Hearing of the House Energy and Commerce Committee's Oversight and Investigations Subcommittee, Panel III- Security of the Nation's Food Supply?
Interview
Hearing of the House Energy and Commerce Committee's Oversight and Investigations Subcommittee, Panel III- Security of the Nation's Food Supply?
REP. STUPAK: We'll dismiss this panel and we'll call up our third panel of witnesses.
We have Dr. David Acheson, assistant commissioner for Food Protection at the Food and Drug Administration; Ms. Margaret Glavin, the associate commissioner for Regulatory Affairs at the Food and Drug Administration. They're accompanied by Mr. Michael Rogers, director of Field Investigations Division at the FDA, Mr. Domenic Veneziano, the director of Import Operations and Policy at FDA, and Mr. Donald Kraemer, deputy director of the Office of Food Safety and the Center for Food Safety and Applied Nutrition at the FDA. We also have Dr. Richard Raymond, who is the undersecretary for Food Safety at the U.S. Department of Agriculture, Food Safety and Inspection Service. Dr. Raymond is accompanied by Dr. Bill James, who is the deputy assistant administrator for International Affairs at the USDA Food Safety and Inspection Service.
It's the policy of this subcommittee to take all testimony under oath. Please be advised that witnesses have the right under the rules of the House to be advised by counsel during their testimony. Do any of you wish to be represented by counsel? Everybody indicating they do not, so we will move forward.
You have all risen. Raise your right hand and we'll take the oath.
(The witnesses are sworn in.)
REP. STUPAK: Let the record reflect the witnesses have replied in the affirmative. They are now under oath. We will now hear a five-minute opening from the witnesses, and they may submit a longer statement for inclusion in the hearing record.
Dr. Acheson, would you like to start for an opening statement?
MR. ACHESON: Good morning, Mr. Chairman and members of the subcommittee.
I'm Dr. David Acheson, assistant commissioner for Food Protection at the U.S. Food and Drug Administration. FDA Commissioner Andrew von Eschenbach has appointed me to this new position to provide leadership on strategic and substantive food safety and food defense matters. Thank you for the opportunity to discuss the important issues relating to the safety of imported food.
FDA regulates everything Americans eat, except for meat, poultry and processed egg products which are regulated by our partners at the Department of Agriculture. The agency is committed to ensuring that the nation's food supply continues to be as safe as possible. In recent years, the FDA has done a great deal to detect and prevent both unintentional and deliberate contamination of imported products though we continue to face many significant challenges to food safety, including changes in consumer expectations, changes in production, manufacturing and processing techniques, increased globalization and terrorism. One of the major issues we face is the rapidly increasing level of food imports.
Currently, FDA oversees more than 9 million line entries of imported food annually. Shipments of food represent about 60 percent of FDA-regulated imports. We're looking to enhance product safety by broadening our knowledge and applying enhanced risk-based criteria to the entire life cycle of imported products. The president in engaged directly in the effort to ensure that FDA and other agencies are doing we can to protect Americans from unsafe imports. On July the 18th, the president issued an executive order creating a Cabinet-level working group on import safety, which I'll discuss in more detail later. My priority assignment as assistant commissioner is to coordinate the development of a new food protection strategy. This will enhance our food safety and food defense systems by addressing the challenges we face.
The food protection strategy will be comprised of three fundamental elements. First, a proactive prevention strategy to build safety in from the start. Second, risk-based interventions to ensure preventive approaches are effective. And third, rapid responses when contaminated food is detected or when there's harm to humans or animals. This integrated approach will build on exiting partnerships with industry, other regulators and consumers and fully utilize our advances in technology. FDA's overall goal is to ensure a comprehensive and robust food safety and food defense program that'll provide the level of food protection that American consumers expect. With regard to imports, we need a fundamental shift from the current model that relies on snapshots at the border to a cost-effective, prevention-focused model that identifies and targets those steps in the life cycle of imported food where the risks of unsafe products are greatest.
The model's consistent with the president's Interagency Working Group on Import Safety. The working group includes members from 12 federal departments and agencies, and its mission is to review the procedures, regulations and practices under which we manage the safety of all imported consumer products. Secretary of Health and Human Services Michael Leavitt chairs the working group, and FDA plays a key role. Secretary Leavitt and Commissioner von Eschenbach have traveled extensively throughout the United States during the past few months. The insights they've gained during their reviews helped shape the strategic framework that was released by the working group on September 10th. That report outlines an approach, like FDA's food protection strategy, that's based on the organizing principles of prevention, intervention and response.
With respect to the recent well-publicized issues with regard to the safety of imported products from China, FDA is conducting a series of meetings with Chinese officials to negotiate memoranda of agreement aimed at creating a framework to help assure the safety, quality and effectiveness of products exported from China to the U.S. The agreements also aim to increase cooperation and information sharing between the regulatory bodies of the two nations with the goal of strengthening China's regulatory process.
These negotiations are ongoing with the goal of finalizing the agreements by year's end.
Ensuring the safety of imported foods is a difficult task, but I want to assure you that FDA is diligently working to efficiently and effectively use the resources and authority we have been provided by Congress to help protect American consumers.
Thank you for the opportunity to discuss FDA's activities to enhance the safety of imported food. I'd be happy to answer any questions you may have.
REP. STUPAK: Thank you, Dr. Acheson.
Ms. Glavin, opening statement, please.
MS. GLAVIN: Good morning -- good afternoon, Mr. Chairman and members of --
REP. STUPAK: You may want to pull that up. Yeah.
MS. GLAVIN: (Off mike.)
REP. STUPAK: And turn it on.
MS. GLAVIN: Thank you for inviting me. I'm Margaret Glavin. I'm the associate commissioner for Regulatory Affairs at the Food and Drug Administration.
The Office of Regulatory Affairs is the lead organization within FDA responsible for enforcing FDA's public health laws and regulations. We're guided in our mission, which is to protect consumers and enhance public health, by maximizing compliance of FDA regulated products and minimizing risk associated with those products. To meet these responsibilities, ORA is staffed with a work force of approximately 3,200 employees, 2,700 of them are disbursed geographically throughout the country.
My testimony today will discuss ORA's import operations and the tools we have at our disposal to prevent adulterated or misbranded imported goods from entering domestic commerce. I will also provide an overview of the challenges that confront us and measures that are being contemplated to enhance our coverage of imported goods.
In July when I testified before this committee, I discussed ORA's proposed transformation initiative, a component of which involved consolidating FDA's field laboratories. That effort, including the proposal to close laboratories, is no longer under consideration. What remains as relevant today, as it was in July, are the challenges that confront ORA in our efforts to fulfill our mission to protect the public health. These challenges have not gone away and are continuing to grow. For these reasons, ORA has undertaken a planning process that examines how we can meet our future needs and public health mandates.
This process, which is drawing on the experience, expertise and input of all ORA employees, will allow us to be more strategic in our efforts to ensure that we invest in the right tools, skill sets and programs to meet the challenges posed by emerging threats, ongoing public health emergencies, increasingly complex technological advances in the industries we regulate and burgeoning imports -- one of the topics this committee is addressing today.
The volume of goods offered for entry into the United States is growing exponentially and these imported products include every type of FDA regulated product and come from more than 200 countries and more than 300,000 manufacturers worldwide. As has been said many times this morning, we physically inspect less than 1 percent of the imported food that is offered for entry into the U.S. To better ascertain which food we ought to physically inspect, FDA uses a number of approaches to help us make risk-based decisions. One of these involved having FDA inspectors conduct inspections of foreign manufacturing facilities that export FDA-regulated goods to the U.S. to make certain that they are following good manufacturing processes and other regulatory requirements, such as HAZOP for seafood and juice products.
