[Federal Register: June 4, 2004 (Volume 69, Number 108)]
[Rules and Regulations]
[Page 31659-31705]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04jn04-10]
[[Page 31659]]
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Part II
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Parts 1, 10, and 16
Administrative Detention of Food for Human or Animal Consumption Under
the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002; Final Rule
[[Page 31660]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 10, and 16
[Docket No. 2002N-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: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final
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 final rule implements the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
(the Bioterrorism Act), which authorizes the use of administrative
detention and requires regulations establishing procedures for
instituting on an expedited basis certain enforcement actions against
perishable food subject to a detention order.
DATES: This rule is effective July 6, 2004.
FOR FURTHER INFORMATION CONTACT: Kelli Giannattasio, Center for Food
Safety and Applied Nutrition (HFS-007), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1432.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background and Legal Authority
II. Highlights of the Final Rule
III. Comments on the Final Regulation
A. General Comments
B. Comments on Foreign Trade Issues
C. Comments on What Definitions Apply to This Subpart? (Proposed
Sec. 1.377)
1. Definition of ``The Act''
2. Definition of ``Authorized FDA Representative''
3. Definition of ``Calendar Day''
4. Definition of ``Food''
D. Comments on What Criteria Does FDA Use to Order a Detention?
(Proposed Sec. 1.378)
E. Comments on How Long May FDA Detain an Article of Food?
(Proposed Sec. 1.379)
1. Comments on Where and Under What Conditions Must the Detained
Article of Food be Held? (Proposed Sec. 1.380)
2. Comments on May a Detained Article of Food be Delivered to
Another Entity or Transferred to Another Location? (Proposed Sec.
1.381)
3. Comments on What Labeling or Marking Requirements Apply to a
Detained Article of Food? (Proposed Sec. 1.382)
F. Comments on What Expedited Procedures Apply When FDA
Initiates a Seizure Action Against a Detained Perishable Food?
(Proposed Sec. 1.383)
G. Comments on When Does a Detention Order Terminate? (Proposed
Sec. 1.384)
H. Comments on How Does FDA Order a Detention?
1. Comments on Who Approves a Detention Order? (Proposed Sec.
1.391)
2. Comments on Who Receives a Copy of the Detention Order?
(Proposed Sec. 1.392)
3. Comments on What Information Must FDA Include in the
Detention Order? (Proposed Sec. 1.393)
I. Comments on What is the Appeal Process for a Detention Order?
1. Comments on Who is Entitled to Appeal? (Proposed Sec. 1.401)
2. Comments on What Are the Requirements for Submitting an
Appeal? (Proposed Sec. 1.402)
3. Comments on What Requirements Apply to an Informal Hearing?
(Proposed Sec. 1.403)
4. Comments on Who Serves as the Presiding Officer at an
Informal Hearing? (Proposed Sec. 1.404)
5. Comments on When Does FDA Have to Issue a Decision on an
Appeal? (Proposed Sec. 1.405)
6. Comments on How Will FDA Handle Classified Information in an
Informal Hearing? (Proposed Sec. 1.406)
IV. Conforming Amendment to Part 10
V. Conforming Amendment to Part 16
VI. Analysis of Economic Impact
A. Final Regulatory Impact Analysis
B. Final Regulatory Flexibility Analysis
C. Unfunded Mandates
D. Small Business Regulatory (SBREFA) Major Rule
VII. Paperwork Reduction Act of 1995
VIII. Analysis of Environmental Impact
IX. Federalism
X. References
I. Background and Legal Authority
On May 9, 2003 (68 FR 25242), FDA issued a proposed rule providing
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. The events of
September 11, 2001, had highlighted the need to enhance the security of
the United States' food supply. Congress responded by enacting the
Bioterrorism Act (Public Law 107-188), which was signed into law on
June 12, 2002. Section 303 of the Bioterrorism Act amends section 304
of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
334) 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 of 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 seizure
or injunction actions against perishable food subject to a detention
order on an expedited basis. Section 303 of the Bioterrorism Act also
amends the FD&C Act by adding a new prohibited act as paragraph (bb) to
section 301 of the FD&C Act (21 U.S.C. 331).
The major components of section 303 of the Bioterrorism Act are as
follows:
Criteria used to trigger an administrative detention:
Amends section 304 of the FD&C 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
FD&C 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.
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.
Period of detention: The detention period will be for a
reasonable period, not to exceed 20 calendar days, unless a greater
period, not to exceed 30 calendar days, is necessary to enable the
Secretary to institute a seizure or injunction action.
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.
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.
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 calendar days
after
[[Page 31661]]
such 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.
Prohibited act: Amends section 301 of the FD&C 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 final regulation. The temporary hold provision
authorizes FDA to ask the Secretary of the 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. 2002N-0275). FDA plans to consider these
comments as we develop our approach on how best to implement this
provision of the Bioterrorism Act.
Under the Homeland Security Act of 2002 (Public Law 107-296), the
responsibilities and functions of the Secretary of the Treasury for all
relevant Customs authorities have been transferred to the Secretary of
Homeland Security, who has in turn delegated them to the Commissioner
of the Bureau of Customs and Border Protection (CBP). Thus, wherever
section 303 of the Bioterrorism Act refers to the Secretary of
Treasury, we will refer to the Secretary of Homeland Security.
In addition to amending title 21 of the Code of Federal Regulations
(21 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,'' this final rule also makes
conforming amendments to part 16 (21 CFR part 16) entitled ``Regulatory
Hearing Before the Food and Drug Administration'' and part 10 (21 CFR
part 10) entitled ``Administrative Practices and Procedures.''
Although the statutory requirements in section 303 of the
Bioterrorism Act are self-executing and are currently in effect, FDA is
issuing this regulation to further refine aspects of the administrative
detention requirements. Section 303 of the Bioterrorism Act requires
FDA only to issue regulations establishing procedures for instituting
on an expedited basis certain enforcement actions against perishable
food subject to a detention order; however, FDA also is describing in
this regulation the procedures for how we will detain both perishable
and nonperishable articles of food and the process for appealing a
detention order. FDA established requirements for the process for
appealing a detention order in this final rule to ensure that we meet
section 303's timing requirements and to define certain terms used in
the Bioterrorism Act (e.g., perishable food).
This final rule is not related to, and does not implement, section
801(a) of the FD&C Act (21 U.S.C. 381), even though it uses the term
``detention.'' This final rule implements section 303 of the
Bioterrorism Act, which amends the seizure provision at section 304 of
the FD&C Act by adding paragraph (h) to that section. This amendment
grants FDA the authority to detain (i.e., prevent the further movement
of) any article of food that is found during an inspection,
examination, or investigation if FDA has credible evidence or
information indicating that such article presents a threat of serious
adverse health consequences or death to humans or animals.
Some of the comments that we received continue to reflect some
confusion of our authority to detain food administratively under
section 304(h) of the FD&C Act (as added by the Bioterrorism Act) with
our authority to refuse admission of imported food under section 801(a)
of that act, despite our explanation of this issue in the proposed
rule. (See 68 FR 25242.) The following discussion provides additional
explanation of FDA's authority under each of these provisions so as to
make clear that our authority to detain food administratively under
section 304(h) of the FD&C Act is separate and distinct from our
authority to refuse admission of imported food under section 801(a) of
the FD&C Act.
Section 801 of the FD&C Act sets out standards and procedures for
FDA review of imports under its jurisdiction. Generally, when an FDA-
regulated product is imported, customs brokers submit entry information
to CBP on behalf of the importers of record. CBP then provides entry
information to FDA to enable admissibility decisions to be made. If FDA
determines that refusal under section 801(a) FD&C Act appears
appropriate, FDA, as set out in its regulations, gives written notice
to the owner or consignee. (See Sec. 1.90(a).) In guidance dating back
many years, FDA refers to this written notice as the notice of
detention and hearing.
FDA's evaluation of imported foods under section 801(a) of the FD&C
Act largely focuses on whether the article of food appears to have been
safely produced, packed, and held; contains no contaminants or illegal
additives or residues; and is properly labeled. Section 801(a) of the
FD&C Act provides that an article of food is subject to refusal of
admission if it ``appears, from physical examination or otherwise'':
(1) To have been manufactured, processed, or packed under insanitary
conditions; (2) to be forbidden or restricted in sale in the country in
which it was produced or from which it was exported; or (3) to be
adulterated or misbranded. The food adulteration and misbranding
provisions (sections 402 and 403 of the FD&C Act (21 U.S.C. 342 and 21
U.S.C. 343)) set out most of the FD&C Act's requirements for foods.
In section 304(h) of the FD&C Act, Congress gave FDA the authority
to detain food administratively where we have credible evidence or
information that the article of food presents a threat of serious
adverse health consequences or death to humans or animals so that we
can bring such food under FDA control. Historically, FDA has had the
authority to seize misbranded or adulterated food in domestic commerce;
however, adulterated food could enter commerce and put consumers at
risk during the time that it takes to file a seizure action. In some
instances, FDA has been able to partner with State authorities to have
such food embargoed by the State where the food is located so that it
is under their control while the seizure action is being prepared and
filed, until the court issues the warrant, and until the U.S. marshal
can seize the food. However, this process is not always possible.
We do not, at this time, foresee frequently using administrative
detention under section 304(h) of the FD&C Act to control the movement
of imported food subject to section 801 of the FD&C Act. When FDA
determines it is appropriate to bring imported food under FDA control
using the authority under section 304(h) of the FD&C Act, the standard
for administrative detention will be the same as it is for other
products, i.e., we must have credible evidence or information that the
article of food presents a threat of serious adverse health
consequences or death to humans or animals.
This final rule implements the administrative detention
requirements in section 303 of the Bioterrorism Act.
[[Page 31662]]
This final rule, published today, as well as the interim final rules
that FDA and CBP published on October 10, 2003, to implement section
307, prior notice of imported food shipments (68 FR 58974), and section
305, registration of food facilities (68 FR 58893), of the Bioterrorism
Act, along with the final rule implementing section 306 of the
Bioterrorism Act (maintenance and inspection of records for food),
which will be published in the Federal Register in the near future,
will help FDA act quickly when responding to a threatened or actual
bioterrorist attack on the U.S. food supply or to other food-related
emergencies. Administrative detention will provide FDA with an added
measure to help ensure the safety of the nation's food supply. In
establishing and implementing this final rule, FDA believes it has
complied fully with the United States' international trade obligations,
including the applicable World Trade Organization (WTO) agreements and
the North American Free Trade Agreement (NAFTA).
In addition to section 303 of the Bioterrorism Act, which amends
the FD&C Act as described previously in this document, FDA is relying
on section 701(a) of the FD&C Act (21 U.S.C. 371(a)) in issuing this
final rule. Section 701(a) authorizes the agency to issue regulations
for the efficient enforcement of the FD&C Act.
II. Highlights of the Final Rule
The key features of this final rule are as follows:
An officer or qualified employee of FDA may order the
detention of food for up to 30 calendar 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.
FDA's 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.
FDA may require that the detained article of food be
labeled or marked as detained with official FDA tags or labels. FDA's
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.
A violation of a detention order or the removal or
alteration of the tag or label is a prohibited act.
FDA will state in the detention order the location and any
applicable conditions under which the food is to be held.
If FDA determines that removal to a secure facility is
appropriate, the article of food must be removed to a secure facility.
An article of food moved to a secure facility remains under detention
before, during, and after such movement.
FDA may approve a request for modification of a detention
order to permit movement 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. In any of these circumstances, an article of food may be
transferred but remains under detention before, during, and after the
transfer.
Any transfer of a detained article of food in violation of
a detention order is a prohibited act.
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.
This rule includes appeal and hearing timeframes for both
perishable and nonperishable detained articles of food.
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 calendar days
after the appeal is filed.
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 the
appeal and FDA grants the request, the hearing will be held within 2
calendar days after the appeal is filed.
FDA's decision on appeal will be issued 5 calendar days
after the appeal is filed.
The expedited procedures for initiating certain
enforcement actions with respect to perishable foods require FDA to
submit a seizure recommendation to the Department of Justice (DOJ)
within 4 calendar days after the detention order is issued, unless
extenuating circumstances exist.
Confirmation of a detention order by FDA's presiding
officer is considered final agency action.
In response to comments that were received, FDA has made two
changes to the proposed rule. First, the required information in the
detention order did not include the name of the authorized FDA
representative who approved the detention order. This is required
information in this final rule (Sec. 1.393(b)(14)). Second, the
proposed rule stated that, 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 has been filed for perishable food, and
within 3 calendar days after the date the appeal has been filed for
nonperishable food (Sec. 1.402(d)). This section III.I.2 of this final
rule is revised to state that the hearing will be held within 2
calendar days after the date the appeal is filed for both perishable
and nonperishable foods. In addition, FDA has also made clarifying
revisions to the procedures that apply to an informal hearing on an
administrative detention. Revised. Sec. Sec. 1.403(h) and 1.405(a)
provide that the presiding officer must issue a written report of the
hearing, including a proposed decision with a statement of reasons. The
hearing participant may review this report and suggest changes within 4
hours of the issuance of the report. The presiding officer will then
issue the final agency decision. In addition, FDA has added Sec.
1.403(i) and (k) to clarify the components of the administrative record
and the record of the administrative proceeding. We have also included
clarifying comments in the preamble to this final rule.
We have made two other changes to the proposed rule in order to
avoid confusion with CBP terminology and requirements. First, the
proposed rule used the term ``limited conditional release'' to refer to
the process whereby FDA grants a request to modify a detention order to
permit movement of a detained article of food. The term ``limited
conditional release'' has a different meaning as used by CBP. In order
to avoid confusion, we have therefore changed applicable sections of
the codified in this final rule to eliminate the use of this term, and
instead use the term ``request for modification of a detention order.''
Second, Sec. 1.381(a) in the proposed rule prohibited delivery of
a detained article of food ``to another entity under the execution of a
bond.'' This section could have been misinterpreted to prohibit
delivery of an article to a
[[Page 31663]]
storage facility just because it is under a customs bond (as opposed to
a penal bond), thereby potentially slowing the flow of trade. In the
final rule, Sec. 1.381(a) has been revised to make clear that the
existence of an appropriate customs bond required by Customs law and
regulation does not prohibit movement of a detained article at FDA's
direction.
As noted in the proposed rule, FDA intends to define ``serious
adverse health consequences'' in a separate rulemaking.
III. Comments on the Final Regulation
FDA received approximately 100 submissions in response to the
proposed rule, and each of them raised one or more comments. To make it
easier to identify comments and FDA's responses to the comments, the
word ``Comment'' will appear in parentheses before the description of
the comment, and the word ``Response'' will appear in parentheses
before FDA's response. FDA also has numbered the sets of comments to
make it easier to identify a particular issue. The number assigned to
each set of comments is purely for organizational purposes and does not
signify the comment's value or importance or the order in which it was
submitted to FDA's docket.
A. General Comments
(Comment 1) Many comments state that administrative detention
should be limited to use only when there is intentional adulteration
(bioterrorism) against the food supply. One comment indicates that
administrative detentions should be imposed only when there are no
other means to prevent the product from moving in commerce, e.g., when
a responsible company will not recall or hold the product. Some
comments argue specifically that we should continue to request Class I
recalls in situations involving unintentional adulteration. One comment
argues that we should not use administrative detention to deal with
imported food containing undeclared allergens.
(Response) The Bioterrorism Act gives FDA the authority and
flexibility to detain administratively articles of food for which FDA
has credible evidence or information indicating that such article
presents a threat of serious adverse health consequences or death to
humans or animals. The Bioterrorism Act does not limit FDA's
administrative detention authority to only those situations involving
intentional adulteration. Unintentional adulteration can pose the same
threats of serious adverse health consequences or death. Therefore, the
agency has not changed the final rule as requested by comment 1 in
section III A. of this document.
In response to the comment that FDA should only employ an
administrative detention when voluntary cooperation is not available,
FDA believes that a detention may not be necessary if a firm takes
prompt and complete voluntary action, e.g., in a Class I recall
situation. However, FDA may nonetheless choose to detain
administratively an article of food that has been recalled.
Circumstances under which FDA may choose to do so include, but are not
limited to, when there is concern that the food may reenter commerce.
Thus, FDA will not limit its authority to detain an article of food
that presents a threat of serious adverse health consequences or death
to humans or animals.
(Comment 2) FDA sought comments on whether its conclusion that it
has authority to detain food in intrastate commerce administratively is
correct, and if so, whether the agency should use that authority. A few
comments agree with FDA's conclusion that it has authority to impose an
administrative detention on articles of food that are only in
intrastate commerce. One comment is concerned about the broader
jurisdictional implications of FDA not meeting the interstate commerce
criterion. Another comment argues that FDA's conclusion that it has
authority to detain food administratively that does not enter
interstate commerce is inconsistent with limitations imposed by the
commerce clause of the U.S. Constitution. In response to FDA's
assertion that Congress, in the Bioterrorism Act, gave the agency
authority to detain food administratively in intrastate commerce, this
comment states that the commerce clause generally restricts Congress'
power to regulate purely intrastate commerce, and that Congress cannot
delegate power to FDA that it does not possess. The comment argues that
FDA should have assumed that Congress did not intend to violate the
Constitution, and that FDA should amend the administrative detention
provisions accordingly.
Another comment argues that the agency's use of administrative
detention authority on articles of food that are engaged only in
intrastate commerce challenges long established federal and state
jurisdictional boundaries. This comment further states that, under
these new regulations, FDA is moving into areas delegated to state
control under the enabling statute and the 10th Amendment to the U.S.
Constitution, and that by proposing this regulatory scheme, the agency
can avoid and circumvent the very safeguards established to provide
against rampant unauthorized expansion of federal authority.
(Response) In the preamble to the proposed rule, FDA tentatively
concluded that all food would be subject to administrative detention
under section 303 of the Bioterrorism Act if the agency has credible
evidence or information that the food presents a threat of serious
adverse health consequences or death to humans or animals, whether or
not the food enters interstate commerce. FDA is mindful that our
interpretation of the Bioterrorism Act should not cast doubt on the
constitutionality of the statute. (See Solid Waste Agency of Northern
Cook County v. U.S., 531 U.S. 159 (2001).) The agency has considered
the relevant provisions of the Bioterrorism Act, the comments submitted
on this issue, FDA's responsibilities in implementing the Bioterrorism
Act, and the law interpreting the commerce clause of the Constitution
(Art. I, section 8). Based on these considerations, FDA does not change
its conclusion that it has the authority to detain food
administratively that does not enter interstate commerce.
Section 304(h) of the FD&C 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 FD&C Act providing for administrative detentions
of devices during inspections conducted under section 704 of that act
(21 U.S.C. 374), a provision that has an interstate commerce component.
In addition, the prohibited act related to administrative detention of
food, section 301(bb) of the FD&C Act, unlike some other prohibited
acts in section 301, does not include an interstate commerce component.
Accordingly, FDA concludes that the Bioterrorism Act does not limit
administrative detention only to those foods that enter interstate
commerce.
Congress's constitutional power to legislate under the commerce
clause is very broad. However, such power is not without limits, see,
e.g, United States v. Lopez, 514 U.S. 549, 567 (1995); U.S. v.
[[Page 31664]]
Morrison, 529 U.S. 598, 618 (2000), and these limits have been
construed in light of relevant and enduring precedents. In particular,
in Lopez, supra, the Supreme Court acknowledged the continuing vitality
of Wickard v. Filburn, 317 U.S. 111 (1942), noting that, ``although
Filburn's own contribution to the demand for wheat may have been
trivial by itself, that was not `enough to remove him from the scope of
federal regulation where, as here, his contribution, taken together
with that of many others similarly situated, is far from trivial.' ''
514 U.S. at 556. This principle applies to the administrative detention
provision of the Bioterrorism Act. Administrative detention prevents
the movement of food where there is credible evidence or information
that the food presents a threat of serious adverse health consequences
or death. Even if that food is so-called ``intrastate'' food, the
collective impact of that food on interstate commerce is such that FDA
believes Congress acted within its power under the commerce clause when
it enacted legislation subjecting that food to administrative
detention.
FDA's conclusion is also consistent with section 709 of the FD&C
Act, which states that, in any action to enforce the FD&C Act's
requirements respecting foods, drugs, devices, and cosmetics, any
necessary connection with interstate commerce is presumed. Likewise,
this outcome is consistent with Congress' goal in enacting the
Bioterrorism Act because the potential harm from bioterrorist attacks
or other food emergencies can be great, whether or not the food moves
from one state to another. The usefulness of the administrative
detention authority also can be significant in food emergencies where
interstate shipment has not occurred. As a practical matter, FDA
believes that this decision should have little if any impact on whether
a given food is subject to administrative detention because virtually
all food manufactured, processed, packed, transported, distributed,
received, held, or imported, moves, or is considered to move, in
interstate commerce. Accordingly, FDA is retaining its conclusion that
it has the authority to detain any food administratively when the
agency has credible evidence or information that the food presents a
threat of serious adverse health consequences or death to humans or
animals, regardless of whether that food enters interstate commerce.
(Comment 3) A few comments state that FDA should make clear that
the detention of cargo always should be managed so as to minimize delay
or interference with the orderly movement of an oceangoing vessel or
other conveyance. They note that this clarification will be consistent
with the intent of the Bioterrorism Act and FDA's relationship with
CBP. These comments state that the Bioterrorism Act grants FDA limited
detention authority, which should not be interpreted as expanding the
agency's authority to inspect and detain imported food on a vessel at a
port of entry when this authority belongs, in the first instance, to
CBP. These comments note FDA's acknowledgment in our proposal that it
intends, primarily, to continue to regulate imported food in
conjunction with CBP and under section 801(a) of the FD&C Act. They
also note that the provision in section 303(c) of the Bioterrorism Act,
which allows an officer of qualified employee of FDA to ``* * * request
the Secretary of Treasury to hold the food at the port of entry for a
reasonable period of time, not to exceed 24 hours, for the purpose of
enabling the Secretary to inspect, examine, or investigate the article
as appropriate'' further confirms that the authority to detain cargo on
board a vessel remains primarily with the CBP service and not FDA.
(Response) As stated in the background section I. of this rule,
because of the authorities available to FDA and CBP to control the
movement of imported food under section 801(a) of the FD&C Act and
various provisions of title 19 of the U.S. Code, FDA does not foresee
frequently using administrative detention under section 303 of the
Bioterrorism Act to control the movement of imported food subject to
those authorities. However, it is within FDA's authority to detain food
under section 303 of the Bioterrorism Act that has been offered for
import into the United States upon credible evidence or information
that the article of food presents a threat of serious adverse health
consequences or death to humans or animals. Consequently, FDA may
detain imported food cargo on a conveyance under section 303 of the
Bioterrorism Act. If FDA detains imported articles of food on a
conveyance, we will consult with CBP to minimize the disruption of the
conveyance movement in trade.
(Comment 4) One comment indicates that most tank truckloads of food
are sealed at all openings and that these seals will be broken by FDA
inspectors who investigate a suspected problem load. They state that,
in the bulk food trucking industry, ``a broken seal equals a rejected
load.'' The comment requests that FDA develop a process whereby an FDA
representative who breaks a seal to gain access to a load that is found
not to present a problem would then reseal the load with an FDA seal
and so indicate it on an official FDA document. While not required to,
a receiver may be more inclined to accept the load.
(Response) FDA agrees in part with this comment, but is not sure
what is meant by an official document upon resealing. Under current
practice, which will be continued after the effective date of this
rule, whenever FDA reseals a conveyance (e.g., a truckload of goods)
after an FDA investigator has broken the seal to examine the goods, the
FDA investigator reseals the conveyance with an official FDA metal
seal. An FDA document does not accompany the metal seal because the FDA
seal is the official indication that FDA has opened and resealed the
conveyance. Our internal practice is to record the number of the seal
in the investigator's official notes.
(Comment 5) A couple of comments suggest that FDA should avoid
implementing a ``one size fits all'' rule for transportation providers
to accommodate the operational differences within the transportation
industry. These comments suggest that, instead, FDA should examine the
operational capabilities and realities of the differing transport modes
to formulate mode-specific rules, as is currently being done by CBP for
the Trade Act of 2002 (Trade Act). These comments further suggest that
the agency work closely with CBP to ensure that any rules for
importation and exportation of food do not conflict with CBP
requirements. The comments suggest that FDA work with CBP to take
advantage of the cross-border supply chain security program already in
place, to avoid burdensome duplication of effort.
(Response) FDA does not agree that it is necessary to adopt
different administrative detention requirements for different modes of
transport. The Trade Act deals with advance notice of items arriving in
the United States, not with detention of potentially unsafe food to
ensure it does not move into distribution pending the filing of a court
action. Congress specifically directed CBP to consider different
advance notice timeframes for items arriving on different modes of
transport (e.g., truck, air, vessel, rail). This Congressional
directive did not extend to actions taken by FDA to implement section
303 of the Bioterrorism Act. In the implementation of section 303,
different transport modes are irrelevant because food subject to
administrative detention will either be detained in place or detained
by offloading it from the transport mode
[[Page 31665]]
and transferring it to another facility. This is true regardless of
whether the mode of transport is truck, air, vessel, or rail. FDA will
continue to work with CBP to coordinate actions at the border.
(Comment 6) One comment states that bulk transportation of food
products in tank trailers and dry bulk trailers is significantly
different from packaged or prepared food transportation. This comment
urges FDA to recognize these differences either in the language of the
regulation, or by a separate section strictly dealing with bulk
transportation.
(Response) Section 1.393(b)(8) states that FDA must include in the
detention order any applicable conditions of transportation of the
detained article of food. FDA will take into consideration the mode of
transportation being used for the detained product, and the form in
which the article of food is being transported, e.g., packaged or dry
bulk, when setting forth these conditions.
(Comment 7) With respect to detained shipments of imported food,
one comment believes that FDA should work with CBP to immediately
control these foods, and to program CBP's Automatic Commercial System
(ACS) and Automated Broker Interface (ABI) to not issue a CBP release
for any such shipment.
(Response) When imported food at the border is found to warrant
administrative detention under section 304(h) of the FD&C Act, FDA will
continue to work with CBP as the agency currently does with respect to
section 801(a) of the FD&C Act. FDA will issue a detention order under
Sec. Sec. 1.392 and 1.393, which will specify the terms of the
detention. Under Sec. 1.393(b)(9), the order will include 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 the
detention order is first modified under Sec. 1.381.'' Accordingly, FDA
does not believe it is necessary to communicate detentions through ACS
or ABI.
(Comment 8) One comment is concerned about where imported food will
be detained. The comment describes FDA's current procedures of only
detaining imported food at the port where the consumption entry is
filed with CBP, which may not be the port of arrival. Currently,
imported food is detained at the port where the consumption entry is
filed after FDA receives the declaration and the Operational and
Administrative System Import Support declaration is made. The comment
wants this procedure to continue unchanged.
(Response) In this comment, the person is describing FDA's current
procedures for refusing admission under section 801(a) of the FD&C Act.
In the event that imported food is detained administratively under
section 303 of the Bioterrorism Act, the product would be detained as
soon as FDA had credible evidence or information that the food product
posed a threat of serious adverse health consequences or death. This
could presumably occur while the product was still at the port of entry
where the goods arrived in the United States. Thus, it is conceivable
that FDA could administratively detain a food product at the port of
entry where arrival took place, the port of destination, or any
location in between. This is consistent with the purpose of
administrative detention, which is to hold in place, and protect
against any movement that could lead to further distribution of, the
food that poses the threat of serious adverse health consequences or
death to humans or animals. Under Sec. 1.393(b)(7), the detention
order will specify the address and location where the article of food
is to be detained and the appropriate storage conditions.
(Comment 9) One comment suggests that their written comments can at
best only highlight some of the issues and implications raised by FDA's
proposal. The comment further states that the best way to address these
subjects is through a working group that brings together members of the
trading community with officials from FDA and CBP. If a meeting is not
possible, the comment requests to schedule a meeting at FDA's earliest
convenience to further discuss the matter.
(Response) FDA conducted extensive outreach on the proposed
administrative detention rule, including attending international and
domestic meetings to ensure that affected parties were aware of the
Bioterrorism Act administrative detention requirements and understood
the proposed requirements so that they could provide meaningful
comments. On May 7, 2003, FDA held a public meeting (via satellite
downlink) to discuss both the administrative detention and
recordkeeping proposed rules. (See 68 FR 16998, April 8, 2003 or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.
) The live
broadcast was available to participants in North America, Central
America, and South America, and the Caribbean. The meeting was later
rebroadcast to Europe, Southern Africa, Asia, and the Pacific. FDA also
has posted transcripts of the broadcast in English, French, and Spanish
(the three official WTO languages) on the agency's Web site.
