[Federal Register: February 11, 2000 (Volume 65, Number 29)]
[Rules and Regulations]
[Page 6881-6886]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11fe00-1]
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[[Page 6881]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Chapter III
[Docket No. 99-060N]
Recent Developments Regarding Beef Products Contaminated With
Escherichia coli O157:H7; Public Meeting
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice of public meeting.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
that it will hold a public meeting on February 29, 2000, to discuss
FSIS' policy regarding Escherichia coli (E. coli) O157:H7 and new
information concerning the pathogen and its relation to human health.
At this meeting, FSIS and other groups will present new data concerning
the pathogen and new developments that may affect the Agency's policy.
The purpose of this meeting is not to debate the policy that the Agency
announced in January of 1999 (64 FR 2803) on the status of certain beef
products contaminated with E. coli O157:H7 but to ensure that that
policy is implemented based on the best available information and in a
manner that will best protect public health. In addition, FSIS will
allow time for comments and discussion regarding FSIS' testing
procedures and other issues on E. coli O157:H7.
DATES: The meeting will be held February 29, 2000, from 9:00 a.m. to
5:00 p.m. Written comments must be received by April 11, 2000.
ADDRESSES: The meeting will be held at the Holiday Inn Rosslyn Westpark
Hotel, 1900 North Fort Myer Drive, Arlington, Virginia, telephone
number: (703) 807-2000. To register for the meeting, contact Ms. Mary
Gioglio by telephone at (202) 501-7244 or by FAX at (202) 501-7642. If
a sign language interpreter or other special accommodation is
necessary, contact Ms. Gioglio at the above numbers by February 18,
2000. If you are planning to present an oral comment at the meeting,
please submit one original and two copies of the prepared comment to
the FSIS Docket Clerk, Docket No. 99-060N, Room 102 Cotton Annex, 300
12th Street, SW, Washington, DC 20250-3700. Send one original and two
copies of all other comments to the Docket Clerk at the address listed
above. All comments received in response to this notice will be
considered part of the public record and will be available for viewing
in the Docket Room between 8:30 a.m. and 4:30 p.m., Monday through
Friday.
FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Ph.D., Director,
Regulations Development and Analysis Division, Office of Policy,
Program Development, and Evaluation, Food Safety and Inspection
Service, Room 112 Cotton Annex, 300 12th Street, SW, Washington, DC
20250. Telephone number (202) 720-5627, fax number (202) 690-0486.
SUPPLEMENTARY INFORMATION:
Background
1. January 1999 Federal Register Notice
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. The Agency stated that, if the latter two
types of products 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. 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 essentially protected from pathogens migrating below the
exterior surfaces. Consequently, customary cooking of these products
will destroy any E. coli O157:H7. FSIS requested comments and
recommendations relevant to the Agency's policy and to any regulatory
requirements appropriate to prevent the distribution of beef products
adulterated with this pathogen.
On March 8, 1999, FSIS held a public meeting to discuss the
policies addressed in its January 19, 1999, policy statement. The
meeting provided the public with an additional opportunity to comment
and discuss the policy announced in this statement and the public
health risks associated with beef products contaminated with E. coli
O157:H7. The meeting also provided an opportunity for participants to
discuss a set of questions and answers that FSIS had developed
regarding the E. coli O157:H7 policy. At this meeting, a group of
companies described a plan for testing carcasses for E. coli O157:H7.
The group stated that they would submit their testing protocol to FSIS.
In addition, individuals from Kansas State University presented
preliminary findings of research on E. coli O157:H7 in blade tenderized
beef steaks.
In its March 15, 1999, Constituent Update, FSIS explained that the
Agency would not act on its January 19, 1999, policy statement until it
had an opportunity to consider the comments received. On April 5, the
American Meat Institute (AMI) submitted a protocol on behalf of the
group of companies participating in the study on carcass testing for E.
coli O157:H7 discussed above. The protocol called for testing 1 in 300
carcasses slaughtered by approximately 12 plants, before and after hide
removal, as well as after processing interventions and at the trimmings
stage, for E. coli O157:H7. In its May 14, 1999, Constituent Update,
FSIS announced the availability of the protocol and the Agency's
response to it and invited comments on these documents.
