[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]]
-----------------------------------------------------------------------
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
-----------------------------------------------------------------------
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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> A violation of a detention order or the removal or
alteration of the tag or label is a prohibited act.
<bullet> FDA will state in the detention order the location and any
applicable conditions under which the food is to be held.
<bullet> 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.
<bullet> 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.
<bullet> Any transfer of a detained article of food in violation of
a detention order is a prohibited act.
<bullet> 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.
<bullet> This rule includes appeal and hearing timeframes for both
perishable and nonperishable detained articles of food.
<bullet> Perishable food:
<bullet> An appeal must be filed within 2 calendar days of receipt
of the detention order.
<bullet> 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.
<bullet> FDA's decision on appeal will be issued 5 calendar days
after the appeal is filed.
<bullet> Nonperishable food:
<bullet> 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.
<bullet> An appeal must be filed within 10 calendar days of receipt
of the detention order.
<bullet> 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.
<bullet> FDA's decision on appeal will be issued 5 calendar days
after the appeal is filed.
<bullet> 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.
<bullet> 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://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://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://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://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://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.''
<bullet> 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