99-14253. Australia's Meat Safety Enhancement Program (MSEP)  

  • [Federal Register Volume 64, Number 108 (Monday, June 7, 1999)]
    [Notices]
    [Pages 30299-30303]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-14253]
    
    
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    DEPARTMENT OF AGRICULTURE
    
    Food Safety and Inspection Service
    [Docket No. 99-026N]
    
    
    Australia's Meat Safety Enhancement Program (MSEP)
    
    AGENCY: Food Safety and Inspection Service, USDA.
    
    ACTION: Notice of equivalence decision.
    
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    SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
    its decision that the Australian Quarantine and Inspection Service's 
    (AQIS) Meat Safety Enhancement Program (MSEP) for slaughter inspection 
    in establishments that slaughter meat for export to the United States: 
    (1) Meets all requirements of U.S. law for the import of product to the 
    United States; (2) provides the same level of public health protection 
    as U.S. domestic slaughter inspection; and, (3) is therefore 
    equivalent. The Agency will review its equivalence decision when AQIS 
    completes the MSEP field trials and prepares a report for FSIS review. 
    In the interim, Australian establishments that participate in the MSEP 
    field trials may ship product to the United States.
    
    ADDRESSES: Copies of the MSEP document are available from the FSIS 
    Docket Clerk, Room 102 Cotton Annex, 300 12th Street, SW, Washington, 
    DC 20250-3700. A copy may also be obtained from the Australian 
    Quarantine and Inspection Service homepage at http://www.dpie.gov.au/
    aqis/homepage. 
        A transcript of the public meeting is available for review by the 
    public in the FSIS Docket Room.
    
    FOR FURTHER INFORMATION CONTACT: Mr. Mark Manis, Director, 
    International Policy Division; Office of Policy, Program Development, 
    and Evaluation; (202) 720-6400; or by electronic mail to 
    mark.manis@usda.gov.
    
    SUPPLEMENTARY INFORMATION:
    
    Background
    
        FSIS published a notice in the Federal Register on January 15, 1999 
    (64 FR 2621) announcing the availability of a document prepared by AQIS 
    that sets forth AQIS's plan to conduct field trials of the MSEP--a new 
    slaughter inspection system. Australia sought the concurrence of the 
    United States in order to continue meat exports to this country from 
    plants that participate in a pilot test of MSEP. FSIS requested 
    comments on the document that the public could submit in writing or at 
    a public meeting.
    
    Public Comments
    
        FSIS held a public meeting on February 3, 1999, to discuss the MSEP 
    program and hear public comments. At this meeting, AQIS presented its 
    program and responded to concerns raised by attendees.
        Most of the written comments expressed opposition to MSEP 
    equivalence.
        Those in favor pointed out that the MSEP proposal resolves issues 
    raised in November 1997 when FSIS informed AQIS that Project 2 (an 
    earlier version of MSEP) was not equivalent because it did not provide 
    an adequate form or intensity of Federal oversight. Favorable comments 
    also cited the AQIS commitment to station a Government inspector on 
    each slaughter line at a point between carcass trimming and final rinse 
    for 100% verification that zero-fecal and other defect requirements 
    have been met.
        Those opposed to MSEP equivalence raised various issues that are 
    discussed in the following sections. Responses provided by AQIS are 
    included in this discussion.
        1. Several comments expressed concerns about an increase in cases 
    of Salmonellosis reported in Australia during 1996 and 1997. These 
    cases were said to reflect problems in the Australian domestic meat 
    inspection system, which is similar to MSEP. AQIS responds to this 
    issue as follows:
    