2. Draft White Paper
FSIS recently developed a draft White Paper on Escherichia coli
O157:H7. FSIS announced the availability of this document in its
November 5, 1999,
[[Page 6882]]
Constituent Update. The document is currently available over the
Internet (URL: http://www.fsis.usda.gov/OA/update/110599__att.htm).
The White Paper discusses new information and developments that
will have a bearing on the Agency's E. coli O157:H7 policy. The paper
explains that new information indicates that E. coli O157:H7 is not as
rare as previously thought. In September 1999, FSIS began using a
method for analyzing samples of products for E. coli O157:H7 that is
four times more sensitive than the previous method. Of the total number
of positive samples found by FSIS since the testing program began in
1994, 40 percent (21 out of 53) have been found using the new test
method. The recent increase in positive samples suggests that the low
rate of positive findings in the past may have had more to do with the
sensitivity of the method being used than with the rarity of the
pathogen.
In addition to the FSIS testing data, the White Paper explains that
the Centers for Disease Control and Prevention (CDC) recently released
estimates of foodborne illness that show a much higher rate of illness
from E. coli O157:H7 than the CDC had previously reported. The CDC
increased its estimates for illnesses associated with E. coli O157:H7
because recent surveillance data allowed a more detailed estimation of
mild illnesses not resulting in physician consultation (Mead, Paul S.,
et al., ``Food-Related Illness and Death in the United States,''
Journal of Emerging Infectious Diseases, Vol. 5, No. 5, 1999). Although
not all of these illnesses are attributable to beef, the increase in
illnesses associated with E. coli O157:H7 indicates that this pathogen
occurs more frequently than was previously thought.
The White Paper also discusses recent research and studies
concerning E. coli O157:H7. The paper explains that the data from the
industry study discussed above are being analyzed and should soon be
available. This study should provide further insight into whether E.
coli O157:H7 is a rare pathogen and whether it occurs on hides and
freshly slaughtered carcasses of beef with some regularity. Under the
study's protocol, 1 in 300 carcasses were tested for E. coli O157:H7
before hide removal, after hide removal, and after pathogen reduction
interventions have been applied. The study was to run for 30 days,
starting in early September. Twelve plants were involved in the study.
The White Paper also notes that the Agricultural Research Service
(ARS), in Clay Center, Nebraska, is conducting research related to
prevalence, and that FSIS plans to conduct some sampling to assess the
feasibility of identifying E. coli O157:H7 on carcasses and of
establishing a routine, Agency-directed sampling program to supplement
or replace FSIS' ongoing ground beef testing.
The White Paper explains that FSIS' risk assessment for E. coli
O157:H7 in ground beef will better enable both the Agency and industry
to identify interventions that can lead to public health improvements
and to weigh available options. The Agency hopes that the risk
assessment will be completed by spring 2000. When the risk assessment
on ground beef is complete, FSIS expects to expand it to cover all meat
products, as well as other products that may be affected by E. coli
O157:H7.
The White Paper also addresses data concerning blade tenderized
roasts and steaks. As discussed above, during the March 8, 1999, public
meeting, individuals from Kansas State University presented preliminary
findings of research on E. coli O157:H7 in blade tenderized beef
steaks. The researchers stated that the blade tenderization process
transfers approximately three to four percent of surface contamination
to the interior of the muscle. The researchers pointed out that proper
cooking to a specified time/temperature combination resulting in rare
steaks could reliably result in safe product. In addition, industry
members have stated that muscle systems from which steaks are derived
could be removed from larger primal or sub-primal cuts hygienically.
The beef industry has been persistent in encouraging FSIS to exempt
blade tenderized product, especially when derived hygienically or with
reduced possibilities for becoming contaminated, from the scope of
products considered adulterated when contaminated with E. coli O157:H7.
