New U.S. Bioterrorism Regulations to Protect Food Supplies

11:00 A.M. EDT

Real Audio of Briefing

MR. DENIG: Good morning, ladies and gentlemen. Welcome to the Washington Foreign Press Center, and particularly, thank you for coming on such short notice. We're very pleased to welcome to the Foreign Press Center two experts. First, Ambassador Allen Johnson, the Chief Agricultural Negotiator from the U.S. Trade Representative's office and Mr. L. Robert Lake, the Director of Regulations and Policy at the Center for Food Safety and Applied Nutrition of the Food and Drug Administration.

They're here today to brief on the topic of the new U.S. Bioterrorism Regulations to Protect U.S. Food Supplies. Ambassador Johnson will have to leave relatively soon this morning, so we'll ask him, first, to give an opening statement, and then we'll be very glad to take your questions to him. Then we'll get into more details on the actual regulations with Mr. Lake.

Ambassador Johnson.

AMBASSADOR JOHNSON: Thank you very much. Thanks for coming today. I think he's going to have the meat of the issues as it relates to how the regulations are going to be moving forward. I just thought I would add a few points as it relates to trade and our international obligations.

As you know, all countries have the right to protect the health and safety of their people; and these are recognized in our WTO Agreements, and countries all around the world have worked on regulations and implemented regulations and procedures to accomplish those objectives.

Food safety has been a top priority for the United States Government, and the events of September 11th, 2001, have highlighted the need for the enhanced security of our food supply.

The regulations that the U.S. Food and Drug Administration has announced on October 9^th are going to build on the U.S. Government's current food safety regulatory system. These are important in terms of facilitating the FDA being able to take action to protect the nation's food supply against any threat of intentional or accidental contamination and other food-related public health emergencies.

We're confident, and we've worked very closely with FDA to ensure that they're consistent with their WTO obligations. There's two Interim Final Regulations that require that, first, all food facilities marketing food in the United States register with the FDA; and second, that the United States be notified in advance of arrival of food imported. This food includes not just feed, but also live animals for food.

And the Interim Final Regulations have -- I think this is important to note -- have been significantly modified from the FDA rules that were originally proposed last January to make them less burdensome on trade than what those proposed rules were. And, in part, this is a response to the reaction and the comments that we had received from our trading partners. And I'll just give you just a couple of examples:

First example is that the FDA's electronic systems are now going to interface with the current Customs and Border Protection Electronic Entry System to minimize additional paperwork and reduce duplication of information to the U.S. Government. Another example is that the timeframes by which prior notification must be made has been significantly reduced from the initial proposed rules of noon, the day before the food arrives to, now, two hours advance notice for food traveling by road, four hours for food traveling by air or rail, and eight hours for food traveling by sea.

Another example, for a foreign facility requiring a U.S. agent, a U.S. agent can now be anyone in the United States authorized by the foreign facility, and that would include importers or customs brokers or others with whom the foreign facility already has a business relationship.

So we're sure that we've made some significant progress. But just to further ensure that these regulations do not unnecessarily disrupt trade, the FDA has invited further comment, and these rules will go into effect on December 12th, 2003, but FDA will continue to accept comments for up to 75 days from interested parties, both domestically and internationally, before publishing the final rule at a later date.

So we're very comfortable with the fact that these are consistent with international obligations. We'll be notifying the WTO of these relevant rules. I know that we have available the risk assessment associated with these rules. And we're going to continue to look and see what we can do to further address any concerns that people have.

So with that, I'll just sort of open it to any questions that you have to follow up on this.

MR. DENIG: Let me remind you to please use the microphone and identify yourself and your news organization. Okay, we'll start up front here.

QUESTION: Lisa Thomas from Kyodo News. Would you characterize these new regulations as a new hidden form of protectionism?

