An estimated one in four Americans gets sick from tainted food every year and 5,000 die. Understanding the proposed overhaul of FDA food safety regulations and what it could mean for farmers, food prices and the agency’s powers.


  • 10:06:54

    MS. DIANE REHMThanks for joining us. I'm Diane Rehm. An estimated one in four Americans contracts food poisoning every year, causing more than 5,000 deaths. Last year, the Obama administration proposed a major overhaul of how the government safeguards the food supply. Both the House and Senate have passed bills to toughen FDA regulations, but getting a new law enacted has run into roadblocks. Though new food safety rules have broad support, some critics question whether new regulations are actually needed.

  • 10:07:39

    MS. DIANE REHMJoining me in the studio to talk about food safety, Erik Olson of the Pew Health Group, Gardiner Harris of The New York Times and Richard Williams of George Mason University. We will take your calls, your messages on Facebook, your e-mails, your tweets a little later in the program. I look forward to hearing from you. Good morning, gentlemen.

  • 10:08:07

    MR. ERIK OLSONGood morning.

  • 10:08:07

    MR. GARDINER HARRISGood morning.

  • 10:08:07

    MR. RICHARD WILLIAMSGood morning.

  • 10:08:08

    REHMGardiner Harris, talk about how significant this food safety measure actually is.

  • 10:08:16

    HARRISThis is a big deal, Diane. I mean, the underlying law governing food in the United States has not really been changed for about 70 years. And this is the first time that Congress has really sort of tackled this issue in a major way. There have been dozens and dozens of hearings on Capitol Hill, you'll recall, about peanut butter, about cookie dough, about spinach, about cantaloupes, tomatoes -- you name it. And, you know, there has basically been a consensus that has built in this country that is rather rare, in which you have the industry and consumer advocates all calling for major change.

  • 10:08:57

    REHMErik Olson, how significant do you regard this to be?

  • 10:09:02

    OLSONWe believe this is a very important piece of legislation. It actually -- as was just stated -- is the first major overhaul of our food safety law for FDA in over 70 years, and really is urgently needed. The law is quite dated. It doesn't keep up with current science -- much less give FDA basic authorities like the ability to recall contaminated food. It includes many new provisions to increase the use of science by FDA, which we think is very important, as well as new authorities to make sure we prevent contamination rather than catching up with the contamination afterwards.

  • 10:09:39

    REHMAnd, Richard Williams, how do you see it?

  • 10:09:43

    WILLIAMSWell, after 30 years in working in food safety, I see this bill actually going in the wrong direction. The kinds of requirements that it's going to make on industry are things that the industry has been doing since the 1970s.

  • 10:09:55

    REHMSuch as?

  • 10:09:56

    WILLIAMSSuch as, there's a procedural kind of a rule called hazard analysis critical control points. This was actually invented by the food industry for food industry. It's pretty much in all of the food industry contracts now. The difference here is that it would be mandated by FDA. And there's not a lot that FDA brings scientifically to the table for these kinds of rules. My concern about this law is that it detracts from trying to find real solutions to food safety rather than just focusing on these process controls.

  • 10:10:30

    REHMAll right. And before we get into the details of the bill itself, Gardiner, tell me about this impasse between the House and the Senate over what's happened here.

  • 10:10:46

    HARRISConstitutionally, any bill that has tax provisions has to originate in the House. There was a portion of this bill that actually originated in the Senate that called for fees to be paid by importers to be part of a sort of a rapid import group so that you could get your products through the border very quickly if you had proven before that you were a good actor. Those fees go to the administration of the program. Thus, it is seen as a tax by the parliamentarian in Congress. And so that parliamentarian basically said that this has to all be done again, that this legislation has to start in the House, be passed by the House and go back and be passed by the Senate.

  • 10:11:36

    HARRISThe problem with that is that, of course, the Republicans in the Senate who are arguing over, obviously, the Bush tax cuts and the Don't Ask, Don't Tell provisions for the gays in the military, they want to slow down what's happened in the lame duck session as much as possible. They get more power in the next session. So they have told Harry Reid that they are not going to play ball. And this legislation may not, indeed, be passed in this session.

  • 10:12:06

    REHMSo you're saying this, among other things, is being held up by Republicans because they want to see those Bush tax cuts extended first?

  • 10:12:20

    HARRISThat's certainly one of the reasons. Obviously, Tom Coburn from Oklahoma also disagrees fundamentally with the underlying bill. He believes that -- you know, he just doesn't sort of believe in government. And so he believes that there should be fewer regulations, not more. He believes that this legislation will actually lead to sort of worse outcomes in the food system.

  • 10:12:39

    REHMOkay. Well, putting aside those kinds of political maneuvers, let's talk about what this would actually do. Erik Olson, give us a sense of how important this would be in terms of what it could and could not mean, that the FDA would have the authority to do.

  • 10:13:03

    OLSONWell, one of the problems we have right now is, on average, FDA is only inspecting about every 10 years. And this legislation would require much more frequent inspections, depending on what the risks are posed by the facility.

  • 10:13:15

    REHMAnd is that throughout the food industry? Or are you talking about one sector?

  • 10:13:20

    OLSONWell, it would apply to, basically, all significant food facilities. There is an exemption that's gathered some controversy for very small facilities. We think it's a tiny percentage of the food supply. But the vast majority of the food supply would be covered by this and would have to have more frequent inspections.

