Ongoing Equivalence Verifications of Foreign Food Regulatory Systems, 26523-26527 [2015-11250]

Download as PDF Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2014–0096] Notice of Decision To Authorize the Interstate Movement of Sea Asparagus Tips From Hawaii Into the Continental United States Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public of our decision to authorize the interstate movement of fresh sea asparagus tips from Hawaii into the continental United States. Based on the findings of a pest list and a risk management document, which we made available to the public for review and comment through a previous notice, we have concluded that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the movement of fresh sea asparagus tips from Hawaii into the continental United States. DATES: Effective May 8, 2015. FOR FURTHER INFORMATION CONTACT: Mr. David Lamb, Senior Regulatory Policy Specialist, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737– 1231; (301) 851–2103. SUPPLEMENTARY INFORMATION: Under the regulations in ‘‘Subpart—Regulated Articles From Hawaii and the Territories’’ (7 CFR 318.13–1 through 318.13–26, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture prohibits or restricts the interstate movement of fruits and vegetables from Hawaii, Puerto Rico, the U.S. Virgin Islands, Guam, and the Commonwealth of the Northern Mariana Islands to the continental United States to prevent the spread of plant pests and noxious weeds that occur in Hawaii and the territories. Section 318.13–4 contains a performance-based process for approving the interstate movement of certain fruits and vegetables from Hawaii and the U.S. territories that, based on the findings of a pest risk analysis, can be safely moved subject to one or more of the six phytosanitary measures listed in § 318.13–4(b). APHIS received a request from the Hawaii Department of Agriculture to allow the interstate movement of fresh sea asparagus tips (Salicornia bigelovii Torr.) to the continental United States. Hawaii has indicated a specific interest asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:38 May 07, 2015 Jkt 235001 in production and shipment of fresh sea asparagus tips, which are currently prohibited from interstate movement from Hawaii to the continental United States. In accordance with the process in § 318.13–4, we published a notice 1 in the Federal Register on January 23, 2015 (80 FR 3548–3549, Docket No. APHIS–2014–0096), in which we announced, for review and comment, the availability of a pest list that identifies pests of quarantine significance that could follow the pathway of interstate movement of sea asparagus tips into the continental United States. Based on that pest list, we prepared a risk management document (RMD) to identify phytosanitary measures that could be applied to the commodity to mitigate the pest risk. We solicited comments on the pest list and RMD for 60 days ending on March 24, 2015. We received two comments by that date, from an organization of State plant regulatory agencies and a private citizen. Neither commenter opposed the action; however, one commenter asked for the scientific name and a general description of sea asparagus. As stated in the RMD, sea asparagus (Salicornia bigelovii Torr.) is grown in salt water ponds on floating plant cultivation platforms where their roots are exposed to brackish waters. The asparagus tips do not touch water, soil, or sediments. Sea asparagus is sometimes referred to as ‘‘sea beans’’ or ‘‘sapphire greens’’ on restaurant menus and ingredient lists. Therefore, in accordance with § 318.13–4, we our announcing our decision to authorize the interstate movement of sea asparagus from Hawaii to the continental United States subject to the following phytosanitary measures: • Sea asparagus tips must be moved interstate as commercial consignments only, and • Each consignment is subject to predeparture inspection in Hawaii prior to interstate movement to the continental United States. These conditions will be listed in the Hawaii Fruits and Vegetables Manual (available at http://www.aphis.usda.gov/ import_export/plants/manuals/ports/ downloads/hawaii.pdf). Authority: 7 U.S.C. 7701–7772 and 7781– 7786; 7 CFR 2.22, 2.80, and 371.3. 1 To view the notice, pest list, RMD, and comments we received, go to http:// www.regulations.gov/#!docketDetail;D=APHIS2014-0096. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 26523 Done in Washington, DC, this 4th day of May 2015. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2015–11124 Filed 5–7–15; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2015–0005] Ongoing Equivalence Verifications of Foreign Food Regulatory Systems Food Safety and Inspection Service, USDA. ACTION: Notice; response to comments. AGENCY: The Food Safety and Inspection Service (FSIS) is responding to comments on the Federal Register notice, ‘‘Ongoing Equivalence Verifications of Foreign Food Regulatory Systems,’’ it published on January 25, 2013. FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205–0495. SUPPLEMENTARY INFORMATION: SUMMARY: Background Imported meat, poultry, and egg products must meet all applicable statutory provisions and regulations, including standards for safety, wholesomeness, and labeling applicable to similar products produced in the United States (see 21 U.S.C. 620, 466, and 1046; 9 CFR 327.2, 381.196, and 590.910). Foreign meat, poultry, and egg products food regulatory systems may apply equivalent sanitary measures if those measures provide the same level of public health protection achieved by U.S. measures. Any country can apply for eligibility to export meat, poultry, or egg products to the United States. Based on FSIS’s review of the information and documentation that the country submits, FSIS decides whether the foreign country’s food regulatory system meets all U.S. requirements in the same or an equivalent manner. This is the document analysis. If so, FSIS performs an on-site audit of the entire foreign meat, poultry, or egg products regulatory system. When both the document analysis and on-site audit show that the country’s system is equivalent to that of the U.S., FSIS publishes a proposed rule in the Federal Register that announces the results of the first two steps and proposes to add E:\FR\FM\08MYN1.SGM 08MYN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES 26524 Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Notices the country to its list of countries eligible to export to the U.S. in FSIS’s regulations. After analyzing the public comments that it receives, FSIS makes a final decision about whether the country’s system is equivalent based upon all the information it has gathered and publishes a final rule in the Federal Register announcing its determination on the country’s eligibility. This comprehensive process is described fully on FSIS’s Web site at http:// www.fsis.usda.gov/wps/portal/fsis/ topics/international-affairs/importingproducts/equivalence/equivalenceprocess-overview. Once a country is determined to be eligible to export to the United States, FSIS continues to monitor that country’s food regulatory system. In a notice published in the Federal Register on January 25, 2013, ‘‘Ongoing Equivalence Verification of Foreign Food Regulatory Systems,’’ (78 FR 5409) (hereafter ‘‘the Federal Register notice’’), FSIS described how it conducts ongoing activities to ensure that food regulatory systems of countries that export meat, poultry, or processed egg products to the United States remain equivalent to FSIS’s system. FSIS explained that it uses a three-part approach that includes (1) document reviews, (2) on-site system audits, and (3) port-of-entry (POE) reinspections. FSIS determines the scope and frequency of foreign on-site system audits based on its analysis of the results of its document reviews and its ongoing assessment of a country’s performance. This performance-based approach allows FSIS to direct its audit resources to foreign food regulatory systems that appear to pose a greater risk to public health than other foreign systems. FSIS uses the equivalence questionnaire, called the Self-Reporting Tool (SRT), to collect information for FSIS’s document review of the food regulatory systems of countries that are listed in the regulations as eligible to export meat, poultry, or egg products to the United States as well as for the systems of countries interested in becoming eligible (78 FR 5409, January 25, 2013). A copy of the SRT is available on FSIS’s Web site at http:// www.fsis.usda.gov/wps/wcm/connect/ 7893547e-d0d2-4fa9-a984fdc17228bfcd/SRT.pdf?MOD=AJPERES. 