Oversight Hearing on the FDA’s Mission: Waxman’s Opening

The Committee on Oversight and Government Reform held a hearing today: “The FDA’s Vital Mission and Challenges for the Future.” The Food and Drug Administration (FDA) plays a large and influential role in the health and safety of the American people. The FDA is responsible for ensuring that drugs and devices are safe and effective, and that food is uncontaminated and properly labeled. This hearing marks the first of a series designed to bring competence and efficiency back to federal agencies.


Food Safety? Sorry to say but there is none …. for any of us!

FDA widens Chinese import alert
By Elizabeth Weise and Julie Schmit, USA TODAY


The Food and Drug Administration is enforcing a new import alert that greatly expands its curtailment of some food ingredients imported from China, authorizing border inspectors to detain ingredients used in everything from noodles to breakfast bars. The new restriction is likely to cause delays in the delivery of raw ingredients for the production of many commonly used products. …

The agency for the first time also said it has received reports, which it has yet to confirm, that approximately 1,950 cats and 2,200 dogs died after eating contaminated food. The only number of pet deaths that the FDA has confirmed thus far is 14.

An import alert of this breadth is rare. Before this new FDA action, only products from two Chinese companies that exported the melamine-tainted wheat gluten and rice protein concentrate had been detained.

Now for the products to reach U.S. foodmakers, the importers will have to prove to the FDA that they are safe. The ingredients restricted include wheat gluten, rice gluten, rice protein, rice protein concentrate, corn gluten, corn gluten meal, corn by-products, soy protein, soy gluten, mung-bean protein and amino acids.


From the above article, you’d think that the FDA was finally getting to work. But, after reading the remarks below, maybe you will think again.

1. Did you know that the FDA does no testing to prevent adulterated imported food from entering the US?

2. Did you know that when food is actually denied entry it is often brought to another U.S. port and then admitted?

3. Did you know that FDA’s current practice is to tell food importers whether their shipments will be inspected even before the shipment is put on a boat or a plane for delivery to a U.S. port of entry?

4. Did you know that the FDA lacks the authority to “trace back” food borne illness beyond the border?

5. Did you know that the FDA does not have mandatory recall authority? That is, if a recall is believed appropriate, the only thing it can do is ask the states to use their recall authority to take a particular food article out of commerce.

6. Did you know we have no mandatory country of origin labeling (COOL) for meat, poultry, seafood and fresh produce? A voluntary program is a joke as every major packer and retailer is not participating and labeling their products.

7. Did you know that the FDA is unable to prohibit importation of food from foreign food firms or foreign governments that deny it the ability to perform an inspection there? They also are unable to prohibit importation from countries, such as China, that do not provide the same level of food safety protection as the U.S.

8. Did you know, that as of 2002, there were only 150 FDA inspectors covering the 307 ports of entry where food now enters the U.S.?

Just read this … and weep … because our Republican congress has sat on needed food safety legislation.


APRIL 23, 2002

Thank you for inviting me to speak today before the 25th Annual National Food Policy Conference sponsored by the Consumer Federation of America. I salute the members of CFA who dedicate themselves to advocating for, and educating consumers on, a wide range of issues, both nationally and at the state level.

This is the largest group of food safety advocates I have ever had the opportunity to address, and for that I want to sincerely thank you. For the past five years, I have had the pleasure of working with Carol Tucker Foreman, Caroline Smith DeWaal and other consumer food safety advocates on improving the Food and Drug Administration’s (FDA) inspection and regulation of imported food.

This conference is particularly relevant to the current work of Congress, in particular defending our Nation’s food supply against threat of terrorist attack. Important work is being done in the House-Senate conference on bioterrorism, and I hope that you will lend your voice to the urgent need for additional resources to improve the safety of our food system.

We knew that something as important as strengthening the Nation’s food safety system would not be an easy task. But the difference now is that the issue is finally getting attention, from the public, the press, from government, and from both proponents and opponents of strong food safety measures. My hope is that this attention will translate to action.

All the past work done by this great organization of consumer advocates, and by all those represented here today, is now paying off. You have an audience that is listening. Much more will be demanded of you in the future as we fight to keep food safety at the forefront of public attention.

In each of the past two congresses, most of my Democratic colleagues on the Committee on Energy and Commerce have joined me in sponsoring legislation aimed at improving the safety of imported food that Americans eat.

Unfortunately, few others have shared our enthusiasm for acknowledging and taking steps to address the threats to food safety generally, and in particular threats to the safety of imported food. The legislation I have introduced in this and past Congresses has not received so much as a hearing. Then came September 11th, and instantly our vulnerabilities as a Nation were exposed to the alarm of everyone. For the first time, we had a Secretary of Health and Human Services say there is a need to take steps to detect the intentional adulteration of food coming into the United States and to prevent entry of food which presents risk of injury to American consumers.

