Not Applying the Mark of Inspection Pending Certain Test Results, 19952-19970 [2011-8408]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food Safety and Inspection Service

[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 19952-19970]
From the Federal Register Online via the Government Printing 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 https://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 https://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 https://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
----------------------------------------------------------------------------------------------------------------
2007:
    FSIS............................                  7                  7                  0                 14
2008:
    FSIS............................                  7                 12                  0                 19
2009:
    FSIS............................                  8                  3                  0                 11
                                     ---------------------------------------------------------------------------
        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.
---------------------------------------------------------------------------

    \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 https://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 https://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 FS