United States Office of Prevention, Pesticides EPA738-R-95-035
Environmental Protection And Toxic Substances January 1996
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Nabam
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case Nabam which
includes the active ingredient Disodium ethylene bisdithiocarbamate. The enclosed
Reregi strati on Eligibility Decision (RED) contains the Agency's evaluation of the data base of
this chemical, its conclusions of the potential human health and environmental risks of the
current product uses, and its decisions and conditions under which these uses and products
will be eligible for reregi strati on. The RED includes the data and labeling requirements for
products for reregi strati on. It may also include requirements for additional data (generic) on
the active ingredient to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses The first set of required responses is due 90 days from the
receipt of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregi strati on Division representative
Jean Holmes at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregi strati on Division representative Venus Eagle at (703) 308-8045.
Sincerely yours,
Lois Rossi, Division Director
Special Review
and Reregi strati on Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms) You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. All data waiver and time extension requests must be
accompanied by a full justification. All waivers and time extensions must be granted by EPA
in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You
must submit the following items for each product within eight months of the date of this
letter (RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as
formulation changes, or labeling changes not related to reregi strati on) separately. You may,
but are not required to, delete uses which the RED says are ineligible for reregi strati on. For
further labeling guidance, refer to the labeling section of the EPA publication "General
Information on Applying for Registration in the U.S., Second Edition, August 1992"
(available from the National Technical Information Service, publication #PB92-221811;
telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI)
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d Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e Certification With Respect to Data Compensation Requirements Complete
and sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are
not complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregi strati on determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Nabam
LIST A
CASE 0641
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
NABAM REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 5
D. Data Requirements 5
E. Regulatory History 5
III. SCIENCE ASSESSMENT 7
A. Physical Chemistry Assessment 7
B. Human Health Assessment 8
1. Toxicology Assessment 8
a. Acute Toxicity 8
b. Subchronic Toxicity 9
c. Chronic Toxicity and Carcinogenicity 10
d. Developmental Toxicity 10
e. Mutagenicity 11
f. Metabolism 14
g. Dermal Absorption 14
h. Toxicity Endpoints 15
2. Exposure Assessment 16
a. Dietary Exposure 16
b. Occupational and Residential 16
3. Risk Assessment 20
a. Dietary 20
b. Occupational and Residential 20
C. Environmental Assessment 31
1. Ecological Toxicity Data 31
a. Toxicity to Terrestrial Animals 31
b. Toxicity to Aquatic Animals 32
c. Toxicity to Plants 35
2. Environmental Fate 36
a. Environmental Fate Assessment 36
b. Environmental Fate and Transport: Nabam and Ethylene
Thiourea 36
c. Water Resources 39
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3. Exposure and Risk Characterization 39
a. Ecological Exposure and Risk Characterization 39
b. Water Resources Risk Implication for Human Health 40
c. Endangered Species 40
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 40
A. Determination of Eligibility 40
B. Determination of Eligibility Decision 41
1. Eligibility Decision 41
2. Eligible and Ineligible Uses 41
C. Regulatory Position 42
1. Tolerance Reassessment 42
2. Reference Dose 42
3. Endangered Species Statement 42
4. Labeling Rationale 42
V. ACTIONS REQUIRED OF REGISTRANTS 44
A. Manufacturing-Use Products 44
1. Additional Generic Data Requirements 44
2. Labeling Requirements for Manufacturing-Use Products 45
B. End-Use Products 46
1. Additional Product-Specific Data Requirements 46
2. Labeling Requirements for End-Use Products 46
3. Clarification of Oil Drilling Mud Use 49
C. Existing Stocks 50
VI. APPENDICES 51
APPENDIX A. Table of Use Patterns Subject to Reregistration 52
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 63
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of Nabam 77
APPENDIX D. Product Specific Data Call-In 113
Attachment 1. Chemical Status Sheets 127
Attachment 2. Product Specific Data Call-in Response Forms (Form
A inserts) Plus Instructions 128
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) Plus Instructions 129
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 133
Attachment 5. List of All Registrants Sent This Data Call-In (insert)
Notice 135
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 137
APPENDIX E. List of Available Related Documents 145
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NABAM REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Michele Cottrill
Frank Hernandez
Phyllis Johnson
Environmental Fate and Effects Division
Silvia Termes
Conchi Rodriguez
Mary Powell
Health Effects Division
Olga Odiott
Byron Backus
Winston Dang
Hugh Pettigrew
Susan Hummel
Registration Division
Marion Johnson
Valdis Goncarovs
Carol Glasgow
Field Operation Division
Biological Analysis Branch
Economic Analysis Branch
LUIS
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Risk Characterization and Analysis Branch
Toxicology Branch II
Occupational and Residential Exposure Branch
Science Analysis Branch
Chemistry Branch II
Antimicrobial Program Branch
Antimicrobial Program Branch
Registration Support Branch
Steve Shapiro
Special Review and Reregi strati on Division
Venus Eagle
Judy Coombs
Walt Waldrop
Reregi strati on Branch
Reregi strati on Branch
Reregi strati on Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The D WEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It i s
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Hg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
Background
This Reregi strati on Eligibility Decision (RED) document addresses the reregi strati on
eligibility of the pesticide nabam, disodium ethylene bisdithiocarbamate.
Nabam was first registered in 1948 as a broad spectrum fungicide used to prevent crop
damage by fungi, to protect harvested products from deterioration, and as an industrial
microbiocide. Nabam and the other ethylene bisdithiocarbamate (EBDC) pesticides
mancozeb, maneb, and metiram, have been the subject of two Special Reviews based on the
presumption that the EBDCs and their common metabolite, ethylene thiourea (ETU), posed
potential risks to human health and/or the environment in the following areas: carcinogenicity,
developmental toxicity, and acute toxicity to aquatic organisms. Three additional areas of
concern that were identified were thyroid toxicity, mutagenicity, and skin sensitization.
As a result of the Special Reviews on nabam, all food uses were voluntarily cancelled
except one FDA-regulated food use on sugar mill grinding, crusher and/or diffuser systems.
Pesticides added to sugar mill processing water systems to control microorganisms is an
indirect food additive and, therefore falls under FDA jurisdiction. All other uses of nabam are
as an industrial biocide in paper mills, water cooling systems, drilling mud and packer fluids
and secondary oil recovery water systems.
The first Registration Standard for nabam, issued in 1987, required further data to
evaluate the environmental and human risks associated with the use of nabam. Prior to the
issuance of the Registration Standard, the Agency had also issued five separate Data Call-Ins
for nabam. The Agency has now completed its review of the nabam target data base
including the data submitted from the Registration Standard and five Data Call-Ins.
Reregistration Eligibility
The Agency has determined that all currently registered uses of nabam will not cause
unreasonable risk to humans or the environment and are eligible for reregi strati on provided
the risk mitigation measures and other changes specified in this document are implemented.
Risk mitigation measures, being imposed include requiring that the liquid formulations be
applied into water cooling systems by a pump metering system or a closed loading/application
delivery system and requiring that all solid/dry formulations of nabam be marketed in water
soluble packaging.
v
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Health Effects
To assess the cancer risks associated with nabam uses, the Agency used estimates of
exposure to ETU based on exposure to nabam, and used the unit risk for ETU. ETU is
present in nabam as a contaminant, metabolite, and the main degradation product. ETU is
classified as a probable human carcinogen (Group B2) with a Qt* of 6.01 x 10"2 (mg/kg/day)"1
based on studies which show that it induced an increased incidence of thyroid adenomas and
adenocarcinomas in rats and hepatomas in mice. A RfD (reference dose) has not been
established for nabam at this time since the intended uses (industrial microbicide) of this
chemical are classified as non-food applications.
Occupational and Residential Exposure
The toxicological endpoints of concern for occupational and residential exposure to
nabam is systemic toxicity based on a rabbit developmental study and from exposure to ETU.
The calculated Margins of Exposure (MOE = NOEL/exposure) for nabam represent
acceptable margins of exposure (greater than 100) for most uses. Exposures to handlers using
open pour liquid formulations in cooling water systems (e.g. towers) and open pour solid
formulations to drilling muds & packing fluids and secondary & tertiary oil recovery water
systems are unacceptable (less than 100) without the additional risk mitigation requirements
imposed in this RED.
Environmental Fate and Ecological Effects
The Agency requires only a limited set of ecotoxicology and environmental fate
studies for microbiocides. While the hazard to aquatic organisms from nabam has been
characterized, a quantitative risk assessment has not been conducted. Risks to aquatic
organisms resulting from the discharge of effluent containing nabam is regulated under the
NPDES permitting program of the Agency's Office of Water. The Agency currently requires
that labels for all nabam products require that discharges to aquatic environments comply with
an NPDES permit.
Existing studies show that nabam was found to be practically nontoxic to birds on an
acute oral and subacute dietary basis and practically nontoxic to bees. Available data indicate
that nabam is slightly to moderately toxic to both cold and warm water fish and moderately
toxic to freshwater invertebrates. Additionally, nabam ranged from being highly toxic to
practically nontoxic to estuarine/marine organisms. Ecological effects testing of ETU
previously had been required; however, because of the current limited uses of nabam, these
tests are not required at this time.
Before reregistering the products containing nabam, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document. These data include
VI
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product chemistry and acute toxicity testing for each registration. After reviewing these data
and any revised labels and finding them acceptable in accordance with Section 3(c)(5) of
FIFRA, the Agency will reregister a product. Those products which contain other active
ingredients will be eligible for reregi strati on only when the other active ingredients are
determined to be eligible for reregi strati on.
vn
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregi strati on of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregi strati on process to be
completed in nine years. There are five phases to the reregi strati on process. The first four
phases of the process focus on identification of data requirements to support the reregi strati on
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregi strati on" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregi strati on 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 reregi strati on eligibility of
the registered uses of nabam. The document consists of six sections. Section I is the
introduction. Section II describes nabam, 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 reregi strati on decision for nabam. Section V
discusses the reregi strati on requirements for nabam. Finally, Section VI is the Appendices
which support this Reregi strati on Eligibility Decision. Additional details concerning the
Agency's review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient(s) are covered by this Reregi strati on Eligibility
Decision:
Common Name:
Nab am
Chemical Name:
Disodium ethylene bisdithiocarbamate
Chemical Family:
Ethylene bisdithiocarbamate (EBDC)
CAS Registry Number: 142-59-6
OPP Chemical Code: 014503
Empirical Formula:
C4H6N2Na2S4
Trade and Other Names: AMA-9, AMA-30, AMA-31, Alcotreat MOS,
AlcotreatLOS, Aquatreat DNM-30, Aquatreat DN-
30, Aquatreat DNM-9, Aquatreat DNM-360,
Aquatreat DNM-25E, Aquatreat DNM-25L,
Aquatreat DNM-80, Amersperse 280
B.
Basic Manufacturer:
Use Profile
Alco Chemical Division of the National Starch &
Chemical Co. and Vinings Industries, Inc.
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of these uses of nabam is in Appendix
A.
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For nab am:
Type of Pesticide:
Use Sites:
Target Pests:
Microbiocide/Microbiostat (slime-forming bacteria,
fungi, and algae), Antifoulant.
AQUATIC NON-FOOD INDUSTRIAL:
Air Washer Water Systems
Commercial/Industrial Water Cooling Systems
(includes shipboard seawater cooling systems)
Evaporative Condenser Water Systems
Oil Recovery Drilling Muds/Packer Fluids*
Pulp/Paper Mill Water Systems
Secondary Oil Recovery Injection Water
INDOOR NON-FOOD:
Fuels/Oil Storage Tank Bottom Water Additive
Oil Recovery Drilling Muds/Packer Fluids*
Pasteurizer/Warmer/Cannery Cooling Water
Systems
Specialty Industrial Products (flue gas
desulfurization thickeners)
INDOOR FOOD:
Food Processing Water Systems (cane and beet
sugar mill processing water - regulated by FDA)
TERRESTRIAL NON-FOOD CROP:
Oil Recovery Drilling Muds/Packer Fluids*
*Registrants must specify on labels, as per Section
V of this document, whether the product is used
on off-shore and/or terrestrial sites.
Slime-forming bacteria, fungi, and algae,
Flavobacterium capsulatum, Aerobacter
aerogenes, Bacillus cereus, Bacillus subtilis,
Pseudomonas sp., Pseudomonasflourescens,
Desulfovibrio de sulfur icons, Aspergillus niger,
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Penicillium expamum, Fusarium oxysporium,
Trichoderma sp., barnacle larvae.
Formulation Types Registered:
Soluble concentrate/liquid, soluble
concentrate/solid.
Method and Rates of Application:
TYPES OF TREATMENT:
Water treatment (recirculating system), Water
treatment (once-through system-shipboard
seawater cooling systems only), Water treatment,
Additive treatment, Preservative treatment.
EQUIPMENT:
Feed system (eductor), Feed system (gravity),
Chemical pump, Metering pump.
RATES OF APPLICATION:
Aquatic non-food industrial
1.5 ppm active ingredient for shipboard seawater
cooling systems (once-through system).
2.4 to 210 ppm active ingredient for all other uses.
Indoor Non-Food
2.4 to 210 ppm active ingredient.
Indoor Food
1.5 to 3 ppm active ingredient for beet and cane
sugar mill processing water.
Terrestrial Non-Food Crop
12 to 210 ppm active ingredient.
Timing: Initial, Subsequent/maintenance, Continuous feed
(initial), Continuous feed (subsequent),
Intermittent feed (initial), Intermittent feed
(subsequent), Intermittent (slug) (initial),
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Intermittent (slug) (subsequent), Not specified on
label (registrant must specify on labeling).
C. Estimated Usage of Pesticide
Of all the nabam sites listed in the use profile, only one in-house source from
the late 1980's showed relatively low levels of annual usage. According to that
proprietary data base, nabam has a relatively minor share of the biocide market in the
paper industry.
D. Data Requirements
Data requested in the 1987 Nabam Registration Standard included product
chemistry, toxicology, ecological effects, environmental fate, and residue chemistry
studies. These data were required to support the uses listed in the Registration
Standard. Data required in five separate Data Call-In Notices issued prior to the
Registration Standard are outlined in the Regulatory History section below. Appendix
B of this RED document includes all data requirements identified by the Agency for
currently registered uses needed to support reregi strati on of nabam.
E. Regulatory History
Nabam was first registered in the United States in 1948 for use as a broad
spectrum fungicide used to prevent crop damage by fungi, to protect harvested
products from deterioration, and as an industrial microbiocide. Nabam and the other
EBDC pesticides, mancozeb, maneb and metiram have been the subject of two Special
Reviews based on the presumption that the EBDCs and their common metabolite,
ETU, posed potential risks to human health and/or the environment in the following
areas: carcinogenicity, developmental toxicity, and acute toxicity to aquatic
organisms. Three additional areas of concern identified were thyroid toxicity,
mutagenicity, and skin sensitization.
Upon conclusion of the first Special Review which was initiated in 1977 and
concluded in 1982, the Agency issued a Final Position Document (PD 4) that required
risk reduction measures to prevent unreasonable adverse effects pending development
of additional data needed to better assess the risks. An additional label statement was
required to warn users of hazards to fish and additional protective clothing was
required to mitigate potential risks of developmental and thyroid effects to applicators.
Additional exposure data were required to address mutagenic effects but it was
determined that the skin sensitization effect did not ultimately meet the criteria for a
Special Review. Following the first Special Review, the Agency classified ETU as a
Group B2 carcinogen shortly after the classification system was established in 1986.
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During the second Special Review, which was initiated in 1987, all food uses
of nabam were voluntarily cancelled (December 1989). At the close of the second
Special Review in 1992, the Agency concluded that industrial uses of nabam could be
retained including one FDA-regulated food use on sugar mill grinding, crusher and/or
diffuser systems. Therefore, the EPA does not require food use data since this use
pattern falls under the purview of the FDA (see 36 FR 24234 dated 12/22/71).
In the Registration Standard for nabam issued in April 1987 (NTIS #PB88-
192745) the Agency reported its evaluation of the studies submitted as a result of the
1985 Data Call-In (DCI). It required further data to evaluate the environmental and
human risks associated with the uses of nabam. This RED document reflects a
reassessment of all data that were submitted in response to the Registration Standard.
The following data were required in the DCI Notices issued for nabam:
1. January 17, 1983 - This notice required the submission of the metabolism,
dermal penetration and mutagenicity data identified in the 1982 Special Review
Decision Document.
2. July 25, 1984 - This notice advised registrants of the Agency's concern about
the existence of pesticides in ground water and the designation of a number of
chemicals, including nabam, which may have the potential to contaminate ground
water. The chemicals were designated based on such factors as chemical structure,
solubility, and use patterns. The notice required submission of certain environmental
fate and product chemistry data for agricultural uses only.
3. October 19, 1984 - This notice required dietary exposure, product chemistry
and toxicology (subchronic feeding and inhalation) data.
4. March 20, 1985 - This notice required registrants of pesticide products
containing nabam to submit all outstanding data requirements as outlined under 40
CFR 158 regulations for disciplines including product chemistry, toxicology, wildlife
and aquatic organisms, and environmental fate.
5. April 30, 1985 - This notice required additional data, not identified in the
October 1984 Data Call-In Notice, considered necessary to the reassessment of the
chemicals. These data included additional toxicological (subchronic feeding and
inhalation - ETU) and residue data for ETU as well as nabam.