From that came the bioterrorism bills that passed both the House and the Senate. The bioterrorism legislation is clearly the most important food safety legislation to be considered by the Congress in years. It has new money and much needed new authorities for FDA to improve its regulation of imported food. This legislation, for the first time, gives FDA authority to act independently at the border. FDA would no longer need to rely on the Department of the Treasury either for information about food at the border or for the ability to detain shipments it suspects are adulterated.

For those of us who advocate stronger food safety protections, our first and most important challenge is to make sure Congress passes the bioterrorism bill with the strongest possible food safety provisions. Although I am generally pleased with the work the conference is doing, I would be less than candid if I did not say I’m more than a little concerned at how long the conference is taking. And the longer it is before agreement is reached, the more opportunity there is for those who don’t want a strong food safety bill to undermine our work.

Furthermore, it should be remembered that the bioterrorism legislation is a big bill. Food safety is only one of several titles in the legislation. While the conference is closer to agreement on food safety than on some other titles of the bill, agreement on the whole bill must be reached before the food safety provisions can be enacted into law.

All who care about food safety should now be making your voices heard. The conferees need to know that you have high expectations for the work they are doing and very long memories should they fail. American consumers have for too long been treated like guinea pigs. A successful bioterrorism conference is critical to defending our food supply.

But, the bioterrorism legislation is only one step in the right direction. Once the bioterrorism legislation becomes law, and I am hopeful it will become law, much will still need to be done on food safety. A high priority for all food safety advocates must be building on and sustaining the concern about food safety that last year’s horrific events created. Active grassroots support will be needed to maintain the momentum for greater food safety.

This afternoon, I want to give you an overview of my food safety goals in the bioterrorism conference. Before I do, however, it’s important to understand what the regulation of imported food looks like today. And I know you will not be surprised that it is not a pretty picture.

As bad as you may believe FDA controls are at the border, the reality is they are much worse than you think. As a result, imported food that is intentionally or unintentionally adulterated is much more likely to end up on America’s dinner table than it is to be detected and held at the border. This is true largely because FDA doesn’t have enough inspectors at ports of entry, but FDA’s own practices and lack of authority make matters worse.

FDA does no testing to prevent adulterated imported food from entering the United States. It should. And when food is actually denied entry it is often brought to another U.S. port and admitted.

FDA’s current practice is to tell food importers whether their shipments will be inspected even before the shipment is put on a boat or a plane for delivery to a U.S. port of entry. This must stop.

FDA lacks authority to “trace back” food borne illness beyond the border. Congress must provide that authority.

And FDA often lacks timely information. Consider this: 54 percent of the fresh fruits and vegetables that come into the U.S. enter at either the Canadian or Mexican border. Yet FDA gets no documentation on more than 10 percent of all food imports entering the United States from Mexico or Canada until 10 days after the food arrives in this country. By then, the food very likely has been eaten. That is almost certainly true in the case of fresh fruit and vegetable imports. We must do better.

But the most pressing problem is straightforward — resources. Currently, there are only 150 FDA inspectors to cover the 307 ports of entry where food now enters the U.S. If there is no FDA inspector present when imported food arrives at a U.S. port, that food is allowed into the U.S. and is eaten by American consumers without FDA so much as reviewing its paperwork.

It would take six times the current number of inspectors just to put one FDA inspector at each port on a full-time basis. It is clear that we cannot detect adulterated imported food at the border unless we have inspectors at the border to inspect and examine shipments of food coming into the United States. More inspectors are needed, and they are needed now.

Over the last five years, the volume of food imported into the U.S. has almost doubled, forcing FDA to admit it is “in danger of being overwhelmed by the volume of products reaching U.S. ports.” With more imports reaching U.S. ports, FDA’s inspection rate for imported food has fallen from eight percent in 1992 to less than one percent last year. At a minimum, FDA needs to be inspecting 10 percent of food imports, and that can only happen if FDA is given greater resources than even the bioterrorism bill envisions.

That’s what things look like today, and here are my goals for the bioterrorism conference:

FDA must have the ability to detain food, at the border and elsewhere, on its own authority. And when no inspector is present at a port of entry, FDA needs the ability to order food held until an inspector can be dispatched to the location. Before imported food can be seized now, FDA must first convince the Justice Department to initiate a case on its behalf, and then Justice has to convince a judge that the seizure is warranted. That’s unacceptable, and the bioterrorism legislation must give FDA this needed authority.

