How Do FSMA's Produce Rule And FSVP Intersect?

By Sam Lewis, editor, Food Online

Be sure to watch the entire web chat and read part one and part two of this series

In this segment of Food Online’s and the Grocery Manufacturers Association’s (GMA) live web chat, Food For Thought: FSMA’s Produce Safety Rule, Jennifer McEntire, VP food safety & technology at United Fresh Produce Association, and Maile Gradison Hermida, partner with Hogan Lovells, discuss how the FDA will enforce FSMA’s Produce Rule, how FSVP intersects with the rule, and some of the rule’s sanitation requirements.

Sam: We have a question around the enforcement of FSMA’s Produce Rule. It reads, “How do you believe the FDA will enforce the grower provisions of the produce safety regulation since the FDA has rarely ever enforced its laws and regulations of the farms?”

Maile: I think that this is a situation where you can't let the past guide the future. Because in the past, we've never had a specific regulation affecting produce safety. And so regulation was under the general adulteration provisions of the statue, which given the FDA's limited resources, they only use one significant public health issues arose. Now however, we have this regulation that's much more detailed about what companies, pardon, farms need to do day to day. So they are going to work more granularly be inspecting for compliance. However, it's going to take some time. I think, realistically, we're talking 10 or 15 years possibly before they really get fully into making sure everybody has every little i dotted and t crossed. The agency’s general mantra is that they're educating while they regulate and we've seen this on a preventive control side.

We're seeing on this Foreign Supplier Verification Program (FSVP) side. And there are lots of signals that that we will absolutely see this for produce as well. They have a whole new inventory of people to inspect, which causes a dozen issues because they don't necessarily know everybody they have to inspect because there is no registration of farms. The FDA is working very closely with the states, in particular with the National Association of State Departments of Agriculture(NASDA) to develop a program to help make sure not only that the farms are ready, but also that the inspectors are ready.

For example, they're doing on farm readiness reviews where they're going to farms and just essentially going to co-notate an audit and help them understand whether they have the right types of programs in place and they're only going to take any kind of enforcement action based on those reviews. If there's a serious issue, the firm won't diplomat corrective actions or there's already product in commerce that's affected by it. But, generally speaking, they have a very set plan. They're having a retreat essentially with the state department's agriculture before the end of the year to come up with specific plans for training everyone and I expect for the first round of inspections they'll take sort of a soft consultative approach and only take action really when there's a public health issue. Recognizing it's going to take farms time to understand this and get everything together.

Jennifer: I think that you’re absolutely right that while this is the first time that the farm is being regulated, the FDA hasn't enforced their laws on farms before because they didn't have the specific laws on farms. But, I absolutely agree with you that while we are optimistic there will be that continuation of educating while they're regulating and if there is public health issue the FDA or the states can and should take action.

 

Sam: Another enforcement-related question came in. It reads, “How does the Produce Safety Rule interact with FSVP for a distributor? What about produce imported from a country with an approved safety system, such as Canada?”

Maile: FSVP applies to all imported food; that includes imported produce. So it requires the person who meets the definition of importer under FSVP to engage in for supplier verification in order to make sure that the food that they're bringing in is safe. And, bear in mind, if you think about FSVP, that the importer is not necessary the importer records for custom purposes, the FSVP rule has a very specific definition of it. So, any food that's brought in needs to be verified under FSVP.

There is a provision in the FSVP regulations for importing certain food from a country with an officially-recognized or equivalent food safety system you're subject to modified requirements. This section only applies to food that's not intended for further manufacturing processing, but that includes package foods and raw agricultural commodities that will not be commercially processed further before consumption. For example, if you are importing strawberries that will get made into strawberry jam, you can't take advantage of that provision. But, if you’re importing strawberries that are going to be sold at retail and they are from one of these countries — Canada, Australia, and New Zealand — then you can take advantage of the modified requirements. Modified requirements essentially relay to making sure that you confirm that your suppliers under the oversight of that country and that you determine that they're in good compliance standing and you monitor their status.

Jennifer: I think you got it right. The burden on the FSVP importer when they're bringing in those products, the specific type of products from Canada, is very much reduced. So, they don't have to do the hazard analysis, they don't have to do the evaluation and approval to supplier and ongoing verification of supplier. I think that we should also note and I know this is not the FSVP web chat, but the supplier is the one who's actually growing or manufacturing the food, not a middle man. But, as long as that supplier is in compliance with, in this case Canadian regulation, then the FSVP importer is in pretty good shape. It's not an exemption, but it is a modification that marks a big difference.

Sam: Thank you both for addressing that. There's definitely been a lot of confusion about FSVP and the Produce Rule. Earlier in our chat, Maile brought up on-site farm readiness audits. Jen, would you be able to talk a little bit about what goes into those and how they work?

