Global Chemical Regulation: TSCA and Its International Counterparts

Agenda and Course Outline

An overview of the course and summary of key provisions of TSCA.

How EPA developed and maintains its inventory of chemical substances, and how chemical manufacturers, importers, processors, and users of chemical substances can use this tool to comply with the law.

How to apply the many rules that determine when a pre-manufacture notification (PMN) must be filed, and how to determine whether exemptions apply and when manufacture or import may begin.

TSCA Enforcement – Trends and Developments

How to prepare a PMN and secure EPA approval prior to manufacturing or importing a new chemical substance.

How to determine whether EPA has exercised its broad authority to require testing for chemical substances and to impose restraints on their manufacture, distribution and use under Significant New Use Rules (SNURs).

How to comply with requirements to certify compliance with TSCA for U.S. Customs and Border Protection at the time that a chemical substance is imported, and how to provide notification to EPA for foreign governments about chemical exports from the United States.

An invaluable opportunity to discuss your specific concerns with the instructors and your colleagues.

How to comply with requirements imposed under the Preliminary Assessment Information Rule the Notice of Commencement of Import or Manufacture, the Inventory Update Rule, and how to maintain a system to keep records of allegation of significant adverse reactions, and to respond to EPA requests for health and safety studies.

How to comply with industry reporting requirements for “significant risk” information, including EPA’s June 3, 2003 revisions to the 1978 “Statement of Interpretation and Enforcement Policy; Notification of Substantial Risk,” which sets forth EPA’s interpretation of industry reporting obligations under TSCA § 8(e).

Enforcement and Self-Protection Issues
Stanley W. Landfair, Esq. 

Civil penalties under TSCA are among the highest imposed under any environmental statute.  This presentation surveys recent enforcement actions, explains the basis for civil and criminal liability and the method for calculating penalties, gives tips on preparing for EPA inspections, and explains how to take advantage of EPA’s Audit Policy.

Auditing for TSCA Compliance
Richard A. Jourdenais, Ph.D.

How various forms of audits — ranging from mock inspections, “systems” audits, and strategic product reviews — can be used to evaluate, monitor, or confirm compliance with TSCA.

REACH Planning and Implementation
Robert A. Matthews, Esq. 
Partner
McKenna Long & Aldridge LLP
Washington, DC

A Review and Analysis of Critical Regulatory Requirements and Business Implications.  This session will discuss how REACH may impact your ability to develop and market your products in The EU.  In addition to providing guidance on REACH compliance, we will focus on provisions that can fundamentally alter your EU business plan, including your relationships within your supply chain and with your customers.  This session will enable you to anticipate and assess these impacts, and to develop a strategic action plan designed to protect past and future product investments.

Regulation of Industrial Chemicals in Canada
Michael Boucher, Esq.

Before new chemicals can be imported into Canada, a thorough knowledge of the Canadian Environmental Protection Act, 1999 (CEPA), its notification requirements, the differences between Canada’s Domestic List and Non-Domestic Substances List, and information schedules is needed.  Learn how Environment Canada administers and enforces CEPA.  This presentation will discuss in detail recent changes to Canada’s New Substance Notification Regulations.

Chemical Regulation in the People's Republic of China
Jeffrey Li, Esq.
Associate
McKenna Long & Aldridge LLP
Washington, DC

In China the various regulations govern the manufacture, distribution, use, transportation and import and export of chemical products.  These regulations focus mostly on manufacturers, distributors and user's qualification and registration requirements but not on product registration.  On October 15, 2003, State Environment Protection Administration (SEPA) adopted a new regulation focusing on the registration of new chemical products -- New Chemical Substance Environmental Administrative Measures -- and on September 23, 2003 SSPA also established an inventory of existing chemical products in China.  The new regulation requires a Pre-manufacture Notification (PMN) for any chemical substance not on the Chinese Inventory.  This presentation will describe these regulations and their requirements for the manufacture and distribution of chemicals in China.

Japan, South Korea, Philippines, and Australia
Richard A. Jourdenais, Ph.D. and Michael Boucher, Esq.

Japan’s Chemical Substance Control Law is written to prevent adverse effects to the environment through chemical exposure.  This presentation will identify and detail the important aspects of the Japanese chemical regulatory scheme.

The Toxic Chemicals Control Act (TCCA) regulates the use of industrial chemicals in South Korea.  This presentation will cover TCCA notification and assessment requirements.

The Philippines’ Department of Environmental Resources (DENR) administers the Toxic Substances and Hazardous and Nuclear Waste Control Act.  This presentation will explain new chemical notification requirements.

Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) protects workers, consumers and the environment from the harmful effects of industrial chemicals.  This presentation will discuss in detail the 2004 amendments to NICNAS.  

Summary and Wrap-Up
Charles A. O'Connor, III, Esq.