Federal Register, Volume 76 Issue 182 (Tuesday, September 20, 2011)

[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Proposed Rules]
[Pages 58157-58165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24043]

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Proposed Rules
Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 76, No. 182 / Tuesday, September 20, 2011 /
Proposed Rules

[[Page 58157]]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 416, 417, and 430

[Docket No. FSIS-2010-0023]

Shiga Toxin-Producing Escherichia coli in Certain Raw Beef
Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final determination and request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) intends to carry
out verification procedures, including sampling and testing
manufacturing trim and other raw ground beef product components, to
ensure control of both Escherichia coli O157:H7 (E. coli O157:H7) and
six other serogroups of Shiga toxin-producing E. coli (STEC) (O26, O45,
O103, O111, O121, and O145). The Agency intends to implement sampling
and testing for the additional STEC. FSIS has determined that they, as
well as O157:H7, are adulterants of non-intact raw beef products and
product components within the meaning of the Federal Meat Inspection
Act (FMIA). The Agency is publishing guidance for use in validating
commercial pathogen detection test kits that may be capable of
detecting the STEC of concern. Finally, the Agency is planning a
comprehensive survey of its field personnel who are stationed in beef
slaughtering and processing establishments, similar to the 2007
``checklist'' survey, to determine the processing practices that are
employed to reduce the likelihood of contamination of intact and non-
intact beef products with these STEC.

DATES: To receive full consideration, comments should be received by
November 21, 2011.
FSIS intends to implement routine testing for the six additional
STEC discussed in this document beginning March 5, 2012, following its
comment period. To allow industry time to implement possible changes to
food safety systems, FSIS will generally not regard raw, non-intact
beef products or the components of such products found to have these
pathogens as adulterated until it begins this routine testing. FSIS
will affirm, in an additional Federal Register notice, the date that it
plans to implement sampling and testing.

ADDRESSES: FSIS invites interested persons to submit comments on this
document. Comments may be submitted by either of the following methods:
Federal eRulemaking Portal: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the online instructions at that site for
submitting comments.
Mail, including floppy disks or CD-ROMs, and hand- or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture (USDA), FSIS, Docket Clearance Unit, 8-164, Patriots Plaza
III, 355 E Street, SW., Washington, DC 20024-3221.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2010-0023. 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 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.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Assistant
Administrator, Office of Policy and Program Development, Food Safety
and Inspection Service, U.S. Department of Agriculture, (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Table of Contents

Background
I. Shiga Toxin-Producing E. coli: E. coli O157:H7 FSIS and Industry
Actions
II. Non-O157 STEC
III. Stakeholder Input
Petition to Declare All Enterohemorrhagic STEC to be Adulterants
Letter to Secretary of Agriculture from American Meat Institute
IV. STEC Policy Implementation
Implementation, Status of Laboratory Methods
On-Going Work
Expected Industry Response
New Checklist
State Programs and Foreign Government Programs
Time-frame for Complete Enforcement
Validation Guidance for Pathogen Detection Test Kits
V. Anticipated Costs and Benefits Associated With This Policy
Costs to the Agency
Costs to the Industry
Expected Benefits
Avoided Recalls
Impact on Small Business
Summary of Requests for Comment
USDA Nondiscrimination Statement
Additional Public Notification

Background

I. Shiga Toxin-Producing E. coli: E. coli O157:H7

While most strains of common intestinal bacteria of the E. coli
species are harmless, and are not adulterants of raw meat, some strains
are highly pathogenic. The Shiga toxin-producing E. coli (STEC) may
cause illnesses of varying severity, from diarrhea (often bloody) and
abdominal cramps to, rarely, kidney disorders. Shiga toxin is the same
toxin as is produced by Shigella, the bacteria that cause dysentery. In
some instances, the toxin will bind to tissues in the kidneys and cause
hemolytic uremic syndrome (HUS), leading to kidney failure and death.
STEC also may cause asymptomatic infections and extraintestinal
infections.\1\
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\1\ U.S. Centers for Disease Control and Prevention. 2005. Shiga
toxin-producing Escherichia coli (STEC). National Notifiable
Diseases Surveillance System (NNDSS), 2005 Case Definition. http://www.cdc.gov/ncphi/disss/nndss/casedef/shiga_current.htm, accessed
September 11, 2010.
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Since the 1990s, FSIS has considered a particular strain of STEC,
E. coli O157:H7, to be an adulterant of raw, non-intact beef products
and the raw intact components used to manufacture these products. On
September 28, 1994, in a speech to the American Meat Institute, then-
FSIS Administrator Michael R. Taylor stated, ``To clarify an important
legal point, we consider raw ground beef that is contaminated with E.
coli O157:H7 to be adulterated within the meaning of the [FMIA]. We are
prepared to use the Act's enforcement tools, as necessary, to exclude
adulterated product from commerce.

[[Page 58158]]

