[Federal Register Volume 68, Number 90 (Friday, May 9, 2003)]
[Proposed Rules]
[Pages 25242-25271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11459]



[[Page 25241]]

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Part V





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Parts 1 and 16



Administrative Detention of Food for Human or Animal Consumption Under 
the Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002; Proposed Rule

  Federal Register / Vol. 68, No. 90 / Friday, May 9, 2003 / Proposed 
Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 16

[Docket No. 02N-0275]
RIN 0910-AC38


Administrative Detention of Food for Human or Animal Consumption 
Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is proposing a 
regulation that provides procedures for the detention of an article of 
food, if an officer or qualified employee of FDA has credible evidence 
or information indicating that such article presents a threat of 
serious adverse health consequences or death to humans or animals 
(``administrative detention''). The proposed regulation implements the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (the Bioterrorism Act), which authorizes the use of 
administrative detentions and requires regulations establishing 
procedures for instituting on an expedited basis certain enforcement 
actions against perishable food subject to a detention order.

DATES: Submit written or electronic comments by July 8, 2003.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Marquita Steadman, Center for Food 
Safety and Applied Nutrition (HFS-007), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-827-6733.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background and Legal Authority
II. Preliminary Stakeholder Comments
III. The Proposed Regulation
    A. Highlights of Proposed Rule
    B. General Provisions
    1. What Definitions Apply to This Subpart? (Proposed Sec.  1.377)
    2. What Criteria Does FDA Use to Order a Detention? (Proposed Sec.  
1.378)
    3. How Long May FDA Detain an Article of Food? (Proposed Sec.  
1.379)
    4. Where and Under What Conditions Must the Detained Article of 
Food be Held? (Proposed Sec.  1.380)
    5. May a Detained Article of Food be Delivered to Another Entity or 
Transferred to Another Location? (Proposed Sec.  1.381)
    6. What Labeling or Marking Requirements Apply to a Detained 
Article of Food? (Proposed Sec.  1.382)
    7. What Expedited Procedures Apply When FDA Initiates a Seizure 
Action Against a Detained Perishable Food? (Proposed Sec.  1.383)
    8. When Does a Detention Order Terminate? (Proposed Sec.  1.384)
    C. How Does FDA Order a Detention?
    1. Who Approves a Detention Order? (Proposed Sec.  1.391)
    2. Who Receives a Copy of the Detention Order? (Proposed Sec.  
1.392)
    3. What Information Must FDA Include in the Detention Order? 
(Proposed Sec.  1.393)
    D. What is the Appeal Process for a Detention Order?
    1. Who is Entitled to Appeal? (Proposed Sec.  1.401)
    2. What Are the Requirements for Submitting an Appeal? (Proposed 
Sec.  1.402)
    3. What Requirements Apply to an Informal Hearing? (Proposed Sec.  
1.403)
    4. Who Serves as the Presiding Officer at an Informal Hearing? 
(Proposed Sec.  1.404)
    5. When Does FDA Have to Issue a Decision on an Appeal? (Proposed 
Sec.  1.405)
    6. How Will FDA Handle Classified Information in an Informal 
Hearing? (Proposed Sec.  1.406)
IV. Conforming Amendment to 21 CFR Part 16
V. Analysis of Economic Impact
    A. Benefit-Cost Analysis
    B. Initial Regulatory Flexibility Analysis
    C. Unfunded Mandates
    D. SBREFA Major Rule
VI. Paperwork Reduction Act of 1995
VII. Analysis of Environmental Impact
VIII. Federalism
IX. Comments
X. References

I. Background and Legal Authority

    The events of September 11, 2001, highlighted the need to enhance 
the security of the U.S. food supply. Congress responded by passing the 
Bioterrorism Act (Public Law 107-188), which was signed into law on 
June 12, 2002. The Bioterrorism Act includes a provision in title III 
(Protecting Safety and Security of the Food and Drug Supply), Subtitle 
A (Protection of Food Supply), section 303, which amends section 304 of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 334 et 
seq.) by adding paragraph (h) to provide that an officer or qualified 
employee of FDA may order the detention of any article of food that is 
found during an inspection, examination, or investigation under the act 
if the officer or qualified employee has credible evidence or 
information indicating that the article of food presents a threat of 
serious adverse health consequences or death to humans or animals. This 
provision also requires the Secretary of Health and Human Services (the 
Secretary) to provide by regulation procedures for instituting on an 
expedited basis certain enforcement actions against perishable food 
subject to a detention order. Section 303 of the Bioterrorism Act also 
amends the act by adding a new prohibited act as paragraph (bb) to 
section 301 of the act (21 U.S.C. 331)
    The major components of section 303 of the Bioterrorism Act are as 
follows:
    [sbull] Criteria used to trigger an administrative detention: 
Amends section 304 of the act to authorize an officer or qualified 
employee of FDA to order the detention of any article of food that is 
found during an inspection, examination, or investigation under the 
act, if the officer or qualified employee has credible evidence or 
information indicating such article presents a threat of serious 
adverse health consequences or death to humans or animals.
    [sbull] Approval required: The Secretary, or an official designated 
by the Secretary, must approve the detention order. An ``official 
designated by the Secretary'' means the District Director of the 
district where the detained article of food is located, or an FDA 
official senior to such director.
    [sbull] Period of detention: The detention period will be for a 
reasonable period, not to exceed 20 days, unless a greater period, not 
to exceed 30 days, is necessary to enable the Secretary to institute a 
seizure or injunction action.
    [sbull] Required rulemaking: The Secretary must by regulation 
provide for procedures for instituting certain enforcement actions on 
an expedited basis with respect to perishable food subject to a 
detention order.
    [sbull] Security of detained article of food: The detention order 
may require that the detained article of food be labeled or marked as 
detained. The order must require the removal of the detained article of 
food to a secure facility, as appropriate.
    [sbull] Appeal procedure: Any person who would be entitled to claim 
the detained article of food if such article were seized may appeal the 
detention order to the Secretary. Within 5 days after such

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appeal is filed, after providing opportunity for an informal hearing, 
the Secretary must confirm or terminate the detention order. The appeal 
process terminates if the Secretary institutes an action for seizure or 
injunction regarding the article of food involved. Confirmation of a 
detention order is considered a final agency action.
    [sbull] Prohibited act: Amends section 301 of the act making it a 
prohibited act to transfer a detained article of food in violation of a 
detention order, or to remove or alter any mark or label required by 
the detention order to identify the article of food as detained.
    Section 303 of the Bioterrorism Act also includes a provision 
authorizing temporary holds at ports of entry that will not be 
addressed in this proposed regulation, but through separate guidance 
that FDA plans to develop and issue. The temporary hold provision 
authorizes FDA to request the Secretary of Treasury to institute a 
temporary hold for up to 24 hours on an article of food offered for 
import at a U.S. port of entry if FDA has credible evidence or 
information indicating that an article of food presents a threat of 
serious adverse health consequences or death to humans or animals, and 
FDA is unable immediately to inspect, examine, or investigate such 
article. FDA has received comments on the temporary hold provision in 
the public docket (Docket No. 02N-0275). FDA plans to consider these 
comments in developing guidance on the temporary hold provision.
    FDA is proposing to amend title 21 of the Code of Federal 
Regulations (CFR) by establishing a new subpart to part 1 (21 CFR part 
1) consisting of subpart K entitled ``Administrative Detention of Food 
for Human or Animal Consumption.'' In this proposed rule, we describe 
the procedures for how FDA will detain an article of food and the 
process for appealing a detention order. We also address procedures for 
instituting on an expedited basis certain enforcement actions with 
respect to detained perishable foods. This proposed rule also makes a 
conforming amendment to part 16 (21 CFR part 16) entitled ``Regulatory 
Hearing Before the Food and Drug Administration.'' Although the 
statutory requirements in section 304(h) of the act are self-executing 
and are currently in effect, FDA is issuing this regulation to further 
refine aspects of the administrative detention requirements.
    The administrative detention process described in this proposed 
rule is modeled after FDA's medical device administrative detention 
regulation found at Sec.  800.55 (21 CFR 800.55). FDA believes that 
this process has been effective and efficient for medical device 
administrative detentions and should also work well for administrative 
detentions of food. In addition, using the medical device regulations 
as a model will be helpful to the agency as field offices are familiar 
with this detention process and training will not need to be as 
extensive.
    Section 303 of the Bioterrorism Act provides for an opportunity for 
an informal hearing as part of the appeal process. The regulations in 
part 16 set out FDA's informal hearing procedures and provide that its 
procedures apply when the act or FDA regulations provide for an 
opportunity for a hearing and no specific hearing regulations exist 
(see Sec.  16.1(b)). Proposed Sec.  1.403 states that any informal 
hearing held on an appeal of a detention order will be conducted in 
accordance with part 16 except as noted therein.
    Although section 303 of the Bioterrorism Act requires FDA only to 
promulgate regulations establishing procedures for instituting on an 
expedited basis certain enforcement actions against perishable food 
subject to a detention order, FDA also is proposing in this regulation 
to describe the procedures for how FDA will detain both perishable and 
nonperishable articles of food and the process for appealing a 
detention order. If FDA did not establish other requirements for the 
process for appealing a detention order in this proposed regulation, it 
would be difficult for FDA to meet certain requirements in section 303 
of the Bioterrorism Act. For example, section 303 of the Bioterrorism 
Act requires FDA, after providing an opportunity for an informal 
hearing, to confirm or terminate a detention order within 5 days after 
the date of appeal. Two of the requirements in this proposed rule would 
be to impose a deadline for filing an appeal and a limitation on the 
length of the informal hearing (see proposed Sec. Sec.  1.402 and 
1.403). These proposed requirements are intended to ensure that FDA 
meets section 303's timing requirements. FDA is proposing to codify the 
procedures for how FDA will detain an article of food to clarify our 
procedures for the public and to follow FDA's model for the 
administrative detention of medical devices that has its procedures 
codified at 21 CFR 800.55. FDA is proposing to incorporate these 
provisions in a regulation instead of a guidance document to make them 
enforceable since guidance documents are not binding.
    FDA wants to make clear that this proposed rule does not implement 
section 801 of the act (21 U.S.C. 381), despite its use of the term 
``detention''. As explained in this preamble, this proposed rule 
implements section 303 of the Bioterrorism Act, which amends section 
304 of the act. This amendment grants FDA the authority to detain food 
upon credible evidence or information of a threat of serious adverse 
health consequences or death to humans or animals. FDA has had similar 
authority for medical devices under section 304(g) of the act since 
1976, and usually refers to this authority as ``administrative 
detention'' (Sec.  800.55). Section 801(a) of the act provides that FDA 
shall refuse the admission of any article of food that has been 
imported or offered for import that appears, among other things, to be 
adulterated or misbranded under the act, based on physical examination 
or otherwise. Under section 801(a), before FDA refuses admission to an 
article that appears violative, importers are provided with a notice of 
hearing on refusal of admission, which notifies them that the article 
may be subject to refusal of admission, and provides them with an 
opportunity to introduce testimony and establish that the article is 
fully in compliance with the act (Sec.  1.94). FDA refers to this 
administrative process concerning imports as detention (see ``FDA 
Regulatory Procedures Manual'' (RPM), chapter 9). Because of the 
authorities available to FDA and the U.S. Customs Service to control 
imported food subject to section 801(a) of the act, FDA does not expect 
to frequently use administrative detention under section 303 of the 
Bioterrorism Act to control such imported food.
    Section 304(h) of the act, as added by section 303 of the 
Bioterrorism Act, provides that:
    An officer or qualified employee of the Food and Drug 
Administration may order the detention, in accordance with this 
subsection, of any article of food that is found during an 
inspection, examination, or investigation under this Act conducted 
by such officer or qualified employee, if the officer or qualified 
employee has credible evidence or information indicating that such 
article presents a threat of serious adverse health consequences or 
death to humans or animals.
    This language does not include a limitation similar to that in 
section 304(g) of the act that provides for administrative detentions 
of devices during inspections conducted under section 704 of the act, a 
provision of the act that has an interstate commerce component. In 
addition, the prohibited act related to administrative detention of 
food, section 301(bb) of the act, unlike some other prohibited acts in 
section 301, does not include an interstate commerce component.

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Therefore, FDA tentatively concludes that all food would be subject to 
administrative detention under section 304(h) of the act, whether or 
not the food enters interstate commerce. Because a bioterrorist threat 
involving food or other food-related emergencies would have the same 
effect on the public health regardless of whether the food had 
originated from an out of State source, FDA believes that 
administrative detention should apply to all food, whether or not the 
food was in interstate commerce. FDA recognizes, however, that section 
304(h) of the act is not clear in this regard. For example, section 
304(h) includes references to certain enforcement provisions of the 
act, such as section 304(a) of the act, an enforcement provision that 
includes an interstate commerce requirement. Because this is an 
important and controversial issue, the agency is seeking comment on 
whether its tentative conclusion that it has authority to 
administratively detain food in intrastate commerce is correct and, if 
so, whether FDA should use that authority. FDA also seeks comments on 
the amounts and types of food that would only be in intrastate 
commerce.
    This proposed rule complies with section 315 of the Bioterrorism 
Act entitled ``Rule of Construction,'' which states that nothing in 
title III of the Bioterrorism Act, or an amendment made by title III, 
shall be construed to alter the jurisdiction between the U.S. 
Department of Agriculture (USDA) and the U.S. Department of Health and 
Human Services under applicable statutes and regulations. Accordingly, 
this proposed rule does not apply to food regulated exclusively by the 
USDA under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the 
Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg 
Products Inspection Act (21 U.S.C. 1031 et seq.). However, food that is 
jointly regulated by FDA and USDA would be subject to this proposed 
rule. An example of a food that is jointly regulated by FDA and USDA is 
frozen TV dinners containing both meat and fish.
    In addition to section 303 of the Bioterrorism Act, which amends 
the act as described previously in section I of this document, FDA is 
relying on section 701(a) of the act (21 U.S.C. 371(a)) in issuing this 
proposed rule. Section 701(a) authorizes the agency to issue 
regulations for the efficient enforcement of the act.

II. Preliminary Stakeholder Comments

    On July 17, 2002, FDA sent an open letter to members of the public 
interested in food issues outlining the four provisions of title III of 
the Bioterrorism Act which require FDA to issue regulations in an 
expedited time period, and FDA's plans for implementing them (see 
http://www.cfsan.fda.gov/[tilde]dms/sec-ltr.html). In the letter, FDA 
invited stakeholders to submit comments to FDA by August 30, 2002, for 
FDA's consideration as it developed this proposed rule. FDA also held 
several meetings with representatives of industry, consumer groups, 
other Federal agencies, and foreign embassies after sending out the 
July 17, 2002, letter in order to solicit stakeholder comments. In 
response to these solicitations, FDA received a number of comments 
regarding section 303 of the Bioterrorism Act.
    FDA has considered all the comments received by August 30, 2002. 
FDA will consider all comments we have received so far with the 
comments we receive during the public comment period for this proposed 
rule in developing the final rule.
    Some of the significant comments FDA received on or before August 
30, 2002, include the following:
    [sbull] The regulations should apply to all foods within FDA's 
jurisdiction, (e.g., processed food, fresh agriculture, and dietary 
supplement products).
    [sbull] The written notice of detention should describe the article 
of food that has been detained, the quantity of the food, its location, 
and the basis for the detention. A written notice of detention also 
should include a written explanation of the appeal right and 
information that will enable a person entitled to appeal to understand 
how to file such an appeal.
    [sbull] FDA's regulations should ensure that if a detained article 
of food is moved to a secure facility, the food will be maintained 
under temperature, humidity, and other conditions that will maintain 
the value and quality of the food.
    [sbull] A period of 24 to 48 hours from the time of request to the 
time of holding a hearing is the appropriate timeframe given the short 
life of many perishable foods.
    [sbull] Any regulations with respect to detention of food should 
specify how disputes and resolutions will be handled in order to help 
prevent spoilage of detained food.
    [sbull] When an appeal against the detention is filed, FDA should 
deal with it expeditiously within a fixed period of time to minimize 
the impact on private businesses.
    [sbull] An appellant should be entitled to file a written statement 
of his or her position. The findings of the Secretary after the hearing 
should be set forth in writing since the Bioterrorism Act provides that 
the Secretary's decision is ``final agency action'' under the 
Administrative Procedure Act, which is judicially reviewable.
    [sbull] A sanction should be imposed if the detained product is 
moved before the detention period has expired or has been terminated.

III. The Proposed Regulation

    This proposed rule implements the administrative detention 
provision in section 303 of the Bioterrorism Act. If the regulation is 
made final as proposed, administrative detention, together with the 
proposed rules implementing section 305 (registration), section 306 
(recordkeeping), and section 307 (prior notice) of the Bioterrorism 
Act, will enable FDA to act quickly in responding to a threatened or 
actual bioterrorist attack on the U.S. food supply or to other food-
related emergencies.
    In establishing and implementing this proposed rule, FDA will 
comply fully with its international trade obligations, including 
applicable World Trade Organization (WTO) agreements and the North 
American Free Trade Agreement. For example, FDA believes this proposed 
rule is not more trade-restrictive than necessary to meet the 
objectives of the Bioterrorism Act. The criteria FDA would use to order 
a detention are taken directly from the Bioterrorism Act and are the 
same for both domestic and foreign articles of food.

A. Highlights of Proposed Rule

    The key features of this proposed rule are as follows:
    [sbull] An officer or qualified employee of FDA may order the 
detention of domestic or imported food for up to 30 days if FDA has 
credible evidence or information that the food presents a threat of 
serious adverse health consequences or death to humans or animals.
    [sbull] The FDA District Director in the district in which the 
article of food is located or an FDA official senior to such director 
must approve a detention order.
    [sbull] FDA may require that the detained article of food be 
labeled or marked as detained with official FDA tags or labels. The FDA 
tag or label will include, among other information, a statement that 
the article of food must not be consumed, moved, altered, or tampered 
with in any manner for the period shown, without the written permission 
of an authorized FDA representative.
    [sbull] A violation of a detention order or the removal or 
alteration of the tag or label is a prohibited act.

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    [sbull] FDA will state in the detention order the location and any 
applicable conditions under which the food is to be held.
    [sbull] FDA may direct that the article of food be moved to a 
secure facility, if appropriate. An article of food moved to a secure 
facility remains under detention before, during, and after such 
movement.
    [sbull] FDA may approve a request for a limited conditional release 
of a detained article of food for purposes of destruction, movement to 
a secure facility, preservation of the detained article of food, or any 
other purpose that FDA believes is appropriate. An article of food 
transferred under a limited conditional release remains under detention 
before, during, and after the transfer.
    [sbull] Any transfer of a detained article of food in violation of 
a detention order is a prohibited act.
    [sbull] Any person who would be entitled to be a claimant for the 
article of food, if seized, may appeal a detention order and, as part 
of that appeals process, may request an informal hearing. If a hearing 
is granted, an FDA Regional Food and Drug Director (RFDD) or another 
official senior to an FDA District Director will serve as the presiding 
officer of the hearing.
    [sbull] The proposed rule includes appeal and hearing timeframes 
for both perishable and nonperishable detained articles of food.
    [sbull] Perishable food:
    - An appeal must be filed within 2 calendar days of receipt of the 
detention order.
    - If a hearing is requested in the appeal, and FDA grants the 
request, the hearing will be held within 2 calendar days after the date 
the appeal is filed.
    - FDA's decision on appeal will be issued 5 days after the appeal 
is filed.
    [sbull] Nonperishable food:
    - A notice of intent to file an appeal and to request a hearing 
must be filed within 4 calendar days of receipt of the detention order.
    - An appeal must be filed within 10 calendar days of receipt of the 
detention order.
    - If a hearing is requested in the notice of intent and appeal, and 
FDA grants the request, the hearing will be held within 3 calendar days 
after the appeal is filed.
    - FDA's decision on appeal will be issued 5 days after the appeal 
is filed.
    [sbull] The proposed expedited procedures for certain enforcement 
actions with respect to perishable foods require FDA to send a seizure 
recommendation to the Department of Justice within 4 calendar days 
after the detention order is issued, unless extenuating circumstances 
exist.
    [sbull] Confirmation of a detention order by the FDA presiding 
officer is considered final agency action.

