Food Safety and Inspection Service, USDA.
Notice of affirmation of equivalence decision.
The Food Safety and Inspection Service (FSIS) is affirming its 1999 decision that Australia's Meat Safety Enhancement Program (MSEP), an alternative to the conventional meat inspection system also maintained by the Australian Government food regulatory authority [Australia Quarantine and Inspection Service (AQIS)], is equivalent to the FSIS domestic meat inspection system. MSEP has been renamed the Australian Export Meat Inspection System (AEMIS), but the system itself will remain the same as that determined to be equivalent by FSIS in 1999 when FSIS announced that slaughter inspection in MSEP establishments meets all requirements of U.S. law for the import of product to the United States, and provides the same level of public health protection as U.S. domestic slaughter inspection. In this notice, MSEP is used for events that occurred under that name, MSEP/AEMIS for unchanging features of the program, and AEMIS for current and projected activities. In January 2011, Australia informed FSIS that AEMIS will be progressively implemented in all Australian beef, sheep, and goat establishments eligible to export to the United States.
The Agency must receive comments by April 4, 2011.
FSIS invites comments on this notice. Comments may be submitted by either of the following methods:
- Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the online instructions at that site for submitting comments.
- Mail, including floppy disks or CD-ROMs, and hand- or courier-delivered items: Send to Docket Clerk, USDA, FSIS, Room 2-2127 George Washington Carver Center, 5601 Sunnyside Avenue, Mailstop 5272, Beltsville, MD 20705-5272.
Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2009-0020. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to http://www.regulations.gov.
Docket: All comments submitted in response to this notice, as well as research and background information used by FSIS in developing this document, will be available for public inspection in the FSIS Docket Room at the address listed above between 8 a.m. and 4:30 p.m., Monday through Friday.Start Further Info
FOR FURTHER INFORMATION CONTACT:
For further information contact Dr. Ronald K. Jones, Assistant Administrator, Office of International Affairs, Food Safety and Inspection Service, USDA, Room 3143-S, 14th and Independence Avenue, SW., Washington, DC 20250-0070; telephone (202) 720-3473, fax (202) 690-3856, e-mail Ronald.Jones@fsis.usda.gov.End Further Info End Preamble Start Supplemental Information
The Federal Meat Inspection Act (FMIA) stipulates that no carcasses, parts of carcasses, meat, or meat food products shall be imported into the United States unless the livestock from which they were produced was slaughtered and processed in accordance with all provisions and regulations applicable to such articles in commerce within the United States (21 U.S.C. 620). These provisions and regulations include standards for safety, wholesomeness, and labeling accuracy.
Foreign countries wanting to export meat to the United States must apply to FSIS, following procedures set out in § 327.2 of Title 9 of the Code of Federal Regulations (CFR). To be found eligible, a foreign country's national government must operate an inspection system with legal authority for the inspection system. Its implementing regulations and other implementing documentation must be equivalent to those of the United States. Specifically, the national meat inspection system must impose equivalent requirements with respect to: (1) Ante-mortem and post-mortem inspection; (2) official controls by the national government over plant construction, facilities, and equipment; (3) direct and continuous supervision of slaughter activities and product preparation; (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 at establishments certified to export and for sanitary handling of product; and (7) official controls over condemned product.
In order to achieve equivalence recognition, a foreign country must submit its inspection system to an evaluation by FSIS consisting of a document review and an on-site review. The document review is an evaluation of the laws, regulations, and other implementing documentation used by the country to enact its inspection program. The foreign country provides a self-assessment of its national meat or poultry inspection system, organized by six components: Government oversight, statutory authority and food safety regulations, sanitation, Hazard Analysis and Critical Control Point (HACCP) systems, chemical residue testing programs, and microbiological testing programs. FSIS evaluates the information submitted in these self-assessment documents and conducts an on-site review to verify all aspects of the country's inspection program, including laboratories and the foreign government's oversight of the individual establishments within the country. This comprehensive process is described fully on the FSIS Web site at http://www.fsis.usda.gov/Regulations_&_Policies/equivalence_process/index.asp.
If FSIS determines that a foreign country's inspection system is equivalent, the Agency is required to conduct a rulemaking to list the country in the meat inspection regulations, at 9 CFR 327.2, as eligible to export meat and meat products to the United States. Once the rulemaking is final, the foreign country certifies appropriate establishments as having met required standards for export. This certification ensures that both establishments producing meat for export to the United States and the products of those establishments comply with requirements that are equivalent to those of the FMIA and the regulations that are promulgated under this statutory authority. To verify that Start Printed Page 11753products imported into the United States are safe, wholesome, and properly labeled and packaged, FSIS re-inspects those products at ports-of-entry (POEs) before they enter the United States. FSIS re-inspects all shipments for overall condition, foreign government certification, and labeling and then selects random lots of product and assigns appropriate types of inspections such as product examination and microbiological and residue testing for a more in-depth examination.
