[Federal Register Volume 67, Number 194 (Monday, October 7, 2002)]
[Rules and Regulations]
[Pages 62325-62334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25504]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 417

[Docket No. 00-022N]


E. coli O157:H7 Contamination of Beef Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Compliance with the HACCP system regulations and request for 
comment.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing 
this document to inform manufacturers of beef products of the Agency's 
views about the application of the hazard analysis and critical control 
point (HACCP) system regulations to contamination with Escherichia coli 
(E. coli) O157:H7.
    FSIS believes that the availability of certain scientific data on 
E. coli O157:H7 constitutes a change that could affect an 
establishment's hazard analysis or alter its HACCP plans for raw beef 
products. Therefore, under the HACCP regulations, if establishments 
have not already reassessed their HACCP plans for raw beef products in 
light of this data, they must do so now. Establishments that have not 
already reassessed their HACCP plans in light of this data must 
reassess their HACCP plans to determine whether E. coli O157:H7 
contamination is a hazard reasonably likely to occur in their 
production process. This requirement applies to HACCP plans for all raw 
beef products, including ground beef, other non-intact beef products, 
and intact beef products. If reassessment results in a determination 
that E. coli O157:H7 contamination is a food safety hazard reasonably 
likely to occur in the establishment's production process, then it must 
be addressed in a HACCP plan.
    All establishments producing raw beef products are required to 
reassess their HACCP plans. However, establishments receiving product 
for grinding may have purchase specifications requiring all their 
suppliers to have one or more critical control points (CCPs) validated 
to eliminate or to reduce E. coli O157:H7 below detectable levels. Such 
establishments may determine that no additional steps to address this 
pathogen are necessary in their production process. Establishments 
adopting this approach should incorporate these purchase specifications 
and their means of ensuring that their specifications are met in their 
HACCP plans, in their Sanitation SOPs, which FSIS has recognized as 
prerequisites for HACCP, or in other prerequisite programs.
    In addition, FSIS is issuing new guidance material related to the 
control of E. coli O157:H7 and is making available the Agency's draft 
comparative risk assessment of intact and non-intact (blade tenderized) 
steaks. (See ADDRESSES.) Additionally, FSIS will be issuing a revised 
E. coli O157:H7 sampling and testing Directive and this notice 
discusses the revisions expected to be made.
    FSIS invites comments on the matters presented in this notice, on 
its guidance material, and on the draft comparative risk assessment.

DATES: Comments may be submitted by December 6, 2002. Establishments 
that produce raw beef products, and that have not already reassessed 
their HACCP plans for those products in light of the scientific data on 
E. coli O157:H7 discussed in this notice, are to reassess their HACCP 
plans by the following dates according to plant size: December 6, 2002 
for large plants (all establishments with 500 or more employees); 
February 4, 2003 for small plants (all establishments with 10 or more 
employees but fewer than 500); and April 7, 2003 for very small plants 
(all establishments with fewer than 10 employees or annual sales of 
less than $2.5 million).
    See the SUPPLEMENTARY INFORMATION for FSIS verification dates.

ADDRESSES: Submit one original and two copies of written comments to 
FSIS Docket Clerk, Docket No. 00-022N, U.S. Department of Agriculture, 
Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12th 
Street, SW, Washington, DC 20250-3700. All comments submitted in 
response to this document and the guidance material will be available 
for public inspection in the Docket Clerk's office between 8:30 a.m. 
and 4:30 p.m., Monday through Friday. The draft comparative risk 
assessment of intact and non-intact (blade tenderized) steaks is also 
available on the Internet at: http://www.fsis.usda.gov/OPPDE/rdad/publications.htm. FSIS is making the guidance material available today 
at the same Internet address.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Director, 
Regulations and Directives Development Staff, Food Safety and 
Inspection Service, U.S. Department of Agriculture (202) 720-5627.

SUPPLEMENTARY INFORMATION:

HACCP

    The Food Safety and Inspection Service (FSIS) administers a 
regulatory program under the Federal Meat Inspection Act (FMIA) (21 
U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 
U.S.C. 451 et seq.) to protect the health and welfare of consumers by 
preventing the distribution of meat and poultry products that are 
unwholesome, adulterated, or misbranded. To further the goal of 
reducing the risk of foodborne illness from meat and poultry products 
to the maximum extent possible, FSIS issued final regulations on July 
25, 1996, mandating Pathogen Reduction-Hazard Analysis and Critical 
Control Point (HACCP) Systems for federally inspected establishments 
(61 FR 38806). These regulations require that federally inspected 
establishments take preventive and corrective measures at each stage of 
the food production process where food safety hazards occur.
    Part 417, the regulations on HACCP systems, requires a hazard 
analysis to determine the food safety hazards reasonably likely to 
occur in the production process and to identify the preventive measures 
an establishment can apply to control those hazards in the production 
of particular products (Sec.  417.2(a)). Ten potential hazard areas, 
including microbiological contamination, are listed to guide 
establishments in this analysis (Sec.  417.2(a)(3)). Whenever a hazard 
analysis reveals one or more such hazards are reasonably likely to 
occur in the production process, the regulations require that the 
establishment develop and implement a written HACCP plan, for each 
product, that includes specified control measures for each hazard so 
identified (Sec.  417.2(b)(1) and (c)).
    Section 417.2(a)(1) provides that a food safety hazard is 
reasonably likely to occur if a prudent establishment would establish 
control measures because the hazard historically has occurred, or 
because there is a reasonable possibility that it will occur

[[Page 62326]]

in the particular type of product being processed, in the absence of 
those controls.
    The likelihood that a food safety hazard will occur in the 
production process for a particular product at a given location, and 
the identification and adequacy of preventive measures to control a 
likely hazard, must be determined by each establishment. Obviously, 
conditions that affect such determinations may change over time. For 
this reason, the HACCP system regulations require that every 
establishment reassess the adequacy of its HACCP plans at least 
annually and whenever any changes occur that could affect the 
underlying hazard analysis or alter the HACCP plans (Sec.  
417.4(a)(3)). New information regarding the fact that E. coli O157:H7 
is more prevalent than was previously thought is such a change. When 
reassessment reveals that a plan no longer meets the requirements for 
the contents of a HACCP plan, the establishment must modify the plan 
immediately (Sec.  417.4(a)(3)).