B. General Provisions

1. What Definitions Apply to This Subpart? (Proposed Sec.  1.377)
    Proposed Sec.  1.377 describes the definitions that apply to this 
subpart and states that the definition of terms that appear in section 
201 of the act (21 U.S.C. 321) apply to such terms when used in this 
subpart.
    Proposed Sec.  1.377 also defines specific terms used in the 
proposal.
    [sbull] Act means the Federal Food, Drug, and Cosmetic Act.
    [sbull] Authorized FDA representative means the FDA District 
Director in whose district the article of food involved is located or 
an FDA official senior to such director. FDA's Office of Regulatory 
Affairs (ORA) is responsible for FDA's field operations and compliance 
related functions. The ORA field organization is divided into regional 
offices, which are headed by RFDDs. The regions are broken down into 
district offices, which are headed by District Directors. An RFDD is an 
FDA official senior to an FDA District Director.
    [sbull] Calendar day means every day shown on the calendar. This 
term includes weekend days.
    [sbull] Food has the meaning given in section 201(f) of the act. 
That definition is: ``(1) articles used for food or drink for man or 
other animals, (2) chewing gum, and (3) articles used for components of 
any such article.'' FDA also is proposing to include some examples of 
products that are considered food under section 201(f) of the act. 
These examples include, but are not limited to: Fruits; vegetables; 
fish; dairy products; eggs; raw agricultural commodities for use as 
food or components of food; animal feed, including pet food; food and 
feed ingredients and additives, including substances that migrate into 
food from food packaging and other articles that contact food; dietary 
supplements and dietary ingredients; infant formula; beverages, 
including alcoholic beverages and bottled water; live food animals 
(such as hogs and elk); bakery goods; snack foods; candy; and canned 
foods. ``Substances that migrate into food from food packaging'' 
include immediate food packaging or components of immediate food 
packaging that are intended for food use. Outer food packaging is not 
considered a substance that migrates into food.
    [sbull] Perishable food means food that is not heat-treated; not 
frozen; and not otherwise preserved in a manner so as to prevent the 
quality of the food from being adversely affected if held longer than 7 
days under normal shipping and storage conditions. This perishable food 
definition has been modeled after the current RPM definition of 
``perishable commodity''. Examples of perishable foods include, but are 
not limited to, fluid milk (but not ultrapasteurized); live fish, 
lobster, crab, other crustaceans, shellfish; and fresh fruits and 
vegetables.
    We decided to use the RPM definition of ``perishable commodity'' as 
the basis for the definition of ``perishable food'' because the RPM 
definition is commonly used and understood by both industry and FDA. 
Furthermore, we believe this definition is appropriate in light of the 
5-day (maximum) deadline for FDA to issue a decision on an appeal of a 
detention. Under the proposed deadlines for appeals involving the 
detention of a perishable food, FDA would issue a decision on an appeal 
prior to the expiration of the 7-day period. We believe the timeframes 
proposed here offer the best protection to appellants and products.
    We invite comments and supporting data on how to best define 
``perishable food'' for the purposes of this proposed rule.
    [sbull] We means the U.S. Food and Drug Administration.
    [sbull] Working day means any day from Monday through Friday, 
excluding federal holidays.
    [sbull] You means any person who receives the detention order or 
that person's representative.
2. What Criteria Does FDA Use to Order a Detention? (Proposed Sec.  
1.378)
    Proposed Sec.  1.378 states the criteria FDA would use to order a 
detention. These criteria are taken directly from section 303 of the 
Bioterrorism Act. FDA may order a detention of an article of food that 
is found during an inspection, examination, or investigation under the 
act if an officer or qualified employee of FDA has credible evidence or 
information indicating that an article of food presents a threat of 
serious adverse health consequences or death to humans or animals.
    The Bioterrorism Act articulates a standard of ``credible evidence 
or information'' for determinations of whether the evidence or 
information indicates that an article of food presents a threat of 
serious adverse health consequences or death to humans or animals. 
``Credible evidence or information'' is an evidentiary standard that in 
simplest terms means evidence

[[Page 25246]]

or information that is ``worthy of belief or confidence; trustworthy.'' 
See Webster's Unabridged Dictionary (1998 ed.) (definition of 
``credible''). Although various statutes and regulations use this or a 
similar standard, and courts have invoked or applied the standard of 
credible evidence or information in a large number of decisions, no 
precise definition of the standard exists. Instead, determinations of 
what constitutes credible evidence or information have been made on a 
case-by-case basis. Likewise, FDA has administered evidentiary 
standards under other provisions of the act (see e.g., section 304(g)) 
on a case-by-case basis without further defining those standards in 
regulation. We believe that a similar approach here is appropriate. In 
applying the credible evidence or information standard to 
administrative detention, FDA may consider a number of factors 
including, but not limited to, reliability, reasonableness, and the 
totality of the facts and circumstances.
    The officers or qualified employees of FDA who may order a 
detention include, but are not limited to, FDA field investigators, 
other government employees commissioned or deputized by FDA, and FDA 
employees who have security clearance to receive national security 
information. An ``authorized FDA representative'' as defined in 
proposed Sec.  1.377, would have to approve a detention order before 
the FDA officer or qualified employee may order a detention.
3. How Long May FDA Detain an Article of Food? (Proposed Sec.  1.379)
    Proposed Sec.  1.379 sets forth the period of administrative 
detention, (i.e., the length of time an article of food may be 
detained), consistent with the requirements of section 303 of the 
Bioterrorism Act. The period of administrative detention must be a 
reasonable period that may not exceed 20 calendar days after the 
detention order is issued, unless it is determined that a greater 
period is required either to seize the article of food or to institute 
injunction proceedings. The Bioterrorism Act provides that FDA may 
detain food for up to 10 additional calendar days if necessary to 
enable FDA to institute a seizure or an injunction action. Proposed 
Sec.  1.379 incorporates this authority. An example of when FDA 
envisions using this authority is when the results of confirmatory 
testing or other evidentiary development is not complete. The 
authorized FDA representative, defined in proposed Sec.  1.377, may 
approve the additional 10 days of detention at the time the detention 
order is issued, or at any time within the initial 20-calendar-day 
period, by amending the detention order.
    Proposed Sec.  1.379 states that the entire detention period may 
not exceed 30 calendar days in total. This proposed section also allows 
the authorized FDA representative, in accordance with proposed Sec.  
1.384, to approve the termination of a detention order before the 
expiration of the detention period. FDA intends to proceed as 
expeditiously as possible to resolve all issues involved with 
particular administrative detentions.
4. Where and Under What Conditions Must the Detained Article of Food be 
Held? (Proposed Sec.  1.380)
    Proposed Sec.  1.380(a) requires you to hold the detained article 
of food in the location and under the conditions specified by FDA in 
the detention order. Use of appropriate storage conditions, such as 
temperature, humidity, and other conditions may be necessary to protect 
the safety and wholesomeness of the detained article of food. This 
proposed requirement is consistent with the legislative history of the 
Bioterrorism Act (see H. Conf. Rept. No. 107-481, at 131 (2002)).
    In proposing Sec.  1.380(a), we also considered the experience that 
States have had with embargoes. As described in comments from States 
familiar with embargoing food on behalf of FDA or on their own 
initiative, States have ordered food embargoed and have provided 
requisite conditions that must be maintained while the food is 
embargoed, e.g., segregation from other products in the same warehouse.
    In proposed Sec.  1.380(b), the detained article of food must be 
moved to a secure facility if FDA determines that such movement is 
appropriate. FDA's determination of whether it is appropriate to 
require movement of a detained article will depend, in part, on whether 
we believe there is danger of the detained article entering the stream 
of commerce. FDA will make such determinations on a case-by-case basis 
considering several factors, including the adequacy of security where 
the detained article is located, and the ability to prevent the 
movement of the food. For example, if it appears likely that the 
detained food would be diverted, we would require the food to be moved 
to a secure facility. However, if the storage conditions are such that 
there appears to be no danger of the detained article of food moving 
into the stream of commerce, we would decide to keep the article of 
food detained at its current location.
    There may be instances where we relocate the detained article of 
food to a secure facility. For example, FDA may not be confident that 
parties involved will adhere to a detention order. Rather than risk 
losing control over the detained article of food, FDA would relocate 
the detained article of food. There may be other situations where FDA 
decides to relocate the detained article to a secure facility.
    Proposed Sec.  1.380(b), also states that a detained article of 
food remains under detention before, during, and after movement to a 
secure facility, if FDA has requested such movement. As such, we will 
also state in the detention order any applicable conditions of 
transportation of an article of detained food. This may include 
determinations that the article to be removed to a secure facility must 
be moved under certain conditions. Similar to determinations of whether 
to require that food be removed to a secure facility, determinations of 
the appropriate conditions of transportation will be made on a case-by-
case basis.
    Proposed Sec.  1.380(c) requires you to have received a limited 
conditional release under proposed Sec.  1.381(c) before you move the 
detained article of food to a secure facility.
    Proposed Sec.  1.380(d) requires you to ensure that any required 
tags or labels under Sec.  1.382 accompany the detained article during 
and after movement to the secure facility. This requirement applies 
until FDA terminates the detention order or the detention period 
expires, whichever occurs first, unless otherwise permitted by the 
authorized FDA representative.
    Proposed Sec.  1.380(e) provides that the movement of an article of 
food in violation of a detention order issued under Sec.  1.393 is a 
prohibited act under section 301 of the act. This proposed provision is 
consistent with the statutory language in section 303 of the 
Bioterrorism Act.
5. May a Detained Article of Food be Delivered to Another Entity or 
Transferred to Another Location? (Proposed Sec.  1.381)
    Proposed Sec.  1.381 describes whether an article of food subject 
to a detention order can be delivered to another entity or transferred 
to another location. Proposed Sec.  1.381(a) states that a detained 
article of food may not be delivered to another entity under the 
execution of a bond. Similarly, this proposed section also states that 
an article of food detained under section 303 of the Bioterrorism Act 
may not be delivered to any of its importers, owners, or consignees 
under section

[[Page 25247]]

801(b) of the act. The provisions found in this proposed paragraph are 
consistent with section 303 of the Bioterrorism Act, and are designed 
to keep foods that present a threat of serious adverse health 
consequences or death from moving in commerce.
    Proposed Sec.  1.381(b) prohibits, except as provided in proposed 
Sec.  1.381(c), the transfer of a detained article of food within or 
from the place where it has been detained, or from the place to which 
it was moved, until an authorized FDA representative releases the 
article of food under proposed Sec.  1.384 or the detention period 
expires under proposed Sec.  1.379, whichever occurs first. This 
provision is necessary to ensure that the article of food subject to a 
detention order is not released into commerce.
    Proposed Sec.  1.381(c) provides that an authorized FDA 
representative may approve, in writing, a request for a limited 
conditional release of the detained article of food for any of the 
following purposes:
    1. To destroy the article of food,
    2. To move the detained article of food to a secure facility as 
described in the detention order,
    3. To maintain or preserve the integrity or quality of the article 
of food, or
    4. For any other purpose that the authorized FDA representative 
believes is appropriate in that case.
    A limited conditional release of a detained article of food will be 
considered only in rare circumstances and only for the purposes 
described. We do not envision authorizing a limited conditional release 
under many circumstances because any movement increases the risk of 
inappropriate or unauthorized movement of detained articles of food 
into commerce. In order to decrease the chance of detained articles of 
food moving into commerce, the food should not be moved unless 
absolutely necessary. However, we recognize there may be cases where 
some movement is necessary. For example, it may be necessary to take 
steps to preserve the article of food until the detention is resolved, 
e.g., movement of a detained article of food from refrigerated storage 
to a freezer. This proposed section would allow such action in those 
limited circumstances that the agency finds appropriate.
    As noted below, an article of food subject to a limited conditional 
release is still subject to detention and the requirements of this 
proposed rule.
    Proposed Sec.  1.381(d) requires you to submit a request for a 
limited conditional release in writing to the authorized FDA 
representative who approved the detention order. Your request must 
state the following:
    [sbull] Reasons for movement;
    [sbull] Exact address of and location in the new facility (or the 
new location within the same facility) where the detained article of 
food will be transferred;
    [sbull] Explanation of how the new address and location will be 
secure, if FDA has directed that the article of food be detained in a 
secure facility; and
    [sbull] Explanation of how the article of food will be held under 
any applicable conditions described in the detention order.
    If your request is for the purpose of destroying the detained 
article of food, you also must submit a verified statement identifying 
the ownership or proprietary interest you have in the detained article 
of food. Under ``Federal Rules of Civil Procedure,'' Supplemental Rule 
C(6)(a), a person who asserts an interest in or right against property 
that is the subject of a seizure action in federal court must file a 
verified statement identifying the interest or right. The purpose of 
this requirement is to minimize the possibility that the detained 
article of food would be released for destruction to a person without 
the proper ownership or proprietary interest in the food.
    Proposed Sec.  1.381(e) states that a detained article of food 
remains under detention before, during, and after the transfer under a 
limited conditional release. Accordingly, we will prescribe applicable 
transportation conditions to an article transferred under a limited 
conditional release. This section also provides another security 
measure to prevent the detained article of food from moving into 
commerce. That is, we also require FDA supervision of all transfers of 
detained articles of food made under a limited conditional release, 
unless FDA declines such supervision in writing. If FDA declines such 
supervision, you will be required to immediately notify in writing the 
authorized FDA representative who approved the limited conditional 
release, that the article of food has reached its new location, and the 
specific location of the detained article of food within the new 
location. Such notification may be in the form of a fax, e-mail, or 
other form agreed to by the authorized FDA representative.
    Proposed Sec.  1.381(f) requires you to ensure that any tags or 
labels required under proposed Sec.  1.382 accompany the detained 
article of food during and after movement. If FDA labels or marks the 
detained article of food under proposed Sec.  1.382, this proposed 
provision would require that the tags or labels remain with the article 
of food until FDA terminates the detention order or the detention 
period expires, whichever occurs first, unless otherwise permitted by 
the approving official.
    Proposed Sec.  1.381(g) provides that the transfer of an article of 
food in violation of a detention order issued under proposed Sec.  
1.393 is a prohibited act under section 301 of the act. This proposed 
provision is consistent with the statutory language in section 303 of 
the Bioterrorism Act.
6. What Labeling or Marking Requirements Apply to a Detained Article of 
Food? (Proposed Sec.  1.382)
    Proposed Sec.  1.382 describes the labeling or marking requirements 
that apply to a detained article of food. This proposed section states 
that the officer or qualified employee of FDA who issues the detention 
order may label or mark the detained article of food with official FDA 
tags or labels that include the following information:
    [sbull] A statement that the article of food is detained by FDA in 
accordance with section 304(h) of the act;
    [sbull] A statement that the article of food must not be consumed, 
moved, altered, or tampered with in any manner for the period shown, 
without the written permission of an authorized FDA representative;
    [sbull] A statement, consistent with the statutory language in 
section 303 of the Bioterrorism Act, that the violation of a detention 
order or the removal or alteration of the tag or label is a prohibited 
act under section 301 of the act, punishable by fine or imprisonment or 
both; and
    [sbull] The detention order number, the date and hour of the 
detention order, the detention period, and the name of the officer or 
qualified employee of FDA who issued the detention order.
    Any label or mark of detention will be attached as appropriate 
given the circumstances. In some instances, the mark or label may be 
attached to the food container, while in other instances, the mark may 
be fastened to a packing container. Where the agency cannot mark or 
label a container or packing container, a mark or label may be attached 
to accompanying documents. FDA may use other means of marking or 
labeling as appropriate or necessary. Once the detained article is 
released, or the detention period expires, FDA would remove, or 
authorize the removal of, the required labels or tags, as described in 
proposed Sec.  1.384. Accordingly, we would not expect the proposed 
labeling and marking provision to impair the future ability to

[[Page 25248]]

distribute or market the article of food if the detention order is 
terminated.
7. What Expedited Procedures Apply When FDA Initiates a Seizure Action 
Against a Detained Perishable Food? (Proposed Sec.  1.383)
    Section 303 of the Bioterrorism Act directs the Secretary to issue 
procedures for instituting certain judicial enforcement actions on an 
expedited basis with respect to perishable food subject to a detention 
order. This provision directs FDA to issue procedures for instituting 
on an expedited basis seizure actions under section 304(a) of the act, 
or injunction actions under section 302 of the act (21 U.S.C. 332), or 
both. We have concluded that it is appropriate to focus on procedures 
to institute seizure actions on an expedited basis because a seizure is 
the most efficient judicial action for rapid control of a violative 
article of perishable food.
    Proposed Sec.  1.383 describes FDA's procedure for sending a 
seizure recommendation under section 304(a) of the act to the 
Department of Justice (DOJ) for a perishable food (defined in proposed 
Sec.  1.377) subject to a detention order. We propose to send the 
seizure recommendation to DOJ within 4 calendar days after the 
detention order is issued, unless extenuating circumstances exist. If 
the fourth calendar day is not a working day when the government is 
open for business, we will advise the DOJ of our plans to recommend a 
seizure action on the last working day before the fourth calendar day 
and send the recommendation as soon as practicable on the first working 
day that follows. For example, if a detention order is issued on a 
Wednesday, the fourth calendar day would be the following Sunday. 
Because Sunday is a non-working day, we would advise the DOJ of our 
plans to recommend a seizure action on Friday and would send the 
recommendation as soon as practicable on the following Monday.
    For purposes of this proposed section, extenuating circumstances 
include, but are not limited to, instances when the results of 
confirmatory testing or other evidentiary development require more than 
4 calendar days to complete.
    Proposed Sec.  1.383 is designed to accelerate the procedure for 
seizure recommendations and takes into account the 7-day timeframe in 
the proposed definition of ``perishable food.'' As noted previously in 
section III.B.7 of this document, we have focused our implementation of 
this provision of section 303 of the Bioterrorism Act on seizure 
recommendation procedures. Use of injunctive relief may be appropriate 
in some circumstances involving detained perishable foods. However, 
expedited procedures for instituting injunction actions would not 
accelerate the judicial control of a particular violative article of 
perishable food as much as expedited procedures for seizure actions.
    We invite comment on this or other procedures that would address 
concerns about expedited enforcement actions with respect to perishable 
food.
8. When Does a Detention Order Terminate? (Proposed Sec.  1.384)
    Under proposed Sec.  1.384, an authorized FDA representative will 
issue a detention termination notice releasing the detained article of 
food if FDA decides to terminate a detention order or the detention 
period expires. FDA will issue the detention termination notice to any 
person who received the detention order or that person's 
representative. FDA also will remove, or authorize the removal of, the 
required labels or tags attached under proposed Sec.  1.382. If FDA 
fails to issue a detention termination notice and the detention period 
expires, the detention order is deemed to be terminated.