        A Communicable Infectious Diseases report of the Australian 
    Department of Health and Aged Care on Salmonella cases in Victoria 
    showed that the main recent outbreaks were attributable to Italian-
    style ice cream, peanut butter, mayonnaise and processed meat 
    products. There was no data indicating an association of cases with 
    raw meat coming from abattoirs. Conclusions from the report indicate 
    that `gross errors in food handling and mishandling by consumers' 
    were the principal contributing factors.
        It was indicated that the `high success rate in tracking the 
    sources of outbreaks, and the associated publicity, probably led to 
    more testing and more reporting of outbreaks which may previously 
    have gone unreported.'
        A recent baseline study conducted on Australian export beef 
    (1996) demonstrated that the incidence of Salmonella on carcases was 
    0.4%. Approximately 17 years ago a similar survey demonstrated that 
    the incidence was 2.0%. The results of the 1996 baseline survey 
    suggests that there has been a five-fold improvement in the 
    reduction of Salmonella on Australian beef. The general prevalence 
    of Salmonellosis world wide has increased, as it has in Australia, 
    but it can be attributed to better testing and reporting in general, 
    and in the case of Australia, to items such as peanuts, coleslaw, 
    eggs, etc. Testing so far for Salmonella in the context of Pathogen 
    Reduction/HACCP implementation in the Australian export meat plants 
    has revealed a 0.05% positive isolation rate from beef carcases.
    
        FSIS notes that comments about domestic foodborne illness rates in 
    Australia do not relate directly to MSEP equivalence or the equivalence 
    of Australian plants certified for export to the United States. AQIS 
    has implemented the same or equivalent Pathogen Reduction/Hazard 
    Analysis Critical Control Point (HACCP) final rule microbial testing 
    programs in all U.S.-certified Australian plants. Additionally, AQIS 
    has collected baseline Salmonella data and other microbial data which 
    indicate that the one plant presently proposed for MSEP pilot testing 
    produces very clean product under traditional inspection. These data 
    will be applied as performance standards during subsequent field trials 
    while the trial plant operates under MSEP. AQIS will hold this plant 
    responsible for attaining the same or better microbiological results 
    under MSEP than it achieved under traditional inspection. As other 
    Australian export plants qualify for MSEP, AQIS and FSIS will review 
    their baseline to ensure that appropriate microbial performance 
    standards are applied.
        2. Some commenters expressed concerns about what activities 
    constitute Government inspection under MSEP. AQIS responds as follows:
    
        Government inspection under MSEP comprises all of the following 
    activities and responsibilities outlined in the appropriate 
    Australian Federal Government legislation (The Export Control Act 
    and associated Export Meat Orders). These activities and 
    responsibilities include: Facilities and site standards of 
    construction, hygiene etc, fit and proper person clearance of 
    company principals, operational process control, ante and post 
    mortem verification and oversight, disposition and control, full 
    time government veterinary officer oversight, 100% verification for 
    zero fecal contamination by a government meat inspector stationed at 
    the end of the slaughter line, microbiological verification (ESAM 
    program), macroscopic verification (Meat Hygiene Assessment), 
    government approved HACCP/QA system and, government certification.
    
        FSIS notes that the AQIS proposal details qualification 
    requirements for establishments that apply for MSEP participation and 
    delineates activities
    
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    that AQIS will perform to ensure product wholesomeness and safety. The 
    AQIS mark of inspection will be applied in MSEP plants to product that 
    is handled, processed and stored in a manner that fully complies with 
    AQIS Export Meat Orders and import requirements of the United States. 
    AQIS will provide additional MSEP inspection controls as follows: (1) 
    The AQIS meat inspector will be stationed on the line in cattle 
    slaughter plants at a point before final wash; (2) final trimming will 
    be under the supervision of the AQIS meat inspector; (3) the AQIS 
    inspector will perform a verification for zero-fecal and other carcass 
    defects on each carcass before final wash; (4) carcass defect data will 
    be collected at this point on the line under the Meat Hygiene 
    Assessment (MHA) program; and (5) the in-plant veterinarian will 
    perform ante-mortem sampling, some verification activities, and 
    oversight functions on the entire slaughter line.
        Thus, AQIS inspection under MSEP will combine direct oversight of 
    company employee functions combined with carcass-by-carcass 
    verification that plant HACCP/Quality Assurance (QA) systems provide 
    safe and wholesome product.
        3. Several commenters questioned why AQIS has not provided baseline 
    data for other plants that will participate in MSEP field trials. AQIS 
    responds as follows:
    
        In 1996/97 five plants were selected for inclusion in the 
    proposed Project 2 pilot trial. Over the course of the collaborative 
    development and evolution of the Project 2 model to the MSEP model, 
    the number of eligible plants has been reduced now to one. This 
    plant is a beef processing plant at Rockdale, NSW. One of the 
    original selected plants dropped out due to the untimely death of 
    the plant's QA manager. Two others wished to retain their EU listing 
    so therefore do not qualify for inclusion in MSEP at this point of 
    time. The other plant does not presently meet the AQIS pre-requisite 
    requirements.
        AQIS intends to bring this and other plants into the trial, once 
    all pre-requisite conditions have been met, including collection of 
    baseline data and prior consultation with FSIS.
        Initial `before' data as outlined in the original Project 2 plan 
    has been collected from these plants. But because only one of the 
    plants progressed to the MSEP stage--benchmark or performance 
    standard MSEP data is not available from any other Australian plant.
    