The data required by these Data Call-In Notices to support the continued
registration of nabam products have been received and considered by the Agency in its
evaluation of nabam reregi strati on eligibility.
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III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Nabam [(disodium ethylene bis(dithiocarbamate)] is an EBDC pesticide
registered for non-food industrial uses, and FDA-regulated food uses in sugar mill
grinding, crusher, and or diffuser systems (21 CFR 173.320(b)(3)). The Agency does
not consider this use to be a food-use for its own regulatory purposes.
H - +
/\ _/N^ /S Na
Na' S ^N ^
H
Empirical Formula: C4H6N2Na2S4
Molecular Weight: 256.3
CAS Registry No.: 142-59-6
Shaughnessy No.: 014503
IDENTIFICATION OF ACTIVE INGREDIENT
Technical nabam is not commercially produced. Nabam is produced as a 30%
manufacturing-use product (MP) or end-use product (EP). Nabam products containing
30% nabam are yellow to amber aqueous solutions. Nabam is soluble in water (40
g/100 mL). The purified or dried nabam is a solid with a melting point of 200 C.
MANUFACTURING-USE PRODUCTS
There is a single nabam manufacturing-use product (MP) registered to Alco
Chemical Division, the 30% FI (formulation intermediate) (EPA Reg. No. 31910-7).
All of the registered end-use products (EPs) contain nabam in combination with
sodium dimethyldithiocarbamate (SDDC). Of the three nabam registrants, only Alco
and Vinings Industries, Inc., which together comprise the Nabam Task Force,
manufacture nabam.
The Agency has concluded that data submitted for the Alco pure active
ingredient (PAI) can support both the Alco and Vinings nabam products. The Agency
notes that, due to Vinings EPs manufacturing system, data are only required on the
isolated TGAI at this time.
-------
Data concerning the presence of nitrosamines in nabam products were required by the
Agency; however, in response to a request by the registrants to waive the data requirement,
the Agency concluded in 1994 that analysis would no longer be required for nabam because
nitrites are not involved in the manufacturing process. The Agency also waived a product
chemistry data requirement for analytical methods capable of distinguishing nabam per se
from other EBDCs and CS2-producing impurities.
The current status of the product chemistry data requirements for the Alco and Vinings
MP and TGAI products is presented in Appendix B of this RED document. Product
chemistry data remain outstanding for both registrations.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base for nabam is adequate and will support
reregi strati on eligibility.
a. Acute Toxicity
Table 1. Acute Toxicity Data
TEST
Oral LD50 - rat *
MRID No. 00097093
Dermal LD50 - rabbit *
MRID No. 00159774
Inhalation LC50 - rat
MRID No. 00159770
Eye irritation - rabbit**
MRID No. 00159775
Dermal irritation - rabbit**
MRID No. 00159776 & 40024201
Dermal sensitization - human**
(open literature)
RESULTS
LD50=1.4g/kg
LD50 >2.0 g/kg
supplementary
study
not irritating
not irritating
dermal sensitizer
CATEGORY
III
III
IV
IV
Sensitizer
* The test material was Aquatreat DN-30 (containing approximately 30% nabam in aqueous solution).
** Note: Data pertaining to acute eye irritation, dermal irritation, and dermal sensitization are not required to support
the reregistration of the TGAI. These data are presented for informational purposes.
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In the acute inhalation toxicity study with rats, the LC50 was
reported to be greater than 2.19 mg/L (no mortalities following a 4-hour
exposure). The study is currently classified as supplementary because
the report does not specifically state what substance (e.g. the active
ingredient, the 30% solution, Aquatreat DN-30) was tested and it is not
evident how this value was calculated. This classification can be
upgraded with additional information. In the April 1987 Registration
Standard for nab am it was noted that a study in the open literature
reported that a sensitization reaction in humans occurred following
exposure to a 19% nabam solution. This finding adequately
demonstrates that nabam is a skin sensitizer and no further dermal
sensitization data are required.
b. Subchronic Toxicity
In a 21-day dermal toxicity study, groups of 5 male and 5 female
Sprague-Dawley rats were dermally exposed to 0, 46, 457, 1525 or
3050 mg Aquatreat DN-30/kg/day (equivalent to 0, 15, 150, 500 and
1000 mg nabam/kg/day) 5 days/week over a 21-day period for a total of
15 six-hour occluded exposures. At termination, the highest-dose
females showed a significant decrease in T4, and the value (2.6 jig/dL)
was below the diurnal range (3 to 7 |ig/dL) stated to be normal for
Sprague-Dawley rats. The systemic NOEL was 1525 mg DN-30/kg/day
(=500 mg nabam/kg/day) for females (based on the decrease in T4) and
3050 mg DN-30/kg/day (=1000 mg nabam/kg/day) for males. The
NOEL for dermal effects was 46 mg Aquatreat DN-30/kg/day (=15 mg
nabam/kg/day) and the LEL for dermal effects (slight to moderate
erythema of the treatment site in some animals) was 457 mg Aquatreat
DN-30/kg/day (=150 mg nabam/kg/day). No other systemic effects and
no other dermal effects were found (guideline 82-2; MRID 42791602).
In a combined subchronic neurotoxicity study and 90-day
subchronic oral toxicity study, Aquatreat DN-30 (31.1% nabam) was
administered by gavage to male and female Sprague-Dawley rats at 0,
0.08, 0.8, 8.0, 80 or 260 mg/kg/day. These doses were equivalent to 0,
0.025, 0.25, 2.49, 24.9 and 80.86 mg of nabam/kg/day. In the
subchronic neurotoxicity study, no treatment-related changes were
noted in either the Functional Observational Battery or locomotor
evaluations. No statistically significant differences in the brain weights
and dimensions were noted between the control and treated animals.
Additionally, no treatment-related histopathological lesions were
observed in the central or peripheral nervous systems. The subchronic
neurotoxicity NOEL was 260 mg Aquatreat DN-30/kg/day (=80.86 mg
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nabam/kg/day), the highest dose tested (guideline 82-7; MRID
42751601).
In the subchronic oral toxicity study, body weights and body
weight gains were decreased in 80 mg Aquatreat DN-30/kg/day males
and 260 mg Aquatreat DN-30/kg/day males and females, but these
decreases were judged to be minimal (<10%) and not of physiological
and/or toxicological importance. Absolute and relative thyroid weights
were increased at 80 mg/kg/day (females only) and at 260 mg/kg/day
(both sexes). Decreases in thyroxine (T4) levels were observed at 80
and 260 mg/kg/day in both sexes; increases in TSH were observed in
260 mg/kg/day males. Macroscopic examination revealed an enlarged
thyroid in one high-dose male; microscopic examination revealed mild
hypertrophy of the follicular epithelium in the thyroid glands of 3/10
high-dose (260 mg/kg/day) males. The systemic LOEL was established
at 80 mg Aquatreat DN-30/kg/day (=24.9 mg nabam/kg/day) in males
(decreased T4) and females (decreased T4 and increased thyroid
weight). The systemic NOEL was 8.0 mg Aquatreat DN-30/kg/day or
2.49 mg nabam/kg/day (guideline 82-1; MRID 42751601).
c. Chronic Toxicity and Carcinogenicity
No chronic studies exist for nabam. However, chronic and
carcinogenicity studies exist for ethylene thiourea (ETU), a metabolite
of nabam. ETU is currently classified as a B2 carcinogen, with a
revised (Feb. 24, 1995) unit risk Qt*(mg/kg/day)"1 of 6.01 x 10'2 in
human equivalents.
d. Developmental Toxicity
Two developmental studies were conducted with New Zealand
white rabbits. In the first study (MRID 40873301), groups of 18
pregnant females were orally dosed with 0, 10, 100 or 200 mg/kg/day of
test material (Aquatreat DN-30, approximately 30% nabam in aqueous
solution) from days 7 through 19 of gestation. The maternal LEL
(based on a weight loss occurring during days 7-13) was 100
mg/kg/day. For fetal malformations, there was a dose-related increased
incidence of hydrocephaly (fetal incidences: 0/98, 3/102, 8/95 and
10/55; with litter incidences of 0/14, 2/16, 4/16 and 5/8 at 0, 10, 100 and
200 mg/kg/day, respectively). Also, there were 7 additional fetuses (not
included among the 55 indicated above) which did not reach term (late
resorptions or abortions) at 200 mg/kg/day which had findings
suggestive of hydrocephaly. Hydrocephaly was also present in a fetus
10
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that was aborted in the 10 mg/kg/day group and one that was aborted at
100 mg/kg/day. In addition, there was a dose-related trend for soft spot
and/or domed cranium (fetal incidences: 0/98, 2/102, 4/95 and 6/55;
litter incidences: 0/14, 2/16, 3/16 and 4/8). Among developmental
variations, there was a trend involving incomplete ossification of the
frontals of the cranium (fetal incidences: 0/98, 4/102, 8/95, and 9/55;
litter incidences: 0/14, 4/16, 4/16 and 5/8). In general, the increased
incidences were statistically significant at 100 and 200 mg/kg/day.
While the incidence of hydrocephaly in the 10 mg/kg/day fetuses was
not statistically significant, the report noted that: "hydrocephaly was not
seen in any of the control rabbits in this study, nor has it been observed
previously in control rabbits utilized by this laboratory." The
developmental toxicity NOEL in this study was below 10 mg/kg/day
(lowest dose tested). The maternal NOEL was 10 mg/kg/day; the LEL
(weight loss days 7-13) was 100 mg/kg/day.
In the second rabbit developmental study (MRID 42437701)
groups of 20 inseminated females were orally dosed with 0, 1, 8 or 100
mg/kg/day of test material (AquatreatDN-30, approximately 30%
nabam in aqueous solution) from days 7 through 19 of gestation. The
maternal LEL (based on a statistically significant inhibition of weight
gain during the first 6 days of dosing and the occurrence of elevated - in
excess of 0.4 grams - thyroid weights in 2 females at termination) was
100 mg/kg/day. Fetal incidences of hydrocephaly were 0/98, 1/117,
3/134 and 3/114 (litter incidences: 0/16, 1/18, 1/18 and 3/18) at 0, 1,8
and 100 mg/kg/day respectively. Two hydrocephalic fetuses at the
median dose and one at the high dose also had cleft palate.
Hydrocephaly had been previously observed in this laboratory, but cleft
palate had not. The developmental toxicity NOEL in this study was 1
mg/kg/day (= 0.328 mg nabam/kg/day); the LEL was 8 mg/kg/day (=
2.62 mg nabam/kg/day) based on the occurrence of hydrocephaly in
association with cleft palate and/or carpal flexure. The maternal NOEL
was 10 mg/kg/day; the LEL (weight loss days 7-13) was 100
mg/kg/day.
The two studies (MRID 40873301 and MRID 42437701) satisfy
the guideline requirement (83-3) for a developmental toxicity study in
rabbits.
e. Mutagenicity
Nabam, tested as a 30% aqueous solution, did not induce a
mutagenic response at the histidine locus in Salmonella typhimurium
11
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strains TA98, TA100, TA1535, or TA1537 either in the absence or
presence of rat-derived S9 (strains TA100, TA1535 and TA1537 were
also tested in the presence of mouse S9, with no indication of any
mutagenic response). The combination of studies (MRIDs 00152701,
42387101) satisfies the guideline requirement for an Ames assay (84-2).
In an initial Chinese Hamster Ovary/hprt assay (MRID
00153559) there was no indication of an increased mutation frequency
at the hprt locus in cells exposed at up to 10 jig nabam/mL in the
absence of S9, or at up to 20 jig nabam/mL in the presence of mouse
S9. The next higher doses (20 jig nabam/mL without S9, and 30 |ig/mL
with mouse S9) were not evaluated, as there was considerable
cytotoxicity (less than 10% relative plating efficiency). In the presence
of rat S9, there was a statistically significant increase in mutation
frequency at the hprt locus following exposure to 300 |ig/mL (highest
dose tested), but not at lower doses (60 - 150 jig nabam/mL). While the
rat S9 significantly detoxified the nabam, the mouse S9 did not. In a
subsequent CHO/hprt assay (MRID 41089901), conducted only in the
presence of rat S9, there were statistically significant increases in
mutant frequencies at the two highest doses (0.2 and 0.3 mg/mL) in a
first trial, and also (with no evidence of a dose-related trend within the
comparatively narrow concentration range of 0.1 to 0.3 mg/mL) in a
second trial. The combination of studies (MRIDs 00153559, MRID
41089901) satisfies the guideline requirement (84-2) for an in vitro gene
mutation assay in a mammalian cell line.
In an in vivo cytogenetics assay (MRID 41177201) there was no
indication of an increased incidence of chromosomal aberrations in
male and female Sprague-Dawley rats which received a single oral dose
of up to 1200 mg/kg Aquatreat DN-30 (approximately 30% nabam) and
were sacrificed 6, 18 or 30 hours following dosage. There were no
indications of an increased incidence of chromosomal aberrations in
another in vivo cytogenetics assay (MRID 00160516) in which groups
of 10 male Fischer 344 rats received five doses of 0 (vehicle control) or
400 mg "nabam"/kg/day (from the wording of the report it was assumed
they received 400 mg Aquatreat DN-30/kg/day) for 5 consecutive days,
with sacrifice 6 hours after the final dose. From the reported toxicity
(two rats died following dosing on day 3, and all animals had diarrhea)
the highest dose was adequate. The study, MRID 41177201, satisfies
the guideline requirement for an in vivo chromosomal aberration assay
(84-2); MRID 00160516 is also acceptable, and the negative findings
are consistent with what was observed in the other study.
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In a single UDS (Unscheduled DNA Synthesis) study (MRIDs
00151954, 41174601) rat hepatocytes were exposed to concentrations
of 0.1, 0.5, 1.0, 5.0 and 10.0 |ig/mL (it is uncertain whether these values
refer to concentrations of Aquatreat DN-30, or to concentrations of
nabam). No cells survived treatment with 50 or 100 |ig/mL. In the
initial review, it was noted that there were increases in mean nuclear
grain counts following exposure to nabam at doses from 0.1 to 1 |ig/mL,
suggestive of a dose-related effect, although these increases were not
statistically significant. At the 5 |ig/mL dose, there was good relative
survival (95%) and a statistically significant increase in mean net
nuclear grain counts. At 10.0 |ig/mL there was a drop in relative
survival (to 34%) and an increase (but not significantly so) in mean net
nuclear grain counts. Subsequent evaluation of individual cell grain
counts (MRID 41174601) showed that at doses of 1.0, 5.0 and 10.0
|ig/mL the incidences of nuclei with >20 net grains were significantly
elevated, indicating a positive response at these dose levels. The
studies, MRID nos. 00151954 and 41174601, are acceptable and satisfy
guideline 84-4, Other Genotoxic Effects.
There have been two SCE (Sister Chromatid Exchange) studies,
both with positive findings. In the first study, (MRID 00160517), slight
(statistically non-significant) increases in sister chromatid exchanges in
CHO were observed under non-activated conditions; significant
increases (with a dose-related trend) were observed at all dose levels
(1000-5000 |ig/mL) in the presence of mouse S9 and at the two highest
dose levels (4000 and 5000 jig/mL) in the presence of rat S9. In the
second SCE study (MRID 42303601), conducted under non-activated
conditions only, there were increased incidences of SCE in CHO cells
correlating with increasing exposure levels to Aquatreat DN-30 (first
assay: significant increases following exposure to 16.7 and 50.1 |ig/mL
Aquatreat DN-30; second assay: significant increases following
exposure to 16.7, 50 and 100 |ig/mL). The two studies (MRIDs
00160517 and 42303601) are acceptable and satisfy guideline 84-4,
Other Genotoxic Effects.
There have been two cell transformation assays. In the first
assay, (MRID 00151955), there was no evidence of an increase in cell
transformation under nonactivated conditions following exposure to
concentrations ranging from 0.1 to 0.8 |ig/mL. At 0.8 |ig/mL there was
18% survival. In the second assay (MRID 41221201), conducted with
activation only (rat S9 was used) there were no indications of an
increased rate of cell transformation at the highest doses (127, 115, and
127 |ig/mL) evaluated in 3 trials, with doses higher than these showing
13
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excessive toxicity. The studies, MRID 00151955 and 41221201, are
acceptable and satisfy guideline requirement 84-4, Other Genotoxic
Effects.
f. Metabolism
In an acceptable metabolism study (MRID 00160125, with
additional information and clarifications in MRID 00161804)
radiolabelled nabam was administered to male and female rats by both
oral and intravenous routes. Group A rats each received a single
intravenous injection at 4.5 mg/kg; group B rats each received a single
oral dose of 4.5 mg/kg. Each group C rat was dosed with 4.5 mg
unlabelled nabam/kg/day, and then received 4.5 mg labelled nabam/kg
on day 15. Each group D rat received a single dose of 100 mg labelled
nabam/kg. For each group, most of the recovered radioactivity was in
the urine (percentages ranged from 56.92 in group D males to 91.82 in
group A females), with most of the remainder in the feces. Although
the amount of radiolabelling in thyroids tended to be relatively low in
terms of total administered 14C (0.001% to 0.008%) concentrations were
relatively high (10X to 3IX) relative to carcass values. ETU was
present in urine (11.7 to 36.6% of total 14C present in the urine, with the
highest percentages occurring in group D rats). No ETU was detected
in the feces from group A animals; but 65.3% of the 14C in the feces of
group D males was from ETU; the value for group D females was
47.5%. This study is acceptable and satisfies guideline requirement
85-1.
g. Dermal Absorption
In a dermal absorption study (MRID 40317901) male rats
received 10-hour occluded exposures to 0.2%, 2% and 20% (equal to
0.013, 0.13 and 1.3 mg/cm2 respectively) radiolabelled nabam in
aqueous solutions; there was absorption of 0.24%, 0.05% and 0.08% of
the label, respectively. Corresponding values for the amounts
remaining on the skin (and presumably available for absorption) were
15.68%, 3.66%, and 1.09% respectively. It is noted that in a dermal
absorption study for ETU (MRID 40312001) "A significant portion of
the dermal dose could not be washed off with soap and water and was
subsequently absorbed." The study MRID 40317901 is acceptable and
satisfies the data requirement for dermal absorption, guideline 85-2.
