[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
SanovaTM 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 log10 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:
On-line TSP reprocessing achieved a 1 log10
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).
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).
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.
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).
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
SanovaTM 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
SanovaTM 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 log10
(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