United States Chemical Safety June 2012

Environmental Protection and Pollution Prevention

Agency (7510P)

Nabam

Summary Document:

Registration Review: Initial Docket

June 2012

Docket Number: EPA-HQ-OPP-2012-0339

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TABLE OF CONTENTS

Nabam Registration Review Team ......................................................................................4

I. Preliminary Work Plan .....................................................................................................5

II. Fact Sheet..........................................................................................13

III. Summary of Anticipated Data Requirements..............................................................18

IV. Appendix A..................................................................................................................20

________________________________________

Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's 

current position based on the following documents:

1. Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in 

Support of Registration Review of Nabam. May 16, 2012

2. Nabam: Human Health Risk Assessment Scoping Document in Support of Registration 

Review. April 18, 2012

Additional supporting documents for the Nabam Case may be found in the registration review 

docket EPA-HQ-OPP-2012-0339 located on the internet at www.regulations.gov.
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Nabam Registration Review Team

Human Health & Environmental Effects

Nathan Mottl

William Hazel

Jonathan Chen

Steven Malish

Srinivas Gowda

James Breithaupt

William Erickson

Risk Management

Wanda Henson

Lance Wormell

Office of General Counsel

Philip Ross
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I. Preliminary Work Plan -- Nabam

Introduction:

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States generally must be registered by the U.S. 

Environmental Protection Agency (USEPA, EPA, or the Agency) based on scientific data 

showing that they will not cause unreasonable risks to human health or the environment when 

used as directed on product labeling. The registration review program is intended to make sure 

that, as the ability to assess risk evolves and as policies and practices change, all registered 

pesticides continue to meet the statutory standard of no unreasonable adverse effects to human 

health or the environment. Changes in science, public policy, and pesticide use practices will 

occur over time. Through the registration review program, the Agency periodically reevaluates 

pesticides to make sure that as change occurs, products in the marketplace can be used safely. 

Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/.

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The Agency will consider benefits information and data as required by FIFRA. The 

public phase of registration review begins when the initial docket is opened for each case. The 

docket is the Agency’s opportunity to state what it knows about the pesticide and what additional 

risk analyses and data or information it believes are needed to make a registration review 

decision. After reviewing and responding to comments and data received in the docket during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the Nabam Case.

The first pesticide product containing disodium ethylene bisdithiocarbamate (Nabam) (PC Code 

014503) as an active ingredient was registered in the United States in 1948. Currently, there are 

eight products containing nabam as an active ingredient registered with EPA for use as an

algicide, bactericide, fungicide, slimicide, and microbicide/microbistat in industrial process and 

water systems such as air washer water, cooling tower water, drilling fluids, evaporative 

condenser water, heat exchanger systems, flood water, flue gas desulferization thickeners, 

fracturing fluids, industrial recirculating water cooling tower, oil recovery drilling mud, oil 

recovery packer fluid, oilfield drilling muds, workover or completion fluids, oilfield water 

treatment and water floods, petroleum industries, secondary and tertiary petroleum recovery, 

secondary oil recovery injection water, pulp and paper mill fresh water, pulp and paper mill 

systems, sugar beet processing equipment, sugar beet processing water, sugarcane processing 

water, sugar industries, sugar beet juice, sugarcane juice, sugarcane mill systems, sugarcane 

processing equipment, beet sugar mills, and cane sugar mills. Nabam is also registered for use as 

a preservative in hydrocarbon fuels, lubricants and hydraulic fluids. Nabam is a member of the 

Ethylene bisdithiocarbamate (EBDC) group of chemicals which are metabolized to ETU 

(ethylene thio urea) in the body and in the environment. 

There are no EPA established tolerances or exemptions from the requirement of tolerances for 

nabam. FDA has deemed the indirect food additive use of nabam safe when used as a slimicide 

in paper/paperboard production with no maximum treatment concentration specified (21 CFR 
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176.300). FDA has also deemed the secondary direct food additive use of nabam safe when used 

as an antimicrobial in sugar production at 3 ppm expressed in terms of the raw sugar beets or 

sugarcane [21 CFR 173.320(b)(2) and –(3)]. 

The Agency completed a Reregistration Eligibility Decision (RED) for Nabam in 1996. 

