharge affluant containino tbis pesticide
into aewaga syatnme without notifying the sownge
traatment plant authority. Do not disoharga affluent
containing this product Into lakes, streams, ponds,
estuarioe, ooeana, of public water INPDES license
MBtrictionl .
Do not discharge effluent containing thia pesticide
into »ewaga systems without notilying ths «»weg«
treatment plant authority. Do nol di«ch*rg
-------
APPENDIX A- CASE 3149, [Tris{HQCH2-)nttromethaneJ Chemical 083902 [2-{HvdroxymethyI)-2-nitra-1,3-propanediol]
SITE Application Typa, Application
Timing, Application Equipment
Preservative treatment, Not on label.
Mot on label
Surface Type; na
Efficacy Influencing Factor: na
Preservative treatment. Hot on label.
Not on lobe)
Surface Type: na
Efficacy Influencing Factor; na
Preservative treatment, Not en label,
Not on label
Surface Type: na
Efficacy Influencing Factor: na
Form
SC/L
SC/L
Cr
Minimum
Application
Rate.
63 pprn by
Voi
63 pprn by
Vol
ppm
cannot be
calculated
Maximum
Application
Rote
50O ppm
by Vol
BOO ppm
by Vol
ppm
cannot be
calculated
Max.
V
App*.
not
spec
not
spec
not
epee
Max,
1
Appn.
e>
M»x.
R*t»
not
Spec
not
spec
not
spec
Min,
Interval
Between
Apps. (§>
Max.
Rele
(OayB)
nor. epec
not epec
not «pec
Rsstficted
Entry
Intflrval
IDaye)
not epac
not spao
not epeo
Geographic
LimitBtiont
Allowed
Dis-
allowed
Uuo Pattnrn Limitations
Oo not discharge affluent oontaining this paeticide
into sawaga syBtsme wilhoyt notifying the sewage
treatment ptant authority- Do not discharge efflunnl
containing this product into lakes, streams, ponds,
estuariae, oceans, or public water fNPDES liconse
taetriction) .
Do not discharge effluent containing this pasticidA
into sewaga systams without notifying th« eawage
treatment plant authority. Do not discharga affluent
containing this product into lakes, etrsame, ponds,
e«tuariaB, ocaarte, or public water INPDES license
restriction).
Do not discharge effluent containing this pesticida
into sewags systams without notifying the sewage
treatment plant authority. Do not discharge effluant
containina this product into lakes, streams, ponds,
eetuariaB, oooane, or public water (NPDES license
reettiction).
Paints, Latox (tn-Can) USB Group(e): Indoor Non-Food
Industrial preservative treatment,
During manufactura. Not on label
Sutfece Type: r»a
Efficacy Influsncing Factor: nt
Industrial preservative treBtment, Not
on labsl, Not an label
Surface Type: na
Efficacy Influencing Factor: na
SC/L
Cr
1000 ppm
oyWr
ppm
caonot be
cateutatod
5000 ppm
by Wt
ppm
cannot foe
calculated
not
spec
not
spac
not
•pec
not
epac
not spec
not spac
not ppac
not spe«
Do not discharge effluent containing this pesticide
into sewage systems without notifying tha Re wage
treatment plant authority. Do not dischargs affluent
containing this product into lakes, streams, ponds,
estuaries, oceana, or public water INPDES license
restriction).
Oo not discharge effluent containing this paaticide
into sewage systems without notifying tho sewaga
treatment plant authority. Do not discharge effluent
containing this product into lakes, streams, ponds,
asUjanee, oceans, or public water INPDES license
restriction).
Poultry (Egg/Meat) Use Groupie): Indoor Non-Food
Animaf equipment treatment, Not on
label, Sprayer
Surface Type: na
Efficacy Influencing Factor: na
SC/L
1 BOO ppm
by Vol
1600 ppm
by Vol
not
spoc
not
spac
not spec
not spec
Praclaan claim. Propaf vantilation requirecf. Ramova
animals ptior to treatment. Remove feed and water
prior to treatment. 10 minutes contact time. Potable
water rinse (non-residual claim!.
43
-------
APPENDIX A- CASE 3149, [Tris{HQCH2-)nitromethane] Chemical 083902 [2-(Hydroxymethvl>-2-nitro-1r3-propanediol]
SITE Application Type, Application
Timing, Application Equipment
Animal equipment treatment Not on
label. Not on label
Surface Type; n»
Efficacy Influencing Factor: na
Equipment treatment. Not on labul,
Sprayer
Surfaca Typa; na
Efficacy Influencing Factor: ns
Equipment treatment, Not on label, Not
on label
Surfaca Type: na
iffioacy Influencing Factor: na
Pfemise treatment, Not on label,
Sprayer
Surface Type: hard
Efficacy Influencing Factor: na
Transportation vehicle treatment, Not
on label, Sprayar
Surface Typo: hard
Efficacy Influencing Faotor: no
Form
SC/L
SC/L
SC/L
SC/L
SCIL
Minimum
Application
Rat*
1 500 ppm
hyVol
1 BOO pprn
by Vat
1 500 ppm
by Vol
1600 ppm
by Vol
1 500 ppm
by Vol
Maximum
Application
Rate
1 500 ppm
by Vot
1 500 ppm
by Vol
1 500 ppm
by Vot
1SOO ppm
by Vol
1500 ppm
by Vol
Max.
#
Apps,
not
epac
not
spec
not
spec
not
apse
not
spec
Max.
f
Apps.
@
Max.
Rats
not
epac
not
spec
not
spec
not
spec
not
spec
Mfn.
Interval
Between
Apps. ©
Mex.
Rata
IQaycl
not spec
not spec
not spec
not spec
not spec
Restricted
Entry
Interval
(Days)
not spec
not epsc
not spoc
not spec
not spec
Geographic
Limitations
Allowed
Dis-
allowed
Use Pattern Limitations
Praclean claim. Proper ventilation required. Remove
animate prior to treatment. Remove foed and water
prior to treatment. 10 minutes contact 1im«. Potable
water rinse (non-reeidual claim!.
Preclean claim. Proper ventilation roquired. Remove
animals prior to treatment. Removo feed and water
prior to treatment. 10 minutss contact time. Potable
water rinaa (non-residual elaim>.
Pracloan claim. Propsr vantilation required. Remove
animals prior to treatment. Remove feed and water
prior to treatment. 10 minutss contact time. Potable
water rinse (non-roeidual claiml.
Preclean claim. Proper ventilation required. Remove
animals prior to treatment. Remove (eed and water
prior to treatment. 10 minutes contact time. Potable
water rinse (non-rosidyai claim).
Preetaan cteim, Proper ventilation required. Remove
animals prior to treatment. Rarnove feed and water
prior to treatment. 1O minutes contact time. Potabla
water rinse (non-residual claiml.
Pulp/Paper Milt Water Systems Usa GroupM; Aquatic Non-Food Industrial
Wator treatment, Continuous feed
(initial). Metering pump
Surface Type: na
Efficacy Influencing Factor: na
W»tsr treatment, Intermittent
(s)ugXinitial), Metering pump
Surface Type: na
Efficacy Influencing Factor: na
SC/L
sea
631 ppm
by Wt
631 ppm
by Wt
2i25 ppm
by Wt
2525 ppm
by Wt
not
epac
not
spec
not
spec
not
spec
not spec
not spac
not spoc
not spue
CA
CA
Do not discharge effluent containing this pesticide
into iews0» «ystems without notifying tha eawago
treatment plant authority. Do not discharge effluent
containing this product into lakea, etf earns, ponds,
SBtuariee, ooeana, or publis walor INPDES liceneo
restrictionr.
Do not discharge effluent containing this pssticids
into eewoga systams without notifying th» 8awag«
treatmarrt plant authority. Do not discharge effluent
containing thie product into lakes, streams, ponds,
estuaries, oceans, or public water {NPDES license
restriction!.
-------
APPENDIX A CASE 3149, (Tris(HOCH2-)nitromethane] Chemical 083902 [2-(Hydraxymethyl)-2-nitro-1,3-propanediol]
SITE Application Type, Application
Tinning, Application Equipment
Water treatment, Continuous feed
(initial), Metering pump
Surface Type: no
Efficacy Influencing Factor: na
Water treatment, Intermittent
fslugHinitiall, Matafing pump
Surface Type; na
Efficacy Influencing Factor; na
Water treatment. Continuous feed
(initial). Metering pump
Surface Type: iw
Eflioacy Influencing Factor: nn
Water treatment. Intermittent
(elug)(initialS, Metering pump
Surface Type: na
Efficacy Influencing Factor: na
Form
SC/L
SC/L
Cr
Cr
Minimum
Application
Rate
170 ppm
by Wt
870 ppm
byWt
835 ppm
by Wt
635 ppm
by Wt
Maximum
Application
Rate
2280 ppm
byWt
2280 ppm
by Wt
2540 ppm
by Wt
2i40 ppm
byWt
Max.
t
Apps,
not
spec
not
spec
not
spac
not
up tic
Max.
f
Apps,
9
Max,
Rats
not
spee
not
spac
not
spec
not
spec
Min.
