[Federal Register Volume 62, Number 229 (Friday, November 28, 1997)]
[Rules and Regulations]
[Pages 63254-63255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31176]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 301, 307, 308, 310, 318, 381, 416, and 417
[Docket No. 97-067N]
Livestock Carcasses and Poultry Carcasses Contaminated With
Visible Fecal Material
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice on complying with food safety standards under the HACCP
system regulations.
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SUMMARY: The Food Safety and Inspection Service is publishing this
notice to assure that the owners and operators of federally inspected
slaughter establishments are aware that the Agency views its ``zero
tolerance'' for visible fecal material as a food safety standard. Fecal
material is a vehicle for microbial pathogens, and microbiological
contamination is a food safety hazard that is reasonably likely to
occur in the slaughter production process. In controlling
microbiological contamination, a hazard analysis and critical control
point plan for slaughter must be designed, among other things, to
ensure that, by the point of post-mortem inspection of livestock
carcasses or when poultry carcasses enter the chilling tank, no visible
fecal material is present.
FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy
Administrator, Regulations and Inspection Methods, Food Safety and
Inspection Service, Washington, DC 20250-3700; (202) 205-0699.
SUPPLEMENTARY INFORMATION: The Food Safety and Inspection Service
(FSIS) administers a regulatory program under the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products
Inspection Act (PPIA) (21 U.S.C. 451 et seq.) to protect the health and
welfare of consumers by preventing the distribution of livestock
products and poultry products that are unwholesome, adulterated, or
misbranded. A livestock product or poultry product is adulterated under
any of a number of circumstances, including the following: if it bears
or contains any poisonous or deleterious substance which may render it
injurious to health, unless when the substance is not an added
substance, the quantity in or on the article does not ordinarily render
it injurious to health; if it consists in whole or in part of any
filthy, putrid, or decomposed substance or is for any other reason
unsound, unhealthful, unwholesome, or otherwise
[[Page 63255]]
unfit for human food; or if it has been prepared, packed, or held under
unsanitary conditions whereby it may have become contaminated with
filth or whereby it may have been rendered injurious to health (21
U.S.C. 453(g)(1), (g)(3), and (g)(4) and 601(m)(1), (m)(3), and
(m)(4)). Both the FMIA and the PPIA include requirements for government
inspection and prohibit transactions in products required to be
inspected unless they have been ``inspected and passed'' or if they are
adulterated (21 U.S.C. 458(a)(2) and 610(c)).
FSIS enforces a ``zero tolerance'' standard for visible fecal
material on carcasses and carcass parts at inspected establishments
that slaughter livestock or poultry. This standard is reflected in the
Agency's regulations under the FMIA and the PPIA (9 CFR chapter III,
subchapter A and subchapter C, respectively), which require (among
other things) that establishments handle livestock carcasses and
carcass parts to prevent contamination with fecal material and promptly
remove contamination if it occurs (Sec. 310.18) and that establishments
prevent poultry carcasses contaminated with visible fecal material from
entering the chilling tank (Sec. 381.65(e)). When inspection program
personnel observe fecal material at post-mortem livestock inspection or
thereafter (i.e., at or after the final rail) under the FMIA or when
poultry carcasses are about to enter the chilling tank or thereafter
(i.e., at any point after the final pre-chiller wash) under the PPIA,
they condemn affected carcasses and carcass parts unless the
contamination is removed in accordance with regulatory requirements.
The Agency is publishing this notice to assure that the owners and
operators of federally inspected slaughter establishments are aware
that FSIS regards its zero tolerance for visible fecal material as a
food safety standard under both the FMIA and the PPIA. Reiterating the
Agency's position is particularly appropriate now, as federally
inspected establishments prepare to comply with the hazard analysis and
critical control point (HACCP) system regulations (part
417).1
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\1\ Part 417 requirements, as well as pathogen reduction
performance standards for Salmonella in establishments that
slaughter cattle, swine, chickens, or turkeys, prepare ground beef
or fresh pork sausage, or process ground chicken or turkey
(Secs. 310.25(b) and 381.94(b)) will apply as of January 26, 1998,
in establishments with 500 or more employees; January 25, 1999, in
establishments with 10 or more but fewer than 500 employees (unless
the establishment has annual sales of less than $2.5 million); and
January 25, 2000, in establishments with fewer than 10 employees or
annual sales of less than $2.5 million.