Documents associated with the registration review of Nabam can be viewed at 

www.regulations.gov in docket EPA-HQ-OPP-2012-0339. Below is a summary of the issues 

relevant to this registration review case.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, 

including an endangered species risk assessment, for all uses of Nabam. The Agency anticipates 

the need to conduct a human health risk assessment. The Agency anticipates needing additional 

data for use in conducting the registration review for Nabam.

Ecological Risk:

The most recent quantitative ecological risk assessment for nabam was completed in 

support of the 1996 RED. 

The Agency has not conducted a risk assessment that supports a complete endangered 

species determination for Nabam. The ecological risk assessment planned during 

registration review will allow the Agency to determine whether Nabam’s use has 'no 

effect' or 'may affect' federally listed threatened or endangered species (listed species) or 

their designated critical habitats. When an assessment concludes that a pesticide’s use 

'may affect' a listed species or its designated critical habitat, the Agency will consult with 

the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the 

Services), as appropriate.

Paper and paperboard mills and sugar beet/cane processing facilities are associated with 

major waste water discharge that have the potential to contaminate drinking water for 

consumption by humans and livestock. As a result, nabam and/or ethylene thiourea 

(ETU) – the most stable, toxic and mobile degradate of nabam – could potentially pass 

through waste water treatment plants (WWTPs).

The Agency anticipates the need to require the following additional ecological data for 

use in the registration review of Nabam.

850.5400 -- Algal Toxicity Tier II (Pseudokirchneriella subcapita formerly called

Selenastrum capricornutum)

1

850.1400 -- Fish early-life stage toxicity test (estuarine/marine) rainbow trout

 

1 An Algal Toxicity Tier II (850.5400) study using nabam as the test substance on Pseudokirchneriella subcapita

formerly called Selenastrum capricornutum, and an Algal Toxicity Tier II (850.5400) study using ETU as the test 

substance on 3 species (Anabaena flos-aquae, Navicula pelliculosa and Skeletonema costatum, are anticipated to be 

required.
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850.1400 -- Fish early-life stage toxicity test (saltwater) silverside species

The Agency anticipates the need to require the following additional environmental fate 

data for use in the registration review of Nabam.

 850.6800 -- Modified activated sludge, respiration inhibition test2

835.3110 -- Ready Biodegradability2

835.3220 -- Porous Pot Test2

835.3280 -- Simulation Tests to Assess the Biodegradability of Chemicals Discharged 

to Wastewater2

835.3240 -- Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units2

For more information, please refer to Product Chemistry, Environmental Fate, and 

Ecological Effects Scoping Document in Support of Registration Review of Nabam, 

located in the docket.

Human Health Risk: 

The most recent human health risk assessment for nabam was performed to support the 

1996 RED. 

The Agency anticipates the need to conduct a dietary risk assessment based on indirect 

food exposure from nabam for use as a slimicide in the pulp slurry of paper mills and in 

beet and can sugar extraction water.

A residential risk assessment is not needed because nabam products are not registered for 

residential use.

The Agency anticipates the need to conduct an aggregate assessment to include food and 

drinking water exposure.

Nabam is a member of the ethylene bisdithiocarbamate (EBDC) group, which includes 

the related active ingredients mancozeb and metiram. Nabam and three other EBDCs are 

all metabolized to ETU in the body and all degrade to ETU in the environment. 

Therefore, EPA will need to consider the combined risks from food and water from 

 

2 The results of the Activated Sludge Respiration Inhibition Test (ASRI) expected to be required will determine 

which of these three biodegradation tests would be anticipated to be required. If the ASRI test EC50 is less than or 

equal to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test – Aerobic Sewage 

Treatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test 

EC50 is greater than 20 mg/L, then the DCI expected to be issued would provide that the registrant would choose to 

conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test –

Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability 

study is conducted and passes, then no further testing would be expected to be required. If, however, the 

antimicrobial fails the Ready Biodegradability study, then the Biodegradation in Activated Sludge or Simulation 

Test – Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be 

required.
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nabam alone, and ETU resulting from nabam use, and ETU from all sources (i.e., the 

other EBDC fungicides: mancozeb and metiram). 

An occupational risk assessment is not expected to be needed because products 

containing nabam are restricted to metering pumps (i.e., closed mixing loading systems) 

and significant occupational exposure is not expected to occur.

The Agency anticipates the need to require the following additional human health data 

for use in the registration review of nabam.

860.1520 -- Processed food/feed 

Special Study3-- Nature of Residue in Paper

Special Study4-- Migration Study

For more information, please refer to Nabam: Human Health Risk Assessment Scoping 

Document in Support of Registration Review, located in the docket.

