However, prior notice submitters are reminded that the HTS Code is required by CBP independent of prior notice. See 19 CFR 143 Subpart D - Electronic Entry Filing, which sets forth the requirements for electronic filing, and specifically 19 CFR 143.32(f), which references the Customs and Trade Automated Interface Requirements (CATAIR) as the defining document for what data has to be submitted. Therefore, filers should keep in mind that ABI/ACS will not accept a submission that lacks the HTS code.  (Source)

FDA and CBP should typically consider not taking any regulatory action if there is a prior notice violation because the prior notice was submitted more than 5 calendar days before the anticipated date of arrival, provided that: (1) the prior notice was submitted less than 10 calendar days before the anticipated date of arrival; and (2) the prior notice was submitted through the Prior Notice System Interface (PNSI). In addition, under the same conditions, FDA should typically provide the Prior Notice Confirmation Number when prior notice has been confirmed for review even if prior notice was submitted more than 5 calendar days before the anticipated date of arrival. Because of the way the Automated Broker Interface of the Automated Commercial System (ABI/ACS) is programmed, when prior notice is submitted through ABI/ACS, the Prior Notice Confirmation Number cannot be provided more than 5 calendar days before the anticipated date of arrival. (source)

INTRODUCTION

There are various regulations that govern food imports into the United States. This paper will explore several of the more current ones, with concentration on one of the most recent and important legislation regulating the import of food. This is the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 or better known as the Bioterrorism Act.

Food imports into the United States (excluding meat, poultry and eggs which are regulated by the United States Department of Agriculture – USDA) are under the jurisdiction of the Food and Drug Administration (FDA).

A. THE BIOTERRORISM ACT

The Bioterrorism Act was enacted to protect the U.S food supply and its human and animal population. In the aftermath of September 11, 2001 and the subsequent anthrax incidents, there were grave concerns about the possibility of unconventional terrorist attacks through biological and chemical means to the food supply chain. The Act lays down laws involving stringent documentary requirements and regulations; encompassing inspections, sampling, testing etc which will affect the import of food and food related goods into the United States.

The Bioterrorism Act was passed by United States Congress and signed into law on June 12, 2002 by President Bush.  FDA) administers the act.

With the Act made into law, the FDA stepped-up its inspections on imported food. For example in 2003, FDA’s increased he examination of imported food by more than five fold - reaching 62,000 inspections by July 2003. This was a new six-month record, as compared to merely 12,000 inspections done in all of 2001.

Foreign food exporters and U.S food importers can fully expect increased vigilance from both FDA and CBP (Bureau of Customs and Border Protection) what more with increased FDA budgets; 655 new recruitment of FDA field personnel, who work exclusively on food security and food safety; and new research to develop new prevention and mitigation technologies and to improve the ability to assess foods for contamination with chemical, biological and radiological agents.

The Bioterrorism Act encompasses various sections:

Section 302 - Protection Against Adulteration of Food.

Section 303 - Administrative Detention

Section 304 - Debarment for Repeated Or Serious Food Import Violations

Section 305 - Registration of Food Facilities

Section 306 - Maintenance and Inspection of Records for Foods

Section 307 - Prior Notice of Imported Food Shipments

Each section is a comprehensive and extensive legislation in itself, but the focus of this paper is on Section 303, 305, 306, and 307

Bioterrorism Act Time Lines

1) SECTION 305 - REGISTRATION OF FOOD FACILITIES

Current Status:

Enforced as law as on Dec 12, 2003. Interim Final Rule will be made final on June 2005.

Definition:

Section 305 of the Bioterrorism Act requires owners, operators, or agents in charge of domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States, to register their facilities with FDA by December 12, 2003, unless the facility is exempted.

For the list of who is exempted from registration, and more information on registration, please log on to www.cfsan.fda.gov/~dms/ffregui4.html for a more detailed explanation. Companies who have not registered can do so by going online at : www.cfsan.fda.gov/~furls/ovffreg.html#register

The purpose of registration is to provide FDA with sufficient and reliable information about food and feed facilities. When used with Administrative Detention (section 303), Record Keeping (section 306) and Prior Notice (section 307), registration will help provide FDA with information on the origin and distribution of food and feed products and thereby, aid in the detection and quick response to actual or potential threats to the U.S food supply.

FDA estimates the total number of food facilities that must register (both domestic US and foreign facilities) to be approximately 420,000, half of which are domestic facilities in the U.S. As of September 17, 2004, FDA had received 221,450 registrations of which 118,963 are foreign and 102,487 are domestic. Japan had the largest number of foreign facility registration at 15,446, followed by China (9,680), Canada (9,363), France (8,764), Italy (7,558) and Mexico (7,300).

