5-3 - ADMINISTRATIVE DETENTION OF FOOD

5-3-1 - Purpose

This section provides the procedures and defines the responsibilities for the various operations related to the Administrative Detention of articles of food.

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5-3-2 - Background

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“the Bioterrorism Act”) (Public Law 107-188) was signed into law on June 12, 2002. The Bioterrorism Act includes a provision, Section 303, which amended Section 304 of the Federal Food, Drug, and Cosmetic Act (the Act) by adding subsection (h) to authorize administrative detention of food. Section 304(h) of the Act 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 Act if the officer or qualified employee has credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals. Section 303 of the Bioterrorism Act also amended the Act by adding Subsection (bb) to Section 301, making it a prohibited act to move an article of food in violation of a detention order or to remove or alter any mark or label required by a detention order that identifies an article of food as detained.

Regulations have been established in 21 CFR Part 1, Subpart K, for administrative detention of foods. Administrative detention is intended to protect the public by preventing movement in commerce of food until FDA has had time to consider the appropriate action to be taken and, when appropriate, to initiate a seizure or injunction action. Administrative detention of food requires prior approval of the district director or official senior to the district director of the district where the detained article of food is located. The period of the detention must be for a reasonable period, not to exceed 20 days. However, the period of detention may be extended up to a total of 30 days, if necessary to provide sufficient time to institute a seizure or injunction action.

Any person who would be entitled to claim the detained article of food, if seized, may appeal the administrative detention and may request a hearing on the appeal. The appeal and request for a hearing must be submitted to the district director of the district that issued the detention order. The hearing must be held within two (2) calendar days after the appeal is filed. The decision to affirm or revoke the detention must be made within five (5) calendar days after the appeal is filed.

1. References

   The regulatory authority for administrative detention of foods and associated operations appears in sections 304(h) and 201(x) of the Act, and in 21 CFR 1.377-1.406, 21 CFR Part 16, 21 CFR 10.19, and 21 CFR 10.45. Investigations Operations Manual (IOM) Subchapter 2.7 Detention Activities contains the instructions for implementing the detention authority.

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5-3-3 - Issuing and Terminating Detention Orders

1. Basis for Detention
   An FDA employee, or State or local officer or employee commissioned by FDA as an officer of the Department, may order a detention as part of his/her function of inspecting, examining, or investigating an article of food. The detention order must be based on credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals. (21 CFR 1.378)
   
2. Approval of Detention Order by the District Director
   The FDA district director in whose district the article of food is located, or an FDA official senior to such director (hereinafter termed “District 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. (21 CFR 1.391)
   
   Prior to approving the detention order, the “District Director” should ensure that there is appropriate scientific support for the determination that the article of food presents a threat of serious adverse health consequences or death to humans or animals. The district should initiate this process by notifying FDA’s Emergency Operations Center (EOC) at 301-443-1240. EOC will coordinate the emergency response activities associated with an article of food that may present a threat of serious adverse health consequences or death to humans or animals and will notify the appropriate center (CFSAN and/or CVM) and ORA offices, either verbally or in writing.
   
   CFSAN or CVM, as appropriate, should determine whether the food presents a threat of serious adverse health consequences or death to humans or animals and verbally provide that determination to the district and EOC. The center should subsequently provide written documentation of the determination, including documentation necessary to support subsequent legal action.
   
3. Center Notification
   As soon as possible after contacting EOC regarding the threat of serious adverse health consequences or death to humans or animals, the district should notify the appropriate center compliance contact of the impending legal action to discuss available evidence, to determine with the center what, if any, additional evidence should be obtained to support the case, and to work with the center to expedite the recommendation.
   1. Compliance Contacts:
      1. Food for Humans: Director, Division of Enforcement, Office of Compliance (HFS-605), Center for Food Safety and Applied Nutrition, 301-436-2417
      2. Food for Animals: Director, Division of Compliance, Office of Surveillance and Compliance (HFV-200), Center for Veterinary Medicine, 240-276-9200.
         