AMBASSADOR JOHNSON: No, not at all. In fact, I think that we've gone out of our way in trying to make sure that these rules are not negatively impacting trade, but at the same time ready to address any legitimate food safety concern that we have. So I think, as you'll hear a little bit later from Mr. Lake as to how they plan on moving forward with enforcement, et cetera, I think it's very accommodating in trying to make sure that it doesn't serve that role. But it does serve its legitimate role and one that we've highly sensitive to, particularly after what happened on September 11th, 2001, to know that we have to be on guard against these sorts of problems.

MR. DENIG: Any other questions for Ambassador Johnson?

Yes, please. Second row, here.

QUESTION: Kathryn McConnell with the Washington File. When you say you're going to notify the WTO, does this mean after December, or right now?

AMBASSADOR JOHNSON: No, I think we're going to be notifying them soon, in terms of making them aware that these regulations, that Interim Final Regulations, are being proposed, and again, as I mentioned earlier, we'll be open to comments from the international community as well as the domestic audience in terms of understanding how this may impact them and how we can address any outstanding concerns.

But, again, I'll just make the point that we have made some significant progress over the last -- since January, of addressing what we think are a lot of the concerns that people already had.

MR. DENIG: Okay. Other questions for Ambassador Johnson?

Okay. In that case, thank you very much, Ambassador Johnson.

AMBASSADOR JOHNSON: Thank you.

MR. DENIG: It's very good to have you. And I will call Mr. Robert Lake to the podium. Thank you.

MR. LAKE: Thank you. Let me first put this in context by going back a little bit in history.

Back throughout the decade of the '90s, there were increasing concerns about food safety, generally. We all know that pathogens find their way into food. Some of them can kill people. Others may not kill people, but make them very, very sick.

We also know that there have been many instances in bygone years and some more recent ones, of situations where toxic chemicals, through one way or another, find their way into food and pose risks, therefore, to consumers of that food. And we have these incidents in the United States. They also occur elsewhere in the world.

One of the concerns, though, if you look at some of the congressional testimony through the decade of the '90s -- the GAO Reports, the Government and Accounting Office Reports -- a growing concern that there were gaps in the authorities that FDA had in the food arena to ensure the American people that that food was safe. So this is a backdrop that I think is important to keep in mind.

When you then, on top of that, get the events of September 11, 2001, which raised to the fore, not only general concerns about food safety, but now the additional concern about the potential for terrorists, and in particular, international terrorists, to use the food supply as a vehicle for injuring citizens of this country, and indeed, many of the pathogens and chemicals that have historically been a problem for all governments in foods, we know, have been considered by terrorist groups as possible vehicles for contaminating food.

We also know that there are other agents that could be used. And so beginning right after the events of September 11, we at FDA, as well as many others in government, began to reassess concerns about terrorism. And the general feeling was that this further exacerbated the gaps that existed in authorities to deal with both food safety -- traditional problems -- as well as the new terrorist concerns.

And so these regulations should be seen, as you know, among the steps to address those gaps in authority. And what I will do is try to briefly talk a little bit about registration, and then give you a chance to ask some questions about that. I will then talk about the prior notice requirements, a little bit about enforcement, and then give you further opportunity for questions.

Again, I would note that both of these Interim Regulations were published in the Federal Register this morning. You will also see in this issue of the Federal Register a notice of availability of the risk assessment that Ambassador Johnson made reference to, which is really about bioterrorism.

Let me just clarify or be sure that we all understand what Interim Regulation means. It is a regulation. Both of these are regulations. They will go into effect on December 12th, as required by law.

However, you will also see if you read these regulations that there are some areas where we are soliciting additional comment. And there are two phases to the comment period. One, beginning today, there is a 75-day period during which any interested party can submit additional comments to either of these regulations. The comment period will then close, but it will reopen probably around March because at that time, the FDA and the Customs and Border Protections have jointly agreed that we are going to put together a joint plan for how we move forward in the future.

And so when that plan is made available to the public, we will reopen the comment period to take additional comment in light of that plan once it becomes available.

I should note, also, that these regulations were jointly signed by Secretary Thompson of the Department of Health and Human Services, which is the parent Department of the Food and Drug Administration, and also by Secretary Ridge of Department of Homeland Security, which is now the parent Department of Customs and Border Protection.