Among the Asian countries (excluding Japan) Vietnam led with 3,111 registrations, followed by Korea (2,601), India (2,513), Thailand (1,709), Taiwan (1,604), Hong Kong (1,026), Indonesia (995), Philippines (909), Malaysia (626) and Singapore (364).

With the logical assumption that the foreign facilities that register are the ones who are already selling food products, or planning to sell food products to the U.S, then it is a clear indication that Malaysia is currently, NOT a major shareholder in the marketplace. Even lesser developed nations with smaller population than Malaysia had higher registrations – for example, Peru had 1,091 registrations, Costa Rica - 925 registrations and Guatemala - 676 registrations.

Since section 305 is already law and compliance is mandatory, failure to register is a prohibited act. At this point in time however, FDA has issued a revised Compliance Policy Guide (CPG) on November 8, 2004 replacing the earlier CPG that was issued on December 2003. The revised CPG is a document to provide guidance on FDA’s strategy of enforcing and achieving compliance with the requirements of the interim final rule for Registration of Food Facilities (section 305) It represents FDA’s current thinking on registration of domestic and foreign facilities. The CPG however does not create or confer any rights for or on any person and does not bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

The regulations states that if any article of food arrive at a U.S port of entry without a valid registration number, the article will be subject to hold until the registration violation is cleared. After November 8, in the revised CPG, FDA states that for foreign facilities, the agency intends to enforce the registration through Prior Notice (section 307) by requiring the registration number of the foreign manufacturer and shipper as part of Prior Notice.

2.) SECTION 307 - PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS

Current Status:

Enforced as of Dec 12, 2003. Still in Interim Final Rule, but will be made final in June 2005

Definition:

Section 307 of the Bioterrorism Act requires that prior notice be given to FDA before food is imported or offered for import into the United States.

The  Bioterrorism Act requires that this information also be provided to FDA in advance of an imported food's arrival to the United States. FDA will use this information in advance of the arrival to review, evaluate, and assess the information, and determine whether to inspect the imported food.

FDA and CBP have collaborated on the implementation of the prior notice interim final rule. Most of the prior notice information required by the interim final rule is data usually provided by importers or brokers to the Bureau of Customs and Border Protection (CBP) when foods arrive in the United States.

Nearly all of the current imported food shipments can comply by using CBP's Automated Broker Interface of the Automated Commercial System (ABI/ACS). Prior notice can be submitted either through ABI/ACS or through FDA's Prior Notice System Interface (PSNI) as of December 12, 2003.

What food is subject to the requirement for submitting prior notice?

Prior notice applies to food for humans and other animals that is imported or offered for import into the United States. For purposes of the interim final rule, "food" is defined by reference to section 201(f) of the Federal Food, Drug, and Cosmetic Act. Section 201(f) defines "food" as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles.

For purposes of the interim final rule and complying with prior notice of imported food shipments, "food" does not include food contact substances or pesticides.

Prior notice is required for food for use, storage, or distribution in the United States, and includes gifts, trade samples and quality assurance/quality control samples, food for transshipment through the United States to another country, food for future export, and food for use in a U.S. Foreign Trade Zone.

What foods are excluded from the prior notice requirement?

Foods that are excluded from the prior notice requirement are:

(1) food carried by or otherwise accompanying an individual arriving in the United States for that individual's personal use (i.e., for consumption by themselves, family, or friends, and not for sale or other distribution)

(2) food that is exported without leaving the port of arrival until export;

(3) meat food products, poultry products and egg products that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act; and

(4) food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the United States.

When must prior notice be submitted?

Prior notice must be received and confirmed electronically by FDA no more than 5 days before arrival and, as specified by the mode of transportation below, no fewer than:

1.                  2 hours before arrival by road

2.                  4 hours before arrival by air or by land by rail

3.                  8 hours before arrival by water

4.                  The time consistent with the timeframe established for the mode of transportation for an article of food carried by or otherwise accompanying an individual if it is subject to prior notice (The food must also be accompanied by the FDA confirmation.)

In addition, prior notice must be received and confirmed electronically by FDA before food is mailed by international mail. (The parcel must be accompanied by confirmation of FDA receipt of prior notice.)

How must the prior notice be submitted?

Prior notice must be submitted electronically. FDA estimates more than 80 percent of prior notice of imported food shipments submissions can be transmitted through ABI/ACS.

Who must submit prior notice?

Any individual with knowledge of the required information may submit the prior notice, including, but not limited to, brokers, importers, and U.S. agents.

