If a facility manufactures or processes food FSMA will impact the almost every facet of its food production. The Food Safety Modernization Act was put in place in 2011 by President Obama to make America’s food supply safer for consumption. Compliance dates will vary according to the size of the facility, but all facilities registered with the FDA will need to comply. Facilities need to be aware of FSMA in detail, not only to be compliant with the law, but to ensure safe food for the American public. Mike Nolan, technical director at ASI Food Safety provides a few of the new, soon to come and key points that facilities need to know about.

Mandatory Training

For the first time in history, the FDA will require food safety training for employees working in food production and manufacturing facilities. “It’s two different levels of training,” Nolan says. “One is a highly qualified individual, and the other is a qualified individual.” The basic definitions of the two levels are:

Highly qualified individual – an individual that has had risk-based training on how to establish a risk-based preventative food safety program. The training needs to be documented and can come from something like HACCP training or job training. Most likely a given facility will have one or two people at this level.

Qualified individual – the individual actually doing the work. The qualified individuals will need evidence that they’ve been trained in things like hand washing and other personal hygiene based procedures.

“The training is going to be a bigger portion in the future,” Nolan says.

Hazard, Risk Analysis

All facilities will need to do a hazard, also known as risk, analysis of their entire process. “The entire process would include everything from ingredients, to packaging, to the processes themselves,” Nolan says. Once a facility completes its analysis, they will next need to put preventative measures into place to mitigate the risk(s). Next, facilities will need to verify the mitigation process. “That’s probably going to be the biggest impact, the risk-based preventative control. It’s called (Hazard Analysis and Risk-based Control Point) HARPC,” Nolan says. “So, whatever risk that the facility has identified, they need to show that they’ve mitigated that risk and then verify that the mitigation is working.”

While HARPC differs from (Hazard Analysis Critical Control Point) HACCP, the two hazard control systems are similar. ”Even though you can have a critical control point under HARPC, it’s a little less restrictive than HACCP,” Nolan says. The hazard analysis concepts are very similar and the flow diagram is similar, but HAPRC has fewer requirements, he adds. The other aspect of HARPC that facilities should understand is that HAPRC relates to products and not facilities. “So you can have a facility that manufactures 15 products and maybe only three of those products would have a HAPRC and the others would not,” Nolan says.


The biggest challenges that producers will face are documents that the government has yet to present. “Those will give us a lot more information,” Nolan says. “One of them has to do with environmental swabbing, and that’s another part of FSMA that’s going to impact people.” Environmental swabbing entails the identifying a number of areas in the facility (50 or so, Nolan says) and swabbing them to find out whether or not you’ve got any pathogenic organisms such as listeria.

“You’ve got to have a program, and a lot of manufacturers I talk to about environmental swabbing tell me that they don’t want to know,” Nolan says. “That’s dangerous. They’ll say, ‘If I don’t swab it then I won’t have to deal with it.’ That’s scary, but some facilities take that approach.”


Another point of FSMA to note is the addition of radiological risk. Facilities will need to find out how far away their location is from the nearest power plant. They’ll need to know if they are within fallout range of a nuclear facility. “The biggest part has to do with whether or not a facility gets its water from a well,” Nolan says. “They’re going to need to make sure they test the well water for radiation.” In cer5tain parts of the country radon is also an issue. The government added the radiation piece to FSMA after the tsunami in Japan caused issue with a nuclear facility there. The US has never had a recall for radiation poisoning, Nolan adds.