[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]
BILLING CODE 3410-DM-P