Congressional Committee Passes IST Measure

March 13, 2008
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US House of Representatives Committee on Homeland Security approved legislation last week that mandates inherently safer technologies (IST) as part of chemical-site security standards, a move that was opposed by the Synthetic Organic Chemical Manufacturers Association.

Washington, DC (Mar. 6)-The US House of Representatives Committee on Homeland Security approved legislation last week that mandates inherently safer technologies (IST) as part of chemical-site security standards, a move that was opposed by the Synthetic Organic Chemical Manufacturers Association (SOCMA). SOCMA is the US-based trade association representing custom and batch manufacturers, including contract manufacturers of active pharmaceutical ingredients and intermediates.

“SOCMA supports making chemical-site security standards a permanent and enforceable law under the jurisdiction of the US Department of Homeland Security,” said Joseph Acker, president and CEO of SOCMA, in a prepared statement. “We are, however, stridently opposed to the merits of mandating inherently safer technology under the guise of site security and as a panacea for fighting terrorism, as passed today by the House Committee on Homeland Security,” he said.

Although SOCMA supports chemical-site security standards, the association and some of its members testified before Congress to voice their opposition to mandating IST in the bill under consideration, “The Chemical Anti-Terrorism Act of 2008” (See “IST Measures Raise Concern for the Pharma Supply Chain from the Mar. 5 issue of Pharmaceutical Technology’s Sourcing and Management.)

Last year, the Department of Homeland Security (DHS) issued the Chemical Facility Anti-Terrorism Standards (CFATS) regulations that established risk-based performance standards for the security of US chemical facilities. CFATS will expire in October 2009, and the legislation would make CFATS permanent and provide further Congressional guidance for the future implementation of CFATS. Requirements for high-risk facilities to reduce their risk by IST were incorporated into the bill passed by the Congressional committee.

“As someone who spent over 25 years managing chemical facilities, I can attest to the enormous amount of energy that goes into considering safer technologies prior to a chemical product’s research, development and production,” said Acker. “The chemical industry practices this concept as a normal part of its manufacturing process and invests substantial assets into determining a product’s impact on health, safety, and the environment. These steps were never designed to ward off terrorists, however,” he continued. “It is therefore inappropriate for Congress to pretend that mandating ‘security’ IST would provide a security blanket with negligible consequences to one of the largest US manufacturing sectors. In fact, these provisions only advance the political agenda of special interests that want to curtail or eliminate products that sustain us as Americans and improve our daily lives, and that want to decrease the competitiveness of US chemical manufacturing.”

Similar concerns were raised by the American Chemistry Council, the US-based trade association of large chemical manufacturers.

“The chemical security bill passed by the House Committee on Homeland Security is an important first step toward establishing a permanent federal regulatory framework for chemical security,” said American Chemistry Council President and CEO Jack N. Gerard.

“We’re pleased to see that the bill reflects many of the security measures already being implemented under the Chemical Facility Anti-Terrorism Standards (CFATS) issued last year by DHS. According to DHS estimates, facilities will need to invest more than $8 billion in additional human, physical, and cyber security resources to meet the stringent security requirements under CFATS,” he said. “Our primary concern, however, is that certain provisions in the bill will divert the focus away from security and instead place DHS in the position of mandating changes to chemical processes and products. As witnesses pointed out at last week’s hearing, these complex decisions should be kept in the hands of industry experts who must consider a host of factors, not just security, when evaluating such changes to avoid unintended consequences.”