14
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Based on this study the Agency has determined that a dermal
absorption value of 16% (15.68% + 0.24%), should be used for risk
assessment purposes.
h. Toxicity Endpoints
The following toxicity endpoints were selected for nabam and its
metabolite ethylenethiourea (ETU):
A NOEL of 0.328 mg/kg/day from a rabbit developmental
toxicity study (MRID 42437701) was the endpoint selected for the short
and the intermediate-term occupational exposure assessment
(Toxicology Endpoint Selection Document, 6/1/95). The LEL in the
study was 2.62 mg/kg/day based on the occurrence of hydrocephaly in
association with cleft palate and/or carpal flexure. These
developmentally toxic effects occurred at doses that are not maternally
toxic.
The carcinogenic potential of nabam has not been evaluated. To
assess the cancer risks associated with nabam uses, the Agency
recommended the estimation of exposure to ETU based on exposure to
nabam, and using the unit risk for ETU (Comments on Calculation of
Cancer Risk from Nabam, June 13, 1995). ETU is present in nabam as
a contaminant, metabolite, and the main degradation product. ETU is
classified as a Group B2 carcinogen with a Qt* of 6.01 X 10"2
(mg/kg/day)"1 based on studies which show that it induced an increased
incidence of thyroid adenomas and adenocarcinomas in rats and
hepatomas in mice (51 CFR 33992, September 26, 1986).
The dermal absorption rate for nabam was calculated at 16
percent (Toxicology Endpoint Selection Document, May 30, 1995).
The percentage of dermally absorbed nabam that is metabolically
converted to ETU was calculated at 7.5 percent (Revision of EBDC
Worker Exposure Assessment for Position Document Four, April 16,
1991). The dermal absorption rate for ETU was calculated at 30 percent
(Exposure and Risk Assessment for Applicators of Nabam-Containing
Microbiocides, Alco Chemical Corporation and Vinings Industries,
May 5, 1988).
The OPP RfD Committee did not set an RfD for nabam at this
time since the intended uses of this chemical are limited to non-food
applications. Nabam's food uses (sugar mill grinding, crusher, and or/
15
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diffuser systems) are regulated under the purview of FDA (21 CFR
173.320(b)(3)).
2. Exposure Assessment
a. Dietary Exposure
The uses of nabam under EPA's regulatory jurisdiction are
limited to non-food applications. The food uses (sugar mill grinding,
crusher, and or diffuser systems) fall under the purview of FDA (21
CFR 173.320(b)(3)). The EPA defers to FDA regarding dietary risk
assessment. Dietary exposure to residues of nabam from EPA-regulated
uses is not expected.
b. Occupational and Residential
Use Patterns
Nabam is applied by hand, open pouring, metering pump, and
drip-feed devices. Applications are made continuously or as-needed.
Application rates range from 1.5 to 3.0 parts per million (ppm) in
sugar processing; 7.2 to 170 ppm in pulp and paper processing; 2.4 to
60 ppm in water cooling towers, and 2.4 to 210 ppm for other industrial
uses.
At this time, no end-use products containing nabam are intended
for homeowner use. Many products containing nabam are labelled for
"industrial use only" and are, therefore, intended for occupational use.
None of the registered uses are likely to involve direct applications at
residential sites.
Handler (Mixer/Loader/Applicator) Exposure
EPA has determined that there is potential for exposure to
handlers during use-practices associated with nabam. Specifically, EPA
is concerned about exposures to handlers at industrial sites. Data from
the Chemical Manufacturer Association's (CMA) Antimicrobial
Exposure Assessment study were used to complete the exposure
assessment. The CMA study includes handlers who wear chemical
resistant gloves, long pants and sleeves, shoes and socks. Alco
Chemical Corporation and Vinings Industries were participants in the
CMA study.
16
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Based on the use pattern, several exposure scenarios are
plausible as defined by the type of application equipment and
procedures that may be employed by nabam handlers. The current
labels indicate that two kinds of loading/application methods are
available: open pouring (liquid and solid formulations) and pump
metering system (liquid formulation in mechanical delivery system)
applications. For those handlers using open pouring methods, there is
the potential for respiratory, dermal, and eye exposure to nabam/ETU.
Application via pump metering delivery systems would significantly
reduce potential exposure.
The exposure scenarios are presented in Tables 2(a) through 4(c)
along with the corresponding exposure and risk assessment for that
scenario. For each of the loading/application methods, open-pour
liquid, metering-pump liquid, and open-pour solid:
• Table "a" contains the exposure and risk estimates for
short-term and intermediate-term exposures to nabam,
• Table "b" contains the average daily exposure estimates
for ETU, and
• Table "c" contains the cancer risk estimates for ETU.
Two exposure settings are presented for open pouring
application of the soluble concentrate liquid:
(1) industrial recirculating water cooling systems and
(2) drilling mud and packer fluids.
Four exposure settings are presented for meter-pump application
of the soluble concentrate liquid:
(1) industrial recirculating water cooling systems,
(2) drilling mud and packer fluids,
(3) sugar mills processing water, and
(4) paper and pulp mill water systems.
Four exposure settings are presented for open pouring
application of the soluble concentrate powder:
(1) industrial recirculating water cooling systems,
(2) drilling mud and packer fluids,
(3) paper and pulp mill water systems, and
17
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(4) secondary and tertiary oil petroleum recovery. (Note that
industry reports indicate that sugar mills and paper/pulp mills do
not use the open-pouring application method).
Short and intermediate-term exposure to nabam was calculated
as shown below. The body weight value for these nabam exposure
calculations was 60 kg, the estimated weight of an average adult female
in the United States, since the endpoint of concern is developmental
toxicity.
• Actual Daily Exposure (ADE) (//g/kg/day) =
Unit Exposure (//g/lb ai) X Amount of A.I. Used (Ib)
Body Weight (60 kg)
• Adjusted Actual Daily Exposure (Adj.ADE) (//g/kg/day) =
ADE (//g/kg/day) X Percent Dermal Absorption of Nabam (16)
Exposure to ethylenethiourea (ETU) was calculated as shown
below. The body weight value for this exposure calculation was 70 kg,
the estimated weight of an average person in the United States, since the
chronic toxicological endpoints pertain to all persons, male and female.
1. ETU Exposure Calculations:
i. Average Daily Nabam Exposure (Nabam ADE)
(//g/kg/day) =
Unit Exposure (//g/lb ai) X Amount of A.I. Used (Ib)
Body Weight (70 kg)
ii. Adjusted Nabam ADE (//g/kg/day) =
Nabam ADE (//g/kg/day) X Percent Dermal Absorption of
Nabam (16%)
iii. Adjusted ETU ADE (//g/kg/day) =
Adj. Nabam ADE (//g/kg/day) X Percent Nabam Converted to
ETU (7.5%)
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2. ETU Exposure Calculations:
i. Average Daily ETU Exposure (ETU ADE) (//g/kg/day)
= Unit Exposure (//g/lb ai) X Amount (Ib) of ETU Contaminate
in Nabam Formulation Used (based on 0.5% ETU contaminate
in nabam formulations) + Body Weight (70 kg)
ii. Adjusted ETU ADE (//g/kg/day) =
ETU ADE (//g/kg/day) X Percent Dermal Absorption of ETU
(30%)
3. Total Calculation of ETU Average Daily Exposure
Total ETU Adjusted Average Daily Exposure =
ETU ADE Converted (Table 2(c)) + Adj. ETU ADE (Table 3(b))
These calculations of daily exposure to nabam and ETU by
handlers are used to assess the risk to those handlers.
Post-Application Exposure
EPA has determined there are possible exposures to persons
working at industrial sites where nabam is applied, such as persons
cleaning or maintaining the equipment. No post-application data are
available to directly assess these exposures. However, post-application
dermal exposures resulting from nabam use-patterns are likely to be
minimal, since the exposures are to highly diluted nabam, not the
concentrate, and the exposures are likely to be brief, since the post-
application tasks do not involve prolonged contact with nabam-treated
surfaces. Post-application inhalation exposures to nabam also are likely
to be minimal, since nabam has very low vapor pressure and is,
therefore, unlikely to generate sufficient vapor to cause a concern to
workers performing post-application tasks.
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3. Risk Assessment
a. Dietary
An assessment for human health risk from dietary exposure was
not performed because nabam has no registered food uses under EPA
purview.
b. Occupational and Residential
The Margin of Exposure (MOE) for nabam was calculated as
follows:
Short and Intermediate-Term MOE =
NOEL (328//g/kg/day)
Adj. Nabam ADE (//g/kg/day)
The cancer risk for ETU was calculated as follows:
1. Average Daily Dose Per Year (ADD) =
Total Adj ETU ADE (//g/kg/day) X [Exposure Frequency (EF) (days) +
365 days/year)]
2. Lifetime Average Daily Dose (LADD) (//g/kg/day) =
ADD (//g/kg/day) X [40 work-years + 75 years lifetime]
3. Cancer Risk =
LADD (//g/kg/day) X Q* (//g/kg/day)'1
Risk From Handler (Mixers/Loaders/Applicators) Exposure
The Agency conducted an assessment of the risks associated
with handler exposures to nabam and its contaminant ETU. The results
are presented in Tables 2(a) through 4(c).
The margins of exposure (MOEs) associated with nabam are
greater than 100 for all exposure scenarios, EXCEPT the following:
1. open-pour liquid applications in water cooling systems (MOE 4),
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2. open-pour solid applications to drilling muds and packer fluids
(MOE 43),
3. open-pour solid applications to secondary and tertiary oil recovery
water systems (MOE 9.6).
The cancer risk associated with exposures to ETU are 1 x 10"5 or
lower, except for open pour liquid applications in water cooling systems
(cancer risk 3.9 x 10"5).
Risk From Post Application Exposure
Since post-application dermal and inhalation exposures resulting
from nabam use-patterns are likely to be minimal, no risk assessment is
required.
21
-------
TABLE 2: USING AQUATREAT DNM-360 SOLUBLE CONCENTRATE LIQUID
WITH 18% OF ACTIVE INGREDIENT NABAM
Assumptions
For industrial recirculating water cooling systems: 1) 10.88 ounces of product per 1,000
gallons of water in the system (100 ppm) as initial dose, and 20,000 gallons of water per use
for a total of 217.6 ounces of product used. 2) By weight, this is equal to: 217.6 ounces
divided by 128 ounces per gallon X 9.8 Ibs per gallon = 16.66 pounds of product added 3)
16.66 Ibs X 0.18 = 3 Ibs of active ingredient handled.
For drilling mud and packer fluids: 1) 4.17 gallons per 100 bbl. of mud (it can be used
directly from the shipping container or pre-diluted with water, it can be put through the mud
hopper or added to the pump suction) 2) By weight, 4.17 gallons of product is equal to: 4.17
gallons X 9.8 Ibs per gallon = 40.87 pounds of product added. 3) 40.87 Ibs X 0.18 = 7.36
pounds of active ingredient were used.
Table 2(a) - Short and Intermediate Term Occupational Exposure and MOEs for
Nabam
OPEN POUR LIQUID
Setting
Cooling Water
Drilling Mud/
Packer Fluid
UE*
(//g/lb ai)
10230
140
Ibai/
used
3
7.36
BW**
(kg)
60
60
ADE***
(//g/kg/day)
511.50
17.17
Adj.
ADE****
(//g/kg/day)
81.84
2.75
MOE
4
119
**
***
Unit Exposure, derived from CM A Study (Amended report, 1992) with gloves.
Body Weight
Actual Daily Exposure (//g/kg/day) = (UE X Ib ai/used) / BW
**** Adj. ADE (//g/kg/day) = ADE adjusted for 16% dermal absorption rate of nabam
NOEL = 0.328 mg/kg/day
MOE =NOEL/Adj. ADE
22
-------
Table 2(b) - Average Daily Occupational Exposure To ETU (from metabolic
conversion and 0.5 % contaminant).
OPEN POUR LIQUID
Setting
Cooling
Water
Drilling Mud/
Packer Fluid
Adj.
ADE*
//g/kg/day
(Nab am)
69.95
2.35
ETU**
//g/kg/day
Converted
5.25
0.18
ADE (ETU)***
//g/kg/day
Exposed
(contaminant)
12.18
0.41
ADJ.
ETU****
//g/kg/day
Exposed
(contaminan
t)
3.65
0.12
Total
ETU ADE
//g/kg/day
8.90
0.30
**
***
Adjusted Average Daily Exposure (using 70 kg body weight)
Based on 7.5% of absorbed nabam metabolically converted to ETU
Average Daily Exposure, based on 0.5% of ETU contaminant in the concentrate
product
**** Adjusted Average Daily Exposure, based on the registrant's assumption of 30% dermal
absorption of ETU
Table 2(c) - Cancer Risk Estimates.
OPEN POUR LIQUID
Setting
Cooling Water
Drilling Mud/
Packer Fluid
Total ETU
ADE
//g/kg/day
8.90
0.30
EF/yr*
50
50
ADD**
//g/kg/day
1.22
0.04
LADD***
//g/kg/day
0.65
0.02
Risk
3.9x 1Q-5
1.2x 1Q-6
**
EF (Exposure Frequency), treatment is assumed once a week, 50 times per year
Average Daily Dose (ADD) per year = ADE x EF/365
*** LADD (Lifetime Average Daily Dose) = ADD x 40/75 (40 working year of 75 year
of lifetime
Cancer risk = LADD x Qx*
Qj* = Cancer Potency Factor = 6.01 x 10"2 (mg/kg/day)"1
23
-------
TABLE 3: USING AMA-30 SOLUBLE CONCENTRATE LIQUID (EPA REG. 9386-
11), 15% OF ACTIVE INGREDIENT NABAM (SUGAR MILLS,
PAPER/PULP AND COOLING SYSTEMS) AND AQUATREAT DNM-
360, 18% OF ACTIVE INGREDIENT (DRILLING MUD & PACKER
FLUIDS)
Assumptions:
For sugar mills processing water : 1) 4 gallons (39.2 pounds) of AMA-30 per 1,000 tons of
beets sliced per 24 hours. 2) By weight, 39.2 pounds of AMA-30 X 0.15 = 5.88 Ibs of active
ingredient used.
For paper mill water: 1) 2 pounds of product per ton of finished paper and 100 tons of
finished paper treated per use for a total of 200 pounds of product added. 3) By weight; 200
Ibs X 0.15 = 30 Ibs of active ingredient used.
For industrial recirculating water cooling systems: 1) 136 fluid ounces of product per
each 1,000 gallons of water in the system (120 ppm) as the initial dose with the mechanical
delivery metering pump 2) 20,000 gallons of water treated and 272 ounces of product used 3)
One gallon of product is 9.6 Ibs (label), and is equal to 128 fluid ounces, therefore, 272
ounces divided by 128 ounces = 2.13 gallons of product 4) By weight, 2.13 gallons of product
X 9.6 Ibs/gallon X 0.15 = 3.07 Ibs of active ingredient used.
For drilling mud and packer fluids: 1) 4.17 gallons of AQUATREAT DNM-360 (18% ai)
per 100 bbl. of mud (it can be used directly from the shipping container or pre-diluted with
water; or it can be put through the mud hopper or added to the pump suction) 2) By weight,
4.17 gallons of product X 9.8 Ibs per gallon = 40.87 pounds of product added 3) 40.87 Ibs X
0.18 = 7.36 pounds of active ingredient used
24
-------
Table 3(a) - Short and Intermediate Term Occupational Exposure and MOEs for
Nabam.
PUMP LIQUID (MECHANICAL DELIVERY SYSTEM)
Setting
Sugar Mills
Processing
Water
Paper/Pulp
Water
Drilling Mud/
Packer Fluids
Cooling Water
UE*
0/g/lb ai)
3.9
3.9
7.5
90
Ibai/
used
5.88
30
7.36
3.07
BW**
(kg)
60
60
60
60
ADE***
//g/kg/day
0.38
1.95
0.92
4.61
Adj.
A T")T7****
//g/kg/day
0.06
0.31
0.15
0.74
MOE
5,466
1,058
2,186
443
**
***
Unit Exposure, from CM A Study (Amended report, 1992) with gloves.
Body Weight of 60 kg.
