Doom and Gloom Challenges for Success Under FSMA

Are you set up to succeed under the Food and Drug Administration’s (FDA) preventive controls final rules for human and animal food that have been sent to the Federal Register? Have you taken preliminary steps in your operation in advance of these rules becoming finalized?

The FDA does not require you to take any advance steps to "get ready." Compliance dates for these final rules are expected to vary based on establishment size. The FDA worked in cooperation with the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) to create the Food Safety Preventive Controls Alliance (FSPCA) which is responsible for developing training courses and technical information establishments can use in the development and implementation of their preventive control plans. This information will be important as it will provide a “road map” to ensure an establishment’s compliance with the final rules that are aimed at preventing contamination in both human and animal food during its production.

While the work of the FSPCA is important, Dr. Doom and Ms. Gloom challenge you to think about steps you can begin taking now in preparation of the final rules.

If you have reviewed the proposed rules, you know that while “preventive controls” is not HACCP, it is very similar. It includes, for example, the need to perform a hazard analysis to determine where you need to implement controls in your operation. Because this is the same as what you do with HACCP, we suggest that rather than re-inventing the wheel, you should take advantage of the learnings from the implementation of HACCP in the meat and poultry industry. Since HACCP was required beginning in 1997, the meat and poultry industry has learned a lot about the written programs (and documentation) needed to show it is controlling hazards from start to finish in their operations.

Looking at the information put together since HACCP was required by regulation in the meat and poultry industry provides many sources of good information on preventing contamination of food – no matter what type it is – as well as examples of written procedures and necessary documentation. Remember that this documentation will be key! We have worked with many FDA establishments that don’t currently, for example, have a program that says what they plan on doing with regard to a specific procedure aimed at controlling a potential hazard, and/or don’t have documentation to prove that they did what they said they would. Ultimately, without documentation of procedures and/or documentation of following the procedures, they have no proof to provide to FDA during an inspection to show hazards have been controlled.

We have done some research to provide you with some examples of information that you can use to start thinking about what you will need to address in your preventive controls plan no matter what “widget” you happen to be producing!

Ready-To-Eat Foods

If you make a ready-to-eat (RTE) product, we would encourage you to review the Food Safety and Inspection Service Compliance Guidelines for controlling Listeria monocytogenes. Are you taking adequate steps to prevent cross contamination from the raw product area? Have you eliminated hollow rollers from your establishment? Do you take extra steps as a precaution any time construction is done in the area? There are many “lessons learned” that are specific to the pathogen, and not related to the product being produced.

When it comes to sanitation, the USDA's Food Safety Inspection Service also has a Compliance Guideline that many establishments may find helpful. This document not only provides useful comments for establishments—there are also links to the applicable sections of the FDA Model Food Code.

Have you considered partnering with a large establishment to learn “best practices” from that establishment? Alternatively, have you considered reaching out to a local meat or poultry establishment to learn from their experiences in implementing HACCP? Finally, we encourage you to attend a local meat or poultry trade event in your area to “take in” some learnings and meet some local vendors. Universities are also a wealth of information on food safety and validation for your programs.

Regardless of the outreach avenues you determine to take advantage of, Doom and Gloom say, “Don’t delay! At a minimum, start reviewing your processes and consider partners that can assist in paving the way without re-inventing the wheel!”

About "Dr. Doom"

Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service's (FSIS) Administrator, Dr. Barbara Masters. Dr. Masters is a veterinarian who spent eighteen years with FSIS - the final three years as Acting Administrator and Administrator. During her rise to the Administrator's position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations. While in these key leadership positions at FSIS, Dr. Masters' primary focus was on the implementation of science-based policies for the protection of public health. Dr. Masters issued the initial Federal Register Notices for a systematic approach to humane treatment of livestock and poultry.

Dr. Masters was involved in the drafting of the training of inspection personnel on the Hazard analysis and critical control points (HACCP) and Sanitation Standard Operating Procedures (SSOP) regulations. She was the lead of the FSIS HACCP Hotline. In addition, Dr. Masters provided technical review for establishment's hazard analysis, HACCP plans and supporting documentation. She started her career at FSIS as a public health veterinarian that had responsibilities for ante-mortem inspection, sanitation inspection and all post-mortem inspection responsibilities. She has a good understanding of what happens at the in-plant location, because she has spent many of long days working there.

About "Ms. Gloom"

In the attorney ranks at OFW Law, there is only one attorney who would raise a hand if all were asked if they had any "hands-on" experience in the operation of a Townsend "Frank-O-Matic" hotdog maker, producing bean sprouts for use in egg rolls or in managing a food facility sanitation crew. In fact, there are probably no attorneys out there who could raise their hands except Jolyda Swaim.

Prior to law school and OFW Law, Ms. Swaim spent years in the food industry, beginning as a microbiologist and Quality Assurance technician. In these years, she had direct charge of quality assurance, production, sanitation and consumer affair departments at various companies producing products from pickles, sauerkraut and barbeque sauce, to various meat and poultry products, to frozen entrees, egg rolls and pizza to spices and spice blends. Her last position at Sara Lee as Director of Food Safety had her auditing its facilities in the United States and Mexico to ensure facilities producing ready-to-eat products were following best practices in sanitation and product handling.

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