Important differences between FDA action levels given in the SERIM and those given by FDA


Action levels provided by the U.S. Food and Drug Administration (FDA) are used as screening benchmarks during Tier III testing evaluations under Section 103 of the Marine Protection, Research, and Sanctuaries Act of 1972 (MPRSA).  These action levels are based on human health and economic considerations and represent limits above which the FDA can take legal action to remove products from the marketplace (EPA and USACE 1991, known as the ‘Green Book’).  The Southeast Regional Implementation Manual (EPA and USACE 2008, known as the ‘SERIM’) provides guidance for MPRSA Section 103 testing evaluations in the southeastern United States.  Some discrepancies exist between the action levels provided by the FDA and those given in the SERIM.  The table below compares action levels between the SERIM, the source document to the SERIM (FDA 2001), and the most current FDA action levels (FDA 2011).

The action level presented in the SERIM for cadmium in bivalve tissue is switched with that of crustacea (see table above).  The SERIM applies the crustacea action levels to include polychaete worms as the FDA lacks any action levels intended for polychates.  The action levels given in the SERIM for mercury are intended for use specifically for methylmercury (FDA 2001 and 2011) rather than for total mercury.

The SERIM (Section [page 24]) and the Green Book (Section 6.3 [not paginated]) suggest the reader use an updated version of the FDA action levels when available.  FDA action levels have been updated since the SERIM was published in 2008 and, therefore, it is useful to refer to FDA (2011) for some or all action levels rather than Appendix H of the SERIM.  However, since FDA (2011) omits arsenic, cadmium, chromium, lead, and nickel, the values given in FDA (2001) may, with the approval of USACE, continue to be used as screening benchmarks for these metals in Tier III evaluations.

Sources Cited Above:

U.S. Environmental Protection Agency and U.S. Army Corps of Engineers.  1991.  Evaluation of Dredged Material Proposed for Ocean Disposal, Testing Manual [Green Book].  EPA 503-8-91-001.  EPA, Office of Marine and Estuarine Protection and Department of the Army, USACE, Washington, DC.

U.S. Environmental Protection Agency and U.S. Army Corps of Engineers.  2008.  Southeast Regional Implementation Manual (SERIM), Requirements and Procedures for Evaluation of the Ocean Disposal of Dredged Material in Southeast U.S. Atlantic and Gulf Coast Waters.  EPA Region 4, Atlanta, GA, and USACE South Atlantic Division, Atlanta, GA.

U.S. Food and Drug Administration.  2001.  Fish and Fishery Products Hazards and Controls Guidance, Third Edition — June 2001 [online document].  Accessed 02/25/11 online at:  http://www.fda.gov/Food/‌GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm.

U.S. Food and Drug Administration.  2011.  Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition — April 2011 [online document].  Accessed 01/09/12 online at:  http://www.fda.gov/Food/‌GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm.

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