E. coli O157:H7 Policy

    In 1994, FSIS notified the public that raw ground beef contaminated 
with E. coli O157:H7 is adulterated under the FMIA unless the ground 
beef is further processed to destroy this pathogen. Also in 1994, FSIS 
began sampling and testing ground beef for E. coli O157:H7. (For the 
Agency's current sampling and testing program instructions, see FSIS 
Directive 10,010.1, Microbiological Testing Program for Escherichia 
coli O157:H7 in Raw Ground Beef, February 1, 1998, available on the 
Internet at http://www.fsis.usda.gov/ oppde/rdad/publications.htm and 
in the Docket Clerk's office.)
    On January 19, 1999, FSIS published a policy statement, ``Beef 
Products Contaminated with E. coli O157:H7'' (64 FR 2803). This 
statement explained the Agency's policy governing beef products that 
contain E. coli O157:H7. The Agency stated that, in evaluating beef 
products contaminated with E. coli O157:H7, it would distinguish intact 
cuts of muscle (e.g., steaks and roasts) distributed for consumption 
from non-intact products (e.g., beef that has been mechanically 
tenderized by needling or cubing) and from intact cuts of muscle that 
are to be further processed into non-intact product prior to 
distribution for consumption (e.g., manufacturing trimmings for use in 
production of ground beef). This statement explained that intact cuts 
of beef that are to be further processed into non-intact product prior 
to distribution for consumption must be treated in the same manner as 
non-intact cuts of beef because pathogens may be introduced below the 
surface of these products when they are further processed into non-
intact products. Manufacturing trimmings (i.e., pieces of meat 
remaining after steaks, roasts, and other intact cuts are removed) are 
an example of this type of product. Although manufacturing trimmings 
may be intact, they are generally further processed into non-intact 
product.
    The Agency stated that if non-intact products or intact products 
that are to be further processed into non-intact product prior to 
distribution for consumption are found to be contaminated with E. coli 
O157:H7, they must be processed into ready-to-eat product, or they 
would be deemed to be adulterated (64 FR 2804). FSIS explained that 
pathogens, including E. coli O157:H7, may be introduced below the 
surfaces of non-intact products as the result of the processes by which 
they are made. As a result, customary cooking of these products may not 
be adequate to kill the pathogens. In contrast, the meat interior of 
intact products remains protected from pathogens migrating below the 
exterior. Consequently, customary cooking of these products will 
destroy any E. coli O157:H7. Finally, in this Federal Register notice, 
FSIS requested comments and recommendations relevant to the Agency's 
policy and to any regulatory requirements that might be appropriate to 
prevent the distribution of beef products adulterated with this 
pathogen.
    On March 8, 1999, FSIS held a public meeting to discuss the policy 
addressed in its January 19, 1999, Federal Register notice. On February 
11, 2000, FSIS announced that it would hold a public meeting on 
February 29, 2000, to discuss recent developments concerning E. coli 
O157:H7 (65 FR 6881). In the February 11, 2000, Federal Register 
notice, FSIS also responded to comments received concerning the 
Agency's E. coli O157:H7 policy and again requested comments. On 
February 29, 2000, FSIS held the public meeting on E. coli O157:H7. At 
the meeting, numerous organizations presented information on E. coli 
O157:H7. FSIS presented information on the new testing procedures that 
it is using for E. coli O157:H7 and on the FSIS risk assessment on E. 
coli O157:H7. The Agricultural Research Service (ARS) presented 
information on research concerning the incidence of E. coli O157:H7 in 
animals entering the slaughter plant and at various stages in the 
slaughter process. Also, the Centers for Disease Control and Prevention 
(CDC) presented information concerning its increased estimates for 
illnesses associated with E. coli O157:H7. A complete transcript of the 
February 29, 2000, public meeting is available on the Internet at 
http://www.fsis.usda.gov/oppde/rdad/frpubs/ecolimtg.pdf.
    On November 5, 2001, FSIS announced the availability of and 
requested comments on its draft risk assessment for E. coli O157:H7 in 
ground beef (66 FR 55912). At this time, FSIS also made the 
interpretive summary of the risk assessment and draft risk assessment 
available on the Internet. The draft risk assessment discusses and 
cites the studies discussed below. As stated below, under ``Relevant 
Data Requiring Reassessment,'' the data from some of these studies and 
FSIS surveillance data provided evidence that E. coli O157:H7 is more 
prevalent than was thought before these data became available.

Risk of E. coli O157:H7 Contamination

    Exposure to E. coli O157:H7 has been linked to serious, life-
threatening human illnesses (hemorrhagic colitis and hemolytic uremic 
syndrome). At the February 29, 2000, public meeting, a representative 
from the CDC presented its national estimates for foodborne illnesses 
associated with E. coli O157:H7. These estimates showed an increase 
from previous CDC estimates of illnesses associated with E. coli 
O157:H7. At that time, CDC increased its estimates for illnesses 
associated with E. coli O157:H7 because surveillance data allowed a 
more detailed estimation of mild illnesses not resulting in physician 
consultation.\1\ As FSIS stated in the February 11, 2000, meeting 
notice, although not all these illnesses were attributable to beef, the 
increase in illness associated with E. coli O157:H7 indicated that this 
pathogen occurred more frequently than was previously thought (65 FR 
6882). CDC continues to collect data on the incidence of reported 
cases. Based on recent preliminary FoodNet data, there does not appear 
to be a sustained decrease in disease associated with E. coli 
O157:H7.\2\
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    \1\ For information on the estimates, see Mead, Paul S., et al., 
``Food-Related Illness and Death in the United States,'' Journal of 
Emerging Infectious Diseases, Vol. 5, No. 5, 1999.
    \2\ Morbidity and Mortality Weekly Report. 2002. Preliminary 
FoodNet Data on the Incidence of Foodborne Illnesses--Selected 
Sites, United States, 2001. Vol. 51, Number 15: 325-329.
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    Also at the public meeting, an FSIS representative presented 
information on the new E. coli O157:H7 testing procedures that the 
Agency began using on September 3, 1999. This method is approximately 
four times more sensitive

[[Page 62327]]