In addition, we conduct outreach to food processors and food producers in foreign countries to enhance their understanding of food safety and good agricultural practices. FDA also works with and provides training to our regulatory counterparts in foreign countries. This training focuses on U.S. public health requirements and methods to improve food safety in order to assure that exporters are able to meet our requirements. And FDA works with our foreign regulatory counterparts to share information regarding each country's laws, requirements and food safety systems ,and which also allows for notification to each other when significant violations are found.
In 2002, Congress provided us with significant new authorities to enhance the protection of the food supply through the provisions of the BT Act -- I'm sorry, the Bioterrorism Act. FDA utilizes this significant new tool provided under this act that requires us to receive prior notification before food is imported or offered for import into the U.S. Advance notice of imported food shipments allows us, with the support of Customs and Border Protection, to electronically screen the shipments for potentially serious threats to health before the food arrives, and to target those products flagged by the system as presenting the most significant risk. This allows us to conduct more intensive import security reviews on potentially high- risk entries and to allocate resources for inspections more effectively.
All prior notice data is validated against FDA's OASIS system for completeness to ensure that it meets minimal data submission requirements. Once the data is validated, it is screened against specific food security criteria established in the system to identify and flag high-risk shipments. Prior notice high-risk screening criteria are based on a number of factors, including risk assessments conducted in accordance with operational risk management and CARVER plus Shock methodologies to identify those food shipments that present the highest food security risk and are most vulnerable. Additional screening criteria are established based upon contemporary intelligence reports.
To conduct intensive manual high-security reviews, the prior notice staff utilizes information contained in internal FDA data systems, as well as those of other agencies such as CBP and the Treasury Enforcement Communication System, to further assess specific risk associated with subject food shipments -- as well as any links that parties associated with the shipment may have to terrorist organizations or criminal intelligence records. They also consider anomalies in shipping patterns and past shipped histories. Based on these risk factors, the prior notice center's staff makes the determination whether the shipment poses a significant security risk to the American public. Those shipments of imported foods that are determined to impose a significant security risk are held upon arrival in the U.S. for a joint examination by FDA and CBP personnel. Those shipments that are not deemed to be a security risk are released for an import admissibility review for food safety concerns.
Another significant provision of the BT Act provided FDA with the authority to commission CBP employees to conduct examinations and investigations of imported foods on FDA's behalf, so that they can assist us in the examination and investigation of imported food at ports of entry or other facilities and locations in close proximity to such ports. This provides FDA with operational assistance from our CBP colleagues when necessary, and has proven to be useful especially at remote ports of entry.
After prior notice requirements have been met, incoming shipments are subject to an admissibility decision as to whether or not a particular shipment of imported food should be allowed to enter domestic commerce. To make this decision, we often use targeted examinations called physical examinations or field examinations. A field examination is a visual examination of a product to determine whether the product is in compliance with our requirements, and it involves actual physical examination of the product for admissibility factors. In addition, a field exam can be supplemented with other activities such as sample collections and analyses for microbiological or chemical contamination.
When relevant product information is gathered from our domestic surveillance inspection programs, FDA factors this information into its import decision-making process. Another key tool used to screen imports is the import alert. Import alerts are used to provide direction to our field personnel indicating that FDA has sufficient evidence or information about a particular product to initially refuse admission of that article being offered for entry, without physically examining the product. This is the practice that was referred to as "detention without physical exam."
REP. STUPAK: Right. Can you summarize, please?
MS. GLAVIN: Absolutely.
As I said, we do those things. We also determine if an imported product should be denied. Once we determine that an imported product should be denied entrance into the U.S., a notice of (detention ?) and hearing is issued. We detain the goods and we allow the importer to present evidence supporting the admissibly of the questionable goods. Based upon our review of the evidence, we may release the goods, but if we maintain our position that the goods cannot be allowed admission into the U.S., the goods must either be destroyed or re-exported within 90 days.
As I described in my testimony today, we use our available tools and authorities to manage the ever-increasing volume of imported food to achieve the greatest protection possible, and ensuring the safety of the food supply continues to be a top priority to FDA.
As Dr. Acheson has indicated, FDA, including ORA, understands the need to better focus our resources to improve consumer protection in the import arena and is committed to moving toward a cost-effective, prevention-focused model that identifies and targets those steps in the life cycle of imported products, where the risks of unsafe products are the greatest.
Thank you for the opportunity to testify, and I'll be pleased to answer any questions.
REP. STUPAK: Dr. Raymond, please, opening statement.
MR. RAYMOND: Yes, sir. Mr. Chairman and members of the subcommittee, I'm very pleased to have the opportunity to appear before you here today. I am Dr. Richard Raymond, undersecretary for Food Safety at the USDA, and I'm here to discuss how the USDA regulates meat, poultry and egg products to protect American consumers.
As the undersecretary for Food Safety, I do oversee the Food Safety & Inspection Service, FSIS. FSIS is the USDA public health regulatory agency responsible for the administration of laws and regulations that are designed to ensure that the nation's commercial supply of meat, poultry and egg products is safe, wholesome and properly labeled, regardless of whether those products are sold in the United States or imported to or exported from the United States.
In contrast to the rise seen in other imported products, the amount of FSIS-regulated imported meat and poultry products has remained approximately the same in the last five years, hovering around 4 billion pounds of meat and poultry in the 33 countries that have equivalent food safety systems. In that time, the amount of imported product that was detained, destroyed or returned has doubled, as we have become more effective at what we do.
FSIS employs a comprehensive three-part system for imports that helps to ensure the safety of imported product. This system consists of, one, establishing the initial equivalence of the meat, poultry or egg product inspection system of a country wishing to export to the United States; two, verifying continuing equivalence of foreign systems through annual audits; and three, providing 100 percent reinspection, with a few exceptions, when products enter the country.
Equivalence is the foundation of our system of imports. It recognizes that an exporting country can provide an appropriate level of food safety even if those measures are different from those applied here in the U.S. FSIS begins the process of determining equivalence by analyzing the country's meat or poultry regulatory system with a document analysis assessment that the country has the laws, the regulations and the infrastructure to support an equivalence system.
This document review focuses on a country's practices in five risk areas. They are sanitation, animal diseases, slaughter processing, residues and enforcement. If the document review is satisfactory, then the process of determining equivalence moves to the on-site review.
During an on-site review, an FSIS audit team evaluates all the aspects of a country's inspection program, from the headquarters of the inspection system to regional offices and local offices, and ultimately to individual establishments within the country and the laboratories who will be testing the product that is destined for the United States.
The second part of our system is to verify continuing equivalence through audits. This means that once a country is determined to have a system equivalent to the United States system, that country is then responsible for ensuring that the entire system that it's exporting to the United States employs standards equivalent to those of the United States.
To verify that this is happening, FSIS conducts annual audits of foreign food safety systems and procedures through on-site visits by FSIS personnel, including certified establishments, laboratories, and review of the government's controls. If a country fails an audit, FSIS can, and we have in the past, suspend imports from that country, from individual plants, or for specific products.
Finally, the last part of our system for ensuring the safety of FSIS-regulated imports is verifying the continuing equivalence of foreign systems through reinspection of products at the border at our 140 import houses. It is here that the initial checks for proper documentation, evidence of tampering, transportation damage and proper labeling are conducted.
In addition to the initial reinspection of product entering the United States, FSIS then performs intensive random reinspection on approximately 10 percent of the shipments of meat, poultry and egg products. More intensive reinspections automatically apply to future shipments of product from a foreign establishment when that product fails reinspection.
Access to Customs and Border Protection's Automated Commercial Environment data base has provided FSIS with a more targeted approach to identifying and controlling ineligible entry of FSIS-regulated product that did not present to an import house for reinspection, as required, and gets closer to the entry point rather than chasing it down after it's released into commerce.
Use of the ACE data base is one of our many success stories. While the amount of imports have been stable, we have markedly increased the amount of detected ineligible product using existing personnel through a collaborative effort with our federal partners at CBP.
