Administrative
Detention of Articles of Food
Under
the Bioterrorism Act
The Food and Drug Administration (FDA) has published a proposed rule establishing procedures for the FDA to detain an article of food, if an FDA officer or qualified employee has credible evidence or information indicating that the article presents a threat of serious adverse health consequences or death to humans or animals. 68 Fed. Reg. 25,242 (May 9, 2003) (hereinafter “Proposed Rule” or “Administrative Detention Proposed Rule”) (copy attached). Comments on the Proposed Rule are due within 60 days of publication in the Federal Register, by July 8, 2003.
The Administrative Detention Proposed Rule, together with a proposed rule that would require the establishment and maintenance of records in food facilities (see our accompanying memorandum), are the final two of four proposed rules implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). The Bioterrorism Act was passed in response to the events of September 11, 2001, and Title III of the Bioterrorism Act includes provisions designed to protect the U.S. food supply from acts of bioterrorism or intentional contamination.
This memorandum summarizes the Administrative Detention Proposed Rule.
Table of Contents
Table of Contents
Summary of the Administrative Detention Proposed Rule
General Provisions Of The Proposed Rule
What Definitions Apply to This Subpart? (Proposed § 1.377)
What Criteria Does FDA Use to Order a Detention? (Proposed
§ 1.378)
How Long May FDA Detain an Article of Food? (Proposed § 1.379)
Where and Under What Conditions Must the Detained Article of
Food be Held? (Proposed § 1.380)
May a Detained Article of Food be Delivered to Another Entity
or Transferred to Another Location? (Proposed § 1.381)
What Labeling or Marking Requirements Apply to a Detained
Article of Food? (Proposed § 1.382)
What Expedited Procedures Apply When FDA Initiates a Seizure
Action Against a Detained Perishable Food? (Proposed § 1.383)
When Does a Detention Order Terminate? (Proposed § 1.384)
How Does FDA Order a Detention?
Who Approves a Detention Order? (Proposed § 1.391)
Who Receives a Copy of the Detention Order? (Proposed §
1.392)
What Information Must FDA Include in the Detention Order?
(Proposed § 1.393)
What Is the Appeal Process for a Detention Order?
Who is Entitled to Appeal? (Proposed § 1.401)
What Are the Requirements for Submitting an Appeal? (Proposed
§ 1.402)
What Requirements Apply to an Informal Hearing? (Proposed
§ 1.403)
Who Serves as the Presiding Officer at an Informal Hearing?
(Proposed § 1.404)
When Does FDA Have to Issue a Decision on an Appeal?
(Proposed § 1.405)
How Will FDA Handle Classified Information in an Informal Hearing?
(Proposed § 1.406)
Submit Comments
I. Summary of the Administrative Detention Proposed Rule
For regulated industry, the Administrative Detention Proposed Rule differs from the other proposed rules implementing the Bioterrorism Act in an important way. While the administrative detention provisions of the Bioterrorism Act, and FDA’s proposed implementing regulations, do provide a new enforcement tool for FDA, the Administrative Detention Proposed Rule primarily sets forth obligations and procedures for FDA to follow. The burdens the Administrative Detention Proposed Rule would impose upon industry are not significantly different from those that currently exist – FDA has long relied upon States to exercise the authority to administratively detain food, and FDA and the U.S. Customs Service (Customs) work together to detain imported products that may be adulterated or misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FDC Act).
The following summarizes the key provisions of the Proposed Rule, if implemented:
· An FDA officer or qualified employee could order the detention of domestic or imported food for up to 30 days if FDA has credible evidence or information that the food presents a threat of serious adverse health consequences or death to humans or animals.
· The FDA District Director in the district in which the article of food is located or an FDA official senior to such director would approve a detention order.
· FDA could require that the detained article of food be labeled as detained with official FDA tags or labels. The FDA tag or label would include, among other information, a statement that the article of food must not be consumed, moved, altered, or tampered with in any manner for the period shown, without the written permission of an authorized FDA representative.
· A violation of a detention order, the removal or alteration of the tag or label, or the transfer of a detained article of food would be a prohibited act under the FDC Act.
· FDA would state in the detention order the location and any applicable conditions under which the food is to be held.
· FDA could direct that the article of food be moved to a secure facility.
