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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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9-19 - Notice of Sampling

9-19 - Notice of Sampling

  9-19 - Notice of Sampling

PURPOSE

To provide uniform guidance in the use of the "Notice of Sampling" or "Notice of FDA Action" for collecting samples of imported articles subject to the laws and regulations enforced by the Food and Drug Administration (FDA).

The statements in this chapter represent the Agency's current thinking on the application of the Notice of Sampling as identified by current regulation. It is intended only to provide operating guidance for FDA personnel and does not create or confer any rights on or for any person, and does not operate to bind FDA or the public.

BACKGROUND

Sections 536(a) and 801(a) (21 USC 360mm and 381(a)) of the Federal Food, Drug, and Cosmetic Act (the Act) direct that notice of sampling shall be given to the owner or consignee of articles imported or offered for import into the United States. FDA regulation (21 CFR 1.90) defines this requirement, stating that such notice is given not only for samples collected but may also be issued for samples that "will be" collected ("notice of delivery of, or intention to deliver, such sample."). The regulation also requires that the owner or consignee receiving the notice "shall hold such article and not distribute it until further notice from the district director or the collector of Customs of the results of examination of the sample."

In developing FDA's automated import system, known as the Operational and Administrative System for Import Support (OASIS), the specific form "Notice of Sampling" has been replaced by the "Notice of FDA Action." The Notice of FDA Action informs the recipient to the sample collected or of FDA's intention of sampling for each line in the entry. The use of the designation "Product Collected by FDA" or similar language should be considered as meeting the standard "giving notice thereof to the owner or consignee". (see 21 USC 381(a))

GUIDANCE

Issuing the Notice of Sampling

Traditionally, the Notice of Sampling was issued by the FDA district office over the facsimile signature of the Regional or District Director of CBP, in accordance with an agreement between FDA and CBP. Under the procedures used in the OASIS system, however, the notice is no longer signed over a facsimile signature. At ports remote from a FDA office, local CBP officials may be re-delegated this responsibility of collecting, sampling and delivering the samples to FDA.

Notices of Sampling issued in OASIS are unsigned. They carry the name, address, phone number of the person creating the Status and Notice (often different individuals will be responsible for this operation for the district).

When to Issue the Notice of Sampling

The law, as cited above, specifies that the Notice must be issued each time a sample is collected. For the purpose of this procedure, a Notice of Sampling or the Notice of FDA Action covering the collection of a sample will issue for each article identified for:

  1. Physical collection of article submitted to the laboratory for examination;
  2. Documentary collections, including labels, photographs, radiological health articles, mail entries, and personal importations.

When collection data is entered into OASIS a new Notice will be generated.

Notice of Sampling Terms Used by OASIS For Notification to Filer, Importer, etc. at Entry Level

Under OASIS, when an entry is filed through the CBP Automated Commercial System (ACS) to FDA, the following electronic messages are sent to CBP and the filer to identify the collection of a sample or intent to collect a sample: (wording use to explain the meaning of the OASIS message may not be exactly the same as presented here due to up-dates in the OASIS system)

  1. FDA REVIEW: All FDA regulated articles in the entry must be held intact and not distributed, pending receipt of written notice or additional message from FDA.
  2. FDA HOLD: Further FDA action is being taken on one or more lines in the entry.
  3. FDA DO NOT DEVAN: All containers or trailers comprising this entry must be held unopened pending FDA examination, or receipt of written notice or additional message from FDA. (importer/consignee and/or filer) Notify FDA when the containers or trailers will be available. All FDA regulated articles will be examined or sampled by FDA. Following CBP release, the unopened containers or trailers may be moved to a location approved by FDA.
  4. FDA EXAM/SAMPLE: All FDA regulated articles in the entry must be held intact and not distributed, pending receipt of written notice or additional message from FDA. (importer/consignee and/or filer) Notify FDA when the products will be available. The articles will be examined or sampled by FDA. Following CBP release, the article may be moved to a location approved by FDA.

