Tag Archives: FSMA Fridays

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

What to do Now to Migrate from HACCP to HARPC

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

There is much talk about HARPC – Hazard analysis and risk-based preventive controls – and how food companies need to either elevate their existing Hazard Analysis at Critical Control Points (HACCP) program, or formulate a new HARPC-based food safety plan, in order to comply with proposed rules under the U.S. Food Safety Modernization Act in the

In a recent FSMA Fridays discussion, Dr. David Acheson and Melanie Neumann of The Acheson Group elaborated along with SafetyChain Software’s Barbara Levin, how HARPC differs from HACCP and what companies can start doing now to be prepared. We present below some excerpts.

How are HACCP and HARPC different?

The key term is that HARPC is risk –based. While HACCCP is more prescriptive, based on the seven-step process, the risk-based analysis requires moving outside of those seven steps to think of how else can I manage risk. Also, under HARPC, it’s no longer deemed sufficient to have a HACCP plan – you need to have a more exhaustive food safety plan.

How should F&B companies approach migrating HACCP to HARPC plans?

In the proposed FSMA rules, FDA has changed the language of defining how and which products should be monitored from ‘reasonably likely to occur,’ which is HACCP type terminology, to ‘significant.’ FDA is doing this in an attempt to differentiate the required HARPC-based food safety plan from traditional HACCP plans. This requires food companies to look at hazards along the whole supply chain – from when we are receiving food to when we are shipping it out (and not just at control points). For instance, environmental controls in a ready-to-eat foods processing area is covered now, which is beyond the traditional HACCP area. So look at those risks in the processing facility and ask if they are significant risks.

Who is the Qualified Individual and how does this impact the HARPC approach?

This is the million dollar question! FDA hasn’t come out with a clear definition yet – only vaguely referring to this person as ‘qualified by training or experience.’ However, this person has a lot of responsibility on their plate – they are responsible for preparing a robust food safety plan that identifies and controls risks, for putting in place corrective actions and validate these, and for doing a reanalysis of the food safety plan as needed. F&B companies need to ask if they have the right person driving this bus. You do need somebody in your business who is capable and qualified to do this, or FDA allows you to use an outside expert as the Qualified Individual.

What will FDA expect to see with HARPC when they come in to see FSMA being enforced?

Once FSMA is implemented (possibly) by August 2016, FDA inspectors can come into F&B facilities and ask to see food safety plans, and details of the HARPC plans. They would want to understand what the process is, what the hazards are, and how and if you are controlling these, and if you are thinking of these hazards from a risk-based preventive controls strategy.

What are top three things that companies should be doing to comply today?

As described often, HARPC is an evolution of HACCP or HACCP on steroids. The first thing you need to do is understand what you are being asked to do with HARPC. Make sure you get the strategy here. Step two, is to get together a team to do this to figure out where your risks are, if they are significant, and build these into food safety plan. Step 3 is look at your current systems and structure. Do you have these now identified significant risks controlled? Have you determined what the controlling steps are, and put in place these preventive controls? Ask yourself if you are controlling these risks, monitoring them, putting in place corrective actions and validating them?

Final point: we often hear people saying, ‘I am going to wait. We are going sit out and watch how the rules evolve.’ But our advice is Do Not Wait! We have a lot of insight on how the final rules are going to pan out and what the compliance requirements will be. So start working now.

For more on this discussion, click here.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA Fridays: Concerns Around High-Risk Food Methodology

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

In February 2014, FDA published a Draft Approach for Designating High-Risk Foods under the Food Safety Modernization Act, with the purpose to identify high-risk foods based on specific parameters for additional recordkeeping requirements to enable rapid, effective tracking in the event of foodborne illness outbreak.

What are the factors by which a food is designated as ‘high-risk?” will FDA do such an analysis for every single food product? And what are concerns about this approach?

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on this topic.

What will the high-risk foods list be used for?

Dr. David Acheson: What FDA wants to do with the high-risk foods list is to mainly leverage this for better product tracking. FDA will also have greater authority to ask for more information and keep more records for these high-risk foods, though the agency hasn’t clearly specified what information yet. Also the frequency of routine inspections for high-risk foods will be greater: once every three years, compared to once in every five years for non-high risk foods. One area which FDA hasn’t elaborated on is importers needing certificates for high-risk foods entering the U.S. Initially, the agency had considered this, but didn’t have a system in place to require this. Now the requirements are proposed in the FSMA rules and third-party audits can support this.

What are factors that will determine if a food is high risk?

Jennifer McIntyre: FDA considered several areas and has finalized a detailed methodology to identify high-risk foods based on the following parameters:

  • Frequency of outbreak and occurrence of illness associated with that food since 1998;
  • Severity of those illnesses;
  • Likelihood of contamination;
  • Growth potential of that food;
  • Is there an opportunity during processing for that product to become contaminated;
  • Consumption of that food product; and
  • Economic impact associated with that food product in case there’s an outbreak or recall.

This approach is based on an evaluation of chemical and microbial hazards combined with foods using criteria that encompass the FSMA-required factors.

How will each food be scored and is there a distinguishing line between high-risk and non-high risk foods?