than the previous method. Prior to the introduction of the new FSIS 
testing method, the prevalence of E. coli O157:H7 in raw ground beef 
samples tested was 0.149 percent. Using the new method between 
September 3, 1999, and September 8, 2002, the prevalence of E. coli 
O157:H7 in raw, ground beef samples tested was 0.797 percent. This 
increase in E. coli O157:H7 prevalence in raw ground beef samples 
suggests that the low rate of positive findings in the past may have 
had more to do with the sensitivity of the method and size of the 
sample being used than with the rarity of the pathogen.
    Also at the February 29, 2000, public meeting, a representative 
from ARS presented information concerning a recent E. coli O157:H7 
prevalence study (hereinafter referred to as the Elder study).\3\ In 
this study of fed cattle, 28 percent (91 of 327) of fecal samples were 
positive for E. coli O157:H7. Previous studies of fed cattle had found 
a fecal prevalence of 2 percent (188 of 11,881 samples),\4\ 4 percent 
(38 of 1046 samples),\5\ 6 percent (14 of 240 samples),\6\ and, for the 
study hereinafter referred to as the Smith study, 23 percent (707 of 
3054 samples).\7\
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    \3\ Robert. O. Elder, et al. Correlation of Enterohemorrhagic 
Escherichia coli O157 Prevalence in Feces, Hides, and Carcasses of 
Beef Cattle During Processing. Proc Natl Acad Sci USA. Mar 2000. 
97(7): 2999-3003.
    \4\ Dargatz DA, Wells SJ, Thomas LA, et al. Factors associated 
with the presence of Escherichia coli O157 in feces of feedlot 
cattle. J. Food Prot. 1997; 60(5): 466-470.
    \5\ Hancock DD, Besser TE, Rice DH, et al. Multiple sources of 
Escherichia coli O157 in feedlots and dairy farms in the 
Northwestern USA. Prev. Vet. Med. 1998; 35: 11-19.
    \6\ Hancock DD, Rice DH, and Besser TE. 1999. Prevalence of E. 
coli O157:H7 in feedlot cattle at slaughter plants. Study funded by 
National Cattlemen's Beef Association. Washington State University.
    \7\ Smith, D, Blackford M, Younts S, et al. 2001. Ecological 
relationships between the prevalence of cattle shedding E. coli 
O157:H7 and characteristics of the cattle or conditions of the 
feedlot pen. J. Food Prot. 64(12): 1899-1903.
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    Three multistate studies reported the apparent prevalence of 
feedlots containing one or more infected cattle. Even if one animal in 
a herd was found positive for E. coli O157:H7 the herd was considered 
positive for E. coli O157:H7. These estimates were 63 percent (63 of 
100 feedlots),\8\ 100 percent (6 of 6 feedlots),\9\ and 100 percent (5 
of 5 feedlots).\10\ Although all the studies cited in the preceding 
sentence found a high proportion of herds to contain at least one 
animal that was positive for E. coli O157:H7, except for the Smith 
study, these studies did not find many animals within a specific herd 
to be positive for E. coli O157:H7. The Smith and Elder studies found 
higher within herd E. coli O157:H7 prevalence than all the other 
studies cited. That is, these studies found more animals within a 
specific herd to be positive for E. coli O157:H7 than the other studies 
did.
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    \8\ Dargatz DA, Wells SJ, Thomas LA, et al. Factors associated 
with the presence of Escherichia coli O157 in feces of feedlot 
cattle. J. Food Prot. 1997; 60(5): 466-470.
    \9\ Hancock DD, Besser TE, Rice DH, et al. Multiple sources of 
Escherichia coli O157 in feedlots and dairy farms in the 
Northwestern USA. Prev. Vet. Med. 1998; 35: 11-19.
    \10\ Smith, D, Blackford M, Younts S, et al. 2001. Ecological 
relationships between the prevalence of cattle shedding E. coli 
O157:H7 and characteristics of the cattle or conditions of the 
feedlot pen. J. Food Prot. 64(12): 1899-1903.
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    The study from ARS mentioned above (Elder 2000) also addressed the 
prevalence of E. coli O157:H7 on carcasses at preevisceration, at 
postevisceration, and at postprocessing. E. coli O157:H7 was found on 
43 percent (148 of 341) of the preevisceration carcasses, 18 percent 
(59 of 332) of the postevisceration carcasses, and 2 percent (6 of 330) 
of the postprocessing carcasses.
    In addition to fed cattle, culled breeding cattle (dairy and beef 
cows and bulls) are an important source of beef products. Four studies 
provided fecal prevalence evidence of E. coli O157:H7 of 1 percent (10 
of 1412 samples),\11\ 1 percent (52 of 4361 samples),\12\ 2 percent (89 
of 4031 samples),\13\ and 3 percent (7 of 205 samples).\14\
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    \11\ Hancock DD, Besser TE, Kinsel ML, Tarr PI, Rice DH, and 
Paros MG. The prevalence of Escherichia coli O157 in dairy and beef 
cattle in Washington State. Epidemiol. Infect. 1994; 113: 199-207.
    \12\ Garber L, Wells S, Schroeder-Tucker L, et al. Factors 
associated with fecal shedding of verotoxin-producing Escherichia 
coli O157 on dairy farms. J. Food Prot. 1999; 62(4): 307-312.
    \13\ Besser TE, Hancock DD, Pritchett LC, et al. Duration of 
detection of fecal excretion of Escherichia coli O157:H7 in cattle. 
J Infect. Dis. 1997; 175: 726-729.
    \14\ Rice DH, Ebel ED, Hancock DD, et al. Escherichia coli O157 
in cull dairy cows on farm and at slaughter. J. Food Prot. 1997; 
60(11): 1386-1387.
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    Five multistate studies reported the apparent prevalence of 
breeding herds containing one or more infected cattle. These estimates 
were 24 percent (22 of 91 herds),\15\ 61 percent (8 of 13 herds),\16\ 
75 percent (27 of 36 herds),\17\ 87 percent (13 of 15 herds),\18\ and 
100 percent (6 of 6 herds).\19\
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    \15\ Garber L, Wells S, Schroeder-Tucker L, et al. Factors 
associated with fecal shedding of verotoxin-producing Escherichia 
coli O157 on dairy farms. J. Food Prot. 1999; 62(4): 307-312.
    \16\ Hancock DD, Besser TE, Rice DH, et al. A longitudinal study 
of Escherichia coli O157 in fourteen cattle herds. Epidemiol. 
Infect. 1997; 118: 193-195.
    \17\ Hancock DD, Rice DH, Herriot DE, et al. Effects of farm 
manure handling practices on Escherichia coli O157 prevalence in 
cattle. J. Food Prot. 1997; 60(4): 363-366.
    \18\ Lagreid WW, Elder RO, and Keen JE. Prevalence of 
Escherichia coli O157:H7 in range beef calves. Epidemiol. Infect. 
1999; 123(2): 291-298.
    \19\ Hancock DD, Besser TE, Rice DH, et al. Multiple sources of 
Escherichia coli O157 in feedlots and dairy farms in the 
Northwestern USA. Prev. Vet. Med. 1998; 35: 11-19.
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    At the February 29, 2000, public meeting, FSIS presented 
preliminary results from the FSIS draft risk assessment for E. coli 
O157:H7 in ground beef. These preliminary results did not incorporate 
the evidence presented at this meeting from the ARS (Elder 2000). The 
best estimate of the prevalence of E. coli O157:H7 in live cattle 
destined for ground beef production was given as just over 10 percent. 
The bounds of uncertainty depended upon the class of animal considered, 
fed or culled, and ranged from less than 5 percent to greater than 15 
percent. For plants that slaughter culled cattle, the estimated 
prevalence of E. coli O157:H7-contaminated 2000 pound combo-bins was 
given as 15 percent, with a range from greater than 5 percent to less 
than 30 percent. For steers and heifers, the estimated combo bin 
prevalence was over 40 percent, with a lower bound greater than 20 
percent and an upper bound less than 60 percent.
    Trim from bins is mixed together and ground to achieve product with 
specific fat content. The mixing of the contents of several combo bins 
disperses the E. coli O157:H7 organisms and results in ground product 
with a lower concentration, but higher prevalence, of contamination 
than in the original bins. Preliminary risk assessment estimates 
suggested that nearly 90 percent of grinder loads had at least one E. 
coli O157:H7 organism present with a lower bound greater than 70 
percent and an upper bound greater than 95 percent.
    The estimates presented at the public meeting were preliminary and 
were premised on the assumption that slaughter plants were achieving an 
average of about 1.5 log10 reduction of E. coli O157:H7 as a result of 
decontamination measures taken after dehiding and after carcass 
splitting. At this time, FSIS does not have information about the level 
of log reduction for E. coli O157:H7 being achieved in specific 
slaughter operations or thereafter, or about whether the 1.5 log10 
reduction modeled in the risk assessment is comparable to what industry 
is achieving today. If validated interventions being used today result 
in more than a 1.5 log10 reduction, and

[[Page 62328]]

other factors remain the same, then the prevalence of E. coli O157:H7 
would be a lower percentage than that reflected in the preliminary risk 
assessment estimates. FSIS requests comment and data on these issues. 
FSIS is still reviewing the draft risk assessment and may further 
modify its estimates in the future.
    As noted above, on November 5, 2001, FSIS announced the 
availability of, and requested comments on, its draft risk assessment 
for E. coli O157:H7 in ground beef (66 FR 55912). At that time, FSIS 
also submitted the draft risk assessment to the National Academies of 
Science (NAS) for scientific peer review. FSIS received 6 comments in 
response to its request for comments in the Federal Register. FSIS is 
currently reviewing those comments. FSIS expects to receive NAS' 
comments concerning the risk assessment shortly and may revise the risk 
assessment based on NAS' comments and the public comments received.

Relevant Data Requiring Reassessment

    Studies before those of Smith and Elder suggested that E. coli 
O157:H7 prevalence rates within herds were low. A 1992-1993 FSIS 
baseline survey of steer and heifer carcasses found 4 (0.2%) of these 
carcasses E. coli O157:H7-positive, and a 1993-1994 FSIS baseline 
survey of cow and bull carcasses found none of the carcasses positive 
for E. coli O157:H7. The USDA's Animal and Plant Health Inspection 
Service-Veterinary Services-National Animal Health Monitoring System 
also completed on-farm surveys of dairy cattle in 1992 and feedlot 
cattle in 1994. These national surveys found E. coli O157:H7 in 0.4 
percent of dairy calves sampled and 1.6 percent of feedlot cattle 
sampled. Thus, these results suggested that E. coli O157:H7 occurred in 
cattle at a prevalence level that would require substantial numbers of 
samples to detect the organism in a population.
    The results from FSIS' E. coli O157:H7 testing program since FSIS 
began using its new testing method and certain research studies 
discussed above provide evidence that E. coli O157:H7 is more prevalent 
than was thought before these data became available, and that this 
pathogen may be a hazard that is reasonably likely to occur at all 
stages of handling raw beef products. The specific studies cited above 
that suggest that E. coli O157:H7 is more prevalent than previously 
thought in live cattle and carcasses are the study by Elder et al. and 
the study by Smith et al. (both cited above).
    FSIS is publishing this document to advise federally inspected 
establishments of the Agency's position on one aspect of its public 
health strategy to deal with E. coli O157:H7 contamination and to 
provide an opportunity for comment on that position, as FSIS continues 
to develop a comprehensive strategy. As explained under the HACCP 
discussion above, the regulations require that establishments reassess 
their HACCP plans whenever any changes occur that would affect their 
hazard analysis or alter their HACCP plans. The availability of FSIS 
testing data since FSIS began using the new testing method and the 
information from the Smith and Elder studies presented above is a 
change that requires establishments to reassess their HACCP plans 
because these data provided evidence that E. coli O157:H7 is more 
prevalent than was thought before this data became available.
    The Elder and Smith studies were completed in 2000 and 1999, 
respectively, and published thereafter, and FSIS surveillance data from 
its new testing method became available in 1999. FSIS has not 
previously informed manufacturers of beef products that it believes 
that the availability of these data constitutes a change that could 
affect an establishment's hazard analysis and alter its HACCP plans for 
raw beef products. The preliminary results of the draft risk assessment 
on E. coli O157:H7 support FSIS' position. No more recent data have 
become available that would affect FSIS' conclusions regarding the 
prevalence of E. coli O157:H7.
    Based on anecdotal information from its inspection program 
personnel and from In-Depth Verification Reviews (IDVs), FSIS believes 
that most establishments have not taken the data discussed above into 
account in their hazard analysis, and that establishments might not 
have addressed E. coli O157:H7 in their HACCP plans or, for grinding 
establishments, in programs that serve as prerequisites to HACCP plans. 
Therefore, the Agency is issuing this notice informing the public of 
its views concerning the implications of the E. coli O157:H7 data 
discussed above.
    According to the data from the studies discussed above, the fecal 
prevalence of E. coli O157:H7 in fed cattle is significantly higher 
than the fecal prevalence of E. coli O157:H7 in culled breeding cattle 
(dairy, beef cows, and bulls). However, FSIS believes that all 
establishments producing raw beef products, including those 
slaughtering culled breeding cattle or using meat from culled breeding 
cattle in processing, need to reassess their HACCP plans because the 
data show that E. coli O157:H7 is present in culled breeding cattle, 
because most slaughter establishments slaughter both fed and culled 
breeding cattle, and because most beef processing establishments use 
meat from both fed and culled breeding cattle. FSIS believes that 
establishments that slaughter both types of cattle or use both types of 
meat in processing would not develop different HACCP plans for 
slaughtering fed versus culled breeding cattle or for processing meat 
from fed versus culled breeding cattle.

