Final Rule: Protecting Food Against Intentional Adulteration http://www.fda.gov/fsma THE FUTURE IS NOW Background Mitigation Strategies to Protect Food Against Intentional Adulteration Proposed on December 24, 2013 Public comments: More than 200 for the
original proposal Final rule publication date: May 27, 2016 What Does the IA Rule Do? Establishes requirements to prevent or significantly minimize acts intended to cause wide-scale public health harm Uses a HACCP-type approach, with important differences from the Preventive Controls for Human Food rule Is risk-based and flexible
Who Is Covered by the IA Rule? Facilities that manufacture, process, pack or hold human food In general, facilities required to register with FDA under sec. 415 of the FD&C Act Not farms or retail food establishments Applies to domestic and imported food Some exemptions and modified requirements apply
Exemptions Very small businesses*
Holding of food, except holding of food in liquid storage tanks Packing, repacking, labeling, or relabeling of food where the container that directly contacts the food remains intact Activities of a farm subject to the Produce Safety Rule Manufacturing, processing, packing, or holding food for animals Alcoholic beverages at certain facilities (under specified conditions) On-farm manufacturing/processing, packing, or holding by a small or very small business, of eggs (in-shell, other than RACs) or certain types of game meats, if such activities are the only activities conducted by the business subject to section 418 of the FD&C Act
Exemption: Very Small Businesses The rule does not apply to very small businesses (VSBs) Averaging less than $10,000,000 per year, in both sales of human food plus the market value of human food manufactured, processed, packed, or held without sale, e.g., held for a fee
VSBs are required to provide for official review, upon request, documentation sufficient to show that the facility qualifies for this exemption What Is Required? Food defense plan Vulnerability assessment Mitigation strategies Procedures for food defense monitoring Food defense corrective action procedures Food defense verification procedures
Records Training Key Terms Actionable process steps Mitigation strategies Food Defense Plan Vulnerability Assessment Identification of those points at highest
risk, i.e., actionable process steps For each point, step, or procedure, a facility must consider, at a minimum: Potential public health impact Degree of physical access to product Ability of an attacker to successfully contaminate the product Food Defense Plan Vulnerability Assessment Must consider the possibility of an inside
attacker Outcome of assessment must be written Key Activity Types are considered an appropriate method to conduct a vulnerability assessment Food Defense Plan Mitigation Strategies Measures to ensure significant vulnerabilities at actionable process steps are significantly minimized or prevented
Must be implemented for each actionable process step Must include written explanation for how strategy minimizes vulnerability Removed distinction between broad and focused Food Defense Plan Mitigation Strategy Management Components Food defense monitoring Food defense corrective actions
Food defense verification As appropriate to ensure the proper implementation of the mitigation strategies, taking into account the nature of the mitigation strategy and its role in the facilitys food defense system Food Defense Plan Food Defense Monitoring Facility must have written procedures, including the frequency they are to be
performed, for monitoring the mitigation strategies (as appropriate to the nature of the mitigation strategies) Monitoring must be documented in records subject to verification Food Defense Plan Food Defense Corrective Actions Facility must have written procedures for steps to be taken when mitigation strategies are not properly implemented (as appropriate to the
nature of the actionable process step and the nature of the mitigation strategy) Identify and correct a problem Reduce likelihood of recurrence Corrective actions must be documented in records subject to verification Food Defense Plan Food Defense Verification Includes (as appropriate to the nature of the
mitigation strategy and its role in the facilitys food defense system): Verification of monitoring and corrective actions Verification that mitigation strategies are properly implemented through records review or other activities Verification must be documented in records Reanalysis of Food Defense Plan
At least every three years Whenever there is a significant change that creates the potential for a new vulnerability or a significant increase in one previously identified When there is new information about potential vulnerabilities associated with a food operation or facility Reanalysis of Food Defense Plan
When a mitigation strategy is not properly implemented Whenever FDA requires reanalysis to respond to new vulnerabilities, credible threats, or developments in scientific understanding Training Food defense awareness Proper implementation of mitigation strategies at actionable process steps*
Certain components of the food defense plan* *Individuals may also be qualified by education or experience Records Establish and maintain certain records, including Food defense plan Food defense monitoring, corrective action, and verification records Documentation related to training of
personnel Use of existing records Compliance Dates Very small businesses (see slide 6): Five years (July 26, 2021) Small businesses (a business with fewer than 500 full-time equivalent employees): Four years (July 27, 2020) All other businesses: Three years (July
26, 2019) Planned Guidance Vulnerability assessment Mitigation strategies Food defense monitoring, corrective actions, and verification Recordkeeping A Small Entity Compliance Guide to assist small and very small businesses to comply with the rule
Training and Technical Assistance - Domestic Established the Intentional Adulteration Subcommittee within the Food Safety Preventive Controls Alliance to create training and technical assistance programs The FDA FSMA Technical Assistance Network has been established Training and Technical
Assistance - International Plans include Collaborating with the Food Safety Preventive Controls Alliance on capacity building through its International Subcommittee Working with regulatory counterparts and multinational organizations Developing and disseminating outreach, education, and technical materials Establishing training and technical assistance networks
For More Information Web site: http://www.fda.gov/fsma Subscription feature available To contact FDA about FSMA and find the online form for submitting questions: http:// www.fda.gov/Food/GuidanceRegulation/FSMA/u cm459719.htm
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