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FDA Official Reveals Agency’s Role In Food Safety Recall

Jim Prevor’s Perishable Pundit, August 31, 2007

When word of the Metz Fresh recall on spinach broke, the reactions recorded in the press were predictable:

Some growers said Metz Fresh’s ability to catch the bacteria showed new testing regimes implemented by the industry were working.

“I think the test of the industry is how we react to these types of situations,” said grower Joseph Pezzini, who heads the board that administers the new produce safety rules. “No one was harmed by the product and that’s important.”

Public health experts questioned that assessment.

“The industry has taken some important steps, but they have certainly not solved the problem if we’re looking at another major recall a year later,” said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest.

Jean Halloran, director of food policy initiatives at the Consumers Union, faulted the produce industry for resisting mandatory government regulations and instead enacting its own leafy green marketing agreement.

Metz Fresh is “certainly to be commended for detecting the problem and issuing the recall, but why wasn’t the system set up to test this before it left the plant?” said Halloran, whose nonprofit organization tests food and provides information about threats to consumers.

The California Department of Public Health and the Food And Drug Administration are investigating the Metz Fresh processing facility in King City.

Salmonella sickens about 40,000 people a year in the U.S. and kills about 600.

We are not sure who Jean Halloran thinks is resisting mandatory regulation, since both United and PMA have endorsed mandatory regulation. However, since it is not here yet, we thought it sensible to analyze the exact role the FDA actually plays in this type of food safety issue.

We asked Pundit Investigator and Special Projects Editor, Mira Slott, to try and learn more. Our source at the FDA asked to be identified simply as “spokesperson” in accordance with FDA protocol:

Q: What is FDA’s role in relation to company recalls, and what is the company’s responsibility?

A: The way this generally works is that food recalls are voluntary. FDA can’t force a company to do a recall except in the case of baby formula. That’s the sole source of nutrition an infant may be receiving so there are increased risks, whereas for everyone else, there’s myriad of foods we may be ingesting during the day.

In the case of Metz Fresh, the individual company had its own testing, which showed a problem and it issued a recall. FDA has been in contact with the company since learning about it and is gathering more information. The company initiated the recall and there have been no illnesses reported so far linked to this product.

Q: Are there instances where the FDA would take a more active role?

A: Typically, where FDA may get involved is say if a company is not willing to do a recall, or maybe they don’t have sufficient means to notify the press. Our main concern is protecting the public health. If a company doesn’t have an effective mechanism to reach out to the press, sometimes the FDA will issue press releases. Or if the problem is widespread, then we may issue press notification to get the word out.

There are plenty of times a recall takes place and the company is on top of it and gets the message out. What’s important is the message gets out and is heard, that the people hear the message and take appropriate action to protect themselves. Metz Fresh took a proactive approach on its own.

The company’s basic responsibility is putting out product that is safe and properly labeled.

Q: When a company gets a presumptive positive on a test and the product is in the consumer stream, what is FDA requiring or recommending of people?

In the case of the Metz Fresh recall, there was a time lag of about four days between when the company discovered the presumptive positive and put product on hold to when they confirmed it as positive and issued the voluntary recall with public notice.

Hypothetically, a consumer who had purchased that product before the recall wouldn’t have known to throw it away and could have eaten it and gotten sick.

A: I can map a few general scenarios but I don’t have a definitive answer. That discussion usually takes place with an FDA expert in the field and with the company.

What people need to look at and ask: What is the pathogen involved? Is it something that will cause a short, mild illness perhaps, or is it something that could potentially kill you? Is the product widely out there in the market, or in warehouses where you are instructing people not to distribute further, while getting a confirmation done? It’s a measured response.

Ultimately, the company bares the responsibility for whether the product is safe and properly labeled. If individuals do become sick because of actions or inactions by the company, it is potentially liable for those decisions. If the problem is something very risky and someone rolls the dice and an outbreak occurs, that is a very serious issue.

These scenarios are all based on tests the company did themselves. Let’s say the company does some tests and they say, ‘We think we can solve the problem and don’t need to alert consumers because there’s not a lot of product out there.’ The FDA conducts its own tests or is looking at epidemiological and inspection evidence. If after our review of the information and that of CDC, we don’t think the company took protective enough steps, we may do press on our own.

I’ve seen this happen before where we were not convinced that the action the company was taking was protective enough of the public health, and we issued an alert. In a case where we don’t have all the information, we may investigate further. Being a regulatory agency, we want to try and have enough information to discern what the appropriate protective action would be.

Q: Could you give an example of what you mean by issuing your own press?

A: We would issue something like FDA is notifying consumers that there have been 27 illnesses of salmonella from ABC brand green beans… these are the symptoms, and if you’ve eaten the product and gotten sick, you should report to your health department and see your doctor, and if you have that product in your house throw it out.

Q: I’ve actually seen that recommendation for consumers on your website. Wouldn’t it be more prudent to have the consumer give the item in question to a public health authority for further testing?

A: What actually works better for testing is if you have someone with the illness that has eaten the product in question and has some of it left over. It is hard to find contamination through end-product sampling because it appears at such a low rate. If you have a half eaten can or bag, that is what should be saved for testing.

The issue with perishable items such as produce is the short shelf life. Depending on the fresh fruit or vegetable product, you may have 5 to 20 days and then it becomes wilted or moldy and is not appetizing anyway. There’s a window of when the illnesses will appear.

We can’t force a recall, but we can notify people. If they hear about the message and are concerned, they probably won’t buy the product. If we definitely know there’s a problem, we can actually seize the product.

A presumptive positive is a heads up there’s a potential problem. You have to look within the context of how these test results come up. If it came from lettuce at a salad bar at the restaurant, should you recall all lettuce from the company? If it’s related to an illness from the employee, it was situational to that restaurant.