Notice of Sampling Terms Used by OASIS for Notification to Filer, Importer, etc. at Line Level

Under OASIS the following terms will be used by the district at the line level to identify the collection of a sample or intent to collect a sample: (wording use to explain the meaning of the OASIS message may not be exactly the same as presented here due to up-dates in the OASIS system)

  1. FDA EXAM: Articles must be held intact and not distributed, pending receipt of written notice or additional message from FDA. The article will be examined or sampled by FDA. Following CBP release, the article may be moved to a location approved by FDA.
  2. FDA EXAM/NOTIFY: Articles must be held intact and not distributed, pending receipt of written notice or additional message from FDA. The article will be examined or sampled by FDA when available. (importer/consignee and/ filer) Notify FDA when the article will be available. Following CBP release, the product may be moved to a location approved by FDA.
  3. FDA EXAM DO NOT DEVAN: All containers or trailers comprising this entry must be held unopened pending FDA examination or receipt of written notice or additional message from FDA. (importer/consignee and/or filer) Notify FDA when the containers or trailers will be available. All FDA regulated articles will be examined or sampled by FDA. Following CBP release, the unopened container or trailers maybe moved to a location approved by FDA.
  4. FDA EXAM REDELIVER: Articles must be held intact and redelivered for FDA examination or sampling. (importer/consignee and/or filer) Contact FDA for redelivery instructions. A written notice with specific information regarding this request will be sent to the filer, importer of record, and consignee.

In those situations where the article is identified as subject to detention without physical examination, or where the action being recommended is for the detention of the article and no additional documentary or physical sample is collected, the notice to the filer to HOLD for FDA Review should be considered as satisfying the requirement for giving notice to the importer. This will also meet the requirement for the article to be held intact until final determination on admission has been made.

Distribution of the Notice of Sampling

For notices issued in OASIS, the firm or person whose name is provided as the Importer of Record in the ACS shall be issued the Notice of FDA Action for the collection of the sample. Copies of the notice generated by OASIS will also be identified for distribution to the filer and consignee, where applicable. Notification to CBP is handled through the FDA/ACS interface. No documents are sent to CBP under OASIS for this notification.

For entries submitted as paper entries, the district will enter the data from the entry documents into the OASIS system, appropriately identify the responsible firm or person shown on the CBP Entry Summary (3461/3461ALT or other appropriate entry document) as the importer of record, and provide them with a Notice of Sampling produced by OASIS. Additional distribution of notices should be made as identified for ACS entries.

Section 801(b) (21 U.S.C. 381(b)) states in part: "Pending decision as to the admission of an article being imported or offered for import, the Secretary of the Treasury may authorize delivery of such article to the owner or consignee upon the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Secretary of the Treasury." The importer of record, who may or may not be the owner or consignee, is the person or firm that posts the CBP redelivery bond covering the importation of the articles and is legally responsible for assuring compliance with all laws and regulations affecting the importation. The importer of record may be a custom house broker, filer, bank, or other entity that is not directly involved with the ownership of the entry. The bond is subject to forfeiture, and the importer of record is subject to regulatory action for violation of the laws and regulations pertaining to the shipment (19 CFR 113.62(l) Consequence of Default).

All persons or firms who are sent a Notice of Sampling or Notice of FDA Action for sampling, must also be sent other official documents pertaining to the sample, i.e., Notices of FDA Action for Release, Detention and Hearing, and/or Refusal of Admission.

Failure To Hold Articles Identified for Examination and/or Sampling

If, after an entry has been filed, electronically or manually, and a Notice of Sampling or Notice of FDA Action has been issued for the entry to be held for examination or sampling, FDA finds that the entry or a portion thereof was not held, and there was disregard of the Notice by the importer, a written request to CBP asking for redelivery of the merchandise should be made. If the distributed article is not returned to CBP for FDA's examination or sample, a bond action should be sought through OASIS or current written procedures (see RPM Bond subchapter 9-1 for guidance on request for redelivery/bond action).

For more information, refer to the Cooperative Agreements Manual, "MOU with U.S. Customs Service to Establish a Working Relationship for Cooperative Enforcement (225-79-4003)", 10/01/80 (Old designation Compliance Policy Guide (CPG) 7155g.03, new designation Section 2-A General Import Agreements) and "MOU with U.S. Customs Service regarding Identifying Roles and Authority Concerning Electronic Products (225-74-6004), 10/01/88 (Old designation CPG 7155g.01).

