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Hearing of the House Subcommittee on Health of the House Committee on Energy and Commerce - H.R. 3610, The Food and Drug Import Saftey Act


Location: Washington, DC

Hearing of the House Subcommittee on Health of the House Committee on Energy and Commerce - H.R. 3610, The Food and Drug Import Saftey Act

REP. PALLONE: (Sounds gavel.) I call the meeting to order.

Good morning to everybody.

Today we're having a hearing on H.R. 3610, the Food and Drug Import Safety Act introduced by our chairman, Mr. Dingell, and I'll recognize myself initially for an opening statement.

Mr. Dingell's legislation seeks to strengthen our nation's import safety system and I am also a proud co-sponsor of the legislation.

We all know that while the U.S. has one of the world's safest food and drug supplies and some of the most stringent standards for consumer protection, recent outbreaks of contaminated products and cases of food-borne illness demonstrate that we have to do better.

Contaminated pet food, toothpaste and seafood products from China have highlighted the failings of our import safety system and sparked fear and distrust among consumers.

Democrats in Congress have heard consumers' concerns and we've already begun to address the issue. Last week Congress passed the Food and Drug Administration Revitalization Act, which we called PDUFA, I guess, or includes PDUFA -- and that bill provides the FDA with the resources and authority necessary to improve our nation's drug safety system.

Also included in this measure, however, are improvements to our nation's food safety program, including new public notification requirements of outbreaks of illness due to contaminated food.

In addition, the PDUFA legislation will establish an adulterated food registry so that incidents can be reported and the FDA can quickly alert the public. It also calls for transparency during recalls of human or pet food and will require the FDA to post information on recalled products in an easy-to-use, searchable format.

While this was a modest step which was included, as I said, in the PDUFA bill, a lot more can and needs to be done with regard to food safety. The recent contamination incidents raised questions about our current food and drug safety laws, many of them enacted in the 1900s.

Have they kept pace with new techniques in food production and processing? Are these laws still sufficient to keep us safe? Rather than reacting to outbreaks of contaminated products, we need to change our system to better prevent such incidents from happening in the first place.

Recently a White House working group -- and I actually spoke to the FDA commissioner about this yesterday -- they released a report on government import safety protocols. This report acknowledges the limitations of our current import safety system and calls for a shift, basically, to review not only our imports at the point of entry into the U.S. but also to regulate production abroad.

The report tells us what we already know, that the current system isn't working. The administration recognizes its failings, a lack of coordination amongst agencies, loopholes in the system that allow contaminated products to slip in. But merely reporting on the problem is too little and too late.

Now, Chairman Dingell has taken the initiative in his legislation that's before us today and proposed a solution for increasing import safety, including requiring agencies to conduct research to develop better testing techniques and ensuring accurate labeling on products to prevent consumer deception. And his bill would give the FDA the authority to recall adulterated products if necessary.

Chairman Dingell's bill would also ensure that products from other countries are only permitted to enter the U.S. if they meet our strict safety standards. And it puts in place regulations for ports of entry, certification and inspection that will enable us to enforce this standard. These new process controls would be paid for by a new imported food inspection fee.

The Dingell bill also addresses imported drugs by allowing the FDA to assess and collect user fees on drugs imported into the U.S. These fees will help pay for inspectors' laboratory tests to detect adulterated drugs and overseas inspections of drug shipments.

But we know that contamination isn't limited to imported products alone. In the last few months E. coli bacterium was discovered on lettuce and spinach from California, we had to recall peanut butter due to salmonella contamination, and botulism was found in canned green beans. All of these recent examples actually involved domestic products; they're incidents of serious concern.

The Centers for Disease Control estimate that 76 million people became ill this year and 5,000 actually die from illnesses caused by the presence of microbial pathogens in their food. The spinach contamination alone caused 200 reported illnesses and three deaths last year.

Now, I've also introduced a bill that I've actually had for a number of years that would strengthen process controls on domestic products by establishing strict inspection and oversight procedures to prevent contamination at food processing facilities.

It would require the FDA to set standards for sanitation and limits for the level of contaminants in food. And my bill would also require food processing facilities to register annually and it would increase the number of inspections at facilities both in our country and in the country of origin. And I'm looking forward to working with Mr. Dingell and my colleagues -- I know others have introduced legislation to address these concerns as well.

If I could just say in conclusion that I think that improving our nation's import and domestic food-drug safety programs is of great importance. I wanted to thank -- he's not here -- but Mr. Stupak, as you know, has had a couple of hearings in the O&I Subcommittee on this issue.