A few days ago, I got sick eating at a restaurant. It turns out the establishment’s walk-in refrigerator was set at 60 degrees and the food wasn’t staying cool enough.

Just like FDA, companies have to get a certain amount of information to know what the next logical step is to follow. Anyone involved has to have a certain amount of information. They have to measure what their responsibility is to have a safe product out there based on the information they have.

Q: Can you address the steps Metz Fresh took more specifically?

A: In the case of Metz Fresh, we don’t have enough details to point to a definitive problem with how they responded. Obviously if anyone got very sick because Metz Fresh waited for the confirmation test before doing the recall, it would be very bad for the company and the industry and even worse for the consumers affected. Manufacturers have to weigh this sort of thing everyday. The goal is you decrease the likelihood of someone getting ill the best you can. You can’t be foolproof.

On the good side, Metz Fresh caught something because of its own testing and moved quickly to track and hold product, and initiated a recall. That is better control than when you see no testing and 15 people get sick. Whether they got lucky with testing or they have a great testing program, the point is they were proactive, taking responsibility, and at this point there are no reported illnesses.

Q: A spokesperson for Metz Fresh said when it issued the voluntary recall on Tuesday August 28, it worked with the FDA to get the company’s recall notice out to the public. Why did it take so long on Wednesday to post the notice and send out e-mail distribution to the media?

A: We didn’t do any of our own press on this. We posted the firm’s own press release. We have model press releases to help companies in getting the necessary information out there. The other issue which arises is that the people who update the website here are on the East Coast, and Metz Fresh is on the West Coast. In many instances we’re not receiving information to post until mid-afternoon or late in the day. That may account for some of the lag there.

There’s a place on the FDA website for recalls, market withdrawals and safety alerts, where media can subscribe to receive FDA recall information. But basically you have to proactively look for the company press release.

If the FDA writes our own press release, the trade and consumer media will likely get a copy. If we generate the release, it’s up on the top of the FDA page. We try and get the information out there as widely as possible through media coverage. The media can also dial into press conferences.

On some days, three or four recalls are going out and we’re not doing press on them.

The company has a huge responsibility in this. You’ve heard FDA say this a zillion times now; food safety is from farm to fork. Any one of those spots can be a problem. Everyone along the way has to do their part and they all have a responsibility.

If it turns out the fields have contaminated product, you have to find a way to correct it. If in the manufacturing plant it may not be a problem with the product you’re bringing in, but you’re cross contaminating it. Or the restaurant is not handling the product properly. And then, even if everything up to that point is done right, the consumer can mess up.

We take from this interview that the consumer advocates have a point.

1) The FDA is very reactive. When asked if it was OK with the FDA if a company had a presumptive positive and didn’t notify the public, thus, potentially, giving individuals time to consume dangerous product, the FDA spokesperson said this:

Ultimately, the company bares the responsibility for whether the product is safe and properly labeled. If individuals do become sick because of actions or inactions by the company, it is potentially liable for those decisions. If the problem is something very risky and someone rolls the dice and an outbreak occurs, that is a very serious issue.

Doubtless it is very serious. If people die or get seriously ill from eating your product, it is serious under all circumstances. If you knew that there was reason for heightened caution — a presumptive positive — and didn’t tell anyone, it is even more serious.

But this is all after someone gets sick or dies. The FDA was saying that it was not going to take proactive action to protect the health of the American people. We doubt that position would win in an up-or-down vote.

2) The FDA is measured in its response and not focused on a consumer’s “right to know”:

What people need to look at and ask: What is the pathogen involved? Is it something that will cause a short, mild illness perhaps or is it something that could potentially kill you? Is the product widely out there in the market, or in warehouses where you are instructing people not to distribute further, while getting a confirmation done? It’s a measured response.

We suspect that even if there is only one bag of spinach in one household in America, most Americans would say that there is an obligation to publicize a known reason for extra caution. Spinach is cheap; life is dear. Having even one family contracting an illness that we could have prevented by warning about a presumptive positive test is surely unacceptable to the industry and the American people. This is an area where, most decidedly, consumers would assert their “right to know.’

3) The FDA isn’t really prepared to take on the responsibility of disseminating information:

We didn’t do any of our own press on this. We posted the firm’s own press release. We have model press releases to help companies in getting the necessary information out there. The other issue which arises is that the people who update the website here are on the East Coast, and Metz Fresh is on the West Coast. In many instances we’re not receiving information to post until mid-afternoon or late in the day. That may account for some of the lag there.

Since, obviously, we can learn about the need for a recall any hour of the day or night on weekdays, on weekends, or on holidays, is it actually possible that the FDA is not prepared to get the word out 24/7/365?

The notion that the system is set up so that the time zone matters is horrifying. It reminds us of when we learned that the Pulsenet bulletin board wasn’t staffed on weekends. It is inexcusable.

The bottom line is that now that United and PMA have endorsed mandatory regulation, we better do something about it because the FDA’s comments make it clear that the agency is not prepared to preemptively protect the health of Americans.

The inclination in the trade is that when one of our members is under attack, we circle the wagons. But if we do that, we will one day all be tarred with the same brush.

Everybody keeps repeating that nobody got sick. First, we don’t know that. Just because no illness has been traced back to this recall does not mean nobody got sick. Second, since some product was released to the public, a failure to notify the public as soon as the presumptive positive was discovered created a window in which people could get sick or die.

That is not the way Nunes handled its presumptive positive. It is not the way Church Brothers/True Leaf handled its presumptive positive, and it should not be an acceptable standard of conduct in the produce community.

That the FDA isn’t prepared to proactively protect the health of the American people gives each of us, individually, and all of us, collectively, a greater responsibility to act.

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