        4. Some commenters suggest that MSEP cannot be found equivalent 
    because AQIS presented no data proving it provides results equal to or 
    better than traditional inspection. AQIS responds as follows:
    
        MSEP has not yet been implemented. One plant has been selected 
    for initial inclusion in MSEP. Performance standard data has been 
    collected from this plant. This has included both macroscopic and 
    microbiological data for product along with an objective measure of 
    process conformance and individual government meat inspection 
    effectiveness.
    
        FSIS notes that AQIS cannot implement MSEP until FSIS agrees to 
    accept meat from trial establishments. One purpose of MSEP field trials 
    is to establish whether company employees achieve the same or better 
    results under AQIS oversight and verification as were achieved by 
    Government inspectors under traditional inspection. Nonetheless, FSIS 
    concludes that MSEP is equivalent because it 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.
        5. Several commenters cited the 1998 European Union (EU) audit of 
    Australia's export meat inspection system as evidence that AQIS 
    controls are not fully effective. AQIS responds as follows:
    
        The EU review of Australian meat export meat establishments, 
    which took place in March and April 1998, raised some concerns in 
    the minds of the EU reviewers. These concerns did not relate to food 
    safety or sanitation but highlighted operational and 
    interpretational differences between European requirements and the 
    Australian system, which have been operating for many years with EU 
    concurrence.
        Following high level consultations between senior Australian and 
    EU officials in Brussels in October 1998, the EU has accepted 
    assurances provided by Australia. The conclusions of the October 
    1998 meeting were viewed positively by both the EU and Australian 
    officials.
    
        FSIS notes that in the February 3 public meeting, AQIS fielded 
    similar comments and explained that Australia and the EU had reached an 
    agreement that preserved Australia's export listing. AQIS made it clear 
    that it did not concur with some EU findings and had presented a 
    vigorous defense of its program that resulted in an agreement of 
    equivalence. In order to allay any lingering EU concerns, AQIS invited 
    the EU to conduct a follow-up audit in 1999 for verification that all 
    aspects of the equivalence agreement have been implemented. In May 
    1999, FSIS will also visit Australia to conduct a full audit of the 
    Australian export meat inspection system. The Agency will make the 
    results of that audit public.
        6. Several commenters, including the Community and Public Sector 
    Union (CPSU) that represents Australian Government meat inspectors, 
    allege that AQIS has misrepresented union support for MSEP. They 
    contend that CPSU has made its opposition to MSEP clear. AQIS responds 
    as follows:
    
        The Australian Council of Trade Unions (ACTU), the national peak 
    body representing Australian workers, has formally endorsed the 
    introduction of Quality Assurance systems into the Australian meat 
    industry, along with systems to further enhance the safety of 
    Australian meat. It further endorses the technical and structural 
    reform processes currently under way in Australia.
        The Community and Public Sector Union (CPSU) representing meat 
    inspectors was originally invited to participate in a Steering 
    Committee oversighting the MSEP, but withdrew because of the 
    potential impact upon government meat inspector numbers.
    
        FSIS notes that the MSEP proposal does not contain a claim that 
    CPSU or its union inspectors are MSEP supporters. Under the section 
    titled Australia's ``Commitment to Food Safety,'' AQIS states in 
    paragraphs 2 and 3:
    
        To further enhance this commitment the Prime Minister of 
    Australia established a comprehensive Food Regulation Review in 
    1997. This review is examining ways to enhance the effectiveness and 
    efficiency of food regulatory arrangements. Further to this review, 
    the Australian Food Council has established a National Safe Food 
    System in association with the Australia New Zealand Food Authority 
    (ANZFA) to develop a coordinated, practical and effective food 
    hygiene system centred on the Food Hygiene Standard and 
    complementary AQIS regulations.
        The union movement in Australia is firmly behind these 
    initiatives. The Australian food industry has formalised an 
    agreement with the Australian Council of Trade Unions (ACTU)--the 
    Australian peak union body, on ways to introduce HACCP to Australian 
    food enterprises.
    
