[Federal Register Volume 65, Number 232 (Friday, December 1, 2000)]
[Proposed Rules]
[Pages 75187-75196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30497]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 381 and 424

[Docket No. 98-062P]


Performance Standards for On-line Antimicrobial Reprocessing of 
Pre-Chill Poultry Carcasses

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend its poultry products inspection regulations to allow, on a 
voluntary basis, the on-line reprocessing of pre-chill carcasses that 
are accidently contaminated with digestive tract contents during 
slaughter. FSIS is proposing that, to permit this on-line reprocessing 
of visibly contaminated birds, the treated carcasses must meet pre-
chill performance standards for Salmonella and E. coli that are 
significantly lower than the existing criteria for verifying process 
control for E. coli and the pathogen reduction performance standards 
for Salmonella for chilled poultry. The proposed change will allow 
contaminated poultry carcasses, including turkeys, to remain on the 
main processing line for treatment, rather than having to be moved off 
the main line. Birds with no visible contamination may undergo the same 
antimicrobial treatment, but they will remain subject to the Agency's 
pathogen reduction performance standards and process control criteria 
already in place for raw chilled product. Birds whose entire carcass is 
affected with contamination or are mutilated will not be permitted to 
be processed on-line. Under this proposal, establishments doing on-line 
antimicrobial reprocessing will need to do so in accordance with the 
Hazard Analysis and Critical Control Point (HACCP) system requirements 
in 9 CFR part 417. This proposed rule is in response to petitions from 
Rhodia Inc., of Cranbury, New Jersey, and Alcide Corporation of 
Redmond, Washington.

DATES: Comments must be received on or before January 30, 2001.

ADDRESSES: Submit written comments to the FSIS Docket Clerk, Room 102, 
Cotton Annex Building, 300 12th Street,

[[Page 75188]]

SW., Washington, DC 20250-3700. Interested persons are requested to 
submit an original and two copies of comments concerning this proposal. 
Written comments should be sent to the Docket Clerk at the address 
shown above and should refer to Docket Number 98-062P. Copies of all 
comments submitted in response to this proposal will be available for 
public inspection in the FSIS Docket Room between 8:30 a.m. and 4:30 
p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy 
Administrator, Regulations & Inspection, Office of Policy, Program 
Development, and Evaluation, FSIS, at (202) 205-0699 or FAX (202) 401-
1760.

SUPPLEMENTARY INFORMATION: FSIS is responsible for ensuring that 
poultry products distributed in commerce are wholesome, not 
adulterated, and properly marked, labeled, and packaged. Under the 
Poultry Products Inspection Act (PPIA) (21 U.S.C. 451-470), FSIS 
provides mandatory inspection of poultry and poultry products 
distributed in interstate and foreign commerce and in designated States 
and U.S. territories. Inspection of poultry slaughtering establishments 
is intended to ensure that fresh, ready-to-cook poultry and parts are 
not adulterated or misbranded.

Poultry Reprocessing

    FSIS estimates that 2 percent of inspected poultry carcasses are 
reprocessed. This estimate is based on approximately two years of in-
plant data collection and represents the national average. The Agency 
requires that poultry with cut, contaminated surfaces be reprocessed by 
trimming, and poultry with uncut, contaminated inner surfaces be 
reprocessed by trimming alone or in combination with other methods, 
such as washing or vacuuming. After viscera removal, the contaminated 
carcasses are hung on a designated area of the retain rack. Carcasses 
are then transferred to the reprocessing station where they are 
suspended to prevent contamination during trimming and washing. The 
crops are removed, and external carcass surfaces are thoroughly washed. 
The contaminant is removed, and the reprocessed carcass is rinsed with 
water containing 20 ppm chlorine. After further examination by plant 
personnel, clean carcasses are lotted and made available for 
reinspection by FSIS inspectors. Carcasses found by the FSIS inspectors 
to be not adulterated are passed for human consumption.
    Reprocessing procedures must be submitted in writing to FSIS. FSIS 
field personnel are authorized to grant approvals for reprocessing 
stations to include 60-day provisional approvals (experimental under 
section 381.3(b)) to permit method development and data accumulation 
via MPI Bulletin 78-40 (``Disposition of Contaminated Poultry 
Carcasses,'' 3/28/78). Provisional approvals can be refused or revoked 
if the establishment cannot maintain consistently effective results. 
Final approvals must be based in part upon data from 20 consecutive 
days of successful operations.
    The statutory basis for poultry reprocessing is section 6(c) of the 
PPIA (21 U.S.C. 455(c)) which provides that carcasses, parts, and 
products that may by reprocessing be made not adulterated, need not be 
condemned and destroyed if reprocessed under the supervision of an 
inspector and found to be not adulterated. The methods used to 
reprocess carcasses have changed over time. In the early 1960's, FSIS 
prohibited reprocessing by washing of poultry carcasses. This meant 
that contamination had to be removed by trimming. As a practical 
matter, the entire back of contaminated carcasses often had to be cut 
out and discarded.
    In 1975, an Agriculture Research Service (ARS) study showed that 
the microbial profile of thoroughly washed carcasses previously 
contaminated with digestive tract contents was no different than the 
microbial profile of uncontaminated birds. Industry responded by 
requesting that FSIS permit contamination to be removed by washing. 
Industry also supplied data to demonstrate that washing also removed 
visible specks of internal contamination.
    Citing newer technology that made the present procedure of trimming 
``unsuitable,'' on August 19, 1977, the Food Safety and Quality Service 
(now FSIS) proposed (42 FR 41873) to permit the reprocessing of 
internally contaminated carcasses if two conditions were met. First, 
each establishment must receive approval from FSIS of the off-line 
reprocessing procedure (trimming, vacuuming, or washing singly or in 
various combinations) and equipment. Second, the surface of each 
reprocessed carcass must be treated with a chlorinated water solution. 
A final rule, issued on March 8, 1978 (43 FR 12846), reduced the 
chlorine requirements from 50 ppm to 20 ppm and clarified some 
information about the areas designated for reprocessing.
    During the 1970's and 1980's, the industry made significant 
technological advances and increased its process control capabilities. 
The development of automated evisceration equipment and improvements in 
genetics, nutrition health, and flock management permitted the poultry 
industry to present uniform lots of birds to inspectors faster than 
inspectors could inspect them using traditional methods. In the 1980's, 
the Agency developed new inspection procedures, including New Line 
Speed (NELS) and Streamlined Inspection System (SIS) for chickens and 
the New Turkey Inspection (NTI) system, which shifted quality control 
responsibilities to the plant and relied more heavily on monitoring and 
verification than in the past. Inspection was now conducted in two 
distinct phases--a post-mortem inspection phase and a reinspection 
phase.
    Under the current regulations, any carcass of poultry accidently 
contaminated during slaughter with digestive tract contents will not be 
condemned if promptly reprocessed in a designated area off-line under 
the supervision of an inspector and found to be not adulterated. Under 
provisions of Sec. 381.91, carcasses of poultry contaminated with 
volatile oils, paints, or any other substance that renders the carcass 
adulterated will be condemned. In addition, any organ or other part of 
a carcass that has been accidentally mutilated in the course of 
processing will be condemned, and if the whole carcass is affected, the 
whole carcass will be condemned.

