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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The House Energy and Commerce Committee approved H.R. 2868, the "Chemical Facility Anti-Terrorism Act of 2009," a measure to modify and codify existing requirements of the Chemical Facility Anti-Terrorism Standards (CFATS) program.
The House Energy and Commerce Committee approved H.R. 2868, the “Chemical Facility Anti-Terrorism Act of 2009,” a measure to modify and codify existing requirements of the Chemical Facility Anti-Terrorism Standards (CFATS) program. CFATS, which were adopted on an interim basis in 2007 and were set to expire in 2009, are requirements administered by the Department of Homeland Security (DHS) relating to risk-based performance standards for the security of US chemical facilities. Although the fine-chemical and chemical industries support the CFATS program, they oppose a measure in the bill that would mandate the use of inherently safe technology (IST). IST is a conceptual framework that covers chemical processing procedures, equipment, protection, and when feasible, the use of safer substances.
Under the CFATS program, US chemical facilities are required to prepare security vulnerability assessments, which identify facility security vulnerabilities, and to develop and implement site-security plans, which include measures that satisfy the identified risk-based performance standards. The IST provisions in the House bill would add a requirement to existing industry security standards to mandate process or chemical substitution of certain chemicals as directed by the DHS Secretary. The IST provisions are supported by certain members of Congress but are opposed by the fine-chemical and chemical industries.
“This legislation requires for the first time that covered chemical facilities must assess whether there are any safer chemicals, processes, or technologies that they can adopt which would reduce the consequences of a terrorist attack against the facility,” said House Energy and Commerce Committee Chairman Henry Waxman (D-CA) in a letter dated Oct. 21, 2009. “This bill will also authorize the Secretary of Homeland Security, under certain circumstances, to require a chemical facility to adopt the safer chemicals, processes, or technologies when necessary to reduce the consequences of an attack.”
The Society of Chemical Manufacturers and Affiliates (SOCMA), the US-based trade association of batch and custom manufacturers, which include contract manufacturers of active pharmaceutical ingredients and intermediates, voiced its opposition to the IST provisions. In a letter to Waxman and House Energy and Commerce Committee Ranking Member Joe Barton (R-TX), SOCMA President Joe Acker said, “The fact is, some of the chemicals that would be high on the Secretary’s candidate list for ‘switching out’ are the same ones used, for example, as active ingredients in everyday pharmaceuticals and health care. We fear that substitution or elimination of these ingredients may cause shortage or elimination of common consumer products or treatments for patients with serious medical conditions. Switching to alternative substances could also increase our reliance on foreign-made pharmaceutical ingredients as American companies become barred from manufacturing chemicals that customers will still demand. Such a result would actually make the U.S. much less safe and less secure and cost Americans jobs.”
SOCMA argues that inherent safety cannot be measured and should not be mandated. In the letter to the committee, SOCMA said, “Even if measuring the effectiveness of IST was possible, the provision takes the decision about risk away from the workers in chemical facilities and leaves them to bureaucrats in Washington.” Instead of adopting IST, SOCMA is urging Congress to extend the existing CFATS program.
The American Chemistry Council (ACC), which represents the large US chemical manufacturers, also raised concerns over the mandated IST provisions although it reiterated its overall support for chemical-facility security and the CFATS program. “We are still unable to find common ground with the committee on the right approach regarding the regulation of process changes and product substitutions,” said Calvin Dooley, president and CEO of the ACC, in an ACC statement. “While we appreciate the committee’s willingness to consider our input regarding this complex aspect of the legislation, it remains the primary reason ACC is unable to endorse the bill. Our members are concerned that providing government with authority to direct process changes or product substitutions could result in making critical products unavailable throughout our economy, with potentially significant impact on our companies and our customers.” ACC said it will continue to work with Congress to establish permanent chemical-security regulations.
The bill has been placed on the House calendar for further consideration.