Actual Daily Exposure (//g/kg/day) = (UE X Ib ai/used) / BW
**** ADE adjusted for 16% dermal absorption rate of nabam
NOEL = 0.328 mg/kg/day
MOE = NOEL/Adj. ADE
25
-------
Table 3(b) - Average Daily Occupational Exposure To ETU (from metabolic
conversion and 0.5 % contaminant)
PUMP LIQUID (MECHANICAL DELIVERY SYSTEM)
Setting
Sugar Mills
Processing
Water
Paper/Pulp
Water
Drilling Mud/
Packer Fluid
Cooling
Water
Adj.
ADE*
//g/kg/day
(Nab am)
0.05
0.27
0.13
0.63
ETU
Converted*
*
//g/kg/day
0.004
0.02
0.01
0.05
ADE
(ETU)***
//g/kg/day
Exposed
0.0108
0.056
0.026
0.13
ADJ.ADE
(ETU)****
//g/kg/day
Exposed
0.0033
0.0168
0.0078
0.039
Total
ETU ADE
//g/kg/day
0.0073
0.0368
0.0178
0.089
* Adjusted Average Daily Exposure (using 70 kg body weight)
** Based on 7.5% of absorbed nabam metabolically converted to ETU
*** Average Daily Exposure, based on 0.5% of ETU contaminant in the concentrate
product
**** Adjusted Average Daily Exposure, based on the registrant's assumption of 30%
absorption rate for ETU
26
-------
Table 3(c) - Cancer Risks.
PUMP LIQUID (MECHANICAL DELIVERY SYSTEM)
Setting
Sugar Mills
Processing
Water
Paper/Pulp
Water
Drilling Mud/
Packer Fluids
Cooling Water
Total ETU
ADE
//g/kg/day
0.0073
0.0368
0.0178
0.089
EF/yr*
26
26
26
50
ADD**
//g/kg/day
0.00052
0.00262
0.00127
0.0122
LADD***
//g/kg/day
0.00028
0.0014
0.00067
0.0065
Risk
1.7 x ID'8
8.4 x ID'8
4.1 x ID'8
3.9x ID'7
* Exposure Frequency
** Average Daily Dose per year = ADE x EF/365
*** Lifetime Average Daily Dose = ADD x 40/75 (40 working year of 75 year of
lifetime
Cancer risk = LADD x Qx*
Qj* = Cancer Potency Factor = 6.01 x 10"2 (mg/kg/day)"1
27
-------
TABLE 4: USING AQUATREAT DNM-80 POWDER, 40% ACTIVE INGREDIENT
OF NABAM
Assumptions:
For cooling water systems: Based on the information from the label (EPA Reg. 31910-20,
2/1/95), 1 pound of product added into 1,000 gallons of water in the industrial recirculating
water cooling tower and evaporative condensers as the initial dose. This dose may be repeated
three times per week. If a system needs 5,000 gallons of water to treat each time, 5 Ibs of
AQUATREAT DNM-80 are added into the system = 2 Ibs of active ingredient handled each
time.
For pulp and paper mill water: Based on the information from the label (EPA Reg. 31910-
20, 2/1/95), 0.75 pounds of AQUATREAT DNM-80 powder added per ton of hydropulper.
Assuming that 1 ton of hydropulper is treated for each handled activity : 0.75 Ibs X 0.4 = 0.3
Ibs of a.i. added into the pulp system.
For drilling mud and packer fluids: Based on the information from the label (EPA Reg.
31910-20, 2/1/95), 15 pounds of AQUATREAT DNM-80, 40% a.i. of nabam powder added
into 100 bbl of mud (300 ppm). A total of 15 Ibs X 0.4 = 6 pounds of a.i. are handled.
For secondary and tertiary petroleum recovery water: Based on the information from the
label (EPA Reg. 31910-20, 2/1/95), a total of 6.7 pounds of AQUATREAT DNM-80 powder
are added per 100 bbl of water. Assuming that 1,000 bbl of water are treated per use, a total
of 67 Ibs X 0.4 = 26.8 Ibs a.i. are handled.
Table 4(a) - Short and Intermediate Term Occupational Exposure and MOEs for
Nabam.
OPEN POUR SOLIDS
Setting
Cooling Water
Paper/Pulp
Water
Drilling Mud/
Packer Fluids
2° Oil Recovery
Water
UE*
(//g/lb ai)
479
479
479
479
Ibai/
used
2
0.3
6
26.8
BW**
(kg)
60
60
60
60
ADE***
//g/kg/day
15.97
2.40
47.90
213.95
Adj.
ADE****
//g/kg/day
2.56
0.38
7.66
34.23
MOE
128
863
43
9.6
* Unit Exposure, derived from CMA Study (Amended report, 1992) with gloves.
** Body Weight of 60 kg.
*** Actual Daily Exposure (//g/kg/day) = (UE X Ib ai/used) / BW
**** ADE adjusted for 16% dermal absorption rate for nabam
NOEL = 0.328 mg/kg/day
MOE = NOEL/Adj. ADE
28
-------
Table 4(b) - Average Daily Occupational Exposure to ETU (from metabolic conversion
and from 0.5 % contaminant).
OPEN POUR SOLIDS
Setting
Cooling
Water
Paper/Pulp
Water
Drilling Mud/
Packer Fluid
2° Oil
Recovery
Water
Adj.
ADE*
//g/kg/day
(Nab am)
2.19
0.32
6.55
29.26
ETU**
//g/kg/day
Converted
0.16
0.02
0.49
2.19
ADE
(ETU)***
//g/kg/day
Exposed
0.17
0.027
0.51
2.28
ADJ.ADE
ETU****
//g/kg/day
Exposed
0.05
0.01
0.15
0.68
Total
ETU ADE
//g/kg/day
0.21
0.03
0.64
2.87
* Adjusted Average Daily Exposure (using 70 kg body weight)
** Based on 7.5% of absorbed nabam metabolically converted to ETU
*** Average Daily Exposure, based on 0.5% of ETU contaminant in the concentrate
product
**** Adjusted Average Daily Exposure, based on the registrant's assumption of 30%
absorption rate for ETU
29
-------
Table 4(c) - Cancer Risk Estimates.
OPEN POUR SOLIDS
Setting
Cooling Water
Paper/Pulp
Water
Drilling Mud/
Packer Fluid
2° Oil
Recovery
Water
Total ETU
ADE
//g/kg/day
0.21
0.03
0.64
2.87
EF/yr*
50
26
26
26
ADD**
//g/kg/day
0.03
0.0021
0.05
0.20
LADD***
//g/kg/day
0.02
0.0011
0.03
0.11
Risk
1.2 x ID'6
6.8x ID'8
1.8 x ID'6
6.6x ID'6
* Exposure Frequency
** Average Daily Dose per year = ADE x EF/365
*** Lifetime Average Daily Dose = ADD x 40/75 (40 working year of 75 year of lifetime
Cancer risk = LADD x Qt*
Q!* = 6.01 x ID'2 (mg/kg/day)'1.
MOE = NOEL/ADD
30
-------
c.
Environmental Assessment
1. Ecological Toxicity Data
Nabam was found to be practically nontoxic to birds on an acute oral
and subacute dietary basis and practically nontoxic to bees. Available data
indicated that nabam is slightly to moderately toxic to both cold and warm
water fish and moderately toxic to freshwater invertebrates. Additionally,
nabam ranged from being highly toxic to practically nontoxic to
estuarine/marine organisms. Ecological testing of ETU, a primary degradate of
nabam, previously had been required; however, because of the current limited
uses of nabam, these tests are not required.
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
To establish the toxicity of nabam to birds, the following
tests are required: one avian single-dose oral (LD50) study on
one species (preferably mallard or bobwhite quail); one subacute
dietary study (LC50) on one species (preferably the mallard duck
or bobwhite quail). The following tables show the results of
these tests.
Avian Acute Oral Toxicity Findings (LD;0)
Species
Northern
Bobwhite
Quail
% A.I.
30
LD50 mg/kg
>2250
MRID/
Author(s)/Year
159771
Beavers, 1986
Toxicity
Category
Practically
nontoxic
Fulfill Guideline
Requirements
Yes
Avian Subacute Dietary Toxicity Findings (LQ0)
Species
Northern
Bobwhite Quail
Mallard Duck
% A.I
93
93
LC50ppm
>5000
>5000
MRID
Author(s)\Year
22923
Hilletal., 1975
22923
Hilletal., 1975
Toxicity
Category
Practically
nontoxic
Practically
nontoxic
Fulfill Guideline
Requirement
Yes
Yes
31
-------
These results indicate that nabam is practically nontoxic to birds
on an acute oral and subacute dietary basis. The guideline
requirements are fulfilled (MRID #159771, 22923).
(2) Insects
A honey bee acute contact LD50 study is required if the
proposed use will result in honey bee exposure. Nabam uses are
aquatic non-food industrial and no honey bee acute testing is
required for this use pattern. However, a study was submitted
and reviewed. The following table shows the results.
Nontarget Insect Acute Contact Toxicity Findings
Species
Apis mellifera
% A.I.
tech
LD50
^g/bee
12.09
MRID No.
Author/Year
36935
Atkins et al.
1975
Toxicity
Category
Practically
nontoxic
Fulfills Guideline
Requirements
Yes
There is sufficient information to characterize nabam as
practically nontoxic to bees. The guideline requirement would
be fulfilled (MRID #36935).
b. Toxicity to Aquatic Animals
(1) Freshwater Fish
To establish the toxicity of a pesticide to freshwater fish,
the minimum data required on the technical grade of the active
ingredient is one freshwater fish toxicity study using either a
coldwater fish (preferably the rainbow trout) or a warmwater fish
(preferably the bluegill sunfish). The following table shows the
results of these studies.
32
-------
Freshwater Fish Acute Toxicity Findings
Species
Rainbow
trout
Bluegill
sunfish
Rainbow
Trout
Bluegill
sunfish
% A.I.
30
30
30
30
LC50ppm
(product)
11
28
1.73
3.44
MRID /Accession
NO.
Autho r(s)/Year
157611
McAllister &
Bowman, 1985
157611
(same as above)
104057
Allen, 1975
104057
Allen, 1975
Toxicity
Category
Slightly Toxic
Slightly Toxic
Moderately
Toxic
Moderately
Toxic
Fulfill Guideline
Requirements
Yes1
Yes1
Supplemental2
Supplemental2
1. Static test on 30% nabam.
2. Static test on 15% nabam and 15% sodium dimethyl dithiocarbamate. Supplemental studies provided
useful information but did not fulfill guideline requirement.
The results of the two 96-hour acute toxicity studies indicate that
nabam and nabam-containing products are slightly to moderately
toxic to both cold and warm water fish. The guideline
requirement for acute toxicity testing on freshwater fish is
fulfilled (Accession #157611).
(2) Freshwater Invertebrates
The minimum testing required to assess the hazard of a
pesticide to freshwater invertebrates is a freshwater aquatic
invertebrate toxicity test, preferably using first instar Daphnia
magna or early instar amphipods, stoneflies, mayflies, or midges.
The following table shows the results of testing with Daphnia
magna.
33
-------
Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
% A.I.
30
EC50 ppm
(product)
5.6
MRID No.
Author/Year
40164046
Forbisetal., 1985
Toxicity
Category
Moderately
Toxic
Fulfills Guideline
Requirements
Yes1
1. Static test on 30% nabam.
There is sufficient information to characterize nabam as
moderately toxic to aquatic invertebrates. The guideline
requirement is fulfilled (MRID #40164046).
(3)
Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine
organisms is required when an end-use product is intended for
direct application to the marine/estuarine environment or is
expected to reach this environment in significant concentrations.
The aquatic nonfood use of nabam may result in exposure to the
estuarine environment.
The requirements under this category include a 96-hour LC50
for an estuarine fish, a 96-hour LC50 for shrimp, and either a 48-
hour embryo-larvae study or a 96-hour shell deposition study
with oysters. The following table shows the results of these
studies.
34
-------
Estuarine/Marine Acute Toxicity Findings
Species
Eastern oyster
Easter Oyster
embryo
Mysid Shrimp
Grass Shrimp
Grass Shrimp
Sheepshead
minnow
Sheepshead
minnow
% A.I
30.83
30
30.2
30.2
30
30.8
30
LC50ppm
(product)
0.96
4.61
0.17
0.179
5.22
>11000
0.14
MRID No.
Author/Year
40966801
Surprenant, 1989
97064
Union Carbide,
1985
40966701
Surprenant, 1989
107905
Conzelmann, 1982
97064
40961601
Surprenant, 1988
107906
Conzelmann, 1982
Toxicity
Category
Highly Toxic
Moderately
Toxic
Highly Toxic
Highly Toxic
Moderately
Toxic
Practically
Nontoxic
Highly Toxic
Fulfills Guideline
Requirements
Yes1
Yes2
Yes1
Supplem.2
Supplem.3
Yes1
Yes2
1. Flow-through conditions with 30% nabam.
2. Static conditions with 15% nabam and 15% sodium dimethyl dithiocarbamate. Supplemental studies
provided useful information but did not fulfill guideline requirement.
3. 48-hr static with 15% nabam and 15% sodium dimethyl dithiocarbamate. Supplemental studies
provided useful information but did not fulfill guideline requirement.
There is sufficient information to characterize nabam and
nab am-containing products as highly to moderately toxic to
estuarine/marine organisms. The guideline requirements are
fulfilled (MRID #40966801, 40966701, 40961601).
c. Toxicity to Plants
Terrestrial and aquatic plant testing (seedling emergence and
vegetative vigor) is not required for the currently registered uses of
nabam. Those studies are required for herbicides with terrestrial
nonfood/feed or aquatic nonfood (except residential) use patterns.
However, if incidents or adverse effects to plants are reported to the
Agency, these plant data may be required.
35
-------
2. Environmental Fate
a. Environmental Fate Assessment
General Issues Related to Nabam-Containing Products
All of the manufacturing-use products and end-products
containing nabam as an active ingredient require a National Pollutant
Discharge Elimination System (NPDES) permit for discharge of treated
effluents. In addition, the discharge of treated fuel tank bottom water is
regulated under the Agency's Resource Conservation and Recovery Act
(RCRA). The only data requirement that applies in this case is
guideline 161-1, Hydrolysis.
Since ethylene thiourea (ETU) is a major degradate of nabam
and one of toxicological concern, data on degradation and transport of
ETU have been included in this assessment.
It is important to realize that all of the registered products
containing nabam as an active ingredient also contain sodium
dimethyldithiocarbamate (SDDC), another active ingredient regulated
separately by the Agency. The present assessment is based on nabam
alone.
b. Environmental Fate and Transport: Nabam and Ethylene
Thiourea
Nabam and its primary degradates, except for ethylene thiourea
(ETU), do not persist in the environment. They are susceptible to
chemical and microbial degradation. ETU does biodegrade, but it is
stable to chemical degradation (hydrolysis and photodegradation). ETU
is persistent in abiotic environments, highly soluble in water and
mobile, with low adsorption to soils, and thus may reach and persist in
ground and surface waters. Because ETU is the most stable, toxic and
mobile degradate of nabam, it is the degradate of environmental
concern.
The degradation of nabam in aqueous media is driven by
hydrolytic reactions. Hydrolytic and photolytic reactions further
contribute to degrade some of the primary hydrolytic products,
particularly ethylene bis-isocyanate (EBIS). In both the abiotic
36
-------
hydrolysis and photolysis in water studies the amount of ETU present is
the highest at pH 9, but at all pHs, the amount of ETU formed increases
with time. However, in irradiated solutions, the amounts of ETU
present at comparable sampling times are lower than in the
abiotichydrolysis studies. Furthermore, the amounts of ethylene urea
(EU) are much higher in irradiated solutions than in non-irradiated,
abiotic solutions. There is evidence that EBIS, which is the first
hydrolytic product of nabam, is likely to be the photolabile species and
behaves as a precursor to ETU and EU via hydrolytic and/or photolytic
reactions. Hydantoin is also a degradate of nabam, but it is a relatively
minor degradation product.
Laboratory studies conducted with ETU as the test substance
indicate that ETU is persistent to abiotic hydrolysis and direct
photolysis, but that it does biodegrade. Data indicate that ETU may
degrade rapidly in viable soils incubated under aerobic conditions; a
laboratory half-life of less than 2 days has been reported. Under
anaerobic conditions, ETU is more persistent, with reported half-lives of
149 days. The adsorption of ETU to soils is weak and seems to be
controlled by the concentration of soil organic matter; Kads values for
ETU are less than or equal to 1.14 in all soils tested. Therefore, ETU
has the potential to leach to and persist in ground water, particularly in
areas of low organic matter, highly permeable soils and shallow ground
water tables.
(1) Hydrolysis and Photodegradation of Nabam in
Aqueous Media
The chemical transformations of parent nabam and its major
degradation products in homogeneous aqueous media are complex and
may involve labile intermediate products that are difficult to analyze. In
addition, reaction products such as ethylene bis-isocyanate (EBIS)
appears to undergo further hydrolysis and be prone to degrade by direct
photolysis.
