The Food and Drug Administration’s (FDA) new rule on protection of food against intentional adulteration does not apply to very small businesses (VSBs). Yesterday, a webinar was hosted by the FDA to brief on the ‘mitigation strategies’ (read risk reducing steps), which will take effect under the final FDA food rule of the Food Safety Modernization Act (FSMA).

The presentation informed VSBs in the food industry which on an average earn less than $10,000,000 ($10 million) per year, along with farms will be exempted from the food defense rule. However such businesses will have to comply with the rule within five years.

The webinar explained the establishments under the new rule finalized on May 27, 2016, which food industry facilities will have to undertake. The rule was initially proposed in December 2013 after the FDA assessed there was danger of deliberate food contamination in the US.

According to the FDA, “The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.”

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Although small businesses also play a role in the food supply chain the FDA decided that such minuscule operations do not pose any risk of wide scale contamination.

Likewise the new measures will also ensure increased food safety, i.e., prevention against unintentional contamination of food, since the US Centers for Disease Control (CDC) estimates more than 48 million people (1 in 6 Americans) fall ill every year from food-borne diseases, as a result of accidental contamination.

“The rule will work in concert with other components of FSMA by preventing food safety problems before they occur,” said Stephen Ostroff, MD, incoming Deputy Commissioner for Foods and Veterinary Medicine at FDA.

There are many forms of intentional adulteration of food, which if they happen, can leave catastrophic consequences on the health and economy of the US population. Groups such as disgruntled employees or competitors, in both domestic and foreign food companies, pose risk of wide-scale harm.

The FDA states, “The rule requires registered food facilities to develop a food defense plan to prevent intentional adulteration of food that may result in large-scale public harm.”

The rule applies to large food corporations which supply to a large proportion of the population and are registered under the Federal Food, Drug, and Cosmetic (FD&C) Act. More than 3,400 corporate firms exist in the US which handle and operate 9,800 food producing facilities.

On the other hand the webinar reported that for the VSBs to be exempted, they will have to give the FDA proof of their small-scale activity in the form of a request form and evidentiary documentation, which will be followed by a review. Both sales and market value within a three year period, of food products directed for human use, of a small business will decide whether it is applicable for the defense plan.

The Produce Marketing Association (PMA) summarized the exemption saying, “This proposed regulation may or may not apply to produce businesses that are FDA-registered food facilities such as fresh-cut processors, packinghouses and distribution centers depending on enterprise size and the types of activities in which they are engaged.”

Keep in mind the rule is not valid on farms or producers of raw food because they are low-risk production practices even if processes such as manufacturing, packing or holding occur on site. In the same way, facilities which manufacture, process or pack food intended for animals or cattle are also excused. Even packing facilities which carry out repacking, labeling, or relabeling of food and makers of certain alcoholic beverages do not have to follow the food defense rule.

However, large food corporations on which the defense rule is compulsory, will have to carry out a vulnerability assessment of their facility to recognize all the steps or places where adulteration can occur. Then the companies will have to come up with new mitigation strategies, so the risk of intentional adulteration can be reduced. All such steps will have to be documented in a written form and concerned personnel will also undergo training on behalf of the FDA, so they can properly monitor and take action to ensure food defense.

The first ever bioterror attack through intentional adulteration of food occurred on US soil in September 1984, when followers of Bhagwan Shree Rajneesh also called Osho, contaminated salad bars in Dallas, Oregon. The followers called Rajneeshees contaminated 10 salad bars with salmonella over a course of 2 months, in order to incapacitate a large majority of the population, so they could be prevented from voting in the local elections.

The Rajneeshee attack is still considered the biggest bioterror attack in US history as 751 people fell ill and more than 45 were hospitalized as a result of salmonella poisoning. The new defense rule will employ various new measures in food manufacturing facilities to ensure food defense against any future event involving intentional adulteration.