1
e first step is to assess the likelihood of toxicity value/regulatory change for the EC. e assessment is conducted by a regulatory specialist who evaluates the likelihood that a regulatory change will occur given the current regulatory status, the requirement(s) for change, state of the science, and other technical, resource, and legal constraints e second step in the Phase I Impact Assessment process consists of gathering ordering and usage information, release and disposal data and Defense Environmental Restoration Program (DERP) data from appropriate Office of the Secretary of Defense and component organizations. Additional searches are performed to gather technical and scientific information (e.g., physicochemical properties, analytical methods and detection levels, toxicity benchmarks and applicable regulations and guidelines). e information and data acquired are organized and summarized for later evaluation. e data gathering process looks across the following functional areas to capture a full range of issues: Environment, Safety and Health Training / Readiness (T&R) Acquisition / Research, Development, Testing, and Evaluation (RDT&E) Production, Operations, Maintenance, and Disposal (POMD) of Assets Cleanup Maintain on Watch List Tungsten 1, 4-dioxane DNT PFOS PCE Dioxin Lead Nickel Elevate to Action List Beryllium PFOA Maintain on Action List Perchlorate Naphthalene Hexavalent chromium TCE RDX Remove NDMA 1, 2, 3-TCP PBDEs Dichlorobenzenes e third step, SME integration and evaluation function, relies on SMEs from within the DoD assessing and reaching consensus on the potential impacts to the DoD from changing toxicity value/regulatory drivers. e SMEs consider the likelihood of change to the toxicity value/regulatory drivers, the background data on the EC (e.g., DoD usage, disposal, releases, etc.) and their expertise related to the EC to determine the potential impacts on the five DoD functionalareas, referenced above. e SMEs perform the integration function in person or via teleconference in a Phase I meeting. e Impact Criteria Assessment Tool (ICAT) (developed by CTC) is used to guide the SMEs through a series of questions to analyze the likelihood and severity of risk to the DoD from the anticipated toxicity value/regulatory change to the EC of interest. e final step of the Phase I Impact Assessment process was integrate the likelihood of toxicity value/regulatory change with the risk areas Identified by the SME. e overall results were briefed to the service Secretariats and the OSD senior leadership. e results of the Phase I Impact Assessments were briefed to DoD senior leadership to foster an integrated Risk management approach. e Office of the Deputy Under Secretary of Defense for Installations and Environment (DUSD[I&E]), Emerging Contaminants (EC) Directorate is implementing a structured process to identify, assess, and manage the risks posed to the department by ECs. e EC Directorate maintains an inventory of ECs divided into an Action List for high priority chemicals and a Watch List for medium priority chemicals. e EC Directorate uses the Phase I Impact Assessment process to examine ECs on the Watch List to examine 1) the likelihood of potential changes in toxicity values/regulatory status and 2) the potential impacts of these changes the department’s operations in five functional areas. On behalf of the EC Directorate and in collaboration with others Noblis, has assisted DoD in examining the potential impacts from 18 ECs. At the completion of the assessments, two of the ECs evaluated (beryllium and PFOA) were nominated for the Action List due to the significant potential risks posed and four of the ECs evaluated (NDMA, 1,2,3-trichloropropane, PBDEs, and dichlorobenzenes) were recommended for removal from the Watch List. It was recommended that the remaining chemicals be maintained on the Watch List. ese assessments bring to the total number of chemicals on the Action List to seven and the total number of chemicals on the Watch List to fourteen. e next step is to develop risk management options for those chemicals on the Action List as part of an integrated risk management framework. e potential risks to the DoD are solicited from Subject Matter Experts (SMEs). e input from the SMEs is entered into the ICAT, which plots the risks to DoD. Phase I Impact Assessments for Emerging Contaminants: Process and Results Andrew Rak, Cathy M. Vogel, and Whitney W. Glaccum Noblis, Falls Church, VA e Phase I Impact Assessment process consists of three primary activities: (1) a likelihood of toxicity value/regulatory change analysis, (2) background data/information queries and (3) an integration and evaluation function using subject matter experts (SMEs) from various DoD components. Introduction Process Step 1 – Assessment of Toxicity Value/Regulatory Change Step 2 – Data Collection Impact Criteria Assessment Tool (ICAT) Step 3 – SME Integration and Evaluation Function Conclusions Recommendations Final Phase I Conclusions Final Output for Phase I Impact Assessment Acknowledgements Developed for: Deputy Under Secretary of Defense (Installations and Environment) Emerging Contaminants Directorate http://www.acq.osd.mil/ie/index.htm Developed under Contract for: Air Force Center for Engineering and the Environment http://www.brooks.af.mil/afioh/ Special Assistance Provide by: US Army Center for Health Promotion and Preventative Medicine Department of Defense (DoD) Directive 4715.1E, Environment, Safety and Occupational Health (ESOH), requires all DoD organizations to plan, program and budget to manage ESOH risks generated by their activities and to “evaluate all activities for current and emerging ESOH resource requirements…” . e Directive further requires DoD organizations to identify and analyze operational and financial risks of emerging ESOH issues. e Office of the Deputy Under Secretary of Defense for Installations and Environment (DUSD[I&E]), Emerging Contaminants (EC) Directorate is charged with the responsibility of identifying, assessing and managing risks to the Department of Defense (DoD) from ECs. is project presents results and recommendations from the Phase I Impact Assessments conducted to identify risks to the DoD from anticipated toxicity value/regulatory changes for various ECs. Based on results of the Phase I Impact Assessments, recommendations are made to move a high risk EC to the Action List, maintain the EC on the Watch List or discard a low risk EC. H H L Probability Adverse Impact Readiness & Training Acquisition/RDT&E ES&H O&M of Assets Cleanup Severity of Impact H H L Probability Adverse Impact Severity of Impact ICAT Data Entry and Output Screens PFOA Risk Matrix Beryllium Risk Matrix Beryllium Risk Matrix Six-step Process for Determining the Likelihood of Change in Toxicity Value/Regulatory Drivers for an EC of Interest 1. Define specific question for EC and media of interest. 3. Determine elements needed to revise or create new legal/policy drivers. 4. Identify available data/information and data gaps. 6. Determine qualitative likelihood of change to legal/policy drivers based on assessment of resources required. 5. Estimate the resources required to revise or create new legal/policy drivers. 2. Determine current status of legal/ policy drivers for EC/media of interest. Readiness & Training Acquisition/RDT&E ES&H O&M of Assets Cleanup H H L Probability Severity of Impact 1-5 yrs L M H Probability Timeframe Probability Timeframe 1. Probability that the USEPA will revise the IRIS toxicity benchmarks for beryllium L M H L M H 1-5 yrs 2. Probability that OSHA will revise the occupational exposure standards for beryllium Likelihood of Toxicity Value/Regulatory Change Note: ACGIH will likely reduce the TLV-TWAs for beryllium in the next 2-5 yrs. Air Force and for beryllium in the next 2-5 yrs. Air Force and Army policy directs that ACGIH TLVs will be met where they are lower than the OSHA PEL.

