[Federal Register Volume 59, Number 133 (Wednesday, July 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16817]
[[Page Unknown]]
[Federal Register: July 13, 1994]
VOL. 59, NO. 133
Wednesday, July 13, 1994
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 381
[Docket No. 94-016P]
RIN 0583-AB79
Enhanced Poultry Inspection
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service is proposing to amend
the poultry products inspection regulations to implement a new system
of post-mortem inspection for all poultry species. The proposed system
contains several innovations to provide assurances that USDA-inspected
and passed poultry products will be free of visible contamination and
will require the use of approved antimicrobial treatments in all
official establishments. The proposed system would replace all existing
systems of poultry post-mortem inspection with a single system in which
two FSIS inspectors would staff each poultry processing line and
examine carcasses for disease and visible contamination. The proposed
regulation would not mandate a reduction in maximum linespeeds. The
proposed system would place additional responsibility on official
establishments to assure that the poultry they process is wholesome and
free of disease. Establishment personnel, positioned before the on-line
post-mortem FSIS inspector, would check carcasses prior to inspection
and present for inspection only those poultry that are free of disease.
Additionally, they would identify all poultry requiring off-line trim,
salvage or reprocessing prior to presentation to FSIS for inspection. A
second FSIS inspector would be positioned at a new inspection station
that would incorporate that portion of the processing line between
viscera harvest and the chiller. This is a location where contamination
can occur but where there is currently no on-line inspection taking
place. Finished Product Standards would be revised to eliminate process
tolerances for fecal contamination. Recordkeeping and verification
procedures would be required so that establishment process control
could be assured. Additionally, all contaminated poultry that are
reprocessed would be reinspected on the main processing line by the
second FSIS inspector and antimicrobial treatments would required to be
applied to carcasses before the chilling operation.
DATES: Comments must be received on or before October 11, 1994.
ADDRESSES: Written comments to Policy Evaluation and Planning Staff,
Attn: Diane Moore, Room 3171 South Agriculture Building, Food Safety
and Inspection Service, U.S. Department of Agriculture, Washington, DC
20250. Oral comments, as provided under the Poultry Products Inspection
Act, should be directed to Dr. Isabel Arrington, at the address given
below. (See also ``Comments'' under Supplementary Information.)
FOR FURTHER INFORMATION CONTACT:
Dr. Isabel Arrington, Staff Officer, Inspection Management Program,
Inspection Operations, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250; (202) 720-7905.
SUPPLEMENTARY INFORMATION:
Comments
The Agency recognizes that there may be additional information that
was not available for its consideration at the time this proposal was
written. Therefore, the Agency is conducting further analysis of the
benefits and costs of the proposal and also is soliciting additional
information on this proposal. In particular, FSIS is interested in
receiving information on inspector sequence, benefits, and costs of the
proposed rule. FSIS expects that this information will be submitted in
the form of comments from the public.
Interested persons are invited to submit comments concerning this
proposal. Written comments should be sent to the Policy Evaluation and
Planning Staff and should refer to the docket number that appears in
the heading of this document. Any person desiring opportunity for oral
presentation of views, as provided under the Poultry Products
Inspection Act, must make such request to Dr. Arrington so that
arrangements may be made for such views to be presented. A record will
be made of all views orally presented. All comments submitted in
response to this proposal will be available for public inspection in
the Policy Office from 9 a.m. to 4:00 p.m., Monday through Friday.
Additionally, FSIS will collect data by pilot testing this proposal
during the comment period. The Agency will comply with all bargaining
obligations under the National Basic Agreement and the Federal Service
Labor Management Relations Statute relating to the impact any Poultry
Enhancement Inspection System pilot test would have on employee working
conditions.
To the extent that the further analysis conducted by USDA and the
comments solicited by this proposal contain meritorious alternatives,
information, or data not previously considered, the Agency may decide
to propose changes to specific provisions of this proposed rule. In
this event, the Agency is committed to supplement this rulemaking to
provide the public an opportunity to comment on the specific revised
regulatory provisions.
Background
Introduction
The Secretary of Agriculture is charged by the Poultry Products
Inspection Act (PPIA--21 U.S.C. 451 et seq.) with carrying out a
mandatory poultry products inspection program. The purpose of this
inspection is to assure that poultry products in interstate and foreign
commerce are wholesome, not adulterated, and properly marked, labeled,
and packaged. The Act prohibits the shipment in commerce of poultry
products that are adulterated or misbranded (21 U.S.C. 458), including
any poultry products that bear or contain any poisonous or deleterious
substance that may render them injurious to health (21 U.S.C.
453(g)(1)) or that for any other reason are unsound, unhealthful,
unwholesome, or otherwise unfit for human food (21 U.S.C. 453(g)(3)).
The Act requires post-mortem inspection of all carcasses of slaughtered
poultry subject to the Act and such reinspection as deemed necessary
(21 U.S.C. 455(b)). The Secretary is authorized to promulgate such
rules and regulations as are necessary to carry out the provisions of
the Act (21 U.S.C. 463(b)).
FSIS has stationed about 2,705 inspectors in 300 poultry
slaughtering establishments nationwide. They are responsible for ante-
mortem and post-mortem inspection, and the inspection of further
processed products at these establishments. They are also responsible
for assuring that facilities and equipment are sanitary and the plant
environment conducive to the manufacture of a wholesome product.
To meet the PPIA requirement for post-mortem inspection of every
poultry carcass, FSIS stations inspectors on every slaughter line
throughout every working shift. Most poultry slaughtering
establishments operate moving production lines that carry the poultry
through all the stages of processing from that of the live bird to the
finished, ready-to-cook stage.
Slaughter and Dressing Process
Currently, live birds are brought to the plant and hung upside-down
on shackles on the moving conveyor line. They are moved first to the
stunning and slaughtering area, where they are bled out. Next, they are
moved into scalding vats where the feathers are loosened. They are then
conveyed to automatic defeathering machines (called ``pickers''), where
the feathers are taken off the carcass by rapidly moving rubber
``fingers.'' After this operation, the birds pass through a hock
removal area. Then they pass to the evisceration area of the plant,
where the birds are eviscerated by automatic machinery. Evisceration is
usually accomplished by cutting the bird's abdomen and ``scooping'' out
the organs with metal ``spoons'' or paddles.
The viscera are left attached to and suspended outside the carcass
throughout post-mortem inspection. The birds are presented for
inspection with the hanging viscera suspended to one side of the
carcass. The inspector conducts a post-mortem examination for signs of
disease or abnormality by holding open the abdominal cavity with one
hand and viewing its interior and then quickly manipulating the viscera
with the other hand. At the same time, the inspector observes the
external surfaces of the carcass for signs of disease, abnormality, or
contamination. The inspector also points out to establishment employees
lesions or other conditions that may be removed by trimming.
Birds that do not pass post-mortem inspection are either removed
from the processing line and placed on a hang-back rack for veterinary
disposition or they are designated for off-line trimming, salvage, or
reprocessing, or condemned. Birds that are inspected and passed by FSIS
move on to the next operations, which include viscera removal, giblet
harvest, and final trimming and washing. The carcasses then proceed to
the chilling operation, where usually they are immersed in ice and cold
water tanks to bring the carcass temperature down to acceptable levels
and to retard bacterial growth. The chilled birds are then packaged and
readied for shipment or further processed.
Basis of Inspection
All post-mortem inspection is based on the use of an organoleptic
method of inspection. That is, inspectors and veterinarians rely on the
use of their five senses in making decisions regarding the disposition
of poultry carcasses and their parts. Additionally, FSIS personnel
monitor chemical residues and microbial baselines by taking random
samples of inspected birds for laboratory microbiological or chemical
analyses. Laboratory analysis can be utilized to confirm post-mortem
dispositions or suspected chemical residues.
The organoleptic method has proven reliable over many years in the
detection of diseases or abnormalities that could be dangerous and are
certainly objectionable to consumers. Nevertheless, the organoleptic
method is not capable of detecting microbial pathogens that may be
present on raw, ready-to-cook product. Because of the continuing and
increasing threat of foodborne pathogens, including pathogens known to
be carried on the surfaces of dressed poultry carcasses and in feces,
the focus of meat and poultry inspection must shift towards enhancing
public health.
Pathogen Reduction Initiatives
In this regard other FSIS initiatives include prevention programs
for use on the farm and during live-animal transit, the development of
rapid detection methods using the latest technologies, the collection
of microbiological baseline data, the development of risk analysis
methods applicable to meat and poultry inspection, microbial detection
and reduction activities in both slaughtering and processing plants,
and an intensified education program directed at retail outlets, food
handlers, and consumers.
Some of these initiatives will obviously take longer than others to
carry out. Some in-plant activities will depend on the development of
new technology. Even though all critical research questions have not
yet been answered, FSIS recognizes and accepts its obligation to
proceed with activities that are likely to succeed based on current
theories about pathogen control. The agency also has the opportunity to
introduce useful microbial detection technologies into the present
inspection program as they become available, not waiting for the fully
developed new system.
This proposal includes several activities which are based on
present knowledge, especially that which suggests that pathogen
presence on carcasses is likely associated with fecal contamination and
that careful process control can reduce the potential for
contamination.
Current Inspection Systems
Several poultry post-mortem inspection systems are currently
operated in federally inspected establishments--traditional, New Line
Speed (NELS), New Turkey Inspection System (NTIS), and the Streamlined
Inspection System (SIS). Within each of these current systems no
product with visible fecal contamination is permitted to enter the
chiller, but the assurance of this standard is based on monitoring
samples; inspectors do not have the opportunity to continuously verify
that fecal contamination doesn't enter the chiller.
Traditional
Under traditional inspection, the oldest system, one inspector
examines a whole bird and is responsible for its proper disposition,
including directing and verifying any required trimming by an
establishment employee who is the ``inspector's helper,'' before the
bird leaves the area of inspection. A sample of inspected product is
reinspected for processing nonconformances through an acceptable
quality level (AQL) statistical program. Line speeds for traditional
inspection were based on work-measurement studies and were set at the
limit at which an inspector could carry out the organoleptic
examination and manipulation of each carcass presented for inspection.
Also, industry was not capable of producing birds at a higher speed and
therefore, these line speeds were acceptable.
SIS
In the mid-1970's, the development of automated evisceration
equipment, as well as improvements in genetics, nutrition, health, and
flock management, allowed the poultry industry to present uniform lots
of birds to inspectors faster than inspectors could inspect using
traditional methods. In 1978, the FSIS approved the use of a new
inspection method known as Modified Traditional Inspection (MTI). MTI
allowed industry to run an eviscerating line at speeds of up to 70
birds per minute.
In 1985, USDA designed a new system to replace MTI that would
permit the industry to continue to operate at 70 birds per minute but
require fewer on-line inspectors. This system became known as the
Streamlined Inspection System (SIS). SIS, which is currently the
standard form of inspection for young chickens, requires one or two
inspectors to be positioned on each processing line after the birds
have been eviscerated. Each inspector performs a whole-bird inspection
involving the examination of the outside, inside, and viscera of the
birds presented for inspection. The one-inspector form of SIS is known
as SIS-1; the two-inspector version, called SIS-2, is the most widely
used (about 140 plants, compared with only about 3 plants for SIS-1).
Inspection under both SIS-1 and SIS-2 is conducted in two phases--a
post-mortem inspection phase and a reinspection phase. In the
inspection phase, inspectors determine which birds must be salvaged,
reprocessed, condemned, retained for veterinary disposition, or allowed
to be moved down the line as a passed bird subject to reinspection.
The reinspection station or stations are located both before and
after each chiller. At the prechill station, inspectors examine
carcasses by visually monitoring, checking quality control data, or
sampling product at the station. SIS incorporates a finished product
standards (FPS) program by which product is evaluated and the results
tracked with the aid of the CUSUM statistical method. The tabulation
and charting of CUSUM results enables the establishment and FSIS
inspectors to determine whether the establishment's processes are under
control, and hence, whether the process will produce consistently
sound, wholesome product.
NELS
During the 1970's and 1980's the industry continued to make
significant technological advances and were capable of better process
control. The FSIS inspection procedure became the limiting factor on
industry productivity. In 1981, the Agency developed a new procedure,
New Line Speed (NELS), that shifted quality control responsibilities to
the plant and relied more heavily on monitoring and verification than
in the past. This is a voluntary program, and, if approved the
establishment can operate at a maximum rate of 91 birds per minute.
NELS combines SIS post-mortem inspection procedures with an
establishment-operated slaughter quality control program that is
monitored by FSIS. The Agency permits the NELS system in appropriately
equipped establishments that have requested and been approved for the
system. The NELS inspection system consists of three FSIS inspectors
performing the NELS whole-bird post-mortem inspection procedure and at
least one inspector monitoring the application of an FSIS-approved,
plant-operated slaughter quality control (QC) program. The QC program
is designed to assure that the processing system is under control.