4. Issuing the Detention Order
   The detention order is issued in writing, in the form of a Detention Notice (Form FDA 2289). The detention order must be signed and dated by the FDA employee (usually an investigator) or commissioned officer who 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.
   
   FDA must issue the detention order to the owner, operator, or agent in charge of the place where the article of food is located. If this individual is not the owner of the article of food, FDA must provide a copy of the detention order to the owner, if the owner’s identity can be readily determined. Copies that cannot be hand delivered by an investigator must be sent expeditiously, usually by overnight delivery, with documentation of receipt of delivery.
   
   If the article of food is detained in a vehicle or other carrier used to transport the detained article, FDA must provide a copy of the detention order to the shipper of record, the owner and operator of the vehicle or other carrier, and the owner of the food, if their identities can be readily determined. Copies that cannot be hand delivered by an investigator must be sent expeditiously, usually by overnight delivery, with documentation of receipt of delivery.
   
5. Detention Notice and Detention Tags - Forms
   Section 2.7.2.3 of the IOM provides instructions for completing the Detention Notice (Form FDA 2289). Section 2.7.2.4 provides instructions for completing the Detention Tag (Form FDA 2290), which should be affixed to the article of food subject to the detention order. If necessary, a label other than the Detention Tag may be used to identify the detained article of food, providing the label includes the information required in 21 CFR 1.382.
   
   The detention order frames the issues for any appeal, including any informal hearing that may result from the detention. Therefore, the information on the order concerning the reason for detention is important.
   
   The detention order must contain a brief, general statement of the reasons for the detention. There is no requirement that the order include all of the reasons for believing that the article of food presents a threat of serious adverse health consequences or death to humans or animals. The reasons used in the detention order do not limit the charges that may be included in a subsequent legal action. If the detention is based on classified information, this information must not be provided in the detention order.
   
6. Length of Detention
   The article of food initially should be detained for 20 calendar days, unless the district believes that additional time will be required to institute a seizure or injunction. In such cases, the detention should be made for 30 calendar days at the time the order is issued.
   
   If the article of food is detained for 20 days and a seizure or injunction cannot be instituted against the article of food within that time frame, the detention can be extended to a total of 30 days. If a detention is extended from 20 to 30 days, FDA will issue another detention order and place new tags or labels on the product. The entire detention period may not exceed 30 days.
   
7. Movement, Use, etc. of a Detained Article of Food
   An article of food subject to a detention order may not be delivered under the execution of a bond. Notwithstanding Section 801(b) of the Act, while any article of food is subject to a detention order under Section 304(h) of the Act, it may not be further delivered to any of its importers, owners, or consignees. This does not preclude movement at FDA's direction of imported food to a secure facility under an appropriate Customs Bond when that bond is required by U.S. Customs and Border Protection law and regulation.
   
   The detained article of food must be held in the location and under the conditions specified by FDA in the detention order. The movement of an article of food in violation of a detention order is a prohibited act under Section 301(bb) of the Act.
   
   Except as noted below, no person may transfer a detained article of food within or from the place where it has been ordered detained, or from the place to which it was removed, until the detention order is terminated by the “District Director” or the detention period expires, whichever occurs first.
   
   1. The “District Director” may approve, in writing, a request to modify a detention order to permit movement of a detained article of food for any of the following purposes:
      1. To destroy the article of food;
      2. To move the detained article of food to a secure facility under the terms of a detention order (see below);
         
      3. To maintain or preserve the integrity or quality of the article of food; or
      4. For any other purpose that the “District Director” believes is appropriate in the case.
         
   The required tags or labels must accompany the detained article during and after movement, and must remain with the article of food until FDA terminates the detention order or the detention period expires, whichever occurs first, unless otherwise permitted by the “District Director” who approves the modification of a detention order.
   
