FDA Actions on New Bioterrorism Legislation

Transcript of May 7, 2003 Satellite Broadcast:
(Proposed Rules on Bioterrorism)

This document also available in Spanish

 

P R O C E E D I N G S

MR. BARNETT: Welcome to this live video teleconference. I'm Mark Barnett of the U.S. Food and Drug Administration and I'll be serving as your moderator this afternoon. This program represents FDA's continuing commitment to keep people informed and updated on proposed regulations being developed under the Bioterrorism Act.

On January 29, we presented a program on the rules for registration and prior notice. The comment period for those two regulations is now closed and FDA staff are in the process of reviewing comments and preparing to draft the final rules on registration and prior notice.

Today, we are going to discuss two new and important regulations being proposed by the FDA that will also help protect our nation against bioterrorism. Both of those regulations concern domestic and imported food and animal feeds that are regulated by the FDA.

One of the regulations would require the establishment, maintenance and retention of certain records. The other regulation would allow for the administrative detention of food products that may pose a threat to public health.

Our show today is being broadcast live throughout the United States, in Canada, Mexico, the Caribbean and throughout South America. Our broadcast audience includes manufacturers, processors, distributors and transporters of food and animal feeds. In addition, there are importers, agents, brokers and representatives from various embassies throughout the world that are tuned in for this broadcast. This broadcast is being simultaneously translated into Spanish and French.

We have two basic goals in doing this broadcast. First of all, we want to be sure that you understand these proposals, why they were proposed, what they provide for an what would be expected of you in complying with them. So, in a way, this broadcast will help to get you ready for new requirements that are being mandated by U.S. law.

Our second purpose is to encourage you to comment on these regulations before they are made final. That is very important. By sending us your comments, you can help us to shape these regulations while they are still being developed.

Here is how the comment system works. Under U.S. law, proposed regulations are published in a document called the Federal Register. This provides a notice of what a government agency is considering in a particular regulation and it allows interested parties to submit comments or suggestions to make the proposed regulation more effective or less burdensome.

Comments on a proposed regulation are accepted for a specified period of time. They are carefully considered by the government agency proposing the regulation and later they are summarized and discussed in the preamble section of the final regulation.

We encourage you to send your comments on these two regulations to our Dockets Management Branch, either electronically or by mail. Throughout the broadcast today, we will giving you (*See errata) information on how you can do that. You can also find information on how to submit comments by going to our Bioterrorism web page.

Now, let me talk a little bit about the format for today's program. For each of the two proposed rules, I will ask a panel of FDA experts some questions that will draw out the information you will need to know about these rules and then you will have the opportunity to ask questions of the panelists, either by phone or fax or e-mail.

The first panel is going to cover the proposed rule on recordkeeping and the second panel will cover administrative detention. In between the two panels, we will have a ten-minute break during which you will see some important information on your screen about how to submit comments on these two regulations to our Dockets Management Branch.

Now, let me tell you how to submit your comments to the panel. The phone number to call today is 800-527-1401. The fax number is 888-361-4011. The e-mail address is tvquestions@cdrh.fda.gov. Those numbers are going to be appearing on your screen right now and they will continue to appear from time to time during the broadcast.

If you choose to phone us, you have two choices. You can ask your questions as panelists directly on the air or you can leave your question with the person answering the phone and it is going to be given to us along with the faxes. I want to clear up a point of possible confusion about your questions during this broadcast. We are encouraging you to ask questions of our panelists to be sure that you understand the regulations, but you cannot use your communication with the panelists today as a means of submitting your comments on the two regulations.

As I said earlier, you have to send those comments, either electronically or by mail, to our Dockets Management Branch and you will get information on how to do that during the break.

Also, please remember that we are no longer taking questions about the first two rules, the ones on registration and prior notice. Those were the ones we covered during our first broadcast and the comment period on those two regulations is closed.

I want to emphasize that we are going to be covering a lot of information during this broadcast. We are going to post the slides that we use during today's broadcast on our website so you can review what we discuss. In addition, you can link to the full text of the proposals from our website, and that website address will be posted at the end of the first discussion and also during the break.

Now, let me introduce our panelists. Bob Lake is Director of the Office of Regulations and Policy in FDA's Center for Food Safety and Applied Nutrition. Leslye Fraser is Associate Director for Regulations in that office. Steve Niedleman (*See errata) is FDA's Assistant Commissioner for Regulatory Affairs.

Bob, let's begin by talking about why FDA is proposing this new system of records.

MR. LAKE: Mark, the answer to that really has two parts. The most immediate answer is that the Public Health security and Bioterrorism (*See errata) Prepared (*See errata) and Response Act of 2002 requires the Secretary of Health and Human Services to publish final regulations by December 12 of 2003.

The other answer is really the underlying reason why this is important. The purpose of these regulations will be to require the establishment and maintenance of records that will enable FDA--and the records relate to the immediate prior source of foods and ingredients as well as the immediate subsequent recipient of these products, these food products.

Let me just give you an example of what (*See errata) that is important. We, from time to time, encounter groupings or outbreaks of people who are getting ill from a food. As we investigate, we may find, for instance, that a particular ingredient in that food is the source of the problem.

What we would then need to be able to do is to trace back where that ingredient came from to identify the source. Then, when we get to that place, we may, then, discover that that contaminated ingredient went to other places as well, to other food companies. So then we can trace forward if we have these kinds of records. We believe, with this authority in place, it will better enable FDA to do its job or protecting (*See errata) the public.

MR. BARNETT: But companies already keep records. Why is it that you need an additional authority for this?

MR. LAKE: That is certainly true, Mark. Companies do regularly keep records and many of them cover much of the material that we are interested in. However, we have found, in our experience, that not all companies keep all of the information we need and it is not always readily available. That is why we need this.

MR. BARNETT: Of course, the ultimate goal of all this is to help protect our nation against bioterrorism. What connection can you make between these records and that goal?

MR. LAKE: The goal is, certainly, firstly to protect the public from bioterrorism. But, also, it relates to other situations where, through negligence, a food can become contaminated in a way that poses a serious risk to the public. But we believe that, as a result of having these records, we will be in a much better position to do the trace-back, the trace-forward, and, thus, better do our job of protecting the public.

MR. BARNETT: Steve, there are other requirements for keeping records as well. Are companies going to be required to still fulfil (*See errata) those obligations, too?

MR. NIEDLEMAN (*See errata) Absolutely, Mark. The regulations that are being proposed do not replace any of the existing regulations that may apply to the products that you manufacture such as the specific requirements or regulations for infant formula, animal feed, low-acid canned food or bottled water.

MR. BARNETT: Leslye, let's start talking now about who is going to have to establish and maintain these records under the proposal.

MS. FRASER: Under the proposal, the rule would apply to domestic persons that manufacture, process, pack, hold, transport, distribute, receive or import food for human or animal consumption within the United States. As we use the term "persons" here, it means more than individuals. It also covers partnerships, cooperatives, corporations, government entities such as schools and so forth.

The rule also would apply to foreign facilities that manufacture, process, pack or hold food, again for human consumption in the United States.

MR. BARNETT: You talked about domestic persons and foreign facilities. Distinguish a little bit about what those mean in this context.

MS. FRASER: Yes. The terms do mean different things. The Section 306 of the Bioterrorism Act, which we are implementing here, gives FDA the authority to require records that would require persons, domestic and foreign, again that manufacture, process, pack, hold, distribute, transport, receive or import food.

FDA is distinguishing the scope of coverage domestically from foreign. On the domestic side, we are generally applying the requirements broadly to all persons that fit within that category. On the foreign side, however, we are limiting the coverage to just those facilities that would be required to register with the FDA under our registration rule that we proposed earlier this year.

MR. BARNETT: There are some people who are excluded from keeping these records; is that right

MS. FRASER: Yes; there are. The proposed rule contains a number of different exclusions. We have both total exclusions and partial exclusions. On the total exclusion side are farms, restaurants that prepare and serve food directly to consumers, firms regulated exclusively throughout the entire facility by our United States Department of Agriculture, also shortened and called USDA, and then also excluded from all requirements are those foreign facilities that would be excluded from registering. Basically, those are foreign facilities who prepare food for the United States but the food leaves that facility and goes to another foreign facility where further processing and manufacturing or packaging occurs.

MR. BARNETT: Now, you said there were partial exclusions, too.

MS. FRASER: Yes; there are. In the partial exclusions, FDA started with fishing vessels that do not process food or fish. We had the authority to require fishing vessels to register because they are not excluded in the Bioterrorism Act. But, in the proposal, we are limiting the coverage on fishing vessels, again, to those that would be required to register.

Since, under the Registration Rule, fishing vessels that do not process are exempt, we are proposing to exclude them here. Also from the requirement to establish and maintain records, they would not be excluded from the Records Access Authority.

Also, we have an existing rule that covers BSE facilities that handle pet food and there is an existing rule for BSE. BSE is commonly referred to as mad cow disease. So pet-food entities that are not subject to our BSE Rule would also be partially excluded here from the requirement to establish and maintain records.