Advantages of On-Line Versus Off-Line Reprocessing

    Although FSIS' regulations require any visibly contaminated poultry 
carcass to be reprocessed at an approved reprocessing station away from 
the main processing line, there has been concern that pathogenic 
organisms may be spread by the off-line reprocessing technique 
(Beuchat, LR, and JH Ryu, Produce Handling and Process Practices, 
1997). This technique involves a significant amount of product handling 
and provides an opportunity for cross-contamination.
    On-line reprocessing of pre-chill poultry would provide great 
benefits to poultry slaughtering establishments. Production rates could 
increase considerably if such reprocessing were permitted. An increase 
in annual revenues resulting from an increase in the production rate 
would more than offset any one-time investment for the purchase and 
installation of equipment needed to reprocess on-line.The Agency does 
not foresee that any establishment would need to reduce its linespeeds 
as a result of on-line reprocessing, although the FSIS inspector-in-
charge has discretion to reduce linespeeds, when necessary.

[[Page 75189]]

    The benefits to be derived from on-line reprocessing include 
substantial reductions in pathogens on dressed, ready-to-cook poultry. 
A reduction in contamination, coupled with an antimicrobial treatment, 
would result in reduced microbial loads on dressed poultry carcasses. 
Because carcasses without visible contamination would undergo the 
antimicrobial treatment if reprocessing was done on-line, most poultry 
products would benefit from on-line reprocessing. There would be added 
assurance that reprocessed poultry are free of contamination and 
unlikely to be a cause of cross contamination when introduced into the 
chiller system.
    Industry is aware of the potential benefits to be derived from on-
line reprocessing. Consequently, over the last several years, companies 
have been exploring various methodologies. The first to come forward 
with data from trials performed at five plants (Choctow Maid, Carthage, 
MS; Perdue Farms, Rockingham, NC; Wayne Farms, Jack, AL; Choctow Foods, 
Forrest, MS; and Amick Farms, Batesburg, SC) was Rhodia, Inc., whose 
system uses trisodium phosphate (TSP). Rhodia's data show that its on-
line reprocessing system can achieve pathogen levels significantly 
lower than the Agency pathogen reduction performance standards and 
process control verification criteria.
    In addition, Alcide Corporation has developed the 
Sanova<SUP>TM</SUP> Continuous On-line Processing (COP) antimicrobial 
intervention process for poultry, which uses acidified sodium chlorite. 
FSIS is aware that other companies in addition to Rhodia and Alcide are 
doing in-plant testing and may soon be coming forward with data on the 
effectiveness of their antimicrobial systems.

TSP as a Processing Aid

    Rhodia Inc., Rhone-Poulenc, Inc., its parent company, and Stauffer 
Chemical Company, its predecessor company, have conducted tests on the 
efficacy of various processes using solutions of food-grade TSP as a 
processing aid on raw meat and poultry carcasses for the purpose of 
reducing the numbers and prevalence of various pathogenic 
microorganisms. TSP is listed by the Food and Drug Administration (FDA) 
as generally recognized as safe (GRAS) for multiple-purpose use in 
accordance with good manufacturing practices (GMP) (21 CFR 182.1778). 
As part of the testing of TSP, numerous laboratory, plant, and 
commercial trials have been conducted pre-chill and post-chill in 
slaughtering operations for beef and poultry (chicken and turkey) and 
for poultry giblets.
    The trials tested both TSP spray/drench systems using inside/
outside birdwashers (IOBW) and TSP immersion/application techniques 
using a drag through tank. Each of the commercial plant trials 
consistently demonstrated the efficacy of TSP in reducing prevalence 
and levels of Aerobic Plate Counts (APC's), Campylobacter, E. coli, and 
Enterobacteriaceae on meat and poultry.
    The efficacy of a TSP rinse combined with a chlorine rinse in 
reducing the prevalence and levels of pathogenic bacteria on poultry is 
well documented by Rhodia. From the data submitted by Rhodia, it 
appears that APC's can be reduced up to 1.5 log<INF>10</INF> cycles 
(i.e., just less than 99 percent); Campylobacter prevalence can be 
reduced from 78.6 percent to 41.6 percent, a 37 percent reduction; E. 
coli and Enterobacteriaceae can be reduced to below the level of 
detection; and Salmonella can be reduced to below 1 percent of the 
total number of birds sampled.

Petition for Approval of TSP on Raw, Chilled Poultry Carcasses

    In 1992, Rhone-Poulenc petitioned FSIS for approval of the use of 
TSP on raw, chilled poultry carcasses. The petitioner included data in 
its petition to demonstrate that the use of TSP is effective in 
reducing the prevalence of bacteria, including pathogenic bacteria, on 
raw, chilled poultry products. FSIS evaluated the petitioner's request 
and concluded that the treatment leaves virtually no residues in or on 
the product.
    FSIS also determined that the use of TSP requested by the 
petitioner was suitable for its intended purpose as an antimicrobial 
processing aid, and that the use of this substance on raw, chilled 
poultry carcasses at the stated level would not render the treated 
product adulterated, misbranded, or otherwise not in accordance with 
the requirements of the PPIA. In a final rule issued on July 29, 1996 
(61 FR 39273), FSIS amended the poultry products inspection regulations 
(formerly in Sec. 381.147; now in the table in Sec. 424.21(c)) to add 
``antimicrobial agents'' as a new class of substance for use on poultry 
products and to include TSP as an approved antimicrobial agent whose 
use is limited to raw, chilled poultry carcasses.