So with that introduction, let me now turn to registration. And what I'm going to try to do is really hit the highlights, noting along the way some of the major changes between what we proposed back in February [and what we have today]. And both of these were proposed regulations that were published on February 3rd of this year.

In both cases we got a lot of comment from within the United States and outside the United States. And as we looked at those comments, we decided to make a number of changes.

The final registration, or the Interim Final Registration regulation, like the proposal, applies to both domestic and foreign facilities that manufacture, process, pack or hold food for either human consumption or animal consumption in the United States.

We proposed that as part of the registration, companies would identify the categories of foods or the facilities would identify the categories of foods that they were making in their facilities, and we have retained that for the final regulation.

The foods that are covered, to be clear about that, include the following -- and even this list is not exhaustive, but I wanted to give you a rundown, particularly, I think, in many countries there's not a full understanding of the foods that FDA regulates. But it includes: dietary supplements and dietary ingredients, infant formula, beverages, including alcoholic beverages and bottled water, fruits and vegetables, fish and seafood, dairy products and shell eggs, raw agricultural commodities, whether used as food or as ingredients in food, canned and frozen foods, live food animals, bakery goods, snack food, candy, chewing gum, and, as I indicated earlier, it also does apply to animal feed and pet food.

We did make a couple of significant changes in the final regulation. The original proposal included food contact substances -- and this is mainly food packaging, but it can also include conveyer belts used in a food manufacturing facility, which we do regulate. We have a whole system for regulating those things. But we decided for purposes of these particular regulations that we would not require registration for food contact substances.

We also decided that because there is a separate set of registration requirements and a detailed and very extensive review of food safety by the Environmental Protection Agency with regard to pesticides, that we should exclude them as well. So those are two things that were in the proposal that we deleted from the final regulation.

We are clarifying in the final rule that transport vehicles do not have to register so long as what they're really doing is transporting and not serving as, really, a warehouse. Farms were exempt in the proposal and they are still exempt, but there seemed to be a lot of confusion in the comments that we saw about whether conducting operations such as washing or peeling or stripping off outer leaves and what not, whether that was enough processing to take a farm out of the farm exemption. And we have clarified in the final rule that no, those things can be done by a farm, and they still retain their farm exemption.

We did propose, and the final rule does require, that foreign facilities have a U.S. agent. That agent has to be within the United States. But we saw a lot of confusion in the comments expressing concern that the FDA was requiring that the U.S. agent be the sole agent for doing business in the United States. And we have clarified in the Final Regulation that that is not the case. It is not our purpose to interfere with any existing business relationship or to restrict foreign facilities. You know, they can use any number of business relationships in the United States. We have no restriction on that and no interest in that aspect of this. We do require, though, that they identify somebody as their U.S. agent to serve as a communications point of contact between the FDA and the foreign facility for not only emergency communications, but also for routine communications.

We did modify the requirement that the registration information be updated. We have both mandatory and optional provisions in the registration form. The proposal required that both mandatory and optional information be updated. The final rule, or the Interim Final Rule, only requires the updating of the mandatory information. We've also extended the time for updating from 30 days to 60 days.

Let me also note that we have devised a web-based system that will be operational on October 16th to do the registrations online from anywhere in the world. That system, once it begins functioning, will be opened, usable 24 hours a day, seven days a week. And once the registration has been filled in and submitted, the system will instantly send back to the registering facility a unique registration number that only exists for that one facility.

With that, let me stop and take questions on registration.

MR. DENIG: Okay, any questions on the material dealt with so far? Yes. Middle of the back there, please.

QUESTION: Hi, Miriam Kagan from Interpress News. I'm just curious whether there's been any consideration that these new registration regulations would put undue hardships on smaller producers or smaller facilities, you know, having to find an agent or designate an agent; update information; participate in online registration; that this might add cost for small producers that they can't necessarily bear in the global market, or even in the U.S. market for small --

MR. LAKE: Yeah. We do have a concern about that. We do, in fact, I think, point out in the document that we believe it will increase costs to many of those participants. But that's also one of the areas where we are inviting some additional comment. We are specifically asking for additional comment on the costs of retaining a U.S. agent. And also, because this could, as well, affect small businesses in the U.S. which may be relying on getting certain material from abroad, we've asked, also, for comment on that.

