[Federal Register: October 7, 2002 (Volume 67, Number 194)]
[Rules and Regulations]
[Page 62325-62334]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc02-6]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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.
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\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.
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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