As of fall 1999, FSIS has tentatively determined that there is
insufficient information regarding the hygienic processing of muscle
systems to narrow the scope of products affected by the E. coli O157:H7
policy. FSIS expects its planned effort to broaden the risk assessment
will address some of the issues raised by the industry. Meanwhile, FSIS
has encouraged industry to label their intact and non-intact primal and
sub-primal cuts with appropriate cooking statements. The 1999 Food Code
(section 3-401.11) prescribes appropriate cooking instructions for
intact versus non-intact steaks for destruction of organisms of public
health concern.
The White Paper recognizes that interventions other than cooking
may be available to address E. coli O157:H7 in product under FSIS
control. For example, irradiation offers the possibility of treating
raw meat products to eliminate E. coli O157:H7. The final rule on
irradiation published on December 23, 1999, and will become effective
on February 22, 2000. In addition to irradiation, FSIS is willing to
consider whether other alternatives to cooking product within an FSIS-
inspected establishment could be used to address a positive finding.
The paper notes that several other considerations are likely to be
important as the Agency reviews its policy on E. coli O157:H7. For
example, since January 25, 2000, all meat and poultry plants have been
operating under the pathogen reduction and hazard analysis and critical
control point (PR/HACCP) systems rule. This will likely improve food
safety and may affect the Agency's E. coli O157:H7 policy. In reviewing
this policy, FSIS will also consider the meat industry's efforts to
reduce the pathogen at the production level.
Finally, the White Paper lists areas for consideration concerning
FSIS' E. coli O157:H7 policy. FSIS has revised the questions in the
White Paper to read as follows:
1. If FSIS finds that E. coli O157:H7 occurs with some regularity
on hides and carcasses of cattle raised using certain production
practices (e.g., feedlot cattle) but not on cattle raised under
different production practices (e.g., cull dairy cows), should the
pathogen be considered a hazard ``reasonably likely to occur'' only in
slaughter and processing operations that use the former types of
cattle? Should E. coli O157:H7 be addressed in the HACCP plans of those
operations? Is E. coli O157:H7 a hazard that is reasonably likely to
occur in the production of beef products? If so, what is the best
HACCP-related guidance that FSIS can provide to such plants for use in
their reassessment of their HACCP plans, and what actions should be
taken by the Agency?
2. Should FSIS re-design its testing program? Specifically:
<bullet> Are any changes needed in the proportion of samples taken
in-plant and at retail?
<bullet> Should FSIS alter its policy that 15 consecutive samples
be negative after a positive finding?
<bullet> Should FSIS continue selecting a sample if a plant has a
positive finding within the last 6 months, or should the Agency defer
to plant routine testing completely and remove the 6-month restriction?
If FSIS sampling is continued under these circumstances,
[[Page 6883]]
should the rules for the random selection of samples be changed?
<bullet> Should FSIS sampling of carcasses replace or supplement
ground beef sampling at slaughter plants?
<bullet> Should FSIS develop additional sampling schemes, including
increasing its testing of ground beef and other beef products (e.g.,
carcasses, trimmings, and non-intact cuts)?
<bullet> What alternatives to the FSIS testing program would best
encourage the regulated industry to better ensure that pathogen
reduction interventions specifically for E. coli O157:H7 are
instituted?
3. Should FSIS consider a plant's generic E. coli and Salmonella
results in making its decision on whether to target a plant's products
for E. coli O157:H7 sampling?
4. What effect should a plant's testing or verification program
have on whether and how FSIS targets its testing in that plant? Should
the plant's testing or verification program only be considered
sufficient if included as part of HACCP validation?
5. How should FSIS treat non-intact product? Specifically, should
blade-tenderized beef steaks and roasts--with specific cooking
instructions for destroying the pathogen and handling instructions for
preventing cross-contamination and temperature abuse-- be treated the
same as other non-intact beef with regard to the FSIS policy?
6. How effective are voluntary producer actions in providing
animals with reduced levels of E. coli O157:H7 to plants, and should
these voluntary activities, if effective, affect slaughter plants'
strategies and FSIS' policy?
