SEFft
United States Prevention, Pesticides EPA 739-R-09-001
Environmental Protection and Toxic Substances June 2009
Agency (751 OP)
Sodium and Potassium
Dimethyldithiocarbamate Salts
Amendment to the
Ferbam (PC Code 034801) and
Ziram (PC Code 034805)
Reregistration Eligibility Decisions
ListD
CASE 2180
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Sodium and Potassium Dimethyldithiocarbamate Salts
Amendment to the
Ferbam (PC Code 034801) and
Ziram (PC Code 034805) Reregistration Eligibility Decisions
ListD
CASE 2180
Approved By:
Joan Harrigan Farrelly
Director, Antimicrobials Division
June 30, 2009
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Table of Contents
DDC Salts Reregistration Team i
Glossary of Terms and Abbreviations ii
Abstract iv
I. Introduction 1
II. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification 2
C. Use Profile 4
III. Summary of DDC Salts Risk
Assessments 7
A. Human Health Risk Assessment 7
1. Toxicity of DDC Salts 7
2. Dietary and Drinking Water Risk Summary 7
3. Occupational and Residential Exposure and Risk Assessment.. 7
4. Human Incident Data 7
B. Environmental Risk Assessment 8
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 9
A. Determination of Reregistration Eligibility 9
B. Draft Risk Assessment Comments and Responses 9
C. Regulatory Rationale 10
1. Human Health Risk Management 10
a. Dietary (Food) and Drinking Water Risk Mitigation 10
b. Residential Risk Mitigation 10
i. Handler Risk Mitigation 11
ii. Post-Application Risk Mitigation 11
Hi. Aggregate Risk 11
c. Occupational Risk Mitigation 12
i. Handler Risk Mitigation 12
ii. Post-Application Risk Mitigation 13
2. Environmental Risk Management 13
3. Other Labeling Requirements 14
4. Listed Species Considerations 15
a. The Endangered Species Act 15
b. General Risk Mitigation 15
V. What Registrants Need to Do 17
A. Manufacturing-Use Products 17
1. Additional Generic Data Requirements 17
2. Labeling for Technical and Manufacturing-Use Products 18
B. End-Use Products 20
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1. Additional Product-Specific Data Requirements 20
2. Labeling for End-Use Products that Contain DDC Salts 20
a. Label Changes Summary Table 21
VI. Appendices 22
A. Table of Use Patterns for DDC Salts 23
B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 34
C. Technical Support Documents 41
D. Bibliography Citations 43
E. Generic Data Call-In 52
F. Product Specific Data Call-In 53
G. Batching of End-Use Products 54
H. List of All Registrants Sent the Data Call-In 55
I. List of Available Forms 56
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DDC Salts Reregistration Team
Health Effects Risk Assessment
Najm Shamim
Timothy Leighton
Timothy Dole
Jonathan Chen
Ecological Risk Assessment
Siroos Mostaghimi
William Erickson
Environmental Fate Risk Assessment
James Breithaupt
Risk Management
Eliza Blair
Diane Isbell
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
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
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
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MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
PDF USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24C of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WP S Worker Protection Standard
ill
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Abstract
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for Dimethyldithiocarbamate (DDC) Salts and is
issuing its risk management decision. This decision amends Reregi strati on Eligibility Decisions
(REDs) issued for other active ingredients in the case (2180) Ferbam (PC Code 034801) and
Ziram (PC Code 034805). REDs for these active ingredients were completed in 2005 and 2003,
respectively. The risk assessments, which are summarized below, are based on the review of the
required target database supporting the use patterns of currently registered products. After
considering the risks identified in the revised risk assessments, and mitigation suggestions from
interested parties, the Agency developed its risk management decision for uses of DDC Salts that
pose risks of concern. As a result of this review, EPA has determined that DDC Salts-containing
products are eligible for reregi strati on, provided that risk mitigation measures are adopted and
labels are amended accordingly. That decision is discussed fully in this document.
IV
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984 and amended again by the Pesticide Registration Improvement Act of 2003 to set time
frames for the issuance of Reregistration Eligibility Decisions. The amended Act calls for the
development and submission of data to support the reregistration of an active ingredient, as well
as a review of all submitted data by the U.S. Environmental Protection Agency (EPA or the
Agency). Reregistration involves a thorough review of the scientific database underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of DDC Salts. This determination is based on the required data, the current
guidelines for conducting acceptable studies to generate such data, and published scientific
literature. The Agency has found that currently registered DDC salts products are eligible for
reregistration provided that the risk mitigation and label amendments identified in this RED are
implemented. In an effort to simplify the RED, the information presented herein is summarized
from more detailed information which can be found in the technical supporting documents for
DDC Salts referenced in this RED. The revised risk assessments and related addenda are not
included in this document, but are available in the Public Docket at www.regulations.gov
(Docket ID #EPA-HQ-OPP-2009-0321). This decision amends Reregistration Eligibility
Decisions (REDs) issued for other active ingredients in the case (2180) Ferbam (PC Code
034801) and Ziram (PC Code 034805). REDs for these active ingredients were completed in
2005 and 2003, respectively. These documents are available in the Public Docket at
www.regulations.gov [Docket ID # EPA-HQ-OPP-2004-0337 (Ferbam), and Docket ID # EPA-
HQ-OPP-2005-0459 (Ziram)].
The Food Quality Protection Act (FQPA) requires that the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The DDC Salts belong to the
dithiocarbamate group of fungicides which have neuropathy as a common toxic effect. In
December 2001, EPA concluded, based on the recommendations of the Science Advisory Panel
(SAP), that the neuropathy induced by the dithiocarbamates can not be linked to a common
mechanism of toxicity (Memorandum titled, The Determination of Whether Dithiocarbamate
Pesticides Share a Common Mechanism of Toxicity, From: Marcia Mulkey to Lois Rossi, dated
December 19, 2001). Further, EPA has concluded that the dithiocarbamates should not be
included in the cumulative assessment of the N-methyl carbamates since they do not share
acetylcholinesterase inhibition as their principal mechanism of toxicity. Thus, for the purposes
of this reregistration determination, EPA has assumed that the DDC Salts do not share a common
mechanism of toxicity with other pesticides.
This document consists of six sections. Section I is the Introduction. Section II provides
a chemical overview, a profile of the use and usage of DDC Salts and its regulatory history.
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Section III, Summary of DDC Salts Risk Assessments, provides references for the human health
and environmental assessments, where the details of the risk assessment can be found. Section
IV, Risk Management, Reregi strati on, and Tolerance Reassessment Decision, presents the
reregi strati on eligibility and risk management decisions. Section V, What Registrants Need to
Do, summarizes the necessary label changes based on the risk mitigation measures outlined in
Section IV. Finally, the Appendices list all use patterns eligible for reregi strati on, bibliographic
information, related documents and how to access them, and Data Call-In (DCI) information.
II. Chemical Overview
A. Regulatory History
The first product containing sodium DDC was registered in 1949, and the first product
containing potassium DDC was registered in 1980. For a list of the current products, please see
Appendix A. The DDC Salts case consists of two PC codes: 034803 (potassium
dimethyldithiocarbamate, orKDDC) and 034804 (sodium dimethyldithiocarbamate, orNaDDC).
There are 25 active potassium DDC products and 14 active sodium DDC products. There are no
inert uses and no pending registrations.
DDC Salts act as materials preservatives for fuels, metalworking fluids, paints, coatings,
adhesives, cloth, and paper/paperboard; they act as antifoulants/slimicides in a variety of liquids
including industrial/commercial cooling water, air washer water, sugar mill pulp/process water,
marine heat exchangers, gas/oil recovery fluid, industrial wastewater treatment systems,
industrial water purification systems, reverse osmosis water systems, and pasteurizer cooling
water. Their main uses are as antifoulants in industrial cooling and air washer water systems, as
well as pulp and paper mills and gas/oil drilling muds.
Several uses of DDC Salts are pending cancellation as of the publication of this
document, including all wood-preservative and paints/coatings uses, as well as preservation of
cloth and alginate paste.
B. Chemical Identification
1. Potassium Dimethyldithiocarbamate (KDDC)
Common Name: Potassium Dimethyldithiocarbamate
Chemical Name: Carbamic acid, dimethyldithio-, potassium salt,
hydrate
Other Name(s): Carbamodithioic acid, dimethyl-, potassium salt
Dimethyldithiocarbamic acid, potassium salt
OPP Chemical Code: 034803
CAS Registry No.: 128-03-0
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Case Number: 2180
Empirical Formula: C3H7NS2 K
Molecular Weight: 16033
Percent Active Ingredient
in Technical-Grade Product: 50%
Chemical Structure:
Chemical Properties:
Boiling Point: Not required as PAI is a solid
Melting Point: > 300 C with decomposition
Vapor Pressure: Not required as the MP is > 300 C
Solubility in Water: 132 g/100 ml solvent at 20 C
2. Sodium Dimethyldithiocarbamate (NaDDC)
Common Name: Sodium Dimethyldithiocarbamate
Chemical Name: Carbamic acid, dimethyldithio-, sodium salt
Other Name(s): Carbamodithioic acid, dimethyl-, sodium salt;
Dimethyldithiocarbamic acid, sodium salt
CAS Registry Number: 128-04-1
OPP Chemical Code: 034804
Case Number: 2180
Empirical Formula: CsHyNSl.Na
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Molecular Weight: 144.22
Manufacturers: R.T. Vanderbilt Co., Kemira Chemicals Inc.,
Alco Chemical
Percent Active Ingredient
In Technical Grade
Product: 40%
Chemical Structure:
N
\
CH,
Chemical Properties:
Boiling Point: Not required as PAI is a solid
Melting Point: > 300 C
Vapor Pressure: Not required as MP is > 300 C; estimated vapor pressure is: 3.7 x 10"8 mm Hg
at 25 C.
Solubility in Water: 132 g/100 ml of water at 20 C
C. Use Profile
Information on the currently registered uses of DDC Salts-containing products and an
overview of use sites and application methods follows. The detailed table of uses for DDC Salts
products eligible for reregi strati on is contained in Appendix A.
l.NaDDC
Type of Pesticide: Algaecide, microbicide/microbistat, fungicide
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Use Sites: Materials preservatives for: Adhesives, Paints/Coatings, Fuels/Oils,
Metalworking Cutting Fluids, Paper and Paperboard, Textiles/Cordage Products.