   If FDA approves a request for modification of a detention order to allow the food to be moved, the article may be transferred but remains under detention before, during, and after the transfer. The letter allowing the transfer should reiterate this. A detained article of food may not be transferred without FDA supervision unless FDA has declined in writing to supervise the transfer. If FDA has declined in writing to supervise the transfer of a detained article, the person who received the detention order, or his representative, must immediately notify the “District Director” who approved the modification of the detention order that the article of food has reached its new location, and the specific location of the detained article within the new location. Such notification must be in writing, and may be in the form of a fax, e-mail, or other form as agreed to by the “District Director.”
   
8. Movement to a Secure Facility at FDA’s Request
   If, after a food is detained, FDA determines that removal to a secure facility is necessary, the article of food must be removed to a secure facility at the expense of the owner or claimant. The investigator who issued the initial detention order or other qualified official will issue a modified detention order, indicating the location to where the food must be moved. A detained article of food remains under detention before, during, and after movement to a secure facility. FDA will also state in the detention order any conditions of transportation applicable to the detained article.
   
   As noted above, the detained article of food must not be moved to the secure facility until the FDA modifies the detention order.
   
9. Legal Actions against Detained Food, Including Perishable Food
   The district should expedite the preparation of a legal action recommendation to obtain control over the detained food, particularly perishable food. This will most often be through a seizure action.
   
   If FDA initiates a seizure action against a perishable food, as defined in 21 CFR 1.377, that has been detained, we are required by 21 CFR 1.383 to send the seizure recommendation to the Department of Justice (DOJ) within 4 calendar days of issuing the detention order, unless there are extenuating circumstances. Extenuating circumstances include (but are not limited to) instances where the results of confirmatory testing or other evidentiary development requires more than 4 calendar days to complete. If the fourth calendar day is not a working day, the Office of Chief Counsel (OCC) should advise DOJ on the last working day before the deadline of its plans to recommend a seizure and will send the seizure as soon as practicable on the first working day after the non-work day.
   
   All recommendations for legal action against detained food should be flagged to indicate they involve product that is under detention, include the date the detention expires (and, for perishable food, the deadline for sending the recommendation to DOJ), and be delivered to the responsible center, Division of Compliance Management and Operations (DCMO) (for seizures only), and OCC by the most expeditious means, which may include hand-carrying or electronically. Overnight delivery service may be used if the food is nonperishable and deadlines can still be met.
   
   The center, DCMO, and OCC will review the recommendation concurrently. The center compliance office, DCMO, and OCC should expedite their reviews if the legal action is to be instituted prior to expiration of the detention.
   
   When the action is a seizure, the district is responsible for coordination with the U.S. Attorney's office and the Marshal's Service, to facilitate the prompt filing of the complaint and seizure of the food. The district also is responsible for immediately providing oral or e-mail notice of the accomplishment of the seizure to the appropriate center compliance office, DCMO, OCC, and the presiding officer of any in-process appeal of a detention order.
   
   When FDA institutes a seizure or injunction action regarding the article of food involved in the detention order, the process for the appeal of a detention order terminates. (21 CFR 1.402(c))
   
10. Termination of Detention Orders
    If FDA terminates a detention order or the detention period expires, the “District Director” will issue a detention termination notice releasing the article of food to any person who received the detention order or that person’s representative and will remove, or authorize in writing the removal of, the required tags or labels. While the regulation does not give a time frame for FDA to issue the termination notice, we expect that we will normally be able to issue the termination notice to the person who received the detention order within one calendar day of the decision to terminate the detention order.
    1. FDA will terminate a detention order when one of the following occurs:
       1. FDA determines that the food does not present a threat of serious adverse health consequences.
          
       2. FDA approves voluntary destruction and the destruction is accomplished.
       3. The detention order is appealed and the presiding officer revokes the detention order.
       4. The detention period expires. If FDA fails to issue a detention termination notice and the detention period expires, the detention is deemed to be terminated.
          
