Our chemicals regulation experience includes:
- Conducting a full-scale TSCA compliance audit for a Fortune 200 company, negotiating with the EPA enforcement office under the Audit Policy, and helping develop new TSCA compliance management systems for the company.
- Succeeding in obtaining critical interpretations and rulemaking corrections on the TSCA formaldehyde rule.
- Working closely with clients on their reporting activities under the Inventory Reset rule and the Chemical Data Reporting rule.
- Helping companies navigate the revised New Chemical Review process for chemicals critical to the automotive industry and other sectors.
- Negotiating TSCA section 5(e) consent orders with EPA on behalf of manufacturers and importers of new chemicals.
- Helping a client win EPA approval of a genetically-modified microorganism for use in producing fuel.
- Assisting various clients in meeting the updated California Proposition 65 warning requirements, and advising on proposed agency actions under the California Safer Consumer Products regulations.
- Defending chemical companies in civil enforcement actions brought by federal and state agencies and by citizens under TSCA, the Clean Air Act, the Clean Water Act, EPCRA, and the Resource Conservation and Recovery Act.
- Preparing technical and scientific comments on rulemakings and other agency actions related to human health risk, such as Integrated Risk Information System assessments.
- Completing information correction requests concerning technical and scientific information disseminated by agencies and pursuing administrative and judicial appeals for requests not adequately addressed under the Information Quality Act.
- Representing the U.S. chemical industry in international negotiations concerning international controls on chemical use and production, including the United Nations Environment Programme POPs Convention, the Rotterdam PIC Convention, and initiatives in Europe and North America targeting persistent, bioaccumulative, and toxic chemicals (PBTs).
- Representing a group of more than 300 research-based and generic pharmaceutical companies on emerging pharmaceutical product take-back laws.
- Working with a waste services company in the development of a nationwide program for collection and disposal of unused pharmaceuticals, helping to ensure that it would be consistent with applicable DEA regulations, as well as regulations governing transport of hazardous materials and disposal of hazardous wastes.
- Assisting a leading chemical manufacturer to develop and implement a plan for reporting an apparent regulatory non-compliance involving a controlled substance precursor to DEA and correct the problem with limited disruption to the distribution of products.
- Reviewing and designed improvements to the purchasing and fulfillment processes of a major raw materials distributor to ensure compliance with California’s controlled chemical substance requirements.
- Assisting a major petrochemical company in evaluating the applicable federal and state requirements for handling controlled substances and precursors at its laboratories around the country and in developing strategies for ensuring compliance, including contracting with a third party for certain compliance obligations.
- Advising an oil and gas company on state requirements applicable to precursor chemicals and laboratory apparatus.
- Preparing self-disclosures to the California Department of Justice Controlled Chemical Substances Program regarding errors in controlled chemical reporting, including descriptions of actions taken to address reporting errors and improve overall processes.
- Helping a client determine the applicable requirements for exports of a precursor chemical intended as a solvent in connection with its other products.