[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]

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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.



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



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