In-Plant Trials of On-Line Reprocessing

    Because of the antimicrobial efficacy demonstrated by TSP on 
chilled poultry in commercial poultry slaughter operations, Rhodia 
requested and received authorization from FSIS to conduct in-plant 
trials of the use of TSP for on-line reprocessing of pre-chill 
carcasses. FSIS regulations (Sec. 381.91(b)(1) and (2)) require that 
the carcasses be reprocessed off-line under the supervision of an FSIS 
inspector.
    Under the FSIS-approved protocol, a TSP treatment using an IOBW for 
the on-line reprocessing was tested. In the first stage of the approved 
protocol, visible contamination was removed from carcasses prior to 
zero tolerance verification by using one or more IOBW with a water 
spray containing 20 ppm chlorine. In the second stage, carcasses passed 
through another IOBW where a TSP antimicrobial rinse was applied.
    Two separate phases of sampling took place in each trial at five 
plants. Phase 1 was conducted over a 4-week period and involved 
extensive sampling, in part, to verify proper startup of the system. 
Phase 2 was conducted over an 8-week period and involved collecting a 
lesser number of samples on a random basis.
    The trials were conducted within the following operating 
parameters:
    (1) There was strict compliance with FSIS regulatory policy, 
including the zero tolerance for fecal matter (9 CFR 381.65(e)), and 
with the existing pre-chill finished product standards (9 CFR 381.76, 
Table 1).
    (2) Birds whose entire carcass was affected with contamination were 
not eligible for on-line reprocessing with TSP. These carcasses were 
reprocessed off-line in accordance with 9 CFR 381.91.
    (3) The temperature of the TSP treatment solution did not exceed 
the carcass temperature at the time of treatment, and the treatment 
solution was applied by spraying/drenching carcasses up to 15 seconds.
    (4) The TSP concentration levels were between 8 and 12 percent, 
with a critical limit of not less than 8 percent.
    The 960 samples generated at each plant were divided equally among 
three sampling points. ``A'' samples were taken randomly from 
``normal'' on-line fully eviscerated carcasses with no visible 
contamination before they underwent the first IOBW rinse for on-line 
reprocessing. The ``A'' samples, therefore, can be considered the 
control samples because they represented the actual bacterial load on 
carcasses proceeding on-line during days the sampling was conducted. 
``B'' samples were taken from visibly contaminated carcasses that would 
normally have been reprocessed off-line but that were marked and 
allowed to be reprocessed on-line. ``C'' samples were obtained

[[Page 75190]]

from carcasses after they were reprocessed off-line, where they 
underwent procedures such as vacuuming, washing, or trimming, singly or 
in combination, and treated with chlorinated water. All samples were 
frozen and shipped to laboratories for analysis by AOAC/BAM analytical 
methods.

Results of Trials

    The data submitted to FSIS in support of Rhodia's petition show 
that the combined effects of the TSP and chlorine rinses substantially 
reduced the average APC's and Enterobacteriaceae counts and the 
prevalence of Campylobacter, E. coli, and Salmonella on treated sample 
carcasses. Specifically, the data show that:
    <bullet> On-line TSP reprocessing achieved a 1 log<INF>10</INF> 
greater reduction in average APC's than normally reprocessed on-line 
carcasses before the chiller (``A'' samples) and a one-half log greater 
reduction in average APC's than off-line reprocessed carcasses before 
the chiller (``C'' samples).
    <bullet> The average prevalence of Campylobacter on normal on-line 
carcasses before the chiller (``A'' samples) was 78 percent, and the 
average prevalence was 80 percent for off-line carcasses before the 
chiller (``C'' samples). There was a 32 percent reduction in 
Campylobacter prevalence for TSP reprocessed birds. (There were no 
Campylobacter samples tested in Phase 2 of the trials).
    <bullet> On-line TSP reprocessing resulted in less than a 1.0 
percent prevalence for E. coli. On-line carcasses in the control group 
(``A'' samples) had an average E. coli prevalence of 97 percent before 
the chiller, and off-line reprocessed carcasses (``C'' samples) 
averaged a 22 percent prevalence rate before the chiller.
    <bullet> TSP on-line reprocessing reduced the prevalence for 
Enterobacteriaceae to 1.0 percent of carcasses. The average prevalence 
of Enterobacteriaceae on normal on-line pre-chilled carcasses (``A'' 
samples) was 98 percent, and the average prevalence was 81 percent for 
off-line reprocessed pre-chilled carcasses (``C'' samples).
    <bullet> Salmonella prevalences were based on more than 1,200 
samples each of the normal on-line carcasses, the TSP on-line 
reprocessed carcasses, and the off-line reprocessed carcasses. Less 
than 0.5 percent of the on-line carcasses treated with chlorine and TSP 
rinses were positive for Salmonella. On-line pre-chilled carcasses 
(``A'' samples) averaged a prevalence of 30 percent, and off-line 
reprocessed pre-chilled carcasses (``C'' samples) averaged a 22 percent 
prevalence.

Establishing a Pathogen Reduction Standard for On-Line Reprocessing 
Systems

    In its petition, as noted above, Rhodia presented data from frozen 
samples that showed that the TSP rinse, in combination with a 
chlorinated water system, achieved substantial microbial load reduction 
on treated carcasses. Rhodia Inc., asked that FSIS amend its rules to 
provide for the on-line reprocessing of poultry with a substance or 
reprocessing system that has demonstrated, with statistically 
significant validating data generated under conditions of in-plant 
trial tests, the ability to reduce the pre-chill prevalence of 
Salmonella to less than 0.5 percent and to reduce the pre-chill 
prevalence of E. coli to less than 1.0 percent on frozen samples.
    The on-line reprocessing of carcasses would occur after FSIS post-
mortem inspection (in non-HACCP Inspection Models project plants) and 
the removal from the slaughter/processing line of carcasses extensively 
contaminated with digestive tract content or fecal material, condemned 
poultry carcasses, and parts or organs that are obviously unwholesome 
or unfit for human food. The removal of processing defects 
(nonconformances such as digestive tract contents, lungs, hair, 
feathers, bruises, scabies, airsacculitis, and others listed in 
Sec. 381.76) is unchanged by this proposed rule and would continue to 
occur before on-line antimicrobial processing and before carcasses 
enter the chiller tank.
    Under this proposal, carcasses with visible digestive tract 
contamination, including fecal contamination, would be permitted to 
remain on-line and would be treated with an antimicrobial agent before 
entering the chiller. Carcasses with extensive digestive tract 
contamination would continue to be eligible for reprocessing off-line 
but would not be eligible for on-line reprocessing.
    FSIS is not proposing the specific pre-chill Salmonella and E. coli 
standards because, at this time, various antimicrobial treatments have 
been demonstrated to have differing effects. FSIS does intend to 
establish one or more pre-chill performance standards that 
establishments using on-line reprocessing with an antimicrobial 
treatment will be required to meet. FSIS invites comment, especially in 
the form of additional data, on the specific performance standards that 
establishments should be required to meet.
    E. coli continues to be the best microbial indicator for fecal 
contamination. Salmonella is the most frequently occurring foodborne 
pathogen, and it is widely associated with raw poultry. Because E. coli 
contamination is largely preventable, and because the current E. coli 
and Salmonella requirements contained in Sec. 381.94 were met or 
exceeded in the commercial on-line reprocessing trials, FSIS believes 
that these organisms would be appropriate for pre-chill performance 
standards for reprocessing on line.
    Under provisions of the HACCP final rule, FSIS requires all poultry 
slaughter establishments to test carcasses for generic E. coli using an 
AOAC approved method of analysis to verify process control for fecal 
contamination. The rule establishes testing frequencies based on 
production levels. The HACCP final rule does not require establishments 
to conduct their own testing for Salmonella, but FSIS tests product and 
reports the results to establishments. FSIS has published guide books 
for sampling for both E. coli and Salmonella (footnotes 1 and 3 in 
Sec. 381.94). The guidebooks are available in the Docket Room (See 
ADDRESSES) and on the FSIS web page at http://www.fsis.usda.gov. FSIS 
believes that establishments operating on-line antimicrobial 
reprocessing systems for pre-chilled carcasses should follow the 
guidelines for sample collection for the pre-chill pathogen reduction 
performance standards for E. coli and Salmonella in accordance with 
footnotes 1 and 3 in 9 CFR 381.94.

