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Comments Sought on Proposed Changes to Food Safety Testing

The FDA is proposing to amend its regulations to establish a programme for food safety testing by accredited laboratories. Public comment on these proposed changes, which would be implemented gradually, may be submitted by 3 March 2020.

The FDA’s goal is to protect U.S. consumers by helping ensure that certain food testing of importance to public health is conducted subject to appropriate oversight and in accordance with appropriate model standards, and produces reliable and valid test results. Under this proposal, the FDA would recognise accreditation bodies to accredit labs that conduct food testing and then publish a list of such bodies and accredited labs. The labs would submit their analytical reports of food testing directly to the FDA. The proposed rule contains eligibility requirements for labs, such as requirements related to conflicts of interest, analysis and records. The FDA is including product testing as well as environmental testing (e.g., testing from the growing, harvesting, manufacturing, processing, packing or holding environment) as part of overall food testing. 

While these requirements apply to all food and beverages sold in the U.S. market, the FDA notice focused an extensive discussion on the need to improve the testing of imports. The agency already has authority to refuse admission of an imported food if the food is, or appears to be, adulterated or misbranded. In addition, a procedure known as detention without physical examination (DWPE) is used when there exists a history of the importation of violative products, or products that may appear violative, or when other information indicates that future entries may appear violative. In those cases, the FDA issues import alerts to inform the public that there is evidence that allows for DWPE of products that appear to be in violation of FDA laws and regulations.

The FDA noted that importers and consignees often hire private labs to test the food product and then submit the results of the testing, along with the associated analysis and data, to have the food released from detention. According to the agency, there are concerns that importers may be manipulating or substituting samples at private lab tests and pursuing practices such as “testing into compliance”, in which multiple samples from a shipment are tested but only those results that would allow the shipment to enter the United States are submitted to the FDA.

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