Will FDA provide confirmation of receipt of prior notice?

Yes. FDA will issue a confirmation of prior notice to the transmitter upon successful receipt of the prior notice information.

What information must be included in the prior notice?

The prior notice must be submitted electronically and contain the following information:

·        Identification of the submitter, including name, telephone and fax numbers, email address, and firm name and address

·        Identification of the transmitter (if different from the submitter), including name, telephone and fax numbers, email address, and firm name and address

·        Entry type and CBP identifier

·        The identification of the article of food, including complete FDA product code, the common or usual name or market name, the estimated quantity described from the smallest package size to the largest container, and the lot or code numbers or other identifier (if applicable)

·        The identification of the manufacturer

·        The identification of the grower, if known

·        The FDA Country of Production

·        The identification of the shipper, except for food imported by international mail

·        The country from which the article of food is shipped or, if the food is imported by international mail, the anticipated date of mailing and country from which the food is mailed

·        The anticipated arrival information (location, date, and time) or, if the food is imported by international mail, the U.S. recipient (name and address)

·        The identification of the importer, owner, and ultimate consignee, except for food imported by international mail or transshipped through the United States

·        The identification of the carrier and mode of transportation, except for food imported by international mail

·        Planned shipment information, except for food imported by international    mail

What are the consequences of failing to submit adequate prior notice information of an imported food shipment?

Food that is imported or offered for import with inadequate prior notice is subject to refusal and holding at the port or in secure storage. FDA will provide its staff with enforcement guidance containing the Agency's policies on injunctions, prosecution, and debarment related to failure to provide timely and accurate prior notice, as well as the Agency's policies regarding refusals

For more details and information on Prior Notice, please log on to http://www.cfsan.fda.gov.

NOVEMBER 2004 - FDA’s MOST RECENT REVISED COMPLIANCE POLICY ON PRIOR NOTICE

The Food and Drug Administration (FDA) and the Bureau of Customs and Border Protection (CBP) have revised Compliance Policy Guide (CPG) § 110.310; “Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The first CPG was issued in December 2003 and subsequently June 2004. This November 2004 CPG is the most recently issued

The purpose of this document is to provide guidance on FDA's and CBP's strategy for enforcing and otherwise achieving compliance with the requirements of the interim final rule for submitting prior notice for food imported or offered for import into the United States (68 Fed. Reg. 58974 (Oct.10, 2003) (codified at 21 CFR 1.276 - 1.285)).

FDA's guidance documents, including this Compliance Policy Guide (CPG), do not establish legally enforceable responsibilities. Instead, guidance documents describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidance documents means that something is suggested or recommended, but not required.

The November 2004 revised CPG makes the following important changes in enforcement policy:

Policy

This policy provides guidance to FDA and CBP staff when they encounter the prior notice situations described within this section. The policy contains several references to Tables 1 and 2, which are set out below.

·                    FDA registration number of manufacturer’s facility

FDA and CBP are further relaxing the requirements regarding when the prior notice must include the FDA registration number of the facility that manufactured the food. The revised CPG permits a submitter to enter a “reason code” that explains why the submitter need not, or is unable to, provide the manufacturing facility’s registration number.  (Please refer to Appendix 1 below for the Reason Code.)

Generally, a prior notice must include the name, registration number, city, and country of the facility that manufactured the food being imported or offered for import. If the manufacturing facility is exempt from registration, the prior notice should instead provide the name, street address, city, and country of the manufacturing facility as well as a reason code indicating why the facility is not required to register (e.g., “H. Grower – satisfies farm exemption”).

In this revised CPG, FDA is announcing that the prior notice may omit the manufacturing facility’s registration number in certain situations, even though the manufacturing facility is not exempt from FDA registration.

o       If the article of food is for transshipment, storage and export, or further manipulation and export, the prior notice must include the name, street address (or registration number), city, and country of the manufacturing facility.

o       If the article of food is sent by an individual as a personal gift, the prior notice must include either: (a) the name, registration number (or street address), city, and country of the manufacturing facility; or (b) the name and address of the firm that appears on the food label. The prior notice also must include the appropriate reason code (i.e., “Individual gift – label name/address in lieu of registration number”).

o       If the submitter is unable to determine the manufacturing facility’s registration number after a good faith effort, the prior notice must include the name, street address, city, and country of the manufacturing facility. The prior notice also must include the appropriate reason code (i.e., “Unable to determine the registration number of the manufacturer”).