In fiscal year 2005, prior to FSIS's use of the ACE system, the amount of ineligible product removed from commerce that did not pass through import houses was a little over 36,000 pounds. In fiscal year 2006, this amount increased to 1.6 million pounds. And in fiscal year 2007, 2.1 million pounds was identified, destroyed or redirected to FSIS for reinspection. That is more than three Airbus 380 jetliners' worth of product in FY 2007 alone.
Our three-part approach to imports is supplemented by our critical food defense efforts that protect against accidental or intentional food contamination. Dr. Acheson has already mentioned the Interagency Working Group on Import Safety, and I will not repeat many of his comments except to say that I do represent USDA on that panel, so do have working knowledge of this product and how it's going about its business.
I would now like to take just a moment to clarify the current status regarding the importation of FSIS-regulated poultry products in China, as they requested in April 2004. As I mentioned earlier, any country can apply to be evaluated for equivalence by submitting a request to FSIS. This is exactly what happened when China requested the authority to export poultry to the United States in 2004.
After careful study, China's poultry processing inspection system was determined to be equivalent to our own. In addition, the Animal and Plant Health Inspection Service found no risk to U.S. animal health from importation of this type of product if it meets the cooking standards as approved by APHIS.
After the formal rule-making process was concluded, China was then added to the list of countries eligible to export processed poultry, but the poultry they could process would have to come from either the United States or another country that is approved to export raw poultry products to the United States. In essence, we are talking about processed poultry originating from Canada or the United States, not poultry raised and slaughtered in China.
Currently no plants from China are exporting processed poultry originating from the United States or any other country to the United States. In addition, USDA has not published a rule permitting China to export to the United States poultry that is raised and slaughtered in China.
I want to assure everyone that we do have a strong system in place for imported products regulated by the USDA. I believe that our approach to regulating the safety of imported meat, poultry and egg products is one of the best systems in the world. This is due to our rigorous three-part approach determining the initial equivalence, a continuous evaluation of that equivalence through annual audits, and our vigilant surveillance of meat, poultry and egg products entering the country.
Mr. Chairman and all members of the subcommittee, I would like to thank you for this opportunity to explain the important process that FSIS employs in protecting consumers by assuring the safety of imported food products, and I do look forward to your questions.
REP. STUPAK: Thank you.
Dr. Acheson, if I may, I'll start the questions. We heard Mr. Rice list several countries -- in fact, even Tyson Foods -- that have their own certification process in China. Why doesn't the U.S. have a certification process in China?
MR. ACHESON: There's a complex answer to that. A lot of the ground has been covered on that already earlier on. But let me try to summarize from FDA's perspective.
We are able to hold a product, inspect a product at the port of entry if there's an appearance of adulteration. That's fairly (low- bar ?). Right now we do not have the authority at FDA to require certification from a foreign country.
REP. STUPAK: Are you trying to tell me you need specific requirement from Congress to go certify farms and food producers in China?
MR. ACHESON: If we were to -- it depends what you mean by certification. If you're talking about certification as a requirement for entry into the United States, then we would need a specific legal authority to require that as a reason to refuse if it doesn't have a certification.
REP. STUPAK: So the United States -- Russia has one. Japan has one. Hong Kong has one; all of them. Are you saying they all have legislative authority to do that before they can have certification of farms in another country, to bring it in?
MR. ACHESON: I'm not familiar with the laws in Russia or those other countries. But in the United States, my understanding of U.S. law is that, yes, we would require that legal authority to put in place a system whereby we require certification of certain products from these other countries. We don't have that currently.
REP. STUPAK: Well, you talked about this import working group that's working, and you indicated the president is directly involved in it. Is certification of farms or food producing plants in other countries part of that discussion you're having in this working group?
MR. ACHESON: I think certification is part of the general discussion that's being had around, certainly with regard to ensuring safety of imported products. But as, again, has come out in the earlier panels, one of the things that we need to be certain of at FDA with regard to food safety and food defense is what does that certification mean? Simply having a piece of paper that's a certificate may not be adequate. We have to -- if we set that system up, we have to verify that that certification system is working to a level that meets the standard that we're comfortable with.
REP. STUPAK: Well, if you're not certifying -- we're only inspecting 1 percent of the food coming into this country -- we're not keeping the American people very safe, then, are we? If you're not certifying the farms, you can't certify the food coming in, you only can certify 1 percent, 99 percent is not affected, so how can you assure the American people the food they're consuming is going to be safe?
MR. ACHESON: What we are doing is we're reacting when problems occur.
REP. STUPAK: How do you react? You don't even have recall authority.
MR. ACHESON: We can undertake recalls voluntarily with the firms, and we do that on a regular basis.
REP. STUPAK: The firm has to voluntarily do it.
MR. ACHESON: Exactly. But what we recognize is that there is a need to build prevention in up front. That is where we're headed. That's part of --
REP. STUPAK: Well, for prevention up front, wouldn't you want to certify the farm or the processing plants that's processing the food before it comes here? Isn't that really the first up-front line of defense you could have?
MR. ACHESON: You certainly need to ensure that the product is being manufactured safely, whether it be domestically or from China or India or wherever. Certainly requiring certification is an option that's under consideration. It's part of that process.
REP. STUPAK: Well, let me ask you this. The produce industry has called on the FDA to enact tough new regulations regarding the handling of fresh produce. However, the FDA has not done this. And right there is the exhibit book, exhibit number 20, an article from The Wall Street Journal in February, "Health and Human Services officials rejected the FDA's plan for tough new regulations on the handling of produce." Is it true that the FDA sought mandatory regulations but were overruled by HHS?
MR. ACHESON: I wasn't part of that particular meeting, but my understanding of that was that the FDA did not take a request for specific mandatory regulations to HHS.
REP. STUPAK: What did they do with them? The produce industry has been calling for you to do it. According to news reports, FDA brought it to HHS. So that's not true; they never brought it to HHS?
MR. ACHESON: Those earlier meetings with HHS were high-level discussions around food safety in general. At that time -- that was fairly recently after we'd had the spinach --
REP. STUPAK: I'm talking about produce --
MR. ACHESON: Produce -- (inaudible) -- yes.
REP. STUPAK: Right.
MR. ACHESON: But it was not a specific request for authority that was ultimately turned down.
REP. STUPAK: So it was ultimately turned down.
MR. ACHESON: No, I said it was not a specific request for authority that was turned down.
REP. STUPAK: So you had high-level meetings. What came of the high-level meetings -- anything?
MR. ACHESON: Absolutely. Part of those high-level meetings was a recognition that we needed to step up and do different things to face these new challenges. That's one of the reasons why Commissioner von Eschenbach created my position and instructed me to develop the Food Protection Plan, which we're working on, which I anticipate will be launched sometime within the next month or two.
REP. STUPAK: What can you tell us in this committee that's going to be preventive so we can prevent the action of people getting sick, like on E.coli? And again, I agree it came from spinach from the Salinas Valley, the hearings we've had on it. But what are you doing to prevent that?
MR. ACHESON: There's a number of things. I mean, to put preventive strategies in place, you've got to understand what caused the problem in the first place. Again, as had been alluded to earlier, the close proximity of cattle to spinach fields may be a problem.
REP. STUPAK: And that's been going on for 10 years. We've had 20 outbreaks and the FDA has done nothing to prevent the cattle from polluting the water so it doesn't go in the spinach fields. So where's the preventive action here? You haven't even done an epidemiology study to figure out where it's coming from.
MR. ACHESON: What you're alluding to there is the need for basic science to put those preventive strategies in place. That's not all there.
REP. STUPAK: Well, if we don't have basic science, how are we going to have advanced science to inspect food?
MR. ACHESON: You need the basic science principles to understand how E.coli gets onto spinach in the first place. Yes, we know it's in cattle. But is it coming by the water, by wild animals?