* * * We plan to conduct targeted sampling and testing of raw ground
beef at plants and in the marketplace for possible contamination.'' Mr.
Taylor further stated, ``We know that the ultimate solution to the (E.
coli) O157:H7 problem lies not in comprehensive end-product testing but
rather in the development and implementation of science-based
preventive controls, with product testing to verify process control.''
\2\
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\2\ Michael R. Taylor, FSIS Administrator. September 29, 1994.
``Change and Opportunity to Improve the Safety of the Food Supply.
Speech to American Meat Institute Annual Convention, San Francisco,
CA.
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FSIS currently conducts verification procedures, including testing
of ground beef products, beef manufacturing trimmings, and other raw
ground beef product components for the presence of E. coli O157:H7.
This pathogen can cause bloody diarrhea and other serious infections,
particularly in vulnerable persons--the very young, the
immunocompromised, and the elderly. Very few cells of E. coli O157:H7
are necessary to cause illness. While residing on the exterior surfaces
of contaminated carcasses and primal and subprimal cuts of meat, the
organisms can also contaminate the interior of ground product or other
beef products--such as needle-tenderized or vacuum-tumbled product--
when the protective surfaces of these products have been penetrated. If
these products do not undergo rigorous heat treatment or other
effective processing, the organisms can survive to cause human illness.
FSIS issued a policy statement (64 FR 2803; Jan. 19, 1999) that
stated, ``* * * [g]iven the low infectious dose of [E. coli O157:H7]
associated with foodborne disease outbreaks and the very severe
consequences of an [E. coli O157:H7] infection, the Agency believes
that the status under the FMIA of beef products contaminated with [E.
coli O157:H7] must depend on whether there is adequate assurance that
subsequent handling of the product will result in food that is not
contaminated when consumed.'' FSIS stated that, with the exception of
intact cuts of muscle that are to be distributed for consumption as
intact cuts, an E. coli O157:H7-contaminated beef product must not be
distributed until it has been processed into a ready-to-eat product,
i.e., a food that can be consumed safely without further cooking or
other preparation. FSIS therefore deemed adulterated E. coli O157:H7-
contaminated non-intact products and intact cuts that are to be further
processed into non-intact products before being distributed for
consumption.
In October 2002, FSIS published a rule (67 FR 62325; Oct. 7, 2002)
requiring all manufacturers of beef products to reassess their HACCP
plans relating to E. coli O157:H7 because the prevalence of the
pathogen on cattle brought to slaughter was higher than expected.\3\
FSIS issued compliance guidance for establishments on controlling E.
coli O157:H7.
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\3\ U.S. Department of Agriculture. Food Safety and Inspection
Service. E. coli 0157:H7 Contamination of Beef Products. Oct. 7,
2002. 67 FR 62325.
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The beef industry held a summit in January 2003 to develop a
unified plan and ``best practices'' for E. coli O157:H7 reduction. The
industry introduced several mitigation techniques to reduce the
prevalence of E. coli O157:H7 from the slaughterhouse to the grinding
establishment. Recommended preventive measures included testing the
hides and pre-eviscerated carcasses of cattle in order to benchmark
whether and how the sanitary dressing procedures and antimicrobial
interventions are effective in reducing bacterial contamination,
targeting research on the development of effective interventions and
implementing robust microbiological testing schemes. For the production
of ground products, the recommendations included stopping the practice
of carrying over product from one production day to the next, a
practice that had resulted in a major recall of ground beef. The
industry continues to use many of these techniques in controlling E.
coli O157:H7 and has been focusing increasingly on risk reduction from
the farm to the table.

II. Non-O157 STEC

As mentioned above, E. coli O157:H7 is not the only STEC that can
enter the meat supply and cause illness.\4\ FSIS is aware that other
STEC serogroups may be present in cattle, and can contaminate beef and
other meat products and that consumption of products containing certain
pathogenic STEC can produce a range of symptoms from mild, non-bloody
diarrhea to HUS and death, primarily in very young, elderly, or
immunocompromised individuals.
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\4\ There are approximately 300 to 400 known STEC serotypes that
carry various Stx alleles and many of these serotypes and some of
the Stx alleles have not been implicated in illness. These various
STEC serotypes can be found in soil, water, and other foods and have
even been reported to be present in the intestinal tracts of healthy
humans. However, very few of the 300-400 non-O157 STEC have been
conclusively identified as having caused illness due to being in the
U.S. meat supply.
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The most prevalent pathogenic non-O157 STEC serogroups in the
United States are O26, O45, O103, O111, O121, and O145.\5\ While more
than 50 STEC serogroups have been associated with human illness, U.S.
Centers for Disease Control and Prevention (CDC) data shows that over
70 to 83 percent of confirmed, serogrouped non-O157 STEC illnesses are
caused by these six STEC serogroups.\6\ All of these non-O157 STEC
strains can cause hemorrhagic colitis and all except O45 have been
shown to cause hemolytic uremic syndrome.\7\ We note that the illnesses
associated with these strains have not primarily been due to
contamination on beef.
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\5\ Brooks, J.T., and E.G. Sewers, J.G. Wells, K.D. Greene, P.M.
Griffin, R. M. Hoekstra, and N.A. Strockbine. 2005. Non-O157 Shiga
Toxin-Producing Escherichia coli Infections in the United States,
1983-2002. JID 2005:192 (October 15) 1422-1429.
\6\ Centers for Disease Control and Prevention. Bacterial
Foodborne and Diarrheal Disease National Case Surveillance Annual
Reports, 2003-2006. Available at http://www.cdc.gov/nationalsurveillance/case_surveillance.html.
\7\ See Table 2 of the DRAFT Risk Profile for Pathogenic Non-
O157 Shiga Toxin-Producing Escherichia coli later in this document.
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Though limited data are available on dose response, there is
evidence that the infectious doses of these non-O157 STEC are
relatively low. For example, an investigation of an outbreak of STEC
O26 from fermented beef sausage in Denmark yielded an infectious dose
of 100 cells.\8\ From an outbreak of O111 STEC in beef sausage in
Australia, investigators extrapolated a dose range of 1 to 10
organisms, given as few as 1 cell per 10 g of sausage.\9\ Using the
concentrations of STEC O145 in contaminated ice cream in an outbreak in
Belgium, the estimated infective dose was 400 CFU.\10\ This is
comparable to illness from E. coli O157:H7, which can result from
infection with as few as 10 cells.\11\ Although some of these outbreaks
were attributable to contamination of products other than those the
Agency regulates, the information from them shows how virulent these
pathogenic STEC can be.
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\8\ Boel, J., et al. 2009.
\9\ Paton AW, Ratcliff RM, Doyle RM, Seymour-Murray J, Davos D,
Lanser JA, and Paton JC. 1996. Molecular microbiological
investigation of an outbreak of hemolytic-uremic syndrome caused by
dry fermented sausage contaminated with Shiga-like toxin-producing
Escherichia coli. J Clin Microbiol. 34(7):1622-7.
\10\ Buvens G, Poss[eacute] B, De Schrijver K, De Zutter L,
Pi[eacute]rard D, Lauwers S, and Pierard D. 2011. Virulence
Profiling and Quantification of Verocytotoxin-Producing Escherichia
coli O145:H28 and O26:H11 Isolated During an Ice Cream-Related
Hemolytic Uremic Syndrome Outbreak. Foodborne Pathog Dis. 8(3):1-6.
\11\ Tilden J. Jr, Young W., McNamara A.M., Custer, C., Boesel,
B., Lambert-Fair, M.A., Majkowski, J., Vugia, D., Werner, S.B.,
Hollingsworth, J., and Morris, J.G. Jr. 1996. A new route of
transmission for Escherichia coli: infection from dry fermented
salami. Am J Public Health. 86(8):1142-5.

