Practice/Industry Group Overview
In today's multinational corporate environment, ensuring global regulatory compliance is essential. For over 30 years, Keller and Heckman LLP has had a tradition of serving clients through an interdisciplinary staff with a combination of strong legal and scientific skills. These resources, resident in Washington, D.C., Brussels, San Francisco, and Shanghai, enable us to creatively resolve important regulatory and commercial issues that arise, whatever their complexity. Our expertise on legal and technical issues helps us quickly understand our clients' concerns, and is well received by regulatory agencies worldwide.
Our team of lawyers and scientists maintains close contacts with the national regulatory authorities throughout the world and includes members who have had significant government and industry experience. In addition to the United States, Canada, the European Union (EU), and the Peoples Republic of China, we have considerable experience with chemical control laws in other parts of the world, including Australia, Japan, the Philippines, South Korea, Taiwan, Hong Kong, New Zealand, Malaysia, and Singapore.
We are at the forefront of helping clients adapt and comply with the EU REACH legislation. We also are intimately familiar with initiatives concerning international chemical testing, persistent organic pollutants, the Chemical Weapons Convention, and the Global Harmonized System for hazard communication. We determine Harmonized Tariff Schedule classifications for substances and handle certain other international trade issues such as dual-use.
Keller and Heckman's professionals in its Chemical Control Practice assist companies in complying with the laws and regulations relating to the commercialization of new and existing chemical substances in a single jurisdiction or throughout North America, Europe, Asia, and Australia. In addition to providing opinion letters, carrying on discussions with government authorities, and producing advocacy or defense positions, examples of our full range of services include the following:
- Legal and Scientific support for Strategic Decision-Making, with regards to REACH implementation;
- PBT/vPvB evaluation and/or rebuttals; and
- Appeals against decision of Agencies and legal actions before the EU Court of Justice, U.S. and other courts.
- Pre-registration and Registration submissions under REACH;
- Determine the status of substances in preparations, in articles, and in other categories of substances, such as polymers and determine the applicability of reporting exemptions and exclusions in the above jurisdictions;
- Develop accurate and complete chemical identifications and estimate physical and chemical properties;
- Prepare (or review) and submit new chemical notifications, including Toxic Substances Control Act (TSCA) Premanufacture Notices, Canadian Environmental Protection Act New Substance Notifications, EU Dangerous Substances Directive dossiers, and Chinese notification and exemption filings;
- Determine the classification and labeling of preparations pursuant to the EU Dangerous Preparations Directives;
- Advise clients on TSCA section 8(e) substantial risk reporting;
- File notices for all types of research and development activities, including test marketing, pending notification in the above jurisdictions where needed.
- Provide advice and management regarding testing required to support notifications;
- Conduct negotiations with government authorities regarding new chemical testing requirements, protocols, the use of surrogate data, and waiver justifications in Canada, Europe, Asia, and Australia;
- Provide guidance with regard to voluntary testing initiatives such as the high production volume programs;
- Assist with the formation and management of testing consortia; and
- Negotiate test requirements for existing chemicals in U.S. and Canada as well as the EU REACH Program.
- Perform computerized searches of the TSCA Inventory, the Canadian Domestic Substances List, the European Inventory of New and Existing Chemical Substances (EINECS), China and other national inventories;
- Prepare and shepherd bona fide inquiries of national inventories including China, EU, and TSCA Inventory correction petitions; and
- Address issues stemming from chemical nomenclature ambiguities.
- Provide letters of assurance and other necessary documentation for polymers that are eligible for the TSCA polymer exemption;
- Determine whether polymers are of low-concern in Canada; and
- Determine whether polymers are grandfathered on EINECS and the Chinese inventory.
- Prepare and submit requests for formal Agency interpretations in the U.S., Canada, and the EU; and
- Prepare and submit comments to governmental regulatory agencies.
Audits and Enforcement
- Conduct compliance audits;
- Carry out due diligence reviews;
- Assist companies in developing a strategy to prepare for REACH through evaluations of substances and products;
- Guide clients through inspections and voluntary disclosures of non-compliance; and
- Defend companies against enforcement actions.
Monitoring Legislative Changes
- Monitor legislative changes and policy developments throughout the world; and
- Closely follow the regulatory dialog pertaining to highly fluorinated chemicals, particularly fluoropolymers.
- Provide both fundamental and advanced public chemical control seminars; and
- Conduct private training on general and specialized aspects of tactics and strategy for chemical control compliance.