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The essence of FSIS's position is that fecal material is a vehicle
for microbial pathogens, and microbiological contamination is a food
safety hazard that is reasonably likely to occur in the slaughter
production process (Sec. 417.2(a) and (b)). Consequently, HACCP plans
must control for microbiological contamination at slaughter, and to
meet the zero tolerance standard, an establishment's controls must
(among other things) include limits that ensure that no visible fecal
material is present by the point of post-mortem inspection of livestock
carcasses or before poultry carcasses enter the chilling tank
(Sec. 417.2(c)).
In the Pathogen Reduction-HACCP Systems final rule (61 FR 38806,
July 25, 1996), FSIS explained the reasoning underlying its position on
fecal contamination, and at the beginning of this year, FSIS addressed
the role of its zero tolerance for visible fecal material on poultry
carcasses in the final rule that codified the standard under the PPIA
(62 FR 5139, February 4, 1997). Preparation for implementation of the
HACCP system regulations has not changed the Agency's conclusions about
the appropriateness of this standard, under the FMIA as well as the
PPIA.
As the Agency stated in the Pathogen Reduction-HACCP Systems final
rule (61 FR 38837):
In slaughter establishments, fecal contamination of carcasses is
the primary avenue for contamination by pathogens. Pathogens may
reside in fecal material and ingesta, both within the
gastrointestinal tract and on the exterior surfaces of animals going
to slaughter. Therefore, without care being taken in handling and
dressing procedures during slaughter and processing, the edible
portions of the carcass can become contaminated with bacteria
capable of causing illness in humans. Additionally, once introduced
into the establishment environment, the organisms may be spread from
carcass to carcass.
Because the microbial pathogens associated with fecal
contamination are the single most likely source of potential food
safety hazard in slaughter establishments, preventing and removing
fecal contamination and associated bacteria are vital
responsibilities of slaughter establishments. Further, because such
contamination is largely preventable, controls to address it will be
a critical part of any slaughter establishment's HACCP plan. Most
slaughter establishments already have in place procedures designed
to prevent and remove visible fecal contamination.
As noted in the zero tolerance final rule and confirmed today with
respect to livestock as well as poultry, establishments that process
animals must adopt controls that they can demonstrate are effective in
reducing the occurrence of microbial pathogens, including controls that
prevent the fecal contamination of carcasses (62 FR 5140). Under the
HACCP system regulations, critical control points to eliminate
contamination with visible fecal material are predictable and essential
components of all slaughter establishments' HACCP plans. Initial
validation of a HACCP plan for slaughter and monitoring thereunder, as
verified and documented in establishment records, must demonstrate the
effective operation of the plan's controls on a continuing basis
(Secs. 417.3(a), 417.4, and 417.5).
FSIS personnel will continue to verify compliance with the zero
tolerance standard in slaughter establishments that are subject to part
417 requirements. The Agency will use visual observations and other
findings by FSIS personnel in evaluating the effectiveness of an
establishment's preventive controls and corrective actions for fecal
contamination (Secs. 417.6 and 417.8). The presence of visible fecal
contamination on livestock carcasses presented for post-mortem
inspection or poultry carcasses entering the chilling tank will mean
that establishment controls have failed; repeated failures will
evidence that establishment corrective actions have failed to prevent
recurrence and, thus, possible system inadequacy.
In addition to enforcing the zero tolerance for visible fecal
material, FSIS will use the results of establishment testing for
generic E. coli (Escherichia coli Biotype I, as already required by
Sec. 310.25(a) or Sec. 381.94(a)) in assessing how well an
establishment is controlling its slaughter and dressing processes to
prevent fecal contamination. The pathogen reduction performance
standards for Salmonella (Secs. 310.25(b) and 381.94(b)), which FSIS
will enforce through its own testing program, will complement the zero
tolerance standard and E. coli testing.
Done at Washington, DC, on November 18, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-31176 Filed 11-26-97; 8:45 am]
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