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 ReviewNew 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 PreemptionUniform 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 InformationNew 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 PenaltiesStricter 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 ReportingReporting 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 2016Timeline 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. REACHKey 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 PulitzerRed-on-lineppulitzer@red-on-line.comwww.red-on-line.com