Intentional Adulteration

Training and Materials

FSPCA IA Training Cheat Sheet
FSPCA Food Defense Awareness for the IA Rule
FSPCA IA Rule Overview
FSPCA IA Key Activity Types Course
FSPCA IA Identification and Explanation of Mitigation Strategies Course
FSPCA IA Conducting Vulnerability Assessments Course
FSPCA IA Conducting Vulnerability Assessments Participant Manual v1.0 (English)
FSPCA IA Vulnerability Assessment Lead Instructor Course
FSPCA IA Vulnerability Assessment Lead Instructor Combination Course (Participant Course PLUS Lead Instructor Course)
FSPCA IA Vulnerability Assessment Lead Instructor Criteria and Online Application
FSPCA IA Food Defense Plan Preparation and Reanalysis Course
FSPCA IA Online Course PDFs

FSPCA Food Defense Awareness for the IA Rule

Course Description

The FDA’s Food Safety Modernization Act rule: Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121) (IA Rule) requires that covered facilities develop and implement a food defense plan that protects the facility’s most vulnerable points from acts of intentional adulteration intended to cause wide scale public health harm. The points in a facilities operation that have these significant vulnerabilities are called “actionable process steps”. According the IA rule, individuals assigned to work at actionable process steps and their supervisors, are required to receive training in food defense awareness (21 CFR 121.4(b)(2)). This “Food Defense Awareness for the Intentional Adulteration Rule” is designed specifically for those individuals and will meet the food defense awareness training requirement within the IA rule. It is important to note that the training requirement in the IA rule is flexible, and individuals may choose this training or a similar food defense awareness training to satisfy this requirement.

This curriculum was developed in partnership with the Food Safety Preventive Controls Alliance (FSPCA), Intentional Adulteration Subcommittee (IA Subcommittee). Development was assisted by the International Food Protection Training Institute with funding from the Food and Drug Administration. The information provided by the FSPCA is for training purposes only and does not create binding obligations for FDA or industry. This course is intended as a training tool to assist companies in complying with the FDA’s Food Safety Modernization Act rule: Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121) (IA Rule); however, taking this training does not ensure compliance with the law or FDA’s regulation.

  • Delivery Format: Online course
  • Estimated Seat Time: 20-30 minutes. There is a 4-hour inactivity time-out, so once started, complete the entire course.
  • Certificate: An FSPCA Certificate of Completion is issued at the end of the course that you must print off immediately. This is the only time the certificate is available to be printed (no record is retained). If you need a replacement certificate, you will need to complete the course again.
  • Cost: Free

Download the FSPCA Food Defense Awareness Course Information Packet for full details on the course, access the course and how to print your certificate.

If you receive a similar error message when clicking the link below, click Logout before clicking the “LAUNCH THE COURSE” button below.

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FSPCA OVERVIEW OF THE INTENTIONAL ADULTERATION RULE (IA RULE)

Course Description

This training will provide stakeholders with more information about the Food Safety Modernization Act (FSMA) Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121) (IA Rule). The purpose of the IA Rule is to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm. The final rule establishes various food defense measures that an owner, operator, or agent in charge of a facility is required to implement to protect against the intentional adulteration of food. While this training course is optional and not required for compliance with the IA Rule, the information within this training will assist food facilities that are required to comply with the IA Rule, and other stakeholders, to have a more in-depth understanding of the requirements in the IA Rule.

  • Delivery Format: Online course
  • Estimated Seat Time: 25-35 minutes. There is a 4-hour inactivity time-out, so once started, complete the entire course.
  • Certificate: No certificate is provided for this course because the FSPCA Overview of the IA Rule course does not fulfill a regulatory requirement. No records are retained for your completion of this course.
  • Cost: Free

Download the FSPCA Overview of the IA Rule Course Information Packet for full details on the course, directions on how to access the course and who to contact for support.

If you receive a similar error message when clicking the link below, click Logout before clicking the “LAUNCH THE COURSE” button below.

LAUNCH THE COURSE

FSPCA IA Conducting Vulnerability Assessments using Key Activity Types

Description: The Food Safety Modernization Act (FSMA) Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121) (IA Rule) regulation is intended to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm. The regulation requires covered facilities to conduct a vulnerability assessment (VA) to identify actionable process steps (21 CFR 121.130). The regulation further requires that individuals conducting or overseeing the conduct of a VA “have successfully completed training for the specific function at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to conduct the activities” (21 CFR 121.4(c)(2)). This training developed by the FSPCA is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet this training requirement.

This training course is targeted towards food professionals using FDA’s Key Activity Type (KAT) method to conduct their facility’s vulnerability assessment (VA). By successfully completing this course, the learner will have satisfied the training requirement to conduct a VA using the KAT method.

Please note that this course satisfies the training requirement to conduct a VA using the KAT method ONLY. Any deviation from the KAT method described in this course will necessitate that the individual take a vulnerability assessment training recognized as adequate by the FDA, or be otherwise qualified through job experience to conduct a VA using another VA methodology.

REMEMBER!