C. How Does FDA Order a Detention?

1. Who Approves a Detention Order? (Proposed Sec.  1.391)
    Proposed Sec.  1.391 requires that an authorized FDA representative 
approve a detention order. As defined in proposed Sec.  1.377, an 
``authorized FDA representative'' is an FDA District Director in whose 
district the detained article of food is located or an FDA official 
senior to such director. For example, an RFDD is an FDA official senior 
to an FDA District Director. This is consistent with the approval 
requirements found in section 303 of the Bioterrorism Act. We are 
proposing that if prior written approval of a detention order is not 
feasible, prior oral approval must be obtained and confirmed in writing 
as soon as possible. We believe allowing for oral approval of a 
detention followed by written confirmation allows for efficient 
implementation of the administrative detention provisions.
    For example, the investigator may be at a manufacturing plant 
located a great distance away from the district office and may 
determine that a detention is warranted. Instead of losing valuable 
time driving back to the district office to get a written signature in 
cases where a fax machine is not close by, the investigator may 
telephone the authorized FDA representative to get an oral approval. 
The authorized FDA representative would subsequently confirm the oral 
approval in writing by sending written confirmation to the 
investigator. In other circumstances where there is risk of the product 
moving to another location, we would want to detain the product 
immediately and an oral approval of the detention order may be prudent, 
followed by confirmation in writing. These examples illustrate some 
situations where oral approval may be necessary, but do not constitute 
an all inclusive list.
2. Who Receives a Copy of the Detention Order? (Proposed Sec.  1.392)
    Proposed Sec.  1.392(a) requires FDA to issue the detention order 
to the owner, operator, or agent in charge of the place where the 
article of food is located. If the owner of the article of food is 
different from the owner, operator, or agent in charge of the location 
of the food, FDA must provide a copy of the detention order to the 
owner of the article of food if the owner's identity can be determined 
readily.
    Proposed Sec.  1.392(b) would subject common carriers of articles 
of food to these administrative detention provisions. If FDA issues a 
detention order for an article of food located in a vehicle or other 
carrier used to transport the detained article of food, FDA would be 
required to provide a copy of the detention order to the shipper of 
record and the owner and operator of the vehicle or other carrier, if 
FDA can determine their identities readily.
3. What Information Must FDA Include in the Detention Order? (Proposed 
Sec.  1.393)
    Proposed Sec.  1.393(a) requires FDA to issue the detention order 
in writing, signed and dated by the officer or qualified employee of 
FDA who has credible evidence or information indicating that such 
article of food presents a threat of serious adverse health 
consequences or death to humans or animals. The written detention order 
serves as notice of the detention and provides notice that the persons 
with ownership rights to the detained article of food have the right to 
request an informal hearing.
    Proposed Sec.  1.393(b) requires the detention order to include the 
following information:
    1. The detention order number;
    2. The date and hour of the detention order;
    3. Identification of the detained article of food;
    4. The period of the detention;
    5. A statement that the article of food identified in the order is 
detained for the period shown;

[[Page 25249]]

    6. A brief, general statement of the reasons for the detention;
    7. The address and location where the article of food is to be 
detained and the appropriate storage conditions;
    8. Any applicable conditions of transportation of the detained 
article of food;
    9. A statement that the article of food is not to be consumed, 
moved, altered, or tampered with in any manner during the detention 
period, unless subject to a limited conditional release under proposed 
Sec.  1.381;
    10. The text of section 304(h) of the act and Sec. Sec.  1.401 and 
1.402 of this chapter;
    11. A statement that any informal hearing on an appeal of a 
detention order must be conducted as a regulatory hearing under part 16 
of this chapter, with certain exceptions described in proposed Sec.  
1.403;
    12. The mailing address, telephone number, e-mail address, and fax 
number of the FDA district office and the name of the FDA District 
Director in whose district the detained article of food is located; and
    13. A statement indicating the manner in which approval of the 
detention order was obtained, i.e., orally or in writing.

D. What Is the Appeal Process for a Detention Order?

1. Who is Entitled to Appeal? (Proposed Sec.  1.401)
    Under proposed Sec.  1.401, any person who would be entitled to be 
a claimant for such article of food, if seized under section 304(a) of 
the act, would be able to appeal a detention order. Procedures for 
establishing entitlement to be a claimant for purposes of section 
304(a) of the act are governed by Supplemental Rule C(6)(a) to the 
``Federal Rules of Civil Procedure.''
2. What Are the Requirements for Submitting an Appeal? (Proposed Sec.  
1.402)
    Proposed Sec.  1.402 describes the requirements for submitting an 
appeal. As required by section 303 of the Bioterrorism Act, as part of 
your appeal, you may request an opportunity for an informal hearing. 
Proposed Sec.  1.402(a) will require you to submit your appeal in 
writing to the FDA District Director in whose district the detained 
article of food is located using the contact information provided in 
the detention order. We propose to allow you to submit your appeal in 
person, by mail, e-mail, or fax.
    The timeframe for filing an appeal is determined by whether the 
detained article of food is perishable or nonperishable. If the 
detained article of food is perishable, as defined in proposed Sec.  
1.377, you would be required to file your appeal and request for a 
hearing within 2 calendar days of receipt of the detention order.
    If the article of food subject to the detention order is 
nonperishable, you would be required to file a notice of intent to 
request a hearing within 4 calendar days of receipt of the detention 
order. The notice of intent would enable the agency to determine 
whether resources should be allocated to preparing for a regulatory 
hearing. If you do not file a notice of intent by day four, you do not 
receive a hearing. However, without filing a notice of intent by day 
four, you may still file an appeal without a hearing request. Whether 
or not you are requesting a hearing, your appeal involving a detained 
nonperishable food must be filed within 10 calendar days of receipt of 
the detention order.
    We are using calendar days for the bifurcated deadlines for filing 
appeals to provide the most expeditious procedure for perishable food, 
and to provide a consistent approach for counting days. We are asking 
for comment on whether there are other ways we should be counting days 
for filing appeals, while adhering to the statutory deadline of 5 days 
for FDA to issue a decision on appeal (for both perishable and 
nonperishable food).
    Proposed Sec. 1.402(b) provides that your request for an appeal 
must include a verified statement identifying your ownership or 
proprietary interest in the detained article of food. Under ``Federal 
Rules of Civil Procedure,'' Supplemental Rule C(6)(a), a person who 
asserts an interest in or right against property that is the subject of 
an action must file a verified statement identifying the interest or 
right. The meaning of ``verified statement'' under Supplemental Rule 
C(6)(a) is governed by the local federal district court rules in which 
the detention takes place, and usually means that the statement must be 
accompanied by an oath or affirmation attesting to the statement's 
veracity.
    Proposed Sec.  1.402(c) provides that the appeal process would 
terminate if FDA institutes either a seizure action under section 
304(a) of the act or an injunction under section 302 of the act 
regarding the detained article of food.
    Proposed Sec.  1.402(d) describes the requirements for requesting 
an informal hearing as part of the appeals process. Your request for a 
hearing must be in writing and be included with your appeal. You may 
appeal a detention without requesting an informal hearing; however, if 
you want an informal hearing, you must include your request when you 
file your appeal. This proposed section describes the timeframes for 
holding the hearing if FDA grants your request for an informal hearing 
(see Sec.  16.26 regarding denial of hearing). If the detained article 
of food is perishable, the hearing would be held within 2 calendar days 
after the date the appeal is filed. If the detained article of food is 
nonperishable, the hearing would be held within 3 calendar days after 
the date the appeal is filed. The quick timeframes for holding the 
hearing are necessary to ensure that FDA can adhere to the statutory 
requirement to issue a decision on appeal within 5 calendar days after 
the appeal is filed. FDA notes that under this proposal, the timeframes 
for perishable and nonperishable appeals will not be significantly 
different in instances where an appeal is filed immediately upon 
receipt of a detention order. For example, if you file an appeal and 
request for a hearing on the same calendar day (day one) the detention 
is ordered for a perishable food, the hearing would be held by calendar 
day three, and the decision on appeal could be issued as early as 
calendar day three but no later than calendar day six. If a 
nonperishable food was detained in the same example, the hearing would 
be held by calendar day four, and the decision on appeal could be 
issued as early as calendar day four but no later than calendar day 
six.
    We are requesting comment on the timeframes for holding the 
informal hearing.
3. What Requirements Apply to an Informal Hearing? (Proposed Sec.  
1.403)
    If FDA grants a request for an informal hearing on an appeal of a 
detention order, FDA would conduct the hearing in accordance with part 
16, with the following exceptions:
    [sbull] The detention order under proposed Sec.  1.393, rather than 
the notice under Sec.  16.22(a) of this chapter, would provide notice 
of opportunity for a hearing under this section and would be part of 
the administrative record of the regulatory hearing under Sec.  
16.80(a) of this chapter.
    [sbull] A request for a hearing under this section must be 
addressed to the FDA District Director in whose district the detained 
article of food is located in accordance with proposed Sec.  1.402(a).
    [sbull] The provision in Sec.  16.22(b) of this chapter, providing 
that a person not be given less than 3 working days after receipt of 
notice to request a hearing, does not apply to a hearing under this

[[Page 25250]]

subpart. Rather, the timeframes in proposed Sec.  1.402(a) apply.
    [sbull] The provision in Sec.  16.24(e) of this chapter, stating 
that a hearing may not be required to be held at a time less than 2 
working days after receipt of the request for a hearing, does not apply 
to a hearing under this subpart. Instead, the timeframes in proposed 
Sec.  1.402(c) apply.
    [sbull] Proposed Sec. 1.406, rather than Sec.  16.24(f) of this 
chapter, describes the statement that will be provided to an appellant 
where a detention order is based on classified information.
    [sbull] Proposed Sec.  1.404, rather than Sec.  16.42(a) of this 
chapter, describes the FDA employees, i.e., RFDDs or other officials 
senior to District Directors, who preside at hearings under this 
subpart.
    [sbull] Under proposed Sec.  1.403(f), the presiding officer may 
require that a hearing conducted under this section be completed within 
1 day, as appropriate.
    [sbull] Ordinarily under part 16 hearing procedures, the presiding 
officer issues a report and recommended decision and the Commissioner 
of Food and Drugs issues a final decision. However, under proposed 
Sec.  1.403(g), the presiding officer will issue the final agency 
decision.
    As described previously, the informal hearing requirements in part 
16 state that its procedures are to be used when the act or FDA 
regulations provide for an opportunity for a hearing and no specific 
hearing regulations exist (see Sec.  16.1(b)). Section 303 of the 
Bioterrorism Act provides for an informal hearing opportunity, but does 
not provide specific provisions for the informal hearing. In this 
proposed rule, we are applying part 16 procedures modified by the noted 
exceptions, which is consistent with Sec.  16.5(b).
4. Who Serves as the Presiding Officer at an Informal Hearing? 
(Proposed Sec.  1.404)
    Proposed Sec.  1.404 requires the FDA RFDD, or other official 
senior to a District Director, to act as the presiding officer of an 
informal hearing on an appeal of a detention order. As presiding 
officer, the RFDD would issue the decision on appeal. Because a 
detention must be approved at the District Director level, we believe 
it is appropriate that appeals of those decisions should be handled by 
persons in positions senior to the District Directors.
    The presiding officer may be an RFDD from a region other than the 
one in which the detained article of food is located, or another 
official senior to a District Director.
5. When Does FDA Have to Issue a Decision on an Appeal? (Proposed Sec.  
1.405)
    Proposed Sec.  1.405 describes when FDA must issue a decision on an 
appeal. Proposed Sec.  1.405(a) requires the presiding officer to issue 
a decision confirming or revoking the detention order within 5 calendar 
days after the appeal is filed. If FDA fails to provide an opportunity 
for a hearing, or fails to confirm or terminate the detention order 
within the 5-day period, the detention order is deemed terminated. 
While the Bioterrorism Act does not define the meaning of ``an 
opportunity for an informal hearing,'' we interpret this phrase to mean 
the FDA gives notice of the opportunity for a hearing (see also 
proposed Sec.  1.403(a), which states that the detention order provides 
notice of opportunity for a hearing). Under this interpretation, a 
failure to provide an opportunity for a hearing means a failure to 
provide you with notice of your opportunity to request a hearing. This 
provision is consistent with requirements of section 303 of the 
Bioterrorism Act.
    Proposed Sec.  1.405(b) would allow you to appeal the detention 
order without a request for an informal hearing. Where you appeal 
without requesting a hearing, the presiding officer is still required 
to issue a decision on the appeal confirming or revoking the detention 
within 5 calendar days after the date the appeal is filed. If the 
presiding officer fails to issue a decision within the 5-day period, 
the detention order is deemed terminated.
    Proposed Sec.  1.405(c) states that if you appeal a detention order 
and request an informal hearing and your hearing request is denied, the 
presiding officer is still required to issue a decision on the appeal 
confirming or revoking the detention within 5 calendar days after the 
date the appeal is filed. If the presiding officer fails to issue a 
decision within the 5-day period, the detention order is deemed 
terminated.
    Proposed Sec.  1.405(d) states if the presiding officer confirms a 
detention order, the article of food would continue to be detained 
until FDA terminates the detention order under proposed Sec.  1.384 or 
the detention period expires under proposed Sec.  1.379, whichever 
occurs first.
    Proposed Sec.  1.405(e) states that if the presiding officer 
terminates a detention order, or the detention period expires, FDA 
would be required to terminate the detention order as specified under 
proposed Sec.  1.384 (i.e., FDA would be required to issue a detention 
termination notice releasing the article of food).
    Proposed Sec.  1.405(f) states that confirmation of a detention 
order by the presiding officer is considered a final agency action for 
purposes of section 702 of title 5, United States Code (5 U.S.C. 702).
6. How Will FDA Handle Classified Information in an Informal Hearing? 
(Proposed Sec.  1.406)
    FDA expects that consistent with responding to bioterrorist 
threats, there may be instances where the credible evidence or 
information supporting a detention order consists of Classified 
National Security Information (``classified information''). Protection 
of information critical to our nation's security is a priority 
(Executive Order 12958, April 17, 1995). While mindful of our duty to 
protect our national security interest, we are also mindful of our 
obligation to provide a fair, expeditious, and impartial hearing (see 
Sec.  16.60 regarding hearing procedure). Proposed Sec.  1.406 provides 
that FDA will not release classified information. However, if the 
presiding officer may do so, consistent with safeguarding both the 
information and the source, the presiding officer will give you notice 
of the general nature of the information and an opportunity to offer 
opposing evidence or information. If classified information was used to 
support the detention, then any confirmation of such detention will 
state whether it is based in whole or in part on that classified 
information.
    Given the events of September 11, 2001, and the need to quickly 
respond to actual or threatened bioterrorist attacks, we are 
contemplating the development of general regulations that address 
handling classified information on an agency-wide basis for all the 
products regulated by FDA. We believe, though, that we should go 
forward with the current proposal in this context at this time.

IV. Conforming Amendment to 21 CFR Part 16

    We propose to amend Sec.  16.1(b)(1) to include section 304(h) of 
the act relating to the administrative detention of food for human or 
animal consumption to the list of statutory provisions under which 
regulatory hearings are available.

V. Analysis of Economic Impact

A. Benefit-Cost Analysis

    FDA has examined the economic implications of this proposed rule as 
required by Executive Order 12866. Executive Order 12866 directs 
agencies

[[Page 25251]]

to assess all costs and benefits of available regulatory alternatives 
and, when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). Executive Order 12866 classifies a rule as a significant 
regulatory action if it meets any one of a number of specified 
conditions, including: Having an annual effect on the economy of $100 
million, adversely affecting a sector of the economy in a material way, 
adversely affecting competition, or adversely affecting jobs. Executive 
Order 12866 also considers a regulatory action significant if it raises 
novel legal or policy issues. The Office of Management and Budget has 
determined that this proposed rule is a significant regulatory action 
under Executive Order 12866, although it is not economically 
significant.
    Need for Regulation
    Section 303 of the Bioterrorism Act (Public Law 107-188), gives FDA 
expanded authority to prevent the distribution of any article of food 
for which we have credible evidence or information that the food 
presents a threat of serious adverse health consequences or death to 
humans or animals. Previously, if we received credible evidence or 
information indicating that an article of food presented a threat of 
serious adverse health consequences or death to humans or animals, we 
would typically have taken one of the following actions: (1) Requested 
a voluntary recall of the suspected product; (2) developed enough 
evidence to move directly to seize the food; or (3) referred the matter 
to the appropriate State authority for most cases involving purely 
intrastate commerce. Thus, Congress' expansion of our authority to 
allow administrative detention of food permits us to immediately detain 
food in commerce, which provides an added measure to ensure the safety 
of the nation's food supply.
    Reason for Regulation
    FDA is proposing this regulation to improve food safety. Food 
safety is mostly a private good. Establishments have powerful 
incentives to ensure that the ingredients they purchase are not 
contaminated and that their production processes are protected from 
unintentional and intentional contamination. Deliberate (intentional) 
contamination of food linked to a particular product or plant--
particularly if the plant is considered negligent--would be 
extraordinarily costly to a firm. Indeed, the private incentives to 
avoid deliberate contamination should be similar to the private 
incentives for food safety. Deliberate food contamination events 
nonetheless differ from ordinary outbreaks of foodborne illness in that 
they are more likely to be low probability events with severe public 
health consequences.
    Although private incentives lead to the private efforts to protect 
against deliberate contamination at the plant level, there are external 
effects associated with privately produced protection. The economic 
incentives for firms to engage in food safety activities largely hinges 
on the ability of consumers to identify and avoid products associated 
with the responsible party. However, firms can change both their own 
names and the names of their products, and can also change owners and 
managers. Therefore, it may be quite costly for consumers to obtain the 
information that would allow them to avoid products associated with the 
responsible party. Moreover, some firms might be infiltrated by those 
who wish to launch attacks on food safety, or might even have been 
formed by those having that end in mind. Such firms would not be 
responsive to normal economic incentives to provide food safety.
    The events of September 11, 2001, led Congress to conclude that 
there should be a regulatory mechanism to temporarily remove from 
commerce potentially violative food that presents a threat of serious 
adverse health consequences or death to humans or animals, and store it 
under an appropriate level of security until we can investigate the 
potential threat and evaluate whether to initiate judicial enforcement 
action and, if appropriate, initiate such action. This proposed 
regulation implements this mechanism.
    Regulatory Options
    We considered several regulatory options or alternatives as follows 
in developing this proposal:
    Option One: Establish a regulatory framework for administratively 
detaining food, with expedited procedures for instituting certain 
enforcement actions involving perishable food (i.e. take the proposed 
action);
    Option Two: Take the proposed action, but change the definition of 
perishable food, the maximum timeframe for administrative detention of 
perishable food, or both;
    Option Three: Take the proposed action, but define the level of 
security we require for transportation and storage;
    Option Four: Issue regulations only to establish expedited 
procedures for instituting certain enforcement actions involving 
perishable food (i.e. limit the action to the regulations required by 
section 303 of the Bioterrorism Act).
    We request comments on these options, as well as suggestions on 
other regulatory options that we should consider. We will address 
comments on this analysis in the analysis of the final rule.
    Baseline: The situation before Congress passed the Bioterrorism Act
    Usually, we designate the option of taking no regulatory action as 
the baseline. We then compare the costs and benefits of the various 
regulatory options to the current regulatory state of affairs. However, 
for this rule, we chose the situation that existed before Congress 
enacted the Bioterrorism Act as the baseline. We chose this baseline 
rather than the current regulatory state of affairs because our 
authority to administratively detain food under the Bioterrorism Act 
already exists, regardless of whether we now promulgate regulations 
setting out the procedures we will follow when we detain food.
    Therefore, in order to analyze the impact of Congress giving us the 
authority to administratively detain food, we needed to specify a 
baseline that predated our having received that authority. By 
convention, we do not attribute costs or benefits to the baseline, per 
se, but instead capture the impacts of the regulation by comparing the 
costs and benefits of the other options to the baseline. Prior to 
Congress passing the Bioterrorism Act, we had other enforcement options 
available to us in those situations in which we can now use 
administrative detention, that is, in which we receive credible 
evidence or information that an article of food presents a threat of 
serious adverse health consequences or death to humans or animals. We 
will discuss those enforcement actions as part of the baseline in the 
following analysis.
    In addition, we do not discuss the option of taking no regulatory 
action as one of the non-baseline options, because that option is not 
legally feasible. Option Four (establish expedited procedures for 
instituting certain enforcement actions involving perishable food only) 
most closely resembles the option of taking no regulatory action, 
because in that option we would limit ourselves to only the regulatory 
action that Congress required us to take in the Bioterrorism Act.
    Option One: Establish a regulatory framework for administratively