        The statement about union support in paragraph 3 relates to 
    Australian government initiatives enumerated in paragraph 2. In 
    Attachment A to the MSEP proposal, AQIS provides a joint statement 
    between the Australian Food Council and the Australian Council of Trade 
    Unions pledging support for food safety reforms. MSEP is not a 
    component of those reforms.
        7. Some concern was expressed about the role of the AQIS inspector 
    who will be doing 100% carcass-by-carcass verification inspection at a 
    point in the slaughter line between carcass trimming and final rinse. 
    One concern was how this inspector could perform that function as well 
    as oversee company employees, especially in multi-line plants. AQIS 
    responds as follows:
    
        Government MSEP verification inspection in multi-line plants 
    under MSEP will involve
    
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    carcase by carcase inspection by a government meat inspector; one 
    AQIS inspector per slaughter line. Australia does not have any 
    single species, multi-line plants but has 27 plants listed for the 
    US which process different species. For example, a slaughter plant 
    operating under MSEP and processing cattle and sheep for the US 
    market would have one inspector stationed at the end of the beef 
    slaughter line and another inspector stationed at the end of the 
    lamb/mutton slaughter line, each inspector carrying out verification 
    inspection of every carcase.
    
        FSIS notes that the amended AQIS proposal indicates that the 
    verification inspector will operate at a fixed point on the slaughter 
    line, while the AQIS veterinarian will conduct oversight of company 
    employees.
        8. An additional comment was submitted by the Government 
    Accountability Project (GAP) on March 31, 1999. This comment listed ten 
    allegations GAP has received from what it termed ``Australian 
    whistleblowers.'' Although this letter was received after the comment 
    period closed, FSIS considered it in the spirit of transparency that 
    underlies each equivalence decision that the Agency makes. The 
    allegations are summarized as follows:
    
        (1) Lots sampled were not representative of the day's 
    production.
        (2) Sample sizes were not consistent.
        (3) Corrective action on failures discovered in the morning 
    sample was delayed until collection of afternoon data and averaging 
    of both results, which meant that violations discovered at the 
    beginning of production continued unabated.
        (4) Sample collection times were not consistent, and were 
    manipulated to avoid exposure of defects. In particular, the timing 
    was tailored as a handicap for afternoon ``improvements'' that would 
    neutralize particular morning failures prior to averaging the day's 
    final results.
        (5) AQIS was not expanding the scope of sampling after discovery 
    of excessive violations, because industry promises to conduct 
    carcass specific corrective action changed results from ``fail'' to 
    ``pass.''
        (6) Due to a shortage of government personnel, controls through 
    ``Check the Checker'' AQIS sampling did not begin until mid day to 
    verify the accuracy of industry data. This essentially left the 
    industry on an honor system for morning results.
        (7) For data which AQIS personnel could check in a timely 
    manner, government inspectors and vets found over twice as many 
    defects as reflected in industry records.
        (8) Data underlying the MHA report was not statistically 
    significant, because collection was not genuinely random and there 
    were only two collections daily--inadequate due to inconsistencies 
    in number of samples per lot and number of lots per day that were 
    monitored.
        (9) MSEP will mean the functional elimination of government 
    process monitoring.
        (10) The commitment to a final fecal inspection outpost is only 
    an interim measure that AQIS already has announced may be withdrawn 
    if approved by ``overseas authorities.''
    