(Comment 10) One comment is concerned that pet products will be
administratively detained due to unwarranted association with countries
or geographic areas that may face animal health or food safety
emergencies. Another comment questions whether FDA's administrative
detention authority applies to transit shipments in the United States,
i.e., goods in transit through the United States that are not declared
for U.S. consumption. Another comment asks what relationship or
obligation has been established between the Bioterrorism Act and hazard
analysis and critical control points (HACCP) and good manufacturing
practices (GMPs).
(Response) FDA can detain an article of food administratively only
if FDA has credible evidence or information indicating that such
article presents a threat of serious adverse health consequences or
death to humans or animals. That is the standard that must be met for
administrative detention of all food, including pet food. FDA also has
authority to detain administratively any food in the United States that
meets the standard for administrative detention, including transit
shipments of food. Finally, it is not clear what is meant by the terms
``relationship'' and ``obligation'' with respect to the Bioterrorism
Act and HACCP and GMPs. FDA has authority to detain food
administratively when that food meets the standard for administrative
detention, regardless of how the food comes to meet that standard,
e.g., by failure to follow GMPs, as the result of an act of
bioterrorism, etc. FDA's decision to employ administrative detention or
other applicable authorities under the FD&C Act will be made on a case-
by-case basis depending on the facts of each particular case.
(Comment 11) One comment asks if FDA is suggesting that carriers,
warehouses and others in the supply chain process must adhere to
specific security standards, and if so, suggests that such standards be
clearly identified.
(Response) This final rule does not establish general requirements
or guidance relating to specific security standards or practices for
carriers, warehouses and others in the supply chain. However, FDA
recently published several guidance documents concerning preventative
food safety measures that individual firms may wish to consider as they
develop their own security measures. FDA's guidance documents can be
found on the agency's Web site. (See http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/fsterr.html.
) If FDA does issue a detention order, the order would
[[Page 31666]]
contain the address and location where the article of food is to be
detained, and the appropriate storage conditions.
(Comment 12) One comment indicates that if an officer detains a
product in temporary hold for 24 hours, then the total time invested in
the appeal and hearing process will exceed the timeframe for perishable
foods. This comment asks FDA to specify 7 days for the detention
process from the formal detention until the final resolution or
termination based on the definition for perishable food, which is that
the quality of the product is adversely affected after 7 days of
storage. The comment states that a product that has been under a
temporary hold and detained for 7 days will exceed the useful time of a
perishable food.
Another comment states that FDA must take into account the 24-hour
period of the temporary hold in the detention time of 30 days. Another
comment states that they do not challenge the right of FDA to inspect
food products at the border, but that, in their view, the 24 hour
temporary hold is an unreasonable time to force a truck and driver to
wait for FDA to conduct an inspection and issue a decision. This
comment indicates that the proposed recordkeeping rule will require
companies to turn over records to FDA within 4 hours during normal
business hours, and 8 hours on evenings and weekends, and suggests
that, if FDA is willing to impose such short timeframes on industry,
then it should also be required to adhere to them in the conduct of its
own operations.
Another comment suggests that the guidance on temporary holds
should be made available as soon as possible because there is no
explanation about why FDA must ask specifically the ``Secretary of
Treasury'' to institute the temporary hold. This comment states that it
is not clear if the alternative exists for the ``Secretary of
Treasury'' to designate or to enable someone with proper skills to
replace him when he is not available. A few comments state that the
proposed provision for the temporary holding of imports for 24 hours is
open to abuse. They indicate that not only is there no comparable
provision for domestic products, but there is a real risk that the
provision could amount to a ``holding bay'' for import inspections
while FDA resources are used to deal with domestic alerts elsewhere.
(Response) As indicated in the background section I. of this rule,
the temporary hold provisions authorized in section 303 of the
Bioterrorism Act are outside the scope of this rulemaking. FDA plans to
consider these comments as we develop our approach on how best to
implement this provision of the Bioterrorism Act.
FDA notes, however, that the period of detention for administrative
detention under section 303 of the Bioterrorism Act does not begin
until the detention order is issued.
(Comment 13) Several comments ask that the implementation date of
these regulations be pushed back because the new authorities are
extensive and the timeframe for implementation is unusually quick for
such a sweeping change. Furthermore, the comments state that the
proposed timeframes are not sufficient for producers in exporting
countries to adapt their products to the requirements of the
Bioterrorism Act, and will result in unnecessary costs and delays.
(Response) Even if FDA delayed implementation of the regulations,
the authority for administrative detention is self-executing and
currently in effect. In addition, FDA believes that it is in the
public's interest to implement these regulations as soon as possible to
facilitate the resolution of administrative detentions.
(Comment 14) One comment indicates that the new regulations are
burdensome and overlap with current requirements under parts 7, 110,
123, and 1240 (21 CFR parts 7, 110, 123, and 1240). This comment states
that if these provisions were properly implemented, they would be more
than adequate to address concerns FDA may have with rapid location of
affected product and ingredient traceability that are the major
concerns with this new provision. Another comment states that FDA's
Investigations Operations Manual (IOM), subchapter 750, describes the
procedure that FDA must follow currently for detention activities and
that the new regulations do not appear substantially different. Another
comment questions the need for this rulemaking because it appears that
FDA considers the threshold for detention to be equivalent to the
standard for initiating a Class I recall.
(Response) FDA disagrees with these comments. The regulations in
parts 7, 110, 123, and 1240, and subchapter 750 of the IOM, do not
address administrative detentions of food under section 303 of the
Bioterrorism Act. Further, the regulations cited in the comment are not
based on the substantive standard for administrative detention under
section 303 of the Bioterrorism Act, which is that the detained article
of food presents a threat of serious adverse health consequences or
death to humans or animals.
(Comment 15) Numerous comments ask that FDA provide compensation
for losses incurred as a result of a detention. Some comments refer to
detentions where the product is eventually released, but is no longer
marketable. Other comments want compensation for detentions in which
damages are incurred as a result of any detention, i.e., including
detentions where the product is confirmed to present a threat of
serious adverse health consequences or death to humans or animals.
Another comment states that the regulation does not adequately address
the legal and financial responsibility for the disposal of food as a
result of the threat it presents. This comment suggests that an entity
with a vested interest in the product, e.g., the owner, would bear the
responsibility, and that failure on the part of the food product owner
to pay storage, handling and related costs should be considered a
violation of the FD&C Act. One comment argues that, rather than adding
to industry's burden for food security, we should provide government
funding to help industry institute measures to improve food security.
(Response) Neither the FD&C Act nor the Bioterrorism Act provides
for damages or other costs associated with administrative detention. In
addition, the failure to pay storage, handling, and related costs is
not a violation of the FD&C Act. With respect to the comment that FDA
should provide government funding to help industry institute measures
to improve food security, that issue is beyond the scope of this
rulemaking and would require statutory authorization and
appropriations.
(Comment 16) A few comments suggest that the rule should require
that FDA determine the party actually responsible for the threat
against the food and define their responsibility. One comment indicates
that FDA must consider that the party responsible for the threat could
be a third party, i.e., a party not included in the importation or
distribution of the product. Another comment asks who will be held
responsible in the case where a product is packaged in bulk in one
country and repackaged in another country for export to the United
States. One comment asks how FDA will differentiate between an actual
threat and a hoax and if it will matter. Another comment asks what
penalty exists for the supplier of suspect shipments. Another comment
requests that FDA provide the owner of the food with information about
the threat even if the credible evidence is classified information.
[[Page 31667]]
(Response) The Bioterrorism Act allows FDA to detain articles of
food for which the agency has credible evidence or information that the
food presents a threat of serious adverse health consequences or death
to humans or animals. It does not require FDA to determine who is
responsible for the threat in order to detain the product. Whether the
person responsible for that threat or the person responsible for
supplying the suspect article of food may be held liable or subject to
criminal prosecution under other statutory provisions is beyond the
scope of this rulemaking.
The purpose of any FDA investigation is to determine and document
facts concerning a particular issue so that the agency can make
informed and sound decisions. FDA cannot rule out the possibility that
a hoax could give rise to an administrative detention and, in
evaluating the evidence or information to determine whether it is
credible, FDA will be mindful of the fact that hoaxes do occur.
In response to the comment that FDA provide the owner of the food
with information about the threat even if the credible evidence is
classified information, we will provide a statement of the reasons for
a detention in the detention order, but we will not divulge classified
information to those without the proper security clearance.
(Comment 17) Many comments state that industry is motivated to
cooperate with FDA to protect consumers and maintain national security
interests in the event of a real threat. They indicate that it is
imperative that FDA and industry work together as a team to quickly
address such occurrences. These comments state that FDA must devise a
clear communications strategy and that the agency should test such
plans to make sure that they will work seamlessly.
(Response) These comments are outside the scope of this rulemaking.
We agree that it is imperative that FDA and industry work together to
protect the U.S. food supply. The agency recognizes the cooperation and
effort that the industry has already shown in the area of food safety
and security. One such example of industry and FDA partnering to
protect the U.S. food supply was in the development of a Food Security
Guidance that food producers can use if they choose to improve the
protection of their products against tampering or terrorist actions.
(See http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/fsterr.html.) FDA also agrees that it
is imperative to have clear communication strategies in place and to
test such plans to ensure that they will be effective in the event of a
bioterrorism or other food-related emergency. We have been developing
plans in this area and continue to examine other possible ways to
better manage food emergencies and consult with industry on this.
(Comment 18) One comment states that development of reasonable
preventative measures and appropriate responses, including rational
governmental activities that are effective within every facet of the
food system, are critical to protecting public safety. This comment
asserts that, to be effective, these measures must be driven by the
public and the food industry, not by regulation.
(Response) This comment is outside of the scope of this rulemaking.
As stated in FDA's response to the previous comments, the agency
recognizes the outside cooperation and effort that have already been
shown in the area of food safety and security. However, FDA also
believes that it is important for the agency to implement the statutory
provisions on food safety and to fulfill its statutory mandates
concerning food safety. FDA will provide ongoing opportunities for
consumers, industry, state and local governments, and other
constituents to keep informed of, and involved in, the agency's
activities related to the development of preventative measures and
responding to a threatened or actual bioterrorist attack on the U.S.
food supply or to other food-related emergencies. Before issuing the
proposed rules concerning sections 303, 305, 306, and 307 of the
Bioterrorism Act, the agency provided an opportunity for constituents
to identify concerns and suggest ways to address them. It is imperative
that FDA and its constituents work together to protect the U.S. food
supply.
(Comment 19) Some comments assert that the regulation is
burdensome, costly, discriminatory, and will have a negative impact on
foreign trade. One comment states that this negative impact will likely
result in negative ramifications for U.S. food exports because the
future may well find retaliatory trade restrictions placed upon U.S.
exports as a direct result of the regulatory requirements generated
from the Bioterrorism Act.
(Response) In drafting the final rule, FDA structured the rule to
be consistent with the statutory mandates of the Bioterrorism Act. FDA
carefully considered comments received regarding the burden imposed by
this rule, including its impact on international trade.
(Comment 20) Several comments ask that FDA provide clear guidance
and training to industry personnel at all levels and agency field
personnel about the procedures for implementing the regulation. A few
comments suggest that an easy to follow guide for the appeal process
would be desirable. A few comments request that FDA establish
consultation services at U.S. embassies staffed with speakers of
various different foreign languages, such as Japanese and Spanish, and
that the Bioterrorism Act and all documents associated with the
detention be accompanied by official translations to facilitate
comprehension and proper use. The comments suggest that we disseminate
the translated material on our Web site and by other means.
(Response) FDA conducted extensive outreach on the proposed
administrative detention rule, including attending international and
domestic meetings, to ensure that affected parties were aware of the
Bioterrorism Act administrative detention requirements.
FDA plans similar future outreach efforts. More specifics regarding
our outreach activities will be included on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov
.
FDA also plans training for its field personnel on the
administrative detention procedures.
FDA does not have the resources to establish consultation services
at U.S. embassies staffed with speakers of foreign languages, or to
provide official translations of all documents associated with a
detention and the Bioterrorism Act.
(Comment 21) One comment asks whether the United States has
developed biosecurity and sophisticated devices to test and control
dangerous biological agents and toxins, including those that present a
threat to plants or animals. This comment also asks if the United
States has developed new methods to detect contaminated foods, to work
with state food safety regulators, and to protect crops and livestock.
(Response) The issues described in these comments are outside the
scope of this final rule. However, we are sensitive to these concerns
and wish to assure the comments that the agency is doing a number of
things to increase our ability to detect the presence of agents that
may present a threat to foods for human and animal consumption. We do
not believe it is appropriate to discuss these activities in this final
rule; however, more information can be obtained on FDA's Web site. (See
''Hot Topics'' on the Web site at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov.)
(Comment 22) Two comments state that every effort should be made to
ensure that information regarding the detention of a product is
accurate and publicized only when necessary in an
[[Page 31668]]
effort to protect public health. The comments state that such publicity
should be transmitted in a clear, unemotional, and factual manner
without unduly or inaccurately raising public concern. The comments
also indicate that the agency should be aware that if the public is
told a product has been detained and it is later found to be
nonviolative, the reputation of the company likely will be damaged due
to the public perception that the product was somehow unsafe because it
had been detained. The comment is concerned that information that a
detained product has been released seldom reaches the public. One of
these comments states that to minimize these losses, the detention
order should become a part of the public record only if FDA determines
that the product presents a threat of serious adverse health
consequences or death to humans or animals.
(Response) FDA has no plans to routinely publicize the issuance of
detention orders. However, in the event of a public health emergency,
FDA may issue a Talk Paper or Press Release with information regarding
a detained article of food that presents a threat of serious adverse
health consequences or death to humans or animals. In such an
emergency, FDA may also inform other departments, agencies or
governments. In addition, administrative detentions can be precursors
to enforcement action in Federal court, particularly seizures, which
are public filings in the courts. Information regarding a detention
could be included in the complaint for forfeiture. Information
regarding administrative detentions also may be released under a
Freedom of Information Act (FOIA) request after FDA has removed any
information that is protected from disclosure to the public.
(Comment 23) Several comments request clarity concerning which rule
will be applied to imports and under what circumstances. These comments
indicate that FDA's regulatory framework for imports is more stringent
than that applied to domestic products. One of these comments suggests
that an administrative detention mechanism that allows FDA to take
action against domestic foods that appear to be adulterated or
misbranded is needed. Another of these comments indicates that
historically, detention orders have not been delivered directly to the
owners or importer of record in a timely fashion. This comment further
indicates that, because detention orders have historically covered
future shipments of the product and included nonrelated growers, FDA
should consider removing the time limit to file appeals regarding
detention orders.
Another comment argues that the proposed rule would give a
competitive advantage to domestic food over imported food because
domestic food would be subject only to administrative detention, while
imported food would be subject to both administrative detention and
``normal'' import detention.
(Response) The issues concerning how FDA has implemented section
801 of the FD&C Act are outside the scope of this regulation. FDA
reiterates that this final rule does not implement section 801 of the
FD&C Act, despite its use of the term ``detention.'' This final rule
implements section 303 of the Bioterrorism Act, which amends section
304 of the FD&C Act, by adding paragraph (h) to that section.
Section 304(h) of the FD&C Act applies the same standard to
domestic and imported food. The criteria for administrative detention
under section 304(h) of the FD&C Act are credible evidence or
information that an article of food presents a threat of severe adverse
health consequences or death to humans or animals. The procedures for
administrative detention under section 304(h) of the FD&C Act are
described in this rule and will be applied in the same way to both
imported and domestic food that is detained administratively under
section 304(h).
FDA disagrees that domestic food has a competitive advantage over
imported food. FDA investigators and inspectors are authorized under
the FD&C Act to inspect domestic food manufacturers, packers, and
distributors to determine their compliance with the FD&C Act and its
implementing regulations. As part of its vigorous domestic enforcement
program, FDA inspects domestic food facilities and collects domestic
food product samples for examination by FDA scientists or for label
checks. When warranted, judicial enforcement actions are brought
against violative articles of food and their manufacturers and
distributors.
B. Comments on Foreign Trade Issues
(Comment 24) Some comments question the consistency of the
regulation with U.S. obligations under the NAFTA and various WTO
agreements.
(Response) FDA is aware of the international trade obligations of
the United States and has considered these obligations throughout the
rulemaking process for this regulation. FDA believes that these
regulations are consistent with these international trade obligations.
In addition, and as discussed elsewhere in this preamble, FDA does not
foresee frequently using administrative detention under section 304(h)
of the FD&C Act to control the movement of imported food subject to
section 801 of the FD&C Act.
(Comment 25) Some comments assert that the regulation is
burdensome, costly, discriminatory, and will have a negative impact on
foreign trade.
(Response) In drafting the final rule, FDA structured the rule to
be consistent with the statutory mandates of the Bioterrorism Act and,
at the same time, to reduce the costs associated with compliance. FDA
carefully considered comments received regarding the burden imposed by
this rule, including its impact on international trade.
C. Comments on What Definitions Apply to This Subpart? (Proposed Sec.
1.377)
1. Definition of ``The Act''
(Comment 26) FDA did not receive comments on the definition of
``the act.''
(Response) We did not change the definition in the final rule.
2. Definition of ``Authorized FDA Representative''
(Comment 27) Several comments state that based on the serious
nature of administrative detentions, decisions to detain products
administratively should be made by an official at the regional FDA
director level or higher because of the cost implications and serious
business impact such an action would cause. In addition, some comments
state that approval at the FDA District Director level allows too much
discretion, and that a higher level of approval is necessary to ensure
some level of uniformity.
(Response) Permitting approval of an administrative detention at
the FDA District Director level is consistent with section 303 of the
Bioterrorism Act, which allows such approval at the FDA district level,
or above. As required by Sec. 1.391, all detention orders must be
approved by an authorized FDA representative. FDA defines authorized
FDA representative for the purpose of this final regulation as 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.
(Comment 28) A couple of comments state that defining ``qualified
employee'' at even the District Director level is problematic because
of what the comments characterize as FDA's erroneous decisions in the
past regarding ``tainted foods'' (e.g., fish,
[[Page 31669]]
fruits, vegetables). They note that these industries have fallen victim
to otherwise ``qualified'' federal and state employees who have wrongly
accused many commodities of potential contamination.
(Response) Although a comment alleged that FDA has made wrong
decisions in the past, they did not identify any particular wrong
decision.
FDA is not limiting ``officer or qualified employee'' to the
District Director level or higher. The officers or qualified employees
of FDA who may order a detention include, but are not limited to, FDA
field investigators; FDA employees who have security clearance to
receive national security information; and health, food, or drug
officers or employees of any State, Territory, or political subdivision
thereof, duly commissioned by FDA as officers of the Department under
section 702(a) of the FD&C Act (21 U.S.C. 372). Only an authorized FDA
representative, however, can approve a detention order. FDA is defining
an ``authorized FDA representative'' as an FDA District Director in
whose district the detained article of food is located, or an FDA
official senior to an FDA District Director. This language is drawn
from section 303 of the Bioterrorism Act. Clearly, Congress envisioned
that only FDA officials with a given level of seniority would have
authority to approve a detention order.
(Comment 29) One comment questions how the owner/carrier will know
that FDA's personnel are authorized to detain their product.
(Response) Section 1.391 states that an authorized FDA
representative, i.e., the FDA's District Director in whose district the
article of food is involved is located or an FDA official senior to
such director, must approve the detention order. If prior written
approval is not feasible, prior oral approval must be obtained and
confirmed in writing as soon as possible. Consequently, all FDA
personnel issuing a detention must be authorized in advance to issue
the detention order. Under Sec. 1.393(b)(13), the detention order must
indicate the manner in which approval of the detention order was
obtained, i.e., verbally or in writing.
We have revised the final rule to include Sec. 1.393(b)(14), which
requires that the name and title of the authorized FDA representative
who approved the detention order be included in the detention order.
Section 1.392(a) of the final rule 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
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. Under Sec. 1.392(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. Thus, the owner and carrier will know from
the detention order how the approval was obtained and the name and
title of the authorized FDA representative who approved the detention
order.
(Comment 30) One comment notes that FDA must employ strict internal
procedural requirements for FDA officers and employees and our agents
that are involved in determination of potential adulteration or
intentional contamination.
(Response) FDA officers, employees, and agents authorized to carry
out an administrative detention will be fully trained.
3. Definition of ``Calendar Day''
(Comment 31) FDA did not receive comments on the definition of
``calendar day.''
(Response) We did not change the definition in the final rule.
4. Definition of ``Food''
(Comment 32) A few comments state that alcoholic beverages should
not be covered under this provision because they are regulated by the
Alcohol and Tobacco Tax and Trade Bureau (TTB), as well as by
individual states. One of these comments suggests that FDA should
revise the rule to specify that TTB officials are responsible for
ordering any administrative detentions of alcoholic beverages. Another
comment states that FDA should secure a legislative amendment to the
Bioterrorism Act that exempts wines and spirits and other alcoholic
beverages under the jurisdiction of TTB from its application, in the
same way as meat, poultry, and egg products under the jurisdiction of
the U.S. Department of Agriculture (USDA) are excluded from its scope.
This comment indicates that the inconsistency does not appear to be
founded on any objective criteria such as risk analysis.
(Response) This rule complies with section 315 of the Bioterrorism
Act, ``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 USDA and the U.S.
Department of Health and Human Services (HHS) under applicable statutes
and regulations. Accordingly, this final rule does not apply to food
regulated exclusively by 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.).
Unlike USDA, there are no provisions in section 303 of the
Bioterrorism Act that specifically address the jurisdiction of TTB.
Under existing law, TTB does not have exclusive jurisdiction over
alcoholic beverages. TTB establishes tariffs and licensure
requirements, and has primary jurisdiction over the labeling of
alcoholic beverages. However, FDA exercises jurisdiction over alcoholic
beverages as ``food'' for the purposes of the adulteration and other
provisions of the FD&C Act.
FDA recognizes that working in conjunction with TTB and individual
states is an important tool we have in the event of a threat to the
nation's food supply. However, alcoholic beverages are covered under
the administrative detention regulation because alcohol is food, as
that term is defined in section 201(f) of the FD&C Act (21 U.S.C.
321(f)). As stated in the proposed rule, and discussed in detail in the
following paragraphs, the term ``food'' as used in section 303 of the
Bioterrorism Act has the meaning given in section 201(f) of the FD&C
Act.
FDA reiterates that, under this final rule, any administrative
detention ordered by an officer or qualified employee must be approved
by an authorizing official.
Comments suggesting that FDA should request a legislative amendment
to the Bioterrorism Act are outside the scope of this rulemaking.
(Comment 33) A few comments state that indirect food additives,
such as color pigments for packaging, packaging polymers, and coatings
should be exempt from coverage under section 303 of the Bioterrorism
Act because, by definition as a food additive, the manufacturer must
demonstrate under FDA's food additive regulations that they are safe
and stable. One comment suggests that we exempt raw materials and
formulated products that are used as components in the manufacture of
food contact articles, such as conveyor belts, oven gaskets, coatings
for film, paper, and metal substrates, adhesives, antifoam agents,
antioxidants, polymeric resins, polymer emulsions, colorants for
polymers, rubber articles,
[[Page 31670]]
release coatings, and the like. Another comment suggests that
tableware, including ceramic and lead crystal, also should be exempt
from coverage under this provision of the Bioterrorism Act because
Congress did not intend such a broad scope. This comment states that
contaminated food products present an immediate risk to public health,
whereas adulterated food contact articles present a risk only once they
have contact with food, and only if the poisonous or deleterious
substance actually migrates into the food. The comment further states
that the lack of immediacy means that there is a significant potential
for intervening actions; for example, washing purchased tableware items
before using them for the first time to reduce or eliminate any risks
posed by a bioterrorist act aimed at food contact articles.
Two comments state the belief that live food animals, pet food, and
animal feed, including fertilizers that end up in animal feed, should
not be covered by this rule because Congress did not intend such a
broad scope. Another comment states that any material that might end up
in food, but that has nonfood uses, should be exempt from coverage
under section 303 of the Bioterrorism Act unless the manufacturer knows
the material will be consumed in the United States as food. One comment
states that food that will be used in trade shows should be exempt from
coverage under this provision because the trade shows have their own
self-regulation and because FDA could visit the trade shows and easily
inspect the products. Another comment states that technical samples of
food, e.g. less than 100 grams (g) of a product, should be exempt from
coverage under this rule.
(Response) FDA disagrees with these comments and is finalizing the
definition of ``food'' as proposed. FDA is not excluding food contact
materials, live animals, alcoholic beverages, or other articles of food
from coverage under this regulation.
These comments raise the question of what Congress intended
``food'' to mean for purposes of administrative detention. In
construing the administrative detention provision of the Bioterrorism
Act, FDA is confronted with two questions. First, has Congress directly
spoken to the precise question presented (``Chevron step one'')
Chevron, U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837, 842 (1984). To find
no ambiguity, Congress must have focused directly on the question
presented and have articulated clearly its intention. Young v.
Community Nutrition Institute, 476 U.S. 974, 980 (1986). If Congress
has spoken directly and plainly, the agency must implement Congress's
unambiguously expressed intent. Chevron, 467 U.S. at 842-843. If,
however, the Bioterrorism Act is silent or ambiguous as to the meaning
of ``food,'' FDA may define ``food'' in a reasonable fashion (``Chevron
step two''). Chevron, 467 U.S. at 842-843; FDA v. Brown & Williamson
Tobacco Corp., 529 U.S. 120, 132 (2000).
The agency has determined that, in enacting section 303, Congress
did not speak directly and precisely to the meaning of ``food.'' As
noted, the FD&C Act has a definition of ``food'' in section 201(f) of
the FD&C Act. It is a reasonable assumption that, when the term
``food'' is used in the FD&C Act, section 201(f) applies. However,
although there may be ``a natural presumption that identical words used
in different parts of the same act are intended to have the same
meaning [citation omitted], * * * the presumption is not rigid. * * *''
Atlantic Cleaners & Dyers, Inc. v. U.S., 286 U.S. 427, 433 (1932).
Accord: U.S. v. Cleveland Indians Baseball Co., 532 U.S. 200, 213
(2000). Thus, the same word may be given different meanings, even in
the same statute, if different interpretations are what Congress
intended. (Atlantic Cleaners & Dryers, Inc., supra.)
Even before the Bioterrorism Act amendments, the term ``food'' was
not given an identical meaning throughout the FD&C Act. For example, in
construing the parenthetical ``(other than food)'' in section
201(g)(1)(C) of the FD&C Act, the Seventh Circuit noted that Congress
meant to exclude only ``articles used by people in the ordinary way
that most people use food--primarily for taste, aroma, or nutritive
value'' and not all substances defined as food by section 201(f) of the
FD&C Act. Nutrilab, Inc. v. Schweiker, 713 F.2d 335, 338 (7th Cir.
1983). Similarly, section 409(h)(6) of the FD&C Act (21 U.S.C.
348(h)(6) defines a food contact substance as ``any substance intended
for use as a component of materials used in manufacturing, packing,
packaging, transporting, or holding food if such use is not intended to
have any technical effect in such food (emphasis added).'' This
definition makes sense only if ``food'' in that section is interpreted
to exclude materials that contact food because components of food
contact materials are plainly intended to have a technical effect in
such materials.\1\
---------------------------------------------------------------------------
\1\ FDA's long-standing interpretation of the act's definition
of color additive, section 201(t) of the FD&C Act (21 U.S.C.
201(t)), is an additional example of where ``food'' is used more
narrowly than as defined in section 201(f). A color additive is
defined in section 201(t) of the FD&C Act as a substance that ``when
applied to a food * * * is capable * * * of imparting color thereto
* * *'' The agency's food additive regulations distinguish between
color additives and ``colorants,'' the latter being used to impart
color to a food-contact material. (21 CFR 178.3297(a), see also 21
CFR 70.3 (f).) Thus, ``food'' as it appears in the statutory
definition of color additive, necessarily excludes food contact
materials.
---------------------------------------------------------------------------
Thus, in this larger statutory context, FDA has evaluated section
303 of the Bioterrorism Act to determine whether the meaning of the
word ``food'' is ambiguous. In conducting this Chevron step one
analysis, all of the traditional tools of statutory interpretation are
available to determine whether Congress's intent is ambiguous.
Pharmaceutical Research & Manufacturers of America v. Thompson, 251 F.
3d 219, 224 (D.C. Cir. 2001). Beginning with the language of the
statute, in section 303 of the Bioterrorism Act, ``food'' is used to
describe which subset of FDA-regulated articles are subject to
administrative detention: An officer or qualified employee of the Food
and Drug Administration may order the detention, in accordance with
this section, of any article of food that is found during an
inspection, examination, or investigation under the Bioterrorism 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 (emphasis added).
