Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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FSMA Checklist: Intentional Adulteration Rule

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

Help your organization assess and prepare its level of compliance to FSMA and the Intentional Adulteration rule, which is moving toward compliance for all companies with various compliance dates listed.

The FSMA Intentional Adulteration rule is focused on preventing intentional adulteration from acts intended to cause wide-scale food safety impacts to public health, including acts of terrorism, economic adulteration and disgruntled employees. Such acts, while unlikely, could cause illness, death and economic disruption of the food supply absent mitigation strategies. This rule requires mitigation strategies to reduce risk versus specific food hazards.

How much do you know about the Intentional Adulteration Rule? Test your smarts by taking the FSMA IQ Test here The Intentional Adulteration rule is established to address large companies with products that reach many people, while exempting smaller companies. This rule requires covered facilities to conduct a “vulnerability assessment” to identify vulnerabilities and actions to take for each type of food manufactured, processed, packed or held at the food facility. For each point, step, or procedure in the facility’s process, these vulnerabilities must be identified and evaluated. Covered facilities must also prepare and implement a Food Defense Plan. This written plan must identify the vulnerabilities and actionable process steps; mitigation strategies; and procedures for food defense monitoring, corrective actions and verification. A reanalysis is required every three years or when certain criteria are met, including mitigation strategies that are determined to be improperly implemented.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing FSMA Intentional Adulteration requirements. To complete your own assessment, review and compare your programs to the questions in Table I.

FSMA, Intentional Adulteration
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its Intentional Adulteration program for FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate systems in place to comply with FSMA Intentional Adulteration requirements or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider regarding their program. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all your food safety requirements, and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

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