[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 19952-19970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8408]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2005-0044]
Not Applying the Mark of Inspection Pending Certain Test Results
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice; Request for comment.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
its intention to change its procedures and withhold a determination as
to whether meat and poultry products are not adulterated, and thus
eligible to enter commerce, until all test results that bear on the
determination have been received. Inspection program personnel
periodically sample products for adulterants to verify an
establishment's regulatory compliance. The Agency's practice has been
to allow these products to bear the mark of inspection, and to enter
commerce, even though the test results have not been received. FSIS has
asked, but has not required, official establishments to maintain
control of products represented by a sample pending test results.
Because establishments, including official import inspection
[[Page 19953]]
establishments, are not consistently maintaining control of product,
despite FSIS's request that they do so, adulterated product is entering
commerce. Therefore, FSIS is announcing its tentative determination not
to apply the mark of inspection until negative results are available
and received for any testing for adulterants conducted by the Agency.
FSIS invites comments on this proposed change in policy and procedures.
FSIS will evaluate comments received in response to this notice. In a
subsequent Federal Register notice, FSIS will respond to the comments
it receives. FSIS will make any appropriate changes to the policy and
procedures based on comments, and in that subsequent Federal Register
notice will announce the effective date of the new policy.
DATES: The Agency must receive comments by July 11, 2011.
ADDRESSES: 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 diskettes or CD-ROMs, and hand-delivered or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture (USDA), FSIS, Room 2-2127, George Washington Carver Center,
5601 Sunnyside Avenue, Mailstop 5474, Beltsville, MD 20705-5474.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2006-0044. 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: For access to background documents or to comments received,
go to the FSIS Docket Room at the address listed above between 8:30
a.m. and 4:30 p.m., Monday through Friday.
All comments submitted in response to this proposal, as well as
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 8:30 a.m. and 4:30 p.m., Monday through
Friday.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Director, Policy
Issuances Division, Office of Policy and Program Development, FSIS,
U.S. Department of Agriculture, Room 6065, South Building, 1400
Independence Ave., SW., Washington, DC 20250-3700; telephone (202) 720-
0399; fax (202) 690-0486.
SUPPLEMENTARY INFORMATION:
Background
FSIS is responsible for protecting the nation's meat and poultry
supply by making sure that it is safe, wholesome, not adulterated, and
properly labeled and packaged. FSIS operates under authority provided
by the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and
the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) (the
Acts). These statutes prohibit anyone from selling, transporting,
offering for sale or transportation, or receiving for transportation in
commerce, any adulterated or misbranded meat or poultry products (21
U.S.C. 610 and 458).
There are nine parts to the definition of ``adulterated'' in the
FMIA and eight in the PPIA. Most relevant to product testing are
subparagraphs (1) and (2)(A) of 21 U.S.C. 601(m) and 453(g). 21 U.S.C.
601(m)(1) and 453(g)(1) provide that product is adulterated if it bears
or contains any poisonous or deleterious substance that may render it
injurious to health. Therefore, a ready-to-eat meat or poultry product
found positive for a pathogen, or a raw ground or other raw non-intact
beef product found positive for E. coli O157:H7, is adulterated under
these statutory provisions. In addition, if food contact surfaces are
found positive for Listeria monocytogenes, ready-to-eat product
produced on these surfaces is adulterated under 9 CFR 430.4(a). 21
U.S.C. 601(m)(2)(A) and 453(g)(2)(A) provide that a meat or poultry
product is adulterated if it bears or contains any added poisonous or
added deleterious substance by reason of administration of any
substance to the live animal. Therefore, if FSIS tests carcasses for
residues of animal drugs that have been administered to the live animal
and finds unacceptable levels, the product would be adulterated under
these statutory provisions. FSIS testing conducted for pathogens and
residues that would adulterate product under the provisions above are
the primary focus of the actions outlined in this notice.
In addition, the term ``adulterated'' includes product from which
any valuable constituent has been in whole or in part omitted or
abstracted; for which any substance has been substituted; or to which
any substance has been added or mixed or packed so as to increase its
bulk or weight, reduce its quality or strength, or make it appear
better or of greater value than it is (21 U.S.C. 601(m)(8) and
453(g)(8)). This type of adulteration is referred to as ``economic
adulteration''. FSIS testing that indicates product is economically
adulterated would be subject to the actions outlined in this document.
However, because FSIS conducts minimal testing for economic
adulteration, this notice does not elaborate on such testing.
The FMIA and PPIA also provide that meat and poultry products must
bear an official inspection legend (21 U.S.C. 601(n)(12) and
453(h)(12)) in order to enter commerce. FSIS must be able to determine
that product is not adulterated in order to apply the mark of
inspection (21 U.S.C. 606 and 457(a)). FSIS inspection personnel
conduct a range of activities to determine whether product is
adulterated (9 CFR 417.8). Among these activities is testing for
adulterants.
FSIS's practice is to allow meat and poultry products to be
packaged and labeled with the mark of inspection pending receipt of
results of tests done by FSIS. Currently, FSIS requests, but does not
require, that establishments maintain control of all product
represented by any samples taken until the Agency receives the results
of the sampling. Establishments are not required to maintain such
control and may ship product before test results are available. If the
establishment introduces the product into commerce, and the test result
for that product is positive for a pathogen or other adulterant, FSIS
will request that the establishment recall the product. If the
establishment refuses to recall the product, FSIS will move to detain
and, if necessary, seize it.
Reason for This Notice
The Agency has questioned for some time whether it should continue
to allow product to leave the establishment, albeit subject to a
recall, before relevant test results are received. On December 12,
2002, FSIS held a public meeting in Washington, DC, to both inform the
public about the recall process and to solicit recommendations on
recalls from establishments whose product is subject to recall, from
public health agencies, and from those who represent the public health
interests of consumers. The agenda for this meeting included a
discussion on withholding the decision to apply the mark of inspection
until FSIS test results are available. Presenters and commenters raised
concerns about the effect such a policy would have on small and very
small establishments. FSIS took these comments into account in the cost
[[Page 19954]]
benefit analysis of this policy discussed below.
On June 2-3, 2004, FSIS presented a subcommittee of the National
Advisory Committee on Meat and Poultry Inspection (NACMPI) with the
following question for discussion: Should FSIS delay a decision on
granting the mark of inspection to product that has been tested by FSIS
for the presence of an adulterant until it has received the results of
the testing? The committee made a number of recommendations to the
Agency but was unable to come to consensus on the question of not
applying the mark of inspection until FSIS verification test results
are available. The committee recommended that the Agency continue to
encourage plants to develop a plan for holding products when they are
sampled for adulterants. The committee further recommended that FSIS
provide guidance to plants regarding holding products, and that FSIS
work with the industry on strategies to mitigate some of the practical
problems associated with holding products.
In June 2005, the Agency again requested advice from the NACMPI.
The Agency asked the committee for suggestions on the most effective
way to provide guidance to industry on holding product that has been
tested for pathogens by FSIS, especially to small and very small
plants. The Committee considered the issue and its impact on small and
very small establishments and made a number of recommendations to the
Agency. The Committee recommended: (a) That FSIS refrain from issuing
any guidance at that time but instead review a draft of voluntary
guidelines that representatives from across the meat and poultry
industry had written to ensure that they conform to applicable laws,
regulations, and policies; (b) that industry issue its guidelines after
FSIS review and work with the Agency to ensure widespread distribution
of these guidelines, especially to small and very small plants; and (c)
that FSIS monitor the effectiveness of the industry guidance on an
ongoing basis and take appropriate actions, ranging from
recommendations for improving the guidelines to formal Agency action.
In 2005, the Agency carefully considered the committee's
recommendations and decided not to pursue a change in policy that would
require establishments to hold product pending FSIS test results and to
await the outcome of the industry-issued voluntary guidance on best
practices for maintaining control of product while awaiting FSIS' test
results. The Agency made this decision because of the difficulties a
policy change could present for some small and very small
establishments.
In September 2005, a coalition of trade associations issued a
guidance document, ``Industry Best Practices for Holding Tested
Products.'' This best practices document included, among many other
things, suggestions to aid small and very small establishments in
planning for and maintaining control of product pending FSIS pathogen
test results. FSIS assisted the trade associations in disseminating the
guidance document to all official establishments.
The Agency conducted an initial assessment of the voluntary
guidance document's effectiveness and presented its findings to the
NACMPI at its meeting on May 23-24, 2006. The assessment examined FSIS
test data for the calendar years 2003 through 2005 and the first
quarter of 2006 and grouped the data by establishment size and
pathogen. This initial assessment found that in the first quarter of
2006, establishments were holding between approximately 80% and 100% of
all meat and poultry products until receiving Agency test results, and
that establishments of all sizes were increasingly holding more product
pending receipt of Agency test results every year between 2003 and
2006, with large establishments holding almost all tested product every
year since 2003. The brief, 9-month period from the issuance of the
industry guidelines was not sufficient for the Agency to ascertain the
effectiveness of these guidelines, however.\1\ The Agency continues to
monitor verification test results and the circumstances that result in
recalls. Based on evaluation of 2007-2009 data, the Agency has noted
that establishments releasing product into commerce before receiving
test results continues to be a problem.
