1. International Aerospace Environmental Group
Toxic Substances Control Act (TSCA)
Section 6 Risk Evaluation Framework
March 15, 2018

2. Topics Overview of TSCA Inventory Notification Prioritization
Sections Changed under Amended TSCA
Inventory Notification
Prioritization
Risk Evaluation
Risk Management
TSCA Work Plan Chemicals List
Case Study
Looking Forward

3. Overview of TSCA Section 2 -- Findings Section 3 -- Definitions
Section 4 -- Chemical Testing
Section 5 -- New Chemicals
Section 6 -- Existing Chemicals
Section 7 -- Imminent Hazard
Section 8 -- Reporting and Recordkeeping
Section 9 -- Relationship to Other Laws
Section Research Conducted by U.S. Environmental Protection Agency (EPA)
Section Inspections
Section Exports
Section Imports
Section Disclosure of Data
Section Prohibited Acts
Section Penalties
Section Enforcement and Seizure
Section Preemption
Section Judicial Review
Section Citizens Civil Actions
Section Citizens Petitions
Section National Defense Waiver
Section Employee Protection
Section Employee Effects
Section Administration of the Act
Section Development and Evaluation of Test Methods
Section State Program
Section Authorization for Appropriations
Section Annual Report

4. Amended TSCA
The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) (amended TSCA) fundamentally changed the U.S. federal approach to chemicals management
Introduces new concepts and approaches
Reflects careful balancing of interests
Centralizing concept is unreasonable risk, the evaluation of which:
Does not include consideration of cost/benefit factors
Focuses on conditions of use as determined by EPA
Includes consideration of potentially exposed or susceptible subpopulations identified as relevant by EPA

5. Overview of TSCA -- Sections Significantly Revised under Amended TSCA
Section 2 -- Findings
Section 3 -- Definitions
Section 4 -- Chemical Testing
Section 5 -- New Chemicals
Section 6 -- Existing Chemicals
Section 7 -- Imminent Hazard
Section 8 -- Reporting and Recordkeeping
Section 9 -- Relationship to Other Laws
Section Research Conducted by EPA
Section Inspections
Section Exports
Section Imports
Section Disclosure of Data
Section Prohibited Acts
Section Penalties
Section Enforcement and Seizure
Section Preemption
Section Judicial Review
Section Citizens Civil Actions
Section Citizens Petitions
Section National Defense Waiver
Section Employee Protection
Section Employee Effects
Section Administration of the Act
Section Development and Evaluation of Test Methods
Section State Program
Section Authorization for Appropriations
Section Annual Report

6. Key Changes New chemicals and significant new uses
Existing chemicals prioritization, risk evaluation, and risk management
Preemption
Information gathering and confidential business information
Testing
Fees

7. Inventory Notification
Reporting rule to obtain information on active chemicals
Addresses issue of understanding which chemicals on the TSCA Inventory are “active” in commerce versus those that are “inactive”
Inactive substances may not be manufactured, imported, or processed without first notifying EPA
Required reporting on chemicals manufactured or imported during look-back period was due February 7, 2018
Voluntary reporting for chemicals processed, due October 5, 2018
EPA to designate chemicals as active or inactive
Not an Inventory reset
Both active and inactive chemicals remain on Inventory
Final list of active chemicals anticipated December 2018

10. Section 6 -- Prioritization, Risk Evaluation, Risk Management
Prioritization -- If high priority, EPA must conduct a risk evaluation
Risk evaluation -- If unreasonable risk, EPA must proceed to risk management
Risk management -- EPA must manage risk to the extent necessary

11. Section 6 -- Prioritization
EPA to focus on active chemicals for prioritization
EPA currently working on “pre-prioritization” approaches
Pre-prioritization approach(es) to be implemented June
Prioritization to begin December 2018
Timeframe/opportunity for input
90 days after EPA initiates prioritization
Public to submit relevant information
EPA can extend up to 3 months
90 days after EPA publishes priority designation
At publication, EPA provides basis for decision

12. Section 6 -- Prioritization
Outcomes
HIGH Priority or LOW Priority
High priority: May present an unreasonable risk because of a potential hazard and a potential exposure
Low priority: Does not meet this standard
Where information is insufficient to support low priority, default decision is high priority

13. Section 6 -- Prioritization
Criteria in identifying high priority -- per legislation
Consideration of hazard and exposure potential
Persistence (P), bioaccumulation (B)
Subpopulations
Storage near drinking water
Conditions of use or significant changes in conditions of use
Volume or significant changes in volume

14. Section 6 -- Prioritization
Preference for high priority designation to be given
Chemicals on the 2014 TSCA Work Plan for Chemical Assessments with a P and B score of 3
Chemicals on the 2014 TSCA Work Plan for Chemicals Assessments that are:
Known human carcinogens; and
Have high acute and chronic toxicity

16. Section 6 -- Risk Evaluation
Chemicals designated as high priority MUST undergo risk evaluation
Centralizing concept is unreasonable risk, the evaluation of which:
Does not include consideration of cost/benefit factors
Focuses on conditions of use as determined by EPA
Includes consideration of potentially exposed or susceptible subpopulations identified as relevant by EPA
Legislation requires EPA to derive 50% of risk evaluations within the first 3.5 years from TSCA Work Plan list

17. Section 6 -- Risk Evaluation: Timing and Public Input
Draft scope -- Published no later than 3 months from risk evaluation initiation
45-Day public comment period
Final scope -- Published no later than 6 months after risk evaluation
Draft risk evaluation
60-Day public comment period
Final risk evaluation
To be issued no later than 3 to 3.5 years after identification of chemical as high priority