[[Page 25252]]

detaining food, with expedited procedures for instituting certain 
enforcement actions involving perishable food (i.e. take the proposed 
action)
    In the proposed action, we establish a regulatory framework for 
administratively detaining food.
    Costs
    The primary costs of the proposed rule arise from differences 
between administrative detention and other enforcement actions with 
respect to the following: (1) Cost of transporting and storing food, if 
necessary; (2) cost of canceling previously scheduled transportation 
and storage of the affected food when we remove it from commerce, and 
rescheduling transportation and storage if we later cancel the 
detention order and release it back into commerce; (3) loss of product 
value over the detention period, if we later find the food is not 
violative; and (4) cost of participating in appeals hearings and other 
enforcement activity.
    To analyze the costs of the proposed rule, we first estimate how 
many times we might use administrative detention. We then estimate the 
proportion of cases in which we might administratively detain food that 
we later determine to be not violative. We need to estimate this 
percentage because we estimate the loss of product value over the 
detention period for food that we later find to be not violative. (We 
do not estimate the loss of product value for violative food, because 
we assume that the violation, not our action, reduces the value of that 
food.) We then estimate how costs would change if we substituted an 
administrative detention action for other enforcement actions. We look 
at the change in costs relative to the baseline of taking these other 
actions because we probably would have taken some type of enforcement 
action if we had received the type of information that would allow us 
to use administrative detention. In other words, we analyze the cost of 
administrative detention actions in terms of the costs over and above 
those that would have been associated with the enforcement actions that 
we would otherwise have taken. We then multiply the changes in costs by 
the number of times we might substitute an administrative detention 
action for the other enforcement actions.
    Estimate of number of times we might use administrative detention 
per year
    We do not know how often we will receive credible evidence or 
information that an article of food presents a threat of serious 
adverse health consequences or death to humans or animals that would 
allow us to administratively detain food. However, if we had received 
credible evidence or information that an article of food presented a 
threat of serious adverse health consequences or death to humans or 
animals before Congress granted us authority to take administrative 
detention actions, we would probably have taken one of the following 
three actions: (1) Requested a voluntary recall of the suspected 
product; (2) moved directly to seize the food; or (3) referred the 
matter to State authorities. We specify moving directly to seize food 
because we could also seize food after taking some other enforcement 
action, including administrative detentions. To avoid having to 
describe streams of enforcement actions, we have simplified the 
situation into two phases, a ``preliminary phase,'' in which we take 
some action to detain the food in order to investigate it, and a 
``final phase'' in which we take some final action such as seizing the 
food or referring the matter to State authorities.
    We base our estimate on only these three actions because we believe 
the situations that lead to these types of actions are the most similar 
to the situations that may lead to administrative detention. Thus, we 
assume that any administrative detention would replace issuing class I 
recalls, moving directly to seizure, or referring the matter to State 
authorities for most cases involving purely intrastate commerce. If we 
instead assumed that we might substitute administrative detention 
actions for other types of enforcement actions, including other actions 
that we subsequently follow with seizure actions, then our estimate of 
the number of administrative detentions per year could be significantly 
larger. Examples of other types of enforcement actions include 
detentions without physical examination (DWPE) and requests to States 
to embargo food. We assume that the number of administrative detentions 
might include 0 to 100 percent of the number of class I recalls and 
instances in which we moved directly to seize food, and 0 to 10 percent 
of the number of times we referred matters to State authorities. In all 
cases, we based the low end of the range on the fact that we do not 
know if we would have used administrative detention, even if we had the 
authority to do so, and the criteria for using administrative detention 
had been met. Analyzing all the factors that would lead us to choose 
one enforcement action over another is beyond the scope of this 
analysis. We chose 100 percent as the high end of the range for class I 
recalls because the criteria for class I recalls is quite similar to 
the criteria for administrative detention. We chose 100 percent as the 
high end of the range for instances in which we move directly to seize 
food as a practical expedient because the small number of actions 
implies that such information would have had little or no impact on our 
cost estimates. We chose 10 percent as the high end of the range for 
State referrals because our experience with those actions suggests that 
only about 10 percent of recent referrals involved concerns or 
situations that would have met the criteria for administrative 
detention. The other referrals do not appear to meet the criteria for 
administrative detention.
    In fiscal year (FY) 2002, we initiated 184 class I recalls 
involving food that posed a risk of serious adverse health consequences 
or death to humans or animals. In the same year, we initiated 16 
seizures that may have involved food products that posed hazards to 
human or animal health. In the last 12 months, we estimate that we 
referred 234 of such matters to State authorities.
    These numbers are repeated in table 1 of this document. Based on 
this information, we estimate that we might administratively detain 
food 0 to 223 times per year.

                    Table 1.--Substitutions per year
------------------------------------------------------------------------
                                      Estimated Number of Substitutions
               Action                  of Administrative  Detention for
                                      Other Enforcement Actions per Year
------------------------------------------------------------------------
Class I recalls                      0 to 184
------------------------------------------------------------------------
No preliminary action (move          0 to 16
 directly to seizure)
------------------------------------------------------------------------
No preliminary action (refer matter  0 to 23
 to State authorities)
------------------------------------------------------------------------
Total                                0 to 223
------------------------------------------------------------------------

    Estimate of the proportion of cases in which the food subject to 
administrative detention turns out to be not violative
    Some of the costs that we will discuss later are only relevant if 
we eventually determine that food that we have administratively 
detained is not violative. We do not know the proportion of cases in 
which we might administratively detain food that we later determine to 
be not violative. This rate depends on the type of information we 
receive, and the level of risk aversion we adopt when we apply the 
criteria allowing us to use

[[Page 25253]]

administrative detentions, including ``credible evidence or 
information'' and ``threat of serious adverse health consequences or 
death to humans or animals.'' If we only administratively detain food 
when we are certain or nearly certain that it is violative, then we may 
eliminate administrative detention as an enforcement option for some 
food that is violative. However, if we administratively detain food 
when we are less certain that it is violative, then we will increase 
the rate at which we administratively detain food that we later 
determine is not violative.
    One way of addressing the proportion of cases in which we might 
administratively detain food that we later determine to be not 
violative is to look at data from the detention and release of imported 
food. However, this data cannot be narrowed to situations where we have 
detained or prepared to detain food and then later determined that the 
food was not violative. An import detention is different from 
administrative detention in that imports can be detained for reasons 
other than adulteration or misbranding. These other reasons give rise 
to a large percentage of detentions in which the food is found not to 
be violative. For instance, an import can be detained because the 
product is coded in the OASIS (Operational and Administrative System 
for Import Support system) system as a low acid canned food but the 
importer did not supply the food canning establishment number. The 
OASIS system is a national database on imports, and related enforcement 
activities and findings.
    In the first three quarters of 2002, we released 48 percent of the 
shipments of human and animal food that we detained, excluding the 
shipments that we released because the firm reconditioned the food. The 
percentage of import shipments released includes all releases recorded 
in the OASIS system. These data include releases from detentions 
resulting from:
    [sbull] DWPE notices;
    [sbull] Routine FDA field sampling assignments;
    [sbull] Incorrect or incomplete information provided about the 
product; and
    [sbull] Imports released with comment, which means the product 
technically is misbranded or adulterated but we exercise enforcement 
discretion.
    Because of the factors listed previously, and because import 
detentions may be based on a lower level of information than that 
required for an administrative detention, we cannot directly impose 
these numbers on administrative detentions. Rather, 48 percent is an 
upper limit that will exceed the nonviolative percentage of 
administratively detained food.
    Another way of addressing this issue is to look at the proportion 
of enforcement actions against nonfood products that involved products 
that we later determined were not violative. We have had authority to 
administratively detain medical devices since 1976. During that time, 
we have not administratively detained any products that we later found 
to be not violative. This suggests that the rate at which we 
administratively detain food that is not violative may also be quite 
low, because in both cases we would be using similar administrative 
detention procedures. However, the medical device and food contexts may 
differ with respect to a number of potentially relevant issues, such as 
the type and amount of products on the market, the types of problems 
associated with those products, and the type and level of information 
that we receive on those problems.
    Based on this information, we estimate that 0 to 48 percent of the 
food that we administratively detain will later turn out to be not 
violative.
    Transportation
    Under the proposed rule, we might require a firm to transport food 
that we administratively detain to a storage facility that is both 
secure and capable of providing the proper conditions for storing that 
type of food. In other cases, we might allow firms to hold the food in 
place, but require them to take various other actions to secure the 
food, such as physically segregating it, locking the area in which they 
store it, and possibly posting guards to monitor the area in which they 
store it. We will determine whether or not to require a firm to 
transport administratively detained food to another storage facility, 
and to take other actions to secure that food, on a case-by-case basis.
    An example of where transporting detained food might be problematic 
would be the case of large storage grain bins located at private 
elevators and farms that hold grain. These bins typically hold several 
hundred tons per bin. It would be costly to transport grain to another 
holding area. In addition, transporting contaminated grain might spread 
biological or chemical agents because of the generation and dispersal 
of dust from the grain as we remove it from the bin and transport it to 
another location. In this case, it could be preferable to allow the 
product to be stored in place, possibly with the addition of onsite 
security.
    We do not have sufficiently detailed information on past 
enforcement actions to estimate the proportion of administrative 
detentions in which we might require transportation or any other 
activity. Therefore, we assume that we would require firms to transport 
food to a secure facility and store them there in 0 to 100 percent of 
administrative detention actions. To simplify the analysis, we 
tentatively assume that the estimated costs of transporting food to a 
secure facility and storing it there are equal to or greater than the 
costs of storing the food in place and taking any of the other actions 
that we might require under our administrative detention authority, 
except posting additional guards, which we analyze in the discussion of 
Option Three (take the proposed action, but define the level of 
security we require for transportation and storage). As we discuss in 
the section on Option Three, the estimated cost of providing one 
additional security guard for onsite storage is somewhat higher than 
the estimated cost of transporting food to a secure facility. 
Therefore, we have not discussed the cost of providing an additional 
security guard as part of this option. Nevertheless, providing an 
additional security guard and storing food in place is consistent with 
taking the proposed action, and we may take that action in some cases.
    The cost of transporting food varies along a number of dimensions, 
including the following: (1) Type of conveyance used, (2) distance 
traveled, (3) level of security, (4) type and amount of food involved, 
and (5) number of trips required. These considerations are 
interrelated. For example, the appropriate type of conveyance might 
depend on the level of security, the distance to be traveled, and the 
amount of food involved. Similarly, the distance to be traveled would 
depend, in part, on what type of facility meets our security 
requirements.
    Firms may transport food via truck, rail, air, or ship. Based on 
the distance to be traveled, the level of security we might require, 
and the type and amount of food involved, we tentatively assume that 
firms would usually move administratively detained food by truck.
    We also assume that when we require firms to transport food to a 
``secure storage facility,'' we will usually interpret that term to 
mean a bonded or third party public warehouse. We assume that these 
warehouses would provide proper storage conditions to maintain the 
safety and wholesomeness of the food. Bonded warehouses, refrigerated 
warehouses, and most types of third-party public warehouse facilities 
are readily available around ports of entry into the United States. 
Most metropolitan areas have an international airport that serves as a 
port

[[Page 25254]]

of entry into the United States, and will, therefore, have a variety of 
warehouses available. Therefore, we assume that the distance that we 
would require firms to transport administratively detained food would 
normally be no farther than the distance to the nearest metropolitan 
area. Firms might undergo additional transportation costs if we later 
cancel the administrative detention order and release the food back 
into commerce, because the secure facility might not be as convenient 
to the subsequent destination as the original location. Therefore, we 
calculate the transportation costs associated with food that we later 
release on the basis of round trip travel between its original location 
and the secure storage facility.
    Transportation costs would depend, in part, on the security 
measures that we direct firms to take. We do not define those measures 
in this proposed rule. Instead, we will determine the relevant level of 
security and types of security measures needed on a case-by-case basis. 
We tentatively assume that a normal or average level of security for 
transportation of food would be the level associated with bonded or 
third party carriers. We believe using these types of carriers rather 
than a firm's own transportation system could provide some additional 
security because the owner of the bonded or third-party carrier might 
have a greater financial incentive to monitor and maintain custody of 
the food than do the owners of the food. In some cases, we might 
require higher security. In other cases, we might require lower 
security, such as that associated with a firm's own transportation 
system.
    The cost of transporting food varies widely with the type and 
quantity of food. Some food requires specialized trucks, such as bulk 
liquid or refrigerated carriers. We base our estimate of the average 
transportation costs on the average rates for transporting the ``most 
usual loads'' of various fresh fruits and vegetables as reported in the 
``Agricultural Marketing Service's Fruit and Vegetable Truck Rate 
Report'' for the week ending November 19, 2002 (Ref. 1). These loads of 
fresh fruits and vegetables do not require specialized trucks. We think 
that average transportation costs should be similar because the 
proportion of food that requires specialized trucks is relatively 
small. However, we request comment on this assumption, and on the cost 
of specialized transportation. We assume there would be suitable 
storage facilities in the nearest major metropolitan area. However, we 
do not know the average distance from any randomly chosen point in the 
United States to the nearest metropolitan area. Therefore, we 
tentatively assume that the distance from any location at which we 
might detain food to the nearest metropolitan area would be between 30 
and 200 miles. Most of the trips in the trucking report were much 
longer than 200 miles. However, the report listed 10 trips under 300 
miles. The trucking report included both a low cost and a high cost 
estimate. Using these estimates gives an average cost per mile for the 
10 trips under 300 miles of between $4.26 and $5.13. The actual cost 
per mile varied from a high of $23.91 for the high cost estimate for 
the shortest trip (23 miles) to $1.93 per mile for the low estimate for 
an intermediate length trip (243 miles). Costs per mile are higher for 
shorter trips because some costs are probably fixed and do not increase 
with mileage. We use the range for the average cost per mile for all 
trips under 300 miles because we have insufficient information to 
estimate a distribution of trips by distance. Based on this assumption, 
we estimate that the average transportation cost per truckload will be 
between approximately $100 and $1,000.
    In order to use these transportation rates, we need to know the 
average amount of food that we would administratively detain. The 
amount of food that we administratively detain could be anything from a 
few packages, to a lot, a shipment, or a production run. The amount of 
food involved in class I recalls and seizure actions has ranged from 
100 pounds or less, in the case of some seizure actions, to millions of 
pounds, in the case of some class I recalls. Therefore, we estimate 
that we will administratively detain between 0 and 1 million pounds of 
food per administrative detention. We request comments on this 
assumption.
    To apply the information on transportation costs, which was based 
on the most usual load of produce (as defined by the ``Agricultural 
Marketing Service's Fruit and Vegetable Truck Rate Report''), to our 
assumption about the amount of food that we might administratively 
detain, which we expressed in pounds, we need to estimate the average 
weight in pounds of the most usual loads of produce. One way to do this 
is to look at the average weight of lines of imported produce, and to 
assume that the size of an average line of produce is comparable to the 
size of the most usual load of produce. A line in this context is the 
unit by which we record information on imported food; it does not refer 
to a product line. We base the assumption relating the size of the line 
of produce to the most usual load of produce on the fact that most 
imported produce arrives by truck, so that the typical unit of imported 
produce probably corresponds roughly to a usual truckload of that 
produce. We request comments on this assumption.
    In 2001, firms imported approximately 22.6 billion pounds of 48 
common types of fresh produce into the United States (Ref. 4). We 
extrapolated data on the number of lines in the OASIS database for the 
first three quarters of FY 2002 for all product categories that appear 
relevant to fresh produce to estimate that the total number of lines 
will be approximately 1.5 million by the end of FY 2002. If the amount 
of imports in 2001 were similar to that for FY 2002, then the average 
line would be about 15,000 pounds. Therefore, we assume that the most 
usual load of produce would be about the same size as the average line 
of imported produce, or 15,000 pounds. We have insufficient information 
to estimate the weight of the average line for any other type of food. 
Therefore, we assume that the average truckload across all types of 
food is about 15,000 pounds. Under this assumption, each administrative 
detention may involve transporting approximately 0 to 67 truckloads of 
food.
    Additional transportation costs might arise if we conditionally 
released food that we administratively detained, and firms moved the 
conditionally released food to another location. We have not included 
these costs because of the voluntary nature of these limited 
conditional releases. A firm would not request a limited conditional 
release unless the benefits of doing so outweighed the costs. 
Therefore, any increase in transportation costs would be at least 
offset by some form of cost savings. If we were to analyze the impact 
of the availability of these limited conditional releases, then our 
estimate of the costs associated with this proposed rule would be 
somewhat lower. However, the impact would probably be small, because we 
do not expect many requests for limited conditional release.
    We request comments on all assumptions relating to transportation 
costs, including but not limited to the average amount of food that we 
might administratively detain, the average amount of food per truck 
load or per load of other conveyance, the likelihood that firms will 
use different types of conveyances (i.e. trucks, airplanes, trains, and 
ships), the costs of using various types of specialized conveyances, 
and the distances that firms may need to transport food.
    As explained earlier in this analysis, we are analyzing the cost of

[[Page 25255]]

administrative detention actions relative to the baseline of taking the 
enforcement actions we would have taken prior to having received 
authority to take administrative detention actions. Therefore, only the 
costs that go beyond the costs of those other enforcement actions are 
relevant here. We assume there would be no change in transportation 
costs if we substituted an administrative detention action for a class 
I recall, because firms probably already transport food as part of such 
a recall.
    We considered the costs of transportation under class I recalls to 
be part of the baseline costs, even though such recalls are voluntary, 
because we have some influence over those decisions. We have influence 
over those decisions because we could publicize the fact that we 
requested a firm to recall a product, which might have consequences for 
that firm's profits. Therefore, those decisions are not purely private 
market decisions. As such, it is reasonable to classify the costs 
associated with those recalls as social costs that are comparable to 
the social costs associated with administrative detention actions for 
purposes of determining baseline costs. If we did not treat these costs 
as social costs, then substituting administrative detention for class I 
recalls would generate additional social costs related to transporting 
food.
    Moving directly to a seizure action or referring a matter to State 
authorities does not involve any transportation costs prior to the 
seizure action or referral. Therefore, all transportation costs 
associated with an administrative detention are relevant in the case of 
an administrative detention that replaces a case of moving directly to 
a seizure action or a referral to State authorities. Any transportation 
costs associated with the actual seizure or State action would not be 
relevant in this context, because administrative detentions may be 
followed by seizure actions or State actions, so any transportation 
associated with the seizure action or State action would take place 
irrespective of whether it was preceded by an administrative detention 
or not.
    We present transportation costs in table 2 of this document. We 
calculated these figures by multiplying the number of truckloads that 
we estimated would be involved in an administrative detention (0 to 67) 
by the number of times we might use administrative detention in place 
of class I recall requests, cases of moving directly to seizure, or 
referring a matter to State authorities. The number of one way trips 
includes return trips, which we calculated by multiplying the number of 
trips to secure storage facilities by the estimated percentage of cases 
in which we might terminate a detention order and allow food back into 
commerce (0 to 48 percent). In table 2, we estimate the range of 
additional trips to secure facilities to be 0 to 1,587. The number is 
based on 0 to 16 seizures (in row 1), a maximum of 67 truckloads per 
seizure, and a maximum of 48 percent additional trips for those 
products cleared to enter commerce. We calculate the maximum number of 
trips as: (16 x 67) + (0.48 x 16 x 67)= 1,587. Again, estimated costs 
are higher for administrative actions that replace cases of moving 
directly to seizure actions or referring matters to States than for 
administrative actions that replace class I recalls because we are 
using the costs of those other actions as the baseline, and class I 
recalls already involve transportation, while cases of moving directly 
to seizure actions or referring matters to States do not.