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Page 1: Phase I Impact Assessments for Emerging Contaminants

The first step is to assess the likelihood of toxicity value/regulatory change for the EC. The assessment is conducted by a regulatory specialist who evaluates the likelihood that a regulatory change will occur given the current regulatory status, the requirement(s) for change, state of the science, and other technical, resource, and legal constraints

The second step in the Phase I Impact Assessment process consists of gathering ordering and usage information, release and disposal data and Defense Environmental Restoration Program (DERP) data from appropriate Office of the Secretary of Defense and component organizations. Additional searches are performed to gather technical and scientific information (e.g., physicochemical properties, analytical methods and detection levels, toxicity benchmarks and applicable regulations and guidelines). The information and data acquired are organized and summarized for later evaluation.

The data gathering process looks across the following functional areas tocapture a full range of issues:• Environment, Safety and Health• Training / Readiness (T&R)• Acquisition / Research, Development, Testing, and Evaluation (RDT&E)• Production, Operations, Maintenance, and Disposal (POMD) of Assets• Cleanup

Maintain on Watch List• Tungsten• 1, 4-dioxane• DNT• PFOS• PCE• Dioxin• Lead• Nickel

Elevate to Action List• Beryllium• PFOA

Maintain on Action List• Perchlorate• Naphthalene• Hexavalent chromium• TCE• RDX

Remove• NDMA• 1, 2, 3-TCP• PBDEs• Dichlorobenzenes

The third step, SME integration and evaluation function, relies on SMEs from within the DoD assessing and reaching consensus on the potential impacts to the DoD from changing toxicity value/regulatory drivers. The SMEs consider the likelihood of change to the toxicity value/regulatory drivers, the background data on the EC (e.g., DoD usage, disposal, releases, etc.) and their expertise related to the EC to determine the potential impacts on the five DoD functionalareas, referenced above. The SMEs perform the integration function in person or via teleconference in a Phase I meeting. The Impact Criteria Assessment Tool (ICAT) (developed by CTC) is used to guide the SMEs through a series of questions to analyze the likelihood and severity of risk to the DoD from the anticipated toxicity value/regulatory change to the EC of interest.

The final step of the Phase I Impact Assessment process was integrate the likelihood of toxicity value/regulatory change with the risk areas Identified by the SME. The overall results were briefed to the service Secretariats and the OSD senior leadership.

The results of the Phase I Impact Assessments were briefed to DoD senior leadership to foster an integrated Risk management approach.

