Automated Dioxin-PCB Sample Purification System

Waiver Details

Individual Waiver

The U.S Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), Office of Human and Animal Foods Laboratory Operations (OHAFLO), Arkansas Human and Animal Food Laboratory (ARLHAF) is the national servicing lab for the Persistent Organic Pollutants (POPs) program for the FDA. As part of this program Center for Food Safety and Applied Nutrition (CFSAN) has requested the analysis of 7 polychlorinated dibenzo-para-dioxins (PCDDs), 10 polychlorinated dibenzo-para-furans (PCDFs), 3 non-ortho polychlorinated biphenyls (PCBs), 21 additional PCBs, and 6 polybrominated diphenyl ethers (PBDEs). The analysis of these compounds starts with a very time-consuming sample preparation/extraction and cleanup procedure including multiple transfer steps requiring a very large solvent usage. The ARLHAF workgroup requires efficient and less costly means for critical sample cleanup. ARLHAF has been using automated sample purification systems to purify samples for the persistent organic pollutants, Dioxins, PCBs, and PBDEs for years but they are not 'green' systems. Current automated sample purification systems use very large volumes of solvents, especially Dichloromethane which translates to a definite adverse environmental impact and high cost against our yearly budgets. Currently, the ARLHAF work group is phasing out the use of Dichloromethane due to a current recommendation by the U.S. Environmental Protection Agency to reduce or ban the use of Dichloromethane in the US due to toxicity concerns. Regarding automated fluid handling purification systems, recent technological advances vastly more efficient and less expensive to operate and produce results required by the FDA – specifically, systems which utilize an innovative method of flow switching without the use of valves, essentially a “valve-less” system, that eliminates the inefficiencies and carryover contamination of the current systems. An additional benefit of a valve-less system is a dramatic reduction in environmental waste and impact. The FDA requires a valve-less dioxin/PCB sample preparation system to replace the previous valve-based version.

Yes

07/17/2023

07/19/2023

75F40123Q118591

75F40123Q118591

Dates

07/19/2023

07/19/2023