OneFoodTeam Blog

Blog posts on FSMA, Project Management, Compliance, Packaging, Processing, Reliability and more.

Supplemental Draft Guidance for the IA Rule

In February 2020, the FDA released a supplemental draft guidance for the Intentional Adulteration Rule.  This was the last in three sections of the guidance to be released, and completes the document.  The following is a brief summary of this portion of the draft guidance:

 

The supplemental draft guidance issued in February 2020 completes the IA guidance. Clerically, it fills in chapters missing from the previously published guidance, for chapters 5, 6, 7 and 9 along with some related Appendix.

The guidance will be pretty familiar to those familiar with food safety plans, covering the remaining management components for Mitigation Strategies; the corrective actions, and verification. Also new to this issue are the reanalysis components required for the Food Defense Plan. The management component for monitoring was already covered in the previously published guidance.

Taken together with the previously published guidance, you may notice that there is no validation requirement, such as validating that a kill step will actually result in a pathogen reduction. The Mitigation Strategies intended in the IA rule focus more on design and behaviors that will mitigate significant vulnerabilities, such as limiting access, so no scientific proof like validation is required. The verification requirements are more flexible and less resource intensive.

Similar to a food defense plan, these management components will have two aspects. There is planning for the management components that appear in the food defense plan (monitoring, corrective action and verification). There is also the documentation when you perform those same management components, such as each time you execute a corrective action.

The reanalysis requirements are quite similar to what you would find in a HACCP or Preventive Controls Plan. However the minimum reanalysis is less frequent, at 3 years. You also have to perform at least a partial reanalysis when there are significant changes in activities or new information about potential vulnerabilities or when there is improper implementation, as well as when it is requested (required) by FDA. These would all be similar to a Preventive Controls plan.

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FSMA IA Rule clarified: straight from the source

I am sitting in Minneapolis on May 4, 2017.  Our host at the conference this morning reminds us that today is "Star Wars" day (May the fourth be with you).

Leading the next session are three key leads from the FDA, so update the attendees on the FSMA IA Rule.  Ryan Newkirk, Colin Barthel, and Captain Jon Woody. Collectively they are policy analysts and senior advisors to the FDA Food Defense and Emergency Coordination Staff.

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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.

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Preparing for FSMA by Leveraging what is Familiar

The implementation of the Food Safety Modernization Act (FSMA) is coming, and as it approaches it seems like every day rules are being changed or added and businesses are often left wondering where to begin. The regulation is especially challenging because it brings together both food defense and food safety issues. In many cases, there are rules that are second nature for security professionals, while less familiar for food safety professionals, and vice versa. In an effort to ensure organizations are compliant, organizations should leverage what they already know to put practices in place for rules they are less familiar with.

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FSMA proposed rule: Implications for the Food Defense Plan Builder

The Food Defense Plan Builder (FDPB) is free software, provided by the FDA, to create a robust food defense plan.  It came out before the proposed rule on intentional contamination, so what are the implications?

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Monitoring for the FSMA proposed rule on intentional adulteration

The proposed FSMA rule for intentional contamination adds requirements for monitoring, verification and record-keeping that was not part of previous guidance documents. Experienced quality practitioners will want to skip down to “what’s different.” If you are new to these terms, read on.

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Training for the FSMA proposed rule on intentional adulteration

The FSMA proposed rule on intentional contamination has several training requirements. We will address who needs to be trained, what they need to train on, who needs to conduct the training, and what training documentation is needed.

Who needs training?

Personnel and supervisors assigned to actionable steps must be trained in food defense awareness. This likely includes all of the employees that work in the immediate vicinity of those actionable process steps, the supervisors of those employees. It would likely also include those that are monitoring the mitigation strategies assigned to those actionable process steps (who may or may not be the same employees and supervisors who work there). Depending on the way you interpret the word “assigned” you might also consider all employees with access to those actionable process steps, which could include various maintenance and logistic functions.

For a discussion of what constitutes an actionable process step: 2 ways to look at vulnerability assessments (Part 1)

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10 Ways to Choose a Food Defense Consultant

The proposed FSMA rule for intentional contamination uses the phrase "a person knowledgeable about food defense" in several places. What it doesn't tell you is how to choose a consultant (internal or external) with these capabilities. This blog article explores how to find a provider for your food defense plans.

That phrase, or a similar one, "prudent and knowledgeable about food defense," are used in several contexts. These include the person selecting targeted mitigation measures, the person training employees responsible for implementing targeted mitigation measures, and the person performing a vulnerability assessment.

Note that a vulnerability assessment is not required if the facility chooses to identify "actionable process steps" based on the four identified key activity types. This is a topic of a previous blog: 2 ways to look at vulnerability assessments (Part 1)

The FDA has requested comments on how to determine if a person is "knowledgeable about food defense." By the time the final rule is published, there could be consensus on this question. In the meantime, we offer this suggestion for your consideration:

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What (else) is missing from the proposed rule for intentional contamination (Part 2)

Missing from the proposed FSMA (Food Safety Modernization Act) rule on intentional contamination is any requirement for "broad mitigation strategies."  In this article we will explore the implications that has on protecting our "actionable process steps."

In part 1 of "what's missing" we described that there is no requirement to focus on disgruntled employees or competitors in the proposed rule.  The focus instead is on terrorists or others with an intention to "cause massive public health harm." 

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2 ways to look at vulnerability assessments (Part 2)

In Part 1 of this blog we discussed the first of two approaches for determining "actionable process steps."  This is a facility-specific "point, step, or procedure" in a food process where there could be a significant vulnerability to intentional contamination.  This "actionable process step" is the point where you would choose and apply focused mitigation strategies to reduce that vulnerability.

The first approach is to rely upon four "key activity types" determined by the FDA to have greater vulnerability.  The second approach is to perform your own vulnerability assessment.  Each approach has its pros and cons to consider.  You will have to determine which approach to use in your food defense plan.

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2 ways to look at vulnerability assessments (Part 1)

The FSMA proposed rule on intentional contamination provides two ways to determine what are called "actionable process steps."  This is a facility and process-specific "point, step or procedure" in a food process where there could be a significant vulnerability to intentional contamination.  This "actionable process step" is the point where you would choose and apply focused mitigation strategies to reduce that vulnerability.

The first approach is to rely upon four "key activity types" determined by the FDA to have greater vulnerability.  The second approach is to perform your own vulnerability assessment.  Each approach has its pros and cons to consider.  You will have to determine which approach to use in your food defense plan.

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What is missing from the proposed rule for intentional contamination (Part 1)

People that have been working with Food Defense will notice some things that they have previously focused on that are missing from the proposed rule for intentional contamination. In this post we will discuss one of them.

The explanation of the proposed rule uses the term "terrorist attack" throughout and clarifies that it is predominantly focused on preventing that type of attack which could result in the largest possible consequence to human health.

In the recent past, training materials from the FDA have discussed multiple additional vectors from which an intentional contamination might be made. Those include disgruntled employees, angry competitors and economically motivated adulteration.

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FDA Publishes Proposed Rule for Intentional Contamination

The FDA proposes a new food defense rule under the Food Safety Modernization Act (FSMA) to address intentional adulteration of food.  The proposed rule was filed December 20 and posted online on December 24, 2013.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628.htm

The FDA will hold a public meeting on the Proposed Rule on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.  The meeting will be held in Colleg Park, MD on February 20, 2014.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm377956.htm

As we anticipated, the rule would require written food defense plans.  It would include tiered compliance dates based on facility size.  It would apply to both domestic and foreign facilities that are required to register under section 415 of the FD&C Act.

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