  • 10:13:39

    REHMLet me ask you this, how many food inspectors are there?

  • 10:13:43

    OLSONRight now, there are not enough inspectors, and that's the reason that we have inspections every 10 years or so. And this legislation would actually require a ramping up of more frequent inspections and more inspectors.

  • 10:13:55

    REHMBut, now, given the money situation...

  • 10:13:58


  • 10:13:58

    REHM...Gardiner Harris, how are we going to get more money for FDA?

  • 10:14:03

    HARRISWell, that's obviously another one of the outstanding issues here. Not only are we not sure whether this legislation is going to pass, but the House version of the legislation, which has now sort of gone by the wayside, actually had a provision in it to pay for additional inspections because it would require food facilities to actually pay an annual registration fee of something like $1,500, wasn't it, Erik?

  • 10:14:25

    OLSONFive hundred.

  • 10:14:26

    HARRISFive hundred dollars. And because of the number of food facilities in the United States, that actually would have added up to a considerable amount of money and would have gone a long way toward paying for the additional inspections, not only domestically but actually internationally. And, you know, while domestically, they inspect only once every 10 years, internationally, I think, it's once every -- if they added it up, once every 1900 years. In other words, they almost never inspect foreign facilities. And considering that 20 percent of our food supply is now imported and -- you know, with things like seafood, it's 75 percent. That's a great concern. So what needs to happen is that FDA needs to get more money in addition to getting this legislation.

  • 10:15:11

    REHMWhat about that, Richard Williams?

  • 10:15:13

    WILLIAMSWell, you're absolutely right. The FDA inspects, in some cases, once every 10 years. The recent report showed that some firms hadn't seen anybody -- over half the firms hadn't seen an FDA inspector in over two years. I don't think that's going to make much difference. Right now, private firms inspect each other, in some cases, once a week. That's -- and in many cases the...

  • 10:15:35

    REHMHow diligently do they inspect each other?

  • 10:15:40

    WILLIAMSVery diligently. In fact, the standards that they set for themselves are often much more stringent than FDA standards.

  • 10:15:46

    REHMLet me take you back to this extraordinary egg contamination we had just this summer. Who was inspecting that farm?

  • 10:15:58

    WILLIAMSHonestly, I don't know the details of that case, of who was inspecting the egg farm.

  • 10:16:01

    REHMBut, I mean, doesn't that go against what you're saying, that on a regular basis, they're inspecting each other?

  • 10:16:10

    WILLIAMSI'm not certain of the details of who was inspecting. I do know, though, that there are millions of private food safety contracts. There are millions and millions of inspections. Even if FDA were to get a lot more money -- and let's suppose now, they're looking at firms once every 10 years -- is it really going to make a difference if FDA inspects once every five years or even once every year?

  • 10:16:30

    REHMHow do you answer that, Gardiner?

  • 10:16:32

    HARRISWell, the answer is that the Peanut Corporation of America, whose facilities were rife with contamination -- that had bird droppings all over the place, that had rats throughout the place -- you know, just a few months before they were shut down, they got a gold star from one of these private inspection firms. These private inspection firms repeatedly, in these food contamination cases, will find that just weeks or even days before the FDA shuts them down, a private inspection group has come through and given a gold star to the facility.

  • 10:17:08

    REHMWho pays for these private inspectors, Erik Olson?

  • 10:17:12

    OLSONWell, that's exactly the problem, is that there's a clear conflict of interest, that the company that's being inspected generally will pay for the inspections. And when you have that conflict of interest and no clear standards, that's where we have a formula for, basically, a biased inspection that won't find the problems. And that's been documented repeatedly. We do think that, obviously, there are some things in this legislation that are implemented, even without inspections.

  • 10:17:38

    OLSONFor example, importers are now going to be required to certify compliance subject to criminal penalties if they lie about it for any of the imported foods, that they meet federal standards. That is a huge improvement because currently what we have is about 1 percent or less of imported foods are being inspected by FDA. Just having a certification requirement subject to criminal penalties, we think would be very important.

  • 10:18:03

    REHMWhat do you think about that, Richard Williams, in terms of imported foods?

  • 10:18:08

    WILLIAMSWell, if I could go back just for a moment to the domestic foods...

  • 10:18:12


  • 10:18:12

    WILLIAMSWhat we have -- and this is really recent. What we're now finding is in the -- in as recently as 20 years ago, or even 10 years ago, most firms considered themselves judgment proof. It was impossible to trace problems back to firms so that they would be held accountable. Now, we have new technologies that's holding firms accountable. And that's actually beginning to work. In fact, in PCA's case, it was Nestle that went and found the rat droppings and shut them down.

  • 10:18:39

    REHMRichard Williams, he is director of policy research at George Mason University. Stay with us.

  • 10:20:03

    REHMAnd joining us now from his office here in Washington, Robert Guenther. He's senior vice president for public policy at United Fresh Produce Association. Good morning, sir. Thanks for joining us.

  • 10:20:19

    MR. ROBERT GUENTHERGood morning, Diane. Thank you for having me.

  • 10:20:21

    REHMI know you support the bill overall, but you're not happy with the so-called Tester Amendment. What's in that amendment? And why are you opposed to it?