o       If the submitter is unable to determine either the name and full address or the registration number of the manufacturing facility, the prior notice must provide the name, street address, city, and country of the headquarters of the manufacturer. The prior notice also must include the appropriate reason code (i.e., “L. Unable to determine identity of manufacturer – providing identity of manufacturer’s headquarters”).

o       If the submitter is unable to determine the name, full address, and registration number of the manufacturing facility as well as the name and full address of the manufacturer’s headquarters, the prior notice must include the name, street address, city, and country of the invoicing firm. The prior notice also must include the appropriate reason code (i.e., “M. Unable to determine identity of manufacturer or headquarters – providing invoicing firm’s identity”)

FDA will reject any prior notice that does not include either a valid registration number for the manufacturing facility or an appropriate reason code. Reason codes are listed in Appendix 1 of the revised CPG. (Please see Appendix 1 below for the Reason Code). Where the manufacturing facility’s registration number is not known, submitters should no longer use 10000000000 to complete this field, since this will no longer be accepted.

These changes in enforcement policy will make it easier for someone who does not deal directly with a food’s manufacturer to import food products made by that manufacturer.

On the other hand, FDA and CBP note that submitting a prior notice that does not include the registration number of a manufacturing facility that is required to be registered (or providing identifying information for the manufacturer’s headquarters or for the invoicing firm) may result in the food being delayed at the port of arrival, because it may take more time for FDA and CBP to verify the identity of the manufacturing facility and its registration status and to determine whether the food is subject to hold. In addition, failing to provide required information may be considered as a factor in determining whether and where to examine the article of food.

·                    Early submission of prior notice

If prior notice is submitted more than 5 calendar days before the anticipated date of arrival of an imported article of food, FDA and CBP typically should not take any regulatory action, provided that:

(1) the prior notice was submitted less than 10 calendar days before the anticipated date of arrival; and

(2) the prior notice was submitted through FDA’s Prior Notice System Interface (PNSI). The prior notice must be submitted through PNSI, and not using CBP’s Automated Broker Interface of the Automated Commercial System (ABI/ACS), because the ABI/ACS cannot provide a Prior Notice Confirmation Number more than 5 calendar days before the anticipated date of arrival.

Note that if any of the prior notice information, except the anticipated arrival information, the estimated quantity, or the planned shipment information, changes after FDA has confirmed the prior notice submission for review, the prior notice must be re-submitted. The re-submission must be confirmed by FDA for review no less than 2,4, or 8 hours before arriving at the port of arrival, with the minimum time depending on the mode of transportation. If the prior notice is re-submitted, the previous prior notice should be cancelled.

·                    Express Courier and the omission of anticipated arrival information

If a prior notice does not include anticipated arrival information and/or planned shipment information, FDA and CBP typically should not take any enforcement action, provided that:

(1) the article of food is imported or offered for import via express courier;

(2) the person submitting the prior notice is the express courier;

(3) the prior notice is submitted via PNSI; and

(4) the prior notice includes the shipment’s tracking number in lieu of the required anticipated arrival information and/or planned shipment information.

·                    Gift packs purchased or otherwise acquired by an individual and imported or offered for import for non-business purposes

For gift packs purchased or otherwise acquired by individuals and imported or offered for import for non-business reasons, a single prior notice may be submitted for the gift pack and the prior notice may include identifying information for the facility that packed the gift pack instead of the manufacturing facility. The prior notice also must include the appropriate reason code (i.e., “O. Gift pack for non-business purposes -- providing single prior notice and identity of packer”).

A gift pack is a food that is described with FDA Product Code 37Y-01 (human food) or 72E-99 (animal food). Food is considered to be for non-business purposes when it is not for sale, resale, barter, business use, or commercial use. The policy described in this section applies irrespective of where the individual who purchased or otherwise acquired the gift pack lives and irrespective of the type of carrier. The policy also applies irrespective of whether it involves a commercial or non-commercial shipper,

For the purpose of this CPG, gift packs are considered to be food that is described with FDA Product Code 37Y--01 (human food) or FDA Product Code 72E--99 (animal food).

Examples of gift packs that may be covered are:

o        A gift basket containing fresh fruit and/or vegetables.

o        A gift box containing crackers and cheeses and canned condensed soups.

o        A gift basket of crackers, cheeses and fresh fruit.

o        A wicker basket with champagne, port, scotch whisky, smoked salmon, cheese, tea, coffee, chutney, pistachio nuts, biscuits, marmalade, honey, butter biscuits, crackers, cake, mustard, olive oil, and olives.

o        Tote bag with infant clothing, bib, booties, and coffee and candy for the parents; or a toy dispenser with hard candy and powdered candy.

o        A gift bag with multiple pet food items such as rawhide chews and dog biscuits, with or without non-food items.