MR. BARNETT: How about retail

MS. FRASER: In retail, we have two exclusions that would apply there. There is one that applies to all retail facilities that sell food direction to consumers. (*See errata) The proposed rule would exempt them from the requirement to establish and maintain records governing the sales to consumers. However, those facilities still would have to keep records tracing the incoming food that they receive and they also would remain subject to the Records Access Provisions.

Then, lastly, retail facilities, and these we tend to think of possibly as roadside stands near a farm, that are selling unprocessed food--that is, basically, food in its natural state--from the farm would be, again, excluded. If they had ten or fewer full-time employees, they would not have to comply with any of these regulations.

This exclusion, also, would apply with respect to any processed food like baked goods, syrup, of all of the ingredients (*See errata) used came from the farm. But, again, those facilities would remain subject to the Records Access Provision.

MR. BARNETT: What about an entity that has a mixture of activities; that is, it is a farm but it also engages in processing at the same time

MS. FRASER: We do have those situations. In that case, the facility or the entity would have to keep records only with respect to those activities that are covered by this rule. Again, for an example, we may have a farm that is growing oranges. On that same farm, they have a processing plant in which they are taking the oranges, making orange juice and selling the oranges into commerce.

In that case, the farming activity, the growing of the oranges, is exempt and no recordkeeping requirements would apply to that activity. But the manufacturing and processing of the oranges into orange juice to sell into commerce is a covered activity and records would be required for that aspect.

MR. BARNETT: We talked about who has to keep these records. Now let's talk about what kinds of foods would be applied here.

MS. FRASER: On the food side, we are talking about all foods under FDA's jurisdiction. We have an existing statute, the Federal Food, Drug and Cosmetic Act, that contains a definition of food in Section 201(f). That basically says food is, "Articles used for food or drink, for man or other animals, chewing gum and articles used for components of any such article."

In the proposed rule, we include examples of the types of foods that are covered so that people would have an understanding of the breadth and scope because we tend to think of food often as hard ingredients and products and not necessarily as drink, for example. Some of the items are listed on the screen now. Food includes food and food additives for man or animals. Food, under FDA's jurisdiction includes dietary supplements and dietary ingredients, infant formula, pet food.

We also regulate beverages including alcoholic beverages and bottled water. We regulate fruits and vegetables, fish and seafood, dairy products and shell eggs, raw agricultural commodities that are either used as food or as food ingredients, canned foods, live food animals such as hogs and lobster, and bakery goods, snack food and candy.

MR. BARNETT: The foods that are regulated by the Department of Agriculture, of course, are not included.

MS. FRASER: Absolutely correct. The foods that are excluded are those that are under the Department of Agriculture's exclusive jurisdiction. These tend to be meat products, poultry products and egg products. However, there may be a food product that is sold--for example, a frozen dinner that you could heat up in the microwave or your oven--that contains both products regulated by FDA such as macaroni and cheese and products that would be regulated by USDA such as the meat product. In that case, since there is co-jurisdiction, records would be required but only with respect to those foods that FDA regulates.

MR. BARNETT: Steve, the proposed rule distinguishes between transporters and nontransporters. How do you define those terms in the context of this rule.

MR. NIEDLEMAN (*See errata): Mark, a transporter is a person who has possession, custody or control of an article of food for the sole purpose of transporting it to the next consumer; for example, a trucking company. A nontransporter, on the other hand, is a person who owns food or who processes, packs, distributes, imports the product or receives it such as a manufacturer.

MR. BARNETT: Okay. Now, what records would have to be established and maintained by the nontransporter in order to identify the immediate previous source of the food?

MR. NIEDLEMAN (*See errata) We believe that, for a nontransporter to develop a meaningful trace-back system, they would have to establish and maintain records to identify the nontransporter and transporter immediate previous source of the foods that they receive.

Those records must include the firm name, including the responsible individual and contact information, both domestic and foreign. They need to include the description of the type of food that was received, including the brand name and specific variety; for example, romaine lettuce versus just lettuce.

They would need to include the date the food was received, the lot number or other identifier if that is available, the quantity and how the food is packaged--for example, in twenty-five-pound cartons or in sixteen-ounce cans--and the name of the responsible individual and contact information of the transporters who brought the food to you.

Records must include all information reasonably available to you to identify the specific source of each ingredient that was used to make every lot of finished product.

MR. BARNETT: What does "reasonably available" mean? "Reasonably available information;" what is that?

MR. NIEDLEMAN (*See errata) That will depend on each particular case and each particular firm. What may be reasonably available in one firm might not be in another. We have two examples that we would like to share with you that may clarify that.

In Example 1, we have a cookie manufacturer who receives flour from three distinct sources, Firm A, Firm B and Firm C. That flour is commingled into a common storage bin that is drawn upon by the manufacturer to make the cookies.

In that situation, information reasonably is available to assure the identify of all (*See errata) the potential sources of flour that was used in each finished product. But they are unable to distinguish between Firm A, B or C. (*See errata)

The other example, the same manufacturer who manufactures cookies receives flour from three distinct sources, Firm A, Firm B, Firm C. But they store their flour in individual storage bins based upon the receipt of the flour. The manufacturer draws upon the specific flour to manufacture the cookies.

In that situation, the information is reasonably available to identify the specific source of the flour for each finished product because they know which storage bin that they draw upon to manufacture the product.

MR. BARNETT: Now, what about the records that these nontransporters are going to have to maintain to identify what you call the immediate subsequent recipient?

MR. NIEDLEMAN (*See errata) Basically, it is the same information that must be kept about the immediate nontransporter recipients of all foods released and the transporters who took the food to the recipients; in other words, who received it, what firm or firms, and how it got there, by what transporter, what means, what company.

In this example, we show--this graphic illustrates that a manufacturer must trace the shipping mode, the transporter that transported the product, whether it was directly to the next nontransporter or not, as well as to the retail store who would be considered the next transporter of the goods. So the nontransporter must identify both the transporter and nontransporter as the recipients.

MR. BARNETT: Let's turn our attention now to the transporters, what are the requirements on record keeping for the transporters. You gave the example of a shipping company, for example.

MR. NIEDLEMAN (*See errata) Right. The requirements for transporters are essentially the same as for nontransporters in that the records would have to include the firm name, including the responsible individual and contact information, whether it is domestic or foreign, of the person who had the food immediately before you as well as the person who had the food immediately after you delivered it.

It needs to describe the type of food, including the brand name and specific variety, the dates the food was received and delivered, the lot number or other identifier, if that is available, again, the quantity and how the food is packaged, twenty-five-pound cartons or sixteen-pound tins, No. 16 cans, or whatever, identification of each and every mode of transportation and responsible individuals throughout the transport if the same transportation company was being used during the various legs of travel from the original manufacturer to the final destination.

MR. BARNETT: Let me interrupt this discussion for a moment, and talk to our audience. You don't have to wait until the end of this panel discussion to send your questions in. So you can telephone us or e-mail us or send us a fax as questions occur to you. So you don't have to wait until the end. We are looking forward to hearing from you. We have got a few faxes already and we would like to see more.

Leslye, let's turn now to another question. What if the same transportation company uses several modes of transportation for one shipment, a truck, a plane, a train, and so on? What about records there

MS. FRASER: The proposed rule does distinguish between what one transportation company has within its ability to move food and another transportation company that uses different vehicles. In this example, we have the same manufacturer delivering a product to a retail store but it is one transportation company here. One company owns the first truck that picks up the food product from the manufacturing facility. That same company owns the airplane that the truck delivers the food to.

They also own the second truck that picks up the food in the destination city and takes it to the retail store. Here, the proposed rule would require that transportation company to identify each of those legs. They would have to tell us how long the food was with the truck, the plane and the second truck, when the food was received and released and who the responsible individual was at each step of the way as part of their recordkeeping.

MR. BARNETT: Let's take a totally different example and turn it around and say that it is one shipment, but it involves several different transportation companies

MS. FRASER: Yes. Here the recordkeeping requirement would apply differently because there are different transportation companies involved. Basically, the rule would not require anyone to keep records of transactions to which they are not a party. So, in this case, the first truck is owned by Company A. The plane is owned by Company B. And the second truck is owned by Company C.

Each transportation company would only have to keep records of the person or the facility from which they received the food. So, in Company A, they would only have to say the manufacturer and the person or facility to whom they delivered the food. In this case, for Company A, it would be Company B. So it is one up, one back. They would not have an obligation to keep track of Company A to B to C nor would the manufacturer.

In this example, the manufacturer would have to both keep records, as Steve said earlier, that the nontransporter source was the retail store and the transportation source was Company A or, in the previous slide, it was that purple transportation company.

MR. BARNETT: When must these records be created

MS. FRASER: The records must be created at the time the activity occurs.

MR. BARNETT: Okay. Now, if I am already keeping records that contain the same information, or some of the same information, that you are requiring, can I use those records or do I have to do the whole thing again

MS. FRASER: No; absolutely you could use those records. FDA was well aware that many of the people that would be subject to these requirements are currently keeping records to comply with other federal, state, local or even local (*See errata) laws or even as a matter of good business practice. We fully envision that they would be able to use those records.

