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May 16, 2006

Docket Clerk,

U.S. Department of Agriculture

Food Safety and Inspection Service

300 12th Street, SW.,

Room 102 Cotton Annex,

Washington, DC 20250

> Re: Docket No. 04-026N

*Federal Register* Monday, February 27, 2006

Vol. 71, No. 38

Pages 9772-9777

Gentlemen:

On behalf of National Meat Association (NMA) members we respectfully
submit comments in response to the Food Safety Inspection Service
request regarding the *Federal Register* Notice entitled "*Salmonella*
Verification Sample Result Reporting: Agency Policy and Use in Public
Health Protection"

NMA, organized in 1946, represents the interest of meat packers and
processors throughout the United States. Our general membership is
approximately 300 members of which 85% are beef slaughters and beef
grinders strongly committed to enhancing the safety of meat and poultry.
In this regard, we support the Food Safety and Inspection Service's
(FSIS) efforts to work with all interested parties in reducing the
*Salmonella* incidence rate. Our comments below are suggestions as to
how to improve the effectiveness of the policies articulated in the
Notice.

[Notification to Establishments of FSIS *Salmonella* Test
Results]{.underline}

FSIS will apprise establishments as the individual test results become
available -- currently, establishments have to wait until the end of the
sampling set to receive results.

Docket Clerk,

U.S. Department of Agriculture

Food Safety and Inspection Service

300 12th Street, SW.,

Room 102 Cotton Annex,

Washington, DC 20250

NMA supports providing such information during the sampling set as it
will provide "real-time" feedback to an establishment as to its
performance. This, in turn, could enable an establishment to fine tune
its process, if necessary, in the event positive findings are reported.

We do have one additional comment concerning this topic. In the Notice,
FSIS indicates that by sharing the data during the set, the individual
establishment's completed set results will no longer be exempt from
disclosure under the Freedom of Information Act (FOIA). We respectfully
disagree with this position. As we understand FSIS' justification for
why completed set results are currently exempt from FOIA disclosure, it
is because these results are "pre-decisional." It seems to us that if
the completed sets are pre-decisional and remain so now, even if shared
with the establishment, sharing the underlying individual results should
not and could not alter the pre-decisional nature of the set results.
Therefore the completed sets (as well as the individual results) would
remain exempt from FOIA disclosure.

[Publication of FSIS *Salmonella* Data]{.underline}

FSIS will now publish its *Salmonella* test results on a quarterly
basis, as opposed to yearly. NMA supports this increased frequency of
reporting, but requests that FSIS not make any comparisons to previous
yearly results to avoid any misunderstandings.

[Classification of Establishment Based on Agency Sample
Results]{.underline}

FSIS will establish three categories of establishments and take varying
enforcement actions based on the establishment's classification:

-   Category 1: Consistent Process Control -- An incidence rate of 50%
    or less of the performance standard/baseline guidance.

-   Category 2: Variable Process Control -- An incidence rate from 51%
    to 100% of the performance standard/baseline guidance.

-   Category 3: Highly Variable Process Control -- An incidence rate
    greater than the performance standard/baseline guidance.

The agency will move away from a once per year sample set for all
establishments and adjust frequency based on the test results.

Docket Clerk,

U.S. Department of Agriculture

Food Safety and Inspection Service

300 12th Street, SW.,

Room 102 Cotton Annex,

Washington, DC 20250

Although NMA supports FSIS' intent to focus its resources based on an
establishment's objective performance, a strict application of these
classifications to the beef industry may be excessive given

the low performance standards in terms of the number of positives per
set and the inherent variation in any sampling program. For example, the
ground beef standard is 5 per 53 sample set. Using 50% of the standard
as the level of "consistent process control" means that a beef grinder
would be deemed to lack process control if it had more than 2 positives
in the sample set. It becomes even more extreme for steers and heifers
where the Performance Standard is 1 per 83 sample set. In this case, it
is impossible to be at 50% of the standard.

Based on this, we would respectfully suggest that in the case of
standards which are already low, the agency should exercise discretion
rather than automatically increasing *Salmonella* sampling (and
scheduling Food Safety Assessments) at establishments that are only
marginally over the 50% enforcement standard, absent specific cause.[^1]
In addition, we would respectfully request that FSIS articulate the
factors it would use in allocating resources based on an establishment's
category. This would ensure more transparency in allocating resources.

We do wish to emphasize that the above concern is not based on any
apprehension that our members have in routinely meeting the *Salmonella*
Performance Standard. We are proud of the reduction in *Salmonella*
since the standard was first initiated. Indeed, based on FSIS ground
beef data, the reduction has not only been impressive, it has been
consistent.

  ---------- ------ ------- ------- ------- ------- ------- ------- -------
  Year       1998   1999    2000    2001    2002    2003    2004    2005

  \%         6.4%   4.34%   3.29%   2.83%   2.55%   1.68%   1.63%   1.12%
  Positive                                                          
  ---------- ------ ------- ------- ------- ------- ------- ------- -------

The rates for cow/bull and steer/heifer have likewise demonstrated the
industry's control as measured by the performance standard.

[Serotyping Positive Samples]{.underline}

FSIS will provide establishment with the serotype of any positive
shortly after the positive result is first reported. Additionally, the
cumulative serotype data will be posted on an annual basis. NMA supports
the sharing of serotype results with the establishment and the annual
publication of the results.

Docket Clerk,

U.S. Department of Agriculture

Food Safety and Inspection Service

300 12th Street, SW.,

Room 102 Cotton Annex,

Washington, DC 20250

[Sub-Typing *Salmonella* Positives]{.underline}

FSIS will sub-type *Salmonella* positives and also assess phage-typing.

NMA supports FSIS continuing to conduct sub-typing activities. However,
as we understand the science, there is some question as to whether pulse
field gel electrophoreses (PFGE) is appropriate for *Salmonella*
sub-typing. Instead, phage-typing seems to provide more reliable/useable
information. We respectfully suggest that FSIS explore the merits of
both methods and not take any precipitous action based on one until the
best method is established.

On a related matter, we understand FSIS has and will continue focusing
on a particular establishment if there is a foodborne outbreak and the
epidemiological and laboratory evidence lead to that establishment. It
would seem appropriate for FSIS to provide some formal articulation of
its current thinking so that all establishments can understand, in
advance of a crisis, the agency's policy. This articulation would
further the goal of transparency in regulatory investigations and
possible enforcement.

[Conclusion]{.underline}

We appreciate the opportunity to submit comments on the agency's
*Salmonella* Notice. As always, NMA looks forward to working with FSIS
to further enhance food safety.

Sincerely,

Rosemary Mucklow Ken Mastracchio

Executive Director Associate Director

[^1]: ^\*^ We recognize that FSIS noted that "the slaughter and
    slaughter/processing combination plants are the Agency's first
    concern, but policy for grinders will be assessed during that year
    as well." That being said, we also would respectfully request
    additional clarification so that this priority is uniformly applied
    to all establishments.