FDA Draft Guidance for Intentional Adulteration Rule
Today, the FDA released the first of three installments of a draft guidance document designed to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA). The remaining two installments are expected to come out later this year.
The FSMA final rule on intentional adulteration is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.
Food facilities covered by the rule will be required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working. The first compliance date for the largest facilities arrives in July 2019.
This first part of the draft guidance includes chapters on:
- the components of the food defense plan;
- how to conduct vulnerability assessments using the key activity type method;
- how to identify and implement mitigation strategies; and
- food defense monitoring requirements.
The second installment will focus more specifically on vulnerability assessments and training requirements, with the third including greater detail on corrective action, verification, reanalysis, and recordkeeping requirements.
This draft guidance, in its entirety, is intended to be a resource that will help the food industry implement the IA provisions in a flexible and cost-effective manner. To further assist and engage stakeholders, FDA will announce plans to hold a public meeting on the draft guidance when the second installment is released later this year. All three parts will be available for public comment upon release.
Marshall
While I appreciate the draft guidance documents, I'm not overly optimistic about the time line for release of this.
FDA has yet to release nine or 10 guidance documents for PCHF, the original ones came out in January of this year. A full four months AFTER the law was applicable to all manufacturers.
We shall see.
Marshall
When I had a quick read through, they've set up some "requirements" but have not told you how to meet them and stated those details would come later; talk about putting the horse before the cart
AND when you get to section B, it reads like a human resource nightmare to manage to me......can you imagine a world where HR and QA have to work together??
I can imagine a world where HR and QA have to work together! My job is mostly Food Safety but I am also HR. :) (We are a small company with under 50 employees.)
So, if i get it right, for "Vulnerability Assessment" we now have –
FSMA >> Intentional Adulteration + Intentional Harm but not Unintentional harm
SQF (Manufacturing) >> Intentional Adulteration + Unintentional Harm but not Intentional Harm
BRC7 (Food) >> Intentional Adulteration w/wo Unintentional Harm but not Intentional Harm
GFSI >> ??
Watch This Space !