Meat, Poultry, and Egg Products Refused Entry Into the United States (U.S.) - Revision 2
This directive provides instructions to inspection program personnel (IPP) concerning the identification, control, documentation, and disposition of imported meat (which includes Siluriformes fish), poultry, and egg products that are refused entry into the United States (U.S.). FSIS is reissuing this directive to update regulatory citations for egg products contained in the final rule Egg Products Inspection Regulations (85 FR 68640), to update instruction regarding the amount of time an applicant has to dispose of imported egg products identified as “United States Refused Entry,” and consolidate the instructions IPP use to refuse entry on meat, poultry, and egg products as a result of the egg products final rule.
- Provides instructions to FSIS IPP for verifying the appropriate disposition of refused entry shipments
- Provides clarification of what constitutes reimbursable services with regards to verifying appropriate disposition of refused entry products
- Provides instructions on when to monitor refused entry product at the official import inspection establishment through scheduling of the Import Refused Entry Verification task in PHIS
- Extends the amount of time the applicant has to dispose of egg products identified as “United States Refused Entry” to 45 days
FSIS Directive 9900.8, Revision 1, Meat, Poultry, and Egg Products Refused Entry into the United States (U.S.), 11/3/15
Imported meat, poultry, and egg products that do not meet U.S. requirements are not allowed to enter U.S. commerce and are to be identified as “United States Refused Entry” product. For the purposes of this directive, the owner or consignee is intended to include the importer of record. Products that may be identified as “United States Refused Entry” include those that are:
- Not eligible for importation into the U.S. (see Section IV A. of this directive), or
- Eligible for importation into the U.S. but in a condition that causes them to be refused entry (see Section IV B. and C. of this directive).
IV. IDENTIFYING REASON FOR REFUSED ENTRY PRODUCT IN PHIS
A. Ineligible Product - IPP are to refuse entry of a product when they find that any of the following conditions apply:
- The source or producing country is not eligible to export to the U.S.;
- The source, processing, or preparing establishment is not certified to export to the U.S.;
- The product fails to comply with FSIS or Animal and Plant Health Inspection Service (APHIS) regulations;
- The production dates show that the product was produced when the exporting country was not eligible to export to the U.S.;
- The production dates show that the product was produced when the processing or preparing establishment was not eligible to export to the U.S.;
- The product is derived from a species that the exporting country is not eligible to export to the U.S.;
- The product is not eligible for export to the U.S.; or
- The foreign inspection certificate is incorrect or invalid under 9 CFR 327.4, 381.197, 557.4, or 590.915.
B. Failed Type of Inspection (TOI) - Eligible lots of meat, poultry, or egg products that are reinspected may be refused entry for failure of one or more of the following TOIs:
- Certification: For any of the reasons stated in Section VII.A. of this directive, or for any other reason as indicated in FSIS Directive 9900.1, Imported Product Shipment Presentation;
- Label Verification: For reasons as indicated in FSIS Directive 9900.5, Label Verification of Imported Meat, Poultry, and Egg Products;
- Physical Examinations: (e.g., product examination, net weight, condition of containers) for reasons identified during physical inspections as outlined in FSIS Directive 9900.2, Import Reinspection of Meat, Poultry and Egg Products and FSIS Directive 14950.1, Inspection Program Personnel Responsibilities at Official Import Inspection Establishments That Receive Shipments of Siluriformes Fish and Fish Products;
- NOTE: When product fails a TOI, IPP are to refuse entry of the entire lot, but are to allow recertification of specific TOIs as noted in the directives referenced above. A failed physical examination TOI result reported in PHIS will automatically initiate a refused entry in PHIS for the lot.
- Laboratory Analysis:
- a. Eligible lots of meat, poultry, and egg products that are reinspected may be refused entry for failure (violative results) based on one or more of the following laboratory-related TOIs:
- i. Pathogen Sampling (e.g., E coli O157:H7, Listeria monocytogenes, Salmonella);
- ii. Pathology Testing (includes histopathology, species and central nervous system tissue identification);
- iii. Food Chemistry Testing (e.g. added water, moisture/protein ratio (MPR), total fat, nitrite); or
- iv. Residue Testing (e.g., Multi-Residue Method (MRM), pesticides,metals).