3. FSIS Plans
The Agency intends to consider all information that is ultimately
developed from the sources of information discussed in the White Paper,
as well as all information presented in response to this notice, the
January 1999 notice, and the May 1999 Constituent Update, and to use
that information in deciding how best to address E. coli O157:H7. At
the February 29, 2000, public meeting, FSIS plans to discuss the issues
raised in its White Paper, including the significance of the findings
with its new testing method that the Agency is using to detect E. coli
O157:H7, of the final regulations on irradiation, and of the FSIS risk
assessment for E. coli O157:H7. ARS will present the results of a
survey it performed to estimate the frequency of E. coli O157:H7 in
feces and on hides within lots of fed cattle and the frequency of
carcass contamination during processing from cattle within the same
lots. The industry group will present the results of the industry
study, and Kansas State University will present data concerning E. coli
O157:H7 in blade tenderized steaks. There will be presentations on
interventions available to industry and on new technology. Finally,
consumer groups will present information. The public meeting also will
provide an opportunity for comments and discussion regarding FSIS' E.
coli O157:H7 policy and the course it should take, the Agency's testing
and sampling methods, new issues related to the pathogen, and issues
that arise during the public meeting.
The purpose of the meeting is to move forward with the January 1999
policy. The Agency has accumulated some information that suggests that
a hazard resulting from E. coli O157:H7 in the production of beef may
be more likely to occur than previously thought and that the regulated
industry may not be reassessing its HACCP plans accordingly. Since all
Federally inspected meat and poultry establishments are now operating
under HACCP, and since a yearly reassessment of the HACCP plans (9 CFR
417.4(a)(3)) is required, FSIS hopes to use this public meeting as a
means to ensure that the most current information is available to
interested persons as the Agency arrives at a policy that will best
protect the public health.
4. Comments Received
FSIS received a total of 81 comments in response to requests for
comments in the January 19, 1999, Federal Register (64 FR 2803) and in
the May 14, 1999, Constituent Update. FSIS received one comment in
response to the March 8, 1999, public meeting notice. Comments
addressed issues including the policy discussed in the January 19,
1999, policy statement, related documents, testing for E. coli O157:H7,
and the industry's protocol. A summary of comments and the Agency's
responses to these comments follow.
Consumer Support
Several consumers supported the policy and suggested that it be
expanded to include Listeria monocytogenes and Campylobacter jejuni.
Several consumer groups also supported the policy. Several groups
argued that the policy should be expanded to include intermediate
products, such as those produced from advanced meat recovery systems
and other products that are added to raw ground beef. One animal
welfare organization stated that even intact steaks and roasts and
other cuts of muscle with surface contamination should not be
distributed.
At this time, FSIS does not intend to expand its E. coli O157:H7
policy to cover additional products. Once FSIS' risk assessment on
ground beef is completed, FSIS intends to expand the risk assessment to
cover all meat products and other products that may be affected by E.
coli O157:H7. Depending upon the results of the risk assessment for E.
coli in these products, FSIS may consider expanding the policy to cover
additional products. Also at this time, FSIS does not believe that raw
product contaminated with Listeria monocytogenes or Campylobacter is
adulterated within the meaning of the Federal Meat Inspection Act
(FMIA) (21 U.S.C. 601 et seq.) or Poultry Products Inspection Act (21
U.S.C. 451 et seq.). E. coli O157:H7 is a particularly virulent
pathogen. Based on epidemiological data, low numbers of E. coli O157:H7
may be injurious to health, especially among vulnerable consumers. FSIS
is not aware of any data that suggest that customary cooking of these
beef products does not reduce Listeria monocytogenes and Campylobacter
to levels that are not injurious to health, even among vulnerable
consumers.
Products Covered by the Policy
Numerous industry commenters did not support the policy that non-
intact products contaminated with E. coli O157:H7 must either be
processed into ready-to-eat product or deemed adulterated. Several
industry commenters supported the policy with regard to beef trimmings.
Several other industry commenters stated that trimmings contaminated
with E. coli O157:H7 should not be considered adulterated. One of these
commenters stated that the policy should only be applied to trimmings
that will be used in raw ground products.