Product Chemistry:

The Agency does not anticipate the need to require additional product chemistry data for 

use in this registration review at this time.

For more information, please refer to Product Chemistry, Environmental Fate, and 

Ecological Effects Scoping Document in Support of Registration Review of Nabam, 

located in the docket.

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its 1996 reregistration decision for nabam, EPA reviewed these 

data and selected the most sensitive endpoints for relevant risk assessment scenarios from the 

existing hazard database. However, as required by FFDCA section 408(p), nabam is subject to 

the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

 

3The anticipated DCI will provide that a protocol must be submitted for review and approval by the Agency prior to 

initiating this study. 

4 The anticipated DCI will provide that a protocol must be submitted for review and approval by the Agency prior to 

initiating this study.
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produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 

2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, 

which contains 58 pesticide active ingredients and 9 inert ingredients. Nabam is not among the 

group of 58 pesticide active ingredients on the initial list to be screened under the EDSP.

Accordingly, as part of registration review, EPA will issue future EDSP orders/data call-ins, 

requiring the submission of EDSP screening assays for nabam. For further information on the 

status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test 

guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/.

Timeline

EPA has created the following estimated timeline for the completion of the Nabam registration 

review:

Anticipated Schedule

Activities Estimated Month/Year

Phase 1: Opening the docket

Open Public Comment Period for Docket June 2012

Close Public Comment Period for Docket August 2012

Phase 2: Case Development

Develop Final Work Plan (FWP) December 2012

Issue DCI December 2013

Data Submission December 2015

Open Public Comment Period for Preliminary Risk Assessments June 2017

Close Public Comment Period for Preliminary Risk Assessments July 2017

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision December 2017

Close Public Comment Period for Proposed Reg. Review Decision February 2018

Final Decision and Begin Post-Decision Follow-up 2018

Total (years) 6
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Guidance for Commenters:

The public is invited to comment on EPA’s Preliminary Work Plan and rationale. The Agency 

will carefully consider all comments as well as any additional information or data provided in a 

timely manner prior to issuing a final work plan for the Nabam registration review case.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and 

other stakeholders are asked to comment on any trade irritant issues resulting from lack of 

Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key 

export markets, providing as much specificity as possible regarding the nature of the concern. 

Water Quality:

Nabam is not identified as a cause of impairment for any water bodies listed as impaired under 

section 303(d) of the Clean Water Act, based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88

5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for Nabam, based 

on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id

=885&p_pollutant_group_name=PESTICIDES.

More information on impaired water bodies and TMDLs can be found at 

http://www.epa.gov/owow/tmdl/. The Agency invites submission of water quality data for this 

pesticide. To the extent possible, data should conform to the quality standards in Appendix A of 

the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water 

Quality Data in OPP’s Registration Review Risk Assessment and Management Process (see: 

http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm), in order to ensure the 

data can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to Nabam compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population.

Structure Activity Relationships: 

EPA must rely upon information of appropriate quality and reliability for each decision made by 

the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide 

chemical traditionally begins with the applicant’s submission of a set of studies conducted with 
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the specific pesticide chemical of interest. The use of the results of such testing (measured data) 

is a logical, scientifically rigorous process that identifies the physical, chemical, and 

environmental fate properties of the pesticide, as well as the dose and endpoints at which an 

adverse effect can occur in various animal species. 

Today, there is significant interest in alternative techniques, i.e., techniques other than data 

generation that could significantly inform the Agency’s decision-making process. Recently, OPP 

has made increasing use of structure activity relationship (SAR) as part of its regulatory 

decision-making process. In the SAR process, a chemical's molecular structure is compared to 

that of other chemicals for which data are available. These structural similarities are then used to 

make predictive judgments about a chemical’s physical, chemical, and biological properties. 

Thus, the chemical’s physical, chemical, and biological properties are a function of (or directly 

related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To 

develop a QSAR, a selected set of measured data on a single physical, chemical, or biological 

property is used to derive a model (an equation) to predict the value of that property. 

Since SAR assessments and QSAR modeling are another set of tools that are available to Agency 

scientists, OPP has begun a process shift that envisions shifting from the current study-by-study 

approach to an approach in which the use of predicted data, generated using validated models, is 

considered along with information from open literature and studies specifically generated under 

Part 161 requirements. All relevant information would be considered as part of a weight-of-theevidence evaluation. 

