Eligibility of the Republic of Korea To Export Poultry Products to the United States, 16656-16661 [2014-06652]

Download as PDF emcdonald on DSK67QTVN1PROD with RULES 16656 Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Rules and Regulations pepo Pat., a pathogenic fungus; Synchytrium endobioticum (Schilb.) Percival, a pathogenic fungus that causes potato wart disease; and Thecaphora solani (Thirum. & M. O’Brien) Mordue, a pathogenic fungus that causes potato smut. (a) The national plant protection organization (NPPO) of Mexico must provide a bilateral workplan to APHIS that details the activities that the NPPO of Mexico will, subject to APHIS’ approval of the workplan, carry out to meet the requirements of this section. The bilateral workplan must include and describe the quarantine pest survey intervals and other specific requirements as set forth in this section. (b) The potatoes may be imported in commercial consignments only. (c) The potatoes must be produced by a grower who is registered in a certification program administered by the NPPO of Mexico. The program must require the producer to use only seed that has been certified by the NPPO of Mexico as free of R. solanacearum race 3 biovar 2, R. bunodes, R. pepo, S. endobioticum, and T. solani to produce the potatoes. The program must also require the potatoes to be grown in an enclosed environment or alternatively must require the field in which the potatoes are grown to be surveyed for quarantine pests and tested for R. solanacearum race 3 biovar 2 at regular intervals in accordance with the bilateral workplan. (d) The potatoes must be packed for export in packinghouses that are registered with the NPPO of Mexico and to which the NPPO of Mexico has assigned a unique identifying number. (e) After harvest but prior to packing, the potatoes must be washed, cleaned of soil and debris, and treated with a sprout inhibitor in accordance with the bilateral workplan. (f) A biometric sample of potatoes must be taken from each consignment of potatoes destined for export to the United States in accordance with a protocol jointly agreed upon by APHIS and the NPPO of Mexico and specified within the bilateral workplan. The sample must be visually inspected for evidence of sprouting, as well as evidence of C. decolora, E. cognatus, N. aberrans, R. bunodes, R. pepo, and T. solani. A portion of the potatoes must then be cut open, inspected for evidence of E. cognatus, N. aberrans, R. solanacearum race 3 biovar 2, and T. solani, and submitted to a laboratory approved by the NPPO of Mexico for testing for R. solanacearum race 3 biovar 2. Potatoes may not be shipped to the United States until the results of this testing are obtained. If any potatoes VerDate Mar<15>2010 17:49 Mar 25, 2014 Jkt 232001 are found to be sprouting, or any evidence of these quarantine pests is found, or any potatoes have nonnegative test results for R. solanacearum race 3 biovar 2, the entire consignment of potatoes will be prohibited from importation into the United States. For purposes of this section, a potato is considered to be sprouting when it exhibits green sprouts, regardless of the degree of elongation of the sprout. (g) Each consignment of potatoes shipped from Mexico to the United States must be transported following inspection from the packinghouse to the port of first arrival into the United States in a means of conveyance sealed with an agricultural seal affixed by an individual authorized by the NPPO of Mexico to do so. If the seal is broken en route, an inspector at the port of first arrival will take remedial measures jointly agreed to by APHIS and the NPPO of Mexico and specified in the bilateral workplan. (h) Each consignment of potatoes shipped from Mexico to the United States must be accompanied by a phytosanitary certificate, issued by the NPPO of Mexico, that states that the potatoes have been produced in accordance with this section, and have been inspected and tested and found free of the quarantine pests listed in the introduction to this section. The phytosanitary certificate must also specify the number of the packinghouse in which the potatoes were packed. (i) If quarantine pests are discovered on potatoes from Mexico at a port of first arrival into the United States, the potatoes will be traced back to the packinghouse in which they were packed using the packinghouse number specified on the phytosanitary certificate. (1) The packinghouse must identify the grower from which the potatoes originated, and the grower must identify the place of production in which the potatoes were grown. That place of production will be suspended from the export program for potatoes to the United States for at least the remainder of the shipping season. The suspension will continue into subsequent shipping seasons until APHIS and the NPPO of Mexico jointly agree that the plant pest risk at the place of production is adequately mitigated. (2) If the grower is unable to identify the place of production in which the potatoes were grown, that grower will be suspended from the export program for potatoes to the United States for at least the remainder of the shipping season. The suspension will continue into subsequent shipping seasons until the APHIS and the NPPO of Mexico PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 jointly agree that the plant pest risk at the grower is adequately mitigated. (3) If the packinghouse is unable to identify the grower from which the potatoes originated, that packinghouse will be suspended from the export program for potatoes to the United States for at least the remainder of the shipping season. The suspension will continue into subsequent shipping seasons until the APHIS and the NPPO of Mexico jointly agree that the plant pest risk at the packinghouse is adequately mitigated. (Approved by the Office of Management and Budget under control number 0579–0413) Done in Washington, DC, this 20th day of March 2014. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2014–06619 Filed 3–25–14; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Part 381 [Docket No. FSIS–2012–0019] RIN 0583–AD49 Eligibility of the Republic of Korea To Export Poultry Products to the United States Food Safety and Inspection Service, USDA. ACTION: Final rule. AGENCY: The Food Safety and Inspection Service (FSIS) is amending the Federal poultry products inspection regulations to add the Republic of Korea (Korea) to the list of countries eligible to export poultry products to the United States. FSIS has reviewed Korea’s poultry laws, regulations, and inspection system, as implemented, and has determined that they are equivalent to the Poultry Products Inspection Act (PPIA), the regulations implementing this statute, and the U.S. food safety system for poultry. Under this final rule, slaughtered poultry or parts or other products thereof processed in certified Korean establishments will be eligible for export to the United States. All such products will be subject to re-inspection at United States ports of entry by FSIS inspectors. DATES: Effective Date: May 27, 2014. FOR FURTHER INFORMATION CONTACT: Dr. Andreas Keller, Director, International Equivalence Staff, Office of Policy and SUMMARY: E:\FR\FM\26MRR1.SGM 26MRR1 Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Rules and Regulations emcdonald on DSK67QTVN1PROD with RULES Program Development; Telephone: (202) 720–0082. SUPPLEMENTARY INFORMATION: Background On November 27, 2012, FSIS proposed to add the Republic of Korea (Korea) to the list of countries eligible to export poultry products to the United States (77 FR 70724). This final rule is consistent with the provisions of the proposed rule. As explained in the proposal, section 17 of the PPIA (21 U.S.C. 466) prohibits importation into the United States of slaughtered poultry, or parts or products thereof, of any kind unless they are healthful, wholesome, fit for human food, not adulterated, and contain no dye, chemical, preservative, or ingredient that renders them unhealthful, unwholesome, unfit for human food, or otherwise adulterated. Under the PPIA and the regulations that implement it, poultry products imported into the United States must be produced under standards for safety, wholesomeness, and labeling accuracy that are equivalent to those of the United States. Section 381.196 of Title 9 of the Code of Federal Regulations (CFR) sets out the procedures by which foreign countries may become eligible to export poultry and poultry products to the United States. Section 381.196(a) requires that the standards of a foreign country’s poultry inspection system, its legal authority for the inspection system, and the regulations implementing the system be equivalent to those of the United States. These requirements include: (1) Antemortem and post-mortem inspection performed or supervised by a veterinarian; (2) national government controls over establishment construction, facilities, and equipment; (3) verification of slaughtering of poultry and processing of poultry products by inspectors to ensure that product is not adulterated or misbranded; (4) separation of establishments certified to export from those not certified; (5) maintenance of a single standard of inspection and sanitation throughout certified establishments; (6) requirements for sanitation and for sanitary handling of product at certified establishments; (7) controls over condemned product; (8) a Hazard Analysis and Critical Control Point (HACCP) system; and (9) any other requirements under the PPIA and its implementing regulations (9 CFR 381.196(a)(2)(ii)). The country’s inspection program must also impose requirements equivalent to those of the United States with respect to: (1) Organizational VerDate Mar<15>2010 16:11 Mar 25, 2014 Jkt 232001 structure and staffing in certified establishments to ensure uniform enforcement of laws and regulations; (2) national government control and supervision over the official activities of employees or licensees; (3) qualified inspectors; (4) enforcement and certification authority; (5) administrative and technical support; (6) inspection, sanitation, quality, species verification, and residue standards; and (7) any other inspection requirements (9 CFR 381.196(a)(2)(i)). Inclusion of the country in 9 CFR 381.196 generally implies that the country has a regulatory system equivalent to that of the United States for slaughter and further processing of poultry for all nine processing categories referred to in 9 CFR 417.2 (Slaughter; raw product—ground; raw product—not ground; 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 product with secondary inhibitors—not shelf stable). However, FSIS recognizes that, at the time of the initial equivalence request, a country may not expect to manufacture and export