|PHIS Implementation Letter to Importers|
| Below is the text of a letter sent to Importers from Dr. Ronald K. Jones; the original is available in
April 18, 2012
The United States Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) is the public health regulatory agency responsible for ensuring that domestic and imported meat, poultry, and processed egg products are safe, wholesome, and correctly labeled and packaged. All shipments of meat, poultry, and egg products exported to the United States, which are certified by the foreign country's competent authority, must be presented for reinspection at an FSIS official import inspection establishment, or alternative inspection location authorized by FSIS.
In order to enhance the Agency's ability to better protect public health, FSIS will launch a comprehensive data analytics system called the Public Health Information System (PHIS) as part of its effort to collect, consolidate, and analyze data. PHIS, which will strengthen FSIS detection and response to ineligible imported shipments, will replace the Automated Import Information System (AIIS). To facilitate the implementation of the PHIS, FSIS is proposing changes to the imported products inspection regulations, including amendments to the prescriptive foreign inspection certificate requirements, requiring specific product information that will assist in designating reinspection assignments, and providing a prior notification timeframe for import inspection applications that parallels the U.S. Customs and Border Protection entry timeframe.
Among the many services it provides, PHIS will automate and streamline the import inspection application and certification processes. Specifically, PHIS will electronically link with the Custom and Border Protection's (CBP) Automated Commercial Environment (ACE) to create a unified import processing system for entering data. This system will enable U.S. importers and customs brokers to enter FSIS import inspection application data directly into ACE through the Automated Broker Interface (ABI) as part of the CBP entry process, thereby eliminating the need to file a separate paper application with FSIS. However, when PHIS implements in May, the CBP ACE will only transmit the entry/entry summary data existing in ACE to PHIS. Agency specific data (PGA Message Set) will not be transmitted until later in 2012. In addition, PHIS will enable electronic interface with foreign governments' certifications systems, which will allow for government-to-government electronic certification, eliminating the need for a paper inspection certificate. The electronic receipt of this import information to PHIS will expedite data entry and shipment clearance by FSIS.
When PHIS is implemented on May 29, 2012, U.S. import verification activities will continue to be performed on imported meat, poultry, and processed egg products that have been inspected and certified by an equivalent foreign inspection system. Ultimately, eligibility of the foreign country, foreign establishment, and product will be determined by the system when the application for FSIS import inspection is filed by the U.S. Importer of Record or U.S. Customs Broker. The information will be verified by the FSIS import inspector when the shipment is presented at the official import inspection establishment, using the official inspection certificate issued by the foreign inspection system.
Though FSIS has defined the information required to complete the FSIS application for inspection, these have yet to be incorporated into the PGA Message Set of the ACE ABI Customs and Trade Automated Interface Requirements (CATAIR)(Appendix T) and implemented by CBP. Until such time that the PGA Message Set is implemented by CBP, FSIS will only receive a partial set of data electronically (see
Attachment 1). Importers or brokers currently using an automated system to generate the current FSIS Form 9540-1 (version 05/07/2002) may continue using their current programming to prepare the application, though FSIS requests that the following agency specific data is added to the form in "Box 31 Remarks": 1. the e-mail address of the customs broker or applicant and, 2. the estimated date of arrival. Importers or brokers will continue to submit a paper copy of the current import application (FSIS Form 9540-1 (version 05/07/2002)) to the FSIS import inspector at the designated official import inspection establishment identified on the application where the product will be presented for reinspection, no later than the time of filing with CBP. For applications that are incomplete or contain inaccurate information, the applicant will be requested to correct the application before import reinspection will proceed.
In preparation for implementation of the PGA Message Set, FSIS has revised the Import Inspection Application (FSIS Form 9540-1 (draft)), which will be used for all meat, poultry and egg products shipments. This revised FSIS Form 9540-1 is enclosed (
Attachment 2) and highlights the source of each data element required on the form (e.g. entry summary data from ACE or the foreign inspection certificate). Importers or brokers can use this version to update their data entry screens for the ABI.
Shipments from Canada
When PHIS implements, Canadian exporters will no longer submit an advance copy of the FSIS Form 9540-1 to the official import inspection establishment, or in the case of egg products, the importer will no longer submit an advance copy of FSIS Form 5200-8 (Import Request Egg Products - CFIA Application for Inspection). The FSIS Form 5200-8 will be replaced by FSIS Form 9540-1. When the importer or broker files their entry with CBP, this will provide FSIS with prior notification. All inspection assignments for meat, poultry, and egg products will be generated through PHIS.
It should be noted that once PHIS implements, all importers may continue to use the paper application option, FSIS Form 9540-1, Import Inspection Application, in lieu of electronic entry through ACE. Further, a paper FSIS Form 9540-1 will continue to be required for shipments of meat, poultry, and egg products imported into ports where the CBP ACE system is not available (e.g., American Samoa, Guam, Commonwealth of Northern Mariana Islands).