At this time, EPA believes that for certain endpoints, especially physical/chemical and fate 

properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements 

for many antimicrobial pesticide chemicals. When considering biological properties, at this time, 

EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of 

chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters. This is 

appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a 

screening-level assessment procedure rather than multiple tiers of assessments with progressively 

more data requirements.

If stakeholders believe that submission of predicted data can fulfill one of the data needs for the 

Nabam case, then the Agency invites submission of this information. The submitter would be 

expected to supply a rationale describing the utility of the information and provide 

documentation on the scientific validity of the information. The determination that the predicted 

data fulfills the data requirement would be at the sole discretion of the Agency. Pre-submission 

consultation with the Agency is encouraged.

Additional Information:

Stakeholders are also specifically asked to provide available information and data that will assist 

the Agency in refining its risk assessments, including any species-specific ecological effects 

determinations. The Agency is interested in receiving the following information:

1. Confirmation on the following label information:

a. Sites of application
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b. Formulations

c. Application methods and equipment

d. Maximum application rates

e. Frequency of application, application intervals and maximum number of 

applications

f. Geographic limitations on use

2. Use or potential use distribution

3. Use history

4. Usage/use information for non-agricultural uses (e.g., materials preservation)

5. Typical application interval

6. State or local use restrictions

7. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian 

and mammalian mortalities) not already reported to the Agency

8. Monitoring data

Next Steps:

After the 60-day comment period, the Agency will review and respond to any comments 

received in a timely manner, and then issue a Final Work Plan for the Nabam case. 
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II. Fact Sheet

Background Information:

Active Ingredient: Disodium ethylene bisdithiocarbamate (Nabam)

Case number: 0641

PC Code: 014503

CAS number: 142-59-6

Technical registrants: Akzo Nobel Surface Chemistry, LLC

First approved for use in a registered product: 1948

There are no EPA established pesticide tolerances or exemptions from the requirement of 

tolerances for nabam under the jurisdiction of EPA. FDA has deemed the indirect food 

additive use of nabam safe when used as a slimicide in paper/paperboard production with 

no maximum treatment concentration specified (21 CFR 176.300). FDA has also deemed 

the secondary direct food additive use of nabam safe when used as an antimicrobial in 

sugar production at 3 ppm expressed in terms of the raw sugar beets or sugarcane [21 

CFR 173.320(b)(2) and –(3)].

Antimicrobials Division Chemical Review Manager (CRM): Wanda Henson, 

Henson.Wanda@epa.gov

Antimicrobials Division Product Manager (PM): Marshall Swindell, 

Swindell.Marshall@epa.gov

Chemical Structure: 

Use & Usage Information:

Products containing nabam are registered for use as an algicide, bactericide, fungicide, 

slimicide, and microbicide/microbistat in industrial process and water systems such as air 

washer water, cooling tower water, drilling fluids, evaporative condenser water, heat 

exchanger systems, flood water, flue gas desulferization thickeners, fracturing fluids, 

industrial recirculating water cooling tower, oil recovery drilling mud, oil recovery 

packer fluid, oilfield drilling muds, workover or completion fluids, oilfield water 

treatment and water floods, petroleum industries, secondary and tertiary petroleum 

recovery, secondary oil recovery injection water, pulp and paper mill fresh water, pulp 

and paper mill systems, sugar beet processing equipment, sugar beet processing water, 

sugarcane processing water, sugar industries, sugar beet juice, sugarcane juice, sugarcane 

mill systems, sugarcane processing equipment, beet sugar mills, and cane sugar mills. 

Nabam is also registered for use as a preservative in hydrocarbon fuels, lubricants and 

hydraulic fluids.
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Recent/Pending Regulatory Actions:

There are no recent or pending regulatory actions for Nabam.

Ecological Risk Assessment Status:

The most recent qualitative ecological risk assessment for nabam was completed in 

support of the 1996 RED. 

Nabam and its primary degradates, except for ethylene thiourea (ETU), do not persist in 

the environment. They are susceptible to chemical and microbial degradation. ETU does 

biodegrade, but it is stable to chemical degradation (hydrolysis and photodegradation). 

ETU is persistent in abiotic environments, highly soluble in water and mobile, with low 

adsorption to soils, and thus may reach and persist in ground and surface waters which 

may be important for ecological or drinking water exposure. Because ETU is the most 

stable, toxic and mobile degradate of nabam, it is the degradate of environmental 

concern. 