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\1\ A summary of the Agency's analysis of the industry
guidelines is available electronically at http://www.fsis.usda.gov/OPPDE/NACMPI/May2006/Test_and_Hold_Report_NACMPI.pdf.
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In 2007 there were 14 Class I recalls as a result of FSIS testing;
in 2008 there were 19 Class I recalls; and in 2009 there were 11 Class
I recalls. In 2007 seven of the Class I recalls were for E. coli
O157:H7 and seven for Listeria monocytogenes (Lm). In 2008, seven of
the Class I recalls were for E. coli O157:H7 and twelve for Lm. In
2009, eight of the Class I recalls were for E. coli O157:H7 and three
were for Lm. As discussed in the cost and benefits discussion below,
one such recall was associated with two illnesses. There were no
recalls for Salmonella in Ready-to-Eat (RTE) product between 2007-2009.
These recalls occurred because establishments that produced the product
that tested positive released the product into commerce while test
results were pending. Even though the number of Class I recalls went
down in 2009 compared to 2007 and 2008, there is still product entering
commerce before test results are received. FSIS is currently analyzing
the 2010 recall data. 2010 data show the proportion of the industry (by
size) that holds product until test results are received to be similar
to those from the 2006 study.
These findings have led the Agency to conclude that despite
voluntary compliance efforts, adulterated products are continuing to
enter commerce and that establishments' failure to hold or maintain
control of product pending FSIS test results endangers public health.
Not allowing product to move into commerce until the results of any
testing for adulterants done by FSIS become available would eliminate
this concern.
In June 2008, the American Meat Institute (AMI) sent a letter to
the Under Secretary for Food Safety stating that the organization
supported the Agency requiring companies to hold or control product
tested by FSIS until the results are known. AMI also stated that it did
not support Agency retention of any FSIS tested product. Rather, AMI
supported requiring a company to utilize its own, effective control
measures to ensure the product is not used or distributed for sale
before the test results are known.
On October 19, 2009, AMI sent another letter to Secretary of
Agriculture Vilsack again stating that the organization supported a
policy that would require companies to hold or control product tested
by FSIS until the test results are known.
In March of 2010, the USDA Office of Inspector General issued an
audit report of the FSIS National Residue Program for Cattle. In that
audit, the OIG recommended that establishments should not be allowed to
release potentially adulterated product before residue test results are
confirmed. The proposed change in policies and procedures will address
that recommendation.
FSIS does have a current policy whereby carcasses tested for bovine
spongiform encephalopathy (BSE) must be controlled by the establishment
and are not permitted to enter commerce until test results are
received. FSIS implemented this policy in response to the first
discovery of a BSE-positive cow in December 2003. FSIS issued a Federal
Register notice on January 12,
[[Page 19955]]
2004 (69 FR 1892), announcing that the Agency would not apply the mark
of inspection to any animal carcass tested for BSE until after the
Agency determined that the test results were negative. This policy,
which continues in effect, is consistent with policy and procedures
that FSIS has tentatively decided to implement, as discussed in the
next section.
New Policy
For the reasons discussed above, FSIS intends to implement a new
policy with respect to the application of the mark of inspection that
would in effect require establishments to maintain control of product
tested for adulterants by FSIS and not allow such products to enter
commerce until negative test results are received. Therefore, should
FSIS implement this new policy, the policy would cover non-intact raw
beef product or intact raw beef product intended for non-intact use
that is tested for E. coli O157:H7. Also, the policy would cover any
ready-to-eat products tested for Listeria monocytogenes, E. coli
O157:H7, or Salmonella s. Similarly, this policy would cover ready-to-
eat product that passed over food contact surfaces that have been
tested for the presence of Listeria monocytogenes and Salmonella,
pending receipt of negative test results. This policy would not cover
raw meat or poultry products tested for Salmonella or other pathogens
that FSIS has not designated as adulterants in those products.
Should FSIS implement this new policy, it would also apply to
livestock carcasses subject to FSIS testing for such veterinary drugs
as antibiotics, sulfonamides, or avermectins or the feed additive
carbadox. Because of the significant number of poultry carcasses in a
lot, the economic effect of holding such a lot, and because
historically, FSIS has not seen residue problems in poultry tested for
residues, such product would not need to be held from commerce pending
negative test results.
FSIS requests comments on whether the policy that product cannot be
released into commerce before negative test results are receive should
also apply to tests conducted by establishments.
New Procedures
FSIS recognizes that the mark of inspection is pre-printed on the
package label of many products, and that it is most efficient to allow
the product to be packaged and labeled with the printed mark of
inspection as part of the production process. FSIS intends to continue
to allow meat and poultry establishments to package and label products
sampled and tested for adulterants with the mark of inspection pending
negative Agency test results, but, if FSIS adopts this change, these
products will not be able to enter commerce until negative test results
become available. The pre-shipment review of records associated with
the production lot will not be complete without the pending test
results. Under this new policy, FSIS inspection program personnel will
continue to provide each establishment with notification before
sampling product or food contact surfaces to allow the establishment
time to hold product that is represented by the sample.
Consistent with current policies, should FSIS implement this new
policy, establishments would be able to move product to locations other
than the production facility so long as the establishment maintains
control of the product and maintains the integrity of the lot under
company seal. If the establishment moves the product to other
locations, it would not be able to transfer ownership of the product
until negative test results become available. Inspection program
personnel would notify the establishment when product could move into
commerce based on negative FSIS test results.
Considerations for Holding Product Tested for Pathogens or Residues
For E. coli O157:H7, prior to FSIS's sampling, inspection program
personnel inform the establishment that it is responsible for defining
the sampled lot. Under current policy and under this new policy, some
factors or conditions that the establishment should consider in
defining the sampled lot include any scientific, statistically based
sampling programs for E. coli O157:H7 that the establishment uses to
distinguish between segments of production; Sanitation Standard
Operating Procedures (Sanitation SOPs) or any other prerequisite
programs used to control the spread of E. coli O157:H7 cross-
contamination between raw beef components during production; processing
interventions that limit or control E. coli O157:H7 contamination; and
the use of beef manufacturing trimmings and other raw ground beef
components or rework carried over from one production period to
another.
FSIS does not recognize ``clean-up to clean-up'' alone as a
supportable basis for distinguishing one portion of production of raw
beef product from another portion of production. Rather, establishments
should consider whether the same source materials are used during
different production periods.
For testing of ready-to-eat product or contact surfaces for
Listeria monocytogenes or for testing such product for Salmonella,
inspection program personnel also inform the establishment that it is
responsible for determining the lot. In contrast to E. coli O157:H7,
for these types of testing, the sampled lot is generally considered the
ready-to-eat product that is produced from clean-up to clean-up because
the product typically undergoes consistent cooking and other lethality
procedures during the production period.
For livestock carcasses subject to scheduled FSIS residue testing
or residue testing conducted by the establishment or other entity,
establishments would need to hold the sampled carcasses under this new
policy. For this testing, the carcasses would not receive the mark of
inspection until negative test results are received.
Consistent with current policy, under this new policy, exporting
countries would continue to need to complete all forms of inspection
(including receiving lab results) before applying the mark of
inspection and signing a certificate for export of products to the
United States. Also consistent with current policy, the foreign
countries would continue to certify on official health certificates how
much product in a shipment represents the lot based on the product and
its processing method (e.g., HACCP Processing categories, Product
Species).
Comments Regarding This New Policy
The National Meat Association (NMA), representing seven other trade
associations: The American Association of Meat Processors (AAMP), the
Eastern Meat Packers Association (EMPA), the National Cattlemen's Beef
Association (NCBA), the National Turkey Association (NTA), the North
American Meat Processors Association (NMPA), and the Southwest Meat
Association (SMA), submitted a letter in anticipation of this notice to
FSIS.
NMA raised a number of issues about the prospective adoption of a
revised FSIS hold and test policy. The letter asked how FSIS would
address the issue of products with a shelf life less than the amount of
time required to conduct the analysis. The letter also asked how small
and very small establishments that produce product for same-day
delivery would be affected by this policy, and how FSIS could justify
economic impacts such as interruption of business and loss of
customers.
FSIS recognizes the concern that some very small establishments
might lose some product because of a short shelf life, as well as
experience some inability
[[Page 19956]]
to satisfy customer orders, resulting in a short-term disruption in
business activities. FSIS appreciates the concern. However, the Agency
believes the new policy would not cause significant loss of product
because FSIS inspection program personnel provide establishments with
notification before they collect samples to provide the establishment
time to plan accordingly. Furthermore, establishments may produce small
production lots when they are subject to FSIS testing. In addition,
many establishments already maintain control of product pending test
results. FSIS welcomes comments on additional ways establishments and
FSIS can address this concern. Also, FSIS intends to provide outreach
activities for small and very small establishments, such as Webinars or
Podcasts, as necessary. FSIS will also make compliance guidelines
available.