Numerous industry commenters also stated that FSIS has no data to
support the policy that products other than ground beef that are
contaminated with E. coli O157:H7 should be considered adulterated.
Specifically, many of these commenters discussed the lack of data
concerning non-intact products and the risk associated with blade
tenderized steaks. One commenter from an academic institution stated
that its study demonstrated that there is no difference in risk between
intact and non-intact steaks cooked at temperatures resulting in rare
to well-done levels of doneness.
Several industry commenters suggested that FSIS should not
implement its new policy until after completion of a risk assessment or
the
[[Page 6884]]
industry pilot program for carcass testing, or until available data
show that there is a need for the policy, especially with regard to
non-intact product.
In evaluating the public health risk presented by E. coli O157:H7-
contaminated beef products, FSIS carefully considered the deliberations
of the National Advisory Committee on Microbiological Criteria for
Foods and its Meat and Poultry Subcommittee. As noted in the January
19, 1999, policy statement, in 1998, this Committee concluded that
intact muscle should be safe if the external surfaces are exposed to
temperatures sufficient to effect a cooked color change and additional
heat to effect a complete sear across the cut surfaces (64 FR 2803-
2804). The Committee's definition of ``Intact Beef Steak'' limited the
applicability of this conclusion to muscle that has not been injected,
mechanically tenderized, or reconstructed.
FSIS has tentatively determined that there is insufficient
information regarding the processing of muscle systems to narrow the
scope of products affected by the E. coli O157:H7 policy. When the risk
assessment on ground beef is complete (see 63 FR 44232), FSIS expects
to expand it to cover all meat products, as well as other products that
may be affected by E. coli O157:H7. The Agency's efforts to broaden its
risk assessment for E. coli O157:H7 may also address some of the issues
raised by the industry with regard to non-intact product. Meanwhile,
FSIS has encouraged industry to label their intact and non-intact
primal and sub-primal cuts with appropriate cooking statements. The
1999 Food Code (section 3-401.11) prescribes appropriate cooking
instructions for intact versus non-intact steaks for destruction of
organisms of public health concern. The 1999 Food Code recommends these
products be cooked to 145 deg.F for 15 seconds.
FSIS has received the results of the study referred to in the
comments. The study confirmed that E. coli O157:H7 can be translocated
to the interior of a non-intact steak. Therefore, FSIS will continue to
recommend that non-intact product be cooked to 145 deg.F for 15
seconds, consistent with the Food Code.
Procedural Questions
Several commenters, including industry groups and a government
Agency, stated that FSIS should have issued a proposed rule, and that
FSIS' policy change should be subject to the requirements of the
Administrative Procedures Act (APA).
The January 19, 1999, policy statement was an interpretive rule and
therefore was not subject to the notice-and-comment rulemaking
requirements in section 553(b) of the APA. It was intended to elucidate
the policy that FSIS announced in 1994. Under section 552 of the APA,
FSIS is required to publish interpretive rules in the Federal Register.
FSIS complied with that requirement.
Effect on Industry
Several industry commenters stated that the new policy could put
companies out of business and could be disproportionately burdensome on
small businesses. Two industry commenters stated that the new policy
could result in less voluntary testing by industry.
Experience has shown that these predictions were wrong, at least
for the short-term. The policy resulted in the important carcass
testing that the industry is currently conducting. FSIS' future
direction in testing will be determined in large measure based on the
information that FSIS has gathered since the publication of the January
19, 1999, policy statement and on the information that FSIS receives in
response to this notice.
Consumer Responsibility
Several industry commenters stated that consumers should assume
more responsibility for their safety and expressed the need for
consumer awareness programs regarding the importance of cooking beef
products thoroughly.
Industry can reduce or eliminate risk associated with E. coli
O157:H7 through various controls and interventions, such as steam
pasteurization and irradiation, that can be incorporated into HACCP
systems. Because industry has the means to reduce or eliminate the
hazard, consumers should not be expected to assume all the
responsibility for preventing foodborne illness associated with E. coli
O157:H7.