Antifoulant/slimicide for industrial process water systems including: Pasteurizer Cooling
Water Systems, Air Washer Water Systems, Commercial/Industrial Cooling Water,
Pulp/Paper Mill Water Systems, Gas/Oil Drilling Muds/Packer Fluids, Gas/Oil Recovery
Injection Water Systems, Gas/Oil Workover and Completion Fluids, Flue Gas
Desulfurization Thickeners, Sugar Mills.
Antifouling coatings for: Marine Structures/Equipment (Shipboard Heat Exchangers)
Wood preservatives in: Seasoned Wood Pressure/Thermal Treatment, Wood (veneer),
Unseasoned Forest Products Treatment (Sapstain)
Target Pests: Mold/mildew, deterioration/spoilage bacteria, fungi
Formulation Types: liquid or soluble crystals
Methods and Rates of Application:
The methods and rates of application for NaDDC-containing products vary greatly
depending on use site. Please refer to Appendix A of this document for more information.
Basic Manufacturer: Akzo Nobel Surface Chemistry LLC, Kemira Corporation,
R.T. Vanderbilt Co.
2. KDDC
Type of Pesticide: Algaecide, microbicide/microbistat, fungicide
Use Sites: Materials preservatives for: Adhesives, Caulks, Fuels/Oils, Metalworking
Cutting Fluids, Paints/Coatings, and Papermaking.
Antifoulant/slimicide for industrial process water systems including: Reverse Osmosis
Water Systems, Industrial Water Purification Systems, Air Washer Water Systems,
Commercial/Industrial Cooling Water, Pulp/Paper Mill Water Systems, Gas/Oil Drilling
Muds/Packer Fluids, Gas/Oil Recovery Injection Water Systems, Gas/Oil Workover and
Completion Fluids.
Target Pests: Mold/mildew, deterioration/spoilage bacteria, fungi
Formulation Types: liquid or soluble crystals
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Methods and Rates of Application:
The methods and rates of application for KDDC-containing products vary greatly
depending on use site. Please refer to Appendix A of this document for this information.
Basic Manufacturer: Buckman Laboratories Inc.
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III. Summary of DDC Salts Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features and
findings of these risk assessments and to help the reader better understand the conclusions
reached in the assessments. The human health and ecological risk assessment documents and
supporting information listed in Appendix C were used to formulate the safety finding and
regulatory decision for DDC Salts. While the risk assessments and related addenda are not
included in this document, they are available from the Agency's Public Docket at
www.regulations.gov. The docket identification number is EPA-HQ-OPP-2009-0321. Hard
copies of these documents may be found in the OPP public docket which is located in Room S-
4400, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is open Monday
through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
A. Human Health Risk Assessment
1. Toxicity of DDC Salts
The details on the toxicity of DDC Salts can be found in "Hazard Assessment for the
Reregi strati on Eligibility Decision (RED) Document of Sodium Dimethyldithiocarbamate and
Potassium Dimethyldithiocarbamate", dated June 2, 2009. These documents are available on the
Agency's Public Docket website at www.regulations.gov (Docket ID #EPA-HQ-OPP-2009-
0321).
2. Dietary and Drinking Water Risk Summary
For full information on the dietary and drinking water risk assessment, see "Dietary Risk
Assessment for Potassium Dimethyldithiocarbamate for the RED Process," dated July 14, 2009.
3. Occupational and Residential Exposure and Risk Assessment
The occupational and residential exposure assessment considers all potential pesticide
exposure, other than exposure due to residues in food or in drinking water. Both occupational
and residential exposures of concern were found when examining DDC Salts. For full
information on this assessment, see "Sodium and Potassium Dimethyldithiocarbamate:
Occupational and Residential Exposure Assessment for the Registration Eligibility Decision
(RED)," dated May 14, 2009.
4. Human Incident Data
The Agency consulted the Office of Pesticide Programs' Incident Data System (IDS), the
Poison Control Center database, the California Department of Pesticide Regulation, and the
National Pesticide Telecommunications Network (NPTN) for incident reports associated with
SDDC and/or KDDC.
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There were a total of eight reported incidents associated with exposure to end-use
products containing SDDC and/or KDDC. Most of the incidents are related to irritation and/or
an allergic-type reaction. The most common symptoms reported for cases of dermal exposure
were skin irritation/burning, rash, itching, skin discoloration/redness and blistering. The most
common symptoms reported for cases of inhalation exposure were respiratory irritation/burning,
irritation to mouth/throat/nose, coughing/choking, shortness of breath, dizziness, chemical burn
symptoms, and headache.
For full information on incident reports, see "Incident Report for the Reregi strati on
Eligibility Decision (RED) Document of Sodium Dimethyldithiocarbamate and Potassium
Dimethyldithiocarbamate", dated February 5, 2009.
B. Environmental Risk Assessment
The environmental risk characterization is intended to describe the magnitude of the
estimated environmental risks for DDC Salts use sites and any associated uncertainties.
Aquatic exposures of concern were found when examining DDC Salts. For detailed
discussions of all aspects of the environmental risk assessment, see the Environmental
Hazards and Ecological Risk Assessment for the Sodium and Potassium
Dimethyldithiocarbamate RED, dated May 14, 2008.
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not 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 DDC Salts as an active ingredient. 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 supported products containing DDC Salts.
The Agency has completed its assessment of the residential, occupational, and ecological
risks associated with the use of pesticide products containing the active ingredient DDC Salts.
The Agency has determined that all DDC Salts-containing products are eligible for reregi strati on
provided that: 1) all risk mitigation measures are implemented; 2) current data gaps and
confirmatory data needs are addressed; and 3) label amendments are made as described in
Section V. Appendix A summarizes the uses of DDC Salts that are eligible for reregi strati on.
Appendix B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregi strati on eligibility of DDC Salts and lists the submitted studies that the
Agency found acceptable. Data gaps are identified as generic data requirements that have not
been satisfied with acceptable data.
Based on its evaluation of DDC Salts, the Agency has determined that DDC Salts
products, unless labeled and used as specified in this document, would present risks inconsistent
with FIFRA. Accordingly, should a registrant fail to implement the risk mitigation measures,
submit confirmatory data, and make the label changes identified in this document, the Agency
may take regulatory action to address the risk concerns from the use of DDC Salts. If all
changes outlined in this document are fully complied with, then no risks of concern exist for the
registered uses of DDC Salts and the purposes of this determination. Once an endangered
species assessment is completed, further changes to these registrations may be necessary as
explained in Section III of this document.
B. Draft Risk Assessment Comments and Responses
Through the Agency's public participation process, EPA worked with stakeholders to
reach the regulatory decision for DDC Salts. EPA released its preliminary risk assessment for
DDC Salts for registrant comment on March 25, 2009. The Agency received several comments
from the registrants in two letters during the 30-day public comment period, which closed on
April 27, 2009. The comments were mostly editorial in nature; additionally, they addressed two
issues regarding the risk assessment's mention of ethylenethiourea (ETU). The registrants
claimed that ETU is not a breakdown product of DDC Salts. Finally, the comments corrected an
assumption made during the calculation of risk for air washer/industrial cooling water uses, and
noted that because the technical grade active ingredient (TGAI) and manufacturing-use product
(MUP) are the same in the case of DDC Salts they should not need to resubmit acute toxicity
data for DDC Salts.
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C. Regulatory Rationale
The Agency has determined that DDC Salts are eligible for reregi strati on provided that
risk mitigation measures are implemented as outlined in this document, additional required data
confirm this decision and label changes are made accordingly. Where labeling revisions are
warranted, specific language is set forth in the summary tables of Section V of this document.
1. Human Health Risk Management
a. Dietary (food) and Drinking Water Risk Mitigation
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which
reflects the reference dose (RfD), either acute or chronic. This calculation is performed for each
population subgroup. A risk estimate that is less than 100% of the acute or chronic PAD is not
of concern. The Agency has conducted an indirect food contact dietary exposure and risk
assessment for the use of DDC Salts as a materials preservative in adhesives, and paper coatings
for repeat use food contact surfaces.
Based on the use patterns of DDC Salts, specifically in paper/paperboard and sugar mills,
it is expected that there is potential for indirect food contact; therefore, a dietary risk assessment
was performed. However, no dietary risk was found.
Additionally, possible impact on drinking water was considered. DDC Salts were found
to be unstable in aerobic water conditions and unlikely to contaminate soil or bioaccumulate in
organisms. It is expected that DDC Salts will not impact any source of drinking water; therefore,
a drinking water assessment was not conducted. For more information, see "Drinking Water
Assessment for DDTC (Potassium/Sodium Dimethyl Dithiocarbamates)", dated July 8, 2009.
It should be noted that studies were analyzed for the presence of possible degradates such
as ethylenethiourea (ETU). No evidence was found of ETU forming solely in the presence of
KDDC and SDDC. Additional information can be found in "Dietary Risk Assessment for
Potassium Dimethyldithiocarbamate for the RED Process," dated December 12, 2008.
b. Residential Risk Mitigation
Based on registered use patterns from product labels, it has been determined that
exposure to residential handlers or applicators can occur in a variety of residential environments.
Additionally, post-application exposures are likely to occur in these settings. The representative
scenarios selected by the Agency for assessment were evaluated using maximum application
rates as stated on the product labels. The residential exposure assessment considers all potential
pesticide exposure, other than exposure due to residues in food and drinking water. Exposure
may occur during application for several use patterns including painting/applying via brush/roller
and airless sprayer. Post-application exposure may occur from dermal and incidental oral
contact with treated lumber (playground equipment or decking) or through incidental oral contact
mouthing of treated fabric. Each route of exposure (oral, dermal, inhalation) is assessed, where
appropriate, and risk is expressed as a Margin of Exposure (MOE), which is the ratio of
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estimated exposure to an appropriate No Observed Effect Level (NOAEL) dose. Additional
information can be found in the "Sodium and Potassium Dimethyldithiocarbamate: Revised
Occupational and Residential Exposure Assessment for the Registration Eligibility Decision
(RED)," dated May 14, 2009.
i. Residential Handler Risk Mitigation
Residential handler risks were calculated for the short-term duration (1-30 days) because
it best represents most homeowner applications. All residential handler risks were not of
concern except for the short-term dermal MOE estimated for painters using an airless sprayer at
the maximum application rate; MOE = 350. The target MOE for identifying dermal risks of
concern is 1000 (lOx for interspecies extrapolation; lOx for intra-species variation; and lOx for
database uncertainty).
