16 May, 2017 by Maile Gradison Hermida and Brian D. Eyink, Hogan Lovells US LLP
With the parade of headlines announcing a new food-borne illness investigation, recall, or Food and Drug Administration (FDA) enforcement action continuing unabated, food company executives, quality assurance officers, and legal counsel are struggling to understand the new food enforcement paradigm. Although every situation and company is different, in this article we identify four key developments that all food companies need to be aware of, as well as key steps that will help to prepare for this “new normal” in FDA enforcement.
1. FSMA Inspections Are Different
For the first time, FDA is beginning to conduct inspections under the new FDA Food Safety Modernization Act (FSMA) regulations, and in particular, the Hazard Analysis and Risk-Based Preventive Controls rule. FSMA inspections are going to be very different than previous FDA inspections. FSMA requires that food facilities have in place robust, scientifically based, well-documented food safety systems capable of controlling hazards identified with food production. FDA inspections accordingly will be focused on the entire food-safety system. FDA will continue to look at observable outcomes and physical conditions—such as directly observed good manufacturing practice (GMP) issues—but the focus of inspections in many cases will shift to critically evaluating the overall food safety system.
Under systems-based inspections, FDA will ask critical questions about how the food safety program is set up and documented: Is the hazard analysis complete and well documented? Are all hazards requiring a preventive control addressed in the manufacturing process? If hazards are being controlled upstream or downstream, how is the facility ensuring that is in fact occurring? Are procedures actually being followed and documented? What corrective actions were taken, how were they recorded, and how did the facility conclude they were effective? In other words, expect a thorough analysis of your entire food safety program.
Importantly, merely producing a product that does not contain adulterants won’t be enough; deficiencies in the food safety system itself will give cause for regulatory action, such as FDA Form 483 reports and Warning Letters. For example, if a company implements a preventive control but does not have adequate documentation of the management components (i.e., monitoring, corrective actions, and verification) being applied, FDA may assume that the control was not appropriately implemented.
The result: There are now significantly more opportunities for a company to find itself in violation of regulatory requirements.
2. FDA Will Want To (and Can) See Your Records
FSMA provides FDA substantially more access to manufacturing records, including all procedures, documentation, and records associated with the facility’s food safety plan. For example, if environmental testing is incorporated into the food safety program, which FDA has signaled it generally expects to be the case, environmental testing records will be readily available to FDA.
As a result, FDA will get a very granular view into a facility’s operations on any given day, including verification data showing whether the food safety system was working. Under systems-based inspections, one of FDA’s goals will be to determine whether the food safety system is working day in and day out, and records will be essential to demonstrate that. Conversely, inadequate records—such as records that don’t fully capture all critical parameters of the food safety system, records that aren’t filled out completely and legibly, or missing records—could form the basis for regulatory action.
3. FDA Will Swab Your Facility and Will Whole Genome Sequence the Results
Intensive swabbing has been a hallmark of FDA inspections for several years now, and new regulatory and scientific tools promise to make it even more important. FDA will continue to collect extensive environmental samples (including from food contact surfaces) during inspections to evaluate general sanitary conditions as well as the effectiveness of cleaning and sanitation programs. Already, in 483s FDA cites recurring environmental positives as evidence of inadequate sanitation programs.
The use of Whole Genome Sequencing (WGS) will accelerate this trend. WGS reveals an organism’s genetic code and lets FDA determine to a high degree of confidence whether two organisms are of the same strain. FDA is also building (in cooperation with the Centers for Disease Control and Prevention and other public health agencies) a database known as GenomeTrakr, which will contain information for all test results collected from the environment, products, and patient samples, providing FDA a tremendous amount of data related to test results.
4. WGS Matches Will be Considered Strong Evidence of Insanitary Conditions—And Regulatory Actions Could Result, Especially If There Are Linked Illnesses
If FDA identifies the same genetic strain through WGS in multiple inspections, FDA will likely take the position that the facility has a “resident strain” that the environmental sanitation program has failed to eradicate. Or, if FDA identifies multiple strains in a single inspection, FDA could theorize that the facility has experienced multiple failures that allowed the introduction and establishment of multiple different organisms.
Moreover, whenever FDA gets a WGS result, the agency runs it through a database of strains collected from human illness samples and product samples. If FDA identifies a genetic match between an environmental sample and a sample related to human illness, FDA is very likely to attribute the illness to the facility, resulting in a likely recall, Warning Letter, or both.
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5. What Can You Do To Get Ready?
These four key developments create a “new normal” of heightened enforcement risk in the food industry, but companies can take steps to get ready.
- Don’t Ignore Test Findings. Environmental and (if appropriate, product) testing results provide important early warnings of potentially larger problems. It is critical to develop a robust response program for testing results, both to demonstrate to FDA that you addressed the specific finding and to ensure that you don’t allow a more serious problem to develop in your facility. FDA usually will have access to a facility’s testing records and will see these results, and if a company finds an organism in the environment, chances are good FDA will find it too unless it’s eradicated.
- Be Thorough in Your Corrective Actions. It’s not always enough anymore to simply fix the specific situation; you should make sure you’ve identified the root cause of the issue and addressed it at the source. That might include vector sampling around an environmental positive sample, using intensified cleaning techniques to address potential niche harborages like drains, and reviewing equipment design to ensure it is up to modern sanitary standards. FDA’s recently-issued guidance on Listeria control is a good reference document for understanding the agency’s current expectations for corrective actions.
- Follow Good Recordkeeping Practices. FSMA elevates recordkeeping to an entirely new level of importance. You need to get the basics right every day—everything related to implementation of your food safety plan should be captured in records, records should show actual values, records should be legible, signed, and dated, and so on. Corrective actions should be carefully documented to demonstrate that the company addressed the situation appropriately and took appropriate steps to address the source. Remember that records will need to be able tell the story to FDA potentially years down the road.
- Manage Your Relationship with FDA Appropriately. FDA inspections can be tense situations, and it’s easy to feel overwhelmed or defensive when faced with a rigorous inspection or presented with a 483 after the inspection. It’s important to remain calm and professional, to understand your company’s obligations, rights, and policies, and to strike an appropriate tone and strategy during the inspection and the post-inspection follow-up. Regulatory correspondence such as 483s and Warning Letters should be addressed promptly, professionally, and thoroughly.
The food enforcement world is changing, and companies would be wise to understand these key developments and how to get ahead of them.
- Be Prepared in Advance to Respond to a Crisis. During the middle of an inspection is not the best time to develop a company policy on issues such as voluntary records access or signing affidavits. Companies should develop inspection manuals and ensure that key individuals at manufacturing facilities and at corporate offices are well versed in inspection policies. Likewise, develop and regularly train personnel on recall plans and other crisis management programs so that you’re in a position to address situations proactively. And understand in advance when you might need regulatory counsel or other outside expertise and consider bringing them into the process early to help shape strategy and preserve response options down the road.
Maile Gradison Hermida is a partner with Hogan Lovells US LLP. Maile’s practice has a strong focus on implementation of FSMA. She translates her in-depth knowledge of the law into practical solutions for companies working on compliance strategies. Contact her at email@example.com.
Brian D. Eyink is a senior associate with Hogan Lovells US LLP. Brian helps food and agriculture companies navigate increasingly complex and high-stakes federal and state regulatory issues, including FDA and USDA inspections, investigations, and enforcement actions. Contact him at firstname.lastname@example.org .