[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
[email protected].
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
[[Page 30300]]
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
[[Page 30301]]
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
[[Page 30302]]
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