·                    Food carried by or otherwise accompanying an individual that is not for personal use

In general, the action FDA and CBP staff typically should consider taking is education/communication for minor or inadvertent prior notice violations and refusal for all other prior notice violations.

Manufacturer. Table 1 lists the prior notice requirements for providing information about the identity of the manufacturer for an article of food that is no longer in its natural state. If there is a prior notice violation due to the fact that this information is not provided, FDA and CBP should typically consider not taking any regulatory action under the circumstances described in the first column of Table 2 if the information in the second column of that table is provided.

·                    Food imported or offered for import for non-commercial purposes with a non-commercial shipper, irrespective of the type of carrier

FDA and CBP should typically consider not taking any regulatory action when an article of food is imported or offered for import for non-commercial purposes with a non-commercial shipper. Generally, staff should consider a non-commercial purpose to be when the food is purchased or otherwise acquired by an individual for non-business purposes and the shipper is an individual (e.g., the individual delivers the food to a post office or common carrier for delivery to self, family member, or friend for non-business purposes, i.e., not for sale, resale, barter, business use, or commercial use.)

Examples of foods imported or offered for import that may be covered by this non-commercial category are:

o        food in household goods, including military, civilian, governmental agency, and diplomatic transfers;

o        food purchased by a traveler and mailed or shipped to the traveler's U.S. address by the traveler, not the commercial establishment; and

o        gifts purchased at a commercial establishment and shipped by the purchaser, not the commercial establishment.

Note that the shipper and the carrier are different entities, and the carrier is likely to be a commercial entity even when the shipper is an individual. Thus, the food for non-commercial purposes may arrive by international mail or any other mode of transportation, but must be shipped by one individual to another individual (self, family member, or friend) to be considered for non-commercial purposes.

For example, when an individual ships his or her own household goods, even when the goods are delivered to a mover or carrier for international movement, the individual is the shipper, e.g., the owner or exporter of the article of food who consigns and ships the article from a foreign country or the person who sends an article of food by international mail to the United States (see § 1.276(b)(12) of the prior notice interim final rule).

In another example, when an individual purchases food at Store A and sends that food to an individual by mail, the individual is the shipper and the carrier is the mail service. If the individual uses an express courier, the result is the same: the individual is the shipper and the express courier is the carrier.

However, if Store A ships the food, Store A is the shipper. Since Store A is not an individual, this last example is not covered by the policy described above because the food was not imported or offered for import with a non-commercial shipper. (While a "person" sometimes can be an individual, partnership, corporation, or association, see 21 U.S.C. 321(e), by "individual" we mean a sole human being, not a partnership, corporation, or association.)

·                    Food arriving by international mail that is NOT food imported or offered for import for non-commercial purposes with a non-commercial shipper

In general, the action FDA and CBP staff typically should consider taking is education/communication for minor or inadvertent prior notice violations and refusal for all other prior notice violations.

Manufacturer. Table 1 lists the prior notice requirements for providing information about the identity of the manufacturer for an article of food that is no longer in its natural state. If there is a prior notice violation because this information is not provided, FDA and CBP should typically consider not taking any regulatory action under the circumstances described in the first column of Table 2 if the information in the second column of that table is provided.

·                    Food imported or offered for import for quality assurance, research or analysis purposes only, not for human or animal consumption or resale

If the article of food is imported or offered for import for quality assurance, research or analysis purposes only, not for human or animal consumption and not for resale, then FDA and CBP should follow the enforcement policies described in Table 1 & 2. Please note that with respect to item 1 of Table 2, there is a specific reason code for samples of food that are imported or offered for import for quality assurance, research or analysis purposes (see Appendix 1 Reason Code I. Samples – quality assurance, research or analysis purposes only ). This reason code should be used when it is applicable.

For the purpose of this CPG, samples of food are considered to be imported or offered for import for quality assurance, research or analysis purposes when they are imported in small quantities (i.e., quantities consistent with the quality assurance, research, or analysis purposes) and the entire sample is used up by the analysis or is destroyed after analysis or a reasonable retention period after analysis. The analysis may include sensory analysis or evaluations such as those organoleptic analyses for testing the quality of tea or for testing for histamines.

Evidence that an article of food is imported for quality assurance, research, or analysis purposes only might include, among other evidence, that the food and shipment documents are marked accordingly. The policy in this section does not apply to samples intended for test marketing, such as tasting at trade shows or product promotional tasting events.