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 VerDate Sep<11>2014 16:38 May 07, 2015 Jkt 235001 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 SRT also includes questions for FSIS to use in assessing how frequently it is necessary to conduct on-site audits of the country after FSIS approves export to the United States. FSIS refers to these questions as level of advancement (LOA) questions. The LOA questions are clearly marked in the SRT as ‘‘used for scoring purposes.’’ In answering the LOA questions, foreign countries demonstrate the full extent to which they have developed and implemented an equivalent, systemsbased approach to food safety regulation that achieves the U.S. level of protection. The SRT and LOA questions may change over time to reflect changes in the United States’ inspection system and associated sanitary measures. As explained in the Federal Register notice, the LOA questions are derived from the Codex Alimentarius Commissions’ Guidelines on the Judgment of Equivalence of Sanitary Measures associated with Food Inspection and Certification systems (CAC/GL 53–2003), and the principles outlined in the joint Food and Agricultural Office of the United Nations (FAO) and World Health Organization (WHO) publication, ‘‘Assuring Food Safety and Quality: Guidelines for Strengthening National Food Control Systems’’ (78 FR 5409, January 25, 2013). These questions ask foreign countries to provide information to FSIS on the use of risk analysis principles; the impact of organizational, structural, or administrative change in an exporting country’s competent authority; the availability of contingency plans in the country for containing and mitigating the effects of food safety emergencies; the competent authority’s willingness and ability to take appropriate actions to manage food safety incidents; and the effectiveness of foodborne disease surveillance systems. For each LOA question, FSIS assigns a score. In February 2013, FSIS posted more information on LOA questions and scoring in the supplementary document ‘‘Performance-Based Approach to Foreign Country Equivalence Verification Audits and Point-of-Entry (POE) Reinspections,’’ which is available on FSIS’s Web site at http:// www.fsis.usda.gov/wps/wcm/connect/ c10d362b-c978-4578-8b9e93f956601ccf/Performance_Based_ Approach_Equivalence_Verification_ PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 0213.pdf?MOD=AJPERES. In the Federal Register notice and the supplementary document, FSIS provided examples of criteria applied to assign an LOA to two aspects of a foreign country’s regulatory system (i.e., risk analysis and POE results) but did not provide details on how the various assignments were combined to determine a foreign food regulatory system’s overall LOA (78 FR 5409, January 25, 2013). FSIS has since updated and streamlined the SRT questions and restructured the LOA questions (80 FR 9428, February 23, 2015). As a result, FSIS has changed the way that it scores LOA questions. Specifically, a score of zero or one is assigned for each LOA question. FSIS summarizes these scores and applies adjustments as needed to ensure meaningful comparisons when setting each country’s LOA. FSIS intends to update the supplementary document to provide more information about this change. FSIS uses the results from the analysis of the LOA questions, previous on-site audits, and POE results 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; and adequately-performing countries are to be audited every year. FSIS received approximately 31 comments in response to the Federal Register notice from foreign countries, trade consulting groups, consumer groups, private citizens, a trade association representing the meat industry, and a member of the U.S. Congress. Recent Changes On February 23, 2015, FSIS responded to comments on the Agency’s document review process for determining and verifying initial and ongoing equivalence (80 FR 9428). FSIS announced that it had streamlined the SRT and launched a Web-based version within its Public Health Information System (PHIS) to more efficiently capture up-to-date information about foreign food regulatory systems. A summary of the other issues raised by the commenters in response to the Federal Register notice and the Agency’s responses are below. In addition, FSIS updated the National Advisory Committee on Meat and Poultry Inspection (NACMPI) and the public on the Agency’s progress in incorporating NACMPI’s 2008 recommendations on the equivalence E:\FR\FM\08MYN1.SGM 08MYN1 Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES process on January 7, 2014, and again on January 13, 2015 (see 78 FR 77643 and 79 FR 77441). On January 7, 2014, FSIS received three comments on the Agency’s methodology from two consumer groups and a farmer. On January 13, 2015, FSIS received three comments from two consumer groups and a trade association that represents meat processors. These comments are also summarized and addressed below. Summary of Comments Comment: Several commenters stated that FSIS should have published the proposed changes to its ongoing equivalence verification process in the Federal Register and considered comments from the public before the Agency implemented any of the changes. The commenters argued that FSIS should not have changed its food safety inspection program without stakeholder involvement. A few commenters stated that FSIS should have also conducted a risk assessment and economic analysis before making any changes to its ongoing equivalence verification process. Response: FSIS made changes to its ongoing equivalence verification process, such as developing the Microsoft Word and Web-based versions of the SRT, transitioning from an annual on-site audit to less frequent on-site audits based on performance, and launching PHIS to schedule POE sampling over a period of years. These changes did not create new requirements for establishments or foreign countries and, therefore, did not require amendments to the relevant regulations. Matters relating to Agency management are exempt from the notice-and-comment requirements of the Administrative Procedure Act (APA) (5 U.S.C. 553(a)(2)). Similarly, because FSIS did not propose new requirements for the industry or foreign countries, FSIS did not develop a risk assessment or an economic analysis on the Agency’s decision to change its ongoing equivalence verification process. Nonetheless, the Agency made its decision-making process public. As noted in the Federal Register notice, FSIS held a public meeting with NACMPI on the changes it intended to make before it made any changes to its ongoing equivalence verification process (78 FR 5409, January 25, 2013). Membership of NACMPI is drawn from representatives of consumer groups; producers, processors, and marketers from the meat, poultry, and egg product industries; State and local government officials; and academia. Therefore, the Agency provided an opportunity for stakeholder input before it made any VerDate Sep<11>2014 16:38 May 07, 2015 Jkt 235001 changes to its ongoing equivalence verification process. On-Site Audits Comment: FSIS received several comments on the frequency of the Agency’s on-site audits of foreign countries’ food regulatory systems. A foreign country supported the Agency’s determination that annual visits to countries are not necessary when those systems are documented to be performing ‘‘well’’ or in an ‘‘average’’ way. The foreign country stated that visits every two to three years to these countries, given the other information that is available to FSIS, provide the necessary information for FSIS to determine whether these foreign systems continue to meet the U.S. level of protection. Several commenters stated that FSIS should, at a minimum, conduct annual audits. These same commenters recommended that the scope and intensity of the annual audits should change, based on risk and the conditions in the country when auditors arrive. For example, these commenters stated that information provided through the SRT should provide information necessary for auditors to focus on particular areas of concern that auditors could adjust as appropriate, given actual conditions once they have arrived. The commenters asserted that this approach would ensure that FSIS was auditing foreign countries on a regular basis but would also allow them to devote finite resources to those areas of greatest