Keynote: The long anticipated reform of TSCA in the US - Jim Jones, Former EPA Assistant Administrator for Chemicals Safety, USA

1. The Frank R Lautenberg
Chemical Safety for the
21st Century
James Jones
Helsinki Chemicals Forum

2. Outline
 Context
 Issues with TSCA
 Making a Law
 Key Features of Lautenberg Amendments
 First Year Implementation
 Existing Chemicals Schedule

3. Context
 What is TSCA?
 The Toxic Substances Control Act
 Jurisdiction: Chemicals that are not
Drugs, Cosmetics, Food Additives, or
Pesticides are under the jurisdiction of
TSCA.
 83,000 chemicals currently on the
TSCA Inventory; some subset are in
commerce

4. Political and Social Context
 Numerous States were regulating chemicals due
to lack of federal action
 Retailers were telling suppliers not to use
certain chemicals (private regulation)
 Concern over lack of US Global Leadership

5. Issues with TSCA
 Challenging Safety Standard (made more
challenging by 5th Circuit Court ruling (Corrosion
Proof Fittings)
 Least Burdensome Requirement
 Quantify and Monetize Risks and Benefits
 High bar to require generation of Health and Safety
Data
 Chemicals on the market when law passed in 1976
were grandfathered in with no requirement for EPA
to evaluate them.
 83,000 chemicals on the Inventory were
grandfathered in
 New Chemical review didn’t require an affirmative
finding EPA

6. Making of a Law
 3+ years of active work led by Senators Udall(D) and
Vitter(R) and Representatives Pallone(D) and Shimkus(R).
 House passed its version in June 2015 (1 no vote)
 Senate version passed in December 2015 (unanimous
consent)
 House and Senate worked from January 2016-May 2016 to
reconcile two very different bills.
 Lautenberg Chemical Safety for the 21st Century Act was
the result.
 Lautenberg Bill passed the House in May and the Senate in
June 2016
 President Obama signed it June 22, 2016

7. Key Features of Lautenberg
Amendments
 Risk based safety standard
 Elimination of least burdensome requirement
 Elimination of cost/benefit balancing standard
 Unreasonable risk standard
 Mandatory duty on EPA to review existing chemicals
Deadlines for pace of review and risk management
 New authority for requiring companies to generate safety
data
 Affirmative finding required for new chemicals
 Greater transparency with respect to chemical information
 Preemption of state law when EPA “occupies the field”

8. First Year Implementation
 EPA required to identify first 10 chemicals for
risk evaluation by Dec 19, 2016. On November
29, 2016 EPA announced the 1st 10 chemicals:
1,4-Dioxane, 1-Bromopropane, Asbestos, Carbon
Tetrachloride, Cyclic Aliphatic Bromide Cluster,
Methylene Chloride, N-methylprrolidone (NMP),
Pigment Violet 29, Tetrachloroethylene, and
Trichloroethylene (TCE).
 EPA published proposed Rules to restrict certain
uses of TCE, NMP and Methylene Chloride in
January 2016. Comment periods have ended.

9. First Year Implementation
 EPA is EPA is required to finalize 3 “framework
rules” that will guide Implementation by June 19,
2017. EPA proposed rules in January, 2017 for Risk
Evaluation, Prioritization and the TSCA Inventory
(Active or Inactive). Comment periods are closed
and the final rules are in Interagency review
before being finalized
 EPA is required to publish the “scope” of the risk
evaluations by June 19,2017.
 EPA is beginning to eliminate the backlog of new
chemical submissions that developed with new
affirmative determination.

10. Existing Chemicals Schedule
 By Dec 2018, EPA must be actively
assessing 20 high priority chemicals.
 EPA must complete risk evaluations
including a determination of unreasonable
risk on high priority chemicals within 3
years (including the first 10 chemicals
identified in Nov 2016).
 EPA must identify another High Priority
chemical upon completion of a risk
evaluation.

11. Existing Chemicals Schedule
 If EPA determines that a chemical or its uses
presents an unreasonable risk, EPA must
propose a rule to eliminate the risk within 1
year of the determination. EPA has another
year to finalize the rule.
 If EPA determines a chemical is a low priority
a risk evaluation is not required.
 If EPA determines a chemical is a low priority,
or that it does not present an unreasonable
risk, or it regulates a chemical that poses an
unreasonable risk, states are “pre-empted”
from regulating the chemical.