Parent nabam degrades very rapidly in abiotic aqueous media
(estimated at less than 1 hour). The first major hydrolysis product is
ethylene bisisocyanate sulfide (EBIS), but this degradate appears to
undergo further degradation to ethylene thiourea (ETU). The amount of
EBIS initially formed is higher at pH 9 than at pH 5. In general, the
formation of ETU increases as a function of time, regardless of the pH
of the medium, but the amount formed is higher at pH 9. Other
hydrolytic products are hydantoin (present at pHs 5 and 7 but not at pH
37
-------
9) and ethylene urea (EU). There was not a distinct pattern of formation
and decline for any of the degradates. The maximum amount of ETU
was near 88% of the recovered radioactivity after 504 hours (pHs 7 and
9), but the data suggest that ETU may be more stable at pH 9. No rate
constants or half-lives were calculated for nabam because no
degradation pattern could be established.
There is evidence that EBIS, the first major hydrolytic product of
nabam, is a photolabile species. The electronic absorption spectra (260-
430 nm) of EBIS in aqueous solutions at pHs 5, 7 and 9 show "tailing"
of an absorption band above 290 nm, which indicates that EBIS would
be prone to undergo direct photolysis reactions. In addition, EBIS is
less persistent under irradiation than in the absence of irradiation. Less
ETU and more EU are present in irradiated solutions than in non-
irradiated solutions, suggesting that the relative increase in EU over
ETU may be a result of a photoprocess (either from EBIS and/or from
photo-oxidation of ETU). An estimate of the half-lives of EBIS in
irradiated solutions was 19, 38 and 16 hours at pH 5, 7 and 9,
respectively. These degradation kinetics data do not reflect the actual
degradation of EBIS (as test substance), since EBIS was a reaction
product of nabam that was degrading (hydrolytically and photolytically)
as it was being formed (MRID #00165028, 40535201).
(2) Mobility of Nabam
Nabam and EBIS, its first major hydrolytic product, are not
sufficiently persistent to estimate absorption constants in soils. Since
ETU is a major degradate of nabam and one of toxicological concern,
the mobility and other issues related to the environmental fate of ETU
are addressed below.
(3) Ethylene Thiourea (ETU) - A Degradate of Concern
ETU is stable to abiotic hydrolysis at pH 5, 7 and 9 (MRID
#40466103).
Irradiation of ETU solutions at pH 7 shows that ETU does not
degrade significantly and thus, it is not expected to break down in the
environment by direct photolysis. Photodegradation on Lawrenceville
silty loam soil surfaces is not significant and any degradation occurring
is the result of biodegradation or other oxidative processes, with half-
lives of 2.5 days (dark) and 1.26 days (irradiated). Degradation
products such as EU and 2-imidazoline were identified in this study,
38
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where increasing amounts of non-extractable material were observed
overtime (MRID #40466101, 40466102).
There are no acceptable data on aerobic soil metabolism of ETU,
but data such as that from photodegradation on soil surfaces indicate
that ETU may degrade rapidly on viable soils under aerobic conditions.
However, an anaerobic aquatic metabolism study conducted with maneb
as the test substance indicates that the levels of ETU formed from the
degradation of maneb (via EBIS) remain fairly constant, with an
estimated half-life of 149 days (MRID #00163335).
Data from batch-equilibrium adsorption/desorption studies
conducted with ETU as the test substance indicate that ETU does not
bind strongly to soils. The Freundlich Kad values ranged from 0.51
(clay loam) to 1.13 (silt loam). The organic carbon adsorption
coefficients (Koc) ranged from 34 (clay loam) to 145 (sand). However,
there appears to be no strong correlation with percent soil organic
matter, soil cation exchange capacity or soil pH (MRID #40222902).
c. Water Resources
(1) Ground Water
The current non-agricultural uses of nabam are not likely to
impact ground water resources. All uses of nabam carry an NPDES
permit requirement for discharge of treated effluents.
(2) Surface Water
Nabam is not applied directly to surface water, but industrial
effluents with nabam residues require NPDES permits for discharge into
water bodies.
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
The Agency requires only a limited set of ecotoxicology and
environmental fate studies for microbiocides. While the hazard to
aquatic organisms from nabam has been characterized, a quantitative
risk assessment has not been conducted. The risks to aquatic
environments are regulated under the NPDES permitting program of the
Office of Water. The Agency currently requires that labels for all
39
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nabam products require that discharges to aquatic environments comply
with an NPDES permit.
For microbiocides with once-through cooling tower use patterns,
the Agency uses a dilution factor model to calculate screening level
EECs and develop risk quotients for a risk screen. Although nabam has
a once-through cooling tower use pattern, the use is for shipboard
systems and a screening-level EEC calculation is inappropriate because
this calculation is designed to represent concentrations in rivers and
streams, not complex marine environments. Methods for appropriately
estimating the concentrations resulting from shipboard uses have not
been developed. However, because of the large dilution factor, it is not
expected that discharges into marine environments would result in
concentrations of concern. Discharges into harbor waters may be more
problematic because of the smaller, enclosed area of water and the
potential for concentrations of many types of chemicals in these areas.
b. Water Resources Risk Implication for Human Health
The degradate ethylene thiourea (ETU), a probable human
carcinogen, is regulated by the Agency's Office of Drinking Water. The
longer-term Health Advisory for a 10 kg child is 0.1 mg/L and for a 70-
kg adult, 0.4 mg/L.
c. Endangered Species
The Agency does not anticipate any exposure of concern to fish
and wildlife, providing that all nabam products require that discharges
to the environment comply with all disposal laws or a NPDES permit.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredient are eligible for reregi strati on. The Agency has
previously identified and required the submission of the generic (i.e. active ingredient
specific) data required to support reregi strati on of products containing nabam. The
Agency has completed its review of these generic data, and has determined that the
data are sufficient to support reregi strati on of all products containing nabam.
40
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Appendix B identifies the generic data requirements that the Agency reviewed as part
of its determination of reregi strati on eligibility of nabam, 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 nabam and to determine that nabam can be used as specified in
this document without resulting in unreasonable adverse effects to humans and the
environment, provided the changes specified in this document are implemented. The
Agency therefore finds that all products containing nabam as the active ingredient are
eligible for reregi strati on. The reregi strati on of particular products is addressed in
Section V of this document.
The Agency made its reregi strati on eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data, published scientific literature, etc. and the
data identified in Appendix B. Although the Agency has found that all uses of nabam
as specified in this document 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 nabam, if new
information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient
nabam, the Agency has sufficient information on the health effects of nabam
and on its potential for causing adverse effects in fish and wildlife and the
environment. The Agency has determined that nabam products, labeled and
used as specified in this Reregistration Eligibility Decision, will not pose
unreasonable risks or adverse effects to humans or the environment. Therefore,
the Agency concludes that products containing nabam for all uses are eligible
for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of nabam are eligible for
reregistration. The Agency is prohibiting open pour applications of liquid
formulations in water cooling systems (e.g. towers). Additionally, all solid/dry
formulations of nabam must be placed in water soluble packaging.
41
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C. Regulatory Position
The following is a summary of the regulatory positions and rationales for
nabam. Where labeling revisions are imposed, specific language is set forth in Section
V of this document.
1. Tolerance Reassessment
There are no existing tolerances for nabam regulated by EPA.
2. Reference Dose
The Agency has not set an RfD for nabam at this time.
3. Endangered Species Statement
The Agency does not anticipate any exposure of concern to fish and
wildlife, providing that all nabam products require that discharges to the
environment comply with all disposal laws or a NPDES permit.
4. Labeling Rationale
Occupational and Residential Labeling Rationale/Risk Mitigation
Personal Protective Equipment/Engineering Controls for Handlers
For each end-use product, PPE requirements for pesticide handlers are
set during reregi strati on in one of two ways:
1. If EPA determines that no regulatory action must be taken as
the result of the acute effects or other adverse effects of an active
ingredient, the PPE for pesticide handlers will be based on the
acute toxicity of the end-use product. For occupational-use
products, PPE must be established using the process described in
PR Notice 93-7 or more recent EPA guidelines.
2. If EPA determines that regulatory action on an active
ingredient must be taken as the result of very high acute toxicity
or to certain other adverse effects, such as allergic effects or
delayed effects (cancer, developmental toxicity, reproductive
effects, etc.):
42
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• In the RED for that active ingredient, EPA
may establish minimum or "baseline"
handler PPE requirements that pertain to
all or most end-use products containing
that active ingredient.
• These minimum PPE requirements must be
compared with the PPE that would be
designated on the basis of the acute
toxicity of the end-use product.
• The more stringent choice for each type of
PPE (i.e., bodywear, hand protection,
footwear, eyewear, etc.) must be placed on
the label of the end-use product.
Personal protective equipment requirements usually are set by
specifying one or more pre-established PPE units — sets of items that
are almost always required together. For example, if chemical-resistant
gloves are required, then long-sleeve shirts, long pants, socks, and shoes
are assumed and are also included in the required minimum attire. If the
requirement is for two layers of body protection (coveralls over a long-
or short-sleeve shirt and long or short pants), the minimum must also
include (for all handlers) chemical-resistant footwear and chemical-
resistant headgear for overhead exposures and (for mixers, loaders, and
persons cleaning equipment) chemical-resistant aprons.
Occupational-Use Products
EPA has determined that the establishment of active-ingredient-
based minimum PPE requirements for occupational handlers is
warranted for nabam. All the exposure studies were conducted with
handlers wearing chemical-resistant gloves and there were not sufficient
data to predict the probable exposure without chemical-resistant gloves;
therefore, chemical-resistant gloves will be required on all nabam end-
use product labeling. In addition, since the MOE was greater than 100
for metering-pump liquid applications in water cooling systems (e.g.
towers), but less than 100 for open-pour liquid applications in water
cooling systems, EPA will require liquid formulations in water cooling
systems to be applied by mechanical loading delivery systems (such as
metering pump, gravity fed, manual pump, pressurized, probe, etc.) and
prohibit open-pour applications. The Agency is requiring dry
formulations of nabam to be placed in water-soluble packaging.
43
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Post-Application/Entry Restrictions
Occupational-Use Products
EPA has determined that no regulatory action must be taken to
reduce post-application exposures to nabam, since post-application
dermal and inhalation exposures are already likely to be minimal.
Homeowner-Use Products
There are no homeowner uses of nabam.
Other Labeling Requirements
The Agency is also requiring other use and safety information to be
placed on the labeling of all end-use products containing nabam. The Agency
is also requiring labeling statements to clarify the intent of the oil recovery
drilling muds/packer fluids use either as an aquatic or terrestrial non-food use
pattern. For the specific labeling statements, refer to Section V of this
document.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregi strati on of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of nabam for the
above eligible uses has been reviewed and determined to be substantially
complete for all uses. The following data were previously required in the
nabam Registration Standard and have data deficiencies which can be
upgraded:
PRODUCT CHEMISTRY
Registrant: Vinings Industries
Product: TGAI isolated from EPA Reg. No. 9386-7, 9386-11, or
9386-23.
Guideline 61-2(b) - Discussion of Formation of Impurities
Guideline 63-13 - Stability
44
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Registrant: Alco Chemical Division of National Starch and Chemical
Co.
Product: TGAI isolated from EPA Reg. No. 31910-7
Guideline 63-13 - Stability
TOXICOLOGY
Guideline 81-3 - Acute Inhalation Toxicity - Rat
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR
Notices and applicable policies. In addition, the MP labeling must bear the
following statement under Directions for Use:
"Only for formulation into an [fill blank with Insecticide, Herbicide or
the applicable term which describes the type of pesticide use(s)] for the
following use(s) [fill blank only with those uses that are being supported
by MP registrant."]
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under
"Directions for Use" to permit the reformulation of the product
for a specific use or all additional uses supported by a formulator
or user group:
(a) "This product may be used to formulate products for specific
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
(b) "This product may be used to formulate products for any
additional use(s) not listed on the MP label if the formulator,
user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s)."
Effluent Discharge Statement
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or other waters unless in accordance with the
45
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requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in
writing prior to discharge. Do not discharge effluent containing this
product to sewer systems without previously notifying the local sewage
treatment plant authority. For guidance contact your State Water Board
or Regional Office of the EPA."
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
D, the Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria 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
Worker Protection Standard
No nabam end-use products are within the scope of the Worker
Protection Standard for Agricultural Pesticides (40 CFR parts 170 and 156).
However, personal protective equipment for non-WPS occupational use is
required and is discussed below.
Effluent Discharge Labeling Statements
Refer to subsection A. above for labeling requirements for effluent
discharge.
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain nabam, the
product labeling must be revised to adopt the handler personal protective
equipment/engineering control requirements set forth in this section. Any
conflicting PPE requirements on the current labeling must be removed.
46
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For multiple-active-ingredient end-use products that contain nabam,
the handler personal protective equipment/engineering control requirements set
forth in this section must be compared to the requirements on the current
labeling and the more protective must be retained. For guidance on which
requirements are considered more protective, see PR Notice 93-7.
Products Intended Primarily for Occupational Use
Minimum (Baseline) PPE/Engineering Control Requirements
The minimum (baseline) PPE for all occupational uses of nabam end-
use products is:
Minimum PPE:
"Applicators and other handlers must wear:
—long-sleeve shirt and long pants
—chemical-resistant gloves*,
—socks plus shoes
* For the glove statement, use the statement established for
nabam through the instructions in Supplement Three of PR
Notice 93-7.
Engineering Control Requirements
For liquid formulations:
In the "Directions For Use" portion of the label referring to these uses,
registrants must insert the following language:
"This product must be loaded and transferred only using a
metering-pump system or a closed loading/application system
for the following uses: (list each of the following uses for which
the end-use product is labeled: air washer water systems;
commercial/industrial water cooling systems (includes shipboard
seawater cooling systems); evaporative condenser water systems;
pasteurizer/warmer/cannery cooling water systems; and heat
exchanger water systems.}. Open pouring is prohibited."
For dry formulations:
All nabam end-use products formulated as a dry formulation must be
placed in water-soluble packaging.
47
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Determining PPE Requirements for End-Use Product Labels
The PPE that would be established on the basis of the acute toxicity
category of the end-use product must be compared to the active-
ingredient-based minimum (baseline) personal protective equipment
specified above. The more protective PPE must be placed on the
product labeling. For guidance on which PPE is considered more
protective, see PR Notice 93-7.
Placement in Labeling
The personal protective equipment requirements must be placed on the
end-use product labeling in the location specified in PR Notice 93-7,
and the format and language of the PPE requirements must be the same
as is specified in PR Notice 93-7.
Other Labeling Requirements
Registrants must specify on labeling the complete directions for
use for each use pattern: site of application, type of application, timing
of application, equipment used for application, and the rate of
application (dosage).
Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements to be
located on all end-use products containing nabam that are intended
primarily for occupational use.
Application Restrictions
"Do not apply this product in a way that will contact
workers or other persons."
User Safety Requirements
1. Registrant: place the following statement on the end-use product
label if coveralls are required for pesticide handlers:
"Discard clothing or other absorbent materials that have been drenched
or heavily contaminated with this product's concentrate. Do not reuse
them."
48
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2. Registrant: place the following statement on the end-use product
label:
"Follow manufacturer's instructions for cleaning/maintaining
PPE. If no such instructions for washables, use detergent and hot
water. Keep and wash PPE separately from other laundry."
User Safety Recommendations
• "Users should wash hands before eating, drinking,
chewing gum, using tobacco, or using the toilet."
• "Users should remove clothing immediately if
pesticide gets inside. Then wash thoroughly and
put on clean clothing."
• "Users should remove PPE immediately after
handling this product. Wash the outside of gloves
before removing. As soon as possible, wash
thoroughly and change into clean clothing."
Skin Sensitizer Statement
"This product may cause skin sensitization reactions in
some people."
3. Clarification of Oil Drilling Mud Use
The following statement must be added to the labels for terrestrial non-
food oil/gas drilling muds and packer fluids:
"For use in terrestrial wells only."
And the following statement must be added to the precautionary labeling:
"Do not apply in marine and/or estuarine oil fields."
The following statement must be added to the labels for aquatic non-
food industrial oil/gas drilling muds and packer fluids:
"For use in offshore wells only."
49
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For use in both terrestrial and offshore oil/gas drilling muds and packer
fluids, the following statement must be added:
"This product may be used for terrestrial and offshore oil/gas drilling
muds and packer fluids."
C. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregi strati on
Eligibility Decision (RED). Persons other than the registrant may generally distribute
or sell such products for 50 months from the date of the issuance of this RED.
However, existing stocks time frames will be established case-by-case, depending on
the number of products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register.
Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell nabam
products bearing old labels/labeling for 26 months from the date of issuance of this
RED. Persons other than the registrant may distribute or sell such products for 50
months from the date of the issuance of this RED. Registrants and persons other than
registrants remain obligated to meet pre-existing Agency imposed label changes and
existing stocks requirements applicable to products they sell or distribute.