concern. Some commenters who stated that FSIS should audit foreign countries’ food regulatory systems at least annually stated that FSIS reduced the number of on-site audits because of budget constraints. One commenter stated that NACMPI never recommended that the Agency shift from annual on-site audits to periodic on-site audits. The commenter asserted that NACMPI recommended that FSIS continue to audit foreign country’s food regulatory systems annually and consider risk in determining whether more frequent or more focused audits were necessary. Another commenter stated that FSIS is not conducting on-site audits at a minimum frequency of once every three years for all countries that are exporting meat, poultry, or egg products to the United States. Two commenters stated that food product recalls of imported products from foreign countries show that food safety issues have emerged since FSIS altered its audit frequency schedule. A few other commenters cited recent PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 26525 safety issues related to products produced in China (e.g., baby formula and jerky dog treats linked to illnesses and deaths of babies and dogs, respectively) to support their claim that food products produced in other countries are not always safe and wholesome. The commenters also stated that they were concerned about the safety of poultry products produced in China. Response: FSIS did not change its methodology because of budget constraints. FSIS determined, based on NACMPI’s recommendations and audits conducted over the years, that annual visits are not necessary for countries with systems performing in an average way or well (see 78 FR 5409, January 25, 2013). If FSIS is annually receiving upto-date documentation from the foreign country on the state of its food safety system, conducting periodic on-site audits of these countries that are informed by the documentation that the Agency receives, and reviewing and analyzing FSIS POE results, FSIS is able to determine on an on-going basis whether the countries’ food regulatory systems are maintaining equivalence to FSIS’s system, or whether additional audits are necessary. FSIS may adjust the scope and intensity of audits based on risk and the conditions in the country when auditors arrive. In addition, for countries that FSIS has determined to be eligible to export product to the U.S., FSIS develops an audit plan based on prior concerns that FSIS has identified with the country’s system, any relevant changes the country has made since the last audit, and recent information that the country has submitted to FSIS concerning its system (such as information submitted through the SRT) (see FSIS Notice 35–14, Ongoing Foreign Equivalence Verification Audits, available at http:// www.fsis.usda.gov/wps/wcm/connect/ ac10a0c7-792f-4323-a0c715a8d4ee71bd/3514.pdf?MOD=AJPERES). NACMPI did not recommend that the Agency conduct annual on-site audits to verify ongoing equivalence. In 2008, NACMPI recommended that the ‘‘length of time between audits can be based more on risk and compliance history in the foreign country,’’ 1 and that ‘‘a three1 National Advisory Committee on Meat and Poultry Inspection, ‘‘Report of Sub-committee Number 1,’’ Washington, DC (2008). Available at: http://www.fsis.usda.gov/wps/wcm/connect/ c669100d-7282-4ee2-b04c-2a799516a962/NACMPI_ Subcommittee1_082708.pdf?MOD=AJPERES. E:\FR\FM\08MYN1.SGM 08MYN1 26526 Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES tiered system may be appropriate.’’ 2 NACMPI also recommended that the scope and frequency of on-site audits and POE reinspections be adjusted based on the capability of a country to be transparent and to share useful regulatory information and compliance history. Under FSIS’s three-part approach, FSIS bases the frequency of on-site audits on the results of FSIS’s assessment of the country’s performance. FSIS assesses all countries annually. The assessment focuses on each eligible country’s overall food safety performance relative to the performance of other eligible countries. The assessment includes a statistical analysis of compliance data from POE re-inspections and results from FSIS’s previous on-site audits of the country’s government offices, establishments, and laboratories. This approach is consistent with NACMPI’s recommendation that FSIS adopt a risk-informed and compliance-based approach. FSIS acknowledges that it has not audited all countries eligible to export at least once every three years. Some time was necessary to work through the mechanics of the transition from an annual on-site audit to less frequent onsite audits based on performance (78 FR 5409, January 25, 2013). Going forward, FSIS will conduct on-site audits of countries eligible to export product to the U.S. at least once every three years. Approximately the same number of recalls involving imported products occurred when FSIS conducted annual on-site audits as have occurred since FSIS changed the frequency of on-site audits in certain countries.3 FSIS is committed to protecting the health of U.S. consumers, and it will continue to make every effort to ensure that meat, poultry, and egg products imported into the United States are as safe as products produced in this country. Finally, regarding concerns about products from China, FSIS does not inspect baby formula or jerky dog treats. These products are under the jurisdiction of the U.S. Food and Drug Administration (FDA). Currently, China 2 National Advisory Committee on Meat and Poultry Inspection, ‘‘Report of Sub-committee Number 2,’’ Washington, DC (2008). Available at: http://www.fsis.usda.gov/wps/wcm/connect/ 802e06af-81c1-4fc4-b582-6ccea24d8cba/NACMPI_ Subcommittee2_082708.pdf?MOD=AJPERES. 3 From 2004 to 2008, approximately 16 recalls involved imported amenable products. In 2009, FSIS began its transition from its annual on-site audit to less frequent audits based on performance; there were approximately six recalls that year. From 2010 to 2014, there were approximately 15 recalls. FSIS did not include recalls that involved amenable products produced by a foreign establishment that were delivered into commerce without the benefit of FSIS POE reinspection because FSIS has changed its policy on these types of recalls over the years. VerDate Sep<11>2014 16:38 May 07, 2015 Jkt 235001 is only authorized to export to the United States processed poultry products that originated in the U.S. or another equivalent country. FSIS will reinspect at POE any processed (fully cooked) poultry products exported from China. China has not yet exported such product to the United States. FSIS will conduct annual on-site audits of China’s regulatory system for at least the next three years, as the Agency would do for any country that has just been found to be equivalent. Comment: A few commenters requested that FSIS provide data that show that the new methodology with periodic on-site audits provides the same level of public health protection as FSIS’s previous approach with annual on-site audits. The commenters stated that if the data do not exist, then FSIS should establish metrics to measure the effectiveness of the new methodology. Response: FSIS has had almost 20 years of experience in determining and verifying system equivalence, including conducting on-site audits and POE reinspections. Based on this accumulated experience and on-going analysis discussed in the next paragraph, FSIS is confident that its current approach provides for at least the same level of public health protection as FSIS’s previous approach with annual on-site audits. As noted above, approximately the same number of recalls involving imported products occurred when FSIS conducted annual on-site audits as have occurred since FSIS changed the frequency of on-site audits in certain countries. FSIS measures the effectiveness of its methodology by routinely analyzing information from document reviews, onsite audits, and data from POE reinspections and recalls related to imported products. Since the PHIS import module was implemented on May 29, 2012, FSIS has used PHIS to generate detailed reports, including reports on the amount of product presented for reinspection; the types of activities performed at reinspection; the amount of product refused entry; and whether the product was refused because it failed a Public Health Critical exam (e.g., positive result for Shiga toxin-producing Escherichia coli (STEC) in raw, non-intact beef product). FSIS uses the reports to track trends and to facilitate routine management oversight. FSIS generates these reports at least quarterly. FSIS’s analysis of this reported data shows that FSIS’s current approach ensures that imported meat, poultry, or egg products are safe, wholesome, and properly labeled. Comment: FSIS also received several comments on how the Agency PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 determines a country’s performance score. One commenter stated that FSIS should not determine the performance score for each eligible country based on a comparison of one country’s performance to another country’s performance because it is similar to ‘‘curve grading.’’ The commenter stated that the ‘‘curve grading’’ concept could provide a false sense of food safety compliance when countries are being evaluated relative to one another instead of against FSIS’s import requirements. Two commenters stated that it was not clear how frequently FSIS will audit each country. The commenters requested that FSIS identify which countries it will audit on an annual basis. A few commenters asserted that the LOAs are not well defined and requested that FSIS clarify how it will assign LOAs when determining a country’s performance score. One commenter stated that assigning an LOA to each country or to each equivalence component would complicate the process, and that FSIS should assign one LOA to a group of factors. Response: FSIS disagrees that the Agency’s performance assessment could provide a ‘‘false sense of food safety compliance.’’ The countries are being evaluated against FSIS’s requirements. Further, FSIS will not release the specific annual audit schedule with names of countries it will audit each year because of concerns about security of its auditors, and because providing this information in advance may allow countries too much time to prepare in advance for their audits. As explained above, the SRT includes LOA questions that FSIS encourages countries to answer to demonstrate what they are doing that is above and beyond what is required to be equivalent to FSIS’s system. FSIS then scores the responses. The LOA responses are just 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 5409, January 25, 2013). Previous on-site audits and POE results also contribute to FSIS’s assessment of a country’s performance and to FSIS’s determination of the appropriate audit frequency for that country. Comment: A few commenters encouraged FSIS to post its audit reports on its Web site in a timelier manner. One commenter noted that prior to 2009, FSIS posted its audit reports within 120 days of the completion of the audit. Response: FSIS intends to make audit reports public in a timelier manner. E:\FR\FM\08MYN1.SGM 08MYN1 Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Notices FSIS is currently evaluating how best to improve and streamline this process. asabaliauskas on DSK5VPTVN1PROD with NOTICES POE Reinspections Comment: One commenter stated that the frequency of POE reinspection testing for microbiological and chemical hazards should be dependent on the outcomes of country performance. The commenter previously received regular updates from FSIS on consignment testing frequency and results of testing for a particular country, with a breakdown by species and defect type. The commenter requested that FSIS resume this reporting and questioned whether it can be provided to exporting countries through PHIS. Another commenter stated that FSIS should offer more incentives to high performing countries in addition to reduced audit frequency. The commenter argued that FSIS should not reinspect every product from high performing countries. A few other commenters stated that FSIS should streamline the reinspection process by allowing the exporting countries to conduct inspections and sampling prior to shipment. The commenters asserted that this process would provide for the earliest possible detection of potential problems, prevent recalls, and reduce considerable transport and subsequent storage costs associated with such shipments. Another commenter suggested that FSIS collaborate with the FDA and U.S. Customs and Border Protection (CBP) to develop a consistent standard in the U.S. for determining which products are low or high risk. Response: FSIS is working to develop reports on POE testing for exporting countries. These reports will be provided through PHIS. FSIS will notify exporting countries when these reports are available. FSIS does not intend to change its POE reinspection procedures at this time. In compliance with statutory and regulatory requirements (21 U.S.C. 620, 466, and 1046; 9 CFR 327.6, 381.199, and 590.925), FSIS reinspects all shipments presented at ports of entry to ensure proper certification by the foreign country and examines each shipment for general condition and labeling compliance. Additionally, PHIS randomly assigns more targeted reinspections of the meat and poultry presented to include laboratory sampling and testing to identify microbiological pathogens, drug and chemical residues, and species. PHIS assigns the type of reinspection based on compliance history of the foreign establishment and country and product volume. VerDate Sep<11>2014 16:38 May 07, 2015 Jkt 235001 Because FSIS reinspection is necessary to ensure that all imported meat, poultry, and egg products are properly labeled and not adulterated, FSIS will not rely on other country results in determining whether to allow the product to enter domestic commerce. However, FSIS is committed to collaborating with other U.S. agencies to enhance and streamline inspection efforts. For example, in April 2014, FSIS began a pilot program with CBP’s Participating Government Agency (PGA) Message Set, which allows FSIS to electronically collect the information required by FSIS form 9540–1, Import Inspection Application and Report (see 79 FR 56220). FSIS’s PHIS interfaces with CBP’s Automated Commercial Environment (ACE), enabling a seamless transfer of data required for the application for FSIS import inspection in advance of the shipment arrival. The PGA Message Set pilot will remove tens of thousands of paper-based entry forms from the process and will save Agency resources by avoiding manual data entry. Meat, poultry, and processed egg product inspection and enforcement will be more efficient by having the required data available when shipments arrive at the official import inspection facility, benefitting FSIS, industry, trading partners, and U.S. citizens. In addition, the PGA Message Set pilot supports more efficient protection of public health by transferring all data from the industry for products under FSIS jurisdiction, thus providing the Agency with specific information on FSIS regulated products that could be potentially entering the country from ineligible sources. Finally, the pilot will facilitate compliance through early filing. Through ACE, importers file their FSIS application with their Customs entry, in advance of the shipment arriving at the official import inspection establishment. This early filing will enable FSIS inspection personnel to better monitor shipments and will facilitate faster recalls if amenable products produced by foreign establishments are delivered into commerce without the benefit of FSIS POE reinspection. USDA Non-Discrimination Statement No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/ parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United PO 00000 Frm 00006 Fmt 4703 Sfmt 9990 26527 States under any program or activity conducted by the USDA. How To File a Complaint of Discrimination To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http:// www.ocio.usda.gov/sites/default/files/ docs/2012/Complain_combined_6_8_ 12.pdf, or write a letter signed by you or your authorized representative. Send your completed complaint form or letter to USDA by mail, fax, or email: Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250–9410, Fax: (202) 690–7442, Email: program.intake@ usda.gov. Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA’s TARGET Center at (202) 720–2600 (voice and TDD). Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS Web page located at: http:// www.fsis.usda.gov/federal-register. FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is available on the FSIS Web page. Through the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts. Done in Washington, DC, on May 5, 2015. Alfred V. Almanza, Acting Administrator. [FR Doc. 2015–11250 Filed 5–7–15; 8:45 am] BILLING CODE 3410–DM–P E:\FR\FM\08MYN1.SGM 08MYN1