NTIS
The above discussion regarding MTI, SIS, and NELS is specific to
the development of inspection systems for young chickens, the largest
segment of the poultry industry. Other classes of poultry have not
evolved through the same inspection procedures. However, as the turkey
industry began to grow and become more automated, merely expanding
traditional procedures was impractical and inefficient. Therefore, in
1985, FSIS established the New Turkey Inspection (NTI) system which was
based on the concepts and procedures used in NELS system.
This system calls for one or two inspectors on each inspection line
to inspect the inside, outside, and viscera of each bird presented,
with establishment employees responsible for trimming passed carcasses.
The adequacy of the trimming is assured through an establishment-
operated quality control and finished product standards (FPS) program
that is monitored by FSIS personnel.
Poultry Enhancement Program
Introduction
Experience has shown that there are two points on the poultry main
processing line where birds are more likely to become contaminated. The
first of these is at evisceration, when improperly adjusted equipment
may perforate or burst the intestines as the viscera is ``scooped''
out, resulting in fecal contamination on the interior surface of the
carcass. The second point where contamination may occur is where the
viscera are separated from the carcass. Unless the viscera harvest is
properly carried out, the interior surface of carcasses can become
contaminated with feces. In March, the Secretary of Agriculture
announced a series of measures that are intended to strengthen poultry
products inspection and reduce the occurrence of pathogens on raw
product. The initiatives included a better method for enforcing ``zero
tolerance'' for fecal contamination on raw product by changing the
inspection sequence to provide on-line inspection checks for
contamination, which is not provided by current systems. Also included
among the initiatives are the use of approved antimicrobial treatments
on carcasses and the 100% reinspection of reprocessed carcasses.
Because these initiatives would change procedures that are already
authorized or required by the regulations, it is necessary to amend the
regulations to carry them out.
The proposal would implement a new system of post mortem
inspection, require re-inspection of all reprocessed birds on the main
processing line, revised the existing finished product standards
program, and require the use of an antimicrobial treatment before the
chilling operation. The proposed new inspection system is intended to
assure that only uncontaminated poultry would enter the chiller and the
required antimicrobial treatment is applied to every carcass. A benefit
of these is to reduce the chance of cross-contamination in the chilling
operation.
Inspection Sequence Changes
The proposal would replace all existing systems of poultry post-
mortem inspection with a single system in which two FSIS inspectors
would staff each poultry processing line. The first inspector would
examine eviscerated poultry at an ``on-line post-mortem inspection
station,'' located at or near the present post-mortem inspection
position. This inspector would assure that carcasses sorted by the
establishment are free of condemnable pathology or are properly
designated for off-line trim, salvage, or reprocessing.
The second inspection station, the ``on-line/off-line carcass
inspection station,'' would be positioned just before the chiller. The
inspector at this station would perform on-line inspection for fecal
contamination thus ensuring that no visible fecal contamination is
present on carcasses entering the chiller. This inspector would also be
responsible for observing plant operations between the viscera harvest
and the final wash and for reinspecting all reprocessed birds on the
line.
The Agency requests that comments on the proposal include
information and data on this proposed inspector sequence, or
information and data relative to any alternatives to this proposed
inspector sequence.
Establishment Responsibilities
Establishment personnel, known as sorters, would be positioned
before the first FSIS inspector. This position will be a reassignment
of duties for the current plant presenters and inspector helpers. The
establishment sorters differ in responsibility from the inspectors'
helpers under the current regulations because the sorters would be more
active in detecting disease and abnormality and sorting birds affected
by such conditions from normal birds.
The required establishment sorter or sorters would be responsible
for assuring that no diseased poultry requiring condemnation are
presented for FSIS inspection. They would designate poultry for off-
line salvage, trimming, or reprocessing, or condemn the birds prior to
presentation for inspection, and they would be required to record all
condemnations on a disposition reporting form required for the purpose.
Only those birds without condemnable conditions would be permitted to
reach the post-mortem inspection station, except for those designated
and marked for reprocessing, knife-salvage, or other off-line
procedures. These would be removed from the evisceration line only
after the bird passed the FSIS post-mortem inspector at the on-line
post-mortem inspection station but before the viscera harvest.
Under the proposal, as is currently required, the establishment
would have to position an employee after the post-mortem inspector and
before the viscera harvest. This employee would be required to perform
duties such as removing carcasses marked for salvage or reprocessing,
or placing birds on hangback racks for veterinary disposition or
correlation.
The establishment also would continue to be required to position
one or more trimmers after the giblet harvest and before the final
wash. These trimmers would continue to perform the duties required by
the current regulations, but they would have the additional
responsibility of removing for reprocessing birds that are contaminated
with feces on the inner surfaces and assuring that only birds that are
properly trimmed are presented to the FSIS inspector at the on-line/
off-line carcass inspection station.
Reprocessing
Currently, reinspection of reprocessed birds by FSIS is done by
random sampling of lots. The proposed system would require all
reprocessed birds to be returned to the main processing line at a point
before the second FSIS inspector to assure that they are reinspected.
If any reprocessed bird were found with fecal contamination, all birds
remaining in the reprocessed lot would be returned to the
establishment's reprocessing station for rework.
Equipment and Facilities Requirements
All poultry slaughtering establishments would be required to comply
with the same equipment and facility requirements, which would be
essentially those of the present SIS, NELS, and NTIS inspection
systems, extended to accommodate inspection at the proposed on-line/
off-line inspection station. For example, establishments would have to
furnish adjustable inspection stands and shadow-free lighting with a
minimum intensity of 200 foot candles and a color rendering index of 85
at the inspection stations. Also, guidebars would have to be installed
at both inspection stations in all establishments to permit birds to be
moved smoothly and consistently to the edge of the trough running below
the conveyor so that birds would be properly presented to the FSIS
inspector.
Linespeed
Maximum linespeeds allowed under optimal conditions would remain
the same under the proposed system. The proposed system does not
prescribe specific hand motions which in the past have been a
determining factor in the rate at which an inspector could inspect each
bird. This system would allow the inspector flexibility in the
technique used to inspect each bird. Also, this proposal would
eliminate the presentation for FSIS inspection of those birds with
condemnable conditions.
FSIS also considered the impact linespeeds have on the safety and
wholesomeness of poultry. A study was conducted between June 1990 and
May 1991 at a poultry establishment to determine if the microbiological
quality of poultry carcasses was different when processed at varying
linespeeds. The general conclusion was that mean bacterial counts and
Salmonella prevalence did not change significantly with varying
processing linespeeds.\1\
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\1\Study conducted by USDA, FSIS, Science and Technology. The
study is available for review at the Hearing Clerk's Office.
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Also, there are data to support the incidence of Salmonella on
whole broiler carcasses declined from 36.9% to 25.0% between 1979 and
1992 irrespective of changes in linespeeds.\2\
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\2\Study conducted by USDA, FSIS, Science and Technology. A copy
of this study is available in the office of the FSIS Hearing Clerk.
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Other factors do impact the microbiological quality of the product
such as chlorine and other antimicrobial treatments as well as process
control and the adherence to good manufacturing practices by the
establishment.\3\
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\3\``Effects of countercurrent scalding and postscald spray on
the bacteriologic profile of raw chicken carcasses.'' 1992. W. James
et al. Journal of the American Veterinary Medical Association. Vol.
201, No. 5, pages 705-708. A copy of this document is available from
the FSIS Hearing Clerk, Washington, DC.
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Based on this information, maximum inspection rates for young
chickens would remain at 70 birds per minute for establishments without
approved slaughter PQC programs and at 91 birds per minute for
establishments with approved slaughter PQC programs. The rates for
turkeys with J-type opening cuts and weighing under 16 lbs. would be 20
birds per minute at establishments without such PQC programs and 51
birds per minute at establishments operating such PQC programs. The
rates for such turkeys weighing more than 16 lbs. would be 16 birds per
minute without such PQC and 41 birds per minute with such PQC. The
rates for turkeys with bar-type opening cuts weighing under 16 lbs.
would be 20 birds per minute at establishments without PQC programs and
45 birds per minute at establishments operating PQC programs. The
corresponding rates for such turkeys weighing over 16 lbs. would be 16
birds per minute without a PQC program and 35 birds per minute with a
PQC program. (See Table 1.)
Table 1.--Maximum Production Rates
------------------------------------------------------------------------
Birds per minute
Class of poultry -------------------------------------------------
With PQC Without PQC
------------------------------------------------------------------------
Young chickens........ 91 70
Young turkeys:
J-type opening cut 3-point suspension
Less than 16
pounds........... 51 20
More than 16
pounds........... 41 16
Bar-type opening cut 3-point suspension
Less than 16
pounds........... 45 20
More than 16
pounds........... 35 16
------------------------------------------------------------------------
Under the proposal, the FSIS inspector in charge (IIC) or his/her
designee would retain the responsibility for determining whether
conditions permit adequate post-mortem inspection at the maximum rates.
Criteria for justifying linespeed reductions would include the
inability of the official establishment to present carcasses so that
internal and external surfaces and organs can be inspected, remove
condemnable birds from the line, and properly identify contaminated
birds for trimming or knife salvage.
Finished Product Standards Revisions
The FPS now provided in the regulations would be updated and
tightened to reflect more accurately the current conditions in the
poultry industry.
The current FPS program was developed on the basis of 1983 in-house
data. Since the standards were adopted, the program has proven more
effective in preventing nonconformances than the AQL it supplanted.
However, experience in applying the FPS has disclosed certain
limitations involving the application of testing rules and actions. The
proposed revised FPS would overcome these limitations while preserving
the advantages of the current FPS. The strength of both the current
program and the proposed revised FPS is the effectiveness of on-line
quality control in maintaining processing control. Processing control,
which focuses on prevention rather than the detection of
nonconformances, would continue to be the guiding concept of the FPS.
The proposed FPS program would incorporate the following changes to
the current FPS processing control monitoring program:
(1) Consolidation of nonconformance categories.
(2) Elimination of feces from reinspection categories.
(3) Elimination of post-chill testing.
(4) Setting nonconformances tolerances at same level for all
poultry classes.
(5) Separation of the trimmable lesion/condition category from
processing/trim categories.
(6) Simplification of on-line processing control monitoring rules.
Consolidation of Nonconformance Categories
The proposed revised FPS nonconformance categories (Table 1 at
proposed 9 CFR 381.76(h)) would be fewer than the existing FPS
nonconformance categories and the testing procedure would be simpler.
The proposed category changes would make testing easier and provide
earlier feedback. Appropriate preventive and corrective actions could
be initiated because the carcass nonconformance would be based on
ready-to-cook (RTC) requirements and sanitary dressing procedures.
The current finished product standards (FPS) program has 20
prechill processing, 14 prechill trim, and 3 post-chill categories (37
categories). These groupings are based on the type of nonconformances
found on carcasses. The proposed FPS program would have 8
nonconformance categories and 1 separate trimmable lesion/condition
category. The nonconformances would be assigned to common groups with
respect to control, origin, prevention, or removal. Prechill processing
and trim categories would be combined on one test form to simplify the
testing process so that only one cumulative summation (CUSUM) would be
calculated.
The relative risk of nonconformances would be the same for each
poultry class. Because the comparative risk between categories is not
known, the new nonconformance categories would be weighted equally
(each having a weight factor of one). This change would also eliminate
any tendency to correct only those nonconformances with higher weights.
Elimination of Feces From the Nonconformance Categories
One goal of the FPS program would be to ensure that poultry
carcasses are free of feces. To emphasize the Agency's determination to
enforce the ``zero tolerance'' for such contamination, feces would no
longer be listed among nonconformance categories. Any finding of fecal
contamination during an FPS check would require an immediate line speed
reduction. On-line processing control by the establishment is necessary
to exclude fecal contamination from product ready to enter the chilling
system.
There are two operations in the slaughtering process where there is
a greater chance for carcass contamination. These operations are
evisceration and viscera harvest. Under this proposal, FSIS inspectors
would be stationed after each of these operations to ensure only non-
contaminated carcasses proceed down the line.
Elimination of Post-Chill Testing
One goal of the proposed FPS reinspection test would be to ensure
that the establishment keeps its evisceration process under control
with emphasis on preventing fecal contamination from entering the
carcass chilling system. All carcasses would be subject to sampling
using the proposed FPS test, which includes a modified extraneous
material category, prior to entering the chill system; therefore, these
defects should not enter the chill system. The current FPS post-chill
test focuses on the detection of extraneous material nonconformances
too late in the slaughtering and dressing procedure to provide
information that could be used to improve evisceration controls.