The technical registrant has requested voluntary cancellation of the use of DDC Salts as a
paint preservative; the manufacturing label must be amended to remove this use when the
cancellation is finalized. This cancellation will eliminate all currently-identified residential
handler risks of concern stemming from the use of DDC Salts.
ii. Residential Post-Application Risk Mitigation
Residential post-application risks were calculated for the short-term and intermediate-
term duration (1-30 days) for exposure to the treated cloth use because treated clothing can be
worn on a daily basis. Both dermal exposures from wearing treated clothing and incidental oral
exposures from mouthing treated clothing are anticipated. The dermal MOEs of <1 and 11 are
below the target MOE of 1000. The incidental oral MOE is 2 which is below the target MOE.
In addition, there is a potential for child exposure to DDC residues when playing on
DDC-treated wood structures such as decks and children's playsets. Both dermal and incidental
oral exposures are anticipated. The dermal MOE of 440 and the incidental oral MOE of 360 are
less the target MOE.
The technical registrants have requested voluntary cancellation of all uses of DDC Salts
as a wood and cloth preservative; the manufacturing labels must be amended to remove these
uses when the cancellation is finalized. These cancellations will eliminate all currently-
identified residential post-application risks of concern stemming from the use of DDC Salts.
iii. Aggregate Risk
Based on the use patterns for the DDC Salts, no drinking water assessment was
conducted. In addition, the registrants have requested voluntary cancellation of residential
scenarios where there were risk concerns (e.g., residential painter, preservation of clothing, and
preservation of wood). Therefore, the mitigation measures outlined above for residential risks
will eliminate potential aggregate scenarios with risks of concern.
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c. Occupational Risk Mitigation
Workers can be exposed to a pesticide through mixing, loading, applying a pesticide, or
re-entering treated sites. The DDC Salts are used as a materials and wood preservative.
Potential occupational handler exposure can occur in various use sites during the preservation of
materials that are used for household, institutional, and industrial uses; and the preservation of
wood. As discussed above, each route of exposure (oral, dermal, inhalation) is assessed, where
appropriate, and risk is expressed as a MOE, which is the ratio of estimated exposure to an
appropriate No Observed Effect Level (NOAEL) dose.
The "preservation of materials" refers to the scenario of a worker adding the preservative
to the material being treated (paint, textiles, etc.) through either liquid pour or liquid pump
methods. For the preservation of wood at treatment plants and lumber mills, the methods for
treatment can vary (pressure/non-pressure), such that multiple worker functions were analyzed.
The representative uses assessed include the following materials preservative and wood
preservative incorporation and application methods: mixing and loading of product concentrates
for materials preservative incorporation into paint, paper (production), adhesives; application of
treated paint (paint brush, roller, and airless sprayer); use of metalworking fluids; and application
of protective wood coatings (sapstain control).
i. Occupational Handler Mitigation
Industrial Cooling Water, Oil Production, Pulp and Paper Production, and Pasteurizer
Cooling Water (wettable powder formulations)
There is potential for dermal and inhalation exposure when occupational handlers add
DDC Salts to Industrial Cooling Water, Oil Production, Pulp and Paper Production, and
Pasteurizer Cooling Water systems. The target MOE is 1000 for both dermal and inhalation
exposures. The dermal MOEs ranged from 1 - 6000 for these applications. For inhalation
exposures, the MOEs ranged from 0 - 2000. To mitigate the risks of concern from the use of
wettable powder products, water soluble packaging must be used.
Metalworking Fluids
There is a potential for dermal and inhalation exposure when a machinists use
metalworking fluids treated with DDC Salts. This route of exposure occurs after the chemical
has been incorporated into the metalworking fluid as a preservative and a machinist uses the
fluid during normal machining operations. The dermal exposure was estimated using the film
thickness approach and the resulting dermal MOE is 1200, where the target MOE is 1000. The
inhalation exposure was estimated using the OSHA PEL approach and the resulting MOE is
2800, where the target MOE is 1000.
While there are no risks of concern pertaining to the metalworking fluids use, the Agency
needs confirmatory cancer studies to support metalworking fluids uses where workers may be
chronically exposed.
12
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Pressure-Treated Wood and Sapstain
SDDC may be used to pressure treat wood used for decks, buildings, fences, poles, etc.,
in accordance with two labels (1022-577 and 31910-21). These exposures were assessed using
data from a chromated copper arsenate (CCA) exposure study (MRID 455021-01) that was
sponsored by Arsenical Wood Preservative Task Force of the American Chemistry Council. The
resulting inhalation MOEs range from 400 to 7600 and are of concern for two scenarios because
they are less than the target MOE of 1000. The dermal MOEs range from 19 to 2200 and are of
concern for most of the scenarios because they are less than the target MOE of 1000.
DDC Salts-specific exposure data are not available for assessment of sapstain treatment
occupational exposures. Therefore, this assessment relies on surrogate data from a sapstain
treatment worker exposure study (MRID 455243-04) where DDAC was used. The measured
DDAC exposure values were normalized by the treatment solution concentration used at each of
the 11 facilities in the sapstain treatment exposure study. The resulting inhalation MOEs range
from 100 to 5300; the MOE of 100 for the clean-up crew is of concern because it is less than the
target MOE of 1000. The dermal MOEs range from 47 to 5300 and are of concern for all of the
scenarios except dry wood operations. The lowest dermal MOE of 47 is also for the clean-up
crew. The Sapstain Industry Group (SIG) has recently completed additional worker exposure
monitoring and the study report (MRID 476183-10) has just been submitted to the EPA. This
study has not yet been reviewed. After the review is completed, and if it is considered
appropriate, it may be used to refine the worker risks.
As stated above, the technical registrants have requested voluntary cancellation of all
uses of DDC Salts as a wood preservative including sapstain control; the manufacturing labels
must be amended to remove these uses when the cancellation is finalized.
ii. Occupational Post-Application Risk Mitigation
No occupational post-application exposures are assumed to occur for DDC Salts; all post-
application exposures from the DDC Salts are expected to occur in a residential setting. These
exposure scenarios were discussed above.
2. Environmental Risk Management
Sodium and potassium dimethyldithiocarbamate salts are registered primarily as material
preservatives and for control of bacteria, fungi, and algae in industrial processes and water
systems. Material-preservative uses include adhesives, caulks, fuels, metalworking fluids,
paints, paper, and textiles. The primary uses in industrial processes and water systems are in air
washer systems, water purification systems, cooling waters, drilling fluids, and in recovery
injection water systems. Sodium dimethyldithiocarbamate also is used as an antifouling coating
in shipboard seawater heat exchangers (closed system) and as a wood preservative (pressure and
antisapstain treatment) for wood used for decking, buildings, fences, poles, plywood, and other
wooden items.
13
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Environmental exposure levels from wood preservative applications may be of concern
for organisms exposed to leachate or runoff. Therefore, an ecological risk assessment is
conducted for the wood preservative uses. For additional information on the ecological risks
associated with the DDC Salts use, please see the assessment titled "Environmental Hazards and
Ecological Risk Assessment for the Sodium and Potassium Dimethyldithiocarbamate RED,"
dated January 14, 2008.
Aquatic
Sodium dimethyldithiocarbamate has a potential to reach the aquatic environment due to
movement of leachate from treated wood. Therefore, EECs are modeled for treated wood used
for docks; for antisapstain treatment; and for wood treated by pressurized spray used for houses,
fences, decks, and transmission poles.
Listed (i.e., endangered and threatened) and nonlisted freshwater invertebrates are at
acute risk from exposure to sodium dimethyldithiocarbamate leached from wood in docks.
Listed and nonlisted freshwater fish are at acute risk at low water volume (1 acre foot), and listed
fish also are at risk at 6 to 12 acre feet of water. For antisapstain application, both listed and
nonlisted freshwater invertebrates are at risk for the three dilution rates modeled, with the RQ
being highest at the lowest dilution rate.
Listed and nonlisted saltwater invertebrates are at acute risk from exposure to sodium
dimethyldithiocarbamate leached from wood in docks in saltwater environments (Table 14).
Listed saltwater fish are at acute risk only at a low volume of receiving water (1 acre foot). For
antisapstain application, both listed and nonlisted saltwater invertebrates are at risk for the three
dilution rates modeled (Table 15). Because the LOG is not exceeded, acute risk to fish is
presumed to be minimal. However, the registrants have requested voluntary cancellation of the
DDC Salts pressure treatment and sapstain treatment for wood. This will mitigate all ecological
concerns for the DDC Salts.
Terrestrial
Because sodium dimethyldithiocarbamate is only slightly to practically nontoxic to birds
and is practically nontoxic to mammals, minimal acute risk is presumed from its use as a wood
preservative. Toxicity data are not available to assess risk to honey bees. However, if use of
treated wood is prohibited in bee hives (see Section V, Label Changes Summary Table), minimal
exposure and risk are presumed. As mentioned previously, the registrants have requested
voluntary cancellation of the DDC Salts pressure treatment and sapstain treatment for wood.
This will mitigate all ecological concerns for the DDC Salts.
3. Other Labeling Requirements
In order to be eligible for reregi strati on, various use and safety information will be
included in the labeling of all manufacturing use products containing DDC Salts. For the
specific labeling statements and a list of outstanding data, refer to Section V of this document.
14
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4. Listed Species Considerations
a. The Endangered Species Act
Section 7 of the Endangered Species Act (ESA), 16 U.S.C. Section 1536(a)(2), requires
all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine
and anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. § 402.02.
To comply with subsection (a)(2) of the ESA, EPA's Office of Pesticide Programs has
established procedures to evaluate whether a proposed registration action may directly or
indirectly appreciably reduce the likelihood of both the survival and recovery of a listed species
in the wild by reducing the reproduction, numbers, or distribution of any listed species (U.S.
EPA 2004). If any of the Listed Species LOG Criteria are exceeded for either direct or indirect
effects in the Agency's screening-level risk assessment, the Agency identifies any listed or
candidate species that may occur spatially and temporally in the footprint of the proposed use.