Prior Reassessments Based on Relevant E. coli O157:H7 Data

    Because all establishments are required to reassess their HACCP 
plans at least annually according to Sec.  417.4(a)(3), all 
establishments should have reassessed their HACCP plans at least once, 
and possibly twice, since the February 29, 2000, public meeting. As 
noted above, at that public meeting, FSIS, ARS, and the CDC presented 
some of the data that provided evidence that E. coli O157:H7 was more 
prevalent than previously thought at that time, and that this pathogen 
may be a hazard that is reasonably likely to occur at all stages of 
handling raw beef products. In addition, FSIS placed the transcript 
from the public meeting on its web site shortly after the meeting. 
Finally, FSIS released the draft risk assessment, which discussed the 
published data that provide evidence that E. coli O157:H7 is more 
prevalent than previously thought, on its web page in November 2001.
    Because FSIS made some of the data discussed above available in 
2000 and released the draft risk assessment in 2001, establishments 
that produce raw beef products already may have reassessed their HACCP 
plans based on this data to determine whether E. coli O157:H7 is a 
hazard reasonably likely to occur in their production of these 
products, and, if so, whether their HACCP plans appropriately address 
this hazard. Establishments that already have taken the relevant E. 
coli O157:H7 data into account in a reassessment are not required to 
conduct another reassessment of their HACCP plans, provided these 
establishments have evidence of their reassessment based on this data 
that is available to FSIS inspection program personnel in their hazard 
analysis, HACCP plans, or record of reassessment. Establishments should 
have taken into account all of the data discussed above that suggest 
that E. coli O157:H7 is more prevalent than previously thought: the 
FSIS testing data and the data from the Smith and Elder studies.

[[Page 62329]]

Outcomes of Reassessments Based on Relevant E. coli O157:H7 Data

    Establishments that produce raw beef products that have not 
conducted a reassessment of their HACCP plans based on the relevant E. 
coli O157:H7 data discussed above to determine whether E. coli O157:H7 
is a hazard reasonably likely to occur in their production of these 
products, and, if so, whether their HACCP plans appropriately address 
this hazard, are required to conduct a reassessment. If this pathogen 
is a hazard reasonably likely to occur, then it must be addressed in a 
HACCP plan through one or more CCPs designed to control the pathogen.
    Even establishments that produce intact product will need to 
reassess their HACCP plans based on the new E. coli O157:H7 data. These 
establishments are required to reassess their HACCP plans because much 
intact beef product may be used to make non-intact product, such as 
ground beef. According to Sec.  417.2(a)(2), establishments are 
required to identify the intended use or consumers of the finished 
product. Therefore, to be able to determine the adequacy of their HACCP 
plans, establishments that produce intact beef products need to 
determine whether their products will be used to produce raw, non-
intact product.
    This document addresses only the need for HACCP plan reassessment. 
FSIS cannot predict the likelihood that an establishment producing raw 
beef products will need to incorporate, or alter, controls to prevent, 
eliminate, or reduce E. coli O157:H7 to an acceptable level (i.e., a 
level that would not be detectable using the FSIS testing method or a 
method with a sensitivity at least equivalent to FSIS' method) in one 
or more HACCP plans as a result of plan reassessment. FSIS does 
believe, however, that given the FSIS testing data and the data from 
the Elder and Smith studies discussed above, establishments should 
strongly consider the possibility that E. coli O157:H7 contamination is 
a hazard reasonably likely to occur in their production of beef 
products, especially if an establishment produces non-intact product 
that has been or could be adulterated with E. coli O157:H7 or produces 
intact product that is to be used for non-intact product, and this non-
intact product has been or could be found to be adulterated with E. 
coli O157:H7.
    In determining whether E. coli O157:H7 is a hazard reasonably 
likely to occur in the production process for their raw beef products, 
establishments should take into account whether their raw beef products 
have tested positive for E. coli O157:H7 in either FSIS or industry 
testing. They should also consider whether there is a reasonable 
likelihood of E. coli O157:H7 contamination of their raw beef products 
in the absence of controls (see Sec.  417.2(a)(1)).
    Although all establishments producing raw beef products are 
required to reassess their HACCP plans, some establishments may 
determine that they do not need to change their HACCP plans. For 
example, some establishments may already address E. coli O157:H7 in 
their HACCP plans. Even if these establishments did not take the FSIS 
testing data and the Smith and Elder data into account in their prior 
hazard analysis, they may determine that their HACCP plans are still 
adequate to prevent, eliminate, or reduce E. coli O157:H7 to an 
undetectable level in light of the data, and that these data do not 
affect their hazard analysis. Similarly, establishments that produce 
raw intact product that will not be further processed into raw, non-
intact product may determine that these data do not affect their hazard 
analysis, and that their HACCP plans do not need to be changed.

Critical Control Points and Sanitation SOPs and Other Prerequisite 
Programs

    The regulations require that establishments develop HACCP plans 
that include critical control points (CCPs): points, steps, or 
procedures in a food process at which a control can be applied, and, as 
a result, a food safety hazard can be prevented, eliminated, or reduced 
to acceptable levels. FSIS considers an acceptable reduction for E. 
coli O157:H7 to be a reduction to an undetectable level.
    Because controls to reduce the risk of E. coli O157:H7 
contamination when the product is still intact may be the best means of 
controlling the hazard, FSIS believes that slaughter establishments and 
deboning establishments should strongly consider putting in place one 
or more validated CCPs that are designed to eliminate or reduce E. coli 
O157:H7 and other pathogens. If such establishments have controls in 
place to address E. coli O157:H7 specifically, they cannot conclude 
that the pathogen is not a hazard reasonably likely to occur in the 
absence of those controls. FSIS believes that any interventions that 
slaughter and deboning establishments use to address E. coli O157:H7 
should be incorporated into their HACCP plans. At this time, FSIS is 
not aware of any prerequisite programs that are appropriate for use in 
slaughter and deboning establishments to address E. coli O157:H7. FSIS 
advises that it intends to scrutinize very closely the hazard analyses 
and HACCP plans of those slaughter or deboning establishments that 
conduct, or have conducted, a reassessment and decide that an 
intervention for E. coli O157:H7 is not necessary.
    According to the requirements of Sec.  417.4(a)(1), establishments 
must validate CCPs to ensure that they can successfully apply a 
scientifically appropriate CCP to prevent, eliminate, or reduce E. coli 
O157:H7 under their commercial operating conditions (see 61 FR 38826-
38827). Until establishments demonstrate that the CCP achieves the 
anticipated effect under actual in-plant conditions, effectiveness of 
the CCP is theoretical, and the plan is not validated. Based on 
information from inspection program personnel and IDVs, FSIS believes 
that many establishments have not validated their CCPs based on actual 
in-plant conditions.
    Published scientific studies have demonstrated that there are 
effective decontamination methods that can be used for preventing, 
eliminating, or reducing E. coli O157:H7. Establishments can validate 
their CCPs for E. coli O157:H7 by ensuring that the operation of the 
CCP in their plant can meet the parameters of these studies, and by 
challenge studies using an appropriate surrogate for E. coli O157:H7 
that could include, but not be limited to, E. coli and coliforms. There 
are no situations in which inspection program personnel will ask that 
establishments introduce pathogenic or harmful bacteria into the 
establishments to validate the effectiveness of CCPs. Establishments 
can ensure the effectiveness of their CCPs through monitoring, 
verification, and corrective action procedures in their written HACCP 
plans.
    FSIS believes that establishments that receive product for grinding 
also should address E. coli O157:H7. These establishments can employ 
validated CCPs in their HACCP plans to address E. coli O157:H7. 
Interventions are becoming available to grinders. These establishments 
can also establish and require that specifications for the raw material 
that they purchase be met by suppliers. FSIS believes that grinders 
that have purchase specifications that require that all of their 
suppliers have one or more CCPs in their HACCP plans that are validated 
to eliminate or reduce E. coli O157:H7 below detectable levels and that 
ensure that these specifications are met may determine that no 
additional steps to address E. coli