What they need to examine for themselves, though, is that those records contain all of the information that would be required by this rule. To the extent that it does not, or they do not, then they would just have to supplement their existing records with the information that is required by this rule to make sure that they are in full compliance with everything.

MR. BARNETT: Do these records have to be kept in a specific format that the FDA specifies, or can you use your own format?

MS. FRASER: You can absolutely use your own format. We were interested in allowing covered entities to be able to use existing records as much as possible. So the proposed rule does specify that records can be maintained in any format, either paper or electronic. It is up to that person who has to keep the records to decide which format works best for them.

But, again, the records do need to contain all the required information. We also included an exemption from our existing regulation contained at 21, The Code of Federal Regulations, Part 11. That provision specifies criteria under which FDA generally will accept electronic records.

So, to the extent that records are being created electronically just for this rule, Part 11 would not apply. However, if those records are being used in compliance with another requirement, then Part 11 would still apply.

MR. BARNETT: How long do I have to keep these records if I am establishing them?

MS. FRASER: That would depend on the type of food you have and the form the food is in. The proposed rule would require all records to be maintained for one year if they relate to perishable foods that are not used in nonperishable end products. So, for example, this would be fresh fruits and vegetables that are eaten in their raw state.

We also would require records to be maintained and retained for one year that relates to all animal food including pet food, and then all other records would have to be retained for up to two years. FDA chose these time frames because we found, in past trace-back and trace-forward experiences, that often we are not finding out about a public-health emergency relating to food until several months to a year after the food has been released into commerce. We also received input during our early comment period that some of these food products may stay in the stream of commerce for two or three years.

MR. BARNETT: Where do the records have to be kept?

MS. FRASER: The proposed rule would require the records to be maintained at the site where the activity occurred or in a reasonably accessible location. For example, if you had electronic records that are housed off-site in a computer, as long as you could access them from on-site via a computer terminal, we would count that as on-site.

Also, if you keep paper records and they become too voluminous to keep on site, and you store them somewhere else, as long as they can be retrieved at that on-site location within the time frames required in the proposed rule, FDA would consider that acceptable.

MR. BARNETT: Steve, Leslye talked about experience in which the FDA has not been able to access records quickly. With respect to this rule, how quickly would the records have to be made available to the FDA if the FDA asked to see them?

MR. NIEDLEMAN (*See errata) Mark, under the proposed rule, the required records or other information must be made available to FDA or FDA's representatives within four hours as long as that request is made between 8:00 a.m. and 6:00 p.m., Monday through Friday. If our request is made at another time, the firm has up to eight hours to produce the records.

MR. BARNETT: So it is relatively quick. So the next question gets to be can the FDA simply, in an arbitrary way, just ask for records or does there have to be some criteria before they ask--fulfilling some criteria before they ask for those?

MR. NIEDLEMAN (*See errata) The Bioterrorism Act placed restrictions on FDA's ability to get these records. We can only require access to the records when there is a reasonable belief that the article of food is adulterated and that it presents a threat of serious adverse health consequences or death to humans or animals.

MR. BARNETT: Now, there is some kind of information that can be, in fact, excluded from this recordkeeping; is that right?

MR. NIEDLEMAN (*See errata) That is correct. Certain records will be excluded from the proposed regulations and those are recipes--that is, the quantitative formula or how much of each ingredient is actually used in manufacturing product, but not the individual ingredients. Any financial data, pricing data, personnel data, research data or sales data other than shipment data regarding sales.

MR. BARNETT: You said that the quantitative formula is excluded but not the ingredients. What do you mean by that?

MR. NIEDLEMAN (*See errata) What we are proposing is define a recipe as (*See errata) the quantitative formula of each ingredient used in the manufacture of a product. So, basically, we would be entitled to know what ingredients were being used, just not how much.

MR. BARNETT: So, not the amount, but the name of the ingredients.

MR. NIEDLEMAN (*See errata) Of the actual ingredients that are being used.

MS. FRASER: Mark, just to clarify, when we are saying they are excluded, they are excluded from FDA's access authority.

MR. NIEDLEMAN (*See errata) Right

MS. FRASER: Those records that were listed on the slide, FDA would not have access to.

MR. BARNETT: Steve, what would happen if the FDA requested to see the records and found out, in fact, that those records had not been established and maintained?

MR. NIEDLEMAN (*See errata) The Bioterrorism Act created several new prohibited acts. Failure to establish and maintain the required records or make them available to FDA would be one of those new prohibited acts. The FDA has the option, if they so saw fit, to pursue civil actions in the form of an injunction or proceed with criminal actions in the form of a prosecution in federal court to those individuals who commit prohibited acts.

MR. BARNETT: When is the industry going to have to comply with these regulations?

MR. NIEDLEMAN (*See errata) It is important for everybody to understand that this is currently a proposal and there is no requirement for industry to comply at this point. Under the proposal, all businesses except smaller and very small businesses must comply within six months from the publication in the Federal Register.

Larger businesses, or typical businesses, that are greater than 500 employees, or equal to 500 employees, must comply within six months. Smaller businesses, those with eleven to 499 employees, must comply within twelve months. Very small businesses, with less than or equal to ten employees, must comply within eighteen months.

MR. BARNETT: Bob, when can we expect to see these regulations appear in their final form?

MR. LAKE: Of course, the first step is to publish them as a proposal. In this case, this proposal was put on display on Monday of this week. It will be published on Friday of this week, May 9. Then, after FDA has received all the comments and reviewed them, we, then, we have to prepare the final regulation. The statute requires that the final regulation be published by December 12 of 2003.

MR. BARNETT: We have obligations in the FDA under the World Trade Organization, under NAFTA. What is the relationship between this regulation and those obligations?

MR. LAKE: You are absolutely right, Mark, that we do have those obligations. Nothing in the statute changes those obligations. We are fully cognizant of them and believe that we are in compliance with them. We are notifying the World Trade Organization of these proposals simultaneous with publication so that the international community will be able to comment on them as well as those in the U.S.

In addition to that, this proposal and the next one that we are going to talk about as well, really apply every bit as much to domestic producers as to those abroad; in fact, really more so to domestic companies.

MR. BARNETT: What are the next steps, now, in getting these regulations finalized?

MR. LAKE: There are actually a series of things. One, the most important thing next is for those who have an interest to review the proposed regs, to then comment on them to the Food and Drug Administration. Then it would be up to FDA to deal with each and every issue that is raised in the comments and prepare the final regulation.

MR. BARNETT: If I want to submit comments, how can I go about doing that?

MR. LAKE: There are a couple of ways of doing that. The first and most traditional way is to submit comments to our Dockets Management Branch. The address for that is now on the screen. Again, it is very important to include the docket number which, in this case, is 02N-0277, to be sure that the comment goes into the right file.

MR. BARNETT: Also, you can do this electronically?

MR. LAKE: That is correct. The slide is now on the screen as well. This is the way that you can submit your comments electronically. Here, again, it is very important that you include the docket number.

MR. BARNETT: You can also get updated information on the progress of the regulation from time to time.

MR. LAKE: That is correct, Mark. Updates are available on FDA's website and the slide showing how to access that is now on the screen. As information becomes available, we will be putting it on that website.

MR. BARNETT: We have some faxes and I hear that more are coming in momentarily, but let me begin with the ones that have already come in. This first one says, "In following raw agricultural products through the chain of custody, wouldn't it be more appropriate to trace these bulk products in such as way as to limit the number of potential sources of contamination rather than just listing all of the suppliers?"

MR. LAKE: Mark, shall I take that one? I think there may be two questions lurking there. One seems to have the notion that limiting the number of people who handle the food limits the potential risk of contamination. That is certainly a factor but it is not a part of this rulemaking, beyond the scope of this rulemaking.

The other issue that I see lurking in that question is the notion of preserving the identity of a food from the farm and maintaining all the ingredients that relate--that came from that farm all the way through the entire system.

This is done voluntarily, for instance, in the case of organic foods. But we felt that that, too, was beyond the scope of what we wanted to do in this proposal. So this is not about identity preservation. It is about recordkeeping and access to facilitate trace-back and track-forward.

MR. BARNETT: This one says, "Does the recordkeeping requirement apply to customs brokers and freight-forwarders who 'facilitate'," and that is in quotes, "who 'facilitate' and/or arrange the import and transportation of these covered goods?"

Leslye, do you want to handle that

MS. FRASER: Yes; it does. The statute and the proposed rule on the domestic side does apply to persons who import food along with those who manufacture, process, pack, hold, distribute, transport or receive. On the foreign side, with respect to exporters, it would also apply basically to the last foreign facility who did a major manufacturing, processing or packaging activity with respect to that food as well as to any other foreign facility that did some of the minor type of activity, what we call a de minimis activity, such as putting on a label.

MR. BARNETT: This one says, "Does the recordkeeping rule apply to manufacturers of food-packaging materials?"