        FSIS interprets allegations one through eight as pertaining to AQIS 
    baseline data collections that were conducted in the one Australian 
    establishment presently participating in MSEP field trials. Mr. Brian 
    Macdonald, Director, Meat Inspection Division, responded for AQIS to 
    these eight allegations as follows:
    
        From the construction of Questions 1-8 it would appear that the 
    GAP's information relates to the implementation of the Meat Hygiene 
    Assessment (MHA) program at the Rockdale Plant in a general sense. 
    This has led to a questioning of the validity of the six-month data 
    set presented at the public meeting on February 3.
        While some of the wording suggests the information received 
    relates to activity on a specific day the following comments assume 
    their concerns relate to on-going performances.
        Question 1. The MHA system requires lots to be determined by the 
    carcase identification system, that is, a lot is a group of animals 
    with the same tailtag (a property of origin alphanumeric identifier 
    tag). A lot may represent the entire production for a shift, or any 
    part thereof. It is recommended that wherever possible the selection 
    of samples be randomised. The Veterinary Officers in Charge (VOIC) 
    at the plant have indicated that the correct procedure is followed 
    at Rockdale. The official AQIS policy for MHA operation across the 
    export meat inspection program is random selection of carcases where 
    possible.
        Question 2. MHA sampling rates are appropriate and have been 
    determined from the statistically validated Australian Standards 
    1199-1988, Sampling Procedures and Tables for Inspection by 
    Attributes. The sampling rate is based on the number of animals in a 
    lot and it has been confirmed with the AQIS VOICs that the sampling 
    rate is consistent with the MHA document.
        Question 3. Under MHA the sampling frequency and corrective 
    action are clearly stated. Rockdale sources the majority of animals 
    from an adjacent feedlot. For MHA purposes an entire day's 
    production may be treated as a single lot. Thus animals slaughtered 
    early in the day and late in the day may form a single lot for 
    monitoring purposes. There is therefore, nothing of a sinister 
    nature in the information that may have been passed to GAP.
        This is not to say that appropriate corrective action was not 
    taken immediately upon finding there had been a violation. Defects 
    on product are required to be removed at the time they are 
    identified by trimming. Also, assessment of procedures may require a 
    delay in implementation of a definitive corrective action to assess 
    if the issue is related to human error or procedural error. AQIS 
    staff on the establishment concerned have been and will continue to 
    exercise their regulatory responsibilities in this regard.
        Question 4. As you can appreciate it is very difficult to 
    respond to this allegation without further supporting evidence. 
    Sampling times are supposed to vary as it is desirable that they do 
    so to remove predictability from the system--employees would quickly 
    learn when they are being monitored or are scheduled to be 
    monitored, which would negate the value of the monitoring.
        Monitoring is primarily a company responsibility and is thus one 
    of a number of tasks that company employees carry out during their 
    day. It is recommended in the MHA that ``the selection of samples be 
    as random as possible'' therefore if sample selection times were 
    consistent AQIS would be concerned that manipulation was at risk of 
    taking place. In addition, independent monitoring is carried out by 
    AQIS and any significant deviation in results between company and 
    AQIS monitoring is followed up by AQIS as the regulatory authority. 
    The AQIS VOICs have indicated there is no evidence of manipulation.
        The point of afternoon improvements used to neutralise morning 
    failures is also opposite to all practical findings on the issue of 
    production line manufacturing efficiencies. Most process workers 
    will perform well in the morning when they are fresh and will 
    deteriorate over time due to mental and physical fatigue. There are 
    many studies that substantiate that defects are more likely to occur 
    toward the end of a shift than in the beginning of the shift, unless 
    the operators are dealing with new procedures.
        Question 5. Under the MHA there is a defined protocol for the 
    changing of sampling intensity depending on the number of 
    consecutive unacceptable or marginal defects identified by the 
    company at monitoring, and AQIS on-plant staff have the 
    responsibility to ensure the company complies with the MHA sampling 
    parameters.
        The VOICs have confirmed that where consecutive unacceptable or 
    marginal defects are identified the intensity of monitoring as 
    required in the MHA documentation is being implemented.
        However, where a company has an MSQA in place and is monitoring 
    a CCP on the processing floor, a violation of the CCP will not be 
    subject to the MHA requirements. Such a violation will be subject to 
    the specific corrective actions identified in the HACCP plan, and 
    must be immediate since a CCP relates specifically to food safety 
    issues. AQIS on-plant staff again are responsible for ensuring the 
    company complies with its HACCP plan.
        Question 6. The MHA system requires AQIS to perform check the 
    checker monitoring on a twice weekly basis. It is not correct to 
    conclude that at all other times industry is left to its own 
    devices. Full-time AQIS inspection presence is provided at every US-
    listed abattoir, otherwise the establishment simply does not operate 
    for the day.
        Randomised AQIS monitoring may well mean that a check was not 
    conducted in the morning. The aim of the AQIS process is to ensure 
    that the company is not likely to know when check the checker 
    process will occur during a shift or during the week. However there 
    is an equal likelihood that any
    