Campylobacter

    In 1999, the National Advisory Committee on Meat and Poultry 
Inspection requested that the National Advisory Committee for 
Microbiological Criteria for Foods evaluate options for defining a 
performance standard for Campylobacter. Campylobacter is the most 
frequent cause of bacterial foodborne illness in the United States. It 
is estimated that between 60 and 80 percent of chilled whole birds 
sampled at processing facilities are contaminated with the 
microorganism. The National Advisory Committee for Microbiological 
Criteria for Foods expressed concern in defining a Campylobacter 
standard, in part, because of the paucity of data on the relationship 
among Campylobacter, other microorganisms (e.g., Salmonella and generic 
E. coli), and poultry. For example, there are no available on-farm or 
slaughter intervention strategies designed to eliminate Campylobacter, 
and a new method developed by the Agricultural Research Service to 
detect

[[Page 75191]]

and quantify Campylobacter has not yet been fully assessed and compared 
against the current method used by FSIS. Consequently, FSIS believes 
that there are insufficient data to establish a performance standard 
for Campylobacter as part of this proposed rulemaking for on-line 
antimicrobial reprocessing of pre-chill poultry carcasses. However, 
FSIS is interested in establishing such a standard for this pathogen 
and is seeking comment and data regarding this issue.

Alcide's Petition for Acidified Sodium Chlorite

    In January 1999, FSIS granted interim approval to the Alcide 
Corporation of Redmond, Washington, to permit the use of 
Sanova<SUP>TM</SUP> equipment using acidified sodium chlorite as an 
antimicrobial treatment for reducing microbial levels on raw poultry 
carcasses. The Agency's approval did not extend to the use of the 
equipment and acidified sodium chlorite for on-line reprocessing of 
contaminated poultry. FSIS stated in the January 1999 letter that it 
would eventually add the substance to the chart specifying the food 
ingredients approved for use in the preparation of meat and poultry 
products under the heading ``Antimicrobial agents'' for pre-chilled 
poultry carcasses at Sec. 424.21(c).
    In November 1999, FSIS received a petition from Alcide requesting 
that the Agency conduct rulemaking to approve the use of its 
Sanova<SUP>TM</SUP> continuous on-line processing (COP) system, which 
uses acidified sodium chlorite as an antimicrobial treatment for on-
line reprocessing of contaminated poultry. The process can be used in 
conjunction with an IOBW, but an IOBW is not a requirement of the 
system. The COP system features a spray cabinet to deliver an 
antimicrobial treatment of acidified sodium chlorite (500 to 1200 ppm 
sodium with citric acid) to poultry carcasses before the carcasses are 
chilled.
    FSIS intended to initiate rulemaking to amend the chart to include 
acidified sodium chlorite until a recent final rule (64 FR 72168) and a 
Memorandum of Understanding with the Food and Drug Administration (FDA) 
on the listing of food ingredients (MOU; FDA/FSIS Regarding the Listing 
of Food Ingredients and Sources of Radiation Used in the Production of 
Meat and Poultry Products, January 2000) were issued. The documents 
provide that FDA will list in its regulations in title 21 of the Code 
of Federal Regulations (CFR) all food ingredients and sources of 
radiation that are safe for use in the production of meat and poultry 
products. FSIS, through a separate rulemaking activity, intends to 
delete the chart in Sec. 424.21(c), and the contents of the chart will 
be appended to 21 CFR. Meanwhile, FDA amended its food additive 
regulations to provide for the safe use of acidified sodium chlorite as 
a antimicrobial agent in the processing of red meat carcasses (63 FR 
11118), on red meat parts and organs (65 FR 1776), in poultry 
processing (64 FR 26841), and on poultry carcass parts (65 FR 16312).
    Alcide also requested that any regulatory proposal on performance 
standards for on-line reprocessing of poultry be deferred until FSIS 
has had the opportunity to evaluate Alcide's petition. The Agency has 
reviewed Alcide's petition and the accompanying data. The Agency's 
review of the test results from Alcide indicates that the COP system 
achieves an average reduction in Salmonella prevalence of 27.27 
percent, and an average reduction of Campylobacter prevalence of 25.6 
percent. Alcide's samples were fresh and chilled, not frozen. Of the 
1,070 post-COP treated carcasses sampled in the five establishments, an 
average of 34 percent were negative for E. coli, and 66 percent were 
positive. Assuming that 10 or fewer cells of E. coli are considered as 
a limit of detection, the estimated prevalence in the sampling is 26.4 
percent. If the samples were frozen, Alcide estimated that freezing 
would reduce the number of organisms in a sample by 1 log<INF>10</INF> 
(i.e., 90 percent) resulting in only 5.4 percent of the samples having 
a count greater than 10.
    Unlike the Rhodia data that were quantitative and focused on 
absolute levels of reduction (i.e., less than 0.5 percent of the 
treated samples were positive for Salmonella), Alcide's data documented 
degrees of reduction (i.e., there was an average reduction by 27.27 
percent of the prevalence of Salmonella on the treated samples). 
Alcide's data appear to document statistically significant food safety 
enhancements achieved at the five test establishments, without 
establishing specific numerical performance standards as Rhodia did 
through its petition. Therefore, at this time, the Agency has not been 
able to equate the results of the data from the two petitions. 
Nonetheless, because the Agency has decided to go forward with this 
rulemaking, it has granted the Alcide petition, in part, except for the 
company's request to use non-quantitative performance standards. FSIS 
is seeking public comment on performance standard levels and hopes to 
receive further data that are relevant to this issue. It also seeks 
comment on whether is is possible to equate the Rhodia and Alicde data.

