As Congress begins a new session, the Synthetic Organic Chemical Manufacturers Association (SOCMA) is making its legislative priorities known. SOCMA is the US-based trade association of batch and custom manufacturers, which includes contract manufacturers of pharmaceutical intermediates and active pharmaceutical ingredients (APIs). Through its “First 100 Days” initiative, SOCMA says it plans to meet with new agency heads and key Congressional members to share the priorities of the specialty and batch manufacturing industry and to seek bipartisanship wherever possible.

Among its policy goals, SOCMA is addressing three important areas: the US Food and Drug Administration’s inspection process of foreign drug-manufacturing facilities, security at chemical facilities, and chemical testing and risk management.

A key goal of SOCMA is to continue its efforts to reform FDA’s process for inspecting foreign manufacturing facilities of APIs. “Congress should encourage innovation and reform within the Food and Drug Administration to enhance its safety and inspection functions to suit a globalized marketplace and address recent quality issues as well as create a level playing field for US manufacturers,” said SOCMA President Joe Acker in an association press release.

SOCMA also says it wants to continue current chemical security regulations under the Chemical Facility Anti-Terrorism Standards (CFATS) “without product substitution requirements under the guise of inherently safe technology (IST).” The CFATs established risk-based performance standards for the security of US chemical facilities, and one issue under debate is whether to require IST for high-risk facilities to reduce their risk. IST is a conceptual framework that covers chemical processing procedures, equipment, protection, and when feasible, the use of safer substances. SOCMA opposes incorporating IST specifically in the standards on the grounds that it is already incorporated into manufacturing practices and over concerns that it cannot be effectively regulated. “It is inappropriate for Washington bureaucrats to be given authority over which chemicals to substitute for security purposes,” said Acker. “It will also likely create dangerous unintended consequences.”

SOCMA also wants to maintain a risk-based approach to chemical control policy and supports further development of the US Environmental Protection Agency’s Chemical Assessment and Management Program (ChAMP). Under ChAMP, EPA is fulfilling US commitments made under the Security and Prosperity Partnership of North America (SPP). The SPP of North America Leaders’ Summit, held in Montebello, Canada, in August 2007, called for cooperation on chemicals and outlined commitments on behalf of the US, Canada, and Mexico to work together to ensure the safe manufacture and use of industrial chemicals. Each country is sharing scientific information and approaches to chemical testing and risk management. To fulfill its part of the SPP commitment, the United States will, by 2012, complete screening-level hazard and risk characterizations and initiate action, as appropriate, on more than 6750 chemicals produced above 25,000 pounds per year.

In supporting ChAMP, SOCMA is taking a pre-emptive strike to avoid the adoption of broader measures such as the REACH regulation recently adopted in Europe. “Congress must ensure that any chemical risk-management reform be narrowly tailored and avoid sweeping regulation that will stifle industry growth and innovation as well as international trade,” said Acker.

How successful will SOCMA be in advocating for these measures? The Obama administration and the new Congress face a myriad of challenges, and it is too early to know in a vast sea of interests and issues, if the voice of custom and batch manufacturers will be heard.