products to the United States that meet the requirements of each of these processing categories. Even so, FSIS determines whether the foreign country has equivalent government oversight, statutory authority and food safety regulations, sanitation performance standards, hazard analysis and critical control point systems, chemical residue control and microbiological testing programs, and the infrastructure in place to ensure that, if products in any of the nine processing categories were to be exported, the products would meet United States standards of safety and wholesomeness.1 1 At this time, FSIS is taking steps to publish on its Web site a chart that identifies which of the nine processing categories FSIS specifically reviewed in FSIS in-country audits, and which the Public Health Inspection System (PHIS) is set up to allow to be imported into the U.S. This PHIS-based chart will also reflect any processing category limitations as a result of animal health restrictions for that foreign country, as provided for in 9 CFR part 94. Because FSIS public health policies may change subsequent to the time at which the foreign country is listed in 9 CFR 327.2 or 381.196, or a foreign country may decide to later certify product exported to the U.S. from a processing category not listed for that country on the PHIS-based chart, FSIS will determine whether an in-country audit is necessary before FSIS modifies the PHIS-based chart. Regarding a foreign country’s initial request for equivalence for egg products in accordance with 9 CFR 590.910, all the requirements in part 590 must be met as there are no similar processing categories as provided for livestock and poultry products. PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 16657 Evaluation of the Korean Poultry Inspection System In 2005, the government of Korea requested approval for the importation of Korean poultry products into the United States. Korea stated that its immediate intention was to export two types of ginseng chicken stew products to the United States. FSIS then began to evaluate Korea’s inspection system to determine whether it is equivalent to the United States system. FSIS conducted a document review to evaluate the laws, regulations, and other documentation used by Korea to execute its poultry inspection program. FSIS examined the information submitted by Korea to verify that the following critical points relating to equivalence were addressed satisfactorily with respect to standards, activities, resources, and enforcement: (1) Government Oversight; (2) Statutory Authority and Food Safety Regulations; (3) Sanitation; (4) HACCP Systems; (5) Chemical Residue Testing Programs; and (6) Microbiological Testing Programs. The document review was satisfactory to FSIS, and FSIS scheduled an on-site review to evaluate all aspects of Korea’s inspection program. In 2008, FSIS conducted an on-site audit of Korea’s poultry inspection system and identified systemic deficiencies within five equivalence components. In response to this audit, Korea submitted a corrective action plan that addressed FSIS’s findings. In 2010, FSIS conducted a comprehensive on-site audit to determine whether Korea had satisfactorily implemented all the laws, regulations, and other issuances that FSIS found to be equivalent during the document analysis, and whether the findings of the previous audit had been addressed. The 2010 audit revealed that Korea had fully implemented the corrective action plan that it had submitted in response to the 2008 audit. Nonetheless, the new audit identified new systemic deficiencies in three equivalence components: Statutory Authority and Food Safety Regulations, Chemical Residue Testing Programs, and Microbiological Testing Programs. During the audit, establishments made changes to address some deficiencies. In addition to the actions taken during the audit, Korea submitted a corrective action plan on how it would incorporate the actions it took during the audit into its food safety system. FSIS reviewed this corrective action plan and, for the reasons explained below, concluded that Korea had satisfactorily addressed the findings of 2010 audit. E:\FR\FM\26MRR1.SGM 26MRR1 16658 Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Rules and Regulations emcdonald on DSK67QTVN1PROD with RULES Consequently, on November 27, 2012, FSIS published a proposed rule to find that Korea’s poultry inspection system (slaughter and processing) is equivalent to the United States’ poultry inspection system and proposing to add the Republic of Korea (Korea) to the list of countries eligible to export poultry products to the United States. For more detailed information on FSIS’s evaluation of the Korean poultry inspection system, see the proposed rule (77 FR 70724) and for the full audit report go to https://www.fsis.usda.gov/ wps/portal/fsis/topics/internationalaffairs/importing-products/eligiblecountries-products-foreignestablishments/foreign-audit-reports. render the product economically adulterated. Products that pass reinspection will be stamped with the official mark of inspection and allowed to enter United States commerce. If they do not meet United States requirements, they will be refused entry and within 45 days will have to be returned to the country of origin, destroyed, or converted to animal food (subject to approval of FDA), depending on the violation. The import re-inspection activities can be found on the FSIS Web site at https://www.fsis.usda.gov/wps/ portal/fsis/topics/international-affairs/ importing-products/port-of-entryprocedures/fsis-import-reinspection/ct_ index9. Final Rule After considering the comments received on the proposed rule and discussed below, FSIS concludes that Korea’s poultry inspection system is equivalent to the United States’ inspection system for poultry and poultry products. Therefore, FSIS is amending its poultry products inspection regulations to add Korea to the list of countries eligible to export poultry products to the United States (9 CFR 381.196(b)). Under FSIS’s import regulations, the government of Korea must certify to FSIS that those establishments that wish to export poultry products to the United States are operating under requirements equivalent to those of the United States (9 CFR 381.196(a)). Although a foreign country may be listed in FSIS regulations as eligible to export poultry to the United States, the exporting country’s products must also comply with all other applicable requirements of the United States. These requirements include restrictions under 9 CFR part 94 of the Animal and Plant Health Inspection Service (APHIS) regulations, which also regulate the importation of poultry products from foreign countries into the United States. Under this final rule, all slaughtered poultry, or parts and products thereof, exported to the United States from Korea will be subject to re-inspection at the United States ports of entry for, but not limited to, transportation damage, product and container defects, labeling, proper certification, general condition, and accurate count. In addition, FSIS will conduct other types of reinspection activities, such as incubation of canned products to ensure product safety and taking product samples for laboratory analysis to detect any drug or chemical residues or pathogens that may render the product unsafe or any species or product composition violations that would Summary of Comments and Responses FSIS received four comments in response to the proposed rule. One individual and a consumer advocacy organization opposed the rule, and one individual and three trade associations, representing the poultry and egg products industries, submitted a single comment that supported the proposed rule. Following is a discussion of the relevant issues raised in the comments and FSIS’s responses. Comment: One individual stated that all poultry from Korea should be banned in the United States. The individual was concerned about the safety of food from foreign countries, including Korea, and animal welfare and inhumane slaughter in Korea. The individual argued that the United States should not import any food from any country. Response: Under the PPIA, if a country maintains a poultry safety inspection system that is equivalent to that of the United States, it is entitled to ship poultry products to the United States should it seek to do so. FSIS has conducted a thorough review of Korea’s laws, regulations, written procedures, policies, and other official documents, including evaluating whether poultry slaughter establishments maintained good commercial practices consistent with those required in United States poultry slaughter establishments (see 9 CFR 381.65(a)–(b)). These practices ensure that poultry is humanely slaughtered. In addition, FSIS conducted two on-site verification audits of Korea’s poultry inspection system. Taking the findings of the two audits together, FSIS has determined that Korea’s poultry inspection system is equivalent to the United States inspection system for poultry and poultry products. The comment has not presented any basis on which FSIS could make a contrary determination. VerDate Mar<15>2010 16:11 Mar 25, 2014 Jkt 232001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 As stated above, for Korea to be eligible to export poultry to the United States, it must implement and maintain a poultry inspection system that is equivalent to the United States’ system. To determine whether Korea maintains an equivalent inspection system, FSIS uses a three-part approach that includes (1) on-going document reviews, (2) periodic on-site system audits, and (3) ports of entry re-inspections. If Korea fails to maintain a poultry inspection system that is equivalent to the United States’ system, FSIS will act to suspend or terminate its eligibility to export to this country. Comment: A consumer advocacy organization stated that, although Korea will initially export only two types of chicken stew, the proposed rule understated the magnitude of future exports to the United States because Korea is being added to the list of countries eligible to export poultry products to the United States with no restrictions. Response: FSIS has no basis for finding that it understated the magnitude of future exports from Korea to the United States. As described in more detail in the Economic Analysis below, Korea will initially export only two types of chicken stew products to the United States. Because of the limited market in the United States for these products, the projected export volume of these products from Korea is likely to be very small, and thus the impact on the United States economy is likely to be very small as well. However, it is true that Korea would not be precluded from exporting other poultry products to