Final Rules Will Be Here Soon: What to Expect

We have been talking about the Food Safety Modernization Act (FSMA) since the latter part of the last decade. It was during the 2006 spinach E. coli O157:H7 outbreak that the produce industry began calling on FDA to put food safety regulations in place for the fresh produce industry. Then in 2007, we had melamine in pet food which put the focus on imported foods and further calls to tighten up regulatory requirements. The melamine event caused FDA to publish The Food Protection Plan in the latter part of 2007. This plan called on Congress to give FDA new authority around preventive controls and imported foods. But it was not until the Peanut Corporation of America situation in 2009 that there was real Congressional traction for change. And from then on, forward change accelerated.

Jump to January 2011 when FSMA was signed into law, and here we are August 2015: almost 10 years since the momentum began and four and a half years after FSMA became law, we are going to have final rules. Or are we?

I ask this question because it is one that I often get. Will we have final rules, will they change much, will all the rules go final, and will FDA just give up due to lack of funding? These are great questions and my view is that most certainly we will have final rules—all of them. Some, like the food defense rule, may be a little late—but not by much. And I only say that because I know it was one of the rules with which FDA was struggling most.

FDA will not give up. They will do what they can with the resources they have and likely will not be able to inspect as much as they would like and not as much as Congress mandated in FSMA. However, they will be out there with new authority, and I have no doubt they will use it.

So the key question is: Will the final rules change much from the proposed rules and their amendments? Given that FDA fought to get these proposed rules through the White House Office of Management and Budget, I don’t expect to see big changes. FSMA clearly lays out FDA authorities, and the proposed rules match that pretty closely.
 

Preventive Controls.

When it comes to the Preventive Controls Rule for Human Food—one of the most impactful, we have a very clear blueprint of the final. It boils down to a move to Hazard Analysis and Risk-Based Preventive Controls (HARPC). In simple terms, figure out your significant risks, and show that you are controlling them on an ongoing basis. This, along with how you control supply chain risk and set up environmental monitoring programs (for certain RTE production), are the core of this rule.

Figuring out how to write your Food Safety Plan (FSP) is key. What to put in it, how to show FDA that you “get it,” both are very important. But also important is that you link your FSP with your ongoing monitoring program to show that your controls are working. FDA will want to see not only that you have a FSP but that you are using it each and every day. You will need to focus on keeping the right records to show you are following your FSP, and have them available for an FDA routine inspection. FDA wants you to not only talk the talk in your FSP, but really walk the walk with regard to ongoing risk-based preventive controls. Get that right and likely you will have what is close to a pleasant experience (well maybe not) during your routine FDA inspection.

If you make animal foods, the same concepts apply since the Preventive Control Rule for Animals is very much like the human rule. This will be a big shift for some in the animal food industry and I hope that FDA does a clear job explaining which types of animal feeds will need to follow these new rules and which do not.
 

Produce Safety.

The Produce Safety Rule is due at the end of October, and this, too, will have a major impact on growers of many types of fresh produce. The basic principles of this rule are to require Good Agricultural Practices for growers of fresh produce that is typically consumed raw. The rule is focused only on microbiological risk, and I don’t see that changing. What is difficult to predict is the interface between when a farm (subject to the produce rule) becomes a processor (subject to the preventive control rule). For some, this shift is clear, such as a pistachio nut grower that also roasts the nuts. FDA has made attempts to better articulate how this will all work but I hope in the final rule, or in accompanying documents, it is made very clear.
 

FSVP.

The other rule that will be very impactful is the Foreign Supplier Verification Program (FSVP) due out as final at the end of October. FSVP is targeted toward importers, which seems to be defined as those who “cause the food to be imported into the U.S.” So that may be an entity in the U.S. or an entity in a foreign country. This may not be the same as the importer of record of the Bioterrorism Act requirements. FSVP is about supply-chain risk control. If you are an importer subject to FSVP, you will need to build a program that ensures your suppliers are meeting FDA requirements, including all the new ones of FSMA. This will include risk analysis and a process to ensure that your suppliers are following the rules. It also will be accompanied by a great need for recordkeeping so you can show FDA during an inspection that you are meeting the requirements.
 

FSMA compliance.

The various rules have different exemptions and different timelines for coming into compliance. But generally speaking, if you are a very small company (less than $1m/year of business), you will have three years to comply. If you are small (less than 500 people), you will have two years to comply. Everyone else will have one year to comply.

In the coming months, we will be writing a lot about the new rules and working to develop simple approaches that will help regulated industries become compliant. My best advice is: As soon as the rules are out, focus on three things. First, know which rules apply to you; second, determine the gaps you need to fill to become compliant; and third, develop a timeline and approach to meet each compliance deadline.

It sounds simple, but it won’t be. These rules are complex and truly game changing, and I hope FDA recognizes that we all will be on a learning curve for several years to come—including the FDA inspectors themselves.