  • 10:20:33

    GUENTHERWell, I think fundamentally, as you mentioned, the produce industry has been very strongly in favor of reforming the food safety laws of this country. We've seen firsthand how this has impacted the industry, whether you're a small operation or a large operation in terms of impacting broad, you know, industry compliance with food safety standards.

  • 10:20:56

    GUENTHERWhat's happened, unfortunately, in the Senate, was an amendment was put in -- the Manager's Amendment -- that would exempt, as Erik mentioned, certain small farms and facilities based on the size of their operation, their geographic location or who they sell the product to. And we think that's fundamentally flawing the risk-based, science-based approach to the entire bill that currently is being considered by the House.

  • 10:21:21

    REHMNow, let's be clear. That amendment was put forward by Sen. Jon Tester, Democrat of Montana. He says that producers with less than $500,000 in annual sales, who sell most of their food locally, he says that they're -- that they would have a real problem with that. Is that correct?

  • 10:21:56

    GUENTHERWe don't believe that's the case. We think that, you know, food safety is something that, you know, we need to remember, is based for consumer confidence, consumer safety. And if you are selling in the commercial marketplace, that you have a responsibility to be growing, selling, shipping and harvesting the safest food possible. And, I think, that's been the fundamental goal of what we have said throughout this whole food safety debate, that, you know, it should apply across the board in terms of a risk-based, science-based approach to food safety. And...

  • 10:22:28

    REHMSo does that mean that United Fresh is going to withdraw its support for the entire bill?

  • 10:22:37

    GUENTHERYes, we are. We have -- because of this amendment, we think that this flawed the entire piece of legislation. And we are actively working with the House and -- to try and get a conference with this legislation. I mean...

  • 10:22:55

    REHMHow important, Erik Olson, do you believe that Tester Amendment to be?

  • 10:23:01

    OLSONWell, we weren't out advocating for the Tester Amendment, but we feel you've got to look at this bill as a whole. Most of the estimates that we've seen -- there was an Economic Research Service study that was done on how much food is locally grown and locally produced and how much of it is direct to consumers. It's probably somewhere in the neighborhood of a couple of a percent of the food supply. Our concern is that we not throw out the baby with the bathwater, that although we wouldn't have advocated for this, we think that the vast majority of the food will be covered by this legislation. And we think on balance, it's a very good, strong piece of legislation.

  • 10:23:36

    HARRISListen to what's going on here, Diane. You've got the industry actually pushing for even tougher standards, and you've got one of the big consumer advocates sort of saying, it's okay. A slight lessening of the tough standards will be okay. Don't throw the baby out. You know, it is the -- it is a measure of just how extraordinary this moment is, that they actually -- the industry wants an even tougher standard than even the consumer advocates. And it shows just how frustrated everyone is with the present system.

  • 10:24:05

    REHMAnd you, Richard Williams?

  • 10:24:06

    WILLIAMSWell, first of all, you have to be careful when you say the industry. There's the industry, and there's the industry. If you're going to use a risk-based approach, that means you do different things for different types of farms, for example. Small farms might use incredibly different ways of keeping their food safe than large farms. If large farms are against this amendment, there's probably a reason for that.

  • 10:24:27

    GUENTHERWell, I would argue. I would argue.

  • 10:24:28

    WILLIAMSI don't think...

  • 10:24:29

    REHMHold on.

  • 10:24:29's either necessary or fair not to exempt small farms from the same requirements that you'd impose on large farms.

  • 10:24:35

    REHMOkay. Go ahead, Bob Guenther.

  • 10:24:37

    GUENTHERThank you. I would argue -- you know, what I would argue, too, is I think we have, again, seen firsthand. I mean, when the spinach outbreak happened in 2006 that people, you know, want to mention, it only took a small farm, a 50-acre farm, to bring down an entire industry to their knees and shut down the spinach industry in this country. When you look at 2008, it took a small jalapeno farm in Mexico to bring down, not just the jalapeno industry, but the entire tomato industry.

  • 10:25:02

    GUENTHERThis is not about big versus small. This is about -- you know, when you're talking about small percentage, it doesn't matter with produce. We're only as strong as our weakest link. And we have to remember that, that we need some basic food safety standards in place across the board so that the consumers have confidence in the products that they purchase at the stores, where they go to restaurants, where they go to a farmers' market, wherever they try to purchase, you know, fruits and vegetables, that they have confidence that that supply is safe.

  • 10:25:30

    HARRISThe thing about produce, Diane, is that brands are not that important in produce. So you go to the grocery store, and you just buy lettuce. And you go to the grocery store, and you just buy, you know, spinach. And so you don't really do that much distinguishing between the spinach made by these guys and the spinach made by that guy. So if one of that set of spinach is bad, then the entire crop gets thrown out. So it's quite understandable that the fresh produce guys at this point, who have been beaten around the face and the neck for years and years and years -- there have been dozens of recalls of lettuce and of spinach over the last decade. And they are simply tired of it, which is why they, of all people, are demanding the highest standards across the country.

  • 10:26:19

    REHMBut doesn't Richard Williams make a good point...

  • 10:26:22


  • 10:26:22

    REHM...when he argues that standards are different for small farmers, the manner of production is different for small farmers, that there's less likely to be that contamination?

  • 10:26:41

    HARRISWell, not the last part -- the less likely to be the contamination -- but, certainly, one worries what will happen to farmers' markets across the country...