Under the World Trade Organization (WTO) Agreement on Sanitary and Phytosanitary Measures (SPS), the United States has international obligations to respond to requests from other nations to establish the equivalence of meat and poultry processing measures that differ from those of the United States. In 1996, Australia, which has long been eligible to export meat to the United States under its conventional meat inspection system, approached FSIS with an alternative meat slaughter inspection program called “Project 2.” FSIS announced in the Federal Register (62 FR 29326, May 30, 1997) that it was making available an AQIS submission on Project 2 and seeking public comment in order to help in determining whether the United States should accept meat produced by Australian establishments participating in Project 2 trials.
After extensive review, FSIS determined that Project 2 was not equivalent because it did not provide adequate government oversight. AQIS modified the proposed program, and FSIS announced the availability of a new AQIS paper on the program, renamed MSEP, in a Federal Register Notice (64 FR 2621, January 15, 1999; the MSEP paper is available on the FSIS Web site with this notice at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp). The 1999 notice also announced a public meeting on MSEP for February 3, 1999, to seek input from U.S. industry, U.S. consumer groups, and other FSIS stakeholders.
FSIS evaluated comments on the AQIS paper and the public meeting and determined that MSEP is equivalent to the U.S. meat slaughter inspection program. FSIS announced this decision in a Federal Register Notice (64 FR 30299, June 7, 1999; MSEP equivalence). The Agency added that it would review its equivalence decision once AQIS had conducted field trials and submitted the results to FSIS and would then publish its conclusions in a Federal Register Notice. In the interim, establishments participating in MSEP field trials could export product to the United States. At the time, AQIS expected a beef establishment to participate in MSEP field trials in the near future. For various reasons, however, it was not until 2006 that a different beef slaughter establishment volunteered for MSEP field trials. That establishment is the one referenced in this notice.
MSEP/AEMIS is an alternative meat slaughter inspection program in which establishment employees perform certain duties traditionally performed by government inspectors. Under MSEP/AEMIS, establishment employees instead of government inspectors are responsible for post-mortem examination of the heads and viscera of livestock. AQIS veterinarians are responsible for performing ante-mortem inspection, verifying post-mortem inspection, verifying establishment examination activities, providing final disposition on animals and carcasses/heads/viscera where there is evidence of disease, verifying HACCP and SSOP programs, and performing other food safety activities. AQIS inspectors are responsible for final inspection of each carcass for food safety defects. It should be noted that the establishment employees who are responsible for the initial examination of the heads and viscera for referral to AQIS veterinarians have completed the same training and have the same qualifications as established by AQIS for its government inspectors.
An establishment wishing to participate in MSEP/AEMIS must meet entry conditions detailed in an Approved Arrangement with AQIS. An applicant establishment must be able to demonstrate consistent performance under the Meat Hygiene Assessment (MHA) national plant performance rating system administered by AQIS. For the purposes of the beef establishment trials, the current MSEP/AEMIS beef standards are detailed in an AQIS MSEP paper of March 2007, Meat Safety Enhancement Program: Establishing Performance Standards for Beef Slaughter. This paper is available on the FSIS Web site with this notice at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
MSEP/AEMIS Performance Standards
The MSEP/AEMIS performance standards for beef slaughter are based on those used in the FSIS HACCP-Based Inspection Models Project (HIMP) for swine, which were first published in July 1998 (HIMP inspection models) and later detailed in the Federal Register in November 2000 (65 FR 65828-65829; performance standards for HIMP plants). Several HIMP market hog establishments have been operating since 2000. MSEP/AEMIS incorporates the same food safety performance standards as established by FSIS for HIMP, which included a zero tolerance for post-mortem infectious conditions, fecal material, ingesta, milk, and ante-mortem conditions found in cattle, such as neurological conditions, and moribund, febrile, and non-ambulatory cattle. The MSEP/AEMIS performance standards also include the HIMP performance attributes for wholesomeness, i.e., non-infectious conditions, such as post-mortem carcass and offal pathology and general carcass and offal contamination. In addition, MSEP/AEMIS performance standards include a performance standard for Aerobic Plate Counts of 100 colony forming units per square centimeter (100 cfu/cm2).
In applying the MSEP/AEMIS performance standards for the field trials, AQIS compared MSEP results against MHA data from eight Australian beef slaughter establishments certified to export to the United States under conventional inspection. MHA records establishment performance against food safety standards established by AQIS for all Australian establishments exporting meat products to the United States and other countries. AQIS selected these eight establishments as the best performers based on AQIS inspection and compliance data and results of FSIS audits of these establishments that had occurred within the previous five years. These establishments also represent one-third of Australia's annual total beef production. For a close comparison, data from these eight establishments certified under conventional inspection were gathered at the same time as at the MSEP establishment. In addition, cattle slaughtered at these eight establishments were the same type of cattle as slaughtered at the MSEP establishment.