Agencies

[Federal Register Volume 80, Number 89 (Friday, May 8, 2015)]
[Notices]
[Pages 26523-26527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11250]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2015-0005]


Ongoing Equivalence Verifications of Foreign Food Regulatory 
Systems

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice; response to comments.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is responding to 
comments on the Federal Register notice, ``Ongoing Equivalence 
Verifications of Foreign Food Regulatory Systems,'' it published on 
January 25, 2013.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    Imported meat, poultry, and egg products must meet all applicable 
statutory provisions and regulations, including standards for safety, 
wholesomeness, and labeling applicable to similar products produced in 
the United States (see 21 U.S.C. 620, 466, and 1046; 9 CFR 327.2, 
381.196, and 590.910). Foreign meat, poultry, and egg products food 
regulatory systems may apply equivalent sanitary measures if those 
measures provide the same level of public health protection achieved by 
U.S. measures.
    Any country can apply for eligibility to export meat, poultry, or 
egg products to the United States. Based on FSIS's review of the 
information and documentation that the country submits, FSIS decides 
whether the foreign country's food regulatory system meets all U.S. 
requirements in the same or an equivalent manner. This is the document 
analysis. If so, FSIS performs an on-site audit of the entire foreign 
meat, poultry, or egg products regulatory system. When both the 
document analysis and on-site audit show that the country's system is 
equivalent to that of the U.S., FSIS publishes a proposed rule in the 
Federal Register that announces the results of the first two steps and 
proposes to add

[[Page 26524]]

the country to its list of countries eligible to export to the U.S. in 
FSIS's regulations. After analyzing the public comments that it 
receives, FSIS makes a final decision about whether the country's 
system is equivalent based upon all the information it has gathered and 
publishes a final rule in the Federal Register announcing its 
determination on the country's eligibility. This comprehensive process 
is described fully on FSIS's Web site at http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/equivalence/equivalence-process-overview.
    Once a country is determined to be eligible to export to the United 
States, FSIS continues to monitor that country's food regulatory 
system. In a notice published in the Federal Register on January 25, 
2013, ``Ongoing Equivalence Verification of Foreign Food Regulatory 
Systems,'' (78 FR 5409) (hereafter ``the Federal Register notice''), 
FSIS described how it conducts ongoing activities to ensure that food 
regulatory systems of countries that export meat, poultry, or processed 
egg products to the United States remain equivalent to FSIS's system. 
FSIS explained that it uses a three-part approach that includes (1) 
document reviews, (2) on-site system audits, and (3) port-of-entry 
(POE) reinspections. FSIS determines the scope and frequency of foreign 
on-site system audits based on its analysis of the results of its 
document reviews and its ongoing assessment of a country's performance. 
This performance-based approach allows FSIS to direct its audit 
resources to foreign food regulatory systems that appear to pose a 
greater risk to public health than other foreign systems.
    FSIS uses the equivalence questionnaire, called the Self-Reporting 
Tool (SRT), to collect information for FSIS's document review of the 
food regulatory systems of countries that are listed in the regulations 
as eligible to export meat, poultry, or egg products to the United 
States as well as for the systems of countries interested in becoming 
eligible (78 FR 5409, January 25, 2013). A copy 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. 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 SRT also includes questions for FSIS to use in assessing how 
frequently it is necessary to conduct on-site audits of the country 
after FSIS approves export to the United States. FSIS refers to these 
questions as level of advancement (LOA) questions. The LOA questions 
are clearly marked in the SRT as ``used for scoring purposes.'' In 
answering the LOA questions, foreign countries demonstrate the full 
extent to which they have developed and implemented an equivalent, 
systems-based approach to food safety regulation that achieves the U.S. 
level of protection. The SRT and LOA questions may change over time to 
reflect changes in the United States' inspection system and associated 
sanitary measures. As explained in the Federal Register notice, the LOA 
questions are derived from the Codex Alimentarius Commissions' 
Guidelines on the Judgment of Equivalence of Sanitary Measures 
associated with Food Inspection and Certification systems (CAC/GL 53-
2003), and the principles outlined in the joint Food and Agricultural 
Office of the United Nations (FAO) and World Health Organization (WHO) 
publication, ``Assuring Food Safety and Quality: Guidelines for 
Strengthening National Food Control Systems'' (78 FR 5409, January 25, 
2013). These questions ask foreign countries to provide information to 
FSIS on the use of risk analysis principles; the impact of 
organizational, structural, or administrative change in an exporting 
country's competent authority; the availability of contingency plans in 
the country for containing and mitigating the effects of food safety 
emergencies; the competent authority's willingness and ability to take 
appropriate actions to manage food safety incidents; and the 
effectiveness of foodborne disease surveillance systems. For each LOA 
question, FSIS assigns a score.
    In February 2013, FSIS posted more information on LOA questions and 
scoring in the supplementary document ``Performance-Based Approach to 
Foreign Country Equivalence Verification Audits and Point-of-Entry 
(POE) Reinspections,'' which is available on FSIS's Web site at http://www.fsis.usda.gov/wps/wcm/connect/c10d362b-c978-4578-8b9e-93f956601ccf/Performance_Based_Approach_Equivalence_Verification_0213.pdf?MOD=AJPERES
. In the Federal Register notice and the supplementary document, FSIS 
provided examples of criteria applied to assign an LOA to two aspects 
of a foreign country's regulatory system (i.e., risk analysis and POE 
results) but did not provide details on how the various assignments 
were combined to determine a foreign food regulatory system's overall 
LOA (78 FR 5409, January 25, 2013). FSIS has since updated and 
streamlined the SRT questions and restructured the LOA questions (80 FR 
9428, February 23, 2015). As a result, FSIS has changed the way that it 
scores LOA questions. Specifically, a score of zero or one is assigned 
for each LOA question. FSIS summarizes these scores and applies 
adjustments as needed to ensure meaningful comparisons when setting 
each country's LOA. FSIS intends to update the supplementary document 
to provide more information about this change.
    FSIS uses the results from the analysis of the LOA questions, 
previous on-site audits, and POE results 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; and adequately-performing countries are to be 
audited every year.
    FSIS received approximately 31 comments in response to the Federal 
Register notice from foreign countries, trade consulting groups, 
consumer groups, private citizens, a trade association representing the 
meat industry, and a member of the U.S. Congress.

