Last month we discussed the problems that U.S. companies faced during 2007 with respect to products imported from China that posed serious health and safety concerns and subsequently had to be recalled. To do something about the problem, the U.S. and Chinese governments reached an accord on a food safety inspection and certification program that is hoped to stem the tide of deficient, and, in some cases, adulterated products being imported into the United States. The agreement is aimed at reducing the flow of counterfeit products to the U.S. as well.
The U.S. Department of Health and Human Services (HHS) and the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) of the People’s Republic of China signed a Memorandum of Agreement (MOA) on Dec. 11, 2007. The Agreement includes registration and certification requirements for Chinese manufacturers that import food and feed into the U.S., and provides for greater information exchange between AQSIQ and the Food and Drug Administration (FDA).
The agreement covers low-acid canned products, pet food and pet treats, ingredients for food and feed, such as wheat gluten and rice protein, and all aquaculture farming products other than molluscan shellfish. Other products will be added, subject to agreement of both countries.
Under the MOA, Chinese companies that register to export food or feed to the U.S. must agree to an annual inspection by AQSIQ/¬CNCA (Certification and Accreditation Administration). China will notify the FDA of any manufacturers that fail the inspection, and provide the reasons for failure. In addition, the Chinese agencies will implement a system capable of tracing products (and components of products) from production to exportation as a way to contain and resolve safety problems.
The certification program will be based on meeting the FDA requirements and calls for the implementation of a testing program to ensure compliance with the requirements. Once Chinese inspectors determine that a shipment meets the requirements, they will issue a certificate with an identifying number. In addition, China and the U.S. will develop joint training programs and activities, including laboratory and risk-assessment methodologies, compliance and enforcement programs.
Both countries will notify the other within 48 hours of any significant risks to public health related to product safety, recalls and other situations. The agreement also gives the agency increased access to Chinese production facilities, and allows the FDA to request that AQSIQ conduct a timely investigation regarding any covered product if there is reason to believe that the product could pose a health or safety risk to U.S. citizens.
HHS and the State Food and Drug Administration (SFDA) of the People’s Republic of China signed a similar MOA covering Chinese drugs and medical devices exported to the United States on the same day.