National Chicken Council Data

    Meanwhile, a third set of data was submitted to the Agency by the 
National Chicken Council (NCC). The NCC conducted testing in five 
establishments regarding the commercial application of TSP. The NCC 
data, like the Rhodia data, show that on-line antimicrobial 
reprocessing is superior to off-line reprocessing, and that the 
prevalence of E. coli and Salmonella can be reduced considerably. In 
contrast to the Rhodia data, however, the NCC data show that freezing 
the samples has an impact on the prevalence and counts of E. coli and 
results in lower numbers. Although the prevalence of Salmonella was 
lower in frozen samples than in refrigerated samples in the NCC study, 
the difference between frozen and refrigerated samples was not 
statistically significant. NCC asserted that its sampling (1,840 
samples were analyzed for Salmonella spp, and 1,320 were analyzed for 
E. coli) demonstrated that the that the 0.5 percent pre-chill 
performance standard for Salmonella and the 1.0 percent pre-chill 
performance standard for E. coli were not achievable following TSP 
application in commercial operations.
    NCC's study was conducted in four stages. Carcass rinses of whole 
birds were performed at three designated sites along the production 
line: pre TSP (post IOBW), post TSP, and post-chill. The sample types 
included ``visually clean/no TSP,'' ``visually contaminated/with TSP,'' 
and ``visually contaminated/off-line reprocessed/no TSP.'' All carcass 
rinses were tested for the presence or absence of E. coli and 
Salmonella using validated rapid screening methods. Carcass rinses were 
kept chilled on wet ice or refrigerated until transported to the 
laboratory. Frozen samples were held on dry ice for 18 to 24 hours and 
thawed before setting. Positive results were confirmed biochemically 
and serologically.
    Because the NCC data results are substantially different from the 
Rhodia data, the Agency is seeking comment on what should be the new 
pre-chill performance standards in order to balance public health 
benefits for consumers and achievable goals that encourage 
establishment participation. The Agency also is seeking comments on the 
issue of the effect freezing has on samples and any other aspects of 
the NCC data. The data are available in the FSIS Docket Room and on the 
FSIS web page.
    The NCC data point out another factor. Currently, even in plants 
where

[[Page 75192]]

TSP or the Sanova system is in use, birds that are grossly 
contaminated, and then reprocessed off-line, enter the chiller without 
the TSP or Sanova treatment. This fact is significant because there is 
sometimes a higher prevalence of Salmonella in these plants post-chill 
than pre-chill. Thus, FSIS requests comment on whether it should 
include, as a condition for permitting on-line reprocessing, that all 
birds entering the chiller, including those reprocessed off-line, be 
treated with the antimicrobial intervention.

Environmental Impact

    There are increasing environmental concerns associated with the use 
of nutrients, particularly nitrogen, phosphorus, and potassium, in 
agricultural systems. In response to the growing body of evidence about 
the relationship among solid nutrient loadings, nutrient transport off-
sites, and surface and ground water quality, USDA's Natural Resources 
Conservation Service (NRCS) and other Federal agencies have revised 
their policies for delivering nutrient management and issued new 
technical guidelines.
    In agriculture, the greatest focus is on the inputs of nutrients in 
the form of fertilizers that exceed outputs of nitrogen and phosphorus 
in the form of crops and manure production. High densities of poultry 
plants in some areas in the United States have generated concerns about 
manure production exceeding the needs of crops to which the manure is 
applied. The density of animals on the land is directly related to 
nutrient flows to aquatic ecosystems.
    In addition, there is a concern about the introduction of 
additional substances into the agricultural production process, 
particularly in view of NRCS's stated goal of reducing nutrients used 
in agricultural production. However, the waste water of the more than 
80 poultry establishments that are engaged in on-line reprocessing 
operations with TSP is handled routinely by existing water treatment 
systems or recycled as by-products without entering the plant's 
systems, municipal water systems, or the ground water.
    However, would establishments operating under more restrictive 
state environmental laws and regulations incur additional costs as a 
result of on-line reprocessing operations? Are such operations 
restricted in some States? FSIS would like the public to comment on the 
environmental impacts associated with on-line reprocessing operations.

Request for Comments

    FSIS has decided to publish this proposed rule and to solicit 
comments on the exact performance standard that it should adopt. 
Although the Agency is not now proposing specific performance levels, 
FSIS is giving the public an opportunity to comment on and provide data 
that would support adopting a particular performance level as the 
standard.
    The Agency is aware that not all antimicrobial substances or 
processing systems for poultry pre-chill may be capable of attaining 
the pathogen reduction levels Rhodia claims to have achieved in its 
trials. FSIS is proceeding with this proposal because it considers 
pathogen reduction to be one of its primary goals, and data supplied to 
date appear to show significant improvements in the ability to reduce 
microbial contamination of poultry. FSIS remains open to considering 
other new technologies or treatments, and alternate standards, in 
developing a final rule. In recent years, trials with TSP and other 
substances have proliferated. FSIS would like to accommodate any 
technology that is safe and will significantly reduce the prevalence of 
E. coli, Salmonella, and other microorganisms on poultry carcasses pre-
chill.
    In developing an appropriate standard, the Agency believes that 
poultry contaminated with digestive tract contents must be held to a 
more rigid pathogen reduction standard than product that is not visibly 
contaminated because digestive tract contents are a source of pathogens 
and other microorganisms. Furthermore, physical removal of visible 
contamination does not necessarily remove significant levels of these 
pathogens and other microorganisms, as evidenced by the Rhodia trials 
involving off-line reprocessed pre-chill carcasses.
    Persuasive data that support specific performance standards for on-
line reprocessed visibly contaminated poultry pre-chill will be the 
basis for the final rule. The Agency would like public consideration of 
the following questions: Should the performance standards be based on 
organisms other than E. coli and Salmonella? What is the appropriate 
standard if chilled (i.e., not frozen) samples are submitted for 
laboratory analysis?
    It is important to emphasize that Rhodia used frozen, not chilled, 
laboratory samples in its in-plant trials. Data obtained by Rhodia on 
the effects of freezing whole carcass rinse samples indicated that 
there was no difference between frozen or chilled TSP treated samples. 
All TSP treated samples were negative for E. coli, Enterobacteriaceae, 
and Salmonella. These results are based on a 2-day split sampling and 
testing study at a plant conducting on-line reprocessing using TSP. A 
copy of these results is available to the public for review in the FSIS 
Docket Room (See ADDRESSES). No data were obtained regarding frozen 
Campylobacter samples. Campylobacter cells are sensitive to freezing 
and generally die off when subjected to temperatures at or below 
freezing.
    If adopted, the performance standards should not only significantly 
improve a single establishment's performance but also should lower the 
national baseline, compelling improvements in process control and 
pathogen reduction by all establishments. FSIS is interested in hearing 
from the poultry industry, industry-related organizations, the 
scientific community, academia, consumers, consumer groups, and other 
interested persons before developing a final rule.