Nabam is moderately to very highly toxic to freshwater and estuarine/marine animals and 

practically nontoxic toxic to birds. On an acute basis, ETU is practically nontoxic to 

slightly toxic to birds and fish but is slightly to moderately toxic to aquatic invertebrates. 

On a chronic basis, ETU impacted both growth and reproduction of freshwater 

invertebrates at low exposure concentrations. Chronic data for fish are lacking but are 

required for the risk assessment based on the potential for chronic exposure to ETU and 

because chronic impacts were found in aquatic invertebrates. ETU is practically nontoxic 

to the vascular aquatic duckweed, Lemna gibba, but aquatic non-vascular plants appear 

much more sensitive.

Please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping 

Document in Support of Registration Review of Nabam, located in the docket, for a detailed 

discussion of the ecological risk assessments.

Human Health Risk Assessment Status:

The following are key findings of the recent human health risk assessments for Nabam. Please 

refer to Nabam: Human Health Risk Assessment Scoping Document in Support of Registration 

Review, located in the docket, for a detailed discussion of the human health risk assessment.

Hazard Characterization:

According to the 1996 nabam reregistration eligibility decision (RED) document, nabam 

and other EBDCs are metabolized to ETU (ethylene thiourea) in the body and in the 

environment. ETU has been shown to cause thyroid cancer in both mice and rats and 

liver cancer in female mice. The mutagenic test data on nabam yielded both positive and 
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negative results. Nabam is also considered teratogenic with increased incidence of 

hydrocephaly in rabbit development studies.

Dietary (Food and Water):

Registered nabam uses that could potentially result in residues in food include slimicides

in the pulp slurry of paper mills and in beet and cane sugar extraction water, and treated 

paper and paperboard used for food packaging. FDA has deemed the indirect food 

additive use of nabam safe when used as a slimicide in paper/paperboard production with 

no maximum treatment concentration specified (21 CFR 176.300). FDA has also deemed 

the secondary direct food additive use of nabam safe when used as an antimicrobial in 

sugar production at 3 ppm expressed in terms of the raw sugar beets or sugarcane [21 

CFR 173.320(b)(2) and –(3)].

Residential:

There are no residential uses for products containing nabam. 

Aggregate:

In examining aggregate exposure, EPA takes into account the available and reliable 

information concerning exposures to pesticide residues in food and drinking water, and 

non-occupational pesticide exposures. Dietary (food and drinking water) exposures are 

anticipated for nabam and ETU. Residential exposures are not of concern. An aggregate 

risk assessment for nabam as well as ETU is needed to assess aggregate exposures from 

food and drinking water.

Occupational:

The Agency conducted an occupational and residential exposure assessment for the RED 

in 1996 (D208114, D215335). The RED specified mitigation requirements that included 

a provision that “all products must be loaded and transferred only using a metering-pump 

system or a closed loading/application system.” All the existing labels now have 

language that specifies metering pumps or closed loading systems and occupational 

handler and postapplication exposures are minimized. As a result, the Agency does not 

anticipate the need to develop occupational handler and/or postapplication assessments 

for this registration review.

Cumulative:

Nabam is a member of the ethylene bisdithiocarbamate (EBDC) group, which includes 

the related active ingredients mancozeb and metiram. Nabam and three other EBDCs are 

all metabolized to ETU in the body and all degrade to ETU in the environment. 

Therefore, EPA will need to consider the combined risks from food and water from 

nabam alone, and ETU resulting from nabam use, and ETU from all sources (i.e., the 

other EBDC fungicides: mancozeb and metiram). 
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Incidents:

Ecological:

No Nabam ecological incidents have been reported in the Agency’s Ecological Incident 

Information System (EIIS).

Human Health:

No Nabam human poisoning incidents have been reported in the OPP’s Incident Data 

System (IDS).

Tolerances and International Harmonization:

There are no EPA established tolerances or exemptions from the requirement of 

tolerances for nabam. FDA has deemed the indirect food additive use of nabam safe 

when used as a slimicide in paper/paperboard production with no maximum treatment 

concentration specified (21 CFR 176.300). FDA has also deemed the secondary direct 

food additive use of nabam safe when used as an antimicrobial in sugar production at 3 

ppm expressed in terms of the raw sugar beets or sugarcane [21 CFR 173.320(b)(2) and –

(3)]

Data Call-In Status:

There are no outstanding Data Call-Ins for Nabam.

