FDA Requirements for Food Defense Planning and Implementation: 2-Day In-person Seminar by Ex-FDA Official
The seminar also will involve a detailed discussion of an acceptable Food Safety Plan to be developed by the companies which are covered by the Rule. Another element of the seminar will be the requirements for implementation of the Food Safety Plan, such as monitoring of compliance with the Plan, actions in response to issues found during monitoring, mitigation in the event of safety problems, training and recordkeeping. We also will discuss the resources to support industry compliance currently available or under development by FDA.
Upon completing this course participants should:
Understand the background and basic food defense requirements of FSMA and the Food Defense Rule
Know which companies are and are not covered by the Food Defense Rule
Recognize the applicability of exemptions from coverage based on the size of a company and the type of food product
Identify the deadlines for compliance with the Rule applicable to their business
Understand the elements of an acceptable Food Safety Plan
Understand the actions which must be taken to implement the Plan
Be informed on the recordkeeping requirements of the Food Defense Rule
Recognize the FDA resources which have been established to help industry comply with the Rule
Understand the consequences of non-compliance
For the first time, the Food Safety Modernization Act (FSMA), passed in 2013, required FDA to impose on food producers an obligation to draft and implement Food Defense Plans for defense of their food processes and products against terrorists compromising the safety of the food supply. In May 2016, FDA issued the final rule to implement the requirements of FSMA for FDA to require companies to develop and maintain Food Defense Plans to protect food against intentional adulteration. Food Defense and intentional adulteration of food in this context mean intentional contamination that could cause serious adverse health consequences to humans or animals, as determined by FDA in consultation with the Department of Homeland Security.
Pursuant to the FSMA mandate, on May 26,2016, FDA issued the final rule entitled Migration Strategies to Protect Food Against Intentional Adulteration (the Food Defense Rule). The Rule applies to all food facilities, domestic and foreign, which produce food for consumption in the United States and are therefore required to register with FDA under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food Defense Rule is subject to certain exemptions, which will be discussed in the seminar.
The Rule became effective July 26, 2016, but FDA extended the time for companies to comply. For very small businesses (averaging less than $10,000,000 per year in sales of human food), the compliance period is 5 years from publication of the Final Rule. Very small businesses also are able to comply through some requirements which are less onerous than for larger businesses. For small businesses (businesses with fewer than 500 employees but are not very small businesses) the Final Rule requires compliance 4 years after publication of the Rule.
Businesses that are not very small or small and do not qualify for any other exemptions have 3 years from publication of the Rule to comply. According to FDA, the Rule is primarily aimed at larger companies whose products reach many people. The Agency estimates that there are 3,400 covered firms that operate 9,800 facilities.
Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM - 9:00 AM
Session Start: 9:00 AM
Introduction to the provisions of FSMA with respect to the risk of intentional contamination of the food supply
Overview of the Food Defense Rule
Hazard Analysis Critical Control Point (HACCP)-type approach
The meaning of intentional adulteration in the context of FSMA and the Food Defense Rule
Businesses covered by the Food Defense Rule
Exemptions from coverage
Very small business, but documentation of very small status required
Holding of food, except in liquid storage tanks
Packing, repacking, labeling or relabeling for food where the container that directly contacts food remains intact
Activities that fall within the definition of “farm”
Manufacturing, processing, packing, or holding of food for animals
Alcoholic beverages under certain conditions
On-farm manufacturing, processing, packing of holding by a small or very small business of certain foods identified as having low-risk production practices. The exemption applies if such activities are the only activities conducted by the business subject to the Rule. These foods include types of eggs and certain types of game meat
Deadlines for compliance
Vary with size of business
Consequences of non-compliance
Prohibited acts under FD&C Act
FD&C Act is a strict liability criminal statute
Day Two (8:30 AM – 4:30 PM)
FDA requirements for the elements of a Food Defense Plan
Covered facilities must have a written Food Defense Plan, which must include the following elements
Conduct or have conducted a vulnerability assessment for each type of food manufactured, processed, packed, or held at your facility using appropriate methods to evaluate each point, step, or procedure in your food operation to identify vulnerabilities and actionable process steps
An actionable process step means a point, step, or procedure in a food process where a significant vulnerability exists and at which mitigation strategies can be applied and are essential to significantly minimize or prevent the significant vulnerability
Identify and implement mitigation strategies at each actionable process step to provide assurances that the significant vulnerability will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under the FD&C Act
Establish and implement written procedures, including the frequency with which they are to be performed, for food defense monitoring of the mitigation strategies
Establish and implement written food defense corrective action procedures that must be taken if mitigation strategies are not properly implemented.
Food Defense Verification
Verification that defense monitoring is being performed according to the Plan
Verification that appropriate decisions about food defense corrective actions are being made
Verification of reanalysis
Reanalysis of the Food Defense Plan, as a whole, at least once every 3 years
Reanalysis if there is a significant change in operations, upon new information about potential vulnerabilities
Reanalysis on finding that a mitigation strategy is not properly effective
Qualifications of individuals who perform activities with respect to the Food Defense Plan
Company must ensure that each individual who performs activities with respect to the Plan is a qualified individual
Qualified individual means a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity under the Plan, as appropriate to the individual´s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.
The Food Defense Plan must be retained onsite at the facility covered by the plan
Existing records may be used in meeting the FDA recordkeeping requirements, but all documents used as part of the Plan must be maintained onsite
Other records may be maintained onsite if available within 24 hours
All records required by the Food Defense Rule must be retained at the facility for at least 2 years after they were prepared
FDA resources to assist industry compliance
FDA has established an Intentional Adulteration Subcommittee with the Food Safety Preventive Controls Alliance to develop food defense training resources for industry and regulators
FDA intends to publish guidance documents on issues such as conducting a vulnerability assessment, identifying and implementing mitigation strategies, and writing procedures for food defense monitoring, corrective actions, and verification
Tools currently available on FDA´s website
Mitigation Strategies Database is an online, searchable listing of mitigation strategies that can be applied to different steps in a food operation
The FDA FSMA Food Safety Technical Assistance Network is operational and provides a central source of information to support industry understanding and implementation of FSMA. Questions submitted online or by mail will be answered by information specialists of subject matter experts.