FSMA Fridays: The Food Defense Rule (Part Three Of Three)

On the last Friday of every month, Barbara Levin of Safety Chain, a leading provider of food safety and quality assurance automation and compliance solutions, hosts FSMA Fridays™, the leading online forum for the food and beverage community to learn the latest information about the FDA’s Food Safety Modernization Act (FSMA). Featuring Dr. David Acheson, the popular monthly interactive pod/webcast is sponsored by SafetyChain Software and The Acheson Group. In the most recent installment, the panel discusses the Food Defense rule. This is a transcript of the February 28 pod/webcast. The only items not included in this article are warm-up conversations and segues in the discussion.

In FSMA Fridays: The Food Defense Rule, Part Two, Barbara Levin of Safety Chain and the Acheson Group panel discussed similarities and differences between preventative controls for human food and the food defense rule, how to know if a company’s approach to food defense will be effective, and why economically motivated food adulteration is not included in the FDA’s rule on food defense. Here, in FSMA Fridays: The Food Defense Rule, Part Three, the team invites the pod/webcast’s audience to ask questions regarding FSMA’s food defense rule. The Acheson Group’s David Acheson and Melanie Neumann will address questions regarding exemptions that may or may not be granted to dairy farms, retail establishments, and facilities producing alcoholic beverages. Additionally, what defines an exemption, the FDA’s food defense plan building tool, and other questions regarding FSMA’s food defense rule will be explored.

Let’s go to this question from Robert. If a dairy farm is under ten million dollars, will they be exempt? Or will the fact that they have a key activity place, bulk liquid storage and loading, will that override the exemption as a small business?

David: That’s a really good question. I think, to be honest with you, I’m not sure I know the definitive answer, but let me tell you where I think the FDA is going with this one. There is a, and I’m going back in history here a little bit to 9-11, during the post 9-11 era, there was a lot of concern around bulk liquid milk. Those of you who are in that industry will remember that the push to look at pasteurization temperatures and to make it an industry requirement to put locks on tankards really took off, but it became almost 100 percent required, which is now kind of best practice state of the art for the industry.

The reason I’m saying this is, of all the food, this is probably the one where the FDA has the most concern. It is based on some logic, it is based on analytics, it’s based on some thinking, and some risk assessment. So my view of that is that if they go down this road of requiring something to be done on farms for bulk milk, it will apply to every farm, I think. I don’t think the $10 million cutoff will account because that would probably exclude a lot of farms, and thus would not be mitigating a lot of potential risk.

The vulnerability assessments would tell us that if a terrorist was to add a bad agent in a relatively small amount of milk on a farm, they could add enough that, despite dilution in a milk tankard. Say it goes from 500 or 300 gallons to 5,000 in a milk tankard. Then that milk tankard is dumped into a large storage tank, say 60,000 gallons. You could still put enough bad agents in the milk at the farm that would have consequences down the road once that 60,000 gallons was pasteurized and was served in gallon jugs to people.

So, it’s a long-winded answer, but hopefully it’s a bit of background. This is an area where I would encourage comment if you’re in the diary specs, because my read of it is that they won’t use the $10 million cutoff. But, I don’t think they’ve specifically said that. But farms are definitely, for milk, are areas of focus.

Dan’s asking if the rule applies to retail establishments. Melanie, do you want to take that one?

Melanie: Yes. No, actually the rule would not apply to retail establishments.

Okay. David, Becky is saying the food defense rule has suggested some alcoholic beverage producers are exempt, but they don’t seem to define exemption as they did for the preventive control rules. Do you have any insight on this for wineries?

David: That’s an interesting question. I believe they are exempt. You know, the alcoholic beverages have been pretty much exempt across the board in everything to do with FSMA in my recollection with all the preventive control rules and so on and so forth. I think they’re exempt from this one, too, which makes you sort of think of the logic, because clearly wineries are all about bulk liquids. But I believe that they’re exempt, as that’s kind of the drift of the question.

We have several additional questions. This one is from Bill and Brian. They are mentioning the food defense plan builder tool that’s been provided by the FDA. Can these tools be used to build your food defense plan and then who validates them to see if they’re appropriate?

David: Yeah, those tools are actually very good. When I was in the FDA, we built how to carve a shark program because that’s what we were all using, and it was clunky, it was complicated, it wasn’t easy to use by any means. The FDA’s done a nice job in developing, I think, readily understandable software that helps people work their way through this. The food defense builder, that’s a really good one, we’ve used it, we’ve run through it, we’ve run through it with some companies, and it’s nice —it’s easy to use.

So, they said you don’t need to validate, which we talked about. As Melanie mentioned, if you are doing this vulnerability yourself, you as Melanie said, you need somebody involved with that who knows what they are doing. They kind of steered away from the qualified individual words, which have popped up many times, but, to me, somebody in the team needs to know one end of the food defense system from the other. So, I think that the intent that companies can use these tools, otherwise why build them?

Then it leaves a little bit of a gray zone. Well does this mean we’ve done it right? I think that that’s a dunce question. I’m not sure that the agent has been real clear on that except they said, “You don’t need to validate.” They have sort of said, “Make sure that somebody who’s working on this knows what they’re doing,” without really defining what that means.

That means?

David: Another gray zone. Opportunity for comment.

There you go. We have quite a few additional questions, and some were mentioned at the beginning. David is speaking in just a few minutes here at the GFSI conference, so we’ll take one more question and, I think that given the length of time we’ve got for comment, I don’t think this will be the last time that we are discussing food defense at FSMA Friday. Let’s end with a question that Sherrod is asking. Where can our participants find an all-inclusive list of possible agents that they need to be concerned with? Is that out yet? Is that somewhere?

David: Oh, geez, what a great question! You know, the FDA guide to attacking the food supply is not online. You know, what’s the chemical du jour that you should use? You know, it’s a real fine line between providing a road map and expecting us to figure it out. I don’t think such a list exists, at least not in the public domain. I can tell you the FDA has those lists for sure, of course they do, but they’re not out there in the public domain. I don’t think the list exists there, and even though the agency has said, “Think about agents,” I wouldn’t overstress on that. The assumption is, think about your system, look at your bulk tanks, look at your big mixers, and look at the access to those, and who has access to those, and focus that way instead of worrying too much about the agents.

As Barbara said, we’ve got time on this. There will be guidance documents. The tools that the FDA’s put together really don’t get too heavily into agents. So even though they mentioned it, don’t focus on it. Just focus on the bigger picture. Where are those access points in my system? Rather than worrying about what somebody might actually add at that point.

Well, with that, we are going to thank everybody for joining us today. We will, I’m sure, be having food defense part two for FSMA Fridays.  David, have a great session. Good luck with your talk that I know you need to run with. Melanie, as always, thank you. We hope to see everybody in March, where we are going to be discussing the recently proposed sanitary transport rule. So everybody, TGIFF, and have a great day and a great weekend.

The Next FSMA Friday pod/webcast will take place on Friday, March 28 and will cover the sanitary transport of food rule in FSMA. If you would like to attend FSMA Fridays, registration is free at www.fsmafridays.com. FSMA Fridays is a registered trademark of SafetyChain Software.

Miss the first two parts of FSMA Fridays: The Food Defense Rule? You can read the first segment of the transcribed pod/webcast here, and the second installment here.