MR. DENIG: Okay, any other questions at this point?

(No response.)

MR. DENIG: All right. Then why don't we proceed with the remarks--

MR. LAKE: Okay, let me shift gears and talk about prior notice. The prior notice Interim Final Regulation is changed to a much greater degree than the registration Interim Final. There was clearly a lot more concern about the prior notice requirement, and so we have worked extra hard to try to deal with those issues.

One of the things we did back in the spring is we worked out with our colleagues at Customs and Border Protection a couple of things that I think are very important, that help us and hopefully will help them as well, but made for a less burdensome regulation.

One of them that Ambassador Johnson noted a little bit ago is that we were able to work out arrangements whereby the existing ABI/ACS system that brokers are accustomed to using with Customs and Border Protection, use that window as a way of submitting prior notice to FDA because we have an interface between our OASIS system and their system so that brokers can submit their prior notice into the system they regularly use for entries into the U.S. That information will, then, be instantly transmitting to Food and Drug Administration. And if all the information is completed, the system will automatically generate a confirmation number that will go back to the person submitting the notification. So that minimizes the amount of duplication and it is our view that the vast majority of foods imported into the U.S. will use that system.

We have, however, also prepared or developed a separate FDA system whereby firms can submit directly to FDA their prior notification. This will be required in the case of mail because the Customs and Border Protection system does not include mail in terms of their interface.

The other thing that we are doing is, of course, working in a cooperative way at the border. We've cooperated for a long time, but we've increased that level of cooperation and are also committed, as I indicated earlier, to work together with them for developing future plans to, you know, on the one hand, ensure that the job is done, that the American people are protected, but also to minimize duplication and ensure efficiency, and also to minimize any adverse impacts on trade.

The definition of food, including the new exemptions for prior notice, is identical to what I just described for registration, so I won't go back through that again.

One of the big issues in the proposal, or in the comments to the proposal related to the timeframes for submitting information to FDA -- let me go through that because we did make substantial changes in that.

Now, by statute, we are not allowed to accept submissions earlier than five days before the shipment arrives in the U.S. unless the shipment is coming by mail. For shipments, the latest that [notification] can be provided varies depending on the type of transportation.

In the case of trucks, the notification must be received two hours in advance of arrival at the port of arrival. If the shipment is coming by air or rail, then the prior notice must be submitted four hours in advance. And if it is coming by ship, or by water, the notification has to come eight hours in advance. And then for international mail, it's simply before the mail is sent.

We, in the proposal, require, or propose to require, that this information could be submitted only by someone within the U.S. We have changed that in the Interim Final Regulation so that anyone who has the information may now submit the information, including people in other countries.

With that, let me -- because those are really kind of the highlights -- so let me stop. No, wait a minute. I do need to say something about enforcement.

First let me note that following the proposal, we did a major satellite downlink as well as other outreach, both within the U.S. and abroad, and we are planning to do the same thing over the next couple of months. In particular, we will be doing a major satellite downlink on October the 28th. It'll discuss both of these Interim Final Regulations and it will be broadcast live in the Americas, and later rebroadcast throughout the rest of the world.
I believe we will have simultaneous translation into Spanish and French. We will also have a mechanism for taking questions that will be answered by the panelists who are participating in that downlink.

And there are other outreach efforts, as well. But we recognize that no matter how much outreach we do that there is just not a lot of time between now and December 12, when these regulations become effective. And for that reason, we will be exercising our enforcement discretion to focus our efforts over the first four months, not on hard enforcement, but rather, on education and training.