In addition, NMA asked how FSIS will ensure that all products that
should be held have indeed been held. If the policy is adopted after
evaluating the comments, FSIS will issue necessary instructions to its
field force on how to verify that establishments are maintaining
control of product pending test results for adulterants. Similarly,
FSIS would develop Agency procedures to promptly inform the
establishment that product is not adulterated and thus may enter
commerce when negative results become available.
NMA also noted that some recalls occur because the establishment
did not properly hold all products associated with a tested sample.
FSIS acknowledges that this new policy, if implemented as planned, will
not guarantee establishments correctly identify the sampled lot.
However, FSIS will continually evaluate the policy to provide updated
instructions to inspection program personnel and guidance to
establishments so that lots sampled for pathogens by FSIS do not enter
commerce.
Finally, the letter asked whether FSIS intended to mandate 100%
testing at establishments that do not currently test but receive tested
trim, such as raw ground beef at grinders. FSIS does not require such
testing and does not intend to require such testing in the future.
However, all establishments are required to conduct on-going
verification activities to ensure that their HACCP plans are
effectively implemented (9 CFR 417.4(a)(2)).
I. Expected Benefits of the Action
The Agency expects benefits from this policy to accrue to
consumers, Government and to industry.
If an establishment fails to hold a product when FSIS tests for a
pathogen, and the test is positive, the establishment will be asked to
recall the product. Because the pathogens for which FSIS does testing
represent an immediate threat to human health, the recall would be
classified as a Class I recall.\2\ Table 1 shows Class I recalls (2007-
2009) for FSIS testing that are included in the universe for the Test
and Hold policy analysis. These recalls were for E. coli O157:H7,
Listeria monocytogenes, and Salmonella in RTE product. In 2007 there
were 14 Class I recalls as a result of FSIS testing; in 2008 there were
19 Class I recalls; and in 2009 there were 11 Class I recalls. In 2007
seven of the Class I recalls were for E. coli O157:H7 and seven for
Listeria monocytogenes (Lm). In 2008, seven of the Class I recalls were
for E. coli O157:H7 and twelve for Listeria monocytogenes (Lm). In
2009, eight of the Class I recalls were for E. coli O157:H7 and three
were for Listeria monocytogenes (Lm). There were no recalls for
Salmonella in Ready-to-Eat (RTE) product between 2007-2009 for FSIS
testing.
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\2\ There are three classes of recalls. Class I: A health hazard
situation where there is a reasonable possibility that the use of
the product will cause serious, adverse health consequences; Class
II: A health hazard situation where there is a remote probability of
adverse health consequences from the use of the product; and Class
III: A situation where the use of the product will not cause adverse
health consequences.
Table 1--Class 1 Recalls Included in Test and Hold Policy Universe Derived From FSIS Tests
[2007-2009]
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Listeria
Year and type E. coli O157:H7 monocytogenes Salmonella Total
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2007:
FSIS............................ 7 7 0 14
2008:
FSIS............................ 7 12 0 19
2009:
FSIS............................ 8 3 0 11
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Total....................... 22 22 0 44
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Note: Data source FSIS recall division.
If the combination of industry and government costs per recall on
average is $1 million,\3\ then the total annual cost of FSIS recalls
could be on average as high as $15 million per year.\4\
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\3\ ``Preliminary Regulatory Impact Analysis and Initial
Regulatory Flexibility Analysis of the Proposed Rules to Ensure the
Safety of Juice and Juice Products'' (63 FR 24258; May 1, 1998).
\4\ The annual figure of $15 million is derived by summing the
total number of FSIS recalls for 2007-2009 from Table 1, then
multiplying the total by $1 million which is the average cost per
recall for industry and government. That figure is then divided by 3
to get the annual amount. (14 + 19 + 11 = 44 * 1M = 44M/3 = $14.7 M
per year).
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Considering costs to retailers as well as manufacturers and State,
local, and Federal authorities, a class I recall may cost as much as $3
million to $5 million.\5\ Using a conservative estimate, if the actual
cost of a recall for industry and government combined is closer to $3
million than $5 million,\6\ then the annual cost of the recall (the
benefit of avoiding these recalls) could be as high as $44.0 million
annually. FSIS requests comment on these estimates and the total costs
to industry and government associated with USDA Class I recalls.
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\5\ ``Preliminary Regulatory Impact Analysis and Initial
Regulatory Flexibility Analysis of the Proposed Rules to Ensure the
Safety of Juice and Juice Products'' (63 FR 24258; May 1, 1998).
\6\ Ibid.
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In addition to the cost savings attributed to avoiding recalls
described above, firms generally suffer a loss of sales, at least
temporarily, following a Class I or Class II recall. This alone does
not result in a social cost, but rather a social transfer, as other
firms will step
[[Page 19957]]
forward to capture sales lost by the recalling firm. However, in
addition to the resources invested in recalling the product, the
recalling firm may incur additional advertising costs to recapture the
loss of sales plus the flow of future sales, which is a social cost.
Additionally, there can be a loss of reputation for the manufacturer
and the brand associated with recalls that may affect future sales.
Consumer
FSIS expects the consumer to benefit from: (1) Reduced incidence of
adulterated product being released into commerce, (2) fewer recalls
resulting in higher confidence and acceptability of products, and (3)
lower levels of illness. This new policy will lead to increased
consumer confidence and acceptance of product through reduced recalls
and negative press.\7\
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\7\ Ollinger, Michael, working paper. ``Many economists have
examined the effects of reputation loss and the production of unsafe
food. Packman (1998) argues that the negative publicity generated
from a recall can erode prior investments in reputation and brand
capital. Economists (Thomsen and McKenzie, 2001; Pruitt and
Peterson; Salin and Hooker) found that firms that voluntarily
recalled contaminated meat and poultry products suffered a decline
in long run profitability (i.e., significant declines in stock
prices). A number of studies (Piggott and Marsh, 2004; Marsh,
Schroeder, and Mintert, 2004) determined that adverse meat and
poultry food safety events led to temporary declines in meat and
poultry consumption. Thomsen, Shiptsova, and Hamm (2006) established
that sales of branded frankfurter products declined more than 20
percent after product recalls.''
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Government
FSIS expects there to be a reduction in the number of recalls, and,
therefore, the Agency expects to benefit from lower Agency costs for
recalls and recovery of adulterated product because of: (1) Reduced
inspection program personnel activities at Federal establishments (2)
reduced overtime hours for FSIS staff, and (3) reduced staff travel to
establishments after recalls to conduct Food Safety Assessments (FSA)
and recall effectiveness checks. These expenses would include air,
train, or car travel; lodging; and per diem expenses for meals. In
addition, FSIS should have less need to disseminate information about
food recalls through press releases and recall releases.
Industry
Under this policy change, the meat and poultry processing and
slaughter industries will benefit from fewer recalls and negative
press. As the number of recalls declines, there will likely be: (1) An
increase in consumers' confidence, (2) reduced costs for recalls, (3)
greater consumer acceptance of products.
Initially, preventing adulterated product from going into commerce
should reduce operating costs. Operating costs will be lower because
companies will be less likely to have a recall and experience the
adverse impacts to business reputation as well as the product loss
associated with a recall. Avoiding adverse impacts on business
reputation is an indirect benefit.
Imported Product
There were 9 Class I recalls of FSIS tested imported product for
the 2007-2009 (Table 1) time period, 4 for E. coli O157:H7 and 5 for
Listeria monocytogenes. One recall occurred in 2007 for Lm and eight in
2008 (4 for E. coli O157:H7 and 4 for Lm). There are no recalls from
FSIS testing for imported product in 2009. All of these recalls are
included within the universe described in Table 1 and therefore are
included in the Benefits section within this analysis.
Human Health Benefits
Introduction
The Centers for Disease Control and Prevention (CDC) has estimated
that Shiga toxin-producing E. coli O157:H7 infections cause 63,000
illnesses annually in the United States, resulting in more than 2,138
hospitalizations and 20 deaths.\8\ Economic Research Service (ERS)
estimates that the annual economic cost of illness caused by E. coli
O157:H7 is $478 million (in 2009 dollars) for all cases, not just for
foodborne cases.
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\8\ Scallan E. Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson MA,
Roy SL, et al. Foodborne illness acquired in the United States--
major pathogens. Emerg Infect Dis. 2011 Jan: [Epub ahead of print]
Table 2 of this report provides foodborne STEC O157: H7 illnesses
at: 63,153, with 90% confidence of (17,587-149,631). Table 3 of this
report provides STEC O157:H7 hospitalizations at 2,138, with 90%
confidence of (549-4,614) and deaths of 20, with 90% confidence of
(0-113).
---------------------------------------------------------------------------
The occurrence of recalls demonstrates that pathogens have been
present on raw meat and poultry products distributed in commerce under
FSIS' existing approach. These pathogens represent a hazard to human
health. Thus, public health likely will benefit because meat and
poultry products will be held until results of pathogen tests are
returned as negative. If test results are positive, the product will be
destroyed, or further processed to destroy the pathogen, rather than
having to be recalled. This change will thus reduce foodborne pathogens
in products that are released into commerce. The economic health
benefits are expected to be small relative to the economic benefits of
avoided recalls.
