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Americas: Doing food business under US laws


As the Food Safety Modernization Act (FSMA) goes into effect in the US, it is essential for those governed by this regulation within the food industry to have the proper plans and procedures in place that fully comply with the new regulations.

However, many have learned over the last year that applying the new rules to their processing plant, supply chain or other covered components of the industry is not as simple as the written rules may make it seem (or sound).

While FSMA is the primary focus of the US food safety landscape, there are other trends working in conjunction to help with the early identification and prevention of issues associated with foodborne illness.

On the right footing

The Center for Disease Control and Prevention (CDC) estimates one in six Americans get sick, 128,000 are hospitalized and 3,000 die each year from foodborne diseases.

FSMA’s goal is to prevent widespread food illness created by improper processing or sanitation practices through the reduction of food safety risks, and to bring food safety into the 21st century by adopting proactive measures.

Making FSMA a success means the Food and Drug Administration (FDA) must ensure industry compliance, and this will primarily be accomplished by conducting inspections.

The FDA has grown in power under FSMA, with mandatory recall authority for all food products, expanded administrative detention of products that are potentially in violation of the law and suspension of a food facility’s registration.

Once the FDA posted its seven final foundational rules for FSMA in fall 2015 mid 2016, food brands asked: How do the rules fit together, which apply to me and what do I need to do to comply?

Now FSMA has evolved to the compliance stage, and a new question has emerged: How do I implement those procedures and policies necessary to meet FSMA requirements?

Last year saw the start of a few FSMA compliance dates, including those seeking accreditation as third-party certification bodies in January 2016, and compliance for preventative controls for human food and animal for non-small businesses in September.

In our work to help those reach compliance, we have found that the most important factor to integrating FSMA rules is taking advantage of new technology that enables on-site pathogen detection, including product testing and environmental monitoring.

The most difficult part of FSMA adoption appears to be what piece of the regulations you own and what pieces others in the supply chain are responsible for controlling.

In the early stages of compliance, the best strategy for everyone is to assume the need to validate all previous testing and to then deploy advanced testing techniques to satisfy FSMA and protect against pathogens.

American food companies are increasingly being reminded that they are ultimately responsible for the safety of their products and cannot so easily pass blame to their suppliers.

This means processors, manufacturers, shippers, distribution centers and other middle-men need to broaden their perspective to understand every tract of participation in food safety.

They should carefully consider the testing performed by whomever had custody of an ingredient or product prior to it reaching them.

Will the new administration mean a new approach?

On the campaign trail, newly elected President Trump expressed that he did not believe in ‘food police’, and has consistently declared a need for less regulation across American industries.

However, in the food industry, consumers can dominate public perception and cause the largest companies involved to put into place practices that are specific to consumer demand.

Wal-Mart, Costco, McDonald’s and the other large entities of the food world will continue to place the good of the consumer ahead of any lack of regulatory input or the loosening of inspections.

Even with an absence of audits by the FDA, the risk of consumers being struck by a foodborne illness is not something any company wants to be culpable of since it can have a severe impact on business success.

The role of whole genome sequencing

In addition to introducing new rules for FSMA in 2016, the FDA is making Listeria a point of emphasis for 2017.

There were several Listeria outbreaks last year, such as the frozen foods recall where more than 350 consumer products sold under 42 brand names and at least 100 other products prepared with associated ingredients were affected.

To pinpoint Listeria and other pathogens such as Salmonella, Campylobacter and E. coli, the CDC has begun using whole genome sequencing to find and solve outbreaks.

This use of whole genome sequencing – which can track an outbreak back to its specific origin using a molecular signature – has already started to deliver an added layer of food safety throughout the supply chain, with the CDC reporting that the technology is helping not only contain large-scale outbreaks but smaller incidents too.

Results from whole genome sequencing technology led to the CDC reporting in March 2016 that it could source two Listeria illnesses that occurred in 2014 as genetically matched to raw milk produced by a single farm.

The CDC is working with the FDA to help the agency understand how whole genome sequencing can be beneficial for regulatory purposes and keep the U.S. food industry ahead of the game.

Manufacturers might be slightly concerned that FDA access to such powerful technology will lead to greater regulatory scrutiny, but every sector of the industry needs to be dedicated to the eradication of pathogens.

Knowledgeable consumers

Another important development within the US food safety scene has been that consumers have become increasingly smarter about what is in their food, and have a greater view of what is going on in the food industry.

They have a more powerful voice, too, as the CDC is now allowing consumers to post food safety concerns and complaints – justified or not – on public forums on their site, and the viral nature of social media can easily create manias that vex, if not destroy food companies’ brands.

What will be important is for processors, manufacturers, suppliers, restaurants and all involved to be diligent and not shy away but embrace the increased focus on food safety.

The smarter companies become about food safety across the entire industry – from the actions of original ingredient supplier to the mindset of the consumer – the better positioned they will be to develop a food safety management system that meets, if not exceeds, regulatory measures.

Story by John Wadie, marketing operations manager, 3M Food Safety