Written by Jon Kimble and Katie Edwards
As you are probably already aware, the FDA’s Food Safety Modernization Act (FSMA) has been finalized and is in the final stages of being implemented. What we’ve seen throughout the industry, however, is that although inspections are already taking place, many food producers still struggle to comply with the new laws. This article is meant to help provide a clear understanding of the FSMA requirements and provide guidance on any new compliance strategies to take.
The History of FSMA
Before you can effectively implement compliance strategies, it is important to understand how we got here. The Food Safety Modernization Act, passed by President Obama on January 4th, 2011, had a massive impact on the food industry. The changes have been so vast that today the legislation is considered the most sweeping reform of U.S. food safety laws in more than 70 years. The purpose of the act was to create more effective methods for preventing food safety risks in the U.S. food supply. The way the FDA chose to do that was with seven rules, each with unique guidelines and requirements. These rules affect how produce is grown, packed, processed, shipped, and imported into the U.S., changing the culture of food safety as we know it.
- Preventive Controls for Human Food
- The Produce Safety Rule
- The Foreign Supplier Verification Rule
- Accredited Third-Party Certification
- Sanitary Transport of Food & Feed
- The Intentional Adulteration Rule
- Preventive Controls for Animal Food
Since 2011, the FDA has worked to develop and implement each rule in the regulation, with the mentality “educate before you regulate.” As the regulation timeline grows closer for producers, Safe Food Alliance wants to help ensure that growers, producers, and processors alike all are prepared to meet the FSMA requirements.
Meeting Customer and Regulator Expectations
With the new regulations, a few common occurrences have presented themselves throughout the industry. The first is 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, but what safe and high quality can mean varies greatly. The second is that not all companies are up to date on the FSMA regulations. Lastly, some customers require their suppliers 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 get 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 have to implement effective food safety programs in your facility.
Produce Safety Rule or ‘Covered Produce’
By now you have undoubtedly 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 the rule covers many types of plant-based foods. The rule covers most “raw agricultural commodities.”
Produce Safety Rule Checklist:
- 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.
- Attend the FDA-recognized one-day grower training that was produced by the Produce Safety Alliance. Training is a requirement of the regulation. For upcoming training courses in California, click here.
- Make sure to 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.
- Be strategic with the 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.
- Reach out to others in the industry with experience, such as those with GAP certifications. 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 Safety Rule include:
- Produce consumed on the farm
- Specific commodities considered “rarely consumed raw” based on consumption data, including pecans. Further information about this list can be found here.
- 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.
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. The exemption includes any validated pasteurization.
You May Be Exempt If You:
- Are a “secondary farm.”
- Communicate to any domestic customers that the product they are receiving is raw using specific language designated by FDA.
- Note* An additional requirement in the rule is currently delayed under a recent action by FDA called “Enforcement Discretion.” More information can be found here.
For help with determining which rule the operation falls under click here.
Key Facts about the FSMA Preventive Controls for Human Food
Preventive Controls are steps that are taken to reduce or eliminate food safety hazards. By September 17, 2018, all food processing and manufacturing facilities had to comply with the rule. Under this rule:
management is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their duties; practices and procedures are required to control allergen cross-contact; and provisions for holding and distributing human food by-products that are used for animal food.
Preventive Controls Rule – Next Steps
- Ensure your GMPs and other “pre-requisite programs” are up to date per the regulation.
- Someone on the food safety team needs to take the 2.5-day PCQI training course, this training is required. For upcoming public courses, click here.
- Download the “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food.”
- 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 for additional information.
- Make sure your documented recall program meets the regulatory requirements.
Foreign Supplier Verification Programs Rule or FSVP
The “Foreign Supplier Verification Programs” rule, or FSVP, outlines importer requirements. An excellent reference for this is the FDA’s coverage flow chart. The FDA has begun enforcement of this rule and has found that a large number of importers are not yet in compliance. Although the FDA does not require the training, Safe Food Alliance highly recommends at least one employee take the FSMA FSVP course. For a list of upcoming classes, click here.
Intentional Adulteration Rule – Protect Your Food and Your Brand
The Intentional Adulteration 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.
Covered facilities must develop and implement a food defense plan that includes an analysis of vulnerabilities and implementation of mitigation strategies. Covered facilities are identified as facilities – either in the U.S. or any other country – that are required to register with the FDA as food facilities because they manufacture/process, pack, or hold human food for consumption in the U.S.
Critical Requirements Of The Intentional Adulteration Rule
- The rule requires a written food defense plan for all covered facilities unless an exemption applies (21 CFR 121.5). The written plan must include (21 CFR 121.126):
- A vulnerability assessment to identify significant vulnerabilities and actionable process steps and associated explanations.
- Mitigation strategies and associated explanations
- Procedures for food defense monitoring
- Methods and procedures for food defense corrective actions
- Procedures for food defense verification
- Each facility must obtain training for specific personnel. See (21 CFR 121.4) on more details on training.
- The rule requires covered facilities to maintain the food defense plan as a record as well as records for training, food defense monitoring, food defense corrective actions, and food defense verification. (21 CFR 121.126(c), 121.140(c), 121.145(b), and 121.150(c))
- The rule requires a reanalysis of the food defense plan. (21 CFR 121.157)
Overall the Food Safety Modernization Act is not going anywhere. If anything, there will be modifications made to the rule in the future, but these new food safety plans will always be a part of the food facility system and will need to be maintained and updated frequently.
A graphic breakdown of all of the FSMA compliance dates can be found here.