- NOTE: Laboratory TOIs with a reported failed TOI result do not automatically initiate a refused entry in PHIS for the lot. IPP are to generate the refused entry manually in PHIS, selecting the most appropriate reason(s) based on the TOI and the failure.
- b. Product from other lots implicated with violative product based on laboratory analysis:
- i. The Recall Management and Technical Analysis Division (RMTAD) is to coordinate with the Office of International Coordination (OIC) to contact the central competent authority (CCA) of the foreign country from which the violative lot of product originated and request that information be provided so that RMTAD can make a determination as to whether other product, in addition to the lot of product that was tested and failed, also needs to be refused entry or recalled if in commerce. RMTAD is to provide direction on what product IPP are to retain when a laboratory violation occurs.
- ii. IPP are to retain any product that has been presented for import reinspection from the same foreign establishment (same process category/product group). IPP do not reinspect product until the determination is made by RMTAD that no other product is implicated. Implicated product will be refused entry in PHIS and disposed of properly under FSIS IPP supervision, controlled (e.g., stock recovery), or recalled if in commerce.
- a. Eligible lots of meat, poultry, and egg products that are reinspected may be refused entry for failure (violative results) based on one or more of the following laboratory-related TOIs:
C. Partial Lot Refused Entries - When IPP identify that a portion of a lot of product presented for reinspection is non-compliant with FSIS requirements and does not result in a failed TOI or results in a failed TOI that may be rectified, IPP are to be aware that the non-compliant product can be sorted and removed from the lot before continuing with the reinspection. The most common reasons for partial refused entries are that shipments include shipping containers that have transportation damage, missing shipping marks, or illegible shipping marks. IPP are also to be aware that compromised immediate containers or protective coverings resulting in loss of package integrity, including that resulting in product spoilage, may also be sorted from the lot as a partial refused entry.
NOTE: Compromised Vacuum Packaging has been added to PHIS as a Refusal Reason, as illustrated below: On full PDF
This new refusal reason reflects the need to differentiate between the damage that may occur to packaging during shipping and the loss of integrity of a package that exists due to a defect not related to shipping, such as the failure to adequately seal the package resulting in a loss of vacuum (leaking vacuum package), or a tear in the package.
NOTE: IPP are to refuse entry to directly compromised immediate containers or protective coverings and not to the entire shipping container that contains the compromised immediate container or protective covering package.
D. Food Defense – If IPP observe evidence of product tampering or other food defense concerns, they are to follow the instructions provided in FSIS Directive 5420.1, Food Defense Verification Tasks And Threat Notification Response Procedures For The Office Of Field Operations, and notify their supervisor immediately. For product that has not been presented, inspected, and passed, IPP may be instructed to refuse entry to all or a portion of the lot.
V. REFUSED ENTRY PROCEDURES
A. When a lot of meat, poultry, or egg products is entered in PHIS and is ineligible for any of the reasons identified in Section IV. A. of this directive, IPP are to:
- Review for accuracy the data entry in PHIS pertaining to the lot by comparing it to the foreign inspection certificate;
- Based on this review, if IPP find any data entry errors in the PHIS entry, they are to correct the application in PHIS; and
- If IPP find no data entry errors, IPP are to contact RMTAD to determine if the foreign country’s annual certification is up to date or if there is a data entry error in the country/establishment profile. RMTAD will coordinate with the Import Librarian and the International Equivalence Staff to ensure that the country/establishment profile is updated if needed or advise the IPP to refuse entry.
NOTE: PHIS will display a warning message when product is ineligible such as: Displayed On full PDF
B. If RMTAD confirms that the ineligibility message is correct, IPP are to access the Lot Manager page for the lot and:
- Click on the Refused Entry button;
- Click on Add New Reason, and then select the most appropriate Refusal Reason from the drop-down menu;
- Select the most appropriate Defects reason from the drop-down menu to align with the Refusal Reason selected;
- Click on Save; and
- Click on Send To Applicant.
C. Meat, poultry, or egg products that are refused entry for any of the reasons identified in Section IV. A. of this directive are to be identified as “United States Refused Entry” product. IPP are to access PHIS and enter defects/comments as applicable and enter all data concerning a lot that fails a TOI following the completion of the reinspection. If PHIS is not accessible, IPP are to enter the data as soon as PHIS is accessible.