50
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VI. APPENDICES
51
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52
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USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
AIR WASHER WATER SYSTEMS
W 1.4985
W 1.4985
W 1.5
W 1.494
W 1.4985
W 1.5
W 1.5
W 1.5
53
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USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
)))))))))))))))))))))))))))))))
AIR WASHER WATER SYSTEMS (con't)
W 17
W 18
W 18
W 14
W 2.7
W 6 * NS NS NS NS
W 4.8 * NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
U 1.5 * NS NS NS NS
A08, C12
A08, C12
A08, C18, C24
A08, C12
A08, C12, C18
54
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USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
)))))))))))))))))))))))))))))))
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't;
SC/L
SC/L
SC/L
SC/S
EVAPORATIVE CONDENSER WATER SYSTEMS
SC/L
SC/L
SC/L
SC/S
FUELS/OIL STORAGE TANK BOTTOM WATER ADDITIVE
W 2.8
W 2. 9
W 3
W 2.4
W 17
W 18
W 18
W 14
W 2.7
W 2.8
W 2. 9
W 3
W 2.4
W 5. 6 * NS NS
W 5 . 9 * NS NS
W 6 * NS NS
W 4.8 * NS NS
A08, C12
A08, C12
A08, C18, C24
A08, C12
A08, C12, C18
55
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USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
V
V
V
V
V
No
U
W
36
37
40
40
210
Calc
24
13
V 179
V 150
V 198
V 199
V 210
No Calc
U 120
W 64
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
56
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USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
V
V
V
V
V
No
U
W
36
37
40
40
210
Calc
24
13
V 179
V 150
V 198
V 199
V 210
No Calc
U 120
W 64
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
57
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SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS
PULP/PAPER MILL WATER SYSTEMS
Use Group: TERRESTRIAL NON-FOOD CROP (con't)
U 120 * NS NS NS NS NS NS
W 64 * NS NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W 48 * NS NS NS NS NS NS
58
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USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
)))))))))))))))))))))))))))))))
PULP/PAPER MILL WATER SYSTEMS (con't)
SPECIALITY INDUSTRIAL PRODUCTS
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 150 * NS NS NS NS NS NS
W 150 * NS NS NS NS NS NS
W 150 * NS NS NS NS NS NS
59
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LEGEND
444444
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
: Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
: Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
: Maximum dose applied to a site over a single crop cycle or year. System calculated.
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Restr. Entry Interv (days
PRO Report Date
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
0 : Others
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briguet,
briguets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04" is eguivalent to ".0001234"
60
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USE LIMITATIONS CODES
A08 : Preclean claim.
A10 : minute(s) contact time.
All : hour(s) contact time.
C12 : Do not apply in marine and/or estuarine, oil fields, or discharge effluent into lakes, streams, ponds or public water. (NPDES license restriction)
CIS : Do not discharge effluent containing this pesticide into sewage systems without notifying the sewage treatment plant authority (POTW).
C23 : NPDES license restriction.
C24 : Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water. (NPDES license restriction)
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
61
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62
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active ingredients
within the case nabam covered by this Reregi strati on Eligibility Decision Document. It contains generic data
requirements that apply to nabam in all products, including data requirements for which a "typical
formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they appear
in 40 CFR Part 158. the reference numbers accompanying each test refer to the test protocols set in the
Pesticide Assessment Guidelines, which are available from the National Technical Information Service, 5285
Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements
apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column lists
the identifying number of each study. This normally is the Master Record Identification (MRID) number, but
may be a "GS" number if no MRID number has been assigned. Refer to the Bibliography appendix for a
complete citation of the study.
63
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64
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Nabam
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
63-11
Registrant: Vinings Industries
Product: EPA Reg. No. 9386-7, 9386-11 and 9386-23.
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
Octanol/Water Partition
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
N/A
00155163
43183301, 43241301, Upgradable
43183301,43183302
N/A
N/A
00155163
00155163
00155163
42163002
00155163
N/A
00155163
N/A
42163002
00155163
65
-------
Data Supporting Guideline Requirements for the Reregistration of Nabam
REQUIREMENT
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
pH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion characteristics
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
00155163
Upgradable
N/A
N/A
N/A
N/A
N/A
N/A
N/A
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Nabam
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
63-11
Registrant: Alco Chemical Division of National Starch and
Chemical Co Product: EPA Reg. No. 31910-7
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
Upgradable
Database1
Database1
42163003,43212401
Upgradable
Upgradable
Database1
Database1
Database1
42163002
Database1
N/A
Database1
N/A
42163002
Database1
67
-------
Data Supporting Guideline Requirements for the Reregistration of Nabam
REQUIREMENT
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
ECOI
71-1A
71-1B
71-2A
71-2B
71-3
71-4A
71-4B
71-5A
71-5B
72-1A
pH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion characteristics
.OGICAL EFFECTS
Acute Avian Oral - Quail/Duck
Acute Avian Oral - Quail/Duck
TEP
Avian Dietary - Quail
Avian Dietary - Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
Avian Reproduction - Duck
Simulated Field Study
Actual Field Study
Fish Toxicity Bluegill
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CFLM
CFLM
C2
C2
CITATION(S)
Database1
Upgradable
Upgradable
N/A
N/A
Upgradable
Database1
N/A
Database1
00159771
Not Required
00022923
00022923
Not Required
Not Required
Not Required
Not Required
Not Required
00157611
-------
Data Supporting Guideline Requirements for the Reregistration of Nabam
REQUIREMENT
72-1B
72-1C
72-1D
72-2A
72-2B
72-3A
72-3B
72-3C
72-3D
72-3E
72-3F
72-4A
72-4B
72-5
72-6
72-7A
Fish Toxicity Bluegill - TEP
Fish Toxicity Rainbow Trout
Fish Toxicity Rainbow Trout-
TEP
Invertebrate Toxicity
Invertebrate Toxicity - TEP
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Estuarine/Marine Toxicity Fish-
TEP
Estuarine/Marine Toxicity
Mollusk - TEP
Estuarine/Marine Toxicity
Shrimp - TEP
Early Life Stage Fish
Life Cycle Invertebrate
Life Cycle Fish
Aquatic Organism Accumulation
Simulated Field - Aquatic
USE PATTERN
[CF]3
CFLM
[CF]3
CFLM
[CF]3
F4
F4
F4
F3
F3
F3
CITATION(S)
00157611,00104057
00157611
00157611,00104057
00157611
00157611
40961601
40966801
00107905, 40966701
40961601,00107906
40966801, 00097064
00097064, 40966701, 00107905
Not Requried
Not Required
Not Requried
Not Required
Not Required
72-7B
Organisms
Actual Field - Aquatic Organisms
Not Required
69
-------
Data Supporting Guideline Requirements for the Reregistration of Nabam
REQUIREMENT
122-1A
122-1B
122-2
123-1A
123-1B
123-2
124-1
124-2
141-1
141-2
141-5
TOXICOT
81-1
81-2
81-3
81-4
81-5
Seed Germination/Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth
Seed Germination/Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth
Terrestrial Field
Aquatic Field
Honey Bee Acute Contact
Honey Bee Residue on Foliage
Field Test for Pollinators
,OGY
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation -
USE PATTERN CITATION(S)
Not Required
Not Required
Not Required
Not Required
Not Required
Not Required
Not Required
Not Required
C2 00036935
Not Required
Not Required
CFLM 00121050, 00097093
CFLM 00159774
CFLM 00159770, Upgradable
CFLM 00159775
CFLM 00159776,40024201
81-6
Rabbit
Dermal Sensitization - Guinea Pig
CFLM
00121050
70
-------
Data Supporting Guideline Requirements for the Reregistration of Nabam
REQUIREMENT
USE PATTERN
CITATION(S)
81-7 Acute Delayed Neurotoxicity -
Hen
82-1A 90-Day Feeding - Rodent
82-1B 90-Day Feeding - Non-rodent
82-2 21-Day Dermal - Rabbit/Rat
82-3 90-Day Dermal - Rodent
82-4 90-Day Inhalation - Rat
82-5A 90-Day Neurotoxicity - Hen
82-5B 90-Day Neurotoxicity - Mammal
83-1A Chronic Feeding Toxicity -
Rodent
83-1B Chronic Feeding Toxicity -
Non-Rodent
83-2A Oncogenicity - Rat
83-2B Oncogenicity - Mouse
83-3A Developmental Toxicity - Rat
83-3B Developmental Toxicity - Rabbit
83-4 2-Generation Reproduction - Rat
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
CFLM
CFLM
CFLM
CFLM
CFLM
CFLM
CFLM
CFLM
CFLM
CFLM
CFLM
CFLM
CFLM
CFLM
CFLM
Not Required
42791601, 42378801, 42751601
Waived
42791602
Reserved
Reserved
N/A
42751601
Waived
Waived
Waived
Waived
41935001, 40733101, Wavied
40873301,42437701
Waived
00153559, 00152701, 00152702,
00152700, 00152699, 00160516, 00151954,
41089901,41177201,
00151955, 00151954, 41174601, 00160517,
42303601,41221201
71
-------
Data Supporting Guideline Requirements for the Reregistration of Nabam
REQUIREMENT USE PATTERN
85-1 General Metabolism CFLM
85-2 Dermal Penetration CFLM
86-1 Domestic Animal Safety
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A Foliar Residue Dissipation C
132-1B Soil Residue Dissipation C
133-3 Dermal Passive Dosimetry
Exposure
133-4 Inhalation Passive Dosimetry
Exposure
231 Estimation of Dermal Exposure at
Outdoor Sites
232 Estimation of Inhalation
Exposure at Outdoor Sites
233 Estimation of Dermal Exposure at
Indoor Sites
234 Estimation of Inhalation
Exposure at Indoor Sites
ENVIRONMENTAL FATE
CITATION(S)
00160125,00161804
40317901,00156613
Not Required
Waived
Waived
Not Required
Not Required
Not Required
Not Required
Not Required
Not Required
160-5 Chemical Identity
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
CF
CF
C
Not Required
00165028, 40466103, 40535201
00165028,40535201
40466101
72
-------
Data Supporting Guideline Requirements for the Reregistration of Nabam
REQUIREMENT
161-4
162-1
162-2
162-3
162-4
163-1
163-2
163-3
164-1
164-2
164-3
164-5
165-1
165-2
165-3
165-4
165-5
166-1
166-2
Photodegradation - Air
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Volatility - Lab
Volatility - Field
Terrestrial Field Dissipation
Aquatic Field Dissipation
Forest Field Dissipation
Long Term Soil Dissipation
Confined Rotational Crop
Field Rotational Crop
Accumulation - Irrigated Crop
Bioaccumulation in Fish
Bioaccumulation - Aquatic
NonTarget
Ground Water - Small
Prospective
Ground Water - Small
USE PATTERN CITATION(S)
Not Required
C Waived
C Waived
CF Waived
CF Waived
CF Waived
Not Required
Not Required
C Waived
Not Required
Not Required
Not Required
C Waived
Not Required
Not Required
CF Waived
Not Required
Not Required
Not Required
Retrospective
73
-------
Data Supporting Guideline Requirements for the Reregistration of Nabam
REQUIREMENT USE PATTERN
166-3
201-1
202-1
RESIDUE
171-4A
171-4B
171-4C
171-4D
171-4E
171-4F
171-4G
171-4H
Ground Water - Irrigated
Retrospective
Droplet Size Spectrum
Drift Field Evaluation
CHEMISTRY
Nature of Residue - Plants L
Nature of Residue - Livestock L
Residue Analytical Method - L
Plants
Residue Analytical Method - L
Animal
Storage Stability L
Magnitude of Residues - Potable
H2O
Magnitude of Residues in Fish
Magnitude of Residues - Irrigated
CITATION(S)
Not Required
Not Required
Not Required
00088825, 00088826, 00088833, 00097231,
00088921, Waived
00088831, 00088834, 00088835, Waived
00088826, 00097051, 00041704, 40065801,
00088891, 00088826, 00159693, 40118601,
40065803, 40065802, Waived
Waived
Waived
Not Required
Not Required
Not Required
Crop
171-41 Magnitude of Residues - Food
Handling
171-4J Magnitude of Residues-
Meat/Milk/Poultry/Egg
171-4K Crop Field Trials
L
Not Required
Waived
Waived
74
-------
Data Supporting Guideline Requirements for the Reregistration of Nabam
REQUIREMENT
171-4L
171-5
171-6
171-7
Processed Food
Reduction of Residues
Proposed Tolerance
Support for Tolerance
USE PATTERN CITATION(S)
L Waived
Not Required
Not Required
Not Required
171-13 Analtyical Reference Standard Not Required
1 The product chemistry "database" includes data reviewed in the Reregistration Standard in addition to the following studies which were reviewed
in the Reregistration Standard addendum #2 dated 12/3/86 or were submitted in response to the Reregistration Standard and the Guidance
Document: 1986-1988; MRIDs 00158666, 00159387, 00161339, 00162198 through 00162204, 00162208 through 00162210, 00162237,
00162311 through 00162319, 00162400, 00162401, 40441601, and 40957301.
2 Not required to support the oil recovery drilling muds/packer fluids use pattern.
3 Presently not required to support any existing use.
4 Required to support the following uses: oil recovery drilling muds/packer fluids and pulp and paper mill water systems.
75
-------
76
-------
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 Reregi strati on
Eligibility Document. Primary sources for studies in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support of past regulatory decisions. Selections
from other sources including the published literature, in those instances where they have been
considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation. The Agency
has also attempted to unite basic documents and commentaries upon them, treating them as a single
study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID number". This number is unique to the citation, and should be
used whenever a specific reference is required. It is not related to the six-digit "Accession
Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)
below for further explanation). In a few cases, entries added to the bibliography late in the review
may be preceded by a nine character temporary identifier. These entries are listed after all MRID
entries. This temporary identifying number is also to be used whenever specific reference is
needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a
citation containing standard elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic conventions used reflect the standard
of the American National Standards Institute (ANSI), expanded to provide for certain special
needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to
show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory could
be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the date
is followed by a question mark, the bibliographer has deduced the date from the evidence
contained in the document. When the date appears as (19??), the Agency was unable to
determine or estimate the date of the document.
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.
77
-------
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.
78
-------
BIBLIOGRAPHY
MRID
CITATION
00001503 Waggoner, P.E. (1956) Chemical treatment of potato seed in Connecticut 1955.
Plant Disease Reporter 40(5):411-413. (Also In unpublished submission
received Jan 15, 1957 under 400-11; submitted by Uniroyal Chemical,
Bethany, Conn.; CDL:003230-E)
00001545 Borders, H.I., (1953?) Downy Mildew (Peronospora parasitica): Cabbage Crop
Test. (Unpublished study received Feb 2, 1954 under 279-835; prepared by
Georgia Agricultural Experiment Station, submitted by FMC Corp.,
Philadelphia, Pa.; CDL: 002272-B)
00003679 FMC Corporation (1964) 1964 New York State Insecticide and Fungicide
Recommendations, (p. VI5 only; unpublished study received Jul 9, 1965
under 279-1182; CDL:008883-C)
00004985 Wells, H.D.; Gay, ?; Littrell, ? (1969?) Efficacy Data of Demonsan on Crops.
(Unpublished study including letter dated May 23, 1969 from H.D. Wells to
Bob Miller, received Jul 23, 1969 under 352-344; prepared by U.S.
Agricultural Research Service, Crops Research Div., Georgia Coastal Plain
Experiment Station, submitted by E.I. du Pont de Nemours & Co., Wilmington,
Del.; CDL: 003046-M)
00011559 Richardson, L.T. (19??) The persistence of Thiram in soil and its relationship to
the microbiological balance and damping-off control. Canadian Journal of
Botany 32(? ):335-346. (Also In unpublished submission received Sep 26,
1972 under 1023-15; submitted by Upjohn Co., Kalamazoo, Mich.;
CDL:024388-B)
00011566 Couch, H.B.; Cole, H., Jr. (1956) Five compounds tested for control of Merion
bluegrass rust. Plant Disease Reporter 40(2): 103-105. (Also In unpublished
submission received Mar 6, 1958 under 1023-10; submitted by Upjohn Co.,
Kalamazoo, Mich.; CDL: 024377-B)
00011568 Couch, H.B. (1955) 1955 Merion Bluegrass Rust Fungicide Trials.
(Unpublished study including letter dated Nov 2, 1955 from H.B. Couch to
William J. Klomparens, received Mar 6, 1958 under 102310; prepared by
Pennsylvania State Univ., Dept. of Botany and Plant Pathology, submitted by
Upjohn Co., Kalamazoo, Mich.; CDL: 024377-E)
00011574 Swartwout, H.G. (1951) 1951--Strawberry Leaf Spot and Leaf Scorch Control.
(Unpublished study including letter dated Mar 25, 1952 from H.G. Swartwout
to Jared H. Ford, received Oct 15, 1953 under 1023-9; prepared by Univ. of
Missouri, Dept. of Horticulture, submitted by Upjohn Co., Kalamazoo, Mich.;
CDL:005440-H)
79
-------
BIBLIOGRAPHY
MRID
CITATION
00012840 Weiss, F.A. (1959) Summary of Tests of Acti-Dione and Acti-Dione RZ for
Control of Azalea Petal Blight (Ovulinia azaleae). (Unpublished study
including letter dated May 22, 1959 from C.N. Hastie, Jr. to George Swank,
received Aug 20, 1959 under 102310; prepared by Magnolia Gardens and
Nurseries, submitted by Upjohn Co., Kalamazoo, Mich.; CDL:024382-G)
00013810 Andison, H. (1961) Control of blister mite on holly. Insecticide Newsletter
10(7):261-262. (Also In unpublished submission received Mar 1, 1962 under
201-EX-16; submitted by Shell Chemical Co., Washington, D.C.;
CDL:122685-M)
00013926 Talmadge, J. (1962) Bidrin Insecticide Field Scale Test Data. (Unpublished
study received Jan 28, 1966 under 201-142; submitted by Shell Chemical Co.,
Washington, D.C.; CDL:000833-AK)
00019691 Betz Entec, Incorporated (19??) Betz Entec 346: Efficacy Data. (Unpublished
study received Apr 23, 1975 under 34571-7; CDL: 240034-A)
00022926 McClure, T.T. (1951) Experiences with cherry sprays in 1951. Phytopathology
42(? ):14. (Abstract; also In unpublished submission received Dec 2, 1976
under 1023-50; submitted by Upjohn Co., Kalamazoo, Mich.; CDL:095620-K)
00024918 McLeod, H.A.; McCully, K.A. (1969) Head space gas procedure for screening
food samples for Dithiocarbamate pesticide residues. Journal of the Association
of Official Analytical Chemists 52(6): 1226-1230. (Also In unpublished
submission received Oct 18, 1979 under 400-112; submitted by Uniroyal
Chemical, Bethany, Conn.; CDL:241184-B)
00025590 Sterner, P.W. (1971) Use of XD-7287L (Slimicide) in Paper Mills: DP-313.
(Unpublished study received Jun 11, 1974 under 464-426; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:241465-J)
00025816 Davis, H.C.; Hidu, H. (19??) Effects of pesticides on embryonic development
of Clams and Oysters and on survival and growth of the Larvae. Fishery
Bulletin 67(2):393-400,403. (Also In unpublished submission received Jan 2,
1980 under 2217-485; submitted by FBI-Gordon Corp., Kansas City, Kans.;
CDL:241581-W)
80
-------
BIBLIOGRAPHY
MRID
CITATION
00030082 Chase, C. (1979) API Bactedostatic Testing on an Antimicrobial Agent for
Vinings Chemical Company: Project No. 069-07-199. (Unpublished study
including published data, received Mar 20, 1980 under 9386-7; prepared by
Weintritt Testing Laboratories in cooperation with American Petroleum
Institute, submitted by Vining Chemical Co., Atlanta, Ga.; CDL:242250-A)
00031110 Miller, P.M. (1956) Control of black root rot of strawberries with
nematocide-fungicide combinations. Plant Disease Reporter 40(l):45-47.