Information about when samples are "food" for the purposes of prior notice is provided in the 2nd Edition of Guidance for Industry, Prior Notice of Imported Food, Questions and Answers, May 2004.at : www.cfsan.gov/~pn/pnqagui2.html

This guidance states that, in general, prior notice is required for samples of food, including animal feed, for research and development and test marketing (Q&A, Section C., Question 1.3).

However, if the samples are items that are in such early stages of research and development that they cannot yet be considered food for the purposes of prior notice, then they would not be subject to prior notice requirements (Q&A, Section C., Question 1.3).

In addition, if the sample is in a form that is not an article of food, such as a slurry of lettuce for pesticide analysis or a sterile sample container filled with juice for heavy metal analysis, then prior notice would not apply (Q&A, Section C., Question 17.2).

APPENDIX 1:           REASON CODES FOR REGISTRATION NUMBER OF

                                    MANUFACTURER NOT PROVIDED

1.      A. Facility is out of business

2.      B. Facility is private residence (21 CFR 1.227(b)(2))

3.      C. Facility is a restaurant (21 CFR 1.226(d); 1.227(b)(10))

4.      D. Facility is retail food establishment (21 CFR 1.226(c); 1.227(b) (11))

5.      E. Facility is non-processing fishing vessel (21 CFR 1.226(f))

6.      F. Facility is non-bottled drinking water collection and distribution establishment (21 CFR 1.227(b)(2))

7.      G. Individual gift - label name/address in lieu of registration number (21 CFR 1.281(a)(6), (b)(5), and (c)(6))

8.      H. Grower - satisfies farm exemption (21 CFR 1.226(b); 1.227(b)(3))

9.      I. Samples - quality assurance, research or analysis purposes only

10.J. U.S. manufacturing facility that is not required to register

11.K. Unable to determine the registration number of the manufacturer.

12.L. Unable to determine identity of manufacturer - providing identity of manufacturer's headquarters

13.M. Unable to determine identity of manufacturer or headquarters - providing invoicing firm's identity

14.O. Gift pack for non-business purposes - providing single prior notice and identity of packer

For the full information on the revised Compliance Policy Guide, log on to: http:// www.cfsan.fda/~pn/cpgpn4.html

3.) SECTION 303 - ADMINISTRATIVE DETENTION

Food and Drug Administration (FDA) has issued a final rule on Administrative Detention of Food for human or animal consumption under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Current Status:

The final rule was published at the Office of the Federal Register on May 27, 2004 The rule became effective on July 6, 2004.

Definition:

Section 303 authorizes and establishes 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.

I. Summary of the Final Rule

The purpose of administrative detention is to prevent adulterated food from entering commerce before FDA brings a seizure or injunction action (i.e., a court action to seize the food or enjoin its distribution). Thus, administrative detention is, by its nature, a temporary, stopgap measure.

The provision giving FDA the authority to administratively detain food, is self-executing. Thus, FDA has had administrative detention authority since enactment of the Bioterrorism Act on June 12, 2002. This final rule, rather than imposing requirements on industry, imposes restrictions on how FDA may exercise its new administrative detention power. In that sense, it differs from FDA’s other rulemakings under the Bioterrorism Act. It primarily sets forth obligations and procedures for FDA to follow.

FDA’s administrative detention authority is expected to have little impact on the food industry. Before the Bioterrorism Act, even though FDA itself did not have administrative detention authority, it usually could rely on state agencies to detain adulterated food on its behalf. Most states have long had the power to administratively detain or “embargo” food under state law.

The following summarizes the key provisions of the final rule:

• An FDA officer or qualified employee may order the detention of any article of food that is found during an inspection, examination, or investigation if FDA has credible evidence or information that the food presents a threat of serious adverse health consequences or death to humans or animals.

• “Food” is defined to mean all food under FDA regulation, including food contact substances. It does not include 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.).

• The FDA District Director of the district in which the article of food is located or an FDA official senior to such director must approve the detention order.

• The detention period is for a reasonable period not to exceed 20 calendar days, unless a greater period of time, not to exceed 30 calendar days, is necessary to enable FDA to institute a seizure or injunction action.

• The detention order may require that the detained article of food be labeled or marked 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.

• The detention order must state the location and any applicable conditions under which the food is to be held.

• If FDA determines that removal of the detained article of food to a secure facility is necessary, the food must be moved to a secure facility. In addition, FDA may approve a request for modification of a detention order to allow movement of the detained article of food for purposes of destruction, movement to a secure facility, preservation, or any other appropriate purpose. The article of food remains under detention before, during, and after such movement.