D. When meat, poultry, or egg products are refused entry for transportation damage or for missing or illegible shipping marks, IPP are to identify the non-compliant product and have the official import establishment sort and remove the non-compliant product from the lot before continuing the reinspection. IPP are to refuse the entire lot of product if the official import establishment refuses to sort the lot. IPP are to control the sorted product until final disposition is determined. For the purposes of refused entry product, “control” means the product is either marked with “United States Refused Entry” or is controlled with a U.S. Rejected – U.S. Retained Tag (FSIS Form 6502-1). IPP are to record all data concerning partially refused entries in PHIS as soon as possible following completion of reinspection.
NOTE: IPP are to be aware that import establishment personnel may sort non-compliant shipping cartons when unloading the cargo container or conveyance and present the lot to IPP already sorted.
E. IPP are to:
- Ensure that the refused entry product is under FSIS control until properly identified as “United States Refused Entry.”
- Notify import establishment management of each refused entry and provide a copy of FSIS Form 9840-3, Refused Entry Notification, upon request;
- Verify that the application of the refused entry stamp occurs in a designated staging area. IPP are to maintain control of the “United States Refused Entry” stamp at all times and document an accurate count of the number of units stamped for each refused entry occurrence;
- NOTE: When livestock carcass shipments or tankers from Canada are labeled with a placard, the placard, not the product or the conveyance, is to be stamped “United States Refused Entry;”
- Submit notification to the applicant in PHIS of the refused entry of the lot (this will also notify U.S. Customs and Border Protection (CBP));
- Notify APHIS and the District Office (DO) when a lot or any portion of a lot from an APHIS restricted country fails an animal health TOI or other APHIS requirement (e.g., pink juices observed in cooked meat, missing or incorrect certification, failed Maximum Internal Temperature (MIT) laboratory analysis). APHIS will advise IPP regarding the product’s disposition;
- Stamp the paper foreign inspection certificate with the “U.S. Refused Entry Amount” and record the amount of refused entry in units and pounds in the blank area of the stamp. If part of the lot is not refused entry, also stamp the paper foreign inspection certificate “U.S. Inspected & Passed.” To the extent possible, apply the stamps to an area of the certificate that does not obstruct required information. If there is no paper inspection certificate (electronic certificate), then a certificate does not get stamped;
- Retain paper foreign inspection certificates in the FSIS in-plant files by country, certificate number, and calendar year;
- Verify that there is proper disposition of product designated as “refused entry;” and
- When final product disposition of the refused entry occurs, access PHIS, enter the disposition status of the product, record as completed in PHIS, then release the lot in PHIS by clicking Release Acceptable Units.
VI. STORAGE AND MONITORING OF REFUSED ENTRY PRODUCT
A. IPP are to use the PHIS task calendar to schedule the Import Refused Entry Verification task for monitoring of refused entry product at official import inspection establishments in accordance with FSIS Directive 13,000.1, Scheduling In-Plant Inspection Tasks in the Public Health Information System (PHIS).
NOTE: IPP do not need to enter the refused entry verification as a lot event on the lot manager page associated with each refused entry. IPP are to perform an inventory of all refused entry product onsite and document the results of that inventory in the task calendar.
B. When IPP are performing the refused entry verification task, IPP are to:
- Verify that all refused entry product controlled at the official import inspection establishment pending disposition remains present and is stored and segregated from other product at the official import inspection establishment until final disposition occurs, or permission to move the shipment is granted by the DO (e.g., movement to the port for direct and immediate exportation or to the end-user, such as an animal food manufacturer (Food and Drug Administration (FDA) approval is required [9 CFR 327.13(a)(2), 381.202(a)(2), 557.13, and 590.945(a)(3)]); and
- Advise the management of the official import inspection establishment of their responsibility to store and segregate the product in this manner.
C. Once IPP have verified the inventory of refused entry product, they are to mark the task as completed.
D. If IPP observe noncompliance during the refused entry verification task (e.g., cannot locate refused entry product), IPP are to contact official import establishment management to ascertain the location of the product.