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[[Page 58159]]

There is also evidence that the thermal resistance of these strains
is high enough that they can survive ordinary cooking of ground beef
products. A recent study examining thermal resistance of STEC-
inoculated non-intact beef revealed that E. coli O157:H7 and non-O157
STEC (a pooled composite of STEC serogroups O45, O103, O111, O121, and
O145) had similar thermal inactivation profiles (Luchansky, unpublished
data).\12\ The recent outbreak in which ground beef was implicated as
the vehicle of infection and other evidence shows that STEC O26
survives typical cooking.\13\
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\12\ Luchansky, J.B. 2010. Unpublished data. Portions of this
research were presented at the Annual Meeting of the International
Association for Food Protection, August 1-4, 2010, Anaheim, CA.
\13\ Duffy G, Walsh C, Blair IS, and McDowell DA. 2006. Survival
of antibiotic resistant and antibiotic sensitive strains of E. coli
O157 and E. coli O26 in food matrices. Int J Food Microbiol.
109(3):179-86.
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Illnesses from person-to-person transmission of STEC serogroups
O26, O45, O103, O111, O121, and O145 have been documented, particularly
in daycare settings and nursing homes, where there is close contact
between persons with immature or compromised immune systems and/or
underdeveloped personal hygiene skills. This occurs when an infected,
sometimes asymptomatic, person sheds bacteria in feces and subsequent
contamination of food or fomites occurs. STEC serogroups O26, O45,
O103, O111, O121, and O145 have been isolated from beef carcasses or
retail beef in the U.S. ^{14 15 16}
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\14\ Bosilevac JM and M Koohmaraie. 2011. Prevalence nd
Characterization of Non-0157 Shiga toxin Producing Escherichia coli
Isolated from Commercial Ground Beef in the United States. Appl
Environ Microbiol. Published ahead of print on 21 January 2011,
doi:10.1128/AEM.02833-10.
\15\ Samadpour M. 2011. Prevalence of Toxin containing non-O157
Escherichia coli found in Commercial Ground Beef. In preparation.
\16\ Arthur TM, Barkocy-Gallagher GA, Rivera-Betancourt M, and
Koohmaraie M. 2002. Prevalence and characterization of non-O157
Shiga toxin-producing Escherichia coli on carcasses in commercial
beef cattle processing plants. Appl Environ Microbiol. 68(10):4847-
52.
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With full consideration of the information described above, FSIS
has determined that raw, non-intact beef products that are contaminated
with these STEC O26, O45, O103, O111, O121, and O145, are adulterated
within the meaning of 21 U.S.C. 601(m)(1). Raw, non-intact beef
products that are contaminated with these pathogens are also
unhealthful and unwholesome (under 21 U.S.C. 601(m)(3)). FSIS also
considers adulterated intact cuts that are contaminated with these
serogroups if they are to be further processed into raw, non-intact
products before being distributed for consumption.
FSIS has developed a laboratory methodology for detection and
isolation of these serogroups from beef, thereby allowing development
of an enforceable policy program targeted to control STECs O26, O45,
O103, O111, O121, and O145. FSIS will verify establishment controls for
these pathogens and will collect product samples in support of its
verification efforts as well as to inform the Agency's regulatory
program with regard to the pathogens. Establishments that manufacture
raw, non-intact beef products or intact raw beef components of those
products will be expected to evaluate whether these non-O157 STEC are
hazards reasonably likely to occur in their products. FSIS will
generally not regard raw, non-intact beef products or the components of
such products found to have these pathogens as adulterated until FSIS
implements a routine sampling program that will include, besides E.
coli O157:H7, six additional STEC serogroups (O26, O45, O103, O111,
O121, and O145). However, if product is associated with an STEC
outbreak before that time, such product will be subject to recall,
consistent with current FSIS practice.

III. Stakeholder Input

On October 17, 2007, FSIS, the Food and Drug Administration's
Center for Food Safety and Applied Nutrition (FDA, CFSAN), and the CDC
held a public meeting to solicit input from industry, consumers,
academia, and other public health and regulatory agencies on the issue
of whether some non-O157 STEC should be considered adulterants (72 FR
57285).\17\ At the public meeting, FSIS indicated that the Agency was
considering non-O157 STEC to be adulterants but also discussed the need
to conduct further research to address the issues associated with these
microorganisms. At the meeting, FSIS also acknowledged the need to
develop the laboratory capacity to support policy decisions with
respect to non-O157 STEC. The Agency requested public input on these
issues.
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\17\ For the transcript and presentations, go to http://www.fsis.usda.gov/News_&_Events/2007_Events/index.asp (accessed
Jul. 20, 2010).
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Petition To Declare All Enterohemorrhagic STEC To Be Adulterants

On October 5, 2009, Marler Clark, LLP, PS, and other parties
petitioned FSIS to issue an interpretive rule declaring all
enterohemorrhagic STEC to be adulterants within the meaning of the
FMIA. They specifically cited 21 U.S.C. 601(m)(1), under which a meat
or meat food product is adulterated if it bears or contains any
poisonous or deleterious substance that may render it injurious to
health. The petitioners argued that applying the provision to STEC in
addition to serogroup O157 is justified because current scientific and
medical research demonstrates that the dangers associated with E. coli
O157:H7 extend to all pathogenic STEC. They referred to the potential
for non-O157 STEC to cause HUS, the prevalence of the non-O157 STEC
among foodborne pathogens, cattle as reservoirs of the pathogen, the
presence of non-O157 STEC in beef products, and the implication of non-
O157 STEC in outbreaks of foodborne illness. Because these non-O157
STEC have the same characteristics as O157 STEC, they argued, these
pathogens ought to have the same legal status as O157 STEC.\18\
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\18\ http://www.fsis.usda.gov/PDF/Petition_Marler_100509.pdf
(Accessed Nov. 30, 2010).
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In an addendum to the petition, filed February 22, 2010,
petitioners submitted a copy of a 2007 journal article by FDA
scientists detailing a PCR method for identifying isolates that include
the six most prevalent non-O157 STEC. The petitioners also provided a
study that they commissioned to analyze retail ground beef samples.\19\
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\19\ http://www.fsis.usda.gov/PDF/Petition_Marler_Clark_022210.pdf and http://www.fsis.usda.gov/PDF/Petition_Marler_Cover%20Letter.pdf (Accessed Nov. 30, 2010.)
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In correspondence with the petitioners, FSIS stated that when the
Agency had an appropriate laboratory method for conducting regulatory
sampling for some non-O157 STEC and had developed a plan for how it
intends to address the issue, it would make the plan available to the
public for comment. The Agency would then provide a final response to
the petition.\20\
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\20\ Philip S. Derfler, Assistant Administrator, Office of
Policy and Program Development, FSIS/USDA. April 8, 2010. Letter to
William Marler, Esq., Marler-Clark, LLP, PS. At: http://www.fsis.usda.gov/PDF/Petition_Marler_Clark_Progress_Response.pdf (Accessed Nov. 30, 2010.)
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The petitioners filed a Supplemental Statement of Additional
Grounds on May 7, 2010. In their Supplemental Statement, they cited
studies of illness outbreaks linked to non-O157 STEC and a paper on the
feasibility of testing ground beef and milk for Shiga-like toxin-
producing E. coli.\21\ The petitioners filed a Second Supplemental
Statement of Additional Grounds on September 2, 2010, in light of the
STEC