MS. FRASER: No; it does not. We are proposing not to--although we did have the authority in the Bioterrorism Act to require records for those who also handle food-packaging materials, because the Act specifies records of foods and its packaging, in the proposed rule, FDA did not require records of packaging materials. But we did take comment on that approach.

MR. BARNETT: This one says, "Will the bills of lading commonly used by trucking companies suffice for the transporter recordkeeping requirements?"

MS. FRASER: It could. It would be for the transporter to make sure that what is contained in their bill of lading contains all of the required information in the proposed rule. We could envision that there are some bills of lading that do meet those requirements and there may be others that do not. But it would be for the transporter to make sure that, if that is the mechanism they want to use as their recordkeeping, that they supplement and deficiencies in their record-keeping ability.

MR. BARNETT: Okay. This one says, "The regulation establishes different recordkeeping for transporters and nontransporters. Why the difference? Why the distinction between the two?"

MR. NIEDLEMAN (*See errata) Basically, a nontransporter is anybody other than a shipping company in very simplistic terms. A transporter just is responsible for the delivery of the product. They need to know from whom they received it and to whom they delivered it. They can't necessarily be responsible for who or where each ingredient came from when that manufacturer received those ingredients and only the manufacturer would be able to put that story together and be able to trace the legacy or the history of that product.

So the nontransporter has additional responsibilities than the transporter

MS. FRASER: In addition to that, part of our philosophy was we wanted to be able to quickly isolate any potentially contaminated food that met the standard of being adulterated or evidence of being adulterated with a serious adverse health consequence to humans or animals. So it would be easier to go through sort of the buyer-seller chain quickly and figure out where the food had gone down the chain and, once we found the source, to go back out and figure out where all the other similarly contaminated food had gone separately from going through each step of the way.

If we go back to that example where we had the manufacturer going to a truck to a plane to a truck to the retail store, it would be easier for us to say, "retail store to the manufacturer," if that is where the contamination occurred.

It also could have occurred during transportation and then we would go separately through that leg. But we were looking at what would be the quickest way we could respond in a public-health emergency related to food, and that was our proposed approach. But, again, we did ask for comment on having nontransporters having basically to keep two tracks of records.

MR. BARNETT: We have about twelve more minutes in this section. We have a lot of faxes coming in so I am going to go a little faster now and ask you to keep your answers brief. Okay. "Are there any recordkeeping requirements," we are probably going to go too fast, now. "Are there any recordkeeping requirements for foreign transporters? It is not mentioned under foreign facilities."

MS. FRASER: No.

MR. BARNETT: There are not. Okay. That was brief. We are going to be through too soon.

"One transportation company example. What about when the product is shipped to a retail store's central warehouse and then, from there, to retail stores. Where does the responsibility for recordkeeping lie?" Is that clear?

MR. LAKE: Well, I think there are a couple of different possibilities there. The central warehousing facility may be servicing several stores owned by the same company. So, from that point forward, it is really the responsibility of that company that is receiving the food to keep records and also to keep records of the transporter that delivered it to them.

The transporter has to know where they pick their stuff up and, of course, where they drop it off.

MR. BARNETT: Okay. This one says, "Are transportation companies required to verify the accuracy of contents reported by the nontransporting shipping company?"

MS. FRASER: We did not specify that one way or the other in the rule. So we would invite comment on that. Our approach was that we needed a record of how much was picked up and how much was delivered so that we could make sure, again, in a trace-back, we had accounted for all goods. We did not speak to verification at all.

MR. BARNETT: Okay. Here are two of them, from one caller, or one faxer, who says, "We are a nonprofit service provider for persons with mental retardation and developmental disabilities. We purchase, transport and prepare food for the individuals we serve. Does the Act require that we keep records for all food purchases for two years?"

MR. LAKE: I can take that one. The answer is that they have to keep records of where they got their food but, to the extent that they would qualify as a retailer, they would not have to keep records on their customers.

MR. BARNETT: Okay. And then, quickly, the second part of this, "Do the recordkeeping requirements of the Act apply to residential service providers such as nursing homes, group homes, and so on?"

MR. LAKE: Yes.

MR. BARNETT: They do.

MR. LAKE: In the same way.

MR. BARNETT: Okay. This one says, "How would a bottled-water processor identify the nontransporter previous source as to the name and responsible individual, address, telephone, fax, and so on?"

MR. NIEDLEMAN (*See errata) They would be identifying the source of the water that they are using in their bottling facility. If it is a spring, then that is the source of the water. If they are purchasing the water from another company, then they would have to identify that and how they received it.

MR. BARNETT: Okay. "FDA was given record-review authority when the Bioterrorism Act was signed last June. Has the FDA exercised its new authority to date, record-review authority?"

MS. FRASER: Access.

MR. LAKE: Yes; I think it really means records-access authority. We have not exercised it so far. But the question is based on the reality. We already have access authority granted by the new law. This relates to what records have to be kept.

MR. BARNETT: Okay. This one says, "The legislation refers to food for human consumption. Packaging materials are not intended for human consumption. Why are you including food-packaging materials in the rule?"

MR. NIEDLEMAN (*See errata) I think we covered that

MS. FRASER: We are not including them.

MR. BARNETT: We are not including it; okay

MS. FRASER: But the Act gave us the authority to include it, but we chose not to but are taking comment on it.

MR. BARNETT: Okay. This says, "Would grain elevators under the jurisdiction of the U.S. Warehouse Act be required to keep records?"

MR. LAKE: The answer to that is yes.

MR. NIEDLEMAN (*See errata) Yes.

MR. BARNETT: Okay. "Does a domestic company have to keep records if they only export products not to be consumed in the U.S.?"

MR. LAKE: That one, to me, sounds like one we would like to have some comment on it.

MR. BARNETT: Okay.

MS. FRASER: But the requirement is for food for consumption in the U.S., so I agree with Bob. We would want comment on whether any of their ingredients, or what are they actually moving and doing.

MR. BARNETT: Okay. That is a good point, then, something that you want to hear from people about.

MR. NIEDLEMAN (*See errata) Right; that is something we want to hear more about.

MR. BARNETT: Good. Okay. I would mention to our audience, we have about six more minutes. I have two more faxes. If you hurry, we might be able to get another question or two in here. Okay. "What steps are being taken to avoid the duplication of recordkeeping requirements with U.S. Customs or ATF?"

MS. FRASER: We don't envision that there should be duplication per se because existing records that are kept for any other reason, whether it is in compliance with a federal law such as U.S. Customs or USDA or as a matter of business practices, those records can be used. To the extent the (*See errata) we are requiring additional information so that we can do an effective trace-back, which is a different purpose than why Customs would require records, then only those additional elements would have to be added to existing records. But it does not require a second set of duplicative records.

MR. BARNETT: This is my last one, here. It says, "If a manufacturer makes canned beans with meat with more than 2 percent of meat, he therefore would be under USDA jurisdiction. Must he keep records of the ingredients other than the meat?"

MR. LAKE: Well, the ingredients, other than the meat, would almost certainly be FDA-regulated ingredients. So the answer is yes.

MR. BARNETT: Okay. Our viewers took me up on my last offer. We have three more. We will do it and we will do it fairly quickly. We will be okay. It says, "Are there penalties for unintentional errors," and unintentional is underlined, "in the recordkeeping?"

MR. NIEDLEMAN (*See errata) That is tough to judge. I mean, what is unintentional? Is it one in 100, or is it one in 100 that you are complying with? I think, again, there is going to be a learning curve associated with this and it is going to be different for any specific situation. It is tough to just make a blanket statement like that or give a blanket response. We are going to have to evaluate the situation.

MR. LAKE: But I would also say this is another area where I think we would be interested in comments, what do our viewers and others think about this.

MR. BARNETT: Okay. It says, "Your description of the definition of food did not mention 'packaging' or food-contact sources where migration occurs." This is another packaging question. "The two previous proposed regulations did describe food to include packaging and migration sources. Are you intending to interpret the meaning of food differently than you have before?

MS. FRASER: No; we are not choosing to interpret or selecting to interpret food differently. The definition of food remains the same. The application of the two requirements is what differs. The Bioterrorism Act in Section 306 said that FDA may issue regulations, or must issue regulations by December 12 that would require records for immediate previous source and immediate subsequent recipients of food and its packaging.

It gave us discretion to decide what food to regulate. We chose, in the proposal, not to regulate packaging just as we chose not to regulate all pet-food entities and we are taking comment on that.

MR. BARNETT: Okay. "Does the nonedible chicken parts from a USDA chicken-processing facility fall under this rule of the nonedible parts are intended to be used for pet food?"

MS. FRASER: If that entity is currently subject to FDA's BSE rule, they would be subject to this rule. I don't know the specifics to answer that question directly. But if they are not subject to FDA's BSE rule, they would be exempt from this rule.

MR. BARNETT: Okay. "Will FDA recognize systems and regulations in place and administered by a foreign country's government as being equivalent to the requirements in the proposed rule?"

MR. LAKE: Let me respond to that. Before, at least in my limited understanding of the way the WTO agreements work, first, we have to establish a requirement. Then we can begin discussions about whether that requirement can be met by equivalent requirements in other countries. Again, the purpose here is to assure that we have the ability to trace food and we are, as we talked earlier, open to any system of records that already exists.