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    part of a production shift will be subjected to an AQIS verification 
    check consistent with well established quality management 
    principles.
        Question 7. It is possible that government officials may have 
    found twice the number of defects as recorded by industry. Such 
    isolated instances might occur, for example where the company was 
    training new personnel. The important point to recognise is that 
    such differences are not systemically or persistently tolerated. 
    Where differences are found in MHA recording results, AQIS requires 
    the company to institute an appropriate corrective plan to bring the 
    monitoring into conformity with standards. This is the purpose of 
    having the AQIS verification checks.
        The AQIS VOICs have confirmed that where their monitoring finds 
    differential recording of defects action is being taken by bringing 
    the matter to the attention of management and implementing a 
    documented corrective action plan.
        AQIS plant records and other reviews and checks indicate that 
    not only is the MHA system working satisfactorily at Rockdale but 
    that the cleanliness and health of the product is consistently of a 
    very high order.
        Question 8. These comments have been addressed already and are 
    summarised as follows:
         Samples are required to be selected at random wherever 
    possible
         A lot is determined by animals carrying the same 
    tailtag
         Sampling rates will be determined by the size of the 
    lot and are based on the Australian Standard 1199-1988
         Lots monitored may represent the entire production of 
    the shift or part thereof.
        Specifically for the Rockdale plant, FSIS's experience of 
    imported product does not bear out the allegations made in GAP's 
    letter alleging ``exposure to food poisoning threats.'' The U.S. 
    rejection data for the establishment from which the empirical data 
    was presented at the public meeting confirms the programs AQIS has 
    implemented are working and sustained. In the last 12 months 
    Rockdale Beef has presented more than 1.5 million pounds of product 
    to US port-of-entry inspection with no rejections for contamination 
    or pathology.
        The response outlined above is specific to the Rockdale plant. 
    If GAP has specific allegations relating to the inappropriate 
    operation of MHA at other Australian plants, AQIS would welcome 
    receiving that advice so that the necessary action can be taken.
    
        Allegations nine and ten presented by GAP concern AQIS' intentions 
    for government oversight of establishments that participate in the MSEP 
    pilot program. AQIS responded as follows:
    
        Question 9. GAP has cited a meeting summary prepared by the meat 
    inspectors union of discussions to explain progress with the MSEP 
    proposal. The context of these discussions was negotiations for a 
    new labour agreement involving an increase in meat inspector 
    remuneration. The discussion on MSEP was an adjunct to this main 
    purpose. Nevertheless it is not an unreasonable reflection of what 
    was conveyed to the union. But, it in no way contradicts my 
    statements and undertakings given at the public hearing on 3 
    February.
        Australia has sought an equivalency decision from the United 
    States on the basis of retaining an inspector at the end of the 
    slaughter line who will undertake carcase by carcase inspection of 
    all product. This was made clear at the public hearing and remains 
    the proposal for which Australia is seeking equivalence. No other 
    arrangement is contemplated for US listed plants.
        GAP suggests that this is breaking a prior commitment for a 
    government slaughter floor inspector to monitor process controls and 
    respond to breaking problems. This was not part of the proposal 
    presented at the public hearing on 3 February. In my [Mr. 
    Macdonald's] presentation I indicated AQIS's slaughter floor 
    presence would be in two parts. First, the AQIS VOIC would undertake 
    oversight and verification activities at a range of designated 
    points in the production process. In the material presented, these 
    points were identified and the verification frequencies quantified. 
    Secondly, an AQIS meat inspector would undertake carcase by carcase 
    inspection of all production after the final trim and before the 
    final wash. Qualified company employees would perform sorting 
    activities within the confines of this arrangement. This was all 
    made very clear in my presentation and will be implemented precisely 
    at trial plants.
        Question 10. The reference in the AQIS/union meeting record to 
    the removal of the final AQIS inspection point needs to be put in 
    context. At that point in the meeting, the discussions were 
    comparing AQIS's presence in MSEP trials at non-US listed plants and 
    US listed plants. AQIS was asked if at some time in the future MSEP 
    could be modified to reflect the current arrangements in non-US 
    listed plants where there is no final carcase by carcase AQIS 
    inspection. This outcome was recognised as a possibility. You might 
    note that AQIS officials modified the union prepared draft to 
    clearly indicate that this was not something which Australia would 
    do unilaterally and would be subject to further approval from US 
    authorities.
        However, the comment is irrelevant. The commitment to carcase by 
    carcase inspection is a fundamental feature of Australia's request 
    for an equivalency determination from the United States. It will 
    remain part of the Australian system for US listed plants.
    