                                                                              Table 2.--Annual Transportation Costs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Additional One Way Trips per Year, in                                     Total Transportation  Cost (in
                  Action                        Number of Actions (see table 1)                      Truckloads                      Cost per one Way Trip                  millions)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative Detention that Replaces     0 to 16                                    0 to 1,587                                $100 to $1,000                   $0 to $2
 Case of Moving Directly to Seizure
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative Detention that Replaces     0 to 184                                   0                                         $100 to $1,000                   $0
 Class I Recall
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative Detention that Replaces     0 to 23                                    0 to 2,323                                $100 to $1,000                   $0 to $2
 Referral to States
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                            $0 to $4
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Storage
    The cost of storing food in secure storage facilities depends on 
the following factors: (1) Level of security of the facility; (2) type 
of food; (3) length of time the food is stored; (4) amount of food; and 
(5) miscellaneous factors, such as geographic location of facility, 
whether the customer is a regular or repeat customer, volume discounts, 
etc.
    We do not define the security requirements for storage facilities 
in this rule. Instead, we will determine the relevant level of security 
on a case-by-case basis. We tentatively assume that the normal or 
average level of security that we would require is the level associated 
with bonded or third party public warehouses. Using these warehouses 
should provide some additional security because the owner of the food 
relinquishes custody of the food to the warehouse. In some cases, we 
might require higher security, such as that associated with secure 
government storage facilities, for example, Customs Examination 
Stations. In other cases, we might require lower security, such as that 
associated with a firm's own warehouses. We understand from a 
discussion with a representative of the International Association of 
Refrigerated Warehouses that the cost difference between bonded and 
nonbonded public warehouses is probably quite small (Ref. 2). 
Therefore, we use the same storage costs for both bonded and nonbonded 
warehouses.
    Storage costs vary with the type of food being stored. However, we 
were unable to find data on average storage rates for different types 
of food under different conditions (Ref. 2). One cold storage facility 
gave us food storage rates that varied from $0.0002 to $0.0006 per 
pound per month for a range of food types (Ref. 3). Rates for food that 
does not need to be refrigerated might be lower than the lower bound of 
the rates for cold storage. However, we do not have information on 
these rates, and we assume that these rates will fall in the same 
range. The same source listed

[[Page 25256]]

handling rates per shipment of $0.01 to $0.02 per pound. We request 
comments on these rates. These rates imply storage costs of $0 to $600 
per day per administrative detention, and handling rates of $0 to 
$20,000 per administrative detention, based on a shipment size of 0 to 
1 million pounds (67 truckloads per shipment x 15,000 pounds per 
truckload).
    We estimate overall storage costs based on the handling fee per 
pound, the storage costs per pound per day, the amount of food we might 
administratively detain, and the change in the maximum number of days 
that we might require firms to store the food. We assume that there 
would be no increase in storage costs if we substituted an 
administrative detention action for a class I recall, because firms 
probably already store food as part of such a recall. There is no 
storage associated with taking no preliminary enforcement action prior 
to a seizure action or a referral of a matter to a State authority. 
Therefore, any storage associated with an administrative detention 
would be an additional cost in comparison to moving directly to seizure 
or referring a matter to a State authority.
    Administrative detention involves a maximum storage time of up to 
30 days. The actual amount of time that firms would store detained food 
depends on whether and when they appeal the administrative detention 
order. Firms would appeal if they expected the costs of doing so would 
be less than the costs of storing the food until we completed our 
investigation, or until the detention period expired. We have 
insufficient information to estimate the percentage of administrative 
detentions that firms would appeal. Therefore, we use a maximum of 30 
days additional storage time for all administrative detentions. We do 
not know how long firms store food that they voluntarily recall before 
reconditioning or destroying the food. We tentatively assume that the 
storage time associated with class I recalls would be similar to the 
storage time associated with administrative detention.
    We provide estimates of annual storage costs, rounded to the 
nearest million dollars, in table 3.

                                                                                 Table 3.--Annual Storage Costs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Change in Days  Storage per        Cost per Day (based  on                                     Change in Total  Storage
               Action                       Number of Actions                    Action                     average shipment)           Handling Cost per  Action        Cost (in millions)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative Detention that        0 to 16                         0 to 30                         $0 to $600                       $0 to $20,000                 $0 to $1
 Replaces Case of Moving Directly
 to Seizure
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative Detention that        0 to 184                        0                               $0 to $600                       $0 to $20,000                 $0
 Replaces Class I Recall
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative Detention that        0 to 23                         0 to 30                         $0 to $600                       $0 to $20,000                 $0 to 1
 Replaces Referral to State
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                               $0 to $2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Loss of product value over detention period, if we later find the 
product is not violative
    Food may lose some or all of its value during an administrative 
detention because the food may deteriorate, and because firms would 
have less time to sell food that has a finite shelf life. Reducing the 
time available to sell food reduces the value of that food because 
consumers only desire a given quantity of a particular food in a 
particular time period. In order to sell additional units of that food 
during that time period, retailers would need to lower the price of the 
food to reflect the value consumers place on the additional units. This 
cost is only relevant if we determine that the food does not present a 
threat of serious adverse health consequence or death to humans or 
animals and, therefore, terminate the detention and release the food 
back into commerce. The loss of product value would not be relevant for 
detained food found to be violative because such food would have lost 
its value due to its violative nature, rather than the administrative 
detention.
    We have not estimated costs connected to the marking or labeling 
food that we administratively detain. As we discussed earlier in this 
preamble, if we required marking or labeling of food in conjunction 
with an administrative detention order, and we subsequently cancelled 
the administrative detention order, then we would remove, or authorize 
the removal of, the marks or labels. Therefore, we assume there will 
not be any loss of value from the marking or labeling requirements 
contained in this proposed rule.
    Administrative detention actions might also cause food that we do 
not administratively detain to lose value if delivery of that food to 
its final destination were delayed as a result of being packed together 
with food that we did detain. We have not included the potential loss 
of value from this source because, based on our experience with other 
enforcement actions, we expect that we will not cause significant 
delays in the delivery of food that is packed with food that we 
administratively detain.
    Loss of value over the detention period depends on the following 
factors: (1) Shelf life of the food under usual storage conditions, (2) 
rate of value loss over time, and (3) starting value of the food.
    The loss of value depends on the shelf life of the food because the 
longer the shelf life, the less the food will deteriorate during a 
given time period, and the smaller the proportional reduction in the 
time remaining to sell the food. For purposes of this analysis, we have 
designated four shelf life categories:
    [sbull] Perishable food. We define perishable food for purposes of 
this analysis as food having a shelf life of 7 days or less. This is 
based on the definition of perishable food discussed earlier in this 
preamble (i.e. perishable food is food that is not heat-treated; not 
frozen; and not otherwise preserved in a manner so as to prevent the 
quality of the food from being adversely affected if

[[Page 25257]]

held longer than 7 days under normal shipping and storage conditions.) 
Examples of this type of food include fluid milk that has not been 
ultra-pasteurized; live fish, lobster, crab, other crustaceans, 
shellfish; and fresh fruits and vegetables (Ref. 5).
    [sbull] Food having a shelf life of between 8 and 30 days. Food 
with this shelf life that we regulate include some fresh and processed 
dairy products, including soft cheeses such as cottage cheese; some 
bakery items, such as bread, rolls, cakes, pies, and cookies; poultry; 
and some fruit and vegetable products (Ref. 6). These examples are 
derived from a list of examples developed by Hurst et al., but do not 
include products listed as examples in our RPM definition of 
``perishable commodity.''
    [sbull] Food having a shelf life of between 30 and 90 days. These 
types of food include dairy products, such as butter, margarine, 
natural hard cheese, processed hard cheese, and ice cream; eggs; some 
picked food; processed salads; some fruit and vegetable products; cured 
meats; fatty meats such as luncheon meats, ground beef, lamb and pork; 
fatty fish such as mackerel; shellfish; giblets; some frozen bakery 
food, such as cake batter, pie shells, fruit pies, yeast breads and 
rolls, frozen bread and roll dough; fried snack food such as potato 
chips; frozen convenience food such as pre-cooked combination dinners 
and frozen french fries; dried bakery products such as cookies and 
crackers; beverages such as ground coffee that is not vacuum packed; 
canned pickled fish; powdered cream; and fats and oils such as 
mayonnaise, salad dressing, and vegetable shortening (Ref. 6).
    [sbull] Food having a shelf life of over 90 days.
    The only type of enforcement action for which we have readily 
available data on the type of food involved is imported food that we 
have refused entry into the United States. Therefore, we used these 
data for analysis, because we expect the distribution of food by type 
for domestic food to be similar. The food categories in these data do 
not correspond precisely to the shelf life categories just discussed. 
If a food category covered more than one shelf life category, we 
assumed that an equal amount of the product in that category belonged 
to each relevant shelf life category. Based on these assumptions and 
definitions, approximately 20 percent of the imported food that we 
refused entry into the United States from August 2001 through July 2002 
was perishable under the definition in this proposed rule, 20 percent 
of the food had a shelf life of 8 to 30 days, 30 percent had a shelf 
life of 31 to 90 days, and 30 percent had a shelf life of 91 days and 
over.
    The rate of value loss over time varies with the type of food 
involved. To simplify our analysis, we assumed that all perishable food 
(i.e., food with a shelf life of up to 7 days) would lose a fixed 
amount of its starting value each day, such that its value would drop 
to zero by the end of day seven. This corresponds to a value loss of 
about 14 percent of the starting value per day. The comparable rates 
for products with a shelf life of between 8 and 30 days, and between 31 
and 90 days, were 3 percent and 1 percent, respectively. We tentatively 
assume that products with a shelf life of 91 days or more will not lose 
value during an administrative detention.
    In order to apply these rates of value loss, we need the starting 
value of the food that we would administratively detain. We previously 
assumed that we would administratively detain 0 to 1 million pounds of 
food per administrative detention action. The value of this quantity of 
food would vary considerably with the type of food involved. To 
estimate an average value, we used the average value of a line of 
imported food because those data were readily available. After 
estimating the average value of a line of imported food, we then divide 
that value by the previously estimated average size of a line of 
imported food, which was 15,000 pounds, to get an average value per 
pound. We then multiply that value by 0 to 1 million pounds to arrive 
at the average value of the amount of food that we might 
administratively detain. According to U.S. Commerce Department data, 
the value of imports of food, feeds, and beverages into the United 
States in 2001 was approximately $47 billion (Ref. 7). To relate the 
total value to the value of an average line for those types of food, we 
extrapolated data on the number of lines in the OASIS system for the 
three quarters of FY 2002 for human and animal food to estimate a total 
of approximately 4 million lines for human and animal food by the end 
of FY 2002. This implies an average value per line of about $11,000. We 
did not have information on the value of other types of imported food, 
such as dietary supplements or live animals. Therefore, we assumed that 
the average value per line for all types of food is approximately 
$11,000. If an average line is 15,000 pounds, then this corresponds to 
a value per pound of $0.73. Therefore, the value of 0 to 1 million 
pounds would be $0 to $730,000. Based on the rates of value loss given 
earlier, the average loss of value per administrative detention action 
would be $0 to $102,000 (14 percent loss per day x $730,000) per day 
for perishable food, and $0 to $22,000 (3 percent loss per day x 
$730,000) per day for nonperishable food.
    We have set the maximum timeframe for all administratively detained 
food, including perishable food, at 30 days. Therefore, we calculated 
the loss of value for all food based on 0 to 30 days of additional 
storage. As we discussed earlier in the preamble, we intend in the case 
of perishable food to send a seizure recommendation to the DOJ within 4 
calendar days after we issue an administrative detention order, unless 
extenuating circumstances exist. However, we do not know how often 
extenuating circumstances will exist, or how much time will elapse 
between our recommendation and the subsequent seizure.
    We do not estimate any change in the loss of value if we substitute 
an administrative detention action for a class I recall request, 
because we previously assumed that substituting an administrative 
detention action for a class I recall would not change the amount of 
time a firm would store the food in question. Therefore, any loss of 
value resulting from taking action against food that was actually not 
violative would be the same under either type of action. In contrast, 
there is no storage associated with moving directly to a seizure action 
or referring a matter to State authorities. Therefore, any loss of 
value from storage associated with an administrative detention action 
would be an additional cost in those cases.
    We provide estimates of the value loss for food in table 4 of this 
document. We estimate the maximum loss of value as the maximum number 
of actions in which the product is not violative, multiplied by the 
maximum loss per action: $730,000, the average total value of a 
shipment.

[[Page 25258]]



                     Table 4.--Annual Loss of Value
------------------------------------------------------------------------
                                                              Change in
                              Number of      Change in Days   Total Loss
          Action              Actions in      Storage per      of Value
                            which Product        Action          (in
                            Not Violative                     millions)
------------------------------------------------------------------------
Administrative Detention   0 to 8           0 to 30          $0 to $6
 that Replaces Case of
 Moving Directly to
 Seizure
------------------------------------------------------------------------
Administrative Detention   0 to 88          0                $0
 that Replaces Class I
 Recall
------------------------------------------------------------------------
Administrative Detention   0 to 23          0 to 30          $0 to 9
 that Replaces Referral
 to State
------------------------------------------------------------------------
Total                                                        $0 to $15
------------------------------------------------------------------------

    Costs of marking or labeling
    We might label or mark food that we have administratively detained. 
If we were to label or mark food that we have administratively 
detained, we could do so in several ways, including, but not limited 
to, affixing a tag having a self-locking pin that would be inserted in 
an appropriate seam, border, flap, or other area of the container or 
product; taping or tying a tag firmly onto the container or item; or 
affixing the tag to the accompanying documents, or to the carrier. 
However, if we subsequently cancelled the administrative detention 
order, then either we, or the firm, would need to remove the label or 
mark. Class I recalls do not involve marking or labeling. Moving 
directly to a seizure action or referring a matter to State authorities 
also does not involve marking or labeling prior to the seizure action.
    In an analysis of another proposed rule that we published in 2001, 
we discussed the costs of marking cartons of imported food with printed 
labels that we could affix with label guns (Ref. 8). In that analysis, 
we assumed that an average shipment of imported food would contain 
about 300 cartons of containers, and that a worker could attach 100 
labels per hour. We estimated that the cost of the labor time necessary 
to attach the labels would be $53 (three hours at $17.64 per hour), and 
that the cost of labels would be $13 (300 labels at $0.045 per label). 
A shipment of imported food can involve any number of lines of imported 
food. Therefore, we assume that one line could contain between 1 and 
300 cartons. We earlier assumed that the average amount of food in a 
line is 15,000 pounds, so we estimate that a shipment contains 0.02 
cartons per pound (300 cartons per shipment/15,000 pounds per 
shipment). Therefore, an administrative detention action involving 
between 0 and 1 million pounds would require 0 to 200 hours of labor 
time (0.02 cartons per pound x 1 million pounds/100 labels per hour), 
and 0 to 20,000 labels (100 labels per hour x 200 hours). The cost of 
the labor time necessary to attach the labels to the cartons would be 
$0 to $3,500 ($17.64 per hour x 200 hours), and the cost of the labels 
would be $0 to $900 ($0.045 per label x 20,000 labels).
    We assume that the costs associated with the type of labeling we 
would require for administrative detention would be similar to the 
costs associated with the type of labeling we discussed in the 2001 
analysis. We also assume it would take the same amount of labor time to 
remove the labels, if we canceled the administrative detention order, 
as it would take us to affix the labels. We request comments on these 
assumptions. Under the proposed rule, we would attach the labels, and 
firms, under our supervision, would remove the labels, if we terminated 
the detention order, or when the detention order expired.
    After rounding to the nearest million, we estimate the cost for 
additional marking or labeling would be $0 to $1 million.

                      Table 5.--Marking or Labeling
------------------------------------------------------------------------
                                                         Change in Total
                                                          Loss of Value
      Action       Number of Actions   Label Cost per      (Rounded to
                                           Action        Nearest Million
                                                               $)
------------------------------------------------------------------------
Administrative     0 to 16            $4,400 to $7,933  $0
 Detention that
 Replaces Case of
 Moving Directly
 to Seizure
------------------------------------------------------------------------
Administrative     0 to 184           $4,400 to $7,933  $0 to $1
 Detention that
 Replaces Class I
 Recall
------------------------------------------------------------------------
Administrative     0 to 23            $4,400 to $7,933  $0
 Detention that
 Replaces
 Referral to
 State
------------------------------------------------------------------------
Total                                                   $0 to $1
------------------------------------------------------------------------

    Costs of Appeals
    The appeals process associated with administrative detention 
actions is another potential source of costs. In order to calculate the 
costs of administrative detention actions relative to the other 
baseline enforcement actions, we must first consider the cost of 
appeals associated with the other actions. There is no formal appeals 
process associated with class I recalls because these are voluntary. 
When FDA requests firms to take class I recalls, there is often an 
informal dialog between those firms and FDA. However, this type of 
dialog may take place with respect to any enforcement activity, 
including administrative detentions and seizures. Therefore, we have 
not included the costs of this informal dialog as part of the baseline 
costs. Based on these assumptions, our estimate of the appeals costs 
for administrative detentions that replace class I recalls is simply 
the total costs associated with appeals of administrative detentions.

[[Page 25259]]

    There is also no appeals process prior to a seizure action in cases 
in which we move directly to a seizure action. However, firms can 
contest seizure actions, once they occur. In addition, firms can appeal 
federal district court resolutions of contested seizure actions. Most 
recently, firms have contested approximately 65 percent of our seizure 
actions involving foods. However, firms rarely appeal federal district 
court resolutions of contested seizure actions. Previously, we noted 
that we would not include the costs associated with seizure actions in 
baseline costs. This is because we might follow an administrative 
detention with a seizure action, so any costs associated with seizure 
actions might take place irrespective of whether those seizure actions 
were preceded by administrative detentions. Instead, we viewed 
administrative detentions as preliminary enforcement actions that had 
no counterpart in cases in which we moved directly to a seizure action. 
However, in this instance, we have included our costs associated with 
contested seizure actions as part of baseline costs. We have included 
these costs because firms that appeal an administrative detention, and 
lose that appeal, are probably less likely to contest a subsequent 
seizure action, than firms that are involved in a seizure action that 
was not preceded by an administrative detention. Therefore, the appeals 
process for administrative detentions may, as a practical matter, 
replace the process of contesting seizure actions in many cases in 
which we administratively detain food and then seize it. On the other 
hand, we have not included the costs associated with appealing federal 
district court resolutions of contested seizure actions as part of 
baseline costs. These types of appeals are quite rare, and estimating 
the costs associated with these types of appeals would have little 
impact on our cost estimates.
    Finally, there is no appeals process associated with referring a 
matter to State authorities. Of course, if State authorities 
subsequently take enforcement action, then various appeals processes 
may be available under State laws or regulations for those actions. 
However, those methods of appeal would be available irrespective of 
whether the State actions were preceded by administrative detentions. 
In addition, the variety of State actions and appeals processes 
suggests that the probability that a firm will appeal a State action is 
probably not highly related to whether it has already filed and lost an 
appeal of an administrative detention. Therefore, we assume that 
administrative detention will not affect the probability that firms 
will appeal subsequent State actions.
    We estimate that our costs for activity related to appeals of 
administrative detentions would be approximately $50,000 to $70,000 per 
administrative detention. We based that estimate on our costs for 
preparing for possible appeals, which would be generated by all 
administrative detention actions, and our costs for participating in 
appeals hearings, which would be generated only by those administrative 
detentions that result in hearings. In order to calculate an average 
cost per administrative detention action, we assumed that 65 percent of 
our administrative detentions would result in an appeals hearing. We 
based that assumption on the proportion of seizure actions that firms 
contest. Therefore, the incremental change in appeals costs associated 
with substituting an administrative detention action for a class I 
recall is approximately $50,000 to $70,000.
    Our costs for activity related to firms contesting our seizures are 
approximately $10,000 to $20,000 per seizure action. We based that 
estimate on our costs for participating in a contested seizure case, 
and a 65 percent chance that firms would contest any given seizure 
action. Therefore, the incremental change in appeals costs associated 
with substituting an administrative detention action for a case of 
moving directly to a seizure action is approximately $30,000 to 
$60,000. We present the resulting cost estimates for the agency in 
table 6 of this document.