the U.S. in the future if those products meet all applicable APHIS and FSIS requirements for the products, and Korea certifies that the producing establishments comply with Korean requirements that FSIS has found to be equivalent to applicable FSIS requirements (9 CFR 381.196(a)). Therefore, FSIS agrees that the longterm economic impact of this rule could be more significant than the immediate impact. FSIS does not have any data, however, that it could use to project the long term impact. Comment: The consumer advocacy organization also argued that Korea should not be added to the list of countries eligible to export poultry products because FSIS’s 2010 audit found deficiencies in Korea’s inspection system, and FSIS did not conduct another onsite audit to verify that Korea implemented corrective actions in response to the 2010 audit. Response: During the 2010 on-site audit of Korea’s poultry inspection E:\FR\FM\26MRR1.SGM 26MRR1 emcdonald on DSK67QTVN1PROD with RULES Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Rules and Regulations system, FSIS auditors found that Korea had implemented the corrective actions that it had proffered in response to the 2008 on-site audit findings. In addition, Korea provided records demonstrating that these corrective action plans had been implemented in a manner consistent with FSIS’ inspection requirements. This finding provides a basis for confidence that Korea will implement all corrective actions it promises in an acceptable manner. As the commenter indicated, the auditors found two new problems with the Korean system. The first problem identified by the auditors was in the Statutory Authority and Food Safety Regulations component: Korea’s central competent authority (CCA), the Ministry for Food, Agriculture, Forestry and Fisheries, was not requiring establishments to maintain conditions that would allow the government inspectors to inspect adequately each carcass. Specifically, FSIS found that: (a) One of the three establishments audited did not have conveniently located controls (e.g., start-stop switches) that would permit government inspection program personnel to stop the line to conduct a protracted postmortem inspection of carcasses when necessary or to prevent adulterated product from entering the chill tank; (b) during the on-site review of records, the Korean inspection regulations did not require inspection stations to have online hand-rinsing facilities with a continuous flow of water within easy access for inspection personnel and establishment personnel to prevent incidental cross-contamination of carcasses resulting from post-mortem inspection procedures, and one establishment audited did not have such online hand-rinsing facilities; and (c) the three establishments audited had 52 footcandles (540 Lux) of lighting at postmortem inspection stations, in compliance with Korea’s inspection regulation, while the United States requires at least 200 foot-candles (2,152 Lux) of shadow-free lighting, with a minimum color-rendering index value of 85, for a system configuration similar to Korea’s inspection system and line speed (Streamlined Inspection System (SIS)). When FSIS discussed these findings with Korea’s CCA during the on-site audit, Korea’s government inspectors at the establishments instructed the establishments to make the changes necessary to conform to United States requirements for the conditions under which government inspection personnel are to perform their inspections. The establishments proposed immediate corrective actions, and Korean VerDate Mar<15>2010 16:11 Mar 25, 2014 Jkt 232001 government inspectors accepted establishments’ proposals. In the establishment that did not have conveniently located controls, it implemented immediate corrective action by relocating the controls (e.g., start-stop switches) to a convenient location. All the three establishments adjusted lighting at post-mortem inspection stations to 200 foot-candles of shadow-free lighting with a minimum color index value of 85. In addition, Korea immediately revised its export requirements for the U.S. to require export facilities to have inspection stations with online hand-rinsing facilities. This document was provided to the auditor before the conclusion of the audit. Korea subsequently provided records, including a photograph, showing that the audited establishment without on-line hand-rinsing facilities had installed such facilities. FSIS auditors verified the immediate corrective actions while still in Korea. However, the auditors told Korea that it needed to submit a comprehensive corrective action plan that included a systematic solution to prevent recurrence of these deficiencies. Following the audit, in July of 2011, Korea provided supporting documentation demonstrating that it had issued new requirements for: (1) Inspection stations to have conveniently located controls (e.g., start-stop switches); (2) online hand- rinsing facilities with a continuous flow of water within easy access; and (3) 200 foot-candles of shadow-free lighting with a minimum color-rendering index value of 85. These requirements, together with the immediate corrective actions taken by the establishments and with Korea’s history of taking effective action to resolve deficiencies found in an audit, provide a basis for FSIS to have confidence that the deficiencies that the auditors found in the establishments have been corrected and will not recur. The second problem regarding the implementation of laboratory quality systems within Korea’s National Residue Program and Microbiological Testing Program was identified in two equivalence components, Chemical Residue Testing Programs and Microbiological Testing Programs. Specifically, the CCA did not have adequate control over the implementation of quality systems in the government laboratories that are part of Korea’s poultry inspection system. While residue and microbiological testing methods appeared to be implemented in an appropriate manner, Korea’s CCA was not verifying that the quality control and assurance programs PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 16659 implemented by the government laboratories were adequate. For example, the frequency and the documentation of equipment verification, calibration, and maintenance related to relevant testing methods varied among the laboratories and were not consistent with international standards. Therefore, Korea did not consistently implement adequate standards for the laboratories. Following the 2010 audit, Korea submitted documents showing that it had implemented quality control and assurance programs. The documentation provided shows that Korea adopted procedures consistent with U.S. procedures to ensure that laboratory equipment and materials are appropriately verified, calibrated, and maintained to meet program requirements (Accreditation Guide 04/ 10, quality system recommendation in accordance with ISO/IEC 17025 international standards). Korea submitted documents to show that the Korean CCA has adequately trained laboratory managers and staff in the quality control and assurance program procedures. Records show that Korea has audited the government laboratories involved in poultry inspection at least once per year, and that the laboratories are meeting Korea’s quality system requirements. FSIS’s review of proficiency testing reports for the year 2012 submitted by Korea in September 2013 found that the participating Korean government laboratories are effectively using the FSIS laboratory testing methods to ensure that products eligible for export to the U.S. are free of contamination. The documents that Korea submitted to FSIS collectively demonstrate that the Korea CCA has effectively implemented procedures in its quality control and assurance programs that are equivalent to U.S. procedures. Comment: Finally, the consumer advocacy organization stated that FSIS should not find Korea equivalent when FSIS is not performing annual audits of all countries currently listed as eligible to export to the United States. Response: FSIS will conduct on-site audits of Korea’s inspection system each year for the next three years. After three years, FSIS will reassess how frequently it needs to conduct on-site audits of Korea’s system. Additionally, all product imported from Korea will be subject to FSIS re-inspection. Executive Order 12866 and Regulatory Flexibility Act This rule has been reviewed under Executive Order 12866 by the Office of Management and Budget (OMB) and has E:\FR\FM\26MRR1.SGM 26MRR1 16660 Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Rules and Regulations emcdonald on DSK67QTVN1PROD with RULES been determined to be not significant for purposes of E.O. 12866. Economic Impact Analysis This rule adds Korea to the list of countries eligible to export poultry products into the United States. Korea will export two types of ginseng chicken stew products to the United States. Given the limited market in the United States for this product, and the projected export volume of this product from Korea, the impact on the United States economy is likely to be very small. According to data from Korea, only two Korean establishments will export ginseng chicken stew to the United States. The average combined annual production of these two establishments is 3.2 million pounds (2006–2010 average), and their projected total export volume to the United States will be about 380,000 pounds in year one (the first year of exporting to the United States), gradually increasing to about 2.25 million pounds in year five, according to the Korean data. Ginseng chicken stew is sold commercially in frozen pouches. The United States market for ginseng chicken stew is so small that no data on domestic production, consumption, or importation could be found. Using label application data, FSIS identified two official establishments that produce and sell ginseng chicken stew. On the basis of information from these establishments, FSIS believes (1) they are very likely the only two establishments that are producing ginseng chicken stew in the United States, (2) the market for ginseng chicken stew is limited, (3) the annual production is about 18,000 pouches for one establishment and 10,000 pouches for the other, and (4) each pouch weighs about two pounds. Therefore, the combined production of these two establishments is about 56,000 pounds per year ((18,000 + 10,000) × 2). The special flavor and taste make ginseng chicken stew unlikely to be a substitute for other kinds of chicken stew in the United States. Therefore, although this rule may affect these two United States establishments, the impact to the United States economy is likely to be insignificant. Expected benefits from this rule will be primarily for consumers in the form of more