The Proposed Rule

    FSIS is proposing to amend the poultry products inspection 
regulations at 9 CFR 381.91 by adding a new subsection (c) that would 
allow poultry carcasses contaminated with digestive tract contents 
during slaughter to remain on the main processing line along with 
uncontaminated carcasses for treatment with an antimicrobial agent 
before the chiller. FSIS also is proposing to amend the chart in 9 CFR 
424.21(c) to extend the use of antimicrobial agents to pre-chill 
poultry carcasses.
    Because FSIS is proposing to hold the visibly contaminated 
carcasses to more rigorous performance standards than apply to other 
birds, plants would need to establish verification and validation 
procedures as part of their HACCP system requirements. As part of the 
plant's on-going verification procedures, FSIS expects that plants will 
identify the visibly contaminated carcasses to distinguish them from 
the uncontaminated carcasses before the birds proceed down the 
processing line in order that the visibly contaminated carcasses can be 
sampled separately from the other birds after the treatment. 
Furthermore, FSIS expects that plants will identify an appropriate 
sampling frequency for verification as part of the HACCP system 
requirements.
    In addition, in accordance with Sec. 417.5(a)(1), establishments 
will need to include in their hazard analyses validating data, 
generated under conditions of in-plant commercial operations, 
demonstrating that the on-

[[Page 75193]]

line reprocessed contaminated poultry carcasses achieve the proposed 
pre-chill standards that FSIS adopts. Establishments would establish 
critical control points for the use of the antimicrobial treatment 
based on the determinations that they make as part of their 
reassessment.
    FSIS is not proposing to change the requirement in Sec. 381.65(e) 
that carcasses contaminated with visible fecal material not enter the 
chilling tank or to change the finished product standards in 
Sec. 381.76(b)(3). In addition, under the proposed regulation, on-line 
reprocessed carcasses, as well as the on-line non-contaminated 
carcasses, must comply with the criteria for verifying process control 
(E. coli testing) and with the pathogen reduction performance standards 
for Salmonella in accordance with Sec. 381.94 of the poultry 
regulations.
    The Agency emphasizes that this proposal would neither mandate on-
line reprocessing by all establishments nor establish the use of 
specific equipment and antimicrobial aids to reprocess pre-chilled 
poultry carcasses on-line.
    Finally, the Agency requests comments on amending the chart in 
Sec. 424.21(c) to extend the use of trisodium phosphate to ``pre-
chill'' poultry carcasses.

Cost of the Proposal

    The economic impact of this rule is likely to be minimal because of 
the voluntary nature of the practice this proposal would authorize. An 
establishment will use on-line reprocessing if it is consistent with 
the objectives of the firm, conforms with plant configuration, provides 
increased efficiency in achieving product standards, improves product 
characteristics, and other factors. The poultry industry is highly 
competitive; an increase in product price by a single producer is 
likely to result in a loss of market share. A firm is not likely to 
purchase new equipment that will increase overall production costs or 
reduce profits.
    The cost for a poultry plant to adopt an acceptable on-line 
reprocessing system will vary from plant to plant and will be 
contingent on the location, physical structure, and age of the plant 
and the adaptability of the equipment. Available information indicates 
that the capital cost per line ranges from $10,000 to more than 
$55,000, with an average cost of $35,600, which is close to the 
manufacturer's estimate for a single line cost of $30,000.
    Operating costs associated with on-line reprocessing systems also 
can vary significantly as a result of plant size, number of lines, 
processing capacity, plant configuration, and other factors. Rhodia 
estimates that the TSP application cost will be about 0.2 cents per 
pound for an average chicken slaughter plant. The application of other 
antimicrobial substances may vary slightly in cost. Plant data suggest 
that total annual operating costs, which include labor, water softener, 
TSP, and water, are very close to the manufacturer's estimate. 
Available information suggests annual operating costs of about $125,000 
per line for an average plant. Costs associated with off-line 
reprocessing would be expected to decline following installation of on-
line reprocessing equipment because of reduced labor and other 
operating requirements. Available data suggest the decrease in 
operating costs because of reduced off-line reprocessing is about 
$70,000 per line, somewhat more than half of the increase in operating 
costs associated with TSP on-line reprocessing. The available plant 
information suggests that about two-thirds of the plants would not 
experience any change in sewage treatment. The remaining third would be 
required to perform additional treatment at the plant to meet discharge 
limits. Two-thirds of the plants would show no change in water use, 
while the remaining plants will have to increase use by 1 to 2 gallons 
per bird, or about 10 percent.
    For the average plant, the net present value of capital costs and 
the net change in operating costs of TSP on-line reprocessing is about 
$1.2 million over a 10-year period using a discount rate of 7 percent. 
Based on the assumptions that the average plant processes about 200,000 
birds per day, that an average bird has a dressed weight of 3.6 pounds, 
and the plant operates an average of 255 days per year over the next 10 
years, the increase in total production costs is slightly more than .2 
cents per pound. The capital costs amortized over a 10-year period are 
minimal on a per pound basis. The costs to the poultry processing 
industry would accrue to plants engaged in slaughter, either 
exclusively or in combination with processing. In 1996, there were 281 
federally inspected plants of this description. Only one Federal-State 
cooperative inspection plant is currently engaged in poultry slaughter. 
If all such plants voluntarily install an on-line reprocessing system, 
the total cost to the poultry industry would be about $345 million over 
a 10-year period.
    The cost of a TSP on-line reprocessing system represents an 
insignificant portion of the retail price per pound of poultry. If 
there is any increase in the retail price of poultry, it will be modest 
and offset by consumer confidence that the product presents lower 
microbial risks.

Cost Impact on Small Entities

    The impact of the proposed rule on small establishments is likely 
to be minimal given that it is voluntary. A firm will adopt the 
practice if it is consistent with its objectives. The limited evidence 
available does not indicate that small firms would be at a disadvantage 
if on-line reprocessing were a uniformly accepted practice. The initial 
capital costs and net change in operating costs do not appear to be 
related to plant size. In addition, the magnitude of the costs, $1.2 
million over 10 years, would not represent a significant share of 
overall costs for small firms.