Microbiological Performance Standards
As part of the MSEP/AEMIS performance standards, AQIS established microbiological performance standards for generic Escherichia coli (E. coli) and Salmonella, which remain the same under the new program name of AEMIS. These MSEP/AEMIS performance standards are equal to or more stringent than the FSIS performance standards for the same organisms. For Australian Start Printed Page 11754establishments producing under MSEP/AEMIS, no positives are allowed for either Salmonella or generic E. coli. In comparison, FSIS microbiological performance standards allow for one positive for Salmonella and one positive for generic E. coli for steers and heifers and two positives for generic E. coli for cows and bulls. The MSEP test results are discussed below.
MSEP Field Trial Proceedings
In January 2006, AQIS notified FSIS that one Australian establishment was interested in producing beef products for export to the United States under MSEP. This was Australia's first interest in exporting beef under MSEP since the 1999 equivalence determination. Because of the extensive time between the FSIS 1999 equivalence decision and the request by Australia to export under MSEP, AQIS submitted a revised MSEP program for consideration by FSIS. The revisions were minor and consisted of clarification of the separation of duties and responsibilities for AQIS and the establishment and an increase in the frequency of testing beef carcasses for Salmonella.
The MSEP field trials for the establishment consisted of two phases, Phase 1 and Phase 2. As part of the 1999 equivalence decision, an Australian MSEP establishment was required to complete a 6-week field trial and would be allowed to export beef products to the United States while undergoing the trial. This agreement was based, however, on the MSEP establishment already being certified by AQIS for export to the United States. The establishment that actually participated in the field trial was not a certified establishment. Therefore, AQIS added an additional 6-week field trial study as Phase 1.
MSEP Field Trial Results and Discussion
The 6-week MSEP field trial at the establishment under Phase 1 began on November 13, 2006, and ended on December 22, 2006. A total of 9,227 cattle were slaughtered and processed during this period. Twenty-one percent, or 1,903 carcasses of the 9,227, were sampled with regard to meeting the MSEP performance standards. The establishment did not export to the United States during Phase 1.
Ante-Mortem and Post-Mortem Inspection
The Phase 1 results showed that the establishment had exceeded the MSEP standards although early non-compliance was detected with regard to controlling fecal, ingesta, or milk contamination. As required by the establishment's HACCP plan, establishment management took corrective action, reassessed its processes, and applied and maintained adequate preventive measures to address problems controlling fecal, ingesta, or milk contamination. The data also demonstrated that establishment achieved results that were better than the average results for the eight certified Australian establishments used by AQIS as a basis for comparison for MSEP performance results. AQIS submitted 24 weeks of additional data (December 27, 2006-June 8, 2007), which showed that the establishment exceeded the MSEP performance standards. Overall, the establishment demonstrated a high level of compliance during Phase 1 and the subsequent 24 weeks.
AQIS collected a total of 300 generic E. coli samples and 300 Salmonella samples during the six-week Phase 1 trial study. Test results indicated zero (CFU/cm2) for generic E. coli and zero percent positive for Salmonella.
Phase 2 of the MSEP Establishment Field Trials
Phase 2 of the field trials at the establishment began on April 28, 2008, and ended on June 2, 2008. A total of 8,620 cattle were slaughtered and processed during this six-week period. Thirteen percent, or 1,122 carcasses of the 8,620, were sampled with regards to meeting the MSEP performance standards. AQIS continued to collect performance data from the establishment between June 10 and October 17, 2008, which is referred to as post Phase 2. The establishment was certified for export and exported raw beef components for grinding to the United States during Phase 2 and post Phase 2.
Ante-Mortem and Post-Mortem
No non-compliance was detected during ante-mortem inspection or post-mortem inspection. There were two occasions of non-compliance with regard to zero tolerance for fecal, ingesta, or milk contamination. As required by the establishment HACCP plan, establishment management took corrective action, reassessed its processes, and applied and maintained adequate preventive measures. AQIS verified the effectiveness of these actions and stated that the primary cause for zero tolerance detection was dirty incoming cattle because of inclement weather.
AQIS collected a total of 280 generic E. coli samples and 280 Salmonella samples during Phase 2. During this six-week period, no samples were positive for Salmonella, and one sample was positive for generic E. coli.