FSIS has informed consumers of the risk of foodborne illness from
products contaminated with E. coli O157:H7. For example, on May 27,
1998, FSIS held a public meeting to discuss safe handling measures
consumers should take in cooking hamburgers. During the meeting,
participants discussed the food safety issues presented by premature
browning, including the question of whether color is an appropriate
indicator that ground beef is cooked to a safe internal temperature.
In addition, the Food Safety Education and Communications Staff
within FSIS provides information to the public concerning numerous food
safety issues, including information on cooking beef products. This
office provides food safety education information through USDA's Toll-
Free Meat and Poultry Hotline (1-800-535-4555), through public service
announcements, printed materials, and a variety of communication
channels. In addition, FSIS makes this information available over the
Internet (URL: http://www.fsis.usda.gov/). Industry and consumers are
invited to present information on how best to communicate the need for
proper handling of non-intact products that are contaminated with E.
coli O157:H7 at the public meeting.
Definition of Adulteration
Several commenters, including industry groups, an academic
organization, and an inspection association, were opposed to the
concept that beef that tests positive for E. coli O157:H7 be considered
adulterated because the organism may be inherent in raw meat and
poultry when produced under current technology.
Under the FMIA, a product is ``adulterated'' if ``it bears or
contains any poisonous or deleterious substance which may render it
injurious to health; but in case the substance is not an added
substance, such article shall not be considered adulterated under this
clause if the quantity of such substance in or on such article does not
ordinarily render it injurious to health * * *.'' (21 U.S.C.
Sec. 601(m)(1)). Because beef products contaminated with E. coli
O157:H7 are often cooked in a manner that may not prevent illness, this
pathogen is a substance that renders ``injurious to health'' even
products that many consumers consider to be properly cooked (see Texas
Food Industry Association, et. al. v. Espy, et. al., Civ. No. A-94-CA-
748 JN.)
Testing for E. coli O157:H7
Several industry commenters recommended carcass sampling rather
than end-product testing or combo bin sampling. In contrast, one
industry organization and one consumer group opined that carcass
testing would not ensure the safety of a carcass that tests positive
for E. coli O157:H7. One consumer group specifically supported testing
raw product, rather than carcasses, at both the processing and retail
levels.
Several industry commenters expressed general concerns regarding
testing for E. coli O157:H7. Several commenters noted that testing is
not a means of eliminating or reducing pathogens. Other commenters
noted that the likelihood of finding a pathogen
[[Page 6885]]
such as E. coli O157:H7 through testing is minimal.
Numerous industry commenters stated that FSIS should not expand its
sampling and testing program. Numerous commenters that submitted the
same letter stated that rather than expand the program, the Agency
should refocus the program on verifying that processes are in control.
Several consumer groups stated that the Agency should expand the
sampling and testing program.
Effective system controls, such as through HACCP, are the
appropriate means of preventing E. coli O157:H7 in ground beef from
entering commerce. FSIS is interested in encouraging industry to
conduct sampling and testing for E. coli O157:H7, as well as
microbiological testing for appropriate non-pathogenic organisms, to
allow verification and validation of HACCP systems. Microbiological
sampling, as part of HACCP systems monitoring, verification, and
validation, is an effective operational indicator. FSIS agrees that
end-product testing alone is ineffective for ensuring process control.
However, FSIS began its testing program for ground beef, an end-product
testing program, as a means of spurring establishments into taking more
aggressive action to control their processes. Establishments can
incorporate sampling and testing for E. coli O157:H7 and appropriate
non-pathogenic organisms into their HACCP plans to reduce risk and can
ensure that they are effectively controlling the pathogen through their
monitoring, verification, and validation activities. The safety of
ground products will likely improve as a result of these activities at
Federal establishments.
Guidance is available to industry for developing sampling and
testing programs for beef. The American Meat Science Association report
entitled, ``The Role of Microbiological Testing in Beef Food Safety
Programs,'' published in 1999, provides guidance for microbiological
testing within a HACCP system. At this time, FSIS believes that some of
the assumptions concerning the prevalence and distribution of E. coli
O157:H7 in this report may not reflect recent data; however, the
guidance for sampling and testing for appropriate organisms within a
HACCP system continues to be useful to industry.