REP. STUPAK: That's why an epidemiology study would determine that, would it not?
MR. ACHESON: Epidemiology --
REP. STUPAK: Twenty outbreaks in 10 years and you still haven't determined that. You haven't even requested an epidemiology study, have you?
MR. ACHESON: We certainly recognize there is the need for that science, and we have --
REP. STUPAK: So are you going to recommend an epidemiology study for Salinas Valley, the salad bowl of America?
MR. ACHESON: What we're going to do is focus more than on leafy greens in Salinas Valley. There's a need for more science.
REP. STUPAK: Right. But are you going to ask for an epidemiology study to try to get down to the source of E.coli bacteria which pollutes the Salinas Valley, which ends up in 20 outbreaks in 10 years?
MR. ACHESON: You're absolutely right. One of the key questions is to answer that. An epidemiology study is maybe a mechanism to get to that. How does the E.coli get from the cattle to spinach? It's a key question, no doubt about that.
REP. STUPAK: Key question -- when are you going to study it, do an epidemiology study?
MR. ACHESON: The Food & Drug Administration is not a research agency. We've collaborated with --
REP. STUPAK: I'm not asking you to research. Don't you have to have the study be done?
MR. ACHESON: We do not -- FDA doesn't have the resources to require that study. But we certainly have put out, through our research colleagues --
REP. STUPAK: Well, you've been a drug czar for some time now. Have you asked for money to do an epidemiology study? Have you asked for more money from the OMB to do an inspection?
MR. ACHESON: As part of the budget process for 2009 and the rolling out of the food protection plan, we've recognized that in order to get where we need to go, we will be needing new research, yes. That is part of the ongoing process. And that --
REP. STUPAK: So you haven't asked for it yet, but you think you will in '09?
MR. ACHESON: That budget process has to follow its tracks. And we recognize that that's just the way the system is set up.
REP. STUPAK: I'm over my time. I'll turn to Mr. Whitfield for questions. And I'm sure we'll have another round of questions here.
REP. WHITFIELD: Thank you, Mr. Chairman.
And Dr. Acheson, you and Ms. Glavin both have responsibility for protecting the food supply in the U.S, which is an awesome responsibility. And with your expertise and with your experience, with that responsibility, what concerns you most from your position about guaranteeing the safety of the American food supply? What are two or three things that concern you the most?
MR. ACHESON: I think the principal concern is to move away from a reacting situation and responding to outbreaks when somebody's sick to building in safety up front, whether that be domestic, as we've just been discussing with regard to spinach, or whether it be from an imported product.
I believe the key to success is to build in preventive strategies at the manufacturing level right up front, wherever that's happening, domestic or foreign.
REP. WHITFIELD: Okay. Now, what kind of progress are we making in doing that?
MR. ACHESON: The progress that we're making is determining what would be steps to get there. That is a significant part of the food protection plan that we're talking about -- shifting emphasis into prevention, yet maintaining inspections, focused on risks. Again, the prevention has to be focused on risks, and building a more robust response system. We do respond well already, but I would be happier if we were even faster, getting a handle on illness quicker, getting it off the shelves faster, protecting humans.
REP. WHITFIELD: So one thing, then, is going from a reactive to a more preventative (APHIS ?). And we're not there yet. What is the second thing?
MR. ACHESON: Well, I've summarized that with the focused risk- based inspections. We need to continue to inspect, obviously. But those inspections need to be focused in the areas of greatest risk. And as part of that, which is the third point, is the need to integrate that with modern technology, not just information technology, which is critical, especially in the area of imports, of getting better, faster systems to integrate the mountain -- the ever- increasing amount of information, but also detection technology. We need to be able to detect problems in foods faster, hopefully in a matter of hours as opposed to days. So we need to build those in as well.
REP. WHITFIELD: Well, I noticed that the largest import refusals come from Mexico, China and India. And so how often do we send inspectors to those countries to look at their facilities, or do we?
MR. ACHESON: We, I think, in the last year -- and my colleagues can give you the specific numbers there -- but it's the order of 100 to 150 foreign inspections that we've done. We can certainly provide you information on which countries that we have been to.
REP. WHITFIELD: Now, are budgetary concerns an issue there or not?
MR. ACHESON: Well, certainly the amount of inspections that we do, both domestically and foreign, are limited by resources.
REP. WHITFIELD: And what is the overall budget for your area of responsibility?
MR. ACHESON: Within food, it's about $400 million I believe. I certainly can get you the exact number --
REP. WHITFIELD: Four hundred million? That doesn't very seem like very much for the -- and what is the total FDA budget? Do you all know that?
MS. GLAVIN: Around 1 billion.
MR. ACHESON: It's about $1 billion for the total FDA budget.
REP. WHITIFIELD: Not a lot, really.
MR. ACHESON: Two billion -- I'm sorry, I'm not familiar with these numbers. We can get them to you for the record.
REP. WHITFIELD: Well, let me ask you another question. If February 2006 FDA had information in hand from PREDICT that other foreign countries, particularly Canada and South Korea, had banned the import of Chinese eel because of the presence of malachite green. Now, that was in February 2006. FDA did not issue import alert on Chinese eels until around November 2006 -- some six, seven, eight, months later. Why did it take so long for FDA to issue an import alert in that situation?
MR. ACHESON: Again, I have colleagues who could speak more to the specifics of an import alert but let me try to summarize it. In order to issue an import alert we have to have the data to show that we can do it, which essentially means demonstrating through a sampling strategy that there is a level of contamination in a certain product of concern -- in this case eel, with a certain agent, malachite green -- that is of sufficient degree to pose a problem and of sufficient extent to issue a countrywide alert.
What we have done when we see problems with individual companies is we can issue an alert very quickly. We did that with melamine. Two companies were of concern. The import alert for melamine for protein concentrates was issued in a matter of weeks in that situation. But the malachite green required more testing to get to the point you could say this is a countrywide issue, it's not just one or two firms that are causing the problem.
MS. GLAVIN: We also had people from the Center for Food Safety in China trying to gather that information and trying to get information and data on the extent of the problem, which helped us in putting that import alert out.
REP. WHITFIELD: Let me just ask one other question now that my time's expired, but why do you refuse to acknowledge China's certificate of export?
MR. ACHESON: It's not that we're refusing to acknowledge it. My point is that we cannot require it as a condition of entry into the United States.
REP. WHITFIELD: So legally you cannot require it?
MR. ACHESON: Legally we cannot say that that is a requirement and without it we would refuse entry.
REP. WHITFIELD: Okay. Okay.
Thank you.
REP. STUPAK: Mr. Melancon for questions.
REP. MELANCON: Thank you, Mr. Chairman.
Ms. Glavin, you talked about high-risk food shipments. I guess -- focusing on that is, what's a high-risk food shipment? Does somebody have to be critically ill or die or what triggers you to --
MS. GLAVIN: Okay, okay. There's a large variety of factors. If we're talking about food safety, the factors would be things like, what is the food -- certain foods are inherently more risky than others. Where is it coming from? Is it coming from a country where we have a history of problems? Is it coming from a manufacturer where we have a history of problems? Do we have any data that shows that there are illnesses connected with that product? So there's a variety of things that -- it's not a static piece of information.
A number of you have mentioned a new system that we are piloting at one port right now and that's the PREDICT system which is a system that is designed to in real time take the information we have and make -- help us make decisions in real time about what we should look at and what we can let go through without a physical examination.
REP. MELANCON: You talked about the department had different authorities, some that may be new, some that may you use -- and how many times has the department implemented any of these authorities in recent times?
MS. GLAVIN: I'm sorry, I don't understand the question.
REP. MELANCON: Well, you talked about -- during your testimony, you talked about these different authorities that the department had. And I'd have to go back --
MS. GLAVIN: Okay, so --
REP. MELANCON: Most of them are acronyms.