Interval
Between
App6, 6
Max.
R*t«
(Days)
not epec
not spec
not spec
not epsc
Restricted
Entry
Intarval
(Days|
not spae
not ip«c
not spac
not spec
Geographic
Limit attons
Allow/ad
Dis-
allowed
CA
CA
Usa Pattarn Limitations
Do not diacharga affluent containing this pesticide
into s*waga eyetnn-e without notifying the sawage
traatment plant authority. Do not discharge efllusnt
containing this product into lakes, streams, pindo.
BStuan'sB, oceans, or public w«tar {NPDES license
raetriction).
Do not diecharga effluent containing this pesticida
into sewage Bystame without notifying the sewage
treatment plant authority. Do not discharga affluent
containing this product into lakes, itraams, ponds,
estuaries, oceans, or public water (NPDES licanso
rastrictionl.
Do not discharge aflluant containing thie posticide
into sewage systems without notifying the wwags
treatment plant authority. Do not Bischarge sffluant
containing this product into lakes, streams, ponds,
astuariaa, oceans, or public water {NPDES license
restriction).
Do not discharge affluent containing this pesticide
into sawago systems without notifying tha aewaga
treatment plant authority. Do not discharge effluent
containing this product into lakoe, straama, ponds,
estuaries, ocsens, or public water (NPDES license
restriction).
Secondary Oil Recovery Injection Water Use GrouplsH Aquatic Non-Food Industrial
Watar treatment. Continuous feed
(initial). Watering pump
Surface Typa: na
Efficacy Influencing Faodor: na
Water treatment. Continuous feed
(subsequent), Matering pump
Surface Typa: na
Efficacy Influencing Factor: na
sen
SC/L
476 ppm
hyVol
476 ppm
by Vol
952 ppm
byVol
476 ppm
by Vol
not
spec
not
spec
not
spac
not
spec
not spec
not epoc
not apoc
not »pao
Do not discharge affluent containing this pesticide
into sewage systems without notifying the sewage
treatment plant authority. Do not discharge affluent
containing this product into lakes, stream», ponds,
flstunrioe, oceans, or public water (NPDES license
restriction).
Do not discharge effluent containing thie pesticide
into sa wage systems without notifyino tha sewage
treatment plant authority. Do not discharge effluent
containing this product into lakse, streams, ponds,
e«tuariei, oceans, of public water (NPDES license
restriction).
45
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APPENDIXA CASE 3149, [Tris(HOCH2-)nitromethane] Chemical 083902 [2-(Hydroxymethyl)-2-nitro-1,3-propanediol]
SITE Application Type, Application
Tiffiint), Application Equipment
Water treafmant, Intermittent
(Blutfllinitial), Maturing pump
Surface Type: m
Efficacy Influencing Factor; rta
Water treatment, Continuous lead
(initiall, Catering pump
Surface Type; na
Efficacy Influencing Factor; na
Water treatment, Continuous feed
(subeaquantl, Matsring Pump
Surfnea Typo: na
Efficacy Influencing Factor: na
Water treatment, (ntermtttarrt
MygHWtial!, Metering pump
Surface Type; no
Efficacy Influencing Factor; n»
Water treatment, Continuous food
(initial), Metering pump
Surface Typo: na
Efficacy Influencing Factor: na
Water treatment. Continuous feed
(subsequent). Metering pump
Surface Type: na
Efficacy Influencing Factor: na
Form
sen
sen
SCIL
SC/L
Cr
Cf
Minimum
Application
Rate
478 ppm
by Vol
476 ppm
by Vol
478 ppm
by Vol
478 ppm
by Vol
580 ppm
byWt
680 ppm
by Wt
Maximum
Application
Rata
952 ppm
by Vol
952 ppm
by Vol
470 ppm
by Vol
952 ppm
bvVoi
11 S3 ppm
by Wt
580 ppm
byWt
Max,
*
Apps,
not
spec
not
spec
not
spec
not
spat;
not
spec
not
spec
Max.
ff
Apps.
<§>
Max.
Rats
not
spec
not
upac
not
spec
not
spec
not
spec
not
spec
Win.
Interval
Batwe«n
App«, @
Max.
Rate
(Daye)
not spec
not spec
not spec
not spec
not spec
not spec
Restricted
Entry
Intsrval
(Days)
not spec
not epac
not epsc
not spoc
not spao
not spec
Geographic
Limitations
Allowed
Dis-
allowed
Use Pattern Limitations
Do not discharge effluent containing thie pesticide
into sewage *y«t«ms without notifying the eewage
treatment plant authority. Do not dischargs affluent
containing this protfuet into lakoe, streams, ponds,
astuariee, oceans, or public watar (NPDES ticensn
restriction).
Do not discharge effluont containing thie pesticide
into sowngo systernB without notifying tha sewagB
treatment plant authority. Do not discharge effluent
containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction).
Do not discharge effluent containing this psstictde
into sewage systems without notifying Ihe sewage
treatment plant authority. Do not discharge offtuont
containing this product into takes, streams, ponds,
estuaries, oceans, or public water {NPDES license
restriction).
Do not discharge affluent containing this pesticide
into sewage systems without notifying tha sewage
treatment plant authority. Do not discharge effluent
containing thie product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDCS license
restriction}.
Do not discharge «fflusnt containing this pesticide
into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent
containing this product into lakes, streams, ponds,
actuaries, oceans, or public water (MPDES license
restriction!.
Do not diBcharflB affluent 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 watar (NPDES license
restriction).
-------
APPENDIXA- CASE 3149, lTris(HOCH2-)nitramethane] Chemtcal 083902 [2-(Hydroxymethvl)-2-nitro-1,3-propanediol]
SITE Application Type, Application
Timing, Application Equipment
Water treatment, Intermittent
(nl'.ig! (initial), Metsring pump
Surface Type: na
Efficacy Influencing Factor; na
Form
Cr
Minimum
Application
Rate
S80 ppm
by Wt
Maximum
Application
Rate
1 1 59 ppm
byWt
Max.
»
Apps.
not
spec
Max.
i
Apps.
@
Mnx.
Rate
not
Spec
Min.
Intarval
Betwenn
Apps. (P
Max.
Rata
(Days}
not eooc
Rsetfiotod
Entry
Interval
(Days)
not epsc
Geographic
Limitations
AHowad
DlK
allowed
Usa Pattern Lirntta!ions
Do not discharge affluent containing this pesttoido
into aawana eystemB without notifying the Bowaga
treatment plant authority. Do not discfiarga affluent
containing this product into lakaa, streams, ponde,
eetuariea, OBeans, or public water (NPDES liconae
rastrietion).
Speciality Industrial Products UBO Groupie); Indoor Non-Food
Preservative traatmant. Not an labs!,
Not on labal
Surface Type: na
Efficasy Influencing Factor; na
Preservative treatment. Not on label.
Not on label
Surl»e» Typa: na
Efficacy Influencing Factor: na
Preservative tcaatmant. Not on label,
Not on label
Surface Type: na
Efficacy Influencing Factor; na
SC/L
SCfl
Cr
500
ppm/gat by
Vol
(from label)
500
ppmfgal by
Vol
(from label)
500
ppm/gaf by
Wt
{from label)
1000
ppm/jjal by
Vol
(from labal)
1000
ppm/gal by
Vol
{tram label!
1000
ppm/gal
by Wl
(from label)
not
upoc
not
epec
not
spec
not
spoc
not
epao
not
sp@c
not spec
not epeo
not spec
not spec
not spec
not apae
CA
CA
Do not diBchnrge effluent containing this pesticide
into aowage oyetame without notifying the eewaga
treatment ptnnt authority. Do nnt diechargs efftyent
containing thia product into lakas, streams, pondls,
eatuarias, oeeana, or public water (NPDES hconse
restriction).
Do not di«olia»go affluent containing thii (•••ticid«
into sewage systemn without nofit-ying th» tuwnyn
traatrnent plant authority. Do no( discharg* effluent
contaitiing this product into Inkss, alfQama, ponds,
satunriaB, oceans, or public water. .(NPDES II cans 8
restriction).
Do not dischargo afflusnt containing this pssticide
into sswaga systBms without notifying the sewaga
treatment plant authority. Do not discharge affluent
containing this product Into lakas, streams, ponds,
estuaries, oceans, or public water (NPDES liceneo
roetrictionl.
