FSMA's Produce Rule: Navigating The Agricultural Water Requirements

By Sam Lewis, editor, Food Online

Be sure to watch the entire web chat

The Grocery Manufacturers Association (GMA), along with the United Fresh Produce Association and Hogan Lovells, partnered with Food Online for a live web chat, Food For Thought: FSMA’s Produce Safety Rule. Here, Jennifer McEntire, VP food safety & technology at United Fresh Produce Association, and Maile Gradison Hermida, partner with Hogan Lovells join Food Online’s editor, Sam Lewis, to discuss agricultural water requirements of FSMA’s Produce Safety Rule.

Sam: Hello everyone, and thanks for attending today's web chat. I’d like to thank GMA for partnering with Food Online and providing us with excellent subject matter experts on this important and timely topic. And thank you attendees for joining us.

It's my pleasure to introduce to you our subject matter experts. We have Dr. Jennifer McEntire; she's the VP of food safety and technology at United Fresh Produce Association. And we have Maile Gradison Hermida; she's a partner at Hogan Lovells.

Jennifer serves as a top of food safety resource for United Fresh Produce Association, supporting both science and policy issues. A food microbiologist by background, she has always worked in the D.C. area bringing the scientific perspective to food safety and regulatory issues. She was previously the VP of Science Operations at GMA where she oversaw the microbiology laboratory process authority team and claims laboratory. She holds a Ph.D. from Rutgers and received a Bachelor’s of Science in Food Science from the University of Delaware. Additionally, she is an IFT member and advisory board member of the Global Food Traceability Center. Jen, it’s great to have you back for another web chat.

Jennifer: Thanks so much!

Sam: We also have Maile Gradison Hermida, partner of Hogan Lovells in Washington, D.C. As a lawyer for the food industry, she has a deep understanding of the issues affecting food companies, from product development through production, distribution, and retail sale. Maile also has considerable experience with FSMA, including advising companies on what FSMA means for their business, helping to develop compliance strategies, and providing strategic advice on public policy issues. Her practice also focuses on enforcement and compliance matters, particularly involving recalls, FDA inspections, and warning letters. Maile graduated from the George Washington University Law School and Summa Cum Laude from Tulane University. Maile, it's a pleasure to have you with us.

Maile: Thank you for including me!

Sam: Here's what we have in store for today. Our goal is to explain some of the requirements of FSMA's Produce Safety Rule, why complying with them is essential, and provide industry-leading practices to do so. Most importantly, we'll spend much of our time addressing and answering your questions. So again, feel free to submit them at any point.

So let's get started. Maile, could you give us a broad view of today's topic, its importance, and some of the challenges the industry is facing?

Maile: Absolutely. So, just to start at the very beginning, the FDA's Produce Safety Rule was issued way back in November 2015. We've had it now for more than two years, but the reason we're talking about it now in particular is because the first compliance date is right around the corner.

The Produce Safety Rule is the first time the FDA has had regulations specifically addressing what farms need to do in order to grow safe produce. What it does is essentially establishes a set of good agricultural practices, this is analogous to good manufacturing practices for processed foods, that everybody who produces produce that could be consumed raw needs to follow. The regulation touches a few specific areas, and I'll just give you a very high level of review here.

The first is agricultural water — water that contacts produce. This includes water that you use for irrigation, or washing, as well as water that you use on food contact surfaces. Jen's going to talk more about this in just a moment because this is one of the thorniest issues under the regulation.

There are also are requirements relating to domesticated and wild animals. These were created to make sure, in particular, that you protect crops from domestic wild animals and make sure their excreta does not come into contact with produce.

There are requirements relating to biological soil amendment of animal origin, which is a fancy name for manure, which could come into contact with produce, as well. This relates to things, for example, like the use of treated and untreated biological soil amendment.

Then there are foundational requirements relating to the health and hygiene of workers that contact produce. These have specific requirements, for example, about workers who engage in harvesting. The basic idea here is that you don't want to transmit any illnesses from individuals to produce. And this is actually in a regulation in part in response to specific outbreaks that have occurred in the past, for example, things like hepatitis A.

