Date: Jun 09, 2004
On June 4, 2004, FDA published the final rule on Administrative Detention promulgated pursuant to section 303 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). The regulations will go into effect on July 6, 2004. We expect that of all FDA bioterrorism regulations, this one will have the least overall impact on industry.
Section 303 of the Bioterrorism Act amends the seizure provision at section 304 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding a new paragraph (h) which allows an officer or qualified FDA employee to order the detention of any article of food 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. An "authorized FDA representative" (defined as the FDA District Director in whose district the article of food involved is located or an FDA official senior to that director) must approve the detention order before an FDA officer or qualified employee orders the detention.
Although the credible evidence standard is undefined, FDA refused to further define the standard in the final rule in order to maintain flexibility and interpretive discretion that may be needed in the event of terrorist threats and activity. The standard will be applied on a case-by-case basis. FDA will consider a number of factors, e.g., reliability, reasonableness, and the totality of the facts and circumstances when determining whether the standard has been met. FDA indicated that it intends to define "serious adverse health consequences" in a separate rulemaking since the term is used throughout Title III of the Bioterrorism Act.
In the final rule, FDA asserts that its administrative detention authority is not limited to situations involving intentional adulteration because threats of serious adverse health consequences may arise from unintended situations. In addition, FDA interprets its administrative detention authority to reach beyond the scope of the language prescribed in the Bioterrorism Act so that it may administratively detain a voluntarily recalled article of food.
The administrative detention period cannot exceed 20 calendar days. However, FDA may detain the food for an additional 10 calendar day period, if necessary, to institute a seizure or injunction action. In no case may the entire detention period exceed 30 calendar days.
Congress did not speak directly to the meaning of "food" in section 303 of the Bioterrorism Act. Therefore, FDA has the authority to define it in a reasonable fashion. FDA acknowledged that although the definition of food in the bioterrorism regulations has been interpreted inconsistently, the same word may be given different meanings even in the same statute, if different interpretations are what Congress intended.
The final rule on administrative detention adopts the FD&C Act's definition of "food." As a result, the administrative detention rule applies to human and pet food, food and feed additives and ingredients, and food packaging materials that contact or may migrate to food. FDA rejected comments seeking to exclude food contact materials, live animals, and/or alcoholic beverages from the definition of food. FDA concluded that all food would be subject to administrative detention regardless of whether it enters interstate commerce. The rule does not apply to food regulated exclusively by the USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.
Section 303 also authorizes regulations setting forth procedures for the expedited institution of enforcement actions against perishable food subject to a detention order. "Perishable food" is "food that is not heat treated; not frozen; and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 days under normal shipping and storage conditions." FDA focuses on procedures for instituting seizure actions on an expedited basis because seizure actions are the most efficient judicial action for the rapid control of a violative article of perishable food.1 Specifically, this part takes into consideration the 7-day timeframe set forth in the proposed definition of "perishable food." FDA plans to send the seizure recommendation to the Department of Justice (DOJ) within 4 calendar days2 after issuance of the detention order, unless extenuating circumstances exist.3
FDA must issue the detention order to the owner, operator, or agent in charge of the place where the article of food to be detained is located.4 This provision would subject common carriers of articles of food to the administrative detention provisions if the article is on the carrier. In such cases, FDA must provide a copy of the detention order to the shipper of record and the owner and operator of the vehicle or other carrier.
The detention order must include the following information: (1) the detention order number; (2) the date and hour of the detention order; (3) identification of the detained food;5 (4) period of the detention;6 (5) a statement that the food identified in the order is detained for the period shown; (6) a brief, general statement of the reasons for the detention;.7 (7) the address and location where the food is to be detained and the appropriate storage conditions; (8) any applicable conditions of transportation; (9) a statement that the food is not to be consumed, moved, altered, or tampered with in any manner during the detention period, unless subject to a request for modification of a detention order; (10) the text of section 304(h) of the FD&C Act and 21 C.F.R. §§ 1.401 and 1.402; (11) a statement that any informal hearing on 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; (12) the mailing address, telephone number, e-mail address, and fax number of the FDA district office, and the name of the FDA District Director in whose district the detained article of food is located; (13) a statement indicating the manner in which approval of the detention order was obtained, i.e., orally or in writing; and (14)the name and title of the authorized FDA representative who approved the detention order.
If FDA decides to terminate a detention order or the detention period expires, an authorized FDA representative will issue a detention termination notice releasing the detained article of food. If FDA fails to issue a termination notice and the detention period expires, the detention order is considered terminated.
