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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The Synthetic Chemical Organic Manufacturers Association (SOCMA) has raised concerns over requirements for security vulnerability assessments (SVA) under the US Department of Homeland Security's (DHS) Chemical Facility Anti-Terrorism Act Standards (CFATS).
Washington, DC (Dec. 3)-The Synthetic Chemical Organic Manufacturers Association (SOCMA) has raised concerns over requirements for security vulnerability assessments (SVA) under the US Department of Homeland Security’s (DHS) Chemical Facility Anti-Terrorism Act Standards (CFATS). SOCMA is the US-based trade association representing custom and batch manufacturers.
DHS issued the CFATS in 2007 for any facility that manufactures, uses, stores, or distributes certain chemicals above a specified quantity. The rule established risk-based performance standards for chemical facilities, and required manufacturers to prepare SVAs, which are used to identify facility security vulnerabilities, and to develop site security plans, which include measures that satisfy the risk-based performance standards.
“SOCMA recently learned that the US Department of Homeland Security has made it nearly impossible for facilities covered under its Chemical Facility Anti-Terrorism Act Standards to submit an alternative security vulnerability assessment, such as SOCMA’s model, that is other than the department’s own model,” said SOCMA in a prepared statement.
SOCMA says that completion of a SVA is a central requirement in CFATS. Covered facilities that are tiered by DHS in Tiers 1 through 3 must submit a completed SVA that is provided by DHS through its Chemical Security Assessment Tool, or CSAT. Tier 4 facilities have the option to submit a completed SVA that is not DHS’s, which must be submitted according to the date specified in the letter sent to covered facilities notifying them of their tier ranking under CFATS.
SOCMA developed an SVA tool in 2003 and said that it had been told by DHS that its SVA tool would be acceptable for Tier 4 facilities. “This appears to remain true, but only partial acceptance is likely,” said SOCMA. “Upon recent discussions with DHS, we have learned that our tool may provide only limited amounts of data necessary for submission to DHS. In fact, it seems clear to us that no SVA other than DHS’s own will provide complete assurance to members that all data necessary for collection under this CFATS requirement will be sufficient. This is a last-minute reversal of what we have been led to believe.”
SOCMA says that its partnership with DHS has been open and transparent, but that it believes a miscommunication resulted because of recent personnel changes at DHS.
SOCMA says it will continue to work with DHS to resolve the matter favorably for its members, but with the compliance deadline due shortly, it is recommending that its members with Tier 4 facilities under DHS’s CFATS rules complete the DHS SVA only “to ensure the highest level of compliance.”