(Also In unpublished submission received Feb 6, 1961 under 464-186;
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:003459-AB)
00031558 Mogul Corporation (1978) Laboratory Study: Pilot Plant Study: Field Trials.
(Unpublished study received Mar 25, 1980 under 8591-EX2; CDL:242184-B)
00034382 Heuberger, J.W.; Wilson, J.D.; Partyka, R.E.; et al. (1953) Efficacy Study
Using Potatoes, Tomatoes and Celery. (Unpublished study received Feb 11,
1954 under 279-837; prepared in cooperation with Univ. of Delaware,
Agricultural Experiment Station, Dept. of Botony and others, submitted by
FMC Corp., Philadelphia, Pa.; CDL:002274-A)
00041704 Clarke, D.G.; Baum, H.; Stanley, E.L.; et al. (1951) Determination of
dithiocarbamates. Analytical Chemistry 23(12): 1842-1846. (Also In
unpublished submission received Apr 3, 1972 under 2F1258; submitted by
Rohm & Haas Co., Philadelphia, Pa., CDL: 095544-F)
00041801 Krister, C.J.; Wilson, C.E., Jr. (1952) Residues of Dithiocarbamate
fungicides—on food crops. Agricultural Chemicals 7(9): 45-48. (Also In
unpublished submission received Jun 15, 1955 under PP0021; submitted by
E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:090020-F)
00044028 Nash Chemical Company (1953?) Kaybam Data. (Unpublished study received
Nov 17, 1964 under unknown admin, no.; submitted by ?; CDL:104252-A)
00047527 Aqua-Treat Chemicals, Incorporated (19??) Water Cooling Tower Application.
Houston, Tex.: Aqua-Treat. (Also In unpublished submission received on
unknown date under unknown admin, no.; CDL:227869-A)
00049273 Gabriel, K.L. (1972) Acute Oral Toxicity-Rats. (Unpublished study received
Mar 22, 1973 under 3876-93; prepared by Biosearch, Inc., submitted by Betz
Laboratories, Inc., Trevose, Pa.; CDL: 222701-A)
81
-------
BIBLIOGRAPHY
MRID
CITATION
00049274 Gabriel, K.L. (1972) Primary Eye Irritation Study-Rabbits. (Unpublished
study received Mar 22, 1973 under 3876-93; prepared by Biosearch, Inc.,
submitted by Betz Laboratories, Inc., Trevose, Pa.; CDL:222701-B)
00049275 Gabriel, K.L. (1972) Primary Skin Irritation Study-Rabbits. (Unpublished
study received Mar 22, 1973 under 3876-93; prepared by Biosearch, Inc.,
submitted by Betz Laboratories, Inc., Trevose, Pa.; CDL:222701-C)
00056307 Williamson, H.O.; McDuffie, W.E.; Teeters, W.R. (1973) Pharmacology
Laboratory Toxicity Report—Screening. (U.S. Environmental Protection
Agency, Pharmacology Laboratory, unpublished study; CDL: 226496-A)
00059001 Drew Chemical Corporation (1963) Efficacy Studies of Biocides.
(Compilation; unpublished study received on unknown date under 1757-23;
CDL:221606-A)
00061849 Ingols, R.S. (1972) Report to Parker Engineered Chemicals, Incorporated:
Slime Control Properties of P48 for Project A-1282-012. (Unpublished study
received Nov 28, 1972 under 14886-3; prepared by Georgia Institute of
Technology, Engineering Experiment Station, submitted by Parker Engineering
& Chemicals, Inc., Atlanta, Ga.; CDL:227949-A)
00061854 Tharp, P.R. (1973) Letter sent to T.E. Adamczyk dated Feb 15, 1973: P-48
powdered algae control. (Unpublished study received Feb 20, 1973 under
14886-3; submitted by Parker Engineering & Chemicals, Inc., Atlanta, Ga.;
CDL:227952-A)
00069162 Drew Chemical Corporation (1971) Efficacy of Biocide on Sugar Cane and
Other Crops. (Compilation; unpublished study received Nov 22, 1965?; Feb 4,
1966?; Dec 23, 1971; Aug 2, 1963? under 175723; CDL:231104-A)
00069163 Drew Chemical Corporation (1960) Analytical Results of Dithane A-40
Residues. (Unpublished study received Feb 4, 1966 under 175723;
CDL:231104-B)
00069164 Luy, T.; Frances, S. (1971) Report on Fish Toxicity Using Biocide 280 Bluegill
Sunfish: Laboratory No. D-7433A. (Unpublished study received Dec 23, 1971
under 1757-23; prepared by Wells Laboratories, Inc., submitted by Drew
Chemical Corp., Boonton, N.J.; CDL:231104-C)
00069165 Luy, T.; Frances, S. (1971) Report on Fish Toxicity Using Biocide 280
Rainbow Trout: Laboratory No. D-7433. (Unpublished study received Dec 23,
82
-------
BIBLIOGRAPHY
MRID
CITATION
1971 under 1757-23; prepared by Wells Laboratories, Inc., submitted by Drew
Chemical Corp., Boonton, N.J.; CDL:231104-D)
00069595 De Azevedo, J.P.; Frances, S. (1975) Report on Eye Irritation Testing in
Rabbits: Laboratory No. F-7738. (Unpublished study received Apr 8, 1975
under 1757-48; prepared by Wells Laboratories, Inc., submitted by Drew
Chemical Corp., Boonton, N.J.; CDL:234751-A)
00069596 De Azevedo, J.P.; Frances, S. (1975) Report on Primary Skin Irritation:
Laboratory No. F-7739. (Unpublished study received Apr 8, 1975 under
1757-48; prepared by Wells Laboratories, Inc., submitted by Drew Chemical
Corp., Boonton, N.J.; CDL:234751-B)
00071103 Coe, B. (1980) Free Amine in Dialkyldithiocarbamates by Relative Vapor
Pressure Measurement. Alco laboratory test method no. 37 dated Apr 4, 1980.
(Unpublished study received May 6, 1980 under 31910-8; submitted by Alco
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00071104 Alco Chemical Corporation (1980) Potassium and Sodium
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00071106 Alco Chemical Corporation (1980) Sodium Potassium Dithiocarbonic Acid
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00071108 Diamond Shamrock Corporation (1978) Material Safety Data Sheet: Sodium
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Laboratory No. G-l 162. (Unpublished study received Dec 11, 1975 under
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1969 under 10329-1; submitted by Ryco, Inc., Conshohooken, Pa.;
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of analysis of four chemical formulations for Nnitrosamine compounds.
(Unpublished study, including TRI project nos. 706-4120 and 57487, received
Mar 29, 1978 under 31910-2; prepared by Campbell Soup Co., submitted by
Alco Chemical Corp., Philadelphia, Pa.; CDL:235152-A)
00097070 Mazer Chemicals, Incorporated (19??) Mazide BC-800. Gurnee, 111.: MCI.
(Technical bulletin; also in unpublished submission received Mar 9, 1979
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00097072 Alco Chemical Corporation (1978) Vulnopol DN-25. Philadelphia, Pa.: ACC.
(Technical bulletin, TB-807; also In unpublished submission received Mar 9,
1979 under 38672-1; submitted by Mazer Chemicals, Inc., Gurnee, 111.;
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00097074 Alco Chemical Corporation (1977) Aquatreat DNM-30 EBDC RPAR Rebuttal.
(Unpublished study received Mar 9, 1979 under 38672-1; submitted by Mazer
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00097075 Mazer Chemicals, Incorporated (1977) Bactericidal Efficacy of Mazide
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38672-1; submitted by Mazer Chemicals, Inc., Gurnee, 111.; CDL:237769-K)
00097081 Newsome, W.H. (1974) The excretion of ethylenethiourea by rat and guinea
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(Also In unpublished submission received Mar 9, 1979 under 38672-1;
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00097082 Mastri, C. (1970) Report to Nalco Chemical Company: Eye Irritation Test on
Nalcon 247 in Albino Rabbits: IBT No. A8677. (Unpublished study received
Aug 6, 1970 under 1706-100; prepared by Industrial Bio-Test Laboratories,
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00097083 Gabriel, K.L. (1972) Acute Dermal Toxi city-Rabbits. (Unpublished study
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00097085 Alco Chemical Corporation (19??) Aquatreat DNM-30 in Brief. Philadelphia,
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00097086 Alco Chemical Corporation (19??) Aquatreat DNM-30. Philadelphia, Pa.:
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00097087 Alco Chemical Corporation (19??) Aquatreat DNM-30-Purity: Alco
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CDL:241190-C)
00097088 Alco Chemical Corporation (19??) Aquatreat DNM-30 in Crude Sugar
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unpublished submission received Oct 19, 1979 under 1706-EX-3; submitted by
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00097089 Alco Chemical Corporation (1979) Aquatreat DNM-30: Handling and Toxicity
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1706-EX-3; submitted by Nalco Chemical Co., Oak Brook, 111.;
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Laboratory No. E-6873. (Unpublished study received Jul 20, 1979 under
31910-2; prepared by Wells Laboratories, Inc., submitted by Alco Chemical
Corp., Philadelphia, Pa.; CDL: 241381-A)
00097091 Luy, T.; Peterson, A.F. (1973) Report on Fish Toxicity: Rainbow Trout:
Laboratory No. E-6872. (Unpublished study received Jul 20, 1979 under
31910-2; prepared by Wells Laboratories, Inc., submitted by Alco Chemical
Corp., Philadelphia, Pa.; CDL: 241381-B)
00097092 Rupp, F., Jr.; Ferrer, L. (1979) Report on Subacute Dietary LcaeSO in Mallard
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prepared by Biosearch, Inc., submitted by Alco Chemical Corp., Philadelphia,
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00097094 Gabriel, K.L. (1979) Acute Inhalation Toxicity-Rats: Aquatreat DNM-30:
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31910-2; prepared by Biosearch, Inc., submitted by Alco Chemical Corp.,
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00097095 Jordan, P.W.; Parke, G.S.E. (1976) The Dermal Corrosivity Study in Rabbits of
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Jul 20, 1979 under 31910-2; prepared by Cannon Laboratories, Inc., submitted
by Alco Chemical Corp., Philadelphia, Pa.; CDL:241382-E)
00097096 De Azevedo, J.P.; Frances, S. (1975) Report on Primary Skin Irritation:
Aquatreat DNM-30: Laboratory No. F-7739. (Unpublished study received Jul
20, 1979 under 31910-2; prepared by Wells Laboratories, Inc., submitted by
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submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.;
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00097233 E.I. du Pont de Nemours & Company, Incorporated (1952) Tomato Residue
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00098639 Rohm & Haas Company (1958) Dithane M-22 Residues on Sugar Beets.
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00098853 Domsch, K.H. (1977) The Effect of Soil Fungicides. IV. Changes in the
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00100704 Conzelmann, P. (1982) Static 96-hour Marine Bioassay Testing Vinings
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415-A60-41. (Unpublished study received Apr 22, 1982 under 9386-7;
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105
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BIBLIOGRAPHY
MRID
CITATION
40966800 Alco Chemical Corp. (1989) Submission of Acute Toxicity to Eastern Oysters
in Response to Nabam Registration Standard. Transmittal of 1 study.
40966801 Surprenant, D. (1989) Acute Toxicity of Nabam/Aquatreat to Eastern Oysters
(Crassostrea virginica) Under Flow-Through Conditions: SLS Rept. #
11927.0788.6102.504. Unpublished study prepared by Springborn Life
Sciences, Inc. 49 p.
41036000 US EPA (1983) Submission of Administrative Record of Rebuttable
Presumption against Registration for EBDC. Transmittal of 1 study.
41036001 U.S. Environmental Protection Agency (1983) GS0118/EBDC: RPAR:
Administrative Record. Unpublished compilation with confidential attachment.
8758 p.
41076800 Nabam Task Force (1989) Submission of Data To Support Registration of
Nabam: Toxicology Data. Transmittal of 1 study.
41076801 Cavagnaro, J. (1989) Supplement to: Salmonella typhimurium/Mammalian
Microsome Plate Incorporation Assay with Compound Nabam: SLS Project
No. 752-108. Unpublished study prepared by Hazleton Biotechnologies Corp.
6 p.
41174600 Nabam Task Force (1989) Submission of Toxicity Data in Support of Nabam
Registration. Transmittal of 1 study.
41174601 Cavagnaro, J. (1989) Supplement to: Unscheduled DNA Synthesis Rat
Hepatocyte Assay with Nabam: Laboratory Project ID # 752-110. Unpublished
study prepared by Hazleton Biotechnologies Corp. 55 p.
41177200 Nabam Task Force (1989) Submission of Toxicological Data to Support the
Nabam Registration Standard. Transmittal of 1 study.
41177201 Ivett, J. (1989) Mutagenicity Test on Aquatreat DN-30 (30% Nabam in Water)
in the Rat Bone Marrow Cytogenetic Assay. Unpublished study prepared by
Hazleton Laboratories America, Inc. 57 p.
41221200 Nabam Task Force (1989) Submission of Toxicity Data in Support of Nabam
Registration Standard. Transmittal of 1 study.
41221201 Myhr, B. (1989) Mutagenicity Test on Aquatreat DN-30 ( 30% Nabam in
Water) in the In Vitro Transformation of Balb/C-3T3 Cells Assay with an S9
Activation System: HLA Study No. 10645-0-488. 53 p.
106
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BIBLIOGRAPHY
MRID
CITATION
41346100 Nabam Task Force (1989) Submission of Efficacy Data to Support the Data
Call-in Notice for Nabam. Transmittal of 1 study.
41346101 Jellinek, Schwartz, Connolly & Freshman, Inc. (1989) Nabam Benefits
Information. 244 p.
41441700 Nabam Task Force (1990) Submission of Efficacy and Cost Benefit Data for
Nabam in Response to the EBDC Position Document No. 2/3. Transmittal of 1
study
41441701 Snow, H. (1990) Nabam Task Force Response to the EBDC PD 2/3: The
Benefits of Nabam Microbiocides. Unpublished study prepared by Jellinek,
Schwartz, Connolly & Freshman, Inc. 127 p
41838000 US EPA (1990) Submission of Administrative Record for GS-0641 (Nabam).
Transmittal of 1 study.
41838001 US EPA (1987) Administrative Record of the Registration Standard for
GS-0641 (Nabam). Unpublished compilation with confidential attachment.
885 p.
41875200 US EPA (1985) Submission of Data to Support the Reregi strati on for Nabam.
Transmittal of 1 studies.
41875201 Ballard, G. (1985) Preliminary Quantitative Usage Analysis of Nabam as a
Pesticide. Unpublished study prepared by U.S. EPA, Benefits and Use Div. 4
P-
41935000 Nabam Task Force (1991) Submission of toxicity data to support the
registration standard for Nabam. Transmittal of 1 study.
41935001 Mitala, J. (1990) Teratogenicity Study in Rats of MRD-87-072 (Aquatreat
DN-30, Approximately 30% Nabam): Amended Final Report of MRID
40873101: Lab Project Number: 207234. Unpublished study prepared by
Exxon Biomedical Sciences, Inc. 140 p.
