Perhaps because it was “Draft Guidance” and “Contains Nonbinding Recommendations”
Lets go back to February 2008 and FDA’s publication of its Draft Guidance which was published to seek comments from consumers and industry – more on that in another post.
Question? Would the Blue Bell Listeria outbreak happen if the “Draft Guidance” had been final and followed? According to the FDA:
This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.
The purpose of this document is to provide guidance to industry on how to control Listeria monocytogenes (L. monocytogenes) in refrigerated or frozen ready-to-eat (RF-RTE) foods. Specifically, this document provides guidance on:
- The formulation of RF-RTE foods to prevent the growth of L. monocytogenes;
- Treatment of foods to destroy viable cells of L. monocytogenes;
- Controls on ingredients;
- Controls on storing RF-RTE foods;
- Controls on:
- Employee hygiene;
- Design, construction, and operation of your physical plant;
- Design, construction and maintenance of equipment; and
- Sanitation controls and monitoring;
- Monitoring critical surfaces and areas to detect locations that harbor Listeria species or L. monocytogenes;
- Corrective actions to consider if you detect Listeria species or L. monocytogenes on critical surfaces or areas or in food;
- Recommended training;
- Methods for collecting environmental samples;
- Methods for preparing environmental samples for analysis;
- Recommended methods to detect or enumerate Listeria species or L. monocytogenes;
- Recommended records of the controls that you establish and implement.
We recommend that you assess this guidance as it relates to each of your operations and tailor your control strategies to the specific circumstances of each operation.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
So, this is all about draft good ideas that are not required and not enforceable. I would if Blue Bell followed them – likely not.
Keep reading – Draft Guidance