Failures to Present
When the PHIS is implemented, FSIS will be able to monitor the movement of imported product more effectively and efficiently. In the event that the shipment fails to present for FSIS reinspection at an official import inspection establishment, FSIS will consider that shipment as ineligible for entry and a request for redelivery will be initiated through CBP. The importer may be subject to appropriate civil penalties associated with this enforcement action. If the shipment fails to return to the official import inspection establishment (e.g. the shipment is delivered to the end user in the U.S.), the imported product, or any product produced from the ineligible product may be subject to FSIS recall or seizure.
The competent authority of the foreign inspection service will continue to be responsible for the certification of shipments of product to the United States, as outlined in 9 CFR 327.4 (a) and (b), 381.197, and 590.915. Regardless of whether a paper or electronic certificate is used, each consignment of meat, poultry or egg products certified for export to the United States must be accompanied with an inspection certificate, prepared in English, and contain the following information:
- Name of country, the date the certificate is issued, and if applicable, the foreign establishment number where the certificate was issued
- Name and foreign establishment number that produced the product
- Species used to produce the product and the source country, establishment number, if the source of the meat, poultry, or egg products originate from a country other than the exporting country)
- Name and address of exporter or consignor
- Name and address of importer or consignee
- Number of units
- Net weight for each lot
- Shipping or identification mark on units
- The product's description, including the product's process category, product category, product group (see
- Production dates, when appropriate
- Seal number(s), when appropriate
- Name (including signature) and title of person authorized to issue inspection certificates for products exported to the United States (paper certificates only).
FSIS no longer prescribes the specific statements that are to appear on the foreign inspection certificates, though the competent authority must certify that any product described on the official certificate was produced in accordance with the regulatory requirements in 9 CFR 327.2 (meat), 9 CFR 381.196 197 (poultry) or 9 CFR 590.910 (egg products). Further, FSIS no longer requires the certificate to be printed in the language of the foreign country of origin certificate, though foreign countries have the option to include this.
Note that FSIS has previously allowed foreign countries to guarantee the replacement of the foreign inspection certificate, which would allow continuation of FSIS reinspection pending the arrival of the certificate within 30 days of the guarantee. FSIS will discontinue this policy when the PHIS is implemented. FSIS will refuse entry on any shipment that has not been properly certified. Replacement certificates will be accepted, either electronically (e.g. scanned copy transmitted by e-mail or replacement through eCertification) or paper, at which time FSIS will continue with the reinspection.
Sampling at port of entry
When PHIS implements in May, FSIS import sampling will continue to be allocated by country, process category, product category, and species. Reinspection of product is performance-based, intended to verify the effectiveness of the foreign inspection system. FSIS ensures that the official inspection certificates issued by the exporting country, whether in electronic or paper format, are authentic and accurate and randomly samples meat, poultry, and egg products prior to releasing the consignment into commerce of the United States. This random sampling focuses on public health risks and food safety, subjecting specific shipments to a more in-depth reinspection of product, which may include product examination or laboratory testing for pathogens and chemical residues. If the shipment fails reinspection, the non-compliant product is refused entry and the automated system intensifies the rate of reinspection to ensure product compliance. FSIS has the discretion to increase the level of sampling for a specific product, country and/or foreign establishment due to cause other than import reinspection failures.
The PHIS will be operational in all U.S. official import inspection establishments handling imported shipments of meat, poultry, and egg products, effective May 29, 2012. At this time, FSIS will replace the existing Import Manual of Procedures, which provides guidance to the FSIS inspection personnel, with FSIS Directives. To facilitate the implementation of PHIS's import applications, FSIS has developed draft compliance guidance that is intended to help U.S. importers, custom brokers and official import inspection establishment plant management understand the regulatory requirements found in 9 CFR 327.5, 381.198, and 590.920. The compliance guide also explains how submitting data through the entry filed in ACE will prevent disruptions in the entry, clearance, and movement of imported FSIS-regulated shipments. FSIS will post this draft compliance guide on its Significant Guidance Documents Web page (http://www.fsis.usda.gov/Significant_Guidance/index.asp) prior to the implementation date.
If you have specific questions about PHIS implementation, please contact FSIS Office of International Affairs, Import Inspection Division at (202) 720-9904 or by e-mail at email@example.com.
Dr. Ronald K. Jones
Office of International Affairs
Attachment 1 (PDF only) - List of data elements that will be transferred from ACE into PHIS initially
Attachment 2 (PDF only) - Revised FSIS Form 9540-1 (Draft)
Attachment 3 (PDF only) - FSIS Product Categorization