webinar: tsca reform
TRANSCRIPT
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
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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
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
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
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
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
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
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: 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 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