Setting Tolerances at the Same Level for All Poultry Classes
It is reasonable to set one tolerance to provide a uniform standard
for evaluating all poultry carcasses after slaughter and dressing since
ready-to-cook (RTC) requirements and the same nonconformances apply to
all poultry classes. Established tolerances for poultry carcasses are
already approaching uniformity. The current FPS pre-chill trim
nonconformance limits for young chickens and turkeys are already the
same. The FPS pre-chill processing and post-chill nonconformance limits
for young chickens and young turkeys are almost the same.
Ideally, if optimal processing controls were maintained, poultry
would be nonconformance-free. Nonconformance-free product may be
theoretically achievable but is not likely to be commercially feasible.
A reasonable tolerance would allow for the presence of a few accidental
nonconformances incidental to the process and, at the same time, define
acceptable quality levels. Establishing a new tolerance for all poultry
classes along with changes in the testing rules would encourage
continual improvement in processing control. Periodic re-evaluation of
these limits would be essential to encouraging the trend toward the
production of poultry that is free of nonconformances.
The current FPS tolerances and action numbers are based on data
collected in 1983. The Agency is now offering for comment the
modifications of these standards that field inspection experience has
shown to be necessary. Even so, the Agency will be especially attentive
to comments addressing the proposed FPS standards.
Currently, the FPS upper limit of acceptability of a 10-bird test
sample is called the subgroup absolute limit. The subgroup absolute
limit is defined by the tolerance number plus 5 (T+5). The ``plus 5''
is the expected normal variance in a process under control. In the
proposed FPS program, the need for the subgroup absolute limit (T+5) is
eliminated by incorporating normal process variability within
tolerance. Following the cumulative summation (CUSUM) method, the
process variability exceeding tolerance is recorded. The proposed FPS
program uses CUSUM to determine when the process is out of control and
to identify product requiring rework. Tolerance levels for
nonconformances would ensure appropriate corrective actions at the
control points. In recent years, a zero CUSUM has been achieved
consistently by establishments under the current FPS program--evidence
that nonconformance process control has improved. A zero CUSUM over
time is not expected. Because of process variation, a certain number of
tests are expected to exceed tolerance and cause an increase in the
CUSUM. The FPS tolerance numbers for nonconformances were set at such a
level that one test in 20 would be expected to exceed the tolerance
number plus 5. Under the present FPS program, exceeding the subgroup
absolute limit (T+5) is usually the only cause for corrective action or
testing. Maintaining a zero CUSUM does not encourage further
improvement in process control.
Separation of the Trimmable Lesion/Condition Category From the
Processing/Trim Categories
One goal of the proposed revised FPS program would be to ensure
process control with a statistically valid method of identifying
trimmable lesions and conditions and product requiring rework. The
confidence level of the proposed on-line test ensures a standard of no
tolerance for trimmable lesions and conditions. The test would be
objective and would result in actions that are firm, fair, and
consistent. The standard for trimmable lesion/condition nonconformances
is met through testing and actions independent of the other proposed
FPS nonconformance categories.
Separating the trimmable lesion/condition category from the other
proposed FPS nonconformance categories allows independent actions which
include: (a) Monitoring a statistically valid number of carcasses on-
line; (b) notifying the IIC immediately of trimmable lesion/condition
nonconformance; (c) accurately identifying product with trimmable
lesion/condition nonconformance for rework; (d) recording and
evaluating corrective actions taken.
The current finished product standards (FPS) program assigns a
point value to the trimmable lesion/condition nonconformances found
during a 10-bird monitoring test. These points are included in the
CUSUM calculation for the pre-chill trim test. At the same time,
trimmable lesion/condition nonconformances have a ``zero tolerance.''
That is, an immediate retest involving an additional 10-bird sample is
required when a trimmable lesion/condition is detected. The 10-bird
retest is not a statistically valid number of carcasses. The
probability that trimmable lesions and conditions will be found through
such 10-bird tests is low, even when the process is out of control.
Thus, the testing does not result in identifying product for rework.
The proposed on-line verification test is statistically based to
ensure processing control and takes a reasonably short time to perform.
The test would be conducted by the establishment on a 300-bird sample
taken after the final wash at the reinspection sample collection site.
An FSIS floor inspector would typically perform verification sampling
for the Agency. A line-stop button would be required to facilitate the
removal of carcasses with trimmable lesions and conditions during the
on-line test.
Simplifcation of Rules for Monitoring On-Line Processing Control
An additional goal of the proposed revised FPS program would be to
modify testing rules and procedures to ensure that testing is sensitive
and specific enough to identify loss of processing control. A high
probability of identifying product requiring rework would be associated
with actions taken on the basis of the tests.
As mentioned, testing rules in the current FPS program are
cumbersome and result in repeated testing which rarely results in
identifying product for rework. When pre-chill nonconformances reach
action levels, immediate multiple location testing and retesting is
required at pre-chill, post-chill, and on-line control points. This
increase in simultaneous testing is labor-intensive for both the
establishment and inspection. This labor-intensive effort rarely
results in the identification of product for rework. There is little
incentive to do testing that almost never leads to regulatory action.
The program requirements generate a lot of paper work, while the
intended effect on processing control is difficult to quantify.
The proposed revised FPS program would identify when the
establishment's processing is out of control and product requires
rework. All monitoring tests would be applied at pre-chill. Under the
current FPS program, product is tested at post-chill using pre-chill
standards to identify product requiring rework. At post-chill, product
from multiple evisceration lines is sometimes commingled in one
chiller. This commingling dilutes nonconformances and decreases the
probability of identifying product for rework when tested post-chill.
With the proposed FPS, all affected carcasses would be subject to
reinspection, identified at pre-chill, and segregated for rework.
The proposed revised FPS is easily applied even when carcasses go
directly to further processing. The proposed categories (Table 1 at
proposed 9 CFR 381.76(h)) are designed to provide feedback to the
establishment to ensure processing control.
Corrective Actions
If the on-line postmortem inspector observed a bird that should
have been condemned or designated and marked for off-line knife-
salvage, trimming, or reprocessing, the inspector would stop the
processing line to make a proper disposition. The inspector would have
the bird condemned, removed from the line, or, if the condition of the
bird was found to be questionable, placed on a hang-back rack for
veterinary disposition.
If the on-line/off-line carcass inspector observes any fecally
contaminated birds, the line would be stopped and the bird removed for
reprocessing. Additionally, a mandatory linespeed reduction would be
required. The linespeed would be reduced to the extent necessary to
ensure process control in preventing/eliminating all feces and for such
duration until it is determined by FSIS that the process can be
maintained in compliance with the no visible fecal contamination
standard.
If any reprocessed bird is found with fecal contamination, the on-
line/off-line inspector will require all birds remaining in the
reprocessed lot to be returned to the establishment's reprocessing
station for rework.
Any finding of fecal contamination during a Finished Product
Standard check would require an immediate linespeed reduction and
reprocessing of the contaminated carcass.
Antimicrobial Treatments
In spite of the best efforts to reduce or eliminate visible
contamination through the measures that this proposal would require,
poultry would still harbor bacteria. The numbers of these invisible
contaminants can only be reduced through antimicrobial treatments. With
this proposed rulemaking, the Agency would require, for the first time,
that poultry slaughtering establishments provide antimicrobial
interventions before the carcasses enter the chilling system.
Thus, in addition to changing post-mortem inspection staffing and
procedures and reinspection criteria, this proposed rulemaking would
mandate the use of an approved antimicrobial treatment for poultry. The
treatments could be applied at any point preceding the chilling
operation. Many establishments would already be in compliance with this
provision of the proposed regulations because they routinely apply a
20-ppm chlorinated spray at the final wash. Spoilage and pathogenic
bacteria naturally reside on the surface of raw poultry. It has been
assumed that a certain level of bacteria present on carcass surfaces
was unavoidable due to the inherent characteristics of animals and raw
poultry meat and the nature of the slaughter and processing operation.
Consequently, organoleptic inspection procedures were designed to
detect obvious carcass diseases or abnormalities. FSIS is expanding its
inspection activities to address increasing concern by the scientific
community and the public about the threat of foodborne illness from
consumption of meat and poultry products. Pathogens of concern in
poultry include Salmonella and Campylobacter, which are frequently
carried on raw poultry. These bacteria cannot be detected by sight,
smell, or taste.
Salmonellae, found in the intestinal tract and waste of most warm-
blooded animals, are the most important cause of bacterial foodborne
illness with a 0.1 percent case fatality rate and highest average cost
per case.\4\ Foods of animal origin, particularly meat and poultry, are
considered to be the primary source of human salmonellosis. The
organisms are present in the skin and feathers of live birds whose
carcasses can also become contaminated during slaughter from intestinal
tract contents of otherwise healthy animals. Cross contamination of
cooked foods from raw meat and poultry, kitchen utensils, or surfaces
has been frequently described as a cause of salmonellosis.
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\4\Agricultural Outlook, Economic Research Service, USDA, AO-197
(June 1993), pp. 32-36. A copy is available for review in the FSIS
Hearing Clerk's office.
---------------------------------------------------------------------------
Campylobacter jejuni lives naturally as a harmless inhabitant in
the intestinal tract of many warm-blooded animals, including poultry.
In many countries the incidence of Campylobacter infection is higher
than that for Salmonella. In North America, campylobacteriosis is
believed to be the principal cause of foodborne enteritis, accounting
for the highest number of cases.\5\ Poultry meat is most often
implicated as the primary source of infection.
---------------------------------------------------------------------------
\5\Agricultural Outlook, Economic Research Service, USDA, AO-197
(June 1993), pp. 32-36. A copy is available for review in the FSIS
Hearing Clerk's office.
---------------------------------------------------------------------------
From 1983 to 1987, 2,397 foodborne disease outbreaks were reported
to the Centers for Disease Control (CDC), representing 91,678 cases.
CDC defined an outbreak as an incident in which two or more persons
experience a similar illness and food is implicated. The etiology was
unknown in the majority of outbreaks. Among outbreaks in which etiology
was determined, bacterial pathogens caused the largest number of
outbreaks (66 percent) and cases (92 percent). During the five-year
interval, meat and poultry accounted for approximately 16 percent of
the bacterial disease outbreaks. Salmonella was the most frequently
reported pathogen each year.\6\
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\6\MMWR (Morbidity and Mortality Weekly Report), Vol. 39/No. SS-
1: ``CDC Surveillance Summaries, March 1990.'' This document is
available for review at the FSIS Hearing Clerk's office.
---------------------------------------------------------------------------
FSIS recognizes that the technologies now available for reducing
bacterial contamination on raw poultry carcasses are limited. There are
currently no approved antimicrobial agents for use pre-chill listed in
the poultry inspection regulations, although several compounds appear
promising. Described below are a few alternative treatment methods
available to the poultry industry for use or further development.
Trisodium phosphate is approved by FDA for use as a processing aid
on raw poultry. It is listed in the FDA regulations as generally
recognized as safe (GRAS) for multiple purpose use in accordance with
good manufacturing practice (21 CFR 182.1778). FSIS has granted
approval for testing of trisodium phosphate at pre-chill and post-chill
locations and has begun rulemaking procedures to include this compound
and its use conditions in the table of substances in 9 CFR
381.147(f)(4). Trisodium phosphate has been shown to reduce microbial
contamination on poultry carcasses when applied by spraying or dipping
carcasses for up to 30 seconds in an 8- to 12-percent solution.
Industry studies show a one to one and one-half logarithm reduction in
the number of Salmonella and other bacteria on carcass surfaces when
carcasses are dipped in or sprayed with trisodium phosphate.\7\
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\7\Study conducted by the Rhone-Poulenc Company. The study is
available for review at the Hearing Clerk's Office.
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Several organic acid compounds, including lactic acid and acetic
acid, have antimicrobial effects and are listed in the FDA regulations
as GRAS. Although listed in 21 CFR, conditions-of-use have not been
established for use of these compounds on poultry products. Researchers
have obtained varying degrees of microbial reductions when treating
carcasses with organic acid compounds. Early studies indicated changes
in carcass skin color when carcasses were treated with organic acid
compounds. More recent studies provide data supporting the
effectiveness of organic acid compounds at concentrations that do not
compromise the sensory properties of the meat.\8\
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\8\``Natural Lactic acid: a natural solution.'' J. Bacus. 1987.
The National Provisioner. June 13, 1987. Pages 19-21. This document
is available for review in the FSIS Hearing Clerk's office.