Abbrevijliorn usad
Header: max = maximum; min *>minimum; apps-applicationB; not spac = not spacified; na = not appficable
Form: SC/L = solubl8 concentratefliquid; SC/S= soluble eonoanlrata/aolid; Cr = cryelallinB; P/T = pBllated/tahlatad
Rato; ai =actiw8 ingredient; ppm = parts par million; Vol = volume; Wt= woight; gal = gallon
47'
-------
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
49
-------
-------
TRIS(HYDROXYMETHYL)NITROMETHANE: DATA CALL-IN CHEMICAL STATUS
SHEET
INTRODUCTION
You have been sent this Generic Data CalOn Notice because you have product(s)
containing TRJS(HYDROXYMETHYL)NITROMETHANE.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
TRIS(HYDROXYMETHYL)NITROMETHANE. This attachment is to be used in
conjunction with (1) the Generic Data Call-In Notice, (2) the Generic Data Call-In Response
Form (Attachment B), (3) the Requirements Status and Registrant's Form (Attachment C),
(4) a list of registrants receiving this DCI (Attachment D), (5) the EPA Acceptance Criteria
(Attachment E), and (6) the Cost Share and Data Compensation Forms in replying to this
TRIS(HYDROXYMETHYL)NITROMETHANE Generic Data Call-in (Attachment F).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for
TRIS(HYDROXYMETHYL)NITROMETHANE are contained in the Requirements Status
and Registrant's Response. Attachment C. The Agency has concluded that additional product
chemistry data on TRIS{HYDROXYMETHYL)NITROMETHANE are needed. These data
are needed to fully complete the reregistration of all eligible
TRIS(HYDROXYMETHYL)NITROMETHANE products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact ERNIE DOBBINS at (703) 308-8071.
All responses to this Notice for the generic data requirements should be submitted to;
ERNIE DOBBINS, Chemical Review Manager
ACCELERATED REREGISTRATION BRANCH
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: TRIS(HYDROXYMETHYL)NITROMETHANE
51
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case 3149 covered by this Reregistration Eligibility Document. It
contains generic data requirements that apply to 3149 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
1 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.
52
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of
TRIS(HYDROXYMETHYL)N1TROMETHANE
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
63-8
63-9
63-10
63- 1 1
63-12
63-13
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
Solubility
Vapor Pressure
Dissociation Constant
OctanoI/Water Partition
PH
Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
42958001
42958001
42958001
42958001
42958001
42958001
42958001
42958001
42958001
42958001
WAIVED
42958001
42958001
42806301
42806301
42958001
42958001
42958001
53
-------
Data Supporting Guideline Requirements for the Reregistration of
TWS{HYDROXYMETHYL)MTRQMETHANE
REQUIREMENT
USE PATTERN
CITATION(S)
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
724A
72-1B
72-1 C
72-1 D
72-2A
72-3A
72-3B
72-3C
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Bluegill - TEP
Fish Toxicity Rainbow Trout
Fish Toxicity Rainbow Trout- TEP
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
F
F
F
WAIVED
WAIVED
94706, 94707
42205203
94709
94708
94709
42205204
WAIVED
42099001
42099002
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
ALL
ALL
ALL
ALL
ALL
94711
43222
DATA GAP
DATA GAP
94711, 109228
54
-------
Data Supporting Guideline Requirements for the Reregistration of
TRIS(HYDROXYMETHYL)NITROMETHANE
REQUIREMENT USE PAITERN
81-6
82-3
83-3A
83-3B
84-2A
84-2B
84-4
Derma! Sensitization - Guinea Pig
90-Day Dermal - Rodent
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
Gene Mutation (Ame§ Test)
Structural Chromosomal
Aberration
Other Genotoxie Effects
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
N/A
41021101
41089301
42303501
41058101
41944301
41944302
OCCUPATIONAL/RESIDENTIAL EXPOSURE
233
234
Estimation of Dermal Exposure at
Indoor Sites
Estimation of Inhalation Exposure
at Indoor Sites
ALL
ALL
41412201
DATA GAP
ENVIRONMENTAL FATE
161-1 Hydrolysis
ALL
DATA GAP
55
-------
-------
APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of 3149
57
-------
-------
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 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 regulator}' 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
59
-------
the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title, In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission;
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The 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.
60
-------
BIBLIOGRAPHY
MRID
CITATION
00043222 Wilbur, S.; Parekh, C. (1980) Acute Dermal Toxicity of P-2350 (Tris nitro
Concentrate): PLR-109; CKP8Q/59; SW80/3. (Unpublished study received
Sep 15, 1980 under 271-39; submitted by International Minerals & Chemical
Corp., Terre Haute, Ind.; CDL;243245-G)
00094706 Ralston Purina Company (1978) CDietary LCae50-« Determination in Bobwhite
Quail | : RT No. 8032836. (Unpublished study received Feb 1, 1982 under
271-40; submitted by International Minerals & Chemical Corp., Terre Haute,
Ind.; CDL:246754-B)
00094707 Ralston Purina Company (1978) CDietary LCs50~> Determination in Mallard
Ducklings | : RT No, 8032836. (Unpublished study received Feb 1, 1982
under 271-40; submitted by International Minerals & Chemical Corp., Terre
Haute, Ind.; CDL:246754-C)
00094708 Lee, T. (1973) Report: WARF No. 3051213. (Unpublished study, including
letter dated May 3, 1973 from R.F. Pureell to Terrence Lee, received Feb 1,
1982 under 271-40; prepared by Warf Institute, Inc., submitted by
International Minerals & Chemical Corp., Terre Haute, Ind.; CDL:246754-D)
00094709 Ralston Purina Company (1978) Analysis for Fish Acute Toxicity (Rainbow
Trout, Bluegill): RT No. 8032836. (Unpublished study received Feb 1, 1982
under 271-40; submitted by International Minerals & Chemical Corp., Terre
Haute, Ind.; CDL:246754-E)
00094711 Parekh, C.K. (1979) LDae5Q-i and Eye Irritation of Tris Nitro Concentrate
(P-2350): Report No. PLR-77. (Unpublished study received Feb 1, 1982
under 271-40; submitted by International Minerals & Chemical Corp., Terre
Haute, Ind.; CDL:246755-B)
00094713 Wilbur, S.; Parekh, C. (1980) Acute Dermal Toxicity of P-2350 (Tris Nitro
Concentrate): Report No. PLR-109. (Unpublished study received Feb 1, 1982
under 271-40; submitted by International Minerals & Chemical Corp., Terre
Haute, Ind.; CDL:246755-D)
00094715 Parekh, C. (1980) Acute Toxicity of P-2350 (Tris Nitro Concentrate): Report
No. PLR-135. (Unpublished study received Feb 1T 1982 under 271-40;
submitted by International Minerals & Chemical Corp., Terre Haute, Ind.;
61
-------
BIBLIOGRAPHY
MRID
CITATION
CDL:246755-F)
00109228 Parekh, C, (1981) Acute Toxicity Profile of Tris Nitro Concentrate (P-2350):
Report No. PLR-146. (Unpublished study received May 18, 1982 under
271-40; submitted by International Minerals & Chemical Corp., Terre Haute,
IN; CDL:247864-B)
41021101 Naas, D. (i 989) Tris Nitro Brand of 2-hydroxymethy 1-2-nitro-1, Spropanediol:
90-day Dermal Toxicity Study in Rats: Project No, Wil-129005. Unpublished
study prepared by Wil Research Laboratories, Inc. 637 p.
41021102 Nemec, M. (1988) Tris Nitro Brand of
2-hydroxymethyl-2-nitro-l,3propanediol: A Range-finding Teratology Study in
Rats: Project No. Wil-129001. Unpublished study prepared by Wil Research
Laboratories, Inc. 87 p.
41058101 Desai, L. (1988) Tris Nitro Brand of 2-Hydroxymethyi-2-nitro-l,3propanediol:
Ames Bacterial/Microsomal Plate Incorporation Assay: Project No. 88G-0017.
Unpublished study prepared by Toxikon Corp. 14 p.
41089301 Nemec, M. (1989) Tris Nitro Brand of
2-Hydroxymethyl-2-nitro-l,3propanediol: A Teratology Study in Rats: Project
No. WIL-129002. Unpublished study prepared by WIL Research Laboratories,
Inc. 220 p.
41412201 Popendorf, W.; Seiim, M.; Kross, B, (1990) Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study: Lab Project ID: Q626.
Unpublished study prepared by Univ, of Iowa, Institute of Agricultural
Medicine and Occupational Health. 209 p.
41944301 Paika, I. (1991) Chromosome Aberrations in Chinese Hamster Ovary (CHO)
Cells: Tris Nitro: Lab Project Number: 90G-0538. Unpublished study
prepared by lexicon Corp. 60 p,
41944302 Paika, I. (1991) Unscheduled DNA Synthesis in Rat Liver Primary Cultures:
Tris Nitro: Lab Project Number: 90G-0537. Unpublished study prepared by
Toxicon Corp. 64 p.
62
-------
BIBLIOGRAPHY
MRID
CITATION
42099001 Graves, W.; Peters, G, (1991) Tris Nitro: A 96-Hour Shell Deposition Test
with the Eastern Oyster (Crassostrea virginica): Final Report: Lab Project
Number: 288A-1Q3. Unpublished study prepared by Wildlife International.
Ltd. 41 p.
42099002 Murphy, D.; Peters, G. (1991) Tris Nitro: A 96-Hour Flow-Through Acute
Toxicity Test with the Saltwater Mysid (Mysidoopsis bahia) : Final Report:
Lab Project Number: 288-102A. Unpublished study prepared by Wildlife
International. 35 p.
42205203 Bowman, J. (1989) Acute Toxicity of Tris Nitro to Fathead Minnow
(Pimephales promelas): Lab Project Number: 38249, Unpublished study
prepared by ABC Labs., Inc. 68 p.