Recent Changes

    On February 23, 2015, FSIS responded to comments on the Agency's 
document review process for determining and verifying initial and 
ongoing equivalence (80 FR 9428). FSIS announced that it had 
streamlined the SRT and launched a Web-based version within its Public 
Health Information System (PHIS) to more efficiently capture up-to-date 
information about foreign food regulatory systems.
    A summary of the other issues raised by the commenters in response 
to the Federal Register notice and the Agency's responses are below. In 
addition, FSIS updated the National Advisory Committee on Meat and 
Poultry Inspection (NACMPI) and the public on the Agency's progress in 
incorporating NACMPI's 2008 recommendations on the equivalence

[[Page 26525]]

process on January 7, 2014, and again on January 13, 2015 (see 78 FR 
77643 and 79 FR 77441). On January 7, 2014, FSIS received three 
comments on the Agency's methodology from two consumer groups and a 
farmer. On January 13, 2015, FSIS received three comments from two 
consumer groups and a trade association that represents meat 
processors. These comments are also summarized and addressed below.

Summary of Comments

    Comment: Several commenters stated that FSIS should have published 
the proposed changes to its ongoing equivalence verification process in 
the Federal Register and considered comments from the public before the 
Agency implemented any of the changes. The commenters argued that FSIS 
should not have changed its food safety inspection program without 
stakeholder involvement. A few commenters stated that FSIS should have 
also conducted a risk assessment and economic analysis before making 
any changes to its ongoing equivalence verification process.
    Response: FSIS made changes to its ongoing equivalence verification 
process, such as developing the Microsoft Word and Web-based versions 
of the SRT, transitioning from an annual on-site audit to less frequent 
on-site audits based on performance, and launching PHIS to schedule POE 
sampling over a period of years. These changes did not create new 
requirements for establishments or foreign countries and, therefore, 
did not require amendments to the relevant regulations. Matters 
relating to Agency management are exempt from the notice-and-comment 
requirements of the Administrative Procedure Act (APA) (5 U.S.C. 
553(a)(2)). Similarly, because FSIS did not propose new requirements 
for the industry or foreign countries, FSIS did not develop a risk 
assessment or an economic analysis on the Agency's decision to change 
its ongoing equivalence verification process. Nonetheless, the Agency 
made its decision-making process public. As noted in the Federal 
Register notice, FSIS held a public meeting with NACMPI on the changes 
it intended to make before it made any changes to its ongoing 
equivalence verification process (78 FR 5409, January 25, 2013). 
Membership of NACMPI is drawn from representatives of consumer groups; 
producers, processors, and marketers from the meat, poultry, and egg 
product industries; State and local government officials; and academia. 
Therefore, the Agency provided an opportunity for stakeholder input 
before it made any changes to its ongoing equivalence verification 
process.