We will be monitoring what is happening about the level of compliance. We will be giving letters to those who are not in compliance, explaining that they are not in compliance and letting them know what they will have to do. But come December 12, we will not be stopping food at the border. Now, after going through these four months of additional education and training, and get feedback to the industry generally, and to individual companies about how things are going, we will then begin to phase in the more traditional types of FDA enforcement.

Okay. I guess that does cover what I wanted to say up front, so let me stop and give you the chance to ask your questions.

MR. DENIG: Yes, please, in the middle in the back.

QUESTION: Miriam Kagan from Interpress. I'm just wondering if you'd go a little bit further and explain how this advance notification requirement will help ensure the safety of the food supply as compared to how it was before and, you know, how this step will make things safer, I guess?

MR. LAKE: One of the things that's noteworthy about both of these regulations is they're about information. We, as well as Customs, already have computer-based systems that contain a lot of information; ours, as much information about our experience with particular products from particular companies from particular parts of the world that we have built up over time.

Feeding into that system, the registration information which will, for the first time, give us a much more complete inventory of who's out there, who's doing business in the United States, and again, the registration applies to facilities in the U.S. as well as abroad. So we'll be, obviously, using this for our U.S. purposes as well. But it's an additional piece of information.

Then the prior notice, actually, is less about providing new information than it is about getting that information to us sooner so that we can make judgments about whether we need to actually have somebody there to meet that shipment and inspect it if that's what's needed.

The other thing to remember is that, of course, we will also be getting information that historically we haven't gotten, such as intelligence from law enforcement agencies, international agencies, so that if we get, say, an indication through international sources that terrorists abroad are focusing on contaminating a particular type of product that might be coming across the U.S. border at a particular time, then we can be alert to that and try to deal with it before it actually gets to consumers.

I should add in this regard, too, that it's clear to us in the United States that as you look at some of the activities of terrorists internationally, that we are a target, as was dramatically shown on September 11, 2001. And so we believe that we need to take steps. We believe that these steps we're taking are helpful. And again, the focus is really combining not only the new information we're getting here, but combining that with other information to allow us to do a job more smartly, more intelligently, more effectively.

MR. DENIG: Okay. Other questions?

Yes, please. In the front row.

QUESTION: Kathryn McConnell with the Washington File. Will these regulations require a larger workforce?

MR. LAKE: Independently of this legislation, actually, before the legislation passed, Congress had already authorized additional hires for FDA because of the concerns about terrorism. So we have hired about 650 new inspectors to work in the foods arena. We will also be hiring, are in the process now of hiring, additional people to run the system that we're talking about. And we, indeed, plan to have a couple of people at the new Targeting Center that is being run by Customs and Border Protection.

MR. DENIG: Yes, please. Front row.

QUESTION: Lisa Thomas, Kyodo News. Have you already shared this information with other governments, and if so, have you received any reaction?

MR. LAKE: Well, we spent all day yesterday talking -- making phone calls to a lot of people. In particular, I participated at 4:00 yesterday afternoon in a call that we arranged with the embassies here in Washington to give them a briefing very similar to the one I'm doing this morning.

And again, we got a lot of questions -- not a whole lot of reaction. I'm sure everybody's wanting to actually read the regulations before they react very much. But, you know, there was a lot of interest and a lot of questions and it was definitely our desire to -- through the embassies -- to give other governments a heads-up of what was coming.

MR. DENIG: Just to make sure that we understand, then, the comments you've been getting over the last few months have been more from food producers here and overseas rather than from foreign governments?

MR. LAKE: Well, a couple of things. And let me back up. We published both of these as proposed rules back on February the 3rd of 2003. And in that we specifically invited public comment, as we always do, from anybody in the world who's interested. And we got a lot of comment.

To facilitate those comments, we did, during the comment period, have a satellite downlink that I referred to earlier. And that was really intended as an aid to understanding in order to facilitate intelligent comments.

What we've been doing, really over the summer, is evaluating those comments and considering what changes we could make and then yesterday, when these regulations went on public display, and therefore became public, but not yet published in the Federal Register, we spent the whole day, then, giving heads-up phone calls to lots of different groups, including, as I said, the embassies here in town. And then I was on the Hill as late as 6:00 last night also briefing congressional staff members.

