On 26th May, the US Food and Drug Administration (FDA) finalized a landmark anti-adulteration food safety rule called the ‘final food defense regulation’. The new rule was passed under the bipartisan FDA Food Safety Modernization Act (FSMA) and is supposed to be a defensive strategy for the food protection of the US population. The rule aims to stop ‘intentional adulteration’ at food companies in the US or in overseas facilities which supply to the masses in the US.

The FDA did admit a complete and absolute elimination of corruption acts i.e. contamination of food is ‘unlikely to occur’, but the new rule will still be able to ensure that the adulteration of food supply will lessen to a great degree.

For the first time food facilities, both domestic and foreign, which supply to the US population, will have to follow a written food defense plan. As the name implies, the final rule by the FSMA marks a historic development for US food safety as a preventive measure against ‘wide-scale public health harm’.

The US Centers for Disease Control (CDC) estimates that every year 1 in 6 Americans i.e., 48 million people, fall ill from foodborne diseases, with 128,000 hospitalizations and 3,000 deaths. The FDA press release states, “The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, […] to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards.”

Interestingly the FDA seems to have given the new rule a more aggressive theme than a normal food safety precaution, which could mean the people at the Pentagon are getting serious about what exactly goes into their food. As part of the plan, food factories will have to list all of their ‘potential vulnerabilities’ which can lead to ‘deliberate contamination’. The fact that deliberate contamination is being mentioned conjures up many supposed scenarios, all leading to one massive conclusion and question — is the US food supply at threat?

The new rule will also enforce a set of rules for food companies to follow for increased safety and it will also advance the current mitigation strategies by the FDA. The written plan will have to be completed and then maintained by food producing units as a way to address their possible weaknesses. The food producing facilities will also work on developing strategies on how to identify and then deal with a food contamination problem if one arises.

On top of it all, new ‘food defense monitoring procedures’ will be set up by every single food production plant as corrective measures if the time ever comes for their use. Even the personnel assigned to areas with the potential to cause contamination of food will have to undergo appropriate training for the task at hand. The personnel will also have to maintain certain records to ensure food quality is being maintained.

“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” said Stephen Ostroff, MD, incoming deputy commissioner for foods and veterinary medicine, FDA. “The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”

A deadline has been set for compliance with the rule and food manufacturers will have to adopt the new defense decree within 3-5 years after its final publication by the FDA. Time compensations will be made for some food manufacturers depending on their size.

The food defense regulation rule was first thought of back in December 2013 when a federal register was set up to review considerations from the food industry, government regulatory partners, consumer advocates etc., which generated more than 200 comments.

According to the FDA, the rule is a measure to minimize illnesses and deaths linked with eating contaminated food. The rule will enforce science-based minimum standards on food producers so that processes such as ‘growing, harvesting, packing, and holding of produce’ will be safe for human consumption without any risk of food borne illnesses.

In their press release, the FDA clarified that the rule does not apply to ‘rarely consumed raw produce’ or products which are ‘raw agricultural commodity’, meaning farmers can take long breaths of relief for being exempted from the rule. Another group having escaped the clutches of the new rule is food producers, who already carry out commercial processing processes for reducing the ‘presence of microorganisms’.

The FDA has promised that for the implementation of the rule, they will provide the food producers with ‘valuable tools’ so they can come up to par with the requirements of the new defense rule, through partnership, education, and training.

The FSMA is considered to be most comprehensive US food safety reform in the last 70 years and was made law by President Obama in January 2011. The job of the FSMA is to ensure food contamination is prevented from the source, before reaching the citizens. The finalization of the defense rule also marks the completion of all the 7 rules of the FSMA which make up its core.