                            Table 6.--Appeals
------------------------------------------------------------------------
                                                         Change in Total
                                                          Loss of Value
      Action       Number of Actions   Label Cost per      (Rounded to
                                           Action        Nearest Million
                                                               $)
------------------------------------------------------------------------
Administrative     0 to 16            $30,000 to        $0 to $1
 Detention that                        $60,000
 Replaces Case of
 Moving Directly
 to Seizure
------------------------------------------------------------------------
Administrative     0 to 184           $50,000 to        $0 to $13
 Detention that                        $70,000
 Replaces Class I
 Recall
------------------------------------------------------------------------
Administrative     0 to 23            $50,000 to        $0 to $2
 Detention that                        $70,000
 Replaces
 Referral to
 State
------------------------------------------------------------------------
Total                                                   $0 to $16
------------------------------------------------------------------------

    A firm's decision to appeal an administrative detention order is 
voluntary. A firm would only appeal an administrative detention order 
if the costs of doing so were less than the costs of not doing so. 
Therefore, a firm's participation in the appeals process would usually 
reduce the costs that we previously estimated for storage and value 
loss by more than the cost of participating in the appeals process. 
Because we have already estimated storage costs and product value loss 
as a range that goes to zero, we have not attempted to analyze the cost 
and benefit implications of firms' decisions to appeal administrative 
detention actions.
    The specific characteristics of the proposed appeals process for 
administrative detentions would affect the cost of the appeals process 
for us and for affected firms. Examples of specific characteristics 
include the time frame under which we would allow firms to file an 
appeal for perishable and nonperishable food, the information we would 
require in an appeal, the timeframes in which we would respond to an 
appeal, and the availability of an appeals hearing, as opposed to some 
other type of appeals process. We request comments on the impacts of 
the specific requirements of the proposed appeals procedure.
    Other Enforcement Costs
    Differences in other enforcement costs associated with 
administrative detention actions, class I recalls, moving

[[Page 25260]]

directly to seizure actions, and referring matters to State 
authorities, are also relevant to this analysis. Both administrative 
detentions and class I recalls require us to undertake certain types of 
activity to implement, and we assume that the costs of this activity 
would be similar for these actions. Although taking no action prior to 
a seizure action or referring a matter to State authorities requires no 
activity, the activity that we undertake to move directly to seize food 
or to provide information on a matter to State authorities probably 
overlaps to some degree with the activity that we would undertake to 
implement an administrative detention action. The cost of the 
additional activity required to seize food following another 
enforcement action is significantly less than the cost of the activity 
required to move directly to seize food, because some of the activity 
of the preliminary action is also relevant to seizing the food. 
Therefore, we assume that the cost of the activity that we undertake to 
directly move to seize food is similar to the cost of the activity we 
undertake to implement an administrative detention action followed by a 
seizure action. Similarly, we assume that the cost of the activity that 
we and States undertake when we refer a matter to State authorities is 
similar to the cost of the activity that we and States undertake to 
implement an administrative detention action followed by State action.
    Cost summary
    We present a summary of the costs in table 7 of this document.

   Table 7.-- Annual Costs for Option 1: Transportation and Perishable
                          Foods (Proposed Rule)
------------------------------------------------------------------------
               Type of Cost                      Cost (in millions)
------------------------------------------------------------------------
Transportation                             $0 to $4
------------------------------------------------------------------------
Storage                                    $0 to $2
------------------------------------------------------------------------
Loss of Product Value                      $0 to $15
------------------------------------------------------------------------
Marking or Labeling                        $0 to $1
------------------------------------------------------------------------
Appeals                                    $0 to $16
------------------------------------------------------------------------
Total                                      $0 to $38
------------------------------------------------------------------------

    Benefits
    Administrative detention authority improves our ability to respond 
to outbreaks from accidental and deliberate contamination from food, 
and deter deliberate contamination. Based on historical evidence, a 
strike on the food supply has a very low probability, but would be a 
potentially high cost event. FDA lacks data to estimate the likelihood 
and resulting costs of a strike occurring. Without knowing the 
likelihood or cost of an event, we cannot quantitatively measure the 
reduction in probability of an event occurring or the possible 
reduction in cost of an event, associated with each regulatory option. 
Further hindering any quantification of benefits is the interactive 
effect of the other regulations that are being developed to implement 
title III of the Bioterrorism Act.
    Administrative detention differs from existing enforcement 
alternatives along the following dimensions: (1) Speed of action, (2) 
need for collaboration with other agencies, (3) maximum level of 
security, and (4) timeframes. Actions that we can implement faster will 
reduce risk more than actions that take longer to implement, because we 
have a higher probability of removing the product from commerce before 
it reaches the consumer. We have a higher probability of successfully 
taking an action that does not require collaboration because actions 
that require us to collaborate with other agencies involve more than 
one set of decision criteria and more than one decision maker. Actions 
that allow us to require higher security transportation and storage 
reduce risks because such actions reduce the probability that we will 
lose control of the product, and that adulterated food will reach 
consumers. Actions with longer time frames reduce risk because we have 
more time to complete our investigation and a lower probability of 
releasing food that is violative back into commerce. The relative 
advantages of the various enforcement actions are provided in table 8 
of this document. The expressions ``permanent'' and ``temporary'' in 
the time frames represent the relative time frames under which we can 
keep a potentially violative food out of the distribution system.

                                   Table 8.--Comparison of Enforcement Actions
----------------------------------------------------------------------------------------------------------------
                                                                       Highest Potential
        Action                 Speed              Collaboration             Security             Timeframes
----------------------------------------------------------------------------------------------------------------
Administrative         High                   No                     High                   Temporary
 Detention
----------------------------------------------------------------------------------------------------------------
Seizure                Low                    No                     High                   Permanent
----------------------------------------------------------------------------------------------------------------
Class I Recall         Low                    Yes                    Low                    Permanent
----------------------------------------------------------------------------------------------------------------
Referral to State      Low                    Yes                    Low                    Unknown
----------------------------------------------------------------------------------------------------------------

    We have insufficient information to quantify the health benefits of 
substituting administrative detention for the other enforcement 
actions. However, to understand the possible costs of an intentional 
strike on the food supply, table 9 of this document presents 
information on five outbreaks resulting from accidental and deliberate 
contamination, involving both domestic and imported foods. These 
outbreaks do not represent possible forms that a terrorist attack might 
undertake, but merely illustrate the public health costs of foodborne 
disasters. It is likely that an intentional attack on the food supply 
that sought to disrupt the food supply and sicken many U.S. citizens 
would be much larger. However, the probability of an attack occurring 
and the exact reduction in risk resulting from administrative detention 
is unknown.

[[Page 25261]]



              Table 9.--Summary of Five Foodborne Outbreaks
------------------------------------------------------------------------
                                      Confirmed    Estimated     Total
  Pathogen     Location    Vehicle   or Reported   Number of    Illness
               and Year                 Cases        Cases        Cost
------------------------------------------------------------------------
Salmonella   Minnesota,   Ice cream  150 cases;   29,100 in    $3,187,74
 enteritidi   1994                    30           MN;          4,000 to
 s                                    hospitaliz   224,000      $5,629,7
                                      ations       Nationwide   92,000
------------------------------------------------------------------------
Shigella     Michigan,    Tofu       3,175 cases  Not          $45,183,0
 sonnei       1988         salad                   available    00 to
                                                                $79,795,
                                                                000
------------------------------------------------------------------------
Outbreaks resulting from deliberate contamination
------------------------------------------------------------------------
Salmonella   Dalles,      Salad      751 cases;   Not          $10,687,0
 Typhimuriu   Oregon,      bars       45           available    00 to
 m            1984                    hospitaliz                $18,875,
                                      ations                    000
------------------------------------------------------------------------
Shigella     Texas, 1996  Muffins    12 cases; 4  All cases    $83,000
 dysentreri                and        hospitaliz   identified
 ae type 2                 doughnut   ations
                           s
------------------------------------------------------------------------
Outbreaks resulting from imported foods
------------------------------------------------------------------------
Cyclospora   United       Raspberri  1465 cases   Not          $3,941,00
 cayaetanen   States and   es         identified   available    0
 sis          Canada,      (probabl   , less
              1996         y          than 20
                           imported   hospitaliz
                           from       ation
                           Guatemal
                           a)
------------------------------------------------------------------------

    Salmonella enteritidis in ice cream
    In 1994, approximately 224,000 people were sickened by ice cream 
contaminated with Salmonella enteritidis. The source of the 
contamination appeared to be pasteurized premix that had been 
contaminated during transport in tanker trailers that carried 
nonpasteurized eggs. There were 150 confirmed cases of salmonellosis 
associated with the outbreak in Minnesota. However, ice cream processed 
during the contamination period was distributed to 48 states. To 
calculate the total number of illnesses associated with the outbreak, 
researchers calculated an attack rate of 6.6 percent. This attack rate 
was extrapolated to the population that consumed the ice cream, giving 
a total number sickened of 224,000 (Ref. 9).
    Salmonellosis most commonly causes gastrointestinal symptoms. 
Almost 91 percent of cases are mild and cause 1 to 3 days of illness 
with symptoms including diarrhea, abdominal cramps, and fever. Moderate 
cases, defined as cases that require a trip to a physician, account for 
8 percent of the cases. These cases typically have a duration of 2 to 
12 days. Severe cases require hospitalization and last 11 to 21 days. 
In addition to causing gastroenteritis, salmonellosis also can cause 
reactive arthritis in a small percentage of cases. Reactive arthritis 
may be short or long term and is characterized by joint pain. Just over 
1 percent of cases develop short-term reactive arthritis and 2 percent 
of cases develop chronic, reactive arthritis.
    FDA estimated the costs associated with salmonellosis, including 
medical treatment costs and pain and suffering. Table 10 of this 
document provides a summary of these estimates. Pain and suffering is 
measured by lost quality adjusted life days (QALDs). QALDs measure the 
loss of utility associated with an illness. A QALD is measured between 
zero and one, with one being a day in perfect health. FDA presents two 
estimates of values of pain and suffering associated with arthritis, 
one based on physician estimates (Ref. 10) and another based on a 
regression analysis approach (Ref. 11). This gives a range of costs for 
the average case of salmonellosis between $14,231 and $25,133.

                             Table 10.--The Value of a Typical Case of Salmonellosis
----------------------------------------------------------------------------------------------------------------
                                      Total QALDs                                                    Weighted
  Severity       Case Breakdown        Lost per      Health Loss per     Medical Costs per Case     Dollar Loss
                                        Illness     Case (Discounted)         (Discounted)           per Case
----------------------------------------------------------------------------------------------------------------
Illness
----------------------------------------------------------------------------------------------------------------
  Mild                   90.7%            1.05                $660                         $0            $599
  Moderate                8.1%            3.68              $2,310                       $283            $209
  Severe                  1.2%            9.99              $6,266                     $9,250            $188
----------------------------------------------------------------------------------------------------------------
Arthritis
  Regression
   Approach
-------------
    Short-                1.26%           5.41              $3,391                       $100             $44
     Term
    Long-                 2.40%       2,613.12            $452,554                     $7,322         $11,048
     Term
----------------------------------------------------------------------------------------------------------------
  Direct Survey Approach
----------------------------------------------------------------------------------------------------------------
    Short-                1.26%          10.81              $6,778                   $100 $87
     Term
    Long-                 2.40%       5,223.15            $904,573                     $7,322         $21,906
     Term
    Death                 0.04%     ..............      $5,000,000     .........................       $2,143
----------------------------------------------------------------------------------------------------------------

[[Page 25262]]

 
Total Expected Loss per Case                                              Regression Approach         $14,231
                                                                       Direct Survey Approach         $25,133
----------------------------------------------------------------------------------------------------------------

    To estimate the economic cost due to illness associated with this 
outbreak, FDA used the range for the average cost per case. For 224,000 
people, this is a total cost of between $3,187,744,000 and 
$5,629,792,000 from this accidental food disaster.
    Shigella sonnei in tofu salad
    In 1988, a tofu salad at an outdoor music festival was contaminated 
with Shigella sonnei and sickened an estimated 3,175 people. Over 2,000 
volunteer food handlers served communal meals at the festival (Ref. 
12). Shigellosis causes similar symptoms and is of similar duration to 
salmonellosis. It also is associated with short-term and chronic 
reactive arthritis; thus FDA assumed the average case of shigellosis 
has the same cost as salmonellosis. This gives a total cost of 
$45,183,000 to $79,797,000.
    Salmonella typhimirium in salad bars
    During September and October of 1984, two outbreaks of S. 
typhimirium occurred in association with salad bars in restaurants in 
The Dalles, Oregon. At least 751 people were affected. Members of the 
local Rajneeshpuram commune intentionally caused the outbreak by 
spraying S. typhimirium on the salad bars in local restaurants. Their 
apparent motivation was to influence a local election by decreasing 
voter turnout. Intentional contamination was not suspected immediately 
and no charges were brought until a year after the attacks (Ref. 13).
    The 751 people affected primarily were identified through passive 
surveillance; thus the true number of people actually sickened is 
undoubtedly much higher. The Dalles is located on Interstate 84 in 
Oregon and is a frequent stop for travelers who were unlikely to be 
identified by passive or active surveillance for salmonellosis. 
However, since we do not have any estimates of the true size of the 
outbreak, we estimated the costs associated with known cases, 
recognizing this is an underestimate of the true cost of the outbreak. 
We use the cost estimates for salmonellosis as ranging from $14,231 to 
$25,133. This gives an estimated cost of known cases for the outbreak 
of $10,687,000 to $18,875,000.
    Shigella dysenteriae type 2 among laboratory workers
    Twelve people working in a laboratory who consumed muffins left in 
the laboratory break room contracted shigellosis. Affected workers had 
diarrhea, nausea, and abdominal discomfort. Investigators concluded 
that the outbreak likely was the result of deliberate contamination. 
All 12 affected workers were treated by, or consulted with, a 
physician. Nine affected workers went to the emergency room, four of 
whom were hospitalized (Ref. 14).
    To estimate the cost of this outbreak, FDA assumed that the eight 
cases requiring consultation with a doctor, but not requiring 
hospitalization, had the same cost as a moderate case of salmonellosis. 
The four cases requiring hospitalization were estimated to have the 
same cost as a severe case of gastroenteritis resulting from 
salmonellosis. This gives a cost of $83,000 for illnesses associated 
with the event.

       Table 11.--Summary of Costs for an Outbreak of Shigellosis
------------------------------------------------------------------------
     Severity        Number of Cases    Cost per Case      Total Cost
------------------------------------------------------------------------
Mild                              0                $0                $0
------------------------------------------------------------------------
Moderate                          8            $2,593           $21,000
------------------------------------------------------------------------
Severe                            4           $15,516           $62,000
------------------------------------------------------------------------
  Total                          12   ................          $83,000
------------------------------------------------------------------------

    Cyclospora cayatanensis in imported raspberries
    In 1996, 1,465 cases of cyclosporiasis were linked to consumption 
of raspberries imported from Guatemala. Nine hundred and seventy eight 
of these cases were laboratory confirmed. No deaths were confirmed and 
less than 20 hospitalizations were reported (Ref. 15). Case control 
studies indicated that raspberries imported from Guatemala were the 
source of the illnesses. Fifty-five clusters of cases were reported in 
20 States, two Canadian provinces, and the District of Columbia (Ref. 
16).
    Cyclosporiasis typically causes watery diarrhea, loss of appetite, 
weight loss, and fatigue. Less common symptoms include fever, chills, 
nausea, and headache. The median duration of illness associated with 
the outbreak was more than 14 days and the median duration of diarrheal 
illness was 10 days (Ref. 16). We estimated the cost of a mild case of 
cyclosporiasis as two and a half times higher than the cost of a mild 
case of gastroenteritis from salmonellosis due to the longer duration. 
The reports of cyclosporiasis outbreaks did not include information on 
the number of physician visits. We assumed that the percentage of total 
cases that result in physician visits would be larger than the 
corresponding percentage for salmonellosis illnesses, due to the longer 
duration of illnesses. We assumed, therefore, that 40 percent of those 
infected with cyclosporiasis visited a physician. Less than 20 
hospitalizations were reported from the cyclosporiasis outbreak (Ref. 
15). No deaths were confirmed.

[[Page 25263]]



      Table 12.--Summary of Costs of an Outbreak of Cyclosporiasis
------------------------------------------------------------------------
     Severity        Number of Cases    Cost per Case       Total Cost
------------------------------------------------------------------------
Mild                            879            $1,650    $1,450,000
------------------------------------------------------------------------
Moderate                        586            $3,748    $2,196,000
------------------------------------------------------------------------
Severe                           19           $15,516      $295,000
------------------------------------------------------------------------
  Total                       1,465   ................   $3,941,000
------------------------------------------------------------------------

    Option Two: Take the proposed action, but change either or both the 
definition of perishable food and the maximum time frame for 
administrative detention of perishable food.
    Costs
    If we established a shorter maximum timeframe for administrative 
detention of perishable food, then we would reduce the potential 
storage costs and loss of value associated with administratively 
detaining that food. If we also broadened the definition of perishable 
food to include products with a shelf life of over 7 days, then we 
would further decrease the storage costs and loss of food product value 
for those additional types of food. One reasonable alternative would be 
to broaden the definition of perishable food to include any food that 
might lose all of its value during a 30-day administrative detention 
period, that is, any food with a shelf life of 30 days or less, and 
reduce the maximum timeframe for administratively detaining a 
perishable food to 14 days. We calculated the costs of this option 
using the same procedures that we used for Option one (take the 
proposed action). We present these costs in table 13.

Table 13.--Annual Costs for Option 2: Alternative Definition and Maximum
                  Detention Period for Perishable Food
------------------------------------------------------------------------
                                        Cost (rounded to nearest million
             Type of Cost                              $)
------------------------------------------------------------------------
Transportation Cost                     $0 to $4
Storage Cost                            $0 to $1
Loss of Product Value                   $0 to $8
Marking or Labeling                     $0 to $1
Appeals                                 $0 to $16
Total                                   $0 to $30
------------------------------------------------------------------------

    If we attempted to maintain the same level of investigation under 
the shorter maximum timeframes for perishable food by using our 
enforcement resources more intensively, then enforcement costs might 
also increase. In that case, we would need to compare the cost of using 
our investigative resources more intensively for a shorter period of 
time relative to using those resources less intensively for a longer 
period of time. More intensive use of resources would probably cost 
more because it would probably require our employees to work overtime 
and possibly over weekends and holidays. Therefore, this would reduce 
any cost savings introduced by the shorter maximum timeframes for 
perishables.
    Benefits
    Changing the definition of perishable food and the maximum 
timeframes for administrative detentions of perishable food could also 
affect the health benefits of this rule. Broadening the definition of 
perishable food and establishing a shorter maximum timeframe for 
administratively detaining that food would reduce the maximum 
timeframes for storage of those products that qualified as perishable 
food relative to the time frame for nonperishable food. The 
significance of this change depends on how often we need the full 30 
days to complete our investigations. If we usually complete our 
investigations in the time allowed under the hypothetical shorter 
maximum detention time we could establish for perishable food, then 
including more products in the perishable category would have little 
effect on the risk that we would fail to catch a violative product 
because of the shorter investigation period. However, if we often need 
the full 30 days to complete our investigations, then including more 
products in the perishable category and establishing a shorter maximum 
detention time for administrative detention of perishable food would 
increase the risk that we would fail to catch a violative product 
during the investigation period. We do not have sufficiently detailed 
information to estimate these changes in health benefits.
    We might also be able to maintain the same effect on risk and 
health benefits under the shorter timeframes by using resources more 
intensively during the shorter investigation period. For example, if we 
were to allocate more employees to work on an investigation, or if our 
employees were to work extra hours, then we might be able to complete 
the same level of investigation under a shorter timeframe. In that 
case, this option would have the same health benefits as Option one, 
but additional costs might be generated by the more intensive use of 
resources.
    Option Three: Take the proposed action, but change the level of 
security we require for transportation and storage.
    Costs
    Instead of judging the need for various levels of security on a 
case-by-case basis, we could require firms to use specified levels of 
security to transport and store food under specified conditions. In 
Option one, we assumed, based on information from a trade group, that 
the costs for using bonded carriers and warehouses were similar to 
those for using nonbonded carriers and warehouses. However, if we chose 
a lower security approach and allowed firms to store administratively 
detained food in place, then we would eliminate the transportation 
costs. Eliminating transportation costs would reduce total costs to a 
range of $0 to $34 million.
    If we required firms to undertake security operations they would 
not otherwise have taken, then we would need to add in the cost of that 
activity. One example of the type of activity we might require is 
posting additional security guards. The average hourly wage of a 
security guard in 2000 was about $9.50 (Ref. 17). We doubled this wage 
to account for overhead, such as health benefits, to get an annual 
hourly wage of about $17. Therefore, the average cost of posting one 
additional security guard would be approximately $450 per day. The 
number of guards would depend on the number of facilities involved. 
Firms might already have distributed food that we administratively 
detain. Based on our experience with other enforcement actions, we 
believe that between 1 and 20 storage facilities might be involved per 
administrative detention action. Therefore, we calculate the cost of 
adding 1 guard by multiplying the cost of 1 additional security guard 
per day,

[[Page 25264]]

times a maximum of 30 days storage, times the number of administrative 
detentions, times the number of facilities involved per administrative 
detention. Using this approach, we estimate the total costs associated 
with no transportation and posting one additional guard would be $0 to 
$45 million.