The Bioterrorism Act is silent as to the meaning of ``food.''
Congress did not specify whether it intended the definition in section
201(f) of the FD&C Act to apply, one of the other possibilities noted
previously, or another meaning. Where, as here, the statutory language
on its face does not clearly establish Congressional intent, it is
appropriate to consider not only the particular statutory language at
issue, but also the language and design of the statute as a whole.
Martini v. Federal Nat'l Mortgage Association, 178 F. 3d 1336, 1345
(D.C. Cir. 1999), citing K Mart Corp. v. Cartier, Inc., 486 U.S. 281
(1988). Indeed, the analysis should not be confined to the specific
provision in isolation, because the meaning or ambiguity of a term may
be evident only when considered in a larger context. FDA v. Brown &
Williamson Tobacco Corp., supra at 132 (2000).
FDA has considered other sections of the Bioterrorism Act and has
concluded that the meaning of ``food'' in the Bioterrorism Act is
ambiguous. FDA previously considered the meaning of
[[Page 31671]]
``food'' in section 305 of the Bioterrorism Act, governing registration
of food facilities, and concluded that it is ambiguous (68 FR 58894).
Section 305 of the Bioterrorism Act amends the FD&C Act by adding
section 415 to that act. In section 415(a)(1) of the FD&C Act, the word
``food'' is modified by the phrase ``for consumption in the United
States.'' It's not clear whether this modifying phrase limits the
definition of ``food'' to food that is ingested--a narrower definition
of ``food'' than that in section 201(f) of the FD&C Act. In addition,
the definition of ``facility'' in section 415(b)(1) of the FD&C Act
exempts ``farms; restaurants; other retail establishments.'' It's not
clear whether the phrase ``other retail establishments'' includes
retailers of food contact materials; the legislative history indicates
that it does not, thereby giving rise to additional ambiguity about
which definition of ``food'' applies to section 415 of the FD&C Act.
FDA also considered the meaning of ``food'' in section 307 of the
Bioterrorism Act, governing prior notice of imported food shipments,
and concluded that it is ambiguous (68 FR 58974). Section 307 of the
Bioterrorism Act amends the FD&C Act by adding section 801(m) to that
act. Section 801(m) of the FD&C Act refers to an ``article of food.''
However, the legislative history of section 307 of the Bioterrorism Act
indicates that packaging materials are not subject to section 307, and
can be read to imply that Congress was not relying on the definition of
food in section 201(f) of the FD&C Act, thereby giving rise to
ambiguity about which definition of ``food'' applies to section 307 of
the Bioterrorism Act.
Finally, FDA considered the meaning of ``food'' in developing a
final rule to implement section 306 of the Bioterrorism Act, governing
maintenance and inspection of records for foods, which will be
published in this issue of the Federal Register in the near future. ''.
. . which will be published in the Federal Register in the near future.
Section 306 of the Bioterrorism Act amends the FD&C Act by adding
section 414 to that act. Section 414(a) of the FD&C Act, which covers
inspection of records, refers to ``an article of food,'' and ``food.''
But section 414(b) of the FD&C Act, which covers establishment and
maintenance of records, refers to ``food, including its packaging.''
Elsewhere in the record provisions, section 414 of the FD&C Act refers
to ``food safety,'' ``a food to the extent it is within the exclusive
jurisdiction of [USDA],'' and ``recipes for food.'' There is, thus,
ambiguity about which definition of ``food'' applies to section 306 of
the Bioterrorism Act.
The ambiguity surrounding Congress's use of ``food'' in sections
303, 305, 306, and 307 of the Bioterrorism Act, coupled with the lack
of a definition of the term in that act, support a conclusion that the
meaning of ``food'' in the Bioterrorism Act is ambiguous.
Having concluded that the meaning of ``food'' in the Bioterrorism
Act and in section 303 of that act is ambiguous, FDA has considered how
to define the term to achieve a ``permissible construction'' of the
administrative detention provision. Chevron, USA, Inc. v. NRDC, Inc.,
supra at 843. In conducting this Chevron step two analysis, the agency
has considered the same information evaluated at step one of the
analysis. Bell Atlantic Telephone Co. v. FCC, 131 F. 3d 1044, 1049
(D.C. Cir. 1997); Chevron U.S.A., Inc. v. FERC, 193 F. Supp. 2d 54, 68
(D.D.C. 2002). FDA has determined that it is permissible, for purposes
of the administrative detention provision, to use the definition of
``food'' in section 201(f) of the FD&C Act.\2\
---------------------------------------------------------------------------
\2\ Alternatively, it may be argued that the meaning of ``food''
in section 303 of the Bioterrorism Act is not ambiguous, and that
the Chevron analysis stops at step one. Under either approach, the
definition of ``food'' in section 201(f) of the FD&C Act applies to
section 303 of the Bioterrorism Act.
---------------------------------------------------------------------------
Use of the definition of food in section 201(f) of the FD&C Act is
consistent with the language of section 303 of the Bioterrorism Act.
Section 303 of the Bioterrorism Act repeatedly uses the term ``food''
without adjectives. There is only one instance in which section 303
uses an adjective with the term ``food,'' and that is in section
304(h)(2) of the FD&C Act, which directs the Secretary to provide for
procedures for instituting certain judicial enforcement actions on an
expedited basis with respect to ``perishable foods.'' Use of the
adjective ``perishable'' in this context does not limit the reach of
section 303 of the Bioterrorism Act to a subset of ``food'' as defined
in section 201(f) of the FD&C Act. Rather, the adjective ``perishable''
serves to distinguish perishable from nonperishable food for purposes
of deciding what type of food is subject to the procedures mandated by
section 304(h)(2) of the FD&C Act. Nonperishable food, though not
necessarily subject to the procedures mandated by section 304(h)(2) of
the FD&C Act, is nonetheless subject to administrative detention.
Use of the definition of ``food'' in section 201(f) of the FD&C Act
is also consistent with the fact the judicial enforcement actions that
may be instituted under administrative detention have been consistently
interpreted to use that same definition. Section 304(a)(1) of the FD&C
Act authorizes seizure of any ``article of food'' that is adulterated
or misbranded under specified conditions. In applying section 304(a)(1)
of the FD&C Act, FDA and the federal courts use the definition of
``food'' in section 201(f) of the FD&C Act. See, e.g., Natick
Paperboard Corp. v. Weinberger, 525 F.2d 1103 (1st Cir. 1975); U.S. v.
An Article of Food, 752 F.2d 11 (1st Cir. 1985). Section 302 of the
FD&C Act authorizes injunction to restrain violation of certain
provisions of section 301 of that act, which repeatedly uses the term
``food.'' In applying section 302 of the FD&C Act (21 U.S.C. 332), FDA
and the federal courts use the definition of ``food'' in section 201(f)
of the FD&C Act. See, e.g., U.S. v. Blue Ribbon Smoked Fish, Inc., 179
F.Supp.2d 30 (E.D.N.Y. 2001).
FDA is therefore retaining its interpretation of ``food'' in
section 303 of the Bioterrorism Act to mean ``food'' as defined in
section 201(f) of the FD&C Act. Food subject to section 303 of the
Bioterrorism Act thus includes, but is 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.\3\
---------------------------------------------------------------------------
\3\ The agency notes that the scope of the definition of
``food'' in the regulations implementing section 303 of the
Bioterrorism Act (administrative detention) is broader than the
scope of the definition of ``food'' in the regulations implementing
sections 305 (registration) and 307 (prior notice) (68 FR 58894,
October 10, 2003, and 68 FR 58974, respectively).
---------------------------------------------------------------------------
The standard for administrative detention-credible evidence or
information indicating that an article of food presents a threat of
serious adverse health consequences or death to humans or animals is a
high threshold. Where this threshold is met for any article of food, it
is appropriate for FDA to use the full authority provided by the
Bioterrorism Act and thereby protect public health to the fullest
extent possible.
[[Page 31672]]
5. Definition of ``Perishable Food''
(Comment 34) FDA sought comments and supporting data on how to best
define ``perishable food'' for purposes of this rule. Several comments
state that the definition for ``perishable food'' should be revised to
mean foods with a shelf life of 90 days from the date of packaging,
including products that are thermally processed or treated to extend
the shelf life to 90 days from the date of packaging. Another comment
states that FDA should use the definitions in the National Institute of
Standards and Technology (NIST) handbook, which are: Perishable, 60-day
shelf life from date of packaging; semiperishable, 60 days to 6 months
shelf life from the date of packaging; and long shelf life, greater
than 6 months shelf life from the date of packaging. Yet another
comment suggests that we use the definition for perishable foods as it
is described in the Perishable Commodities Act. One comment states that
live animals should be considered perishable food items because they
must be fed, watered, and possibly medicated to stay alive. That
comment asks who will be responsible for feeding, watering, and
medicating the animals if they are detained. A few comments state that
the definitions should consider loss of marketability, and not just
loss of physical and biological properties. These comments indicate
that many products have optimum release dates, such as seasonal items
(Valentine's candy), special release items (wines), and strict stock
rotational items (snack foods, baked goods, and tortillas) that would
quickly lose their marketability. Many comments suggest that the
definition for ``perishable food'' should be revised to include foods
that have 120 days of shelf life because products with older ``sell
by'' dates lose their marketability. One comment asks whether products
in bulk form that are intended for further processing and have a short
shelf life are covered under the definition of ``perishable food.''
(Response) FDA disagrees with these comments and is finalizing the
proposed definition for ``perishable food'' without any revisions. The
context in which the term ``perishable food'' appears in section 303 of
the Bioterrorism Act indicates that, at least with respect to
administrative detention, Congress was concerned with articles of food
that would spoil relatively quickly. It is unlikely that Congress would
have mandated expedited procedures for instituting certain enforcement
actions against foods that have a shelf life of up to 90 days, given
that the statute only allows FDA to detain foods for a maximum of 30
days while it seeks to initiate certain judicial enforcement actions.
The definition of ``perishable food'' in this final rule has been
modeled after the current Regulatory Procedures Manual (RPM) definition
of ``perishable commodity.'' 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-calendar day (maximum)
deadline for FDA to issue a decision on an appeal of a detention order.
Under the deadline for appeals involving the detention of a perishable
food, FDA would issue a decision on an appeal before the expiration of
the 7-calendar day period. FDA believes that this timeframe offers the
best protection to appellants and products. FDA notes that a claimant
for any nonperishable detained product may file for an appeal within
the first 2 calendar days after receipt of a detention order, similar
to the procedures set forth in Sec. 1.402(a)(1) for perishable foods.
FDA will determine the conditions for holding detained food,
including live animals, on a case-by-case basis based upon the totality
of information available to us about the article of food. If necessary,
FDA may consult with the owner of the food, if readily known, about
appropriate storage conditions. The business arrangements for storing
detained food, including live animals, are a private matter between the
recipient of the detention order and the facility where the food will
be stored. The recipient of the detention order is responsible for
making these arrangements.
6. Definition of ``We''
(Comment 35) FDA did not receive comments on the definition of
``we.''
(Response) We did not change the definition in the final rule.
7. Definition of ``Working Day''
(Comment 36) FDA did not receive comments on the definition of
``working day.''
(Response) We did not change the definition in the final rule.
8. Definition of ``You''
(Comment 37) FDA did not receive comments on the definition of
``you.''
(Response) We did not change the definition in the final rule.
D. Comments on What Criteria Does FDA Use To Order a Detention?
(Proposed Sec. 1.378)
(Comment 38) One comment agrees that FDA should not define the term
``credible evidence or information'' and should evaluate such decisions
on a case-by-case basis, given that a bioterrorism event may arise in
an unanticipated scenario. This comment agrees that FDA should not bind
its discretion by identifying the types of evidence that it ultimately
may need to rely upon to support a detention order.
The majority of comments request that FDA define by regulation or
guidance clear evidentiary standards and procedures for the
determination of ``credible evidence or information.'' These comments
state that the term should be defined to ensure that the Bioterrorism
Act is not interpreted more broadly than Congress intended and to
ensure that affected persons have some protection against arbitrary or
unsupported detentions. A few comments state that as long as the
factors on which a detention decision is based are not known, there is
no possibility to assess and evaluate the legitimacy of the decision.
These comments request that FDA publish guidance on how the credible
evidence or information standard will be documented (e.g., name all
sources of information that may be considered ``reliable,'' describe
the requirements with respect to accuracy of the information, etc.).
Another comment suggests that guidance should indicate the authorities
that FDA might rely upon to determine whether information it receives
is credible, such as health authorities (i.e., Centers for Disease
Control and Prevention), law enforcement authorities (i.e., Federal
Bureau of Investigation), or other appropriate authorities (i.e.,
Department of Homeland Security). A few comments state that ``credible
evidence/information'' should be similar to a ``probable cause''
standard and more than mere speculation or an anonymous telephone tip.
One comment states that, because administrative detention authority
also is triggered in the context of FDA inspection and sampling
authorities, the agency should ensure that the evidentiary standards
and procedures adopted satisfy applicable Fourth Amendment and other
constitutional requirements. In particular, the comment urges the
agency to examine the ``credible evidence'' standard with reference to
Fourth Amendment and related evidentiary standards developed in case
law, and not to rely on a
[[Page 31673]]
superficial reading of the Bioterrorism Act or a plain language
interpretation drawn from Webster's Dictionary. The comment states that
the ``public health triggers'' defining FDA authority under the
Bioterrorism Act are critically important jurisdictional provisions,
which authorize extraordinary intrusions and control over private
commercial property, including products subject to administrative
detention.
(Response) FDA has considered these comments, and we have decided
to maintain our decision not to define the term ``credible evidence or
information.'' The decision to not define credible evidence or
information reflects how the credible evidence or information standard
has been applied in various other judicial and administrative contexts,
and the need to maintain flexibility, given the range of circumstances
in which articles of food might be detained under the administrative
detention authority. The ``credible evidence or information'' standard
requires fact-specific inquiries for which maximum interpretive
discretion should be maintained. FDA intends to apply the credible
evidence standard consistent with the terms of that standard and with
applicable Fourth Amendment principles and case law.
(Comment 39) One comment states that administrative detention is
triggered by two undefined criteria: The first is ``credible evidence
or information,'' and the second is ``serious adverse health
consequences or death to humans or animals.'' Many comments express
concern that if these standards are not defined, detention decisions
would be subjective, discriminatory and void of objective, scientific
grounds. The comments argue that the question of the role of the
application of the ``precautionary principle'' likewise arises.
(Response) The comment expressing concern about the application of
the ``precautionary principle'' did not explain what they meant by
their use of the term in the context of this rule. The standard for
administrative detention as set out in the Bioterrorism Act is whether
credible evidence or information exists indicating that an article of
food presents a threat of serious adverse health consequences or death
to humans or animals. This is the standard that we must apply. FDA
intends to define ``serious adverse health consequences'' in a separate
rulemaking. We will not define ``credible evidence or information'' for
reasons set forth in our prior response to a similar comment.
(Comment 40) A few comments state that FDA should have clear
evidence, such as laboratory analysis, to confirm the presence of an
adulterant, and/or affidavits sworn under penalty of perjury. Several
comments ask that FDA use internationally recognized methods for
laboratory analyses, as well as internationally recognized standards
such as Codex Alimentarius, an international food code, and provide
countersamples to the owner of the article of food. One comment
requests that FDA require that sampling and diagnostic testing (to
confirm or deny suspicions of food tampering) be initiated within 24
hours of the date the detention order is issued.
(Response) FDA disagrees with these comments. Given the range of
circumstances in which articles of food may be detained under the
administrative detention authority, the agency needs to maintain
flexibility to respond appropriately on a case-by-case basis. The
``credible evidence or information'' standard requires fact-specific
inquiries for which maximum interpretive discretion should be
maintained. FDA intends to apply the credible evidence standard
consistent with the terms of that standard and with applicable
constitutional principles and case law.
With respect to providing what some comments refer to as
countersamples, section 702(b) of the FD&C Act describes FDA's
responsibility to provide a part of an official sample of food to
certain individuals, when a sample is collected for analysis under the
FD&C Act. Section 702(b) of the FD&C Act requires the Secretary to,
upon request, provide a part of such official sample for examination or
analysis by any person named on the label of the article, or the owner
thereof, or his attorney or agent; except that the Secretary is
authorized, by regulations, to make such reasonable exceptions from,
and impose such reasonable terms and conditions relating to, the
operation of this section as he finds necessary for the proper
administration of the provisions of this act. Exceptions from this
section are set forth in 21 CFR 2.10.
(Comment 41) One comment suggests that credible evidence or
information be directly related to a serious health consequence.
Another comment is concerned whether the evidence for suspicion will be
corroborated before an order for detention is made, or whether such an
order would be made on a totally discretionary/subjective basis.
(Response) The Bioterrorism Act authorizes FDA to order an
administrative detention only when 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. Consequently, serious adverse health consequences or
death is an element of the standard FDA will apply in ordering that an
article of food be detained. In evaluating whether credible evidence or
information exists for purposes of administrative detention, FDA may
consider a number of factors including, but not limited to, the
reliability and reasonableness of the evidence or information, and the
totality of the facts and circumstances.
(Comment 42) A few comments recommend issuing guidance with a list
of criteria that define ``serious adverse health consequences'' because
an illustrative list from FDA will ensure that excess (or unnecessary)
detentions do not occur.
A few comments state that indications should be given to limit the
scope of implementation of the law. These comments specifically request
that interpretation of serious adverse health consequences should be
based on the risk to a large part of the population, as opposed to
merely a few individuals. These comments state that in situations where
the risk associated with a food product only affects a very limited
group of people, detention would not be the appropriate action to take.
Furthermore, they state that the health consequences must be severe to
the average person to justify a detention.
(Response) FDA agrees with the comments that the agency should
define the term, ``serious adverse health consequences'' and intends to
define the term in a separate rulemaking. The agency is developing a
separate rule because the term is used in several provisions in Title
III of the Bioterrorism Act, not just in section 303. FDA believes that
defining ``serious adverse health consequences'' will promote
uniformity and consistency across the agency in the understanding of
this term and in the actions taken, as well as inform the public of
what FDA considers a ``serious adverse health consequence.''
(Comment 43) One comment states that non-FDA employees from other
agencies or states commissioned or deputized by FDA should not be
considered officers or qualified employees of FDA for purposes of
administrative detention.
(Response) Section 303 of the Bioterrorism Act provides that an
officer or qualified employee of FDA may order a detention of a food
found during an inspection, examination, or investigation under the
FD&C Act. FDA
[[Page 31674]]
agrees that, under existing law, employees of other Federal agencies
cannot be considered officers or qualified employees of FDA for
purposes of ordering an administrative detention. The same cannot be
said of State employees commissioned by FDA as officers of the
Department. Section 702(a) of the FD&C Act authorizes the Secretary to
conduct examinations and investigations for purposes of the FD&C Act,
through officers and employees of the Department, or through health,
food, or drug officers or employees of any State, Territory, or
political subdivision thereof, duly commissioned as officers of the
Department. Because they are ``officers'' of the Department, FDA
believes that such State and local officers or employees have authority
to order an administrative detention under section 303 of the
Bioterrorism Act. FDA reiterates that under this final rule, any
administrative detention ordered by an officer or qualified employee
must be approved by an authorizing official.
(Comment 44) One comment states that ``qualified employee'' must be
limited to those in FDA who, in their day-to-day job responsibilities,
conduct food inspections, examinations and investigations.
(Response) Consistent with section 303 of the Bioterrorism Act,
Sec. 1.378 provides 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 FD&C Act if the
officer or qualified employee 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.
Consequently, any FDA employees, or State or local officers or
employees commissioned by FDA as officers of the Department, may order
a detention as part of their function of inspecting, examining or
investigating an article of food. FDA does not believe the limitation
proposed by the comment is necessary. Section 1.391 requires any
detention to be approved by the FDA District Director in whose district
the article of food is located or an FDA official senior to such
director.
E. Comments on How Long May FDA Detain an Article of Food? (Proposed
Sec. 1.379)
(Comment 45) Many comments state that FDA should be required to
limit the detention period to that period that is absolutely minimally
necessary to undertake an investigation into the possible threat that
underlies the detention order. These comments further state that the
extension of time up to 30 calendar days must not be by a ``block'' of
10 calendar days, but rather a possible extension of up to 10 extra
calendar days. One comment states that they agree that an article may
be detained for an additional 10 calendar days; however, they want the
reason for the extension to be limited to certain conditions, such as
waiting for test results. This comment also states that the company
should be immediately informed of any additional time requirement, the
reason for the additional time, and the actual time period that will be
required (up to 10 calendar days).
One comment proposes that the only reason a detention should be
extended from 20 to 30 calendar days is to take legal action in a civil
suit. A few comments state that the extension of the detention period
should not be considered justified or ``necessary'' if the reason for
the extension is because the testing of the affected product had not
been conducted expeditiously, or that it could have been completed
within the 20-calendar day period had it been accorded appropriate
priority. One comment asks how FDA is going to notify the owner of the
article of food if the detention period is extended beyond the initial
20 calendar days. Another comment states that there is no indication of
the criteria used to determine the ``reasonableness'' of the detention
period.
(Response) As FDA stated earlier, we intend to proceed as
expeditiously as possible to resolve all issues involved with
administrative detentions. However, FDA disagrees with the comments
that want to preclude FDA from extending a detention in a ``block'' of
10 calendar days. It is not the best use of the agency's resources to
grant extensions of the detention period in small increments, e.g. 1
day at a time. Moreover, the fact that a detention is extended for a
``block'' of 10 calendar days does not mean that an article will always
be detained 10 additional calendar days; just as FDA may terminate a
detention order on any day during the period initially specified in the
detention order, FDA may terminate the detention on any one of the 10
calendar days covered by the extension. FDA has authority to extend a
detention for 10 calendar days as necessary to enable the agency to
institute a seizure or injunction action. Because the development of a
seizure or injunction action is fact-specific, FDA will not always be
able to specify, at the time of the extension, the precise steps that
remain. Indeed, Congress made clear that a maximum detention period of
20 or 30 calendar days is reasonable when Congress included these
detention timeframes in the Bioterrorism Act. Any extension of the
length of a detention period to 30 calendar days requires the agency to
prepare a new detention order and, if applicable, to place new tags or
labels on the detained article of food to indicate the change in the
detention dates.
In addition, FDA notes that under Sec. 1.379(a), FDA can order
detention of the article of food for 30 calendar days in the original
detention order, if we know from the outset that 30 calendar days
rather than 20 calendar days will be needed to institute a seizure or
injunction against the detained article of food.
(Comment 46) Several comments suggest that the maximum length of
time for a detention should be shortened, e.g., to 15 calendar days, 10
calendar days, or 7 calendar days, and for perishable food, to 24
hours, because of the impact a detention can have on the normal flow of
trade. A few comments suggest that fresh fruit should be kept in
detention for only a few hours. A few other comments state that the
maximum period of detention should be in accordance with the type of
product to minimize costs for the exporters.
(Response) FDA disagrees with these comments because it is not
appropriate to limit the authority and flexibility that Congress
intended FDA to have under section 303 of the Bioterrorism Act, which
authorizes FDA to detain an article of food that presents a threat of
serious adverse health consequences or death to humans or animals for
20 calendar days, unless a greater period, not to exceed by 30 calendar
days, is necessary to institute a seizure or injunction action.
However, FDA intends to act as expeditiously as possible on all
detentions. Detentions of perishable foods are subject to the shortened
timeframes for filing an appeal and convening a hearing in Sec.
1.402(a)(1) and (d), respectively, to process these detentions as
quickly as possible. These shortened timeframes require both FDA and
affected parties to move expeditiously.
(Comment 47) A few comments state that the availability of FDA
resources and staff shortages should not be a justification for FDA's
failure to act quickly on administrative detentions. Another comment
states that any sampling and testing conducted with respect to a
detention order should be given top priority at the appropriate FDA
laboratory (or FDA contract laboratory) to expedite the process, such
that the need for an additional 10
[[Page 31675]]
calendar days can be eliminated or shortened to less than 10 calendar
days.
(Response) As we stated previously, FDA intends to proceed as
expeditiously as possible to resolve all issues involved with
administrative detentions. FDA agrees that any investigation and
sampling of articles of food associated with an administrative
detention should be given high priority.
1. Comments on Where and Under What Conditions Must the Detained
Article of Food Be Held? (Proposed Sec. 1.380)
FDA received many comments on this section III.E.1 of the rule. To
clarify the resolution of the issues raised in the comments, we grouped
the comments into topic areas that reflect the paragraphs in Sec.
1.380.
As noted previously, the term ``limited conditional release,''
which was used in proposed rule, has been replaced by the term
``modification of a detention order'' in this final rule. Therefore,
our responses to the comments that discuss a ``limited conditional
release'' refer instead to a ``modification of a detention order.''
Hold the detained article of food in the location and
under the conditions specified by FDA in the detention order (proposed
Sec. 1.380(a)).
(Comment 48) One comment asks how FDA will determine the conditions
under which detained food will be kept and how we will notify the
owner. A few comments recommend that FDA should develop procedures for
administrative detention of perishable foods that include a process for
asking from the owners of such foods information as to the best storage
methods to ensure the salvage of such foods. Another comment indicates
that the rule should include a provision to allow, at the request of
the owner, operator, or agent in charge, the freezing of detained
``fresh'' product that is (or will likely be) detained for 4 or more
calendar days. One comment indicates that the Bioterrorism Act provides
FDA with the authority to direct articles of food to be moved to a
secure facility and, if necessary, to be moved from refrigerated
storage to a freezer (Sec. 1.381), but that such an action is usually
not neutral for the quality and integrity of the food, given that
frozen food may then no longer be marketed as ``fresh'' food. The
comments state that this action will change the intrinsic nature of the
food.
(Response) FDA will determine the conditions for holding detained
food on a case-by-case basis based on the totality of information
available to us about the article of food. For example, if the food
item is simply labeled ``Keep Refrigerated,'' with no additional
information in the shipping documents, we are likely to specify that
the food be stored under refrigerated conditions that comply with
appropriate temperature recommendations (e.g., recommended
refrigeration temperatures for food in retail establishments listed in
FDA's Model Food Code or common commercial practices). On the other
hand, if the shipping documents specify that a specific refrigeration
temperature must be maintained, we are likely to order that the food be
stored at the temperature specified by the shipper. As stated in Sec.
1.393(b)(7), the detention order will describe the appropriate storage
conditions, e.g., storage temperature. If necessary, FDA may consult
with the owner of the food, if readily known, about appropriate storage
conditions.
FDA advises that the removal of a detained article of ``fresh''
food from refrigerated storage to a freezer is an appropriate basis
upon which the person who received the detention order, or that
person's representative, may seek modification of the detention order
of the detained food. However, FDA is unlikely to order a fresh food to
be moved from refrigerated storage to a freezer, unless the owner, or
that person's representative, advises us that such a move is
appropriate. Section 1.381(c)(3) allows for a request to modify a
detention order for this purpose, inasmuch as it provides that the
request may be ``to maintain or preserve the integrity or quality of
the article of food * * *''. Consequently, FDA does not believe a
revision in the rule is needed.
(Comment 49) A few comments state that FDA should, upon request of
the owner, provide the records of the storage conditions maintained
during detention. Several comments state that if the storage conditions
indicated in the detention order are not complied with during
detention, causing loss of quality, there must be an opportunity to
submit a claim to FDA for reimbursement. These comments suggest that
FDA should include an appeal structure in the rules and create a fund
for this purpose.
(Response) As we stated previously, the business arrangements for
storing detained food are a private matter between the recipient of the
detention order and the facility where the food will be stored. The
recipient of the detention order is responsible for these arrangements,
including matters concerning records to document that the specified
storage conditions were maintained throughout the detention period.
Neither the FD&C Act nor the Bioterrorism Act includes a provision for
FDA compensating affected parties for any losses.
(Comment 50) Several comments address concerns about food being
subject to administrative detention aboard a conveyance, i.e., ships,
trucks and railcars. These comments urge FDA to revise the regulation
to require that when FDA issues an administrative detention order and
the food is on a ship, truck, or railcar, FDA also must issue an order
to the transporter to deliver the food to either the consignee or to a
secure location, as determined by FDA officials. The comments further
state that the order should specify that the person with the legal
title to the food (i.e., the shipper, the consignee, or a food broker),
should bear the cost to store the detained food. Some comments state
that the detention order should include provisions for the immediate
removal to secure storage of a food that is detained administratively
aboard a conveyance. One comment suggests that we define and make
available for public comment the conditions that we believe would
warrant transporting administratively detained food to secure storage
facilities. Others state that the bases upon which a claimant may seek
a limited conditional release should explicitly include the removal of
a product from a conveyance to secure storage.