· FDA could approve a request for a limited conditional release of a detained article of food. The limited conditional release would permit removal of the detained article for destruction, movement to a secure facility, preservation, or any other appropriate purpose.
· Any claimant for a detained article of food could appeal a detention order and request an informal hearing. If FDA grants the hearing, an FDA Regional Director or his/her senior would serve as the presiding officer of the hearing.
· There would be different appeal and hearing timeframes depending upon whether the detained article of food is perishable or nonperishable.
· Perishable food:
· An appeal would have to be filed within 2 calendar days of receipt of the detention order.
· If a hearing is requested in the appeal, and FDA grants the request, the hearing would be held within 2 calendar days after the date the appeal is filed.
· FDA’s decision on the appeal would issue 5 calendar days after the appeal is filed.
· Nonperishable food:
· A notice of intent to file an appeal and to request a hearing would have to be filed within 4 calendar days of receipt of the detention order.
· An appeal would have to be filed within 10 calendar days of receipt of the detention order.
· If a hearing is requested in the notice of intent and appeal, and FDA grants the request, the hearing would be held within 3 calendar days after the appeal is filed.
· FDA’s decision on the appeal would issue 5 calendar days after the appeal is filed.
· The proposed expedited procedures for certain enforcement actions for perishable foods would require FDA to send a seizure recommendation to the Department of Justice within 4 calendar days after the detention order is issued, unless there are extenuating circumstances.
FDA distinguishes the administrative detention procedure from its authority, along with Customs, to regulate the importation of food into the United States. Because of the enforcement tools already available to FDA and Customs to control imported food, FDA does not expect to use administrative detention frequently to control imported food.
Section 303 of the Bioterrorism Act also includes a provision authorizing the agency to temporarily hold food at ports of entry. The temporary hold provision authorizes FDA to request the Secretary of Treasury (through Customs) to institute a temporary hold for up to 24 hours on an article of food offered for import at the 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 plans to develop and issue a separate guidance on the temporary hold provision.
The administrative detention process described in the proposed rule is modeled after FDA’s medical device administrative detention regulation, 21 C.F.R. § 800.55.
In one of the most controversial parts of the proposed rule, FDA tentatively concludes that all food would be subject to administrative detention, whether or not the food enters interstate commerce. FDA believes Congress intended to grant the agency authority to detain even food moving only within a State. While, practically, it is not difficult for FDA to establish that an article of food is moving in interstate commerce, it is remarkable, and very likely unconstitutional, for the agency to exempt itself from meeting this burden. The agency is seeking comment on what will be a highly controversial aspect of the proposed rule.
As with the other Bioterrorism Act proposed rules, the Administrative Detention Proposed Rule does not apply to food regulated exclusively by the U.S. Department of Agriculture (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.).
II. General Provisions Of The Proposed Rule
1. What Definitions Apply to This Subpart? (Proposed § 1.377)
Food would have the meaning given in section 201(f) of the FDC Act. That definition is: “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” 21 U.S.C. § 321(f). Examples of food that would be subject to administrative detention include, but are not limited to: fruits; vegetables; fish; dairy products; raw agricultural commodities for use as food or components of food; animal feed, including pet food; food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food; dietary supplements and dietary ingredients; infant formula; beverages, including alcoholic beverages and bottled water; live food animals (such as hogs and elk); bakery goods; snack foods; candy; and canned foods.
“Substances that migrate into food from food packaging” would include immediate food packaging or components of immediate food packaging that are intended for food use. Outer food packaging would not be a substance that migrates into food, and would, therefore, not be subject to the administrative detention provisions.
Perishable food would mean food that is not heat-treated; not frozen; and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 days under normal shipping and storage conditions. This perishable food definition has been modeled after the current Regulatory Procedure Manual (RPM) definition of “perishable commodity.” Examples of perishable foods would include, but are not limited to, fluid milk (but not ultrapasteurized); live fish, lobster, crab, other crustaceans, and shellfish; and fresh fruits and vegetables. FDA invites comments and supporting data on how to best define “perishable food” for the purposes of this proposed rule.
2. What Criteria Does FDA Use to Order a Detention? (Proposed § 1.378)
Proposed § 1.378 would state the criteria FDA would use to order a detention. These criteria are taken directly from section 303 of the Bioterrorism Act. FDA would be able to order a detention of an article of food that is found during an inspection, examination, or investigation under the FDC Act if an officer or qualified employee of FDA has credible evidence or information indicating that an article of food presents a threat of serious adverse health consequences or death to humans or animals. “Credible evidence or information” is an evidentiary standard that means evidence or information that is “worthy of belief or confidence; trustworthy.”