    The “District Director” issues a Detention Termination Notice (Form FDA 2291) to the person(s) who received the Detention Notice, or his representative(s) and, if movement of the food occurred prior to the termination, to the person possessing the food. The notice may be issued in person or by mail. If the termination notice is issued by mail, request that the Detention Tags (Form FDA 2290) be returned. If the termination notice is issued in person, see Section 2.7.2.5 of the IOM for instructions.
    
11. Responsibilities For Issuing And Terminating Detention Orders
    1. District Responsibilities; The district is responsible for:
       1. Notifying the appropriate center as soon as it becomes aware of a situation where administrative detention may be appropriate.
       2. Ensuring legal and scientific support from the senior compliance official of the appropriate center before issuing a detention order.
       3. Issuing the detention order.
       4. Notifying the Director, DCMO, the senior compliance official or designee of the appropriate center, and OCC by phone or e-mail of the detention and supplying them with a copy of the detention order by the most expeditious means available (fax, express mail, e-mail, etc.) immediately after issuance.
       5. Approving and monitoring the movement of detained food.
       6. Notifying the Regional Food and Drug Director (RFDD) that the district issued a detention order. NOTE: The RFDD should not become involved in decisions relating to issuing or monitoring the detention order. The RFDD may be the presiding officer at a hearing, if requested, and so must avoid participating in the investigation or action that is the subject of the hearing, and must be free from bias or prejudice (21 CFR 16.42(b)).
       7. Pursuing, with appropriate speed, the follow-up legal action.
       8. When warranted, issuing a Detention Termination Notice (Form FDA 2291) in a timely manner.
    2. Center Responsibilities; The center is responsible for:
       1. Providing a prompt response to the district’s request for a determination on whether the article of food presents a threat of serious adverse health consequences or death to humans or animals. The center should expeditiously indicate its decision concurrently to the district and EOC by phone, fax, or e-mail.
       2. Providing written documentation of the determination on whether the article of food presents a threat of serious adverse health consequences or death to humans or animals, including documentation necessary to support the subsequent legal action.
       3. Working with the district Compliance Office to identify evidence needed to support the legal case.
       4. Notifying DCMO and OCC about the administrative detention and the legal action.
       5. Promptly notifying the district and OCC of any issues or center concerns that need to be resolved, prior to providing support for the legal action.
       6. Expeditiously reviewing the legal action recommendation and providing expert witnesses and other support, as appropriate, for the legal action.
       7. Coordinating the legal action with DCMO and OCC.
    3. RFDD Responsibilities
       
       Although the RFDD should be informed about an impending administrative detention, the RFDD should refrain from becoming involved in decisions relating to issuing or monitoring the detention order. After the detention order has been issued, the RFDD must insulate himself/herself from all aspects of the detention except those relating to his/her responsibilities as a presiding officer for the hearing, if requested.

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5-3-4 - Appeal of a Detention Order

1. Appeal and Hearing
   
   Any person who would be entitled to be a claimant for the article of food, if seized under the Act, may appeal a detention order. The appeal must be submitted in writing, to the district director, in whose district the detained article of food is located, at the mailing address, e-mail address, or fax number identified in the detention order. The appeal must include a verified statement identifying the appellant’s ownership or proprietary interest in the detained article of food, in accordance with Supplemental Admiralty Rule C of the Federal Rules of Civil Procedure.
   
   If the detention order is appealed, the agency must provide the appellant with an opportunity to request an informal hearing. The request for a hearing must be in writing, must be included in the request for an appeal, and must conform to the time frames specified below. The agency has the authority to deny a hearing when the appeal raises no genuine and substantial issue of fact and FDA is entitled to judgment as a matter of law. If the district director, in consultation with OCC, determines that a hearing is not justified, written notice of the determination will be given to the parties explaining the reason for denial.
   
