Chinese Regulatory Assistance
China has the fastest growing economy in the world, and our clients increasingly request assistance with Asian regulatory issues. With Dr. Andy Chen of our staff, we are able to provide a number of services. Dr. Chen, a Chinese-American organic chemist with considerable experience in chemical regulatory issues, has worked on many matters involving China and other Pacific Rim countries, and is well-suited to assist on a wide range of issues involving Chinese regulatory programs.
Dr. Chen has over 25 years of experience in domestic and international chemical regulatory programs. After graduating from Michigan State University with the University's prestigious Quill Fellowship award, Dr. Chen worked in the R&D laboratories of The Dow Chemical Company and Mobil Chemical Company, and at the environmental consulting firms Science Application International Corporation, Mitre Corporation, Technical Resources Incorporated, and Ariel Research Corporation. He has successfully managed and provided technical consulting services to various U.S. governmental agencies, including EPA, FDA, NCI , NIH, ITC , NTP, NLM, OSHA, NIOSH, CPSC, DOE, DOD, and DOI. Dr. Chen has also provided a wide variety of consulting services to industrial and specialty chemical companies for years.
Dr. Chen received a B.S. in Organic Chemistry from National Tsing Hua University in 1970. He received an M.S. in Physical Organic Chemistry from Cleveland State University in 1973 and a Ph.D. in Organic Chemistry from Michigan State University in 1976.
Dr. Chen has worked on Toxic Substances Control Act (TSCA) issues for over 20 years, and has contributed to the TSCA Section 5 Premanufacture Notification (PMN) program in various capacities since its inception. He had been cleared for TSCA Confidential Business Information review, and has reviewed over 500 PMN chemicals and hundreds of existing chemicals in exposure and risk assessment. Dr. Chen has extensive contacts and background in the Pacific Rim countries. He has also worked in the international chemical regulatory compliance programs dealing with European countries and Mexico .
Among the projects Dr. Chen has completed in the recent past are the following:
• Screened and selected chemical substances for Chinese inventory nomination;
• Prepared and submitted Chinese inventory application forms;
• Ascertained and determined the Chinese inventory status of chemical products;
• Prepared and submitted Chinese New Chemical Notification application forms;
• Prepared and reviewed Chinese Material Safety Data Sheets;
• Conducted corporate audits of compliance with Chinese chemical regulations;
• Made numerous conference presentations on the Chinese chemical regulatory program; and
• Taught courses on Chinese and Asia-Pacific chemical regulatory programs.
Bergeson & Campbell, P.C. (B&C), relying upon Dr. Chen's unique and specialized skills in this area, is able to undertake a wide range of tasks to assist your company in establishing and/or facilitating existing business relationships in China . B&C can:
• Conduct comprehensive reviews of corporate existing practices relating to the Chinese chemical regulation requirements;
• Establish corporate Standard Operating Procedures and procedures for Chinese chemical regulation compliance programs, as well as information system needs and requirements;
• Conduct corporate audits of compliance with Chinese chemical regulations;
• Determine the Chinese inventory status of chemical substances of interest;
• Provide assistance on import and export activities;
• Prepare and submit Chinese New Chemical Notification application forms;
• Track upcoming chemical regulation developments;
• Resolve compliance issues with the competent Chinese authority; and
• Provide Chinese language and cultural translation.