As you are probably already aware, The FDA’s Food Safety Modernization Act (FSMA) is now in the process of being implemented. This article is to help determine which rule you fall under and compliance strategies to take as you prepare.
The Regulator Versus the Customer
With the new regulations, we have noticed a few common occurrences throughout the industry. One being that customer expectations vary significantly. Consumers have a right to expect that the foods they purchase and consume will be safe and of high quality. The second is that not all companies are up to date on the FSMA regulations. And third, some customers are requiring growers and processors to go above and beyond the FSMA regulations.
The lesson for all of us in this is, be prepared for the inevitable questions you will be getting from buyers as compliance dates pass and as market expectations continue to rise. Whether you’re a grower, huller/sheller, packer, processor, or manufacturer you’re faced with a decision as to what sort of food safety programs to implement in your operation.
Grower Requirements – The Produce Safety Rule
By now you have certainly heard about the FDA’s “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” rule, or Produce Safety rule, their first foray into official oversight of growers in the food industry. A more appropriate term would be “covered produce”, as it directs the reader’s attention to the fact that many types of plant-based foods are covered by the rule. The rule covers most “raw agricultural commodities.”
Checklist for Compliance:
- Obtain a copy of the regulation, fact sheet, the small entity compliance guide, and any other documents you find helpful on the FDA’s web site – https://www.fda.gov/fsma
- Attend the FDA-recognized one-day grower training that was produced by the Produce Safety Alliance. Training is a requirement of the regulation. Here’s a link to ours – http://safefoodalliance.com/events
- Make sure you get a copy of the required records list, as well as a copy of the record templates, water calculation tools, and other useful items on the Produce Safety Alliance web site: https://producesafetyalliance.cornell.edu/resources/general-resource-listing
- Be strategic with use of your water sources where you can, keeping in mind the definition of “agricultural water” in the rule.
- Before planning how you’ll comply with the water requirements, take note of the recent changes – there are new test methods now allowed, as well as delayed compliance dates that have been proposed by FDA.
- Reach out to others in the industry with experience, such as those with GAP certifications, as they already have tools that are working and may be useful for you.
- Determine your strategy for how you’ll manage any contracted services, such as labor or spraying.
Exemptions for the Produce Rule include:
- Produce consumed on the farm
- Specific commodities considered “rarely consumed raw” based on consumption data. This does include pecans, but no other nut. Further information about this list can be found here: https://www.fda.gov/downloads/food/guidanceregulation/fsma/ucm576496.pdf
- Growers earning below $25,000 in annual revenue (based on a 3-year rolling average, adjusted for inflation)
- Some growers who primarily sell to “qualified end users” (i.e. direct to consumer or to restaurants or retailers which are in-state and within a 275-mile radius)
- Produce which will receive a commercial processing step that significantly reduces the presence of pathogens.
The “Commercial Processing” Grower Exemption
As referenced above, the Produce Safety rule describes how a grower may take an exemption to the Produce Safety rule under certain circumstances where their produce undergoes commercial processing – if that processing will adequately reduce the presence of pathogens. This includes any type of validated pasteurization.
Obtain Commercial Processing Exemption:
- Must be a “secondary farm”
- Communication to any domestic customers that the product they are receiving is raw using specific language designated by FDA.
- An additional requirement in the rule has recently been delayed under a recent action by FDA called “Enforcement Discretion.” More information can be found here: https://www.fda.gov/food/newsevents/constituentupdates/ucm590667.htm
For help with determining which rule the operation falls under click here: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm517567.htm
Preventive Controls Rule – Next Steps
- Ensure your GMPs and other “pre-requisite programs” are up to date per the regulation.
- Someone in the operation responsible for food safety needs to take the 2.5-day PCQI training course. As with the Produce Safety rule, this training is required.
- Download the “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food.” https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm517412.htm
- Be sure to open Appendix 1 of the guidance above and verify that your food safety plan includes the hazards noted there for the products you produce.
- If you’re new to hazard analysis download the FDA’s “food safety plan builder”.
- Reference Subpart G of the regulation on supply chain requirements.
- Make sure your documented recall program meets the regulatory requirements.
Additional FSMA Rules
In addition to the rules noted above, there are a few more rules to research to see if your operations need to fall in compliance.
- The “Sanitary Transportation of Human and Animal Food” rule, whose compliance dates have already passed at this point.
- The “Foreign Supplier Verification Programs” rule, or FSVP, outlines importer requirements. A great reference for this is FDA’s coverage flow chart. FDA has begun enforcement of this rule and has found that a large number of importers are not yet in compliance.
- Intentional Adulteration rule, this rule is all about security measures, also known as “food defense” measures, and requires a specific, documented mitigation plan which includes an assessment of vulnerabilities and measures implemented to mitigate them.
A graphic breakdown of all of the FSMA compliance dates can be found at the following page: https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM568798.pdf