Labels:

Registered products, including EPA registration numbers are provided in Table 1 below. For 

future reference, during registration review a list of product registration numbers will be included 

in the docket. Product registration labels may be obtained from the Pesticide Product Label 

System (PPLS) website at: http://oaspub.epa.gov/pestlabl/ppls.home.

Table 1. Registered Products – Nabam

Registration # Registration Name Company Name Formulation Type % A.I.

9386-7 AMA-31 KEMIRA CHEMICALS, INC Ready-to-Use 

Solution 15

9386-11 AMA-30 KEMIRA CHEMICALS, INC Ready-to-Use 

Solution 15

9386-23 AMA-9 KEMIRA CHEMICALS, INC Ready-to-Use 

Solution 4.5
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34688-76 AQUATREAT DNM30

AKZO NOBEL SURFACE 

CHEMISTRY LLC

Ready –to-Use 

Solution 15

34688-79 AQUATREAT DN-30 AKZO NOBEL SURFACE 

CHEMISTRY LLC Intermediate 30

34688-80 AQUATREAT DNM-9

AKZO NOBEL SURFACE 

CHEMISTRY LLC

Ready –to-Use 

Solution 4.5

34688-81 AQUATREAT DNM360

AKZO NOBEL SURFACE 

CHEMISTRY LLC

Ready –to-Use 

Solution 18

74229-1 MAGNA CIDE D PRO TECH USA LLC Soluble Concentrate 15
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III. Summary of Anticipated Data Requirements – Nabam

The table below summarizes anticipated data needs for the Nabam Case in Section I of this 

document (Preliminary Work Plan), Product Chemistry, Environmental Fate, and Ecological 

Effects Scoping Document in Support of Registration Review of Nabam, and Nabam: Human 

Health Risk Assessment Scoping Document in Support of Registration Review.

Table 2. Summary of Anticipated Data Requirements – Nabam

Guideline

Number Anticipated Data Requirement Test Material

Estimated Timeframe 

(Measured in months from 

DCI Receipt)

850.5400 Algal Toxicity Tier II5

TGAI and, 

ethylene thiourea 

(ETU), the most 

stable, toxic and 

mobile degradate

12

850.1400 Fish early-life stage toxicity test6

ETU 12

850.6800 Modified activated sludge, 

respiration inhibition test7 ETU 12

835.3110 Ready Biodegradability7

TGAI 12

835.3220 Porous Pot Test7

TGAI 12

835.3280

Simulation Tests to Assess the 

Biodegradability of Chemicals 

Discharged to Wastewater7

TGAI 12

835.3240

Simulation Test – Aerobic Sewage 

Treatment: A. Activated Sludge 

Units7

TGAI 12

 

5 An Algal Toxicity Tier II (850.5400) study using nabam as the test substance on Pseudokirchneriella subcapita

formerly called Selenastrum capricornutum, and an Algal Toxicity Tier II (850.5400) study using ETU as the test 

substance on 3 species (Anabaena flos-aquae, Navicula pelliculosa and Skeletonema costatum), are anticipated to be 

required

6 Results are anticipated to be required for freshwater (rainbow trout) and estuarine/marine (silverside species) 

species.

7 The results of the Activated Sludge Respiration Inhibition Test (ASRI) expected to be required will determine 

which of these three biodegradation tests would be anticipated to be required. If the ASRI test EC50 is less than or 

equal to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test – Aerobic Sewage 

Treatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test 

EC50 is greater than 20 mg/L, then the DCI expected to be issued would provide that the registrant would choose to 

conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test –

Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability 

study is conducted and passes, then no further testing would be expected to be required. If, however, the 

antimicrobial fails the Ready Biodegradability study, then the Biodegradation in Activated Sludge or Simulation 

Test – Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be 

required
Docket Number: EPA-HQ-OPP-2012-0339

www.regulations.gov

19 of 26

860.1520 Processed food/feed TGAI 24

Special 

Study Paper Migration Study TGAI 24

Special 

Study Nature of the Residue in Paper TGAI 24
IV. Appendix A: Use Patterns – Nabam

EPA 

Reg #

used 

for 

Max. 

Appl. 