[[Page 58160]]

O26 outbreak, discussed below, that was linked to ground beef. They
attached a May 21, 2010, CDC memorandum on Non-O157 STEC outbreaks in
the United States. The memorandum, referring to a recent STEC O145
outbreak in romaine lettuce, expressed the opinion that as the ability
of clinical laboratories to detect non-O157 STEC has improved, more of
the organisms were being detected.
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\21\ Acheson, D.W.K., et al. 1996. Detection of Shiga-like
Toxin-Producing Escherichia coli in Ground Beef and Milk by
Commercial Enzyme Immunoassay. J. Food Prot. 59:4:344-349.
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Letter to Secretary of Agriculture From American Meat Institute

In an August 18, 2010, letter from American Meat Institute (AMI)
President and CEO J. Patrick Boyle to Secretary of Agriculture Tom
Vilsack, AMI offered to work with the Department on the control of
STEC. AMI expressed concern that the designation of non-O157 STEC as
adulterants might ``result in a misdirected regulatory program that
would do more harm than good.'' AMI addressed several matters relating
to FSIS policy on non-O157 STEC and the extent to which the non-O157
STEC are a health risk. We have considered these concerns and
recommendations as we have developed this policy.
FSIS regards testing of non-intact raw beef products and components
of products as just one of several verification methods the Agency
uses. These include verification of establishment HACCP systems,
Sanitation Standard Operating Procedures (Sanitation SOPs) and other
prerequisite programs, comprehensive food safety assessments, and
checks on records of purchases from suppliers.
FSIS actively engages experts and the public in ongoing discussions
of public health issues and the science associated with our actions.
For example, FSIS held public meetings on non-O157 STEC policy in 2007
and 2008 that involved presentations by domestic and international
experts from Government, industry, and academia. Participants discussed
the bases for determining non-O157 STEC to be adulterants,
epidemiological evidence of increasing incidence of non-O157 STEC, and
the importance of barriers and interventions in food production and
processing to prevent contamination with STEC. The Agency is planning
further evaluations and will use the findings to assess industry
compliance and controls for pathogens in raw beef products. FSIS
requests comments on whether to hold a technical meeting during the
comment period for this document or later.
FSIS has prepared guidance for the validation of test kits for the
detection of pathogens, including both E. coli O157:H7 and non-O157
STEC (see below). This guidance should enable test kit developers to
determine the effectiveness of their products. Also, as discussed
elsewhere in this document, FSIS is making available its screening and
isolation methods for non-O157 STEC. These methods were included in the
Agency's Microbiology Laboratory Guidebook.
FSIS intends to perform a nationwide microbiological baseline
survey on beef carcasses in late 2011. This microbiological survey will
analyze samples from carcasses for the presence of the pathogens E.
coli O157:H7 and the STEC identified in this rule, Salmonella, and
indicator bacteria (generic E. coli, coliforms, and
Enterobacteriaceae). Regarding the analytical method to be used, FSIS
is making its method publicly available and will include it in the
Agency's Microbiological Laboratory Guidebook.

IV. STEC Policy Implementation

Implementation, Status of Laboratory Methods

As noted above, FSIS intends by March 5, 2012, to begin
implementing a routine sampling program that will include, besides E.
coli O157:H7, six additional STEC serogroups (O26, O45, O103, O111,
O121, and O145). FSIS will initially sample raw beef manufacturing
trimmings and other ground beef product components produced
domestically and imported, and test the samples for these serogroups.
When FSIS implements its testing program, the Agency will consider
other products, including raw ground beef contaminated with any of the
six additional STEC serogroups to be adulterated. The Agency is
planning later--as soon as laboratory capacity is available--to expand
this program to conduct verification testing of ground beef products
for these serogroups. Data gathered from the sampling will enable the
Agency to gauge more precisely the level of hazard posed by these STEC.
In general, FSIS will review the information and adjust its policies
and implementation strategies consistent with direction in Executive
Order 13563 to retrospectively analyze rules ``that may be outmoded,
ineffective, insufficient, or excessively burdensome, and to modify,
streamline, expand, or repeal them in accordance with what has been
learned.'' FSIS will issue a Federal Register document informing
stakeholders before expanding its verification testing to include raw
beef products other than beef manufacturing trimmings and other ground
beef components.
When FSIS samples trim or other ground beef components, FSIS will
now test up to two portions of product (up to 325 g per portion)
collected at an establishment to test for E. coli O157:H7 and, upon
initiation of the actions outlined in this document, for the additional
six non-O157 STEC (serogroups O26, O45, O103, O111, O121, and O145).
Also, a single 325-g ground beef sample will now be tested for E. coli
O157:H7 upon initiation of the actions outlined in this document.
FSIS has previously tested five separate 65-g sub-samples of the
sample collected at an establishment for E. coli O157:H7. An Agency
study showed the new method to be not as sensitive as the old method in
detecting the lowest levels (1-4 CFR/325g) of E. coli O157:H7 cells.
However, the difference in sensitivity was not statistically
significant. Using the new method would permit FSIS to analyze more
samples at the same or less laboratory costs than the present method.
Because the sensitivity of the new method is comparable, if not
actually equal, to that of the present method, FSIS expects the new
approach to yield laboratory cost efficiencies with no significant
statistical difference in the analytical results.
The Agency will use the new modified trypticase soy broth with
novobiocin plus casaminoacids (mTSB+n) enrichment medium described in
the FSIS Microbiology Laboratory Guidebook MLG chapters 5.06 and 5B.01
the preparation step of its procedure for identifying the six non-O157
STEC. Testing for non-O157 STEC with a polymerase-chain-reaction (PCR)
test involves a two-stage PCR screening test: the first stage will
detect samples positive for stx and eae (intimin). In the second stage,
samples will be screened for the presence of one of the six public
health-relevant serogroups (O26, O45, O103, O111, O121, and O145). A
sample will be identified as ``potential positive'' when it tests
positive for the stx gene and the eae gene and is also positive for one
or more of the target O-group genes (on day three of the analysis).
Samples that are ``potential positive'' are further analyzed by
using immunomagnetic beads to capture the target analyte. The
immunomagnetic beads are used to inoculate Rainbow Agar plates. After
incubation (day 4 of the analysis), the plates are observed for
colonies that have an appearance typical of the target analyte. Typical
colonies are tested with latex agglutination reagents specific for the
target serogroup, if at least one colony tests positive by latex
agglutination, the sample is called ``presumptive