Request for Comments on Economic Impact

    The Agency would like comment from the public and especially from 
poultry firms that are currently engaged in TSP or acidified sodium 
chlorite reprocessing on the costs presented in this document. Are the 
economic assumptions valid? Do the decreases in operating costs for 
reduced off-line reprocessing appear to be reasonable? The Agency 
expects that on-line reprocessing will provide establishments with 
considerable economic advantages related to cost savings gained from no 
longer having to reprocess birds off-line. What levels of savings would 
accrue to plants adopting on-line reprocessing operations? How much 
will the proposed new standards for Salmonella and E. coli, if 
implemented, contribute to higher costs for product sampling? If the 
pathogen reduction standards become tighter, can compliance costs be 
expected to increase? Because adopting on-line reprocessing is 
voluntary, the amounts of the increase are difficult to determine. FSIS 
also would like to hear from the public about whether the Agency should 
consider deleting the provisions for off-line reprocessing in 
Sec. 381.91(b)(1) and (2) if on-line reprocessing is implemented. FSIS 
would like comments on the economic impact on both large and small 
establishments if such actions were taken.

Industrial Hygiene Survey

    At the request of FSIS, because of concerns raised by in-plant 
inspectors, an industrial hygiene survey was conducted in 1999 by an 
independent firm to evaluate potential dermal, ocular, respiratory, or 
other exposure of inspectors to TSP while working with

[[Page 75194]]

TSP-treated poultry or around TSP treatment facilities. The study did 
not address TSP exposure to plant employees, whose job activities 
differ significantly from those of inspection employees. Based on 
interviews and observations of inspectors and sampling results, the 
risk of bodily contact with significant quantities of TSP solution is 
minimal for slaughter line inspectors. They are not present when the 
TSP solution is prepared and inspect and handle the birds prior to TSP 
application. This indicates no alkalinity, TSP contact, or dermal 
hazard. The survey results also show no respiratory or ocular hazard 
from ambient TSP dust or mist in the plant.
    Other inspectors who perform a variety of tasks throughout the 
plant may come into contact with small quantities of TSP solution when 
conducting pre-chill finished product standard checks and Acceptable 
Quality Level (AQL) giblet checks. There is also the potential for 
transient ocular exposure. The survey recommends the mandatory use of 
safety glasses when performing activities where exposure to TSP occurs 
and PVC or natural rubber gloves when handling poultry post TSP 
application. It encourages the consideration of barrier creams on a 
voluntary basis, routine washing at signs of TSP solution contact, and 
awareness of emergency lavage for accidental eye contact. The study 
recommends that federally inspected establishments provide emergency 
eyewashes within a limited distance from TSP use areas and training 
regarding these recommendations.
    Rhodia Inc. conducted a later study in June 1999 to monitor the 
effects of TSP exposure on both plant and inspection employees at four 
locations in 46 plants. The study concluded that there were no safety 
risks to either plant or inspection employees from exposure to TSP. 
Food Safety Benefits of On-line Reprocessing.
    Scientific and public concern about microbiological contamination 
of poultry products has expanded from the processing of such products 
to conditions under which poultry are slaughtered to pre-slaughter 
poultry production. FSIS has encouraged the scientific community and 
the industry to develop slaughter and processing methods and treatments 
that would yield raw poultry products that are as free as practicable 
of pathogenic bacteria.
    The use of TSP and other antimicrobial rinses would not eliminate 
the need for continued careful handling of raw poultry products. 
However, by allowing the visibly contaminated carcasses to remain on-
line, all carcasses are subject to further rinsing and antimicrobial 
treatment. The result will be lesser risks because of reduced pathogen 
prevalence on contaminated poultry carcasses. Not handling contaminated 
carcasses in off-line reprocessing may reduce the risk of foodborne 
pathogens from cross-contamination of the contaminated carcasses.

Executive Order 12866

    FSIS has determined that this regulatory proposal is not a 
significant rule under Executive Order 12866 and, therefore, it has not 
undergone review by the Office of Management and Budget.

Alternatives

    Executive Order 12866 requires that FSIS identify and assess 
alternative forms of regulation. FSIS considered two alternatives to 
this proposed rule: (1) Not proposing to allow for the on-line 
reprocessing of contaminated carcasses and (2) proposing to require 
plants to perform on-line reprocessing of pre-chill contaminated 
carcasses and establishing specific numerical performance standards 
that the reprocessed poultry must meet using a mandated antimicrobial 
treatment or process. FSIS rejected both alternatives for the reasons 
explained below.

Failing To Propose

    FSIS is committed to reducing the levels of microbial pathogens in 
poultry products. On-line reprocessing of poultry in commercial trials 
using solutions of TSP/chlorine and acidified sodium chlorite has been 
shown to be a highly effective method of reducing the microbial levels 
of raw poultry to levels substantially below the performance standards 
and criteria established by the pathogen reduction/HACCP final rule.

Mandating Procedures, Materials, and Methods

    FSIS is proposing to give all establishments the option of adopting 
on-line reprocessing of visibly contaminated birds. By not mandating 
that all plants adopt on-line reprocessing, FSIS is recognizing that 
there are other solutions to reducing bacterial loads that may be more 
appropriate and cost-effective for small plants. There are many 
possible solutions for pathogen reduction of raw poultry and poultry 
products, and the industry continues to seek out new products and 
equipment that will be effective.
    Pathogen reduction is central to the FSIS food safety strategy. 
However, eliminating as many prescriptive or command-and-control 
regulations as possible also is an important part of the overall 
strategy for updating and improving inspection in light of HACCP. 
Therefore, there will be no mandate proposed for establishments to use 
TSP or any other substance as the antimicrobial reprocessing aid.
    Various substances have undergone trials to determine their 
potential as antimicrobial processing agents. Such substances include 
acidified sodium chlorite; organic acids such as lactic, acetic, and 
formic acids; chlorine dioxides; and ozone. Plants will be free to use 
other products that have demonstrated their efficacy in reducing levels 
of microorganisms in in-plant commercial trials. This is consistent 
with the Agency's strategy of encouraging the industry to take 
advantage of new technology to reduce the risks associated with the 
consumption of meat and poultry products.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This proposed rule would provide for the on-line 
reprocessing of poultry carcasses accidently contaminated with 
digestive tract contents during slaughter.
    States and local jurisdictions are preempted under the PPIA from 
imposing any requirements with respect to federally inspected premises 
and facilities, and operations of such establishments, that are in 
addition to, or different from, those imposed under the PPIA. States 
and local jurisdictions also are preempted under the PPIA from imposing 
any marking, labeling, packaging, or ingredient requirements on 
federally inspected poultry products that are in addition to, or 
different than, those imposed under the PPIA. States and local 
jurisdictions, however, may exercise concurrent jurisdiction over 
poultry products that are misbranded or adulterated under the PPIA or, 
in the case of imported products, which are not at such an 
establishment after their entry into the United States. States and 
local jurisdictions also may make requirements or take other actions 
that are consistent with the PPIA, with respect to any other matters 
regulated under the PPIA.
    Under PPIA provisions, States that maintain poultry inspection 
programs must impose requirements on State inspected products and 
establishments that are at least equal to those required under the 
PPIA. These States, however, may impose more stringent

[[Page 75195]]

requirements on such State-inspected products and establishments.