On-Site Audits

    Comment: FSIS received several comments on the frequency of the 
Agency's on-site audits of foreign countries' food regulatory systems. 
A foreign country supported the Agency's determination that annual 
visits to countries are not necessary when those systems are documented 
to be performing ``well'' or in an ``average'' way. The foreign country 
stated that visits every two to three years to these countries, given 
the other information that is available to FSIS, provide the necessary 
information for FSIS to determine whether these foreign systems 
continue to meet the U.S. level of protection.
    Several commenters stated that FSIS should, at a minimum, conduct 
annual audits. These same commenters recommended that the scope and 
intensity of the annual audits should change, based on risk and the 
conditions in the country when auditors arrive. For example, these 
commenters stated that information provided through the SRT should 
provide information necessary for auditors to focus on particular areas 
of concern that auditors could adjust as appropriate, given actual 
conditions once they have arrived. The commenters asserted that this 
approach would ensure that FSIS was auditing foreign countries on a 
regular basis but would also allow them to devote finite resources to 
those areas of greatest concern.
    Some commenters who stated that FSIS should audit foreign 
countries' food regulatory systems at least annually stated that FSIS 
reduced the number of on-site audits because of budget constraints.
    One commenter stated that NACMPI never recommended that the Agency 
shift from annual on-site audits to periodic on-site audits. The 
commenter asserted that NACMPI recommended that FSIS continue to audit 
foreign country's food regulatory systems annually and consider risk in 
determining whether more frequent or more focused audits were 
necessary.
    Another commenter stated that FSIS is not conducting on-site audits 
at a minimum frequency of once every three years for all countries that 
are exporting meat, poultry, or egg products to the United States.
    Two commenters stated that food product recalls of imported 
products from foreign countries show that food safety issues have 
emerged since FSIS altered its audit frequency schedule. A few other 
commenters cited recent safety issues related to products produced in 
China (e.g., baby formula and jerky dog treats linked to illnesses and 
deaths of babies and dogs, respectively) to support their claim that 
food products produced in other countries are not always safe and 
wholesome. The commenters also stated that they were concerned about 
the safety of poultry products produced in China.
    Response: FSIS did not change its methodology because of budget 
constraints. FSIS determined, based on NACMPI's recommendations and 
audits conducted over the years, that annual visits are not necessary 
for countries with systems performing in an average way or well (see 78 
FR 5409, January 25, 2013). If FSIS is annually receiving up-to-date 
documentation from the foreign country on the state of its food safety 
system, conducting periodic on-site audits of these countries that are 
informed by the documentation that the Agency receives, and reviewing 
and analyzing FSIS POE results, FSIS is able to determine on an on-
going basis whether the countries' food regulatory systems are 
maintaining equivalence to FSIS's system, or whether additional audits 
are necessary.
    FSIS may adjust the scope and intensity of audits based on risk and 
the conditions in the country when auditors arrive. In addition, for 
countries that FSIS has determined to be eligible to export product to 
the U.S., FSIS develops an audit plan based on prior concerns that FSIS 
has identified with the country's system, any relevant changes the 
country has made since the last audit, and recent information that the 
country has submitted to FSIS concerning its system (such as 
information submitted through the SRT) (see FSIS Notice 35-14, Ongoing 
Foreign Equivalence Verification Audits, available at http://www.fsis.usda.gov/wps/wcm/connect/ac10a0c7-792f-4323-a0c7-15a8d4ee71bd/35-14.pdf?MOD=AJPERES).
    NACMPI did not recommend that the Agency conduct annual on-site 
audits to verify ongoing equivalence. In 2008, NACMPI recommended that 
the ``length of time between audits can be based more on risk and 
compliance history in the foreign country,'' \1\ and that ``a three-

[[Page 26526]]

tiered system may be appropriate.'' \2\ NACMPI also recommended that 
the scope and frequency of on-site audits and POE reinspections be 
adjusted based on the capability of a country to be transparent and to 
share useful regulatory information and compliance history. Under 
FSIS's three-part approach, FSIS bases the frequency of on-site audits 
on the results of FSIS's assessment of the country's performance. FSIS 
assesses all countries annually. The assessment focuses on each 
eligible country's overall food safety performance relative to the 
performance of other eligible countries. The assessment includes a 
statistical analysis of compliance data from POE re-inspections and 
results from FSIS's previous on-site audits of the country's government 
offices, establishments, and laboratories. This approach is consistent 
with NACMPI's recommendation that FSIS adopt a risk-informed and 
compliance-based approach.
---------------------------------------------------------------------------

    \1\ National Advisory Committee on Meat and Poultry Inspection, 
``Report of Sub-committee Number 1,'' Washington, DC (2008). 
Available at: http://www.fsis.usda.gov/wps/wcm/connect/c669100d-7282-4ee2-b04c-2a799516a962/NACMPI_Subcommittee1_082708.pdf?MOD=AJPERES.
    \2\ National Advisory Committee on Meat and Poultry Inspection, 
``Report of Sub-committee Number 2,'' Washington, DC (2008). 
Available at: http://www.fsis.usda.gov/wps/wcm/connect/802e06af-81c1-4fc4-b582-6ccea24d8cba/NACMPI_Subcommittee2_082708.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    FSIS acknowledges that it has not audited all countries eligible to 
export at least once every three years. Some time was necessary to work 
through the mechanics of the transition from an annual on-site audit to 
less frequent on-site audits based on performance (78 FR 5409, January 
25, 2013). Going forward, FSIS will conduct on-site audits of countries 
eligible to export product to the U.S. at least once every three years.
    Approximately the same number of recalls involving imported 
products occurred when FSIS conducted annual on-site audits as have 
occurred since FSIS changed the frequency of on-site audits in certain 
countries.\3\ FSIS is committed to protecting the health of U.S. 
consumers, and it will continue to make every effort to ensure that 
meat, poultry, and egg products imported into the United States are as 
safe as products produced in this country.
---------------------------------------------------------------------------

    \3\ From 2004 to 2008, approximately 16 recalls involved 
imported amenable products. In 2009, FSIS began its transition from 
its annual on-site audit to less frequent audits based on 
performance; there were approximately six recalls that year. From 
2010 to 2014, there were approximately 15 recalls. FSIS did not 
include recalls that involved amenable products produced by a 
foreign establishment that were delivered into commerce without the 
benefit of FSIS POE reinspection because FSIS has changed its policy 
on these types of recalls over the years.
---------------------------------------------------------------------------

