[Federal Register Volume 64, Number 11 (Tuesday, January 19, 1999)]
[Notices]
[Pages 2872-2873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-359]


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 Notices
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  Federal Register / Vol. 64, No. 11 / Tuesday, January 19, 1999 / 
Notices  

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service
[Docket No. 98-004N]


Ground Beef Processing Guidance Material

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of its revised guidance document intended to assist 
processors of ground beef, especially small processors, in developing 
procedures to minimize the risk of Escherichia coli O157:H7 (E. coli 
O157:H7) and other pathogens in ground beef products produced in their 
establishments. This is an updated version of the guide that FSIS made 
available to the public in March 1998 and presented in a public meeting 
on April 22, 1998.

ADDRESSES: Single copies of the guidance document are available from 
the FSIS Docket Clerk in Room 102, Cotton Annex Building, 300 12th 
Street, SW., Washington, DC 20250-3700 from 8:30 a.m. to 4:30 p.m., 
Monday through Friday. An electronic version of the revised guidance 
document is available on line through the FSIS web page located at 
http://www.fsis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Mr. William J. Hudnall, Assistant 
Deputy Administrator, Office of Policy, Program Development, and 
Evaluation, at (202) 205-0495.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 20, 1998 
(63 FR 13618), FSIS announced that, as a result of recent product 
recalls involving E. coli O157:H7, the Agency had prepared guidance 
material to help beef grinding operators minimize the risk of, and 
potential effects associated with, E. coli O157:H7 and other microbial 
pathogens in raw ground beef. FSIS also intended that this guidance 
help grinding operators, especially small and very small establishments 
prepare for the development and implementation of Hazard Analysis and 
Critical Control Point (HACCP) systems. The guidance included 
recommendations for development of purchase specifications to ensure 
receipt of safe and wholesome raw materials; storage, handling, and 
transport of raw products; the grinding process, including rework and 
risk-based product separation; packaging, cooling, and storage; 
shipping, handling, and distribution; recordkeeping, product coding 
systems, and recall plans; and food safety education.

Comments

    FSIS received several comments on the guidance in response to the 
March 20, 1998 Federal Register Notice. Overall, the comments were in 
support of the recommendations in the guidance. Comments and 
suggestions were directed at microbial sampling, purchase requirements, 
rework, distribution, traceback and recordkeeping, and education.
    1. Several comments were directed at the recommendation to test for 
E. coli O157:H7. One commenter stated that testing for E. coli O157:H7 
provides an indication to grinders that HAACP systems do not provide 
the most effective method of minimizing the risk in commercial 
circumstances from microbiological hazards of gastrointestinal origin.

    HACCP is designed to prevent, eliminate, or reduce to an 
acceptable level, the presence of hazards in food. However, 
implementation of HACCP will not eliminate all risks. E. coli 
O157:H7 has been linked to or found in ground beef that caused 
foodborne illness. Thus, the guidance recommends that grinding 
operators test for E. coli O157:H7 as one means of minimizing the 
risk of illness from the consumption of ground beef. If grinders 
find a positive sample, they can divert the product to further 
processing that will make it safe.

    2. A commenter questioned the need to test for E. coli O157:H7 
because testing only provides limited assurance that the pathogen is 
present, and a negative result will not guarantee that the pathogen is 
absent.

    We agree that the pathogen is often present at low levels, and 
that the number of samples taken may not be adequate to find it. 
However, regular testing at an appropriate frequency will enhance 
chances of detection if the pathogen is present.
    The use of process interventions capable of reducing the number 
of E. coli O157:H7 is recommended. Incorporating these process 
interventions, and microbial testing at an appropriate frequency, as 
part of the establishment's HACCP system will provide an increased 
level of public health protection.

    3. One commenter questioned why testing for E. coli O157:H7 was not 
instituted as part of the HACCP rule.

    One objective of the Pathogen Reduction/Hazard Analysis and 
Critical Control Point (PR/HACCP) rule was pathogen reduction. FSIS 
selected Salmonella as the target pathogen to be tested for in meat 
and poultry products to attain this objective. Salmonella is an 
appropriate target pathogen for measuring success in achieving this 
objective, because (1) it is prevalent in raw beef, pork, and 
poultry; (2) at the time of the PR-HAACP final rule, it was the most 
common bacterial cause of foodborne disease in humans; (3) 
enumeration procedures for this pathogen are reliable and 
affordable; and (4) intervention strategies aimed at reducing fecal 
contamination and other sources of Salmonella on raw product should 
be effective against other pathogens, including E. coli O157:H7.
    Testing for E. coli O157:H7 has a much narrower purpose--to help 
ensure that ground beef in the market place is safe. FSIS started 
the Microbiological Testing Program for Escherichia coli O157:H7 in 
Raw Ground Beef in 1994 and issued a directive on the testing 
program in 1998 (Directive  10,010.1).

    4. A commenter stated that any imposition by U.S. grinders of an E. 
coli O157:H7 testing regime on overseas suppliers of frozen, boneless 
boxed manufacturing meat would pose additional logistic difficulties 
for exporting country packers. According to the commenter, these 
difficulties arise partly because the ultimate fate of the product 
(i.e. for grinding or for manufacturing purposes involving validated 
lethality steps) is not necessarily known at the time of packing or 
shipping.

    U.S. grinders may impose an E. coli O157:H7 testing regime on 
overseas suppliers of frozen, boneless boxed manufacturing meat through 
purchase specifications. Use of such specifications would be consistent 
with the establishment's obligation to control its source materials. On 
the other hand, some purchasers may only require documentation from the 
supplier that its

[[Page 2873]]

raw material was produced under a HACCP-based system, or that 
intervention methods were used, and that the raw material does not pose 
a risk.