  • 10:26:48

    REHMI see.

  • 10:26:49

    HARRIS...if those sort of rigorous standards are imposed on even the smallest of growers. So that was the argument. You know, what's interesting here is you've got sort of the radical left and the radical right here meeting in the middle because, you know, those -- the organic, very small produce people have been arguing that this will destroy them, on the one hand. And then you got the libertarians, all the way in the radical right, sort of joining up with them and saying, you know, government rules are going to destroy the food supply.

  • 10:27:20

    REHMRobert -- go ahead, Robert.

  • 10:27:22

    GUENTHERAnd I would just make another point about that. I agree with what was just said in terms of the ability to have a scalable system. I think -- again, we have always pushed that, you know, FDA, you know, needs to be focusing on high-risk products, high-risk commodity. And that is throughout this entire bill, and that's why we were supportive of this entire bill, up until this amendment was put in. So now you have an arbitrary decision, meaning, if you're within 275 miles of your customer, you're exempt.

  • 10:27:48

    GUENTHERWhat if you sell 276 miles or what if you're 274 miles? What does that tell the consumer? Are they going to have mileage markers now on their products to say when -- you know, what's been complying with food safety standards and what hasn't? It is a crazy system that has no basis of science, no basis of risk-based approach.

  • 10:28:07


  • 10:28:09

    GUENTHERThat's very important to food safety, you know, throughout this country...

  • 10:28:12


  • 10:28:12 matter if you're produce or whatever food product.

  • 10:28:14

    REHMSo, Robert, what kind of possibility do you see for compromise on that Tester Amendment?

  • 10:28:22

    GUENTHERWe are going to continue to push that, you know, with this problem that's going on -- that Gardiner mentioned, and you guys have talked about it earlier in the show -- that this is an opportunity to go in and try to make this better, to make this -- fix it, to get rid of this amendment or to improve it so that it's more of a risk-based approach to addressing food safety related to produce.

  • 10:28:42

    REHMOkay. One other question. When the Obama administration first proposed this overhaul for the FDA, many industry groups expressed concern that new regulatory costs would be passed on to consumers. Do you believe that is the case?

  • 10:29:04

    GUENTHERNo. I don't believe that's the case. I think the industry is -- as some have mentioned -- I think Richard had mentioned -- not just within the food industry, but within produce, we have been actively engaged in food safety reform, food safety compliance, industry-based standards for many years. And that has never been passed on to consumers. It's part of doing business. It's part of protecting the consumers' interest of a safe food supply.

  • 10:29:27

    REHMErik, how do you see it?

  • 10:29:29

    OLSONWell, I think it's -- I would agree. As a general matter, it's not going to cost anything significant. We actually did some polling at Pew of the public, and the public strongly supports -- in the numbers of 70, 80, 90 percent -- making these kinds of changes to improve the food safety system, even if it costs additional money. The other point I wanted to make is we've got to focus on the fact that right now there are no national standards for produce safety. There are none for federal produce safety, and most states -- in fact, only Florida has standards, and those only apply to tomatoes.

  • 10:30:02

    OLSONSo the only standards we have now are voluntary standards adopted by the industry. We're thrilled that United Fresh and a lot of growers have voluntarily adopted standards. But what we see with, as he's mentioned at the top of the show, tens of millions of people getting sick every year, thousands dying, hundreds of thousands hospitalized every year from foodborne illness, that the voluntary system -- as good as it is for the best actors -- is not solving a problem. And a 70-year-old statute just is not up to snuff. We've got to improve it.

  • 10:30:33

    HARRISAnd that's why the industry is pushing for this. In other words, you know, Diane, for a long time, this was sort of the Republican idea for decades, right? Was that industry would come up with voluntary standards, police themselves and the government would not need to get involved, and that's what folks like United Fresh really pushed. But what they realized -- and why I think Richard is dead wrong -- is that there are companies who don't follow the voluntary standards. They don't really join the trade association. They don't do all the nice things that, you know, they want -- that others want them to do.

  • 10:31:07


  • 10:31:08

    HARRISAnd so this is why rules actually make a difference and laws.

  • 10:31:12

    WILLIAMSAnd, point of fact, the states are actually doing quite a bit. But I think what's happening here is people are beginning to believe, gosh, if only we could pass the national standards, that would be a silver bullet and solve problems. It won't be. There's no silver bullet. Simply following these standards is not going to solve problems. These problems need scientific solutions, and the industry and FDA have been looking for those solutions for quite some time. As to the firms that are not following standards that seem to be obvious, guess what? They're not going to be able to sell their products. Right now, you see supermarkets saying, all right, we're going to establish standards.

  • 10:31:47

    WILLIAMSWe're going to inspect to those standards. If you don't meet those standards, you can't sell your product. So more and more, we're developing a food safety system that is protecting itself. It's not perfect. It's not in place yet, but it's coming. I don't -- what I see, by trying to put national standards in place, what that's going to do is that's going to create an opportunity cost. It means people are not going to be going out looking for solutions. Instead, they're just going to be concentrating on following these sort of general rules, which are not going to improve food safety.