Another comment states that detaining food in place on a ship will
affect the ship's schedule, causing deliveries of other cargoes to be
delayed, which could cause plant shutdowns for lack of product. This
comment also states that discharging a suspect cargo ashore into
storage tanks would allow the cargo to be tested while under government
supervision, which would provide the most cost effective solution while
providing for security concerns.
(Response) FDA understands that detention of food aboard a
conveyance may impact other activities of commerce that are dependent
upon the ongoing operation of the conveyance. FDA will consult with CBP
concerning the movement of food detained administratively aboard a
conveyance to limit the impact on the flow of trade. However, we
disagree with the suggestion that we should revise the regulation to
obligate FDA to issue an order to the transporter to deliver the food
to a specified destination at the expense of the person with the legal
title to the food. We believe that the determination of whether we
should order the food to be moved from the conveyance to another
location should be made based on considerations about the nature of the
contaminant, security,
[[Page 31676]]
preservation of the food, and accessibility to the food during the
period of administrative detention. Based on our historical use of
administrative detention with medical devices, we believe that we would
detain food on a conveyance only under rare circumstances. It is more
likely that we will allow the detained food to be removed from the
conveyance to a storage facility.
FDA also disagrees with the suggestion that we specify in the
detention order that a third party (e.g., the shipper, consignee, or
food broker) bear the cost of the transport of the food to secure
storage. The business arrangements for storing detained food are a
private matter between the recipient of the detention order and the
facility where the food will be stored. The recipient of the detention
order is responsible for making these arrangements.
With regard to the transporter's concerns that the detention of
food aboard a conveyance has the potential to impact other activities
of commerce that are dependent upon the ongoing operation of the ship,
truck, or railcar, FDA advises that a transporter may seek modification
of a detention order in order to remove a detained food from a
conveyance to a storage facility. In Sec. 1.381(c)(4), allows the
transporter to request modification of a detention order for this
purpose, inasmuch as it provides that the request may be ``for any
other purpose that the authorized FDA representative believes is
appropriate * * *.'' Accordingly, FDA does not believe a revision to
Sec. 1.381(c)(4) is warranted. However, FDA also advises that,
although the regulations allow a transporter to request modification of
a detention order to move the food from a conveyance to a storage
facility, we will evaluate any such request on a case-by-case basis,
considering all of the factors relevant to the specific case, such as
whether the storage facility identified in the request can provide the
necessary level of security for the food.
(Comment 51) One comment states that the proposed rule does not
adequately address the case in which pet food products are detained
administratively with shipments that may contain suspect food. The
comment further states that the resulting delay could result in great
loss to firms who plan to exhibit the detained products at a trade
show.
(Response) If articles of detained food are part of a shipment
containing food that is not subject to the detention order, the
articles of food that are not subject to the detention order and can be
readily segregated, can be so segregated and moved.
(Comment 52) One comment states that the detention process itself
could increase the risk of intentional contamination of food because
food, which normally moves quickly from farm to table, would be more
vulnerable to attack when held for periods of time in storage or on a
truck. The comment expresses concern about attacks on food under
detention occurring in unguarded storerooms and garage sheds. Several
comments ask that the detention be done where the merchandise is
dispositioned to avoid the increase of the storage costs and the risk
of robbery or damage of the merchandise. Another comment asks whether
an article of food that is subject to a detention order must always be
moved to a secure location.
(Response) The purpose of administrative detention is to help
ensure that food for which the agency has credible evidence or
information that the food presents a threat of serious adverse health
consequences or death to humans or animals does not move in commerce,
and to help ensure that such food is not distributed before the agency
can initiate judicial enforcement actions against the food as
appropriate. If FDA is concerned that a detained food is vulnerable to
attack while under storage, we would order the storage to take place in
an appropriately secured facility.
Section 1.380(b) states that if FDA determines that removal to a
secure facility is appropriate, the article of food must be removed to
a secure facility. FDA will consider, on a case-by-case basis, whether
the article of food must be moved to a secure facility based on the
situation and whether a given facility can provide the appropriate
level of security.
(Comment 53) One comment addresses the potential impact of
administrative detention on farmers. The comment states that, for many
farmers, and all dairy farms, limited on-farm storage of perishable
products will lead to a complete loss of value if products are stopped
from shipment to markets or for further processing. The comment urges
FDA to be careful when prohibiting shipment of food products from farms
due to the unrecoverable costs of unmarketable product to the affected
farm or farms. The comment further states that, for certain products, a
critical market opportunity and the reputation of that farm as a
reliable supplier could be lost for many years by a disruption in their
ability to market their products.
(Response) FDA notes that the standard to detain any article of
food is very high--credible evidence or information that the food
presents a threat of serious adverse health consequences or death to
humans or animals. If FDA orders a food to be detained administratively
on a farm, and storage at the farm is limited, the farmer may, under
Sec. 1.381(d), request modification of the detention order to move the
food to an offsite facility. In evaluating the request, we will
consider, on a case-by-case basis, whether the facility identified in
the request can provide an appropriate level of security.
In addition, we reiterate that we intend to proceed as
expeditiously as possible to resolve all issues associated with
particular administrative detentions.
Removal to a secure facility, if FDA determines that such
movement is appropriate (proposed Sec. 1.380(b)).
(Comment 54) One comment states that it would be beneficial for FDA
to identify any specific security requirements for storing detained
product. This comment also states that nothing in the proposed
regulation should be interpreted as elevating a warehouse's duty of
care beyond that identified in the Uniform Commercial Code (UCC), as to
do so will jeopardize the warehouse's insurance coverage.
(Response) Under the final rule, the detention order will identify
specific storage security requirements for the detained food at issue.
Issues regarding a warehouse's duty of care are beyond the scope of
this rulemaking.
(Comment 55) One comment states that, if FDA orders the movement of
a detained article of imported food to a secure location before a
consumption entry is filed at the port of entry, the shipment would
have to be moved in-bond, creating additional work and expense to the
carrier and consumer. This comment suggests that FDA should publish,
for public comment, the conditions that would warrant detained food
articles to be transported before finalizing this rule. The comment
states that it is critical that affected persons understand what the
conditions are to ensure compliance with such conditions.
(Response) There are many situations that may arise that would
warrant the movement of detained food to secure locations. At the
present time, it is extremely difficult for FDA to anticipate and
describe all scenarios and all conditions that would warrant detained
food to be transported to a secure facility. When it is necessary for
such transportation to occur, FDA will specify the appropriate
conditions on a case-by-case basis in the detention order.
[[Page 31677]]
(Comment 56) One comment believes that FDA stated that detained
articles of food should be moved by bonded carriers to make sure that
the merchandise will be delivered to the facility that will be selected
by FDA after the merchandise is released by CBP. In this situation, the
comment asks that FDA put a high security seal (provided by the U.S.
broker ahead of time) on the trailer and release the food to the U.S.
broker or the trucking company facility. The comment states that this
would be less expensive to the importers due to the fact that bonded
carriers are expensive; demurrage charges are based on how many days it
will take an FDA inspector to release or refuse the merchandise.
Affected parties also will incur additional costs from the company that
will be receiving the trailers, swamper and forklift services.
(Response) We do not define the security requirements for carriers
or storage facilities in this rule. Instead, we will determine the
relevant level of security of the facility on a case-by-case basis.
In some cases, we might require higher security, such as that
associated with secure government storage facilities. In other cases,
we might require lower security.
We note that we do not define the term ``secure facility'' either
in this final rule or the final rule on prior notice. As we stated in
the proposed rule on administrative detention, we will determine the
relevant level of security for storage facilities on a case-by-case
basis. Although we do not define the term ``secure facility,'' we note
that the range of facilities available for storage of food that is
detained administratively is broader than the range of facilities
available for storage of food offered for import that is refused
admission for a prior notice violation. This is because food offered
for import that is refused admission for a prior notice violation is
``general order merchandise'' under title 19 of the United States Code.
(See Sec. 1.283(a)(2).) That merchandise must be stored in a bonded
warehouse authorized to accept general order merchandise if one is
available and capable of such storage. By comparison, food that is
detained administratively has not been deemed to be subject to title 19
of the United States Code's limitations on general order merchandise.
Accordingly, if the food product is imported and still subject to CBP
control, FDA and CBP may determine that a facility other than a general
order warehouse constitutes a ``secure facility'' for purposes of
administrative detention.
(Comment 57) One comment states that detained articles of food
should only be ordered moved to a secure facility in exceptional
circumstances.
(Response) FDA will not know in advance all of the circumstances
that may warrant removal to a secure facility. Each administrative
detention action will be assessed based on the facts of the particular
situation, including whether the storage facility can provide the
necessary level of security for the food.
(Comment 58) Several comments raise issues concerning the costs for
secure and nonsecure storage of detained food. One comment asks how
recipients of the detention order would be informed about the costs
charged by secure facilities for holding food. Other comments ask FDA
whether there would be a standard fee for the storage costs, and
whether FDA would ensure that the responsible party is able to afford
the storage costs.
(Response) If removal to a secure facility is appropriate, FDA will
state a specific location for storage of the food in the detention
order, as provided in Sec. 1.380(a), or in response to a request for
modification of the detention order under Sec. 1.381(c). The recipient
of the detention order may contact the storage facility to determine
the costs for storing the detained product. It is also possible that
FDA could order a detained article of food to be stored in government
storage, which may be less expensive.
(Comment 59) A few comments address the importance of adequate
facilities being available for holding detained food. One comment
states that FDA must guarantee that there will be enough facilities to
``ensure the conservation of the merchandise that is detained.''
(Response) Inasmuch as FDA will not operate the facilities that
will be used to store detained foods, we are unable to guarantee that
any particular facility will be available for use in storing detained
foods at any particular time. However, we note that detained food will
not necessarily be required to be removed to a secure facility. If
detained food is required to be removed to such a facility, then, as we
stated in the proposed rule, secure facilities are readily available
throughout the United States.
(Comment 60) One comment states that it is necessary to know who is
in charge of transporting food that is under administrative detention
and where FDA has ordered such transportation.
(Response) FDA will decide on a case-by-case basis who will be
responsible for transporting detained food. In some cases it may be
necessary for us to designate a third party to transport the food, for
example, if we believe that control of the food could be lost if the
recipient of the detention order transported it. In cases where we
believe that this risk is not present, we may direct the recipient of
the detention order to transport the food.
If FDA directs you to move the detained article of food to
a secure facility, you must receive a modification of the detention
order before you move the detained article of food. (proposed Sec.
1.380)(c))
See comments under Sec. 1.381, ``May a Detained Article of Food be
Delivered to Another Entity or Transferred to Another Location?''
You must ensure that any required tags or labels accompany
the detained article during and after movement. (proposed Sec.
1.380)(d))
See comments under Sec. 1.382, ``What Labeling or Marking
Requirements Apply to a Detained Article of Food?''
The movement of an article of food in violation of a
detention order is a prohibited act under section 301 of the FD&C Act.
(proposed Sec. 1.380(e))
(Comment 61) FDA did not receive comments on this issue.
(Response) We did not make any changes to this section.
2. Comments on May a Detained Article of Food be Delivered to Another
Entity or Transferred to Another Location? (Proposed Sec. 1.381)
(Comment 62) A few comments state that FDA should be required to
allow detained food to be delivered to the importer, owner or
consignee, subject to conditional recall, except where FDA believes
there is an immediate threat of harm. One of these comments states that
FDA could retain a bond to allow detained articles to be released for
delivery to the importer, owner, or consignee until the detention has
been terminated.
(Response) FDA disagrees with these comments because we do not have
the authority to allow the delivery of foods that have been detained
administratively to the owner's or importer's premises under bond.
Section 303 of the Bioterrorism Act specifically states that this
section may not be construed as authorizing the delivery of an article
of food that is subject to a detention order under the execution of a
bond while the article of food is subject to a detention order, and
section 801(b) of the FD&C Act does not authorize the delivery of the
article under the execution of a bond while the article is subject to
the order.
(Comment 63) A couple of comments ask if FDA will ensure fast
procedures
[[Page 31678]]
with respect to requests for the authorized movement of the detained
article of food.
(Response) FDA intends to proceed as expeditiously as possible to
resolve all issues involved with particular administrative detentions.
(Comment 64) One comment asks if the period of detention is
suspended for the amount of time that it takes to complete the request
and move the article of food under a limited conditional release.
(Response) The length of time to process a request for modification
of a detention order and to move an article of food does not affect or
extend the period of detention stated in the detention order (a maximum
of 20 or 30 calendar days, as appropriate).
(Comment 65) One comment states that, if the distributor does not
have direct control of the mode of transport, FDA's limited conditional
release should stipulate that the mode of transport must not introduce
any condition or substance that would adulterate or otherwise
deleteriously impact the quality of the detained food.
(Response) As stated previously, FDA will decide on a case-by-case
basis who will be responsible for transporting food that is detained
administratively. In some cases it may be necessary for us to designate
a third party to transport the food, if we believed that control of the
food could be lost if the recipient of the detention order transported
it. In cases where we believed that this risk is not present, we may
direct the recipient of the detention order to transport the food. FDA
does not believe that it is necessary to state in its approval of a
request for modification of a detention order that the mode of
transportation must not introduce an adulterant or otherwise
deleteriously impact the quality of the detained food. However, if the
food does become further adulterated during transport, possible
ultimate release of the food could be affected.
(Comment 66) One comment indicates that FDA's current practice is
to place routine imports of certain items on the ``Refused Entry/
Administrative Detention'' status as part of the standard protocol for
items such as raisins and avocado paste. The comment states that such a
product is then held for additional testing in the United States before
release when the product is shown to present no threat to U.S. health.
The comment encourages FDA to exhibit discretion and allow for limited
conditional release of such items and allow the product to be held in a
facility capable of maintaining and preserving the integrity and
quality of the article of food because they are low risk.
(Response) FDA believes that this comment is confusing FDA's
refusal authority under section 801(a) of the FD&C Act and our
``administrative detention'' authority under section 303 of the
Bioterrorism Act. Any current import alerts, such as those for raisins
and avocado paste, are unaffected by this final rule.
3. Comments on What Labeling or Marking Requirements Apply to a
Detained Article of Food? (Proposed Sec. 1.382)
(Comment 67) One comment recommends that, in addition to the
information on the FDA tags or labels described in Sec. 1.382(d) of
this rule, they should also include the expiration date of the
detention order and the name of the authorized FDA representative who
approved the detention order. This comment also states that if the
detention period is extended for any additional time up to the 10-
calendar day limit, the detention order and the affixed tags or labels
should be amended accordingly.
(Response) FDA disagrees with the comment to revise Sec. 1.382(d)
to add the expiration date of the detention order and the name of the
authorized FDA representative who approved the detention order to FDA's
tags or labels. The name of the person who issued the detention order
is required to be on the tag or label. In addition, FDA is revising the
final rule to include Sec. 1.393(b)(14), which requires that the
detention order include the name and title of the authorized FDA
representative who approved the detention order.
The period of detention is required on the tag or label; thus, the
expiration date of the detention can be determined from this
information. FDA agrees that, in the event that a detention is extended
from 20 to 30 calendar days, another detention order must be issued and
new tags affixed to the articles.
(Comment 68) A few comments state that applying a label or mark to
the detained product should be avoided at all cost because, if the
product is detained erroneously, the label or mark may make the food
unmarketable. A few other comments ask whether FDA will remove the
labels or marks upon termination of a detention order. One comment
strongly recommends that detained articles be marked only on the
packing cases, because any visible detention mark would make the food
unmarketable.
(Response) As FDA stated in the proposed rule, 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 detention order is terminated, FDA
will remove, or authorize the removal of, the required labels or tags,
as described in Sec. 1.384. Accordingly, we would not expect the
labeling and marking provision to impair the marketability of an
article of food for which the detention order is terminated.
F. Comments on What Expedited Procedures Apply When FDA Initiates a
Seizure Action Against a Detained Perishable Food? (Proposed Sec.
1.383)
(Comment 69) FDA requested comments on this or other procedures
that would address concerns about expedited enforcement actions with
respect to perishable food. One comment states that the provision for
expedited procedures to initiate a seizure action against a detained
perishable food is unfair because the claimant would be robbed of any
right to appeal a detention order in certain circumstances. The comment
states that if the detention order is issued on a Wednesday, the
claimant would be required to file its appeal by Friday. However,
according to this comment, the FDA also is obligated to ``file'' its
seizure action with the DOJ on that same day (Friday) because the
actual 4th calendar day after detention is Sunday, when the Court is
not in session. The comment argues that the claimant would not have a
chance to appeal since the right to appeal is terminated when a seizure
action is initiated.
(Response) FDA disagrees with this comment. The Bioterrorism Act
requires FDA to provide by regulation, expedited procedures for
instituting certain judicial enforcement actions involving perishable
foods that are detained under section 303 of the Bioterrorism Act. The
purpose of this statutory requirement is to ensure that FDA decides on
an expedited basis whether to pursue Federal court seizure of detained
perishable food, and that the owners of such perishable food have
timely information about how the government plans to proceed with
respect to their detained food.
The final rule is consistent with the Bioterrorism Act's directive.
The comment appears to misunderstand the mechanics of the regulation's
procedures. FDA's process of sending a
[[Page 31679]]
seizure recommendation to DOJ is not contemporaneous with the filing of
that action in federal court. FDA anticipates that, if we send a
seizure recommendation in these circumstances, the seizure will be
filed, the court will issue a warrant, and the U.S. Marshal will seize
the food, soon after the recommendation is sent to the DOJ. FDA lacks
authority to mandate the timing of these actions. As a result, the
filing and execution of the seizure may not occur on the same calendar
day that the recommendation is sent to DOJ.
Moreover, the Bioterrorism Act provides that an appeal of an
administrative detention is terminated once an enforcement action
involving the detained food is instituted in Federal court, that is,
when the court has issued a warrant, and the U.S. Marshal has seized
the food. The regulation is consistent with this statutory provision.
Until the seizure action is filed in Federal court, the appeal process
will continue. Owners of detained food can increase their chances of
having their views heard in the administrative forum of the appeal
process by submitting an appeal immediately after the food is detained.
Once a seizure action has been filed in Federal court, and the food has
been seized, however, any challenge to the administrative detention
would be moot, as the food would be under seizure under Federal
district court rules. The owner of the food, or another party with
sufficient interest in the food, can then contest the seizure action in
Federal court. There, it can challenge the government's position that
the food is adulterated or misbranded and is subject to seizure,
condemnation, and forfeiture under section 304(a) of the FD&C Act. A
claimant in a seizure action has the same opportunity to be heard in
Federal court as the government. Although the forum may change from an
administrative hearing before an FDA presiding officer to a judicial
proceeding before a Federal court judge, the claimant nonetheless has
the right to challenge FDA's determination that the food should be
removed from commerce.
G. Comments on When Does a Detention Order Terminate? (Proposed Sec.
1.384)
(Comment 70) One comment asks how a detention order can expire if
confirmation of a detention order is considered final agency action.
(Response) Confirmation of a detention order by the presiding
officer at a hearing on an appeal of a detention order is considered
final agency action for purposes of the judicial review provisions of
the Administrative Procedure Act (5 U.S.C. 702). Even if the order is
confirmed, it expires on the 21st calendar day (or 31st calendar day if
the detention has been extended) following the issuance of the
detention order.
(Comment 71) One comment suggests that FDA amend Sec. 1.379(c) to
state that, in accordance with Sec. 1.384, information regarding the
termination of a detention shall be provided to the company in writing
within calendar day of the decision by FDA that the order shall be
terminated.
(Response) FDA expects that we would normally be able to issue the
detention termination notice to the person who received the detention
order (e.g., the owner, operator or agent in charge of the place where
the food is located and the owner of the food, if known) within 1
calendar day of the decision to terminate a detention, unless
extenuating circumstances exist. However, we are not revising the rule
to incorporate such a deadline because in some instances it may not be
possible to inform the company in writing within 1 calendar day due to
unforeseen circumstances beyond the agency's control.
H. Comments on How Does FDA Order a Detention?
1. Comments on Who Approves a Detention Order? (Proposed Sec. 1.391)
(Comment 72) One comment recommends the establishment of a national
detention approval board to ensure a uniform application of the
regulation and to avoid costly errors and delays. A few comments state
that the detention order must be approved at the Regional Food and Drug
Director level or higher because the judgment of credible threats is
case-by-case and the District Director level provides too much
discretion.
(Response) FDA disagrees with these comments. Congress included
language in the Bioterrorism Act that specifies who is authorized to
approve a detention order, i.e., the Secretary or an official
designated by the Secretary (who may not be so designated unless the
official is the director of the district in which the article involved
is located, or is an official senior to such director). FDA believes
that the Bioterrorism Act does not contemplate any sort of a national
detention approval board. To the contrary, the statute makes clear that
Congress expected that FDA District Directors, or officers senior to
such directors, could and would exercise this authority.
(Comment 73) One comment states that the approval of a detention
order should always be written to avoid misunderstandings.
(Response) Written approval of a detention order is required under
Sec. 1.391. This Sec. 1.391 states that prior written approval must
be obtained, or if prior written approval is not feasible, prior oral
approval must be obtained and confirmed in writing as soon as possible.
Thus, written approval always will be obtained.
2. Who Receives a Copy of the Detention Order? (Proposed Sec. 1.392)
(Comment 74) Many comments state that it is imperative that FDA
provide a copy of the detention order to the owner of the article of
food that has been detained to ensure that such owner has all of the
necessary information to address any potential corrective action or to
determine if an appeal should be filed. These comments suggest that the
recordkeeping and facility registration provisions of the Bioterrorism
Act should permit identification of the owner of the food.
(Response) As provided in Sec. 1.392, FDA will provide the
detention order to the owner or agent in charge of the place where the
detained article of food is located and the owner of the food, if the
owner's identity can be determined readily. Examples of steps FDA will
take to determine the identity of the owner of a detained article of
food include examining any readily available bills of lading or
invoices for the article of food and asking the owner, operator, or
agent in charge of the place where the detained article of food is
located for any information he or she may have regarding the identity
of the owner of the article of food.
As the comment suggests, section 305 of the Bioterrorism Act
requires facilities that manufacture, process, pack, or hold food for
human or animal consumption in the United States to register with FDA
by December 12, 2003 (68 FR 58893); however, this registration
information does not always identify the owner of a particular article
of food. The registration documents contain information such as the
name of the facility that manufactured/processed the food (which may or
may not be the current owner of the food), the type of establishment
and what product(s) the facility manufactures/processes. Therefore, the
fact that FDA has a registration from a manufacturer, processor,
packer, or holder of an article of food does not necessarily facilitate
contacting the owner of an article of food that has been detained. Nor
is information identifying the owner of the food necessarily readily
available from the records that are required to be
[[Page 31680]]
maintained under section 306 of the Bioterrorism Act.
(Comment 75) One comment asks whether the agent in charge of the
place where the article of food is located is the same U.S. agent who
is responsible for registration and prior notice under the Bioterrorism
Act.
(Response) Use of the term ``agent in charge'' in this final rule
simply means the person who is in charge of the place where an article
of food is located at the time of a detention. The registration interim
final rule (68 FR 58893), issued under section 305 of the Bioterrorism
Act, requires that all foreign facilities required to register have a
U.S. agent. The U.S. agent must be a person residing or maintaining a
place of business in the United States, whom the owner, operator, or
agent in charge of a foreign facility designates as its U.S. agent for
purposes of registration. Thus, depending on where and when an article
of food is detained, the U.S. agent may or may not be the same person
as the agent in charge of the place where an article of food is located
at the time of a detention. The prior notice interim final rule (68 FR
58974) does not require a U.S. agent.
(Comment 76) Several comments state that the exporting country of
an article of food that has been detained must receive information
concerning the detention so that it may take appropriate action. These
comments suggest that FDA should contact the embassy of the country or
the competent authority of the country. A few comments state that
various parties should be informed of the administrative detention of
imported articles of food (e.g., the exporter, agent or importer, and
the customhouse broker). A few other comments state that FDA should be
able to notify the recipients of products subject to the detention
order at multiple locations by accessing records maintained under the
recordkeeping section of the Bioterrorism Act.
(Response) FDA disagrees with these comments in part. FDA will
issue the detention order to the owner or agent in charge of the
facility where the food is located and, as stated previously, the owner
of the food, if their identity is readily available. However, FDA does
not currently plan to routinely publicize the issuance of detention
orders. The parties who receive the detention order may choose to
inform any additional interested parties regarding the detention. In
the event of a public health emergency, FDA may issue a Talk Paper or
Press Release with information regarding an article of food that
presents a threat of serious adverse health consequences or death to
humans or animals. In such an emergency, FDA also may inform other
departments, agencies or governments to ensure public health
protection, as deemed appropriate based on the circumstances of each
case.
Although it may be possible to identify other interested parties by
accessing records maintained under the recordkeeping provisions, we do
not believe that it is appropriate for FDA to be obligated to notify
all of the various parties requested by the comments. Interested
parties may request information regarding administrative detentions
under an FOIA request. Such information may be released after FDA has
removed any information that is protected from disclosure to the
public.
(Comment 77) One comment suggests that FDA should publish
information concerning administrative detentions in the Import Refusal
Report. A few other comments state that information concerning
administrative detentions should be considered confidential and only
disclosed to the owner of the products and the exporting country when
there is a proven threat of serious adverse health consequences or
death to humans or animals. These comments suggest that such disclosure
should be through a rapid alert system. Some comments suggest that we
devise and test a method of communicating essential information to key
industry officials in the United States in the event of a food security
event.
(Response) As we stated previously, FDA will issue the detention
order to the owner, operator, or agent in charge of the facility where
the detained article of food is located, and as stated previously, the
owner of the food if its identity is readily available. At this time,
we have no plans to routinely publicize the issuance of detention
orders, e.g., in Import Refusal Reports or the European Union's Rapid
Alert System. This is consistent with the practice FDA uses for medical
device detentions, which are not routinely publicized in the manner
suggested by these comments.
However, FDA agrees that there may be information related to
administrative detention of food that is confidential or classified. A
number of statutes, regulations, and policies address protection of
these kinds of information from unauthorized disclosure.
We believe the request for FDA to devise and test a method of
communicating essential information to key industry officials in the
United States in the event of a food security event is intended to
include activities beyond administrative detention. Consequently, this
discussion is outside the scope of this rulemaking.
(Comment 78) One comment states that procedural safeguards should
be put in place to protect both manufacturers and their customers
during what is essentially a seizure-type action. This comment
recommends that FDA revise the regulation to ensure that, similar to
FDA's seizure authority under the FD&C Act and relevant court rules,
notice of detention be accompanied by personal service upon the
responsible party at individual locations.
(Response) FDA believes that the regulation in its present form
adequately protects the interests of potential claimants. We note that
administrative detention is not the equivalent of a seizure action, but
is instead an administrative action that may precede a seizure action
in Federal Court. If we were to institute a seizure after an
administrative detention, the government would provide notice of that
action in accordance with the Federal Rules of Civil Procedure and
applicable local rules, which vary as to their requirements for
personal service.
3. Comments on What Information Must FDA Include in the Detention
Order? (Proposed Sec. 1.393)
(Comment 79) A couple of comments state that the detention order
should include a copy of the written approval granted by the authorized
FDA representative. These comments state that the approval should
include the information upon which the administrative detention was
based, what actions will be taken with the product, and the expected
time period for which the product will be held. A few other comments
state that the detention order should include information such as
grower codes, lot codes and other identifiers. A few comments believe
it would be valuable for the appeal procedures and applicable deadlines
to be explained in the detention order. One comment suggests that the
detention order should include provisions regarding the appropriate
storage and transportation conditions, such as refrigerated foods kept
under 40 degrees Fahrenheit (F) and frozen foods kept under -4 degree F
to meet the regulatory requirements and common industry practices and
satisfy their customer expectations.
(Response) FDA agrees in part with these comments. Section
1.393(b)(6) requires that the detention order include a brief, general
statement of the reason for the detention. Section 1.393(b)(4) requires
that the detention order include the period of the detention. Section
1.393(b)(3) requires that the detention
[[Page 31681]]
order include information about the identification of the detained
article of food. Identifying codes, such as lot numbers, may be
included in the description of the detained article of food provided on
the detention order. However, most food products are not required to
bear a manufacturer's code; thus, this information may not be
available. FDA notes that section 303 of the Bioterrorism Act provides
that FDA may detain food for up to 30 calendar days to enable FDA to
institute a seizure or an injunction action. Section 1.393(b)(10)
requires that the detention order include the text of section 304(h) of
the FD&C Act (section 303 of the Bioterrorism Act), as well as
Sec. Sec. 1.401 and 1.402, which describe the administrative detention
authority, who may submit an appeal, and the requirements for
submitting an appeal, respectively.