[[Page 62330]]

O157:H7 are necessary in their production process for ground beef. 
However, given the nature of the pathogen, FSIS strongly recommends 
that grinders that have purchase specifications addressing E. coli 
O157:H7 determine whether CCPs preventing E. coli O157:H7 growth or 
contamination after product receipt are necessary.
    Grinders could incorporate purchase specifications to prevent E. 
coli O157:H7-contaminated product from entering their establishment in 
their HACCP plans. However, the Agency also recognizes that some may 
argue that purchase specifications addressing E. coli O157:H7 do not 
lend themselves to a point, step, or procedure in a food process at 
which control can be applied (see definition of ``critical control 
point'' in Sec.  417.1). Also, if grinding establishments have purchase 
specifications addressing E. coli O157:H7 that require that incoming 
product has been treated to eliminate or reduce E. coli O157:H7 to an 
undetectable level, and if they ensure that these specifications are 
met, these establishments may determine that they do not need a 
separate CCP to eliminate or reduce E. coli O157:H7 after receipt of 
product. In recognition of these arguments, FSIS advises that grinders 
may choose not to include purchase specifications addressing E. coli 
O157:H7 as CCPs in their HAACP plans. If they do not include these 
purchase specifications as CCPs in their HACCP plans, however, 
establishments should incorporate them in their Sanitation SOPs, which 
FSIS has recognized as prerequisites for HACCP (61 FR 38834), or in 
other programs that are prerequisites for HACCP (prerequisite 
programs).
    Current regulations do not include specific requirements for 
prerequisite programs other than Sanitation SOPs. However, under Sec.  
417.5(a)(1), establishments must maintain records of their hazard 
analysis, including all supporting documentation. According to the 
regulations, the hazard analysis must include the food safety hazards 
that can occur before, during, and after entry into the establishment 
(Sec.  417.2(a)). If an establishment has determined in its hazard 
analysis that E. coli O157:H7 is a hazard that can occur at one of 
these points but is not reasonably likely to occur in the 
establishment's processing because the establishment has a prerequisite 
program with purchase specifications addressing E. coli O157:H7, 
information concerning the prerequisite program is supporting 
documentation that must be maintained under Sec.  417.5(a)(1). All 
documentation supporting the hazard analysis must be made available to 
FSIS upon request (Sec.  417.5(f)).
    FSIS expects the supporting documentation concerning prerequisite 
programs other than Sanitation SOPs to include the programs' procedures 
and operational controls in writing. In addition, FSIS expects the 
documentation to include records that document that the program is 
effective, and that E. coli O157:H7 is not reasonably likely to occur. 
Without this documentation, FSIS would question the adequacy of the 
establishment's HACCP system and hazard analysis.
    Establishments should revise their prerequisite programs, as 
necessary, to ensure their effectiveness and should take appropriate 
corrective actions when they determine that their prerequisite programs 
may have failed to prevent contamination or adulteration of product. If 
establishments that address E. coli O157:H7 in their prerequisite 
programs and not in their HACCP plans produce E. coli O157:H7-positive 
product, this occurrence would be considered a ``deviation not covered 
by a specified corrective action'' or an ``unforeseen hazard'' (Sec.  
417.3(b)). Therefore, these establishments would be required to take 
the corrective actions, including reassessment, set forth in Sec.  
417.3(b).
    As with other prerequisite programs that include purchase 
specifications addressing E. coli O157:H7, establishments with 
Sanitation SOPs that include purchase specifications addressing E. coli 
O157:H7 may conclude that the pathogen is not reasonably likely to 
occur in the establishments' processing because of the Sanitation SOPs. 
However, unlike other prerequisite programs, current regulations 
provide requirements for Sanitation SOPs and ensure that FSIS has 
access to establishments' records documenting the implementation and 
monitoring of the Sanitation SOPs. According to the Sanitation SOP 
regulations, establishments that include purchase specifications 
addressing E. coli O157:H7 in their Sanitation SOPs will need to 
evaluate routinely the effectiveness of these purchase specifications 
in preventing the adulteration of their products. They will also need 
to revise these purchase specifications as necessary to keep them 
effective (see Sec.  416.14). Moreover, they will need to maintain 
records to document the implementation, monitoring, and correction of 
their purchase specifications (see Sec. Sec.  416.15 and 416.16).
    Under Sec.  416.15, establishments are required to conduct 
corrective actions when they determine that their Sanitation SOP may 
have failed to prevent direct contamination or adulteration of product; 
however, under Sec.  416.15, establishments are not required to 
reassess their Sanitation SOPs when they determine that their 
Sanitation SOPs may have failed to prevent direct contamination or 
adulteration of product. If establishments that address E. coli. 
O157:H7 in their Sanitation SOPs and not in their HACCP plans produce 
E. coli. O157:H7-positive product, this occurrence would be considered 
a ``deviation not covered by a specified corrective action'' or an 
``unforeseen hazard'' (Sec.  417.3(b)). Therefore, these establishments 
would be required to take the corrective actions, including 
reassessment, set forth in Sec.  417.3(b).
    FSIS received a petition dated December 30, 1999, signed by 
numerous meat and poultry trade organizations (see 65 FR 30952 for 
information on this petition and the text of this petition). The 
petition stated that a HACCP plan is only one part of a plant's overall 
food safety system, and that other integral components of that system 
include Sanitation SOPs, various good manufacturing practices, and 
other prerequisite programs that are needed to form the foundation for 
the HACCP system. The petition stated that FSIS should recognize these 
other components of establishments' food safety systems when 
determining whether HACCP plans are adequate.
    In this notice, FSIS is recognizing that establishments receiving 
raw beef product for grinding can effectively include purchase 
specifications addressing E. coli. O157:H7 in Sanitation SOPs and other 
prerequisite programs. FSIS has made no general determinations 
concerning food safety hazards other than E. coli. O157:H7 and no 
general determinations concerning what circumstances other than 
grinders' receiving product that meets purchase specifications can be 
addressed through prerequisite programs, rather than HACCP. If 
establishments, other than grinders, address any food safety hazard in 
a prerequisite program, and if grinders include more than purchase 
specifications addressing E. coli. O157:H7 in their prerequisite 
programs, FSIS will review the establishments' supporting documentation 
for these programs and will make a determination concerning the 
adequacy of these programs, applicable HACCP plans, and hazard analyses 
on a case-by-case basis.
    FSIS does not believe that establishments receiving raw beef 
product for grinding will be able to substitute Sanitation SOPs or 
other

[[Page 62331]]

prerequisite programs addressing E. coli. O157:H7 for their HACCP plans 
in their entirety because the Agency does not believe that E. coli. 
O157:H7 contaminated product from outside sources would be the only 
food safety hazard reasonably likely to occur in the production of 
ground beef in the absence of controls. For establishments receiving 
raw beef product for grinding, FSIS believes that Sanitation SOPs or 
other prerequisite programs together with HACCP plans function as food 
safety HACCP systems that effectively produce safe, unadulterated 
product.