Further biological assessment is undertaken to refine the risk. The extent to which any species
may be at risk determines the need to develop a more comprehensive consultation package as
required by the ESA.
For certain use categories, including all current DDC Salt uses other than wood
preservative uses, the Agency assumes there will be minimal environmental exposure, and only a
minimal toxicity data set is required (Overview of the Ecological Risk Assessment Process in the
Office of Pesticide Programs U.S. Environmental Protection Agency - Endangered and
Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB, p 81). Uses in
these categories do not undergo a full screening-level risk assessment and are considered to fall
under a no effect determination.
The assessment for wood preservative uses indicates that there is a potential for sodium
dimethyldithiocarbamate exposure of listed freshwater and saltwater aquatic species and that a
more refined assessment is warranted, to include direct, indirect and habitat effects. However, as
discussed previously, the registrants for the DDC Salts have requested voluntary cancellation of
its use as a wood preservative and for sapstain control; therefore, no additional risk assessment or
risk mitigation measures are needed.
b. General Risk Mitigation
DDC Salts end-use products (EPs) may also contain other registered pesticides.
Although the Agency is not proposing any mitigation measures for products containing DDC
Salts specific to federally listed species, the Agency needs to address potential risks from other
15
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end-use products. Therefore, the Agency requires that users adopt all listed species risk
mitigation measures for all active ingredients in the product. If a product contains multiple
active ingredients with conflicting listed species risk mitigation measures, the more stringent
measure(s) should be adopted.
16
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V. What Registrants Need to Do
The Agency has determined that DDC Salts are eligible for reregi strati on provided that:
(i) additional data that the Agency intends to require confirm this decision; (ii) label amendments
are made; and (iii) risk mitigation measures identified in this document are adopted (Section IV).
To implement this decision, the registrant must amend their product labeling to incorporate the
label statement set forth in the Label Changes Summary Table in Section B below (Table 1).
The additional data requirements that the Agency intends to obtain will include, among other
things, submission of the following:
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of DDC Salts has been reviewed and
determined to be substantially complete. However, the following additional data requirements
have been identified by the Agency as confirmatory data requirements. A generic data call-in
(DCI) will be issued at a later date.
While there are no risks of concern pertaining to the metalworking fluids use of DDC
Salts, the Agency needs a confirmatory cancer studies for all metalworking fluids uses where
workers may be chronically exposed. This will include a two-generation reproduction study and
a combined chronic toxicity/carcinogenicity study.
Previously-submitted SDDC studies on reproduction and fertility effects (870.3800)
(MRID 42905, 82096), chronic toxicity in rats (870.4100) (MRID 82096), and chronic toxicity
in dogs (870.4100) (MRID 82905) were considered inadequate for this risk assessment because
they were conducted with the chemical Vancide 51, an end use product. Vancide 51 is made up
two active ingredients, which is not considered appropriate for testing the effects of one active
ingredient.
The study used to derive the inhalation endpoint had a very wide dose range of 0, 0.2, 2
and 100 mg/kg/day which resulted in the 50-fold difference between the LOAEL of 100
mg/kg/day and the NOAEL of 2 mg/kg/day. The target MOE is 1000 instead of 100 because it
includes an additional factor often to account for database uncertainty. If this factor could be
eliminated by the submission of additional data then the number of scenarios that would be
considered to be of concern would be greatly reduced. For occupational and residential
exposures, the Agency needs additional exposure data, including dermal and inhalation indoor
exposure, product use information, and applicator exposure monitoring data reporting, in order to
fill this information gap.
For DDC Salts technical grade active ingredient products, the registrant needs to submit
the following items:
17
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Table 1. Confirmatory Data Needs for Reregistration of DDC Salts
Guideline Study Name
Reproduction and Fertility Effects
Combined Chronic Toxicity/Carcinogenicity
Dermal Indoor Exposure
Inhalation Indoor Exposure
Applicator Exposure Monitoring Data
Reporting
Product Use Information
New OPPTS Guideline No.
870.3800
870.4300
875.1200
875.1400
875.1600
875.1700
2. Labeling for Technical and Manufacturing Use Products
To ensure compliance with FIFRA, technical and manufacturing-use product (MP)
labeling should be revised to comply with all current EPA regulations, PR Notices and
applicable policies. The Technical and MP labeling should bear the labeling contained in the
Label Changes Summary Table below.
Within 90 days from receipt of the generic data call-in (DCI):
1. completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. cite any existing generic data which address data requirements or submit new generic
data responding to the DCI.
Please contact Eliza Blair at (703) 308-7279 with questions regarding generic reregi strati on.
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Eliza Blair Eliza Blair
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
18
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For end-use products containing the active ingredient DDC Salts, the registrant needs to submit
the following items for each product:
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. completed response forms to the PDCI (i.e., PDCI response form and requirements
status and registrant's response form); and
2. submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
1. two copies of the confidential statement of formula (EPA Form 8570-4);
2. a completed original application for reregi strati on (EPA Form 8570-1). Indicate on
the form that it is an "application for reregi strati on";
3. five copies of the draft label incorporating all label amendments outlined in Table 13
of this document;
4. a completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
5. if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. the product-specific data responding to the PDCI.
Please contact Eliza Blair at (703) 308-7279 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail:
Document Processing Desk
Eliza Blair
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
By express or courier service:
Document Processing Desk
Eliza Blair
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard
2777 South Crystal Drive
Arlington, VA 22202
19
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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 registrant
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 the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product. A product-specific data call-in, outlining data requirements, will be sent to registrants
at a later date.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above.
Specific language to incorporate these changes is specified in the Label Changes Summary
Table.
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 document.
Persons other than the registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the mitigation described in 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.
20
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a. Label Changes Summary Table
In order to be eligible for reregi strati on, all product labels must be amended to
incorporate the risk mitigation measures outlined in Section IV of the DDC Salts RED. The
following table describes how language on the labels should be amended.
Table 2. Label Changes Summary Table
Description
Amended Labeling Language
Placement on Label
Environmental
Hazards
Statements
Required by the
RED and
Agency Label
Policies
"This pesticide is toxic to fish and aquatic
invertebrates. Do not contaminate water when
disposing of equipment washwaters. Do not
discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or other
waters unless in accordance with the requirements
of a National Pollutant Discharge Elimination
System (NPDES) permit and the permitting
authorities are 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."
Precautionary
Statements
PPE
Requirements
for All Wettable
Powder End-Use
Products
Intended for
Occupational
Use
Engineering Controls: This product is not to be
used in open pour applications. Water soluble
packaging must be used for all wettable powder
products.
21
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VI. APPENDICES
22
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Appendix A. Table of Representative Use Patterns for DDC Salts
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Material Preservatives
Adhesives
Caulks
Fuels/Oils
Metalworking Cutting
Fluids
Paper and Paperboard
Ready-to-use
1022-563
1965-8
Ready-to-use
1022-563
Ready-to-use
1022-563
31910-2
Manufacturing
Use:
1448-381
Ready-to-use
1022-563
Ready-to-use
1965-8
Ready-to-use
1965-8
Closed systems
for liquid
applications.
Closed systems
for liquid
applications.
Open pour
n/a
Open pour
Open pour
Closed systems
for liquid
applications.
Water soluble
packaging for
Add product for
concentrations of 0.02-0.2%
based on total wet weight of
product
Add product for
concentrations of 0.03-0.2%
based on total wet weight of
product
Add product at rate of 6oz.-
2.3 pints per 1000 gal. oil
n/a
Add product for
concentrations of 0.03-0.2%
based on total wet weight of
product
Add 4.175-8.35 Ibs. of
product per 1000 gallons of
fluid
Add 1.65-3. 3% product based
on weight of sheet
None
None
None
n/a
None
None
None
23
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Use Site
Papermaking
Dispersion/Emulsions/
Solutions/Suspensions
Formulation
Ready-to-use
1022-563
Ready-to-use
1022-563
Method of
Application
wettable
powder
formulations
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
Application Rate/ No. of
applications
Add product to material for
concentrations of 50-400 ppm
w/w
Add product for
concentrations of 0.03-0.2%
based on total wet weight of
product
Use Limitations
None
None
Industrial Processes and Water Systems
Pasteurizer Cooling Water
Systems
Air Washer Water
Ready-to-use
31910-20
Ready-to-use
Water soluble
packaging for
wettable
powder
formulations
Water soluble
Initial dose: Apply 4.8 oz.-l
Ib. of product per 1000
gallons of water
Subsequent dose: 0.8-1. 6 oz.
of product per 1000 gallons of
water every 3 days
Initial treatment: Add 3.5-
None
None
24
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Use Site
Systems
Formulation
527-108
1022-563
1448-70
1448-185
1448-198
1448-202
1448-277
1448-282
1448-283
1448-338
1448-339
1448-389
1448-390
1448-391
1448-392
3862-15
9386-11
10707-25
10707-26
31910-2
31910-11
31910-12
31910-20
44392-5
46622-1
68329-2
68329-3
Manufacturing
Use:
1448-381
9386-39
Method of
Application
packaging for
wettable
powder
formulations
n/a
Application Rate/ No. of
applications
128 liquid oz. of product per
1000 gallons of water.
Maintenance dose: Add 3.5-
72.5 liquid oz. of product per
1000 gallons of water.
n/a
Use Limitations
None
n/a
25
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Use Site
Reverse Osmosis Water
Systems
Industrial Water
Purification Systems
(including Filters,
Clarifiers, and Ion
exchange Equipment)
Commercial/Industrial
Cooling Water
Formulation
Ready-to-use
1448-70
1448-198
1448-277
1448-282
1448-337
1448-338
1448-339
31910-5
44392-5
Ready-to-use
1448-70
1448-198
1448-277
1448-282
1448-337
1448-338
1448-339
31910-5
44392-5
Manufacturing
Use:
1448-381
Ready-to-use
527-108
1022-563
1022-574
1448-70
1448-185
1448-198
Method of
Application
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
n/a
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
Application Rate/ No. of
applications
Off-line: feed product at
concentration of 5-50 fl.
oz./lOOO gallons of water for
4-8 hrs.
On-line: dose product at rate
of 1-10 fl. oz./lOOO gallons of
water for 6-12 hrs.
