From TSCA to REACH and Beyond

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 imposed under the Preliminary Assessment Information Rule and the Notice of Commencement of Import or Manufacture.

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

How to comply with the Inventory Update Rule (old and new), to maintain a system to keep records of allegations 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).

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.

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.

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.

The classification and labeling of chemical substances and preparations under Directives 67/548/EEC (for substances) and 99/45/EC (for preparations) and the placing of restrictions or bans on specific dangerous chemicals under Directive 76/769/EEC. Hazard versus risk assessment approach.

Even as it anticipates new chemicals legislation, industry continues to face numerous challenges created by the existing legislation. This session will identify both the nature and complexity of these challenges and strategies adopted by several companies to defend their products.

Getting Ready for REACH: Requirements for the Registration, Evaluation, Authorization and Restriction of Chemicals
This session will discuss how provisions of this pending legislation may impact your ability to develop and market your products in the EU. We will identify self- audit procedures that will enable you to anticipate and assess these impacts, and we will suggest strategies for you to consider in order to protect past and future product investments.

The world of global inventory compliance has become more complex as new countries enact legislation to address the environmental, health and safety of chemical substances that are manufactured, imported or marketed in those countries. The chemical control regulations typically differ in these jurisdictions.  Companies that use chemical substances in their product lines must be aware of these differences and put into place processes and programs that assure compliance. This presentation will discuss how the Hewlett-Packard Company, a manufacturer of computers and peripherals not usually associated with chemical compliance issues, manages this challenge.

Japan’s Chemical Substance Control Law is written to prevent adverse effects to the environment through chemical exposure. The Ministry for Economy, Trade and Industry and Industrial Safety and Health Law chemical inventories list existing, approved chemicals, and new chemicals must be notified before commercialization can take place. New chemical testing begins with environmental tests. This presentation will identify and detail the important aspects of the Japanese chemical regulatory scheme.

In China the “Dangerous Chemical Products Administrative regulations;” “Dangerous Chemical Products Registration Administrative Measures;” “Chemical Products First Importation and Toxic Chemical Import and Export Environmental Administrative and Registration Regulations;” and "Chemical Products First Importation and Toxic Chemical Import and Export Environmental Administrative Registration Implements” 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 23rd, 2005 it also established an inventory list for 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 detail what these regulations say and how to comply for the manufacture and distribution of chemicals in China.

Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) protects workers, consumers and the environment from the harmful effects of industrial chemicals. Chemical substances not listed on the Australian Inventory of Chemical Substances must be reviewed through a notification process, which is some cases, requires a permit. This presentation will discuss in detail the 2004 amendments to NICNAS.

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.

The Toxic Chemicals Control Act (TCCA) regulates the use of industrial chemicals in South Korea. Chemical substances not listed on the Existing Chemical Inventory may be subject to a notification and assessment process. Notifications are simplified if a new substance already is listed on two foreign inventories. This segment will cover TCCA notification and assessment requirements, including simplified notification procedures for chemicals listed on qualified foreign inventories.

The Philippines’ Department of Environmental Resources (DENR) administers the Toxic Substances and Hazardous and Nuclear Waste Control Act. Existing chemicals are listed on the Philippine Inventory of Chemicals and Chemical Substances (PICCS). New substances are subject to a notification process that requires the submission of physical/chemical and toxicological studies. This presentation will explain DENR’s requirements for the submission of data and how DENR maintains the PICCS.