Verification

    All establishments are required to conduct on-going verification 
activities to ensure that their HACCP plans are effectively implemented 
(Sec.  417.4(a)(2)). Whether the establishment has CCPs addressing E. 
coli. O157:H7 in their HACCP plans or has concluded the pathogen is not 
reasonably likely to occur because it has purchase specifications that 
prevent the pathogen from entering the facility, the establishment is 
required to conduct on-going verification activities to ensure that any 
CCP is adequately addressing E. coli. O157:H7, or that the purchase 
specifications continue to prevent the pathogen from entering the 
facility. FSIS recommends that establishments' verification activities 
include testing for E. coli. O157:H7.

State Inspection Programs and Programs Outside the United States (U.S.)

    Establishments in states that have their own inspection programs 
that produce raw beef products and that have not already done so must 
reassess their HACCP plans in light of the E. coli. O157:H7 data 
discussed above. Similarly, producers outside the U.S. that import raw 
beef product into the U.S. that have not already done so will have to 
reassess their HACCP systems based on the data discussed above.

FSIS Actions To Enforce and Facilitate Compliance With the Reassessment 
Requirement

    Establishments that produce raw beef products are to reassess their 
HACCP plans unless they have already reassessed their HACCP plans based 
on the E. coli. O157:H7 data that suggest that the pathogen may be more 
prevalent than previously thought, and they have evidence of this 
reassessment that is available to FSIS inspection program personnel in 
their hazard analysis, HACCP plans, or record of reassessment. Although 
establishments are not required to maintain a written record of their 
reassessment, FSIS encourages them to do so.
    The Agency intends to instruct its inspection program personnel to 
determine whether reassessments were conducted or are being conducted 
and to begin making this determination on November 6, 2002. At this 
time, inspection program personnel will ensure that all establishments 
producing raw beef products are aware that the Agency has issued this 
notice and will ensure that those establishments that have not yet 
reassessed their HACCP plans based on the relevant E. coli O157:H7 data 
discussed above begin their reassessment in time to complete it by the 
following date according to plant size: December 6, 2002 for large 
plants (all establishments with 500 or more employees); February 4, 
2003 for small plants (all establishments with 10 or more employees but 
fewer than 500); and April 7, 2003 for very small plants (all 
establishments with fewer than 10 employees or annual sales of less 
than $2.5 million). FSIS will not begin enforcing the required 
reassessment until December 6, 2002 for large plants; February 4, 2003 
for small plants; and April 7, 2003 for very small plants. By looking 
into establishments' reassessment actions prior to the time they are 
required to complete their reassessments, FSIS will ensure that all 
establishments producing raw beef products, including those that are 
small and very small businesses that may not belong to a trade 
association, are aware of this notice. FSIS will mail this notice to 
all small and very small plants prior to the effective date for 
reassessment.
    The Agency then intends to instruct its inspection program 
personnel to collect data concerning the outcomes of the required 
reassessment and to begin collecting this data on: December 23, 2002 
for large plants; February 19, 2003 for small plants; and April 21, 
2003 for very small plants. Inspection program personnel will collect 
data concerning (1) whether establishments reassessed their HACCP plans 
based on the relevant E. coli O157:H7 data prior to or after 
publication of this notice; (2) whether establishments changed their 
HACCP plans or prerequisite programs as a result of a reassessment that 
took this data into account; (3) if establishments changed their HACCP 
plans or prerequisite programs, how the plans or prerequisite programs 
were changed; and (4) if establishments did not change their HACCP 
plans or prerequisite programs, the reasons the plans or programs were 
not changed. If an establishment does not reassess its HACCP plans in 
accord with this document, FSIS will evaluate the establishment's 
compliance with Part 417.

Guidance

    FSIS is making available guidelines entitled, ``Guidance for Beef 
Grinders and Suppliers of Boneless Beef and Trim Products'' on the 
Internet (http://www.fsis.usda.gov/oppde/rdad/publications.htm). In 
this guidance material available today, FSIS is providing 
recommendations for reducing the occurrence of E. coli O157:H7 and 
Salmonella in ground beef, boneless beef, and trim products. FSIS 
initially made this guidance material available to the public in March 
1998. FSIS has expanded this guidance material to include guidance for 
suppliers of boneless beef and trim and recommendations for reducing 
Salmonella in ground beef, boneless beef, and trim products.
    In the guidance material, to further reduce the risk of E. coli 
O157:H7 contamination after product receipt, FSIS is recommending that 
grinders receiving product from more than one supplier prevent any 
mixing of product from different suppliers, unless they can demonstrate 
that the source materials from the different suppliers have been 
adequately treated to eliminate or reduce E. coli O157:H7 to an 
undetectable level. Keeping product from different suppliers separate 
will prevent any potentially E. coli O157:H7-contaminated source 
material from adulterating source materials from other suppliers. Also, 
by keeping product from different suppliers separate, grinders will be 
able to identify the potential source of any E. coli O157:H7-
contaminated product should the pathogen be detected. If FSIS finds 
samples of ground beef produced from suppliers' source materials 
outside the grinding establishment or retail facility to be positive 
for E. coli O157:H7, FSIS intends to notify the supplying 
establishments that they may have supplied E. coli O157:H7-positive 
product to a grinding establishment or retail facility.
    FSIS intends to gather pertinent information concerning suppliers 
from Federal grinding establishments and retail facilities. If FSIS 
confirms that ground product is positive for E. coli O157:H7, FSIS 
intends to obtain from Federal grinding establishments the following 
information concerning their suppliers of the source materials: the 
name, point of contact, and phone number for the establishments 
supplying the source materials for the lot of ground beef sampled; the 
supplier lot numbers and production dates; and any other information 
that would be

[[Page 62332]]

useful to suppliers that may have supplied E. coli O157:H7-positive 
product to Federal grinding establishments. Similarly, at the time FSIS 
collects samples of ground beef from retail facilities, FSIS will 
obtain from the retail facility the names and establishment numbers of 
the establishments supplying the source materials for the lot of ground 
beef sampled, the supplier lot numbers and production dates, and any 
other information that would be useful to suppliers if they are later 
notified of an E. coli O157:H7 positive finding.
    Under Sec.  320.1(b)(1), establishments and retail facilities are 
required to keep records of each transaction involving their purchasing 
or receiving any meat or meat food product. These records must show the 
name or description of the articles they purchase or receive (Sec.  
320.1(b)(1)(i)) and the name and address of the seller of the articles 
they purchase (Sec.  320.1(b)(1)(iv)). Establishments and retail 
facilities must provide FSIS access to these records (Sec.  320.4, 21 
U.S.C. 642). FSIS expects that supplier lot numbers and production 
dates are normally available at Federal grinding establishments and 
retail facilities. In addition, FSIS expects that establishments or 
retail facilities would normally obtain the contact information FSIS is 
collecting.
    In addition, FSIS is making available on the Internet address 
previously listed new guidance material on reducing the occurrence of 
E. coli O157:H7 for beef slaughter establishments and for live animal 
producers. In the guidance material for beef slaughter establishments, 
FSIS has included examples of published studies of decontamination 
methods that can be used as critical control points addressing E. coli 
O157:H7.
    The Agency invites comments on the guidance materials it is making 
available. In the guidance materials, FSIS is emphasizing that it is 
important for everyone who is involved in producing beef products to 
have in place measures designed to prevent, eliminate, or reduce the 
presence of E. coli O157:H7 in their products.
    In both the guidance material for beef grinders and suppliers of 
boneless beef and trim products and the guidance material for beef 
slaughter establishments, FSIS is recommending that establishments 
consider that E. coli O157:H7 prevalence may be higher in April through 
September than during other times of the year, and that they may have 
to account for this increased prevalence in their HACCP systems. 
Several studies show that the period from June to September is a high 
prevalence season.\20\ In addition, FSIS has recently reviewed 
establishment testing data that show greater E. coli O157:H7 prevalence 
in April through September. To account for increased E. coli O157:H7 
prevalence, establishments may need to conduct more frequent or more 
rigorous verification activities, and they may need to employ more 
rigorous interventions, during April through September.
---------------------------------------------------------------------------