    Finally, regarding concerns about products from China, FSIS does 
not inspect baby formula or jerky dog treats. These products are under 
the jurisdiction of the U.S. Food and Drug Administration (FDA). 
Currently, China is only authorized to export to the United States 
processed poultry products that originated in the U.S. or another 
equivalent country. FSIS will reinspect at POE any processed (fully 
cooked) poultry products exported from China. China has not yet 
exported such product to the United States. FSIS will conduct annual 
on-site audits of China's regulatory system for at least the next three 
years, as the Agency would do for any country that has just been found 
to be equivalent.
    Comment: A few commenters requested that FSIS provide data that 
show that the new methodology with periodic on-site audits provides the 
same level of public health protection as FSIS's previous approach with 
annual on-site audits. The commenters stated that if the data do not 
exist, then FSIS should establish metrics to measure the effectiveness 
of the new methodology.
    Response: FSIS has had almost 20 years of experience in determining 
and verifying system equivalence, including conducting on-site audits 
and POE reinspections. Based on this accumulated experience and on-
going analysis discussed in the next paragraph, FSIS is confident that 
its current approach provides for at least the same level of public 
health protection as FSIS's previous approach with annual on-site 
audits. As noted above, approximately the same number of recalls 
involving imported products occurred when FSIS conducted annual on-site 
audits as have occurred since FSIS changed the frequency of on-site 
audits in certain countries.
    FSIS measures the effectiveness of its methodology by routinely 
analyzing information from document reviews, on-site audits, and data 
from POE reinspections and recalls related to imported products. Since 
the PHIS import module was implemented on May 29, 2012, FSIS has used 
PHIS to generate detailed reports, including reports on the amount of 
product presented for reinspection; the types of activities performed 
at reinspection; the amount of product refused entry; and whether the 
product was refused because it failed a Public Health Critical exam 
(e.g., positive result for Shiga toxin-producing Escherichia coli 
(STEC) in raw, non-intact beef product). FSIS uses the reports to track 
trends and to facilitate routine management oversight. FSIS generates 
these reports at least quarterly. FSIS's analysis of this reported data 
shows that FSIS's current approach ensures that imported meat, poultry, 
or egg products are safe, wholesome, and properly labeled.
    Comment: FSIS also received several comments on how the Agency 
determines a country's performance score. One commenter stated that 
FSIS should not determine the performance score for each eligible 
country based on a comparison of one country's performance to another 
country's performance because it is similar to ``curve grading.'' The 
commenter stated that the ``curve grading'' concept could provide a 
false sense of food safety compliance when countries are being 
evaluated relative to one another instead of against FSIS's import 
requirements.
    Two commenters stated that it was not clear how frequently FSIS 
will audit each country. The commenters requested that FSIS identify 
which countries it will audit on an annual basis.
    A few commenters asserted that the LOAs are not well defined and 
requested that FSIS clarify how it will assign LOAs when determining a 
country's performance score. One commenter stated that assigning an LOA 
to each country or to each equivalence component would complicate the 
process, and that FSIS should assign one LOA to a group of factors.
    Response: FSIS disagrees that the Agency's performance assessment 
could provide a ``false sense of food safety compliance.'' The 
countries are being evaluated against FSIS's requirements. Further, 
FSIS will not release the specific annual audit schedule with names of 
countries it will audit each year because of concerns about security of 
its auditors, and because providing this information in advance may 
allow countries too much time to prepare in advance for their audits.
    As explained above, the SRT includes LOA questions that FSIS 
encourages countries to answer to demonstrate what they are doing that 
is above and beyond what is required to be equivalent to FSIS's system. 
FSIS then scores the responses.
    The LOA responses are just 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 5409, January 25, 2013). 
Previous on-site audits and POE results also contribute to FSIS's 
assessment of a country's performance and to FSIS's determination of 
the appropriate audit frequency for that country.
    Comment: A few commenters encouraged FSIS to post its audit reports 
on its Web site in a timelier manner. One commenter noted that prior to 
2009, FSIS posted its audit reports within 120 days of the completion 
of the audit.
    Response: FSIS intends to make audit reports public in a timelier 
manner.

[[Page 26527]]

FSIS is currently evaluating how best to improve and streamline this 
process.

POE Reinspections

    Comment: One commenter stated that the frequency of POE 
reinspection testing for microbiological and chemical hazards should be 
dependent on the outcomes of country performance. The commenter 
previously received regular updates from FSIS on consignment testing 
frequency and results of testing for a particular country, with a 
breakdown by species and defect type. The commenter requested that FSIS 
resume this reporting and questioned whether it can be provided to 
exporting countries through PHIS.
    Another commenter stated that FSIS should offer more incentives to 
high performing countries in addition to reduced audit frequency. The 
commenter argued that FSIS should not reinspect every product from high 
performing countries. A few other commenters stated that FSIS should 
streamline the reinspection process by allowing the exporting countries 
to conduct inspections and sampling prior to shipment. The commenters 
asserted that this process would provide for the earliest possible 
detection of potential problems, prevent recalls, and reduce 
considerable transport and subsequent storage costs associated with 
such shipments. Another commenter suggested that FSIS collaborate with 
the FDA and U.S. Customs and Border Protection (CBP) to develop a 
consistent standard in the U.S. for determining which products are low 
or high risk.
    Response: FSIS is working to develop reports on POE testing for 
exporting countries. These reports will be provided through PHIS. FSIS 
will notify exporting countries when these reports are available.
    FSIS does not intend to change its POE reinspection procedures at 
this time. In compliance with statutory and regulatory requirements (21 
U.S.C. 620, 466, and 1046; 9 CFR 327.6, 381.199, and 590.925), FSIS 
reinspects all shipments presented at ports of entry to ensure proper 
certification by the foreign country and examines each shipment for 
general condition and labeling compliance. Additionally, PHIS randomly 
assigns more targeted reinspections of the meat and poultry presented 
to include laboratory sampling and testing to identify microbiological 
pathogens, drug and chemical residues, and species. PHIS assigns the 
type of reinspection based on compliance history of the foreign 
establishment and country and product volume.
    Because FSIS reinspection is necessary to ensure that all imported 
meat, poultry, and egg products are properly labeled and not 
adulterated, FSIS will not rely on other country results in determining 
whether to allow the product to enter domestic commerce. However, FSIS 
is committed to collaborating with other U.S. agencies to enhance and 
streamline inspection efforts. For example, in April 2014, FSIS began a 
pilot program with CBP's Participating Government Agency (PGA) Message 
Set, which allows FSIS to electronically collect the information 
required by FSIS form 9540-1, Import Inspection Application and Report 
(see 79 FR 56220). FSIS's PHIS interfaces with CBP's Automated 
Commercial Environment (ACE), enabling a seamless transfer of data 
required for the application for FSIS import inspection in advance of 
the shipment arrival. The PGA Message Set pilot will remove tens of 
thousands of paper-based entry forms from the process and will save 
Agency resources by avoiding manual data entry. Meat, poultry, and 
processed egg product inspection and enforcement will be more efficient 
by having the required data available when shipments arrive at the 
official import inspection facility, benefitting FSIS, industry, 
trading partners, and U.S. citizens.
    In addition, the PGA Message Set pilot supports more efficient 
protection of public health by transferring all data from the industry 
for products under FSIS jurisdiction, thus providing the Agency with 
specific information on FSIS regulated products that could be 
potentially entering the country from ineligible sources.
    Finally, the pilot will facilitate compliance through early filing. 
Through ACE, importers file their FSIS application with their Customs 
entry, in advance of the shipment arriving at the official import 
inspection establishment. This early filing will enable FSIS inspection 
personnel to better monitor shipments and will facilitate faster 
recalls if amenable products produced by foreign establishments are 
delivered into commerce without the benefit of FSIS POE reinspection.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410, 
Fax: (202) 690-7442, Email: program.intake@usda.gov.
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Update is available on the FSIS Web page. Through the 
Web page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

    Done in Washington, DC, on May 5, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-11250 Filed 5-7-15; 8:45 am]
 BILLING CODE 3410-DM-P