Post Phase 2, an additional 479 Salmonella samples and 522 generic E. coli samples were taken during this 19-week period. There were two instances each of Salmonella and generic E. coli detected during post phase 2. As required by the establishment HACCP plan, establishment management took corrective action, reassessed its processes, and applied and maintained adequate preventive measures. While the two positives for Salmonella exceeded the MSEP microbiological performance standard of zero percent positive, the prevalence rate of 0.01 percent was within the Australian export and U.S. performance standards (1.0 percent for steers and heifers) and below the prevalence rate of 0.12 percent for the eight conventional inspection establishments tested over the same period.
AQIS also took 280 samples for Aerobic Plate Counts during Phase 2 and 532 samples during post Phase 2. From a total of 812 samples, two counts numbered above the performance standard of 100 cfu/cm2. Therefore, data showed 99.8 percent compliance with the performance standard.
In December 2007, AQIS implemented an E. coli O157:H7 control program for Australian establishments exporting raw beef components for grinding to the United States. The MSEP field trial establishment became part of this program during Phase 2 and post Phase 2. The establishment was subject to E. coli O157:H7 testing during this same period. A total of 65 samples were taken for E. coli O157:H7 during Phase 2 and post Phase 2, with no positives detected.
Complete MSEP field trial reports for Phases 1 and 2 are available in the FSIS docket room.
FSIS Audit Results
FSIS conducted three audits of this establishment while it was operating under the MSEP program. These audits occurred August 29, 2007, May 14, 2008, and August 15, 2008. FSIS results from the 2007 audit, before the establishment was certified for export to the United States, identified shortcomings in process control and HACCP procedures. The later audits found that the establishment had corrected these problems. The audits indicated full compliance with the Start Printed Page 11755MSEP requirements and no food safety concerns.
FSIS Port-of-Entry Data
From June 25, 2008 through December 31, 2009, FSIS re-inspected 39 lots of boneless beef from the establishment with a total weight of approximately 588,000 pounds. FSIS re-inspection activities for boneless beef included boneless meat examination, chemical residue testing, or testing for E. coli O157:H7. Thirty-two of 39 lots received re-inspection consisting of a boneless meat examination, with all lots passing. Two of 39 lots were tested for pesticides or herbicides, with both tests negative. Twelve of 39 lots were tested for E. coli O157:H7, with all tests negative.
Australia's meat inspection system is equivalent to that of the U.S. Australia has demonstrated that it provides an appropriate level of oversight to AQIS employees in establishments operating under the conventional meat inspection system and to AQIS employees in the MSEP/AEMIS establishment. In addition, in the establishment operating under MSEP/AEMIS, FSIS has concluded that Australia verifies that establishment employees perform necessary examination of heads and viscera. Based on its review of the field trial data and the establishment's performance, discussed above, FSIS is affirming its 1999 equivalence decision for MSEP/AEMIS.
AEMIS will be progressively implemented in all Australian beef, sheep and goat establishments eligible to export to the United States. While the Australian beef establishment discussed above was undergoing the MSEP field trials and exporting to the U.S., FSIS did conduct enhanced port-of-entry re-inspection of product from this Australian establishment in addition to conducting on-site audits of the establishment. FSIS will initially conduct similar enhanced procedures for additional Australian establishments operating under MSEP and exporting to the U.S. FSIS will also conduct continuing system audits, which include data analyses and document reviews, and port-of-entry re-inspection to verify that Australia continues to operate a meat inspection system equivalent to the United States. Additionally, FSIS will verify that Australia continues to apply appropriate performance measures and ensure that establishment employees perform necessary examination of heads and viscera. This information, including FSIS audit reports, will be made available on the FSIS Web site.
USDA Nondiscrimination Statement
The U.S. Department of Agriculture (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.
Additional Public Notification
Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it online through the FSIS Federal Register Publications & Related Documents Web page. View Notices by year for 2010.
The Regulations.gov Web site is the central online rulemaking portal of the United States government. It is being offered as a public service to increase participation in the Federal government's regulatory activities. FSIS participates in Regulations.gov and will accept comments on documents published on the site. The site allows visitors to search by keyword or Department or Agency for rulemakings that allow for public comment. Each entry provides a quick link to a comment form so that visitors can type in their comments and submit them to FSIS.
FSIS will also 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, recalls, 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 e-mail 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 is also available on the FSIS Web page. Through the Listserv and Web page, FSIS is able to provide information to a much broader, more diverse audience.
In addition, FSIS offers an e-mail subscription service which provides an automatic and customized notification when popular pages are updated, including Federal Register publications and related documents. This service allows FSIS customers to sign up for subscription options across eight categories. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/. Options range from recalls to export information to regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to protect their accounts with passwords.Start Signature
Done at Washington, DC on March 1, 2011.
Alfred V. Almanza,
[FR Doc. 2011-4902 Filed 3-1-11; 4:15 pm]
BILLING CODE 3410-DM-P