        FSIS notes that AQIS clearly presented the details of their MSEP 
    proposal in the February 3 public meeting and has in no way modified 
    them since that meeting. AQIS responded to the other issues raised in 
    the GAP letter, as follows:
    
        The GAP also raised two other issues. The first concerned 
    reduction in the number of inspection staff in the Australian meat 
    inspection program. It was suggested that this was being driven by 
    the Australian Government's policy of full cost recovery for meat 
    inspection services.
        Inspectors have only been removed where there has been no impact 
    on mandatory import country requirements and on food safety, which 
    remains the fundamental imperative of the Australian meat inspection 
    program. Due to historical reasons the AQIS meat inspection program 
    was grossly over staffed, work practices delivered extremely poor 
    productivity and there was institutionalised manipulation of working 
    arrangements to maximise payments such as travel allowance, overtime 
    and penalty payments. It is these elements that have been 
    eliminated. All elements related to public health requirements have 
    been continued and, indeed, reinforced where necessary. It is 
    interesting to note that the reduction in inspector numbers has 
    coincided with an improvement in the Australian performance at US 
    port of entry testing. You may recall that I provided this data in 
    my presentation at the public hearing on 3 February.
        AQIS does not regard the additional costs imposed on industry by 
    MSEP as a negative factor. MSEP requires a significant commitment by 
    industry to quality systems and good manufacturing practice. 
    Australian industry knows that such commitments are necessary to 
    maintain markets in a world concerned with food safety and quality 
    products. They are prepared to pay the price.
        The extra costs are not a reason why only one plant is ready to 
    proceed on the trial at this point in time. As I explained at the 
    public hearing, one plant, which is not US listed, did not continue 
    with the development of the necessary systems due to the untimely 
    death of a young woman who was implementing MSEP at that plant. The 
    establishment was a small family business and the young woman was an 
    intimate family relative. Her death had far reaching implications 
    for that company in the circumstances.
        Two other plants could join the trial immediately but are also 
    listed for the European Union where Australia has yet to achieve an 
    equivalency determination for MSEP. Both plants remain highly 
    committed to all of the quality systems developed for MSEP which are 
    in place and operating except for company sorting.
        The final plant delayed implementation of MSEP in the light of 
    the delays occurring in securing an equivalency decision from the 
    United States. Company management has informed me they will now join 
    the trial when an equivalency decision is announced.
        Finally, GAP raised the findings of a review by the European 
    Commission of Australian export meat plants in March 1998. Australia 
    does not accept many of the findings of the European Commission 
    review, which did not look at food safety issues. Rather it examined 
    Australia's conformance with European Union legislation and where 
    this did not occur in detail drew conclusions about confidence in 
    the Australian system. In our view there is a very large gap between 
    the strict letter of European Union law and food safety outcomes. 
    The former does not guarantee the latter.
        At the public hearing on 3 February I invited US consumers to 
    calibrate the judgements of the European Commission reviewer against 
    the food safety outcomes being secured by Australia at US port-of-
    entry testing. I would ask you to continue to do so in any further 
    consideration of the Australian request for equivalency.
    
    [[Page 30303]]
    
        In conclusion, there has been no manipulation of the data 
    presented at the public hearing in Washington on 3 February. 
    Implementation of the trial will proceed precisely as explained at 
    that public hearing should the United States grant equivalence to 
    our proposal.
    