42205204 Forbis, A. (1989) Acute Toxicity of Tris Nitro to Daphnia magna: Lab Project
Number: 38250. Unpublished study prepared by ABC Labs., Inc. 57 p
42303501 Nemec, M. (1992) A Developmental Toxicity Study of Tris Nitro in Rabbits:
Lab Project Number: 129008. Unpublished study prepared by WIL Research
Laboratories, Inc. 286 p.
42806301 Bollmeier, A. (1993) Supplemental Product Chemistry: TRIS NITRO Brand of
Tris(HydroxymethyI) Nitromethane. Unpublished study prepared by ANGUS
Chemical Co. 7 p,
42958001 Bollmeier, A. (1993) Supplemental Product Chemistry: TRIS NITRO brand of
tris(hydroxymethyl)nitromethane. Unpublished study prepared by ANGUS
Chemical Company. 32 p.
63
-------
-------
APPENDIX D. List of Available Related Documents
65
-------
-------
The following is a list of available documents related to 3149. 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 3149 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. 3149 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
67
-------
-------
APPENDIX E. PR Notices 86-5 and 91-2
-------
-------
PR Notice 86-5
71
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
,t WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OP
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXtC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATQRS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act {FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA).
I, Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
Ill- 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 PR 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
73
-------
specify the format for data submitted to EPA under Section 3 of
FlFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be compatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy {PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional costs and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of application.
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting into the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket -
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list of all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support for the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party. That requirement is not altered by this notice, 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.
74
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- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package ......... 3 17
B. Transmittal Document 4 11
C. Individual Studies ..... 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10 (d) (1) ) 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims {other than those based on FIFRA §10(d)(1)) 8 14
D, 5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
P. 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).
75
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B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--i.e,, a registration application,
petition, experimental use permit (EUP}, §3(c)(2)(B) data
call-in, §6 (a) (25 submittal, or a special review; the transmit:tal
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 CPR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C, . . . . of the petition or application, as defined in 40 CFR 180.7
and 158,125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title.- Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed In section C.I, Each study included in a submittal
package must be bound as a separate entity. (See comments on
binding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study cr.
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.
76
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When a single study is extremely long, binding it in mul-
tiple volumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.1 Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical control data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
b- Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
conventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12? the second
would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second would cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain Confidential Business Information-as defined in FIFRA
§10(d)(1)(A), {B), or {C), and if so must be handled as described
in section D.3. of this notice.
77
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c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop. When more than one commodity is derived from a
single crop (such as beet tops and beet roots) residue data on
all such commodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D.
Organization of Each Study Volume
Each complete-study must include all applicable elements in
the list below, in the order indicated. (Also^ see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports laboratory Page 16
work subject to GLP require-
ments
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
For certain toxicology studies {When
flagging requirements are finaliz;ed.}
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (D (A) , (B) , or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
S10(d)(1)(A), (B) , or (C) Page 15
Only if confidentiality is Page 14
claimed on a basis other than
FIFRA §10{d)(1)(A), (B), or (C)
78
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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 INCLTJDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study..title. The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study.
c. Author (s_)_. Cite only individuals with primary intellectual
responsibility for the content of the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports
work done by one or more laboratories, include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or 'supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the
previously submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary study. Do not include supplements to more than one
study under a single title page).
g. Facts of Publication. If the study is a reprint of a pub-
lished document, identity on the title page all relevant facts of
publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
79
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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)(1) data confidentiality (§158,33(b)} or
to waive such a claim (§l58.33(c)). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. Do not make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions (see NOTE Pg 13) .
D,3. Confidential Attachment
If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
§10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and
confined to a separate study-specific Confidential Attachment,
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5}.
The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page. Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d){1} on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4}
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10(d)
(1)(A), (B), or (C)» the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental'Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
80
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D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6,
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOE ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us to retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies should .not be included in the transmit -
tal document, but should be incorporated into the statement of
the method of support for the application,
P. Physical Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black ink, with high contrast and good resolution. Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
instructions before submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
* Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than
black ink.
• Make sure that photocopies are clear, complete, and
fully readable,
* Do not include oversize computer printouts or fold-out
pages.
* Do not bind any documents with glue or binding tapes,
» Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
Numberof Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The proposed regulations specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management Syscer.
and getting it into review.)
81
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G.
Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy,
» Remove the "Supplemental Statement of Data
Confidentiality Claims".
» Remove the "Confidential Attachment".
» Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d)(1)(A), (B), or {C}. Do not
close up or paraphrase text remaining after this
excision,
» Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential",
V.
For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
i«s V. Ak train
Acting Oirtctor,
ftvgiaeration 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
82
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
"""Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date),
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth,
Vol 2. Title of first study in the submittal (Guideline
No.)
Vol n Title of nth study in the submittal (Guideline
No. )
* Applicants commonly provide this information in a tran-
smittal letter, This remains an acceptable practice so
long as all four elements are included.-
* Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data,
Company Official:.
Name Signature
Company Name: :
Company Contact; ____^_^________.^_
Name Phone
83
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C, Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
84
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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
contained in this study on the basis of
the scope of FIFRA 6§10 (d) (I) (A) , (B) ,
Company
Company Aqent : Typed Name
Title
any information
its falling within
or (C) .
Date:
Signature
2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B), or
(C) .
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling
within the scope of FIFRA §10(d) Si) (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
NOTE; Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical
Methods Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
85
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1}(A), (B), or (C), but for which you claim
confidential treatment on another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
» Identify specifically by page and line number(s) each
portion of the study for which you claim
confidentiality.
» Cite the reasons why the cited passage qualifies for
confidential treatment.
• Indicate the length of time — until a specific date or
event, or permanently--for which the information should
be treated as confidential.
« Identify the measures taken to guard against undesired
disclosure of this information.
» Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
» Enclose copies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information,
» If you assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why
they should be viewed as substantial.
• If you assert that the information in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
86
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase Chat has been deleted
from the study)
CROSS REFERENCE NUMBER l. This cross reference number is used in the study
in place of the following words or phrase at the
indicated volume and page references.
DELETED WORDS OR PHRASE: gt-T-iyl one a] ycv-n
PAGE LIME REASON .FOR THE DELETION FIFRA REFERENCE
6 14 Identity of Inert Ingredient §10(d)(!)(C}
12 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 )
( )
PAC3E LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process §10(d)(1)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7. This cross reference number noted on a place-
holder page is used in place of the following
whole pages at the indicated volume and page
references.
DELETED PAGE(S): are attached immediately behind this page,
PAGE LINEg REASON FOR THE DELETION FIFRA REFERENCE
20, 2-17 Description of the product manufacturing process §10(d)(1)(A)
87
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example l.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor ——— __^_—
Study Director
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and differs
in the following ways;
1.
3.
Submitter
Sponsor
Study Director
Example __3_._
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160,
Submitter
-------
ATTACHMEHT 7.
FORMAT OP THE SUBMITTAL PACKAGE
Transntittal Document.
Belated Administrative Materials
(e.g., Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of »tjdies
to aid in their review).
Studies, submitted as unique
physical «ntiti«f, according
to the format below.
FORMAT OF SUtHITTtD STUDIES
LEGEND
title page.
St*t«ment o£ Confidentiality Claims.
GLP *nd flagging* »tat«m«nts - at appropriate.
at th« »tudy, with English
language tranalation if required.
to th* atudy,
Title Page of the Confidential
Attachment.
Conf Wenciai Attachment.
Supplemental Statement
of Confidentiality Claims,
* Mien flagging requirements
are finalized.
Documents which wust &e auboitted a*
appropriate to *«et e«tabli«h«d requirement*.
^
Documents submitted at submitter'a option,
89
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PR Notice 91-2
91
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 20460
flFFICE OF
PREVENTION, PESTICIDES
4NO TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
'AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158,153(1). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
of identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed, the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product,
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting good manufacturing practices ,40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
93
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CFR 158,175 (c) (3) .
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175, The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1}(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a) (1) (C) .
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE,11 all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. Copies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to provide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) and on a case by case
basis as specified by EPA. These limits are to be set based 011
representative sampling and chemical analysis{i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR IBS-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153,640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
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(3) All other products /applications that are not subject to
(l) and (2) above will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests,
VI . FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
C^»— «— £-" •
Ann* E. fcirtdaay, Director
Registration Division (M-75OS
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APPENDIX F. Generic Data Call-in
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GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment I of this Notice, the Data Call-in Chemical Status Sheet.
to submit certain 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(s). 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
1 through 4; 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 data in the manner specified
by this Notice (see section E-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 produet(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-in ^Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 4).
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).
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This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-in Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 - Data Call-In Chemical Status Sheet
Attachment 2 - Data Call-In Response Form
Attachment 3 - Requirements Status And Registrant's Response Form
Attachment 4 - List Of All Registrants Sent This Data Call-in Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because you
have product(s) containing the subject active ingredients).
SECTION n. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant's Response Form. Depending on the results of the studies required
in this Notice, additional testing may be required.
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.
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C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
158.70). When using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements of 40 CFR § 158.