E. If IPP determine that the official import inspection establishment has not handled refused entry product in compliance with the regulations (e.g., destroyed the product or moved it from the official import inspection establishment without FSIS knowledge) or is otherwise unable to locate refused entry product, IPP are to:
- Withhold inspection of imported products at the official import inspection establishment;
- Indicate noncompliance under the Regulations tab of the task results in PHIS and click “Save”. PHIS will then allow IPP to document a noncompliance record (NR) citing 9 CFR 500.3(a)(5);
- Notify the Frontline Supervisor (FLS);
- Provide a copy of the NR to the official import inspection establishment; and
- Await instruction through supervisory channels.
F. The District Manager (DM) or designee is to decide whether this violation requires the initiation of a suspension under 9 CFR 500.3(a)(5). When the violation warrants a suspension, the DM is to ensure that the Grants Curator properly updates the Grant Status in the PHIS Establishment Profile. The DM is to continue to withhold inspection until suitable corrective actions are implemented and:
- If the DM or designee determines that a suspension is warranted, the DM or designee is to notify the official import inspection establishment management in accordance with 9 CFR 500.5(a); or
- If the DM or designee decides not to initiate a suspension, the DM or designee is to issue a letter to the management of the official import inspection establishment regarding the serious nature of removing or losing control of refused entry product; and
- The DM or designee is to provide direction through supervisory channels during this period.
G. As appropriate, the DM or designee will contact the Office of Investigation, Enforcement and Audit (OIEA) Compliance and Investigation Division (CID) Regional Director (RD) to provide notification and to request a follow-up investigation of the whereabouts of the refused entry product removed from the official import inspection establishment.
VII. TIME PERIOD FOR REFUSED ENTRY PRODUCT DISPOSITION
A. After notice is given to CBP by clicking Send to Applicant on the Refused Entry page in PHIS, the owner or consignee has 45 days , to take the action as required by 9 CFR 327.13(a)(2), 381.202(a)(2), 57.13 and 590.945(a)(4) for product that has been refused entry. For product that is refused entry because of APHIS animal disease restrictions, APHIS or CBP will notify IPP and the FLS regarding the products’ disposition and any additional timeframes for required disposition (e.g., 72 hours), including the method of disposal for the product.
B. The applicant may contact the DO to request an extension of the time limit for product disposition. Requests for extensions beyond the regulatory time period for disposition are only granted by the DO and only when extreme circumstances warrant, such as an unforeseeable vessel delay or dock strike, as required by 9 CFR 327.13(a)(5), 381.202(a)(4), 557.13, and 590.45(a)(4).
C. If final disposition of the refused entry product has not been accomplished within the regulatory time period, IPP are to:
- Retain the refused entry product using a retain tag (FSIS Form6502-1);
- Notify the DO and FLS; and
- Follow instructions provided by the DO to ensure that proper disposition of the product occurs.
D. The DO is to notify the appropriate OIEA (RD). OIEA will initiate actions as necessary to facilitate disposition of the refused entry product including, but not limited to, contacting the owner or consignee to complete disposition of the refused entry product or initiating the seizure process.
VIII. TYPES OF DISPOSITION FOR REFUSED ENTRY PRODUCT
A. IPP are to receive communication from the owner/consignee/import establishment on the type of product disposition to be used from the methods listed below (9 CFR 327.13, 381.202, 557.13, and 590.945):
- Exportation (return) of the product to the originating country or to a third country, if permitted (see 9 CFR 327.13(a)(2), 381.202(a)(2), 557.13, and 590.945(a)(3)). If the owner/consignee/import establishment requests permission to export (return) the product, the FLS is to approve or deny the request. IPP may approve the request for Canadian product arriving at the border by truck. If approved, the IPP is to coordinate with the owner/consignee/import establishment and supervise the loading of refused entry product onto the conveyance;
- a. The DO may receive a request from a foreign consignee or original applicant for the refused entry product to be consolidated from multiple official import establishments for direct and immediate export. If the consolidation will include import establishments in more than one District, the DO where the final pickup will occur prior to export will receive the request. Requests for consolidation of refused entry product are only to be granted by the DO. The DO must receive sufficient information to demonstrate controls on how the product is to be consolidated, including means (e.g., seals or other mechanisms) sufficient to demonstrate that the load remains intact during movement from one import establishment to the next. The plan must also include information on the export of the product, including the name of the vessel and the date of export as required by 9 CFR 327.13(a)(3), 381.202(a)(3), and 557.13. Once the DO approves the plan for consolidation of refused entry product for exportation, or if an approved plan is modified, the DO is to notify the appropriate FLSs of all the affected import establishments in that District. If the consolidation will include import establishments in multiple Districts, the approving DO is to coordinate with the other affected DOs. The FLSs are to notify the IPP at the affected import establishments. An approved plan may only be modified with the consent of the approving DO.