Additional Public Notification/Request for Comments

    FSIS has considered the potential civil rights impact of this 
proposed rule on minorities, women, and persons with disabilities. FSIS 
anticipates that this proposed rule will not have a negative or 
disproportionate impact on minorities, women, or persons with 
disabilities. However, proposed rules generally are designed to provide 
information and receive public comments on issues that may lead to new 
or revised Agency regulations or instructions. Public involvement in 
all segments of rulemaking and policy development is important. 
Consequently, in an effort to better ensure that minorities, women, and 
persons with disabilities are aware of this proposed rule and are 
informed about the mechanism for providing their comments, FSIS will 
announce it and provide copies of this Federal Register publication in 
the FSIS Constituent Update.
    FSIS provides a weekly FSIS Constituent Update, which is 
communicated via fax to more than 300 organizations and individuals. In 
addition, the update is available on line through the FSIS web page 
located at http://www.fsis.usda.gov. The update is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and any other types of 
information that could affect or would be of interest to our 
constituents/stakeholders. The constituent fax list consists of 
industry, trade, and farm groups, consumer interest groups, allied 
health professionals, scientific professionals, and other individuals 
that have requested to be included. Through these various channels, 
FSIS is able to provide information to a much broader, more diverse 
audience. For more information and to be added to the constituent fax 
list, fax your request to the Congressional and Public Affairs Office, 
at (202) 720-5704.

Paperwork Requirements

    FSIS has reviewed the paper and recordkeeping requirements in this 
proposed rule in accordance with the Paperwork Reduction Act. 
Establishments choosing to reprocess poultry on-line using an 
antimicrobial treatment before the chiller will need to do so in 
accordance with 9 CFR Part 417. Accordingly, establishments will 
reassess their HACCP plans as prescribed in Sec. 417.4(a)(3). Also, in 
accordance with Sec. 417.5(a)(1), establishments will need to generate 
and maintain validating data, generated under conditions of in-plant 
commercial operation, demonstrating that the reprocessing substance or 
system resulted in product that meets any performance standard that 
FSIS adopts. Based on the determinations establishments make as part of 
their reassessments, they may establish critical control points for the 
use of the antimicrobial treatment.
    Estimate of Burden: The Agency estimates that it will take 8 hours 
for establishments to reassess their HACCP plans and to prepare the 
validating data they will include in their hazard analysis. For 
purposes of this paperwork analysis, FSIS will assume that all 
establishments will establish a critical control point for the use of 
the antimicrobial treatment. Accordingly, an establishment will spend 
about 5 minutes a day (250 days) completing one monitoring record and 2 
minutes a day filing the record for one HACCP plan.
    Respondents: Meat and poultry product establishments.
    Estimated Number of Respondents: 80.
    Estimated Number of Responses per Respondent: 1 for HACCP 
reassessment; 250 for monitoring records, and 250 for filing the 
record.
    Estimated Total Annual Burden on Respondents: 2,974.
    Copies of this information collection assessment can be obtained 
from Lee Puricelli, Paperwork Specialist, FSIS, USDA, Room 109 Cotton 
Annex Building, Washington, DC 20250-3700.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the Agency, including whether the information will have practical 
utility; (b) the accuracy of the Agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
method and assumption used; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; (d) ways to minimize 
the burden of the collection of information on those who respond, 
including through use of appropriate automated, electronic, mechanical, 
or other technological collection techniques or other forms of 
information technology. Comments may be sent to Mr. Puricelli at the 
address above and to the Desk Officer for Agriculture, Office of 
Information and Regulatory Affairs, Office of Management and Budget 
(OMB), Washington, DC 20253.

List of Subjects in 9 CFR Parts 381 and 424

    Poultry and poultry products.

    For the reasons discussed in the preamble, FSIS is proposing to 
amend 9 CFR part 381 as follows:

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    1. The authority citation for part 381 continues to read as 
follows:

    Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470, 7 CFR 2.18, 
2.53.

    2. Section 381.91 would be amended by adding paragraph (c) to read 
as follows:


Sec. 381.91  Contamination.

* * * * *
    (c) In lieu of the provisions in paragraph (b) of this section, any 
poultry carcass contaminated during slaughter with digestive tract 
contents may remain on the main processing/slaughter line and be 
reprocessed while on-line through use of an antimicrobial technique, in 
accordance with the Hazard Analysis and Critical Control Point (HACCP) 
system requirements in part 417 of this chapter. Validating data, 
generated under conditions of in-plant commercial operations, must 
demonstrate that the visibly contaminated carcasses that are 
reprocessed on-line meet the pre-chill performance standard of: ____. 
Birds whose entire carcass is contaminated by digestive tract contents 
under paragraph (b)(1) of this section or birds that have been 
mutilated under paragraph (a) of this section may not remain on the 
main processing/slaughter line and may not be reprocessed using the on-
line antimicrobial technique.

PART 424--PREPARATION AND PROCESSING OPERATIONS

    3. The authority citation for 9 CFR part 424 continues to read as 
follows:

    Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-470, 601-695; 
7 CFR 2.18, 2.53.

    4. The table in Sec. 424.21(c) would be amended by adding an entry 
for ``Antimicrobial agents for use as secondary additives'' after the 
entries for ``Antimicrobial agents'' to read as follows:


Sec. 424.21  Use of food ingredients and sources of radiation.

* * * * *
    (c) * * *

[[Page 75196]]



 
----------------------------------------------------------------------------------------------------------------
       Class of  substance             Substance            Purpose            Products             Amount
----------------------------------------------------------------------------------------------------------------
 
       *                  *                   *                   *                  *                   *
                                                          *
Antimicrobial agents for use as   Trisodium           To reduce           Raw, chilled or     8 to 12%; in
 secondary additives.              phosphate.          microbial levels    pre-chilled         conjunction with
                                                       during              poultry carcasses.  a water spray
                                                       reprocessing.                           containing 20 ppm
                                                                                               chlorine;
                                                                                               solution to be
                                                                                               maintained
                                                                                               between 45-55
                                                                                               deg.F after
                                                                                               chilling and
                                                                                               applied by
                                                                                               spraying chilled
                                                                                               or pre-chilled
                                                                                               carcasses for up
                                                                                               to 15 seconds in
                                                                                               accordance with
                                                                                               21 CFR 182.1778.
 
       *                  *                   *                   *                  *                   *
                                                          *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Done at Washington, DC, on: November 22, 2000.
Thomas J. Billy,
Administrator.
[FR Doc. 00-30497 Filed 11-30-00; 8:45 am]
BILLING CODE 3410-DM-P