DHS Proposes Regulations for Chemical Facilities - Pharmaceutical Technology

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DHS Proposes Regulations for Chemical Facilities


ePT--the Electronic Newsletter of Pharmaceutical Technology

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Washington, DC (Dec. 28)—The US Department of Homeland Security (DHS, www.dhs.gov) has proposed regulations for improving security at high-risk chemical facilities, a category that may include some pharmaceutical production facilities.

“The consequences of an attack at a high-risk chemical facility could be severe for the health and safety of the citizens in the area and for the national economy,” said Homeland Security Secretary Michael Chertoff in a prepared Dec. 22 statement. “Congress has provided the department with a critical new authority to set performance standards that are both sensible and disciplined, allowing owners and operators the flexibility to determine an appropriate mix of security measures at their facility under our supervision and subject to our approval. We’re grateful for this new authority, and we intend to implement it quickly and apply it aggressively.”

The proposed regulations require that chemical facilities fitting certain profiles (based largely on data from the US Department of Environmental Protection risk management chemical safety program) to complete a secure online risk assessment to determine overall risk. High-risk facilities will then be required to conduct vulnerability assessments and submit site-security plans that meet the department’s performance standards. 

The Homeland Security Appropriations Act of 2007 requires that the proposed regulations be issued by April 4, 2007, and the Department says that the rules will go into effect immediately for the highest-risk facilities, with other plants coming into compliance through 2007 and 2008. The proposed regulations provide chemical facilities with opportunities to challenge the disapproval of a site security plan.  Failure to comply with performance standards may result in civil penalties up to $25,000 per day, and egregious instances of noncompliance could result in an order to cease operations.

The DHS proposal notes that most chemical facilities already have voluntary security programs.

The full proposed rule was published in the Dec. 28, 2006, Federal Register, and is available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/06-9903.htm

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