choices in the marketplace. As mentioned above, the volume of trade stimulated by the rule is likely be so small as to have little effect on supply and prices. Another potential benefit of this rule would result in efficiency gains of United States poultry producers due to the increased competition from Korea. VerDate Mar<15>2010 16:11 Mar 25, 2014 Jkt 232001 The cost of this rule will be incurred by domestic producers in the form of competition from Korea. The two establishments that are currently producing ginseng chicken stew are likely to encounter competition pressure, for the projected import volume in year one is already 6.8 times the combined production volume of these two establishments. The imported volume, however, is likely to have little impact on the overall United States economy. Also, these two establishments may change their production mix if they find it difficult to compete with imports. countries wanting to export poultry and poultry products to the United States are required to provide information to FSIS certifying that their inspection system provides standards equivalent to those of the United States, and that the legal authority for the system and their implementing regulations are equivalent to those of the United States. FSIS provided Korea with questionnaires asking for detailed information about the country’s inspection practices and procedures to assist that country in organizing its materials. This information collection was approved under OMB number 0583–0094. Effect on Small Entities The FSIS Administrator has made a determination that this rule will not have a significant impact on a substantial number of small entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601). As mentioned above, the expected trade volume will be very small, and the effect will be on only two very small establishments that produce ginseng chicken stew domestically. E-Government Act FSIS and the United States Department of Agriculture (USDA) are committed to achieving the purposes of the E-Government Act (44 U.S.C. 3601, et seq.) by, among other things, promoting the use of the Internet and other information technologies and providing increased opportunities for citizen access to Government information and services, and for other purposes. Potential Long-Term Effect When foreign countries apply for eligibility of their meat, poultry, or egg products for entry into this country, FSIS determines whether their inspection systems are equivalent to the system maintained by the United States. FSIS does not make equivalence determinations on the basis of particular products; rather, the equivalence decision is based on the evaluation of the countries’ inspection systems. Although Korea indicates that it intends to export two types of ginseng chicken stew products for now, it would not be precluded from exporting other poultry products in the future if the products meet all applicable APHIS and FSIS requirements for those products. If additional Korean establishments export product to the United States, the longterm economic impact could be more significant. However, no data is available to assess such future impacts. Executive Order 12988 This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under this rule: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) no retroactive proceedings will be required before parties may file suit in court challenging this rule. Paperwork Reduction Act No new paperwork requirements are associated with this final rule. Foreign PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 Additional Public Notification FSIS will officially notify the World Trade Organization’s Committee on Sanitary and Phytosanitary Measures (WTO/SPS Committee) in Geneva, Switzerland, of this rule and will announce it on-line through the FSIS Web page located at: https:// www.fsis.usda.gov/wps/portal/fsis/ topics/regulations/federal-register/ interim-and-final-rules. FSIS also will make copies of this Federal Register 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 communicated via Listserv, a free email subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The Update also is available on the FSIS Web page. 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 https://www.fsis.usda.gov/subscribe. Options range from recalls to export information to regulations, directives, and notices. Customers can add or delete subscriptions themselves, and E:\FR\FM\26MRR1.SGM 26MRR1 Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Rules and Regulations have the option to password protect their accounts. USDA Nondiscrimination Statement USDA prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA’s Target Center at (202) 720–2600 (voice and TTY). To file a written complaint of discrimination, write USDA, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250–9410 or call (202) 720–5964 (voice and TTY). USDA is an equal opportunity provider and employer. List of Subjects in 9 CFR Part 381 Imported products. For the reasons set out in the preamble, FSIS is amending 9 CFR part 381 as follows: PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS 1. The authority citation for part 381 continues to read as follows: ■ Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451–470; 7 CFR 2.7, 2.18, 2.53. § 381.196 2. Amend § 381.196(b) to add the ‘‘Republic of Korea’’ in alphabetical order to the list of countries. ■ Done at Washington, DC, on March 20, 2014. Alfred V. Almanza, Administrator. [FR Doc. 2014–06652 Filed 3–25–14; 8:45 am] BILLING CODE 3410–DM–P FEDERAL ELECTION COMMISSION 11 CFR Parts 4, 100, 102, 104, 110, 111, and 114 [Notice 2014–07] Federal Election Campaign Act Rules; Corrections Federal Election Commission. ACTION: Correcting amendments. emcdonald on DSK67QTVN1PROD with RULES AGENCY: The Commission is making technical corrections to various sections of its regulations. DATES: Effective March 26, 2014. FOR FURTHER INFORMATION CONTACT: Ms. Amy L. Rothstein, Assistant General VerDate Mar<15>2010 16:11 Mar 25, 2014 Jkt 232001 Background The existing rules that are the subject of these corrections are part of the continuing series of regulations that the Commission has promulgated to implement the Federal Election Campaign Act of 1971, as amended, 2 U.S.C. 431 et seq. (‘‘FECA’’). The Commission is promulgating these corrections without advance notice or an opportunity for comment because they fall under the ‘‘good cause’’ exemption of the Administrative Procedure Act. 5 U.S.C. 553(b)(B). The Commission finds that notice and comment are unnecessary here because these corrections are merely typographical and technical; they effect no substantive changes to any rule. For the same reason, these corrections fall within the ‘‘good cause’’ exception to the delayed effective date provisions of the Administrative Procedure Act and the Congressional Review Act. 5 U.S.C. 553(d)(3), 808(2). Accordingly, these corrections are effective upon publication in the Federal Register. The Commission is not required to submit these corrections for congressional review. See 2 U.S.C. 438(d)(1), (4). Corrections to FECA Rules in Chapter I of Title 11 of the Code of Federal Regulations [Amended] SUMMARY: Counsel, Ms. Joanna S. Waldstreicher, Attorney, or Mr. Eugene Lynch, Paralegal, 999 E Street NW., Washington, DC 20463, (202) 694–1650 or (800) 424–9530. SUPPLEMENTARY INFORMATION: A. Correction to 11 CFR 4.8 The Commission is correcting an erroneous citation in paragraph (a) of this section by replacing the reference to 11 CFR 4.6(d) with 11 CFR 4.7(h). Paragraph (a) refers to notification ‘‘pursuant to § 4.6(d)’’ that a request for inspection or a copy of a record has been denied, but section 4.6 addresses the discretionary release of records by the Commission, not notification of a denial of access to records. Moreover, section 4.6 does not contain a paragraph (d). Section 4.7(h) concerns the notification to a person who has been denied access to records. B. Correction to 11 CFR 100.1 This section lists the statutes implemented by subchapter A of chapter I of the Commission’s regulations. The list in this section is currently incomplete. To encompass all relevant statutes, the Commission is revising this section to note that subchapter A implements FECA, as amended, 2 U.S.C. 431 et seq. PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 16661 C. Correction to 11 CFR 100.18 This section defines the term ‘‘the Act’’ as used in the Commission’s regulations to include the Federal Election Campaign Act of 1971 and each subsequent amendment to it. The list of amendments in this section is currently incomplete. To encompass all relevant statutes, the Commission is revising this section to define ‘‘the Act’’ as FECA, as amended, 2 U.S.C. 431 et seq. D. Correction to 11 CFR 100.29 The Commission is correcting a typographical error in paragraph (c) of this section by italicizing the first instance of the word ‘‘electioneering,’’ so that the entire phrase ‘‘electioneering communication’’ is italicized and not just the word ‘‘communication.’’ E. Corrections to 11 CFR 100.52 The Commission is correcting typographical errors in two citations in paragraph (a) of this section by replacing the references to 11 CFR 100.72 and 100.73 with 11 CFR 100.82 and 100.83, respectively. Section 100.52(a) excludes ‘‘a loan made in accordance with 11 CFR 100.72 and 100.73’’ from the definition of ‘‘contribution.’’ Sections 100.72 and 100.73, however, concern the ‘‘testing the waters’’ and media exceptions to the definition of ‘‘contribution,’’ not loans. The Commission is therefore replacing the references to sections 100.72 and 100.73 in 11 CFR 100.52(a) with references to sections 100.82 and 100.83, which concern bank loans and brokerage loans and lines of credit. The Commission is also correcting an erroneous citation in paragraph (b)(5) of this section by replacing the reference to 11 CFR 110.4(a) with a reference to 11 CFR 110.20. Section 100.52(b)(5) states that payments of interest on loans to a political committee ‘‘shall be made from funds subject to the prohibitions of section 110.4(a).’’ Section 110.4(a) previously prohibited foreign nationals from making contributions or expenditures, but that provision was moved to section 110.20 in 2003, and section 110.4(a) was reserved. The Commission is therefore replacing the reference to 11 CFR 110.4(a) with a reference to section 110.20, which also conforms this citation to the citation in a corresponding provision in the same paragraph. F. Correction to 11 CFR 100.82 The Commission is correcting a typographical error in a citation in paragraph (f) of this section by replacing the reference to 11 CFR 100.73 with 11 CFR 100.83. Section 100.82(f) states that ‘‘this section shall not apply to loans E:\FR\FM\26MRR1.SGM 26MRR1