Rate

Formulation % AI in 

End Use 

Formulati

on

Use 

Category

Use Site Treatment 

Site/surfaces

Method of 

Application

Max 

Application/

Use Rate

Use 

Limitations

9386-7

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Pulp and 

paper mill 

water 

systems

Paper Mill 

water systems

Metered. 6-30oz per 

2,000lbs of 

paper product

9386-7

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Oil Drilling 

muds/packe

r fluids

Oilfield drilling 

muds and 

workover or 

completion 

fluids

Metered. 59 gallons per 

1,000 barrels 

(1600ppm)

9386-7

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Oil Drilling 

muds/packe

r fluids

Oilfield water 

treatment and 

water floods

Metered. 0.84 gallons 

per 1,000 

gallons 

(967ppm)

9386-

11

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Evaporative 

Condenser 

Water 

Systems

Industrial 

recirculating 

water cooling 

tower, 

evaporative 

condensers 

and air washer 

systems

Metered. 2.18-43.60 oz 

per 1,000 

gallons (20-

400ppm)
Docket Number: EPA-HQ-OPP-2012-0339

www.regulations.gov

21 of 26

9386-

11

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Pulp and 

paper mill 

water 

systems

Paper Mill 

water systems

Metered. 0.1-2.0 lbs 

per 2,000lbs 

of paper 

product

9386-

11

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Beet Sugar 

Mills

Metered. 0.186-

0.372oz/min 

per 1000 tons 

(10-20 ppm)

9386-

11

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Cane Sugar 

Mills

Metered. 4 gallons per 

1000 tons of 

cane per 24 

hours.

9386-

23

Ready-to-Use 

Solution

4.5 Industrial 

process 

and 

water 

systems

Oil Drilling 

muds/packe

r fluids

Oilfield drilling 

muds and

workover or 

completion 

fluids

Metered. 3.7-18.6 

gallons per 

100 barrels of 

mud

9386-

23

Ready-to-Use 

Solution

4.5 Industrial 

process 

and 

water 

systems

Cane Sugar 

Mills

Metered. 0.620-1.240 

oz/min per 

1000 tons 

(33.3-66.7 

ppm). 15 

gallons per 

1000 tons of 

cane per 24 

hours max.

9386-

23

Ready-to-Use 

Solution

4.5 Industrial 

process 

and 

water 

systems

Evaporative 

Condenser 

Water 

Systems

Industrial 

recirculating 

water cooling 

tower, 

evaporative 

condensers 

and air washer 

Metered. 7.3-43.5 oz 

per 1,000 

gallons (66.7-

400ppm)
Docket Number: EPA-HQ-OPP-2012-0339

www.regulations.gov

22 of 26

systems

34688-

76

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Oil Drilling 

muds/packe

r fluids

Flue gas 

desulfurization 

thickeners

Metered. 50-500ppm 

once per 

week.

34688-

76

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Oil Drilling 

muds/packe

r fluids

Fracturing 

fluids

Metered. 0.81-4.3lbs 

per 1000 

gallons of 

fluids

34688-

76

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Oil Drilling 

muds/packe

r fluids

Workover and 

completion 

fluids

Metered. 1-4 quarts per 

1000 gallons 

of fluids.

34688-

76

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Oil Drilling 

muds/packe

r fluids

Oilfield drilling 

mud

Metered. 1-5 gallons 

per 100 bbl of 

mud (0.02-

0.1%)

34688-

76

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Oil Drilling 

muds/packe

r fluids

Secondary and 

tertiary 

petroleum 

recovery

Metered. 1 pint- 1.8 

gallons per 

100 bbl of 

water

34688-

76

Ready-to-Use 

Solution

15 Industrial 

process 

and

water 

systems

Evaporative 

Condenser 

Water 

Systems

Industrial 

recirculating 

water cooling 

tower, 

evaporative 

condensers 

Metered. 2.18-43.60 oz 

per 1,000 

gallons (20-

400ppm)
Docket Number: EPA-HQ-OPP-2012-0339

www.regulations.gov

23 of 26

and air washer 

systems

34688-

76

Ready-to-Use 

Solution

15 Industrial 

process 

and

water 

systems

Pulp and 

paper mill 

water 

systems

Paper Mill 

water systems

Metered. 0.1-2.0 lbs 

per 2,000lbs 

of paper 

product

34688-

76

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Beet Sugar 

Mills

Metered. 0.186-

0.372oz/min 

per 1000 tons 

(10-20 ppm)

34688-

76

Ready-to-Use 

Solution

15 Industrial 

process 

and 

water 

systems

Cane Sugar 

Mills

Metered. 4 gallons per 

1000 tons of 

cane per 24 

hours.