Normally, the Agency will not extend deadlines for complying with data requirements
when the studies were not conducted in accordance with acceptable standards. The
OECD protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C, 20006.
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a}(6)].
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(cV2YB) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede
or change the requirements of any previous Data Call-Infs). or any other agreements
entered into with the Agency pertaining to such prior Notice. Registrants must comply
with the requirements of all Notices to avoid issuance of a Notice of Intent to Suspend
their affected products.
SECTION ffl. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice 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 FV-A and IV-
B,
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B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements
imposed by this Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option,
the Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the 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 (Attachment 2) and the Requirements Status and
Registrant's Response Form (Attachment 3). The Data Call-in Response Form must be
submitted as part of every response to this Notice. 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 identified in
Attachment 1.
1 • Voluntary Cancellation - You may avoid the requirements of this Notice
by requesting voluntary cancellation of your produet(s) containing the active
ingredients) 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 choose 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 W-C.
2. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply. If you
wish to amend your registration to delete uses, you must submit the Requirements
Status and Registrant's Response Form, a completed application for amendment,
a copy of your proposed amended labeling, and ail other information required for
processing the application. Use deletion is option number 7 on the Requirements
Status and Registrants Response Form. You must also complete a Data Call-in
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Response Form by signing the certification, item number 8. Application forms for
amending registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to
specific data requirements, further sale, distribution, or use of your product after
one year from the due date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an
applicant for registration of a product is exempt from the requirement to submit
or cite generic data concerning an active ingredient(s) if the active ingredient(s)
in the product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). EPA has concluded, as an exercise of its
discretion, that it normally will not suspend the registration of a product which
would qualify and continue to qualify for the generic data exemption in section
3(c)(2)(D) of FIFRA. To qualify, all of the following requirements must be met;
a. The active ingredient(s) in your registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source
not connected with you; and,
b. every registrant who is the ultimate source of the active
ingredient(s) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which
this Notice applies.
To apply for the Generic Data Exemption you must submit a completed
Data Call-In Response Form. Attachment 2 and all supporting documentation.
The Generic Data Exemption is item number 6a on the Data Call-in Response
Form. If you claim a generic data exemption you are not required to complete
the Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for product specific data,
If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant(s)
who have committed to generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer in compliance with
this Data Call-in Notice, the Agency will consider that both they and you are not
in compliance and will normally initiate proceedings to suspend the registrations
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of both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will
not grant a time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice - There are various
options available to satisfy the data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on
the Requirements Status and Registrant's Response Form and option 6b and 7 on
the Data Call-In Response Form. If you choose option 6b or 7, you must submit
both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section III-D
of this Notice and are covered by options 8 and 9 on the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must
submit both forms as well as any other information/data pertaining to the option
chosen to address the data requirement.
C, SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or 7), then you must select one of
the six options on the Requirements Status and Registrant's Response Form related to
data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production
are the first six options discussed under item 9 in the instructions for completing the
Requirements Status and Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section. The options are:
1. I will generate and submit data within the specified time frame
(Developing Data),
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
4, I am submitting an existing study that has not been submitted previously
to the Agency by anyone (Submitting an Existing Study),
5. I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study),
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6, I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study).
Option 1. Developing Data -
If you choose to develop the required data it must be in conformance with
Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rale (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. In addition, certain studies require Agency
approval of test protocols in advance of study initiation, Those studies for which
a protocol must be submitted have been identified in the Requirements Status and
Registrant's Response Form and/or footnotes to the form. If you wish to use a
protocol which differs from the options discussed in Section II-C of this Notice,
you must submit a detailed description of the proposed protocol and your reason
for wishing to use it. The Agency may choose to reject a protocol not specified
in Section II-C, If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from
the date you are required to commit to generate or undertake some other means
to address that study requirement, such as making an offer to cost-share or
agreeing to share in the cost of developing that study, A 90-day progress report
must be submitted for all studies. This 90-day progress report must include the
date the study was or will be initiated and, for studies to be started within 12
months of commitment, the name and address of the laboratory(ies) or individuals
who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than
1 year, interim reports must be submitted at 12 month intervals from the date you
are required to commit to generate or otherwise address the requirement for the
study. In addition to the other information specified in the preceding paragraph,
at a minimum, a brief description of current activity on and the status of the study
must be included as well as a full description of any problems encountered since
the last progress report.
The time frames in the Requirements Status and Registrant's Response
Form are the time frames that the Agency is allowing for the submission of
completed study reports or protocols. 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
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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 requirement(s), you
must submit a request to the Agency which includes: (1) a detailed description
of the expected difficulty and (2) a proposed schedule including alternative dates
for meeting such requirements on a step-by-step basis. You must explain any
technical or laboratory difficulties and provide documentation from the laboratory
performing the testing. While EPA is considering your request, the original
deadline remains. The Agency will respond to your request in writing. If EPA
does not grant your request, the original deadline remains. Normally, extensions
can be requested only in cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in
submitting the 90-day responses. Extensions will not be considered if the request
for extension is not made in a timely fashion; in no event shall an extension
request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost to Develop. Data --
If you choose to enter into an agreement to share in the cost of producing
the required data but will not be submitting the data yourself, you must provide
the name of the registrant who will be submitting the data. You must also
provide EPA with documentary evidence that an agreement has been formed.
Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve
the terms. Section 3(c){2)(B) provides that if the parties cannot resolve the terms
of the agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development -
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
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data) to share in the burden of developing that data. You must also submit to the
Agency a completed EPA Form 8570-32, Certification of Offer to Cost Share in
the Development of Data, In addition, you must demonstrate that the other
registrant to whom the offer was made has not accepted your offer to enter into
a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer
must, in addition to anything else, offer to share in the burden of producing the
data upon terms to be agreed or failing agreement to be bound by binding
arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this
offer. The other registrant must also inform EPA of its election of an option to
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
committirig to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not
withdraw your offer to share in the burdens of developing the data. In addition,
the other registrant must fulfill its commitment to develop and submit the data as
required by this Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as well as that of the
other registrant will normally be subject to initiation of suspension proceedings,
unless you commit to submit, and do submit the required data in the specified
time frame. In such cases, the Agency generally will not grant a time extension
for submitting the data.
Option 4. Submitting an Existing Study —
If you choose to submit an existing study in response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone. Existing studies are studies which predate
issuance of this Notice. Do not use this option if you are submitting data to
upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required date of submission. The Agency may
determine at any time that a study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing
study, all of the following three criteria must be clearly met:
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above, apply to all data submissions intended to upgrade studies. Additionally
your submission of data intended to upgrade studies must be accompanied by a
certification that you comply with each of those criteria as well as a certification
regarding protocol compliance with Agency requirements,
Option 6. Citing Existing Studies --
If you choose to cite a study that has been previously submitted to EPA,
that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-guideline" or "core
minimum." For ecological effects studies, the classification generally would be
a rating of "core." 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.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and the second is a waiver request based on your
belief that the data requirement(s) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver — Option 8 on the Requirements Status
and Registrant's Response Form. Section 3(c)(2)(A) of FIFEA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume
pesticides only those active ingredient(s) whose total production volume for all
pesticide registrants is small. In determining whether to grant a low volume,
minor use waiver the Agency will consider the extent, pattern and volume of use,
the economic incentive to conduct the testing, the importance of the pesticide, and
the exposure and risk from use of the pesticide. If an active ingredient(s) is used
for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient(s) are low volume and the combined
volumes for all uses are also low, then an exemption may be granted, depending
on review of other information outlined below. An exemption will not be granted
if any registrant of the active ingredient(s) elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain within the sales
figures in then: forecast supporting the waiver request in order to remain qualified
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for such waiver. If granted a waiver, a registrant will be required, as a condition
of the waiver, to submit annual sales reports. The Agency will respond to
requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s), If applicable to the active
ingredients), include foreign sales for those products that are not
registered in this country but are applied to sugar (cane or beet), coffee,
bananas, cocoa, and other such crops. Present the above information by
year for each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of produces) containing the active
ingredient(s) by year for the past five years. Include information on raw
material cost, direct labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s)
by year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient(s), such as costs of initial
registration and any data development.
e. A list of each data requirement for which you seek a waiver.
Indicate the type of waiver sought and the estimated cost to you (listed
separately for each data requirement and associated test) of conducting
the testing needed to fulfill each of these data requirements.
f. A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill
each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of product(s) containing the active ingredient(s) (following the
parameters in item c above), indirect production costs of product(s)
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containing the active ingredient(s) (following the parameters in item d
above), and costs of data development pertaining to the active
ingredient(s).
h. A description of the importance and unique benefits of the active
ingredient(s) to users. Discuss the use patterns and the effectiveness of
the active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To assist the Agency
in determining the degree of importance of the active ingredient(s) in
terms of its benefits, you should provide information on any of the
following factors, as applicable to your product(s):
(1) documentation of the usefulness of the active ingredient(s)
in Integrated Pest Management, (b) description of the beneficial impacts
on the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result in denial of the request
for a waiver.