QUESTION: Mineko Tokito from Yomiuri Shimbun. You said that there were a lot of foreign comments coming in. Was there a certain country that had more concerns than others, or?

MR. LAKE: No. We heard from many governments around the world and I don't remember who all of them were. Actually my sense is, as I reflect back on them is that, you know, the concerns tended to be very similar, actually, from different governments around the world.

I do specifically recall we got comments from the Government of Japan.

QUESTION: Could you elaborate on what they had said?

MR. LAKE: Well, I think the concerns, and if you look at the preamble to our regulations you will see that most of that is about responding to the comments we got. But there were concerns about the U.S. agent requirement and the costs, just like the question that was raised here; concerns about the timeframes in the case of the prior notice proposed requirement; concerns about having duplicate systems at FDA and Customs and Border Protection. Those, I think, really, were the recurring themes that many governments raised in these comments.

MR. DENIG: Other questions? Yes, please.

QUESTION: Have there been any governments that have indicated they might refuse to participate or might, you know, in any way, kind of, have you gotten any responses saying that some producers might pull out, or --

MR. LAKE: No. We certainly haven't heard anything like that. Of course, this is really not about government participation. It's about, and the obligations go, in the case of registration, to facilities that are doing business in the U.S., and then the prior notice really relates to the food shipments that are coming into the United States.

It'll be up to those individuals what their decision would be. The registration process can be done in a matter of minutes, and it can be done from anywhere in the world by anybody who has access to the Internet. It would seem to me that that in and of itself would not be the problem. In the case of the prior notice, the information that we are asking for is basically already submitted.

What we are really doing in the prior notice requirement is asking for that information to be submitted sooner than it is now submitted. Again, each person or businessman will have to make his own decision, but I would think that most of them would find that while they may not have preferred this regulation, that they can live with it.

QUESTION: After the first four-month period where you're more educating than enforcing, what will be the penalties? Are they not going to be allowed -- if somebody fails to register or prior notice -- are they no longer going to be allowed to import food products or produce them within the United States?

MR. LAKE: Well, in the case of registration, the failure to register is a prohibited act under the law, and that means that people who ultimately fail to comply are subject to either court injunction brought if we pursue that avenue, or they could be subject to criminal prosecution as well.

For foreign facilities, in the case of registration, if, in the case of manufactured food where we are requiring the registration number, if that number is not provided, then under the statute, in fact, for any failure to supply prior notice, the statute says that the food could be refused entry into the U.S. until the requirement is complied with.

So those are, really, what the statute provides for. Again, I think, and you know, most facilities, most importers are going to find it to their advantage to go ahead and begin complying on December the 12th.

MR. DENIG: Will the registration number appear on the packaging of food that is imported?

MR. LAKE: No. And in fact, FDA cannot disclose the registration number, so it's initially between us, and the facility, whether it's foreign or domestic. In the case of manufactured food, as I just indicated, the importation of that food will have to have in the documentation an identification of the manufacturer or producer. So there will have to be a relationship then, between the manufacturer and producer and the person who is actually bringing the food into the United States.

MR. DENIG: Okay. Other questions?

All right, maybe one final question.

Could you, perhaps, just comment briefly on the role of the U.S. Department of Agriculture in working with FDA to preserve the safety of the food supply?

MR. LAKE: Well, of course we work with our colleagues at the Food Safety and Inspection Service on a continuing basis. They regulate meat products, poultry products and egg products. And again, while we have a lot of interaction with them, overall, the statute that we're implementing here specifically excluded those products that are regulated solely by the Department of Agriculture. So all of the things that FSIS does is not covered by these regulations. So that being the case, they didn't have much interaction with us on these particular ones.

They have a separate system, actually, that requires, basically, that if you're going to ship meat products into the United States, you really have to be pre-certified by the Department of Agriculture, as I understand it.

MR. DENIG: Okay. Thank you very much, Mr. Lake. Thank you very much, ladies and gentlemen.