[Federal Register Volume 65, Number 29 (Friday, February 11, 2000)]
[Rules and Regulations]
[Pages 6881-6886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3197]



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  Federal Register / Vol. 65, No. 29 / Friday, February 11, 2000 / 
Rules and Regulations  

[[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.

-----------------------------------------------------------------------

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:
     Are any changes needed in the proportion of samples taken 
in-plant and at retail?
     Should FSIS alter its policy that 15 consecutive samples 
be negative after a positive finding?
     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?
     Should FSIS sampling of carcasses replace or supplement 
ground beef sampling at slaughter plants?
     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)?
     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