[Federal Register: May 9, 2003 (Volume 68, Number 90)]
[Proposed Rules]
[Page 25241-25271]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my03-39]
[[Page 25241]]
-----------------------------------------------------------------------
Part V
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
-----------------------------------------------------------------------
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
[[Page 25242]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 25243]]
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.
[[Page 25244]]
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.
[[Page 25245]]
[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