Newsletter – Summer 2019

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FSMA Made Simple
  • FDA Extends Enforcement Date for IA Rule!
  • What are the training requirements for the FDA Intentional Adulteration (Food Defense) Rule?
Upcoming Workshops

Preventive Controls for Human Food-One Day “Blended” Course
September 11, 2019 Twin Falls, ID
NEW! Get the PCQI Certificate in One Day*!

Preventive Controls for Animal Food-One Day “Blended” Course
September 12, 2019 Twin Falls, ID
NEW! Get the PCQI Certificate in One Day*!

Better Process Control School:
September 9-12, 2019 Corvallis, OR

Practical Food Defense Workshop:
October 3- 4, 2019 Boise, ID

Internal Food Safety Auditor:
October 16, 2019 Nampa, ID

*After completing a prerequisite FSPCA online “Part 1” course.



The FDA Intentional Adulteration Rule
FDA Extends Enforcement Date
for Food Defense (IA) Rule Until March, 2020.

The Intentional Adulteration (IA) or Food Defense Rule (21 CFR 121) has its first compliance date of July 26, 2019, for “large” companies with 500 or more full time equivalent employees.  However, FDA received quite a bit of feedback from the food industry that more time is needed to develop food defense plans. On April 17, 2019, FDA announced that it will delay food defense inspections and enforcement at large companies until March, 2020.

Food Defense Training Requirements for the new FDA IA Rule

Somewhat like the Preventive Controls for Human Food (PCHF) rule, the IA rule (21 CFR 121) has created new monikers for trained employees.  Each of these designations has specific training requirements outlined in the rule. These include Qualified Individual (QI)- Assigned to actionable process step; QI- Perform food defense activities; QI- Food defense supervisor, and Food Defense QI- Individual assigned to 4 specific tasks.

The role and training requirements spelled out in 21 CFR 121.4 for these designations is as follows:

  1. QI- assigned to actionable process step: Places or points in a processing line that have significant vulnerabilities to intentional adulteration are known as actionable process steps and require controls called “mitigation strategies”. Full time or temporary employees and supervisors that work in areas or with equipment where there is a mitigation strategy must have “Food Defense Awareness” training, along with “appropriate education, training, or experience” to “implement” the mitigation strategy.
  2. QI- Perform food defense activities in Subpart C: Activities required by this subpart include the food defense plan, vulnerability assessment, mitigation strategies, and mitigation strategies management components (monitoring, corrective actions, and verification).As it relates to a person’s assigned duties, he or she must have appropriate education, training, or experience to perform these activities.
  3. Food Defense QI: There are four specific activities this person performs. These are: preparing the food defense plan, "conducting vulnerability assessments", "identifying mitigation strategies" and providing written explanation how they will control vulnerabilities, and reanalysis of the food defense plan.This individual must have successfully completed training for each of these tasks that is equivalent to, or uses FDA-recognized standardized curriculum.
  4. QI- Food Defense Supervisor: This person has the responsibility to ensure compliance of employees to the requirements of the IA rule. Required training includes both Food Defense Awareness and education, training, or experience to supervise required activities.
How to Complete the IA Rule Training Requirements
  • Food Defense Awareness Training:Defines what is food defense, why it is important, and what do to if suspicious activity is observed.This can be developed and delivered in-house, and there is also a free online training program provided by FSPCA and IFPTI at Food Safety Northwest includes a Food Defense Awareness module in its live “Practical Food Defense Workshop”.
  • Education/Training/Experience for QI’s: Generally developed in-house, as it relates to company-specific activities. For example, this could be an employee-training program on how to monitor mitigation strategies, how to take appropriate corrective actions, and how verification is conducted. The recent FDA guidance document, “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry” (March, 2019), has pertinent information that can be used to compile these training programs.
  • Food Defense QI Training: This requires FDA-recognized training materials for Vulnerabiliity Assessment, Mitigation Strategy, Food Defense Plan, and Reanalysis of the Food Defense Plan. Currently, the FDA in conjunction with FSPCA has developed only two of these modules, and they are available only through on-line training courses ("Conducting Vulnerability Assessments" course, and Identifying and "Explaining Mitigation Strategies" course). To further complicate matters, you can choose to learn how to use the quick and practical “K.A.T.” method of vulnerability assessment, or take another course (soon to be offered as a workshops by FSPCA) involving the very complex and onerous Three Element method of vulnerability assessment. The online courses for Vulnerability Assessmetns, and Mitigation Strategies are also available at : Food Safety Northwest will be offering a live, in-person certification workshop this fall that utilizes training materials equivalent to the recognized FDA curriculum and covers the Vulnerability Assessment and Mitigation Strategies modules, along with Food Defense Awareness. We will be adding the Food Defense Plan and Reanalysis components once they become publicly available from FDA.


Upcoming Workshops

Preventive Controls for Human Food
“Blended” Course
September 11, 2019 - Twin Falls, Idaho

The Blended course requires only one day at an “in-person” workshop, in combination with an online course!  You will receive the same PCQI certificate as the one issued for the 2.5 day public workshop.  This is a great option for those who can’t commit their time for 2.5 days, and it is significantly less expensive.  The blended course will be taught by seasoned food safety practitioners who each have over 20 to 30 years working experience in food safety and are highly rated for their interactive training methods
Registration for the Part 1 online component
Register Now
Registration for Part 2, the in-person workshop offered by FSNW
Registration Open
July 22, 2019

Preventive Controls for Animal Food
“Blended” Course

Sept. 12, 2019 - Twin Falls, Idaho
This course will also provide a PCQI certificate with a one day live workshop, plus online program! More details soon, as FSPCA is just now in the process of releasing this course to Lead Instructors
Registration for the Part 1 online component
Register Now

Practical Food Defense Workshop
October 3-4, 2019

Boise, Idaho  

This is a two-day certification workshop is targeted at those individuals who will serve as the Food Defense Qualified Individual, and are required to have FDA-recognized training in vulnerability assessments and mitigation strategies. Our training program utilizes materials that are equivalent to FDA recognized standardized curriculum, and also includes a module that will satisfy the FDA-required Food Defense Awareness training. Participants wil  learn to build an FDA-compliant Food Defense Plan during the course. Agenda topics include Food Defense Overview, Principles of Food Defense, Vulnerability Assessments, Mitigation Strategies, The Food Defense Plan, and the FDA IA Rule.
registration coming soon

Better Process Control School
September 9-12, 2019

Corvallis, OR

Sponsored by Oregon State University, Department of Food Science.

Supervisors of thermal food processing operations, acidified food processing operations, and food container closure operations.
Each processor of low-acid or acidified foods is required to operate with a certified supervisor on hand at all times during processing. This school provides the necessary training to certify supervisors of such processors.
The Oregon State University Better Process Control School is approved by the FDA and follows the prescribed course of instruction for certification. The two-day course addresses operations of acidified food processing systems, glass packaging systems and container closure inspection. In addition to the first two days, the four-day course addresses operations of retorts, low acid food processing systems, aseptic processing and packaging systems and container closure inspection.
Register Now
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