    \20\ Garber, L., et al., Factors associated with the shedding of 
verotoxin-producing Escherichia coli O157 on dairy farms. J Food 
Prot. 1999; 62(4): 307-312; Hancock, D.D., et al., The prevalence of 
Escherichia coli O157 in dairy and beef cattle in Washington State. 
Epidemiol Infect. 1994; 113: 199-207; Hancock D., Personal 
communication. Ongoing research project in collaboration with FDA-
CVM. 2001; Hancock, D.D., et al., Effects of farm manure handling 
practices on Escherichia coli O157 prevalence in cattle. J Food 
Prot. 1997; 60(4): 363-366. Heuvelink, A.E., et al., Occurrence of 
verocytotoxin-producing Escherichia coli O157 on Dutch dairy farms. 
J Clin. Microbiol. 1998; Dec: 3480-3487; Van Donkersgoed, J.T., et 
al., The prevalence of vertoxins, Escherichia coli O157:H7, and 
Salmonella in the feces and rumen of cattle at processing. Can Vet 
J. 1999; 40:332-338.
---------------------------------------------------------------------------

    Finally, at the Internet address previously listed, FSIS is making 
available guidance material on the procedures for joint FSIS and FDA 
approval of ingredients and sources of radiation, including 
antimicrobials, used in the production of meat and poultry products and 
specific guidance on the use and labeling of ingredients and sources of 
radiation used to reduce microorganisms, particularly E. coli O157:H7, 
on beef carcasses, ground beef, and beef trimmings. This guidance 
document also includes a discussion on direct and secondary direct food 
additives and the appropriate use of the ingredient statement on the 
label of treated meat.

FSIS E. coli O157:H7 Testing Program

    Currently, FSIS tests only raw ground beef products for E. coli 
O157:H7. In addition to continuing to test for E. coli O157:H7 in raw 
ground beef, FSIS is considering testing raw beef trimmings and other 
intact materials used in non-intact product and beef carcasses and 
parts (primals and subprimals) that will be processed into non-intact 
product. FSIS is considering testing trimmings, other source materials 
for non-intact product, and carcasses and parts that will be processed 
into non-intact product because controls to reduce the risk of E. coli 
O157:H7 when the product is still intact may be among the best ways to 
control the hazard. FSIS testing would verify the effectiveness of 
these controls. Such controls would include interventions used at 
slaughter, proper chilling practices, and segregating product that has 
been treated with interventions from product that has not. The only 
treatment available to eliminate E. coli O157:H7 in raw, non-intact 
product (e.g., ground beef, blade tenderized steaks, and blade 
tenderized roasts) is a full bactericidal treatment, such as 
irradiation or cooking. However, there are also treatments that can be 
used that have been shown to reduce significantly the level of this 
pathogen. At this time, FSIS has not finalized plans to begin E. coli 
O157:H7 testing of raw beef trimmings, other intact materials used in 
non-intact product, and beef carcasses and parts that will be processed 
into non-intact product.
    Although it has not finalized its plans regarding verification 
activities at establishments that produce intact product, FSIS intends 
to conduct verification activities at establishments that supply intact 
product to grinding establishments when the Agency determines that a 
supplier may be responsible for E. coli O157:H7-positive ground 
product. In this situation, FSIS intends to conduct verification 
activities concerning the supplier's HACCP system and Sanitation SOPs. 
FSIS also intends to conduct verification tests on trim when the Agency 
finds ground product at a grinder that receives product from outside 
sources positive for E. coli O157:H7 and is able to identify the 
supplier.
    FSIS received a petition from the Center for Science in the Public 
Interest (CSPI), dated July 1, 2002, requesting that, in addition to 
its current testing of raw, ground beef for E. coli O157:H7, FSIS 
conduct E. coli O157:H7 testing of raw beef carcasses and beef trim. In 
their petition, CSPI also stated that slaughterhouses should be 
required to conduct E. coli O157:H7 testing of carcasses and trimmings. 
FSIS has posted a copy of the petition on the Internet at the address 
previously listed.
    FSIS also received a letter from Excel Corporation, dated June 10, 
2002, that included recommendations for changing FSIS'' testing 
program. Excel Corporation stated that FSIS'' sampling frequency should 
be based on what scientific evidence shows about the applied 
intervention's effectiveness in reducing E. coli O157:H7. Excel also 
stated that carcasses would need to be sampled more frequently than 
trim and trim more frequently than ground beef to reach the same level 
of statistical verification of the effectiveness of an intervention 
process.
    Excel also recommended that FSIS provide that ground beef that has 
been tested and found negative for E. coli O157:H7 could be labeled to 
indicate

[[Page 62333]]

this fact, so that FSIS program personnel would reduce their sampling 
of this product once it is at retail. Excel recommended the following 
statement be allowed on product that tests negative for E. coli 
O157:H7: ``Product sampled and sample tested and found negative for E. 
coli O157:H7.'' FSIS has posted a copy of the letter on the Internet.
    In modifying its verification sampling and testing program for E. 
coli O157:H7, FSIS will consider the data that its inspection program 
personnel collect concerning establishments'' actions in response to 
the required HACCP plan reassessment and comments received concerning 
the Agency's E. coli O157:H7 testing program, the CSPI petition, and 
the letter from Excel Corporation.

FSIS Directive 10,010.1

    According to the Agency's current sampling and testing program 
instructions in FSIS Directive 10,010.1, FSIS does not typically 
collect raw ground beef samples for E. coli O157:H7 testing at 
establishments that conduct activities addressing E. coli O157:H7 that 
are specified in the Directive, including testing for E. coli O157:H7. 
Recently, FSIS found that some of these establishments producing raw 
ground beef have had problems with E. coli O157:H7 contamination. 
Therefore, FSIS is in the process of revising the Directive so that no 
establishments producing raw ground beef will be exempt from FSIS E. 
coli O157:H7 sampling and testing. FSIS intends to sample and test 
product from all grinding establishments at this time. FSIS will also 
be developing a risk-based verification program that takes into account 
such factors as volume of production and effectiveness of 
interventions.
    FSIS also intends to revise Directive 10,010.1 to make it 
consistent with HACCP. According to the existing Directive, if FSIS 
collects a raw ground beef sample from an establishment that tests 
positive for E. coli O157:H7, FSIS must continue to collect samples 
from that establishment until the Agency has obtained 15 consecutive 
negative test results.
    FSIS intends to remove this provision from the Directive because 
FSIS believes that this policy is inconsistent with HACCP. Under HACCP, 
it is the establishment's responsibility to take appropriate corrective 
actions when a sample tests positive for E. coli O157:H7.
    When FSIS has removed from the Directive the provision requiring 15 
consecutive negative FSIS E. coli O157:H7 test results following an 
FSIS E. coli O157:H7 positive test result, FSIS will exercise its 
discretion in determining the appropriate number of follow-up samples 
to collect and test and will make this determination based on the 
suspected cause of E. coli O157:H7 contamination and the 
establishment's corrective action.
    The current Directive defines the ``sampled lot'' as all raw ground 
beef products produced between performance of complete cleaning and 
sanitization procedures for all equipment used in handling or 
processing a raw ground beef product. FSIS believes that this 
definition is too prescriptive, and that, under HACCP, establishments 
should be given more flexibility concerning the definition of the 
sampled lot. Therefore, FSIS is revising the Directive to recognize the 
establishment's definition of the sampled lot, provided the 
establishment has a scientific or other supportable basis for defining 
the sampled lot.
    FSIS cautions, however, that an establishment's defined lot size 
does not relieve an establishment from its responsibility to consider 
whether there are connections between lots. For example, if multiple 
lots of raw ground product were produced from source materials from the 
same production lot of a single supplier, and some of this product was 
found positive for E. coli O157:H7, FSIS would expect the establishment 
to have a scientific basis that justifies why any raw ground product 
produced from those source materials should not be considered to be 
adulterated.
    Finally, FSIS intends to revise the Directive to specify that the 
Agency will only collect samples of product that has passed pre-
shipment record review in accordance with Sec.  417.5(c).
    FSIS does not intend to discontinue its E. coli O157:H7 testing 
program. By conducting its own verification sampling and testing 
program, FSIS will have meaningful data on the occurrence of E. coli 
O157:H7 in beef processing operations. FSIS invites comment on the 
issues related to FSIS Directive 10.010.1.

