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What can you do now to prepare for FSMA?

How to Prepare for FSMA Today


Since the Food Safety Modernization Act (FSMA) was first signed into law by President Obama in 2011, it seems as though its seven proposed rules have undergone constant updates and changes. The Food and Drug Administration (FDA) has now agreed to court-ordered deadlines to issue final regulations for all seven rules. Specifically, the first ones for preventive controls for both human and animal food are due by August 30, 2015 and the last rule for intentional adulteration is due by May 31, 2016. The establishment of these deadlines is the first step towards the implementation of the law.


While many of these deadlines are still more than a year out, and specific details within the rules may change, there’s one common theme across all FSMA rules that businesses should consider: proactively creating a food defense and safety plan – or updating a current one – is the first step to ensure compliance with all FSMA rules. In this blog, Ned Mitenius, founder and president at Periscope Consulting, LLC and Don Hsieh, director of commercial industrial marketing at Tyco Integrated Security, share steps organizations can take now to ensure they are in compliance as FSMA’s deadlines approach.


Ned Mitenius

The first step toward FSMA compliance is to stay abreast of the rules. One of the easiest ways to do this is through the FDA’s FSMA website. If businesses find it challenging to understand the regulation intricacies, visiting the website and reading the preamble for each proposed rule is helpful. The preambles list out the details of the rules in plain language and, in general, the website can serve as an organization’s go-to source for FSMA information.


Additionally, the FDA offers a Food Defense Plan Builder. It’s a free software tool that allows companies to create a robust food defense plan. I’ve detailed it in this blog post. As I mention in the post, although the software pre-dated the publication of the proposed rule, it was finalized after FSMA was enacted. In addition, the same team of technical experts at FDA worked on both the software project and the proposed rule. So organizations could anticipate significant overlap.


However, businesses may still be uncertain about which rules are most pertinent to their industry and the best way to ensure compliance. This is where third party consultants and trade associations can help. All organizations in the industry are going through this together, and it’s important for them to learn from one another. Partnering with a third-party consultant can help determine which rules impact your business and work with you on the most practical steps to ensure compliance with those rules.


It’s important to consider which consultant will be a best fit for the company. Businesses should consider items like academic credentials and additional certifications like food defense, years in the business, experience and thought leadership position. Organizations should do their due diligence and look for any previous thought leadership or speaking sessions by the consultant to ensure they agree on his or her industry credibility.


In addition, engaging in industry or trade organizations will prove helpful, as they provide educational materials, thought leaders and communities assembled around the FSMA topic. Businesses also may be able to find events or conferences that bring together other regional companies to discuss tactics and best practices for complying.


Don Hsieh

In developing an effective food defense strategy, consider the 4A’s: assess, access, alert and audit. It’s a four-step methodology for building a proactive and comprehensive food defense strategy. First, businesses should assess the risks throughout their supply chains. Start by conducting a vulnerability assessment of critical control points to identify where someone could attempt product adulteration – both inside and outside of company walls.  That’s the point of using the FDA Food Defense Plan Builder or similar tool.  Businesses may discover gaps in their food safety/defense plans. As Ned mentioned above, it may be beneficial to hire a consultant to stay on the right track toward compliance. Whether working with a consultant or going it alone, there are specific steps companies should take to mitigate those risks. Another tool the FDA provides to assist businesses is its Food Defense Mitigation Strategies Database.


Second, organizations should consider who has access to each actionable process step. In particular, they should pay close attention to the four key activity types that the FDA has identified as particularly vulnerable to adulteration: for example, mixing and grinding activities that involve a high volume of food with a high potential for uniform mixing of a contaminant; ingredient handling with open access to the product stream; bulk liquid receiving and loading; and liquid storage and handling, which is typically done in remote, isolated areas.


Third, companies should employ technology to alert the appropriate individuals of intentional and unintentional instances of food adulteration. In this phase, response time is critical. Every passing minute is a minute when more health risks could develop, leading to a greater chance of negative impacts on a brand and, most importantly, public safety.


Lastly, organizations should audit operational and regulatory compliance to ensure and maintain best food defense practices and provide documentation of compliance to regulators.


Businesses may look at the deadlines for FSMA and think it’s not essential to focus on compliance right now. With the rules undergoing seemingly endless changes, they can be daunting and easy to ignore for the time-being. By considering the items outlined above and creating a proactive food defense and safety plan, however, businesses can ensure they are in compliance when the rules go into effect to maintain brand integrity now, regardless of what the details of the final rulings will state.

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