So, if another government requires adequate records for trace-back, then the companies complying with the requirement would probably be in compliance with their own as well.

MR. BARNETT: Okay. Well, it is time to end this part of the discussion. This is the one on recordkeeping. It is time for a ten-minute break. When we come back, we are going to discuss the second proposed rule, the one on administrative detention.

Now, during the break, we are going to be showing some important information on your screen. You will see the electronic and mail addresses you should use to submit your comments to our Dockets Management Branch and you will see the internet address for FDA's Bioterrorism web page. On that web page, you will find a link to all of the comments received by FDA on the proposed rules, updated information on future satellite downlinks, and a wide variety of topics on FDA's activities involving bioterrorism.

So we will see you back here in just a few minutes.

[Break.]

MR. BARNETT: We are back live and ready to discuss the proposed regulation on administrative detention. So, Bob Lake, let's begin by asking what it is. What is administrative detention?

MR. LAKE: Well, Mark, the new Bioterrorism Law provides authority for FDA to detain products in domestic commerce if they present a threat of serious adverse-health consequences or death to humans or animals. The authority that has been provided is currently in effect and could be used even now.

MR. BARNETT: Why did you need it?

MR. LAKE: We have lacked authority to hold a food in place, as it were, in the past. This new authority gives us the ability to do that in order to allow us to go into federal court and file a seizure action.

MR. BARNETT: While the food is being held.

MR. LAKE: While it is being held in place; that's correct.

MR. BARNETT: Do you envision that this will be used more for domestic or imported foods?

MR. LAKE: It could be used for either but, as a practical matter, we already have authority for detaining foreign products coming into the U.S. that violate U.S. law. And we have been exercising that authority to simply keep those foods out of the U.S. for many, many years.

What this new authority does is allow us to detain product that is in the United States. This, therefore, will apply mainly, I believe, to domestic producers. But it could apply to an imported food that was originally allowed into the U.S. and then found out to be contaminated at some later time.

MR. BARNETT: Leslye, let me ask you a similar question to the one I gave you on recordkeeping and that is what kinds of foods are going to be subject to administrative detention.

MS. FRASER: Again, it is the same foods, foods under FDA's jurisdiction. The difference here from records is that records was limited to foods that were intended for consumption by humans or animals in the United States. By comparison, administrative detention would apply to all foods, whether or not they were going to be consumed in the United States, that currently are under our authority.

Again, we have the definition of the Federal Food, Drug and Cosmetic Act that applies and the same examples that we went through previously as the types of food that we regulate. Again, it is food and food additives for man or animals, dietary supplements and dietary ingredients, infant formula, pet food including alcoholic beverages and bottled water, fruits and vegetables, fish and seafood, dairy products and shell eggs, raw agriculture commodities used as food or components of food, canned food, live food animals, bakery good, snack food and candy.

MR. BARNETT: Again, a parallel question to what I asked you about recordkeeping. What food is not subject to administrative detention by FDA

MS. FRASER: It also is the same, that foods that are under the exclusive jurisdiction of the U.S. Department of Agriculture would not be subject to administrative detention. That, again, is meat products, poultry products and egg products. If there is a product out there, though, that contains food that is both subject to our jurisdiction along with food subject to USDA's jurisdiction in one package, such as, again, a frozen dinner that is intended to be heated up in a microwave, we could detain that food because we would have jurisdiction over the FDA food.

MR. BARNETT: Bob, the statute only requires the FDA to set standards for perishable foods. Yet, it is interesting that in the proposed rule, you are going beyond that. Why are you doing that?

MR. LAKE: Mark, the reason for that is that--first, you are right. We are only required to do the rulemaking for perishables but we decided that, while we were at it, we would include all foods. The advantage is that this enables us to be sure that we have procedures in place that will allow us to meet the statutory time frames and, in particular, we felt that it was important to spell out the details of how the appeal process would work. That process is really the same for both. It is the timing that is different between the perishable and nonperishable.

MR. BARNETT: Okay. Leslye, in the context of this rule, what is perishable? What does that mean?

MS. FRASER: FDA has included a proposed definition for perishable food in this rule and in the recordkeeping rule. They are both the same definition. It is taken from our current definition of perishable commodity in our Regulatory Procedures Manual. That definition is, "Food that is not heat treated, not frozen, and not otherwise preserved in a manner as to prevent the quality of food from being adversely affected if it is held longer than seven days under the normal shipping and storage conditions for that food."

We are taking comment on that definition. In this rule, it impacts which appeals process and the timing for appeals would apply. In the recordkeeping rule, it affects the retention times. So, in both rules, we are taking comment.

MR. BARNETT: Steve, the administrative detention is not new to the FDA. The are (*See errata) administrative detentions in other FDA regulations. What are they?

MR. NIEDLEMAN (*See errata) The proposed rule is modeled after the Medical Device Administrative Detention Authorities that exist in 21, Code of Federal Regulations, 800.55. We believe that the device detention process has been effective and efficient and should equally be as efficient for foods, and it has been modified moderately to accompany that.

This is useful because using the device model as a model for the field, they are familiar with the process. It will reduce the amount of time we need to train our field staff as to how to properly implement the new Food Detention Authorities.

I would also like to note that the administrative detention requirements that are being proposed and as required by the Bioterrorism Act require us to provide an opportunity for an informal hearing as part of the appeal process if an appeal is filed and that 21, Code of Federal Regulations, again Title 21, Part 16, sets out the FDA's informal hearing process that will be followed when the administrative detention is put in place.

MR. BARNETT: Steve, just in a general way, how do you think the detention process is going to work?

MR. NIEDLEMAN (*See errata) Mark, once the standard is met to impose a detention, we will consider whether or not that is the most efficient way for us to proceed. But, assuming that it is, we will be able to temporarily place and prevent further distribution of that product in commerce as well as further sale of that product for up to thirty days while it is being detained.

During that time, the agency can proceed with final agency action to remove the product from commerce and we anticipate that the final agency action would be a seizure. Seizures are in rem processes which basically just affect product and do not affect individuals. They do not include individuals.

For those who are not familiar with the term "seizure," what we mean by it, basically, FDA would seek, through the Assistant U.S. Attorney's Office, the ability to control or arrest the product and segregate it from nonviolative product and prevent it from entering commerce.

MR. BARNETT: That is an interesting comparison. It is the arrest of a product as opposed to arrest of a person.

MR. NIEDLEMAN (*See errata) Individual; that's correct.

MR. BARNETT: Who is authorized, Leslye, to order one of these administrative detentions

MS. FRASER: An officer or qualified employee of FDA may order an administrative detention. Those are people like investigators, inspectors or other employees of other federal agencies that we have commissioned to assist us with investigations or inspections.

MR. BARNETT: I am assuming that, before you detain a product in this way, that you have certain criteria you use that have to be met before you can take this kind of action.

MS. FRASER: Yes; we do. The statute, both the statute and the proposed rule, specify that a detention may be ordered if, during an inspection, an investigation or an examination, an officer or qualified employee has credible evidence or information that an article of food presents a threat of serious adverse-health consequences or death to humans or animals. So that standard would first have to be met, the serious adverse-health consequences, before and administrative (*See errata) detention could be ordered on an article of food.

MR. BARNETT: But, before it is ordered, someone else in the FDA has to also approve it; is that right

MS. FRASER: Absolutely right. The FDA district director with responsibility for the geographical location where the food is located would have to approve the detention or someone senior to that person. That approval can be obtained in writing or it may be obtained orally with a written confirmation to follow.

For example, if someone is in a remote part of town and doing an investigation and finds food, or has a reasonable belief that there is this article of food presenting the serious threat, they can call and obtain oral approval if there isn't a fax machine rather than have to drive and obtain that approval. But then the approval would have to be followed up with a written confirmation.

MR. BARNETT: Talk about the detention order, itself. It has to include certain--the FDA, now. Not the other person. I am changing things around here. The FDA has to include certain information in that detention order. What is that information?

MS. FRASER: FDA specified a number of elements that must be contained in the detention order in the proposed rule. And we do invite comment on that. What we proposed is that the detention order must include the detention-order number, the hour and date of the order, the identification of the detained article of food, the detention period of time, a statement that the food cannot be--or how long the food is going to be detained for.

The order also has to include general reasons, or a general statement, giving the reasons for the detention, the address and location where the food is to be detained and any appropriate storage conditions to maintain the quality of the food, any applicable conditions of transportation; for example, if FDA determines it appropriate (*See errata)to move the food to secure storage or to a cooled storage, we would have to specify the transportation of that, and a statement that the food may not be consumed, moved, altered or tampered with in any manner during the detention period unless we have given written approval and permission to do that.

MR. BARNETT: Steve, how long can the FDA detail--oh; did you want to add something? Go ahead.

MS. FRASER: Sorry. Yes; there is some more. The order also has to include information regarding how to appeal the detention and the name and contact information of the district director in whose district the food is located. Again, this is the person that generally has approved the order. And, then, lastly, how that approval was obtained; was it orally or was it in writing.