  • 10:32:17


  • 10:32:17

    OLSONWell, I'll say we've tried that approach for 70 years, and it hasn't worked very well of having voluntary standards. I mean, certainly, the good guys in the industry are doing what they can. But what we find -- I mean, anybody that's ever traveled on a highway knows that if you don't have a cop every once in a while, checking on whether people are complying with the speed limit, voluntary compliance doesn't always work. You see people blowing by you at 85 miles an hour. That's what we have now.

  • 10:32:39

    REHMOne last question for you, Robert. What do you think the new FDA rules would mean for food suppliers?

  • 10:32:48

    GUENTHERI think most importantly -- at least for fresh produce -- I think that it will provide consumer confidence in a product that, quite frankly -- as someone had mentioned there on your panel -- has been beaten over the head numerous times over the last several years that we're not doing enough.

  • 10:33:07

    REHMWhat about a tracing system?

  • 10:33:09

    GUENTHERI think tracing is very important. I think that's been one of the issues that we faced in produce. And I think -- again, someone had mentioned about -- when someone buys lettuce, they buy lettuce or they buy -- when someone buys spinach, they buy spinach. The problem is when we have an outbreak, there is an issue related to traceability. I think the industry has good internal systems related to traceability. But, really, when there's an outbreak, and we're under this type of crisis-type moment, that having a traceability system that both works with the federal government, state and local officials who are trying to track and trace where the product was located to resolve this and move forward, is important. So that's why we think a traceability system is very important for the produce industry.

  • 10:33:48

    REHMRobert Guenther of the United Fresh Produce Association, thank you so much for joining us.

  • 10:33:57

    GUENTHERThank you.

  • 10:33:57

    REHMAnd you're listening to "The Diane Rehm Show." We have many callers. We'll open the phones, 800-433-8850. First to Durham, N.C. Good morning, Matt.

  • 10:34:15

    MATTGood morning, Diane. Thank you for taking my call.

  • 10:34:16


  • 10:34:17

    MATTI would like to contend Mr. Guenther's point against the Tester Amendment. I truly believe that local food is inherently safer. If you have a mistake on a small scale, your consequences are on a small scale. But as we've seen with spinach and eggs and peanut butter, when you have outbreaks on an industrial scale, the results are catastrophic and your risk is spread over such a larger pool than if you're just -- you know, your food is just coming locally. So I think the Tester Amendment is very important, and I would like to see it stay intact.

  • 10:34:51

    WILLIAMSYeah, I agree. That's absolutely true. From a risk point of view, smaller farms, smaller factories have smaller exposure, so I think that's absolutely right. I would like to just go back to one point in terms of whether or not we've tried the voluntary standards. In fact, in the 1990s, the FDA did passed two of these types of rules -- for seafood and for juice. For seafood, it has made absolutely zero difference. It has not improved. It has not improved the safety of seafood at all. The reason? We didn't have scientific solutions. All we had were these process requirements. FDA promised to go back and look at the efficacy of the seafood rule. At the end of the rule, once it was in place, FDA has never done that.

  • 10:35:31

    REHMErik Olson.

  • 10:35:33

    OLSONWell, I think it's true that we need improvement in the seafood arena, but most of our seafood is imported, and, right now, one of the big problems is that FDA has real problems regulating and governing imports. The vast majority of the imports are never checked, and that, I think, fundamentally, is the big problem here.

  • 10:35:51

    HARRISRight. They -- in fact, there's a big issue going on with catfish. Catfish are imported sort of almost entirely, and, in fact, they're imported now from China. There's a lot of antibiotics and things in that. So the catfish producers locally actually got USDA to start overseeing catfish so they could start having some real strict standards on catfish and stop the imports.

  • 10:36:15

    REHMBut let's go back to Matt's point about exempting small farmers.

  • 10:36:20

    HARRISAbsolutely. You know, his point is that if there is a problem, it will be all sort of a small problem. In other words -- and this goes to the basic industrialization and globalization of our food supply, Diane. But it doesn't make what you eat locally any safer necessarily than what you're getting sort of broadly. In other words, if there's going to be a problem, the problem will be limited just to the local food supply. But that does not mean that those local growers necessarily are growing more safely than the sort of the big industrial growers.

  • 10:36:52

    REHMWould you agree with that?

  • 10:36:54

    WILLIAMSNo. I think it's much easier to sort of keep control over a smaller farm than it is a larger farm. With a larger farm, you do need sort of big, systematic types of controls. I think with a smaller farm, it's not a problem. I'd like to go back to the imports for a minute, if I could. Right now, FDA has, and historically has, only sampled about 2 percent of imports. Even a huge amount of money is never going to change that percentage much. That's not going to be the answer to the problem. In addition to which the idea that we can go over and start inspecting foreign plants, we can only do so if we're invited by the countries themselves.

  • 10:37:26

    REHMRichard Williams of George Mason University, for 27 years, he worked at the FDA. We'll take a short break. When we come back, more of your comments, your calls. Stay with us.

  • 10:40:03

    REHMAnd as we talk about prospective rules, changes for the Food and Drug Administration, here's an e-mail from Dave in Gainesville, Fla., who says, "Having worked in the restaurant business since I was 14 years old, I disagree with your guests that this is bad. More inspections or fear of inspections is good. Once a year to check a restaurant? That's ridiculous. If you're awesomely clean, then maybe once a year is okay. If you had 78 violations in a year, you should probably be checked monthly or shut down." The difference between restaurants and food suppliers, Gardiner?