2. Time Frames
   1. Perishable food - The appeal must be filed within 2 calendar days of receipt of the detention order.
   2. Nonperishable food - The appeal must be filed within 10 calendar days of receipt of the detention order. However, if the appeal includes a request for a hearing, the notice of intent to request a hearing must be filed within 4 calendar days of receipt of the detention order, or the hearing will not be granted.
      
   The date of filing the appeal will be the date the submission is received by the district office.
   
   If a hearing is requested, and FDA grants the request, the hearing must be held within 2 calendar days after the date the appeal is filed. The decision to affirm or revoke the detention must be made within five (5) calendar days after the appeal is filed.
   
   The appeal process terminates if FDA institutes a seizure or injunction action regarding the article of food involved in the detention order. (21 CFR 1.402(c)).
   
   A summary of these timeframes is presented in Exhibits 5-8 and 5-9 “Timeframes for Administrative Detention of Food.”
   
3. Presiding Officer
   
   The presiding officer for an appeal and an informal hearing must be an RFDD or another FDA official senior to an FDA district director. (21 CFR 1.404) Generally, the RFDD of the region where the detained article of food is located will serve as the presiding officer. If that individual is not able to serve as the presiding officer, he or she is responsible for arranging to have an RFDD from another region serve as the presiding officer. If an RFDD is not available, the Director, Office of Enforcement (OE), ORA will serve as the presiding officer.
   
4. Communications between Parties to the Hearing and the Presiding Officer
   
   Parties to the hearing should avoid any off-the-record communication with the presiding officer. If any communication of this type occurs, it must be reduced to writing and made part of the administrative record of the hearing. The other party must be provided with a copy of the letter or memorandum of the communication and must be provided an opportunity to respond (21 CFR 16.44(b)).
   
   The person who writes a letter or memorandum of meeting between a participant in the hearing and the presiding officer must send a copy to all of the participants (21 CFR 16.44(c)).
   
5. Appeal Processing Responsibilities
   1. District Responsibilities
      Preparation for an appeal should begin when the district decides to detain an article of food.
      1. When the district receives an appeal, the district director:
         • Dates and time stamps the appeal and notifies the appellant of receipt of the appeal.
           
           If the appeal has not been filed within the established time frame, the appeal is not valid and the detention remains in place until it is terminated.
           
           If it is determined that the appeal does not demonstrate ownership or proprietary interest as required in 21 CFR 1.402(b), the appeal is not valid. OCC may be consulted on this issue. At the discretion of the district director, if sufficient time is available, the district may notify the appellant of the requirement to provide written demonstration of ownership or proprietary interest and allow the appellant to re-file the appeal with the required information. The re-filing must be accomplished within the applicable timeframe.
           
           If the appeal does not clearly specify that a hearing is requested, a hearing will not be granted.
           
         • Notifies, orally or by email, the center, DCMO, OCC, and the RFDD of the appeal immediately and forwards a copy of the appeal to them as soon as possible by fax or electronically. Requests assistance of the center and OCC for completing the next item.
      2. When the appeal includes a request for a hearing:
         • Prepare a general summary of the information that will be presented by FDA at the hearing in support of the detention order (“general summary”) and a comprehensive statement of the basis for the detention order (“comprehensive statement”), in accordance with 21 CFR 16.24(f).
           
           EXCEPTION: When a detention order is based on classified information, 21 CFR 16.24(f) does not apply, and the district should consult with OCC to determine whether the presiding officer can give the appellant notice of the general nature of the information consistently with safeguarding the information and its source. (21 CFR 1.403(e) and 1.406)
           
           The detention order (Detention Notice) may serve as the comprehensive statement only if the reason for detention is described in sufficient detail. See Exhibits 5-10 and 5-11 for an example of a general summary and a comprehensive statement, respectively.
           
           Except when the detention is based on classified information, forward the general summary and the comprehensive statement to the appellant (21 CFR 16.24(f) and Section 201(x)(3) of the Act), the presiding officer, center, and OCC representatives to the hearing. Send the documents immediately so that they arrive as soon as possible, but at least one day prior to the hearing. If the detention is based on classified information, do not forward any information (or statements) to the appellant without the concurrence of OCC.
           