MR. BARNETT: So, Steve, how long can the FDA detain an article of food?

MR. NIEDLEMAN (*See errata) Well, Mark, we detain products for a reasonable period, generally up to twenty days, unless a greater period, not to exceed thirty days, is needed to enable us to take a more permanent action or more final regulatory action against the violative product.

MR. BARNETT: Where is the detained article of food held and under what conditions?

MR. NIEDLEMAN (*See errata) The detained product needs to be detained in place at the location and under the conditions that we identify in our detention order. We must also order, if appropriate, the removal of the product to secure storage if that is indicated or not already located in secure storage.

MR. BARNETT: Can the detained article be delivered to somebody else or maybe transferred to another location by the owner?

MR. NIEDLEMAN (*See errata) An article of food that has already been detained may not be further distributed to the next person in line. It may not be distributed to the importer or to another owner or to another consignee. It may not be transferred from the place where it has been ordered detained or from the secure-storage facility where it is currently being held until a FDA-authorized representative releases the article or the detention period expires, whichever occurs first.

MR. BARNETT: But there are certain circumstances where the food can be moved to another location; is that right?

MR. NIEDLEMAN (*See errata) That is correct. With FDA approval, we may allow limited conditional release of a detained article. Some of those conditions for release would be moving the detained article to a secure facility, moving it so that it maintains or preserves the integrity or the quality of the product, as Leslye said, perhaps to a refrigerated warehouse so that the product maintains its integrity or for any other appropriate purpose that we feel is appropriate.

MR. BARNETT: Leslye, can the FDA require that the detained food be labeled or marked in some way to distinguish it?

MS. FRASER: Yes; we can. Both the Bioterrorism Act and the proposed rule specify that FDA could require marking or labeling that the food is detained. This needs to be distinguished from--some people are familiar with Section 308 of the Bioterrorism Act which requires marking of food that has been refused entry. That is imported food. This is not that kind of marking. This is simply a marking or a label that would indicate the food has been detained, the conditions of the detention, and then also an indication that the food may not be moved or consumed or the label be removed without written permission of FDA.

If the detention order is terminated, then the labels or the markings would be removed so that we don't envision this--if the food turns out not to present that serious threat, we don't envision this as something that would inhibit the ability to sell the product elsewhere or where it was intended to go.

MR. BARNETT: Who actually receives the detention order?

MS. FRASER: The proposed rule would require, at minimum, the agent operator or owner of the facility or place where the food is being detained to receive a copy of the order. If the person that owns the food isn't one of those three entities, FDA also would provide a copy of the detention order to that party if that person's identity could be reasonably determined.

And then, if the food is detained on a carrier or other transportation vehicle, we also would provide a copy of the detention order both to the person that is transporting the food as well as the shipper of record, again if we could reasonably determine their identities.

MR. BARNETT: Okay. Let me interrupt for a moment and say to our audience, we already have received several faxes. We would certainly like to see more. You don't have to wait until the end to start sending your question. So fax us or phone us or e-mail us and you can start doing that at any time, starting now.

Steve, what procedures apply when the FDA initiates a seizure action against a detained, nonperishable food? We have a nonperishable and it has been detained and now the FDA wants to seize it. How does that work?

MR. NIEDLEMAN (*See errata) FDA would follow its already-in-place procedures that are already stipulated in our Regulatory Procedures Manual. These are long-established procedures for how to effect a seizure. We certainly fully support expeditious and speedy handling and processing of seizure actions. However, there is no specific time frame included in the RPM to file a seizure action with the Assistant U.S. Attorney at the jurisdiction where the product is located.

Basically, agency policy is we would not like to take a seizure action based on evidence that is older than sixty days, which is way beyond the detention period. So that should not apply as a factor in a detained product.

MR. BARNETT: Now, what about the perishable foods? Any difference there in terms of seizure?

MR. NIEDLEMAN (*See errata) Yes. As required by the Bioterrorism legislation, by the Bioterrorism Act, we have implemented expedited procedures for seizure of a perishable product. If we decide to initiate seizure action against a perishable food, we will send that seizure recommendation to the Department of Justice within four calendar days of the filing of the detention unless certain extenuating circumstances exist.

Extending circumstances could be awaiting laboratory analysis or other conditions for which we have no control.

MR. BARNETT: Now, Leslye, can an FDA detention order be appealed? Suppose the person getting the order doesn't agree with it?

MS. FRASER: Yes. That person may appeal the detention order and the way in which you would appeal would be specified on the detention order. The appeals would go to the FDA district director in which the food is located, where the food is located.

MR. BARNETT: Talk about how this would work when we are dealing with a seizure or a detention of a nonperishable food.

MS. FRASER: For a nonperishable food, and actually let me back up a minute with respect to who can appeal. The person who can appeal is the person that would be able to file an action or to appeal if we brought a seizure action. So whoever could claim the food, if it were seized, is the one that is authorized to actually appeal. So it is not everyone who gets the detention order can appeal.

With that, if we have a nonperishable food, a person can choose to appeal with the request for an informal hearing or just to appeal where written materials would be reviewed. If they want an informal hearing in a nonperishable food, they would have to let us know with four days of receiving the detention order that they were requesting the hearing and indicating that they were going to appeal.

Then we would have to receive the appeal, itself, within ten days of their receiving the detention order. After that, FDA, the time when we receive the appeal, that triggers the clock for us holding the hearing if one was requested. We would have to hold the hearing within three days of receiving the appeal.

MR. BARNETT: How does that differ, now, if we are talking about a perishable food

MS. FRASER: For a perishable food and, again, this is one that we basically said would lose its quality within seven days, the timing is similar but faster. We do not have an intent to request the hearing that has to be filed. You would have to file the appeal with or without the request for hearing within two days of receiving the detention order and then FDA would have to hold the hearing within two days.

Again, the comparison, if you assume that someone would appeal on the first day that they received a detention order, then the timing for a perishable and a nonperishable food really would differ by just a day. But, for a nonperishable food, the party, at their choosing, can take longer to choose to appeal, but that is the difference in the timing.

MR. BARNETT: The FDA does have a limit on it in terms of responding or issuing a decision on an appeal. They can't just delay this for a long time

MS. FRASER: Correct. FDA is required by the Bioterrorism Act for both nonperishable and perishable foods to issue a decision within five days of receiving an appeal. That, again, is in part why we develop regulations or propose regulations that address the timing so that we can insure that we meet that five-day time frame.

As part of the appeal which would be heard by a regional food and drug director at the FDA, that person who was the hearing officer, that is the person that would hear or review the materials if it is just in writing or preside over the informal hearing. They also would render the decision. But they could require the hearing to be held within one day, to be held and completed within one day. Again, that is to make sure we can render a decision within five days of receiving the appeal as required by the Act.

MR. BARNETT: You mentioned the five-day limit several times. Is that five calendar days including weekends, or not including weekends? How does that work

MS. FRASER: It is five calendar days including weekends and holidays.

MR. BARNETT: Bob, how is the FDA going to handle classified information when you have an informal hearing and the company, obviously, doesn't want this information to be released?

MR. LAKE: Certainly, in this environment where we have to be concerned about possible terrorist actions, it is certainly possible that our information is coming from classified documents. They are classified for national-security reasons and we could not disclose those documents. On the other hand, we certainly do recognize the need to have a fair and proper hearing.

So to the extent that we can, it is our belief that the hearing officer should be able, in most cases, to at least reveal the general nature of the information and offer an opportunity for the person who is concerned about the goods, the food, to present evidence to contradict that information.

The other point with regard to use of classified information is that if we make a decision that is based on classified information, that will be noted in the decision, itself.

MR. BARNETT: Steve, when does a detention order terminate?

MR. NIEDLEMAN (*See errata) Mark, an authorized FDA representative will issue a detention-termination notice releasing the detained articles either once we are satisfied that the product no longer needs to be detained or the detention has expired, the detention period has run its course.

If FDA fails to issue a detention-termination notice by the time the detention does expire, the goods are automatically deemed to be no longer detained. We generally will issue the detention-termination notice to the same individual that we issued the detention notice to or to their representative. As Leslye mentioned earlier, we would also either authorize or ourselves (*See errata) remove any tags or markings that may have been placed on the goods so that the product can return to commerce unblemished and ready to be sold.

MR. BARNETT: Bob, this, of course, is a proposed regulation. So what are the next steps in carrying it on and getting it through.

MR. LAKE: First, again, we have to actually publish the proposal and, as with records, this will occur on this Friday, May 9. The next step after that is that we receive comments and, again, in both of these cases, the comments will be due by July 8.

MR. BARNETT: If someone out there wants to comment, how do they do that? First of all, how do they get a copy of the proposed rule?

MR. LAKE: All right. Now, on the screen is an indication as to how one can get a copy of our proposed rules. This can be obtained electronically or you can write to the Dockets Management Branch at the address on the screen.

MR. BARNETT: And then, once you have it, how do you get the comments in?