[[Page 58161]]

positive.'' This is similar to E. coli O157:H7 analysis; typical
colonies are tested using latex agglutination reagents on analytical
day 4.
Samples that screen positive at the first stage of testing (stx+,
eae+) for non-O157 STEC but screen negative at the second stage (O-
group negative) will not be regarded as potential positive results.
FSIS would not consider the results to be evidence of adulteration.
However, such screen-positives do indicate the potential presence of an
organism capable of producing Shiga toxin (stx) and intimin (eae) and
may indicate conditions that allow pathogenic STEC through the system.
Therefore, FSIS will use these results to inform its verifications of
HACCP system adequacy, in accordance with 9 CFR 417.8.
In order for a sample to be ``confirmed positive,'' FSIS will
further characterize the isolates by biochemical tests. A confirmed
positive sample will be one where an isolate has stx, eae, and one or
more of the target O-group genes and has been biochemically confirmed
to be E. coli. (By comparison, a sample is confirmed positive for E.
coli O157:H7 if biochemical tests identify the isolate as an E. coli,
serological or PCR tests identify it as an O157, and serological or PCR
tests detect Shiga toxin production, or are positive for the stx gene,
or determine the isolate to be ``H7.'')
The detection and isolation methodology for non-O157 STEC is
described in chapter MLG 5B.00, or current revision, of the FSIS
Microbiology Laboratory Guidebook, available at: http://www.fsis.usda.gov/PDF/Mlg_5B_00.pdf. FSIS will advise the
establishment to hold the sampled product and not release it pending
negative test results. If test results are positive and product has
been released into commerce, FSIS will request that the producing
establishment recall that product.
FSIS estimates that most sampled product will screen negative for
non-O157 STEC at the first stage of testing and that the negative
results will be available within 48 hours of shipment of the samples to
the laboratory. For samples that screen positive, an additional three
to five days may be necessary for a confirmed positive or negative
result. However, as the Agency gains experience and data, and as the
performance of test methods improves, the Agency hopes to reduce the
time needed to obtain definitive results.
For imported products tested at port of entry, if the product tests
positive at the second stage and has been not been held at the import
establishment, it will be subject to recall. If the product has been
held, the product will be refused entry. As always, product
subsequently presented for import inspection from the same foreign
country and establishment will be held at the official import
establishment pending results. The FSIS Office of International Affairs
will notify the program officials of the affected exporting country as
soon as a positive result is reported, so that they can determine
whether the producing establishment has exported any other product from
the same production lot to the United States. As in the control of E.
coli O157:H7, if the foreign establishment has properly defined the
product lot on the basis of specific control factors, and accurately
tracked the containerization of product produced under those controls,
the establishment can reduce the likelihood that adulterated product
will enter commerce, and can more easily recover product if a sample is
positive.
Control factors recommended by FSIS for use in defining the product
and container destined for the United States include E. coli sampling
programs for distinguishing production subsets; cross-contamination
preventions incorporated in Sanitation SOPs; re-work controls; and
other prerequisite programs. Other control factors may include sanitary
dressing procedures; employee hygiene, processing interventions that
limit or reduce E. coli contamination; elimination of ``carry over'' of
manufacturing trimmings, raw beef components, or re-work from one
production period to the next; and sanitation of product contact
surfaces, including machinery and employee hand tools.
Generally, FSIS recommends that establishments develop and
implement in-plant sampling plans that define production lots or sub-
lots that are microbiologically independent of other production lots or
sub-lots. Production lots that are so identified may bear distinctive
markings on the shipping cartons and--on exported product--foreign
health certificates. If a foreign government or establishment does not
apply control factors, FSIS may default to defining the product
represented by a microbiological sample as all product produced on a
particular production day.
FSIS expects to begin the non-O157 STEC program by analyzing raw
beef manufacturing trimmings and other ground beef product components.
For imported product, FSIS intends to conduct sampling of imported beef
manufacturing trim and ground beef components at official import
inspection establishments.
FSIS believes that, by testing trim samples and other components
for the non-O157 STEC, the Agency can offer an immediate measure of
public health protection commensurate with the Agency's regulatory
requirements. The Agency expects eventually to test ground beef,
hamburger, and beef patty products for STEC. In taking a staged
approach to the implementation of this new testing program, the Agency
should be able to use its resources most effectively.

Expected Industry Response

The beef industry currently applies a range of sanitary slaughter
methods to control E. coli O157:H7 in raw non-intact beef products.
These include hide washing, sanitary hide removal, pre-evisceration
organic acid rinses, spot cleaning of carcasses with viscera
contamination, thermal pasteurization of dressed carcasses to reduce
microbial loads, and chilled carcass treatments. These methods are
typically applied in a slaughter plant sanitation program to prevent
the carry-over of bacterial contamination from the farm or feedlot to
the slaughter floor and meat processing areas.
Many establishments that produce raw non-intact beef products, such
as ground beef, incorporate such antimicrobial interventions as organic
acid sprays in their processing. These methods should be as effective
in controlling non-O157 STEC as they are in controlling E. coli
O157:H7. In this respect, the industry would incur no additional
processing costs in controlling non-O157 STEC as a result of the policy
the Agency is adopting. However, from the experience in controlling E.
coli O157:H7, FSIS anticipates that many firms will want to implement
their own testing programs and even to conduct the same kind of testing
that FSIS plans to carry out. Some firms already test their products
for E. coli O157:H7 and provide the further processing, wholesale, or
retail businesses they supply with certificates of analysis on the
product testing they have conducted. They may want to test for non-O157
STEC and certify to their customers that they have done so.
FSIS will follow the same procedures with respect to non-O157 STEC
as it follows for E. coli O157:H7. A first-stage screen positive (stx
and eae) is evidence of the presence of Shiga toxin and intimin and may
indicate that an establishment is not adequately addressing hazards
reasonably likely to occur. Establishments should reassess their HACCP
plans, Sanitation Standard Operating Procedures, or other prerequisite
programs on the basis of

[[Page 58162]]

this evidence. If the reassessment results indicate that pathogenic
STEC are reasonably likely to occur in the production process, the
establishment's HACCP plan must address them.

