Contents

6.2 - IMPORT PROCEDURES

6.2.1 - SCOPE

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 5.2.1.2.

6.2.2 - DIVISION OF AUTHORITY

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.

6.2.3 - ENTRIES

6.2.3.1 - Formal Entries

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, commercial invoice, bill of lading and any other relevant documents to aid in making an admissibility decision), and which also document interstate commerce. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

6.2.3.2 - Informal Entries

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. When FDA takes action on an informal entry not filed electronically by the filer, FDA personnel will input the informal entry into OASIS as a manual entry.  When taking FDA action with an informal entry, Customs will be requested to convert it into a formal consumption entry.

6.2.3.3 - Mail/Personal Baggage

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter 9-2 "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

6.2.3.4 - Import for Export (IFE) Entries

6.2.3.4.1 - IFE Entry Review

Import for Export entry procedures are as follows:

1. If electronic submission is made, it is unlikely all of the information required under section 801(d)(3) FD&C Act [21 U.S.C. 381 (d)(3)] will be provided electronically. Districts should request the supporting documents (if not already received from the broker or importer) by setting an entry option of Documents Requested (DRQ) and/or Entry Incomplete (DEF) on all entries with IFE in the Affirmation of Compliance (AOC) field in OASIS, or those suspected to be IFE, which lack complete supporting documents.
2. If the entry is indeed an IFE entry and the AOC was not included in the original entry, the entry reviewer should modify the AOC field in OASIS to indicate “IFE”.

If the required documentation is not provided after a DRQ, entry reviewers should take the appropriate compliance follow-up, under the basis the required IFE documentation was not provided to FDA at the time of initial importation.

Districts should determine the appropriate time frame for receiving the required IFE documents in particular circumstances. It is anticipated three (3) days from the DRQ or DEF notice will usually be adequate for the required IFE documentation to be submitted. This is because the broker may need to communicate FDA’s requirement for documents to an importer. If all required documentation is provided, the entry should be given a “May Proceed”. NOTE: All documentation supporting the IFE entry should be processed in accordance with step 4 below.

If documentation is not adequate, the district should issue a detention after review of the documentation, in accordance with normal procedures outlined in the RPM Chapter 9.

3. If the entry is marked IFE, but review of the entry information or supporting documents indicates the AOC was entered inappropriately, the entry reviewer should note this in the entry remarks section.
4. Copy and attach all entry documentation and forward to the FDA home district of the initial owner or consignee, identifying the following:
   1. FOREIGN MANUFACTURER/SHIPPER
   2. ENTRY NO.
   3. U.S.IMPORTER OF RECORD
   4. INITIAL OWNER/CONSIGNEE
   5. ARTICLE/PRODUCT

6.2.3.4.2 - Domestic Follow-up

The FDA home district of the initial owner or consignee should:

6.2.3.4.3 - Inspection Guidance

When a firm is scheduled for inspection, you should:

2. Verify during the inspection the IFE article:
   1. Was used to produce an exported product,
   2. Was destroyed, or
   3. Still under the firm’s control pending disposition. If the article is pending disposition, verify a current and valid Customs bond covering the article exists, and the article is the same article that was offered for entry.

If the article was exported or destroyed, you should request the manufacturer's import, export, and/or destruction records to verify the imported article was further processed or incorporated into another product and was exported in accordance with sections 801(e) or 802 of the FD&C Act [21 U.S.C. 381 (e) or 382] or section 351(h) of the PHSA, or destroyed. Please note, for drug products, an initial owner or consignee may be allowed to retain a sample of the imported article in order to comply with good manufacturing process (GMP) regulations concerning sample retention.

Include in the Establishment Inspection Report or a memo the status of the IFE product and if further follow-up is required.

Following review and determination of the necessity of further follow-up, forward the completed EIR or memo and supporting documents to the District which initiated the IFE follow-up.

Upon receipt of the completed IFE Follow-up, ensure the following actions are taken:

6.2.3.5 - Prior Notice of Importation of Food and Animal Feed

6.2.3.5.1 - Prior Notice Reception

Prior notice for food articles subject to the rule 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 land 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.)

6.2.3.5.2 - Products Requiring 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 prior notice requirements, "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.