  • You have six months to complete the course after you enroll, otherwise your enrollment will expire, and you will need to re-enroll and pay the enrollment fee.
  • You must pass the 10-question final assessment at the end of the course with a score of 80%
    or higher. If you do not pass after 3 attempts, you will need to contact lmsadmin@ifpti.org,
    pay the enrollment fee again, and start over.
  • If you click too quickly through the course, the screen may freeze, and you will have to restart the course where you left off.
  • Delivery Format: Online course
  • Estimated Seat Time: 45-62 minutes. There is a 4-hour inactivity time-out, so once started, complete the entire course.
  • Certificate: An FSPCA Certificate of Training is issued at the end of the course. The certificate will remain in your transcripts of the Learning Management System (LMS). If you need a replacement certificate, you will be able to login to the LMS and print the certificate at any time.
  • Cost: $159.00 USD per user
  • Recommendation: If you plan to take the 1-day, in-person FSPCA IA Vulnerability Assessments course (coming soon), while not required, it is STRONGLY recommended that you complete this FSPCA IA Conducting Vulnerability Assessments using Key Activity Types course before attending the in-person FSPCA IA Vulnerability Assessments course.

Download the FSPCA IA Conducting Vulnerability Assessments using Key Activity Types Information Packet for full details on the course, directions on how to access the course and who to contact for support.

Enroll in THE COURSE

FSPCA IA Identification and Explanation of Mitigation Strategies

Description: The Food Safety Modernization Act (FSMA) Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121) (IA Rule) regulation is intended to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm. The regulation requires covered facilities to identify and implement mitigation strategies at actionable process steps identified by a vulnerability assessment (21 CFR 121.135). The regulation further requires that individuals identifying and explaining the mitigation strategies “have successfully completed training for the specific function at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to conduct the activities” (21 CFR 121.4(c)(2)). This training developed by the FSPCA is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet this training requirement.

REMEMBER!

  • You have six months to complete the course after you enroll, otherwise your enrollment will expire, and you will need to re-enroll and pay the enrollment fee.
  • You must pass the 10-question final assessment at the end of the course with a score of 80% or higher. If you do not pass after 3 attempts, you will need to contact lmsadmin@ifpti.org, pay the enrollment fee again, and start over.
  • If you click too quickly through the course, the screen may freeze, and you will have to restart the course where you left off.
  • Delivery Format: Online course
  • Estimated Seat Time: 2.5-3 hours. There is a 4-hour inactivity time-out, so once started, complete the entire course.
  • Certificate: An FSPCA Certificate of Training is issued at the end of the course. The certificate will remain in your transcripts of the Learning Management System (LMS). If you need a replacement certificate, you will be able to login to the LMS and print the certificate at any time.
  • Cost: $169.00 USD per user

Download the FSPCA IA Identification and Explanation of Mitigation Strategies Information Packet with complete details about the course, instructions to access to the course and how to print/save the FSPCA certificate of completion.

Enroll in the Course

FSPCA IA CONDUCTING VULNERABILITY ASSESSMENTS COURSE

Description: This course will provide participants with the knowledge to implement the requirements of conducting a vulnerability assessment under the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) regulation of the U.S. Food and Drug Administration (FDA). This regulation is one of a number of regulations and guidance that implement the provisions of the 2011 Food Safety Modernization Act (FSMA), which focuses on safe food practices.

The Mitigation Strategies to Protect Food Against Intentional Adulteration regulation (referred to as the IA rule) is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. The regulation requires that certain activities must be completed by a “food defense qualified individual” who has successfully completed training in the conduct of a vulnerability assessment. This course developed by the FSPCA is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet the requirements for a “food defense qualified individual” responsible for conducting a vulnerability assessment.

These courses are taught by Lead Instructors trained by the FSPCA, who have been instructed in how to teach the FDA-recognized standardized curriculum.

The IA rule does not specify a particular method that you must use to conduct your vulnerability assessment. Two potential methods that can be used are the Key Activity Type (KAT) and/or the Three Fundamental Elements methods. If you  conduct your vulnerability assessment using the KAT method with no modifications, you should consider completing the FSPCA IA Conducting Vulnerability Assessments Using Key Activity Types course and may not need the training provided in this course. However, if you use any modifications to the KAT method or plan to use the Three Fundamental Elements method, then this course would provide valuable insights.

FSPCA IA VULNERABILITY ASSESSMENT LEAD INSTRUCTOR COURSE

Description: This course provides the participant the knowledge and tools needed to perform the duties of a Lead Instructor for the standardized training curriculum that FDA considers adequate in meeting the requirements for training of a “food defense qualified individual” for conducting a vulnerability assessment under the IA rule.

The course content is focused on strategies to aid in the effective instruction of the food defense activities and documentation that support conducting a vulnerability assessment using the three fundamental elements outlined in the IA rule. Administrative tasks for issuing Food Safety Preventive Controls Alliance certificates is also covered as well as a refresher on effective presentation for the adult learner.