• A violation of a detention order, including removal or alteration of a tag or label or transfer of the detained article of food in violation of the detention order, is a prohibited act under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

• Any person who would be entitled to claim the detained article of food if such article were seized may appeal the detention order and request an informal hearing. If FDA grants a hearing, an FDA Regional Food and Drug Director (RFDD) or another official senior to an FDA District Director will serve as the presiding officer at the hearing.

• The timeframes for appeals and hearings differ depending upon whether the detained article of food is perishable or nonperishable.

• Perishable food:

• An appeal must be filed within 2 calendar days of receipt of the detention order.

• If a hearing is requested in the appeal, and FDA grants the request, the hearing will be held within 2 calendar days after the date the appeal is filed.

• FDA’s decision on the appeal will be issued 5 calendar days after the appeal is filed.

• Nonperishable food:

• A notice of intent to file an appeal and to request a hearing must be filed within 4 calendar days of receipt of the detention order.

• An appeal must be filed within 10 calendar days of receipt of the detention order.

• If a hearing is requested in the notice of intent and the appeal, and FDA grants the request, the hearing will be held within 2 calendar days after the appeal is filed.

• FDA’s decision on the appeal will be issued 5 calendar days after the appeal is filed.

• Confirmation of a detention order by the FDA presiding officer is considered final agency action, subject to judicial review.

• If the detained article of food is a perishable food, FDA must submit a seizure recommendation to the Department of Justice within 4 calendar days after the detention order is issued, unless there are extenuating circumstances.

• FDA is not financially responsible for the costs of storing or transporting detained articles of food, nor for any damages or other costs associated with an administrative detention.

The administrative detention procedures for food described in the final rule were modeled after FDA’s medical device administrative detention regulation, 21 C.F.R. § 800.55.

II. Changes from the Proposed Rule

The final rule differs only slightly from the proposed rule published by FDA in May 2003. The following changes have been made:

• The final rule requires that the detention order include the name and title of the FDA official who approved the order. The proposed rule did not require the detention order to include this information.

• The final rule provides that the appeal hearing, if requested and granted by FDA, will be held within 2 calendar days after the date the appeal is filed for both perishable and nonperishable foods. The proposed rule would have given FDA 3 calendar days to hold the hearing with respect to nonperishable foods.

• The final rule requires the presiding officer at the hearing to issue a written report of the hearing, including a proposed decision with a statement of reasons. It also provides that the hearing participant may review this report and suggest changes to it within 4 hours of issuance of the report, after which the presiding officer will issue a final agency decision. The proposed rule did not contain these provisions.

• The final rule uses the term ”request for modification of a detention order” to refer to a request to permit movement of a detained article of food. The proposed rule used the term request for “limited conditional release.” Because Customs defines the term “limited conditional release” differently, FDA decided to use a different term in order to avoid confusion.

III. General Provisions Of The Final Rule

1. What Definitions Apply to This Subpart? (21 C.F.R. § 1.377)

“Food”has the meaning given that term in § 201(f) of the FD&C 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 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.

Note that the definition of food in this final rule is broader than that in FDA’s interim final rules on food facility registration and prior notice of food imports. While FDA’s registration and prior notice rules do not apply to food contact substances, such as food packaging and ceramicware, the administrative detention final rule does. “Substances that migrate into food from food packaging” 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 administrative detention.

“Perishable food”means food that is not heat-treated; not frozen; and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 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 include, but are not limited to, fluid milk (but not ultrapasteurized milk), fresh fish and shellfish, and fresh fruits and vegetables.

2. What Criteria Does FDA Use to Order a Detention? (§ 1.378)

An officer or qualified employee of FDA may order the detention of an 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 the article of food presents a threat of serious adverse health consequences or death to humans or animals.

“Credible evidence or information” is not defined in the final rule, and FDA declines to define it in a way that might limit the agency’s interpretive discretion. However, FDA has indicated that it will consider a number of factors including reliability, reasonableness, and the totality of facts and circumstances. FDA intends to apply the credible evidence standard consistent with relevant case law.

“Serious adverse health consequences” also is not defined in the final rule. FDA intends to define this term in a separate rulemaking. However, this is similar to the standard FDA currently uses to classify recalls as Class I. It is not limited to situations involving bioterrorism or intentional contamination.

3. How Long May FDA Detain an Article of Food? (§ 1.379)

FDA may detain an article of food for a reasonable period that may not exceed 20 calendar days after the detention order is issued. However, FDA may detain the article of food for an additional 10 calendar days (i.e., for a total of 30 calendar days after the detention order is issued) if additional time is needed to institute a seizure or injunction action.