---------------------------------------------------------------------------
The washing of carcasses with chlorinated water to reduce the
numbers of spoilage and pathogenic bacteria on carcasses is a longtime
practice in the poultry industry. As early as 1951, researchers noted
the effectiveness of in-plant chlorination in lowering bacteria counts
on product, increasing shelf life, reducing odors in the establishment,
and reducing slime on equipment.\9\ Chlorine is used now in most
poultry establishments, primarily in chill water, to prevent bacterial
cross-contamination and as an effective sanitizing agent on facilities
and equipment usually at levels of 20 to 50 parts per million available
chlorine.\10\ A 1992 FSIS study showed significant microbial reductions
on raw chicken carcasses and giblets immersed in chlorinated chill
water.\11\
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\9\``In-Plant Chlorination Does a 3-Way Job.'' H. Gorseline.
1951. U.S. Egg and Poultry Magazine. April. Pages 12, 13, 29-31.
This document is available for review in the Hearing Clerk's office.
\10\``List of Proprietary Substances and Nonfood Compounds,''
USDA, FSIS, Miscellaneous Publication No. 1419, January 1, 1994.
Page II-vi. This document is available for review in the FSIS
Hearing Clerk's office.
\11\``Effects of chlorination of chill water on the
bacteriologic profile of raw chicken carcasses and giblets.'' 1992.
W. James et al. Journal of the American Veterinary Medical
Association. Vol. 200, No. 1, pages 60-63.
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Manufacturers of chlorine dioxide have petitioned FDA to permit the
use of this compound to disinfect waters contacting fresh meat, fresh
poultry, processed meat, and processed poultry.\12\ Studies have shown
that chlorine dioxide used at lower concentrations is as effective as
chlorine in reducing bacterial levels on poultry.''\13\
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\12\``Rio Linda Chemical Co., Inc.; Filing of Food Additive
Petition.'' Notice was published in the Federal Register, Vol. 59,
No. 22, by FDA on February 2, 1994. A copy is available for review
in the FSIS Hearing Clerk's office.
\13\``Effect on Broiler Carcasses and Water of Treating Chiller
Water with Chlorine or Chlorine Dioxide.'' H.S. Lillard. 1980.
Poultry Science, Vol. 59, pagess 1761-1766. A copy is available for
review in the FSIS Hearing Clerk's office.
---------------------------------------------------------------------------
Mechanical process modifications have also been studied. Good
effects in reducing bacterial levels on carcasses have been obtained
when conventional scald and chilling systems have been replaced with
countercurrent scald and chilling systems. In countercurrent systems,
carcasses exit from the system where the water is the cleanest.14
In 1991, the industry conducted a major study that showed that a
combination countercurrent scald system, post-scald rinse, and
chlorination at several control points on the evisceration line
effectively reduced the number of spoilage and pathogenic organisms on
carcass surfaces.15
---------------------------------------------------------------------------
\1\4``Effects of countercurrent scalding and postscald spray on
the bacteriologic profile of raw chicken carcasses.'' 1992. W. James
et al. Journal of the American Veterinary Medical Association. Vol.
201, No. 5, pages 705-708. A copy of this document is available from
the FSIS Hearing Clerk, Washington, DC.
\1\5``Effects of Six Modifications on the Incidence and Levels
of Spoilage and Pathogenic Organisms on Commercially Processed
Postchill Broilers.'' 1992. Amy L. Waldroup et al. Journal of
Applied Poultry Science. Res. 1:226-234. A copy of this document is
available for review at the FSIS Hearing Clerk's office.
---------------------------------------------------------------------------
Washing the carcass more often during the slaughter and dressing
operation has been shown to reduce the levels of bacteria on carcass
surfaces. Researchers theorize that spray washing at critical points
during the process creates a water film between the bacteria and the
carcass surface which prevents bacteria from attaching to carcass
surfaces. Simply washing carcasses with hot water has also been shown
to be effective in reducing the levels of bacteria on carcass
surfaces.16
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\1\6``Salmonella Savvy.'' R. Mulder. 1987. Poultry Processing.
December 1987. Pages 72-74. This document is available for review in
the FSIS Hearing Clerk's office.
---------------------------------------------------------------------------
FSIS is studying the use of the Hazard Analysis Critical Control
Point (HACCP) concept in official establishments as an effective means
of improving the process and reducing bacterial loads on carcasses.
Using HACCP in poultry inspection was proposed by the National Academy
of Science in a 1985 study, ``Meat and Poultry Inspection: The
Scientific Basis of the Nation's Program.''17 The first step in
developing an effective HACCP plan is to define the hazards.
Microbiological hazards are defined as ``the unacceptable survival by
microorganisms of concern to safety or spoilage and/or the unacceptable
production or persistence in foods of products of microbial
metabolism.'' After hazards are identified, critical control points are
established. The critical control point describes the location or
points in the process which, if not correctly controlled, could lead to
contamination with unacceptable growth.18
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\1\7This document is available for review at the Hearing Clerk's
Office, Washington, DC.
\1\8``The Use of HACCP in the Production of Meat and Poultry
Products.'' R. Tompkin. 1990. Journal of Food Protection, Vol. 53,
No. 9, pages 795-803. A copy is available for review in the FSIS
Hearing Clerk's office.
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The use of an antimicrobial treatment on raw poultry carcasses
would not eliminate the need for continued careful handling of raw
poultry products, but would reduce the levels of bacteria that may be
present. Establishments have several options to use as effective
treatments in reducing bacterial contamination on carcass surfaces.
Some treatments will require further development as indicated. Finding
practical ways to reduce bacterial contamination on raw poultry
products will continue to be a top priority in the agency.
Anticipated Improvements
Inspectors and veterinarians would be free to concentrate their
attention on disease problems, on more intensive inspection of various
on-line and off-line plant operations and on microbial controls. The
Agency could more effectively utilize its inspection resources to
maintain bird-by-bird inspection at this time, particularly for
pathology and disease conditions, while enhancing and increasing its
use of a comprehensive program of sampling and quality assurance. This
proposal would also allow the Agency to begin to lay the groundwork
necessary for further training of personnel to perform monitoring and
prevention activities needed to implement the Hazard Analysis and
Critical Control Points System in the future. The poultry enhancement
initiatives included in this proposal are intended to improve the
current inspection system and not be a substitute for inspection. A
comparison of the current and proposed systems is summarized in Table
2.
Table 2.--Comparison of Current and Proposed Inspection Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Process
carcass/ Number of Pre-chill clean Plant pre- corrective Mandatory
viscera post- pre-chill carcass sorting of Maximum line Reprocessed action for antimicrobial FPS fecal
mortem carcass enforcement product speed product finding of locations tolerance
inspectors inspectors feces
--------------------------------------------------------------------------------------------------------------------------------------------------------
TRAD........ Varies...... 0 Monitoring Off- No........ Varies......... Monitoring..... Varies......... Reprocessing Yes.
Line Equipment
SIS-1....... 1........... 0 Monitoring Off- No........ 35............. Monitoring..... Retest......... Reprocessing Yes.
Line Equipment
SIS-2....... 2........... 0 Monitoring Off- No........ 70............. Monitoring..... Retest......... Reprocessing Yes.
Line Equipment
NELS........ 3........... 0 Monitoring Off- No........ 91............. Monitoring..... Retest......... Reprocessing Yes.
Line Equipment
NTIS-1...... 1........... 0 Monitoring Off- No........ Range 17-26.... Monitoring..... Retest......... Reprocessing Yes.
Line Equipment
NTIS-2...... 2........... 0 Monitoring Off- No........ Range 35-51.... Monitoring..... Retest......... Reprocessing Yes.
Line Equipment
PEP......... 1........... 1 Monitoring Off- Yes....... See Table #1... 100% Re- Automatic Line Reprocessing No.
Line and inspection. Speed Equipment
On-Line Reduction. Carcasses
Inspection
--------------------------------------------------------------------------------------------------------------------------------------------------------
There are currently a total of 8382 in-plant inspector positions,
including poultry and meat inspectors. These proposed enhancements
would not have any impact on the total number of inspector positions.
There are 424 total in-plant inspector vacancies. FSIS has requested
funds for 200 additional inspectors for FY95 to help fill some of these
vacancies. The implementation of these poultry enhancement changes
would not have an impact on the number of vacancies.
The total number of inspectors available for off-line duties as a
result of the proposed poultry enhancement program would be 139. (See
Tables 3a. and 3b.)
Table 3a.--Inspection Position Changes Resulting From Converting to
Enhanced Poultry Inspection
------------------------------------------------------------------------
Current on- On-line
Inspection system Total Total line inspectors
plants lines inspectors under PEP
------------------------------------------------------------------------
SIS......................... 139 367 1,275 1,266
NELS........................ 45 118 630 414
NTIS........................ 27 46 88 124
Traditional................. 79 96 168 218
-------------------------------------------
Total................. 290 627 2,161 2,022
------------------------------------------------------------------------
Table 3b.--Total In-plant Inspection Positions Under Current System and
PEP
------------------------------------------------------------------------
Number of USDA inspection positions in poultry Current
slaughter establishments system PEP
------------------------------------------------------------------------
Veterinarians......................................... 456 456
On-line Inspectors.................................... 2,161 2,022
Off-line Inspectors................................... 502 641
-----------------
Total........................................... 3,119 3,119
------------------------------------------------------------------------
Currently, the average net increase in in-plant inspector positions
is 55-57 per year. The majority of increased positions have resulted
from industry growth. It is projected that the growth of the poultry
industry will continue and possibly increase. Additionally, FSIS
expects an increased need for inspectors for HACCP monitoring and
additional microbiological duties. The 139 inspection personnel
resulting from the implementation of the enhanced poultry inspection
system could fill the new positions resulting from industry growth, as
well as the new positions created for HACCP monitoring and additional
microbiological duties. Other positions considered could include
permanent relief inspector positions or additional off-line inspector
positions.
Although not available for the present rulemaking, new
microbiological tests and sampling programs are under development. The
proposed system requires inspection at a point where FSIS expects some
microbiological testing to occur. Research is aimed at determining
typical microbial conditions at various in-plant and in-process
locations. On the basis of such information, it is hoped, criteria can
be developed for determining when plant processes are in control and in
compliance with a standard, based on microbiological test results. In
the future, with the aid of rapid in-plant tests, inspectors and
veterinarians should be able to determine more precisely the source and
nature of microbial threats to public health.
Executive Order 12866
FSIS has determined that this proposed rule is significant, but
does not believe it to be economically significant, for the purposes of
Executive Order 12866, because it raises significant policy issues
arising out of legal mandates and the Administration's priorities,
which include a regulatory system that improves, protects, and
maintains public health and safety without imposing unacceptable costs
on the private sector.
The proposed rulemaking would meet the objectives of the Secretary
of Agriculture to enhance poultry inspection by enforcing a more
stringent policy for the removal of feces from dressed poultry
carcasses and by requiring the application of antimicrobial treatments.
It is thereby intended to improve public health and safety and
strengthen consumer confidence in poultry products.
While the proposed rulemaking would impose initial costs and
additional responsibilities on the regulated industry, the Agency's
assessment indicates that the proposed rulemaking is cost-effective as
compared to the alternatives considered. There would be no reduction in
maximum poultry production linespeeds currently allowed under optimal
conditions, but the proposed regulation would provide inducements to
industry to improve processing controls and further ensure the quality
and safety of outgoing product.
At the same time, the proposed rulemaking would apply the
President's regulatory philosophy by addressing a compelling public
need ``. . . to protect or improve the health and safety of the public
. . . or the well-being of the people.'' (E.O. 12866, section 1(a).)
This need is evidenced by epidemiological and economic studies carried
out in recent years that show the presence of microbial pathogens on
raw poultry products to be a continuing and possibly an increasing
threat to the public health and the economy of the nation.\19\
---------------------------------------------------------------------------
\19\Agricultural Outlook, Economic Research Service, AO-198
(July 1993), pp. 33-38.
Healthy People 2000. Department of Health and Human Services.
1994. Food and Drug Safety: Health Status Objective 12.1.
Copies of these documents are available for review in the office
of the FSIS Hearing Clerk.
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Preliminary assessment by FSIS indicates that this proposal is
consistent with other planned regulatory actions and with
Administration policy goals. For example, this proposed rulemaking
would be both compatible with and a precursor of the planned mandatory
Hazard Analysis and Critical Control Points (HACCP) programs for meat
and poultry establishments. The inspection and plant sorting stations
to be provided for control of disease and contamination would be
consistent with certain control points that would be chosen for
monitoring under a HACCP system. The proposal is also intended to
contribute to the fulfillment of the Administration's public health
objectives as set forth in the Healthy People 2000 initiative.