Section 1.393(b)(7) requires that the detention order include a
description of the appropriate storage conditions, and Sec.
1.393(b)(8) requires a description of any applicable conditions of
transportation. As we stated earlier, FDA will determine the conditions
under which detained food must be held on a case-by-case basis, based
upon the totality of information available to us about the article of
food. The record evidencing written approval and the detention order
would be released to a requester under an FOIA request after FDA
removes any information that is protected from disclosure to the
public.
(Comment 80) Another comment states that the detention order should
include the type of analysis, procedures for analysis, and the criteria
used to determine if the product is adulterated. This comment further
states that it is not clear who will do the sampling, who will pay for
this process, and whether there will be a guarantee that the food has
not been contaminated.
(Response) FDA disagrees with this comment because the nature of
bioterrorist attacks or other food emergencies makes it difficult to
predict whether sampling and analysis will be necessary, or the types
of analyses that will be needed. If an analysis is done, FDA may
disclose the type of analysis or the analytical procedure during an
informal hearing. FDA routinely uses approved and validated methods.
For information related to FDA's laboratory, laboratory procedures, new
techniques and useful analytical findings in support of FDA regulatory
activities. (See http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/science_ref/default.htm.) In
most situations, FDA will do the sampling and offer to pay for the
sample. FDA will do the sample analyses. However, the agency cannot
guarantee that a particular article of food has not been contaminated,
even if there are negative analytical findings of samples of the
article. Given the nature of bioterrorist acts, the varied possible
scenarios for contamination of food, and the various possible
contaminants that may be used, we do not believe that it is possible
for anyone to absolutely guarantee that a particular article of food
has not been contaminated.
I. Comments on What Is the Appeal Process for a Detention Order?
1. Comments on Who is Entitled To Appeal? (Proposed Sec. 1.401)
(Comment 81) One comment asks whether someone who does not have a
proprietary interest in the detained object, but has a commercial
interest (e.g., the importer, U.S. agent (as defined in the
registration interim final rule), or shipper), can appeal a detention
order. Another comment asks whether someone designated by the owner,
such as a lawyer or food technologist, can appeal a detention order.
One comment indicates that the rule should state whether the person who
appeals the detention has to have certain characteristics and reside in
the United States.
(Response) We do not know what is meant by ``certain
characteristics,'' but a person entitled to appeal a detention order
need not be a resident of the United States. With respect to whether a
proprietary interest is required, section 304(h)(4) of the FD&C Act
states in part that ``any person who would be entitled to be a claimant
for such article if the article were seized under section (a) may
appeal the order.'' Thus, if a person were entitled to be a claimant in
a seizure action, that person would also be entitled to be a claimant
in an appeal from a detention order. To be a claimant in a seizure
action, a person must have an interest in the seized goods sufficient
to confer standing under both Article III of the U.S. Constitution, and
Supplemental Rule C(6) of the ``Federal Rules of Civil Procedure''
(available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.uscourts.gov/rules). The local rules of the
Federal Court district in which a seizure or administrative detention
occurs set forth the procedures by which a party establishes
entitlement to be a claimant. 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) 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. A determination of
whether a party has a sufficient interest in the food is made on a
case-by-case basis. As such, it is outside the scope of this
rulemaking.
2. Comments on What Are the Requirements for Submitting an Appeal?
(Proposed Sec. 1.402)
(Comment 82) FDA sought comments 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). One comment states that for
appeals, and any other sections of the regulations that incorporate
specific timeframes, the timeframes should be ruled by ``international
timetables.''
(Response) FDA's understanding is that the comment is asking FDA to
take international time zones into consideration when counting calendar
days to meet the various timeframe deadlines described in this final
rule. FDA disagrees with this comment. It is not feasible for FDA to
make exceptions on how we count calendar days based on the time zone
where the owner of the goods is located. The total elapsed time from
the time the detention order is issued throughout the detention process
will be the same regardless of the time zone in which the detention
order was issued. Under the final rule, the ``start'' and ``end'' times
of a detention order, and all deadlines within that period, will be
measured by the time zone in which the detention order was issued.
(Comment 83) One comment says that FDA stated that the request for
appeal by the industry could be verbal, and FDA will respond by mail or
letter, but it is not clear how quickly FDA is going to answer the
request. Another comment asks whether the 5 days from the date of
appeal that FDA has to issue a decision on an appeal are natural or
working days.
(Response) FDA believes that this comment misunderstood the
requirements in Sec. 1.402(a). Section 1.402(a) of this rule requires
all appeals to be submitted in writing. The written appeal can be
delivered to the FDA District Director in person, by mail, e-mail, or
fax. As stated previously, the Bioterrorism Act requires FDA to issue a
decision on an appeal within 5 calendar days after the date of appeal.
Therefore, FDA will issue a decision within the 5-calendar day
statutory deadline. However, as FDA states earlier in this rule, FDA is
committed to acting
[[Page 31682]]
as expeditiously as possible when we detain an article of food,
especially in the case of an article of perishable food. Section 1.405
requires FDA to issue a decision on appeal within 5 calendar days from
the date of appeal. Section 1.377 of the rule defines ``calendar day''
to mean every day shown on the calendar, which includes holidays and
weekends.
(Comment 84) One comment states that Congress's directive that FDA
issue procedures to expedite detention of perishable food appears at
section 304(h)(2) of the FD&C Act as added by section 303(a) of the
Bioterrorism Act, which is a provision relating to the ``period of
detention.'' The comment asserts that FDA's proposal to implement this
directive, however, relates only to appeals of detention orders, a
subject addressed at section 304(h)(4) of the FD&C Act. In the
comment's opinion, Congress's decision to place its mandate for the
expediting of administrative detention procedures for perishable foods
in the section entitled ``period of detention,'' rather than in the
section entitled ``appeal of detention order,'' indicates its intent
that FDA take direct action to accelerate the pace with which
erroneously detained perishable food may be released, not merely the
pace at which an informal hearing may be convened. The comment states
that Congress required issuance of the expedited procedures to
safeguard a claimant's rights with respect to perishable food, and
FDA's proposal to restrict the rights of prospective claimants to
appeal detention of such food is inconsistent with that objective.
Another comment is concerned that the appeals procedure may cause undue
delay in the detention process.
(Response) FDA disagrees with these comments. Section 303(a)(2) of
the Bioterrorism Act requires the Secretary to provide procedures for
instituting certain judicial enforcement actions under the FD&C Act on
an expedited basis with respect to perishable foods. FDA provides for
expedited procedures for initiating seizure actions in Sec. 1.383 by
requiring FDA to submit a seizure recommendation for a detained
perishable food to DOJ within 4 calendar days after FDA issues the
detention order, unless extenuating circumstances exist. Although a
claimant may opt not to appeal the detention order, FDA is required to
offer the opportunity to appeal under section 304(h)(4) of the FD&C
Act.
The appeal and hearing procedures assist the process of appealing a
detention order. Section 304(h)(4) of the FD&C Act requires FDA to
confirm or terminate any detention order within 5 calendar days after
an appeal is filed. However, if a claimant files an appeal sooner
rather than later in the time period for filing appeals, a decision to
terminate a detention order could occur before the 5-calendar day
statutory deadline is reached.
(Comment 85) One comment suggests that FDA should provide for an
``automatic appeal'' on the second day after an administrative
detention order is issued, with a decision on the appeal to be made
within 24 hours of the hearing. Another comment requests that the
appeal process for chilled, live shellfish that have a commercial shelf
life of 48 hours following harvest, be measured in hours, with all
attempts to release suitable consignments within 24 hours.
(Response) FDA disagrees with these comments and maintains the same
timeframe for perishable food as we proposed. A more rapid procedure is
not practicable. Furthermore, even a more rapid procedure would result
in reductions in the shelf life of highly perishable food products,
such as fresh seafood, possibly requiring such products to be
reconditioned and sold as something other than ``fresh seafood.'' We do
plan to work with claimants to preserve the article of food when
possible; a request for modification of a detention order, for
instance, may be used to move a detained article of food from
refrigerated storage to a freezer. As we stated earlier, we are
committed to acting as expeditiously as possible when we detain an
article of food.
(Comment 86) A few comments ask that FDA treat all foods in the
same manner as perishable foods for appeal purposes. Another comment
indicates that a ``reasonable period'' of 20 calendar days, which could
be extended to 30 calendar days, means in practical terms that all
perishable foods/drinks, including those ``commercially'' perishable,
are no longer suitable for sale. The comment states that this means
that, if a ``fast-track'' appeal for perishable food does not allow a
quicker release of detained food when it is found to be safe, the value
of such an appeal is questionable.
(Response) FDA disagrees with these comments and is maintaining the
same timeframes for appeal as we proposed. The Bioterrorism Act allows
FDA to institute a detention for a reasonable period, not to exceed 20
calendar days, unless a greater period, not to exceed 30 calendar days,
is necessary to enable the Secretary to institute a seizure or
injunction action. As stated earlier, the Bioterrorism Act also
requires FDA to provide an opportunity to file an appeal of the
detention order and to confirm or terminate the detention order within
5 calendar days after an appeal is filed. If a claimant files for an
appeal sooner rather than later in the time period for filing appeals,
a decision to terminate a detention could occur before the 5-day
statutory deadline for rendering a decision on appeal. The Bioterrorism
Act also requires FDA to confirm or terminate a detention order within
5 calendar days after an appeal is filed, whether the food is a
perishable commodity or not. Thus, the claimant of a nonperishable
food, including one that is seasonal in nature could file an appeal
within the first 2 calendar days after receipt of the detention order
rather than later in the 10 calendar days allowed under the procedures
for a nonperishable food, and obtain a decision as soon as than would
occur under the ``fast-track'' appeal process for perishables.
(Comment 87) One comment states that FDA should establish that, in
cases where the detention order is given to someone who is not
authorized to appeal it, the time table for submitting the appeal
should not begin until a person who has the right to appeal has been
notified.
(Response) FDA disagrees with this comment. As described in Sec.
1.392(a) of the final rule, FDA will provide a copy of the detention
order to the owner or agent in charge of the place where the detained
articles of food are located. Under Sec. 1.392(a) of this rule, FDA
also will provide a copy of the detention order to the owner of the
food if their identities can be readily determined. Under Sec.
1.392(b) of this rule, 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 also will 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. Examples of steps FDA will take to determine the identity of
the owner of a detained article of food include examining any readily
available bills of lading or invoices for the article of food and
asking the owner, operator, or agent in charge of the place where the
detained article of food is located for any information he or she may
have regarding the identity of the owner of the article of food. There
may be times when FDA cannot determine who would be entitled to be a
claimant of the article. The purpose of administrative detention is to
hold in place, and protect against any movement that could lead to
further distribution of, the
[[Page 31683]]
food that poses the threat of serious adverse health consequences or
death to humans or animals. Consequently, the action is against the
articles, not the owner of the articles. We believe that it is likely
that any responsible firm who has had product detained on their
premises will notify the rightful owner. In addition, it is an owner's
responsibility to know the whereabouts of its food product, and to be
familiar with the chain of custody related to that food.
3. Comments on What Requirements Apply to an Informal Hearing?
(Proposed Sec. 1.403)
(Comment 88) Several comments argue that FDA should not have
discretion to deny a request for an informal hearing; the comments
argue that our interpretation is inconsistent with the Bioterrorism
Act's plain meaning and legislative history, and violates due process
under the Fifth Amendment. A few comments indicate that FDA must
determine and specify the criteria used to concede or deny a hearing.
(Response) FDA disagrees with these comments because the
Bioterrorism Act requires only that FDA ``provid[e] opportunity for an
informal hearing''; the statutory language does not require FDA to
conduct an informal hearing for every claimant who appeals a detention
order. Our interpretation of this section of the Bioterrorism Act is
consistent with our long-standing interpretation of similar statutory
language in section 304(g) of the FD&C Act (21 U.S.C. 334(g)), which
governs medical device detentions. FDA has authority to deny a hearing
when the appeal raises no genuine and substantial issue of fact. (See
Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 620-621
(1973).)
The final rule also is consistent with our regulation at Sec.
16.26(a), which states that we do not have to grant all requests for
hearings:
A request for a hearing may be denied, in whole or in part, if
the Commissioner or the FDA official to whom the authority to make
the final decision on the matter has been delegated under part 5
determines that no genuine and substantial issue of fact has been
raised by the material submitted. If the Commissioner or his or her
delegate determines that a hearing is not justified, written notice
of the determination will be given to the parties explaining the
reason for denial.
(Comment 89) FDA sought comments on the timeframes for holding the
informal hearing. One comment states that the hearing should be held
within 2 calendar days from appeal. Another comment asks that FDA
shorten the period for holding a hearing in appeals for perishable food
to 3 calendar days. One other comment states that, because the timing
of the hearing has no direct impact on the rendering of the agency's
confirmation or termination of the detention order, FDA's proposal
would have no inherent effect on expediting the release of erroneously
detained perishable food. Another comment believes that the FDA has
wisely decided upon an expedited hearing process for perishable foods
that are detained administratively, but states that the proposed
process is not fast enough. The comment notes that, as stated in the
proposed regulation, an appeal and request for a hearing must be filed
within 2 calendar days of receipt of a detention order. If FDA grants
the request, the hearing will be within 2 calendar days after the date
the appeal is filed. FDA's decision on the appeal must be issued within
5 calendar days of the date of the appeal filing. The comment states
that this proposed procedure will still take up to 7 calendar days, and
for highly perishable fresh seafood products, this would leave only 2
to 3 calendar days of acceptable shelf life remaining. Practically,
these remaining days would be used in distribution so that a shipment
of perishable food (e.g., fresh seafood), in most cases, would be a
total loss. One comment asks that FDA extend the time limit so that
exporting countries will have enough time to prepare documents. Another
comment states that, because the presiding officer may be an RFDD from
another region or another official senior to the district director, the
transit time from one region to the other must be factored into the
established hearing deadlines.
(Response) FDA acknowledges that the timeframes for holding a
hearing are relatively short. Because the Bioterrorism Act requires FDA
to issue a decision on an appeal within 5 days after the appeal is
filed, FDA had to establish quick timeframes for holding the hearing to
ensure that we adhere to the statutory requirement. Short timeframes
also should help to minimize the impact on an article of food that is
detained, but is subsequently released from detention. FDA did not
receive any comments that suggested alternate procedures that would
both allow for a hearing and for compliance with the statutory
requirement for the agency to issue a decision on an appeal within 5
days after the appeal is filed. Therefore, FDA is maintaining the
timeframes we proposed.
If FDA grants a hearing, the timeframes will adhere to Sec.
1.402(d) of the rule, which requires FDA to hold a hearing for food
that has been detained within 2 calendar days after the date the appeal
is filed. A claimant can control the time by which the hearing has to
take place and the time by which FDA has to issue a decision if the
claimant appeals the detention order sooner rather than later, i.e.,
this final rule specifies the maximum timeframes claimants have to file
an appeal. Claimants certainly can file earlier.
4. Comments on Who Serves as the Presiding Officer at an Informal
Hearing? (Proposed Sec. 1.404)
(Comment 90) Many comments recommend that the individual presiding
over an appeal hearing must be senior to the individual who approved
the detention order. Another comment suggests that the informal hearing
on an appeal of a detention order also should allow third-party
participants or attendees, not just participation by an FDA Regional
Food and Drug Director or another FDA official senior to an FDA
District Director.
(Response) FDA disagrees with the comment that the individual
presiding over an appeal hearing must be senior to the individual who
approved the detention order. FDA's regulation on presiding officers,
Sec. 16.42, ensures that the officer presiding over an appeal hearing
is free from bias or prejudice.
Under Sec. Sec. 16.42(c)(2) and 1.404, an FDA Regional Food and
Drug Director, or another FDA official senior to an FDA District
Director, may preside over an appeal hearing as long as that person has
not participated in the investigation or action that is the subject of
the hearing, or is subordinate to a person, other than the Commissioner
of Food and Drugs (the Commissioner), who has participated in such
investigation or action.
With respect to the suggestion that the hearing should allow
participation or attendance by third parties, Sec. 16.60 states that
``a regulatory hearing is public, except when the Commissioner
determines that all or part of a hearing should be closed to prevent a
clearly unwarranted invasion of personal privacy; to prevent the
disclosure of a trade secret or confidential commercial or financial
information * * *.'' FDA also notes that, if the hearing involves the
discussion of classified information, we only would allow participation
by parties, both within and outside FDA, by persons with the
appropriate security clearance.
[[Page 31684]]
5. Comments on When Does FDA Have To Issue a Decision on an Appeal?
(Proposed Sec. 1.405)
(Comment 91) Several comments recommend that FDA's decision on
appeal should be sooner than within 5 calendar days after the appeal is
filed, e.g., within 2 calendar days or 3 calendar days after the appeal
is filed. Many comments recommend that FDA's decision on appeal should
be made within 2 calendar days after the hearing for detained
perishable and nonperishable foods. Another comment asks whether FDA
can realistically accommodate administrative detention appeals in a
timely manner. These comments state that, when identifying the
detention and appellate timeframes, the agency must consider the
logistical requirements (placing shipping orders, transportation and
other distribution requirements) in evaluating the potential shelf life
and value of the food product.
(Response) Under section 303 of the Bioterrorism Act, FDA must
confirm or terminate a detention order within 5 calendar days after an
appeal is filed. Because each detention and appeal will be assessed
based on the facts of the particular situation, FDA can not know in
advance what work will have to be accomplished or what information will
have to be considered to make our decision to confirm or terminate a
detention order following an appeal. Therefore, it is not appropriate
to limit the authority and flexibility that Congress provided in the
Bioterrorism Act by reducing the number of calendar days the agency has
to confirm or terminate a detention order following an appeal. FDA
notes that these are maximum timeframes for rendering a decision. As
stated previously, FDA intends to act as expeditiously as possible.
Thus, FDA may render decisions on appeal sooner than 5 calendar days if
we are able to do so.
(Comment 92) One comment acknowledges that confirmation of a
detention order by the presiding officer is to be considered a final
agency action for purposes of the Administrative Procedure Act (5
U.S.C. 702) and asks if it is possible to further appeal a decision on
the detention.
(Response) After the presiding officer confirms the detention
order, no provisions for further review or appeal within the agency or
HHS apply. A claimant's further recourse would be to initiate
proceedings in Federal court.
In the proposed rule, Sec. 1.402(d), which governs the
requirements for submitting an appeal, referenced the definition of an
informal hearing in section 201(x) of the FD&C Act. Section 201(x)(5)
of the FD&C Act requires the presiding officer to prepare a written
report of the hearing, and states that the participants in the hearing
shall be given the opportunity to review and correct or supplement the
presiding officer's report. FDA is revising Sec. Sec. 1.403 and 1.405
to provide this opportunity for the hearing participant to review and
request changes to the conclusions of the presiding officer, as
reflected in his or her proposed decision. FDA is revising Sec.
1.403(h) to clarify that Sec. 16.60(e) and (f) does not apply to an
informal hearing on an administrative detention. Revised Sec. Sec.
1.403(h) and 1.405(a) provide that the presiding officer must issue a
written report of the hearing, including a proposed decision with a
statement of reasons. This section also provides for a 4-hour
opportunity during which the hearing participant may review and comment
on the written report. Under Sec. 1.403(h), the presiding officer will
then issue the final agency decision.
FDA is also revising Sec. 1.403, which governs the requirements
that apply to an informal hearing, by adding new paragraph (j) to make
clear that Sec. 16.119 does not apply to an informal hearing on an
administrative detention. Section 16.119 states that, after any final
administrative action that is the subject of a hearing under part 16,
any party may petition the Commissioner for reconsideration or a stay
of the decision or action.
FDA is revising Sec. 1.403 to clarify that Sec. 16.80(a)(4) does
not apply to an informal hearing on administrative detention. Revised
Sec. 1.403(i) states that the presiding officer's report of the
hearing and any comments on the report by the hearing participant under
Sec. 1.403(h) are part of the administrative record.
FDA is also revising Sec. 1.403 to clarify that Sec. 16.95(b)
does not apply to an informal hearing on an administrative detention.
New Sec. 1.403(k) states that the administrative record of an informal
hearing on an administrative detention as specified in Sec. Sec.
16.80(a)(1), (a)(2), (a)(3), (a)(5), and 1.403(i) constitutes the
exclusive record for the presiding officer's final decision on an
administrative detention. In addition, Sec. 1.403(k) states that, for
purposes of judicial review under Sec. 10.45, the record of the
administrative proceeding consists of the record of the hearing and the
presiding officer's final decision.
(Comment 93) One comment argued that the proposed expedited
procedures for perishable foods do not accomplish what Congress
intended in the Bioterrorism Act, i.e., implementing regulations
mandated by the Bioterrorism Act are supposed to achieve accelerated
termination of detention orders and release of the detained perishable
food when the agency finds there to be a lack of credible evidence or
information that the detained article presents a threat of serious
adverse consequences or death to humans or animals. The comment further
explains that our proposed procedure would do nothing to expedite
release of such food. The comment further states that, in some cases,
the proposed procedure would allow FDA 3 calendar days after an
informal hearing to render its decision with respect to perishable
food, but only 2 calendar days with respect to nonperishable food (the
example in the comment uses an appeal date of 2 calendar days after
receipt of the detention order for both a perishable and nonperishable
food).
(Response) FDA disagrees with this comment because it appears to
confuse the expedited procedures mandated by the Bioterrorism Act for
initiating certain enforcement actions against detained perishable food
with the process for appealing a detention order. The Bioterrorism Act
requires the Secretary to provide procedures for instituting certain
judicial enforcement actions under the FD&C Act on an expedited basis
with respect to perishable foods. Section 1.383 provides for expedited
procedures for initiating seizure actions by requiring FDA to submit a
seizure recommendation against a detained perishable food to DOJ within
4 calendar days after the detention order is issued, unless extenuating
circumstances exist.
The appeal and hearing procedures assist the process of appealing a
detention order. The Bioterrorism Act requires FDA to confirm or
terminate any detention order within 5 days after an appeal is filed.
However, if a claimant files for an appeal sooner rather than later in
the time period for filing appeals, a decision on a detention order
could occur before we are statutorily required to render that decision.
FDA notes that the comment is correct in that there is one
situation where FDA would have more time to consider whether to confirm
or terminate a detention order for perishable food than for
nonperishable food and that would be if the appeals for both a
perishable food and a nonperishable food were filed on the same
calendar day and the hearings were held on the second and third
calendar days following the appeals, respectively. The only way to
eliminate this situation while still allowing FDA up to 5 calendar days
to
[[Page 31685]]
render a decision on appeal is to revise the timeframe within which FDA
would hold a hearing, if granted, to 2 calendar days after the date the
appeal is filed for both perishable and nonperishable food. FDA is,
therefore, revising Sec. 1.402(d)(1) and (d)(2) to state that if a
hearing is granted, it will be held within 2 calendar days after the
date the appeal is filed for both perishable and nonperishable food. As
we stated previously, FDA intends to proceed as expeditiously as
possible to resolve all issues involved with administrative detentions.
6. Comments on How Will FDA Handle Classified Information in an
Informal Hearing? (Proposed Sec. 1.406)
(Comment 94) Many comments are concerned that this provision may
lead to withholding information that a company would find necessary to
prepare its defense against a detention order, including sampling and
testing of the product to determine whether the article of food
presents a threat of serious adverse health consequences or death to
humans or animals. These comments also are concerned that this
provision would restrict a company's ability to appeal or prepare for a
hearing on the detention order. The comments ask that FDA provide,
whenever possible, the specific reason why the agency believes the
article of food presents a threat of serious adverse health
consequences or death to humans or animals, i.e., the product may be
contaminated with agent X.
(Response) FDA is finalizing this provision as proposed. Under
existing law, there is no accommodation or exception for disclosing
classified information to individuals without the proper security
clearance. However, we will provide as much information as we can
without compromising the classified nature of the information. FDA
notes that private companies can choose to obtain private facility
security clearances through the Defense Industrial Security Clearance
Office (DISCO) within the Defense Security Service (DSS), which is an
agency within the Department of Defense.
FDA indicated in the proposed rule that the agency may develop
general regulations for handling classified information on an agency-
wide basis. After further review, however, we have decided that such
regulations are unnecessary. The handling of classified information is
a standardized process across the Federal Government and is governed by
Executive Order 12958. Executive Order 12958 was last amended in March
of 2003 (68 FR 15313, March 28, 2003).
IV. Conforming Amendment to Part 10
We are amending Sec. 10.45(d) because under the administrative
detention procedures, it is the final decision of the presiding
officer, and not the Commissioner, that constitutes final agency
action.
V. Conforming Amendment to Part 16
We are amending Sec. 16.1(b)(1) to include section 304(h) of the
FD&C 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.
VI. Analysis of Economic Impacts
A. Final Regulatory Impact Analysis
We have examined the economic implications of this final rule as
required by Executive Order 12866. Executive Order 12866 directs us 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 regulatory action 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 or more, adversely affecting a sector of the economy in
a material way, adversely affecting competition, or adversely affecting
jobs. Executive Order 12866 also classifies a regulatory action as
significant if it raises novel legal or policy issues. We have
determined that this final rule is a significant regulatory action as
defined by Executive Order 12866.
Costs and Benefits of Administrative Detention Final Rules: Summary
Administrative detention of food is a new enforcement tool, and we
are not able to directly estimate how often it will be used. For an
indirect estimate, we assumed that events that trigger certain existing
enforcement actions represent a pool of events some of which might in
the future trigger administrative detention. To estimate the size of
this pool, we used the sum (for fiscal year 2002) of Class 1 recalls
(184), instances in which we moved directly to seizure (16), and 10
percent of the instances referred to State authorities (23, or 0.01 x
230 actions referred to States). This sum--223 actions--represents the
upper bound number of times we anticipate using administrative
detention. The lower bound is zero; we may not use administrative
detention at all.
The benefits of administrative detention will be the value of the
illnesses or death prevented because the agency administratively
detained food suspected of being adulterated. These benefits will be
generated if the following two conditions hold: (1) The food is in fact
adulterated, and (2) administrative detention prevents more illnesses
or deaths than would have been prevented had we relied on our existing
enforcement tools. The more often these conditions hold, and the larger
the amount of adulterated food administratively detained, the larger
will be the benefits of this final rule. There may also be benefits in
terms of deterrence, to the extent that administrative detention
increases the likelihood that adulterated products will not be shipped
in the future.
One of the main costs of administrative detention, the loss of
product value over the detention period, is associated with the
administrative detention of food that is not in fact adulterated.
We do not know what fraction of detained products will prove to not
be adulterated. For an upper bound we used the fraction of imported
foods that we detain and then release: 48 percent. This percentage is
an overestimate as applied to administrative detention, because less
evidence is needed to detain an import under our current program than
will be required to detain a food administratively. The lower bound
percentage is zero, because we might never detain a food
administratively that is not adulterated.
We estimate the range of costs for this final rule using a range of
0 to 223 administrative detentions and a range of 0 to 48 percent of
those detentions involving products that turn out not to be
adulterated. The total costs of this final rule will be the sum of the
following components:
Additional transportation to secure storage facility,
Additional storage,
Delay of conveyances that contain detained products,
Loss of product value for foods with limited shelf lives,
Marking or labeling of detained products, and
Costs of appeals of administrative detentions.
The following summary table 1 shows the estimated range of costs:
[[Page 31686]]
Summary Table 1.--Annual Costs for Administrative Final Rule
------------------------------------------------------------------------
Types of cost Costs (in millions)
------------------------------------------------------------------------
Transportation............................ $0 to $4
Delay of Conveyances...................... $0 to $4
Storage................................... $0 to $2
Loss of Product Value..................... $0 to $22
Marking or Labeling....................... $0 to $2
Appeals................................... $0 to $16
-----------------------------
Total................................. $0 to $50
------------------------------------------------------------------------
Regulatory Options
We considered the following regulatory options in the analysis of
the proposed rule: (1) Take the proposed action (establish a regulatory
framework for detaining food administratively, with expedited
procedures for instituting certain enforcement actions involving
perishable food); (2) take the proposed action but change the
definition of perishable food, the maximum timeframe for administrative
detention of perishable food, or both; (3) take the proposed action but
define the level of security we require for transportation and storage;
(4) 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 received comments pertaining to the first two
options. We also received some comments on the maximum timeframe for
administrative detention of nonperishable food. We have included these
under Option Two and have renamed that option as follows: Take the
proposed action but change the definition of perishable food, the
maximum timeframe for administrative detention, or both. In addition,
we received comments suggesting that we revise the proposed rule in
various ways that we did not address in any of the other regulatory
options. We will discuss the economic implications of these comments
under a new regulatory Option Five: Take the proposed action but revise
the proposed action in some other way. In many cases, a comment
discussed a cost and suggested a way to minimize that cost. In those
cases, we discuss the portion of the comment that dealt with the cost
of the proposed rule under Option One (take the proposed action), and
we discuss the portion of the comment that suggested revising the rule
under one of the other options.