     Table 14.--Annual Costs for Option 3: No Transportation and One
                            Additional Guard
------------------------------------------------------------------------
                                            Cost  (rounded to nearest
             Type of Cost                          million $)
------------------------------------------------------------------------
One additional guard                    $0 to $11
Storage Cost                            $0 to $2
Loss of Product Value                   $0 to $15
Marking or Labeling                     $0 to $1
Appeals                                 $0 to $16
Total                                   $0 to $45
------------------------------------------------------------------------

    We do not have information on the costs of using high security 
transportation and storage. However, requiring high security 
transportation and storage would probably substantially increase 
transportation and storage costs.
    Benefits
    As discussed in Option one, bonded and third party carriers and 
warehouses provide some degree of additional security relative to 
relying on a firm's own transportation system and storage facilities. 
However, they do not provide the highest level of security because food 
can be stolen from such facilities, and because the owners of those 
facilities could, themselves, become involved in deliberately 
adulterating food. Therefore, requiring a higher level of security for 
transportation and storage would reduce the probability that an 
adulterated product might find its way back into commerce during a 
detention. We have insufficient information to estimate the change in 
health benefits from more secure transportation and storage.
    Option Four: Issue regulations only to establish expedited 
procedures for instituting certain enforcement actions involving 
perishable food (i.e., limit the action to that required by section 303 
of the Bioterrorism Act).
    The Bioterrorism Act requires us to issue regulations establishing 
expedited procedures for instituting seizure actions, injunction 
actions, or both against perishable food. Therefore, taking no 
regulatory action with regard to those procedures would not be a 
legally viable option. However, we could promulgate a more limited rule 
that covered only expedited procedures for enforcement actions 
involving perishable food, rather than a rule that also included 
general procedures for administrative detention.
    Costs
    If we were to issue a more limited rule, we would still be able to 
administratively detain food because Congress has already granted us 
that authority under the Bioterrorism Act. We would probably 
administratively detain food in the same situations in which we would 
have taken this action under the proposed rule. Therefore, the costs we 
estimated under Option One would also apply to this option. In 
addition, there could be some additional enforcement cost associated 
with relying on the language of the act rather than our own regulations 
when taking this action. These additional costs would be caused by our 
need to develop and defend our interpretation of the language of the 
Bioterrorism Act piecemeal in court, rather than through implementing 
regulations. These court proceedings would probably take longer and be 
more complicated than they would be if we were enforcing more specific 
regulatory language. We have insufficient information to estimate this 
change in costs. Therefore, we can only determine that the lower bound 
of the range of potential costs for this option would be somewhat 
greater than $0 million, and the upper bound would be somewhat higher 
than $38 million, and the costs associated with this option would be 
somewhat greater than those associated with Option one under any given 
scenario.
    Benefits
    Again, even if we did not include the overall framework for 
administrative detention in this rule, we would probably use 
administrative detention in the same situations in which we would use 
administrative detention under the framework developed in this proposed 
rule. However, we expect we would have somewhat more difficulty using 
administrative detention if we relied only on the language of the act 
rather than also on our more detailed regulations. For example, if we 
needed to develop and defend our interpretation of the language of the 
Bioterrorism Act piecemeal in court, our ability to pursue 
administrative detentions while such proceedings are ongoing might be 
limited or even precluded. Therefore, the benefits of this option might 
be somewhat lower than those for Option one.
    Summary of Options
    We summarize the costs and benefits of the various options in table 
15.

             Table 15.--Summary of Annual Costs and Benefits
------------------------------------------------------------------------
                                        Costs (in         Benefits (in
              Option                    millions)          millions)
------------------------------------------------------------------------
1--transportation and perishable    $0 to $38           $0
 foods as proposed
------------------------------------------------------------------------
2--perishable foods alternatives    $0 to $30           $0,
                                                        but < Option 1
------------------------------------------------------------------------
3--no transportation, but one       $0 to $45           $0
 additional guard
------------------------------------------------------------------------
4--limited to Act                    $0 to   $0,
                                      $38    but < = Option 1
------------------------------------------------------------------------

    The ranges generated by the underlying uncertainties in our 
analysis, particularly concerning benefits, preclude us from drawing 
any firm conclusions about the relative net benefits of the various 
regulatory options. The potential costs for Option One (the proposed 
rule) are lower than those for Option Three, and we are unable to 
differentiate the potential benefits of these two options. The 
similarity between the estimated ranges of costs and benefits for these 
two options suggests that we should determine whether to require 
transportation or storage in place on a case-by-case basis, as we have 
proposed. The potential costs for Option One are higher than those for 
Option Two. However, the estimated benefits of Option One are also 
higher than those of Option Two. We have insufficient information to 
quantify the difference in benefits. The potential costs for Option One 
are lower than those for Option Four, and the benefits of Option One 
are greater or equal to those of Option Four. Therefore, Option One 
would lead to higher net benefits than Option Four.

[[Page 25265]]

B. Initial Regulatory Flexibility Analysis

    We have examined the economic implications of this proposed rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires us to analyze 
regulatory options that would lessen the economic effect of the rule on 
small entities. We find that this proposed rule would not have a 
significant economic impact on a substantial number of small entities. 
Nonetheless, we have provided an initial regulatory flexibility 
analysis under the Regulatory Flexibility Act, which consists of the 
analysis below with other relevant sections of this document.
    This proposed rule may affect firms involved in the production or 
handling of human food and animal feed such as the following: (1) Food 
producers such as farms, ranches, fisheries, dairies, bakeries, 
breweries, distilleries, and manufacturers of processed food, food 
additives, dietary supplements, infant formula, and food contact 
substances; (2) food importers; (3) food wholesalers or brokers; (4) 
food retailers; (5) food service establishments; and (6) food 
transporters. The rule might affect producers because we could 
administratively detain food at one of the producer's facilities prior 
to distribution of that food to wholesalers or brokers. We could also 
administratively detain food anywhere in the distribution system, from 
wholesaler and retailer warehouses, to retail store shelves, to food 
service establishment kitchens or storerooms. The rule might affect 
transporters because we might detain food that is en route to another 
location, and the food might be packed together with food that we would 
not detain. This might cause delays in the deliveries of the other 
food.
    Potentially affected firms fall into a number of different North 
American Industry Classification System (NAICS) codes, including the 
following: 111 Crop Production, 112 Animal Production, 1141 Fisheries, 
311 Food Manufacturing, 3121 Beverage Manufacturing, 325412 
Pharmaceutical Preparation Manufacturing, 4224 Grocery and Related 
Products Wholesalers, 4225 Farm Product Raw Material Merchant 
Wholesalers, 4248 Beer, Wine, and Distilled Alcoholic Beverage Merchant 
Wholesalers, 445 Food and Beverage Stores, 446191 Food (Health) 
Supplement Stores, 481112 Scheduled Freight Air Transportation, 481212 
Nonscheduled Chartered Freight Air Transportation, 482 Rail 
Transportation, 483111 Deep Sea Freight Transportation, 483113 Coastal 
and Great Lakes Freight Transportation, 483211 Inland Water Freight 
Transportation, 484 Truck Transportation (except 48421 Used Household 
and Office Food Moving, 4842201 Local Hazardous Materials Trucking, 
4842203 Dump Trucking, and 4842301 Long Distance Hazardous Materials 
Trucking), and 722 Food Service and Drinking Places. There is also no 
NAICS code for manufacturers of food contact material. However, the 
following NAICS codes cover some of the potentially affected firms: 
322215 Non-Folding Sanitary Food Container Manufacturing, 32222 Paper 
Bag and Coated and Treated Paper Manufacturing, 32611 Plastics 
Packaging Materials and Unlaminated Film and Sheet Manufacturing, 
327213 Glass Container Manufacturing, and 333993 Packaging Machinery 
Manufacturing. There are no NAICS codes for manufacturers of food 
additives or for food importers, and we assume these firms are included 
in the other categories.
    The 1997 Economic Census lists 1.6 million establishments in these 
categories, excluding NAICS codes 111, 112, 1141, and 482, which are 
not included in the Economic Census. The 2000 County Business Patterns 
updates some of the numbers from the 1997 Economic Census. However, the 
County Business Patterns data includes only establishments with 
employees. In order to obtain another estimate of the number of firms 
using the updated data, we combined the number of establishments with 
employees from the 2000 County Business Patterns with an estimate of 
the number of establishments without employees based on the proportion 
of firms with and without employees in the 1997 Economic Census. This 
procedure also led to an estimate of approximately 1.6 million 
establishments in these categories, excluding NAICS codes 111, 112, 
1141, and 482. An establishment without employees is an establishment 
that is staffed only by the owners of that establishment.
    We also used the Dun and Bradstreet Market Identifiers database to 
get a count of the number of firms in these categories. This database 
uses Standard Industry Classification (SIC) codes rather than NAICS 
codes. SIC codes do not correspond exactly to NAICS codes. We based our 
estimate on all SIC codes that even partially corresponded to relevant 
NAICS codes. This database allows one to count firms rather than 
establishments, and also allows one to identify firms by both primary 
and secondary activities. According to this database, approximately 1.8 
million firms could be affected by this rule. However, we would not be 
able to affect more firms in 1 year than the estimated number of 
administrative detentions that we might take in 1 year. In the analysis 
of impacts above, we estimated that we might administratively detain 
food between 0 and 200 times per year. Therefore, we estimate that this 
rule may affect between 0 and approximately 200 firms per year.
    The Small Business Administration (SBA) publishes definitions of 
small businesses by six-digit NAICS code (Ref. 18). Some of the NAICS 
codes listed previously above are less than six digits. In those cases, 
we used the range of small business definitions for all six-digit 
subcategories in the relevant NAICS code. The current SBA definitions 
in terms of either maximum annual average receipts or number of 
employees are as follows: 111 ($0.75 million), 112 ($0.75 to $10.5 
million), 1141 ($3.5 million), 311 (500 to 1,000), 3121 (500 to 750), 
322215 (750), 32222 (500), 325412 (750), 32611 (500), 327213 (750), 
333993 (100), 4224 (100), 4225 (100), 42251 (100), 4228 (100), 445 ($6 
to $23 million), 446191 ($6 million), 481112 (1,500), 481212 (1,500), 
482 (500), 483111 (500), 483113 (500), 483211 (500), 484 except 48421, 
4842201, 4842203, and 4842301 ($21.5 million), 722 ($6 million to $17.5 
million). We applied the relevant range of sizes to the SIC codes that 
at least partially corresponded to the relevant NAICS codes and found 
that approximately 84 to 90 percent of the firms that this rule might 
affect are small businesses under SBA size definitions. Therefore, we 
estimate that this rule may affect between 0 and 180 small businesses 
each year.
    The potential cost per administrative detention for small entities 
based on taking the proposed action and the information and assumptions 
in the preceding impact analysis would be $20,000 to $330,000, 
depending on the type of product involved and the type of enforcement 
action that we would replace with an administrative detention, and 
whether or not the firm appealed the administrative detention order. 
However, we based this range on a number of assumptions that are 
probably more reasonable when applied to average or expected costs 
across a large number of actions than to a single action. Thus, the 
actual range of potential costs for a single detention action would be 
much larger. In addition, the cost per firm would depend on the number 
of times that we

[[Page 25266]]

detain that firm's products in a given time period. The most we can say 
about costs on a per firm basis is that the average expected cost per 
firm across all potentially affected firms would presumably be quite 
low, but the cost for a particular firm in a particular year could be 
significant, depending on a number of variables including the type and 
amount of product involved. FDA requests comment on the impact of this 
proposed rule on small entities.
    The fact that most of the potentially affected firms are small 
businesses suggests that the options that would be relevant to small 
businesses are the same as the options relevant for all firms discussed 
in the impact analysis above. Options two and three would both reduce 
the impact on small firms. However, these options would also reduce 
benefits, and we do not have sufficient information to estimate the 
change in net benefits.
    Administrative detention involves preventing the movement of food 
upon credible evidence or information that the food presents a threat 
of serious adverse health consequences or death to humans or animals. 
This standard is applicable without regard to the size of any business 
involved. Most of the businesses impacted by this proposed rule are 
small businesses. To provide an exemption for small businesses under 
this proposed rule would defeat the purposes of the statute. 
Accordingly, we are not providing exemptions from the requirements of 
this regulation to small businesses.

C. Unfunded Mandates

    Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 
104-4) requires cost-benefit and other analyses before any rule making 
if the rule would include a ``Federal mandate that may result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted annually 
for inflation) in any 1 year.'' The current inflation-adjusted 
statutory threshold is $112.3 million per year. We have estimated that 
the total cost of the proposed rule would be no more than $38 million 
per year. Therefore, we have determined that this proposed rule does 
not constitute a significant rule under the Unfunded Mandates Reform 
Act.

D. SBREFA Major Rule

    The Small Business Regulatory Enforcement Fairness Act of 1996 
SBREFA (Public Law 104-121) defines a major rule for the purpose of 
congressional review as having caused or being likely to cause one or 
more of the following: an annual effect on the economy of $100 million; 
a major increase in costs or prices; significant adverse effects on 
competition, employment, productivity, or innovation; or significant 
adverse effects on the ability of U.S.-based enterprises to compete 
with foreign-based enterprises in domestic or export markets. In 
accordance with SBREFA, the Office of Management are Budget (OMB) has 
determined that this proposed rule, when final, will not be a major 
rule for the purpose of congressional review.

VI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520).
    We tentatively conclude that these proposed information collection 
provisions are exempt from OMB review under 44 U.S.C. 318(c)(1)(B)(ii) 
and 5 CFR 1320.4(a)(2) as collections of information obtained during 
the conduct of a civil action to which the United States or any 
official or agency thereof is a party, or during the conduct of an 
administrative action, investigation, or audit involving an agency 
against specific individuals or entities. The regulations in 5 CFR 
1320(c) provide that the exception in 5 CFR 1320.4(a)(2) applies during 
the entire course of the investigation, audit or action, but only after 
a case file or equivalent is opened with respect to a particular party. 
We seek comment on our tentative conclusion that these information 
collections are exempt from OMB review.

VII. Analysis of Environmental Impact

    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded under 21 CFR 25.30(h) that 
this action is of a type that does not individually or cumulatively 
have a significant effect on the human environment. Therefore, neither 
an environmental assessment nor an environmental impact statement is 
required.

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
the agency tentatively concludes that the proposed rule does not 
contain policies that have federalism implications as defined in the 
Executive order and, consequently, a federalism summary impact 
statement has not been prepared.

IX. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this document. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. FDA cannot be 
responsible for addressing comments submitted to the wrong docket or 
that do not contain a docket number. Received comments may be seen in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.
    FDA notes that the comment period for this document is shorter than 
the 75-day period that the agency customarily provides for proposed 
rules that are technical or sanitary or phytosanitary (SPS) measures. 
FDA believes that a 60-day comment period is appropriate in this 
instance. Executive Order 12889, ``Implementation of the North American 
Free Trade Agreement'' (58 FR 69681, December 30, 1993), states that 
any agency subject to the Administrative Procedure Act must provide a 
75-day comment period for any proposed Federal technical regulation or 
any Federal SPS measure of general application. Executive Order 12889 
provides an exception to the 75-day comment period where the United 
States considers a technical regulation or SPS measure of general 
application necessary to address an urgent problem related to the 
protection of human, plant, or animal health. FDA has concluded that 
this proposed rule is subject to the exception in Executive Order 
12889.
    The Bioterrorism Act states that it is intended ``[t]o improve the 
ability of the United States to prevent, prepare for, and respond to 
bioterrorism and other public health emergencies.'' The provisions in 
this proposed rule that describe the procedures for how FDA will detain 
an article of food, how FDA will expedite certain enforcement actions 
with respect to perishable food, and the process for appealing a 
detention order will enhance FDA's ability to prevent distribution of 
food that presents a threat of serious adverse health consequences or 
death to humans or animals. The legislative history of the Bioterrorism 
Act, with respect to the regulation required by section 303 of that 
act, notes that the ``Secretary

[[Page 25267]]

should promptly complete such rule making'' (H. Conf. Rept. No. 107-
481, at 131 (2002)). This expedited timeframe reflects the urgency of 
the U.S. Government's need to prepare to respond to bioterrorism and 
other food-related emergencies.
    FDA has concluded that the urgency of this matter is sufficient 
justification for shortening the public comment period for this 
proposal to 60 days, consistent with Executive Order 12889.
    FDA will not consider any comments submitted after the 60-day 
comment period closes. Due to the need to promptly complete this 
rulemaking, FDA does not intend to grant any requests for extensions of 
the comment period.

X. References

    The following references have been placed on display in the Dockets 
Management Branch (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the 
Web site addresses, but is not responsible for subsequent changes to 
the Web sites after this document publishes in the Federal Register.
    1. ``Fruit And Vegetable Truck Rate Report,'' Agricultural 
Marketing Service, U.S. Department of Agriculture, week ending 
Tuesday, November 19, 2002.
    2. Memorandum of phone call between Ed Puro, FDA, and Benjamin 
Milk, International Association of Refrigerated Warehouses, 
September 30, 2002.
    3. Price list from California Refrigerated Services, Inc., 
received October 3, 2002.
    4. Fresh Fruit and Vegetable Shipments for Calendar Year 2001, 
Agricultural Marketing Service, U.S. Department of Agriculture, 
table 1, pp. 8-9, available on Internet at http://www.ams.usda.gov/fv/mncs/shipsumm01.PDF, accessed September 22, 2002.
    5. ``Regulatory Procedures Manual,'' August 1997. Division of 
Compliance Policy, Office of Enforcement, Office of Regulatory 
Affairs, U.S. Food and Drug Administration, U.S. Department of 
Health and Human Services. chap. 11, p. 497, August, 1997.
    6. Hurst, W. C., Reynolds, A. E., Schuler, G. A., and Christian, 
J. A. Maintaining Food Quality in Storage, The University of Georgia 
College of Agriculture and Environmental Sciences Cooperate 
Extension Service, available on the Internet at http://www.ces.uga.edu/pubcd/b914-w.html, accessed January 24, 2003.
    7. Bureau of Economic Analysis, U.S. Department of Commerce, 
U.S. International Transactions Accounts Data, table 2, U.S. Trade 
in Goods, Line C-77 for 2001, available on Internet at http://www.bea.doc.gov by choosing International Transactions Accounts, 
then customized data button next to table 2, then entering 2001, 
annual, and line C-77. Accessed November 14, 2002.
    8. ``Marking Requirement for and Prohibitions on the 
Reimportation of Imported Food Products That Have Been Refused 
Admission into the United States,'' Federal Register, volume 66, No. 
14, Monday, January 22, 2001, pp. 6508-6509.
    9. Hennessy, T. W., Hedberg C. W., Slutsker L., White K. E., 
Besser-Wiek J. M., Moen N.E., Feldman J., Coleman W. W., Edmonson L. 
M., MacDonald K. L., Osterholm M. T., and the Investigation Team, 
``A National Outbreak of Salmonella Enteritidis Infections From Ice 
Cream,'' The New England Journal of Medicine, May 16, 1996, pp. 
1281-1286.
    10. Zorn, D. and Klontz, K., 1998, Appendix: The Value of 
Consumer Loss to Foodborne Reactive Arthritis, Federal Register, May 
1, 1998.
    11. Scharff, R. and Jessup, A., Valuing Chronic Disease for 
Heterogeneous Populations: The Case of Arthritis, 2002, Mimeo.
    12. Lee L. A., Ostroff S. M., McGee H. B., Johnson D. R., Downes 
F. P., Cameron D. N., Bean N. H., and P.M. Griffin, ``An Outbreak of 
Shigellosis at an Outdoor Music Festival,'' American Journal of 
Epidemiology, 133:6:608-615.
    13. Torok T. J., Tauxe R. V., Wise R. P., Livengood J. R., 
Sokolow R., Mauvais S., Birkness K. A., Skeels M. R., Horan J. M., 
and L. R. Foster, ``A Large Community Outbreak of Salmonellosis 
Caused by Intentional Contamination of Restaurant Salad Bars,'' The 
Journal of the American Medical Association, 278:5:389-397.
    14. Kolavic S. A., Kimura A., Simons S. L., Slusker L., Barth 
S., and C. E. Haley, ``An Outbreak of Shigella Dysenteriae Type 2 
Among Laboratory Workers Due to Intentional Food Contamination,'' 
The Journal of the American Medical Association, 278:5:396-403.
    15. Colley D. G., Widespread Foodborne Cyclosporiasis Outbreaks 
Present Major Challenges (letter), Emerging Infectious Diseases, 
2:4:354-356.
    16. Herwaldt B. L., Ackers M. L., and Cyclospora Working Group, 
``An Outbreak in 1996 of Cyclosporiasis Associated With Imported 
Raspberries,'' New England Journal of Medicine, May 29, 1997, pp. 
1548-1556.
    17. 2000 National Occupational Employment and Wage Estimates, 
Protective Service Occupations, U.S. Department of Labor, Bureau of 
Labor Statistics, available on Internet at http://stats.bls.gov/oes/2000/oes_33Pr.htm, accessed October 22, 2002.
    18. Small Business Size Standards Matched to North American 
Industry Classification System (NAICS), Small Business 
Administration, available on Internet at http://www.sba.gov/size/sizetable.html, accessed November 20, 2002.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, and 
Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 1 and 16 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

    1. The authority citation for 21 CFR part 1 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 304, 321, 331, 
334, 343, 350c, 350d, 352, 355, 360b, 362, 371, 374, 381, 382, 393; 
42 U.S.C. 216, 241, 243, 262, 264.
    2. Subpart K is added to part 1 to read as follows:
Sec.
Subpart K--Administrative Detention of Food for Human or Animal 
Consumption
General Provisions
1.377 What definitions apply to this subpart?
1.378 What criteria does FDA use to order a detention?
1.379 How long may FDA detain an article of food?
1.380 Where and under what conditions must the detained article of 
food be held?
1.381 May a detained article of food be delivered to another entity 
or transferred to another location?
1.382 What labeling or marking requirements apply to a detained 
article of food?
1.383 What expedited procedures apply when FDA initiates a seizure 
action against a detained perishable food?
1.384 When does a detention order terminate?
How does FDA order a detention?
1.391 Who approves a detention order?
1.392 Who receives a copy of the detention order?
1.393 What information must FDA include in the detention order?
What is the appeal process for a detention order?
1.401 Who is entitled to appeal?
1.402 What are the requirements for submitting an appeal?
1.403 What requirements apply to an informal hearing?
1.404 Who serves as the presiding officer at an informal hearing?
1.405 When does FDA have to issue a decision on an appeal?
1.406 How will FDA handle classified information in an informal 
hearing?