Benefits of Proposed Rule
The benefits to be derived from the proposed rule include potential
reductions in the microbial profile of dressed, ready-to-cook poultry,
including both pathogens and other bacterial organisms. A reduction in
visible contamination, combined with antimicrobial treatments, can
result in a decrease in the microbial load on dressed poultry
carcasses.\20\
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\20\``Comparison of the Microbiological Quality of Inspection-
Passed and Fecal Contamination-Condemned Broiler Carcasses.'' L.C.
Blankenship, et al. 1975. Journal of Food Science, Vol. 40, pages
1236-1238. A copy of this article is available for review in the
office of the FSIS Hearing Clerk.
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Foodborne illness exacts a significant annual toll on the American
people and economy. An estimated 6.5 million to 33 million people in
the United States become ill and 6,000 to 9,000 die each year from
foodborne illness. Meat, poultry, dairy, and seafood products are the
foods most likely to contain contaminants. Microbial foodborne disease
causes an estimated $2.5 billion to $3.4 billion in medical costs and
reduced productivity to be spent each year for four major bacterial
pathogens and $2.6 billion each year for parasitic diseases.\21\
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\21\USDA, Economic Research Service, Agriculture Information
Bulletin No. 664-53, September 1993. A copy of this publication is
available in the office of the FSIS Hearing Clerk.
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Of the four bacterial pathogens, Salmonella, Campylobacter jejuni,
Listeria monocytogenes, and Escherichia coli 0157:H7, the first three
are found on poultry. In as many as 17.2 percent of salmonellosis
cases, poultry products have been implicated as the vehicle (immediate
source of infection). Annual medical costs attributable to
salmonellosis range from $1.2 billion to $1.6 billion. The costs
associated with campylobacteriosis cases are in the neighborhood of $1
billion per year. More than 40 percent of campylobacteriosis cases can
be attributed to the consumption of improperly handled chicken.
Productivity losses from such cases are estimated at over $400 million
for 1992.\22\ The growing proportion of the U.S. population that is
compromised by immunologic deficiencies and age exacerbates the problem
because these subpopulations are more susceptible to infection and
death resulting from infection.
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\22\Agriculture Outlook, Economic Research Service, USDA, AO-198
(July 1993), pp. 33-36.
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The costs associated with foodborne illness attributable to
improperly handled poultry are thus substantial in both human and
monetary terms, and the Department has undertaken a comprehensive
program of research, regulation, and consumer education to try to
improve the situation. The reduction of foodborne pathogens on meat,
meat food, and poultry products remains the Agency's highest research
priority. Eight of the Agency's ``top ten'' research topics concern
aspects of this problem. FSIS is developing a number of regulations,
including this proposed rule, to deal comprehensively with the problems
associated with pathogens on raw meat and poultry. For example, the
Agency recently promulgated a regulation requiring safe handling
labeling on all meat and poultry products that are raw or have not been
subjected to a process that would make them ready-to-eat. A vigorous
consumer education campaign is underway to publicize the safe handling
labels and to remind consumers of the importance of food safety
practices.
The proposed rule would strengthen the Department's pathogen
reduction effort by providing enhanced assurance that ready-to-cook
poultry are free of disease and visible contamination that may harbor
pathogens. This would be accomplished, first, by requiring official
establishments to meet their responsibility to present for post-mortem
inspection only birds that have been presorted for condemnable
conditions. Second, FPS process tolerances for fecal contamination
would be eliminated. The effort to reduce such contamination is likely
to yield corresponding reductions in harmful bacteria on dressed
poultry carcasses.
Third, the on-line/off-line carcass inspector, provided by the
proposal, would be able to increase FSIS oversight over establishment
dressing procedures, such as viscera harvest, and on-line trimming.
Inspectors would now have the opportunity to inspect every carcass
after the viscera harvest operation. Because, under the current
inspection systems, there is no on-line inspection position after
viscera removal, Federal inspectors are not able to view every carcass
at the end of the production line before the carcasses enter the
chiller. This proposal would correct that situation.
Fourth, all reprocessed poultry would be reinspected. Added
assurance would thus be provided that reprocessed poultry are free of
visible contamination and unlikely to be a cause of cross contamination
when introduced into the chill system.
Fifth, a pre-chill antimicrobial treatment step would be required.
This would help assure lower microbial populations on raw carcasses.
The additional assurance of poultry wholesomeness provided by the
proposed regulation would increase consumer confidence in the U.S.
poultry supply, with further increases in the domestic and export
markets for U.S. poultry a likely result.
Another benefit of the proposed regulation would be improved safety
and health conditions for FSIS inspectors. The new inspection
procedures to be implemented by this proposal would result in the
elimination of most repetitive inspector hand motions, and this would
lead in turn to a dramatic reduction in repetitive motion disorder
among FSIS poultry inspectors--including days off from work for medical
consultation and treatment. Annual claims reported by FSIS inspectors
(both poultry and red meat) to the Office of Workers Compensation
Programs of the Department of Labor have amounted to over $500,000 per
year for repetitive motion disorder. In addition to such well-
publicized conditions as carpal tunnel syndrome and tendinitis,
inspector have reported cases of epicondylitis, ganglionic cyst, and
other conditions imposing compensation costs of $4,000 to $5,000 per
case.
Finally, the proposed regulation would establish a single, uniform
inspection system for all classes of poultry that are subject to the
PPIA. Poultry processors would have added assurance that--no matter
what kind of poultry they market--the standards and procedures by which
the poultry are inspected are the same, and that all birds are expected
to meet uniform requirements. All establishments would be able to
maintain, and some establishments would be able to increase, their
production rates.
The Agency would gain short-term flexibility in assigning
inspectors from some line positions to existing vacancies in the
inspection program, and long-run flexibility to train personnel in a
uniform methodology and to assign or reassign them more readily to
locations where they are most needed. Implementation of enhanced
poultry inspection would benefit the Agency by helping to offset the
need for more inspectors to meet industry growth, fulfill HACCP
monitoring requirements, and carry out microbiological sampling
programs. Finally, consumers would gain the assurance that the same
dressing and contamination standards had been applied to all types of
federally inspected poultry.
The Agency requests that comments on these and other benefits be
submitted to help evaluate the advantages that could be expected from
implementation of a final rule.
Costs of Proposed Rule
The major impacts of the proposal on the poultry industry would be
the one-time costs associated with installing new facilities and
equipment and the on-going costs associated with information
collections and the 100-percent reinspection of reprocessed birds.
Preliminary estimates of these costs are summarized in Table 4. The
Agency requests that comments on the proposal include information on
the costs to the extent it is available. These comments would help
evaluating the costs in the final rule. As indicated in the section of
this preamble concerning the Paperwork Reduction Act, a detailed
analysis of the information collection requirements of the proposal is
being submitted to the Office of Management and Budget.
Table 4.--Costs to Establishments Under Current Inspection Systems of Converting to Enhanced Poultry Inspection, by System and Cost Category
--------------------------------------------------------------------------------------------------------------------------------------------------------
Training,
Inspection hiring of Reprocessing
Current system stands and Lighting additional inspection Reconfiguration Antimicrobial Information Total
guidebars, establishment cost to treatment collection
installation employees industry*
--------------------------------------------------------------------------------------------------------------------------------------------------------
Traditional............................. $792,160 $96,000 $179,000 $196,000 $40,000 $24,000 $395,000 $1,722,160
SIS-1................................... 23,880 3,000 15,000 6,700 3,000 1,000 15,000 67,580
SIS-2................................... 716,440 0 223,000 1,056,720 182,000 41,000 680,000 2,898,160
NELS.................................... 231,280 0 75,000 809,340 60,000 14,000 225,000 1,414,620
NTIS-1.................................. 95,520 12,000 20,000 30,240 6,000 3,000 35,000 201,760
NTIS-2.................................. 270,640 0 32,500 73,920 17,000 6,000 100,000 500,060
---------------------------------------------------------------------------------------------------------------
Column totals..................... 2,129,920 110,000 544,500 2,172,920 308,000 89,000 1,450,000 6,804,340
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Indicates per-annum cost; other costs computed on one-time-only basis.
The figures listed in Table 4 take into account the number of
federally inspected poultry slaughter establishments currently in
operation and the number of slaughtering lines for each inspection
system. The estimates provided for inspection stand purchase and
installation are based on consultation with several equipment
manufacturers. Most of the approximately 186 establishments currently
operating under SIS-2 and NELS may be able to use or move existing
inspection stands at a cost of no more than $1,000 each. For example,
an establishment currently operating under the NELS inspection system
may be able to provide a reconfigured inspection line by moving an
inspection stand from the post-mortem inspection area to the pre-
chiller carcass inspection station. Some plants, however, would have to
purchase or construct and install at least one new inspection stand at
a cost of $6,000 to $10,000 per installation. A guidebar would have to
be installed at each on-line post-mortem inspection station to permit
eviscerated birds to be presented to the inspector for examination.
The estimates for installation of 200 foot-candle lighting take
into account the fact that establishments operating under several of
the current inspection systems (SIS, NELS, and NTIS) are already
provided with enhanced lighting. Establishments operating under
traditional inspection (as many as 96 lines) would have to install new
lighting at a cost of about $1,000 per purchase and installation. The
enhanced lighting is necessary to ensure the effectiveness of post-
mortem inspection and the FPS checks under the new system.
As noted, most projected costs are one-time only. A few
establishments may have to hire new personnel to staff some poultry
slaughter lines. Additional expenses for retraining establishment
personnel are likely to be incurred by all establishments. In addition,
most establishments affected by this proposal would incur miscellaneous
line reconfiguration expenses involving space reallocation at an
estimated $1,000 per establishment.
To meet the requirement for antimicrobial treatment before the
chiller, approximately 30 percent of poultry plants would have to
install equipment. Most poultry establishments would not be affected
immediately by the requirement because their final washers are already
using an antimicrobial agent. Those establishments that are not using
their final washes to add an antimicrobial agent could do so for
approximately $500 per processing line simply connecting their existing
chlorine supply to their final carcass wash equipment.
The industry would incur additional annual costs in connection with
the 100-percent on-line reinspection of reprocessed birds. These costs
have been computed on the basis of the average linespeeds for the
different inspection systems and the assumption of a 2-percent overall
rate of reprocessing. It has also been assumed that most reinspection
of reprocessed carcasses would result in overtime hours and that a
labor cost would be incurred for rehanging birds on the processing
line. Overtime salaries for Federal inspectors (paid by affected
establishments) and wages for establishment personnel have been
factored into the estimates. The 2-percent reprocessing rate is based
on approximately two years of in-plant data collection and represents
the national average. Through a combination of process control, good
husbandry practices, and good manufacturing practices individual
establishments can lower this rate thereby decreasing this on-going
cost.
Also, an allowance for minor plant reconfigurations has been made.
It is expected that some establishments would have to move equipment
and rearrange their slaughtering lines to a limited extent to make room
for inspection locations.
Below are estimated costs to the poultry industry of converting to
enhanced poultry inspection:
Inspection and plant sorter stands and guidebars for at most 643 lines:
$2,129,920
Enhanced lighting for as many as 100 lines: $110,000
Expenses for training and hiring new establishment personnel: $544,500
Cost of inspection of reprocessed carcasses: $2.2 million
Miscellaneous processing line reconfiguration costs: $308,000
Cost of minimal equipment installations to meet final wash
antimicrobial treatment requirement: $89,000
Estimated annual cost of information collections: $1.4 million
Total estimated direct impact on federally inspected establishments:
$6.8 million
Estimated direct impact on (approx. 160) State-inspected establishments
operating under ``at least equal to'' programs: $3.4 million
Estimated direct impact on poultry industry: $10.2 million
The Agency does not expect economic losses to occur as a result of
slowing linespeeds due to proposed corrective action. As indicated
earlier in the preamble to this rule, maximum linespeeds allowed under
optimal conditions would remain the same. If establishment sorters
fulfill their responsibility, as outlined in this proposal, then
maximum linespeeds should be attainable. Establishments currently
operating under traditional inspection may be able to achieve increases
in linespeeds under this proposal but such action could only occur if
quality and safety of the outgoing product was ensured. As indicated by
this analysis, the industry could operate with maximum effectiveness
with a small investment in personnel and training. As currently
allowed, the FTIS inspector in charge or his/her designee would retain
the discretion to reduce linespeeds when necessary.
Alternatives Considered
FSIS considered two alternatives to this proposal that would meet
the Secretary's objectives. The first of the alternatives would involve
detaching the viscera from poultry carcasses prior to inspection and
presenting the organs and the carcass for inspection at the same time,
but separated. A separate belt or tray would be provided for the
viscera to prevent the viscera from contaminating the carcass. However,
the cost to industry would be approximately $140 million for new
equipment. In addition, downtime for construction and installation
could cost the industry as much as $780 million.