  • 10:40:53

    HARRISRight. Well, restaurants are inspected by local and state health inspectors. That's a totally different system. And also, I think, what the...

  • 10:41:00

    REHMBut it is under the FDA aegis?

  • 10:41:03

    HARRISNo, it is not. It is...

  • 10:41:04

    REHMIt is not?

  • 10:41:05

    HARRISNo, it's an entirely different system.

  • 10:41:06

    REHMI see.

  • 10:41:07

    HARRISThe FDA has authority to go into restaurants but basically almost never does. And, actually, FDA can set up and does set up a co-inspection system with a lot of state and local inspectors, but it almost never involves restaurants.

  • 10:41:24

    REHMAll right. To Trenton, N.J. Good morning, Anne. Thanks for joining us.

  • 10:41:29

    ANNEOh, thank you. My father was a public health veterinarian for the state of New Jersey, and he was one of the people that went around and inspected the (word?) farms and the poultry farms and the dairy farms. And one of his concerns -- and this was in the 1950s, '60s and '70s when he retired -- was that politics were becoming involved in the meat inspection business and that public safety was being put in danger because public health veterinarians were being excluded from the work, you know, in savings and -- so I was wondering, how come the states has dismantled so many of their programs?

  • 10:42:18

    REHMErik Olson, is it money?

  • 10:42:21

    OLSONWell, what -- just one preliminary thing, which is this legislation covers 80 percent of the food supply which is regulated by the Food and Drug Administration. It does not cover meat and poultry, which are regulated by...

  • 10:42:31

    REHMAnd that's the Department of Agriculture.

  • 10:42:33

    OLSONThat's correct.

  • 10:42:33


  • 10:42:34

    OLSONSo the Department of Agriculture regulates meat and poultry, and a lot of states were -- basically, all states regulate meat and poultry, too. I think it is true that sometimes politics can play a role in both cutting inspections and, frankly, in what kind of enforcement is taken at many state levels. But meat and poultry is outside of the ambit of this legislation.

  • 10:42:57

    REHMAll right.

  • 10:42:57

    HARRISBut, I mean, and that is, of course, one of the problems of this legislation, Diane. There were some people on Capitol Hill who wanted to have finally --you know, there are 13 different federal agencies that oversee some aspect of food safety. You know, the two most prominent being FDA and USDA. And that division has always been something of a problem. In the most recent egg recall, the Wright County Egg, there were USDA inspectors at Wright County giving them the USDA seal through all of the early part of this year. And, in fact, in their inspection reports, those inspectors noticed that problems were really starting to crop up in the production of the eggs.

  • 10:43:36

    REHMAnd yet they never...

  • 10:43:36

    HARRISBut they never said anything to the FDA, and so these eggs went into the system and ended up sickening, obviously, thousands of people. So there are some real problems with the sort of bifurcation of oversight of food in the federal government and state government.

  • 10:43:54

    WILLIAMSI would also add, I think the caller is exactly right but nowhere -- doesn't understand anywhere near the amount of politics that enters into it. Certainly, in the FDA, politics are how FDA makes decisions. The idea that we could sit down here and design a perfect regulation -- and that's what would come out of the process -- never happens. It is always a political process. The decisions are always political. And at the end of the day, the regulations you end up with may not be effective at all, but they might satisfy some stakeholders, either business stakeholders or food safety activists.

  • 10:44:26

    HARRISI'm shocked...

  • 10:44:27

    REHMYeah, we're shocked, shocked, shocked.

  • 10:44:27

    HARRIS...shocked that politics would be involved here, Diane.

  • 10:44:29

    REHMYeah, right. Here's another e-mail on small farms. Ray says, "While there's no doubt large factory farms have sickened scores of people, the problem with the bill is it puts small farmers under a regulatory microscope that may well drive many small farmers out of business for disease outbreaks that do not originate on small farms. Small farmers are just about the most ethical and conscientious people I have ever met." Erik Olson.

  • 10:45:07

    OLSONWell, this was exactly the argument that gave rise and created the Tester Amendment that's in the legislation.

  • 10:45:13

    REHMTo exempt the small farmers.

  • 10:45:13

    OLSONSo just to exempt the small farmers, which is really why the Tester Amendment ended up in the legislation.

  • 10:45:20

    REHMOkay. Let's go to Damien in Dallas, Texas. Good morning to you.

  • 10:45:27

    DAMIENGood morning. I've got a quick point. You know, listening -- sitting back and listening to the back and forth in the conversation, it sounds more -- from a consumer standpoint -- to be businesses, large growers, large businesses wanting to squash a local or a recent or more recent movement towards wanting locally produced foods and the competition that that provides through our farmer's markets. And that's really troubling considering that, you know, locally grown food is very important in reducing our carbon footprint in what we consume. And, you know, some of these regulations could be too taxing in terms of what it would cost these smaller farmers to bring food to their local farmer's market.

  • 10:46:25

    REHMAny comment, Gardiner?

  • 10:46:27

    HARRISThat's been the argument. I mean, I think there's a vigorous back and forth about this. Of course, the large folks are saying, you know, there really should never be an exemption to safe food. And while there are some paperwork requirements in this legislation for this whole provision of trace-back requirements so that you actually know where the food comes from, they are not crazy requirements.