2. Request for Waiver of Data —Option 9 on the Requirements Status and
Registrant's Response Form. This option may be used if you believe that a
particular data requirement should not apply because the corresponding use is no
longer registered or the requirement is inappropriate." You must submit a
rationale explaining why you believe the data requirements should not apply.
You must also submit the current label(s) of your product(s) and, if a current
copy of your Confidential Statement of Formula is not already on file you must
submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that- the data requirements of this Notice do not apply to your
produces), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for your product(s). you
must choose a method of meeting the requirements of this Notice within the time
frame provided by this Notice. Within 30 days of your receipt of the Agency's
written decision, you must submit a revised Requkements Status and Registrant's
Response Form indicating the option chosen.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this
Notice due to failure by a registrant to comply with the requirements of this Data Call-In
Notice, pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not limited to, the following:
1, Failure to respond as required by this Notice within 90 days of your
receipt of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review,
3. Failure to submit on the required schedule an adequate progress report on
a study as required by this Notice.
4, Failure to submit on the required schedule acceptable data as required by
this Notice.
5. Failure to take a required action or submit adequate information pertaining
to any option chosen to address the data requirements (e.g., any required
action or information pertaining to submission or citation of existing
studies or offers, arrangements, or arbitration on the sharing of costs or
the formation of Task Forces, failure to comply with the terms of an
agreement or arbitration concerning joint data development or failure to
comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of
submitted studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in
the cost of developing data and provided proof of the registrant's receipt
of such offer, or failure of a registrant on whom you rely for a generic
data exemption either to:
a. inform EPA of intent to develop and submit the data requked by
this Notice on a Data Call-in Response Form and a Requirements Status
and Registrant's Response Form: or,
b. fulfill the commitment to develop and submit the data as required
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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.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to
Suspend. The grounds for suspension include, but are not limited to, failure to meet any
of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of required studies.
Such requirements include, but are not limited to, those relating to test material,
test procedures, selection of species, number of animals, sex and distribution of
animals, dose and effect levels to be tested or attained, duration of test, and, as
applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review,
3. EPA requirements regarding the reporting of data, including the manner
of reporting, the completeness of results, and the adequacy of any required
supporting (or raw) data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR 86-5. All studies must be submitted
in the form of a final report; a preliminary report will not be considered to fulfil!
the submission requirement.
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 Federal Insecticide, Fungicide, and
Rodenticide Act.
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The Agency has determined that such disposition by registrants of existing stocks
for a suspended registration when a section 3(c)(2)(B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You must also explain why an
"existing stocks" provision is necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale, distribution, and use. Unless
you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is in full compliance with all Agency requirements, you will
have, under most circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will allow
persons other than the registrant such as independent distributors, retailers and end users
to sell, distribute or use such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products containing an active
ingredient(s) for which the Agency has particular risk concerns will be determined on
case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to sell.
distribute, or use existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full compliance with all
Agency requirements, including the requirements of this Notice. For example, if you
decide to voluntarily cancel your registration six months before a 3 year study is
scheduled to be submitted, all progress reports and other information necessary to
establish that you have been conducting the study in an acceptable and good faith manner
must have been submitted to the Agency, before EPA will consider granting an existing
stocks provision.
SECTION V, REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long
as the products are registered by the Agency.
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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person 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 (Attachment 2) and
a completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice, and should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours.
- ****» A.
Ekniel M. Barolo, Djleetor
Special Review /
and Reregistration Division
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Attachment 1. Chemical Status Sheet
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3149: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Callln Notice because you have product(s)
containing 3149.
This Generic Data Call-in Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of 3149. This
attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic
Data Call-In Response Form (Attachment B), (3) the Requirements Status and Registrant's Form
(Attachment C), (4) a list of registrants receiving this DCI (Attachment D), (5) the EPA
Acceptance Criteria (Attachment E), and (6) the Cost Share and Data Compensation Forms in
replying to this 3149 Generic Data Call-In (Attachment F), Instructions and guidance
accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for 3149 are
contained in the Requirements Status and Registrant's Response. Attachment C. The Agency
has concluded that additional product chemistry data on 3149 are needed. These data are needed
to fully complete the reregistration of all eligible 3149 products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Ernie Dobbins at (703) 308-8071.
All responses to this Notice for the generic data requirements should be submitted to:
Ernie Dobbins, Chemical Review Manager
Accelerated Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: 3149
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Attachment 2. Generic DCI Response Forms Inserts (Form
A) plus Instructions
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
has sent you the form entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed
by the registrant as appropriate Items 8 through 11 must be completed by the registrant
before submitting a response to the Agency.
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 suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, U S Environmental Protection Agency, 401 M St , S W , Washington, D C
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D C 20503.
INSTRUCTIONS
Item 1, This item identifies your company name, number and address.
Item 2. This item identifies the ease number, ease name, EPA chemical number
and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the
Agency of your response regarding any product that you believe may be
covered by this data call-in but that is not listed by the Agency in Item 4.
You must bring any such apparent omission to the Agency's attention
within the period required for submission of this response form.
Item 5. Cheek this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
cancelled.
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Item 6a. Check this item if this data call-in is for generic data as indicated in Item
3 and if you are eligible for a Generic Data Exemption for the chemical
listed in Item 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that
you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and-any other outstanding Data Call-In Notice), and
incorporate that product into all your products, you may complete this
item for all products listed on this form If, however, you produce the
active ingredient yourself, or use any unregistered product (regardless of
the fact that some of your sources are registered), you may not claim a
Generic Data Exemption and you may not select this item.
Item 6b, Check this Item if the data call-in is a generic data call-in as indicated in
Item 3 and if you are agreeing to satisfy the generic data requirements of
this data call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants' Response Form that indicates
how you will satisfy those requirements.
Item 7b, Check this item if this call-in is a data call-in for an end use product
(EUP) as indicated in Item 3 and if your product is an end use product for
which you agree to supply product-specific data. Attach the Requirements
Status and Registrant's Response Form that indicates how you will satisfy
those requirements,
Tfem 8. This certification statement must be signed by an authorized representative
of your company and the person signing must include his/her title.
Additional pages used in your response must be initialled and dated in the
space provided for the certification.
Item 9, Enter the date of signature.
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Item 10. Enter the name of the person EPA should contact with questions regarding
your response.
Item 11, Enter the phone number of your company contact.
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Attachment 3. Requirements Status and Registrants*
Response Forms Inserts (Form B) plus Instructions
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion of uses or (2) request
for a low volume/minor use waiver. These instructions are for completion of generic _data
requirements.
EPA has developed this form individually for each data call-in addressed to each registrant, and
has preprinted this form with a number of items. DO NOT use this form for any other active
ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all
other items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 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 suggesting for reducing this burden, to Chief, Information Policy Branch,
PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, B.C. 20460;
and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support
the produces) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-in Notice, govern the conduct of the required studies.
Item 5. This item identifies the study title associated with the guideline reference number
and whether protocols and 1, 2, or 3-year progress reports are required to be
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submitted in connection with the study. As noted in Section III of the Data
Call-In Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to
this guideline reference number to the Requirements Status and
Registrant's Response Form.
Item 6, This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
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 crop
J. Forestry
K. Residential
L. Indoor food
M, Indoor non-food
N. Indoor medical
O. Indoor residential
Item 7. This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade
Active Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure ActiveIngredientRadiolabelledandMetabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and Plant
Metabolites
TEP Typical End-Use Product
* Typical End-Use Product, Percent Active Ingredient
Specified
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TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active Ingredient
and Metabolites
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
TGAI Technical Grade Active Ingredient
TGAI/TEP Technical Grade Active Ingredient or Typical
End-Use Product
TGAI/PAI Technical Grade Active Ingredient or Pure Active
Ingredient
MET Metabolites
IMP Impurities
DEGR Degradates
*See: guideline comment
Item 8, This item identifies the time frame allowed for submission of the study or
protocol identified in item 2. The time frame runs from the date of your receipt
of the Data Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data
Call-In Notice contains a fuller description of each of these options,
1. (Developing Data) I will conduct a new study and submit it within the
time frames specified in item 8 above. 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 and that I will provide the protocol and progress
reports required in item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or
more registrants to develop data jointly. By indicating that I have chosen
this option, I certify that I will comply with all the requirements
pertaining to sharing in the cost of developing data as outlined in the Data
Call-in Notice.
3. (Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop data jointly. I am submitting a copy of
the form "Certification of Offer to Cost Share in the Development of
Data" that describes this offer/agreement. By indicating that I have
chosen this option, I certify that I will comply with all the requirements
pertaining to making an offer to share in the cost of developing data as
outlined in the Data Call-In Notice.
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4. (Submitting Existing Data) I am submitting an existing study that has
never before been submitted to EPA, By indicating that I have chosen this
option, I certify that this study meets all the requirements pertaining to the
conditions for submiftal of existing data outlined in the Data Call-in
Notice and I have attached the needed supporting information along with
this response.