Agencies

[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Rules and Regulations]
[Pages 16656-16661]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06652]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 381

[Docket No. FSIS-2012-0019]
RIN 0583-AD49


Eligibility of the Republic of Korea To Export Poultry Products 
to the United States

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal poultry products inspection regulations to add the Republic of 
Korea (Korea) to the list of countries eligible to export poultry 
products to the United States. FSIS has reviewed Korea's poultry laws, 
regulations, and inspection system, as implemented, and has determined 
that they are equivalent to the Poultry Products Inspection Act (PPIA), 
the regulations implementing this statute, and the U.S. food safety 
system for poultry.
    Under this final rule, slaughtered poultry or parts or other 
products thereof processed in certified Korean establishments will be 
eligible for export to the United States. All such products will be 
subject to re-inspection at United States ports of entry by FSIS 
inspectors.

DATES: Effective Date: May 27, 2014.

FOR FURTHER INFORMATION CONTACT: Dr. Andreas Keller, Director, 
International Equivalence Staff, Office of Policy and

[[Page 16657]]

Program Development; Telephone: (202) 720-0082.

SUPPLEMENTARY INFORMATION: 

Background

    On November 27, 2012, FSIS proposed to add the Republic of Korea 
(Korea) to the list of countries eligible to export poultry products to 
the United States (77 FR 70724). This final rule is consistent with the 
provisions of the proposed rule.
    As explained in the proposal, section 17 of the PPIA (21 U.S.C. 
466) prohibits importation into the United States of slaughtered 
poultry, or parts or products thereof, of any kind unless they are 
healthful, wholesome, fit for human food, not adulterated, and contain 
no dye, chemical, preservative, or ingredient that renders them 
unhealthful, unwholesome, unfit for human food, or otherwise 
adulterated. Under the PPIA and the regulations that implement it, 
poultry products imported into the United States must be produced under 
standards for safety, wholesomeness, and labeling accuracy that are 
equivalent to those of the United States. Section 381.196 of Title 9 of 
the Code of Federal Regulations (CFR) sets out the procedures by which 
foreign countries may become eligible to export poultry and poultry 
products to the United States.
    Section 381.196(a) requires that the standards of a foreign 
country's poultry inspection system, its legal authority for the 
inspection system, and the regulations implementing the system be 
equivalent to those of the United States. These requirements include: 
(1) Ante-mortem and post-mortem inspection performed or supervised by a 
veterinarian; (2) national government controls over establishment 
construction, facilities, and equipment; (3) verification of 
slaughtering of poultry and processing of poultry products by 
inspectors to ensure that product is not adulterated or misbranded; (4) 
separation of establishments certified to export from those not 
certified; (5) maintenance of a single standard of inspection and 
sanitation throughout certified establishments; (6) requirements for 
sanitation and for sanitary handling of product at certified 
establishments; (7) controls over condemned product; (8) a Hazard 
Analysis and Critical Control Point (HACCP) system; and (9) any other 
requirements under the PPIA and its implementing regulations (9 CFR 
381.196(a)(2)(ii)).
    The country's inspection program must also impose requirements 
equivalent to those of the United States with respect to: (1) 
Organizational structure and staffing in certified establishments to 
ensure uniform enforcement of laws and regulations; (2) national 
government control and supervision over the official activities of 
employees or licensees; (3) qualified inspectors; (4) enforcement and 
certification authority; (5) administrative and technical support; (6) 
inspection, sanitation, quality, species verification, and residue 
standards; and (7) any other inspection requirements (9 CFR 
381.196(a)(2)(i)).
    Inclusion of the country in 9 CFR 381.196 generally implies that 
the country has a regulatory system equivalent to that of the United 
States for slaughter and further processing of poultry for all nine 
processing categories referred to in 9 CFR 417.2 (Slaughter; raw 
product--ground; raw product--not ground; 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 product with secondary inhibitors--
not shelf stable). However, FSIS recognizes that, at the time of the 
initial equivalence request, a country may not expect to manufacture 
and export products to the United States that meet the requirements of 
each of these processing categories. Even so, FSIS determines whether 
the foreign country has equivalent government oversight, statutory 
authority and food safety regulations, sanitation performance 
standards, hazard analysis and critical control point systems, chemical 
residue control and microbiological testing programs, and the 
infrastructure in place to ensure that, if products in any of the nine 
processing categories were to be exported, the products would meet 
United States standards of safety and wholesomeness.\1\
---------------------------------------------------------------------------