On Day 3 there is a Practicum “teach back” where each person will be asked to present a lesson from the curriculum (in English) to demonstrate your instructor skills and understanding of the FSPCA training materials. Failure to demonstrate instructor skills and an understanding of FSPCA training materials through participation in exercises, questions asked, and teach back observations may result in you not receiving your Lead Instructor certificate.

Upon successful completion of the full, 3-day FSPCA Intentional Adulteration Vulnerability Assessment Combination Course, you will be qualified to be a Vulnerability Assessment Lead Instructor by the FSPCA. The Conducting Vulnerability Assessments participant course within this combination course is the standardized curriculum recognized as adequate by FDA for the qualified individual responsible for conducting vulnerability assessments. Completing this training allows you to deliver the Conducting Vulnerability Assessments course as a Lead Instructor. You will receive email notification upon completion of the course with instructions on how to download the Vulnerability Assessment Lead Instructor FSPCA certificate of completion. You will also receive a FSPCA certificate of completion for the Conducting Vulnerability Assessments participant course.

Prerequisites:

  1. Participants must be an approved Intentional Adulteration Vulnerability Assessment Lead Instructor candidate
  2. Successful completion of FSPCA IA Conducting Vulnerability Assessments using Key Activity Types course
  3. Successful completion of FSPCA IA Identification and Explanation of Mitigation Strategies course
  4. Participants must attend the entire 3 days

FSPCA INTENTIONAL ADULTERATION VULNERABILITY ASSESSMENT LEAD INSTRUCTOR COMBINATION COURSE (PARTICIPANT COURSE PLUS LEAD INSTRUCTOR COURSE)

Description: This course combines the FSPCA IA Conducting Vulnerability Assessments participant course with the FSPCA IA Vulnerability Assessment Lead Instructor course. Detailed course descriptions above.

Disclaimer

The information provided by the Food Safety Preventive Controls Alliance (FSPCA) is for training purposes only. The FSPCA is not your attorney and cannot provide you with legal advice. The FSPCA curriculum is intended as a training tool to assist companies in complying with the FDA Food Safety Modernization Act (FSMA) intentional adulteration regulation; however, following this curriculum does not ensure compliance with the law or FDA’s regulations. For advice regarding the legal compliance with FSMA, please consult your legal counsel.

The information provided by the FSPCA will vary in applicability to each food manufacturer. It is not possible for the FSPCA training curriculum to address every situation. Companies should implement practices and programs that are appropriate to their individual operations. FSPCA materials do not outline the only approach to developing and implementing a Food Defense Plan. Companies can follow any approach that satisfies the requirements of the applicable statutes and regulations related to FSMA. The information provided by FSPCA does not create binding obligations for the Food and Drug Administration or industry.

FSPCA does not guarantee the accuracy, adequacy, completeness or availability of any information provided in its curriculum and is not responsible for any errors or omissions or for any results obtained from the use of such information. FSPCA gives no express or implied warranties, including but not limited to, any warranties of merchantability or fitness for a particular purpose or use. In no event shall FSPCA be liable for any indirect, special or consequential damages in connection with any use of this training curriculum.

FSPCA IA Food Defense Plan Preparation and Reanalysis

Description: The Food Safety Modernization Act (FSMA) Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121) (IA Rule) regulation is intended to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm. The regulation requires covered facilities to prepare, or have prepared, and implement a written food defense plan (21 CFR 121.126) and conduct a reanalysis of the food defense plan (21 CFR 121.157). The regulation further requires that individuals preparing the food defense plan and performing reanalysis “have successfully completed training for the specific function at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to conduct the activities” (21 CFR 121.4(c)(2)). This training developed by the FSPCA is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet this training requirement. Although this training contains some information about incorporating vulnerability assessments and mitigation strategies into a food defense plan, this training is not intended to be the standardized curriculum for food defense qualified individuals responsible for  conducting a vulnerability assessment or identifying and explaining mitigation strategies. Please see other applicable FSPCA IA courses on the FSPCA website.

REMEMBER!

  • You have six months to complete the course after you enroll, otherwise your enrollment will expire, and you will need to re-enroll and pay the enrollment fee.
  • You must pass the 10-question final assessment at the end of the course with a score of 80% or higher. If you do not pass after 3 attempts, you will need to contact lmsadmin@ifpti.org, pay the enrollment fee again, and start over.
  • If you click too quickly through the course, the screen may freeze, and you will have to restart the course where you left off.
  • A few of the course pages have images of diagrams and example forms with very little text. You will want to be sure to listen to the audio for the information related to these pages.
  • Delivery Format: Online course
  • Estimated Seat Time: 2-3 hours. There is a 4-hour inactivity time-out, so once started, complete the entire module.
  • Certificate: An FSPCA Certificate of Training is issued at the end of the course. The certificate will remain in your transcripts of the Learning Management System (LMS). If you need a replacement certificate, you will be able to login to the LMS and print the certificate at any time.
  • Cost: $99.00 USD per user

Download the FSPCA IA Food Defense Plan Preparation and Reanalysis Course Information Packet for full details on the course, directions on how to access the course and who to contact for support.

Enroll in THE COURSE