To reach this conclusion FSIS analyzed both the actual illnesses
from the universe described in Table 1 and estimated future illnesses
averted as a result of this change. We discuss in Section A (Potential
averted illnesses from this policy using actual case data) the research
conducted by the Economic Research Service (ERS) for each of the
pathogens, E. coli O157:H7, Listeria monocytogenes, and Salmonella, as
well as their associated costs per case.\9\
---------------------------------------------------------------------------
\9\ ERS cost calculator can be found on their Web site at http://www.ers.usda.gov.
---------------------------------------------------------------------------
A. Potential Averted Illnesses From This Policy Using Actual Case Data
(1) During 2007-2009, there were 22 recalls for E. coli O157:H7
from FSIS testing. None of these recalls resulted in any illnesses
according to the Office of Public Health Science (OPHS) data. The ERS
estimate excludes a number of other potential costs, such as those for
special education, nursing homes, travel, childcare, and pain and
suffering. Illnesses for E. coli O157:H7 are divided into seven
severity levels depending on whether the patient visits a physician or
not, develops Hemolytic Uremic Syndrome (HUS) or not, develops End-
stage renal disease or not, and finally whether death occurs. ERS
estimates $6,510 as the average cost per case.\10\
---------------------------------------------------------------------------
\10\ The cost per illness for the seven severity levels is
between $30 (for an individual who did not obtain medical care) and
$7.2 million for a patient who died from Hemolytic Uremic Syndrome
(HUS).
---------------------------------------------------------------------------
(2) During 2007-2009 there were 22 recalls for Listeria
monocytogenes from FSIS testing. Only one of these recalls was
associated with illnesses. In 2008, there were two illnesses, one of
which was fatal, when a customer consumed chicken salad that had been
released into commerce before the FSIS test results were returned as
positive. We know that the cost of Lm illnesses with hospitalization
ranges from $10,815 (moderate) to $30,000 (severe). Ninety-five percent
of all hospitalized Lm cases are severe. The economic value of a life
ranges between $6 and $7 million based on the value of statistical life
(VSL) economic literature in 2001 dollars. Benefits from averting the
two illnesses had the establishment held the product until the test
results returned a positive would be $60,000 ($30,000 * 2), or $20,000
annually, and the benefit from averting the fatality would range from
$5.7 to $6.8 million. The mid-point of the benefit from averting the
death is $6.25 million or $2.1 million annually.
[[Page 19958]]
Actual annual benefits during 2007-2009 for Lm would be $2.10 million.
(3) There were no recalls from FSIS testing for Salmonella in RTE
product during 2007-2009. Research has shown that the cost per case of
a Salmonella illness is $18,000.\11\
---------------------------------------------------------------------------
\11\ See ``Prevention of Salmonella Enteritidis in Shell Eggs
During Production, Storage, and Transportation'' (74 FR 33030, July
9, 2009).
---------------------------------------------------------------------------
B. Estimated Averted Illnesses From This Policy
FSIS has developed a model \12\ to estimate annual illnesses
averted per positive sample, from holding FSIS tested product until
testing results are returned. This model is based on 2007-2009 recall
data, as well as the OPHS illness data occurring from these
recalls.\13\ The model estimates expected illnesses by accounting for
volume of product recalled and ``time in days'' between the dates of
production of adulterated product until the date of recall of that
adulterated product. If the Agency proceeds with this new policy, the
FSIS model estimated the upper 95% confidence bound of averted E. coli
O157:H7 illnesses to be approximately 2.61 for a three-year period
(based on the 2007-2009 data). FSIS estimated human health benefits,
based on averting these 2.61 E. coli O157:H7 illnesses to be
approximately $5,664 annually. ($6,510 * 2.61/3)
---------------------------------------------------------------------------
\12\ See Appendix 1: ``Development of model for predicting
averted illnesses due to E. coli O157:H7 from Test and Hold'' and
Appendix 2: ``Data used in Analysis.'' A copy of these documents is
available for viewing in the FSIS Docket Room and on the FSIS Web
site as related documents associated with this docket.
\13\ OPHS data was used for the model that contained illnesses
from all recalls and all sources. This included Outbreak, Illness,
FSIS Test, and Establishment Test. This was done only for the
purpose of estimating the rational expectation of future illnesses
averted by this policy.
---------------------------------------------------------------------------
Using similar methodology and an estimated number of illnesses of
0.18 for Listeria monocytogenes and .57 for Salmonella in RTE product,
the annual cost is $1,800 and $3,420, respectively. For the three
pathogens, E. coli O157:H7, Listeria monocytogenes, and Salmonella,
human health benefits are estimated from the model to be approximately
$10,884 annually. See Table 2.
Table 2--Human Health Benefits From Actual Recalls and Estimated Model
[2007-2009]
--------------------------------------------------------------------------------------------------------------------------------------------------------
FSIS estimated
Actual CASES 2007- Actual annual cases averted Annual benefit
Pathogen Cost per CASE 2009 benefit 2007-2009 (Model) 2007- (Model)
2009 **
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. coli O157:H7.......................................... $6,510 0 0 2.61 $5,664
Listeria Monocytogenes................................... 30,000 2 $20,000 .18 1,800
Salmonella............................................... 18,000 0 0 .57 3,420
Death (Annual) *......................................... 6.25 1 2.1 M ................. .................
----------------------------------------------------------------------------------------------
Total................................................ ................. ................. 2.1 M 3.36 10,884
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Note: LM is known to have a high death rate and as such one death is included in the expectation of benefits from illnesses averted. The cost of 2 LM
illnesses ($60,000) is accounted for in the Model.
** Table 3 of the Model (Appendix) estimates illnesses for 10 years. To make the numbers comparable we used estimated illnesses from the model/10 * 3 to
derive the numbers in this column.
Total human health benefits from the FSIS model and actual reported
illnesses combined would be approximately $2.11 million annually ($2.1
M + $10,884). Differences may be due to rounding.
Residue Benefits
Microbiological hazards are expected to drive the cost-benefit
analysis because they result in an attributable short term, low
(morbidity) to high (morbidity) impact consequences that can be
realistically estimated.
The cost-benefit analysis for chemical hazards on the other hand is
difficult to quantify. The negative health effects of exposure to low
levels of chemicals are long term and multifactorial. Single exposure
to low levels of chemicals or cumulative exposure can contribute to
negative health effects 10, 20, or more years later; for example,
cancer. Of course, over such long periods of time, individuals are
exposed to a variety of hazards making it impossible to quantify the
contribution of the chemical exposure to societal and medical costs.
The approach for conducting a cost benefit analysis for single
incidents of contamination at levels that cause immediate morbidity/
mortality, i.e., where the health effects are readily attributable to
the exposure, is comparable to microbiological hazards.
The Environmental Protection Agency (EPA) \14\ and the Food and
Drug Administration (FDA) conduct risk assessments to establish what
level of chemical residues are acceptable.\15\ They consider acute and
chronic exposure scenarios to set residue limits and include a wide
margin of safety in their calculations. Meat, poultry, and egg products
with chemical residues that exceed the tolerances or other limits set,
or for which no scale level has been set, by EPA and FDA are
adulterated and unsafe for human consumption.
---------------------------------------------------------------------------
\14\ Drugs are used on plants as well as in/on animals, so some
of the chemicals regulated by EPA are drugs (for example antibiotics
and antifungals). EPA establishes safe methods of use for chemicals
(drugs, pesticides, fungicides, etc) and sets the allowable residual
levels in the environment, water and air resulting from use, based
on the risk to people through direct and indirect exposure to the
residues.
\15\ See General Accounting Office (GAO) report ``Chemical Risk
Assessment: Selected Federal Agencies' Procedures, Assumptions, and
Policies'', GAO-01-810, August 2001.
---------------------------------------------------------------------------
Summary of Benefits
The annual benefits from this policy change come from:
(1) Reduced costs of recalls, $15 million to $44 million,
(2) Actual averted death, $2.1 million as shown in Table 2 and
(3) Estimated Averted illnesses for E. coli O157:H7, Listeria
moncytogenes and Salmonella of $10,884 as shown in Table 2.
Total benefits from this policy change are estimated to range
between $17.1 million and $46.1 million annually.
II. Expected Costs of the Action
FSIS prepared a paper in September, 2006 to provide data on trends
in the industry practice of holding meat and poultry products pending
results of
[[Page 19959]]
FSIS microbiological testing.\16\ Identifying trends in industry
holding practices provides a context and baseline for any future
evaluation of the effects of holding product pending test results. FSIS
examined test data for the calendar years 2003 through 2005, as well as
data for the first eight months of 2006, and grouped data by
establishment size and pathogen. Specifically, FSIS examined the hold/
release information included with FSIS testing results for the
following pathogens in five different groups: (1) E. coli O157:H7 in
raw, non-intact beef produced by domestic official establishments,\17\
(2) E. coli O157:H7 in domestically-produced ready-to-eat (RTE) meat
and poultry; (3) Salmonella in domestically-produced RTE meat and
poultry; (4) Listeria monocytogenes (Lm) in domestically-produced RTE
meat and poultry; and (5) Lm on food-contact surfaces in establishments
that produce RTE meat and poultry products.