    \1\ At this time, FSIS is taking steps to publish on its Web 
site a chart that identifies which of the nine processing categories 
FSIS specifically reviewed in FSIS in-country audits, and which the 
Public Health Inspection System (PHIS) is set up to allow to be 
imported into the U.S. This PHIS-based chart will also reflect any 
processing category limitations as a result of animal health 
restrictions for that foreign country, as provided for in 9 CFR part 
94. Because FSIS public health policies may change subsequent to the 
time at which the foreign country is listed in 9 CFR 327.2 or 
381.196, or a foreign country may decide to later certify product 
exported to the U.S. from a processing category not listed for that 
country on the PHIS-based chart, FSIS will determine whether an in-
country audit is necessary before FSIS modifies the PHIS-based 
chart. Regarding a foreign country's initial request for equivalence 
for egg products in accordance with 9 CFR 590.910, all the 
requirements in part 590 must be met as there are no similar 
processing categories as provided for livestock and poultry 
products.
---------------------------------------------------------------------------

Evaluation of the Korean Poultry Inspection System

    In 2005, the government of Korea requested approval for the 
importation of Korean poultry products into the United States. Korea 
stated that its immediate intention was to export two types of ginseng 
chicken stew products to the United States. FSIS then began to evaluate 
Korea's inspection system to determine whether it is equivalent to the 
United States system.
    FSIS conducted a document review to evaluate the laws, regulations, 
and other documentation used by Korea to execute its poultry inspection 
program. FSIS examined the information submitted by Korea to verify 
that the following critical points relating to equivalence were 
addressed satisfactorily with respect to standards, activities, 
resources, and enforcement: (1) Government Oversight; (2) Statutory 
Authority and Food Safety Regulations; (3) Sanitation; (4) HACCP 
Systems; (5) Chemical Residue Testing Programs; and (6) Microbiological 
Testing Programs. The document review was satisfactory to FSIS, and 
FSIS scheduled an on-site review to evaluate all aspects of Korea's 
inspection program.
    In 2008, FSIS conducted an on-site audit of Korea's poultry 
inspection system and identified systemic deficiencies within five 
equivalence components. In response to this audit, Korea submitted a 
corrective action plan that addressed FSIS's findings.
    In 2010, FSIS conducted a comprehensive on-site audit to determine 
whether Korea had satisfactorily implemented all the laws, regulations, 
and other issuances that FSIS found to be equivalent during the 
document analysis, and whether the findings of the previous audit had 
been addressed. The 2010 audit revealed that Korea had fully 
implemented the corrective action plan that it had submitted in 
response to the 2008 audit. Nonetheless, the new audit identified new 
systemic deficiencies in three equivalence components: Statutory 
Authority and Food Safety Regulations, Chemical Residue Testing 
Programs, and Microbiological Testing Programs. During the audit, 
establishments made changes to address some deficiencies.
    In addition to the actions taken during the audit, Korea submitted 
a corrective action plan on how it would incorporate the actions it 
took during the audit into its food safety system. FSIS reviewed this 
corrective action plan and, for the reasons explained below, concluded 
that Korea had satisfactorily addressed the findings of 2010 audit.

[[Page 16658]]

    Consequently, on November 27, 2012, FSIS published a proposed rule 
to find that Korea's poultry inspection system (slaughter and 
processing) is equivalent to the United States' poultry inspection 
system and proposing to add the Republic of Korea (Korea) to the list 
of countries eligible to export poultry products to the United States. 
For more detailed information on FSIS's evaluation of the Korean 
poultry inspection system, see the proposed rule (77 FR 70724) and for 
the full audit report go to https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.

Final Rule

    After considering the comments received on the proposed rule and 
discussed below, FSIS concludes that Korea's poultry inspection system 
is equivalent to the United States' inspection system for poultry and 
poultry products. Therefore, FSIS is amending its poultry products 
inspection regulations to add Korea to the list of countries eligible 
to export poultry products to the United States (9 CFR 381.196(b)). 
Under FSIS's import regulations, the government of Korea must certify 
to FSIS that those establishments that wish to export poultry products 
to the United States are operating under requirements equivalent to 
those of the United States (9 CFR 381.196(a)).
    Although a foreign country may be listed in FSIS regulations as 
eligible to export poultry to the United States, the exporting 
country's products must also comply with all other applicable 
requirements of the United States. These requirements include 
restrictions under 9 CFR part 94 of the Animal and Plant Health 
Inspection Service (APHIS) regulations, which also regulate the 
importation of poultry products from foreign countries into the United 
States.
    Under this final rule, all slaughtered poultry, or parts and 
products thereof, exported to the United States from Korea will be 
subject to re-inspection at the United States ports of entry for, but 
not limited to, transportation damage, product and container defects, 
labeling, proper certification, general condition, and accurate count.
    In addition, FSIS will conduct other types of reinspection 
activities, such as incubation of canned products to ensure product 
safety and taking product samples for laboratory analysis to detect any 
drug or chemical residues or pathogens that may render the product 
unsafe or any species or product composition violations that would 
render the product economically adulterated. Products that pass re-
inspection will be stamped with the official mark of inspection and 
allowed to enter United States commerce. If they do not meet United 
States requirements, they will be refused entry and within 45 days will 
have to be returned to the country of origin, destroyed, or converted 
to animal food (subject to approval of FDA), depending on the 
violation. The import re-inspection activities can be found on the FSIS 
Web site at https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/port-of-entry-procedures/fsis-import-reinspection/ct_index9.

