FSMA Re-Proposals

On Friday September 19, 2014, FDA finally released re-proposals to four of the main rules of the Food Safety Modernization Act (FSMA): Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program. To immediately address the question in the headline above—Yes, some of the changes are a big deal; others could be considered as streamlining the process.

While it’s always been clear that the rules are interrelated, the re-proposals further underscore how FDA envisions a continuum of food safety that will exist once the rules are finalized and fully implemented.
 

Preventive Controls.

As usual, the Preventive Controls for Human Foods rule sets the stage for where FDA has gone with the major changes, and one can say that the Preventive Control Rules for Animal Foods has followed the exact same lines. But I think there are some positive aspects of this re-proposed rule that will help those who manufacture human food, yet direct scraps into the animal food chain. Some of the key changes are:

• The recognition that the risk of a food handled on a farm is not dependent on whether the food was grown on that farm or another farm.
• The replacement of the term “hazards reasonably likely to occur” with “significant hazards.” This reflects the fact that FDA is not mandating HACCP and is not expecting food facilities to come up with a whole host of new CCPs.
• A requirement to determine if a public health hazard could result from economically motivated adulteration. (FDA specifies that it is concerned about the public health, not quality, impact of this type of adulteration.)
• The expectation that 1,867 human food facilities and 105 animal production facilities will use environmental monitoring to verify the safety of foods. (For human foods, this is primarily ready-to-eat products exposed to the environment.)
• The recognition that some significant hazards are controlled by suppliers, and that “supplier controls” would be appropriate, including an annual onsite audit if the hazard presents a serious adverse health consequence to humans (or animals, if you’re covered by the animal food rule).
• The inclusion of finished-product testing as a means to verify the adequacy of the food safety system—“if appropriate.”
• The proposal that a “very small business” is one that sells less than $1M human food or $2.5M animal food annually.
• A determination that human food facilities that send byproducts to animal food facilities do not need to evaluate the food for hazards to animals, as long as they follow GMPs for human food, and as long as there are measures in place to make sure the byproducts are not accidentally comingled with trash.
   

So what should the food industry make of the re-proposals? Again, there are few surprises in these documents. At the same time there is increased clarity around what a facility will need to do in order to comply, although in some instances FDA’s move toward providing increased flexibility might be viewed as increased ambiguity. The best examples of this are around testing requirements: When is ingredient testing appropriate, and when is finished-product testing required? It appears that ingredient testing is an option to verify suppliers on whom you are relying to control hazards. But how do you know if that is the best option to manage the risk? FDA leaves that determination up to each facility.

Similarly, FDA is proposing that finished-product testing can be used as a verification tool to demonstrate that the food safety plan is working. When should finished product testing be conducted? FDA says “as appropriate to the facility, the food, and the nature of the preventive control.” While I am not sure what that means, I was interested to see that in the cost calculations, FDA estimated that only 319 facilities would need to develop a finished-product testing plan.

FDA is clearly looking to link and harmonize the rules. For instance, FDA notes that, although some of the changes may eliminate the requirement for some farms (that were previously deemed to be processors) to follow GMPs, it views the corresponding practices proposed in the Produce Safety rule as providing a similar level of public health protection. Similarly, the inclusion of supplier controls in the Preventive Controls rules attempts to align these rules with the foreign supplier verification program.

As noted earlier, the preventive controls for animal food mirror many of those proposed in the human food rule:

• Swapping “significant hazard” for one “reasonably likely to occur.”
• Requiring environmental monitoring if environmental pathogens are deemed to be significant hazards. (FDA considers animal foods as being ready to eat.)
• The use of finished product testing as appropriate to the food and hazard.
• The need for supplier controls if they are relied upon to control hazards.
• The inclusion of economically motivated adulteration in hazard identification.
   

But there also are some animal-specific changes to the proposed rule. For example, the language describing GMPs for facilities producing animal food is much clearer and applicable to animal foods. FDA claims that the adjustments make the GMPs more flexible so that these have the appropriate application of GMPs relative to a facility producing pet food and animal feed. Thus, FDA appears to be accounting for the diverse production covered under the animal rule.
 

The FSVP PRogram.

The proposed rule for Foreign Supplier Verification Program (FSVP) also has some major changes. In addition to wording alignment with the Preventive Controls rules (using the term “significant hazards”), FDA recognized that facilities subject to preventive controls that implement supplier controls don’t need to duplicate their efforts to comply with FSVP. Rather:

• As long as an importer can demonstrate that it has a process to approve suppliers, and that it follows the process, there is no need to maintain a list of approved suppliers.
• In recognizing the role that suppliers play in food safety, FDA now requires an evaluation of supplier risk along with product risk. The factors to be considered include regulatory compliance (previously proposed to be an a la carte evaluation), the history with the supplier (including test results and their willingness to correct problems), and any other relevant factors.
• FDA proposed two options for supplier verification, from which it ostensibly has chosen option 1, requiring on-site audits for suppliers that supply an ingredient or product that has a significant likelihood of causing a serious adverse health consequence or death (Class 1 recall language). If, however, the importer can demonstrate that the risk can be managed in some other way and suppliers can be just as effectively verified through other means, then the importer is free to use other tools.
• FDA will not require food manufacturing facilities that are subject to preventive controls (and who rely on suppliers to control significant hazards) to have an additional plan in place to comply with FSVP. We see this as a very sensible approach—if you’re controlling your supplier, you’re controlling your supplier.
  
   

Produce Safety.

Finally, the Produce Safety Rule also has undergone some major revisions. Several of the initial proposals, especially around water testing, were hotly contested. The revisions include:

• Explicit language to demonstrate that this rule would not encourage farmers to violate other rules with respect to treatment of wildlife.
• Recognition of uncertainty in application intervals for untreated biological soil amendments of animal origin. (FDA will be conducting more research in this area.)
• Water testing changes, including microbial limits for generic E. coli that are better aligned with EPA recreational water standards (with opportunities to demonstrate microbial die-off over time); reduced testing intervals; and the development of a water-quality profile and baseline surveys in some circumstances.
• Determination that exempt farms include those with less than $25,000 annual produce sales (vs. all food sales).
• Alignment with Preventive Controls related to the definition of “farm,” such that a farm handling another farm’s products is still a farm and need not register.
   

While many of the changes better align the rules, there are some major new requirements. I see the two most critical as the requirement to have a supply-chain risk-control program in place and that of having an environmental-monitoring program for ready-to-eat foods in certain situations. For me, both of these requirements fit very well into industry best practices—but for many, it will involve some major investments of time and resources to become compliant.

Finally, should you wait for the rules to be final or should you get going on looking at your systems? My view is most certainly, Do not wait any longer. These changes are major, and you should start to look for gaps in your systems that will need to be filled to be FSMA compliant. I recognize that these rules are not final, but I don’t believe they will change very much. So if you don’t have a FSMA implementation plan, I suggest you get one going right now, given the monumental changes that are coming at us.