5. (Upgrading a Study) I am submitting or citing data to upgrade a study that
EPA has classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing existing
data to upgrade a study described in the Data Call-in Notice. I am
indicating on attached correspondence the Master Record Identification
Number (MRID) that EPA has assigned to the data that I am citing as well
as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study,
7, (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice
and I request a low-volume minor use waiver of the data requirement. I
am attaching a detailed justification to support this waiver request
including, among other things, all information required to support the
request. I understand that, unless modified by the" Agency in writing, the
data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) 1 have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-In
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, among other
things, all information required to support the request. I understand that,
unless modified by the Agency in writing, the data requirement as stated
in the Notice governs.
Item 10. This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages
of this form.
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Item 11. Enter the date of signature,
Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13, Enter the phone number of your company contact.
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Attachment 4. List of Registrant(s) sent this DCI (Insert)
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APPENDIX G. 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 us
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 lisi of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
(expiration date 12-31-92).
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This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-in Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III- Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
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You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
H-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
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, B.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)].
H-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fcK2)fB) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or change the
requirements of any previous Data Call-In(s). or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the requirements of all Notices to
avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III, COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
HI-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,
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in-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is presented
below, A discussion of the various options available for satisfying the product specific data
requirements of this Notice is contained in Section 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 3. The Data Call-in Response Form must be submitted as part of every response to this
Notice, In addition, one copy of the Requirements Status and Registrant's Response Form must
be submitted for each product listed on the Data Call-in Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-in Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do not
alter the printed material. If you have questions or need assistance in preparing your response, call
or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-in
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions
of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options 1 through 6 on the Requirements
Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response
Form. Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements.
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3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement,
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the product
specific data requirements (i.e. you select item number 7a or 7b), then you must select one of the
six options on the Requirements Status and Registrant's Response Form related to data production
for each data requirement. Your option selection should be entered under item number 9,
"Registrant Response." The six options related to data production are the first six options discussed
under item 9 in the instructions for completing the Requirements Status and Registrant's Response
Form. These six options are listed immediately below with information in parentheses to guide
registrants to additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1. Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The tune frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of dils 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
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including alternative dates for meeting such requirements on a step-by-step basis. You must explain
any technical or laboratory difficulties and provide documentation from the laboratory performing
the testing. While EPA is considering your request, the original deadline remains. The Agency
will respond to your request in writing. If EPA does not grant your request, the original deadline
remains. Normally, extensions can be requested only in cases of extraordinary testing problems
beyond the expectation or control of the registrant. Extensions will not be given in submitting the
90-day responses. Extensions will not be considered if the request for extension is not made in a
timely fashion; in no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
data tables that your product and at least one other product are similar for purposes of depending
on the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted in
the agreement to cost share by the registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data. You must
also provide EPA with documentary evidence that an agreement has been formed. Such evidence
may be your letter offering to join in an agreement and the other registrant's acceptance of your
offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA {by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice, EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has in good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To quality for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share in the burden
of developing that data. You must also submit to the Agency a completed EPA Form 8570-32.
Certification of Offer to Cost Share in the Development of Data, Attachment 7. In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to
anything else, offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must
not qualify this offer. The other registrant must also inform EPA of its election of an option to
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develop and submit the data required by this Notice by submitting a Data Call-In Response Form
and a Requirements Status and Registrant's Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data,
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice, You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice,
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware diat if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to
be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements
of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in
40 CFR 160,3(j) " 'raw data* means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed verbatim, dated, and
verified accurate by signature), the exact copy or exact transcript may be substituted
for the original source as raw data. 'Raw data' may include photographs, microfilm
or microfiche copies, computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments." The term
"specimens", according to 40 CFR 160.3(k), means "any material derived from a
test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
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requirements of 40 CFR Part 160, Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant,
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the
Agency for consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the
Agency's policy regarding acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG are met by the study,
clearly articulate the rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data are usually not available for such
studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must
satisfy or supply information to correct all deficiencies in the study identified by EPA. You must
provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
why the study should be rated as acceptable to EPA. Your submission must also specify the MRID
number(s) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.
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Do not submit additional data for the purpose of upgrading a study classified as unacceptable
and determined by the Agency as not capable of being upgraded,
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRJD number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with etch of those criteria
as well as a certification regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency, Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable," With respect to any studies for which you wish
to select this option you must provide the MRID number of the study you are citing and, if the
study has been reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
ni-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 toxkity and
efficacy (where appropriate) are required for all products and the Agency would grant a waiver only
under extraordinary circumstances. You should also be aware that submitting a waiver request will
not automatically extend the due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in force.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3{c)(2)(B), Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure
of a registrant on whom you rely for a generic data exemption either to:
a, inform EPA of intent to develop and submit the data required by this Notice
on a Data CalHn Response Form and a Requirements Status and Registrant's
Response Form:
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
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Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9, Failure to lake any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-in Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary
report will not be considered to fulfill the submission requirement.
IV~C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent widi
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 m exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
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quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until
the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular risk concerns will be
determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision,
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall submit the information to the
Agency. Registrants must notify the Agency of any factual information they have, from whatever
source, including but not limited to interim or preliminary results of studies, regarding unreasonable
adverse effects on man or the environment. This requirement continues as long as the products are
registered by the Agency,
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified hi Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice,
Sincerely yours,
^c, /
3faniel M. Barolo, Direcj^fr1"
Special Review and *
Reregistration Division
Attachments
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report Form
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Attachment 1. Chemical Status Sheet
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3149 DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
produci(s) containing 3149,
This Product Specific Data Call-in Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistratkm of
3149. This attachment is to be used in conjunction with (1) the Product Specific Data Call-in
Notice, (2) the Product Specific Data Call-In Response Form (Attachment B), (3) the
Requirements Status and Registrant's Form (Attachment C), (4) EPA's Grouping of End[-]Use
Products for Meeting Acute Toxicology Data Requirement (Attachment D), (5) the EPA
Acceptance Criteria (Attachment E), (6) a list of registrants receiving this DCI (Attachment F)
and (7) the Cost Share and Data Compensation Forms in replying to this 3149 Product Specific
Data Call[-]In (Attachment G), Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for 3149 are contained
in the Requirements Status and Registrant's Response, Attachment C. The Agency has
concluded that additional data on 3149 are needed for specific products. These data are required
to be submitted to the Agency within the time frame listed. These data are needed to fully
complete the reregistration of all eligible 3149 products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of 3149, please contact at
(703) 308-8071.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Frank Rubis at (703) 308-8184.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Frank Rubis
Planning and Reregistration Branch (H7508W)
Special Review and Reregistration Branch
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: 3149
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4, Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes". If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the
Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA reregistration numbers of your source (s); you would not complete the
requirements status and registrant's response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." if you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option
7 (Waiver Request) for each study for which you are requesting a waiver. See item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
Note: You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another that you have already voluntarily cancelled this product.
For these cases, please supply all relevant details so that EPA can ensure that its records
are correct.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3. Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice,
Item 4. The guidelines reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart c,
Item 5, The study title associated with the guideline reference number is identified.
Item 6, The use patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/ or pests indicated.
Item 7. The substance to be tested is identified by EPA, For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1, I will generate and submit data by the specified due date (Developing Data)
By indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in
the Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Snaring). I am submitting a copy of this agreement. I understand [hat
this option is available on for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this notice that my product is similar. Enough to
another product to qualify for this option. I certify that another party in ihe
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
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I understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-In Notice that my
product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that data. I am also submitting a
completed " Certification of offer to Cost Share in the Development Data" form.
i am including a copy of my offer and proof of the other registrant's receipt of that
offer. I am identifying the party which is committing to submit or provide the
require data; if the required study is not submitted on time, nay product may be
subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section III-C.l.) apply as well.
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in option 4 in the Data Call-In Notice (Section III-C.L) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response, I also certify that
I have determined that this study will fill the data requirement for which I have
indicated this choice,
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (upgrading a study).
I will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study). If I am citing another registrant's study,
I understand that this option is available only for acute toxicity or certain efficacy
data and only if the cited study was conducted on my product, an identical product
or a product which EPA has "grouped" with one or more other products for
purposes of depending on tlie same data. I may also choose this option if I am citing
my own data. In either case, I will provide die 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 repletions, guidelines or
policies. [Note: any supplemental data must be submitted in the format required by
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request. If the Agency approves my waiver
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request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
FIFRA. If the Agency denies my waiver request, I must choose a method of
meeting the data requirements of this Notice by the due date stated by this Notice.
In this case, I must, within 30 days of my receipt of the Agency's written decision,
submit a revised "Requirements Status chosen, I also understand that the deadline
for submission of data as specified by the original data caj-m 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.
161
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
163
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EPA'S BATCHING OF a-ChydroxymethyD-Z-nitro-l^-propanediol PRODUCTS FOR
MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill
the acute toxicity data requirements for reregistration of end-use products containing the
active ingredient 2-(hydroxymethyl)-2-nitro-lJ3-propanediol, the Agency has batchedproducts
which can be considered similar for purposes of acute toxicity. Factors considered in the
sorting process include each product's active and inert ingredients (identity, percent
composition and biological activity), type of formulation (e.g., emukifiable concentrate,
aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification,
precautionary labeling, etc.). Note that the Agency is not describing batched products as
"substantially similar" since some products within a batch may not be considered chemically
similar or have identical use patterns.
