Sanitation Standard Operating Procedures
PHIS Implementation Letter to Official Import Inspection Establishments
Below is the text of a letter sent to official import inspection establishments from Dr. Ronald K. Jones; the original is available in PDF.
April 30, 2012
To: Official Import Inspection Establishments
The United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) will implement the import components of the Public Health Information System (PHIS) on May 29, 2012. PHIS is a user-friendly, Web-based application that will consolidate and replace many existing FSIS systems, such as the Performance Based Inspection System (PBIS) and the Automated Import Information System (AIIS). PHIS will integrate our paper-based business processes and individual automated systems into one comprehensive and fully automated data-driven system.
The implementation of PHIS does not change the need for all shipments of meat, poultry, and egg products exported to the United States, to be presented for reinspection at an FSIS official import inspection establishment, or alternative FSIS authorized inspection location. The importer of record is the responsible party for a shipment and must ensure that the application for inspection is submitted to FSIS. Agency communication regarding decisions or actions to be taken on the product will be coordinated with the importer of record or designee.
As an official import inspection establishment, you will have the option to access PHIS over the Internet using a secure account. This will allow your business to interact electronically with FSIS in performing a wide variety of operations, such as responding to and appealing noncompliance records, viewing reports, and accessing Memorandums of Interview (MOI). Interested parties are required to obtain a USDA eAuthentication (eAuth) Level 2 account from USDA as the first step in the access process. The steps to obtain an account can be found on FSIS' Web site.
The Agency recently completed a pilot with industry representatives which tested domestic establishment access to PHIS. However, when PHIS implements in May, the industry access feature will not yet be available. When available, further instructions on industry access will be posted to FSIS' Web site at http://www.fsis.usda.gov/PHIS/.
To facilitate the implementation of the PHIS, FSIS is proposing changes to the imported products inspection regulations. Proposed amendments to the foreign inspection certificate requirements include the development of standard operating procedures for sanitation, more specific product information that will assist in designating reinspection assignments, and clarification of the required prior notification for FSIS reinspection that will now parallel the entry filed with U.S. Customs and Border Protection (CBP). These changes are detailed below.
Standard operating procedures for sanitation (Sanitation SOPs) are written procedures that official establishments develop, implement, and maintain to prevent direct contamination or adulteration of meat or poultry products. To ensure that imported meat and poultry products do not become contaminated while undergoing reinspection prior to entering the U.S. FSIS will be proposing in the Federal Register to amend 9 CFR 304.3(a) and 381.22(a) to clarify that before being granted Federal inspection, official import inspection establishments must have written Sanitation SOPs (9 CFR 416.11 through 416.17). These Sanitation SOPs are not required on May 29, 2012, though once the final rule is in effect, all official import inspection establishments currently operating under Federal inspection would then be required to develop Sanitation SOPs.
Import inspection personnel will continue to perform sanitation inspection tasks and other directed procedures within the official import inspection establishment that will be scheduled through PHIS. Unscheduled procedures prompted by a trigger event, such as a pre-stamping violation, will also be documented in PHIS. The agency will also maintain an establishment profile, based on the information provided on FSIS form 5200-1, Application for Federal Inspection, in PHIS.
PHIS electronic link with Customs and Border Protection
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.
Application and presentation for reinspection
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 additional data elements have yet to be implemented by CBP. Until such time, FSIS will only receive a partial set of data electronically (Attachment 1).
Therefore, importers (or their brokers) will continue to submit a paper copy of the current import application (FSIS Form 9540-1 (version 03/26/2004)) 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. FSIS requests that the applicant provide the following information to "Box 31 Remarks:"
- The email address of the customs broker or applicant and,
- The estimated date of arrival.
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 Agency specific data (the PGA Message Set), FSIS has revised the Import Inspection Application (Meat, Poultry & Egg Products) (DRAFT FSIS Form 9540-1), which will be used for all meat, poultry and egg products shipments. This revised DRAFT 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 be required to submit an advance copy of the FSIS Form 9540-1 to the official import inspection establishment. 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) to FSIS' Office of International Affairs. 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. The importer or designee will be responsible for submitting the paper copy of the FSIS form 9540-1 to the import inspector along with the official inspection certificate.
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 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.
Foreign Inspection Certificate Requirements
Whether a paper or electronic certificate is used, each shipment 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 (Attachment 3)
- Production dates, when applicable
- Name (including signature) and title of person authorized to issue inspection certificates for products exported to the United States (paper certificates only).
The product lots identified on the import inspection application must match the product lots as certified on the foreign official inspection certificate. Lot groupings are based on product, species, product category and product group. The mixing, matching, splitting of lots is not permitted at the official import inspection establishment. The importer should coordinate with the foreign exporter to designate lots during the certification process in the foreign country.
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 intends to discontinue this policy when the PHIS is implemented. FSIS will refuse entry to any shipment that has not been properly certified. Replacement certificates will be accepted, either electronically (e.g. scanned copy transmitted by e-mail (gov't-to-gov't) or replacement through eCertification) or paper. Once received, FSIS will continue with the reinspection.
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.
On May 29, 2012, PHIS will be operational in all U.S. import inspection establishments handling shipments from all countries eligible to export meat, poultry, and egg products. At that time, FSIS will replace the existing Import Manual of Procedures, which provides guidance to the FSIS inspection personnel, with FSIS Directives. FSIS will provide further guidance and information to both foreign governments as well as industry regarding PHIS prior to the implementation date. The updates to information related to PHIS will be available on FSIS' website at http://www.fsis.usda.gov/PHIS/.
If you have specific questions about PHIS implementation, please contact the FSIS Office of International Affairs (OIA), Import Inspection Division at (202) 720-9904 or by email at firstname.lastname@example.org.
Dr. Ronald K. Jones
Office of International Affairs