The Office of the Deputy Under Secretary of Defense for Installations and Environment (DUSD[I&E]), Emerging Contaminants (EC) Directorate is implementing a structured process to identify, assess, and manage the risks posed to the department by ECs. The EC Directorate maintains an inventory of ECs divided into an Action List for high priority chemicals and a Watch List for medium priority chemicals. The EC Directorate uses the Phase I Impact Assessment process to examine ECs on the Watch List to examine 1) the likelihood of potential changes in toxicity values/regulatory status and 2) the potential impacts of these changes the department’s operations in five functional areas. On behalf of the EC Directorate and in collaboration with others Noblis, has assisted DoD in examining the potential impacts from 18 ECs. At the completion of the assessments, two of the ECs evaluated (beryllium and PFOA) were nominated for the Action List due to the significant potential risks posed and four of the ECs evaluated (NDMA, 1,2,3-trichloropropane, PBDEs, and dichlorobenzenes) were recommended for removal from the Watch List. It was recommended that the remaining chemicals be maintained on the Watch List. These assessments bring to the total number of chemicals on the Action List to seven and the total number of chemicals on the Watch List to fourteen. The next step is to develop risk management options for those chemicals on the Action List as part of an integrated risk management framework.

The potential risks to the DoD are solicited from Subject Matter Experts (SMEs). The input from the SMEs is entered into the ICAT, which plots the risks to DoD.

Phase I Impact Assessments for Emerging Contaminants: Process and ResultsAndrew Rak, Cathy M. Vogel, and Whitney W. Glaccum

Noblis, Falls Church, VA

The Phase I Impact Assessment process consists of three primary activities: (1) a likelihood of toxicity

value/regulatory change analysis, (2) background data/information queries

and (3) an integration and evaluation

function using subject matter experts (SMEs) from various DoD components.

Introduction

Process

Step 1 – Assessment of ToxicityValue/Regulatory Change

Step 2 – Data Collection

Impact Criteria Assessment Tool (ICAT)

Step 3 – SME Integration and Evaluation Function

Conclusions

Recommendations

Final Phase I Conclusions

Final Output for Phase I Impact Assessment

AcknowledgementsDeveloped for:

Deputy Under Secretary of Defense (Installations and Environment) Emerging Contaminants Directorate http://www.acq.osd.mil/ie/index.htm

Developed under Contract for:Air Force Center for Engineering and the Environment

http://www.brooks.af.mil/afioh/

Special Assistance Provide by:US Army Center for Health Promotion and Preventative Medicine

Department of Defense (DoD) Directive 4715.1E, Environment, Safety and Occupational Health (ESOH), requires all DoD organizations to plan, program and budget to manage ESOH risks generated by their activities and to “evaluate all activities for current and emerging ESOH resource requirements…” . The Directive further requires DoD organizations to identify and analyze operational and financial risks of emerging ESOH issues. The Office of the Deputy Under Secretary of Defense for Installations and Environment (DUSD[I&E]), Emerging Contaminants (EC) Directorate is charged with the responsibility of identifying, assessing and managing risks to the Department of Defense (DoD) from ECs. This project presents results and recommendations from the Phase I Impact Assessments conducted to identify risks to the DoD from anticipated toxicity value/regulatory changes for various ECs. Based on results of the Phase I Impact Assessments, recommendations are made to move a high risk EC to the Action List, maintain the EC on the Watch List or discard a low risk EC.

H

HL

Pro

babi

lity

Adv

erse

Impa

ct

Readiness & Training Acquisition/RDT&E

ES&H

O&M of AssetsCleanup

Severity of ImpactH

H

L

Pro

babi

lity

Adv

erse

Impa

ct

Severity of Impact

ICAT Data Entry and Output Screens

PFOA Risk MatrixBeryllium Risk Matrix

Beryllium Risk Matrix

Six-step Process for Determining the Likelihood of Change in Toxicity Value/Regulatory Drivers for an EC of Interest

1. Define specific question for EC and media of interest.

3. Determine elements needed to revise or create new legal/policy drivers.

4. Identify available data/information and data gaps.

6. Determine qualitative likelihood of change to legal/policy drivers based on assessment of resources required.

5. Estimate the resources required to revise or create new legal/policy drivers.

2. Determine current status of legal/ policy drivers for EC/media of interest.

Readiness & Training Acquisition/RDT&E

ES&H

O&M of AssetsCleanup

H

H

L

Pro

babi

lity

Severity of Impact

1-5 yrs

L

M

H

Probability Timeframe Probability Timeframe

1. Probability that the USEPA will revise the IRIS toxicity benchmarks for beryllium

L

M

H

L

M

H

1-5 yrs

2. Probability that OSHA will revise the occupational exposure standards for beryllium

Likelihood of Toxicity Value/Regulatory Change

Note: ACGIH will likely reduce the TLV-TWAs for beryllium in the next 2-5 yrs. Air Force and for beryllium in the next 2-5 yrs. Air Force and Army policy directs that ACGIH TLVs will be met where they are lower than the OSHA PEL.