Subpart K--Administrative Detention of Food for Human or Animal 
Consumption

General Provisions


Sec.  1.377  What definitions apply to this subpart?

    The definitions of terms that appear in section 201 of the act (21 
U.S.C. 321)

[[Page 25268]]

apply when the terms are used in this subpart.
    In addition, for the purposes of this subpart:
    Act means the Federal Food, Drug, and Cosmetic Act.
    Authorized FDA representative means an FDA District Director in 
whose district the article of food involved is located or an FDA 
official senior to such director.
    Calendar day means every day shown on the calendar.
    Food has the meaning given in section 201(f) of the act (21 U.S.C. 
321(f)). Examples of food include, but are not limited to, fruits, 
vegetables, fish, dairy products, eggs, raw agricultural commodities 
for use as food or components of food, animal feed, including pet food, 
food and feed ingredients and additives, including substances that 
migrate into food from food packaging and other articles that contact 
food, dietary supplements and dietary ingredients, infant formula, 
beverages, including alcoholic beverages and bottled water, live food 
animals, bakery goods, snack foods, candy, and canned foods.
    Perishable food means food that is not heat-treated; not frozen; 
and not otherwise preserved in a manner so as to prevent the quality of 
the food from being adversely affected if held longer than 7 days under 
normal shipping and storage conditions.
    We means the U.S. Food and Drug Administration (FDA).
    Working day means any day from Monday through Friday, excluding 
Federal holidays.
    You means any person who received the detention order or that 
person's representative.


Sec.  1.378  What criteria does FDA use to order a detention?

    An officer or qualified employee of FDA may order the detention of 
any article of food that is found during an inspection, examination, or 
investigation under the act if the officer or qualified employee has 
credible evidence or information indicating that the article of food 
presents a threat of serious adverse health consequences or death to 
humans or animals.


Sec.  1.379  How long may FDA detain an article of food?

    (a) FDA may detain an article of food for a reasonable period that 
may not exceed 20 calendar days after the detention order is issued. 
However, an article may be detained for 10 additional calendar days if 
a greater period of time is required to institute a seizure or 
injunction action. The authorized FDA representative may approve the 
additional 10 calendar day detention period at the time the detention 
order is issued or at any time within the 20 calendar day period by 
amending the detention order.
    (b) The entire detention period may not exceed 30 calendar days.
    (c) An authorized FDA representative may, in accordance with Sec.  
1.384, terminate a detention order before the expiration of the 
detention period.


Sec.  1.380  Where and under what conditions must the detained article 
of food be held?

    (a) You must hold the detained article of food in the location and 
under the conditions specified by FDA in the detention order.
    (b) If FDA determines that removal to a secure facility is 
appropriate, the article of food must be removed to a secure facility. 
A detained article of food remains under detention before, during, and 
after movement to a secure facility. FDA will also state in the 
detention order any conditions of transportation applicable to the 
detained article.
    (c) If FDA directs you to move the detained article of food to a 
secure facility, you must receive a limited conditional release under 
Sec.  1.381(c) before you move the detained article of food to a secure 
facility.
    (d) You must ensure that any required tags or labels under Sec.  
1.382 accompany the detained article during and after movement. The 
tags or labels must remain with the article of food until FDA 
terminates the detention order or the detention period expires, 
whichever occurs first, unless otherwise permitted by the authorized 
FDA representative.
    (e) The movement of an article of food in violation of a detention 
order issued under Sec.  1.393 is a prohibited act under section 301 of 
the act.


Sec.  1.381  May a detained article of food be delivered to another 
entity or transferred to another location?

    (a) An article of food subject to a detention order under this 
subpart may not be delivered to another entity under the execution of a 
bond. Notwithstanding section 801(b) of the act (21 U.S.C. 381(b)), 
while any article of food is subject to a detention order under section 
304(h) of the act, it may not be delivered to any of its importers, 
owners, or consignees.
    (b) Except as provided in paragraph (c) of this section, no person 
may transfer a detained article of food within or from the place where 
it has been ordered detained, or from the place to which it was 
removed, until an authorized FDA representative releases the article of 
food under Sec.  1.384 or the detention period expires under Sec.  
1.379, whichever occurs first.
    (c) The authorized FDA representative may approve, in writing, a 
request for a limited conditional release of a detained article of food 
for any of the following purposes:
    (1) To destroy the article of food,
    (2) To move the detained article of food to a secure facility under 
the terms of a detention order,
    (3) To maintain or preserve the integrity or quality of the article 
of food, or
    (4) For any other purpose that the authorized FDA representative 
believes is appropriate in the case.
    (d) You must submit your request for the limited conditional 
release of the detained article in writing to the authorized FDA 
representative who approved the detention order. You must state in your 
request the reasons for movement; the exact address of and location in 
the new facility (or the new location within the same facility) where 
the detained article of food will be transferred; an explanation of how 
the new address and location will be secure, if FDA has directed that 
the article be detained in a secure facility; and how the article will 
be held under any applicable conditions described in the detention 
order. If you are requesting a limited conditional release for the 
purpose of destroying the detained article of food, you also must 
submit a verified statement identifying the ownership or proprietary 
interest you have in the detained article of food, in accordance with 
Supplemental Rule C to the ``Federal Rules of Civil Procedure.''
    (e) If FDA approves a request for limited conditional release, the 
article may be transferred but remains under detention before, during, 
and after the transfer. FDA will state any conditions of transportation 
applicable to the detained article. You may not transfer a detained 
article of food without FDA supervision unless FDA has declined in 
writing to supervise the transfer. If FDA has declined in writing to 
supervise the transfer of a detained article, you must immediately 
notify in writing the authorized FDA representative who approved the 
limited conditional release of the article of food that the article of 
food has reached its new location, and the specific location of the 
detained article within the new location. Such written notification may 
be in the form of a fax or e-mail or other form as agreed to by the 
authorized FDA representative.
    (f) You must ensure that any required tags or labels under Sec.  
1.382 accompany the detained article during and after

[[Page 25269]]

movement. The tags or labels must remain with the article of food until 
FDA terminates the detention order or the detention period expires, 
whichever occurs first, unless otherwise permitted by the authorized 
FDA representative who approves the limited conditional release of the 
detained article of food under this section.
    (g) The transfer of an article of food in violation of a detention 
order issued under Sec.  1.393 is a prohibited act under section 301 of 
the act.


Sec.  1.382  What labeling or marking requirements apply to a detained 
article of food?

    The officer or qualified employee of FDA issuing a detention order 
under Sec.  1.393 may label or mark the detained article of food with 
official FDA tags or labels that include the following information:
    (a) A statement that the article of food is detained by FDA in 
accordance with section 304(h) of the act (21 U.S.C. 334(h));
    (b) A statement that the article of food must not be consumed, 
moved, altered, or tampered with in any manner for the period shown, 
without the written permission of an authorized FDA representative;
    (c) A statement that the violation of a detention order or the 
removal or alteration of the tag or label is a prohibited act, 
punishable by fine or imprisonment or both; and
    (d) The detention order number, the date and hour of the detention 
order, the detention period, and the name of the officer or qualified 
employee of FDA who issued the detention order.


Sec.  1.383  What expedited procedures apply when FDA initiates a 
seizure action against a detained perishable food?

    If FDA initiates a seizure action under section 304(a) of the act 
against a perishable food subject to a detention order under this 
subpart, FDA will send the seizure recommendation to the Department of 
Justice within 4 calendar days after the detention order is issued, 
unless extenuating circumstances exist. If the fourth calendar day is 
not a working day, FDA will advise the Department of Justice of its 
plans to recommend a seizure action on the last working day before the 
fourth calendar day and send the recommendation as soon as practicable 
on the first working day that follows. For purposes of this section, an 
extenuating circumstance includes, but is not limited to, instances 
when the results of confirmatory testing or other evidentiary 
development requires more than 4 calendar days to complete.


Sec.  1.384  When does a detention order terminate?

    If FDA terminates a detention order or the detention period 
expires, an authorized FDA representative will issue a detention 
termination notice releasing the article of food to any person who 
received the detention order or that person's representative and will 
remove, or authorize in writing the removal of, the required labels or 
tags. If FDA fails to issue a detention termination notice and the 
detention period expires, the detention is deemed to be terminated.

How does FDA order a detention?


Sec.  1.391  Who approves a detention order?

    An authorized FDA representative, i.e., the FDA District Director 
in whose district the article of food involved is located or an FDA 
official senior to such director, must approve a detention order. If 
prior written approval is not feasible, prior oral approval must be 
obtained and confirmed in writing as soon as possible.


Sec.  1.392  Who receives a copy of the detention order?

    (a) FDA must issue the detention order to the owner, operator, or 
agent in charge of the place where the article of food is located. If 
the owner of the article of food is different from the owner, operator, 
or agent in charge of the place where the article is detained, FDA must 
provide a copy of the detention order to the owner of the article of 
food if the owner's identity can be determined readily.
    (b) If FDA issues a detention order for an article of food located 
in a vehicle or other carrier used to transport the detained article of 
food, we also must provide a copy of the detention order to the shipper 
of record and the owner and operator of the vehicle or other carrier, 
if their identities can be determined readily.


Sec.  1.393  What information must FDA include in the detention order?

    (a) FDA must issue the detention order in writing, in the form of a 
detention notice, signed and dated by the officer or qualified employee 
of FDA who has credible evidence or information indicating that such 
article of food presents a threat of serious adverse health 
consequences or death to humans or animals.
    (b) The detention order must include the following information:
    (1) The detention order number;
    (2) The date and hour of the detention order;
    (3) Identification of the detained article of food;
    (4) The period of the detention;
    (5) A statement that the article of food identified in the order is 
detained for the period shown;
    (6) A brief, general statement of the reasons for the detention;
    (7) The address and location where the article of food is to be 
detained and the appropriate storage conditions;
    (8) Any applicable conditions of transportation of the detained 
article of food;
    (9) A statement that the article of food is not to be consumed, 
moved, altered, or tampered with in any manner during the detention 
period, unless subject to a limited conditional release under Sec.  
1.381;
    (10) The text of section 304(h) of the act and Sec. Sec.  1.401 and 
1.402;
    (11) A statement that any informal hearing on an appeal of a 
detention order must be conducted as a regulatory hearing under part 16 
of this chapter, with certain exceptions described in Sec.  1.403;
    (12) The mailing address, telephone number, e-mail address, and fax 
number of the FDA district office and the name of the FDA District 
Director in whose district the detained article of food is located; and
    (13) A statement indicating the manner in which approval of the 
detention order was obtained, i.e., orally or in writing.

What is the appeal process for a detention order?


Sec.  1.401  Who is entitled to appeal?

    Any person who would be entitled to be a claimant for the article 
of food, if seized under section 304(a) of the act, may appeal a 
detention order as specified in Sec.  1.402. Procedures for 
establishing entitlement to be a claimant for purposes of section 
304(a) of the act are governed by Supplemental Rule C to the ``Federal 
Rules of Civil Procedure.''


Sec.  1.402  What are the requirements for submitting an appeal?

    (a) If you want to appeal a detention order, you must submit your 
appeal in writing to the FDA District Director, in whose district the 
detained article of food is located, at the mailing address, e-mail 
address, or fax number identified in the detention order according to 
the following applicable timeframes:
    (1) Perishable food: If the detained article is a perishable food, 
as defined in Sec.  1.377, you must file an appeal within 2 calendar 
days of receipt of the detention order.
    (2) Nonperishable food: If the detained article is not a perishable 
food, as defined in Sec.  1.377, you must file a

[[Page 25270]]

notice of an intent to request a hearing within 4 calendar days of 
receipt of the detention order. If the notice of intent is not filed 
within 4 calendar days, you will not be granted a hearing. If you have 
not filed a timely notice of intent to request a hearing, you may file 
an appeal without a hearing request. Whether or not it includes a 
request for hearing, your appeal must be filed within 10 calendar days 
of receipt of the detention order.
    (b) Your request for appeal must include a verified statement 
identifying your ownership or proprietary interest in the detained 
article of food, in accordance with Supplemental Rule C to the 
``Federal Rules of Civil Procedure.''
    (c) The process for the appeal of a detention order under this 
section terminates if FDA institutes either a seizure action under 
section 304(a) of the act or an injunction under section 302 of the act 
regarding the article of food involved in the detention order.
    (d) As part of the appeals process, you may request an informal 
hearing. Your request for a hearing must be in writing and must be 
included in your request for an appeal specified in paragraph (a) of 
this section. If you request an informal hearing, as defined in section 
201(x) of the act, and FDA grants your request, the hearing will take 
place according to the following applicable timeframes:
    (1) Perishable food: If the detained article is a perishable food, 
as defined in Sec.  1.377, the hearing will be held within 2 calendar 
days after the date the appeal is filed.
    (2) Nonperishable food: If the detained article is not a perishable 
food, as defined in Sec.  1.377, the hearing will be held within 3 
calendar days after the date the appeal is filed.


Sec.  1.403  What requirements apply to an informal hearing?

    If FDA grants a request for an informal hearing on an appeal of a 
detention order, FDA must conduct the hearing in accordance with part 
16 of this chapter, except that:
    (a) The detention order under Sec.  1.393, rather than the notice 
under Sec.  16.22(a) of this chapter, provides notice of opportunity 
for a hearing under this section and is part of the administrative 
record of the regulatory hearing under Sec.  16.80(a) of this chapter.
    (b) A request for a hearing under this section must be addressed to 
the FDA District Director in whose district the article food involved 
is located.
    (c) The provision in Sec.  16.22(b) of this chapter, providing that 
a person not be given less than 3 working days after receipt of notice 
to request a hearing, does not apply to a hearing under this subpart.
    (d) The provision in Sec.  16.24(e) of this chapter, stating that a 
hearing may not be required to be held at a time less than 2 working 
days after receipt of the request for a hearing, does not apply to a 
hearing under this subpart.
    (e) Section 1.406, rather than Sec. 16.24(f) of this chapter, 
describes the statement that will be provided to an appellant where a 
detention order is based on classified information.
    (f) Section 1.404, rather than Sec.  16.42(a) of this chapter, 
describes the FDA employees, e.g., regional food and drug directors or 
other officials senior to a district director, who preside at hearings 
under this subpart.
    (g) The presiding officer may require that a hearing conducted 
under this section be completed within 1 day, as appropriate.
    (h) Provisions of part 16 of this chapter that provide for the 
presiding officer to issue a report and recommended decision only do 
not apply. The presiding officer will issue the final agency decision.


Sec.  1.404  Who serves as the presiding officer at an informal 
hearing?

    The presiding officer of an informal hearing on an appeal of a 
detention order, who also must decide the appeal, must be an FDA 
regional food and drug director or another FDA official senior to an 
FDA district director.


Sec.  1.405  When does FDA have to issue a decision on an appeal?

    (a) The presiding officer must issue a decision confirming or 
revoking the detention within 5 calendar days after the appeal is 
filed. If FDA either fails to provide you with an opportunity to 
request an informal hearing, or fails to confirm or terminate the 
detention order within the 5-day period, the detention order is deemed 
terminated.
    (b) If you appeal the detention order but do not request an 
informal hearing, the presiding officer must issue a decision on the 
appeal confirming or revoking the detention within 5 calendar days 
after the date the appeal is filed. If the presiding officer fails to 
confirm or terminate the detention order during such 5-day period, the 
detention order is deemed terminated.
    (c) If you appeal the detention order and request an informal 
hearing and your hearing request is denied, the presiding officer must 
issue a decision on the appeal confirming or revoking the detention 
within 5 calendar days after the date the appeal is filed. If the 
presiding officer fails to confirm or terminate the detention order 
during such 5-day period, the detention order is deemed terminated.
    (d) If the presiding officer confirms a detention order, the 
article of food continues to be detained until we terminate the 
detention under Sec.  1.384 or the detention period expires under Sec.  
1.379, whichever occurs first.
    (e) If the presiding officer terminates a detention order, or the 
detention period expires, FDA must terminate the detention order as 
specified under Sec.  1.384.
    (f) Confirmation of a detention order by the presiding officer is 
considered a final agency action for purposes of 5 U.S.C. 702.


Sec.  1.406  How will FDA handle classified information in an informal 
hearing?

    Where the credible evidence or information supporting the detention 
order is classified under the applicable Executive order as requiring 
protection from unauthorized disclosure in the interest of national 
security (``classified information''), FDA will not provide you with 
this information. The presiding officer will give you notice of the 
general nature of the information and an opportunity to offer opposing 
evidence or information, if he or she may do so consistently with 
safeguarding the information and its source. If classified information 
was used to support the detention, then any confirmation of such 
detention will state whether it is based in whole or in part on that 
classified information.

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

    3. The authority citation for 21 CFR part 16 continues to read as 
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
    4. Section 16.1 is amended in paragraph (b)(1) by adding a new 
statutory provision in numerical order as follows:


Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (1) * * *
Section 304(h) of the act relating to the adminstrative detention of 
food for human or animal consumption (see part 1, subpart k, of this 
chapter).
* * * * *


[[Page 25271]]


    Dated: April 30, 2003.
Mark B. McClellan,
Commissioner of Food and Drugs.
    Dated: May 5, 2003.
Tommy G. Thompson,
Secretary of Health and Human Services.
[FR Doc. 03-11459 Filed 5-5-03; 5:08 pm]
BILLING CODE 4160-01-S