MR. LAKE: Again, there are two ways of doing this. One can either submit the comments electronically or they can be submitted in written form in the traditional way to the Dockets Management Branch at the address that is shown on the screen, and then the e-mail address, or the electronic address, is also on the screen for how the comments can be submitted electronically.

MR. BARNETT: Now, people can also get updated information on all the FDA bioterrorism activities including these proposed rules. And they can do that how?

MR. LAKE: That is correct, Mark. Again, the screen is now showing the website for obtaining up-to-date information on our bioterrorism activities which include the proposals we published before as well as these proposals and we will have other information as it develops.

MR. BARNETT: We have a nice pile of faxes here. Folks, you can keep sending them in. We have almost half an hour left. We have plenty of faxes, but we can use more. So keep sending us your questions.

This one says, "When and if a product is detained and needs to be moved to a secured warehouse, can any trucker be used?"

MR. NIEDLEMAN (*See errata) I don't think the regulations specify what type of trucker can be used but, generally speaking, we would expect, in concert with security issues, we probably would want a bonded trucker who can be assured that the product will reach its final destination.

MR. BARNETT: Okay. "Will the detention proposal change the relationship between state and federal enforcement?"

MR. LAKE: It may, to some degree. Historically, FDA has. When we wanted to seize and were concerned that it might move away from us before we could get the papers filed in court, we have turned to state authorities. States typically have what they call embargo authority which is essentially the same kind of authority to hold it in place until FDA could pursue its seizure action.

There may still be situations where we follow that similar process. But now that we have our own specific authority, we may be using that much more often--well, obviously more than we have in the past.

MR. BARNETT: Right. This one says, "Do either of the proposals discussed today apply to foods that are not in interstate commerce?" Leslye, do you want to take that one

MS. FRASER: I guess I would turn that question around and say the proposals apply to all foods whether or not they are in interstate commerce.

MR. LAKE: Let me just, on that--we are specifically inviting comment on that issue, also on the question on secure transportation. That also sounds to me like an area where it would be useful to submit comments to the FDA.

MR. BARNETT: All right. This one says, "Will FDA increase personnel to handle all of these proposed changes?"

MR. LAKE: It depends on the Congress and whether they give us more budget.

MR. BARNETT: Okay. "The Bioterrorism Act immediately gave FDA its detention authority. Has FDA used this authority to date?"

MR. NIEDLEMAN (*See errata) Not for foods. We have not used the detention authority although it is available to us.

MR. BARNETT: Okay. "Will the administrative detention authority be used to detain food for which no prior notice was submitted?"

MR. LAKE: Let me answer that. This, I think, is not the way we will deal with failures to adhere to the prior-notice requirement. Again, the prior-notice provision of the law has built into it a requirement that, if the prior notice is not submitted in a timely way, then FDA is to refuse entry. So the food would not be allowed in the U.S. but it would be based on the prior-notice law rather than on this detention authority.

Let me come back to my remark about the Congress to note that, separate from the Bioterrorism Law but as part of the budgetary process last year, we did get significant new authority to hire a large number of people. Those people are all now in place. Whether we get people beyond that would depend on future budget considerations.

MR. NIEDLEMAN (*See errata) Mark, can I just go back to that question and further elaborate a little bit on whether or not we would use it for prior notice. The standard for using or implementing an administrative detention is when the agency has credible evidence or information that the food product presents a threat of serious adverse-health consequences or death to humans or animals. Just not filing a prior notice, unless there is absent other information, would not raise (*See errata) to the standard for implementing an administrative detention.

MR. BARNETT: Okay. This one says, "If a product is detained for a period of time in which the product is no longer fit for consumption, then gets released, what responsibility falls on FDA?"

MR. LAKE: The procedures are designed to assure that there is care exercised by FDA and the statute provides some of that. Our proposed rule is providing additional safeguards. And, of course, one of the things, as Steve has just pointed out, is that the standard for using the authority is a pretty high standard.

But if the standard is met and we have followed the procedures, then, obviously, we believe that that food is a problem. We do not bear the responsibility of what happens to the food in that situation. It would be on the owner. This is not unlike what already exists with regard to seizures or with products that are refused entry into the U.S. because they are not in compliance with the U.S. law.

MR. NIEDLEMAN (*See errata) Just to further elaborate, again, we are sensitive to the fact that if a product is labeled as requiring refrigeration, or requiring certain storage conditions, that we would certainly assure that all effort is made to maintain those products and store them so that spoilage or deterioration is minimized

MS. FRASER: I guess, just to tag along, I think the other part of it is that the appeal process is designed to be as rapid as possible and FDA does recognize that there is a potential impact on foods. So we would look to be moving as quickly and as expeditiously as possible any time we did detain a food both to protect the public health if the food really did have that serious adverse-health consequence and then, conversely, to release a product as quickly as we could if it did not.

MR. BARNETT: This one says, "Does FDA have warehouses? Will the FDA use customs facilities for storing detained goods?"

MS. FRASER: It would depend on the circumstances. We would use facilities that we deem appropriate. It might be customs warehouses. It might be a warehouse where the food already exists if we think that is a secure facility and there is no danger of the food getting into commerce. So it really would be a case-by-case basis on where we would detain the food and that would be specified in the detention order, itself.

MR. LAKE: I want to add to that a little bit. FDA does not, itself, own warehouses so it wouldn't be in an FDA warehouse. But it would depend. Again, most of the situations, I believe, are going to happen where the product is found somewhere in the United States, not necessarily--in fact, I think generally not--at the border.

So it would be with whatever warehouse is available in the area so long as we can be assured that the product is not going to be further distributed to consumers.

MR. BARNETT: Okay. This one says, "How does the FDA plan to draw a distinction between an order of detention for a suspected act of bioterrorism and an historically more routine reason; for example, plant or supplier indirect accidental adulteration, and so on?"

MR. NIEDLEMAN (*See errata) Again, it is the standard by which we can implement the administrative detention authority, and that is credible evidence or information that the product poses a threat of serious adverse-health consequences or death. That is the standard that we would use to impose an administrative detention. That is what Congress gave us to use and that is what we would live by.

MR. BARNETT: So your answer essentially is that you are not drawing a distinction between--

MR. NIEDLEMAN (*See errata) Right.

MR. LAKE: Let me just add on to that. It is not going to be uncommon that we, through an analysis or otherwise, know that the product is dangerous or hazardous to people or animals long before we understand why it got hazardous. So the point is to keep it from getting to consumers. So we would not make the distinction as to how it got contaminated so long as, as Steve points out, the statutory standard is met.

MR. BARNETT: Okay. This one says, "Has FDA considered the economic impact of this proposal?"

MS. FRASER: Yes; we have and there is an extensive economic analysis for each of the rules that we have proposed and we do invite comments on those aspects of the proposal as well. In particular, to the extent that reviewers disagree with our assumptions or our analyses, we invite comment on that but what would be most helpful is accompanying data that supports the new analyses or the approaches that are offered.

MR. BARNETT: Okay. This one says, "Can the administrative detention or other provisions of the bioterrorism regulations be used for non-terrorist contaminations such as insects, bacteria and chemicals?" I think you touched on that.

MR. NIEDLEMAN (*See errata) Yes; while the regulations and the authority was granted under the Bioterrorism Act, it is not specific to bioterrorism or to a terrorist attack. It is based upon the standard of credible evidence of serious adverse-health consequences or death to humans or animals. It goes beyond just terrorist type of activities.

That is not to say insects may raise to (*See errata) that level or filth or contamination of such nature. We must meet the burden or the hurdles that were placed in front of us before we can use this tool.

MR. BARNETT: This one says, "Could extenuating circumstances ever exist to justify the immediate seizure and destruction," and destruction is underlined, "of an article without receipt of an order of detention?"

MR. LAKE: Now, that would be outside the procedures. Again, the purpose of detention is to keep the food from getting further into commerce, into consumers' hands, while we, then, go through the next step. The step that the statute has long provided is for us to go into federal court and file what amounts to a law suit against the goods.

At that point, the marshal takes over custody of those goods, take possession effectively, and then the matter is litigated in court. Now, arising out of that court decision, I mean, the product could be destroyed. But the idea is to keep it from moving while we go through the rest of this process.

MR. BARNETT: Right.

MR. NIEDLEMAN (*See errata) The other thing I want to clarify is the administrative-detention authority that we have is the authority is solely for administrative detention. It does not affect our ability to seize product without imposing an administrative detention as we currently do. We will seize product based upon filth, insect infestation, et cetera, as we have done for many, many, many years.

This is an ability to just freeze the product in place when we have credible evidence or information about the serious adverse-health consequences. We will still proceed with seizures without providing notice under administrative detention for other type of scenarios.

MR. BARNETT: Good. Okay. This one says, "If an importer or customs broker imports food on weekends and that food gets transported to another location not in the original FDA district it was imported through, if FDA wants to see if it can--" this is hard to read. "If the FDA wants to see it, can the shipment," commas would be helpful here, "If FDA wants to see it, can the shipment be inspected by another FDA district or returned to the original district?"