42151200 Nabam Task Force (1991) Submission of toxicity data to support the
registration standard for Nabam. Transmittal of 1 study.
42151201 Lawlor, T. (1991) Mutagenicity Test on Aquatreat DN-30 (30% Nabam in
Water) in the Salmonella/Mammalian-Microsome Reverse Mutation Assay
with a Confirmatory Assay: Supplement to MRID 43107681: Lab Project
107
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BIBLIOGRAPHY
MRID
CITATION
Number: 14806-0-401R. Unpublished study prepared by Hazleton
Washington, Inc. 39 p.
42163000 National Starch and Chemical Co. (1992) Submission of product chemistry
data in support of a registration standard for Nabam. Transmittal of 3 studies.
42163001 Patterson, S. (1991) Aquatreat DN-30: Product Identity and Composition.
Unpublished study prepared by Alco Chemical Division of the National Starch
& Chemical Co. 12 p.
42163002 Patterson, S. (1991) Physical and Chemical Characterisitics of Aquatreat
DN-30. Unpublished study prepared by Alco Chemical Division of the
National Starch & Chemical Co. 4 p.
42163003 Patterson, S. (1991) Aquatreat DN-30: Preliminary Analysis. Unpublished
study prepared by Alco Chemical Division of the National Starch & Chemical
Co. 22 p.
42303600 Nabam Task Force (1992) Submission of Data To Support Nabam Registration
Standard: Toxicology Study. Transmittal of 1 study.
42303601 Murli, H. (1992) Aquatreat DN-30 (30 percent Nabam in Water): Measuring
Sister Chromatid Exchange in Chinese Hamster Ovary (CHO) Cells with
Replicate Cultures Under Nonactivation Conditions: Final Report: Lab Project
Number: 14806-0-438. Unpublished study prepared by Hazleton Washington,
Inc. 37 p.
42314200 Nabam Task Force (1992) Submission of Toxicity Data To Support FIFRA
Section 6(a)(2) Requirements for Nabam. Transmittal of 1 study.
42314201 Allemang, D. (1992) Letter Sent to L. Rossi dated May 7, 1992: Providing
preliminary results from the Nabam developmental toxicity study in rabbits.
Prepared by Nabam Task Force. 5 p.
42378800 Nabam Task Force (1992) Submission of FIFRA 6(a)2 data for Nabam
Adverse Effects. Transmittal of 1 study.
42378801 Allemang, D. (1992) Letter Sent to Lois Rossi, dated June 26, 1992:
Concerning Preliminary Results from a Nabam 21-day Oral Range Finding
Suchronic Study in Rats. Prepared by Nabam Task Force. 16 p.
42437700 Nabam Task Force (1992) Submission of toxicity data in support of the Nabam
registration standard. Transmittal of 1 study.
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BIBLIOGRAPHY
MRID
CITATION
42437701 Nemec, M. (1992) A Developmental Toxicity Study of Aquatreat DN-30 in
Rabbits: Final Report: Lab Project Number: WIL-190002: 985.0. Unpublished
study prepared by WIL Research Labs, Inc. 566 p.
42455700 Nabam Task Force (1992) Submission of toxicity data in support of the FIFRA
6(a)(2) requirements for Nabam. Transmittal of 1 study.
42455701 Allemang, D. (1992) Letter Sent to Lois Rossi, RB dated August 28, 1992 on
behalf of Nabam Task Force concerning preliminary findings in 21-day rat
subchronic dermal toxicity study. Prepared by Jellinek, Schwartz & Connolly,
Inc. 3 p.
42683700 Nabam Task Force (1993) Supplemental submission of toxicity data in support
of the Nabam registration standard. Transmittal of 1 study.
42683701 Severs, L. (1993) A Determination of Nabam and Ethylene Thiourea in
Aqueous Preparations: Supplemental Final Report: Lab Project Number:
WIL-190005. Unpublished study prepared by WIL Research Labs, Inc. 20 p.
42751600 Alco Chemical (1993) Submission of Toxicity Data in Support of the
Registration Standard for Nabam. Transmittal of 1 Study.
42751601 Lamb, I. (1993) A Combined Subchronic (13 Week) Toxicity and
Neurotoxicity Study of Aquatreat DN-30 in Rats: Final Report: Lab Project
Number: WIL-190004. Unpublished study prepared by WIL Research
Laboratories, Inc. 1482 p.
42791600 Alco Chemical Division of National Starch and Chemical Co. and Vinings
Industries, Inc. (1993) Submission of toxicity data in support of registration
standard for Aquatreat DN-30 (Nabam). Transmittal of 2 studies.
42791601 Lamb, I. (1993) A 21-Day Range-Finding Acute Study of Aquatreat DN-30 in
Rats: Final Report: Lab Project Number: WIL-190003. Unpublished study
prepared by WIL Research Labs, Inc. 324 p.
42791602 Goad, M. (1993) Twenty-One Day Sub-Chronic Dermal Toxicity Study with
Aquatreat DN-30 (Approximately 30% Nabam in Water) in Rats: Final Report:
Lab Project Number: 41178. Unpublished study prepared by Arthur D. Little,
Inc. 212 p.
43183300 Vinings Industries, Inc. (1994) Submission of Product Chemistry Data for
Nabam/SDDC in Support of Reregi strati on. Transmittal of 6 studies.
109
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BIBLIOGRAPHY
MRID
CITATION
43183301 Colvin, A. (1994) Analysis of Product Samples: Analysis of Vinings' 30%
Nabam: Lab Project Number: 94-02. Unpublished study prepared by Vinings
Industries, Inc. 63 p.
43183302 Colvin, A. (1994) Analysis of Product Samples: Analysis of Vinings' Dried
Nabam: Lab Project Number: 94-02. Unpublished study prepared by Vinings
Industries, Inc. 62 p.
43183305 Colvin, A. (1994) Analysis of Product Samples: Analysis of Vinings' 15%
SDDC: 15% Nabam: Lab Project Number: 94-01. Unpublished study prepared
by Vinings Industries, Inc. 75 p.
43183306 Colvin, A. (1994) Analysis of Product Samples: Analysis of Vinings' Dried
SDDC/Nabam: Lab Project Number: 94-01. Unpublished study prepared by
Vinings Industries, Inc. 75 p.
43212400 Alco Chemical Division of National Starch & Chemical Co. (1994) Submission
of Product Chemistry Data for Aquatreat DN-30 in Support of Reregi strati on.
Transmittal of 1 study.
43212401 Patterson, D. (1994) Revised Series 62 Analysis of Aquatreat DN-30: Analysis
and Certification of Product Ingredients: Lab Project Number: D-20-001:
LC-100. Unpublished study prepared by National Starch & Chemical Co.,
Alco Chemical Div. 80 p.
43241300 Vinings Industries, Inc. (1994) Submission of Product Chemistry Data for
Nabam in Support of Reregi strati on. Transmittal of 1 study.
43241301 Hinton, R. (1994) Discussion of Impurities: Nabam. Unpublished study
prepared by Vinings Industries, Inc. 5 p.
43641400 Maneb Data Task Force and Elf Atochem (1995) Submission of Risk Data in
Support of the Special Review of EBDC Pesticides. Transmittal of 1 Study.
43641401 Weinberg, D.; Weiss, D. (1987) Response of the Maneb Data Task Force and
Pennwalt Corporation to the Environmental Protection Agency's Initiation of
Special Review of the EBDC Pesticides: (Risk Exposure Assessment).
Unpublished study prepared by Fox, Weinberg & Bennett. 28 p.
43641500 Elf Atochem (1987) Submission of Risk to Humans Data in Support of EBDC
Pesticides Special Review. Transmittal of 1 Study.
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BIBLIOGRAPHY
MRID CITATION
43641501 Weinberg, D.; Weiss, D. (1987) Response of Pennwalt Corporation to the
Environmental Protection Agency's Initiation of Special Review of the EBDC
Pesticides/Mancozeb: (Risk Assessment): (Includes "EBDC Special Review:
Toxicological Issues"). Unpublished study prepared by Fox, Weinberg &
Bennett. 51 p.
Ill
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s? UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
p* WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet.
to submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration
of your product(s) containing this active ingredient. Within 90 days after you receive this
Notice you must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; 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).
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If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list
of all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31-96).
This Notice is divided into six sections and six 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 Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms, and Confidential Statement of
Formula
SECTION! 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.
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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
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the study
will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 2001 L Street, N.W.,
Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-785-
0350).
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) 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.
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SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must be
submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is presented
below. A discussion of the 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.
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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.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select one
of the six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item number
9, "Registrant Response." The six options related to data production are the first six options
discussed under item 9 in the instructions for completing the Requirements Status and Registrant's
Response Form. These six options are listed immediately below with information in parentheses to
guide registrants to additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1. Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
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submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule
including alternative dates for meeting such requirements on a step-by-step basis. You must
explain any technical or laboratory difficulties and provide documentation from the laboratory
performing the testing. While EPA is considering your request, the original deadline remains. The
Agency will respond to your request in writing. If EPA does not grant your request, the original
deadline remains. Normally, extensions can be requested only in cases of extraordinary testing
problems beyond the expectation or control of the registrant. Extensions will not be given in
submitting the 90-day responses. Extensions will not be considered if the request for extension is
not made in a timely fashion; in no event shall an extension request be considered if it is submitted
at or after the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data — Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
data tables that your product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the group.
The registration number of the product for which data will be submitted must be noted in the
agreement to cost share by the registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data. You must
also provide EPA with documentary evidence that an agreement has been formed. Such evidence
may be your letter offering to join in an agreement and the other registrant's acceptance of your
offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer to
pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has in good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share in the burden of
developing that data. You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data, Attachment 7. In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
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registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to
anything else, offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and
must not qualify this offer. The other registrant must also inform EPA of its election of an option
to develop and submit the data required by this Notice by submitting a Data Call-In Response Form
and a Requirements Status and Registrant's Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer to
share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4. Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency or
previously cited by anyone. Existing studies are studies which predate issuance of this Notice. Do
not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to
be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
As stated in 40 CFR 160.3(j) " '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."
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b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available
from NTIS). A study not conducted according to the PAG may be submitted to the
Agency for consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the
Agency's policy regarding acceptable protocols. If you wish to submit the study, you
must, 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 MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those criteria
as well as a certification regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if the
study has been reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit a
completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical reasons,
data and references to relevant EPA regulations, guidelines or policies. (Note: any supplemental
data must be submitted in the format required by PR Notice 86-5). This will be the only
opportunity to state the reasons or provide information in support of your request. If the Agency
approves your waiver request, you will not be required to supply the data pursuant to section
3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an option for
meeting the data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the Requirements Status and Registrant's
Response Form. Product specific data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products and the Agency would grant a waiver
only under extraordinary circumstances. You should also be aware that submitting a waiver
request will not automatically extend the due date for the study in question. Waiver requests
submitted without adequate supporting rationale will be denied and the original due date will
remain in force.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure
of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-In Response Form and a Requirements Status and Registrant's
Response Form:
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
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c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting, the
completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
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use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until
the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular risk concerns will be
determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate to
the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as the
products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois Rossi, Division Director
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 Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
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NAB AM DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing nabam.
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 reregi strati on of
nabam. This attachment is to be used in conjunction with (1) the Product Specific Data Call-In
Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this nabam Product Specific
Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for nabam are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on nabam 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 reregi strati on of all eligible nabam products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and
procedures established by this Notice, please contact Jean Holmes at (703) 308-8008.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Jean Holmes
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: nabam
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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 registration numbers of your source(s); you would not
complete the "Requirements Status and Registrant's Response" form. Examples of
such products include repackaged products and Special Local Needs (Section
24c) products which are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you are requesting a waiver.
See Item 6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a
signed letter that accompanies this form. For example, you may wish to report
that your product has already been transferred to another company or that you
have already voluntarily canceled this product. For these cases, please supply all
relevant details so that EPA can ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in
Item 3 This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements, all
use patterns are covered by the data requirements. In the case of efficacy data, the
required studies only pertain to products which have the use sites and/or pests
indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed in this
table. Fuller descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in
the Data Call-In Notice. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4)
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand
that this option is available only for acute toxicity or certain efficacy data and
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only if EPA indicates in an attachment to this Notice that my product is similar
enough to another product to qualify for this option. I certify that another party in
the agreement is committing to submit or provide the required data; if the required
study is not submitted on time, my product may be subject to suspension. By the
specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29)
and (2) two completed and signed copies of the Confidential Statement of
Formula (EPA Form 8570-4)
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-In Notice that
my product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that data. I am also submitting a
completed "Certification of Offer to Cost Share in the Development Data"
form. I am including a copy of my offer and proof of the other registrant's receipt
of that offer. I am identifying the party which is committing to submit or provide
the required data; if the required study is not submitted on time, my product may
be subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section III-C.l.) apply as well. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA
Form 8570-4)
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (Submitting an Existing Study).
I certify that this study will meet all the requirements for submittal of existing data
outlined in Option 4 in the Data Call-In Notice (Section III-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify
that I have determined that this study will fill the data requirement for which I
have indicated this choice. By the specified due date, I will also submit a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) to show what data compensation
option I have chosen. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4)
5. By the specified due date, I will submit or cite data to upgrade a study classified
by the Agency as partially acceptable and upgradable (Upgrading a Study). I
will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
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Accession number of the study at the due date. I understand that the conditions
for this option outlined Option 5 in the Data Call-In Notice (Section III-C.l.)
apply. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4)
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If I am citing another
registrant's study, I understand that this option is available only for acute toxicity
or certain efficacy data and only if the cited study was conducted on my product,
an identical product or a product which EPA has "grouped" with one or more
other products for purposes of depending on the same data. I may also choose this
option if I am citing my own data. In either case, I will provide the MRID or
Accession number(s) for the cited data on a "Product Specific Data Report" form
or in a similar format. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4)
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request,
including technical reasons, data and references to relevant EPA regulations,
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state the reasons or provide information in support of my request.
If the Agency approves my waiver request, I will not be required to supply the
data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies my waiver
request, I must choose a method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I must, within 30 days of my
receipt of the Agency's written decision, submit a revised "Requirements Status
and Registrant's Response" Form indicating the option chosen. I also understand
that the deadline for submission of data as specified by the original data call-in
notice will not change. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4)
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a
signed letter that accompanies this form. For example, you may wish to report
that your product has already been transferred to another company or that you
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have already voluntarily canceled this product. For these cases, please supply all
relevant details so that EPA can ensure that its records are correct.
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EPA'S BATCHING OF NAB AM 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 reregi strati on of products containing the active ingredient
Nabam, the Agency has batched products which can be considered similar for purposes of acute
toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see acceptance
criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity,
and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than
one confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must
decidewhether he/she will provide the data or depend on someone else to do so. If a registrant
supplies the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
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choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
One product in this group of chemicals, 31910-7, has only one active ingredient, Nabam.
This product was used to provide the data used in the Acute Toxicity section of the Science
Assessment: III(B)(l)(a). As can also be seen from this section, the acute toxicity data is
incomplete, missing a valid inhalation toxicity study. To complete re-registration of this product
the missing data is required.
The remainder of products in the category have two actives, Nabam and sodium
dimethyldithiocarbamate, or Dibam, in about equal amounts.
The table below shows five products which were batched together.
BATCH NO. EPA REG. NO. % of Nabam % of Dibam Formulation
Type 1 9386-7 15.0 16.0 Liquid
9386-11 15.0 15.0 Liquid
31910-2 15.0 15.0 Liquid
31910-12 18.0 18.0 Liquid
56473-3 15.0 15.0 Liquid
The table below shows products which were not batched because of significant
differences in active concentrations and inert ingredients.
EPA REG. NO. % of Nabam % of Dibam Formulation Type
9386-23 4.5 4.5 Liquid
31910-11 4.5 4.5 Liquid
31910-16 12.5 12.5 Liquid
31910-18 12.5 12.5 Liquid
31910-20 40 40 Liquid
In the table above, the product with the greatest percentage of Nabam and Dibam is
31910-20. Because EPA does not wish for excess duplicative tests to be performed, the
following testing scheme is suggested:
Do complete acute toxicity testing on 31910-20. At this point it may be possible
to bridge to Batch 1 and/or 9386-23. If bridging is not possible, a complete test
battery on one product from Batch 1 will be necessary, and with this, it may be
possibe to bridge this to 9386-23.
At this point acute oral toxicity tests will need to be performed on 31910-11 and 31910-
18 with the possibility of bridging to 31910-16.
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ATTENTION CRM::: PLEASE NOTE:::
REMOVE THIS PAGE AND INSERT THE LIST OF REGISTRANTS RECEIVING
THIS DCI
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source product's
label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Maine
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
141
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
,^Ttu
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing th
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with section
3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration
or reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
143
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The following is a list of available documents for nabam that my further assist you in
responding to this Reregi strati on Eligibility Decision document. These documents may be
obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special
Review and Reregi strati on Information System at 703-308-7224. They also are
available on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or
using ftp on FTP.EPA.GOV, or using WWW (World Wide Web) on
WWW.EPA.GOV., or contact Jean Holmes at (703)-308-8008.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for nabam.
The following documents are part of the Administrative Record for nabam and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person
listed on the Chemical Status Sheet.
1.Health and Environmental Effects Science Chapters.
2.Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
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