New Checklist

In addition, in the coming months, FSIS plans to conduct a new
``checklist'' survey of its field inspection personnel who are
stationed in beef slaughtering and processing establishments. As they
did in 2007 with respect to E. coli O157:H7, inspection personnel at
official establishments that slaughter, fabricate, grind, mechanically
tenderize, or enhance by tumbling, massaging, or injecting beef
products with substances such as marinades will complete an on-line
checklist on how the establishments address STEC. This checklist will
provide information on this class of establishments regarding the
methods they use to prevent product contamination.

State Programs and Foreign Government Programs

States that have their own meat inspection programs for meat
products produced and transported solely within the State are required
to have mandatory ante-mortem and post-mortem inspection, reinspection,
and sanitation requirements that are at least equal to those in the
Federal Meat Inspection Act (21 U.S.C. 661(a)(1)). Therefore, these
States' sampling procedures and testing methods for non-O157 STEC in
raw beef products must be at least as sensitive as FSIS's procedures
and testing methods for non-O157 STEC.
Foreign countries that are eligible to export meat products to the
United States must apply inspection, sanitary, and other standards that
are equivalent to those that FSIS applies to those products (21 U.S.C.
620). Thus, in evaluating a foreign country's meat inspection system to
determine the country's eligibility to export products to the United
States, FSIS will consider whether the testing methods and procedures
for non-O157 STEC that the country applies are equivalent to those that
FSIS uses.

Time-Frame for Complete Enforcement

FSIS intends to be able to begin implementing regulatory sampling
for the six non-O157 STEC in March 2012. FSIS would take action on
positive samples following the same procedures as those currently
followed with respect to samples that test positive for E. coli
O157:H7.
In an effort to increase awareness of this policy, FSIS will
conduct extensive outreach to FSIS- and State-regulated small and very
small meat establishments throughout the U.S. and its territories in
2011 and early 2012 as well as to foreign countries. The Agency plans
to hold workshops and webinars throughout the United States. FSIS will
announce exact locations and dates of these events once they are
determined. In addition, FSIS will extend its outreach to these
establishments by participating at conferences, trade shows, and
meetings that cater to meat producers, and developing and disseminating
written articles, and audio podcasts on the changes. FSIS welcomes
comments on this implementation plan and on whether the Agency should
hold a public meeting on the issues addressed in this document during
the public comment period.

Validation Guidance for Pathogen Detection Test Kits

FSIS is announcing the availability of a compliance guide on
validating performance of pathogen test kit methods. FSIS will post
this compliance guide on its Significant Guidance Documents Web page
(http://www.fsis.usda.gov/Significant_Guidance/index.asp). FSIS
encourages those organizations that design or conduct validation
studies for foodborne pathogen testing methods to avail themselves of
this guidance document in meeting the pertinent regulatory
requirements. FSIS is also soliciting comments on this compliance
guide. The Agency will consider carefully all comments submitted and
will revise the guide as warranted.

Note: The use of ``validation'' in the guidance document is not
intended to have any application to the implementation of 9 CFR
417.4(a)(1) (Validation, Verification, Reassessment) on initial
validation of HACCP plans.

V. Anticipated Costs and Benefits Associated With This Policy

FSIS has estimated that implementation of its non-O157 STEC testing
policy will result in costs to FSIS laboratories and to the regulated
industry. However, the costs are low for a policy that we believe is
warranted, given the information presented above, and we believe that
the benefits justify the costs.

Budgetary Costs to the Agency

There will be direct, immediate costs to FSIS laboratories for
analyzing trim samples for non-O157 STEC. The Agency has estimated
these costs to be approximately $204,050 to $338,270 per year in 2010
dollars, depending on the number of samples analyzed.\22\ The costs
include equipment, supplies and labor for screening, screen-positive
isolations, most-probable-number (MPN) procedures, MPN-positive
isolation, pulsed-field gel electrophoresis (PFGE), and PFGE-positive
isolation.\23\ Some key assumptions behind these cost estimates are as
follows:
---------------------------------------------------------------------------

\22\ The costs are about $204,100 if 2,578 samples are collected
and analyzed, or $338,300 if 4,600 samples are collected and
analyzed. Please see assumption in the text.
\23\ Data are from the Laboratory Director, Office of the
Assistant Administrator, Office of Public Health Science, FSIS.
---------------------------------------------------------------------------

Because the laboratory analysis of samples of beef trim
and other components for non-O157 STEC is an extension of the program
for E. coli O157:H7, we only have to estimate the marginal or
additional cost. There is no additional cost for shipping or sample-
collection time.
The annual number of samples is the same as the number of
E. coli O157:H7 beef trim samples--currently an average of 2,578
samples for beef trim and other components are analyzed per year (2008-
2010, sample collection rate about 45 percent).\24\ However, the Agency
is aiming to increase the sample collection rate to 80 percent. In that
case, the annual number of samples to be analyzed will be about 4,600.
---------------------------------------------------------------------------

\24\ Data are from the Data Analysis and Integration Group, the
Office of Data Integration and Food Protection, FSIS. The numbers of
samples include both domestic and imported product samples.
---------------------------------------------------------------------------

Screen-positive sample rate is 2 percent, the same as with
E. coli O157:H7.
Confirmed positive sample rate is 0.5 percent, again the
same as with O157:H7.\25\
---------------------------------------------------------------------------

\25\ Data are from the Laboratory Director, Office of the
Assistant Administrator, OPHS, FSIS.
---------------------------------------------------------------------------

FSIS will conduct follow-up testing as it does for E. coli O157:H7.
The Agency data show that the average number of domestic follow-up
testing in 2008-2010 is about 880.\26\ The Agency also estimates that
the cost per follow-up testing is about $80. Therefore, the cost for
follow-up testing will be about $70,400.
---------------------------------------------------------------------------

\26\ Data is from Data Analysis and Integration Group, the
Office of Data Integration and Food Protection. The numbers of
samples include both domestic and imported product.
---------------------------------------------------------------------------

In addition, FSIS will conduct a for-cause food safety assessment
(FSA) for every positive sample, as it does currently for E. coli
O157:H7-positive samples. The Agency estimates the average cost to
conduct an FSA (including laboratory work) to be about $14,000.
Assuming the foregoing, the cost to FSIS to conduct the for-cause FSA
related to non-O157 STECs will be

[[Page 58163]]

about $180,460 to $322,140 per year (i.e. cost per FSA x annual number
of samples x confirmed positive sample rate).\27\ Adding the cost to
conduct sample testing, follow-up testing and for-cause FSAs, the total
cost to the Agency is about $454,910 to $730,810. Note that these cost
estimates do not include the costs of expanding testing to raw ground
beef products. FSIS intends to provide a full analysis of costs before
expanding the testing policy.
---------------------------------------------------------------------------