Off-line: feed product at
concentration of 5-50 fl.
oz./lOOO gallons of water for
4-8 hrs.
On-line: dose product at rate
of 1-10 fl. oz./lOOO gallons of
water for 6-12 hrs.
n/a
Initial treatment: Add 1-128
liquid oz. of product per 1000
gallons of water.
Maintenance dose: Add 1.0-
17.9 liquid oz. of product per
1000 gallons
Use Limitations
Not for use in potable water systems
Not for use in potable water systems
n/a
None
26
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Use Site
Formulation
1448-202
1448-277
1448-282
1448-283
1448-338
1448-339
1448-389
1448-390
1448-391
1448-392
3862-156
9386-11
9386-23
9386-37
10707-25
10707-26
31910-2
31910-5
31910-6
31910-11
31910-12
31910-20
44392-5
46622-1
68329-2
68329-3
Manufacturing
Use:
1448-381
9386-39
Method of
Application
powder
formulations
n/a
Application Rate/ No. of
applications
n/a
Use Limitations
n/a
27
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Use Site
Industrial Wastewater
Treatment Systems
Pulp/Paper Mill Water
Systems
Formulation
Ready-to-use
1448-70
31910-5
Manufacturing
Use:
1448-381
Ready-to-use
1022-563
1022-574
1448-70
9386-11
9386-37
31910-2
31910-5
31910-6
31910-11
31910-12
31910-20
Ready-to-use
9386-7
31910-5
31910-6
Method of
Application
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
n/a
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
Drip feed
Closed systems
for liquid
applications.
Water soluble
Application Rate/ No. of
applications
Product dosed to system at
rate of 0.5-3 fl. oz./lOOO
gallons of water
Continuous feed: add at rate
of 0.1-1 fl. oz./lOOO gallons of
water
n/a
Add 0.04-6.67 Ibs. of product
per ton of pulp/paper
Intermittent feed: Add 18-30
fl. oz. of product per ton of
paper for 2 hours every eight
hours
Continuous feed: Add 6-20
Use Limitations
None
n/a
None
28
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
packaging for
wettable
powder
formulations
fl. oz. of product per ton of
paper on continuous basis
Manufacturing
Use:
1448-381
9386-39
n/a
n/a
n/a
Gas/Oil Drilling
Muds/Packer Fluids
Ready-to-use
1022-563
1022-574
1448-70
1448-85
1448-198
1448-202
1448-337
1448-339
9386-23
31910-2
31910-5
31910-6
31910-11
31910-12
46622-1
68329-2
68329-3
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
Add product at rate of 0.6-25
gallons/100 barrels of fluid
None
29
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Use Site
Gas/Oil Recovery
Injection Water Systems
Formulation
Ready-to-use
9386-7
31910-20
Manufacturing
Use:
1448-381
9386-39
Ready-to-use
1022-563
1448-70
1448-85
1448-185
1448-198
1448-202
1448-337
1448-339
1448-381
9386-7
10707-25
10707-26
46622-1
68329-2
68329-3
Manufacturing
Use:
Method of
Application
Closed systems
for liquid
applications.
n/a
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
Application Rate/ No. of
applications
Add product at rate of 0.56-15
Ibs/barrel
n/a
Add 0.83-12 fl. oz. of product
per 1000 gallons of water
Use Limitations
n/a
None
30
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Use Site
Gas/Oil Fracturing Fluid
Systems
Gas/Oil Workover and
Completion Fluids
Formulation
1448-381
9386-39
Ready-to-use
1022-574
Ready-to-use
31910-2
31910-5
31910-11
31910-12
31910-20
Ready-to-use
31910-2
31910-20
Ready-to-use
31910-2
Method of
Application
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
Closed systems
for liquid
Application Rate/ No. of
applications
Add product at ratio of 6.72-
17 pints per 1000 gallons of
water
Add at rate of 0.3 oz.-6.7
gallons per 100 bbl. of water
Add product at rate of 0.3-4.3
Ibs. per 1000 gallons
Add product at rate of 1-4
quarts per 1000 gallons of
Use Limitations
None
None
None
None
31
-------
Use Site
Flue Gas Desulfurization
Thickeners
Formulation
Ready-to-use
31910-20
Ready-to-use
46622-1
68329-2
68329-3
Manufacturing
Use:
1448-381
9386-39
Ready-to-use
31910-2
Method of
Application
applications.
Water soluble
packaging for
wettable
powder
formulations
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations
n/a
Closed systems
for liquid
Application Rate/ No. of
applications
fluid
Add product at rate of 0.9-3.6
Ibs./l 000 gallons of fluid
Add product at rate of 1 . 1-21
gallons per 100 barrels of
fluid
n/a
Feed at rate of 50-500 ppm of
product at least lonce per
Use Limitations
None
None
n/a
None
32
-------
Use Site
Sugar Mills
(Cane and Beet)
Formulation
Ready-to-use
9386-11
9386-23
9386-37
31910-2
31910-6
31910-11
31910-12
Manufacturing
Use:
9386-39
Method of
Application
applications.
Water soluble
packaging for
wettable
powder
formulations
Closed systems
for liquid
applications.
Water soluble
packaging for
wettable
powder
formulations.
n/a
Application Rate/ No. of
applications
week or as required
Add at rate of 0.155-1.24 oz.
per minute per 1000 tons of
cane ground or 1000 beets
sliced per day
n/a
Use Limitations
None
n/a
Antifouling Coatings
Marine
Structures/Equipment
(Heat Exchangers)
Ready-to-use
31910-2
Add
Feed at rate of 3.88 Ibs. per
100 tons/hr. of system flow
rate
None
33
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision
Guide to Appendix B
Appendix B contains listing of data requirements which support the reregi strati on for active ingredients within case #2180
(DDC Salts) covered by this RED. It contains generic data requirements that apply to DDC Salts in all products, including data
requirements for which a "typical formulation" is the test substance.
The data table is organized in the following formats:
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 Guidance, which are
available from the National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 4). This column indicates the use patterns for which the data requirements apply. The following
number designations are used for the given use patterns.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishment premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
(12) Aquatic areas
2. Bibliographic Citation (Column 5). If the Agency has acceptable data in its files, this column list the identify 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.
34
-------
DATA REQUIREMENT
New
Guideline
Number
Old
Guideline
Number
Study Title
Use
Pattern
CITATION(S)
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7200
830.7220
61-1
61-2a
61-2b
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
41612201
41612201
41612201
42922801
43554002
41612202
41612202
43554002
43554002
42242301
41612203
41612203
42242301
42916701
41612203
Not required
Not required
35
-------
DATA REQUIREMENT
New
Guideline
Number
830.7300
830.7840
830.7860
830.7370
830.7550
830.7560
830.7570
830.7000
830.6313
830.6317
Old
Guideline
Number
63-7
63-8
63-10
63-11
63-12
63-13
63-17
Study Title
Density
Solubility
Dissociation Constant in Water
Partition Coefficient (Octanol/Water)
PH
Stability
Storage Stability
Use
Pattern
CITATION(S)
MRID Number
42242301
41612203
41612203
42922801
42242301
Waived
Waived
41612203
42916701
41612203
42664601
42270401
ECOLOGICAL EFFECTS
850.2100
850.1075
71-1
72-1
Avian Acute Oral Toxicity Test
Acute Freshwater Fish (bluegill)
42561801
159786
159787
42561802
159785
36
-------
DATA REQUIREMENT
New
Guideline
Number
850.1075
850.1010
850.1300
850.1400
850.3030
850.4400
850.5400
850.4225
850.4250
Old
Guideline
Number
72-1
72-2
Study Title
Acute Freshwater Fish (rainbow trout)
Acute Freshwater Invertebrate (daphnia magna)
Freshwater Invertebrate Life Cycle
freshwater fish early life-stage
Honey /beeswax residues and toxicity of treated wood
residues to bees data if bee hives might be
constructed of treated wood or if any product is
intended for application to a bee hive. The study is a
combination of Guidelines 171-4 and 850.3030
aquatic plant growth, vascular plant
aquatic plant growth, algal
seedling emergence, rice
vegetative vigor, rice
Use
Pattern
CITATION(S)
MRID Number
42247901
159785
159784
42504802
159780
Needed
Needed
Needed
Needed
Needed
Needed
Needed
TOXICOLOGY
870.1100
870.1200
870.1300
81-1
81-2
81-3
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
132382
146768
146768
37
-------
DATA REQUIREMENT
New
Guideline
Number
Old
Guideline
Number
Study Title
Use
Pattern
CITATION(S)
MRID Number
870.2400
81-4
Primary Eye Irritation - Rabbit
105157
870.2500
870.2600
870.3100
870.3200
870.3250
870.3465
870.3700a
870.3700
870.3800
870.4100
870.4200
870.4300
870.5100
870.5300
870.5265
81-5
81-6
82-la
82-2
82-3
82-4
83-3a
83-3b
83-4
83-la
83-2a
83 -2b
83-5
84-2
84-2a
Primary Dermal Irritation - Rabbit
Dermal Sensitization
90-Day Feeding-Rodent
21/28-Day Dermal Toxicity - Rat
90-day Dermal Toxicity - Rodent
90-Day Inhalation - Rat
Developmental Toxicity - rodent
Teratogenicity - Rabbit
Reproduction and Fertility Effects - 2 Generation
Repro
Chronic Feeding Toxicity - Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Combined Chronic Toxicity/Carcinogenicity
Bacterial reverse mutation test
In Vitro mammalian cell gene mutation test
Gene Mutation - ames
105157
132380
40140101
40140101
40830801
Needed
40995101
40995101
Needed
Not required
Not required
Not required
Needed
40899001
40631103
38
-------
DATA REQUIREMENT
New
Guideline
Number
870.5385
870.5395
870.5450
870.5900
870.7485
870.7600
Old
Guideline
Number
84-2b
84-2
84-2
85-1
85-2
Study Title
Structural Chromosome Aberration
In Vivo mammalian micronucleus test /Mammalian
erythrocyte micronucleus test
Rodent dominant lethal assay
Mammalian cytogenetics (sister chromatid
exchange)- hamster
General Metabolism
Dermal Absorption
Use
Pattern
CITATION(S)
MRID Number
40899001
40631102
Not required
Not required
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2300
875.1100
875.1200
875.1300
875.1400
875.1600
133-3
233
234
Indoor Surface Residue Dissipation (Dermal Residue
Transfer Studies for Textiles/Clothing,
Mattress/Mattress Ticking and Carpet
Shampoo/Cleaner)
Dermal Outdoor Exposure
Dermal Indoor Exposure
Inhalation Outdoor Exposure
Inhalation Indoor Exposure
Applicator Exposure Monitoring Data Reporting
Needed
Needed
Needed
Needed
Needed
Needed
39
-------
DATA REQUIREMENT
New
Guideline
Number
875.1700
875.2700
875.2800
875.2900
Old
Guideline
Number
133-1
134
Study Title
Product Use Information
Description of Human Activity
Data Reporting and Calculations
Use
Pattern
CITATION(S)
MRID Number
Needed
Needed
Needed
ENVIRONMENTAL FATE
835.2410
835.4100
835.6100
Special
Photodegradation in Soil
Aerobic Soil Metabolism
Terrestrial Field Dissipation
Leaching from Treated Wood
Needed
Needed
Needed
Needed
40
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room S-4400, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is
open Monday through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
The preliminary risk assessment was initially sent to registrants for comment. EPA then
considered comments on the risk assessment and revised the risk assessment and supporting
chapters as necessary. The revised risk assessment will be posted in the docket at the same time
as the RED.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following site:
http://www.regulations.gov
These documents include:
Preliminary Risk Assessment and Supporting Science Documents (RED Supporting
Documents):
• Preliminary Human Health Risk Assessment and Ecological Effects Assessment for the
Reregi strati on Eligibility Decision (RED) of Sodium Dimethyldithiocarbamate and
Potassium Dimethyldithiocarbamate. PC Codes 034803, 034804, Case 2180. DP
Barcode 359712. Risk Assessment and Science Support Branch (RASSB)
Antimicrobials Division (7510P). February 5, 2009, Jonathan Chen, Ph.D., Toxicologist,
Risk Assessor.