Under the second alternative, the current post-mortem inspection
procedures would be retained utilizing existing inspection techniques,
but with an inspector at the end of the line after the viscera have
been removed from the carcasses to examine each carcass for fecal
contamination. This could be accomplished either by moving an existing
inspector to the end of the line, or by adding a new inspector to every
line, or by a combination of both arrangements. However, this would
mean that the Government could incur additional personnel costs of
approximately $16 million per annum. Further, production rates could be
reduced by 30 to 50 percent if the inspectors tasks remained identical,
but fewer inspectors were used to perform those functions. The impact
of the slowed linespeeds could reach $5.2 billion per year for chickens
and turkeys.
In the judgment of the Agency, either of these alternatives would
impose unacceptable costs.
Executive Order 12778
This proposed rule has been reviewed pursuant to Executive Order
12778, Civil Justice Reform. 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 than, those
imposed under the PPIA. States and local jurisdictions are also
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 may, however, exercise
concurrent jurisdiction over poultry products that are outside official
establishments for the purpose of preventing the distribution of
poultry products that are misbranded or adulterated under the PPIA or,
in the case of imported articles, which are not at such an
establishment, after their entry into the United States. States and
local jurisdictions may also make requirements or take other actions
that are consistent with the PPIA, with respect to any other matters
regulated under the PPIA.
Under the PPIA, States that maintain poultry product inspection
programs must impose requirements on State-inspected products and
establishments that are at least equal to those required under the
PPIA. These States may, however, impose more stringent requirements on
such State-inspected products and establishments.
In the event of its adoption, no retroactive effect would be given
to this proposed rule, no administrative procedures must be exhausted
before any judicial challenge can be taken to the application of these
provisions.
Effect on Small Entities
The Administrator has determined that this proposed rule will not
have a significant effect on a substantial number of small entities.
The small entities affected by this proposal are small poultry
slaughtering establishments operating one or two slaughtering lines
each staffed by one FSIS food inspector. They include establishments
operating under the SIS-1 and NTIS-1 inspection systems, and some small
entities operating under the traditional inspection procedures; these
account for 75 of the approximately 300 poultry slaughtering
establishments that would be affected by the proposed rule. Thus, the
proposed rule would affect a substantial number of small entities.
It may be assumed that each establishment with only one single-
inspector processing line would be required to make a one-time
investment of about $10,000 for an inspection platform and
installation, enhanced lighting, equipment installation to meet the
requirement for antimicrobial treatment of dressed poultry, and
training of establishment personnel. Each establishment with two lines
could incur expenses of as much as $17,000.
Also, every establishment would be required to operate a finished
product standards program. Establishments now operating under
traditional inspection would thus assume a modest information
collection burden.
However, there would be no production rate reductions and, in fact,
small establishments could benefit from increases in production rates.
For example, some processing lines staffed by a single FSIS inspector
would now be staffed by two inspectors and plant sorters. That means
that, consistent with physical plant limitations, the class of poultry
processed, market demand for poultry products (which has been steadily
increasing in recent decades), and the establishment's ability to
maintain processing controls and quality standards, production rates on
these processing lines could be increased with the adoption of the
proposed rule. In the most favorable scenario, an establishment
currently operating under traditional inspection and processing young
chickens at the rate of 25 per minute would be able to increase its
production rate up to 70 birds per minute. The increase in annual
returns resulting from such a production-rate increase would more than
offset any necessary one-time investment.
In addition, for reasons given in this notice in support of changes
to the FPS, there would be greater assurances of processing stability
and product quality under the proposed rule. Identification of product
requiring rework would be more certain. Resulting efficiencies could be
expected to yield returns that, combined with productivity gains, would
offset outlays for equipment in the near term for most establishments.
For these reasons, therefore, the proposed rule would not have a
significant net effect on a substantial number of small entities.
Paperwork Requirements
This proposed rule requires paperwork and recordkeeping activities
that would provide FSIS with information to ensure that establishments
are in compliance with the proposed regulations.
Each day, establishments would complete a form that reports that
day's poultry condemnations. Also, under the proposed FPS program,
establishments would report data on only one form. Under the current
FPS system, establishments complete three forms to report data from FPS
checks.
Establishments using chlorinated water to meet the proposed
antimicrobial treatment requirements would be required to monitor the
concentration by testing three times a shift and keeping on file
records of the test results.
Any establishment wishing to operate an approved PQC program would
have to send a copy of the program to the Administrator for approval.
Additionally, an establishment wishing to use antimicrobial compounds
not listed in the table of approved substances may request, in writing,
approval for use of such compounds from the Administrator.
The paperwork requirements contained in this proposal have been
submitted to the Office of Management and Budget for approval under the
Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Comments on the
paperwork burden of this proposed rule should be sent to: Office of
Management and Budget, Desk Officer for FSIS, Office of Information and
Regulatory Affairs, Room 3208, New Executive Office Building,
Washington, DC 20503, and to the Clearance Office, Room 404-W,
Administration Building, Washington, DC 20250.
List of Subjects in 9 CFR Part 381
Poultry inspection, Poultry and poultry products.
Proposed Rule
For the reasons set forth in the preamble, FSIS is proposing to
amend 9 CFR part 381 of the poultry products inspection regulations 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; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR
2.17, 2.55.
2. Section 381.36 would be amended by removing paragraphs (d) and
(e) and by revising paragraph (c) to read as follows:
Sec. 381.36 Facilities required.
* * * * *
(c) Facilities for post-mortem inspection. The following facility
requirements for post-mortem inspection are in addition to the other
requirements to obtain a grant of inspection.
(1) The following provisions shall apply to every inspection
station:
(i) The conveyor line shall be level for the entire length of the
inspection. The vertical distance from the bottom of the shackles to
the top of the adjustable platform (paragraph (c)(1)(iv) of this
section) in its lowest position shall not be less than 60 inches.
(ii) Floor space shall consist of 4 feet along the conveyor line
for each inspector, with a total of 8 feet for the two inspection
stations, and 4 feet for the inspector helper provided by the
establishment as required under Sec. 381.76(d).
(iii) Guidebars shall be installed in all establishments so that
the inspector will receive birds on at least 6-inch centers for young
chicken lines and at least 12-inch centers for turkey lines. The
guidebar must move the bird to the edge of the trough for the
inspector, and provide smooth, steady, and consistent movement through
both the on-line post-mortem inspection station and the on-line/off-
line carcass inspection station.
(iv) The on-line post-mortem inspection station and the on-line/
off-line carcass inspection station shall meet the requirements
specified in Sec. 381.53. Each inspection station shall have a platform
that is slip-resistant and can be safely accessed by the inspector. The
platform shall be designed so that it can be easily and rapidly
adjusted for a minimum of 14 inches vertically while standing on the
platform. The platform shall be a minimum length of 4 feet and have a
minimum width of 2 feet; the platform shall be designed with a 42-inch
high rail on the back side and with \1/2\ inch foot bumpers on both
sides and front to allow safe working conditions. The platform must
have a safe lift mechanism and be large enough for the inspector to sit
on a stool and to change stations during breaks or inspector rotation.
(v) Conveyor line stop/start switches shall be located within easy
reach of each inspector.
(vi) A trough or other facilities complying with Sec. 381.53(g)(4)
shall extend beneath the conveyor at all places where processing
operations are conducted from the point where the carcass is opened to
the point after the second inspector. The trough must be of sufficient
width to preclude trimmings, drips, and debris from accumulating on the
floor or platforms. The clearance between the suspended carcasses and
the trough must be sufficient to preclude contamination of carcasses by
splash.
(vii) A minimum of 200 footcandles of shadow-free lighting with
minimum color rendering index value of 85\1\ where the birds are
inspected to facilitate inspection, notwithstanding the requirements of
Sec. 381.52(b).
---------------------------------------------------------------------------
\1\This requirement may be met by deluxe cool white type of
fluorescent lighting.
---------------------------------------------------------------------------
(viii) ``On-line'' handrinsing facilities with a continuous flow of
water conforming to Sec. 381.51(f) shall be provided for and within
easy reach of each inspector and each establishment employee working on
the line.
(ix) Hangback racks shall be provided for and positioned within
easy reach of the inspector.
(x) The on-line post-mortem inspection station shall be provided
with receptacles for condemned carcasses and parts. Such receptacles
shall conform to the requirements of Sec. 381.53(m).
(2) In addition to the requirements prescribed in paragraph (c)(1)
of this section, the establishment shall provide safely accessible
space for the on-line/off-line carcass inspector to perform on-line
inspection checks of carcasses between the viscera harvest and the
final wash.
(3) Reinspection stations for Finished Product Standards (FPS)
monitoring, as prescribed in Sec. 381.76(h), are required. The Agency
will determine the number of stations needed in those establishments
having more than one processing line or more than one chiller. One or
more FPS reinspection stations shall be conveniently located at the end
of the line or lines prior to chilling. Each reinspection station must
meet the following provisions:
(i) Floor space shall consist of 3 feet along each conveyor line.
The space shall be level and protected from all traffic and overhead
obstructions.
(ii) A table at least 2 feet wide and 2 feet deep and 3 feet in
height shall be provided for reinspecting the sampled carcasses, except
that such a table shall be at least 3 feet wide and 2 feet deep in
establishments processing turkeys. All such tables shall be designed to
be readily cleanable and drainable.
(iii) A minimum of 200 footcandles of shadow-free lighting with a
minimum color rendering index of 85\1\ on the table surface shall be
provided.
(iv) A separate clip board holder shall be provided for holding the
recording sheets.
(v) Hangback racks designed to hold 10 carcasses shall be provided
for and positioned within easy reach of persons at the station.
3. Section 381.67 would be revised to read as follows:
Sec. 381.67 Maximum post-mortem inspection rates.
(a) The maximum post-mortem inspection rates for the classes of
poultry are specified in the following table. Establishments that
operate under an approved partial quality control (PQC) program, as
prescribed in Sec. 381.76(i), may operate at higher production rates
when optimum conditions are met. These maximum rates shall not be
exceeded.
Maximum Production Rates
------------------------------------------------------------------------
Birds per minute
Class of poultry -------------------------------------------------
With PQC Without PQC
------------------------------------------------------------------------
Young chickens........ 91 70
Young turkeys:
J-type opening cut 3-point suspension
Less than 16
pounds........... 51 20
More than 16
pounds........... 41 16
Bar-type opening cut 3-point suspension
Less than 16
pounds........... 45 20
More than 16
pounds........... 35 16
------------------------------------------------------------------------
(b) The inspector in charge or his or her designee shall be
responsible for reducing production rates where, in the inspector's
judgment, the post-mortem inspection procedure cannot be adequately
performed with the time available because of either of the following
conditions:
(1) The official establishment cannot present the birds in such a
manner that the carcasses including both internal and external surfaces
and all organs, are readily accessible for inspection, or
(2) The establishment cannot properly remove diseased birds or
properly identify contaminated birds and birds for off-line trimming or
knife salvage.
4. Section 381.68 would be removed and reserved.
5. Subpart I would be amended by adding a new Sec. 381.69 to read
as follows:
Sec. 381.69 Treating carcasses to reduce bacterial contamination.
(a) General. Raw, unchilled poultry carcasses shall be treated at
any point during the slaughter and dressing operation to reduce levels
of bacterial contamination on carcass surfaces.
(b) Treatment methods. Official establishments shall use any of the
following treatment methods to reduce bacterial contamination, provided
that the equipment used to apply the treatment has been approved under
Sec. 381.53, the operation of the method results in full compliance
with the Act and this part, and that the method permits effective and
efficient monitoring by program employees.
(1) Any chlorine compound approved by the Administrator and
administered to raw, unchilled whole poultry carcasses or major carcass
portions at 20 to 50 parts per million (ppm) in the intake water at the
final wash. The Administrator will prepare a list containing compounds
approved for use in official establishments. A copy of the list may be
obtained from the Compounds and Packaging Division, Regulatory
Programs, Food Safety and Inspection Service, U.S. Department of
Agriculture, Washington, DC 20250-3700.
(i) The establishment must conduct three tests per 8-hour shift on
the intake water of each final washer using a starch-iodide titration
test kit, or any other chlorine analysis method acceptable to the IIC,
to assure that chlorine intake levels are within the range prescribed
above. An initial test must be conducted at the start of the shift
before the first carcass enters the final washer. The two other tests
must be conducted at randomly selected times during the shift. Records
of chlorine test results that specify the time of the test, chlorine
concentration levels, and the name and position of the person
administering the test shall be on file in the establishment and shall
be made available to program employees, upon request.
