Docket No. FSIS-2009-0020

[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11752-11755]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4902]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2009-0020]

Australia's Meat Safety Enhancement Program; Notice of
Affirmation of Equivalence Decision

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of affirmation of equivalence decision.

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SUMMARY: 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.

DATES: The Agency must receive comments by April 4, 2011.

ADDRESSES: 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.

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.

SUPPLEMENTARY INFORMATION:

Background

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 Sec. 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

[[Page 11753]]

products 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

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/cm\2\).
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

[[Page 11754]]

establishments 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

Phase 1
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.

Microbiological Sampling

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/cm\2\) 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.

Microbiological Sampling

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/cm\2\.
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

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MSEP 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.

FSIS Conclusions

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.

Done at Washington, DC on March 1, 2011.
Alfred V. Almanza,
Administrator.
[FR Doc. 2011-4902 Filed 3-1-11; 4:15 pm]
BILLING CODE 3410-DM-P