34688-

79

Formulation 

Intermediate

30 For formulating 

microbicide for 

cooling towers, 

air washers, 

and the pupl, 

paper, sugar 

and petroleum 

industries.

Not for 

forumlation 

into products 

for use in 

leather, 

leather 

processing, 

metalworking 

fluids, 

ornamental 

plants or 

sugar beet 

flume water.
Docket Number: EPA-HQ-OPP-2012-0339

www.regulations.gov

24 of 26

34688-

80

Ready-to-Use 

Solution

4.5 Industrial 

process 

and 

water 

systems

Oil Drilling 

muds/packe

r fluids

Oilfield drilling 

mud

Metered. 3.7-18.6 

gallons per 

100 bbl of 

mud (0.067-

0.33%)

34688-

80

Ready-to-Use 

Solution

4.5 Industrial 

process 

and 

water

systems

Oil Drilling 

muds/packe

r fluids

Secondary and 

tertiary 

petroleum 

recovery

Metered. 3.3 pint- 6.2 

gallons per 

100 bbl of 

water

34688-

80

Ready-to-Use 

Solution

4.5 Industrial 

process 

and 

water 

systems

Evaporative 

Condenser 

Water 

Systems

Industrial 

recirculating 

water cooling 

tower, 

evaporative 

condensers 

and air washer 

systems

Metered. 7.27-43.53 oz 

per 1,000 

gallons (66.7-

400ppm)

34688-

80

Ready-to-Use 

Solution

4.5 Industrial 

process 

and 

water 

systems

Pulp and 

paper mill 

water 

systems

Paper Mill 

water systems

Metered. 0.33-6.67 lbs 

per 2,000lbs 

of paper 

product

34688-

80

Ready-to-Use 

Solution

4.5 Industrial 

process 

and 

water 

systems

Beet Sugar 

Mills

Metered. 0.820-

1.240oz/min 

per 1000 tons 

(33.3-66.7 

ppm)

34688-

80

Ready-to-Use 

Solution

4.5 Industrial 

process 

and 

water 

systems

Cane Sugar 

Mills

Metered. 0.820-1.240 

oz/min per 

1000 tons 

(33.3-66.7 

ppm). 15 

gallons per 

1000 tons of 

cane per 24 
Docket Number: EPA-HQ-OPP-2012-0339

www.regulations.gov

25 of 26

hours max.

34688-

81

Ready-to-Use 

Solution

18 Industrial 

process 

and 

water 

systems

Oil Drilling 

muds/packe

r fluids

Oilfield drilling 

mud

Metered. 0.83-4.17 

gallons per 

100 bbl of 

mud (0.017-

0.083%)

34688-

81

Ready-to-Use 

Solution

18 Industrial 

process 

and 

water 

systems

Oil Drilling 

muds/packe

r fluids

Secondary and 

tertiary 

petroleum 

recovery

Metered. 1 pint- 1.5 

gallons per 

100 bbl of 

water

34688-

81

Ready-to-Use 

Solution

18 Industrial 

process 

and 

water 

systems

Evaporative 

Condenser 

Water 

Systems

Industrial 

recirculating

water cooling 

tower, 

evaporative 

condensers 

and air washer 

systems

Metered. 1.82-10.88 oz 

per 1,000 

gallons (16.7-

100 ppm)

34688-

81

Ready-to-Use 

Solution

18 Industrial 

process 

and 

water 

systems

Pulp and 

paper mill 

water 

systems

Paper Mill 

water systems

Metered. 0.08-1.67 lbs 

per 2,000lbs 

of paper 

product

34688-

81

Ready-to-Use 

Solution

18 Industrial 

process 

and 

water 

systems

Beet Sugar 

Mills

Metered. 0.155-0.310 

oz/min per 

1000 tons 

(8.3-16.6 

ppm)
Docket Number: EPA-HQ-OPP-2012-0339

www.regulations.gov

26 of 26

34688-

81

Ready-to-Use 

Solution

18 Industrial 

process 

and 

water 

systems

Cane Sugar 

Mills

Metered. 0.155-0.310 

oz/min per 

1000 tons 

(8.3-16.6 

ppm) 33 

gallons per 

1000 tons of 

cane per 24 

hours max.