International Aerospace Environmental Group Toxic Substances Control Act

International Aerospace Environmental Group Toxic Substances Control Act (TSCA) Section 6 Risk Evaluation Framework March 15, 2018 Kathleen M. Roberts Bergeson & Campbell, P. C. Washington, D. C. www. lawbc. com © 2018 Bergeson & Campbell, P. C. All Rights Reserved.

Topics Overview of TSCA Ø Sections Changed under Amended TSCA Inventory Notification Prioritization Risk Evaluation Risk Management TSCA Work Plan Chemicals List Case Study Looking Forward © 2018 Bergeson & Campbell, P. C. All Rights Reserved. 2

Overview of TSCA Section 2 -- Findings Section 16 -- Penalties Section 3 -- Definitions Section 17 -- Enforcement and Seizure Section 4 -- Chemical Testing Section 18 -- Preemption Section 5 -- New Chemicals Section 19 -- Judicial Review Section 6 -- Existing Chemicals Section 20 -- Citizens Civil Actions Section 7 -- Imminent Hazard Section 21 -- Citizens Petitions Section 8 -- Reporting and Recordkeeping Section 22 -- National Defense Waiver Section 9 -- Relationship to Other Laws Section 23 -- Employee Protection Section 10 -- Research Conducted by U. S. Environmental Protection Agency (EPA) Section 24 -- Employee Effects Section 26 -- Administration of the Act Section 11 -- Inspections Section 27 -- Development and Evaluation of Test Methods Section 12 -- Exports Section 13 -- Imports Section 28 -- State Program Section 14 -- Disclosure of Data Section 15 -- Prohibited Acts Section 29 -- Authorization for Appropriations Section 30 -- Annual Report © 2018 Bergeson & Campbell, PC. All Rights Reserved. 3

Amended TSCA The Frank R. Lautenberg Chemical Safety for the 21 st Century Act (Lautenberg) (amended TSCA) fundamentally changed the U. S. federal approach to chemicals management Ø Introduces new concepts and approaches Ø Reflects careful balancing of interests Centralizing concept is unreasonable risk, the evaluation of which: Ø Does not include consideration of cost/benefit factors Ø Focuses on conditions of use as determined by EPA Ø Includes consideration of potentially exposed or susceptible subpopulations identified as relevant by EPA © 2018 Bergeson & Campbell, PC. All Rights Reserved. 4

Overview of TSCA -- Sections Significantly Revised under Amended TSCA Section 2 -- Findings Section 16 -- Penalties Section 3 -- Definitions Section 17 -- Enforcement and Seizure Section 4 -- Chemical Testing Section 18 -- Preemption Section 5 -- New Chemicals Section 19 -- Judicial Review Section 6 -- Existing Chemicals Section 20 -- Citizens Civil Actions Section 7 -- Imminent Hazard Section 21 -- Citizens Petitions Section 8 -- Reporting and Recordkeeping Section 22 -- National Defense Waiver Section 9 -- Relationship to Other Laws Section 23 -- Employee Protection Section 10 -- Research Conducted by EPA Section 24 -- Employee Effects Section 11 -- Inspections Section 26 -- Administration of the Act Section 12 -- Exports Section 13 -- Imports Section 27 -- Development and Evaluation of Test Methods Section 14 -- Disclosure of Data Section 28 -- State Program Section 15 -- Prohibited Acts Section 29 -- Authorization for Appropriations Section 30 -- Annual Report © 2018 Bergeson & Campbell, PC. All Rights Reserved. 5

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 © 2018 Bergeson & Campbell, PC. All Rights Reserved. 6

Inventory Notification Reporting rule to obtain information on active chemicals Ø Addresses issue of understanding which chemicals on the TSCA Inventory are “active” in commerce versus those that are “inactive” Ø 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 Ø Voluntary reporting for chemicals processed, due October 5, 2018 EPA to designate chemicals as active or inactive Ø Not an Inventory reset Ø Both active and inactive chemicals remain on Inventory Ø Final list of active chemicals anticipated December 2018 © 2018 Bergeson & Campbell, PC. All Rights Reserved. 7

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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 © 2018 Bergeson & Campbell, PC. All Rights Reserved. 10

Section 6 -- Prioritization EPA to focus on active chemicals for prioritization EPA currently working on “pre-prioritization” approaches Ø Pre-prioritization approach(es) to be implemented June 2018 Ø Prioritization to begin December 2018 Timeframe/opportunity for input Ø Ø 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 © 2018 Bergeson & Campbell, P. C. All Rights Reserved. 11

Section 6 -- Prioritization Outcomes HIGH Priority or LOW Priority Ø High priority: May present an unreasonable risk because of a potential hazard and a potential exposure Ø Low priority: Does not meet this standard Ø Where information is insufficient to support low priority, default decision is high priority © 2018 Bergeson & Campbell, PC. All Rights Reserved. 12

Section 6 -- Prioritization Criteria in identifying high priority -- per legislation Ø Consideration of hazard and exposure potential • Persistence (P), bioaccumulation (B) • Subpopulations • Storage near drinking water Ø Conditions of use or significant changes in conditions of use Ø Volume or significant changes in volume © 2018 Bergeson & Campbell, PC. All Rights Reserved. 13