The bottom line is that American consumers should be able to trust that the products they purchase have been properly regulated and inspected and thereby making them safe, and that's why we're here today.

And I thank all of you and the witnesses are here who are to help us in that regard. And at this point I would recognize Mr. Deal, our ranking member for an opening statement.


REP. PALLONE: Thank you.

I'm going to recognize myself for questions.

I wanted to ask Dr. Acheson, if I could -- I'm just reading from a publication that said that you testified yesterday, I guess, before the House agricultural appropriations subcommittee that the agency needs more powers to police the nation's food supply.

And I guess there wasn't a time for the chairman of the subcommittee to ask what new authorities the agency might seek, so I would simply ask that: What kind of authorities, Mr. Acheson, would you seek? Are these in the Dingell bill by reference or would they be something beyond the Dingell bill, if you would?

DR. ACHESON: There is currently a very active dialogue going on within FDA and HHS to address exactly what new authorities we would seek as part of this plan.

So at this point it is not fully defined, but there are a number of areas that are under consideration.

REP. PALLONE: You don't want to comment on some of them at all or just give us some idea?

DR. ACHESON: At this stage, I'm not able to really say much beyond what I just articulated.

REP. PALLONE: All right. Well, I'd ask you if you could get back to us in writing and give us some indication.

DR. ACHESON: Absolutely. And I would hope in the future, as the plan starts to take shape, that we could work jointly between what we're developing and what the subcommittee is developing so that we have a holistic view of this that's fully integrated, building the best of all of these ideas.

REP. PALLONE: Absolutely.

Then I want to go back to Dr. Lutter.

You know, you -- well, everyone knows that part of the problem with the food safety system is the lack of resources that the FDA has available to perform its responsibilities. I mean, it's a recurring theme. I've heard it, you know, for years.

Can you talk about the financial resources the FDA has to perform its safety responsibility, and, you know, has that budget increased or how has that budget increased, if any? And I'll ask you some more specific things but just in general.

MR. LUTTER: I'd prefer to pass that question on to my colleague --

REP. PALLONE: Sure, go ahead. Dr. Acheson?

MR. LUTTER: -- food protection. David?

DR. ACHESON: Yeah. In recent history, while there have been increases in the budget on the food side, they have largely been used to keep pace with inflation and pay increases and there have not been substantive increases in programmatic support.

REP. PALLONE: And do you have a specific percentage each year over the past five years or you would say just to keep up with inflation essentially?

DR. ACHESON: I'd have to get back to you with the specific numbers. I don't have all that --

REP. PALLONE: All right. I would appreciate it if you would. But basically you said what keeps up with inflation and that's it.

Well, do you think that an importation fee like what Mr. Dingell is proposing, you know, is a good way to fill in the gaps in, you know, the lack of resources?

DR. ACHESON: User fees are a double-edged sword. I think that there can be potential advantages to them. Clearly, as you've articulated -- as have many of your colleagues -- in order to make a new system work that's going to be radically different, you have got to adequately resource it. So those resources have to come from somewhere.

User fees is a potential source of revenue to do that, but one has to be very circumspect about whether you can implement them in a meaningful way that is fair and is actually going to get you where you want to go. It's an option.

REP. PALLONE: But clearly, you do think that your resources are inadequate -- you agree we need more resources, right? I didn't ask that question because I thought it was obvious, but do you --

DR. ACHESON: It is obvious.


Then I wanted to go back to Dr. Lutter, unless you want to pass it over to him again.

The budget -- well, let me say this: Mr. Dingell's bill directs funds specifically to strengthen imports -- the system to regulate and inspect imports -- but some of the recent contamination incidents, as I mentioned in my opening statement, have involved domestic products not imports.

Considering the current funding levels and the fact that very little money is targeted for imports regulation, how do you foresee strengthening inspection of national products while simultaneously managing the new import regulations?

In other words, if we're going to spend more money on imports, you know, how are we going to strengthen inspection of domestic products given the fact that, you know, that we don't have a lot more money available so far?

MR. LUTTER: The food protection strategy that we're developing would be holistic and integrated in the sense that it addresses both imported foods and domestic foods as well as risk from deliberate contamination and accidental contamination and over the life cycle, so in that sense, the approach would be intended to encompass both domestic foods.

And we've acknowledged that there are risks that are worthy of concern and additional action, particularly with respect to leafy greens, which are -- recent outbreaks have been domestic.

So yes, we share concerns about that.

REP. PALLONE: Okay. All right. Thank you.