MS. GLAVIN: Well -- I'm sorry. I do use acronyms. I apologize.
There are two issues with respect to food -- there are two different kinds of things that we do. The first one is unique to food and that is we look for -- we have a specific responsibility to look for evidence of bioterrorism, intentional adulteration or tampering of food. And that's done in conjunction with CBP; it's done on all food coming into the country. All food coming into the country has to -- we have to be notified before it can enter the country so that we can do that screen.
The second screen -- if that screen is passed and it, thank goodness, usually is -- the second screen is our food safety screen. And that's where we look for food safety problems and look -- but that's the second set of criteria that are used that are specific to safety not to the security side. And that would include things like the type of food, where it's sourced, where the -- what the company history is, what the history of the importer is, et cetera.
REP. MELANCON: When you get a product that comes in, has no certificate, shouldn't that be a flag that we ought to be testing that food immediately?
MS. GLAVIN: Well, not all countries have certificates so -- but if a country offers a certificate, we certainly can consider the lack of a certificate, if a certificate is available, as one of the factors. What Dr. Acheson was saying is that we can't use the lack of a certificate as the sole reason for denying admission.
REP. MELANCON: Why can't we require a certificate on all food products?
MS. GLAVIN: We don't have that authority.
REP. MELANCON: USDA, you have the authority.
MR. RAYMOND: Federal Meat Inspection Act and the Poultry Products Inspection Act gives us the authority and requires us to determine the country has an equivalent food safety system.
REP. MELANCON: So I guess the question is, has anybody asked for that authority over at FDA?
MS. GLAVIN: I'm not aware that they have.
REP. MELANCON: We know we've got a problem; nobody wants to say, maybe you all need to help us give us the tools.
MR. ACHESON: Let me respond to that. We certainly recognize that we've got challenges, and I've acknowledged in my testimony that part of the food protection plan that we're developing is to address those very challenges that we're discussing today.
REP. MELANCON: I mean, the large quantities of commodities that come in -- and of course maybe it's easier or harder, I'm not sure -- USDA has the ability, maybe FDA needs to be talking to them about how to monitor this stuff and get it done. And somebody needs to say to the Congress, "Look, we've got a problem" -- food safety and other issues that are coming in that are creating problems.
And in this day and time I find it difficult, especially after I've been though two years of excuses from FEMA and other agencies about why they haven't done anything.
As a member of the bureaucracy that's supposed to be trying to protect America, tell us what we need to do. Don't come here and give me an excuse about why we can't do it. I can find excuses not to do it. FEMA's got a great agency for telling how to do that.
So where I am and I think where we're trying to come from is I don't want to continue to see food products come into this country -- and I've said this on many occasions, we've got the dumbest system in the world for negotiating trade deals. It's give them anything they ask for, don't check what comes in and just, you know, go about your business and -- it's not a good system. One person negotiates a deal and then nobody's back here to follow it up.
Shouldn't you be talking with USDA and saying, "Look, we need food safety; we need country of origin; we need labeling; we need certification." If we're going to protect Americans, shouldn't you as the protectorate of the food supply be asking for that authority or that in those trade deals or that of this Congress?
MR. ACHESON: Again, I find I'm repeating myself. I mean, I agree with everything you're saying. And our mission is to protect the public health at FDA. That's what we're about. And part of -- describing of my job is regards to food safety and food defense. And that's critical.
The plan that I -- that I keep mentioning is getting into the throes of clearance, and I would look forward to bringing that to this committee or to use it personally in saying here's where we think we need to go, and let's have a dialogue and establish a partnership in terms of -- of whether the feeling is that this meets the needs.
We recognize we've got challenges. We recognize we need to make changes and we need a new approach. And that is exactly what we're working on. We're -- we're just not quite at the point yet where -- where this is out for public viewing.
REP. MELANCON: My time's run out.
REP. STUPAK: Thank you, Mr. Melancon.
Mr. Burgess for questions, please?
REP. BURGESS: Thank you, Mr. Chairman.
Dr. Acheson, thank you for being with us today. Dr. Raymond testified -- or in his written testimony has a much more eloquent definition of equivalence than I used when I spoke a little earlier. Would -- why doesn't the FDA have a similar program of that equivalence concept that the USDA uses?
MR. ACHESON: There's two answers to that, at least, if not more.
REP. BURGESS: Give me the short answer. And I'm actually going to submit this for a written response, because I think it deserves a written response. But let me just ask you to please make that timely. We have been working with -- and make no mistake, you know, I love the FDA. I love everything you do, but you guys are slow when it comes to getting responses. So give me the short answer on equivalence, and then I really would appreciate a much longer written response.
MR. ACHESON: The short answer is authority and complexity.
REP. BURGESS: The authority being -- you don't have the authority and you need us to give you the authority legislatively?
MR. ACHESON: We don't have the same authority that -- that USDA has.
REP. BURGESS: You need that from us in legislation, is that correct?
MR. ACHESON: Well, in order to set up an equivalent system.
REP. BURGESS: Are you asking us for that authority?
MR. ACHESON: I am not asking you for that authority. I'm answering your question as to why -- why do we not have it.
(Cross talk.)
REP. BURGESS: Well, and I think it would be a good idea if you had it, so if I want you to have it, then we need to write you the legislation that gives you the authority to have it?
MR. ACHESON: I think that leads into my second answer, which is complexity.
REP. BURGESS: But before we get into complexity, let me just ask the other question. Would you use it if we gave it to you?
MR. ACHESON: Within the confines of complexity, you've got to look at whether it's usable.
REP. BURGESS: I was hoping to stay away from complexity for just a moment.
MR. ACHESON: You cannot -- you cannot disassociate the two.
REP. BURGESS: Would you use -- would you use it? Would it be a useful tool? Would it be part of your armamentarium that you could go forward and provide the protection that Mr. Melancon so eloquently requested of -- of your agency?
MR. ACHESON: If equivalency was applied uniformly to all countries, to all products that FDA regulates, it would, frankly, be crippling.
REP. BURGESS: Crippling in the fact that we would have such an enormous bureaucratic burden we could never surmount it?
MR. ACHESON: In many ways. We're talking about 200-plus countries, hundreds of products --
REP. BURGESS: Is there a way -- is there a way to develop a program of equivalency that has the proper safeguards and parameters and boundaries so that it is not crippling but at the same time provides a base coat of safety that we can once again assure the American people that we're doing? Because they don't believe us right now.
MR. ACHESON: I -- I think with adequate resourcing of both finance and brainpower to figure it out --
REP. BURGESS: Okay -- (inaudible) -- forward. Does -- have you reviewed the legislation that's been put forward by Chairmen Dingell?
MR. ACHESON: Yes.
REP. BURGESS: Does the resourcing present in the legislation put forward by Chairman Dingell, does that provide an adequacy of resources for you?
MR. ACHESON: It's more than just money. To sort out all of these issues of -- of the complexity, and I apologize that I keep coming back to that --
REP. BURGESS: And that's where -- that's where I want your written response, because I know that's important. I'm not -- I'm not trying to ignore it.
MR. ACHESON: That -- that is where it gets complex, because we're not just talking about meat, poultry and egg products; we're talking about hundreds of different FDA-regulated commodities with many, many different standards in different countries. And developing that level of equivalency would be unbelievable complicated.
REP. BURGESS: So again, I do look forward to a timely written response. We will phrase that as a written question. And Mr. Chairman, I really do want to see the response to that, because I think it has to be part of our discussion when we craft this legislation.
Let me just ask you in the little time I have left, were you astounded by the response that if someone is up there checking for their own product in another country and they find something really bad, they don't feel obligated to disclose that to any of the regulatory agencies that are also charged with protecting food safety?
MR. ACHESON: As a person who spent many years in clinical practice as a physician, it worries me that there may be problems out there that we can perhaps do something about and don't hear about it, but that's a business decision. It's not a requirement.