• Sodium and Potassium Dimethyldithiocarbamate: Preliminary Occupational and
Residential Exposure Assessment for the Registration Eligibility Decision (RED). PC
Codes 034803, 034804, Case 2180. DP Barcode D359715. Risk Assessment and Science
Support Branch (RASSB) Antimicrobials Division (7510P). January 23, 2009, Timothy
C. Dole, CJJi, Industrial Hygienist, Risk Assessor.
• Preliminary Product Chemistry Science Chapter for Reregi strati on Eligibility Decision
(RED) Process for Sodium and Potassium Dimethyldithiocarbamates (Na/K DDC). PC
Codes 034803, 034804, Case 2180. DP Barcode D359713. Regulatory Management
Branch II, Antimicrobials Division (7510P). December 18, 2008, A. Najm Shamim,
PhD, Chemist, Risk Assessor.
• Preliminary Dietary Risk Assessment for Potassium Dimethyldithiocarbamate for the
RED Process. PC Codes 034803, 034804, Case 2180. DP Barcode D359714. Regulatory
Management Branch II, Antimicrobials Division (7510P). December 18, 2008, A. Najm
Shamim, PhD, Chemist, Risk Assessor.
• Preliminary Hazard Assessment for the Reregi strati on Eligibility Decision (RED)
Document of Sodium Dimethyldithiocarbamate and Potassium Dimethyldithiocarbamate.
PC Codes 034803, 034804, Case 2180. DP Barcode D359711. Risk Assessment and
Science Support Branch (RASSB) Antimicrobials Division (7510P). February 5, 2009,
Jonathan Chen, Ph.D., Toxicologist, Risk Assessor.
41
-------
Revised Final Risk Assessment and Revised Supporting Science Documents (RED Supporting
Documents):
• Revised Human Health Risk Assessment and Ecological Effects Assessment for the
Reregi strati on Eligibility Decision (RED) of Sodium Dimethyldithiocarbamate and
Potassium Dimethyldithiocarbamate. PC Codes 034803, 034804, Case 2180. DP
Barcode 359712. Risk Assessment and Science Support Branch (RASSB)
Antimicrobials Division (7510P). June 27, 2009, Jonathan Chen, Ph.D., Toxicologist,
Risk Assessor.
• Drinking Water Assessment for DDTC (Potassium/Sodium Dimethyl Dithiocarbamates).
PC Codes 034803, 034804, Case 2180. DP Barcode D359714. Regulatory Management
Branch II, Antimicrobials Division (7510P). July 8, 2009, A. Najm Shamim, PhD,
Chemist, Risk Assessor.
• Sodium and Potassium Dimethyldithiocarbamate: Revised Occupational and Residential
Exposure Assessment for the Registration Eligibility Decision (RED). PC Codes
034803, 034804, Case 2180. DP Barcode D359715. Risk Assessment and Science
Support Branch (RASSB) Antimicrobials Division (7510P). May 14, 2009, Timothy C.
Dole, CM, Industrial Hygienist, Risk Assessor.
• Dietary Risk Assessment for Potassium Dimethyldithiocarbamate for the RED Process
(amended). PC Codes 034803, 034804, Case 2180. DP Barcode D359714. Regulatory
Management Branch II, Antimicrobials Division (7510P). July 14, 2009, A. Najm
Shamim, PhD, Chemist, Risk Assessor.
• Product Chemistry Science Chapter for Reregi strati on Eligibility Decision (RED) Process
for Sodium and Potassium Dimethyldithiocarbamates (Na/K DDC) (amended). PC Codes
034803, 034804, Case 2180. DP Barcode D359714. Regulatory Management Branch II,
Antimicrobials Division (751 OP). July 21, 2009, A. Najm Shamim, PhD, Chemist, Risk
Assessor.
• Hazard Assessment for the Reregi strati on Eligibility Decision (RED) Document of
Sodium Dimethyldithiocarbamate and Potassium Dimethyldithiocarbamate. PC Codes
034803, 034804, Case 2180. DP Barcode D359711. Risk Assessment and Science
Support Branch (RASSB) Antimicrobials Division (7510P). June 2, 2009, Jonathan
Chen, Ph.D., Toxicologist, Risk Assessor.
• Environmental Hazards and Ecological Risk Assessment for the Sodium and Potassium
Dimethyldithiocarbamate RED. PC Codes 034803, 034804, Case 2180. DP Barcode
D359717. Risk Assessment and Science Support Branch (RASSB) Antimicrobials
Division (7510P). January 14, 2009, W. Erickson, Ph.D., Biologist, Risk Assessor.
42
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the Reregistration Decision (Bibliography)
MRID#
105157
132380
132381
132382
138774
143448
143449
146768
159389
159680
159681
159688
Citations
Thompson, G. (1982) Primary Eye Irritation—Method, Summary; Raw Data Attached.
Hazleton Raltech, Inc. RT Lab No. 926777. MRID. Unpublished
Goad, P.; Frith, C.; Keck, L. (1983) Delayed Contact Hypersensitivity: Busan 85. Intox
Laboratories, Inc., USA. Intox No. 381; Project No. BUC-AT-035. August 4, 1983.
MRID. Unpublished.
Baetcke, K. et al. (1983) Acute Dermal Toxicity Study: Busan 85. Intox Laboratories,
Inc., USA. Lab ID: BUC-AT-034. June 22, 1983. Unpublished.
Goad, P.; Frith, C.; Crowder, D. (1983) Acute Oral Toxicity: Busan 85. Intox
Laboratories, Inc., USA. Intox No. 381; Project No. BUC-AT-033. May 24, 1983.
MRID. Unpublished.
Kukulinski, M. (1983) Acute Oral Toxicity: ACI Melon Fungicide. Tox Monitor
Laboratories, Inc., Report No. TM 83-184. July 26, 1983. MRID. Unpublished.
Costello, BA. (1997) Summary of Results of Acute Toxicity Studies: (Aquatreat KM:
Rabbits, Rats). Bioresearch, Inc., Philadelphia, PA. Project No. 82-3438A. October 28,
1983. MRID. Unpublished compilation, pp. 23.
Costello, B. (1984) Summary of Results of an Acute Dermal Toxicity LD50 Study:
(Aquatreat KM). Biosearch, Inc., Philadelphia, PA. Project No. 82-3438A-1. July 19,
1984. MRID. Unpublished, pp.10.
Goad, P. (1984) Acute Dermal Toxicity of Busan 85. Intox Laboratories, Inc., USA.
Project No. BUC- AT-044. September 19, 1984. MRID. Unpublished, pp.107.
Alco Chemical Corp. (1986) Stability Evaluation of Sodium Dimethyldithiocarbamate.
Unpublished, pp. 2.
Use of NaDDC and Nabam in sugar production processes.
Putman, D. (1985) Chromosome Aberration Assay in Chinese Hamster Ovary (CHO)
Cells: Test Article Sodium Dimethyldithiocarbamate: Final Report: Microbiological
Associates, Inc., USA. Study No. T4305.337. December 6, 1985. MRID. Unpublished
pp. 16.
Lawlor, T. (1986) Salmonella/Mammalian-microsome Plate Incorporation Mutagenicity
Assay (Ames Test): Test Article Sodium Dimethyldithiocarbamate. Microbiological
43
-------
159769
159778
159779
159782
159783
160993
160994
160995
161185
164056
40140101
40140102
Associates, Inc., USA. Study No. T4305.501. January 2, 1986. MRID. Unpublished pp.
33.
Wolfe, G. (1986) Acute Inhalation Toxicity Study in Rats: Dibam. Hazleton
Laboratories America, Inc. Project No. 752-112. March 27, 1986. MRID. Unpublished.
pp. 17.
Putman, D. (1986) Sister Chromatid Exchange Assay in Chinese Hamster Ovary (CHO)
Cells: Test Article: Sodium Dimethyldithiocar- bamate: Final Report. Microbiological
Associates, Inc., USA. MA Study No. T4305.334. January 24, 1986. MRID.
Unpublished pp. 16.
Yang, L. (1986) CHO/HGPRT Mutation Assay in the Presence and Ab- sence of
Exogenous Metabolic Activation. Microbiological Associates, Inc., USA. Study No.
T4305.332. January 29, 1986. MRID. Unpublished pp. 19.
Glaza, S. (1986) Primary Dermal Irritation Study in Rabbits. Hazleton Laboratories
America, Inc. USA. Study No. 51001242. January 6, 1986. MRID. Unpublished, pp 6.