         • At least one day before the hearing, provide the appellant, presiding officer, center, and OCC representatives to the hearing, written notice of, or copies of, if they could not reasonably be expected to obtain copies, any published articles or written information to be presented at or relied on at the hearing (21 CFR 16.24 (g)).
      3. When the appeal does not include a request for a hearing:
         • Forward all the information that supports the detention to the presiding officer. This includes the referenced general summary and comprehensive statement and any additional information provided by the appellant. The information should arrive no later than the third calendar day after the appeal is filed, so that the information can be reviewed and a decision rendered within 5 calendar days after the date the appeal is filed.
   2. Presiding Officer Responsibilities
      1. When notified of an appeal, and a hearing is requested, the presiding officer should:
         • Orally contact the parties as soon as possible and set a date for a hearing to be held within two (2) calendar days after the date the appeal is filed. The hearing normally takes place at the district office where the goods are located.
         • Provide all parties with written notification of the time, date, and location of the hearing.
         • Provide the appellant with oral and written notification (see form letter as Exhibit 5-12):
           1. of those portions of 21 CFR Part 16 that are excluded or modified under 21 CFR 1.403 and waived or modified for hearings on appeal of administrative detentions (see "Informal Hearing on Appeal of a Detention Order.");
           2. that the informal hearing is not a public hearing per 21 CFR 16.60(a), in order to protect investigatory records compiled for law enforcement purposes that are not available for public disclosure under 21 CFR 20.64, or trade secrets and confidential commercial information that is not available for public disclosure under 21 CFR 20.61;
           3. that the appellant should provide, at the hearing, a brief summary of any lengthy documents for presentation at the hearing (e.g., volumes of computer printouts);
           4. that the appellant should provide the district director written notice of, or a copy of (if the district director could not reasonably be expected to obtain a copy), any published articles or written information for presentation at or relied on at the hearing, at least 1 day before the hearing, if feasible, as required by 21 CFR 16.24(g); and notification
           5. of the requirements under 21 CFR 16.44(c) (see "Communications between Parties to the Hearing and the Presiding Officer.")
      2. When notified of an appeal, and no hearing is requested , the presiding officer should orally notify the:
         • parties that they should submit information supporting their positions as soon as possible, and no later than the third calendar day after the appeal is filed, so that the information can be reviewed and a decision issued within 5 calendar days after the date the appeal is filed.
         • appellant of the requirement under 21 CFR 16.44(c) (see "Communications between Parties to the Hearing and the Presiding Officer," above.)
      3. When advice of the OCC is needed, the presiding officer should contact the Deputy Chief Counsel for Litigation.
   3. OCC Responsibilities; OCC is responsible for:
      
      1. Assigning an OCC attorney to review information on the detention order and to represent the district during any appeal and hearing;
      2. Expediting review of information provided by the district;
      3. Determining whether the district and the presiding officer require legal counsel; and,
      4. Working with the district to prepare for any hearing and appeal.
   4. Center Responsibilities The center is responsible for providing:
      
      1. scientific, technical, and policy support to the district; and,
      2. representatives to the hearing, if necessary.
   5. DCMO Responsibilities; DCMO is responsible for ensuring that all:
      1. agency and OCC components are notified of and prepared for a hearing; and,
      2. documentation from the district relating to the detention and hearing is provided to the center compliance office and OCC.

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5-3-5 - Informal Hearing on Appeal of a Detention Order

1. Background
   Section 304(h)(4) of the Act requires the Secretary to provide the appellant with an opportunity for an "informal hearing." Section 201(x) of the Act defines this term. 21 CFR 1.403 requires that FDA conduct the hearing in accordance with 21 CFR Part 16, Regulatory Hearing before the Food and Drug Administration, with the waivers and modifications noted below. 21 CFR 16.5(b) advises that Part 16 procedures apply to the extent that they are supplementary to, and not in conflict with, the other procedures specified in a regulation that provides a person with an opportunity for a hearing. 21 CFR 10.19 and 21 CFR 16.60(h) give the presiding officer the authority to suspend, modify, or waive provisions under Part 16.
   