Recognize Mr. Buyer, from Indiana.


REP. PALLONE: Thank you very much.

Let me start the questions with the panel. I wanted to start with Congressman Dooley.

I've got a couple questions I wanted to ask you, Cal.

In your testimony, you speak about the GMA/FPA's four pillars: one, mandatory foreign supplier quality assurance program; two, voluntary quality import food safety program; three, build the capacity of foreign governments; and four, expand the capacity of FDA.

Now, when I look at Mr. Dingell's bill, some of his provisions include: one, a new requirement that imported food meets the same standards as domestic foods; two, a voluntary program for companies that import food to agree to abide by specific safety guidelines; three, significant new resources for food, drug safety via an importation fee.

I mean, the question I have, Cal, is that you state that your proposal will do more to ensure the safety and quality of imported food products and ingredients than would the adoption of many of the provisions of the Dingell bill. But I don't see the difference on how your plan is superior. You want to just tell us why you think it is better or why you think it would do more to ensure safety and quality?

MR. DOOLEY: Sure, and the way I respond to that is that the proposal that we have tabled really relies much more on prevention than from inspection. Our assessment of Chairman Dingell's bill is that it really is looking at how do you enhance the level of inspection capacity and resources at FDA to try to enhance the level of food safety. We think that there is -- that we need to approach this by defining the -- what the private sector can do most effectively and complementing that with the defined role of where FDA can best utilize its resources.

And so where, you know, the Dingell proposal would rely on perhaps a certification of what is by FDA's testimony today would literally be hundreds of thousands of foreign suppliers of ingredients, which we don't think they have the capacity to do, is that our approach would be to have a partnership with the private sector where the private sector would have to develop these mandatory supplier programs, import programs, that would embody almost without question audits of those facilities and those suppliers. And that would be a private sector approach that would mitigate the need for FDA to have to go out and, you know, certify again these literally hundreds of thousands of facilities. And we think that would be a role that would be more effective and more -- certainly more pragmatic with our approach.

REP. PALLONE: Well, you mentioned about the different models the FDA could adopt to strengthen their efforts to regulate food safety. But are there things your members are doing to mirror those FDA efforts at this point?

MR. DOOLEY: Well, what you find is that the reason what we really have a limited number of food safety incidences, even as it relates to imported food products, is that most, you know, importers of products today do in fact have best practices in place that are including, you know, the supplier audits, that do have the chain of custody that they can account for throughout the supply chain, do have testing protocols to ensure that there's not an adulteration of a product. They have those practices in place.

But unfortunately, there are a limited number of people in the industry that aren't deploying that same level of best practices. What our proposal would suggest is that we need to mandate that those best practices apply to any company or -- any company that is importing a food ingredient or food product, and they would have to be in compliance with those guidelines and guidance that would be developed by FDA.

REP. PALLONE: I wanted to ask you about the import user fee because you're pretty critical of that and you have a number of reasons for your opposition. For example, you say that user fees are generally appropriate -- appropriated when the benefits accrue to individuals or individual companies and that the benefits of import inspections and research flow to all Americans. Of course, I don't agree with you on this because, you know, we just went through the PDUFA process and the MDUFA process and it is very similar where you have the industry paying for user fee that essentially helps, you know, all Americans or all consumers. And I don't really see how that's any different than a user fee that we would, you know, how a user fee on imports for food would be any different than a user fee on drugs or device applications.

So I guess my question is what's your -- well, what is your answer to that? I mean, it's no different, in my opinion. Do you think it is?

MR. DOOLEY: Yeah, I think it's dramatically different because when a pharmaceutical company is working with FDA to gain approval of a product that they're going to enter -- provide into the marketplace, they have a proprietary interest. They get a protection of a product that is going to have a patent protection for a period of time which derives, you know, financial benefits to that company who is paying that user fee.

In this case, we have no proprietary interests on, you know, what we could be paying for here, is that we are paying for basically a public good in terms of an inspection of a food ingredient that has no -- that we have no proprietary interest in it. Even if we go in and we have a food additive that a member company in the food industry might be requesting that FDA approve, that food additive immediately goes into the public domain and we have no, you know, financial benefit from that.


MR. DOOLEY: So we think it's a dramatically different approach.

REP. PALLONE: Of course, we have -- a lot of what we just passed in PDUFA was post-market, too, you know. In other words, that was the big issue that it's not just for the approvals. A lot of what we're doing in the new bill is post-market.

