[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
Federal Register
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This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
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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
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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