(ii) If the chlorine level is above or below the range of 20 to 50
ppm available chlorine in the final wash water, the establishment shall
adjust the chlorine level to an acceptable level within 15 minutes. If
adjustments are not made within 15 minutes, the establishment shall
suspend the treatment and shall not permit any carcasses to enter the
final washer until the chlorine level is within the prescribed range.
(2) Any antimicrobial compound listed in the table in
Sec. 381.147(f)(4) permitted for use on poultry products may be used
under the conditions specified therein.
(3) Any compound previously approved for use in poultry or poultry
products as a food additive or processing aid by the Food and Drug
Administration (FDA) and listed in title 21 of the Code of Federal
Regulations, parts 73, 74, 81, 172, 173, 182, or 184 may be used,
provided the owner or operator has received approval for such use from
the Administrator in accordance with section 381.147(f)(1). The owner
or operator shall submit to the Administrator information and data
indicating the site of application and that the substance is effective
in reducing bacterial contamination on carcass surfaces, and its use is
in compliance with applicable FDA requirements and will not render the
carcass adulterated or misbranded or otherwise not in compliance with
the requirements of the Act.
(4) Any countercurrent scalder, designed such that potable water
enters at or near the point where carcasses exit the scalder, overflow
outlets are located at or near the point where carcasses enter the
scalder, and exiting carcasses do not come in contact with overflow
water, that is used concurrently with a post-scald rinse may be used,
provided the equipment is evaluated and found acceptable by the
Administrator. The Administrator will prepare a list containing each
model approved for use in official establishments. A copy of the list
may be obtained from the Facilities, Equipment, and Sanitation
Division, Science and Technology, Food Safety and Inspection Service,
U.S. Department of Agriculture, Washington, DC 20250-3700.
(5) Any mechanical process modifications, other than that listed in
paragraph (b)(4) of this section, such as hot water rinses, used singly
or in combination with approved antimicrobial compounds may be used,
provided the owner or operator has received approval for such use from
the Administrator. The owner or operator shall submit to the
Administrator information and data indicating that the proposed method
is effective in reducing bacterial contamination on carcass surfaces,
and it will not render the carcass adulterated or misbranded or
otherwise not in compliance with the requirements of the Act.
6. Section 381.76 would be amended by adding a heading for
paragraph (a), revising paragraphs (b) and (c), and adding new
paragraphs (d) through (h) to read as follows:
Sec. 381.76 Post-mortem inspection, when required; extent; rate of
inspection.
(a) General. * * *
(b) Line configuration. There are two inspection stations located
on each post-mortem inspection line. The first inspection station is
located immediately after the establishment sorter or sorters who are
positioned immediately after evisceration. This is known as the ``on-
line post-mortem inspection station.'' The second inspection station is
located after the final wash and prior to the chiller. This is known as
the ``on-line/off-line carcass inspection station.''
(c) Presentation. (1) The establishment is responsible for
presenting to the on-line post-mortem inspector only carcasses that are
free of pathology and disease that would result in condemnation, in
accordance with this part, designated for trimming or knife salvage of
such conditions, or designated for reprocessing. The establishment
shall present each carcass to the on-line post-mortem inspector
properly eviscerated with the back side toward the inspector and the
viscera uniformly trailing or leading.
(i) The establishment shall place a sorter or sorters immediately
after evisceration and prior to the on-line post-mortem inspector to
sort the carcasses and remove and condemn the carcasses, as necessary,
or designate the carcasses for knife salvage, off-line trimming, or
reprocessing. The establishment sorter or sorters shall be positioned
on the processing line in a manner that does not impede inspection. The
establishment records the reason for condemnation of every carcass for
each sorter.
(ii) The on-line post-mortem inspector shall assure that carcasses
are appropriately designated for knife salvage, off-line trimming, or
reprocessing, and that condemnable carcasses are condemned.
(iii) If the on-line post-mortem inspector finds any birds on the
processing line that should have been condemned or designated for knife
salvage, off-line trimming, or reprocessing, he or she shall stop the
line for proper disposition, and require removal of such birds, and
recording of condemned birds by the establishment. The on-line post-
mortem inspector shall retain questionable birds for disposition by the
inspector in charge.
(iv) Carcasses with certain defects not requiring condemnation of
the entire carcass that were not designated by the establishment sorter
for off-line trimming, knife salvage, or reprocessing shall be passed
by the on-line post-mortem inspector, but he or she shall stop the line
and the establishment shall be required to remove them for off-line
trimming or knife salvage.
(v) Carcasses that are designated for off-line trimming shall be
removed from the processing line by the establishment after the on-line
post-mortem inspector and prior to viscera harvest.
(vi) Carcasses that are designated for knife salvage shall be
removed from the processing line by the establishment after the on-line
post-mortem inspector and before the viscera harvest.
(vii) Carcasses that are designated for reprocessing shall be
removed from the processing line by the establishment after the on-line
post-mortem inspector and prior to the viscera harvest and reprocessed
at an approved reprocessing station, as prescribed in Sec. 381.91(b).
Such reprocessed birds shall be returned to the processing line by the
establishment after viscera harvest and prior to the on-line/off-line
carcass inspector for reinspection.
(2) The establishment is responsible for presenting to the on-line/
off-line carcass inspector only carcasses that are free of fecal
contamination and have been properly trimmed or reprocessed.
(i) The establishment shall position a trimmer or trimmers between
the viscera harvest and the final wash to trim carcasses for trimmable
lesions and quality defects, and to remove for reprocessing carcasses
that are contaminated on inner surfaces with feces. The trimmer or
trimmers shall be positioned on the processing line in a manner that
does not impede inspection.
(ii) If the on-line/off-line carcass inspector finds any carcasses
on the processing line that should have been designated for
reprocessing, he or she shall stop the line for proper disposition, and
require removal of the carcasses, and recording of any such carcasses
condemned by the establishment. Carcasses that are reprocessed by the
establishment shall be returned to the processing line by the
establishment at a point after the viscera harvest and prior to the on-
line/off-line carcass inspector.
(iii) If the on-line/off-line carcass inspector finds any fecal
contamination on a reprocessed carcass, the establishment shall be
required to rework all remaining reprocessed carcasses in that
reprocessed lot which shall be identified as prescribed in
Sec. 381.91(b).
(iv) Under the following conditions, the establishment's production
rate shall be reduced immediately to the extent necessary to ensure
process control in preventing fecal contamination, and for such
duration, until FSIS determines that the establishment can demonstrate
process control at the higher production rate:
(A) When the on-line/off-line carcass inspector finds any fecal
contamination on a carcass, other than reprocessed carcasses, or
(B) When the establishment or the inspector finds any fecal
contamination on a carcass during testing under the Finished Product
Standards Program, as prescribed in paragraph (h) of this section.
(d) Inspector helper. The on-line post-mortem inspector shall be
flanked by an establishment employee assigned to duties such as
removing carcasses previously designated by the establishment for knife
salvage, off-line trimming, or reprocessing or, as directed by the
inspector, removing birds for veterinary disposition or correlation.
(e) Inspection rates. (1) Establishments shall operate at the rates
prescribed in Sec. 381.67. Establishments that operate under an
approved PQC program, as prescribed in paragraph (i) of this section,
may operate at higher rates than establishments operating without PQC.
(2) For the establishment to run its production line at maximum
speed, optimal conditions must be maintained so that inspection may be
conducted efficiently. The inspector in charge or his or her designee
determines the speed at which each processing line may be operated to
permit inspection. A variety of conditions may affect this
determination including the health of each flock and the manner in
which birds are being presented to the inspector for inspection and the
accuracy of the establishment sorters.
(f) Facilities. Each inspection station must comply with the
facility requirements in Sec. 381.37(c).
(g) Recordkeeping. Establishments shall record information
pertaining to the birds that are condemned.
(h) Finished Product Standards. The Finished Product Standards
(FPS) shall be conducted in all poultry slaughter establishments.
(1) For purposes of this paragraph (h), the following definitions
shall apply:
(i) Cumulative sum (CUSUM). A statistical concept used by the
establishment and monitored by the inspector whereby compliance is
determined based on sample results collected over a period of time. For
purposes of determining compliance with the finished product standards,
the CUSUM is equal to the sum of prior test results plus a measure of
the current test minus the tolerance, with the condition that the
resulting CUSUM cannot go below zero.
(ii) Tolerance number. A measure that equates to product being
produced at a national product quality level.
(iii) Action number. A level reached by the CUSUM where the process
is out of control and product action is required by the establishment
or the inspector.
(iv) Start number. A value halfway between zero and the action
number. The start number is used to determine the starting CUSUM for
the first subgroup of a shift and to reset the CUSUM value if the CUSUM
is equal to or greater than the action number.
(v) Subgroup. A 10-bird sample collected before product enter the
chiller.
(vi) FPS testing. Testing conducted by the establishment to
determine the CUSUM on consecutive 10-bird subgroup samples collected
prior to product entering the chilling system.
(vii) Rework. Reconditioning the product to correct the condition
or conditions causing the nonconformances listed in Table 1.
(2) Finished Product Standards are criteria applied to processed
birds to ensure the product consistently meets ready-to-cook
requirements. The FPS Program is designed to monitor the quality and
effectiveness of the dressing and evisceration procedures. The criteria
consist of nonconformances (see Table 1 of this section), the incidence
of which is determined from 10-bird subgroup samples, reduced to a
CUSUM number, and measured against the standards (see Table 2 of this
section). Standards are applied to permit the Agency to estimate when
the production process is in control and when it is out of control. The
establishment is responsible for maintaining the FPS Program which, in
turn, is monitored by the inspector. If an out-of-compliance condition
is found, the product is segregated for rework, reworked, and retested
before it may proceed into commerce.
(i) Actions to be taken when the process is in control. If the
CUSUM is less than the action number and the most recent subgroup
sample is tolerance or below, the process is judged to be in control.
(A) Establishment actions. The establishment shall:
(1) Randomly select and record subgroup sampling times for each
production unit of time before product reaches the FPS reinspection
station on the production line. In no case shall the time between tests
exceed 1 hour of production time.
(2) Conduct a 10-bird subgroup test at a random time on each
poultry slaughter line. These times are preselected by the
establishment and available to the inspector prior to the start of the
shift/day's operation. All 10 samples of the subgroup shall be
collected at the random time.
(3) Record the test results. If the subgroup total is tolerance or
below, conduct the next randomly scheduled subgroup test.
(B) Inspector actions. The inspector shall:
(1) Select random times for monitoring subgroup tests for each
half-shift on the evisceration line. In establishments that have
multiple evisceration lines on a production shift, monitor all lines of
product at the random times.
(2) Collect the subgroup samples to be monitored at preselected
times. All 10 samples of the subgroup shall be collected at the random
time selected.
(3) Conduct the 10-bird monitoring subgroup test. Record the test
results. If the subgroup total is tolerance or below, conduct the next
randomly scheduled subgroup test.
(ii) Actions to be taken with rising CUSUM. If the establishment or
inspection subgroup test result is above tolerance, the process is
judged to be under questionable process control.
(A) Establishment actions. The establishment shall:
(1) Immediately notify the inspector in charge and the production
supervisor responsible for the affected evisceration line.
(2) Take specific process corrective actions for each FPS category
with nonconformances to prevent the process from yielding product
requiring rework. These actions are recorded on the FPS form.
(3) Suspend random time FPS testing. Conduct additional subgroup
tests a minimum of 15 and a maximum of 30 minutes apart at the
reinspection station to determine the adequacy of process corrective
actions. Include the test results in the CUSUM. If the testing results
in an additional subgroup total exceeding tolerance or CUSUM equals or
exceeds the action number, identify subsequent product for rework and
follow procedures for process out of control.
(4) If two consecutive additional subgroup tests a minimum of 15
and a maximum of 30 minutes apart demonstrate process control with
subgroup totals equal to or less than tolerance, but they do not cause
CUSUM to fall to the start line or below, reset CUSUM at the start
number.
(5) Resume random time subgroup testing as set forth in actions to
be taken when the process is in control.
(B) Inspector actions. The inspector shall monitor product and the
effectiveness of process corrective actions by making spot-check
observations to ensure that all program requirements are met.
(iii) Actions to be taken when the CUSUM reaches the action number.
If the subgroup test results in CUSUM equal to or exceeding the action
number, or results in a rising CUSUM and a subsequent subgroup test
above tolerance, the process is judged not in control.
(A) Establishment actions. The establishment shall:
(1) Identify subsequent product for rework.
(2) Immediately notify the inspector in charge and production
supervisor responsible for the affected evisceration line.
(3) Take specific process corrective actions for each FPS category
with nonconformances to regain process control and minimize rework.
These actions shall be recorded on the FPS form.