Examples of "food" include:

1. Dietary supplements and dietary ingredients
2. Infant formula
3. Beverages (including alcoholic beverages and bottled water)
4. Fruits and vegetables
5. Fish and seafood
6. Dairy products and shell eggs
7. Raw agricultural commodities for use as food or components of food
8. Canned and frozen foods
9. Bakery goods, snack food, and candy (including chewing gum)
10. Live food animals
11. Animal feeds and pet food

6.2.3.5.3 - Products Excluded from Prior Notice

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;
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; and
5. Food in diplomatic pouches.

6.2.3.5.4 - Prior Notice Submission

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

1. Identification of the submitter, including name, telephone and fax numbers, email address, and firm name and address
2. Identification of the transmitter (if different from the submitter), including name, telephone and fax numbers, email address, and firm name and address
3. Entry type and CBP identifier
4. 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)
5. The identification of the manufacturer, including registration number of the facility that manufactured/processed the food
6. The identification of the grower, if known
7. The FDA Country of Production
8. The identification of the shipper, including the registration number if applicable, except for food imported by international mail
9. 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
10. The anticipated arrival information (location, date, and time) or, if the food is imported by international mail, the U.S. recipient (name and address)
11. The identification of the importer, owner, and ultimate consignee, except for food imported by international mail or transshipped through the United States
12. The identification of the carrier and mode of transportation, except for food imported by international mail
13. Planned shipment information, except for food imported by international mail

6.2.3.5.5 - Inadequate Prior Notice Submission

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 provided guidance to its stakeholders and U.S. Customs and Border Protection staff on enforcing the prior notice requirements in a Compliance Policy Guide, Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 at http://www.cfsan.fda.gov/~pn/cpgpn6.html.  This guidance, however, does not affect FDA's ability to take actions that may be necessary, including conducting inspections for food safety and security concerns or taking any other action under the Federal Food, Drug, and Cosmetic Act. This policy will also not affect the ability of Customs to assess penalties under 19 U.S.C. 1595a(b) or to take enforcement action under any other authority.

6.2.3.5.6 - Prior Notice Process

This prior notice process begins with an automated screening process. If additional evaluation of the prior notice information is necessary, all review of prior notice information is performed by the Prior Notice Center (PNC); FDA headquarters staff, operating 24 hours a day, 7 days a week.  The review process is a manual review by the PNC. It is designed to identify food products that may pose serious risks to public health so that appropriate action can be taken upon arrival in the United States. The review process is not impacted by the method of electronic submission. The results of this process will be transmitted to CBP.

The PNC reviews and assesses the prior notice information and may initiate an examination or other action by FDA or CBP of the article of food at the port of arrival or elsewhere, or in the case of rail shipments, within the confines of the closest appropriate examination site.  The PNC will advise the FDA field offices and/or Customs of the inspection requirements.  The PNC is also responsible for communication with submitters regarding the compliance of prior notice, the initiation of refusal due to inadequate prior notices, the response to requests for review of refusals, and the completion of the prior notice process.

In addition, the OASIS system review will determine if further staff evaluation of the article of food is necessary for admissibility determinations under section 801(a) of the FD&C Act (e.g., subject to the guidance in an import alert). If the food meets the prior notice requirements; the food will be subject to further review by FDA staff for determination of admissibility under section 801(a) of the FD&C Act.

This admissibility examination may take place at the border but may also take place at an examination site, a public warehouse, or other appropriate locations. If FDA determines that refusal under section 801(a) of the FD&C Act is appropriate, the appropriate admissibility procedures will be used.

6.2.3.6 - Entry Processing

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

6.2.3.6.1 - U. S. Customs

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

6.2.3.6.2 - FDA

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)
2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.
3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and
4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (A of C) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the A of C is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 6-1.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.

6.2.4 - SAMPLING

6.2.4.1 - Ports Covered by FDA

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. If the entry is to be held intact for FDA examination or sampling;
2. Only those designated items need be held; etc.

6.2.4.2 - Ports not Covered by FDA

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

6.2.4.3 - Entry Sampling

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice," and indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening, or after the district performs an "On-Screen-Review". (NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]).