REP. BURGESS: And that -- a business decision, to be sure. But do you have any -- with your regulatory authority, do you have the ability to go in and assess the quality control measures that are being used by a private company that is then importing to the United States, whether it be an American or a foreign company? Can you go in and look at their quality assurance methods to make sure they're up to snuff? We talked about the statistical tests before. Do you have the authority to do that and, if so, would you find such a problem with the analysis of just the quality assurance, or do you need another method of getting that information?
MS. GLAVIN: With respect to food, sir, the -- we have -- we do not have the authority to mandate a foreign -- an inspection of a foreign firm if they choose not to have us come.
REP. BURGESS: Well, I don't mean to interrupt, but I'm just astounded by that. So if a private company that's importing poultry to this country says, "Whoa on this shipment. We've got polonium under the chicken wings," we're not going to bring it in, but we just don't say anything about it?
MS. GLAVIN: Well, poultry is under the USDA -- (chuckles). But if it was peaches, yes.
REP. BURGESS: Okay. Well, then say it was -- if it was, well, whatever. Shellfish or whatever. If you found a problem of that order of magnitude, which to me means bioterrorism, would you not have authority under the Bioterrorism Act to -- to require that information be given to you?
MS. GLAVIN: If we had information, absolutely.
REP. BURGESS: But if they have information and they just choose not to tell you, it's a business decision because they don't want to irritate the People's Republic of China. That's okay?
MS. GLAVIN: Well, I'm not saying it's okay. I'm saying that we don't have the authority to mandate that they give it to us.
REP. BURGESS: And that would be the situation. If they -- if they said, "Well, we just don't want to irritate our hosts so we're not going to give you that information," that's what would happen?
MS. GLAVIN: That's right.
REP. BURGESS: And so we, as we sit up here on this dais attempting to assure the American people we're providing oversight, we've really got no mechanism to go back and -- and check that. Is that correct?
MS. GLAVIN: On that --
REP. BURGESS: I mean, this gets back to Mr. Melancon's questions about the trade agreements. And I realize it's out of the purview of this committee and this argument, but -- but clearly that's a -- seems to me that's a gaping hole that's got to be closed. Or -- or am I missing something?
MR. ACHESON: I think in the context of -- of foreign companies, you're correct. And Ms. Glavin's pointed out we don't have the authority to do that.
REP. BURGESS: Do you agree that that's a potential liability for us, a potential vulnerability for us?
MR. ACHESON: It's one of the areas that we -- that we're considering in the -- in the food protection plan is what do we need to do to address those kinds of gaps?
REP. BURGESS: Well, and I'm not one that normally eats Chinese eels and I don't intend to ever begin, but just the whole story with the malachite green stuff is a little disturbing, that you found the problem and it took so long to control the problem. What if it were something much more serious? When I say serious, i.e., involving a food that I might eat. (Laughter.)
MR. ACHESON: If it was food you were eating, we'd be right on it, I can assure you.
No -- a serious point. We did react very quickly when we had issues with melamine. That was in a matter of days or weeks, once we knew there was a problem.
REP. BURGESS: And I would submit that I don't know that we -- we really know when that problem began. I mean -- just uncorroborated testimony from veterinarians back in my district, boy, we were losing a lot of pets, and we didn't know why. And that worries me, because I don't -- again, I don't --
And it comes back to the point if someone knew they were grinding up countertops and putting them in our dog food, they've got to be -- they've got to -- they've got to tell you that so you know to look for it. Someone has to -- somewhere along the line, there has to be some responsibility of the companies that are -- that are providing imports into this country or they lose their license, I think. Just my opinion.
Mr. Chairman, I'll yield back. I know I've gone over.
REP. STUPAK: Well, thank you. I'm sure we'll go another round or two at least with this panel.
You mentioned melamine. That was Customs Border Patrol that stopped melamine. It wasn't FDA.
MR. ACHESON: No. It was FDA who issued the import alert.
REP. STUPAK: It was -- boy, we had a hearing on -- that it was Customs Border Patrol that was stopping melamine before FDA ever got around to it. Even after the FDA got around to it, it took your lab like 48 hours to -- to discover the melamine, because it didn't know what it was looking for, right?
MR. ACHESON: No, I beg to differ. It was -- it was FDA who -- it was FDA labs who identified that it was indeed melamine.
REP. STUPAK: Right, 48 hours.
MR. ACHESON: And then it was FDA --
REP. STUPAK: And that was the lab you're going to close.
MR. ACHESON: And then it was FDA that sent out the import alert. We then worked with Customs and Border Protection to put that into practice.
REP. STUPAK: Okay. When is this plan going to be done? You keep talking about this plan you want. When is it going to be done?
MR. ACHESON: As soon as possible.
REP. STUPAK: And that means what?
MR. ACHESON: I would anticipate -- and as I told -- as I said earlier, it's in high levels of clearance within our department right now, within HHS and I --
REP. STUPAK: So when do you anticipate it's going to be done?
MR. ACHESON: I hope within the next two to three weeks, we will be able to get this out.
REP. STUPAK: Okay. And are you going ask for an equivalency standard like the USDA has in this plan?
MR. ACHESON: How it would -- the specifics of our plan are still under discussion with our department. I can't get into the specifics of what may be in there at this point.
REP. STUPAK: Why can't you get into specifics of it?
MR. ACHESON: Simply because it's not been cleared by my administration.
REP. STUPAK: So who's the administration? The White House or HHS?
MR. ACHESON: It's both.
REP. STUPAK: Okay. So you're getting pressure from the White House and HHS to do certain things in this bill?
MR. ACHESON: I didn't say we were getting pressure. I said --
REP. STUPAK: No, I did.
MR. ACHESON: No, I'm not getting pressure.
REP. STUPAK: You're not getting pressure.
MR. ACHESON: But there is a required -- there's a required process of clearance and it's just not completed.
REP. STUPAK: Has the -- does the FDA require additional legislative authority to apply HACCP requirements to all domestic food producers and processors like we have for juice and seafood?
MR. ACHESON: Well, as you've just acknowledged, we have put out HACCP requirements for two products --
REP. STUPAK: For juice and seafood.
MR. ACHESON: Right.
REP. STUPAK: So do you require further legislative authority to do all domestic food producers and processors is my question. Do you require additional authority or can you do it underneath the existing HACCP authority since you've done it for juice and seafood?
MR. ACHESON: I'd have to seek a legal answer to that and I'm not an attorney, but my understanding of that is if we've done it for two, we could potentially do it for more using that same approach.
REP. STUPAK: Sure. Why wouldn't you, then -- use those requirements, make American consumers safer? You did it for juice and seafood. Why won't you do it for the rest?
MR. ACHESON: As I've said, I believe that we do need to be seriously looking at putting in preventative controls, and using a HACCP-type approach is potentially a way to do that.
REP. STUPAK: You indicated to Mr. Burgess you need more resources. We indicated the Dingell/Pallone/Stupak bill which is currently pending, which would generate $50 a line or almost up to $600 million a year for food. Would that be adequate resources?
MR. ACHESON: It would certainly help.
REP. STUPAK: But would it be adequate?
MR. ACHESON: Adequate to do what?
REP. STUPAK: Well, that's to provide food safety -- to inspect the 99 percent we're not inspecting.
MR. ACHESON: No. No. If the goal is to inspect 100 percent --
REP. STUPAK: The goal isn't 100 percent -- or is that going to be the goal of your plan, 100 percent?
MR. ACHESON: No, no, no.
REP. STUPAK: Is there a percentage your plan indicates?
MR. ACHESON: No, because simply throwing more money at this to do more inspections is not a solution.
REP. STUPAK: I agree.
MR. ACHESON: What we've got to do is we've got to do smart inspections, and that means the risk and it gets back to your earlier point.
