The Latest on FSMA

As part of our continued efforts to keep you up to date on the latest developments within FDA’s Food Safety Modernization Act regulations, we wanted to share are a few key updates we think you should be aware of. Although there were hints that the new administration may make changes to this set of regulations, it seems that implementation of the rules is going forward as expected.

Produce Safety Rule: Training, and Water Testing Requirements

Safe Food Alliance has begun to conduct the first sessions of the FDA-approved Produce Safety training developed by the Produce Safety Alliance through Cornell University.

…the rule is focused on minimizing risk by implementing preventive programs on the farm.

Although chemical and physical hazards to consumers remain a consideration at the grower level, the main focus of the regulation is definitely on minimizing microbiological risk from pathogens such as E. Coli, viruses such as Hepatitis, and parasites which may be present in water or contributed by wildlife. As we have emphasized in the training sessions, the rule is focused on minimizing risk by implementing preventive programs on the farm. Regulators do understand that there are some key food safety controls that must be implemented at all levels of the food chain, including at processor facilities and even at the retail level. But food safety controls do start on the farm.

Some growers are surprised by the amount of recordkeeping that the regulation requires and the number of new programs they may find themselves implementing. But we have observed that those growers who already have GAP (Good Agricultural Practices) programs in place seem to be well positioned to comply with the new rule, with only a few key items that they still need to work on. As part of the training we distribute some templates that can be used by growers to develop their own records, as well as further information about water testing, exemptions to the rule, and list of records required by the regulation. Much of this information can be found at the Produce Safety Alliance web site.

Many labs do not currently offer the right method to test the water (the 1603 method), although it’s worth noting that the Safe Food Alliance laboratory in Fresno does offer this test and you can contact us with questions.

One of the most contentious parts of the Produce Safety Rule has been the water testing requirements. Many labs do not currently offer the right method to test the water (the 1603 method), although it’s worth noting that the Safe Food Alliance laboratory in Fresno does offer this test and you can contact us with questions. Additionally, the method itself includes some specific time limitations which many growers find challenging. The good news is, as a result of industry feedback, FDA recently issued a notice that they are reconsidering the water testing requirements, as well as a notice that they plan to delay the compliance dates for the water testing requirements under the rule, as noted here.

Preventive Controls: The Latest Update

FDA has visited some of our customers and conducted inspections under the new FSMA rule or have provided feedback to processors to aid them in preparing for compliance with the rule. There are a few key take-aways that we have been sharing from these visits.

Although many processors have good programs in place with regard to HACCP and Critical Control Points, there are still some gaps being noted with regard to identifying Preventive Controls in their operations. The FDA does expect companies to identify and document specific controls which are in place and are key controls to prevent specific hazards to consumers.

FDA is also noting gaps in calibration, including not having a regular calibration schedule for a measuring device, or the device is not traceable. Calibration is a key part of a company’s validation programs to ensure their processes are effective.

If you don’t document it, it didn’t happen.

Another area of opportunity is review of records. Under the new rule any records relevant to food safety should be reviewed by the company’s PCQI, or their review should be overseen by the PCQI. This includes records such as third-party audits of suppliers, calibration records, sanitation records, and similar items. Please remember, as we emphasize in our training, “If you don’t document it, it didn’t happen” So when you review and verify records of these processes be sure to sign and date to indicate it.

FDA has also been referring back to some of the draft guidance it has published for the rule, including the documented potential hazards reference, which is very useful and a key tool that all processors should be referring to for purposes of their food safety plan development.

…it’s very important to point out that FDA’s approach to regulating “ready to eat” foods has changed notably in recent years

Finally, it’s very important to point out that FDA’s approach to regulating “ready to eat” foods has changed notably in recent years. The term was re-defined in the Preventive Controls regulation as any food intended to be eaten in its raw state, or any other food for which it’s reasonably foreseeable that it may be consumed as-is. Many such foods have begun being scrutinized my more closely than in the past due to outbreaks, notably with items like frozen foods (Listeria) and raw flour (E. Coli). The very first example of this that I recall seeing was the Blue Bell Ice Cream recalls, which were initiated after mishandling of ice cream in a hospital turned low-level contamination of the ice cream with Listeria, into a significant health issue for a group of individuals with compromised immune systems. As you can see the FDA is increasing this scrutiny for good reason, but it’s definitely a change to be aware of. In that vein, it’s important that we remind readers of FDA’s recently released draft guidance on control of Listeria in ready to eat food operations.

Wrapping Up

In this time of rapidly evolving regulations and customer expectations for food growers and processors, it’s important that members of the food industry keep up to date with the latest developments. Consider the following:

  • Go to FDA’s web site, and sign up for email updates on the latest recalls, as well as updates on FSMA regulatory developments.
  • If you and members of your team haven’t attended training relevant to your industry, make that a priority.
  • Make sure members of your team are signed up for our newsletter and our email distributions about food safety.
  • Lastly, contact us for training or assistance!