        In subsequent communications, AQIS further clarified MHA random 
    sampling as the ``recommended'' procedure but acknowledged that 
    ``random'' often means ``unpredictable'' rather than statistically 
    random. It emphasized that MHA sampling is conducted by quality control 
    personnel, and that production personnel have no prior knowledge or 
    influence over when or how sampling occurs.
        AQIS also clarified two additional issues. One is the U.S. 
    reinspection record of the Rockdale establishment. It stated that 
    during the period from April 1998 to March 1999, Rockdale exported 91 
    lots to the United States. Eighteen of these lots were identified for 
    further reinspection while seventy-three were checked only for 
    container integrity and labeling. As noted earlier in this notice, AQIS 
    reports that Rockdale had no product rejected for contamination or 
    pathology for the last 12 months.
        The second additional issue concerns Australian exports to the 
    European Union. AQIS reported that no interruptions of trade have 
    occurred as a result of its disagreement with the EU over the March 
    1998 audit results. For example, AQIS reported that from January 1999 
    through April 1999, Australian establishments have shipped to EU 
    countries 4,220 tonnes of beef, 7,608 tonnes of sheep and lamb, 1,177 
    tonnes of horse meat, and 51 tonnes of goat meat.
        FSIS notes that AQIS has consistently provided immediate, 
    comprehensive and credible responses to all questions that FSIS has 
    raised about MSEP and to issues raised in public comments.
    
    Finding of Equivalence
    
        The World Trade Organization (WTO) Agreement on Sanitary and 
    Phytosanitary measures (commonly referred to as the ``SPS Agreement'') 
    obliges the United States to respond to requests by other contracting 
    parties to establish the equivalence of specified meat and poultry 
    processing measures with those of the United States.
        The Australian Government formally requested that the United States 
    make an equivalence determination regarding its Meat Safety Enhancement 
    Program to pilot-test a revised slaughter inspection system. FSIS has 
    reviewed the MSEP with particular emphasis on two criteria:
        (1) Does the MSEP meet all USDA requirements for the import of meat 
    and meat products to the United States?
        (2) Does the MSEP afford American consumers the same level of 
    public health protection provided by USDA domestic slaughter 
    inspection?
        In summary, FSIS finds that the MSEP meets these criteria because 
    MSEP will provide direct Federal oversight of Australian export 
    establishment slaughter operations and verification that all U.S. 
    safety and wholesomeness requirements have been met. FSIS further finds 
    that AQIS has satisfactorily addressed the comments and concerns raised 
    in the February 3, 1999 public meeting, the written comments presented 
    in response to the Federal Register notice of January 15, 1999, and all 
    subsequent comments.
        Consequently, FSIS has determined that the AQIS MSEP program (1) 
    meets all USDA requirements for import of meat and meat products to the 
    United States, (2) will afford American consumers the same level of 
    public health protection provided by USDA domestic slaughter 
    inspection, and (3) is therefore equivalent. Accordingly, AQIS-
    certified establishments that participate in the MSEP field trials may 
    ship meat and meat products to the United States.
        AQIS has advised FSIS that it will soon begin MSEP implementation 
    testing in one beef slaughter establishment and will initiate baseline 
    data collections in others as they qualify. AQIS has pledged to share 
    its baseline data with FSIS before the second and any subsequent 
    establishment begins implementation testing. FSIS will provide periodic 
    MSEP progress summaries through the Constituent Alert.
        FSIS will review this equivalence determination when AQIS completes 
    its MSEP field trials and prepares a report for FSIS review. FSIS will 
    announce the results of that review in the Federal Register. FSIS will 
    monitor MSEP field trials in the interim through discussions with AQIS 
    personnel, review of establishment baseline and implementation data, 
    periodic on-site audits, and continuous port of entry reinspection of 
    products shipped to the United States. A copy of the FSIS monitoring 
    plan may be obtained from Mr. Mark Manis at the address shown in FOR 
    FURTHER INFORMATION CONTACT at the beginning of this notice.
    
        Done at Washington, DC, on June 1, 1999.
    Thomas Billy,
    Administrator.
    [FR Doc. 99-14253 Filed 6-4-99; 8:45 am]
    BILLING CODE 3410-DM-P
    
    
    

Document Information

Published:
06/07/1999
Department:
Food Safety and Inspection Service
Entry Type:
Notice
Action:
Notice of equivalence decision.
Document Number:
99-14253
Pages:
30299-30303 (5 pages)
Docket Numbers:
Docket No. 99-026N
PDF File:
99-14253.pdf