REP. STUPAK: Well, let's go back to the Dingell legislation. Has the FDA taken a position on the Dingell legislation?
MR. ACHESON: Not that I'm aware of.
REP. STUPAK: Has the FDA taken any position on any of the bills that have been introduced for the last 10 years on food safety? Have you taken any positions on them?
MR. ACHESON: I would have to get back with you with what the official positions are on any of those previous bills. They predate my time in this position.
REP. STUPAK: Okay. Ms. Glavin, do you know?
MS. GLAVIN: I don't know. Sorry.
REP. STUPAK: I can tell you, I wrote the first one in 1998 and we're still waiting for an answer. So I hope your plan's not going to be 10 years.
Let me ask you this. What specific requests have you made in terms of resources from either the commission -- from the commissioner or Office of Management and Budget? Have you made requests to them for more money or resources or inspections, for overseas work?
MR. ACHESON: We've made requests through the 2008 budget process for an increase in --
REP. STUPAK: And how much was that increase?
MR. ACHESON: I think it was about $10 million or thereabouts, was that required --
REP. STUPAK: And what was the $10 million going to be targeted for? Hopefully not bonuses.
MR. ACHESON: It was -- I know a portion of was research. I think --
MS. GLAVIN: Some for foreign inspections.
MR. ACHESON: Yeah, some for foreign inspections. Again, for the record, I could get back to you the breakdown exactly of what the 2008 budget request was.
REP. STUPAK: Let me ask you this. Do you support recall authority to be given to the FDA, Dr. Acheson?
MR. ACHESON: We've managed for years without it and I believe that we have an effective system. It is certainly one more tool in the toolbox that could potentially be used in certain situations.
REP. STUPAK: So are you -- do you support recall authority for the FDA?
MR. ACHESON: Are you asking me personally?
REP. STUPAK: I'm asking you first of all as a drug czar.
MR. ACHESON: Food czar.
REP. STUPAK: Food czar, okay. We'll get to drugs next week -- November 1st.
MR. ACHESON: As I've said, I believe that it could be a tool in the toolbox that could, under certain situations, expedite recalls. Since I've been working at FDA in this role for --
REP. STUPAK: So what do you want? Do you only want recall authority for certain types of food or what?
MR. ACHESON: To me --
REP. STUPAK: I mean, why would you be opposed to the recall authority, let me put it like that.
MR. ACHESON: I'm not opposed to it. I'm simply --
REP. STUPAK: You're saying only in certain circumstances. I mean, you've got to have the authority before you can use it. Just because you have the authority doesn't mean you'll use it.
MR. ACHESON: Right.
REP. STUPAK: So you can use it where you want.
MR. ACHESON: No, I'm not --
REP. STUPAK: You can't use it if you don't have it.
MR. ACHESON: I'm not opposed to us having that authority at all.
REP. STUPAK: Okay, good.
Let me ask you this. You said that your group is looking at a proactive, risk-based and rapid response. Correct?
MR. ACHESON: Correct.
REP. STUPAK: Okay. Proactive. Explain that. In what way are you going to be proactive?
MR. ACHESON: That's getting back to the prevention issue. What we've got to do is we've got to build safety in right up front with the manufacturer, at the processor so that what's being done at the manufacturing level is building preventative controls in up-front as opposed to reacting to them when we get illnesses.
REP. STUPAK: Sure. I agree with that.
So let's go back to certification -- let's say, like in China, the farms and the plants or food processing place if that's going to be proactive. And even the president's fond of saying, "We have to fight terrorism overseas so we don't have to fight them on our own shores." So why don't we have that same attitude when we have to fight food safety issues instead of waiting for it to arrive in America? How come we're not being proactive in taking it overseas? Instead, we allow 99 percent of the food to come in without ever being inspected.
MR. ACHESON: That's exactly what we're proposing to do.
REP. STUPAK: Really?
MR. ACHESON: That's part of --
REP. STUPAK: How's your -- is it in your proposed certification of --
MR. ACHESON: No, no. What you're alluding to is pushing the borders out.
REP. STUPAK: Correct.
MR. ACHESON: What we're trying to get away from is this snapshot at the port of entry where we make a determination based on the information that we receive.
REP. STUPAK: And how are you going to get it overseas?
MR. ACHESON: How?
REP. STUPAK: Yeah. How are you going to be proactive overseas? Are you going to assign inspectors overseas in countries?
MR. ACHESON: There's a number of avenues that we can take. One is to have a greater foreign presence physically from FDA --
REP. STUPAK: Is that one something you're going to recommend?
MR. ACHESON: It's certainly one of the possibilities that we're looking at.
REP. STUPAK: Okay.
MR. ACHESON: The second is to develop memorandas of agreement with foreign governments and to work with foreign governments, and as part of that to get a better insight into the processes and standards that are occurring in foreign countries, particularly in the countries that we have concern about with regards to its safety. And then the second part is working with industry in terms of working with them to look at their processes, their data in terms of what they're doing in foreign countries to help determine relative risk of the product coming into the United States.
I don't know whether you've got something to add to that.
REP. STUPAK: All right. My time's up.
Mr. Whitfield for questions.
REP. WHITFIELD: Just one other question I want to ask Dr. Raymond.
Dr. Raymond, the Food and Drug Administration has a list of -- in their regulations, they have a list of drugs and they say, "If one of these drugs is present in an animal that is to be slaughtered for human consumption, then it's disallowed." And at a time when they were slaughtering horses in the U.S., even though that meat was being exported to other countries, about four of the listed drugs were specifically used by -- in animals that were used in horse racing. And it was a common drug and a significant number of these horses that were slaughtered were race horses. How do you ensure that those drugs are not present when the animal is slaughtered?
MR. RAYMOND: We do -- part of our regular testing is testing for residues. I don't know that I could answer your question that we'd know which --
(Cross talk.)
REP. WHITFIELD: But how --
MR. RAYMOND: -- Were slaughtered, but we tested them --
REP. WHITFIELD: Yeah.
I was told that not every animal was tested and --
MR. RAYMOND: That would be correct.
REP. WHITFIELD: That's correct.
So there is a likelihood that the -- I mean, like -- fortunately it's not consumed in the U.S., but it was going to Europe and Japan. And these drugs -- many of them as a matter of course are given to animals that race. So they are in there, so there's a likelihood that a lot of the meat going abroad had a prohibitive substance in it, I would say.
MR. RAYMOND: I would think that a lot of the drugs that you're referring -- I don't know the exact ones, of course, but they're probably things were -- that were used to treat ailments like a tender knee or something like that, like an anti-inflammatory drug that made be in the system for a very short period of time. And most of the horses that would go to slaughter were horses that have long sinced racing and they may not be taking those drugs, and they're probably not drugs that stay in the meat.
REP. WHITFIELD: Well, yeah. But some of them haven't been off the track long when they're slaughtered. Okay, but you've answered the questions, so thank you very much.
REP. STUPAK: Let me ask a few more questions, if I may.
Ms. Glavin, you made mention of the detain-without-physical- examination alert, that food products are actually delivered to the importer premises, correct?
MS. GLAVIN: That's right.
REP. STUPAK: And isn't it also true that the importer may obtain a private lab certification that the product is not in violation?
MS. GLAVIN: Well, when something is detained without physical examination, it is the importer's responsibility to demonstrate that the product should be admitted and --
REP. STUPAK: And the way they do that, they go to a private lab to show that the food --
MS. GLAVIN: That is one way they can do it, yes, sir.
REP. STUPAK: Okay. Does the FDA -- may the FDA audit the private laboratory results?
MS. GLAVIN: We have no regulatory authority over the labs themselves. We certainly look at the lab worksheets in determining whether or not we're going to accept those results.
REP. STUPAK: So you can't even audit the lab?
MS. GLAVIN: No, we do some audits, but we have no regulatory authority over those labs.