Jennifer: I can't say I've seen the on farm readiness review in action. This is a tool that's been developed, or at least the development has been spearheaded by NADSA, in cooperation with subject matter experts including those in cooperative extension. My understanding of the on-farm readiness review is that they, the regulators or cooperative extension, can go out to farms that volunteer to have the on farm readiness review and it is a tool that can help access the farms compliance with the rule in a sort of a non-regulatory or maybe a less scary type of situation. So it is there to help. I'm anxious to learn more and I believe that the tool will be more broadly available this winter. Though, it’s something that I have been encouraging our United Fresh members to watch out for and to take advantage of because I think that'll really help further that educate while we regulate philosophy.

Sam: Excellent. We're running out of time, but I think we have time for a couple more questions and we're going to come full circle, these last two have to do with the water requirements. First one's a pretty basic one and I’ll send it your way Jennifer. Are there requirements for bin washing, and if so, what are they?

Jennifer: There are requirements for washing, in general, and bins are covered under that. This is under subpar L for the equipment tool building and sanitation. So, I would refer the inquirer to that part, to subpar L. It is very similar to a GMP requirements that things need to be cleanable, they need to be cleaned, there do need to be records associated with the type of cleaning as well. So, the date and the method of cleaning and sanitizing equipment, generally speaking, do need to be documented. So yes there are requirements, so pay attention to those.

Sam: Perfect. Thank you. This last question, again, has to do with water requirements, and it’s very specific. I'll just read it verbatim. It reads, “How does the Ag water portion of the produce rule affect indoor growing of mushrooms? The mushrooms are not watered directly, water is used for humidity, and water is also from a municipal source. Mushrooms are harvested, but not washed for cut further, we currently test quarterly. Do you have any advice about practices for this producer of mushrooms?”

Jennifer: I'll start by saying that as they said at the beginning, the entirety of the Ag water requirements subpar E is a little bit up in the air and likely to be delayed further. So, I don't think that growers should get too concerned with the specific details of that subpar at this point in time until we better understand where the FDA is going with it. But, I will make a couple of comments, taking it bit by bit.

First, is the difference between indoor growing and outdoor growing; the FDA doesn't differentiate them. Generally speaking, in this instance, would not differentiate, so Ag water is Ag water. That said, the definition of Ag water is water that is intended to or likely to come in contact with produce or with the food contact surface. So in this case, if the mushrooms are not watered directly and that water is not going to come in contact with either the mushrooms or with the food contact surface, then that is not considered Ag water and whatever requirements are inactive wouldn't apply. There is further, again kind of generally speaking, when water is from a municipal source, that's covered under section 112.46 A1. So, there are different requirements for municipal water because those are presumed to be tested and okay, and so there aren't an additional redundant testing requirements that a grower. If it does meet the definition of Ag water, then water from municipal source would not need to be tested the same way.

Maile: I’d encourage any individual grower with these types of questions about their operations to take a close look at the rule and think about whether you need to work with someone outside your company to understand it. I think web chats like this are a great resource to sort of stop the issues that you need to follow up on. But, definitely don't take what we’re saying here and say, “OK, now I know the answer.” These are complicated rules and they are very fact specific, so Jen and I aren't in the position to say exactly what you have to do at your operation in order to be in compliance.

Sam: Yeah it's definitely a great idea to reach out to as many sources as you can. Nowadays, information sources, consultants, and industry associations are as far away as your computer and you can get help and advice on literally anything. So yes, please reach out to professional resources if you have any questions or confusions about any portions of the rules.

And nowadays just tapping on your keyboard you can get an answer to pretty much anything. So yeah, please reach out to as many sources as you can if you have any questions or confusions about any portions of the rules.

But, it looks like we are just about out of time. We had quite a productive chat. Jen, do you have any closing thoughts for our audience?

Jennifer: I would just really reiterate Maile's comment to read the rules itself. These rules are all available on the FDA’s website. You can find the facts sheets. At this point in time, they are the most accurate source of information. While you can kind of google an answer, what's returned may not always be correct and some of these things are subject to misinterpretation. So, looking at the rule itself, finding those areas where you need additional information, and reaching out to someone with expertise in this area I think is a great approach. The codified rules are not that long; they always appear at the very end of the document. The document, you know when you open it is often hundreds of pages, but it’s really just those pages at the end that has the rule itself. So I encourage people who have not read the rule to go ahead and do that.

Maile: I just want to thank you guys for holding this web chat. I think it’s really important to help people to understand what's out there. You know every time you listen to something like this you think about something else that you haven't quite considered for your operation before. So, I want to thank you guys for holding it, but also commend everybody who joined for taking the first step in doing more to educate yourself about the rule.

I would encourage you to also think about going ahead and attending one of the trainings under the produce safety alliance curriculum. It’s just one day, but since it is an official standardized curriculum, you’re really going to get very in depth knowledge. So, it’s sort of one step beyond the resource that Jen was talking about. You know read the rule, educate yourself, look at the resources the FDA has, but then when you want to know more, that's a great way to really dive in with a reputable source.

Sam: Absolutely. With that, our time has come to an end. Thank you both, Jennifer and Maile, for your willingness to educate the industry and thank you, attendees, for taking the time to join us. We hope that you enjoy the rest of your day.