In applying the credible evidence or information standard to administrative detention, FDA would consider a number of factors including, but not limited to, reliability, reasonableness, and the totality of the facts and circumstances.
The officers or qualified employees of FDA who would be able to order a detention include, but are not limited to, FDA field investigators, other government employees commissioned or deputized by FDA, and FDA employees who have security clearance to receive national security information. An “authorized FDA representative” (the FDA District Director in whose district the article of food is located or an FDA official senior to such director) would have to approve a detention order before the FDA officer or qualified employee may order a detention.
3. How Long May FDA Detain an Article of Food? (Proposed § 1.379)
Proposed § 1.379 would set forth the period of administrative detention. The period would not exceed 20 calendar days after the detention order is issued, unless FDA determines that a greater period is required either to seize the article of food or to institute injunction proceedings. The authorized FDA representative could approve an additional 10 days of detention. Proposed § 1.379 states that the entire detention period may not exceed 30 calendar days in total.
4. Where and Under What Conditions Must the Detained Article of Food be Held? (Proposed § 1.380)
Proposed § 1.380(a) would require that the detained article of food be held in the location and under the conditions specified in the detention order. Use of appropriate storage conditions, such as temperature, humidity, and other conditions may be necessary to protect the safety and wholesomeness of the detained article of food.
Pursuant to proposed § 1.380(b), the detained article of food could be moved to a secure facility. FDA intends to make such removal determinations on a case-by-case basis considering several factors, including the adequacy of security and the ability to prevent the movement of the food. If FDA requests movement of the detained article, the article remains under the detention order before, during, and after movement to a secure facility.
The movement of an article of food in violation of a detention order is a prohibited act under the FDC Act. Proposed 21 C.F.R. § 1.380(e).
5. May a Detained Article of Food be Delivered to Another Entity or Transferred to Another Location? (Proposed § 1.381)
Proposed § 1.381(a) would prohibit the delivery of a detained article of food to another entity, even under the execution of a bond. A detained article of food could not be delivered to its importers, owners, or consignees. Unless subject to a conditional release, a detained article of food simply could not be moved.
Under proposed § 1.381(c), an authorized FDA representative would be able to approve, in writing, a request for a limited conditional release allowing for the movement of the detained article for any of the following purposes:
· To destroy the article of food;
· To move the detained article of food to a secure facility;
· To maintain or preserve the integrity or quality of the article of food; or
· For any other purpose that the authorized FDA representative believes is appropriate.
FDA does not envision authorizing these limited conditional releases under many circumstances. To obtain a conditional release, the owner of the detained article would submit the following in writing to FDA:
· Reasons for movement;
· Exact address of and location in the new facility (or the new location within the same facility) where the detained article of food will be transferred;
· Explanation of how the new address and location will be secure, if FDA has directed that the article of food be detained in a secure facility; and
· Explanation of how the article of food will be held under any applicable conditions described in the detention order.
If the conditional release is for the purpose of destroying the detained article of food, the submitter would also have to provide a verified statement identifying the ownership or proprietary interest in the detained article of food.
The transfer of an article of food in violation of a detention order is a prohibited act. Proposed 21 C.F.R. § 1.381(g).
6. What Labeling or Marking Requirements Apply to a Detained Article of Food? (Proposed § 1.382)
Proposed § 1.382 describes the labeling or marking requirements that would apply to a detained article of food. The label or mark applied to a detained food would include the following information:
· A statement that the article of food is detained by FDA in accordance with section 304(h) of the FDC Act;
· A statement that the article of food must not be consumed, moved, altered, or tampered with in any manner for the period shown, without the written permission of an authorized FDA representative;
· A statement that the violation of a detention order or the removal or alteration of the tag or label is a prohibited act under section 301 of the FDC Act, punishable by fine or imprisonment or both; and
· The detention order number, the date and hour of the detention order, the detention period, and the name of the officer or qualified employee of FDA who issued the detention order.
Once the detained article is released, or the detention period expires, FDA would remove, or authorize the removal of, the labels or tags. FDA does not expect the proposed labeling and marking provision to impair the future ability to distribute or market the article of food if the detention order is terminated.
