This is another of a series looking at how DHS might construct an Inherently Safer Technology Assessment Tool (ISTAT) for the Chemical Security Assessment Tool if Congress were to include a requirement for conducting an IST assessment as part of their legislation to make the CFATS program permanent. The other postings in the series were: An IST Tool for CSAT Reader Email – 03-04-10 IST Rules IST Questions – Inventory Management As I noted in the first blog in the series, there are four general categories of ways that a substitute chemical can be used to replace a Release Toxic chemical of interest (RTCOI) in a chemical process. Those categories, in order of increasing difficulty, are:
Straight drop-in, Process drop-in, Process change drop-in, and Process development drop-in.
DHS will identify known replacement chemicals for all RTCOI to be evaluated by the facility. The facility security team will determine which category the replacement chemical falls into for that facility and answer the questions associated with that category. The facility will also be asked if it knows of any other potential replacement chemicals for the RTCOI; those chemicals will also be required to be evaluated. References will be requested for newly identified replacement chemicals. References in the public domain will be shared with other facilities using the same RTCOI chemical. Straight Drop-in Straight drop in chemicals use the same equipment and manufacturing processes with only minor, well-understood adjustments required. To be considered for this category the new chemical will not be known or suspected to cause potential quality problems with the process used at the facility. The facility will be asked to provide information on the cost of the RTCOI and the substitute chemical. Current utilization rates for the RTCOI and the expected utilization rates for the substitute will also be reported. Process Drop-in Process drop-in chemicals will require new chemical storage and/or handling equipment but only minor, well-understood process adjustments. To be considered for this category the new chemical will not be known or suspected to cause potential quality problems with the process used at the facility. In addition to the cost and utilization questions asked for the Straight Drop-in category, the facility will be expected to provide information about the types and quantities of the new equipment required to handle the replacement chemical. The facility will be expected to supply quoted prices for the purchase/lease of the equipment as well as engineering estimates for the installation of the equipment. As I noted in the previous blog, DHS will have to establish some sort of standards for the estimation of installation costs. The facility will also be required to provide estimates for the cost of completing the process adjustments as well as an estimate for the time required to complete those adjustments. The facility will also have to identify if they will be able to run the current process in parallel while the new process is being adjusted and validated. If not, there will be questions about the estimated costs of providing for substitute product inventory while the process adjustments are completed. Process Change Drop-in Process change drop-in chemicals will require storage and/or handling equipment changes with significant process changes that have been verified to work in similar facilities. Known or suspected quality issues are typically expected to be dealt with in this type of substitution process. The facility will have to identify if it has the necessary expertise in house to identify and make the required process modifications; if not, the facility will have to identify the probable cost of hiring appropriate consultants for the adjustment process. The equipment change questions identified I the previous category will also apply for this type of substitution program. The facility will also have to include an estimate of the process adjustment costs and time to complete. Among the costs will have to be an estimate of the amount of off-specification product that will have to be adjusted or disposed of and its associated costs. Again, if the current process cannot be run in parallel while the adjustment phase is complete, the cost of providing alternative product during the development will also have to be identified. Process Development Drop-in The Process development drop-in has been identified in the lab or chemical literature, but has never been scaled-up to production level in similar equipment. This type of substitution will be the most difficult to judge the fiscal aspects of the substitution because of the large number and variety of unknowns involved in the analysis. Even the equipment costs will have larger uncertainty associated with them since there is not a good definition of the equipment that will ultimately be needed. The technical feasibility will also be difficult to evaluate.
Many would suggest that any substitution falling into this category should automatically be determined to be not currently technically feasible. While that would certainly be a justifiable position for ISTAT, it would not provide DHS with the information needed to identify appropriate process development research that it could encourage with grant monies. So the whole slate of questions asked in the previous categories should be answered for this substitution possibility with a more expansive fudge factor allowed for each of the estimates required for responses.