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TSCA Reform:
What’s next?
Chemical Safety in the US:
Where we’ve been
Where we are
Where we’re going
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
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
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
Frank R Lautenberg Chemical
Safety for the 21st Century Act
Key Facts
Timeline for Compliance
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
1. Broader EPA Authority and
Chemical Review
New Chemical Uses v. Existing Uses
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
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
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
2. State Preemption
Uniform National Approach
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
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
3. Confidential Business Information
New limits on CBI
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
4. Increased Penalties
Stricter Civil and Criminal Penalties
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
5. Mercury Reporting
Reporting Mandate and Export Restrictions
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
LCSA 2016
Timeline for Compliance: EPA & Regulated Community
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
LCSA 2016: How to Prepare
 Prepare Chemical Inventory
 Monitor Regulatory Alerts & Rule Proposals
 Understand Risks Related to Chemicals Used
 Prepare for new CBI Requirements
TSCA v. REACH
Key Differences
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
Philip Pulitzer
Red-on-line
ppulitzer@red-on-line.com
www.red-on-line.com

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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