Bergeson & Campbell, P.C. (B&C) is an AV-rated (highest ranking) Washington, D.C. law firm focusing on conventional and nanoscale industrial, agricultural, and specialty chemical product regulation and approval matters, including TSCA matters, FIFRA/FQPA matters, FDA medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and litigation issues. B&C’s clients are involved in many businesses, including conventional and nanoscale, basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; consumer products; medical devices and diagnostic products; paints and coatings; and plastic products.

B&C represents and counsels individuals, business entities, trade associations, and industry coalitions. Our professionals conduct advocacy before EPA, FDA, USDA, OMB, OSHA, NTP, the Departments of State, Interior, and U.S. Trade Representative, state governmental bodies, federal and state courts, and in other forums, and play active roles in business strategy development, compliance planning, acquisitions, and related activities.

B&C’s fundamental goals are to solve our clients’ existing problems, and to minimize future difficulties. Reliance on only a single set of skills often is not enough. Legislative opportunities, rulemaking, and litigation options must be coordinated and effectively implemented. B&C takes a multi-disciplinary approach in assisting our clients, partnering with toxicological, chemical, engineering, economic, and other experts on individual matters as necessary to achieve results effectively and efficiently. Attention must be paid to the interplay of all branches of government and interest groups. Our capabilities, borne of site- and issue-specific experience, combined with our national and international view on policy and regulatory developments, position us to handle all these tasks with judgment, creativity, and efficiency.

Lynn Bergeson is a founding member of B&C. Ms. Bergeson’s focus is on product regulation under international, federal, and state regulatory programs, including, TSCA, FIFRA, and REACH, and the law, policy, and regulation of emerging technologies, including nanotechnology and biotechnology. She represents individual corporations and a wide range of trade associations on chemical-specific legislative, regulatory, and enforcement-related matters. Ms. Bergeson is widely published, and lectures frequently on legal, regulatory, and policy issues affecting chemicals under federal, state, and international regulatory programs.

Lisa Campbell has practiced environmental law since 1985. She concentrates on chemicals regulation and compliance matters under TSCA, FIFRA, RCRA, OSHA, and other environmental statutes and assists corporations and trade associations on a wide variety of matters in these areas. Ms. Campbell writes frequently on chemical regulatory issues.

Other B&C attorneys and non-attorney professionals have complementary backgrounds. For example, Jim Aidala, former EPA Assistant Administrator for Toxics under the Clinton Administration, has a technical background, having attended Brown University, Harvard, and MIT before joining the government. Bethami Auerbach has practiced environmental law both in the private sector and at EPA -- where she argued in defense of EPA regulations in five federal appellate courts and helped develop policies to implement the 1977 CAA Amendments. She also has taught environmental law and land use planning at the law school level. Timothy D. Backstrom worked with EPA’s Office of General Counsel on both air and toxics issues and has a unique understanding of the CAA Section 211 fuel additives program, having counseled the Office of Transportation and Air Quality for many years.

B&C’s consulting affiliates, The Acta Group, L.L.C. (Acta) and The Acta Group EU, Ltd (Acta EU), were established to control the spiraling costs and inefficiencies encountered by clients seeking approvals to market chemicals, products of nanotechnology and biotechnology, and medical device products. Acta and Acta EU manage products from concept to approval, utilizing the skills and experience of professionals who have worked in the specific product areas in government and industry. Acta and Acta EU represent the following disciplines: regulatory affairs, with particularized expertise with the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation; toxicology; and government affairs. Acta and Acta EU professionals have experience in regulations affecting chemical product approvals under North American (USA, Canada, and Mexico), European Union (EU), South American, Asian, and Pacific Rim regulatory programs. They regularly track significant legislative, administrative, and scientific initiatives that relate to the business of clients marketing chemicals and medical products for multiple uses.

The experience and expertise of Acta and Acta EU professionals cover a wide range of chemicals and products, including pesticides; industrial and specialty chemicals regulated under TSCA; products of nanotechnology and biotechnology; and medical devices. Acta and Acta EU concentrate on obtaining and maintaining product approvals and overcoming impediments to the successful and profitable marketing of approved products. The multi-disciplinary skills possessed by members of Acta and Acta EU are essential to a cost-effective and timely product approval project. Today’s regulatory approvals hinge on the utilization of multiple sources of information, resources, and skills. Acta and Acta EU offer a complete line of services intended to take a product or product concept to the point of its commercial marketing, to protect the market position of new and existing products, and to maintain products once they have been approved.

B&C’s consortia management affiliate, B&C Consortia Management, L.L.C. (BCCM), provides core support services for industrial, agricultural, and biocide chemical advocacy, testing, and research consortia. BCCM provides a full compliment of consortia management services, including consortia formation, full financial services managed by a C.P.A., organizational support, administration services, and infrastructure/communication platforms to ensure consortium participants have secure access to consortia documents and operations wherever they may happen to be located. BCCM also provides effective and efficient laboratory communication and management services for consortia that expend significant resources on study data production.

BCCM structures and manages its consortia to conform with the realities of the industrial and agricultural chemical business communities, and offers a variety of state-of-the-art actual and/or virtual electronic platforms or a combination of the two to ensure consortia participants have a business organizational model that allows seamless access to and communication with the consortia and its business affairs. These services free time for consortium members to focus on substantive issues, thus helping to ensure the consortium’s interests are protected and its voice heard on a wide range of domestic and international regulatory, scientific, legal, and related issues.

We also make substantial use of non-attorney regulatory analysts. These professionals provide counseling, monitoring, project support, and direct client assistance on a variety of federal and state regulatory, legislative, and policy issues.

TSCA: Toxic Substances Control Act, Basic Practice Series