---------------------------------------------------------------------------
\16\ A summary of the FSIS's analysis is available
electronically at http://www.fsis.usda.gov/OPPDE/NACMPI/May2006/Test_and_Hold_Report_NACMPI.pdf.
\17\ In this paper, FSIS did not examine results from the
recently initiated FSIS baseline testing of beef trim for E. coli
O157:H7 and Salmonella.
---------------------------------------------------------------------------
A. Domestic Product
(1) Micro Testing
FSIS found the following results of meat and poultry product being
held by establishments prior to receiving FSIS test results. Table 3
shows the results by establishment size for the first 8 months of year
2006 for the five test groups described above.
Table 3--Percent of Product Being Held by Establishment Size for 2006 Jan-Aug
[In percent]
----------------------------------------------------------------------------------------------------------------
Large Small Very small Unknown
----------------------------------------------------------------------------------------------------------------
Group 1......................................... 100 83 79 57
Group 2......................................... 100 93 88 100
Group 3......................................... 100 90 82 93
Group 4......................................... 99 91 82 93
Group 5......................................... 100 97 88 --
----------------------------------------------------------------------------------------------------------------
Group 1: Percent of raw, non-intact beef Products held after Agency E. coli O157:H7 Sampling.
Group 2: Percent of RTE Products held after Agency E. coli O157:H7 Sampling.
Group 3: Percent of RTE Products held after Agency Salmonella Sampling.
Group 4: Percent of RTE Products held after Agency Lm Product Sampling.
Group 5: Percent of RTE Products held after Agency Lm Food Contact Surface Sampling.
Note: This data is the latest available data for product held in establishments from FSIS testing. Study by the
Office of Program, Evaluation, Enforcement, and Review (OPEER.).
Based on evaluation of recent data, the Agency has noted that
establishments releasing product into commerce before receiving test
results continues to be a problem.
However, using the percentage numbers from Table 3 for the first
eight months of 2006 will provide a basis for establishing the costs
for 2007-2009 to hold product until test results are returned.
Table 4 shows the number of Federally inspected meat and poultry
establishments by establishment size and illustrates in columns 3 and
4, based on the results from Table 3, the number of establishments
currently holding product, as well as the number of establishments that
will need to hold product as a result of this policy change.
Table 4--Federal Inspected Meat/Poultry Establishments.
----------------------------------------------------------------------------------------------------------------
Number of Does not hold
Establishment size establishments * Holds product product
(1) (2) (3) (4)
----------------------------------------------------------------------------------------------------------------
LARGE.................................................. 362 362 0
SMALL.................................................. 2,366 1,964-2,295 71-402
VERY SMALL............................................. 2,900 2,291-2,552 348-609
UNKNOWN................................................ 578 329-578 0-249
--------------------------------------------------------
TOTAL.............................................. 6,206 4,946-5,787 419-1,260
----------------------------------------------------------------------------------------------------------------
* Source: Performance Based Inspection System (PBIS) 1/3/2008. There has been no substantial change in
establishment numbers.
The data provided in Table 3 are used to calculate the number of establishments holding product (column 3) and
the number of establishments not holding product (column 4).
Across establishment size, between 79 percent and 100 percent of
establishments already hold product pending test results and between
zero and 21 percent will need to hold product pending test results.
Based on the percentage results shown in Table 4, FSIS assumes for
cost purposes only that all 362 large establishments are holding all
tested product for results. Approximately 71-402 small establishments,
348-609 very small establishments, and between 0 and 249 unknown size
establishments do not hold tested product and will be affected by this
new policy. Table 4, column 4 shows the range of establishments that
will have to hold product pending negative test results before FSIS
will award the USDA mark of inspection. A total of between 419 and
1,260 federally inspected meat and poultry establishments will be
affected by this policy change. There will be no additional costs to
any of the large establishments as they are assumed to hold all tested
product. FSIS expects
[[Page 19960]]
that among the remaining establishments that do not hold tested
product, there will be an adjustment of lot size to accommodate
necessary storage capacity at the establishment prior to an FSIS test.
FSIS conducted further research on all FSIS tests conducted in the
year 2007. Combining the percentages of product held from Table 3 and
the estimates of common lot sizes from the following Table 5, FSIS
reached certain conclusions about the additional pounds of product that
would need to be held by the small and very small establishments, which
is shown in Table 6.
Table 5--Estimated Lot Sizes by Establishment Size
----------------------------------------------------------------------------------------------------------------
Lot (pounds) size Average lot (pounds)
Establishment size produced size tested *
----------------------------------------------------------------------------------------------------------------
LARGE......................................................... 2,000-30,000 2,000
SMALL......................................................... 1,000-10,000 1,000
VERY SMALL.................................................... 50-2,000 50-60
----------------------------------------------------------------------------------------------------------------
Source: Common Industry Practice and expert elicitation.
* Tested lots are smaller than typical production lot sizes.
FSIS estimates the common industry practice for average lot sizes
tested to be approximately 2,000 pounds at large establishments, 1,000
pounds at small establishments, and between 50-60 pounds at very small
establishments. As a result of the above lot size estimations, there
may be a certain number of small and very small establishments that
will incur costs relative to additional storage (recurring costs) or
for capital equipment (one-time costs), in order to hold tested
product.
Table 6--Additional Cost per Establishment To Hold Estimated Pounds of Product
----------------------------------------------------------------------------------------------------------------
Cost per
Lbs to be held by Days product to establishment
establishment be held store product
----------------------------------------------------------------------------------------------------------------
LARGE.................................................. 0 3-8 $0
SMALL.................................................. 4,511 3-8 5,000
V/SMALL................................................ 1,329 3-8 1,000
UNKNOWN................................................ 1,011 3-8 1,000
----------------------------------------------------------------------------------------------------------------
Source: FSIS/OPEER/OCIO data.
Cost per commercial freezer @ $5,000 per 300 cu. ft. for small establishments. Cost of stand-up freezer for very
small establishments @ $1,000.
Factors affecting this cost impact include: (1) The amount of
product needed to be handled and placed into storage; (2) the average
number of days of storage; (3) the number of times per year that tests
occur; and (4) the cost per day in handling and storage.
The costs shown in Table 6 would predominately be one-time capital
expenditures to purchase freezers for storage of tested product. There
would be a small amount of electricity charges to operate the
refrigeration units, but we do not anticipate that they would be
significant. Labor costs would also be minimal to accommodate the
additional product stored. Additionally, FSIS recognizes the concern of
some very small establishments that they could lose some product
because of the product's short shelf life, and that an establishment
could experience some inability to satisfy customer orders, resulting
in a short-term disruption in business activities.\18\ FSIS does not
have sufficient information to include costs associated with this
disruption in the analysis, but we request comments on these costs and
on additional ways establishments and FSIS can address the effect this
policy may have on small and very small establishments that produce
product with a short shelf life.
---------------------------------------------------------------------------
\18\ The American Meat Institute (AMI) survey dated April 2007,
conducted for the Listeria monocytogenes (Lm) Final Regulatory
Impact Analysis shows various amounts reported for spoilage due to
products exceeding shelf life prior to obtaining test results or
diminished shelf life after obtaining test results for Lm. Large
establishments report a range of $0-$50,000 or on average $3,571 and
a median of $0; small establishments report a range of $0-$150,000
or on average $5,750 and median of $0; and very small establishments
report a range of $0-$5,000, or on average $450 and a median of $0.
Only 16 very small and 75 small establishments responded to the
survey. There are 2,900 very small and 2,366 small federally
inspected establishments from PBIS data.
---------------------------------------------------------------------------
Table 7 combines the results of tables 4, 5 and 6 and shows that
the estimated total costs to all small and very small (and unknown)
establishments that do not hold product domestically would range
between $703,000 and $2.87 million.
Table 7--Total One-Time Cost per Establishment Size
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number establishments Cost/Est. to store
Establishment size affected Table 5 (col. product Table 7 One-time total cost to Annualized 7%-10 years
1) (column 4) hold product *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large............................................... 0 $0 $0 $0
Small............................................... 71-402 5,000 $355K-$2.01M $50,541-$299,000
Very Small.......................................... 348-609 1,000 $348K-$609K $49,545-$86,700
Unknown............................................. 0-249 1,000 $0-$249K $0-$17,227
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 19961]]
Total........................................... 419-1,260 ....................... $703,000-$2.87 M $100,000-$408,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
* NOTE: Total cost to hold product is result of of Establishments affected * cost/Est to store product.
(2) Residue Testing
The National Residue Program (NRP) consists of two sampling plans:
Domestic and import. These plans are further divided to facilitate the
management of chemical residues such as veterinary drugs, pesticides,
and environmental contaminants in meat, poultry, and egg products. The
domestic sampling plan includes both a scheduled sampling program that
is derived statistically by an interagency (FSIS, EPA, and FDA)
technical team and by inspector-generated sampling in which samples are
collected by in-plant veterinarians when they suspect an animal
presented for slaughter may have violative levels of chemical residues.
