FDA should rethink food defense approach, says USP

The US FDA should put in place specific measures to tackle economically-motivated adulteration (EMA) of food rather than rely on generic, preventive controls, says the US Pharmacopeia (USP).

USP urged the FDA to reconsider its strategy as part of a public comment period on the agency's proposed rule on Focused mitigation strategies to protect food against intentional adulteration, which was published in the Federal Register towards the end of March.

Under the 2011 Food Safety Modernization Act (FSMA) the FDA is required to draw up regulations to help prevent intentional adulteration of food, for example through acts of terrorism, that could cause large-scale public harm.

USP wants EMA to be considered as a category of adulteration in its own right as it has "its own challenges,  posing a threat to public safety, eroding consumer confidence in the integrity of food and disrupting markets by placing control of the supply chain in the hands of criminals," according to the organisation's chief executive Ronald Piervincenzi.

Rather than an approach based on preventive measures such as import controls as laid out in the FDA proposals, USP believes it would better to develop a risk-based model based on vulnerability assessment and a vulnerability control plan.

"The best way to protect consumers and safeguard industry is to focus on determining where EMA is most likely to occur," said Piervincenzi, adding that publicly available standards are also valuable safeguards against this type of activity.

Different forms of EMA include dilution of one material with another - such as olive oil diluted with potentially toxic tea tree oil or products watered down using non-potable water - the substitution of one food component with another, for example sunflower oil laced with mineral oil or the addition of hydrolysed leather protein to milk.

USP also notes that cases of EMA include incidents of concealment, such as the use of harmful food colourings to cover defects in fresh fruit - and mislabelling of ingredients. Examples of the latter include the labelling of toxic Japanese star anise as Chinese star anise.

"Any food ingredient can be adulterated, and the list of potential adulterants is equally unlimited," said Piervincenzi.  "EMA should be addressed as its own unique category of food adulteration."

The FDA said in March it had received extensive feedback on the proposed rules and had implemented a 90-day extension on the comment period to June 30, 2014. It also provided a 45-day extension to the comment period (to May 22) for its proposals on the designation of high-risk foods for tracing.

You can learn more about the FSMA and its implications at the Food Recalls and Traceability Summit in Washington, District of Columbia, on September 29-30.


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