1. Option One: Take the Proposed Action (Establish a Regulatory
Framework for Detaining Food Administratively, With Expedited
Procedures for Instituting Certain Enforcement Actions Involving
Perishable Food)
General
(Comment 95) One comment argues that our analysis of the proposed
rule did not meet guidelines established by the Office of Management
and Budget (OMB) for the five elements of a regulatory impact analysis.
According to this comment, we did not adequately consider the need for,
and consequences of, the rule on society in general; we did not show
that the potential benefit of the rule outweighs the costs; we did not
select our regulatory objectives with the goal of maximizing net
benefits for society; we did not select the regulatory alternative
having the lowest net cost for society; and we did not consider the
affected food industries, potential future regulatory actions, and the
weak state of the national economy.
(Response) We disagree that we did not meet the guidelines
established by OMB for a regulatory impact analysis. We were unable to
estimate annual benefits because this rule addresses low probability
but potentially high risk events. These events do not occur regularly,
and we have insufficient information to predict their occurrence. Our
inability to estimate annual benefits meant that we were also unable to
evaluate regulatory options that generated tradeoffs between costs and
benefits to the extent that we would normally do so. However, the
guidelines for regulatory impact analyses acknowledge that we will not
always have sufficient information to quantify all relevant effects.
Benefits
(Comment 96) One comment suggests that the proposed rule would not
generate any benefits because we can already request Class I recalls in
situations in which we could use administrative detention. Another
comment argues that the proposed rule would do little to improve food
safety.
(Response) We discussed the benefits of the proposed rule given our
enforcement alternatives prior to enactment of the Bioterrorism Act,
including Class I recalls, in the analysis of the proposed rule. These
comments did not provide information that would allow us to revise that
discussion.
(Comment 97) One comment argues that we failed to consider the
potential benefits of the proposed rule that go beyond avoiding adverse
health consequences. This comment notes that an intentional food
contamination event could have significant national and international
implications because it could lead authorities to impose restrictions
on the distribution and sale of similar products or lead some consumers
to avoid buying the product. As an example of the latter effect, this
comment notes that the discovery of a single cow in Alberta, Canada
that tested positive for bovine spongiform encephalopathy (BSE) caused
significant changes in cattle prices and retail sales of beef products.
(Response) Preventing adverse health consequences from adulterated
food may reduce disruptions in consumer demand for that type of food.
The effect of changes in consumer demand is primarily distributional
because such changes harm some industries and help others. Of course,
these distributional effects may be significant for the firms involved.
In addition, these effects could generate net social costs by causing
temporary unemployment, the loss of value of specialized inputs, and
the loss of inventory, that are not balanced by increases in employment
and the value of specialized inputs, and the use of otherwise unusable
inventory, in competing industries that benefit from the shift in
demand. Preventing adverse health consequences from food may also
reduce the probability that authorities would place restrictions on the
distribution and sale of food. The effect on industry of these
restrictions would be similar to the effect of a shift in consumer
demand, but these restrictions might also generate social costs in the
form of lost consumer utility and enforcement costs because they would
not necessarily reflect underlying changes in consumer demand. We
recognize that preventing such effects would be a benefit of this rule.
However, we have insufficient information to quantify these effects.
Costs
In the analysis of the proposed rule, we requested comments on a
number of issues. These issues included the type of transportation, the
cost of any specialized transportation, the amount of food that we
might detain in an average administrative detention, the size of an
average truckload of food that we might detain, the distances that we
might need to transport food, storage and handling rates, labeling and
marking costs, and the impact of the specific requirements of the
proposed appeals procedures. We did not receive comments on any of
these issues except for the appeals procedures. However, we received
comments on a number of
[[Page 31687]]
other issues relating to the costs of this rule.
(Comment 98) One comment argues that the administrative burden
generated by the proposed rule would dilute effective food safety
measures by industry and divert our resources away from more effective
food safety measures. This comment suggests that the net effect of the
proposed rule would be to reduce food safety rather than increase it.
Another comment argues that the proposed rule might increase food
safety risks because it would slow the movement of food through the
distribution system, thereby creating additional opportunities for
adulteration. The comment envisioned numerous unguarded storerooms or
garage sheds containing detained food, which the comment suggests would
significantly increase the statistical probability that that food would
be attacked.
(Response) This rule will not generate any administrative burden
for a particular firm unless that firm were actually involved in an
administrative detention. In the analysis of the proposed rule, we
estimated 0 to 223 administrative detentions per year, and we estimated
the universe of potentially affected firms to be 1.6 to 1.8 million
firms. Therefore, the expected annual administrative burden for all
potentially affected firms would be quite small and would not
significantly displace food safety expenditures by industry. Similarly,
this rule will only generate enforcement costs in those cases in which
we choose to use it, and we would only use it if it were the most
effective enforcement alternative available in a particular situation.
Therefore, we disagree that this rule will generate a significant
reallocation of our enforcement resources away from more effective food
safety measures. This rule would slow distribution times for any food
that we detain administratively and subsequently release. However, we
can require firms to move food to secure storage or take other actions
to ensure that food that we detain administratively is secure.
Therefore, food that we detain administratively would not make an easy
target for intentional adulteration during the detention period.
(Comment 99) Some comments note that the proposed rule could affect
a wide variety of firms. These comments discuss live food animals;
restaurants; color pigments used in indirect food contact applications;
outer food packaging; raw materials and formulated products that are
used as components in the manufacture of food-contact articles, such as
conveyor belts, oven gaskets, coatings for film, paper, and metal
substrates, adhesives, antifoam agents, antioxidants, polymeric resins,
polymer emulsions, colorants for polymers, rubber articles, release
coatings, and the like; ceramic and lead crystal tableware; and animal
feed and pet food.
(Response) We discussed the wide variety of firms that might be
affected in the analysis of the proposed rule. However, we based the
cost estimate on conventional fresh or processed food for human
consumption. The cost of an administrative detention for each of the
product categories and types of firms mentioned by these comments would
vary along a number of dimensions, including the production and
distribution system, the typical mode of transport, the typical lot or
shipment size, handling and storage costs, and rate of product value
loss, if any. The comments did not provide estimates of how the costs
for these firms would differ from the costs we estimated for the
analysis of the proposed rule, and it would be costly and time
consuming for us to analyze the costs for every type of firm and
product that this rule might affect. In addition, as we discuss later
in this analysis, if it were technically difficult or impossible to
adulterate these types of food, then we would rarely or never receive
information that would require us to detain it administratively. Based
on these considerations, we have not revised the analysis to include a
discussion of each of these types of products and firms.
(Comment 100) Some comments were concerned that any labeling or
marking that we put on food that we detain administratively would
remain on the food if we later determined that the food was not
adulterated and terminated the detention order. One comment argues that
we should place any marking or labeling on packing cases and not on the
product itself. The comment notes that consumers would be skeptical of
purchasing a product that we had marked in conjunction with an
administrative detention.
(Response) Labeling or marking would not lead to a loss of product
value because, if we terminated an administrative detention order, we
would remove any labeling or marking, or authorize someone else to
remove it.
(Comment 101) One comment suggests that we add the expiration date
of administrative detention orders to the information that we put on
the tags or labels that we affix to food that we detain
administratively. The comment also suggests that we amend the tags or
labels if we later amend the expiration date.
(Response) We would indicate the initial 20- or 30-calendar day
expiration date of an administrative detention order on any tags or
labels that we affix to food that we detain administratively. If the
initial period for the detention were 20 calendar days and we extended
the period an additional 10 calendar days, then we would amend the tags
or labels to reflect the new expiration date of the detention period.
We did not include the cost of amending tags or labels in the analysis
of the proposed rule. We assume that the cost of amending a tag or
label is the same as the cost of affixing the tag or label. We do not
know how frequently we may need to use the additional 10 calendar days
of detention, so we also assume that we may need to amend every tag or
label. Under these assumptions and using the same procedures that we
used to estimate these costs in the analysis of the proposed rule, we
estimate this cost to be $0 to $2 million per year, rather than $0 to
$1 million per year that we reported in the analysis of the proposed
rule.
(Comment 102) One comment argues that we might detain entire
containers or truckloads, but subsequently determine that only one or a
very few cases of food are actually adulterated. This comment suggests
that we might release a majority of the food that we detain
administratively. Another comment suggests that we might intentionally
detain more food than we believed was actually adulterated. For
example, we might believe that a particular lot was adulterated, but we
might detain the container that holds that lot along with other lots.
One comment notes that a single shipping container might hold many
small shipments of different products of different origins. The comment
suggested we might detain the entire container in such a situation.
(Response) In the analysis of the proposed rule, we estimated that
we might release 0 to 48 percent of the food that we detain
administratively. Although this is not consistent with the comment's
suggestion that we might release a majority of the food that we detain
administratively, it is consistent with the notion that we might
release a considerable portion of it. As we discussed in the analysis
of the proposed rule, we based the upper end estimate of 48 percent on
the number of import detentions that we subsequently released during
the first three quarters of 2002. As we discussed in that analysis, it
is highly unlikely that we would release a higher proportion of the
food that we detain administratively than the proportion of food that
we
[[Page 31688]]
place on import detention and subsequently release because the legal
standard for administrative detention is higher than the legal standard
for import detention. The comment did not provide sufficient
information for us to change this assessment. If we determine that a
container of food products contains both food that meets the criteria
for administrative detention and food or other items that do not meet
the criteria, the food or other items that can be readily segregated
and not detained can be segregated and moved.
(Comment 103) Some comments argue that some food that has a shelf
life of more than 7 days might suffer a significant loss of value if we
detained it administratively under the conditions applying to
nonperishable foods. One comment argues that this is true of snacks and
snack ingredients. Another comment discusses pasteurized chilled juices
and juice beverages that are transported and stored under
refrigeration. This comment argues that most consumer outlets (retail
and institutional) would not accept this type of food unless it had a
remaining shelf life greater than it would have if we detained it
administratively for 20 calendar days prior to delivery. This comment
argues that the rate at which this food would lose value during an
administrative detention is greater than the 1 to 3 percent per day
that we assumed in the analysis of the proposed rule.
Some comments note that bakery products such as tortillas or snack
cakes, might have a shelf life of 10 to 35 days, but retailers and
distributors are more likely to reject delivery of these products, if
the expiration date is less distant than other comparable products that
are available at the time of purchase because consumers prefer products
with more distant expiration dates. According to these comments, even a
relatively brief administrative detention could render such products
unmarketable. These comments also note that potato chips and cookies
might have a shelf life of 60 to 120 days, but would be subject to a
loss of value by the same mechanism. Some comments made a similar point
about ``nouveau'' wines, which firms release for consumption on a
specific date. These comments argue that this product would lose a
significant amount of its value if it were not available for sale at
the optimum date. These comments also note that the annual sales of
this product typically take place within a brief period of 2 to 3
weeks.
One comment notes that farms often have limited on-farm storage and
inflexible deadlines for delivering products to markets or for further
processing. The comment notes that the loss of value of food that we
detain administratively on farms could be very rapid. One comment
discusses ``fresh products'' that have a shelf life of more than 7
days. This comment argues that one would not be able to market these
products if we detained them for 7 days because they would not have
enough shelf life left.
(Response) In the analysis of the proposed rule, we assumed that
all administrative detentions could last up to 30 calendar days. We
also assumed that food with a shelf life of 8 to 30 days would lose 3
percent of its starting value per day, which would essentially reduce
the value of that product to zero by day 30. We have revised the daily
rate of value loss to the more precise 3.3 percent. It is possible that
food with a shelf life of more than 30 days might also lose its entire
market value during a 30-calendar day detention period. However, in
many cases, one could presumably sell such food at a discount to
reflect the shortened shelf life or the suboptimal selling time. To
reflect the possibility that this food might lose all of its value
during a 30-calendar day detention, we have revised the rate of product
loss for all shelf life categories that we used in the analysis of the
proposed rule to 3.3 percent per day. Under this assumption and using
the same procedures that we used to estimate these costs in the
analysis of the proposed rule, we estimate this cost to be $0 to $22
million per year, rather than $0 to $15 million per year that we
reported in the analysis of the proposed rule.
(Comment 104) One comment notes that our proposed definition of
perishable food refers to the shelf life of the food from the time it
was produced rather than from the time we detain it administratively.
(Response) One implication of this comment is that food with a
shelf life of more than 30 days might become unmarketable during the
detention period if we detained it when it had only part of its shelf
life remaining. We discussed this phenomenon in the context of a
previous comment. However, another implication of this comment is that
we may have overestimated the loss of value for food that we detain
near the end of its normal shelf life. Under the linear method that we
used to estimate loss of product value over time in the analysis of the
proposed rule, such food would already have lost a considerable portion
of its starting value for reasons unrelated to the detention. However,
we do not need to revise our analysis to account for this effect
because our estimated range of the potential annual loss of product
value goes to $0 at the low end.
(Comment 105) One comment discusses the shelf life of air freighted
fish and fish products. This comment notes that chilled finfish has a
normal commercial shelf life of about 7 days from the time of capture.
They argue that attempting to extend the shelf life of this fish by
freezing it would destroy its commercial value. Some comments note that
chilled, live shellfish and crustaceans have a commercial shelf life of
about 48 hours from the time they are packed for export. This comment
notes that one may extend the shelf life for some species by
introducing them back into temperature controlled, oxygenated, salt
water. However, these comments doubted that we intended to operate
appropriate tanking facilities at airports to handle detained live
seafood in this way. Consequently, these comments argue that the
current timeframes for administrative detention would almost certainly
eliminate the value of these products if we detained and subsequently
released them. These comments argue that any detention period longer
than 24 hours would result in a loss of the value of the product.
Another comment argues that a detention period of 7 calendar days
was excessive in the case of fresh salmon because the quality of fresh
salmon would begin to deteriorate within 4 days. One comment notes
that, for perishable foods, the maximum time between receipt of the
detention order and an appeal is 2 calendar days, and that we have 5
calendar days from receipt of the appeal to confirm or set aside the
detention order. This comment argues that these time periods are
impracticable and would lead to the loss of the product. Some comments
note that the appeals process may take up to 7 calendar days, assuming
owners request an appeal within 2 calendar days of receipt of the
administrative detention notice and we would reach a decision on the
appeal 5 calendar days after the date of the filing of the appeal. This
comment suggests that this would leave only 2 or 3 days of acceptable
shelf life for highly perishable fresh seafood products, which would be
insufficient time to distribute it to retail outlets. Thus, this
comment suggests that the proposed procedure would lead to a total loss
of value for this type of product.
(Response) These comments are consistent with the analysis of the
proposed rule, in which we estimated that perishable food might lose up
to all of its value during the detention period.
[[Page 31689]]
We discuss suggestions to revise the rule under Options Two and Five.
(Comment 106) One comment argues that we might direct someone to
move food that we detain administratively from refrigerated storage to
a freezer. The comment notes that this might reduce the value of the
food because the owner could no longer sell it as ``fresh.''
(Response) We would not direct someone to move food from
refrigerated storage to a freezer. If we detained the food in place,
then the food would remain under existing storage conditions unless the
owner requested us to change those conditions. Similarly, if we
directed a firm to transport food to a secure storage facility, then we
would allow that firm to maintain existing storage conditions during
transport and storage, unless the owner requested otherwise.
(Comment 107) Some comments were concerned about the economic
consequences of detaining large oceangoing vessels. They noted that
detaining such vessels administratively for up to 30 calendar days
would generate large costs. One comment notes that detaining such
vessels might cause the deliveries of other cargoes to be delayed,
which could cause some manufacturing plants to shut down because they
lacked necessary inputs. Some comments thought we might detain or
reroute trucks and their drivers for up to 30 calendar days. One of
these comments notes that we did not account for the costs associated
with the idling of trucks and their drivers during administrative
detentions. One comment discusses trucks that transport bulk food,
including liquid commodities such as vegetable oil. This comment notes
that if we detained such a vehicle, then the trailer would be unusable
for the period of the detention.
(Response) In situations involving conveyances, a request can be
made for modification of a detention order to offload the cargo to a
secure storage facility. However, in some cases, it may not be feasible
to offload the cargo. In that case, the conveyance itself might be
delayed. The comment did not provide information on the costs of
delaying a ship. However, a recent newspaper story suggested that
delaying one ship for 1 day may cost as much as $80,000 (Ref. 1). This
implies that detaining one ship for 30 calendar days could cost up to
$2.4 million. It is possible, but unlikely, that a single
administrative detention could involve more than one ship. We might
also detain other types of conveyances.
The comment that discussed the costs of delaying tanker trailers
did not provide information on those costs. However, one firm that
posted a cost proposal on the Internet listed a standard rate as of
July 1, 2002, of $250 per day for a semitrailer with code tanker and
$200 per day for a semitrailer with liquid transporter (Ref. 2). These
rates probably overstate the cost of the loss of a tanker trailer
because in some cases in which we detain food on a tanker trailer, the
semitrailer itself could probably be used with another tanker trailer.
However, this might not always be possible. This implies that the loss
of the use of one tanker trailer could cost up to $8,000 over a 30-
calendar day detention period. In addition, in some cases, the drivers
of tanker trailers may be idled during the detention period. The
average wage of a truck driver in July 2002 was $14.40 per hour (Ref.
3). If we assume 100 percent overhead, then idling a truck driver for
30 calendar days would cost an additional $7,000. Therefore, the total
potential cost of detaining one tanker truck and driver for 30 calendar
days could be up to $15,000. A single administrative detention might
involve more than one tanker trailer or other types of equipment. In
the analysis of the proposed rule, we assumed that any given detention
could involve up to 67 truckloads of food. Detaining 67 tanker trailers
for up to 30 calendar days could generate estimated costs of up to $1
million.
We do not have information on the cost of delaying other types of
conveyances such as trains, airplanes, or other types of trucks.
However, those costs are probably similar to the cost of delaying ships
and tanker trucks. Delaying conveyances could also generate costs by
disrupting the delivery or production schedules of other firms. We do
not have information on these costs. We could attempt to construct a
model to estimate these costs. However, that would be costly and time
consuming and would reflect a great deal of variability in the
potential costs. Therefore, we determined that it would probably not be
worthwhile to construct such a model for this rule. Although the costs
of detaining conveyances are potentially quite high, the probability
that we would need to detain conveyances is quite low. None of the 223
enforcement actions that we discussed in the analysis of the proposed
rule in the context of estimating the maximum number of times we might
use administrative detention per year involved a situation in which we
would have detained conveyances. In addition, none of the 24 seizure
actions that we took in fiscal year 2002 or in fiscal year 2003
involved a situation in which we would have detained conveyances.
Therefore, our best estimate of the number of times per year that we
might need to detain conveyances is zero.
Detaining food located on conveyances may also generate other costs
that we did not discuss in the analysis of the proposed rule. In those
cases in which we required a firm to transport the detained food to a
secure storage facility, we would generate costs associated with the
loss of the use of the conveyance and the idling of the crew or drivers
during the offloading process and the costs for other firms generated
by that delay. If we assume that offloading takes 0 to 6 hours, then
the cost of delaying a ship would be $0 to $20,000 based on a cost of
up to $80,000 for delaying a ship 24 hours. We do not have information
on the costs for other firms generated by the delay of a ship, and the
estimated cost of $80,000 per day might already reflect those costs.
Again, it is unlikely that we would delay more than one ship as part of
a single administrative detention.
The estimated cost of delaying a fleet of tanker trucks by 0 to 6
hours would be $0 to $8,000 based on the cost information we provided
earlier. We assume that the cost of delaying other types of
conveyances, such as trains, airplanes, and other types of trucks,
would be less than the cost of delaying a ship, despite the higher
probability that we might delay more than one of these other types of
conveyances. We do not know how many of the 223 enforcement actions on
which we based our estimate of the maximum number of administrative
detentions in the proposed rule involved food located on conveyances.
Therefore, we assume that between 0 and 223 of the estimated
administrative detentions that we might take per year could involve
food located on conveyances. In that case, the estimated cost from
delaying conveyances would be $0 to $4 million per year.
(Comment 108) One comment notes that most tanker trucks containing
food are sealed at all openings and that we would need to break those
seals to investigate such food. The comment notes that receivers would
not accept loads with broken seals. The comment suggests that some
receivers might not accept such a load even if we resealed the load
using an FDA seal.
(Response) If we were to break the seal on a truck or other
conveyance and subsequently release all or some of the cargo on that
conveyance, then we would reseal the conveyance with an FDA seal.
Therefore, transporters would not need to deliver loads with broken
[[Page 31690]]
seals. In the analysis of the proposed rule, we did not account for the
possibility that a receiver might not accept a load even if we resealed
it with an FDA seal. The comment did not provide information on the
prevalence of this practice. However, we would expect market forces to
minimize this effect because investigating and resealing a load should
have little effect on the underlying value of that load. Therefore, we
have not revised the analysis to account for this possibility.
(Comment 109) One comment notes that firms challenge our food
seizure actions 65 percent of the time and suggests that firms would
probably challenge administrative detentions at least as often, and
perhaps more often, because of the ambiguity of the legal criteria
involved.
(Response) In the analysis of the proposed rule, we assumed that 65
percent of administrative detentions would result in appeal hearings
based on the rate at which firms have contested recent seizure actions.
It is possible that firms might be more likely to request appeal
hearings for administrative detentions than they are to contest seizure
actions. However, we have no information establishing this would be the
case. In the proposed rule, we noted that the credible evidence or
information standard has been applied in various other judicial and
administrative contexts. In addition, we are currently developing a
separate rulemaking that defines ``serious adverse health
consequences,'' as this term is used in several provisions in Title
III, Subtitle A, of the Bioterrorism Act, not just in its section 303.
Therefore, the ambiguity surrounding the criteria for administrative
detention may be less than suggested by this comment.
In addition, we would only grant a request for a hearing after an
appeal is filed, if the information a firm submitted raised a genuine
and substantial issue of fact. In contrast, we have no comparable pre-
screening process to determine whether firms can contest seizure
actions. This suggests that the rate at which firms contest seizure
actions may be greater than the rate at which we would hold appeal
hearings for administrative detentions. We have no way of knowing
whether the rate for contesting seizure actions will be greater than
the rate at which we would hold appeal hearings for administrative
detentions. Therefore, we have assumed for purposes of this analysis
that we will grant all requests for appeal hearings. Based on these
considerations, we have not revised our assumption concerning the
estimated number of appeal hearings.
(Comment 110) One comment notes that it appeared as though we
attempted to expedite the appeals process for perishable food by
conducting appeal hearings within 2 calendar days from when a firm
filed a request for such a hearing rather than within 3 calendar days,
as for nonperishable food. This comment notes that this provision would
not necessarily reduce the timeframes for perishable food, because the
date on which we hold an appeal hearing does not necessarily dictate
when we will reach a decision on that appeal. Some comments note that
we said that we would make a decision on an appeal involving
nonperishable goods within 2 calendar days of the hearing, but that we
committed to no comparable deadline for perishable food.
One comment notes that the expedited hearing process for perishable
food is not fast enough to prevent the effective total loss of market
value of fresh produce, fluid milk, and live fish and seafood. They
note that a claimant must file an appeal within 2 calendar days of
receiving the detention order. Then, if we grant a hearing, we would
hold the hearing within 2 calendar days of when the appeal was filed.
We would then reach a decision based on the hearing within 5 calendar
days. This comment notes that this process implies a total time for the
appeal hearing process for perishable food of 4 to 10 calendar days
after a firm receives the administrative detention order.
(Response) The timeframe under which we must reach a decision on an
appeal hearing is 5 calendar days after the appeal is filed for both
perishable and nonperishable food. In the analysis of the proposed
rule, we estimated that perishable food might lose up to all of its
value during the detention period even under the expedited appeal
hearing process.
(Comment 111) One comment argues that the ambiguity surrounding the
legal criteria for using administrative detentions would encourage some
firms to attempt to use administrative detention to discredit
competitors.
(Response) If this effect were to occur, then it would decrease the
net benefits of this rule by generating administrative detentions that
have costs but no corresponding benefits. This effect would probably be
minimal because of the legal and financial consequences of supplying us
with false information to discredit competitors.
(Comments 112) Some comments argue that firms would not be able to
provide counterevidence during an appeal because we would not provide
them with complete information on the reasons we detained a food
administratively. These comments argue that this would make the appeal
process ineffective, which could lead to administrative detentions that
appear arbitrary.
(Response) As we explain earlier, if we detain an article of food
based on classified information, we will provide as much information as
we can without divulging classified information to those without the
proper security clearance. Finally, we disagree that the appeals
process would necessarily be rendered ineffective because of our
inability to share classified information with those that do not have
the proper security clearance. Based on these considerations, we have
not revised the rule.
Distributional Issues
(Comment 113) One comment thinks that we were unclear about who
would pay for the storage of food that is detained administratively.
The comment wonders how we intend to ensure that the owner or carrier
would be able to afford the storage costs, if they were responsible for
those costs. Another comment asks who would be responsible for feeding,
watering, and providing adequate housing and medical care to live
animals that we detain. One comment asks who would be responsible for
the costs associated with administrative detention in the case of a
food that was produced in one country and then repackaged in another
country before being imported into the United States.
(Response) The party or parties responsible for paying the storage
costs of food that we detain administratively is a matter between the
private parties involved with the food. FDA is not liable for those
costs. An owner, operator, or agent in charge of the place where the
food is located can always request modification of a detention order to
destroy the food if they do not want to store it. This does not change
the analysis of the proposed rule because firms would not choose to
destroy food unless the cost of doing so were less than the combined
cost of storing the food and any loss of product value during the
storage period. We set the low end of our range of potential costs to
zero to account for the fact that we might not detain any food during a
given year. Therefore, the estimated range includes the costs that
would arise if some owners found it less costly to destroy food than to
pay for storage.
(Comment 114) One comment argues that the proposed rule would give
a
[[Page 31691]]
competitive advantage to domestic food over imported food because we
only subject domestic food to administrative detention, but we subject
imported food to both administrative detention and normal import
detention. One comment notes that in the analysis of the proposed rule,
we based the upper end of the estimated range of the potential number
of administrative detentions per year that involve food that we later
determine is not adulterated on the number of import detentions that we
released per year. The comment notes that we stated that we expected
that this rate would probably be less than the rate at which we release
import detentions, because the criteria for administrative detention
are more restrictive than the criteria for normal import detentions.
The comment argues that this showed that we treated imported food
unfairly relative to domestic food.
(Response) This rule covers both domestic and imported food, and we
will apply it in the same way to both types of food.
(Comment 115) One comment notes that the costs associated with
administrative detentions would impose a substantial hardship on
farmers because they have little or no ability to pass on any costs.
The comment also notes that administrative detentions could create
marketing disruptions that could cause a farm to lose its reputation as
a reliable supplier for many years. One comment argues that a motor
carrier and driver would bear some of the costs of administrative
detention because the motor carrier would lose the use of the equipment
during the period of the detention, and the driver might be detained or
rerouted, thereby losing compensation for miles driven.
(Response) This rule may adversely affect some farmers and motor
carriers. We have insufficient information to quantify the expected or
average effect on these specific types of firms, nor did comments
submit such information.
(Comment 116) Some comments suggest that if we told the public that
we detained a particular product, then we would damage the reputation
of the company that manufactured the product, even if we subsequently
found that the product was not adulterated and reported that
information to the public.
(Response) We do not currently plan to routinely inform the public
of administrative detentions, although we might if there were public
health reasons for doing so. Therefore, it is possible that we might
inform the public of an administrative detention that we later
terminated based on a successful appeal or that we later determined
involved food that did not pose a threat of serious adverse health
consequences or death to humans or animals. In that case, our
announcement of the administrative detention could generate changes in
consumer perceptions that might adversely affect some firms. We
classify this type of impact as a distributive issue rather than a
social cost, per se, because reductions in the demand for a given
product will be offset by increases in the demand for other products,
so that the net impact to society is uncertain. We have insufficient
information to quantify this effect, nor did comments provide this
information.