Multiport Coverage

Many importers maintain distribution points throughout the country and will move articles to those locations for immediate distribution upon receipt of their releases from CBP and other agencies. As long as the articles are under the importer's full control and are not further distributed, or has been delivered to their consignee but are still under the full control of the importer, the importer may request the article be examined by the district in whose jurisdiction the article is held. This practice should not be encouraged, nor should importers consider the allowance of such practice to be a license to request all their importations be examined at destination. Allowing movement and requesting foreign district examination/sample should be at the discretion of the district, depending on the article to be examined or sampled.

Under certain conditions, filers may use various means of filing entries, for example multiport entries for clearing cargo. Under these provisions of CBP, the filer may be in one port location (port A) but enter the cargo in port B. However, the cargo itself may be physically located at port C, and the examination will take place at port D. For FDA coverage, the examination of the cargo may be dependent on the FDA location where the cargo is entered and/or where it is physically located. District coverage of such importations should be evaluated on a case by case basis. Ultimately, the FDA district responsible for the entry will be that district covering the responsible CBP port for the entry.

Simultaneous Multiple Entries

The following guidance is being provided to assist districts in the collection of import compliance samples from multiple, simultaneous entries (within a 24 hour period) of the same product(s) from the same manufacturer/grower or shipper:

The district will identify each entry individually for coverage. OASIS does not include provisions for consolidating multiple entries under one number, since all actions are based on individual entry numbers. However, districts may relate one entry to another to show they are making their determination of admission on all associated entries from the one entry sampled/examined.

Documentation MUST show a direct relationship between the samples, e.g., date of manufacture, production codes, fields of harvest, etc.

This procedure is recommended whenever compliance sample of suspect multiple shipments are collected. It may also be used when multiple entries are made to accommodate different consignees with the same product, such as canned foods.

Under no circumstances where districts receive paper entries should different Importer's Entry Notification for portions of the same entry be accepted or processed. Each notification should represent a unique entry. If this situation is encountered, districts may wish to reject the notifications and request the broker to consolidate the information into one notification. Under the OASIS procedure, where entries are filed through the CBP ACS, this procedure may not be applicable.

Also, under the OASIS screening procedures, if a district notices a trend to separate shipments from the same manufacturer, shipper, or grower in order to receive a favorable "May Proceed" on as many portions of the same product through the screening process, the district may consider requesting, as appropriate, the particular product/manufacturer combinations be screened as "examination" to assure all shipments are provided to the district for review before being may proceeded.

(See RPM subchapter 9-19 Import Sampling and Field Examination Guidance for additional information on SIMULTANEOUS MULTIPLE ENTRIES sampling/examination)

Single Entry of Multiple Commodities

Under the OASIS procedures, when an entry consisting of multiple food items is presented, the district must issue a single Notice of FDA Action identifying all items in the entry for FDA hold/examination. In the case of paper entries, designate the entire entry to be held as "foodstuffs", or use another appropriate term.

There is no prohibition against issuance of one Notice of FDA Action for collection of samples for an entire multiple commodity entry. In the OASIS procedures, the Notice will indicate the specific lines that are to be covered by the district. The intent of the Notice is to provide the owner/consignee with information as to whether the sample(s) have been collected or will be collected. It may not be possible to know in advance of an examination what problems or conditions will be encountered before the entry is examined. Therefore, Notice of FDA Action identifying all commodities present as "HOLD ALL" pending examination does not conflict with FDA regulation or policy. (See OASIS notice statements under "B", "When to Issue the Notice of Sampling")

Because the exact article to be examined/sampled may not be known until after the vehicle transporting the goods has been unloaded, one Notice is issued to assure that all products are held for examination. FDA has authority to request that the entire entry be held pending examination, and whether numerous individual Notices, or one blanket Notice is issued, the effect is the same: the entire entry must be held.

When the importer advises the district of the location and the availability of articles in the entry, the district personnel will visit the site to perform the examination and/or collection. At this time, a new Notice of FDA Action for the collection of the specific articles is issued. Any article not covered by a specific Notice of FDA Action will be designated as "Released" or "May Proceed."

(Note: See exhibit 9-6 for examples of Notices which include identification of products sampled by FDA.)