Summary of Comments and Responses

    FSIS received four comments in response to the proposed rule. One 
individual and a consumer advocacy organization opposed the rule, and 
one individual and three trade associations, representing the poultry 
and egg products industries, submitted a single comment that supported 
the proposed rule.
    Following is a discussion of the relevant issues raised in the 
comments and FSIS's responses.
    Comment: One individual stated that all poultry from Korea should 
be banned in the United States. The individual was concerned about the 
safety of food from foreign countries, including Korea, and animal 
welfare and inhumane slaughter in Korea. The individual argued that the 
United States should not import any food from any country.
    Response: Under the PPIA, if a country maintains a poultry safety 
inspection system that is equivalent to that of the United States, it 
is entitled to ship poultry products to the United States should it 
seek to do so.
    FSIS has conducted a thorough review of Korea's laws, regulations, 
written procedures, policies, and other official documents, including 
evaluating whether poultry slaughter establishments maintained good 
commercial practices consistent with those required in United States 
poultry slaughter establishments (see 9 CFR 381.65(a)-(b)). These 
practices ensure that poultry is humanely slaughtered. In addition, 
FSIS conducted two on-site verification audits of Korea's poultry 
inspection system. Taking the findings of the two audits together, FSIS 
has determined that Korea's poultry inspection system is equivalent to 
the United States inspection system for poultry and poultry products. 
The comment has not presented any basis on which FSIS could make a 
contrary determination.
    As stated above, for Korea to be eligible to export poultry to the 
United States, it must implement and maintain a poultry inspection 
system that is equivalent to the United States' system. To determine 
whether Korea maintains an equivalent inspection system, FSIS uses a 
three-part approach that includes (1) on-going document reviews, (2) 
periodic on-site system audits, and (3) ports of entry re-inspections. 
If Korea fails to maintain a poultry inspection system that is 
equivalent to the United States' system, FSIS will act to suspend or 
terminate its eligibility to export to this country.
    Comment: A consumer advocacy organization stated that, although 
Korea will initially export only two types of chicken stew, the 
proposed rule understated the magnitude of future exports to the United 
States because Korea is being added to the list of countries eligible 
to export poultry products to the United States with no restrictions.
    Response: FSIS has no basis for finding that it understated the 
magnitude of future exports from Korea to the United States. As 
described in more detail in the Economic Analysis below, Korea will 
initially export only two types of chicken stew products to the United 
States. Because of the limited market in the United States for these 
products, the projected export volume of these products from Korea is 
likely to be very small, and thus the impact on the United States 
economy is likely to be very small as well.
    However, it is true that Korea would not be precluded from 
exporting other poultry products to the U.S. in the future if those 
products meet all applicable APHIS and FSIS requirements for the 
products, and Korea certifies that the producing establishments comply 
with Korean requirements that FSIS has found to be equivalent to 
applicable FSIS requirements (9 CFR 381.196(a)). Therefore, FSIS agrees 
that the long-term economic impact of this rule could be more 
significant than the immediate impact. FSIS does not have any data, 
however, that it could use to project the long term impact.
    Comment: The consumer advocacy organization also argued that Korea 
should not be added to the list of countries eligible to export poultry 
products because FSIS's 2010 audit found deficiencies in Korea's 
inspection system, and FSIS did not conduct another onsite audit to 
verify that Korea implemented corrective actions in response to the 
2010 audit.
    Response: During the 2010 on-site audit of Korea's poultry 
inspection

[[Page 16659]]

system, FSIS auditors found that Korea had implemented the corrective 
actions that it had proffered in response to the 2008 on-site audit 
findings. In addition, Korea provided records demonstrating that these 
corrective action plans had been implemented in a manner consistent 
with FSIS' inspection requirements. This finding provides a basis for 
confidence that Korea will implement all corrective actions it promises 
in an acceptable manner.
    As the commenter indicated, the auditors found two new problems 
with the Korean system. The first problem identified by the auditors 
was in the Statutory Authority and Food Safety Regulations component: 
Korea's central competent authority (CCA), the Ministry for Food, 
Agriculture, Forestry and Fisheries, was not requiring establishments 
to maintain conditions that would allow the government inspectors to 
inspect adequately each carcass. Specifically, FSIS found that: (a) One 
of the three establishments audited did not have conveniently located 
controls (e.g., start-stop switches) that would permit government 
inspection program personnel to stop the line to conduct a protracted 
post-mortem inspection of carcasses when necessary or to prevent 
adulterated product from entering the chill tank; (b) during the on-
site review of records, the Korean inspection regulations did not 
require inspection stations to have online hand-rinsing facilities with 
a continuous flow of water within easy access for inspection personnel 
and establishment personnel to prevent incidental cross-contamination 
of carcasses resulting from post-mortem inspection procedures, and one 
establishment audited did not have such online hand-rinsing facilities; 
and (c) the three establishments audited had 52 footcandles (540 Lux) 
of lighting at post-mortem inspection stations, in compliance with 
Korea's inspection regulation, while the United States requires at 
least 200 foot-candles (2,152 Lux) of shadow-free lighting, with a 
minimum color-rendering index value of 85, for a system configuration 
similar to Korea's inspection system and line speed (Streamlined 
Inspection System (SIS)).
    When FSIS discussed these findings with Korea's CCA during the on-
site audit, Korea's government inspectors at the establishments 
instructed the establishments to make the changes necessary to conform 
to United States requirements for the conditions under which government 
inspection personnel are to perform their inspections. The 
establishments proposed immediate corrective actions, and Korean 
government inspectors accepted establishments' proposals. In the 
establishment that did not have conveniently located controls, it 
implemented immediate corrective action by relocating the controls 
(e.g., start-stop switches) to a convenient location. All the three 
establishments adjusted lighting at post-mortem inspection stations to 
200 foot-candles of shadow-free lighting with a minimum color index 
value of 85. In addition, Korea immediately revised its export 
requirements for the U.S. to require export facilities to have 
inspection stations with online hand-rinsing facilities. This document 
was provided to the auditor before the conclusion of the audit. Korea 
subsequently provided records, including a photograph, showing that the 
audited establishment without on-line hand-rinsing facilities had 
installed such facilities.
    FSIS auditors verified the immediate corrective actions while still 
in Korea. However, the auditors told Korea that it needed to submit a 
comprehensive corrective action plan that included a systematic 
solution to prevent recurrence of these deficiencies.
    Following the audit, in July of 2011, Korea provided supporting 
documentation demonstrating that it had issued new requirements for: 
(1) Inspection stations to have conveniently located controls (e.g., 
start-stop switches); (2) online hand- rinsing facilities with a 
continuous flow of water within easy access; and (3) 200 foot-candles 
of shadow-free lighting with a minimum color-rendering index value of 
85. These requirements, together with the immediate corrective actions 
taken by the establishments and with Korea's history of taking 
effective action to resolve deficiencies found in an audit, provide a 
basis for FSIS to have confidence that the deficiencies that the 
auditors found in the establishments have been corrected and will not 
recur.
    The second problem regarding the implementation of laboratory 
quality systems within Korea's National Residue Program and 
Microbiological Testing Program was identified in two equivalence 
components, Chemical Residue Testing Programs and Microbiological 
Testing Programs. Specifically, the CCA did not have adequate control 
over the implementation of quality systems in the government 
laboratories that are part of Korea's poultry inspection system. While 
residue and microbiological testing methods appeared to be implemented 
in an appropriate manner, Korea's CCA was not verifying that the 
quality control and assurance programs implemented by the government 
laboratories were adequate. For example, the frequency and the 
documentation of equipment verification, calibration, and maintenance 
related to relevant testing methods varied among the laboratories and 
were not consistent with international standards. Therefore, Korea did 
not consistently implement adequate standards for the laboratories.
    Following the 2010 audit, Korea submitted documents showing that it 
had implemented quality control and assurance programs. The 
documentation provided shows that Korea adopted procedures consistent 
with U.S. procedures to ensure that laboratory equipment and materials 
are appropriately verified, calibrated, and maintained to meet program 
requirements (Accreditation Guide 04/10, quality system recommendation 
in accordance with ISO/IEC 17025 international standards). Korea 
submitted documents to show that the Korean CCA has adequately trained 
laboratory managers and staff in the quality control and assurance 
program procedures. Records show that Korea has audited the government 
laboratories involved in poultry inspection at least once per year, and 
that the laboratories are meeting Korea's quality system requirements. 
FSIS's review of proficiency testing reports for the year 2012 
submitted by Korea in September 2013 found that the participating 
Korean government laboratories are effectively using the FSIS 
laboratory testing methods to ensure that products eligible for export 
to the U.S. are free of contamination. The documents that Korea 
submitted to FSIS collectively demonstrate that the Korea CCA has 
effectively implemented procedures in its quality control and assurance 
programs that are equivalent to U.S. procedures.
    Comment: Finally, the consumer advocacy organization stated that 
FSIS should not find Korea equivalent when FSIS is not performing 
annual audits of all countries currently listed as eligible to export 
to the United States.
    Response: FSIS will conduct on-site audits of Korea's inspection 
system each year for the next three years. After three years, FSIS will 
reassess how frequently it needs to conduct on-site audits of Korea's 
system. Additionally, all product imported from Korea will be subject 
to FSIS re-inspection.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866 by the 
Office of Management and Budget (OMB) and has