Section 6 -- Prioritization Preference for high priority designation to be given Ø Chemicals on the 2014 TSCA Work Plan for Chemical Assessments with a P and B score of 3 Ø Chemicals on the 2014 TSCA Work Plan for Chemicals Assessments that are: • Known human carcinogens; and • Have high acute and chronic toxicity © 2018 Bergeson & Campbell, PC. All Rights Reserved. 14

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Section 6 -- Risk Evaluation Chemicals designated as high priority MUST undergo risk evaluation Centralizing concept is unreasonable risk, the evaluation of which: Ø Does not include consideration of cost/benefit factors Ø Focuses on conditions of use as determined by EPA Ø 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 © 2018 Bergeson & Campbell, P. C. All Rights Reserved. 16

Section 6 -- Risk Evaluation: Timing and Public Input Draft scope -- Published no later than 3 months from risk evaluation initiation Ø 45 -Day public comment period Final scope -- Published no later than 6 months after risk evaluation Draft risk evaluation Ø 60 -Day public comment period Final risk evaluation Ø To be issued no later than 3 to 3. 5 years after identification of chemical as high priority © 2018 Bergeson & Campbell, PC. All Rights Reserved. 17

Section 6 -- Risk Evaluation Assessment of hazard and exposure Conditions of use -- Industry stakeholders will need to provide relevant information for EPA assessment Ø Ø Ø Ø Ø 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? © 2018 Bergeson & Campbell, PC. All Rights Reserved. Ø Location of processing materials Ø How is waste chemical treated? • Wastewater, recycling, off site Ø Environmental controls Ø Environmental releases • Permits (federal, state) Ø Worker exposure controls Ø Applicable worker exposure limits Ø Typical personal protective equipment (PPE) used 18

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Section 6 -- Risk Management Chemicals found to present unreasonable risk must proceed to risk management Ø Risks to be managed to the extent necessary Ø 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 © 2018 Bergeson & Campbell, PC. All Rights Reserved. 20

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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? © 2018 Bergeson & Campbell, PC. All Rights Reserved. 22

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 2014 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 © 2018 Bergeson & Campbell, PC. All Rights Reserved. 23

Case Study: Bisphenol A Included on 2014 TSCA Work Plan list Hazard Criteria Met Hazard Exposure Criteria Score Met Reproductive toxicity 3 Exposure Score Electrical and 3 electronics equipment, optical media, linings in drinking water pipes, thermal paper coatings, automotive transportation equipment © 2018 Bergeson & Campbell, PC. All Rights Reserved. P&B Criteria Met P&B Use Score Low 1 environmental persistence Low bioaccumulation potential Consumer Industrial 24

Case Study: Bisphenol A Prioritization Ø Hazard potential Score of 3 out of 3, reproductive toxicity concerns Ø Exposure potential Score of 3 out of 3 Ø P, B Score of 1 out of 3 Ø Subpopulations of concern Women of childbearing age, children, workers Ø Storage near drinking water Not clear if stored near drinking water, but used in drinking water pipes Ø Conditions of use Widespread consumer and industrial uses Ø Volume High production volume © 2018 Bergeson & Campbell, PC. All Rights Reserved. 25

Case Study: Bisphenol A Risk evaluation Ø No consideration of cost/benefit factors Ø EPA to evaluate for all conditions of use Ø EPA to evaluate for all potential exposed populations Including subpopulations © 2018 Bergeson & Campbell, P. C. All Rights Reserved. 26

Case Study: Bisphenol A § Conditions of use Ø Description of industry Ø How is chemical used? • Solvent, reactant, formulant, additive? Ø Concentrations used in processing? Ø Processing equipment • Enclosed, controlled release, open? Ø Batch or continual processing Ø Temperature used during processing? Ø Physical form of chemical during processing Ø Storage of chemical on site • Tanks, bulk containers, totes? Ø Is chemical present in final product? • Intentionally or unintentionally? Ø Location of processing facilities Ø How is waste chemical treated? • Wastewater, recycling, off site Ø Environmental controls Ø Environmental releases • Permits (federal, state) Ø Worker exposure controls Ø Applicable worker exposure limits Ø Typical PPE § Potentially exposed or susceptible subpopulations Ø Women Ø Workers © 2018 Bergeson & Campbell, PC. All Rights Reserved. Ø Children 27

Case Study: Bisphenol A Risk management “to the extent necessary” Exemptions if: Ø Specific condition of use is critical or essential and no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; Ø Compliance with risk management would significantly disrupt national economy, national security, or critical infrastructure; or Ø Specific condition of use, as compared to reasonably available alternatives, provides substantial benefit to health, the environment, or public safety © 2018 Bergeson & Campbell, PC. All Rights Reserved. 28

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

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? © 2018 Bergeson & Campbell, PC. All Rights Reserved. 30

Looking Forward -- Suggestions for International Aerospace Environmental Group Remain engaged as companies or as members of trade associations Ø 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 alternativelysourced chemical substance Think big -- Sustainability will continue to drive business practices and limit product and tort liability © 2018 Bergeson & Campbell, P. C. All Rights Reserved. 31

Thank You Kathleen M. Roberts BERGESON & CAMPBELL, P. C. 2200 Pennsylvania Avenue, N. W. Suite 100 W Washington, D. C. 20037 kroberts@lawbc. com www. lawbc. com http: //www. tscablog. com © 2018 Bergeson & Campbell, PC. All Rights Reserved. 32