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Statement of Need: FSIS is proposing these regulations to provide for the electronic submission of import product and establishment certificates to allow the electronic interchange and transmission of data to Agency’s computer-based Public Health Information System (PHIS), which is currently under development. Providing an electronic format for imported certificates will enable the government-to-government exchange of data between FSIS and foreign customs and inspection authorities. Sanitation SOPs are written procedures that are developed and implemented by establishments to prevent direct contamination or adulteration of meat or poultry products. Sanitation SOPs are required at official (domestic) establishments. Current regulations are ambiguous concerning Sanitation SOP requirements for official import inspection establishments. FSIS is proposing to require that official import inspection establishments comply with the Sanitation SOPs regulations to eliminate that ambiguity and ensure that products do not become contaminated as they enter this country.

Summary of the Legal Basis: The authorities for this proposed rule are: the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451-470), Egg Products Inspection Act (EPIA)(21 U.S.C. 1031-1056) and the regulations that implement these Acts.

Alternatives: The electronic processing of import certifications is voluntary, therefore, importers still have the option of using the current paper-based system. The Agency is proposing to require that official import inspection establishments adopt Sanitation SOPs to prevent direct contamination or adulteration of product. Therefore, no alternatives were considered.

Anticipated Costs and Benefits: The opportunity cost of not amending the regulations would hinder the Agency’s implementation of PHIS. The amendments that provide for the electronic interchange of data are voluntary, so establishments will not take them on unless the benefits outweigh the costs. It has been the Agency’s expectation that official import establishments will maintain Sanitation SOPs, this proposed rule codifies that expectation. Therefore, the proposed amendment on sanitation requirements will have no costs to the industry. The proposed rule will facilitate FSIS’s use of the PHIS system, enabling the electronic transmission, issuance, and authorization of imported product data. The PHIS will enable FSIS import inspection personnel to verify and authorize shipments using electronic data, reducing inspector workload. The electronic exchange of certificate data will help to reduce the fraudulent alteration or reproduction of certificates. The Agency estimates that the electronic processing of import certificates will reduce the data-entry time for import inspectors, by 50 to 60 percent.

Risks: None