Table 2.--Annual Costs for Option One: Final Rule
------------------------------------------------------------------------
Types of cost Costs (in millions)
------------------------------------------------------------------------
Transportation............................ $0 to $4
Delay of Conveyances...................... $0 to $4
Storage................................... $0 to $2
Loss of Product Value..................... $0 to $22
Marking or Labeling....................... $0 to $2
Appeals................................... $0 to $16
-----------------------------
Total................................. $0 to $50
------------------------------------------------------------------------
2. Option Two: Take the Proposed Action but Change the Definition of
Perishable Food, the Maximum Timeframe for Administrative Detention, or
Both
(Comment 117) A number of comments address the option of changing
the definition of perishable food or the maximum timeframe for
administrative detentions. Many of these comments suggest changes that
would reduce costs but might also reduce benefits. However, these
comments did not provide sufficient information to allow us to quantify
the changes in costs or benefits. Therefore, we are unable to revise
our estimates of the costs and benefits of this option.
Some comments recommend that we define perishable food as food with
a shelf life of 90 days or less. Other comments recommend that we
define perishable food as food with a shelf life of 120 days or less.
One comment suggests that we define perishable foods according to the
definition in the Perishable Commodities Act, which includes fresh
fruits and vegetables of every kind and character where the original
character has not been changed. One comment suggests that we base our
definition of a perishable food on the definition of perishable food in
the NIST Handbook 130 Regulations for Uniform Open Dating. The comment
also suggests that we adopt the definition of semiperishable foods from
that regulation and that we treat semiperishable food the same as
perishable food. The comment notes that the relevant definition of
perishable food is any food having a significant risk of spoilage, loss
of value, or loss of palatability within 60 days of the date of
packaging, and the definition of semiperishable food is any food having
a significant risk for spoilage, loss of value, or loss of palatability
after a minimum of 60 days and a maximum of 6 months after the date of
packaging.
One comment suggests that we revise the rule to define perishable
food as ``food that may have been heat-treated or otherwise preserved
so as to prevent the quality of the food from being adversely affected
for a period of 90 days or less under normal shipping and storage
conditions.'' This comment notes that this definition would include raw
agricultural commodities, refrigerated pasteurized products (milk and
milk products, juice and juice concentrates), and packaged produce, all
of which have a short shelf life and need to move expeditiously through
marketing channels to the consumer. However, the comment notes that,
even under this revised definition, detaining perishable food which has
less than 14 days of shelf life remaining would essentially prevent the
product from reaching the market, even with an expedited appeal process
and a decision in favor of the owner of the food. One comment argues
that we should not consider the issue of whether a food had been
subjected to heat treatment or thermal processing to be relevant to the
definition of perishable food. Some comments argue that we should take
into account not only physical or biological properties, but also how a
product is marketed. Some comments argue that we should treat all food
as perishable food for purposes of an appeal.
(Response) Changing the definition of perishable food as suggested
by these comments would allow more products to qualify for the
expedited procedures for appeals and for initiating certain judicial
enforcement actions that we established for perishable food. The
expedited procedures for initiating certain judicial enforcement
actions may reduce the overall duration of an administrative detention
in some cases. However, we have insufficient information to determine
the impact of these procedures on the duration of administrative
detentions. If these procedures reduced the duration of detentions,
then it would also reduce storage and loss of product value in cases in
which detentions involved food
[[Page 31692]]
that we later determined does not present a threat of serious adverse
health consequences or death to humans or animals. However, it might
also increase our enforcement costs or reduce benefits. It would
increase our enforcement costs if we could compensate for the shortened
timeframe by assigning additional personnel to the enforcement action.
It would decrease benefits in those cases in which we could not fully
compensate for the shortened timeframe by assigning additional
personnel. Treating more or all food as perishable for appeal purposes
would reduce the maximum timeframe in which firms must file appeals for
that food from 10 calendar days to 2 calendar days after receipt of the
detention order. The reduced timeframe would probably reduce the number
of appeals, because any firm that could file an appeal within 2
calendar days is not precluded from doing so with a maximum specified
timeframe for filing an appeal of 10 calendar days. Some firms,
however, that would be able to file an appeal within 10 calendar days
might have difficulty doing so with a maximum specified timeframe for
filing an appeal of 2 calendar days. Reducing appeals would decrease
our enforcement costs for administering hearings. However, it might
also reduce benefits because appeals may allow us to terminate
detention orders that we would not have terminated in the absence of
appeals. Terminating detention orders would eliminate the storage and
loss of product value for detained articles of food. However, reducing
the timeframe in which we hold appeal hearings would also increase our
enforcement costs and possibly reduce benefits. Again, it would
increase our enforcement costs if we could compensate for the shortened
timeframe by assigning additional personnel to the appeal hearing. It
would decrease benefits in those cases in which we could compensate
fully for the shortened timeframe by assigning additional personnel.
(Comment 118) A number of comments raised various issues relating
to the timeframes involved in administrative detentions. Some comments
argue that we should provide information on the criteria that we intend
to use to determine the ``reasonable period'' of time that we detain
food administratively because of the impact of that decision on the
costs of administrative detention. One comment questions whether this
reasonable period of time would depend on the availability of FDA
resources. Another comment argues that we should give top priority to
any sampling and testing associated with administrative detentions to
ensure that we minimize the amount of time that we require. One comment
suggests that we initiate any sampling and diagnostic testing within 24
hours of issuing an administrative detention order.
(Response) Defining the criteria that we would use to establish the
reasonable amount of time that we would detain food administratively
would increase the cost for us to develop this rule because we would
need to evaluate every consideration that might affect that time. Also,
if we wrote these criteria into the rule, and we failed to anticipate
all considerations that might affect this timeframe, then we might need
to release food that we detained administratively before we determined
that such food should be released. The benefit of defining these
criteria is that it would allow the public to provide input on the
factors that we believe lead to these time requirements.
(Comment 119) Some comments suggest that we reduce the maximum time
of administrative detentions from 30 to 15 days. One comment suggests a
maximum of 10 days. One comment suggests a maximum of 7 days. One
comment argues that we should revise the rule to limit the period of
detention for perishable commodities, including fresh cut salads, fresh
fruits, and vegetables to 7 days. One comment suggests that we revise
the rule to limit the administrative detention period to 7 days for
foods with a shelf life of between 8 and 30 days. Some comments suggest
that we develop a system to determine within 24 hours if detention
continues to be necessary for perishable food such as fruit,
vegetables, and fresh fishery products. These comments suggest that we
should only detain fresh noncitrus fruit a few hours, and that we
should not detain peppers and citrus fruits for more than 24 hours.
(Response) Reducing the maximum time that we could detain food
administratively would reduce storage costs and the loss of value of
any food that we later determine is not adulterated. However, this
change would also reduce benefits by increasing the risk that an
administrative detention order would terminate before we were able to
fully assess the health risks associated with the detained food.
(Comment 120) One comment argues that we should inform the owner
within 1 calendar day if we terminate an administrative detention
order. The comment argues that this would minimize the possible loss of
market value by allowing the owner to distribute the food as soon as
possible.
(Response) We would only directly inform the owner of the
termination of a detention order if we had been able to readily
identify the owner and had sent the owner a copy of the detention
order. In such a case, we would normally be able to inform the owner of
the termination of the detention order within 1 calendar day of when we
terminated the detention order. In some other cases, owners could make
arrangements with the owner, operator or agent in charge of the place
where the food is located to notify them if we notified the owner,
operator or agent in charge of the place where the food is located that
we terminated a detention order. The timeframe in that case would also
be 1 calendar day because we expect that we would normally be able to
inform the owner, operator or agent in charge of the place where the
food is located within 1 calendar day. Allocating additional employees
to this task could generate opportunity costs by reducing the employees
that we can assign to other tasks having public health consequences. We
have insufficient information to quantify these opportunity costs. The
benefit of committing to informing the owner within 1 calendar day, if
we inform the owner, would be up to a 1-calendar day reduction in
storage costs and loss of product value.
(Comment 121) Some comments state that we set a deadline for making
decisions on appeals involving nonperishable food, but we did not set a
comparable deadline for appeals involving perishable food. These
comments suggest that we revise the rule to specify that the same
deadline that applies to nonperishable foods also applies to perishable
foods. One comment suggests that we reach decisions on appeals
involving perishable foods within four days of the date of the appeal.
One comment suggests that we commit to reaching decisions on appeals
involving perishable food within 24 hours of the appeal hearing. One
comment suggests that we set up an expedited appeal procedure for
perishable food.
(Response) Our deadline for making decisions on appeals is the same
for both perishable and nonperishable food, i.e., no more than 5
calendar days after an appeal is filed. Reducing the timeframe in which
we must render a decision on appeals involving perishable food from 5
to 4 calendar days or to 1 calendar day would either increase our
enforcement costs or decrease benefits as per the mechanism we
described earlier. It would increase
[[Page 31693]]
our enforcement costs if we could compensate for the shortened
timeframe by assigning additional personnel to the appeal. In other
cases, reducing the time we have to reach decisions might decrease
benefits by increasing the risk that we would inappropriately terminate
detention orders. However, reducing the time we have to reach decisions
on appeals involving perishable foods would also reduce storage costs
and loss of product value in those cases in which we terminated those
detentions because of those appeals.
(Comment 122) One comment suggests that we extend the timeframe for
appealing detentions beyond the proposed 4 calendar days for
nonperishable foods and 2 calendar days for perishable food. The
comment argues that, in the case of imports, the parties in the
exporting countries would not have sufficient time to prepare the
necessary documents under the proposed deadlines.
(Response) Although firms must indicate their intention to appeal
administrative detentions of nonperishable food within 4 calendar days
of when we deliver the detention notice to the owner, operator, or
agent in charge of the place where the food is located, they have 10
calendar days to prepare and file their appeals. Therefore, in the case
of nonperishable food, both the proposed rule and this final rule are
consistent with the comment. Extending the timeframe for appealing
nonperishable food would increase our enforcement costs because we
would need to keep employees assigned to those cases throughout the
potential appeal period to prepare for a possible appeal. It would also
increase the number of appeals, which would increase our enforcement
costs for reviewing those appeals and administering any appeal hearings
that we might grant. However, increasing the number of appeals might
also increase benefits by allowing us to terminate some detentions that
we might not have otherwise terminated or that we might have terminated
after a longer detention period.
We were unable to determine that any of the suggested revisions
would generate higher net benefits than the actions that we discussed
in the analysis of the proposed rule, which were to broaden the
definition of perishable food to include any food with a shelf life of
30 days or less and reduce the maximum timeframe for detaining a
perishable food administratively to 14 calendar days. However, we have
updated the cost estimates for that action to reflect the revisions we
previously discussed under Option One.
Table 3.--Annual Costs for Option Two: Alternative Definition and
Maximum Detention Period for Perishable Food
------------------------------------------------------------------------
Types of cost Costs (in millions)
------------------------------------------------------------------------
Transportation............................ $0 to $4
Delay of Conveyances..................... $0 to $4
Storage.................................. $0 to $1
Loss of Product Value.................... $0 to $15
Marking or Labeling...................... $0 to $2
Appeals.................................. $0 to $16
-----------------------------
Total................................ $0 to $42
------------------------------------------------------------------------
3. Option Three: Take the Proposed Action, but Define the Level of
Security We Require for Transportation and Storage
We did not receive any comments on this option. However, we have
updated the cost estimates for that action to reflect the revisions we
previously discussed under Option One.
Table 4.--Annual Costs for Option Three: No Transportation and One
Additional Guard
------------------------------------------------------------------------
Types of cost Costs (in millions)
------------------------------------------------------------------------
One Additional Guard..................... $0 to $11
Delay of Conveyances..................... $0 to $4
Storage.................................. $0 to $2
Loss of Product Value.................... $0 to $22
Marking or Labeling...................... $0 to $2
Appeals.................................. $0 to $16
-----------------------------
Total................................ $0 to $56
------------------------------------------------------------------------
4. 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 did not receive any comments on this option.
5. Option Five: Take the Proposed Action But Revise the Proposed Action
in Some Other Way
(Comment 123) In the analysis of the proposed rule, we requested
comments on other regulatory options that we should consider. A number
of comments suggested revisions that did not correspond to any of the
other regulatory options. Many of these suggestions involved revisions
that would reduce costs but might also reduce benefits. Other
suggestions involved revisions that would reduce some costs, such as
costs faced by industry, but would increase other costs, such as our
enforcement costs.
(Response) The comments did not provide sufficient information to
allow us to quantify the changes in costs or benefits. Therefore, we
have insufficient information to determine that any of the recommended
changes would increase the net benefits of this rule. Nevertheless, we
list the more significant suggested revisions in the following
paragraphs and indicate the tradeoffs that would be involved in those
revisions.
a. General. (Comment 124) One comment argues that rather than
adding to industry's burden for food security, we should provide
government funding to help industry institute measures to improve food
security.
(Response) This comment raises an issue that is beyond the scope of
this rulemaking. In the discussion of Option One, we argued that the
expected annual burden for all potentially affected firms would be
quite small and would not significantly displace food safety
expenditures by industry. Declining to issue this rule would generate
minimal cost savings because the authority to detain food is self-
implementing and is in effect now. This regulation specifies procedures
and defines terms to ensure we meet the statutory timeframes for
detaining food, and rendering a decision on appeal.
(Comment 125) Some comments suggested that we provide foreign
language translations of the Bioterrorism Act and any explanatory
information that we prepare on this regulation. The comments suggest
that we disseminate the translated material on our Web site and by
other means. Some comments request that we establish foreign language
consultation services at U.S. embassies.
(Response) As stated earlier in this rule, we have posted on FDA's
Web site transcripts of the May 7, 2003, public meeting that we held to
discuss both the administrative detention and recordkeeping proposed
rules. We also posted transcripts of the broadcast in English, French,
and Spanish, which are the three official WTO languages. We plan to
make similar outreach efforts directed to both domestic and
international stakeholders after publication of this final rule.
Providing other translations and foreign language consultants would
increase our enforcement costs, but reduce the costs of foreign firms
that wished to appeal administrative detentions. Reducing the cost of
appeals for firms would probably increase the number of appeals. As we
discussed earlier, increasing the number of appeals would increase our
[[Page 31694]]
enforcement costs but would also allow us to terminate administrative
detentions that we would otherwise not have terminated or terminated
after a longer detention period. Terminating administrative detentions
would reduce storage costs and loss of product value.
b. Coverage. (Comment 126) One comment suggests that we exempt
regulated indirect food contact color pigments that firms may use in
the manufacture of food packaging. This comment argues that exempting
these products would have a minimal effect on benefits. According to
this comment, our regulations require that indirect food contact color
pigments be proven safe and incapable of migrating into food in more
than de minimis quantities. This comment also argues that color
pigments must be almost completely insoluble in the medium in which
they are used, particularly for food packaging, which means that the
amount of contaminant that would be necessary to pose a threat to food
by migration from polymers and coatings would almost certainly
compromise the basic stable coloration function of the pigment. This
comment also states that if someone did manage to adulterate these
products, then it would probably affect the chemistry of these
substances in such a way that the pigment would no longer function
correctly in the packaging, polymer or coating systems. The comment
also notes that they know of no biological contaminants that could
occur in food that could survive in the harsh environment of bulk
commercial color pigments or the severe environment that occurs in the
manufacturing of plastics, inks and coatings. Finally, the comment
notes that they know of no cases of foodborne illness that have been
attributed to contaminants that migrated from a color pigment used in
food packaging.
Some comments suggest that we exempt outer food packaging. These
comments argue that the risk to humans and animals from the
adulteration of outer food packaging is relatively small compared to
the risk from the adulteration of food contact packaging.
One comment suggests that we exempt raw materials and formulated
products that are used as components in the manufacture of food-contact
articles, such as conveyor belts, oven gaskets, coatings for film,
paper, and metal substrates, adhesives, antifoam agents, antioxidants,
polymeric resins, polymer emulsions, colorants for polymers, rubber
articles, release coatings, and the like.
One comment suggests that we exempt ceramic and lead crystal
tableware. This comment argues that such products would be unlikely to
feature in terrorist incidents and that deploying our resources to deal
with these products would reduce our ability to deal with other
products.
One comment suggests that we exempt animal feed and pet food and
limit the scope of the proposed regulations to food that is intended
for direct human consumption without further processing.
One comment suggests that we exempt food in purely intrastate
commerce.
(Response) The scope of the detention authority extends to those
articles that meet the definition of food in section 201(f) of the FD&C
Act. Exempting the products in this comment that meet this definition
would have little effect on estimated costs because, if it were
technically difficult or impossible to adulterate these types of food,
then we would rarely or never receive information that would require us
to detain it administratively. There are no costs associated with this
rule for products that do not appear to present a threat of serious
adverse health consequences to humans or animals. However, exempting
these products could significantly reduce benefits because we would be
unable to use administrative detention in the unlikely case that
someone did manage to adulterate these products in a way that generated
a risk of serious adverse health consequences. This type of event,
although rare, could generate significant health costs. Therefore, the
net effect of this revision would be to reduce the net benefits of this
rule.
(Comment 127) Some comments suggest that we limit our use of
administrative detention to situations involving real or suspected
intentional acts of terrorism. Some comments argue specifically that we
should continue to request Class I recalls in situations involving
unintentional adulteration. One comment argues that we should not use
administrative detention to deal with imported food containing
undeclared allergens.
(Response) Limiting the use of administrative detention to
situations involving real or suspected terrorism would significantly
reduce both the potential costs and benefits of this rule. Only one of
the 223 enforcement actions upon which we based our estimate in the
proposed rule of the potential maximum number of times we might use
administrative detention in 1 year may have involved intentional
contamination, and it is possible that none of them did. We did not
estimate the number of outbreaks per year that this rule might prevent
due to our ability to remove food that presents a threat of serious
adverse health consequences or death to humans or animals from commerce
by placing it under administrative detention while we pursue a seizure
action. However, the number of intentional outbreaks would be much
smaller than the number of intentional outbreaks plus the number of
unintentional outbreaks because most outbreaks have been unintentional.
(Comment 128) Some comments suggest that we cooperate with TTB of
the U.S. Department of the Treasury when detaining alcoholic beverages
administratively because the TTB is normally responsible for regulating
these products and has expertise on that sector of the economy. The
comment suggests that we revise the rule to specify that TTB officials
are responsible for ordering any administrative detentions of alcoholic
beverages.
(Response) As stated previously, FDA recognizes that working in
conjunction with TTB is an important tool we have in the event of a
threat to the nation's food supply. However, TTB does not have
exclusive jurisdiction over alcoholic beverages. FDA exercises
jurisdiction over alcoholic beverages as ``food'' for the purposes of
the adulteration provisions and other provisions of the FD&C Act. FDA
has concluded that alcoholic beverages are covered under the
administrative detention regulation because alcohol is food, as that
term is defined in section 201(f) of the FD&C Act. The term ``food'' as
used in section 303 of the Bioterrorism Act has the meaning given in
section 201(f) of the FD&C Act.
c. Definition of criteria. (Comment 129) Some comments state that
we should define ``credible evidence or information'' and ``threat of
serious adverse health consequences or death to humans or animals.''
These comments argue that these steps would be necessary to protect
against arbitrary or unsupported detentions that might function as
trade barriers. Some comments suggest we use internationally valid
standards, such as Codex standards, when defining these terms. One
comment suggests that we provide additional guidance on ``credible
evidence or information'' by naming all the sources of information that
we consider reliable and describing requirements with respect to
accuracy of the information. One comment suggests that we adopt a more
precise definition of the criteria involved because it would minimize
the cost of wrongly ordered detentions. One comment argues that we
should not define the criteria for
[[Page 31695]]
administrative detention, but should instead decide whether a
particular case meets the definition on a case-by-case basis, as we
proposed. This comment argues that we should not limit our discretion
to use administrative detention by identifying the types of evidence
that we would need to support a detention order because terrorist
events might arise under conditions that we could not anticipate.
One comment offers suggestions about how to define ``threat of
serious adverse health consequences or death to humans or animals.''
Some comments suggest that we define ``credible evidence'' to require
evidence, such as laboratory analyses, to confirm the presence of an
adulterant or affidavits sworn to under penalty of perjury. One comment
argues that we should define ``serious adverse health consequences or
death to humans or animals'' so that it necessarily involves risks for
a large part of the population and also for the average consumer, not
just a sensitive subpopulation.
(Response) We are developing a separate rule in which we will
define the phrase, ``serious adverse health consequences or death to
humans or animals.'' This phrase is also used in other provisions in
Title III, Subtitle A, of the Bioterrorism Act, not just in its section
303. Therefore, it would not be efficient to define this phrase in this
rule.
More precisely defining ``credible evidence or information'' would
increase the cost for us to develop this rule because we would need to
consider and evaluate a number of possible scenarios in order to define
that term. In addition, if we wrote a definition of this term into this
rule, then we might need to revise the rule as we encountered new
situations. Also, if we wrote a definition into the rule, and we failed
to anticipate all relevant situations, then we might be unable to use
administrative detentions in some situations in which there might be
benefits from doing so. The benefit of more precisely defining this
term is that it would reduce the possibility that some people might
perceive administrative detentions as arbitrary. In the discussion of
Option One, we pointed out that the credible evidence or information
standard has been applied in various other judicial and administrative
contexts.
d. Administrative detention orders and the dissemination of other
information relating to administrative detentions. (Comment 130) A
number of comments addressed the issue of who would receive copies of
administrative detention orders. One comment notes that Sec. 1.392 of
the proposed rule provides that we would provide a copy of the
detention order to the owner, operator or agent in charge of the place
where the food is located, and that we would provide a copy to the
owners of the food if we could readily determine their identity. The
comment notes that because we are requiring operators to register with
us, we should be able to readily identify the sending company, the
buying company and all intermediaries of the food detained. The comment
argues that at least one of these parties would typically be the owner
and suggested that we inform all of them of detention orders. The
comment suggests that this would be the only way to give the owner a
realistic chance to file an appeal.
One comment notes that the owner of the place or the vehicle where
we detain food administratively might not have a vested interest in the
detained product. This comment suggests that we also notify the
importer or the owner of the food. One comment suggests that if we
detain an exporter's product, then we should notify that exporter. One
comment suggests that we notify the importer and exporter of record and
the Customhouse broker. One comment requests that we notify the agent
or importer. One comment requests that we notify people of
administrative detentions by both a formal written communication and a
telephone call.
(Response) We will issue an administrative detention order to the
owner, operator, or agent in charge of the place where the food is
located. We will also provide a copy of the detention order to the
owner of the food, if the owner of the food is different from the
owner, operator, or agent in charge of the place where the food is
located, and if we can readily determine the owner's identity. Finally,
we will provide a copy of the detention order to the shipper of record
and to the owner and operator of the vehicle or other carrier, if the
food is located on a common carrier, and if we can readily determine
the identities of the owners and operators. We intend personally to
deliver the detention order to the owner, operator, or agent in charge
of the place where the food is located because it permits our
investigator to observe the article of food and therefore better
describe it in the detention order. We will notify other parties using
whatever method of communication is quickest, given the information
that we can readily determine about how we can contact them. The
registrations that we will be requiring in another rulemaking will not
provide us with a list of parties that would probably include the
owners of food that we detain administratively. Committing to notifying
additional parties beyond those specified in the proposed rule,
notifying owners even when we cannot readily determine their
identities, or notifying owners by telephone and written communications
even when we cannot readily determine their phone numbers or addresses,
would increase our enforcement costs.
The benefit of such a revision is that it would increase the
probability that we would notify a party that has an incentive to
appeal an administrative detention in time for them to meet our
deadlines for filing an appeal. This would increase the number of
appeals. As we previously discussed, this may generate social benefits
because appeals may allow us to terminate some detentions. Terminating
detentions would limit the storage and loss of product value associated
with those detentions.
(Comment 131) One comment suggests that we revise the rule to
require that we accompany a notice of detention by personal service
upon the responsible party at individual locations.
(Response) We will notify in person the owner, operator, or agent
in charge of the place where the food is. If more than one location is
involved, then we would notify in person the owner, operator, or agent
in charge of each location. Committing to notifying other parties in
person would substantially increase our enforcements costs and might
decrease benefits because notifying other parties in person might not
be the quickest way of notifying them. The comment did not provide a
mechanism by which notifying other parties in person would generate
benefits. Therefore, this change would probably not increase the net
benefits of this rule.
(Comment 132) A number of comments ask questions about who would
receive information on administrative detentions other than copies of
detention orders. Some comments suggest that we provide essential
information, such as the cause of administrative detentions, to key
industry officials in the event of a food security event. One comment
suggests that we provide information on administrative detentions to
the government of the home country of the owner, operator, or agent in
charge of the place where the food is located. Some comments suggest
that we inform foreign governments if we detain products from their
countries so they can take measures to recall or otherwise deal with
the products. One comment suggests that we provide information on
[[Page 31696]]
administrative detentions to foreign governments only if the product
from that country constituted a serious threat. Some countries suggest
methods by which we could provide information. One comment suggests
that we notify foreign governments using a rapid alert system, if a
product from that country constituted a serious threat. Some comments
suggest that we devise and test a method of communicating essential
information to key industry officials in the United States in the event
of a food security event.
(Response) We will directly notify foreign governments and industry
officials of administrative detentions on a case-by-case basis when we
think there would be benefits to doing so. Committing to notifying
these parties of every administrative detention would increase our
enforcement costs. However, it might also generate benefits because we
might otherwise fail to notify these parties of administrative
detention in some situations in which such notification would generate
benefits. The probability that we would fail to notify these parties in
situations in which such notification would generate benefits is
probably small.
(Comment 133) Some comments raise the issue of the information that
we would provide to owners or others, either as part of the
administrative detention order or otherwise. Some comments request
information that would help them identify the detained food. Some
comments suggest that we provide owners with grower codes so that they
or others could trace the secondary supplier. One comment suggests that
we provide a description of the food, the quantity, and the lot or code
numbers or other identifiers.
(Response) We will provide information relevant to identifying food
that we detain administratively in the detention order. This
information will typically include a description of the food, the
quantity of food, and any identifying codes, such as grower codes and
lot numbers, that we can readily determine. Committing to always
providing particular codes would increase our enforcement costs. In
some cases, such as a detention involving a number of pallets
containing products from multiple lots, it might be difficult for us to
identify all of the relevant lot codes. Committing to always providing
particular identifying codes would generate benefits because it would
help owners, and possibly other parties such as foreign governments, to
take steps to investigate the potential problem and possibly reduce the
risk of additional serious adverse health consequences. In addition,
some parties may find particular identifying codes useful during the
appeal process.
(Comment 134) One comment suggests that we provide foreign
governments with the produce name and lot number, the producer, and the
exporter of the detained food.
(Response) In those cases in which we directly inform foreign
governments of administrative detentions, we would provide them with a
copy of the detention order and any other information we deem
appropriate, which may include the name of the product, the lot number,
the producer, and the exporter. Committing to always providing foreign
governments with this information would increase our enforcement costs
and possibly increase other food safety risks. The benefit of
committing to always providing this information is that foreign
governments might be able to take more effective steps to address
potential food safety risks than they would otherwise. We have
insufficient information to quantify the net impact of this revision.
(Comment 135) Other comments discuss the information that we would
provide as the bases for administrative detentions. One comment
suggests that we include in the detention order the information upon
which we based an administrative detention. Some comments suggest that
we provide owners with complete information on the reasons for
detentions so that owners can provide counterevidence during an appeal.
One comment suggests that we should at least include a description of
the ``credible evidence or information'' that resulted in the detention
order, because without such information, the owner of the detained
article would be denied information critical to its own investigation,
which would hamper or deny its ability to make a meaningful appeal. The
comment notes that we could provide information on why we believe the
article of food subject to the order ``presents a threat of serious
adverse health consequences or death to humans or animals'' even if the
``credible evidence'' that we used is classified information. One
comment suggests that we provide foreign governments with the reasons
for administrative detentions.
(Response) We will provide a statement of the reasons for a
detention in the detention order, but we will not divulge classified
information to those without the proper security clearance. Similarly,
in those cases in which we directly notify foreign governments or other
parties of administrative detentions, we will provide a statement of
the reasons for those detentions as is consistent with national
security considerations and applicable disclosure laws. Providing
classified information to those without the proper security clearance
could generate costs by increasing the risk of future food safety
incidents. It would also be illegal.
(Comment 136) One comment suggests that we include in the detention
order a description of the actions we intend to take with the product
and the amount of time we intend to hold the product.
(Response) Detention orders will be dated and will include the
period of detention. Therefore, anyone can determine the expiration
date of that detention order. We could attempt to predict at the time
we issued detention orders whether we might terminate those detention
orders or move to seizure actions before the expiration date, or
whether we might need to extend the detentions for an additional 10
calendar days. We could then revise detention orders as our assessment
changed over time. However, that would substantially increase our
enforcement costs. The benefit of this action is that the recipient of
the detention order might be in a better position to plan any appeals
or subsequent disposition of the food.