Comments

    In response to the February 11, 2000, notice announcing the 
February 29, 2000, public meeting, FSIS received 294 comments, 285 of 
which were identical comments. Comments were from consumers, consumer 
groups, industry associations, a food animal concerns organization, and 
an FSIS employee. Comments addressed various issues including FSIS'' 
policy concerning non-intact products announced in the January 19, 
1999, policy statement, FSIS and industry testing for E. coli O157:H7, 
and the FSIS E. coli O157:H7 risk assessment data that were presented 
at the February 29, 2000, public meeting. In addition, several 
commenters responded specifically to the questions for consideration 
that FSIS listed in the February 11, 2000, notice.
    FSIS considered these comments when it developed plans to make the 
intended changes to Directive 10,010.1 discussed above. FSIS will 
continue to consider these comments, any comments submitted in response 
to this notice, the data that its inspection program personnel collect 
concerning establishments' actions resulting from the required 
reassessment, and baseline data for raw beef components of ground beef 
and beef patties and, possibly, baseline data for carcasses, as it 
determines how it will modify its E. coli O157:H7 testing program and 
as it makes any additional changes to the Directive addressing the 
program.

E. coli O157:H7 in Intact and Non-Intact (Tenderized) Beef

    In May 2001, FSIS requested that the National Advisory Committee on 
Microbiological Criteria for Foods (NACMCF) answer several questions 
with regard to E. coli O157:H7 in blade-tenderized, non-intact beef. 
NACMCF reviewed data from Kansas State University to respond to these 
questions. A February 14, 2002, report from NACMCF that includes FSIS' 
questions and NACMCF's response to the questions is available on the 
Internet at: http://www.fsis.usda.gov/OPHS/NACMCF/index.htm.
    Based on the Kansas State data, NACMCF concluded that non-intact, 
blade tenderized beef steaks could potentially contain an infective 
dose of E. coli O157:H7 in their interior. NACMCF also concluded that 
blade tenderized steaks do not present a greater risk to consumers than 
intact beef steaks with regard to E. coli O157:H7 if the meat is oven 
broiled and cooked to an internal temperature of 140[deg]F or above. 
However, NACMCF did not conclude that blade tenderized steaks pose no 
greater risk than intact steaks when cooked by other methods or when 
cooked to lower temperatures. The report suggested that blade-
tenderized steaks may pose a risk, particularly to immunocompromised 
individuals, when served very rare with cold spots (that is, when 
cooked to an internal temperature of less than 120[deg]F). All of 
NACMCF's risk estimates were based on a worst case scenario that 
assumed a very high concentration (3 x

[[Page 62334]]

103 cfu/gm) of E. coli O157:H7 in raw product.
    NACMCF concluded that there is insufficient data to assess whether 
non-intact, blade tenderized beef roasts present a greater risk to 
consumers than intact beef roasts with regard to E. coli O157:H7 if 
prepared similarly to intact beef roasts.
    Similarly, NACMCF concluded that there was insufficient data to 
respond to the question of whether scientific evidence supports the 
need for a labeling requirement to distinguish between intact and non-
intact products to protect the public.
    The NACMCF report identifies research needs for addressing E. coli 
O157:H7 in blade tenderized steaks and makes recommendations to FSIS 
concerning the Agency's future requests to NACMCF about this issue. In 
the event of an outbreak or a sporadic case of illness attributed to 
the consumption of beef steak, the report recommends that the CDC and 
FSIS gather data on cooking practices for the product that caused the 
illness, the processing of this product, and the purchase locations of 
this product.
    FSIS has also conducted a comparative risk assessment of intact 
(nontenderized) and non-intact (blade tenderized) steaks. The results 
of the risk assessment are consistent with those of NACMCF. The risk 
assessment concluded that the risk of E. coli O157:H7 illness is not 
greater for broiled tenderized steaks than for broiled non-tenderized 
steaks at temperatures between 110[deg]F and less than 140[deg]F, 
regardless of the initial E. coli O157:H7 contamination level or the 
susceptibility of the consumer. Also, the risk assessment concluded 
that the risk of illness associated with E. coli O157:H7 from broiled 
tenderized and broiled non-tenderized steaks cooked to 140[deg]F is 
miniscule, regardless of the initial contamination level or 
susceptibility of the consumer. Finally, the FSIS risk assessment 
concluded that the risk of illness is slightly higher for grilled or 
fried tenderized steaks compared to grilled or fried non-tenderized 
steaks at temperatures between 110[deg]F and 140[deg]F. The FSIS 
comparative risk assessment of intact and non-intact (blade tenderized) 
steaks is still a draft document and is available on the Internet 
address at: http://www.fsis.usda.gov/ oppde/rdad/publications.htm. FSIS 
invites comments on this risk assessment.
    FSIS also received a letter dated August 27, 2002, from the 
National Cattlemen's Beef Association concerning a study that evaluated 
the surfaces of beef sub-primal cuts for the presence of E. coli 
O157:H7 prior to mechanical tenderization. According to this letter, 
the results of this study show that the incidence of E. coli O157:H7 on 
sub-primals is very low. FSIS is interested in evaluating the data from 
this study. The Agency may incorporate these data into its comparative 
risk assessment of intact and non-intact steaks. Therefore, these data 
may influence the comparative risk assessment.
    FSIS is reviewing the NACMCF report and its draft risk assessment 
for E. coli O157:H7 in intact and non-intact (blade tenderized) steaks 
and will consider NACMCF's conclusions and the conclusions from the 
risk assessment with regard to the policy announced for non-intact 
products in the January 19, 1999, Federal Register (discussed above, 
under ``E. coli O157:H7 policy''). At this time, FSIS believes that the 
public health hazard presented by E. coli O157:H7 and the prevalence of 
E. coli O157:H7 in these products continues to support application of 
the policy announced in the January 19, 1999, Federal Register. There 
is a lack of data on industry and consumer practices for cooking 
pinned, needled, and blade tenderized steaks (e.g., grilling, oven 
broiling, or frying) and a lack of data on the proportion of industry 
outlets and consumers that prepare these products according to each of 
these different methods. If FSIS obtains substantial and reliable data 
showing that industry and consumers customarily cook pinned, needled, 
and blade tenderized products in a manner that destroys E. coli 
O157:H7, FSIS would consider modifications to its policy concerning E. 
coli O157:H7 in these products.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to better ensure 
that minorities, women, and persons with disabilities are aware of this 
notice, FSIS will announce it and make copies of this Federal Register 
publication available through the FSIS Constituent Update. FSIS 
provides a weekly Constituent Update, which is communicated via 
Listserv, a free e-mail subscription service. In addition, the update 
is available on-line through the FSIS web page located at http://www.fsis.usda.gov. The update is used to provide information regarding 
FSIS policies, procedures, regulations, Federal Register notices, FSIS 
public meetings, recalls, and any other types of information that could 
affect or would be of interest to our constituents/stakeholders. The 
constituent Listserv consists of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals that have requested to be 
included. Through the Listserv and web page, FSIS is able to provide 
information to a much broader, more diverse audience.
    For more information contact the Congressional and Public Affairs 
Office, at (202) 720-9113. To be added to the free e-mail subscription 
service (Listserv) go to the ``Constituent Update'' page on the FSIS 
web site at http://www.fsis.usda.gov/oa/update/update.htm. Click on the 
``Subscribe to the Constituent Update Listserv'' link, then fill out 
and submit the form.

    Done at Washington, DC, on October 3, 2002.
Garry L. McKee,
Administrator.
[FR Doc. 02-25504 Filed 10-3-02; 11:15 am]
BILLING CODE 3410-DM-P