McEntire: Food will be rated on a 1 to 9 scale, with 1 being low, 3 being medium, and 9 being high. Companies have these three options to choose from. There’s no clear line the agency has proposed to determine what foods are on the list and what aren’t.

Is FDA going to do this analysis for every single food product? Where will they get the data from?

Acheson: There’s no way the agency can do this for every single food product. They are looking at a lot of parameters to consider. What they might do, and they are already doing, is try to bunch food products and commodities together, so there will be buckets of food identified as high-risk and non high-risk. Getting all that data will prove to be a challenge, considering that what’s available is quite thin. Private sector may have data that could help the agency, but then there’s the concern that if you share the data voluntarily, you have a risk of your product being classified as high-risk.

Are there any concerns being expressed in the industry about this approach?

McEntire: There are many concerns that industry is expressing right now, such as, given the limited data, how do you choose which foods to look at? How do you make sure that the analysis of one food can be applied to another food? How can we factor differences in processing and facilities? How will all the data be used? The parameters specify considering outbreaks going back to 1998 – some of this information has changed tremendously, and this will not factor in new regulations under FSMA.

One major concern is how can I get off the list? If you are considered a high-risk food now, but change your methodologies etc., can you get off the list? We need to see another iteration of this proposed rule from FDA to see if this rule can evolve and address some of these concerns.

What are some next steps for high-risk food methodology and what should industry do to prepare?

Acheson: Determining whether a food is high-risk or low risk will depend on the type of data being collected. The agency’s authority to increase demand for data for purposes of better tracking will require more robust data collection on the part of industry. Food companies will need to assess the data sets they are collecting now, and their product tracking system. Consider the IFT report and its recommendations to learn specifically what data should be collected. If a company determines that some of its products are going to be designated as high-risk, then they need to consider what the criteria will be for gaining that import certificate. Is that food being produced according to the standards that FDA is expecting? Pay attention to your foreign suppliers and ensure that they understand the need to be compliant with FSMA rules, and have sound food safety programs in place.

If this rule is a one-way street, where a food can only be moved from low-risk to being designated as ‘high-risk,’ then that would be disappointing and would detract from seeking improvement and rewarding behavior. The rule needs to consider situations when a company puts in specific mitigation steps in place, so can the food then be categorized as low risk?

For more details and to access FSMA Fridays webinars, please click here.

Food Defense Rule – What You Need to Know

By Food Safety Tech Staff
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What is the Food Defense rule and how is it different from the Preventive Controls rule proposed under FSMA?

On December 24, 2013, the U.S. Food and Drug Administration proposed the Rule for Focused Mitigation Strategies to Protect Food against Intentional Adulteration under the Food Safety Modernization Act

Also known as the food defense rule, the proposed rule would require domestic and foreign facilities to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm, and would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation. Comments are due by end of the month.

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, Dr. David Acheson, and Melanie Neumann of The Acheson Group discussed this rule. We present some excerpts below). 

Who does the Food Defense rule apply to?

The goal of this rule is to put preventive controls in place where terrorism is a threat. By making this rule risk-based, FDA aims to prevent a single-point attack with potential mass casualties. This rule is focused on large manufacturers and processors of human food with sales of over $10 million. It will not affect small manufacturers or farmers with the exception of dairy operations and bulk liquids. 

If the rule applies to you, what do you need to do?

Assemble a food defense team with industry experts and come up with a food defense plan. Conduct vulnerability assessments. Think about the possible agents and the processes whereby that agent could be added to one of your foods. What are your actionable process steps and mitigation strategies? For instance, how can you control access to bulk liquids and bulk mixing? The food defense plan does not need to be validated, but it does call for training, monitoring, and documentation. 

What are the similarities and differences between Preventive Controls and Food Defense rules?

Unlike Preventive Controls rules, there is no need to validate that the Food Defense mitigation strategies are effective. Also, if you’re doing your own vulnerability assessment, you need to have someone who knows what they’re doing, but they don’t need to be a ‘qualified individual’ as required under the Preventive Controls rule. Another distinction is that with Food Defense, there’s no assumption that the food you produce is automatically adulterated if there are problems with your mitigation strategy.

How will I know if my Food Defense approach is effective?

It is impossible to know if a food defense strategy is effective without challenging the system. It is highly unlikely that FDA will simulate an attack to gauge Food Defense effectiveness. Even though the likelihood of a terrorist attack on the food supply is rare, the industry must go through due diligence to try to prevent attacks from happening. It is not enough to have a security camera in place if that camera doesn’t work or if no one is monitoring it. 


This rule will not be finalized until Spring of 2016. FDA wants comments from industry on Food Defense and on how it can be shaped into a practical and economically feasible program. 

Where does economically motivated adulteration fit into this?

FDA is covering economically motivated adulteration with the Preventative Controls rule, not Food Defense. There has been a lot of controversy regarding this decision. Where does precedent lead to a reasonably likely event to control? If the scope is not limited, this could require an excessive amount of testing for many different compounds in incoming ingredients with significant economic impact. 

More information visit www.SafetyChain.com/FSMA-Fridays.