FSIS considers its end-product testing as one means of preventing
adulterated product from reaching consumers. Currently, FSIS is
scheduling more sampling at Federal establishments than at retail
stores because more product is accessible for testing.
Control at Farm
Several commenters, including industry organizations and an animal
welfare organization, stated that FSIS or another entity within the
Department of Agriculture should promote efforts to control the
incidence of E. coli O157:H7 on the farm.
FSIS agrees that there should be a farm-to-table approach to
reducing or preventing the risk of E. coli O157:H7. At the animal
production level, FSIS encourages research, applied studies, and
educational activities to enhance adoption of food safety practices.
FSIS' Animal Production Food Safety Staff supports research to develop
voluntary, science-based food safety practices and verification
procedures for food animal production that will reduce the risk of
microbial hazards, such as E. coli O157:H7, entering the food chain.
This staff also provides information to the animal production community
to assist them in meeting reasonable, science-based requirements for
animals at the receiving stage of processing. Finally, this staff works
with outside organizations to promote adoption of food production
practices by producers and suppliers that result in safe and high
quality animals being presented to meat and poultry slaughtering
establishments.
Interventions
Several industry commenters emphasized the importance of microbial
interventions, such as thermal carcass washing and irradiation, in
producing safe product. Several industry commenters urged FSIS to
publish its final regulations on irradiation, noting that irradiation
should ensure the elimination of E. coli O157:H7.
FSIS agrees with commenters that interventions are integral
features of any process for reducing or eliminating E. coli O157:H7 in
beef products. However, FSIS has data that show that not all
interventions are effective, and that interventions must be implemented
properly to be effective. Establishments using interventions to prevent
or reduce the risk of E. coli O157:H7 should incorporate these
interventions into their HACCP plans and validate the effectiveness of
the interventions.
The final rule on irradiation published on December 23, 1999, and
will become effective on February 22, 2000. Therefore, this
intervention will soon be available to establishments producing raw
beef products.
Other Meat and Poultry Products
One industry commenter stated that this policy discriminates
against beef processors, because the pork and poultry industries are
similarly faced with pathogens that contribute to foodborne illnesses,
but this broadened policy interpretation would not apply to them.
FSIS does not consider raw pork or poultry products to be
adulterated when they are contaminated with bacteria, because these
products are customarily cooked in a manner that will ensure that any
pathogenic microorganisms are eliminated.
Exporting Countries
Two government organizations representing countries that export
meat to the United States did not support the policy with regard to
non-intact beef products. One commenter stated that any testing
required of product shipped to the U.S. would cause numerous problems.
The commenter explained that producers do not know whether beef cuts
will be used for making non-intact product, such as reformed steaks, at
the time of shipment.
The other commenter did not believe that end-product testing is the
best means to ensure consumer protection against E. coli O157:H7
because of its low prevalence. This commenter also stated that the
policy explained in the January 19, 1999, policy statement would be
difficult to implement. As an alternative, the commenter recommended
that any beef used to manufacture ground beef should be subject to
compliance action if it is contaminated with E. coli O157:H7. Further,
the commenter stated that appropriate compliance action should be
determined based on the level of generic E. coli in the contaminated
product.
One FSIS bargaining unit employee stated that millions of pounds of
block frozen beef enter the United States daily from countries such as
Australia. This commenter further stated that Australia has practically
eliminated its government inspection program, and that U.S. import
inspectors are allowed to sample only an insignificant amount of the
product.
In response to the first comment discussed above, FSIS notes that
product testing is not mandatory. With regard to the statement that
exporting producers do not know whether beef cuts will be used for
making non-intact product at the time of shipment, the HACCP
regulations require that establishments identify the intended use or
consumers of the finished product (Sec. 417.2(a)(2)). Countries
exporting product to the United States are required to operate
according to HACCP systems (Sec. 327.2(a)(2)(ii)(H)). Therefore,
[[Page 6886]]
the exporting producer should make an effort to determine whether the
beef will be used to produce intact or non-intact product. If the
shipping company does, and it conducts any testing and finds E. coli
O157:H7 on the beef, that company could ensure that the beef is handled
appropriately once it is shipped.
