Chemical Regulation: Preparing to Address the Challenges Ahead

• Date: 01 January 2009

1-2009 NEWS & A NALYSIS 39 ELR 100291-2009 NEWS & A NALYSIS 39 ELR 10029

Chemical

Regulation:

Preparing to

Address the

Challenges Ahead

by Lynn L. Bergeson

Lynn L. Bergeson is the Managing Director of Bergeson &

Campbell, P.C., a Washington, D.C., law f‌irm focusing on

chemical, pesticide, and other specialty chemical product

approval and regulation, environmental, health, and safety law,

chemical product litigation, and associated business issues. The

views expressed in this Article are entirely those of the author.

Editors’ Summary:

There are increasing calls for signif‌icant reform of how

chemicals are regulated in the United States. The advent

of the European Registration, Evaluation, Authorization,

and Restriction of Chemicals system, rapid commercial-

ization of nano-enabled products, increased consumer

awareness, and proliferation of retailer initiatives have

all fundamentally changed the chemical regulatory

landscape. In order to navigate this new territory and to

make any reforms meaningful, it is vital to understand

the implications of both global and domestic chemical

management programs, educate congressional staff about

chemical management, and identify and agree to common

principles upon which any reform efforts should be based.

The environment has enjoyed unprecedented attention as

a presidential campaign issue. While climate change,

energy, and resource issues dominate, chemical regula-

tion reform is plainly a topic gathering steam. As we approach

a new year, a new Administration, and a new Congress, there

is much to consider. Issues pertinent to chemical management

are complicated, the rhetoric is strident, and areas on which

stakeholders agree appear to be few and far between. This

Article offers a few thoughts on how best to prepare for effec-

tive chemical regulation reform.

I. The Changing Playing Field

Debate over the Toxic Substances Control Act’s (TSCA’s)1

strengths and weaknesses is as old as the law itself.2 What is

new is the radically different playing f‌ield on which this debate

will play out over the next congressional sessions. Several

events have changed fundamentally the playing f‌ield and are

both fueling the momentum that will result in TSCA reform

and inf‌luencing the content of the change itself.

A. REACH

The European Union’s ( EU’s) newly enacted comprehensive

regulation for industrial chemicals is, to use the parlance

of the day, a game changer. Adopted in 2006, the Registra-

tion, Evaluation, Authorization, and Restriction of Chemicals

(REACH)3 regulation covers all chemicals, both new and

existing, produced in or imported into the EU in quantities

above one metric tonne per year and requires that each be

registered. W hile there are certain exemptions for low risk

chemicals, the European Chemicals Agency (ECHA), the

new agency created to manage and coordinate REACH

implementation, expects to register some 30,0 00 chemicals.

A dossier must be prepared and submitted on all chemicals,

which w ill be evaluated against a base set of toxicological

data requirements, with ascending levels of data depending

upon production volume. For chemicals produced in quanti-

ties above 10 metric tonnes, a more extensive chemical safety

report is required.

The evaluation component of REACH involves a complete-

ness check for compliance and other related reviews intended

1. 15 U.S.C. §§2601-2692.

2. Several Government Accountability Off‌ice (GAO) reports have catalogued TS-

CA’s strengths and weaknesses. See, e.g., U.S. GAO, CHEMICAL REGULATION: OP-

TIONS EXIST TO IMPROVE EPA’S ABILITY TO ASSESS HEALTH RISKS AND MANAGE ITS

CHEMICAL REVIEW PROGRAM (2005) (GAO-05-458); U.S. GAO, CHEMICAL REGU-

LATION: ACTIONS ARE NEEDED TO IMPROVE THE EFFECTIVENESS OF EPA’S CHEMICAL

REVIEW PROGRAM (2006) (GAO-06-1032T). Prominent public interest groups

also have long criticized TSCA and have called for chemical reform. See, e.g.,

RICHARD A. DENISON, NOT THAT INNOCENT: A COMPARATIVE ANALYSIS OF CANA-

DIAN, EUROPEAN UNION, AND UNITED STATES POLICIES ON INDUSTRIAL CHEMICALS

(2007).

3. EC 1907/2006, available at http://ec.europa.eu/environment/chemicals/reach/

reach_intro.htm.