Shiga Toxin-Producing Escherichia coli, 58157-58165 [2011-24043]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food Safety and Inspection Service

[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Proposed Rules]
[Pages 58157-58165]
From the Federal Register Online via the Government Printing 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 https://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 https://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. https://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 https://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 https://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\ https://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\ https://www.fsis.usda.gov/PDF/Petition_Marler_Clark_022210.pdf and https://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: https://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: https://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 
(https://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:
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    \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.
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     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.
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    \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.
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     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\
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    \25\ Data are from the Laboratory Director, Office of the 
Assistant Administrator, OPHS, FSIS.
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    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.
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    \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.
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    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.
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    \27\ Data are from the Laboratory Director of Office of the 
Assistant Administrator, OPHS, FSIS and from the Budget Division, 
Office of Management, FSIS.
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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.
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    \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.
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    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.
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    \32\ Economic Research Service (ERS), USDA, Market and Trade 
Economics Division provided the data; which are originally from Red 
Meats Yearbook (https://usda.mannlib.cornell.edu/MannUsda/viewDocumentInfo.do?documentID=1354) and Livestock, Dairy, and 
Poultry Newsletter tables (https://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.
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    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.
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    \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\
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    \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.
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    \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)
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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 https://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 fo