Document Reviews of Foreign Food Regulatory Systems: New Web-based Self-Reporting Tool
A foreign country interested in exporting to the United States is required to submit information concerning its food regulatory system to FSIS (see 9 CFR 327.2(a)(2)(iii), 381.196(a)(2)(iii), and 590.910). As explained in the January 2013 Federal Register notice, FSIS uses the equivalence questionnaire, called the SRT, to collect this information for the Agency’s document review of the food regulatory system of foreign countries that are listed in the regulations as eligible to export meat, poultry, or egg products to the United States and for countries interested in becoming eligible (78 FR 5411). The SRT is a repository for key documents about a foreign food safety inspection system (e.g., inspection system laws, regulations, and policy issuances) that FSIS uses, in addition to on-site audits, to verify whether the laws, regulations, and implementing policies of a foreign country establish an inspection system that is equivalent to the U.S. system. It also allows FSIS to evaluate whether a country maintains system effectiveness and to assess any impacts that an administrative or legislative change has had on a foreign food regulatory system. FSIS conducts a document review at least annually.
The information in the SRT allows FSIS to conduct a comprehensive assessment of a foreign country’s food safety regulatory system. These comprehensive assessments inform the Agency’s determination of whether a country’s system should be found equivalent and the country eligible to export product into the United States. FSIS also assesses information in the SRT on an ongoing basis to verify whether a country maintains equivalence.
In the past, the SRT was available in a Microsoft Word format, and once completed by the country, it was submitted to FSIS along with corresponding supporting documentation either by mail or email communication. A PDF copy of the Microsoft Word version of the SRT is available on FSIS’s Web site at: http://www.fsis.usda.gov/wps/wcm/connect/ 7893547e-d0d2-4fa9-a984-fdc17228bfcd/SRT.pdf?MOD=AJPERES. On February 17, 2015, FSIS will launch a Web-based version of the SRT within its Public Health Information System (PHIS) to more efficiently capture up-to-date information about foreign food regulatory systems. PHIS is a comprehensive Web-based data-analytics and inspection system that automates and replaces many of FSIS’s paper-based processes.
The Web-based SRT will be beneficial for countries exporting meat, poultry, and egg products to the United States; countries interested in exporting product to the United States and applying for equivalence; and FSIS personnel. With the Web-based SRT, countries can link supporting documentation to each question. With the Microsoft Word version, the supporting documentation is provided as a supplement to the SRT. As a result, during the review process, FSIS must sift through documents to match up information with the corresponding questions in the SRT.
Using PHIS as a platform for the SRT allows for a more secure exchange of information between FSIS and foreign countries because countries will be accessing the SRT through a secure USDA Web site that requires a unique ID and password acquired through an authentication process. To guarantee that the security of the Web-based SRT in PHIS is maintained and to gain access to the system, each potential user will have to register for a USDA eAuthentication (eAuth) Level 2 account and complete the authentication process. FSIS will send a letter to foreign countries with instructions on obtaining an eAuth account and using the Web-based version of the SRT. FSIS strongly encourages countries to use the Web-based SRT. However, the use of the Web-based SRT is voluntary, and FSIS will continue to accept the current Microsoft Word version of the SRT. To ensure that the transition to the Web-based SRT is as seamless as possible, FSIS pre-entered into PHIS the SRT responses and supporting documentation that countries actively exporting meat, poultry, or egg products to the United States have provided to FSIS. FSIS requests that countries review the pre-entered responses for completeness and accuracy.
In addition to a Web-based version of the SRT, foreign countries will note that the revised SRT asks fewer and more targeted questions necessary for FSIS to verify system equivalence. FSIS expects countries to answer all the targeted questions in the SRT to facilitate the review process. FSIS may not be able to make an equivalence determination without answers to all of these questions.
The SRT also includes questions for FSIS to use in assessing how frequently to conduct on-site audits of the country. FSIS refers to these questions as level of advancement (LOA) questions. As explained in the Federal Register notice, the sum of the LOA responses is one of the factors that FSIS considers as part of an annual analysis of country performance to determine the frequency and scope of on-site audits (78 FR 5412). FSIS uses the results from the analysis to place exporting countries into one of three categories, based on food safety performance, with corresponding audit frequencies: Well-performing countries are to be audited every three years.
Average-performing countries are to be audited every two years. Adequately-performing countries are to be audited every year. Thus, the completeness of a country’s SRT contributes to FSIS’s assessment of that country’s performance and to FSIS’s determination of the appropriate audit frequency for that country. Countries with incomplete SRTs will not be considered “well-performing” because they will not have provided the Agency enough information to give the Agency confidence in their food safety systems. FSIS will provide more information on LOAs in a subsequent Federal Register notice that addresses all comments received in the January 2013 Federal Register notice and provides additional updates on the FSIS equivalence determination process.
To ensure that a complete and up-to-date SRT is being considered as part of FSIS’s annual assessment of country performance, countries must submit their completed SRTs to FSIS before May 18, 2015, and on an annual basis moving forward. If a country submits partial or inaccurate information, FSIS personnel will follow up with additional questions until all outstanding issues are resolved. FSIS must have complete and accurate information to verify that the foreign country’s food regulatory system is robust, transparent, and science-based. If a country does not provide FSIS with documentation showing its system is equivalent, or if it continues to submit inadequate documentation, FSIS will not have sufficient information to determine the viability of the food safety system and may have to pursue a series of actions directed at product presented for reinspection (e.g., intensified testing for microbial adulterants, indicator organisms, chemical residues, or species) to address the absence of a government-supplied explanation of inspection system controls. In addition, FSIS likely would begin refusing to list establishments newly certified by the foreign government, or to relist certified establishments, because of a lack of confidence in the government-supplied explanation of its inspection system. FSIS may conduct specially designed in-country audits to obtain information. FSIS may, within a reasonable period of time, refuse entry to products exported from that country. Finally, if it becomes necessary, FSIS will take steps to remove the country from the list of countries eligible to export meat, poultry, or processed egg products.
Any country can apply for eligibility to export meat, poultry, or egg products to the United States. The application process begins with a letter to FSIS from a foreign country asking for consideration to export its products for sale in the United States. FSIS responds to these letters with a standard package that contains information on the SRT and information on gaining eAuthentication. More information on how to apply for initial equivalence is available on FSIS’s Web site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/equivalence/equivalence-process-apply-for-initial-equivalence.
FSIS asks that a foreign country applying for initial equivalence submit a complete SRT to FSIS in PHIS within one year of receiving the questionnaire. If FSIS needs additional information, or if FSIS’s regulations change, the Agency will request that the country update its SRT to provide additional information to demonstrate that the country has an equivalent food regulatory system to the United States’ system. If FSIS’s document review supports that the foreign country’s food regulatory system may be equivalent to the United States’ system, the Agency will conduct an on-site audit.
However, if a foreign government applying for initial equivalence does not submit a complete SRT or fails to respond to additional requests for information within one year of receiving the SRT, FSIS will not be able to determine that the country maintains an inspection system equivalent to FSIS’s system and will discontinue its analysis.
FSIS will accept information submitted in any one of the three official languages of the World Trade Organization (WTO)—English, French, or Spanish. Please note that it may take the Agency a longer period of time to review documents submitted in French or Spanish because the information will have to be translated.