Seafood Inspection Program U.S. Department of Commerce 1315 East-West Highway Room 10840 Silver Spring, Maryland 20910-3282 USA December 19, 2013 Mr. Liu Jinlong Department for Supervision on Animal and Plant Quarantine General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China No.9 Madiandonglu Haidian District Beijing, China 100088 Dear Mr. Liu: This is in response to your recent suspension of shipments of bivalve molluscs from FAO Area 67 to the People’s Republic of China due to your finding of violative Paralytic Shellfish (PSP) toxin in a shipment of geoduck clams from Alaska and high inorganic Arsenic in a shipment of geoduck clams from Washington State. The U.S. Department of Commerce National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program (SIP) has been collaborating closely with the U.S. Food and Drug Administration (FDA) and the two states involved in this issue. Both states have completed thorough reviews of the situation and their reports are attached for your review. Additionally, SIP performed regular audits of the shipping facilities associated with the violative shipments. FDA and the coastal states are the regulatory authorities for ensuring the safety of bivalve molluscan shellfish. The joint FDA-state program is known as the National Shellfish Sanitation Program (NSSP) and it ensures that molluscan shellfish growing waters are safe. NOAA relies on this oversight program to ensure the safety of molluscan shellfish offered for export. Prior to certifying shellfish for export to China, NOAA ensures that it was produced under NSSP oversight and that the molluscs came from safe harvesting areas and the producing firm is in good regulatory standing with the relevant state and FDA. Every consignment is then examined by NOAA or by the shipper under NOAA’s supervision to ensure that the shellfish are alive and healthy before shipment. The state of Alaska has a rigorous testing protocol that does not allow any geoduck clams to be harvested unless PSP testing is conducted for the specific harvest area and it shows the product to be safe. The state of Washington also rigorously monitors PSP in geoduck clams in all harvest areas. Neither state’s recent data shows violative levels in the harvest areas associated with the October shipments. It is worth noting that both states have a superb reputation for the rigorous protection of public health from harmful algal blooms. If we understand your notification correctly AQSIQ has suspended shipments of bivalve molluscs from all of FAO Area 67. If this is the case we request that AQSIQ limit the suspension to live geoduck clams pending consideration of this request because this species was the only one implicated. The finding of a high inorganic Arsenic level in geoduck clams is surprising to the regulating agencies. The United States does not have a tolerance level for Arsenic and it is not usually monitored in the aquatic environment. Neither the states nor the Federal agencies routinely monitor for Arsenic in Puget Sound of Washington State. However a study was conducted in 2007 to examine certain harvest areas for the presence of total Arsenic and to determine their suitability for geoduck clam harvests (see attached). This study showed that the Arsenic levels in the “edible portion” and the “gut balls” (which would normally be consumed in China) were 2.28 to 5.22 ppm of total Arsenic. Generally, inorganic Arsenic would be less than 10 percent of the total Arsenic. The 2007 study is also supported by NOAA’s Mussel Watch Program that monitors contaminants in molluscs in coastal waters all over the United States. On December 19, 2013 The Puyallup Tribe of Indians and the State of Washington Department of Natural Resources closed Redondo Tract Number 10380 to commercial harvest until further notice. This is a precautionary measure to ensure public safety until an investigation can be completed. The state has also voluntarily undertaken further inorganic arsenic testing of geoduck clams in this tract. This is the harvest area where the geoduck clams found by your agency to have an inorganic Arsenic level of 1.7 ppm originated. Based on the information provided above and the state and tribal actions taken, NOAA and FDA believe geoducks clams and molluscs in FAO Area 67 harvested or farmed in compliance with state and federal regulations are safe for consumption and meet PRC safety requirements. For that reason we believe that exports to the People’s Republic of China should be allowed to resume. Thank you for your consideration of this request. Sincerely yours, Timothy Hansen Director, Seafood Inspection Program NOAA Fisheries