Practice Areas & Industries: Keller and Heckman LLP

 





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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:

Product Defense

  • 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.

Notifications

  • 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.

Testing

  • 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.

Inventory Searching

  • 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.

Polymers

  • 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.

Comments/Interpretations

  • 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.

Education

  • 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.

 

Services Available

 
Group Presentations
  Webinar: TSCA Reform, Ready for Prime Time?, April 16, 2015
 
Upcoming Seminars
  TSCA and International Chemical Regulatory Law Seminar, Washington, DC, October 27, 2015
 
Past Seminar Materials
  TSCA, Food-Contact Substances, and Other FDA-Regulated Products, Chicago, Illinois, May 5, 2015
 
 
Articles Authored by Lawyers at this office:

Summary of EPA's Proposed Rule for Nanoscale Substances
, April 15, 2015
EPA is proposing to collect information from companies that have manufactured, imported, or processed chemical substances at the nanoscale in the three years prior to the effective date of the rule. Reports are due 6 months from the effective date of the rule.

Taiwan Releases Draft Regulation on New and Existing Chemical Notification
Thomas C. Berger,Wilfred Feng,Chen Hu, September 23, 2014
On August 25, 2014, the Republic of China’s (Taiwan) Environmental Protection Administration (EPA) released a draft “Regulation of Chemical Substance Registration and Management” (Regulation). The Regulation was developed to implement amendments to Taiwan’s Toxic Chemical...

Senator Boxer Releases Confidential TSCA Reform Proposal
Thomas C. Berger,Herbert Estreicher,Martha E. Marrapese,Adrienne M. Timmel, September 22, 2014
U.S. Senator Barbara Boxer (D-CA) has publicly released her proposed amendments to a confidential proposal that Senators David Vitter (R-LA) and Thomas Udall (D-NM) have been working on for over a year to build bipartisan support for passage of TSCA reform. Senator Boxer, who chairs the Senate...

What Happens Next to Earthjustice's Demand for CBI Reassertion and Resubstantiation?
Herbert Estreicher,Eric P. Gotting,Martha E. Marrapese, September 18, 2014
The designation and treatment of Confidential Business Information (“CBI”) is frequently at the center of the Toxic Substances Control Act (“TSCA”) reform debate. One issue receiving increased attention is whether chemical companies should be required to reassert or...

EPA is Considering Amendments to its Chemical Risk Management Program (RMP) Rule that Would Impose Burdensome Additional Requirements on both Covered Facilities and Facilities Not Currently Covered by the RMP Rule
Trent M. Doyle,Lawrence P. Halprin, doyle, July 30, 2014
On August 1, 2013, reacting to a number of high-profile incidents and the constant drumbeat from the Chemical Safety Board, President Obama signed Executive Order 13650, entitled Improving Chemical Facility Safety and Security. Among other things, EO 13650 directs EPA and OSHA to consider possible...