The import re-inspection sampling plan verifies the equivalence of
inspection systems of exporting countries. FSIS inspectors collect
samples randomly from imported products, and the intensity of sampling
increases when products fail to meet U.S. requirements.
Residue Costs
In CY 2008, under the National Residue Plan, there were 22,709 FSIS
residue samples completed. An additional 135,552 inspector-generated
samples were taken. The number of samples includes those taken in-
plant, taken from show animals, taken by inspectors or OPEER personnel
as part of their regular work, and as part of state programs.
The average range of days between a sample arriving at the lab and
the report being available is generally 3-10 working days. Some screen
results are available the same day by Kidney Inhibition Swab (KIS)
tests, while other tests may take longer than 10 days.
The Agency does not anticipate any substantial cost impact from
additional storage space requirements for FSIS residue testing. For
establishment residue testing, the establishment as part of its HACCP
program should already be holding any tested carcasses. The Agency asks
for comments on possible additional storage space requirements.
Products will have a reduced shelf-life at retail as a result of
carcasses being held pending FSIS and establishment test results. Some
beef product that has been residue tested and held for three to ten
days will lose freshness and will need to be frozen. Over the past nine
years, on average, the difference in fresh vs. frozen beef prices is
approximately $0.054 a pound.\19\ The worst case scenario for loss of
business revenue for dairy cows, used for beef estimation purposes,
would be approximately $39,500.\20\ While these lost revenue estimates
are a worst case scenario, we also estimate the range for reduced beef
sales to be between $19,700 and $39,500. The Agency requests comments
on reduced sales.
---------------------------------------------------------------------------
\19\ Beef price data provided by the Economic Research Service,
USDA. The data is for 90% lean beef, not carcasses and can be
interpreted as cents per pound or dollars per cwt of product.
\20\ Estimation of worst case business loss for dairy cows:
Total number of animals selected for dairy cows (300) * 4 (number of
chemicals sampled) * average lbs of animal (609) = total lbs to be
held * price difference per lb. from fresh to frozen ($0.054)
---------------------------------------------------------------------------
Additionally, roaster pig carcasses could go rancid and would also
need to be frozen. Some product will go to secondary markets, such as
renderers, pet foods, and fertilizer product. For roaster pigs, we
estimate a worst case scenario loss of business at approximately
$92,400.\21\ The lower estimate for roaster pigs is $46,200. The Agency
requests comments on reduced sales revenues.
---------------------------------------------------------------------------
\21\ Estimation of worst case business loss for roaster pigs:
Total number of animals selected for roaster pigs 300 * 4 (number of
chemicals sampled) * average lbs of animal (70) = total lbs to be
held * price per lb. ($1.10)
Table 8--Loss of Revenues for Domestic Beef and Roaster Pigs Due to Residue Test and Hold Policy
----------------------------------------------------------------------------------------------------------------
Roaster pigs
Establishment size Beef number of Beef $$ lost number of Roaster pigs $$
establishments establishments lost
----------------------------------------------------------------------------------------------------------------
Large............................... 132 $1,264 4 $601
Small............................... 810 7,900 85 13,860
Very Small.......................... 3,164 30,099 467 77,616
Unknown............................. 25 237 2 323
---------------------------------------------------------------------------
Total........................... 4,131 39,500 558 92,400
----------------------------------------------------------------------------------------------------------------
Source of data: Data Analysis Integration Group (DAIG) and Office of Policy and Program Development (OPPD)/Risk
Management Division.
B. Imported Product
Imported Re-Inspection Sampling Plan
Import Inspection Personnel are to sample imported ready-to-eat
(RTE) meat and poultry products produced in foreign establishments.
Analyses will include Listeria monocytogenes and Salmonella testing for
all RTE products, and E. coli O157:H7 for cooked beef patties and dry
or semi-dry fermented sausages.
Ready-to-eat cooked meat or poultry product is subjected to
microbial sampling at the port-of-entry. This includes any product that
is intended to be consumed without any further safety preparation
steps. Import inspection personnel do not sample products for Listeria
monocytogenes or Salmonella that are labeled with cooking
[[Page 19962]]
instructions or ``Not Fully Cooked''. These products are not considered
RTE and are not sampled under this program.
Table 9 describes the two different types of tests that are
conducted on imported product, (1) micro testing, and (2) residue
testing (column 1). Column 2 shows the number of samples where product
was held, while column 3 shows the number of samples where the product
was not held. Column 4 shows the number of samples for which the
available data do not show whether or not the product was held. Column
5 is the total of all tests taken on imported product (sum of columns
2, 3 & 4). Column 6 is the percentage of tested product that is
currently being held.
Table 9--Percent of Imported Product Held That Has Been FSIS Tested
[By lots]
----------------------------------------------------------------------------------------------------------------
Percentage
Type Held Not held Not indicated Total product
currently held
(1) (2) (3) (4) (5) (6)
----------------------------------------------------------------------------------------------------------------
Micro........................... 1,994 1,799 88 3,881 51.4
Residues........................ 2,320 2,490 493 5,303 43.7
----------------------------------------------------------------------------------------------------------------
Source: FSIS International Policy Division.
Table 10 shows the type of samples (column 1) and the number of
FSIS samples taken (column 2). The average lot size derived by dividing
the total pounds of product presented for import in 2008 by the total
lots presented for import in 2008 is shown in column 3 (3,270,643,817/
210,592). Column 4 and 5 are percentage of product currently held and
percentage of product to be held. Column 6 and 7 represent the total
pounds to be held and the cost of holding that product. The cost of
holding imported product when this policy becomes effective will range
from approximately $757,000 to $832,000.\22\ The Agency asks for
comments on costs of storage.
---------------------------------------------------------------------------
\22\ The storage cost data was not robust, therefore a cost +
10% range was cited. Adding the 10% leads to a storage cost of
$832,242.
Table 10--Cost To Hold Imported FSIS Tested Product
--------------------------------------------------------------------------------------------------------------------------------------------------------
Additional
Number of FSIS Average lot Percent percent of Total pounds Cost for
Type samples size product now product to be to be held holding
held held * product
(1) (2) (3) (4) (5) (6) (7)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Microbial............................................... 3,881 15,530 51.4 48.6 29,292,158 $292,922
Residue................................................. 5,303 15,530 43.7 56.3 46,366,197 463,662
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. .............. 756,584
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Cost is based on storage of product for up to 30 days @ $.01/pound.
Source: FSIS--International Policy Division.
* Column 5 is the additional percentage of product that will need to be held once this policy becomes effective. (100%-column 4 percentage)
Summary of Annual Costs:
Total Domestic Product--$100,000-$408,600.
Loss of Business Revenue--$66,000-$131,900.
Total Import Product--$757,000-$832,000.
Total Cost: $923,000-$1.4 million.
Estimated annual benefits range between $17.1 million and $46.1
million and exceed the estimated costs. Annual net benefits range
between $16.2 million and $44.7 million.
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
document, FSIS will announce it online through the FSIS Web page
located at: http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
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 constituents
and stakeholders. The Update is communicated via Listserv, a free
electronic mail subscription service for industry, trade and farm
groups, consumer interest groups, health professionals, and other
individuals who have asked to be included. The Update is available on
the FSIS Web page. Through the Listserv and the Web
[[Page 19963]]
page, FSIS is able to provide information to a much broader and more
diverse audience. In addition, FSIS offers an e-mail subscription
service that provides automatic and customized access to selected food
safety news and information. This service is available at: http://www.fsis.usda.gov/news_and_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 password-protect their accounts.
Done at Washington, DC, on: April 5, 2011.
Alfred V. Almanza,
Administrator.
Appendix 1
FSIS is planning to require product to be held when FSIS test
for pathogens. (E coli O157:H7 in ground and trim beef products, and
Salmonella and Listeria monocytogenes (LM) in ready-to-eat (RTE)
products), until the test result is reported negative. Benefits from
averted illnesses from this policy thus would accrue if it were the
case that instead of holding tested product that was contaminated,
the product was released before a positive result was found and
portions of that product would have been consumed, which would have
led to illness. It takes 6 days before samples are confirmed to
contain E. coli O157:H7 (1 day for sending the sample from the
establishment to the laboratory and 5 days once the sample arrives
in the laboratory); for the other two pathogens it takes 8 days. The
expected decreased risk of illness (the estimated benefits) to
consumers by the execution of this policy is estimated by modeling
the observed relationship of reported illnesses due to E. coli
O157:H7, Listeria monocytogenes (LM) and Salmonella associated with
recent recalls (2007-2009), with the number of days before the
recall and the amount of product associated with the recall. From
this model, the expected number of illnesses that would occur for
product recalled x days after sampling can be estimated. There are
many assumptions implicit in the model, for example, the recalled
volume might not reflect the actual volume of product for which
consumers were exposed. One would expect, though, that the longer
time between the recall date and manufactured date, the more the
exposure and thus the greater opportunity for illness from the
product. Thus, it is expected that illnesses would increase if
volume increases or days before recall increase, given everything
else being equal; that is, the number of illnesses is an increasing
function of volume and days. In Appendix 2 are the data used in the
analysis, consisting of 75 cases, within 2007-2009, for which
product volume, days between manufactured and recall dates, and
illnesses associated with the recall were available.\23\
---------------------------------------------------------------------------
\23\ Recalls cited in Table 1 in the main report do not include
all E. coli O157:H7 recalls. Rather, Table 1 includes only those
recalls based on FSIS or establishment E. coli O157:H7 positive test
results. The data used for modeling include all recalls of relevant
FSIS regulated product besides those indentified in Table 1 of the
main report, such as recalls resulting from outbreaks or state
laboratory testing.
