It is too early to predict what impact proposed changes to US rules on chemical plant security and anti-terrorism measures would have on the drug industry according to PhRMA.
Last week , Patrick Meehan (R-Penn), chairman of the House Committee on Homeland Security Subcommittee Cybersecurity, Infrastructure Protection and Security Technologies, proposed changes to the Chemical Facility Anti-Terrorism Standards (CFATS).
The CFATS programme was introduced in 2007 as a set of security regulations for the chemical facilities that manufacture, handle and store substances deemed to be at risk of terrorist attack by the US Government.
While the legislation was primarily designed for plants involved in the petrochemical and agrochemical sectors it also applies to pharmaceutical manufacturing facilities that use chemicals the US Government considers to be a potential threat .
The new Bill seeks to improve the certification process by allowing automatic re-approval of alternative site security plans (ASP) – which are required under CFATS - and permitting third-party audits and inspections.
The changes are largely supported by the chemical industry.
The Society of Chemical Manufacturers and Affiliates (SOCMA) said the proposed changes give more regulatory certainty.
VP of Government and Public Relations Bill Allmond said that: “The CFATS program should be permanent to be successful.”
“This bill provides a stronger foundation for the program, lays out clearer direction for the Department of Homeland Security, and helps our members better anticipate compliance as a result of a multi-year authorization.”
We asked the Pharmaceutical Research and Manufacturers of America (PhRMA) what impact the proposed changes to CFATS would have on members, but the industry group told us it “is still analyzing the Bill and it is too early to have any conclusions.”