\27\ Data are from the Laboratory Director of Office of the
Assistant Administrator, OPHS, FSIS and from the Budget Division,
Office of Management, FSIS.
---------------------------------------------------------------------------

Costs to the Industry

The major costs to the industry will be two-fold: (1) Costs to
establishments of starting their own screening for non-O157 STEC and
(2) costs of diverting the positive product to cooking or other
treatment that would render the product suitable for human food.
(Positive-testing product also can be destroyed--sent to a landfill,
incinerated, etc.--or rendered into pet food and other products not for
human food.) To estimate these costs with precision, we need to know
how many establishments will be testing for non-O157 STEC under this
document and their HACCP sizes (large, small, or very small). Because
the Agency cannot predict with certainty either the number of
establishments or the size distribution, our estimate is preliminary.
FSIS is not aware of data on how many establishments are currently
testing for non-O157 STEC, or the size distribution of these
establishments. The Agency's best estimate is that about 20 percent of
the establishments are testing.\28\ According to information collected
under FSIS Notice 65-07, 33 percent of the beef slaughter
establishments test for E. coli O157:H7.\29\ Assuming that the
percentage of establishments testing for non-O157 would increase to the
same level (i.e. 33 percent), we would see 13 percent more
establishments starting to test for non-O157 because of this document.
The most current Agency beef trim volume survey data, computed from the
number of bins of trim produced, show that the total beef trim
production is about 2.05 billion pounds per year.\30\ Given that in
commercial testing a combo bin is 2,000 pounds, an additional 133,000
combo bins will be tested (total beef trim production/weight per combo
bin x additional percentage that will test). Further assuming the cost
per test is $30 to $40, the preliminary estimate for the cost of the
additional 13 percent of establishments testing for non-O157 is about
$4.0 million (if $30 per test) to $5.3 million (if $40 per test.) \31\
This is a preliminary estimate and we invite the regulated industry and
the public to comment.
---------------------------------------------------------------------------

\28\ This is based on internal experts' opinion.
\29\ U.S. Department of Agriculture. Food Safety and Inspection
Service. August, 2008. Results of Checklist and Reassessment of
Control for Escherichia coli O157:H7 in Beef Operations. Table
5.4.31, p. 57.
\30\ Data are from Applied Analysis Branch, Data Analysis and
Integration Group, Office of Data Integration and Food Protection/
FSIS/USDA as of October 12, 2010.
\31\ Other assumptions behind this estimate include: (1)
Positive sample rate being 2 percent--the same with the positive
sample rate in FSIS sampling, (2) one test per sample, and (3) using
IEH methodology.
---------------------------------------------------------------------------

To estimate the loss of value from diverting the products to
cooking once they test positive, we rely on market data on the
wholesale price for beef trim and on internal experts' opinion on the
price differential between beef trim and cooked beef products. Market
data show that the 3-year average wholesale price for beef trim is
about $1.47 per pound.\32\ Agency experts estimate that the value for
cooked beef products is significantly lower--only about one-half to
one-third of the value of beef trim, because the quality of product
directed to cooking is generally inferior. On the basis of this
assumption, we calculate the loss to the industry from diverting the
products to cooking to be about $3.9 to $5.2 million.\33\ Again, this
is a very preliminary estimate, and we invite comment.
---------------------------------------------------------------------------

\32\ Economic Research Service (ERS), USDA, Market and Trade
Economics Division provided the data; which are originally from Red
Meats Yearbook (http://usda.mannlib.cornell.edu/MannUsda/viewDocumentInfo.do?documentID=1354) and Livestock, Dairy, and
Poultry Newsletter tables (http://www.ers.usda.gov/publications/ldp/LDPTables.htm) [both accessed Jan. 20, 2011]. The 3-year range is
September 2007 to August 2010.
\33\ The equation for calculating the cost for diverting product
to cooking is: annual beef trim produced (in pound) x screening
positive sample rate x percentage of the value lost x dollar value
per pound x percentage of additional establishments testing for
STEC.
---------------------------------------------------------------------------

As for the cost of holding the products while awaiting test
results, Agency data show that the great majority of the establishments
are already holding their products while awaiting the results of other
pathogen testing.\34\ The Agency cannot estimate with precision how
many more products will be held as a result of FSIS testing for one
more pathogen group, but given that the great majority of the products
are already being held, the addition is not likely to be significant.
Because non-O157 STEC tests will use the samples collected for existing
sampling programs, there will be no additional collection of samples.
For the establishments that are already holding products for O157 and
other pathogen test results, the additional cost will only be holding
for one extra day waiting for the confirming non-O157 STEC results,
which is minimal. For the few establishments that are not holding
products, they would have to do so under the proposed ``Test and Hold''
Notice, and the additional cost would also only be holding for one more
day waiting for the non-O157 STEC results.
---------------------------------------------------------------------------

\34\ According to the most recent full-year data (2009) from
Data Analysis and Integration Group/Office of Data Integration and
Food Protection, the percentages of beef trim and components held by
establishments pending FSIS E. coli O157:H7 test results are: 99
percent by large, 97 percent by small and 88 percent by very small
establishments. Data are as of December 23, 2010.
---------------------------------------------------------------------------

As we have stated in this document, many establishments that
produce raw non-intact beef products implement controls for E. coli
O157:H7. These methods should be as effective in controlling non-O157
STEC as in controlling E. coli O157:H7. In this respect, the industry
would incur no additional processing costs in controlling non-O157 STEC
as a result of this document.
Note that these cost estimates do not include the costs associated
with expanding FSIS testing to raw ground beef products. FSIS intends
to provide a full analysis of costs before expanding the testing
policy.