---------------------------------------------------------------------------
Besides estimates of illnesses associated with potential
recalls, there are 4 factors that need to be accounted for in
estimating the potential benefits that would be realized from the
test and hold policy:
(1) The number of establishments that would not be holding
product if not for the policy;
(2) The volume of the product being held;
(3) The number of tests expected to be conducted, yearly; and
(4) The expected proportion of tests that would be positive.
Another assumption made is that large establishments (as determined
from FSIS' HACCP size classification) already hold product when it
is being tested and thus this policy will not result in averted
illnesses from this sector of the industry. It is only assumed that
some HACCP-size small and very small establishments will need to
hold product that otherwise would not have, and thus will have
averted illnesses as a result of this policy.
Regarding the proportion of tests expected to be positive, the
proportion could be a function of the volume of product per test
that is held. However, a test consists of an analysis of a certain
amount of material, which is assumed constant; thus for modeling the
potential benefits, it is assumed that this proportion is
independent of volume. The percentage of positive test results that
would be seen in the future is assumed to be equal to that observed
for the years 2007-2009 (up to the middle of November). The
percentage of positive results depends upon the HACCP size of the
establishment (Table 1) as well as the particular test. For LM,
since FSIS tests multiple samples per ``unit'' (unit = a collection
of samples for product and food contact surfaces, excluding other
environment samples), the results below report the percentage of
units that had at least one positive result, since even one positive
result from these samples leads to a determination of an adulterated
product that would be subject to recall.
Table 1--Numbers of Tests and Numbers and Percents Positive by HACCP Size and Test-Type, From 2007-2009 (Mid-November), Covering 34.5 Months, for all
FSIS' Tests on Ground and Trim Beef for E. coli O157:H7 and Ready-to-Eat (RTE) Product for Salmonella and Listeria monocytogenes (LM)
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. coli O157:H7 Salmonella LM * Other LM
Size -------------------------------------------------------------------------------------------------------
Test Positive Test Positive Test Positive Test Positive
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small........................................... 17,772 115 17,898 7 671 19 17,630 90
........... 0.65% ........... 0.039% ........... 2.83% ........... 0.51%
Very small...................................... 20,313 74 12,821 10 125 6 12,735 41
........... 0.36% ........... 0.078% ........... 4.80% ........... 0.32%
--------------------------------------------------------------------------------------------------------------------------------------------------------
* LM numbers refer to the number of units (set of product and food contact surface samples, from which any positive would lead to declaration of product
adulteration).
For LM, estimating the number of tests and percent of those that
would be positive and lead to held product, the numbers for the two
types of LM sampling are added together. Thus, for example, for the
small size establishments, it is assumed that there are 17,630 + 671
tests for Lm of which 90 + 19 of them were positive.
For Salmonella and Listeria testing, it is assumed that the number
of samples used in the past would remain the same. In this case, the
number of positive results that would lead to holding product that
otherwise would not have been is determined by just multiplying the
number of test times the expected percentage of positive results, times
a factor that represents the fraction of establishments that would not
be holding product if not for this rule. This percentage is taken from
Table 4 of the main report, which provides the percentages of
establishments by HACCP size category that hold product for the
different types of sampling. As mentioned above, it is assumed that all
large establishments would hold product and thus do not contribute in
the analysis presented here. For Salmonella, the assumed percentages of
the tested small and very small establishments that hold product are
90% and 82% respectively (Table 4 of the main report). For LM, since
either a positive result for a food contact surface
[[Page 19964]]
or product leads to recall, the lower percentages establishments
holding product of the groups associated with LM testing from Table 4
of the main report are assumed. That is, it is assumed that percentages
of the tested small and very small establishments that hold product are
91% and 82% respectively (Table 4 of the main report, group 4). Thus
the number of positive samples over a 10-year period associated with
product that would not have been held if not for the proposed
regulation is 10Q(1-w)12/34.5 where Q is the number of positive results
for 34.5 months given above in Table 1, and w is the fraction of
establishments that already hold product (Table 4 of the main report).
For E. coli O157:H7 sampling, since FSIS' sampling plan calls for
sampling each establishment once a month, the number of establishments
assumed are the number that are being sampled presently. There are 570
and 884 small and very small size establishments, respectively, that
were sampled. From Table 4 of the Notice it is assumed that 17% and 21%
of them, respectively, are not presently holding product. In addition 5
establishments were sampled for which the size was not known for which
(from Table 4 of the main report) is assumed that an expected 43% did
not hold product. These 5 establishments are assumed to be distributed
between the small and very small establishments by the ratio of 570/
(884 + 570). Thus, after calculations, it is assumed that 98 small and
187 very small establishments presently do not hold product for E. coli
O157:H7 sampling. Since for E. coli O157:H7 testing, it is assumed that
every establishment will be tested once a month, for 10 years, the
expected number of positive tests in the next 10 years per
establishment is 10(12)p, where p equals 0.65% for small establishments
and 0.36% for very small establishments (Table 1 above). This number is
multiplied by the number of establishments assumed involved, which
would be equal to 98 for the small establishments and 187 for the very
small establishments to derive the expected number of positive tests in
a 10-year period, K.
Regarding the number of pounds that would be held, FSIS policy
permits the number of pounds likely to be subjected to being tested and
held to be small since the establishment will be given prior
notification of the test and will, most likely, prepare smaller amounts
of product for testing. As discussed in the economic analysis (Table
6), it is anticipated that, for small establishments, the product
volume held would be on average 1000 pounds, and for very small
establishments, the held volume will be on average 50-60 pounds. In the
analysis, 60 pounds was used.
The estimated number of averted illnesses is estimated by
multiplying the expected number of positive results in 10 years times
the expected number of illnesses averted per positive test resulting in
a recall x days after the manufacturing date, where x equals 6 for E.
coli O157:H7 and equals 8 for the other two pathogens. For modeling
this expected number of averted illnesses, as mentioned above, it is
assumed that number of illnesses associated with a positive test is an
increasing function of the volume of the recalled product and the days
after the initial manufactured date of the product. Specifically, a
general model considered was:
[GRAPHIC] [TIFF OMITTED] TN11AP11.001
where v = volume, x = days, g is a function with parameters: a, b,
c, * * *, whose values are to be estimated from the data in the
appendix, and [egr] is random variable, with expected value equal to 0,
and standard deviation equal to [sigma]. Estimated values were obtained
using the non-linear mixed effects model of PC-SAS version 9.1 (PROC
NLMIXED). For this procedure, [egr] is assumed to be distributed as a
normal distribution, since this is the only option permitted. The
procedure maximizes the marginal likelihood function, integrated over
the distribution of [egr]. Thus [lambda] is distributed as a lognormal
distribution, and the expected value of the number of illnesses, given
v and x, is
[GRAPHIC] [TIFF OMITTED] TN11AP11.005
The benefit for a given volume, B(v, x), and days before recall, x,
is obtained by:
[GRAPHIC] [TIFF OMITTED] TN11AP11.006
where K is the number of expected positive tests for the next 10 years
for product that would not be held if not for the requirement. For
small HACCP size establishments, it is assumed v = 1000 pounds; for
very small size establishment, v = 60 pounds. And as mentioned above,
for E. coli O157:H7, x = 6 days and for Salmonella and LM, x = 8 days.
Comparisons of models used to estimate g and [sigma] are based on
the log-likelihood ratio test, where the distribution of the difference
of statistics, L = -2 log(likelihood), for two models being compared is
approximated by the appropriate chi-square distribution.
To help determine the form of g, the function of independent
variables associated with the variable `days' between the date of
manufacturing and recall and the volume of the recalled product, Figure
1 presents graphs of the natural logarithm of the ratio of the number
of illnesses divided by product volume, ln(illnesses/volume), versus
days (right side) and versus the natural logarithm of days + 1, ln(days
+1) (left side). When the number of illnesses was 0, the value assigned
was -14. The smooth lines are spline curve,
[[Page 19965]]
constructed using the default options of the S-Plus[supreg] for
Windows, version 8.1. The graph on the right indicates the high degree
of influence the data point with days = 365 could have on a model
predicting number of illnesses using days as an independent variable.
This point would have less influence if ln(days+1) were used instead of
days as an independent variable.