- b. IPP are to verify disposition as per Section IX. A. of this directive. In addition, IPP are to verify documents and seals or other means of ensuring control of the product as specified in the consolidation plan in the preceding paragraph a. After completing these tasks, IPP are to notify the IPP at the next import inspection establishment from which product will be consolidated.
- Destruction of the refused entry product so that it can no longer be used for human food (9 CFR 327.13(a)(2), 381.202(a)(2), 557.13, and 590.945(a)(3)) by one of the following methods:
- a. Landfill (requires documentation sufficient to show that movement has been scheduled);
- b. Rendering for industrial, non-food purposes (requires documentation sufficient to show that movement has been scheduled);
- c. Incineration (normally required by APHIS when product is refused entry for animal disease restrictions); or
- d. Denaturing the product (9 CFR 325.13, 327.25, 381.202(e), 557.25, and 590.945);
- Conversion of the product to animal food (9 CFR 327.13(a)(2), 381.202(a)(2), 557.13 and 590.945(a)(3)) if permitted and approved by the FDA, and that permission is communicated to the DO; or
- Rectified, if the reason for refusal has been corrected (only in certain limited circumstances, e.g., new inspection certificate, re-labeling).
B. Once the owner/consignee/import establishment informs FSIS of the intended disposition (9 CFR 327.13(a)(5), 381.202(a)(4), 557.13, 590.945(a)(3)), IPP are to enter the method of disposition inPHIS.
C. IPP are to verify that the disposition of refused entry product occurs within the regulatory time limits (9 CFR 327.13(a)(2), 381.202(a)(2), 557.13, and 590.945(a)(4)), and that the disposition is completed.
IX. VERIFYING DISPOSITIONS
A. After the request to export refused entry product has been approved by the IPP for Canadian product or by the FLS for product from all other countries, or by the DO for consolidated shipments, IPP are to:
- Access PHIS and document that the applicant has requested exportation;
- Select the Released to Port Date in PHIS and click Save;
- Notify official import inspection establishment management that the lot may be moved for export;
- Receive documentation from the owner/consignee/import establishment demonstrating that product was exported. Documentation is not limited to specific items but must be sufficient to demonstrate that exportation of the product occurred. The FLS is to correlate with IPP regarding acceptable documentation;
- Attach the documentation to the appropriate case file, as applicable; and
- NOTE: IPP are to retain all documents related to a specific inspection event in a case file. This would include any documentation provided by the establishment to initiate the inspection, any documents or notes generated by IPP during performance of the inspection, any documentation provided by the establishment or applicant regarding appeals, any documentation regarding refused entry extensions and dispositions, and any additional documentation or correspondence requested by his or her immediate supervisor. Case files are to be filed by country and certificate number and retained under FSIS control in accordance with FSIS Directive 2620.1, Revision 5, FSIS Records Management Program.
- Access PHIS and check Disposition Complete for the lot disposition.
B. For exportation of Canadian refused entry product to Canada, in addition to the steps outlined above, IPP are to:
- Complete and print FSIS Form 9135-1, Notice of Shipment of Refused Entry Product, and FSIS Form 9840-3 from PHIS;
- Make a copy of the inspection certificate;
- Place FSIS Form 9135-1, the original inspection certificate, and a copy of FSIS Form 9840-3 in an envelope, seal the envelope, and write “Attention: CFIA” on the outside of the envelope;
- a. Place the envelope prominently inside the rear of the shipping conveyance; and
- b. Seal the shipping conveyance with USDA Foreign Meat (Red Ball) seals; and
- Notify the appropriate Canadian Food Inspection Agency (CFIA) contact by e-mail, with a copy to the FLS. The list of CFIA contacts is located in the FSIS Import Inspection SharePoint site.