FDA needs to know in advance when food is going to be presented for importation. At the same time, notice must not be given so far in advance that shippers learn whether their shipments will be inspected even before they are ready for transport to the U.S. Unless FDA receives adequate advance notice that a shipment of food is coming to port, it faces a serious handicap in being able to determine whether that shipment should be detained. FDA needs to know what is being imported, the manufacturer and shipper of the article being imported, and if known, the grower of the article, the country of origin, the country from which the article is shipped, and the anticipated port of entry. Without this basic information submitted sufficiently in advance of the food’s arrival, FDA cannot effectively evaluate when a shipment of imported food may present a threat of serious illness or death.

FDA needs to have inspectors present when food comes through a U.S. port of entry. There is no substitute for on-site examination of product and product documentation that can only be performed effectively by a trained, inquisitive, inspection professional. The Administration says it can hire 600 new inspectors with the funds authorized by the bioterrorism legislation. That’s a big increase over the 150 FDA inspectors who must now cover 307 ports of entry. But even this sizeable increase in the inspection force will ensure that only one inspector will be on duty at all times at all 307 ports. That’s a good start, but it’s not enough. And it’s not at all clear to me that the 600 new inspectors will actually be hired. We will need to address the adequacy of FDA’s inspection force again in the future, and I hope I can count on your support for making sure FDA has the inspectors it needs to do a thorough and effective job at the borders.

FDA also needs to know who it is regulating. Today it does not know this. Sounds like a simple enough proposal, but it has caused much controversy. To remedy this deficiency, both the House and Senate bioterrorism bills provide that every food warehouse, factory, or establishment must register with the FDA and provide its name and address. Access to records gives FDA its best chance of identifying food that is adulterated, intentionally or not. For this reason, a strong recordkeeping and records access provision must be retained in the conference bill.

Other important new powers I expect the conference bill to provide include the ability for FDA to “debar” importers who are convicted of felonies in connection with the importation of food into the U.S. or who repeatedly offer adulterated food for importation. FDA also needs the authority to mark food it does not permit to be imported with a “refused entry” stamp so that if the importer tries to bring a rejected shipment of food through another U.S. port, inspectors can readily identify it as having already been “refused entry.” And to make sure food that has been refused entry stays out, such food must be deemed to be adulterated, allowing FDA to bring legal action to stop the food itself.

We must also develop rapid test technologies that will allow inspectors to detect contaminants on imported food right at the border. Currently, inspectors don’t even bother to test imported food because it can take up to two weeks to get test results back, and by that time the food has most likely already been eaten by American consumers.

These new authorities and resources that I expect to be included in the bioterrorism bill will be a great start. But in the coming years, more will be needed.

My ongoing goals for food safety include the following:

FDA needs, but does not have, mandatory recall authority. If FDA believes a recall is appropriate today, the only thing it can do is ask the states to use their recall authority to take a particular food article out of commerce. It is very interesting that all but one state has food recall authority, but FDA does not.

FDA needs a user fee to fund the additional cost of inspecting imported food. This would insure a steady revenue stream for much needed inspectors and tests to detect pathogens at the border.

Imported food regulated by the FDA should be labeled to identify its country of origin. American consumers have a right to know whether their food was grown halfway around the world or at the local farm down the street.

FDA needs, but does not have, the ability to file a seizure action without the Department of Justice. The Department of Justice does not always have the same priorities as FDA, and as a result, FDA enforcement suffers along with the safety of our food supply.

If a foreign food firm or foreign government denies FDA the ability to perform an inspection in a foreign country, or if the foreign country does not provide the same level of food safety protection as the U.S., then FDA should be able to prohibit importation of food from that country. Either FDA can establish with some certainty the safety of imported food, or it cannot. And if it cannot, the food should not be allowed into the U.S.

These deficiencies, which we were unable to resolve in the bioterrorism bill, must be addressed in the future. The legislation my Democratic colleagues on the Committee on Energy and Commerce and I have introduced contains many of these additional authorities that FDA very much needs. H.R. 3075, the “Imported Food Safety Act” that so many in this room have supported, needs your help. I urge you to contact your Members of Congress and encourage them to cosponsor this important legislation.

The key to being able to do these important things in the future lies right here in this room. You must not let the American people, the Congress, or the Administration forget how vulnerable our food supply is. We must not wait for the unthinkable to happen again before we do what is needed to protect the safety of our food, both imported and domestic. Our window of opportunity to do something important is still open. Don’t let it close without getting the job done. I pledge my efforts to this cause. Together we can make it happen.

Thank you.

Prepared by the Democratic staff of the Energy and Commerce Committee
2322 Rayburn House Office Building, Washington, DC 20515