International Regulatory and Legislative Advocacy

Overview:

As companies develop a new product or substance, a primary goal is to bring the substance/product to market as quickly, efficiently, and cost effectively as possible. Standing between the client and success in the marketplace are regulatory hurdles and policy expectations that expand with the client’s international reach and product characteristics. In the U.S., European Union (EU), and Asia, there is a panoply of authorities to contend with, including the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), U.S. Food and Drug Administration (FDA), the European Chemicals Agency (ECHA), Member State authorities, China’s State Administration of Work Safety (SAWS), and China’s Ministry of Environmental Protection (MEP), among others. The task of navigating all the many authorities standing in the way of reaching the marketplace may be daunting, especially given the ever-changing regulatory landscape. 

The Acta Group (Acta^®) provides critical and highly skilled guidance to help clients avoid the errors in regulatory compliance that can delay or derail commercialization of critically important substances/products, affecting significantly a company’s strategic plan and opportunities for success.  Thanks to our significant legal and policy knowledge-base and network of government contacts in the U.S. and abroad, we are uniquely qualified to help client companies to product commercialization and beyond.

Once our clients reach their markets, Acta helps them maintain their presence by guiding ongoing compliance needs as they change. We maintain a steady focus on our clients’ business purposes -- while working through and around policy imperatives.

Our Experience:

Acta offers clients a uniquely seasoned and expansive group of expert consultants located in the U.S., EU, and Asia. Our team is comprised of individuals with years of experience working with and within government, undertaking and overseeing regulatory completion for start-ups as well as major multinational corporations, and providing consulting and advocacy work for clients across the chemical, agricultural, and energy spheres (among others). We are legislative and regulatory consultants, business professionals, and scientists with the technical and policy know-how to understand -- and advocate for -- our clients’ commercial objectives and products’ regulatory needs. 

James V. Aidala brings years of experience in senior government positions at EPA, including the top EPA pesticide official as Assistant Administrator for what is now EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), after spending almost a decade working for various lawmakers on Capitol Hill on a variety of pesticide and chemical legislative issues. While at EPA, Mr. Aidala led the team charged with drafting (and shepherding enactment of) the Food Quality Protection Act (FQPA) and is keenly aware of all current pesticide issues.

Oscar Hernandez, Ph.D., is an exceptional resource for clients addressing legislative and regulatory policy on chemical substances. During his 30-year career at EPA, most recently as Director of the Risk Assessment Division (RAD) in the Office of Pollution Prevention and Toxics (OPPT), Dr. Hernandez was integrally involved in the hazard and risk assessment of chemicals being reviewed pursuant to the Toxic Substances Control Act (TSCA) and other regulatory programs.  His understanding of both the scientific basis for risk assessment and the Agency review process assists clients in achieving their commercial objectives.

Jane S. Vergnes, Ph.D., DABT^®, based in the United States, has 25 years of experience designing toxicology testing strategies to meet a wide variety of global regulatory requirements, including working with laboratories and regulatory agencies to adapt study plans to suit the chemical compound, the client’s marketing strategy, and the regional regulatory realities.

Lara Hall, M.S., a Scientist and Registered Quality Assurance Professional for Good Laboratory Practice (RQAP GLP) based in the United States, assists clients in ensuring scientific integrity and regulatory compliance through all phases of data development to support new and existing product registrations worldwide and interfacing with a global network of regulatory officials.

What We Do:

Acta provides the expert resources clients need to get their products to market quickly and keep them there. We help clients obtain regulatory approval and work through the legislative process. We counsel and assist clients on how to best approach officials at regulatory agencies to ensure the most accurate scientific information and policy arguments are incorporated into pending decisions. Successful and meaningful interaction with officials is particularly important in evolving spaces, such as in the EU and China, where the regulatory framework is new to regulators and market entrants alike.

• U.S.-Based Acta Initiatives and Deliverables –
  • Provide clients with timely information on and insight into key applicable regulatory developments, challenges, and opportunities to commercialize products and grow markets
  • Assist clients with developing strategies for navigating government policies and achieving and maintaining regulatory and commercial success
  • Arrange and accompany clients to meetings with federal agency officials, including, most notably, EPA, USDA, and FDA
  • When appropriate, arrange and accompany clients to meetings with the White House Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB)
  • Inform committee staff and key state delegation members of client issues with the regulatory process and, if warranted, request letters from Congress to agency officials to help advance the process.  Provide pertinent information to Congressional staff for such letters
  • Guide and draft legislation and legislative initiatives pertinent to client products
• EU-Based Acta Initiatives and Deliverables –
  • Provide clients with timely information on and insight into key applicable regulatory developments, challenges, and opportunities to commercialize products and grow markets in the EU 
  • Assist clients with developing strategies for navigating government policies and achieving and maintaining regulatory and commercial success
  • Draft and submit comments on pending proposals by ECHA and Member States concerning specific client substances/products
  • Arrange and accompany clients to meetings with the European Commission (EC), Member State authorities, and ECHA
• Asia-Based Acta Initiatives and Deliverables –
  • Assist clients in navigating the cultural differences that impact regulatory developments, interactions, and interpretation
  • Provide clients with timely information on and insight into key applicable regulatory developments, challenges, and opportunities to commercialize products and grow markets in Asia with emphasis in China
  • Interact with key regulatory authorities to advance client product strategies; arrange and accompany clients to meetings with the regulatory authorities

Representative Engagements:

• Assist significant metals consortia in better understanding the EU regulatory process; prepare for and accompany to a meeting with the EC -- support legal team in further action.
• Assist significant U.S.-based substance consortia in better understanding the EU regulatory process; prepare for and accompany to a meeting with the EC -- support legal team in further action.
• Assist several significant multinational chemical manufacturers in understanding the regulatory framework in China, dialogue with the respective regulatory authorities to better gauge interpretation of the regulations while also offering practical solutions to complex scenarios.