The next areas are equipment, tools, buildings, and sanitation. And this is pretty self-explanatory, just as the name suggests — requirements relating to the sanitary nature of the tools and utensils that you use containers and equipment. To simply visually inspecting to make sure that everything is in appropriate condition for use before you use it.

And then finally, there's a focus on growing, harvesting, packing, and holding activities that could be a source of contamination.

So what you see FDA has done here is, fundamentally, they’ve taken a lot of the types of practices the industry has followed voluntary under GAP, Good Agricultural Practice Program, and brought them into the regulation of course with more specificity in certain areas.

Now, I'll turn it over to Jen to talk a little bit more about the agricultural water standards.

Jennifer: Thanks, Maile. As you mentioned, this is one of the more challenging parts of the rule, I think, in terms of the ability in the entirety of the industry to comply. And there are several different issues all tied up in this Ag water prevision, and the FDA has, over the past year or so, in several points in time, indicated that they understand that this is a challenging area and express their willingness to take another look at this sub-part E and determine if there are opportunities to simplify the requirements in the section of the rule to facilitate grower compliance.

To break this down into a couple of areas and give an update on where things are at with agricultural water. One question, one main challenge was around the method the FDA specified in the rule itself. So, the FDA was requiring the use of the particular EPA method that, honestly, wasn't really available from many laboratories. And thankfully, the FDA did work with industry experts at the urging and facilitation by the center of produce safety and in September did publish a list of other methods that could be used as alternatives. So, the rule does provide the opportunity for individual growers to use alternatives, but the kind of scientific criteria to use an alternative is intimidatingly high. And so I think that it was a great effort by FDA to go ahead and, for the agency, to put out this list of alternative methods that could be used. But, there's no need to begin evaluating those other methods and determining their suitability for your farm at this point in time because the FDA has also proposed — and it's proposed not final — that the requirements associated with agricultural water be delayed two years past whenever that farm would ordinarily have to comply with the remainder of the rules.

So, the overall compliance date for the produce safety rule do stand, but whereas water initially had an additional two years to meet that compliance date, that would be extended by another two years if this proposed rule is finalized. And the comment period on that closed rather recently. But, we are hopeful that if finalized, that this extension on the compliance date would enable the FDA to work with industry to a greater extent to sort out some of the other issues, not just the test method, but there are a number of issues related to sampling. It's fundamental at what you're actually sampling for whether that's generic E coli or in some environments, if another type of organism is more suitable or another type of analyte is more suitable.

The FDA also indicated that they intend to collect more information and more feedback from stakeholders during a water summit. And this water summit has not yet been scheduled. I know the organizers are working aggressively to finalize a location and a date. But, we're hopeful that this water submit will occur within the next several months and that it will generate some useful information for the FDA to reevaluate this portion of the rule.

Finally, there are some broader issues associated with the produce safety rule. Although, the compliance date is coming up next month for the larger farms, the FDA has indicated that they don't intend to aggressively enforce the rule for about another year until the spring of 2019. And that's because for this rule, overall, we really haven't seen a whole lot in the way of guidance. The FDA is working with the states and will be deferring to the states and in most instances to enforce the rule and the states need some time to come up to speed and ready themselves to enforce the produce safety rule.

We also have a kind of fundamental question over who needs to comply with the produce safety rule. So, the official title of the rule is The Standards For Growing, Harvesting, Packing, And Holding Produce, but it's not always clear for some types of operations where that line is drawn and when they're subject to produce safety versus preventive control. So, that's another issue that we know the agency is working on trying to figure out and trying to draw a sensible and clear line between the rules.

So, there's some rational, I think, between the proposal to extend the compliance date on Ag water. The FDA's indication that enforcement wouldn't really take place for another year because there are a number of issues despite the fact that the rule has been final for some time, as Maile indicated. There are some issues that need to be worked out before this rule can be appropriately enforced.