Figure 2 provides a graph of ln(illness/(days+1)) versus
ln(volume). When the number of illnesses is zero, a value of -5.5 was
assigned. The dark smoothed line is the quadratic fit; the dashed-
dotted red line is the curve derived from fitting: a +
ln(be-cln(v) + cebln(v)), a function borrowed
from one used to describe cell population growth assuming two phases: A
lag phase and an exponential phase.
These figures suggest a model for estimating the number of
illnesses as a function of ln(volume) and ln(days+1) be based on a
Poisson regression with log-link a function of ln(days+1) and
ln(volume), plus a random error (Equation 1). It is assumed that g is
the full quadratic function of these variables:
[GRAPHIC] [TIFF OMITTED] TN11AP11.002
where b, c, d, e, and f are constants, and a depends upon the pathogen.
For the full model in Equation 4, the model has 9 parameters (including
[sigma]) since there are three ``intercepts'' being estimated, one for
each pathogen.
Table 2 presents differences of values of L for selected models
from the value obtained from the full quadratic model given in Equation
4, excluding the 2 outlier data points identified. All models converged
by the G- convergence criterion (gradient) using the default quasi-
Newton optimization technique.
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[GRAPHIC] [TIFF OMITTED] TN11AP11.003
[[Page 19966]]
[GRAPHIC] [TIFF OMITTED] TN11AP11.013
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Table 2--L = -2 log(Likelihood) for Selected Models From the Value
Obtained From the Full Quadratic Model Given in Equation 4. Models Are
Designated by Free Parameters Not Assigned To Be Zero, in Equation 4
------------------------------------------------------------------------
Number of L = -2 log
Model parameters likelihood
------------------------------------------------------------------------
Linear model (a, b, c, [sigma])......... 6 208.8
(a, b, c, d, [sigma])................... 7 207.8
(a, b, c, f, [sigma])................... 7 207.2
(a, b, c, e, [sigma]) *................. 7 206.6
(a, b, c, d, f, [sigma])................ 8 207.4
(a, b, c, d, e, [sigma])................ 8 206.7
(a, b, c, e, f, [sigma])................ 8 206.6
Full model.............................. 9 206.6
------------------------------------------------------------------------
* Model M1.
From Table 2, it appears that the linear model provides the best
fitting parsimonious model. The model that includes e - the coefficient
of the square of ln(x+1), decreases L by 2.22, with 1 degree of
freedom, which under normal theory would be significant with p-value
equal to 0.136. The value of e was estimated to be negative; however
the term cln(x+1) + e[ln(x+1)] \2\ is greater than zero for x < 4989
which is well outside the range of concern. Thus, for our purposes, the
function g (Equation 4) for M1 is an increasing function of the
variable days in the region of concern, and thus can be used. Because
the p-value is not large, this model cannot be rejected, thus an
estimate associated with this model, M1, is also considered in order to
help evaluate the range of uncertainty of the estimates and to see the
impact of the more complicated model. Table 3 provides the estimates of
averted illnesses.
Table 3--Estimated Illnesses and Total Averted Costs (TAC) Over 10 Years Together With Upper 95% Confidence
Limit for the Two Models Considered. Estimates Derived Using Mixed Effect Model With Assumption of Lognormal
Distribution (See Equations 2 and 3)
----------------------------------------------------------------------------------------------------------------
Upper 95%
Statistic Estimate limit linear Estimate M1 Upper 95%
linear model model model limit M1 model
----------------------------------------------------------------------------------------------------------------
Tot ill for Sal................................. 0.7 1.9 0.5 1.7
Tot ill for LM.................................. 0.3 0.6 0.4 1.0
[[Page 19967]]
Tot ill for E coli.............................. 5.6 8.7 4.0 10.6
----------------------------------------------------------------------------------------------------------------
The residuals of these models do not appear to be normally
distributed, based on the QQ plots (for both the linear and model M1)
given in Figure 3, with occasional large residuals. The QQ plots take
on the appearance it does because of many results with no illnesses.
However, the models provide estimated values of [lambda] (Equation 1)
that are close to the actual illnesses, thus, conditionally, the
goodness-of-fit, as determined by the closeness of the estimated value
of [lambda] and the number of illnesses is good. Using a chi-square
approximation, of the square of the difference between the estimated
[lambda] and the actual number of illnesses, divided by [lambda], for
the linear model, the sum of these terms over the 75 observations is
14.3; for all recalls for which the illnesses are reported as zero, the
largest estimated value of [lambda] is 1.04, which is not inconsistent;
the largest difference is about 2, which occurs for a recall that
reported 11 illnesses for which the estimated value of [lambda] is
9.06. This data point is the one with the largest residual (top right
corner of the top graph of Figure 3). For the model M1, the chi-square
statistic is slightly larger (20.4 because for one recall with 1
reported illness, the estimated value of [lambda] is 0.06 (whereas for
the linear model the estimated value of [lambda] is 0.10); thus the
chi-square statistic associated with this observation is large, causing
the larger chi-square statistic compared to that for the linear model.
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[GRAPHIC] [TIFF OMITTED] TN11AP11.004
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In conclusion, the estimates of the averted illnesses are highly
uncertain because of the small number of data points and the high
degree of variability of these data, leading to statistical uncertainty
regarding the predicted number of illnesses given a model and
uncertainty regarding the best model to use for estimating the number
of averted illnesses. However, from the above models, it appears that,
with 95% confidence, the expected number of illnesses would be, on
average, no more than about 1 illness per year averted, over the 10
years, with expected total averted costs as much as about $120,000,
depending upon the model used.
These estimates though reflect (only) expectations, and do not
include the possibilities of averted cost for a given expected value.
There is a distinct probability that one of these averted illnesses
could result in severe, long
[[Page 19969]]
term illness, or death. In that case the averted costs would be
substantially larger than the expected costs that are being estimated
above.
Appendix 2: Data Used in Analysis
----------------------------------------------------------------------------------------------------------------
Reported
Assigned days before recall Volume (lbs) illnesses Pathogen
----------------------------------------------------------------------------------------------------------------
4.............................................. 50 0 E coli.
4.............................................. 65 0 E coli.
4.............................................. 375 0 E coli.
6.............................................. 128 0 E coli.
6.............................................. 219 0 E coli.
6.............................................. 345 0 E coli.
6.............................................. 884 0 E coli.
6.............................................. 1900 0 E coli.
6.............................................. 4663 0 E coli.
6.............................................. 6152 0 E coli.
7.............................................. 75 0 E coli.
7.............................................. 925 0 E coli.
9.............................................. 26669 0 E coli.
10............................................. 4240 0 E coli.
11............................................. 780 0 E coli.
13............................................. 13275 0 E coli.
14............................................. 16743 0 E coli.
17............................................. 13150 0 E coli.
22............................................. 1560 0 E coli.
26............................................. 1084384 0 E coli.
30............................................. 68670 0 E coli.
50............................................. 2340 0 E coli.
50............................................. 4200 0 E coli.
50............................................. 20460 0 E coli.
52............................................. 420 0 E coli.
56............................................. 39973 0 E coli.
88............................................. 3516 0 E coli.
55............................................. 5920 1 E coli.
123............................................ 173554 1 E coli.
45............................................. 95927 2 E coli.
8.............................................. 107943 5 E coli.
64............................................. 188000 6 E coli.
72............................................. 95898 6 E coli.
14............................................. 259230 8 E coli.
30............................................. 3300000 8 E coli.
43............................................. 117500 9 E coli.
58............................................. 845000 10 E coli.
42............................................. 2758 11 E coli.
72............................................. 129000 17 E coli.
65............................................. 380000 20 E coli.
51............................................. 5700000 27 E coli.
47............................................. 545699 29 E coli.
45............................................. 153630 33 E coli.
365............................................ 21700000 40 E coli.
63............................................. 1360000 42 E coli.
43............................................. 5300000 54 E coli.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Reported
Assigned days before recall Volume (lbs) illnesses Pathogen
----------------------------------------------------------------------------------------------------------------
6.............................................. 1591 0 LM.
7.............................................. 16 0 LM.
7.............................................. 285 0 LM.
7.............................................. 290 0 LM.
7.............................................. 4535 0 LM.
7.............................................. 6970 0 LM.
8.............................................. 130 0 LM.
8.............................................. 172 0 LM.
8.............................................. 290 0 LM.
8.............................................. 750 0 LM.
8.............................................. 39514 0 LM.
10............................................. 6907 0 LM.
11............................................. 872 0 LM.
11............................................. 70400 0 LM.
12............................................. 140 0 LM.
13............................................. 930 0 LM.
14............................................. 207 0 LM.
15............................................. 5250 0 LM.
22............................................. 564 0 LM.
40............................................. 2268 0 LM.
[[Page 19970]]
47............................................. 28610 0 LM.
52............................................. 3590 0 LM.
72............................................. 1 0 LM.
136............................................ 2184 0 LM.
137............................................ 3780 0 LM.
137............................................ 10368 0 LM.
192............................................ 286320 2 LM.
61............................................. 466236 14 Sal.
63............................................. 825769 42 Sal.
----------------------------------------------------------------------------------------------------------------
[FR Doc. 2011-8408 Filed 4-8-11; 8:45 am]
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