I don't want to argue with you. I mean, I do, but I'm -- (laughter)-- we've already -- you know where I stand.

Did Ms. DeWaal or Mr. Hubbard, did you want to comment on that? I'm already over the time, but I just figured I'd give the loyal opposition, or whatever they are, the opportunity.

MR. HUBBARD: Ms. DeWaal may -- might differ with me -- from me, Mr. Chairman, but I wasn't very much involved in the creation of the original user fees for drugs in 1992. The downside has been that as the drug program has gotten wealthier, the appropriators and the budgeters in OMB have seen an opportunity to cut back on appropriations. And the problem is because the drug money had to be kept up, based on provisions in the law, they cut it out of foods in the field and inspectors, so the FDA has lost a thousand people in the food safety and inspection area since PDUFA was created. And so my fear here is that if you do this user fee, they will find a way to use that to supplant appropriations and we won't be any better off for it. So, you know, if you could find a way to prevent that, great, but I -- I'm pessimistic about user fees.

REP. PALLONE: I understand.

Ms. DeWaal?

MS. DEWAAL: Thank you. We don't have a fundamental problem with the concept of user fees. But in this context, we are very concerned that the user fee proposal in this narrow construct where it's only applying to one segment, the imported food, and also there are some -- there may be some restrictions in how that money is used -- it could actually distract from the important work the committee needs to do in terms of looking at the authorities. So while we're happy to work with the committee on what the overall structure might look like, I think it's just vitally important that you really focus on what authorities are needed today that will improve the safety of the products both domestic and imported going to consumers tomorrow.

REP. PALLONE: Sounds like the same arguments that we heard in PDUFA and MDUFA, and of course, we ended up doing it anyway because we didn't know where the money was going to otherwise come from.

Mr. Buyer.


REP. PALLONE: Thank you.

I'm going to ask a couple more questions, too, so if you want to, you can.

I just had two questions of Mr. Hubbard.

In your testimony, you talk about building safety into products, and you specifically cite hazard analysis and critical control points as a model adopted by the FDA and the Department of Agriculture in the '60s. Given all the recent contaminations we've had with spinach, peanut butter, other products, I'm wondering why this model no longer appears to be effective. What's changed, essentially?

MR. HUBBARD: Well, it's not in place for those products; it's only in place for meat and poultry at USDA and for seafood and juice at FDA. So -- in fact, I understand there have been press reports that the FDA leadership requested that the secretary allow them to move to adopt that for produce at a meeting in February but was denied.

So, you know, I think it's been proven, first by the industry and then later by FDA regulation, that the concept does work, because it builds in safety and it's -- much as Mr. Dooley was describing, you've got the people in the supply chain now taking some responsibility rather than putting it all on the FDA to inspect a product at the end, which is proven not to work.

You don't want to rely on that inspection at the end because it will fail. You need to have everyone producing safe food and then letting FDA be the regulator that comes in and verifies that folks are in fact building safety in, keeping records so that you know they're doing that, and keeping them honest, and then you have, in my opinion, a safe process.


And then the second question: In your testimony, you state that you think that re-engineering our import safety system could actually improve some of our trade relationships, but there are members, you know, who are looking at this legislation, especially the import user fee, and see it as a possible trade barrier. Can you elaborate on why you think may be good for trade?

MR. HUBBARD: Well, let's take the case of China. They've been hit pretty hard by this. They produce a tremendous amount of goods for our country. Most of it's very safe. You know, we've got a small problem here. One would hope that if processes are in place that say to the producers in China "produce safer food," then the overall Chinese export economy will improve.

I'm told by experts on China -- and a number of them -- that the Chinese government does not have the wherewithal to ensure the safety of exports to us, that they don't have the reach-in into the hinterlands of China, they don't have the regulatory structure -- they could take years to develop such a thing. So if by putting in place the preventive system we're talking about to have the Chinese producers producing safer food, the sense I get is the Chinese government will say we win in that because then products coming out of China are safer products, and then they have a better reputation on the world market.

I would defer to a trade expert on that, but I would argue that in the end, they win too.

REP. PALLONE: Thank you.

Did you want to ask anything else? All right.

Let me just remind everybody that members may submit additional questions for the record to be answered by all of you, and those questions should be submitted to the clerk within the next 10 days and then the clerk will notify you if we have any.

And again, I just want to thank you all. I know it's been a long day here with the interruptions from the floor, but that's the way things go. Mr. Dooley is certainly familiar with it. (Laughs.)

And without objection, this meeting of the subcommittee is adjourned. (Sounds gavel.)

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