Batching has been accomplished using the readily available information described
above, and frequently acute toxicity data on individual end-use products has been found to
be incomplete. Notwithstanding tie batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual end-use product should the need
arise.
Registrants of end-use products within a batch may choose to cooperatively generate,
submit or cite a single battery of six acute lexicological studies to represent all the products
within that batch. It is the registrants' option to participate in the process with all other
registrants, only some of the other registrants, or only their own products within a batch, or
to generate all the required acute lexicological studies for each of their own products. If
a registrant chooses to generate the data for a batch, he/she must use one of the products
within the batch as the test material. If a registrant chooses to rely upon previously
submitted acute toxicity data, he/she may do so provided that the data base is complete and
valid by today's standards (see acceptance criteria attached), the formulation tested is
considered by EPA to be similar for acute toxicity, and the formulation has not been
significantly altered since submission and acceptance of the acute toxicity data. Regardless
of whether new data is generated or existing data is referenced, registrants must clearly
identify the test material by EPA Registration Number.
In deciding how to meet the product specific data requirements, registrants must
follow the directions given in the Data Call-in Notice and its attachments appended to the
RED. The DCJ Notice contains two response forms which are to be completed and
submitted to the Agency within 90 days of receipt The first form, "Data Call-in Response,"
asks whether the registrant will meet the data requirements for each product. The second
form, "Requirements Status and Registrant's Response," lists the product specific data
required for each product, including the standard six acute toxicity tests. A registrant who
wishes to participate in a batch must decide whether he/she will provide the data or depend
on someone else to do so. If a registrant supplies the data to support a batch of products,
he/she must select one of the following options: Developing Data (Option 1), Submitting
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an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing
Study (Option 6). If a registrant depends on another's data, he/she must choose among:
Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study
(Option 6). If a registrant does not want to participate in a batch, the choices are Options
1, 4, 5 or 6. However, a registrant should know that choosing not to participate in a batch
does not preclude other registrants in the batch from citing Ms/her studies and offering to
cost share (Option 3) those studies.
Only nine products have been found which contain 2-(hydroxymethyl)-2-nitro-l»3-
propanediol as an active ingredient. Since some products differ in regard to the active and
inert ingredients, formulation type, labeling and acute toxicity, two batches (Table I) and a
"no batch" category (Table H) have been formed as follows:
Table I
Batch
1
2
EPA Reg. No.
4808-1
4808-2
48301-1
48301-33
48301-4
48301-11
2-(hydroxymethyl)-2-nitro-l,3-
propanediol
98.5%
98.5%
100%
100%
50%
50%
Fonaulation
Type
Solid
Solid
Solid
Solid
liquid
Liquid
Table H lists three products that were either considered not to be similar 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 separately for each product.
Table H
EPA Reg. No.
134-65
48301-10
48301-17
2-(nydroxymethyl)-2-nitro-l,3-
propanediol
19.2%
98.5%
25%
Formulation
Type
liquid
Solid
liquid
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Attachment 5. EPA Acceptance Criteria
167
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
169
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1, Name of technical material tested (include product name and trade name, if appropriate).
2.__ Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at >_ 0,1% by
weight and for certain toxicologically significant impurities (e.g., dioxins, aitrosamines) present at
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
assigned experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
__ EPA Registration Number if registered; for other beginning materials, the Mowing:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity,
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment,
Description of physical conditions {temperature, pressure, humidity) controlled in each step and
the parameters that are maintained.
Statement of whether process involves intended chemical reactions,
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
which may be present at _>_ 0,1% or was found at _>_ 0.1% by product analyses and (2) certain
toxicologically significant -impurities (sec #3),
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present
the information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
and all impurities present at > 0.1%.
2. Degree of accountability or closure .>. £§ 98%.
3. Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the
case of products containing dmitroanilmes or containing secondary or tertiary amines/alkanolamines plus
ninites; polyhalogenated dibenzodioxins and dibenzofurans). (Note that in the case of nitrosamines both
fresh and stored samples must be analyzed. ]-
4._ Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6, Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
1. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
with explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at >_ 0.1% and for certain toxicologieally
significant impurities at <0.1% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required
if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and
accuracy.
171
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63 -4 Odor
__ Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported
with reference to water at 20" C, [Note: Bulk density of registered products may be reported in Ibs/ft3
or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used 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)
172
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63-11 Octanol/water Partition Coefficient
Measured at about 20-25" C
Experimentally determined and description of procedure provided (preferred method-45 Fed, Register
77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to. metal ions and metal determined
Stability at normal and elevated temperatures
__ Sensitivity to sunlight determined
173
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxiciiy 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
174
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81-1 Acute Oral Toxkity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
!.___ 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 iirs.
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 narked with an * are supplemental and may not be required for eveiy study.
175
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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 before dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion,
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights,
14, Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study,
176
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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 panicles of inhalable size for man (aerodynamic diameter 15 ^m 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 1+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.
177
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of <2 or _>,! 1.5.
3, 6 adult rabbits.
4. Dosing, instillation into the conjunctiva! sac of one eye
per animal.
5._ Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or paniculate substance.
6,_ Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
an, 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 tnd may not be required for evety study.
178
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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 >_11.5,
3. 6 adult animals.
4, Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosiag,
7. Application site approximately 6 cm1.
8, Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined gnd graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14
days (whichever is shorter),
i 1 .^ Individual daily observations.
Criteria mariced with an * are supplemental and may not be required for every study.
179
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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 epicutaoeous 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 wiflj an * are supplemental and may not be required for eveiy study.
180
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Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice
181
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Attachment 7, Cost Share Data Compensation Form, and Confidential
Statement of Formula Form
183
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oo
Confidential Business Information: Does Not Contain National Securit]
UnM*d SIMS* f nvh wvtnnnl Proi^etian Agency
g^ QftittrtPMtlcWtPMWimilTS-Wl
^Of t Hr\, Confidential Statement of Formula
1 . Sam* and Addrew of Applf:un/ft»al*trBni//nc/yrf«W Corfu;
3. Product Him
EPA USE ONLY
10 Component! in Formulation (tin w »ctuton
% by WmgM
4 Uppw L^*MI b UniwlvniE
'^T-
20. Ptiont Ma. //nctoi/e Ana Cwtt)
21. Daio
tPA Form IS70-4 (H»v. 12-911) Pf wtoui wJlllon* «r» obiolei* If you can photocopy inis. pltas« submit an addilwnal copy. Whl» - EPA FMe Copy
YoUow -
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 hi 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.
187
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form ApprovwJ
OMB No. 2070-0106
2ffT»MMIS7
Approvtl Explrt*
Public reporting burden lor triis collection of Infoimatton is estimated to average 15 minutes per response, including
time for reviewing instructions, starching 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, indudmg suggestions for reducing this byrden, 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 20S03.
Please flit in blanks toe km.
CompH&v Kuurac'
IVmtuci FXitmt*
Company Nimtbtr
KPA M*j. N«.
I Certify tnat:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodentlcide 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)(DI) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was mads to the following firm(s) on the folio wing
date{s):
NMIM at Rrm{*)
0»t« of Orftr
Certification:
certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and afl attachments therein are tme, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punisnawe by fine or imprisonment CK both under applicable law.
Slgniiert of Company1 1 Authorized R*prt**ntitJv*
Data
Nam» »nd TJii« (Pteast Typ* or Print)
EPA Fu«iSS7«-S2 (SSI)
A Fen* 8SM, w ttdi fa
189
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?,EPA
United Stat** Environmental
Washington, OC
CERTIFICATION WITH
DATA COMPENSATION
Protection Agency
204M
RESPECT TO
REQUIREMENTS
PubUe reporting Duidcn for this cofltctkxi of trrfomtwion it estimated to average 15 minutes per response, inducing
time for rtvitwine, instructions, searching existing data setvcas, fathering and maintaining the data needed, and
campltting and f eviewing the coDtciion ef irtornyaion. S«nd commtnts mganfing th« buidtn esllmaw or any other
aspad of this collector of information, inducSng suggtstiom for reducing mil bur&n. to CNef r Information Poticy
Srantfi. PM.223, U.S. EftwowiwnaJ FreMdion Agtncy, 401 M St^ S.W.. Washington, DC 20460: and to the Offic*
ef Managcmert and Budo«t Paptfwork Rwjuctkwi Proj«t (207WHOC}. Washington, OC 20503,
(IB In biarHts bttow.
)C«rWytnat
Floderticid* Act {FIFRA} that Is an txdusK* use audy J afn jht oogna! data sirtamlttr, or ! h«v» obUtfied th«
ptrroisiion of Vw original data fubrnitwr 10 at* that study.
That lor tacd study dad In support of ragfetntion si rtngtstration undtr FIFRA tn«t« NJOTw wduvvt u«
study, t am tnt ettginai data tubmttir, or l havt ottaintd tht wrtttft ptrmiwion el Ow original data subm««f, or i
h«v«ncffitdinwriiir9tfMe9RViny(it^ (a) Pay
comptreaioo for tDost data In acoorflanc* with sictions 3
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