7. What Expedited Procedures Apply When FDA Initiates a Seizure Action Against a Detained Perishable Food? (Proposed § 1.383)
FDA has proposed expedited procedures with regard to detained perishable foods. FDA has concluded that it is appropriate to focus on procedures to institute seizure actions when perishable food is administratively detained. For perishable foods under a detention order, FDA proposes sending a seizure recommendation to the Department of Justice (DOJ) within 4 calendar days after the detention order is issued. If the fourth calendar day is not a working day when the government is open for business, FDA would advise the DOJ on the last working day before the fourth calendar day and send the seizure recommendation as soon as practicable on the first working day that follows.
FDA would follow this 4-day timetable unless there
are “extenuating circumstances.”
Extenuating circumstances include, but would not be limited to, instances when
the results of confirmatory testing or other evidentiary development require
more than 4 calendar days to complete. FDA stated at a public meeting on this
proposed rule that it would make the results of any such testing done on a detained
product available to the article’s owner for parallel testing.
8. When Does a Detention Order Terminate? (Proposed § 1.384)
Under proposed § 1.384, an authorized FDA representative would issue a detention termination notice releasing the detained article of food if FDA decides to terminate a detention order or the detention period expires. FDA would remove, or authorize the removal of, the required labels or tags attached to the detained article. If FDA fails to issue a detention termination notice and the detention period expires, the detention order would be deemed to have terminated, apparently without any further action from FDA.
III. How Does FDA Order a Detention?
1. Who Approves a Detention Order? (Proposed § 1.391)
Proposed § 1.391 would require that an authorized FDA representative approve a detention order. “Authorized FDA representative” is an FDA District Director in whose district the detained article of food is located or an FDA official senior to such director. If prior written approval of a detention order is not feasible, FDA proposes that prior oral approval would have to be obtained and confirmed in writing as soon as possible.
2. Who Receives a Copy of the Detention Order? (Proposed § 1.392)
Proposed § 1.392(a) would require FDA to issue the detention order to the owner, operator, or agent in charge of the place where the article of food is located.
3. What Information Must FDA Include in the Detention Order? (Proposed § 1.393)
The detention order would be required to include the following information:
· The detention order number;
· The date and hour of the detention order;
· Identification of the detained article of food;
· The period of the detention;
· A statement that the article of food is detained for the period shown;
· A brief, general statement of the reasons for the detention;
· The address and location where the article of food is to be detained and the appropriate storage conditions;
· Any applicable conditions of transportation of the detained article of food;
· A statement that the article of food is not to be consumed, moved, altered, or tampered with in any manner during the detention period, unless subject to a limited conditional release;
· The text of section 304(h) of the FDC Act and (proposed) 21 C.F.R. §§ 1.401 and 1.402;
· A statement that any informal hearing on an appeal of a detention order must be conducted as a regulatory hearing under 21 C.F.R. Part 16, with certain exceptions described in proposed 21 C.F.R. § 1.403;
· The mailing address, telephone number, e-mail address, and fax number of the FDA district office and the name of the FDA District Director in whose district the detained article of food is located; and
· A statement indicating the manner in which approval of the detention order was obtained, i.e., orally or in writing.
IV. What Is the Appeal Process for a Detention Order?
1. Who is Entitled to Appeal? (Proposed § 1.401)
Under proposed § 1.401, any person who would be entitled to be a claimant for the detained article of food would be able to appeal a detention order.
2. What Are the Requirements for Submitting an Appeal? (Proposed § 1.402)
Proposed § 1.402 describes the requirements for an appeal of a detention order:
· The claimant would have to submit the appeal in writing to the FDA District Director in whose district the detained article of food is located. The appeal could be submitted in person, by mail, e-mail, or fax.
· If the detained article of food is perishable, the claimant would have to file an appeal and request for a hearing within 2 calendar days of receipt of the detention order.
· If the detained article of food is nonperishable, the claimant would have to file a notice of intent to request a hearing within 4 calendar days of receipt of the detention order. The notice of intent would enable FDA to determine whether resources should be allocated to preparing for a regulatory hearing.
· If the claimant of detained nonperishable food does not meet the four-day deadline, it would still be able to appeal the detention order, but would receive no hearing. The claimant for detained nonperishable food would have to file an appeal within 10 calendar days of receipt of the detention order.