(Comment 137) One comment suggests that we provide information on
the analyses and methods that we use to analyze food that we detain
administratively.
(Response) As we discussed earlier in this preamble, information on
the analyses and methods that we use to analyze food is available on
FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov.
(Comment 138) Some comments suggest that we provide the owner a
sample of the detained food to allow them to conduct their own tests.
(Response) With respect to providing counter-samples, section
702(b) of the FD&C Act describes FDA's responsibility to provide a part
of an official sample of food to certain individuals, when a sample is
collected for analysis under the FD&C Act. Section 702(b) of the FD&C
Act requires the Secretary to, upon request, provide a part of such
official sample for examination or analysis by any person named on the
label of the article, or the owner thereof, or his attorney or agent;
except that the Secretary is authorized, by regulations, to make such
reasonable exceptions from, and impose such reasonable terms and
conditions relating to, the operation of this section as he finds
necessary for the proper administration of the provisions of the FD&C
Act. Therefore, when our own collection of a sample requires us to
[[Page 31697]]
provide a part of that sample to the owners, we will do so. However,
when we are not required to provide a part of that sample to the
owners, we will not do so. If we do not take a sample, then we will
also not provide owners with a sample. Always providing owners with a
sample when we collect a sample would increase our enforcement costs
but might reduce costs in some situations by allowing us to terminate
some detention orders. Providing owners with samples in situations in
which we do not take samples for our own purposes would increase our
enforcement costs and would have a minimal impact on other costs. In
particular, if we did not rely on testing to establish our case for an
administrative detention, then providing owners with samples would
probably likely have little impact on the appeal.
(Comment 139) One comment suggests that we allow owners of detained
food to have access to the written approval granted by the authorized
FDA representative to ensure that the owners have all of the necessary
information to address any potential concerns.
(Response) The owner of detained food can obtain a copy of the
written approval granted by the authorized FDA representative under
FOIA, after we have removed any information that is protected from
disclosure to the public. However, owners might not be able to get such
a copy quickly enough to use during their appeal. Providing owners of
food that we detain administratively faster access to written approvals
granted by authorized FDA representatives would increase our
enforcement costs and would probably generate no or minimal benefits.
Allowing owners access to written approvals would allow them to confirm
that administrative detention orders were properly approved. However,
owners do not need access to those documents to raise this issue in an
appeal. Therefore, making this change would probably not increase net
benefits.
(Comment 140) Some comments were concerned about the information
that we would provide to the public concerning administrative
detentions. Some comments suggest that we should only make information
on administrative detentions public if it were necessary to protect
public health. These comments suggest that we ensure that any
information that we release to the public on administrative detentions
is accurate and that we transmit such information in a clear,
unemotional, and factual manner without unduly or inaccurately raising
public concern.
(Response) We do not currently plan to publicize administrative
detentions unless it is necessary to protect the public health.
However, members of the public can request information on
administrative detentions under the Freedom of Information Act. If we
found it necessary to inform the public for public health reasons, then
we would ensure that the information that we provided to the public is
accurate and that we transmitted it in an appropriate manner that would
not unduly or inaccurately raise public concern.
(Comment 141) One comment suggests that we revise the rule to
require that Regional FDA Directors or more senior level officials
approve administrative detentions because of the serious cost
implications involved.
(Response) This revision would increase our enforcement costs by
reducing the number of eligible authorizing officials and by increasing
the payroll and opportunity costs associated with approving detentions.
The potential benefit would be a reduction in the number of
administrative detentions that we later terminate because of a
successful appeal or because we later determined that they involved
food that did not pose a serious adverse health consequences or death
to humans or animals threat. We have no information establishing that
this benefit would occur.
(Comment 142) One comment notes that we proposed that government
employees commissioned or deputized by FDA may order a detention. This
comment argues that we should revise the rule to allow only FDA
employees to order and administer detentions because that would aid in
the credibility of the process.
(Response) Revising the rule to allow only FDA employees to order
and administer administrative detentions would increase our enforcement
costs. If this revision aided the credibility of the process, then it
might reduce the possibility of legal complaints and might also reduce
the number of unjustified appeals, both of which would decrease costs.
However, the comment did not provide information establishing that this
effect would occur.
e. Compensation. (Comment 143) Many comments argue that we should
compensate firms for costs associated with administrative detentions
that we later terminate because of a successful appeal or because we
later determined that it involved food that did not pose a threat of
serious adverse health consequences or death to humans or animals. One
comment suggested that we should at least compensate firms for some
percentage of the costs, because it would provide us with an incentive
to avoid excessive use of administrative detentions. One comment
suggests that we compensate farmers for the costs of administrative
detentions.
(Response) Neither the FD&C Act nor the Bioterrorism Act provide
FDA with authority to compensate firms for costs associated with
administrative detention. Even if FDA had such authority, if we
compensated firms for costs associated with administrative detentions,
then we would shift the burden of those costs from the affected firms
to taxpayers in general. This is primarily a distributional issue that
goes beyond the scope of this analysis.
f. Labeling and marking. (Comment 144) One comment suggests that we
add the name of the authorized FDA representative to the information
that we put on the tags or labels that we affix to food that is
detained administratively.
(Response) Including the name of the authorized FDA representative
on the tags or labels that we affix to detained food would increase our
enforcement costs slightly, but would not affect other costs or
benefits. We will provide information on how to appeal or obtain more
information on administrative detentions in the detention order. It is
possible that someone might have access to the tag or label but not the
detention order, so there could be some benefit to adding a contact
name to the tag or label. However, this situation is probably unlikely.
Most people who may be interested in appealing an administrative
detention will probably be able to obtain a copy of the detention
order. Therefore, this change would probably not increase net benefits.
g. Transportation. (Comment 145) One comment suggests that we
define and make available for public comment the conditions that we
believe would warrant transporting food that is detained
administratively to secure storage facilities.
(Response) Defining the conditions that would warrant transporting
food to secure storage facilities would increase the cost for us to
develop this rule because we would need to consider and evaluate every
scenario that might require transportation. In addition, if we wrote
these conditions into the rule, then we might need to revise the rule
as we gain experience with administrative detentions. Also, if we wrote
these conditions into the rule, and we failed to anticipate all
situations in which transportation was appropriate, then we might need
to resort to relatively inefficient and expensive alternatives.
[[Page 31698]]
The benefit of defining the conditions warranting transporting food to
secure storage facilities is that it would prevent inconsistent
decisions about transporting food to secure storage and would allow the
public to provide input on when transportation would be most
worthwhile.
(Comment 146) One comment requests that we change the rule to
include some provisions regarding appropriate transportation
conditions, such as keeping refrigerated foods under 40 degrees F and
frozen foods under -4 degrees F. One comment notes that we did not
define the mode of transport in the case of limited conditional release
and argues that we should require that the mode of transport not
introduce any condition or substance that would adulterate or otherwise
deleteriously impact the quality of the detained food.
(Response) We will normally maintain existing storage conditions
during transportation to secure storage facilities. If the owner
wishes, he or she can request that we maintain different storage
conditions or request modification of a detention order. In the case of
a request to modify the detention order, the party requesting
modification of the detention order would determine the conditions
during transportation.
(Comment 147) One comment requests that we revise the rule to
require that the owner, purchaser, importer, or consignee, pay the
transportation costs of food that is detained administratively. This
comment notes that this would be consistent with the rule on prior
notice (part 1, subpart I). The comment argues that a trucking company
should not have to pay transportation costs because they have no
control over the quality or safety of what a shipper loads into the
trailer.
(Response) Resolving the issue of who should pay for transportation
is a distributional issue that is beyond the scope of this analysis.
h. Storage facilities. (Comment 148) Some comments state that we
should guarantee that we will have enough secure storage facilities
with appropriate storage conditions for products that we detain
administratively.
(Response) Guaranteeing that we have appropriate secure storage
facilities for all food that we might detain administratively could
generate significant costs because of the uncertainty over the number
and location of detentions and whether there is a need to transport
detained food to secure storage. It would generate minimal benefits
because, in many cases, it may be cheaper and more or equally effective
to secure detained food in place. Therefore, this change would probably
increase the net costs of this rule.
(Comment 149) One comment notes that our decision to move food to
secure storage, and our selection of appropriate storage facilities,
could have a significant impact on the storage costs that the owners of
detained food would face. The comment suggests that we ensure that such
storage facilities impose the minimum cost necessary to achieve the
objectives of the detention, with respect to both security and food
storage conditions such as refrigeration.
(Response) Ensuring that storage facilities impose the minimum cost
necessary to achieve the objectives of administrative detentions would
increase our enforcement costs by requiring us to spend time shopping
for storage facilities. This would also increase the time we need to
implement administrative detentions, which might reduce benefits. The
benefit of ensuring that we use the lowest cost storage facility is
that it would give us an incentive to reduce storage costs to the
lowest level possible. This benefit would probably be small. When we
use commercial storage facilities, the price difference between the
facility that we choose and the lowest cost appropriate storage
facility would probably be relatively modest due to price competition
in the commercial storage market. The same considerations apply to any
conveyances that we use to move food that we detain administratively to
secure storage facilities.
(Comment 150) One comment suggests that we require the person
holding legal title to the food to bear the cost of storing food that
is detained administratively. This person might be a shipper, the
consignee, or a food broker. One comment requests that we revise the
rule to require that the owner, purchaser, importer, or consignee pay
any storage costs. This comment notes that this would be consistent
with the rule on prior notice (part 1, subpart I). The comment argues
that a trucking company should not pay storage costs because they have
no control over the quality or safety of the food a shipper loads into
the trailer.
(Response) The issue of who should pay for storing food that is
detained administratively is a distributional issue that is beyond the
scope of this analysis.
(Comment 151) One comment suggests that we provide records of
storage conditions during detention to owners of detained food, upon
request.
(Response) Providing records of storage conditions to owners upon
request would increase our enforcement costs slightly. This revision
would probably have a minimal impact on benefits or distributional
effects because we will allow owners to verify storage conditions,
except where security concerns prevent it.
(Comment 152) Some comments argue that owners should be able to
inform us about the optimal storage conditions for food that we detain
administratively and that they should be able to submit a claim against
us if we do not follow their recommendations. One comment requests that
we revise the rule to include some provisions regarding appropriate
storage, such as keeping refrigerated foods under 40 degrees F and
frozen foods under -4 degrees F. One comment requests that we commit to
holding refrigerated and frozen food at the same refrigerated and
frozen temperatures and conditions that are found in U.S. commercial
cold storage facilities. This comment also suggests that we allow
owners, operators, or agents to request that we freeze detained fresh
products that are or are likely to be, detained for 4 or more days. One
comment recommends that we develop procedures regarding administrative
detention for perishable foods, including a specific process that would
ensure the preservation of such foods until we resolve the
administrative detention.
(Response) We will normally maintain existing storage conditions
during administrative detentions. If the owner wishes, he or she can
request that we hold the food under different conditions or request
modification of the detention order. We would accede to one or the
other of these requests except where security concerns prevent it. We
know of no process that would ensure the preservation of perishable
foods during the detention period.
i. Off loading from conveyance/partial loads. (Comment 153) One
comment suggests that we reduce the potential economic effects of
detaining large oceangoing vessels by taking one of the following
actions: (1) Not detaining products on vessels at ports without first
allowing the product to be offloaded to secure storage; (2)
specifically providing for the removal of products from vessels to
secure storage in the detention order; or (3) specifying that moving
detained product from the vessel qualifies as a basis for a conditional
release, thus permitting the movement of detained product to secure
storage. One comment notes that ships carrying bulk vegetable oils hold
the oil in individual parcel tanks. This comment notes that a ship
might transport many parcel tanks of various types of vegetable oil to
many buyers in different locations. The comment notes
[[Page 31699]]
that a single ship could carry more than 50 separate parcel tanks. This
comment argues that if we receive intelligence on the potential
contamination of a particular parcel tank, then we should remove that
parcel tank to secure shore storage and allow the ship to proceed with
deliveries of the remaining parcel tanks. One comment argues that
removal of a product from a conveyance to secure storage should be one
of the bases on which a claimant may seek a limited conditional
release. Another comment suggests that we revise the rule to indicate
that, if we detain food on a truck, then we will issue an order to the
trucking company to deliver the food to either the consignee or to a
secure location.
(Response) Owners and operators of conveyances may request
modification of a detention order to move food from a conveyance to
other storage. We generally would accede to such requests unless they
generated health risks or raised security concerns. If we determine
that only a portion of a cargo of food products meets the criteria for
administrative detention, the food or other items that can be readily
segregated and not detained can be segregated and moved. In the
analysis of the proposed rule, we noted that our experience with other
enforcements actions is that we would not cause significant delays in
the delivery of food that is packed with food that we detain
administratively. These comments did not provide information that would
require us to revise that assessment.
(Comment 154) One comment requests that we develop a process by
which we would reseal a tank truck load that we determined did not
present a problem with an FDA seal and indicate the resealing on an
official FDA document. The comment notes that receivers might still
reject the load, but that they would be less likely to reject it under
these conditions.
(Response) We will reseal a tank truck load that did not present a
problem with an FDA seal, but we will not provide an official FDA
document to that effect. Providing an official FDA document would
increase our enforcement costs slightly. It is possible that such a
document might reduce costs by encouraging receivers to accept resealed
loads. However, in the discussion of this issue under Option One, we
concluded that market forces would probably minimize unnecessary
rejections of resealed loads. The comment did not provide information
that would allow us to quantify this practice or to estimate the effect
of an official FDA document on reducing it.
j. Timeframes. (Comment 155) One comment argues that if we needed
to use any of the additional 10 calendar days beyond the initial 20-
calendar day period, then we should inform the owner of the food of
this additional time requirement, the reasons we need the additional
time, and the actual time period that we will require, up to the
maximum of 10 calendar days.
(Response) The initial detention order will include an expiration
date based on the initial 20-calendar day period. In addition, FDA
notes that under Sec. 1.379(a), FDA can order detention of the article
of food for 30 calendar days in the original detention order, if we
know from the outset that 30 rather than 20 calendar days will be
needed to institute a seizure or injunction against the detained
article of food.
If we needed to use the additional 10 calendar days, then we would
issue a new detention order with a new period of detention based on
that time period. Basing the period of detention of the new detention
order on our estimate of the portion of the maximum period of 10
calendar days that we think we might require would increase our
enforcement costs because it would require us to develop a model to
estimate the time required, and we might need to prepare additional
detention orders if we underestimated the time that we needed. The
benefit of this change is that it would allow owners to make plans
based on our current assessment of the time that we require. This
benefit would probably be minimal because we will inform owners as
quickly as possible if we terminate a detention order before the
detention period has expired. Providing owners with the reasons we need
additional time would also increase our enforcement costs. The benefit
of providing this information to owners is unclear. Any benefit would
probably be minimal because we intend to proceed as quickly as possible
with activities pertaining to food that we detain administratively.
Therefore, these changes would probably not increase net benefits.
k. Appeal hearings. (Comment 156) One comment suggests that we
start the timeframe for appeal when we notify someone who is authorized
to file an appeal. One comment requests that we revise the rule to give
the shipper the right to appeal. One comment wonders whether everyone
with a commercial interest in the food, such as an importer, could file
an appeal. One comment suggests that we revise the rule to allow the
owner to designate someone else to appeal a detention order, such as a
lawyer or a food engineer, in case the owner felt that he or she did
not have the proper skills to do so.
(Response) Any person who would be entitled to be a claimant for
the article of food, if seized under section 304(a) of the FD&C Act,
may appeal an administrative detention. The local rules of the Federal
court district in which a seizure or administrative detention occurs
set forth the procedures by which a party establishes entitlement to be
a claimant, or files a statement of interest under the revised
Supplemental Rule C(6) of the ``Federal Rules of Civil Procedure,'' and
a determination of whether a party has a sufficient interest in the
goods is made on a case-by-case basis.
As required in Sec. 1.392, we will provide a copy of the detention
order to the owner, operator or agent in charge of the place where the
food is located and to the owner of the food, if the owner's identity
can be determined readily. Examples of steps FDA will take to determine
the identity of the owner of a detained article of food include
examining any readily available bills of lading or invoices for the
article of food and asking the owner, operator, or agent in charge of
the place where the detained article of food is located for any
information he or she may have regarding the identity of the owner of
the article of food. Though FDA will make reasonable efforts to
identify the owner of the food and to notify that person of the
administrative detention while there is still time to file an appeal,
it may not always be possible for us to identify the owner of the food.
Other parties with a commercial interest in the food, including
importers and shippers, would generally be able to file an appeal.
Owners or other parties who wished to appeal an administrative
detention may choose to have other parties, such as lawyers and food
engineers, represent them for purposes of the appeal, once the appeal
is filed in the owner's name.
Changing the rule to ensure that at least one party that is able to
file an appeal has time to file an appeal after they learn of the
detention, or that everyone with a financial interest in the food has
time to appeal a detention, or that owners or other parties who wished
to appeal a detention have an opportunity to arrange for other parties
to represent them, would increase our enforcement costs. It would also
probably increase the number of appeals, which would further increase
our enforcement costs but also increase benefits by the mechanism we
described earlier. These changes might also address some distributional
concerns.
[[Page 31700]]
The revised Sec. Sec. 1.403(h) and 1.405(a) require the presiding
officer to issue a report, including a proposed decision confirming or
revoking the detention order, by noon on the fifth calendar day, while
giving the participant 4 hours to submit changes and corrections before
a final decision is issued. These changes will increase the probability
that we will correctly terminate a detention order when the food does
not present a risk, but will also increase our enforcement costs by
some amount.
(Comment 157) Some comments argue that we should guarantee the
right to a hearing. One comment suggests that we establish a national
detention approval board to ensure uniform application of the
regulation. The comment argues that establishing such a board would
allow us to avoid costly errors and delays.
(Response) As we indicated earlier, we would only grant a request
for a hearing after an appeal is filed, if a firm submitted material
that raised a genuine and substantial issue of fact. Guaranteeing the
right to an appeal hearing would increase our enforcement costs. It
might also increase benefits, because in some cases, our initial
assessment of whether a firm submitted material that raised a genuine
and substantial issue of fact might be incorrect. In that case, we
might fail to terminate a detention that we would otherwise have
terminated. This effect would probably be minimal because, as stated
earlier, we will probably grant a hearing in most cases in which a
hearing is requested.
Establishing a national detention approval board would increase our
enforcement costs. It might reduce the costs of this rule by allowing
us to avoid costly errors and delays. However, the comment did not
provide evidence that this effect would occur.
(Comment 158) Some comments request that we provide additional
guidance on how to file an appeal, addressing such issues as whether we
require all appeals to include certain basic information. One comment
suggests that we run workshops for local trainers and prepare slide and
video presentations, online training manuals, and explanatory leaflets
on how to appeal administrative detentions. One comment suggests that
we describe appeal procedures and deadlines in the detention order. The
comment suggests that we include the following information in the
detention order: The claimant has a right to appeal the order; the
appeal must be submitted in writing to the appropriate (and identified)
FDA District Director, the number of days the claimant has to file the
appeal and request a hearing, and the date by which such an appeal and
request must be made.
(Response) We will provide information on how to appeal
administrative detentions in the detention orders. As stated
previously, we also plan extensive outreach materials, including
explanatory materials, such as slide presentations, a satellite
downlink meeting, and fact sheets, to explain the requirements of the
final rule, similar to what we did for the proposed rule. Providing
other information and guidance would increase our enforcement costs. It
would probably have a minimal impact on other costs and distributional
effects because anyone wishing to file an appeal could learn what to do
from these materials.
(Comment 159) Some comments suggest that we revise the rule to
require that the official presiding at an informal hearing be senior to
the official who approved the detention order. They argue that
presiding officials may be less likely to terminate detention orders if
FDA employees senior to those presiding officials authorized those
orders.
(Response) Revising the rule as this comment suggests might
increase the likelihood that we would terminate some administrative
detention orders during the appeal process for the reasons this comment
suggests. However, we have insufficient information to establish that
this effect would take place. This revision would increase our
enforcement costs by reducing the pool of employees that would be
eligible to either authorize administrative detentions or to preside at
appeals hearings.
(Comment 160) One comment suggests that appeals hearings should
include participation or attendance by third parties.
(Response) Including a third party in appeals hearings would
increase the costs associated with those hearings. The comment did not
explain the mechanism by which the presence of a third party would
reduce costs or increase benefits. We note, however, that hearings
generally are open to anyone who wishes to attend as a nonparticipant,
unless classified or confidential information (e.g., information exempt
from disclosure under applicable laws) is being discussed.
1. Summary. Table 5 of this document summarizes the range of costs
and benefits for the five options that we have considered. We have
indicated that we cannot determine the effects of many of the suggested
revisions that we discussed under Option Five. However, we have
insufficient information to establish that any of those revisions would
increase net benefits.
Table 5.--Summary of Annual Costs and Benefits
----------------------------------------------------------------------------------------------------------------
Option Costs (in millions) Benefits
----------------------------------------------------------------------------------------------------------------
One--Transportation and Perishable $0 to $50................. >$0.
Foods as Proposed.
Two--Perishable Foods Alternatives..... $0 to $42................. >$0, But < Option One.
Three--No Transportation, But One $0 to $56................. >$0.
Additional Guard.
Four--Limited to the Bioterrorism Act.. >$0 to >$50............... >$0, But <= Option One.
Five--Revise in Other Ways............. N/A....................... N/A.
----------------------------------------------------------------------------------------------------------------
B. Final Regulatory Flexibility Analysis
We have examined the economic implications of this final 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 final rule would not have a
significant economic impact on a substantial number of small entities.
(Comment 161) In the analysis of the proposed rule, we requested
comments on the impact of the proposed rule on small entities. The only
comment we received on this issue noted that most firms making indirect
food contact color pigments that firms may use in the manufacture of
food packaging are small businesses.
(Response) This comment is consistent with the analysis in the
proposed rule. Therefore, we have not
[[Page 31701]]
revised the analysis that we presented in the proposed rule.
C. Unfunded Mandates
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires cost-benefit and other analyses before any rulemaking 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 $50 million
per year. Therefore, we have determined that this final rule does not
constitute a significant rule under the Unfunded Mandates Reform Act.
D. Small Business Regulatory Enforcement Fairness Act (SBREFA) Major
Rule
SBREFA (Pub. L. 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, OMB has determined that this final rule is not
a major rule for the purpose of congressional review.
VII. Paperwork Reduction Act of 1995
This final 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 conclude that these information collection provisions are exempt
from OMB review under 44 U.S.C. 18(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. Such a case
file would be opened as part of the decision to detain an article of
food.
VIII. 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.
IX. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the final
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 concludes that
the final 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.
X. References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 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 FDA is not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register.
1. Holcomb, Harry, Area officials have adapted a tracking system to
watch over U.S. ships in an age of terrorism, accessed on the Internet
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.philly.com/mld/inquirer/5369951.htm, accessed on
September 16, 2003.
2. AAA Environmental Industry, Inc., Cost Proposal, Schedule of
Standard Rates Effective July 1, 2002, available on the Internet at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://vendornet.state.wi.us/vendornet/wais/bulldocs/1431_4.doc,
accessed on September 16, 2003.
3. National Compensation Survey: Occupational Wages in the United
States, July 2002. U.S. Department of Labor, Bureau of Labor
Statistics, June 2003. Available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://stats.bls.gov/ncs/ocs/sp/ncbl0539.pdf
, accessed on September 16, 2003.
List of Subjects
21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 10
Administrative practice and procedure, News media.
21 CFR Part 16
Administrative practice and procedure.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1, 10, and 16 are amended as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
0
1. The authority citation for 21 CFR part 1 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355,
360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262,
264.
0
2. Subpart K is added to part 1 to read as follows:
Subpart K--Administrative Detention of Food for Human or Animal
Consumption
General Provisions
Sec.
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?
[[Page 31702]]
1.403 What requirements apply to an informal hearing?
1.404 Who serves as the presiding officer for an appeal, and for 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) 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 calendar
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 modification of the detention order
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 (21 U.S.C. 331).
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 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 (21 U.S.C. 334(h)), it may not be delivered to any of its
importers, owners, or consignees. This section does not preclude
movement at FDA's direction of imported food to a secure facility under
an appropriate Customs' bond when that bond is required by Customs' law
and regulation.
(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 to modify a detention order to permit movement 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 modification of the detention
order 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 modification of a detention order 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.''
[[Page 31703]]
(e) If FDA approves a request for modification of a detention
order, 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 modification of the detention order 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, 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 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 modification of a detention order
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;
(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 (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, FDA will advise the DOJ 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, FDA 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 the detention order is first modified under Sec.
1.381(c);
(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;
(13) A statement indicating the manner in which approval of the
detention order was obtained, i.e., verbally or in writing; and
(14) The name and the title of the authorized FDA representative
who approved the detention order.
[[Page 31704]]
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 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
(21 U.S.C. 276) 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, and FDA grants your
request, the hearing will be held within 2 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 of 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 calendar day, as appropriate;
(h) Section 16.60(e) and (f) of this chapter does not apply to a
hearing under this subpart. The presiding officer must prepare a
written report of the hearing. All written material presented at the
hearing will be attached to the report. The presiding officer must
include as part of the report of the hearing a finding on the
credibility of witnesses (other than expert witnesses) whenever
credibility is a material issue, and must include a proposed decision,
with a statement of reasons. The hearing participant may review and
comment on the presiding officer's report within 4 hours of issuance of
the report. The presiding officer will then issue the final agency
decision.
(i) Section 16.80(a)(4) of this chapter does not apply to a
regulatory hearing under this subpart. The presiding officer's report
of the hearing and any comments on the report by the hearing
participant under Sec. 1.403(h) are part of the administrative record.
(j) No party shall have the right, under Sec. 16.119 of this
chapter to petition the Commissioner of Food and Drugs for
reconsideration or a stay of the presiding officer's final agency
decision.
(k) If FDA grants a request for an informal hearing on an appeal of
a detention order, the hearing must be conducted as a regulatory
hearing pursuant to regulation in accordance with part 16 of this
chapter, except that Sec. 16.95(b) does not apply to a hearing under
this subpart. With respect to a regulatory hearing under this subpart,
the administrative record of the hearing specified in Sec. Sec.
16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 1.403(i) constitutes the
exclusive record for the presiding officer's final decision on an
administrative detention. For purposes of judicial review under Sec.
10.45 of this chapter, the record of the administrative proceeding
consists of the record of the hearing and the presiding officer's final
decision.
Sec. 1.404 Who serves as the presiding officer for an appeal, and for
an informal hearing?
The presiding officer for an appeal, and for an informal hearing,
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 written report that includes
a proposed decision confirming or revoking the detention by noon on the
fifth calendar day after the appeal is filed; after your 4 hour
opportunity for submitting comments under Sec. 1.403(h), the presiding
officer must issue a final decision within the 5-calendar day period
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-calendar 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-calendar 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
[[Page 31705]]
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-calendar 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 10--ADMINISTRATIVE PRACTICES AND PROCEDURES
0
3. The authority citation for 21 CFR part 10 continues to read as
follows:
Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.
0
4. Section 10.45 is amended by revising paragraph (d) introductory text
to read as follows:
Sec. 10.45 Court review of final administrative action; exhaustion of
administrative remedies.
* * * * *
(d) Unless otherwise provided, the Commissioner's final decision
constitutes final agency action (reviewable in the courts under 5
U.S.C. 701 et seq. and, where appropriate, 28 U.S.C. 2201) on a
petition submitted under Sec. 10.25(a), on a petition for
reconsideration submitted under Sec. 10.33, on a petition for stay of
action submitted under Sec. 10.35, on an advisory opinion issued under
Sec. 10.85, on a matter involving administrative action which is the
subject of an opportunity for a hearing under Sec. 16.1(b) of this
chapter, or on the issuance of a final regulation published in
accordance with Sec. 10.40, except that the agency's response to a
petition filed under section 505(j)(2)(C) of the act (21 U.S.C.
355(j)(2)(C)) and Sec. 314.93 of this chapter will not constitute
final agency action until any petition for reconsideration submitted by
the petitioner is acted on by the Commissioner.
* * * * *
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
0
5. 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.
0
6. Section 16.1 is amended in paragraph (b)(1) by adding an entry in
alphanumerical order as follows:
Sec. 16.1 Scope.
* * * * *
(b) * * *
(1) * * *
Section 304(h) of the act relating to the administrative detention
of food for human or animal consumption (see part 1, subpart k of this
chapter).
* * * * *
Dated: May 13, 2004.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
Dated: May 25, 2004.
Tommy G. Thompson,
Secretary of Health and Human Services.
[FR Doc. 04-12366 Filed 5-27-04; 10:57 am]
BILLING CODE 4160-01-P