[[Page 16660]]

been determined to be not significant for purposes of E.O. 12866.

Economic Impact Analysis

    This rule adds Korea to the list of countries eligible to export 
poultry products into the United States. Korea will export two types of 
ginseng chicken stew products to the United States. Given the limited 
market in the United States for this product, and the projected export 
volume of this product from Korea, the impact on the United States 
economy is likely to be very small. According to data from Korea, only 
two Korean establishments will export ginseng chicken stew to the 
United States. The average combined annual production of these two 
establishments is 3.2 million pounds (2006-2010 average), and their 
projected total export volume to the United States will be about 
380,000 pounds in year one (the first year of exporting to the United 
States), gradually increasing to about 2.25 million pounds in year 
five, according to the Korean data.
    Ginseng chicken stew is sold commercially in frozen pouches. The 
United States market for ginseng chicken stew is so small that no data 
on domestic production, consumption, or importation could be found. 
Using label application data, FSIS identified two official 
establishments that produce and sell ginseng chicken stew. On the basis 
of information from these establishments, FSIS believes (1) they are 
very likely the only two establishments that are producing ginseng 
chicken stew in the United States, (2) the market for ginseng chicken 
stew is limited, (3) the annual production is about 18,000 pouches for 
one establishment and 10,000 pouches for the other, and (4) each pouch 
weighs about two pounds. Therefore, the combined production of these 
two establishments is about 56,000 pounds per year ((18,000 + 10,000) x 
2). The special flavor and taste make ginseng chicken stew unlikely to 
be a substitute for other kinds of chicken stew in the United States. 
Therefore, although this rule may affect these two United States 
establishments, the impact to the United States economy is likely to be 
insignificant.
    Expected benefits from this rule will be primarily for consumers in 
the form of more choices in the marketplace. As mentioned above, the 
volume of trade stimulated by the rule is likely be so small as to have 
little effect on supply and prices. Another potential benefit of this 
rule would result in efficiency gains of United States poultry 
producers due to the increased competition from Korea.
    The cost of this rule will be incurred by domestic producers in the 
form of competition from Korea. The two establishments that are 
currently producing ginseng chicken stew are likely to encounter 
competition pressure, for the projected import volume in year one is 
already 6.8 times the combined production volume of these two 
establishments. The imported volume, however, is likely to have little 
impact on the overall United States economy. Also, these two 
establishments may change their production mix if they find it 
difficult to compete with imports.

Effect on Small Entities

    The FSIS Administrator has made a determination that this rule will 
not have a significant impact on a substantial number of small 
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601). 
As mentioned above, the expected trade volume will be very small, and 
the effect will be on only two very small establishments that produce 
ginseng chicken stew domestically.

Potential Long-Term Effect

    When foreign countries apply for eligibility of their meat, 
poultry, or egg products for entry into this country, FSIS determines 
whether their inspection systems are equivalent to the system 
maintained by the United States. FSIS does not make equivalence 
determinations on the basis of particular products; rather, the 
equivalence decision is based on the evaluation of the countries' 
inspection systems.
    Although Korea indicates that it intends to export two types of 
ginseng chicken stew products for now, it would not be precluded from 
exporting other poultry products in the future if the products meet all 
applicable APHIS and FSIS requirements for those products. If 
additional Korean establishments export product to the United States, 
the long-term economic impact could be more significant. However, no 
data is available to assess such future impacts.

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) no 
retroactive proceedings will be required before parties may file suit 
in court challenging this rule.

Paperwork Reduction Act

    No new paperwork requirements are associated with this final rule. 
Foreign countries wanting to export poultry and poultry products to the 
United States are required to provide information to FSIS certifying 
that their inspection system provides standards equivalent to those of 
the United States, and that the legal authority for the system and 
their implementing regulations are equivalent to those of the United 
States. FSIS provided Korea with questionnaires asking for detailed 
information about the country's inspection practices and procedures to 
assist that country in organizing its materials. This information 
collection was approved under OMB number 0583-0094.

E-Government Act

    FSIS and the United States Department of Agriculture (USDA) are 
committed to achieving the purposes of the E-Government Act (44 U.S.C. 
3601, et seq.) by, among other things, promoting the use of the 
Internet and other information technologies and providing increased 
opportunities for citizen access to Government information and 
services, and for other purposes.

Additional Public Notification

    FSIS will officially notify the World Trade Organization's 
Committee on Sanitary and Phytosanitary Measures (WTO/SPS Committee) in 
Geneva, Switzerland, of this rule and will announce it on-line through 
the FSIS Web page located at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/interim-and-final-rules.
    FSIS also will make copies of this Federal Register 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 communicated via Listserv, a free email 
subscription service consisting of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals who have requested to be included. 
The Update also is available on the FSIS Web page. 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 https://www.fsis.usda.gov/subscribe. Options 
range from recalls to export information to regulations, directives, 
and notices. Customers can add or delete subscriptions themselves, and

[[Page 16661]]

have the option to password protect their accounts.

USDA Nondiscrimination Statement

    USDA prohibits discrimination in all its programs and activities on 
the basis of race, color, national origin, gender, religion, age, 
disability, political beliefs, sexual orientation, and marital or 
family status. (Not all prohibited bases apply to all programs.) 
Persons with disabilities who require alternative means for 
communication of program information (Braille, large print, audiotape, 
etc.) should contact USDA's Target Center at (202) 720-2600 (voice and 
TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue 
SW., Washington, DC 20250-9410 or call (202) 720-5964 (voice and TTY). 
USDA is an equal opportunity provider and employer.

List of Subjects in 9 CFR Part 381

    Imported products.

    For the reasons set out in the preamble, FSIS is amending 9 CFR 
part 381 as follows:

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

0
1. The authority citation for part 381 continues to read as follows:

    Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7, 
2.18, 2.53.


Sec.  381.196  [Amended]

0
2. Amend Sec.  381.196(b) to add the ``Republic of Korea'' in 
alphabetical order to the list of countries.

    Done at Washington, DC, on March 20, 2014.
Alfred V. Almanza,
Administrator.
[FR Doc. 2014-06652 Filed 3-25-14; 8:45 am]
BILLING CODE 3410-DM-P
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