  • 10:46:51

    REHMBut I want to go back to a basic point that, it seems to me, Richard's been making. Is there, in this bill, a requirement for a standard of safety? Who establishes that standard of safety? And who's going to enforce it?

  • 10:47:16

    WILLIAMSWell, I think one of the things that we're overlooking is -- but with respect to standards of safety is -- what is going to keep food safe is if we get over the fact that most producers, most retailers, up to now, have been judgment-proof. We haven't been able to trace problems back, whether they're a large farm or small farm, we haven't been able to trace them back, hold those firms accountable and also find out what went wrong, find out what the solutions are.

  • 10:47:41

    WILLIAMSWhat could have solved the problem? What's really going to make a difference -- and there was some good aspects in this bill that address trace-back -- is expanding trace-back kinds of provision, expanding the FDA programs like FoodNet and PulseNet, which actually help make that system stronger, which actually help hold firms accountable. Once firms are held accountable, you don't need regulation. You don't need inspection. Once they're held accountable, they're going to take due care.

  • 10:48:08


  • 10:48:08

    HARRISBut, Diane, they're held accountable after people die. I mean, that's the whole point here, is that the regulations here are hoping to prevent deaths.

  • 10:48:17

    REHMTo put those in place.

  • 10:48:18

    HARRISRight. So the accountability that he's talking about -- FoodNet and all those or these surveillance programs that sort of try to trace why -- you know, how people got sick. And the point of this legislation is to try to prevent people from getting sick in the first place by requiring companies to actually set up plans to do this well in the first place.

  • 10:48:38

    REHMAs I understand it, the House bill requiring once a year inspections for high-risk firms, the Senate bill allows once every five years. The FDA claims they're already going into high-risk firms more than that. Are they?

  • 10:49:04

    OLSONWell, first of all, just one correction, the current situation is about once every 10 years on average. The legislation requires, for high-risk facilities, at least once every five years initially...

  • 10:49:16

    HARRISAnd then down to three years.

  • 10:49:16

    OLSON...and then, eventually, it gets down to every three years. That's not frequent enough in our view, but it's the best we can do right now. We'd like to see it more frequent. But, again, we can't forget that right now the system is broken, and this legislation will move us forward.

  • 10:49:33

    REHMAnd if the system is broken, surely, it's going to take a lot of money to fix it. And what I keep wondering is where is this money coming from when we see a debt and deficit commission wanting to slash everything?

  • 10:49:52

    OLSONI liken this situation to trying to tell a child to keep his room clean, and say, I want you to keep your room clean. And I -- incidentally, I know I've only been inspecting once every 10 years, but now I'm going to inspect you once every three years. It's not going to make any difference. What makes a difference is when you have companies inspecting you that you have to sell to once a week. That's what's making a difference. So when you say the food safety system is broken, it's not broken.

  • 10:50:17

    HARRISLet me...

  • 10:50:17

    OLSONIt's actually much safer than what...

  • 10:50:19

    HARRISRichard made the point that the peanut plant was actually shut down by Nestle -- that is dead wrong. Nestle came in, inspected that plant, found that it was totally rife with problems, decided not to buy from it and told no one else about it. So, of course, that plant…

  • 10:50:36

    REHMSo there is no requirement to say.

  • 10:50:38

    HARRISThere's no requirement that -- right, that you can have these inspectors come in, but it's entirely private system right now. So that if you flunk an inspection...

  • 10:50:46

    REHMHow do you respond to that, Richard?

  • 10:50:48

    WILLIAMSI respond to it -- look, everybody is becoming more and more a part of this contractual system. If you have problems, the word gets around. You're not going to be able to carry your product.

  • 10:50:56

    REHMBut the word didn't get around.

  • 10:50:57

    HARRISThat is dead wrong. It is dead wrong.

  • 10:50:58

    WILLIAMSIn this particular case, there is absolutely no silver bullet. And, frankly, this legislation is certainly not a silver bullet.

  • 10:51:04

    REHMYou know, I have to say, I, as a citizen, am never looking for silver bullets. What I am looking for is some small measure of improvement. If, in fact, this would move us forward one step, what's the drawback?

  • 10:51:26

    WILLIAMSThere has been one major improvement in food safety in the last 100 years, okay? And that was pasteurization. We had a chance for a really significant improvement with irradiation. We lost it because the nonscientists, basically, were able to tie irradiation to nuclear. That was ridiculous. The difference in an irradiated food, how much radiation is on it -- if you're sitting outside in the sun, you're sitting down, you stand up, you're that much closer to the sun -- but we lost that. There was a chance for a real improvement. New technologies are what's going to make the improvement. There's another new technology coming on line that will actually make a huge difference in food safety. If the FDA is able to approve it quickly and get out the word on what the risk can...

  • 10:52:06

    REHMWhat is that technology?

  • 10:52:07

    WILLIAMSThat's nanotechnology -- already shown some tremendous improvements. These are the things that are going to make food safe. It's not going to be going from 10 years of inspection to three years inspection.

  • 10:52:18


  • 10:52:19

    HARRISWell, this happens all the time, these arguments, which is that the perfect gets to be the enemy of the good. And I, you know -- and, Diane, I just sort of have to go back. I'm sorry, but Richard is very much in a very small minority here. You've got all the large industry players and even many of the small industry players. You've got the consumer advocates like Erik here. You've got nearly everybody who is deeply involved with food, pushing for this legislation, and I think that says something.