Expected Benefits

Reduced Illnesses and Deaths
One benefit from sampling and testing for non-O157 STEC is the
reduction of illnesses and deaths caused by non-O157 STEC, if testing
leads to preventative controls that reduce the risk of illness. As we
have stated, controls for E. coli O157:H7 already in place should be as
effective in controlling non-O157 STEC as in controlling E. coli
O157:H7, and the industry would not need to take additional measures to
control non-O157 STEC as a result of the document. However, to the
extent that establishments reassess their HACCP plans after receiving
positive test results and make appropriate additional changes, overall
control of pathogens may improve and illness reductions may result.
Avoided Recalls
Through early detection of products contaminated with non-O157
STEC, this new program may prevent some food recalls. However, on net,
the additional testing may increase the total number of recalls as the
new policy would require the recall of all products that test positive
and have entered commerce, regardless of whether they are

[[Page 58164]]

associated with an outbreak or not. Any recall may have a significant
impact on the industry, including the loss of sales revenue, the cost
to dispose of recalled products, and the loss of consumer confidence
and business reputation. Recalls negatively impact consumers by
creating anxiety and time-consuming inconveniences (e.g. looking for
recall information, checking the products purchased, returning or
disposing of products identified by the recalls, etc.). For the
Government, the Agency incurs costs for conducting recalls \35\ and
recovery of adulterated products. The Food and Drug Administration has
estimated that a Class I recall \36\ may cost as much as $3 to $5
million for the manufacturer, retailers, and State, local, and Federal
authorities.\37\
---------------------------------------------------------------------------

\35\ This includes inspectors' activities at the establishments,
FSAs and recall effectiveness checks, and dissemination of
information about recalls through press releases.
\36\ A Class I recall is defined as a health hazard situation
where there is a reasonable possibility that the use of the products
will cause serious, adverse health consequences. Non-O157 STEC
outbreak fits in this category.
\37\ Preliminary Regulatory Impact Analysis and Initial
Regulatory Flexibility Analysis of the Proposed Rules to Ensure the
Safety of Juice Products, 63 FR 24258, May 1, 1998.
---------------------------------------------------------------------------

The first and only FSIS non-O157 STEC recall to date took place in
August 2010. It is not clear how many recalls would have occurred if
the new testing policy had been implemented or whether, on net, the
policy will decrease or increase the number of recalls.
Net Benefits
As explained in the Expected Costs and Expected Benefits Sections,
there are uncertainties in our cost and benefit estimates. For example,
we do not know how many illnesses will actually be prevented. It is not
clear whether on net there will be a reduction in the number of
illnesses. It is also challenging to know what the industry cost will
be because it is difficult to predict how many establishments will
start to test and what the size distribution will be or to what extent
industry will take additional measures that will prevent, reduce, or
control those hazards, as they do with regard to O157 STEC.\38\
However, the Agency has determined that the potential public health
benefits justify the costs.
---------------------------------------------------------------------------

\38\ One common measure that establishments use is purchase
specifications in a prerequisite program. FSIS Directive 10,010.1
stipulates that FSIS expects the establishment to have: (1) A
document from each supplier that provides assurance that the
supplier employs CCPs (critical control points) that address E. coli
O157:H7, (2) certificates of analysis and the sampling method used
by the supplier, and (3) records that verify on an on-going basis
that the receiving establishment is executing its program
effectively. Other measures establishment can use include (a)
treating or washing the product when removed from Cryovac bags and
trimming the outer surface before processing non-intact product, and
(2) using antimicrobials or other lethality treatments on raw beef
product and verifying the effectiveness of those antimicrobials.
(FSIS Directive 10,010.1)
---------------------------------------------------------------------------

Impact on Small Business ³⁹
---------------------------------------------------------------------------

\39\ Based on FSIS' HACCP (Hazard Analysis and Critical Control
Points) size definition: very small establishments have fewer than
10 employees or generate less than $2.5 million in annual sales; and
small establishments have 10 or more but fewer than 500 employees
and generate more than $2.5 million in annual sales.
---------------------------------------------------------------------------

This FSIS document on non-O157 STEC does not impose a testing
requirement on official establishments. As mentioned above,
establishments are already required to identify hazards reasonably
likely to occur and to take measures that will prevent, eliminate, or
reduce those hazards under HACCP. The measures could include purchase
specifications in a prerequisite program, sanitary activities, and
using antimicrobials or other lethality treatments on raw beef product.
Establishments that produce non-intact raw beef products, such as
ground beef, or the intact raw components of those products, must
already operate food safety systems that control STEC O157. Therefore,
this document does not impose significant negative impact on a
significant number of small and very small businesses. FSIS is
requesting comment on the impact of this document on small businesses.

Summary of Requests for Comment

FSIS is requesting comment on the following specific subjects
discussed in this document related to non-O157 STEC serogroups O26,
O45, O101, O121, and O145:

FSIS regulatory sampling plan for non-O157 STEC for the above
serogroups
Suggestions for baseline survey of non-O157 STEC prevalence in
certain raw beef products
Whether a technical meeting on methods for controlling non-
O157 STEC should be held during the comment period
Whether to hold an additional public meeting on the plan for
implementing the policy on non-O157 STEC
Validation guidance for pathogen detection test kits
Preliminary estimates of the cost per test for non-O157 STEC
Estimates of the loss to industry of diverting positive-
testing product to cooking
The usefulness of technical workshops for small and very small
establishments
What obstacles might prevent establishments from adjusting to
the FSIS policy on non-O157 STEC by March 5, 2012 and what alternative
implementation date would be more practical
What education, outreach, or training materials would be of
greatest assistance to establishments in preparing for implementation
of the Agency's policy
For foreign governments, what additional information would be
helpful in addressing equivalency or implementation concerns not
already addressed in this document and accompanying materials

We are also requesting comment on the DRAFT Risk Profile for Pathogenic
Non-O157 Shiga Toxin-Producing Escherichia coli that we are making
available at http://www.fsis.usda.gov/PDF/Non_O157_STEC_Risk_Profile.pdf. FSIS undertook the preparation of the risk profile to help
clarify the extent of the scientific literature available for
evaluating the issues raised by the Citizen's Petition.

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 the
public and in particular minorities, women, and persons with
disabilities, are aware of this document, FSIS will announce it on-line
through the FSIS Web page located at http://www.fsis.usda.gov/regulations/2010_Notices_Index/.
FSIS also will 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,

[[Page 58165]]

FSIS public meetings, and other types of information that could affect
or would be of interest to our constituents and stakeholders. The
Update is communicated via Listserv, a free e-mail subscription service
consisting of industry, trade, and farm groups, consumer interest
groups, allied health professionals, scientific professionals, and
other individuals who have requested to be included. The Update also is
available on the FSIS Web page. Through Listserv and the Web page, FSIS
is able to provide information to a much broader, more diverse
audience. In addition, FSIS offers an e-mail subscription service which
provides automatic and customized access to selected food safety news
and information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/. Options range
from recalls, export information, regulations, directives, and notices.
Customers can add or delete subscriptions themselves, and have the
option to password protect their accounts.

Done, at Washington, DC, September 13, 2011.
Alfred V. Almanza,
Administrator.
[FR Doc. 2011-24043 Filed 9-19-11; 8:45 am]
BILLING CODE 3410-DM-P