Such a 10-day extension requires approval of an “authorized FDA representative” and requires that FDA issue a new detention order and, if applicable, place new tags or labels on the detained article of food to indicate the change in detention dates. Alternatively, FDA may order detention for the full 30 calendar days in the original detention order if FDA knows at the outset that 30 calendar days will be needed to institute a seizure or injunction action.

4. Where and Under What Conditions Must the Detained Article of Food be

Held? (§ 1.380)

A detained article of food must be held in the location and under the conditions specified in the detention order. FDA will determine the conditions for holding the detained food on a case-by-case basis based on the totality of information available to FDA about the article of food.

For example, if the shipping documents require a specific refrigeration temperature for the food, FDA likely will order that the food be stored at that temperature. If necessary, FDA may consult with the owner of the food, if readily known, about appropriate storage conditions.

If FDA determines that removal of the food to a secure facility is appropriate, the food must be removed 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 removal to a secure facility is appropriate, FDA will identify a specific location to which the food should be moved in the detention order. The costs of secure storage are a private contractual matter between the owner of the secure facility and the recipient of the detention order.

It is also possible that FDA may order the food to be stored in government storage.

If a detained article of food is on board a conveyance, FDA will consult with the Bureau of Customs and Border Protection (Customs) concerning movement of the detained article of food to limit the impact on the flow of trade. FDA believes it will detain food on board a conveyance only under rare circumstances.

In that event, a transporter may request modification of the detention order to allow removal of the detained food from the conveyance to a storage facility. If the detained article of food is part of a shipment that also contains other foods that are not subject to the detention order and that can be readily segregated, the other articles of food may be moved.

The movement of an article of food in violation of a detention order is a prohibited act under the FD&C Act.

5. May a Detained Article of Food be Delivered to Another Entity or Transferred to Another Location? (§ 1.381)

A detained article of food may not be delivered to any other entity, even upon execution of a bond. It may not be delivered to its importers, owners, or consignees. Until an “authorized FDA representative” releases the detained food by issuing a detention termination notice, the detention period expires, or FDA issues a modification to the detention order allowing movement, a detained article of food simply may not be moved.

As discussed above, FDA may require removal of a detained article of food to a secure storage facility. The recipient of the detention order also may request a modification of a detention order to permit movement to another location. Such a request must be submitted in writing to the authorized FDA representative that approved the detention order. The request must state:

• The reasons for movement;

• The exact address of and location in the new facility (or the new location within the same facility) where the detained article of food will be transferred;

• An explanation of how the new address and location will be secure, if FDA has directed that the article of food be detained in a secure facility; and,

• An explanation of how the article of food will be held under any applicable conditions described in the detention order.

If the modification of the detention order is for the purpose of destroying the detained article of food, the submitter must also provide a verified statement identifying its ownership or proprietary interest in the detained article of food.

The authorized FDA representative may approve, in writing, a request to modify a detention order to permit movement of the detained article of food 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 will decide on a case-by-case basis who will be responsible for transporting the detained article of food. FDA may transport the food to the secure facility itself; FDA may direct the recipient of the detention order to transport the food; or FDA may designate a third party to transport the food (e.g., if FDA believes that control of the food might be lost if the recipient of the detention order were to transport the food).

If FDA directs the recipient of the detention order to transport the food, that person must obtain a modification of the detention order before moving the detained article of food. FDA must supervise the transport of the detained food unless FDA has declined in writing to supervise the transfer.

If FDA declines in writing to supervise the transfer, the recipient of the detention order must immediately notify, in writing, the authorized FDA representative who approved the modification of the detention order when the detained food has reached its new location and must provide the specific location of the detained food within the new location.

In addition, the recipient of the detention order must ensure that any required tags or labels accompany the detained food during and after transport.

A detained article of food remains under detention before, during, and after movement to another facility. The transfer of an article of food in violation of a detention order is a prohibited act.

6. What Labeling or Marking Requirements Apply to a Detained Article of Food? (§ 1.382)

A detention order may require that the detained article of food be tagged or labeled. The tag or label applied to a detained food must include the following information:

• A statement that the article of food is detained by FDA in accordance with section 304(h) of the FD&C 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, 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.

The mark or label may be attached to the food container, a packing container, accompanying documents, or some other location.

Once the detained article is released, or the detention period expires, FDA will remove, or authorize the removal of, any labels or tags. FDA does not expect that such tags or labels will impair the future marketability of the article of food.

7. What Expedited Procedures Apply When FDA Initiates a Seizure

Action Against a Detained Perishable Food? (§ 1.383)

FDA will expedite seizure actions when perishable food is administratively detained. For perishable foods under a detention order, FDA will send 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 will advise the DOJ of its plans on the last working day before the