· The appeal must include a verified statement identifying ownership or proprietary interest in the detained article of food.
· The appeal process would terminate if FDA institutes either a seizure action or an injunction.
· If the detained article of food is perishable, the hearing would be held within 2 calendar days after the date the appeal is filed. If the detained article of food is nonperishable, the hearing would be held within 3 calendar days after the date the appeal is filed.
· Under the Bioterrorism Act, FDA must issue its decision within 5 calendar days after the appeal is filed.
3. What Requirements Apply to an Informal Hearing? (Proposed § 1.403)
If FDA grants a request for an informal hearing on an appeal of a detention order, it would conduct the hearing in accordance with existing regulations in 21 C.F.R. Part 16, with the certain exceptions.
4. Who Serves as the Presiding Officer at an Informal Hearing? (Proposed § 1.404)
Proposed § 1.404 would require the FDA Regional Food and Drug Director, or other official senior to a District Director, to preside at a hearing on an appeal of a detention order.
5. When Does FDA Have to Issue a Decision on an Appeal? (Proposed § 1.405)
Proposed § 1.405(a) would require the presiding officer to issue a decision confirming or revoking the detention order within 5 calendar days after the appeal is filed. If FDA fails to provide an opportunity for a hearing, or fails to confirm or terminate the detention order within the 5-day period, the detention order is deemed terminated. Moreover, while the claimant would be able to appeal the detention order without a request for an informal hearing, the presiding officer would still be required to issue a decision on the appeal confirming or revoking the detention within 5 calendar days after the date the appeal is filed. If the presiding officer fails to issue a decision within the 5-day period, the detention order is deemed terminated.
Proposed § 1.405(d) states that if the presiding officer affirms a detention order, the article of food would continue to be detained until FDA terminates the detention order or the detention period expires, whichever occurs first. If the presiding officer affirms a detention order, the decision would be deemed a final agency action, appealable to federal court.
6. How Will FDA Handle Classified Information in an Informal Hearing? (Proposed § 1.406)
FDA expects that there may be instances where the credible evidence or information supporting a detention order consists of Classified National Security Information (“classified information”). Proposed § 1.406 provides that FDA will not release classified information. However, if the presiding officer is able to do so, consistent with safeguarding both the information and the source, the presiding officer would give to the claimant of a detained article notice of the general nature of the information and an opportunity to offer opposing evidence or information.
FDA is contemplating the development of general regulations that address handling classified information on an agency-wide basis.
FDA is unsure whether the proposed rule would have a significant economic impact on a substantial number of small businesses. FDA requests comments on the effect of the proposed rule on small businesses. In particular, FDA seeks comments on whether setting staggered compliance dates that would allow small businesses more time to comply would be consistent with Section 305 of the Bioterrorism Act.
Submit Comments Electronically
Submit Written Comments:
Submit written comments in duplicate [individuals may submit one copy] to: Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 ATTN: Docket No. 02N-0275
* * *
FDA provides a detailed analysis of the estimated costs and benefits of the Administrative Detention Proposed Rule, the proposed rule’s possible effects upon small businesses, and other issues. Those analyses are not discussed herein. However, we note that these technical sections of FDA’s other bioterrorism proposed rules contained important information and, in some instances, FDA’s estimates, particularly of costs for compliance, were very suspect. We suggest you review the proposed rule carefully, in its entirety, particularly if your business involves the production, holding, or shipment of perishable commodities. Costs to your business may be far greater than FDA estimates; if so, the flaws in the agency’s cost/benefit analysis should be highlighted.
At a public meeting discussing the Administrative Detention Proposed Rule, among other things, FDA stated that the claimant would bear the costs to store detained articles of food. The Administrative Detention Proposed Rule does not identify where detained articles will be warehoused. The lack of guidance on this important issue is one on which interested parties may wish to comment. FDA likely would bear the costs to mark or label articles of food as detained.
As mentioned above, comments are due on both the recordkeeping and administrative detention proposed rules by July 8, 2003. Please contact us if we can be of any assistance in interpreting these complex proposals, or in drafting comments.
The other proposed rules issued by FDA to implement the Bioterrorism Act have been analysed by Olsson, Frank & Weeda for the Food Institute and are available to you at no charge. Click here to view the other analyses.
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