MS. FRASER: The question is, in terms of the procedures for detention, it is stopping the food where it currently is. So, if the food has moved from wherever it entered the country, or where it was manufactured in the country to another place in a different district, and that is where we determine that there is credible evidence or information of the serious adverse-health consequence, we would stop it here and it is now the FDA district director who is responsible for the new location that has to approve the detention order. It doesn't go back to the old FDA district director because that is where it originated.

MR. NIEDLEMAN (*See errata) There is additional authority under Bioterrorism Law that is associated with administrative detention but not included in the regulations; that is, FDA does have the authority to put a 24-hour hold on incoming products so that we can examine it and determine whether a detention would be appropriate or other action, including an import detention, et cetera. So it would depend upon the specific situation but, as Leslye says, if it is moved to another district, that is where it is detained, that district would have the jurisdiction.

MR. BARNETT: This one says, "On what legal authority are you relying to regulate foods that are not in interstate commerce"?

MS. FRASER: We did not see a limitation in this provision of the act that said that it was limited to food in interstate commerce. There are other provisions in the Act that specifically specify interstate commerce as a component of that requirement and so our interpretation of both records which applies to all persons who manufacture, process, pack, hold, transport, distribute, receive or import foods, we didn't see a limitation there or with respect to the ability to detain food administratively if it had a threat of serious adverse-health consequences, we see a limitation there.

So we did recognize that this is an important question and, as Bob said earlier, in both rules, you will see a specific request for comment on that issue.

MR. LAKE: Let me just elaborate on that a little bit, too. As a practical matter, most food is in interstate commerce or is in packaging that has been in interstate commerce. So what is purely intrastate these days is not a big percentage of the U.S. food supply.

Aside from that, even the stuff that might qualify as intrastate is generally affecting interstate commerce. So Congress, I believe, and this is not my area, but I believe they do have the authority, using that authority under the Constitution, to regulate the intrastate commerce. It appears that the way they wrote the law, to us, that that is what they did.

But, again, as we pointed out, we are inviting comment on that and we would be very interested in what people have to say.

MR. BARNETT: Okay. This one says, "When is the effective date for administrative detention ruling?"

MS. FRASER: Administrative-detention authority is in effect now. It was in effect when the Bioterrorism Act passed. These regulations would not take effect until after we issued the final rule and specified an effective date in that rule. And, as Bob said earlier, our goal is to publish the final rule by December 12 of this year and, under U.S. law, we would have to give at least thirty days notice before the rule could take effect.

So the earliest the proposed rule or the final rule could take effect would be thirty days after publication of the final rule.

MR. BARNETT: Okay. This one says, "If administrative detention is issued for a single article of food on an import vessel, a truck or plane, et cetera, with multiple articles, are all the articles on that vessel held or only the single article in question?"

MR. NIEDLEMAN (*See errata) That particular article of food would be segregated off. It would be marked. It would be identified and every effort would be made to minimize the chance of it being distributed in commerce. It would be segregated into a quarantine area or somehow, if the quarantine area isn't available, it would be roped off, tied off, et cetera. It would be segregated.

MS. FRASER: The one thing I would like to add to that, though; it also would depend on what we thought it was contaminated with or what was the serious health consequence or risk because you could have a situation where one article of food on that shipment was contaminated but it had the ability to cross-contaminate other shipments that were collocated, in which case, our credible evidence or information might be that it is not just the one that was contaminated but all of them might pose the serious health consequence, in which case--so it would be a case-by-case basis based on what we thought the credible evidence or information was.

MR. NIEDLEMAN (*See errata) It could cross-contaminate other product.

MR. BARNETT: I am going to do the same thing I did with the last panel. We keep getting these faxes in, which is wonderful, but it means that we are going to have to go a little bit quicker because we have got about ten minutes left.

I think you covered this before, Leslye, but I will ask you it again, just to be sure. "You refer to days in the appeals time line. Does that mean working days or calendar days?"

MS. FRASER: It means calendar days which means hearings could be held on a weekend or holiday.

MR. BARNETT: Okay. "Are pet foods exempt as they are in the recordkeeping regulation?"

MS. FRASER: No; they are not.

MR. BARNETT: "What information would be available to an owner of food product concerning testing of the product during the detention period?"

MR. NIEDLEMAN (*See errata) Can you repeat that, Mark?

MR. BARNETT: Yes. "What information would be available to the owner of a food product concerning testing of the product during the detention period?" In other words, I think it means are you going to let them know what you are doing?

MR. NIEDLEMAN (*See errata) We always--it is FDA's policy to share sample results, once they become available, with the owner of the property. When we collect a sample of a food, we also collect an (*See errata) sufficient supply for the owner to run parallel tests to do confirmatory testing of their own as well.

MR. BARNETT: Okay. It says, "Are administrative detentions going to be part of the public record and will they be available? Will detention records be in a searchable system like recalls and import alerts?"

MR. NIEDLEMAN (*See errata) Yes; they will. They have historically for medical devices and they will continue to be so for foods. That is public information.

MR. BARNETT: Okay. "Can you explain the difference between an import detention and an administrative detention?"

MR. NIEDLEMAN (*See errata) Certainly. The burden for an import detention is a much lower threshold for the agency. We just need to have an appearance of an adulterated or a misbranded product to be able to place a product under import detention and refuse its entry into the United States or provide an opportunity for someone to present evidence as to why that product should enter into this country.

For an administrative detention, as I mentioned before, you have a much higher threshold that you have credible evidence or information that the product poses a threat of serious adverse-health consequences or death, which is a much higher standard than just the appearance of adulteration or misbranding, which is why it is less likely we will use this authority for imported products.

MR. LAKE: I would just like to emphasize that. Because the word "detention" is here, and I can tell from the questions that a lot of the audience is thinking import detention, this really is about detained product that is moving in commerce within the United States.

Because of the authority that we already have and have been exercising for many, many year for keeping product out of the U.S., we will continue to use that when we know there is a problem when it is being offered for entry.

This authority that we are talking about here today is brand-new authority and it is not fundamentally about imports. It is about food moving in domestic commerce which means it is mainly going to be about U.S.-produced food. Now, it could be that a product that was imported and originally allowed in is later found to be contaminated or it could be that that product, whether it was originally import or manufactured in the U.S., was okay when it left the manufacturer and that somewhere in transit a terrorist got a hold of it and contaminated it.

It is in these situations where we find it somewhere in the United States and it triggers the standard that we would be detaining using this authority.

MS. FRASER: I would sort of like to go back to the pet-food question about why this applies to pet food. Again, it goes back to the standard of we can detain food that we see presents a threat of serious adverse-health consequences to death to humans or animals. So there could be instances where pet food or other food for animals that are used as food for humans would be at risk.

So that is why there is a distinction. With records, we looked at those records that we thought would be needed in areas that could most impact a trace-back investigation and the trace-forward investigation.

MR. BARNETT: Okay. We have about seven minutes before the program is over. We still have a few faxes. This one says, "It is not clear in the Act who will assume the cost of storage and protection of the food. This is especially important because foods can be detained for up to twenty or thirty days. Similarly, it is not clear who will pay the costs of labeling or marking the article of food. Who bears these costs?"

MR. LAKE: Basically, the cost is on the owner. If we find that the food presents a serious threat to humans, of serious adverse consequences or death to humans or animals, then, to execute our public-health responsibility, we have to act. The cost will be born by the owner of the product. However, the other aspect of that question with regard to marking, frankly, at least in my mind is less clear and we would invite comment on that.

MR. NIEDLEMAN (*See errata) Just to add to that. Traditionally, in the area of medical devices, the agency has marked the product, has identified it and segregated it.

MR. BARNETT: Okay. "Does the Act address procedures for reparation if the basis for the detention is proved to be groundless? We are concerned about both monetary losses and the reputation of the company."

MR. LAKE: The Act does not address that.

MR. BARNETT: Okay. These I think you have covered already. So I am finished with my pile of faxes. I am told that there is one more coming in, at the last minute. So we will wait for that one to come in.

This was a very good discussion, by the way. I think--ah; here we go. Last one. It says, "Does the detention proposal apply to food--"I think you covered this, but, "Does the detention proposal apply to food-contact material such as substances that migrate from packaging to food?"

MS. FRASER: Yes; it does. Under our definition of food, food-contact substances are considered food and this would give us the authority. Again, if it rises to that level of creating a serious health consequence, we would detain the food.

MR. LAKE: Let me just add to that. I think normally a migrant from a food-packaging material would not be. But it is certainly conceivable that a terrorist could decide to line food packaging with something that would pose a serious threat to humans. Certainly, in that context where it migrated into the food, it would be a food. So, if we found it, we would act against it.

MR. BARNETT: That is the last word. I thank you all. This was a very good discussion. We hope you found this broadcast interesting and that the information is going to be useful to you. Again, we really want your comments on these two regulations, so please send them to our Dockets Management Branch.

In just a moment, we are going to show that address on your screen as well as the FDA Bioterrorism website address where you can get information on future broadcasts. Until then, this is Mark Barnett.

[Whereupon, at 2:55 p.m., the broadcast was concluded.]

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(See Errata Sheet)