Supplemental Draft Guidance for the IA Rule

In February 2020, the FDA released a supplemental draft guidance for the Intentional Adulteration Rule.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  The following is a brief summary of this portion of the draft guidance:

 

The supplemental draft guidance issued in February 2020 completes the IA guidance.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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Sabotage - your boss's boss has already torpedoed your project.

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How can it be that your boss's boss has sabotaged your project?  It happens with too much frequency, and it can happen even before you have been assigned to the project.

 I started thinking about this when I saw a reader's comment on one of my previous blogs discussing project challenges:

 Another big (challenge) I face is "sponsors that are not aligned to scope. Also a charter that has many items misrepresented or wording that leaves too much room for misinterpretation."

The problem with sponsors that aren't aligned, and vague and ambiguous charters is common, they are related, and they can be overcome with the same techniques.

We don't want to think that the boss is purposely torpedoing our project.  That may be true in rare cases.  But what are the four most common causes of unintentional sabatoge?

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3 Pitfalls Sure to Put Your Project in Crisis

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We sometimes are called upon to "rescue" a failed project.  While there are many reasons which can lead to a project needing to be rescued, these three are frequent offenders.  You know the sad thing?  They are all preventable.

In the three cases I will discuss, project failure isn't some abstract concept known only after the fact.  You see it coming, with a sense of impending doom as your project is caught in a landslide, hurtling toward a cliff.  That is the common theme of these problems; you come to realize you are in trouble, but it is too late to do much of anything about it but watch.

Another common theme is how pitfalls unfold.  Your project looks ok, looks ok, looks a little behind, oh no - big trouble!

1.  Understimating the complexity and scope

This pitfall unfolds as your project progresses, and you continue to find little things that are needed, but were not planned.  Most are minor gaps in the scope you defined, but as they occur and accumulate you get further and further behind.

At the conceptual stage, and even sometimes at the approval stage, the big outlines of the project are known and understood.  But the details haven't been established, and missing a small but critical detail can derail any project.

Before the project is approved, if possible, and at the least immediately after the project is approved, there should be a diligent scope-defining exercise.  This should drill down to individual tasks and needs, and so far as possible, into the construction sequence.

Without this diligence, all the little details will get done.  But they will get done when you realize the need which may be too late to keep your project on track.

With most of the little details defined up front, you can prepare for them, sequence the work, track them, and insure they don't slow down your project.  And you can focus on the few that you missed.

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Work like it is your last day

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We've heard a similar adage about living our life like it is our last day.  But what about work?  What is the value of a work day? 

Imagine this, you are near the end of your project, right where you go from construction to testing, or when you finish testing and begining production.  Every day, every hour is important!  Work is urgent!  There is no time to loiter.  

But what about the beginning of the project?  Was there a decision that took a month, which should have taken a week.  Did you lose .a week somewhere when a key person was on vacation?  Excess time for some approval?

Why are those days valued less, what problems does that cause, and how do you prevent it?

In my experience on projects, we do NOT treat every day as though it has the same value.  We should!  The failure to understand the value of each day leads directly to the failure of many projects.  Here's how that happens:

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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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Beware the FSPCA Certified Training or Instructor

You are searching for a Preventive Controls for Human Foods (PCHF) course that will satisfy the requirement for a "Preventive Controls Qualified Individual" (PCQI) as part of the FSMA requirements.  You want to make the best choice, and insure the course you choose is legitimate and well designed.

FSPCA CERTIFIED!

FSPCA ACCREDITED!

FSPCA APPROVED!

These titles jump out at you, from the top of your search listings, from the paid, sponsored ads!  Beware!

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How to choose a Preventive Controls Course

The final FDA rule for Preventive Controls for Human Food (PCHF) have been published and deadline dates for compliance are established.

Offerings for courses in Preventive Controls are beginning to pop up.  What are the important considerations to choosing?

Primary considerations

The primary consideration must be to help expand the knowledge for the protection of the food supply.  Any Preventive Controls course must help you to:

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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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Do you need to schedule snow days in Florida?

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I grew up in central Florida, where snow was rare. When it happens, it usually means a few small flakes. But now I live in Dallas, Texas where we have been hunkered down for four days after ice and sleet closed our roads. (If you are from “up north” where you have real winter storms, don’t laugh just yet, but hang with me while I make a point).

This local article was talking about the lingering effects of the storm including anticipated potholes:  http://ireader.olivesoftware.com/Olive/iReader/StarTelegramPress/SharedArticle.ashx?document=FWST%5C2013%5C12%5C10&article=Ar00702.

The article also answered questions about potential construction delays on major road projects in the area, since no work has been done for several days.

 

Of course there is no overall schedule impact because the schedule has “snow days” built in, to accommodate for some reasonable amount of bad weather. So far we have had fewer bad weather days than anticipated, and these projects are on schedule if not slightly ahead.

But what about construction in Florida? What about installing a new production line inside a factory in Nevada? What about a new product rollout in New Mexico? Do those projects need to schedule “snow days?”

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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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