PHIS Implementation Letter to Foreign Countries
Below is the text of a letter sent to Foreign Countries from Dr. Ronald K. Jones; the original is available in PDF.
March 20, 2012
To: Foreign Country
The United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) is implementing the import components of the Public Health Information System (PHIS), effective May 29, 2012. The PHIS is a web-based application that will replace the existing Automated Import Information System (AIIS). Many of the changes associated with this new system were outlined during the outreach sessions held in 2011 and are highlighted below.
The competent authority of the foreign inspection service will continue to be responsible for completing the certification of eligible establishments, as outlined in 9 CFR 327.2 and 381.196 (a)(3), as well as 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. In the near future, FSIS will publish proposed revisions to the import regulations in the Federal Register that will include changes to the certification requirements and data required for certifying eligible foreign establishments and inspection certificates accompanying the shipments of product to the United States. One significant change is that the import component of the PHIS will provide for a government-to-government electronic transmission of the certificate data as an alternative to the paper certification, which will continue to be accepted by FSIS. In the first phase of implementation, electronic certification will be limited to two countries, Australia and New Zealand, both of which already have agreements in place for the use to electronic certificates. Other foreign governments interested in pursing electronic certification should contact the FSIS Office of International Affairs (OIA) for further guidance and requirements. Foreign countries exporting to the United States may still use paper inspection certificates.
Regardless of the format of the annual establishment certification, the following data elements will be required: foreign establishment's name and address, control number (e.g. establishment number) assigned by the foreign inspection system, type of operations conducted at the establishment (e.g. slaughter, processing, storage, or export certification), and eligibility status (e.g. new, listed as eligible the previous year, delisted, relisted (if previously delisted). Slaughter and processing establishments must identify the species and types of products produced in the establishment, as well as the process categories for products produced. The process categories include raw nonintact; raw - intact; thermally processed - commercially sterile; not heat treated - shelf stable; heat treated - shelf stable; fully cooked -not shelf stable; heat treated but not fully cooked - not shelf stable; and, products with secondary inhibitors - not shelf stable, and egg products.
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 Attachment 1)
- 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).
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, though foreign countries have the option to include this.
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 to 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.
Presentation for import reinspection and sampling at port of entry (POE)
U.S. importers will continue to apply for FSIS import inspection of any meat, poultry or egg products offered for entry into the United States. When implemented in May, the PHIS will interface with the U.S. Customs and Border Protection's (CBP) Automated Commercial Environment (ACE), which is the U.S. commercial trade processing system that automates entry of products into U.S. commerce. The interface between ACE and PHIS will permit the direct electronic transfer of FSIS-specified shipment data when the applicant files entry with the CBP. This electronic transfer will provide FSIS with prior notice of the shipment's arrival into the United States.
When the PHIS import component 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 penalties associated with this enforcement action. If the shipment is returned to the official import inspection establishment, the shipment will be refused entry. If 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 destruction.
The Agency's focus will remain on the performance of the foreign inspection system, rather than an individual establishment. FSIS will continue to perform a variety of inspection activities to verify on-going equivalence of the foreign inspection system. Every shipment will receive visual inspection including verification for physical attributes such as transportation damage, and accurate box count, certification, and labeling. Shipments randomly selected by the PHIS for more in-depth reinspection will be subjected to applicable types of physical inspections, such as product examination, checking the condition of the container of thermally processed product, as well as laboratory analyses for food chemistry, pathogens (microbiological testing), and residues. The FSIS import inspector will verify the accuracy of data from the import application filed by the importer with the foreign inspection certificate on every shipment presented for reinspection. When product fails to meet U.S. requirements, the lot(s) will be refused entry.
Designation of Ready-to-Eat (RTE) versus Not Ready-to-Eat Products (NRTE)
The FSIS import inspector will use certain labeling features, such as the product name and the presence of cooking or heating instructions to verify the classification of the process and product categories. As an example, label features on NRTE products would convey that the product needs to be further cooked prior to consumption, e.g., "cook and serve", "uncooked," "cook thoroughly", validated cooking instructions and in some cases safe handling instructions. It is essential that the product is properly categorized, as this impacts whether the shipment is subjected to microbiological testing. Unless defined by a standard of identity at RTE, such as hotdogs, frankfurters, pork with barbecue sauce, etc., FSIS permits meat or poultry products traditionally considered to be fully cooked to be identified as NRTE provided the product is intended to receive a lethality treatment by the consumer. As described above, the product must have proper labeling features and validated cooking instructions to discern that the product must be cooked for safety by the purchaser. If the product has historically been viewed by the consumers as a RTE product, e.g., "heat and eat", it is especially important for the establishment to make the distinction between the RTE product and the NRTE product. In addition, the "cooking instructions" should not be the same "heating" instructions that were previously used on labeling for the RTE products. Cooking instructions should explicitly state the product needs to be cooked for safety, e.g., "for safety cook to.." and would need to include the internal temperature to which the product is expected to reach for the consumer to eat the product safely.
Effective May 29, 2012, the PHIS will be operational in all U.S. import inspection establishments handling shipments from all eligible countries eligible to export meat, poultry, and egg products. 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 the PHIS prior to the implementation date. The updates to information related to PHIS will be available on the FSIS Web page, which can be accessed at http://www.fsis.usda.gov/PHIS/.
If you have specific questions about PHIS implementation, please contact FSIS Office of International Affairs (OIA), Import Inspection Division at (202) 720-9904 or by e-mail at firstname.lastname@example.org.
Dr. Ronald K. Jones
Office of International Affairs