2. Waivers and Modifications to 21 CFR Part 16
   If FDA grants a request for an informal hearing on an appeal of a detention order, FDA must conduct the hearing in accordance with 21 CFR Part 16, except that:
   1. The detention order under 21 CFR 1.393, rather than the notice under 21 CFR 16.22(a), provides notice of opportunity for the hearing and is part of the administrative record of the regulatory hearing under 21 CFR 16.80(a);
   2. A request for a hearing must be addressed to the FDA district director in whose district the article of food involved is located;
   3. The provision in 21 CFR 16.22(b), providing that a person not be given less than 3 working days after receipt of notice to request a hearing, does not apply;
   4. The provision in 21 CFR 16.24(e), stating that a hearing may not be required to be held at a time less than 2 working days after receipt of the request for a hearing, does not apply;
   5. 21 CFR 1.406, rather than 21 CFR 16.24(f), describes the statement that will be provided to an appellant where a detention order is based on classified information;
   6. 21 CFR 1.404, rather than 21 CFR 16.42(a), describes the FDA employees, e.g., Regional Food and Drug Directors or other officials senior to a district director, who preside at hearings;
   7. The presiding officer may require that the hearing be completed within 1 calendar day, as appropriate;
   8. 21 CFR 16.60(e) and (f) do not apply to the hearing. The presiding officer must prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. The presiding officer must include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and must include a proposed decision, with a statement of reasons. The hearing participant may review and comment on the presiding officer's report within 4 hours of issuance of the report. The presiding officer will then issue the final agency decision;
   9. 21 CFR 16.80(a)(4) does not apply to the hearing. The presiding officer's report of the hearing and any comments on the report by the hearing participant under 21 CFR 1.403(h) are part of the administrative record;
   10. No party shall have the right under 21 CFR 16.119 to petition the Commissioner of Food and Drugs for reconsideration or a stay of the presiding officer's final agency decision; and,
   11. If FDA grants a request for an informal hearing on an appeal of a detention order, the hearing must be conducted as a regulatory hearing pursuant to regulation in accordance with 21 CFR Part 16, except that 21 CFR 16.95(b) does not apply to the hearing. With respect to the regulatory hearing on an appeal of a detention order, the administrative record of the hearing specified in 21 CFR 16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 1.403(i) constitutes the exclusive record for the presiding officer's final decision on an administrative detention. For purposes of judicial review under 21 CFR 10.45, the record of the administrative proceeding consists of the record of the hearing and the presiding officer's final decision.
       
   21 CFR 16.60(b), which provides that all parties may confront and conduct reasonable cross-examination of any person (except for the presiding officer and counsel for the parties) who makes any statement on the matter at the hearing, is modified. Reasonable questions will be allowed instead. Reference Congressional intent: House of Representatives Report no. 94-853. Also, see 21 CFR 16.5 and 16.60(h).
   
3. Conducting the Hearing
   The presiding officer should inform the parties of the applicable modifications to 21 CFR Part 16 “Regulatory Hearing Before the Food and Drug Administration,” as provided for in the administrative detention regulation (21 CFR 1.403). The presiding officer will explain that the purpose of the hearing is to determine whether FDA, at the time of the detention and as charged in the detention order, had credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.
   
   The FDA representative(s) must explain the bases for the detention and answer reasonable questions from the appellant.
   
   The appellant may present relevant information to support his/her position that the article should not be subject to detention.
   
   Both parties may conduct reasonable questioning of the other (section 201(x)(4) of the Act; 21 CFR 16.60(b), as modified herein).
   
   The presiding officer will ensure that the material presented and the questions asked are relevant to the issue of the hearing.
   
