[Federal Register Volume 61, Number 130 (Friday, July 5, 1996)]
[Proposed Rules]
[Pages 35157-35158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17001]


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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

9 CFR Parts 319 and 381

[Docket No. 95-056N]


Public Health Hazard Analysis Board Report; Availability

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability of report; request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of a report prepared by the Public Health Hazard 
Analysis Board on ``Bone Particles and Foreign Material in Meat and 
Poultry Products.'' The report contains an executive summary by the 
Public Health Hazard Analysis Board, which includes the Board's 
conclusions on the establishment of criteria for determining the safety 
of meat and poultry products containing bone particles and foreign 
materials such as glass, metal and plastic; a list of Board members and 
other participants; and a bibliography. FSIS is seeking comments on the 
need for and nature of any additional regulatory actions beyond those 
provided for in its meat and poultry regulations that should be taken 
regarding bone particle size and foreign material, such as glass, 
metal, and plastic, in boneless meat and poultry products deboned by 
hand or other means.

DATES: Comments will be accepted through August 19, 1996.

ADDRESSES: Interested persons may submit an original and two copies of 
written comments and requests for single copies of the report to: FSIS 
Docket Clerk, DOCKET #95-056N, Room 4352 South Agriculture Building, 
Washington, DC 20250-3700. Oral comments, as provided by the Poultry 
Products Inspection Act, can be given to Dr. Jill Hollingsworth, (202) 
205-0293. The report and comments will be available for public 
inspection in the FSIS Docket Room from 8:30 a.m. to 1:00 p.m. and from 
2:00 p.m. to 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Dr. Jill Hollingsworth, Deputy 
Director, Epidemiology and Emergency Response Program, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Room 2168 South 
Building, Washington, DC 20250-3700, (202) 205-0293.

SUPPLEMENTARY INFORMATION: FSIS is announcing the availability of a 
report prepared by the Public Health Hazard Analysis Board (the Board) 
on ``Bone Particles and Foreign Material in Meat and Poultry 
Products.'' The Board consists of public health, medical, and food 
safety experts in FSIS and other government agencies. Private medical 
specialists were contacted by the Board for additional information on 
the subject. The Board was charged with determining health and safety 
concerns related to bone particles or foreign material in boneless meat 
and poultry products. Consequently, the Board provided criteria for use 
by the Agency to determine the existence of a potential safety hazard, 
due to bone particles or foreign material, such as glass, metal, and 
plastic, in meat or poultry products, that warrant recall of the 
affected product in order to protect the public health.
    The Board determined that bone particles less than 0.4 inches (10 
mm) would not be considered a safety hazard. Bone particles from 0.4 to 
0.8 inches (10 to 20 mm) may present a discomfort, but would be a low 
risk for a safety hazard, and bone particles greater than 0.8 inches 
(20 mm) have the potential to be a safety hazard and may cause injury 
to consumers. According to the Board, any occurrence of foreign 
material, such as glass, metal, and plastic, in meat or poultry 
products, has the potential to be a safety hazard and should be 
evaluated on a case-by-case basis to determine whether it presents such 
a hazard.
    The Board agreed that boneless product produced in accordance with 
the provisions in 9 CFR 319.5 for mechanically-separated meat (MSM) and 
provisions in 9 CFR 381.173 (59 FR 62629, December 6, 1994, and 59 FR 
55962, November 3, 1995) for mechanically-separated poultry (MSP) to be 
effective on November 4, 1996, does not present a safety hazard. 
Regulatory requirements limit bone particle size in MSM and MSP which 
is produced by crushing or grinding of bone before removal of edible 
tissue. Provisions in 9 CFR 319.5 for MSM require that at least 98 
percent of bone particles present in MSM be no greater than 0.2 inches 
(5 mm) in their greatest dimension, with no bone particles larger than 
0.034 inches (0.85 mm) in their greatest dimension. Similar provisions 
in 9 CFR 381.173 for MSP require that at least 98 percent of bone 
particles present in MSP be no greater than 0.06 inches (1.5 mm) in 
their greatest dimension, with no particles greater than 0.08 inches (2 
mm) in their greatest dimension. FSIS has concluded that

[[Page 35158]]

these bone particle size limitations represent good manufacturing 
practices and reflect processes that are in control and protect 
finished product quality. Because bone particles are extremely small in 
MSM and MSP, they would not be considered to be a safety hazard.
    Products containing bone fragments larger than 0.8 inches (20 mm) 
are of regulatory concern to FSIS, and the Agency will consider 
regulatory action, as appropriate, to protect consumers. There are 
currently no regulations that specifically address the limiting of bone 
particle size for boneless meat and poultry products deboned by hand, 
or for meat produced by an advanced mechanical method that does not 
involve crushing or grinding the bones (59 FR 62551, December 6, 1994). 
Safety determinations about boneless product produced by these methods 
are made on an ad hoc basis, based on the criteria recommended by the 
Board. Companies producing boneless meat and poultry products deboned 
by hand or produced by advanced mechanical separation generally employ 
manufacturing practices that keep the size of bone particles well below 
the 0.8-inch (20-mm) level considered to be a potential safety hazard 
by the Board.
    FSIS's proposed rule, ``Pathogen Reduction; Hazard Analysis and 
Critical Control Point (HACCP) Systems,'' (60 FR 6774, February 3, 
1995) proposes requiring meat and poultry processors to establish HACCP 
systems of preventive controls to ensure the safety of foods they 
produce. This would include the addressing of potential physical 
hazards in meat and poultry products, such as bone particles, in HACCP 
plans. The proposed HACCP system would place an affirmative duty on 
companies to establish procedures to prevent bone particles of foreign 
material from presenting a safety hazard in boneless meat and poultry 
products.
    FSIS invites comments on whether additional regulatory action is 
needed, beyond that provided by FSIS in its regulations, regarding bone 
particle size and foreign material, such as glass, metal, or plastic, 
in boneless meat and poultry products deboned by hand, produced by 
advanced mechanical separation, or by other procedural means not 
identified in current meat and poultry regulations.

    Done at Washington, DC, on: June 27, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 96-17001 Filed 7-03-96; 8:45 am]
BILLING CODE 3410-DM-P