  • 10:52:47

    REHMGardiner Harris, he's science reporter for The New York Times, author of the mystery novel, "Hazard."

  • 10:52:55

    HARRISThank you for mentioning that.

  • 10:52:56

    REHMAnd you're listening to "The Diane Rehm Show." Let's go back to the phones to Mercille (sp?) in Decatur, Ind. Good morning, you're on the air.

  • 10:53:08

    MERCILLEYes, good morning. With regard to farmers' markets and how we might allow really small producers -- like, I grow tomatoes in my backyard, and I'd like to take some to the farmers' market in the summer and sell them. They have a policy at our farmers' market that they use now with regard to prepared foods. They allow certain non-refrigerated, prepared-in-the-home foods to be sold with a disclaimer clearly on the item that this has not been inspected by anybody. It's done in a home kitchen, and you take your risk...

  • 10:53:43

    REHMYou take your own risk as you go.

  • 10:53:46

    OLSONYes. And that's -- many of the states have these so-called cottage laws that say that. If you make the -- if you make a processed food, jams or jellies or whatever, you'll have to label it as not being inspected by anyone. This legislation actually exempts those completely from the federal standards, but a lot of states will have these cottage laws.

  • 10:54:05

    REHMAll right.

  • 10:54:05

    HARRISBut a lot of states don't, Diane. And that's actually -- you actually -- in many states, you actually have to have a commercial kitchen. You can't do it in your own kitchen. I mean, you have to actually check this out. I mean, a lot of people don't actually know that, that it's illegal to sell things you make out of your own kitchen.

  • 10:54:19

    REHMI'd better check my Christmas baklava.

  • 10:54:22

    OLSONThere are all sorts of interesting ways to keep food safe. One plant I visited had a really interesting method. They train their employees in what to do and then they sell them the food for less than half of what they charged at retail, which meant that the employees couldn't afford not to buy the food and take it home and feed their families. They definitely took care of the food that they were producing.

  • 10:54:40

    REHMAll right, let's go to Jacksonville, Fla. Finally, David, you're on the air.

  • 10:54:47

    DAVIDHi. How are you?

  • 10:54:48

    REHMYes, go right ahead, sir.

  • 10:54:51

    DAVIDI'd just like to open up with just a quote I read, and then I have something to say. But President Thomas Jefferson said, "If people let the government decide what foods they eat and what medicines they take, their bodies will some be in as sorry a state as are the souls of those who live under tyranny." And after listening to the back and forth conversations, I just -- I mean, I don't know if anybody has addressed the fact that the head of the FDA is a former employee of Monsanto's, the head of operations, former...

  • 10:55:17

    HARRISNot true.

  • 10:55:18


  • 10:55:19

    REHMDid you just hear -- David, excuse me. Did you just hear Gardiner Harris say what you just said is not true?

  • 10:55:29

    DAVIDWell, my mistake.

  • 10:55:29

    WILLIAMSIs he talking about Mike Taylor?

  • 10:55:31

    HARRISYeah, yeah.

  • 10:55:32

    DAVIDBut -- and besides that fact, I just -- I think that the problem with this...

  • 10:55:35

    REHMBut, wait a minute -- I mean, hold on a minute. David, where did you get that information in the first place? And why would you call in to a radio program and make such a statement without any confirmation?

  • 10:55:54

    DAVIDI can -- I could actually pull up documentation if I needed to, but...

  • 10:55:57

    REHMGo ahead.

  • 10:55:59

    HARRISHe's talking about Mike Taylor who is a deputy -- now a deputy commissioner of the FDA who for, I think, about a year-and-a-half was a lobbyist for --...

  • 10:56:07

    REHMWas acting...

  • 10:56:08

    HARRIS...was acting in part as a lobbyist for Monsanto. He is now head of their, essentially, food oversight as the deputy commissioner. You know, I think a lot of people had been concerned about Mike's past. Mike Taylor has certainly expressed regret forever associating himself with Monsanto, and I think most people -- I think Erik worked with Mike Taylor for a long time. Richard, I think you even worked with him.

  • 10:56:36

    WILLIAMSI count Mike as a personal friend...

  • 10:56:39

    HARRISHe is...

  • 10:56:39

    WILLIAMS…and he is a dedicated person involved in food safety.

  • 10:56:43

    REHMAll right. And...

  • 10:56:44

    HARRISBut Peggy Hamburg, the head of FDA, had nothing to do with Monsanto at ever any part of her career.

  • 10:56:51

    REHMAnd that is the voice of Gardiner Harris of The New York Times, Richard Williams at George Mason University, Erik Olson of Pew Health Group's Food Portfolio. Thank you all so much. We'll see what happens next.

  • 10:57:10

    HARRISThank you, Diane.

  • 10:57:11

    WILLIAMSThank you, Diane.

  • 10:57:11

    REHMThanks for listening all. I'm Diane Rehm.

  • 10:57:14

    ANNOUNCER"The Diane Rehm Show" is produced by Sandra Pinkard, Nancy Robertson, Susan Nabors, Denise Couture and Monique Nazareth. The engineer is Tobey Schreiner. Dorie Anisman answers the phones. Visit for audio archives, transcripts, podcasts and CD sales. Call 202-885-1200 for more information.

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