   The appellant may request that a transcript of the hearing be taken. However, the appellant must pay the cost of the transcript and furnish the presiding officer a copy for the record. FDA also may request a transcript of the hearing, in which case the costs are borne by the government.
   
   The appellant may obtain a copy of the government transcript by submitting a request under the Freedom of Information Act (FOIA). 21 CFR Part 20 applies to the release of the transcript.
   
   The presiding officer should notify the parties that his/her decision will not await transcription or correction of the transcripts so ordered.
   
4. Responsibilities For The Hearing:
   1. Center Responsibilities
      The center will provide documents, witnesses, or office representatives for the hearing if requested by the district or the OCC attorney counseling the district.
   2. OCC Responsibilities
      OCC will provide counsel for the district and/or the presiding officer, as appropriate, for the hearing.
   3. District and Presiding Officer Responsibilities
      The section “Conducting the Hearing” includes individual responsibilities of the district and the presiding officer.

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5-3-6 - Issuing the Decision on an Appeal and Requirements After a Hearing on an Appeal of a Detention Order

1. Confirming or Revoking the Detention Order
   If the agency can demonstrate it 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, the presiding officer will affirm the detention order. If not, the presiding officer will revoke the detention order.
   
2. Time Period for Rendering Decision
   The presiding officer must issue a final decision confirming or revoking the detention order within five calendar days after the appeal is filed. If the presiding officer fails to confirm or terminate the detention order within the five calendar day period, the detention order is deemed terminated.
   
3. Issuance of the Order
   The decision should be issued in the form of an order. If classified information was used to support the detention, then any confirmation of the detention must state whether it is based in whole or in part on that classified information, but will not reveal the classified information. (See Exhibit 5-13 for model order, to be used when no hearing is held, or when the order cannot be consolidated with the Written Report of the Hearing because the report cannot be completed within the timeframe for issuing the order.)
   
   The appellant should be orally notified of the order immediately. A copy of the order should then be mailed to the appellant to ensure overnight delivery and documentation of receipt of delivery (e.g., FedEx or certified mail, return receipt requested). The center, DCMO, and OCC should be notified of the decision as soon as possible.
   
4. Additional Requirements After a Hearing
   1. Written Report of Hearing and Opportunity for Comment
      The presiding officer must issue a written report of the hearing that includes a proposed decision confirming or revoking the detention by noon on the fifth calendar day after the appeal is filed. The report must include a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and must include a proposed decision confirming or revoking the detention, with a statement of reasons. All written material presented at the hearing must be attached to the report.
      
      The hearing participants must be given a four hour opportunity to submit comments on the report.
      
      The presiding officer must issue the final order on the detention within the five calendar day time period after the appeal is filed. The completion of the written report of the hearing should not delay the order. Normally, the order is consolidated with the written report of the hearing. However, when the presiding officer needs additional time to complete the written report of the hearing, the report is separate from and will shortly follow the order.
      
   2. Administrative Record of the Hearing
      The presiding officer should prepare the Administrative Record of the Hearing, which consists of the following items (21 CFR 1.403(k)):
      1. The notice of opportunity for hearing and the response (e.g., the detention order that indicates the opportunity for a hearing and the request for hearing or appeal without a request for a hearing);
      2. All written information and views submitted to the presiding officer in conjunction with the hearing;
      3. Any transcript of the hearing;
      4. All letters and memoranda of meetings and communications between participants and the presiding officer referred to in 21 CFR 16.44(c); and,
      5. The presiding officer’s written report of the hearing and any comments on the report, including comments on the proposed decision, by the hearing participant under 21 CFR 1.403(h).
      
      The original Administrative Record of the Hearing should be filed with the firm’s official file at the district office after completion of the report. A copy should be forwarded to the involved center compliance office for its information. A copy of the record should be sent to and maintained by the office of the presiding officer, if requested.
5. FOIA Requests
   21 CFR Part 20 applies to all requests for documents involved in administrative detentions.

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