18. Section 6 -- Risk Evaluation
Assessment of hazard and exposure
Conditions of use -- Industry stakeholders will need to provide relevant information for EPA assessment
Description of industry
How is chemical used?
Solvent, reactant, formulant, additive?
Concentrations used in processing?
Processing equipment
Enclosed, controlled release, open?
Batch or continual processing
Temperature used during processing?
Physical form of chemical during processing
Storage of chemical on site
Tanks, bulk containers, totes?
Is chemical present in final product?
Intentionally or unintentionally?
Location of processing materials
How is waste chemical treated?
Wastewater, recycling, off site
Environmental controls
Environmental releases
Permits (federal, state)
Worker exposure controls
Applicable worker exposure limits
Typical personal protective equipment (PPE) used

20. Section 6 -- Risk Management
Chemicals found to present unreasonable risk must proceed to risk management
Risks to be managed to the extent necessary
Exemptions if:
Specific condition of use is critical or essential
No technically and economically feasible safer alternative is available, taking into consideration hazard and exposure;
Compliance with risk management would significantly disrupt national economy, national security, or critical infrastructure; or
Specific condition of use, as compared to reasonably available alternatives, provides substantial benefit to health, the environment, or public safety

22. Section 6 -- Mandated Timelines
Once a chemical begins prioritization process, EPA will make a prioritization designation within 12 months
Once a chemical is designated as high priority, EPA will immediately initiate a risk evaluation
EPA shall complete a risk evaluation no later than 3 years after initiation (with possible 6-month extension)
If EPA finds the chemical presents a risk, risk management must be issued within 2 years (with 2- year extension possible)
How do these timeframes compare with those needed to make full scale changes in commercial markets/processes?

23. What Is the 2014 TSCA Work Plan?
Developed under Obama Administration
Goal is to focus and direct the activities of its Existing Chemicals Program
First list of chemicals issued in 2012; updated in
About 90 chemicals or chemical categories listed
Reminder: EPA to give prioritization preference to TSCA Work Plan chemicals meeting set parameters
Reminder: Legislation requires at least 50% of ongoing risk evaluations to come from TSCA Work Plan chemicals list

24. Case Study: Bisphenol A
Included on 2014 TSCA Work Plan list
Hazard Criteria
Met
Hazard
Score
Exposure Criteria
Exposure
P&B Criteria Met
P&B Score
Use
Reproductive toxicity 3
Electrical and electronics equipment, optical media, linings in drinking water pipes, thermal paper coatings, automotive transportation equipment
Low environmental persistence
Low bioaccumulation potential 1
Consumer
Industrial

25. Case Study: Bisphenol A
Prioritization
Hazard potential
Score of 3 out of 3, reproductive toxicity concerns
Exposure potential
Score of 3 out of 3
P, B
Score of 1 out of 3
Subpopulations of concern
Women of childbearing age, children, workers
Storage near drinking water
Not clear if stored near drinking water, but used in drinking water pipes
Conditions of use
Widespread consumer and industrial uses
Volume
High production volume

26. Case Study: Bisphenol A
Risk evaluation
No consideration of cost/benefit factors
EPA to evaluate for all conditions of use
EPA to evaluate for all potential exposed populations
Including subpopulations

27. Case Study: Bisphenol A
Conditions of use
Description of industry
How is chemical used?
Solvent, reactant, formulant, additive?
Concentrations used in processing?
Processing equipment
Enclosed, controlled release, open?
Batch or continual processing
Temperature used during processing?
Physical form of chemical during processing
Storage of chemical on site
Tanks, bulk containers, totes?
Is chemical present in final product?
Intentionally or unintentionally?
Location of processing facilities
How is waste chemical treated?
Wastewater, recycling, off site
Environmental controls
Environmental releases
Permits (federal, state)
Worker exposure controls
Applicable worker exposure limits
Typical PPE
Potentially exposed or susceptible subpopulations
Women
Workers
Children

28. Case Study: Bisphenol A
Risk management “to the extent necessary”
Exemptions if:
Specific condition of use is critical or essential and no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure;
Compliance with risk management would significantly disrupt national economy, national security, or critical infrastructure; or
Specific condition of use, as compared to reasonably available alternatives, provides substantial benefit to health, the environment, or public safety

29. Looking Forward -- Expected EPA Actions
Implementation/regulatory actions
2018: Fees rulemaking
December 2018: Final active/inactive list published
Ongoing: Risk evaluations for first 10 chemicals
Policy, procedure, and guideline development
Enforcement actions?
Unclear how aggressive EPA will be in enforcement
February 16, 2018, Bloomberg BNA article, “EPA Collecting Half the Penalties Under Trump as Predecessors”
Concerns with finding chemicals not on the Inventory during review for active notification 

30. Looking Forward -- EPA Reality
Short deadlines for mandated rulemakings
Staff shortages in addition to retirements
Funding for contractor support limited and time intensive
Litigation outcomes?

31. Looking Forward -- Suggestions for International Aerospace Environmental Group
Remain engaged as companies or as members of trade associations
Do not rely on others to comment; make your case
Think strategically -- Chemicals likely to be highly restricted will fall into disuse and new formulations; take time to develop
Think creatively -- Consider alternatively- sourced chemical substance
Think big -- Sustainability will continue to drive business practices and limit product and tort liability

32. Thank You
Kathleen M. Roberts BERGESON & CAMPBELL, P.C Pennsylvania Avenue, N.W. Suite 100W Washington, D.C