United States Chemical Safety June 2012 Environmental Protection and Pollution Prevention Agency (7510P)



# Nabam Summary Document: Registration Review : Initial Docket

June 2012Docket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

3 of 26 

### 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 an d 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

.Docket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

4 of 26 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 RossDocket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

5 of 26 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 stan dard 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 implement ing 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 regist ration

. 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 pes ticide 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 C ase.

The first pesticide product containing d isodium ethylene bisdithiocarbamate (Nabam) (PC Code 014503 ) as an active ingredient was registered in the United States in 1948

. Currently

, there are eight product s containing nabam as an active ingredient registered with EPA for use as an

a lgicide, bactericide, fungicid e, 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, fractur ing 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 p etroleum 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 bisdithioca rbamate (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 a dditive use of n abam safe when used as a slimicide in paper/paperboard production with no maximum treatment concentration specified (21 CFRDocket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

6 of 26 176.300). FDA has also deemed the secondary direct food additive use of n abam 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 199 6

. Documents associated with the registration review of Na bam can be viewed at www.regulations.gov in docket EPA

- HQ

- OPP

- 2012

- 0339

. Below is a summary of the issues relevant to th is 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 199 6 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 en dangered 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 a nd/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 c apricornutum ) 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.Docket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

7 of 26

850.14 0 0

-- Fish early

- life stage toxicity test (saltwater) silverside species

The Agency anticipates the need to require the following additional environmenta l fate data for use in the registration review of Nabam.

850.6800

-- Modified activated sludge, respiration inhibition test 2 835.3110

-- Ready Biodegradability 2 835.3220

-- Porous Pot Test 2 835.3280

-- Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 2 835.3240

-- Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units 2

F or 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 f ood 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 t he 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 (AS RI) 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 ei ther: (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 furt her 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 st udy would be expected to be required.Docket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

8 of 26 nabam alone, and ETU resulting from nabam use, and ETU from all sources (i.e., the other EBDC fun gicides: 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 Study 3

-- Nature of Residue in Paper Special Study 4

-- Migration Study

F or 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.

F or 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 Screen ing 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 evaluate s 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), n abam is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determi ne whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect

3 The 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 revi ew and approval by the Agency prior to initiating this study.Docket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

9 of 26 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 neces sary 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 A gency 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
grou p 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 n abam

. For further i nformation 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 est imated 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) 6Docket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

10 of 26 Guidance for Commenters:
The public is invited to comment on EPA’s P reliminary W ork P lan 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, t he 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 Res idue 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 l isted 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 develop ed 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 Proc edure: 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/r egistration_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 poli cies. 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 N abam compare d 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 withDocket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

11 of 26 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 a nd 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

. Thes e 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 chemica l’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

.
Sinc e 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, generate d 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

- the

evidence 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 ch emicals 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 t he Nabam c ase, 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 determinatio n 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 informat ion 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. S ites of applicationDocket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

12 of 26

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, amphi bian and mammalian mortalities) not a lready 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 c ase

.Docket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

13 of 26 II. Fact Sheet

Background I nformation: Active Ingredient: Disodium ethylene bisdithiocarbamate (Nabam) C ase 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 n abam safe when used as a slimicide in paper/paperboard production with no maxim um treatment concentration specified (21 CFR 176.300). FDA has also deemed the secondary direct food additive use of n abam safe when used as an antimicrobial in sugar production at 3 ppm expressed in terms of the raw sugar beets or sugarcane [21 CFR 173.32 0(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 a lgicide, 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 desul ferization 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 indust ries, 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 industrie s, 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.Docket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

14 of 26 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 degradat es, 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 ab iotic 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 mo bile 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
req uired 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 plan ts ap pear 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 detai led 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 andDocket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

15 of 26 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 slimicide s in the pulp slurry of paper mills and in beet and cane sugar extraction water, and treated paper and paperbo ard used for food packaging. FDA has deemed the indirect food additive use of n abam 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 fo od additive use of n abam 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) exp osures 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 occupation al 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/appli cation 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 occupa tional 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 a re 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).Docket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

16 of 26 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 I ncident 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 n abam 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 n abam safe when used as an antimicrobial in sugar production at 3 ppm expressed in terms of th e 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, dur ing 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: htt p://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 4.5Docket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

17 of 26 34688

- 76 AQUATREAT DNM

30 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 DNM

360 AKZO NOBEL SURFACE CHEMISTRY LLC Ready

– to

- Use Solution 18

74229

- 1 MAGNA CIDE D PRO TECH USA LLC Soluble Concentrate 15Docket Number: EPA

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

18 of 26 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 Timef rame (Measured in months from DCI Receipt)

850.5400 Algal Toxicity Tier II 5 TGAI and, ethylene thiourea (ETU) , the most stable, toxic and mobile degradate 12

850.1400 Fish early

- life stage toxicity test 6 ETU 12

850.6800 Modified activated sludge,

respiration inhibition test 7 ETU 12

835.3110 Ready Biodegradability 7 TGAI 12

835.3220 Porous Pot Test 7 TGAI 12

835.3280 Simulation Tests to Assess the

Biodegradability of Chemicals Discharged to Wastewater 7 TGAI 12

835.3240 Simulation Test

– Aerobic Sewage

Treatment: A. Activated Sludge Units 7 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 ( silversi de 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 P orous 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 S imulation Test

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

- HQ

- OPP

- 2012

- 0339

www.regulations.gov

19 of 26 860.1520 Processed food/feed TGAI 24

S pecial S tudy Paper Migration Study TGAI 24

S pecial S tudy Nature of the Residue in Paper TGAI 24IV. 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 24Docket 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.