    5. One commenter suggested that FSIS consider E. coli O157:H7 found 
on any meat as an adulterant.

    No changes are being made to the guidance document as a result 
of this comment. However, FSIS regularly assesses the public health 
implications of this pathogen for products other than ground beef 
and will take this comment into consideration in connection with 
this process. To date, FSIS has only stated that E. coli O157:H7 is 
an adulterant in ground beef. The Agency is publishing in this issue 
of the Federal Register its policy on this matter.

    6. A commenter stated that guidelines do not have the force of law, 
are not binding, and are only recommendations.

    The Agency agrees. The guidance for beef grinders is intended to 
illustrate how grinders can avail themselves of opportunities to 
minimize food safety hazards associated with their products. The 
guidance may be used in conjunction with the Agency's draft generic 
HACCP model for raw ground meat and poultry products. The HACCP 
system of process control is mandatory now for large plants and will 
become mandatory in small and very small plants in January 1999 and 
January 2000, respectively.

    7. A commenter suggested that lots or batches be limited to raw 
materials from a single slaughterhouse.

    Limiting lots or batches of raw materials to a single 
slaughterhouse represents one means of controlling the quality and 
safety of the raw materials. However, demand will dictate whether a 
grinding plant can secure all the raw materials that it needs from a 
single slaughterhouse. The guidance recommends control of source 
materials by establishing purchase requirements and demanding 
appropriate records from the suppliers. It is up to individual 
plants to decide whether they want to get their source materials 
from one or several slaughterhouses.

    8. One commenter suggested that FSIS should require identification 
of the farm of origin, slaughterhouse, and subsequent processors on the 
consumer package.

    The guidance recommends that grinding plants require suppliers 
to maintain records that facilitate traceback to the farm or animal 
source. Furthermore, the guidance recommends that grinding plants 
develop and institute codes on retail-ready packages of ground beef 
to facilitate traceback and trace-forward. However, at this time, 
FSIS is not proposing to adopt these recommendations as 
requirements. FSIS believes that the guidance is adequate to assist 
processors of ground beef to minimize the risk of E. coli O157:H7.

    9. A commenter stated that there is a higher probability of 
handling mistakes, such as temperature abuse, when there are numerous 
intermediate distributors compared to just one.

    The Agency agrees with the point made in the comment; however, 
the current food production and distribution system is complex, 
often involving lengthy distances, multiple distribution points, and 
numerous handlers. For this reason, the guidance recommends that 
intermediate distributors, in addition to the ultimate retailer, be 
included in the recordkeeping to facilitate trace-forward in case 
there is a need to do so. The guidance also recommends the use of 
tamper-proof time-temperature indicators on boxes of finished 
products to disclose temperature abuse.

    10. One commenter asked what FSIS can do, aside from education, to 
achieve the recommendation that grinders structure their operations to 
take into account the handling and preparation of meat by consumers 
after it leaves the store.

    In addition to educating consumers by training and educational 
programs, FSIS requires that important consumer information be 
included on labels of meat and poultry products. Food labels inform 
consumers about whether the product is ready-to-eat or needs to be 
cooked, and about how to store the product. Non-ready-to-eat meat 
and poultry products are required to include safe handling 
instructions, which instruct consumers about handling, storing, and 
cooking the product. In addition, cooking instructions may be 
included on labels of non-ready-to-eat products.

    11. A commenter stated that the guidance did not stress food 
handler education.

    The Agency disagrees with this comment. The guidance recommends 
training and education of employees, food handlers, distributors, 
and consumers on the risks of foodborne illness associated with 
ground beef and suggests measures to prevent foodborne illness. In 
addition, the plant's Sanitation Standard Operating Procedures may 
include training and education of employees and food handlers. The 
Agency does agree, however, with the suggestion from the commenter 
that training food handlers in their native language will make the 
training more effective and meaningful. In response to this comment, 
FSIS revised the education section of the guidance by recommending 
that establishments provide training to food handlers and other 
employees in their native language, if necessary.

    12. There was a suggestion from a commenter to spell out sanitation 
of the carrier in the subsection on transport of raw materials.

    In the original guidance document, the subsection on transport 
of raw materials included examination of conditions of transport, 
such as temperature inside transport vehicles, and of meat itself, 
as well as duration of transport. In response to this comment, FSIS 
expanded the subsection on transport of raw materials to add 
sanitation of the carrier and details on the different conditions of 
transport, such as presence of cracks, debris, foreign material or 
off-odors, condition of the insulation and of the door seals.

Revised Guidance Document

    In addition to the changes noted above in response to the comments 
and suggestions, the Agency has incorporated details on rework and 
product recall plans that were derived from the guidance material 
provided by the National Meat Association and the American Meat 
Institute. As a result, the section on the grinding process has been 
expanded, especially the subsection on lotting, rework, unprocessed raw 
material and outside trimmings. The shipping, handling and distribution 
section has also been expanded to include more details on transport, 
secondary distributors, inventory control and in-house recall plans.
    FSIS intends to update the guidance regularly and to make it 
available through the FSIS web page. Recommendations for improving this 
guidance material are welcome at any time.

    Done in Washington, DC on December 21, 1998.
Thomas J. Billy,
Administrator.
[FR Doc. 99-359 Filed 1-15-99; 8:45 am]
BILLING CODE 3410-DM-P