Any person who is entitled to be a claimant for a detained article of food may appeal a detention order. If the detained article of food is perishable, the appeal and request for a hearing must be filed within 2 calendar days of receipt of the detention order. If the article of food is nonperishable, a notice of intent to request a hearing must be filed within 4 calendar days of receipt of the detention order. An appeal for nonperishable foods may be filed, if it does not request a hearing, within 10 calendar days of receipt of the detention order. All hearings will be held within 2 calendar days after the date the appeal is filed .8 Timeframes are necessary to ensure that FDA can adhere to the statutory requirement to issue a decision on appeal within 5 calendar days after the appeal is filed. The appeals process will terminate if FDA institutes a seizure or injunction action regarding the detained article of food.
If FDA grants a request for an informal hearing on an appeal of a detention order, the hearing will be conducted in accordance with the procedures set forth in 21 C.F.R. Part 16, "Regulatory Hearing before the Food and Drug Administration," with several exceptions designed to take into account the specifics of the administrative detention provision. One exception is that once a final decision is reached, parties do not have the recourse that is available under section 16.119 to petition the Commissioner of Food and Drugs for reconsideration or to stay the presiding officer's final agency decision.
The final rule revises the procedure applicable to informal hearings. The presiding officer must issue a written report of the hearing that includes a proposed decision explaining the reasoning behind the decision. The hearing participant may review this report and suggest changes within 4 hours of the report's issuance. The presiding officer will then issue the final agency decision.
The final rule also clarifies the components of the administrative record and the record of the administrative proceeding. The presiding officer's report of the hearing and comments by participants are part of the administrative record.
Detained food must be held in the location and under the conditions specified by FDA in the detention order. The movement of an article in violation of a detention order is a prohibited act under section 301 of the FD&C Act.
The detained article of food may not be delivered to any of its importers, owners, or consignees. The rule prohibits the delivery of a detained article of food to another entity under the execution of a bond unless the secured facility is under an appropriate customs bond, which is required by Customs laws and/or regulations.
The owner, importer, or consignee must make a "request for modification of a detention order"9and have it approved before moving the detained article of food. In addition, any required tags or labels must accompany the article during and after movement to the secure facility.
An authorized FDA representative may approve a "request for modification of a detention order" for any of the following purposes: (1) to destroy the article of food; (2) to move the detained article of food to a secure facility as described in the detention order; (3) to maintain or preserve the integrity or quality of the detained article of food; or (4) for any other purpose that the authorized FDA representative believes to be appropriate in that case. FDA advises that transporters seek a modification of a detention order to remove a detained food from a conveyance to a storage facility so that the ship, truck or railcar will be free to operate. In general, FDA will rarely modify the detention order because any further movement of the article of food increases the risk of inappropriate or unauthorized movement of the article into commerce.
FDA may mark or label the detained article of food with labels or tags that include the following information: (1) a statement that the food is being administratively detained by FDA; (2) the detention order number, the date and hour of the order, the detention period, and the name of the officer or FDA employee who issued the detention order; (3) a statement that the article of food must not be consumed, moved, altered, or tampered with in any manner for the period shown, without written permission; and (4) 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 FD&C Act punishable by fine or imprisonment or both.
1 However, FDA notes that use of injunctive relief may also be appropriate in some circumstances involving detained perishable foods.
2 If the fourth calendar day is not a working day when the government is open for business, FDA will advise DOJ of its plans to recommend a seizure action on the last working day before the fourth calendar day, and will send the recommendation as soon as practicable on the first working day that follows.
3 FDA has explained that extenuating circumstances could include, but are not limited to, instances when the results of confirmatory testing or other evidentiary development require more than 4 calendar days to complete.
4 If the owner of the article of food is different from the owner, operator, or agent in charge of the location of the food, FDA must also provide a copy of the detention order to the owner of the article of food, if the owner's identity can be readily determined. Examining any readily available bills of lading or invoices for the article of food and asking the owner, operator, or agent in charge of the place where the detained food is located for any information regarding the identity of the owner will determine the identity of the owner.
5 This information will typically include a description of the food, the quantity of food, and any identifying codes (i.e., grower codes and lot numbers).
6 This information gives one the ability to determine the expiration date of the detention order.
7 This information will include an explanation as to how the food presents a threat of serious adverse health consequences or death to humans or animals. It could be the result of an act of bioterrorism or it could be any other reason, such as failure to follow GMPs.
8 The proposed rule differentiated between perishable and nonperishable foods-hearings for perishable foods would occur 2 days after the appeal file date and 3 days for nonperishable foods.
9 Referred to as "limited conditional release" in the proposed rule.
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