In response to the second commenter above, as discussed under
Testing for E. coli O157:H7, FSIS agrees that end-product testing alone
is ineffective for ensuring process control. However, FSIS began its
testing program for ground beef, an end-product testing program, as a
means of spurring establishments into taking more aggressive action to
control their processes. Also, at this point, FSIS does not intend to
narrow the scope of products affected by the E. coli O157:H7 policy.
With regard to this commenter's suggestion that appropriate compliance
action should be determined based on the level of generic E. coli in
the contaminated product, data show that levels of generic E. coli are
not necessarily indicative of the levels of E. coli O157:H7 in product.
In response to the comments from the FSIS bargaining unit employee,
FSIS ensures that products exported to the United States are produced
under inspection requirements equivalent to those in the Federal meat
inspection regulations. In addition, FSIS schedules sample collection
for imported ground beef product. These samples are collected and
tested for E. coli O157:H7 according to the same procedures as are used
for domestic product.
Comments on Related Documents
FSIS received comments recommending changes to FSIS Directive
10,010.1, ``Microbiological Testing Program For Escherichia coli
O157:H7 in Raw Ground Beef.'' FSIS also received comments regarding the
questions and answers it developed shortly before the March 8, 1999,
public meeting.
FSIS is currently considering whether and how to revise these
documents. In considering revisions to these documents, FSIS will take
into account the comments submitted and information from the risk
assessment on ground beef. Further, FSIS soon expects to receive the
results from the industry carcass testing study and will consider
modifying the directive based on its review of the results of the
study.
Industry Protocol
Two consumer groups objected to FSIS' decision to delay
implementation of the policy discussed in the January 19, 1999, policy
statement. One of these commenters stated that FSIS should not await
the results of the industry study before implementing the policy. The
other expressed concerns with regard to FSIS' interest in comments to
the industry protocol. For example, the commenter questioned what
bearing comments from the public will have on the study. In addition,
this commenter expressed doubt that the industry study would be carried
out in an unbiased manner.
Another consumer group stated that data from the industry's study
could offer valuable insight into both the prevalence of the pathogen
and the ability of existing intervention technologies to eliminate it
from beef carcasses. However, the commenter suggested that certain
changes should be made to the protocol. For example, the commenter
stated that FSIS' recommended changes should be incorporated into the
study, and that industry should ensure that the plants involved in the
study are representative of the variations that exist among plants that
produce raw ground and non-intact beef products.
FSIS delayed implementation of the policy discussed in the January
19, 1999, policy statement because it was waiting for the results of
the risk assessment for E. coli O157:H7 in ground beef and needed time
to consider comments received concerning the policy, not because of the
industry study. With regard to the industry study, FSIS reviewed the
protocol and provided suggested changes to the industry. In addition,
FSIS made the comments discussed above available to the industry
through the FSIS docket room. Although FSIS reviewed and provided
suggested changes to the industry, this study is an industry study;
therefore, the industry was not required to revise its protocol based
on comments from FSIS or from the public. FSIS has not yet received the
results of the study. When reviewing the results, FSIS will take into
account any short-comings in the protocol.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development are important. Consequently, in an effort to better ensure
that minorities, women, and persons with disabilities are aware of this
notice of public meeting, FSIS will announce it and provide copies of
this Federal Register publication in the FSIS Constituent Update. FSIS
provides a weekly FSIS Constituent Update, which is communicated via
fax to over 300 organizations and individuals. 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 fax list 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 these various channels, FSIS is able to provide
information to a much broader, more diverse audience. For more
information and to be added to the constituent fax list, fax your
request to the Congressional and Public Affairs Office, at (202) 720-
5704.
Done at Washington, DC, on: February 7, 2000.
Thomas J. Billy,
Administrator.
[FR Doc. 00-3197 Filed 2-10-00; 8:45 am]
BILLING CODE 3410-DM-P