REP. STUPAK: Do you want regulatory authority over the labs to certify these labs are doing the testing?
MS. GLAVIN: I think that would be something very interesting to look into, yes, sir.
REP. STUPAK: Not interesting. Would you like that authority, as part of the Dingell bill, certification of these labs? There's no certification of these labs, is there? There's no FDA inspections to make sure they're doing the testing properly.
MS. GLAVIN: That's right.
REP. STUPAK: And you've heard testimony here today and we've had it this morning that basically, if you don't get the test result you want, you can come put it in the garbage can; you get another test until you get the one you want. Isn't that sort of what's being said around about these private labs?
MS. GLAVIN: I have heard that said, yes, sir.
REP. STUPAK: So wouldn't it appear that you'd want to certify these labs to make sure that the test results are accurate before we allow this food out in mainstream commerce?
MS. GLAVIN: I think that would improve the system. It would also be a resource concern.
REP. STUPAK: A resource concern. You mean, inspection of these labs?
MS. GLAVIN: Yes, sir.
REP. STUPAK: Have you ever asked for any money to hire inspectors to inspect the labs, certify labs?
MS. GLAVIN: I'm not aware that we've ever asked for that.
REP. STUPAK: Okay.
Dr. Raymond, if I may, recently the USDA announced recalls of two brands of ground beef. In one of those cases, it took the USDA 18 days to recall the product after learning about its potential health hazard. Why did it take so long?
MR. RAYMOND: In that case we had one illness, one person. Cultures from that person's stool did grow out E.coli 15787. That person had consumed frozen hamburgers from their refrigerator, from the freezer. We went and got the remaining hamburgers that were in a box that had been opened and tested 13 tests. Two of them did turn out positive for E.coli 15787.
At the same time, we went out and obtained product that was still in closed, sealed boxes so there would be no risk of having been tampered with, as is routine and normal for us. And all of those samples tested negative. So we had no rock-solid concrete proof to say that that contamination of the young lady occurred from a product that was contaminated in the plant. And at that time, with just one case, we didn't feel we had the legal standing to go do a recall.
The recall, when it did occur 18 days later, was because of other illnesses that had eaten product that had been produced prior to that product that we're talking about. So I'm trying to say, not defensively, but a recall in seven days after we found out would not have prevented any other illnesses. But it took the other illnesses to line up everything to say, beyond the shadow of a doubt, it came from that plant on this production date. And that's when the recall was initiated.
REP. STUPAK: Does USDA have recall authority? Do you have to work with the producer?
MR. RAYMOND: We work with the producers.
REP. STUPAK: So you don't have recall authority either?
MR. RAYMOND: We can seize and detain, but we cannot recall.
REP. STUPAK: Okay. You indicated that under your equivalency standard, you have 33 countries that allow -- they ship food into here because they have equivalent standard to ours?
MR. RAYMOND: Yes, sir.
REP. STUPAK: Okay. Does the Department of Ag limit the number of ports in which USDA-regulated products can be brought into the country?
MR. RAYMOND: Mr. Chairman, we don't limit the ports, but all product has to go through one of our import houses. So it can come through a port where we don't have an import house, but it will have to be moved by truck or rail to an import house.
REP. STUPAK: How many import houses do you have, then?
MR. RAYMOND: There's about 140.
REP. STUPAK: Okay. And I take it they're in close proximity to some of the main shipping ports?
MR. RAYMOND: They are all either at water ports or on cross- border crossings, yes.
REP. STUPAK: Ms. Glavin, how many ports does the FDA allow food to come into?
MS. GLAVIN: Food can come into any U.S. port. FDA-regulated food can come into any U.S. port.
REP. STUPAK: Any port.
MS. GLAVIN: Yes, sir.
REP. STUPAK: How many ports are there in the United States that --
MS. GLAVIN: I believe there are in excess of 300.
REP. STUPAK: Okay, do you have import houses or anything where you limit --
MS. GLAVIN: No, we have inspectors at approximately 90 of those ports.
REP. STUPAK: So if there's 300 and some and there's 90, so one- third at best you have inspectors at?
MS. GLAVIN: Yes, sir.
REP. STUPAK: And are they limited what hours they can come into a port, 8:00 to 5:00, or they can come in any time?
MS. GLAVIN: That's right.
REP. STUPAK: Okay. How does the -- Dr. Raymond, how does the USDA decide which ports of entry to designate as eligible to receive the shipments? Again, it's just your close proximity to the --
MR. RAYMOND: Mr. Chairman, meat and poultry products can come into any port.
REP. STUPAK: Right.
MR. RAYMOND: They cannot enter commerce until they've gone through an import house. We do not limit the ports. The import houses are located --
REP. STUPAK: But do the import houses, are they -- what happens? They come to a port. They get to an import house. What happens in between there? Do they have to maintain them in frozen -- how do you maintain the integrity of the product in between the port and your import house?
MR. RAYMOND: Excellent question. Obviously one of the things we do look at at the import house is to make certain that it appears that there has been no change in the integrity of the product. For instance, if it's a frozen product and the box appears to have had moisture on it, we're going to get concerned that perhaps the integrity was not maintained. But obviously these products are going to be shipped under certain conditions -- refrigerated trucks, et cetera, depending on the product.
REP. STUPAK: How often are the samples of these products collected for testing by a lab? How often are the samples collected? Is it every box?
MR. RAYMOND: No, sir. A little over 10 percent of all the lots that come into this country through an import house are opened and are more intensively inspected, and about -- probably about 50 percent of those boxes that are opened are then further tested for pathogens or residues.
REP. STUPAK: So these lots that come in, you inspect 10 percent, correct?
MR. RAYMOND: We reinspect all lots, but we open about 10 percent of the boxes.
REP. STUPAK: Okay. And then once you do -- who does your inspection, a lab test? Do you have private labs you send this to?
MR. RAYMOND: No, sir. We have three laboratories that we use that are --
REP. STUPAK: So all your testing is done in-house.
MR. RAYMOND: In USDA labs staffed by USDA personnel.
REP. STUPAK: The system you use at USDA, could that be duplicated at the FDA for food?
MR. RAYMOND: You mean, using the import houses, et cetera?
REP. STUPAK: Yes -- testing with your own labs, not private labs.
MS. GLAVIN: Are you asking me? I'm sorry.
REP. STUPAK: No, I'm asking Dr. Raymond. Could your system be duplicated for the FDA?
MR. RAYMOND: I don't know that I can answer for the FDA. Perhaps portions of our system could be modeled. But I have to point out that it's our authorities that require what we do, and it's our authorities that Congress funds us to have those resources available so we can meet the authorities in the Federal Meat Inspection Act.
REP. STUPAK: Well, your resources come from an inspection fee, do they not?
MR. RAYMOND: No, sir. Congress gives us the great majority of our resources to do what we do.
REP. STUPAK: Have you had to come back to Congress to ask for extra resources to do your job, for the USDA to do those inspections?
MR. RAYMOND: We have, and we'll continue to do so, I'm sure.
REP. STUPAK: And have you received the resources you have requested from Congress?
MR. RAYMOND: Periodically, sir; sometimes yes, sometimes no.
REP. STUPAK: Okay. Are you short of resources now?
MR. RAYMOND: I think we have what we need right now to do the job that we're asked to do.
REP. STUPAK: Thank you. I have nothing further.
Mr. Whitfield?
Hearing no other members seeking to ask questions, we'll dismiss this panel. Thank you all very much for being here.
That concludes the questioning. We want to thank all of our witnesses for coming today and your testimony. I ask for unanimous consent that the hearing record will remain open for 30 days for additional questions for the record. Without objection, the record will remain open.
I ask unanimous consent that the contents of our document binder be entered into the record. Without objection, the documents will be entered into the record.
That concludes our hearing. Without objection, the meeting of the subcommittee is adjourned.
END.
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