Webinar: TSCA reform
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TSCA Reform: What’s next? Chemical Safety in the US.
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Webinar: TSCA reform
- 1. TSCA Reform: What’s next? Chemical Safety in the US: Where we’ve been Where we are Where we’re going
- 2. Table of Contents Introduction TSCA Review: Why Change Was Needed Frank R Lautenberg Chemical Safety for the 21st Century Act: Key Facts Timeline for Compliance How to Prepare TSCA v. REACH
- 3. Introduction to Red-on-line Red-on-line Global EHS Consulting, Content, and Software Company 500+ Blue-chip Clients 15,000+ Users 50+ Countries Covered Team of EHS Experts + Partners Learn more online: www.red-on-line.com Webinar Series TSCA Reform: More to come
- 4. TSCA Review: Why Change Was Needed TSCA Was an Old Rule Enacted 1976 with little change since Uniform agreement that change was needed RARE! Industry, EPA, Congress, ACC, Environmental Groups Agreed Change Needed Limited Regulatory Authority Corrosion Proof Fittings v. EPA: Asbestos Ruling Difficult for EPA to regulate even very dangerous chemicals Uncertainty State by state regulation created patchwork
- 5. Frank R Lautenberg Chemical Safety for the 21st Century Act Key Facts Timeline for Compliance
- 6. LCSA 2016: Key Facts Overall: Stronger More Comprehensive Approach 1. Broader EPA Authority and Stronger Chemical Review Process 2. State Preemption: Uniform Approach 3. Confidential Business Information (CBI) Overhaul 4. Increased Penalties: Civil + Criminal 5. Mercury Reporting
- 7. 1. Broader EPA Authority and Chemical Review New Chemical Uses v. Existing Uses
- 8. Existing Chemicals or Uses All Chemicals Subject to EPA Review (and potential regulation) 6 Months: 10 Chemicals Underway from EPA’s Work Plan Chemical List 1 Year: Create Risk-based screening process: high v. low priority 3.5 Years: 20 Ongoing Risk Evaluations High Priority “May present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential rout of exposure under the conditions of use, including an unreasonable risk to a potentially exposed or susceptible population” Industry Reporting Industry Reporting: Chemicals manufactured or processed last 10 years Results used to designate active v. inactive chemicals
- 9. High Priority Chemicals (Existing) Risk Evaluations High Priority Chemical Triggers Risk Evaluation Consider ONLY risks – not cost Purpose: Does the chemical pose unreasonable risk? Yes? Move to Risk Management Process Risk Management EPA to Issue Rule Limiting Unreasonable Risk: Proposed - 1 year/Final rule - 2 years CAN Consider Cost in determining how to regulate, but not whether to regulate Language “Least Burdensome Requirements” Removed EPA Must Address Specific Elements: Effects and magnitude of exposure; benefits of chemical; economic impacts; technically feasible alternatives EPA Has Broad Regulatory Authority – Restrictions Commensurate to Risks
- 10. New Chemicals or Uses More Testing and Reporting Authority Section 5: Pre-Manufacture Notices Manufacturer must notify EPA EPA has 90 days to make determination Must Consider: “Conditions of Use” Health Risks Vulnerable Populations Environment Must NOT Consider Cost Other Non-Risk based factors Section 4: Testing Requirements New authority to require the development of new information Assist in prioritization and risk evaluations EPA MUST explain its reasoning when requesting new information Vertebrate Testing: Reduce and Replace
- 11. 2. State Preemption Uniform National Approach
- 12. State Preemption: Uniform Approach States NOT Permitted to Require additional information about substance regulated by EPA Place restriction on substances determined by EPA not to pose unreasonable risk Impose new use notifications requirements on substances already regulated Impose Stricter Penalties States ARE Permitted to Enforce actions commenced before April 22, 2016 Enforce actions taken pursuant to state laws in effect before August 31, 2003 Implement reporting, monitoring, or information obligations Regulate water quality, air quality, and waste treatment Co-enforce federal laws
- 13. State Preemption: Loopholes? California Proposition 65 Passed by Referendum in 1980’s “Clear and Reasonable” Warning Before Exposure Bounty Hunter Lawsuits Remain – LCSA may offer businesses a new defense and possibly evidentiary support California Safer Consumer Products (“Green Chemistry”) Program Passed After August 31, 2002 Deadline
- 14. 3. Confidential Business Information New limits on CBI
- 15. Confidential Business Information Non-protected information: Manufacturing Volumes Descriptions of Process Used to Manufacture Substance Industrial, consumer, or commercial function of the chemical substance, mixture, or article Previously protected information if a substance is later banned New Procedure for CBI Claim More Access To CBI: Demonstration of Need
- 16. 4. Increased Penalties Stricter Civil and Criminal Penalties
- 17. Increased Penalties: Civil + Criminal Civil Penalties $37,500 per day per violation, up from $25,000 Criminal Penalties $50,000 per day per violation, up from $25,000 Imminent Danger Knowing or willful violation of TSCA with knowledge the violation will cause imminent danger of death or serious bodily injury Person: Up to 15 years in prison and/or $250,000 fine Company: $1,000,000 fine
- 18. 5. Mercury Reporting Reporting Mandate and Export Restrictions
- 19. Mercury Reporting EPA Required to Publish Inventory April 1, 2017 then every 3 years EPA Rule to Come re: Reporting by Manufacturers of Mercury, Mercury-Added Products, and those who use Mercury must make periodic reports Export Restrictions 2020 Mercury Chloride or calomel; mercury oxide, mercury sulfate, mercury nitrate, cinnabar or mercury sulphide Others likely to be added Exception for exports for environmentally sound disposal to OECD Members
- 20. LCSA 2016 Timeline for Compliance: EPA & Regulated Community
- 21. LCSA 2016: Initial Obligations Mandated Review Within 6 Months: Create Risk Evaluation Process to review/update Inventory Initial Risk Evaluations 10 Chemicals to begin Risk Evaluation Prioritization Process Risk Evaluation Process Step 1: Should a chemical be regulated? Consider a chemical’s hazardous and potential exposure; no non-risk factors considered (such as cost) Step 2: How should the chemical be regulated? Risk Management Rule: Health & Environmental effects + cost of implementing rule Inventory Review By June 2017: EPA issue rule for industry reporting chemicals manufactured in last 10 years
- 22. LCSA 2016: How to Prepare Prepare Chemical Inventory Monitor Regulatory Alerts & Rule Proposals Understand Risks Related to Chemicals Used Prepare for new CBI Requirements
- 23. TSCA v. REACH Key Differences
- 24. TSCA Reform Bill v. REACH REACH: Requires companies to develop information on a chemicals’ effects on human health and environment Chemical companies have responsibility to demonstrate that chemicals they place in the market do not adversely affect health or environment; LCSA 2016 Requires companies to notify EPA of intent to manufacture; EPA conducts risk evaluation and risk management process; EPA can require company to develop information only if it determines that it lacks enough information already EPA has responsibility to conduct risk assessments and risk management process