Glaza, S.M. (1986) Dermal Sensitization Study in Guinea Pigs (Closed Patch
Technique). Hazleton Laboratories America, Inc., Madison WI. USA. Study No.
51001243. February 3, 1986. MRID. Unpublished.
Gabriel, K.L. (1978) Acute Oral Toxicity - Rats. Biosearch, Inc., Philadelphia, Project
No. 78-1484A. December 6, 1978. (two documents) Unpublished.
Costello, BA (1983) Acute Dermal Toxicity - Rabbits. Biosearch, Inc., Philadelphia,
PA. Project No. 82-3438A. October 28, 1983. MRID. Unpublished, pp.12.
Hershman, R.(1983) Primary Eye Irritation - Rabbits: Aquatreat NM Lot #93170.
Biosearch Inc. Project No. 82-3438A. October 28, 1983. MRID. Unpublished, pp. 6.
Obrist, J. (1986). The Adsorption/Desorption of Dibam on Representative Agricultural
Soils: Final Report: Study No. 6015-275. study prepared by Hazleton Laboratories
America, Inc.. MRID. Unpublished pp. 71.
Plutnick, R. (1986) MRD-86-933: Subchronic Dermal Toxicity Study in the Rabbit:
(Aquatreat SDM - 40% solution of Sodium Dimethyl- dithiocarbamate). Exxon
Biomedical Sciences, Inc., USA. Project No. 293310. December 30, 1986. MRID.
Unpublished pp. 254.
Wier, P. (1987) Teratogenicity Study in Rats of MRD-86-933: (Aqua- treat SDM:
Approximately 40% Sodium Dimethyldithiocarbamate): Exxon Bio- medical Sciences,
Inc., USA. Project No. 293334. February 3, 1987. MRID. Unpublished pp. 66.
44
-------
40165804
40365701
40365702
40631101
40631102
40631103
40830801
40899001
40957301
40995101
41005501
Wier, P. (1987) Teratogenicity Study in Rabbits of MRD-86-933 (Aq- uatreat SDM:
Approximately 40% Sodium Dimethyldithiocarbamate). Exxon Biomedical Sciences,
Inc., USA. Lab. Proj. ID 293334RB. February 27, 1987. MRID. Unpublished pp. 67.
Obrist, J. (1987). Aerobic Aquatic Metabolism of [Carbon 14]-Dibam (Sodium
N,NDimethyldithiocarbamate): Laboratory Project Identification: HLA 6015-279.
Hazleton Laboratories America, Inc. MRID. Unpublished, pp. 104.
Obrist, J. (1987). Anaerobic Aquatic Metabolism of [Carbon 14]-Dibam (Sodium N, N
Dimethyldithiocarbamate): Laboratory Project Identification: HLA-6015-271. Hazleton
Laboratories America, Inc. MRID. Unpublished, pp. 85.
Cifone, M. (1987) Mutagenicity Test on Busan 85 in the Rat Primary Hepatocyte
Unscheduled DNA Synthesis Assay. Hazleton Laboratories America, Inc., USA. HLA
Study No. 9970- 0-447. November 11, 1987. MRID. Unpublished pp. 28.
Murli, H. (1987) Mutagenicity Test on Busan 85 in an in vitro Cytogenetic Assay
Measuring Sister Chromatid Exchange Frequencies in Chinese Hamster Ovary (CHO)
Cells. Hazleton Laboratories America, Inc., USA. HLA Study No.: 9970-0-438. August
6, 1987. MRID. Unpublished pp. 19.
Jagannath, D. (1987) Mutagenicity Test on Busan 85 in the Ames Sal-
monella/Microsome Reverse Mutation Assay. Hazleton Laboratories America, Inc.,
USA. HLA Study No. 9970-0- 401. November 11, 1987. MRID. Unpublished pp. 34.
Siglin, J. (1988) 91-day Dermal Toxicity Study in Rats with Busan 85: Springborn Life
Sciences, Inc., USA. Final Report: SLS Study No. 3138.15. August 12, 1988. MRID.
Unpublished pp. 730.
Young, R. (1988) Mutagenicity Test on Busan 85 in the CHO/HGPRT Forward
Mutation Assay. Hazleton Laboratories America, Inc., USA. HLA Study No. 10281-0-
435. September 16, 1988. MRID. Unpublished pp. 36.
McGrew, G. (1988) Storage Stability of Nabam and Storage Stability of Sodium
Dimethyldithiocarbamate. Alco Chemical Corp. MRID. Unpublished, pp 13.
Rodwell, D. (1988) Teratology Study in Rabbits with Busan 85. Springborn Life
Sciences, Inc., USA. Final Report: Study No.3138.19. September 20, 1988. MRID.
Unpublished pp. 187.
Rodwell, D. (1988) Teratology Study in Rats with Busan 85. Springborn Life Sciences,
Inc., USA. Final Report: SLS Study No.3138.17. August 31, 1988. MRID. Unpublished
pp. 347.
45
-------
41609401
41609402
41609403
41609405
41609406
41609407
42047201
42242301
42270401
42327801
42916701
43180801
Kawa, C.; Patterson, S. (1990) Aquatreat SDM: Product Identity and Composition.
National Starch and Chemical Co. MRID. Unpublished, pp. 7.
Burke, K.; Kawa, C. (1990) Analysis and Certification of Ingredients: Aquatreat SDM:
Lab Project Number: NOTEBOOK B12-IV: NOTE- BOOK H8-I. National Starch and
Chemical Co. Unpublished, pp. 8.
Burke, K.; Patterson, S. (1990) Physical and Chemical Characteristics of Aquatreat
SDM: Lab Project Number: D-08-004. National Starch and Chemical Co. MRID.
Unpublished, pp. 5.
Kawa, C.; Patterson, S. (1990) Aquatreat KM: Product Identity and Composition.
National Starch and Chemical Co. MRID. Unpublished, pp. 61.
Burke, K.; Kawa, C. (1990) Analysis and Certification of Ingredients: Aquatreat KM:
Lab Project Number: NOTEBOOK B12-IV: NOTE- BOOK H8-I. National Starch and
Chemical Co. MRID. Unpublished, pp. 8.
Burke, K.; Patterson, S. (1990) Physical and Chemical Characteristics of Aquatreat KM:
Lab Project Number: D-08-004. National Starch and Chemical Co. MRID.
Unpublished, pp. 5.
Marquis, J. (1991) 90-Day Subchronic Oral Toxicity Study on Sodium
Dimethyldithiocarbamate in the Rat. Arthur D. Little, Inc., USA. Lab Project No:
66301-00. August 29, 1991. MRID. Unpublished pp. 276.
Watson, C. (1991) Product Chemistry for Dimet: Physical/ Chemical Properties: Lab
Project Number: 17/90-BUC. 5: TCT-007-90-BUC.5-DIM. Buckman Labs,
International, Inc. and Twin City Testing Corp. MRID. Unpublished, pp. 26.
Whetzel, J. (1992) Determination of Stability of Dimet Under Accelerated Storage
Conditions: Lab Project Number: 74/91-BUC. 5. Twin City Testing Corp. MRID.
Unpublished, pp. 31.
Jellinek, Schwartz & Connolly, Inc. (1992) Acute Inhalation Toxicity in Rats with
Dibam: Supplement to MRID 00159769. Hazleton Laboratories America, Inc. May 20,
1992. MRID. Unpublished, pp. 9.
Siemann, L. (1993) Product Chemistry for BUSAN 85 (Dimet): Lab Project Number:
3477-F. Midwest Research Institute. MRID. Unpublished, pp. 28.
Cohen, S. (1994). Sodium Dimethyldithiocarbamate (SDDC): Hydrolysis of SDDC in
Buffered Aqueous Solutions: Final Report: Lab Project Number: ME 9300155. Univ. of
Pittsburgh Applied Research Center. MRID. Unpublished pp.206.
46
-------
43207301
43481501
43544201
43550501
43860601
45502101
45524304
92039001
92039002
92039003
Hinton, R. (1994) Discussion of Impurities SDDC (Sodium Dimethyldithiocarbamate).
Vikings Industries, Inc. MRID. Unpublished, pp. 3.
Hauswirth, J. (1994) Sodium Dimethyldithiocarbamate: Primary Dermal Irritation Study
in Rabbits: Supplemental Information for MRID #00159782. Jellinek, Schwartz, and
Connolly, Inc., Hazleton Labs, and Alco Chemical Div. of National Starch and
Chemical Co. Lab Project Number: 51001242: D-08-004. October 26, 1994. MRID.
Unpublished, pp. 45.
Nemec, M. (1995) An Acute Neurotoxicity Study of Aquatreat SDM in Rats. WIL
Research Labs. Inc., USA. Final Report: Lab Project Number: WIL-230002. January
17, 1995. MRID. Unpublished pp. 1154.
Nemec, M. (1995) A Subchronic (13-Week) Neurotoxicity Study of Aquatreat SDM in
Rats. WIL Research Labs, Inc., USA. Final Report: Lab Project Number: WIL-230003.
January 18, 1995. MRID. Unpublished pp. 1905.
Kuhn, J. (1995) AQUATREAT SDM (46%): Primary dermal irritation study in rabbits.
Stillmeadow Inc., Sugarland, TX, Lab. Study No. 2393-95. November 20, 1995.
MRID. Unpublished.
Bookbinder, M. G. (2001) Assessment of Potential Inhalation and Dermal Exposure
Associated with Pressure Treatment of Wood with Arsenical Wood Products.
September 18, 2001. Arsenical Wood Preservatives Task Force of the American
Chemistry Council.
Bestari, et. al. (1999) Measurement and Assessment of Dermal and Inhalation
Exposures to Didecyldimethylammonium Chloride (DDAC) Used in the Protection of
Cut Lumber (Phase III), University of Guelph, October 25, 1999. Submitted by Lonza,
Inc.
Barbee, D. (1990) Buckman Labs Inc Phase 3 Summary of MRID 00132382. Busan 85
- Acute Oral Toxicity. Intox Laboratories, Inc., USA. Lab ID: BUC-AT-033. April 3,
1990. Unpublished, pp. 9.
Barbee, D. (1990) Buckman Labs Inc Phase 3 Summary of MRID 00146768. Busan 85
-Acute Dermal Screen. Intox Laboratories, Inc., USA. Laboratory ID BUC-AT-044.
