W1: Using Supply Chain Information in Risk Assessment

Kelly Mayo-Bean Lead Instructor
ERM
Syracuse, NY 
United States of America
 
Mon, 10/17: 8:00 AM - 5:00 PM EDT
Workshop Full Day 
Galt House Hotel 
Room: Lily 

Description

Bringing new industrial chemicals to market in the U.S. has become more challenging since the passage of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amends the 1976 Toxic Substances Control Act (TSCA). Under TSCA, the U.S. Environmental Protection Agency must evaluate chemicals across their entire lifecycles and prevent potential risks to workers, the general population, sensitive subpopulations, consumers, and the environment. Access to detailed information about exposure impacts for populations along the supply chain substantially influences review timelines and regulatory outcomes. Therefore, providing this information is critical to reducing delays, identifying risk concerns in advance of submitting chemicals for review, and strengthening internal hazard communication.

This workshop will analyze changes under TSCA that impact the introduction of new chemicals and use an interactive case study to show what supply chain vocabulary to use and which critical elements to highlight when developing information for new chemical submissions. The case study will also demonstrate the EPA's ChemSTEER and E-FAST exposure and release models, which are used for screening level risk assessment under TSCA.

Learning Objectives

After completing this workshop, participants will be able to:

• Describe changes in the new chemical review framework under the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act and why those changes are making new chemical introductions more complicated.
• Demonstrate a basic understanding of exposure assessment and the proper documentation of chemical supply chains.
• Predict how supply chain information will be used in the risk assessment paradigm and influence regulatory decisions.
• Anticipate how the EPA will incorporate information from new chemical applications in exposure models to support chemical risk assessment and risk management actions.
 

Course Outline

Part A of this session will orient the audience to TSCA changes that impact the chemical introduction process. The presenter will provide an overview of common supply chain vocabulary and critical elements that should be highlighted when developing supply chain information for new chemical submissions. These include operation definitions, the importance and impact of chemical states, characterizing common activities associated with exposure and release, and identifying the correct level of detail to support a reasonable and accurate evaluation. This will be demonstrated through interactive development of a case document for a multi-tier supply chain.

Part B of this session will use the case study completed in Part A as the basis for demonstrating the EPA exposure and release models ChemSTEER and E-FAST, which are used for screening level risk assessments under TSCA. Participants are welcome to download the software prior to attendance and follow along. Upon completion of the demonstration, we will discuss the results of the models and highlight important outcomes from the assessment. Part B will cover basic physical-chemical testing that can inform supply chain-based exposure assessments and show how results fit into the risk assessment paradigm and inform regulatory decisions.
 

Risk Assessments

Exposure Considerations based on chemical use

Certified Professional Product Steward Domain Alignment

Domain I: Assessment, Impact Analysis, & Risk Management

Content Level

Intermediate

Interactivity and Engagement

Demo
Q&A

Transfer of Knowledge

Group activities
Hands-on demonstrations and practicum