C. Occasionally, refused entry product will transit through Canada on its way to the country of destination. When this mode of exit is used, IPP are to verify that the requirements in Section IX. A. of this directive are completed, and
- Verify that the shipping conveyance is appropriately sealed with USDA Foreign Meat (Red Ball) seals at the official import inspection establishment;
- Access PHIS and enter the seal numbers used to seal the conveyance; and
- Provide the following information to CFIA by e-mail, with a copy to the FLS:
- a. Name of the trucking company;
- b. Vehicle license number of truck/trailer;
- c. Truck, container, or trailer number; and
- d. Seal numbers used to seal the conveyance.
D. For on-site destruction (denaturing), IPP are to:
- Access PHIS to enter the applicant-provided intended disposition;
- Verify that the selected disposition is acceptable;
- Request that the importer/broker/agent complete FSIS Form 9840-4, Voluntary Destruction of Imported Meat (Including Siluriformes), Poultry, and Egg Product;
- Observe the destruction and verify that control of the product is maintained until destruction is complete; and
- Access PHIS and complete the Disposition, Destruction Date, and Destruction Witnessed By blocks and click Save.
E. For off-site destruction (landfill, incineration, or rendering):
If the applicant requests that the product be transported off-site for destruction, then IPP are to follow the same process that is followed for the off-site destruction of domestic product. If the applicant’s request to move refused entry product to a renderer, incinerator, or landfill operation is granted, IPP are to examine the documentation provided by the applicant or designee to verify that the product received appropriate disposition.
F. For conversion to animal food, the FLS is to:
- Obtain from the product’s owner/consignee/import establishment a copy of written approval from the FDA, authorizing the movement of specific products to a manufacturer of animal foods (327.13(a)(2), 381.202(a)(2), 557.13), and 590.945(a)(3);
- Review the FDA letter of approval to verify that it is intended for the refused product involved; and
- If documentation is acceptable, the FLS is to forward it to the responsible IPP. IPP are to:
- a. Access PHIS, enter the Intended Disposition, place a check mark in the FDA Approval box, enter the Released For Conversion date, and click Save;
- b. Inform official import inspection establishment management that the product may move from the official import inspection establishment;
- c. Obtain documentation sufficient to demonstrate that the refused entry product was received and used by the pet food manufacturer within 45 days. Verify all forms certifying that the product’s conversion to animal food has been properly completed; and
- d. Access PHIS, enter the Disposition as complete, and click Save.
A. FSIS regulations 9 CFR 327.24, 381.202(6)(d), 557.24, and 590.945(d) provide that the importer of record, owner or their representative of imported product may appeal any inspection decision including a failed TOI. Appeals are to be made to the IPP’s immediate supervisor. Supervisors may receive appeals orally or in writing.
B. The following outlines the chain-of-command for appeal decisions:
- Immediate Supervisor;
- DM/Deputy District Manager (DDM);
- Executive Associate for Regulatory Operations (EARO);
- Deputy Assistant Administrator (DAA) for OFO/Assistant Administrator (AA) for OFO; and
- Administrator for FSIS.
NOTE: None of the staffs in the Office of Policy and Program Development (OPPD) (e.g., Import and Export Policy Development Staff (IEPDS), Policy Development Staff (PDS), Risk Management and Innovations Staff (RMIS), or Labeling and Program Delivery Staff (LPDS)) are part of the supervisory chain-of-command regarding the resolution of appeals. Regulatory interpretations provided by these OPPD staffs can be used to support or refute an inspection decision but are not to be considered as denying or granting an appeal.
XI. REIMBURSABLE SERVICES
A. Based on FSIS regulations, IPP inspection activities associated with the disposition of product that has been refused entry or otherwise imported contrary to the Federal Meat Inspection Act, Poultry Products Inspection Act and the Egg Products Inspection Act must be charged as voluntary reimbursable inspection services and billed to the official import inspection establishment. IPP are to complete FSIS Form 5110.1, Services Rendered, according to FSIS Directive 12,600.1, Voluntary Reimbursable Inspection Services, using the appropriate Voluntary Inspection code.
B. Reimbursable charges would apply in any one of the following situations:
- Overseeing and verifying refused entry rectification (e.g., correcting labels, sorting canned product after condition of container failure, or bringing product into compliance relative to net weight); and
- Overseeing, verifying, and documenting disposition of refused entry product by cutting it up, following it to the dump, incinerating, or preparing for re-export (including consolidation).
Refer questions regarding this directive to the OPPD IEPDS through askFSIS or by telephone at 202-690- 4354.