April 3, 1990. Unpublished, pp.10.
Drake. K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 00105157. Potassium
Dimethyldithiocarbamate (Busan 85) Primary Eye Irrtiation (sic). Hazleton Raltech, Inc.
Lab. ID. 926777. May 24, 1990. MRID. Unpublished, pp. 9.
47
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92039005
92043009
92043011
92043012
455021-01
455243-04
Barbee, D. (1990) Buckman Labs Inc Phase 3 Summary of MRID 00132380. Busan 85
- Delayed Contact Hypersensitivity. Intox Laboratories, Inc., USA. Lab ID: BUC-AT-
035. May 25, 1990. Unpublished, pp. 7.
Roberts, KM (1990) Phase 3 Summary of MRID 00160995: Acute Dermal Toxicity
LD50 -Rabbits (Aquatreat SDM). Biosearch, Incorporated, USA. Project No. 82-
3438A. April 25, 1990. MRID. Unpublished, pp. 9.
Roberts, K. (1990) Alco Chemical Corporation Phase 3 Summary of MRID 00161185.
Primary Eye Irritation - Rabbits (Aquatreat SDM). Biosearch, Incorporated, USA.
Project No. 82-3438A. April 25, 1990. MRID. Unpublished, pp. 7.
Roberts, K. (1990) Alco Chemical Corporation Phase 3 Summary of MRID 00159782.
Primary Dermal Irritation Study in Rabbits (Aquatreat SDM). Hazleton Labs America,
Inc., USA. Project No. 51001242. April 25, 1990. MRID. Unpublished, pp. 7.
USEPA, 2002a. Review of the "Assessment of Potential Inhalation and Dermal
Exposure Associated with Pressure-Treatment of Wood with Arsenical Products"
submitted by American Chemistry Council (ACC) for use in assessing Chromated
Arsenicals. D278302, October 31, 2002.
Measurement and Assessment of Dermal and Inhalation Exposures to
Didecyldimethylammonium Chloride (DDAC) Used in the Protection of Cut Lumber
(Phase III), Bestari et. al., University of Guelph, October 25, 1999. Submitted by Lonza,
Inc.
48
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Other Supporting Documents
Aschacher G. and Gruendlinger R., 2000. Methods to evaluate the ecotoxicological risks of anti-
sapstain preservatives. Holzforschung, Austria Research and Development.
www. holzforschung. at/engli sh/img_eng/ascha200. pdf.
Cinalli, Christina, et al. A Laboratory Method to Determine the Retention of Liquids on the
Surface of Hands. Exposure Evaluation Division. September 1992.
EPA, 2004a. Wood Leaching Model: Chemical Concentration Screening Tool, vl.O.
USEPA/OPPT/AD.
EPA, 2004b. High Production Volume (HPV) Challenge Program. The HPV Voluntary
Challenge Chemical List. Robust Summaries and Test Plans. Office of Prevention, Pesticide, and
Toxic Substances.
EPA, 2006. PE5 User's Manual for PRZM EXAMS Modeling Shell, Version 5.0.
Environmental Fate and Effects Division. Office of Pesticide Programs, U.S. Environmental
Protection Agency. November 15 2006.
EPA, 2008. Environmental Fate Assessment of Sodium and Potassium Dimethyldithiocarbamate.
Memorandum from James Breithaupt, Risk Assessment and Science Support Branch,
Antimicrobials Division, Office of Pesticide Programs on August 21, 2008.
File: C: \\ Myfiles\2009 Reports\ sodium dimethyldithiocarbamate \ Estimated Environmental
Concentrations for sodium dimethyldithiocarbamate (SDDC) Leached from Wood into
Soil and Water
CC: RASSB Chemical Files
Siroos Mostaghimi, RASSB
HERA, 2005. Human and Environmental Risk Assessment on Ingredients of Household
Cleaning Products, Guidance Document Methodology, February, 2005
(http://www.heraproject.com/files/HERA%20TGD%20February%202005.pdf).
ICF, 2009. Runoff concentrations of SDDC from Wood Treatment Facilities (TAP 09-2-4),
memorandum submitted to Siroos Mostaghimi, U.S. Environmental Protection Agency, from
Andrew Shapiro, Elizabeth Dederick and Joshua Cleland, ICF International, Inc., January 5,
2009.
Kamden and Mclntyre, 1999. Laboratory Evaluation of CDDC as a Wood Preservative for Red
Oak (Quercus rubra) and Red Maple (Acer rubrum). Holz Roh-Wekstoff 57 (1999) 69-72.
Kline. (2004) Specialty Biocide North America 2004, Kline and Company, Inc.
49
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Krahn, P. and Strub R. 1990. Standard leaching test for antisapstain chemicals: Regional
Program Report 90-10. Environment Canada. Conservation and Protection, Pacific and Yukon
Region North Vancouver, BC. 1990.
Laks et al., 1997. Field Performance of Wood Preservative Systems in Secondary Timber
Species. Paper prepared for the 28th Annual Meeting oft!
Wood Preservation, Whistler, Canada, May 25-30, 1997
Species. Paper prepared for the 28th Annual Meeting of the International Research Group on
NIOSH, 1998. Criteria for a Recommended Standard-Occupational Exposure to Metalworking
Fluids. DHHS (NIOSH) Publication No. 98-102.
Parker, Ronald. 2007. Office of Pesticide Programs. U.S. Environmental Protection Agency.
Personal communication..
Rohm and Haas, 2006. Environmental Risk Assessment of DCOIT for Wood Preservative
Applications. Prepared by John P Carbone and Andrew H. Jacobson, Rohm and Haas Company,
Spring House, PA. Company Report 06R-1006. February 9, 2006.
Swann, RL, Laskowski, DA, McCall, PJ, et al. 1983. A rapid method for the estimation of the
environmental parameters octanol/water partition coefficient, soil sorption constant, water to air
ratio, and water solubility. Res Rev. 85:17-28.
US EPA, 1997a. Exposure Factors Handbook. Volume I-II. Office of Research and
Development. Washington, D.C. EPA/600/P-95/002Fa.
US EPA. 1997b. Standard Operating Procedures (SOPs) for Residential Exposure Assessments,
EPA Office of Pesticide Programs, Human Health Division. Dated December 18.
US EPA, 1999. Evaluation of Chemical Manufacturers Association Antimicrobial Exposure
Assessment Study. Memorandum from Siroos Mostaghimi, Ph.D., US EPA, to Julie Fairfax,
US EPA. 2001. Recommended Revisions to the Standard Operating Procedures (SOPs) for
Residential Exposure, Policy Number 12. EPA Office of Pesticide Programs Health Effects
Division. February 22, 2001.
US EPA, 2002b. Review of "Measurement and Assessment of Dermal and Inhalation Exposures
to Didecyldimethyl-ammonium Chloride (DDAC) Used in the Protection of Cut Lumber (Phase
III)", D278890, December 9, 2002.
US EPA, 2006. Propiconazole ORE Assessment, D330159, June 20, 2006.
US EPA, 2007, Tebuconazole: Residential Exposure and Risk Assessment of Existing
Antimicrobial Uses on Wood Products and in Paints", D346795, November 26, 2007
50
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US EPA, 2008. Occupational Exposure Chapter for Inorganic Arsenicals and Chromium-based
Wood Preservatives in Support of the Reregi strati on Eligibility Decision (RED) Document for
the Chromated Arsenicals (RED Case 0132). D350559, September 18, 2008.
Versar, 2005. ADBAC Antisapstain Modeling (TAP 1-4-10, CM-43), memorandum to Najim
Shamim, U.S. EPA, from Ron Lee and Jignasha Patel, Versar, Inc., December 5, 2005.
Web References
FDA, 2003, A Guidance For Industry: Preparations of food Contact Notifications and Food
Additive Petitions for Food Contact Substances, Chemistry Recommendations. Final Guidance,
April 2003. http://www.cfsan.fda.gov
FDA, 2003. Sanitizing Solutions: Chemistry Guidance for Food Additive Petitions, January
2003. Http://www.cfsan.fda.gov
51
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Appendix E. Generic Data Call-In
The Agency intends to issue a Generic Data Call-In at a later date. See Chapter V of the DDC
Salts RED for a list of studies that the Agency plans to require.
52
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date.
53
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Appendix G. Batching of DDC Salts Products for Meeting Acute Toxicity Data
Requirements for Reregistration
The Agency will complete the batching at a later date.
54
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Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in will be posted at a later date.
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the
internet at the following locations:
8570-1
8570-4
8570-5
8570-
17
8570-
25
8570-
27
8570-
28
Application for Pesticide
Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
http://www.epa.sov/opprd001/forms/8570-
l.pdf
http://www.epa.sov/opprd001/forms/8570-
4.pdf
http://www.epa.sov/opprd001/forms/8570-
5.pdf
http://www.epa.sov/opprd001/forms/8570-
17.pdf
http://www.epa.sov/opprd001/forms/8570-
25.pdf
http://www.epa.sov/opprd001/forms/8570-
27.pdf
http://www.epa.sov/opprd001/forms/8570-
28.pdf
56
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8570-
30
8570-
32
8570-
34
8570-
35
8570-
36
8570-
37
Pesticide Registration Maintenance Fee
Filing
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of
Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties
(in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://www.epa.sov/opprd001/forms/8570-
30.pdf
http://www.epa.sov/opprd001/forms/8570-
32.pdf
http://www.epa.sov/opppmsdl/PR Notices
/Dr98-5.odf
http://www.epa.sov/opppmsdl/PR Notices
/pr98-5.pdf
http://www.epa.sov/opppmsdl/PR Notices
7pr98-l.pdf
http://www.epa.sov/opppmsdl/PR Notices
/or98-l.odf
Pesticide Registration Kit
www.epa.gov/pesticides/resistrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit that contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality
Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
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h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
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2. The booklet "General Information on Applying for Registration of Pesticides in
the United States", PB92-221811, available through the National Technical
Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides.
You can contact NPTN by telephone at (800) 858-7378 or through their Web site:
ace. orst. edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date of
receipt and provide the EPA identifying File Symbol or petition number for the new submission.
The identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or academic facilities).
Please provide a CAS number if one has been assigned.
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