(4) Suspend random time testing. Conduct additional subgroup tests
at the reinspection station to determine the adequacy of process
corrective actions. Include the test results in the CUSUM.
(5) After two consecutive subgroup tests at least 30 minutes apart
result in subgroup totals equal to or less than tolerance, identify
product that will mark the end of the rework action.
(6) If two consecutive additional subgroup tests demonstrate
process control with subgroup totals equal to or less than tolerance,
but they do not cause CUSUM to fall to the start line or below, reset
CUSUM at the start number.
(7) Resume random time subgroup testing as set forth in actions to
be taken when the process is in control.
(B) Inspector action. The inspector shall monitor product and the
effectiveness of process corrective actions by making spot-check
observations to ensure that all program requirements are met.
(iv) Off-line rework of product. (A) When the product has been
identified as having been produced when the process was not in control,
off-line product corrective actions must take place. All corrective
actions such as identifying affected product, segregating product, and
maintaining control through rework actions are the establishment's
responsibility.
(B) The inspector shall spot check the establishment's
identification, segregation, and control of reworked product to ensure
that program requirements are met. If the establishment fails in its
responsibilities, the inspector shall identify, segregate, and retain
affected product to prevent adulterated product from reaching
consumers.
(C) Reworked product must be tested by the establishment with a
randomly selected subgroup test of the accumulated reworked lot. Before
product is released, the subgroup test must be less than or equal to
tolerance. If the subgroup test of the reworked lot exceeds tolerance,
the lot must be reworked again before another subgroup test is
selected. The following actions are required.
(1) Establishment actions. The establishment shall:
(i) Select the 10-bird subgroup from throughout the lot only after
the total lot has been reworked.
(ii) Conduct the 10-bird test.
(iii) Release the lot if the subgroup test is less than or equal to
tolerance.
(iv) Identify and control the lot to be reworked again if the
subgroup again exceeds tolerance.
(2) Inspector actions. The inspector shall spot check the rework
procedure and testing to ensure that establishment monitoring and
production meet the requirements of the program.
(3) Trimmable Lesion/Condition Testing and Actions. The trimmable
lesion/condition test is designed to monitor the establishment's
ability to remove trimmable lesions and conditions from inspected and
passed carcasses. The trimmable lesions and conditions in this category
include, but are not limited to, the definition of trimmable lesion/
condition nonconformances (see Table 1). A 300-bird test is conducted
on-line at the reinspection collection site at the end of the slaughter
process. The test follows the same random schedule selected for FPS
category testing and is conducted immediately following the FPS 10-bird
test. Zero tolerance for trimmable lesion/condition nonconformances is
met through testing and actions independent of the other FPS
nonconformance categories. Trimmable lesions and conditions detected on
carcasses through the FPS 10-bird test are removed before carcasses are
returned to product flow. All product identified through the 300-bird
on-line test as having trimmable lesions or conditions is retained,
reworked, and retested before proceeding into commerce.
(i) Actions to be taken when the process is in control. When no
trimmable lesions or conditions are found on the 300-bird on-line test,
the process is judged in control.
(A) Establishment actions. The establishment shall:
(1) Randomly select and record subgroup sampling times for each
production unit of time before product reaches the reinspection station
on each production line. In no case shall a test represent more than 1
hour of production.
(2) Conduct 300-bird on-line test at random selected time on each
poultry slaughter line. Record the test results. If no trimmable
lesion/condition is detected, continue the random scheduled time 300-
bird on-line testing.
(B) Inspector actions. The inspector shall:
(1) Select random times for 300-bird on-line tests for a minimum of
each half-shift on each evisceration line. In establishments that have
multiple evisceration lines on a production shift, monitor all lines of
product at the random times.
(2) Conduct the 300-bird on-line test at random selected time on
each poultry slaughter line. Record the test results. If no trimmable
lesion/condition is detected, conduct the next 300-bird on-line test at
random scheduled time.
(3) If either establishment or inspection monitoring finds a
trimmable lesion/condition during a 300-bird on-line test, the process
is judged out of control.
(ii) Actions to be taken when the process is out of control. When
any trimmable lesions or conditions are found on the 300-bird on-line
test, the process is judged out of control.
(A) Establishment actions. The establishment shall:
(1) Immediately identify subsequent product for rework.
(2) Immediately notify the inspector in charge of trimmable lesion/
condition.
(3) Record specific process corrective actions taken for the
trimmable lesion/condition category on the test sheet.
(4) Suspend random time testing for the trimmable lesion/condition
category.
(5) Conduct additional 300-bird on-line tests after the final wash
to determine the adequacy of process corrective actions.
(6) After a 300-bird on-line test is free of any trimmable lesion/
condition:
(i) Identify product that will mark the end of the rework action.
(ii) Resume random time 300-bird on-line testing as set forth in
actions to be taken when the process is in control.
(B) Inspector actions. The inspector shall monitor product and the
effectiveness of process corrective actions by making spot-check
observations to ensure that all program requirements are met.
(iii) Off-line rework of product. (A) When the product has been
identified as having been produced when the process was not in control,
off-line product corrective actions must take place. All corrective
actions such as identifying affected product, segregating product, and
maintaining control through rework actions are the establishment's
responsibility.
(B) The inspector shall spot check the establishment's
identification, segregation, and control of reworked product to ensure
that program requirements are met. If the establishment fails in its
responsibilities, the inspector shall identify, segregate, and retain
affected product to prevent adulterated product from reaching
consumers.
(C) Reworked product must be tested by the establishment with a
randomly selected subgroup test of the accumulated reworked lot. Before
product is released, the subgroup test must be free of any trimmable
lesion/condition. If the subgroup test of the reworked lot detects a
trimmable lesion/condition, the lot must be reworked again before
another subgroup test is conducted. The following actions are required.
(1) Establishment actions. The establishment shall:
(i) Select a subgroup sample from throughout the lot only after the
total lot has been reworked.
(ii) Conduct the rework subgroup test.
(iii) Release the lot if no trimmable lesion/condition is found in
the reworked lot.
(iv) Identify and control the lot to be reworked again if any
trimmable lesion/condition is found in the reworked lot.
(2) Inspector actions. The inspector shall monitor product and the
effectiveness of process corrective actions by making spot-check
observations to ensure that all program requirements are met.
Table 1--Finished Product Standards Definitions of Nonconformances
1 Bruises \1/2\''
--Blood clumps or clots in the superficial layers of tissue, skin,
muscle or loose subcutaneous tissue may be slit and the blood
completely washed out. When the bruise extends into the deeper layers
of muscle, the affected tissue must be removed. Very small bruises less
than \1/2\'' (dime size) and areas showing only slight reddening need
not be counted as defects.
--Black/green bruises are bruises that have changed from red to a
black/blue or green color due to age.
--Factor is one.
--A maximum of three incidents per carcass.
Breast Blister
--Inflammatory tissue, fluid, or pus between the skin and keel must be
trimmed if membrane ``slips'' or if firm nodule is greater than \1/2\''
in diameter (dime size).
--Factor is one.
--A maximum of one incident per carcass.
Sores, Scabs, Etc.
--Any defects such as sores, abscesses, scabs, wounds, dermatitis.
--Factor is one.
--A maximum of three incidents per carcass.
Untrimmed Short Hocks
--Factor is one.
--A maximum of two incidents per carcass.
2 Hair >\1/4\'' 26 or more
--Hair which is one-fourth inch long or longer measured from the top of
the follicle to the end of the hair. 26 or more hairs equal one
incident.
--Factor is one.
--A maximum of one incident per carcass.
Feathers and/or Pinfeathers
--Attached feathers or protruding pinfeathers. Scored 1 to 5 per
carcass as one incident, 5 to 10 per carcass as two incidents, and 11
or more as three incidents.
--Factor is one.
--A maximum of three incidents per carcass.
Long Shank--Both Condyles Covered
--Factor is one.
--A maximum of two incidents per carcass.
3 Compound Fracture
--Any bone fracture (i.e., leg, wing, or wingtip) that has caused an
opening through the skin. May be accompanied with a bruise, but not
always. Do not count the bruise in line 3 if it is associated with the
compound fracture.
--Factor is one.
--A maximum of three incidents per carcass.
Note: Bruises not associated with the fracture should be
recorded in the appropriate lines.
External Mutilation
--Mutilation to the skin and/or muscle that is caused by the slaughter,
dressing, or eviscerating processes. Skinned elbows (bucked wings) do
not require trim unless affected wing joint capsule is also opened.
--Factor is one.
--A maximum of three incidents per carcass.
4 Oil Glands Remnant or Whole
--Recognizable fragment(s) up to a whole of one or both oil glands
equals one incident.
--Factor is one.
--Maximum of one incident per carcass.
5 Intestine
--Any identifiable portion of the terminal portion of the intestinal
tract with a lumen (closed circle) present, or split piece of intestine
large enough to be closed to form a lumen.
--Factor is one.
--A maximum of one incident per carcass.
Cloaca
--Any identifiable portion of the terminal portion of the intestinal
tract with mucosal lining.
--Factor is one.
--A maximum of one incident per carcass.
Bursa of Fabricius
--A whole rosebud, or identifiable portion with two or more mucosal
folds.
--Factor is one.
--A maximum of one incident per carcass.
6 Lung
--Any portion of a lung equals one incident.
--Factor is one.
--A maximum of one incident per carcass.
7 Esophagus
--Any portion of the esophagus with identifiable mucosal lining.
--Factor is one.
--A maximum of one incident per carcass.
Crop
--Any portion of the crop that includes the mucosal lining or any
complete crop.
--Factor is one.
--A maximum of one incident per carcass.
Trachea
--Identifiable portion of trachea.
--Factor is one.
--A maximum of one incident per carcass.
8 Extraneous Material
--Include any specks, tiny smears, or stains of material that measure
\1/16\'' or less in the greatest dimension.
Examples: Ingesta, unattached feathers, grease, and bile
remnants, and/or whole gall bladder or spleen, embryonic yolk, etc.
--Factor is one.
--1 to 5 = 1 defect; 6 to 10 = 2 defects; 11 or more = 3 defects. A
maximum of three incidents per carcass.
Extraneous Material >\1/16\''
--The same material as Extraneous material <\1 6\''="" but="" measuring="">\1/
16\'' in the longest dimension.
--Any occurrence equals one incident.
--Factor is one.
--A maximum of three incidents per carcass.
9 Trimmable Lesions/Condition
--A trimmable tumor or identifiable portion of a tumor on any part of
the carcass.
--Trimmable synovitis/airsacculitis (saddle/frog) lesions that have not
been removed.
--Lesion/condition subject to removal following an approved cleanout
process.
Examples: Salpingitis, nephritis, spleen, or liver conditions
requiring removal of the kidneys.
--All kidneys from mature poultry.
Note: All establishments shall develop and maintain a permanent
marking system that identifies carcasses with removable lesions/
conditions on the inside surfaces. When removable lesions/conditions
are identified inside the carcass by the establishment sorter, the
sorter will apply the permanent mark. When removable inside lesions/
conditions are found on a subgroup sample without the permanent
mark, the error is not recorded. The affected carcass(es) will be
hung back for IIC disposition and corrective action.
Table 2--Finished Product Standards Limits
Tolerance number (T)............................................. 25
Action number.................................................... 10
Start number..................................................... 5
(i) Partial quality control program. (1) Any owner or operator of
an official establishment preparing poultry products who wishes to
operate under an approved PQC program must submit to the Administrator
a partial quality control program designed to assure that poultry is
wholesome and properly prepared and shall request a determination as to
whether or not that program is adequate to result in product being in
compliance with the requirements of the Act and therefore qualify for
the higher inspection rates specified in Sec. 381.67.
(2) The approved quality control program for the establishment
shall include control points on the line, which shall be monitored by
the inspector.
(3) Establishment quality control employees shall operate the
poultry carcass on-line quality control program and shall make
immediately available to inspection personnel any and all data
collected and maintained under the approved partial quality control
program.
(4) An inspector shall monitor the establishment's application of
the poultry carcass on-line quality control program and shall take
corrective action when he or she determines that the establishment has
failed to maintain or correct its process as described in the approved
quality control program.
(5) The application, evaluation, and termination procedures for a
PQC program are prescribed in Sec. 381.145. If approval of the PQC
program has been terminated in accordance with the provisions of
Sec. 381.145(g), an application and request for approval of the same or
modified quality control program will not be evaluated by the
Administrator for at least 2 months from the termination date. In order
for the Department to provide the Federal inspection required under the
Act, an establishment whose PQC program has been terminated will be
allowed to continue operating at maximum inspection rates for
establishments without PQC programs as prescribed in Sec. 381.67,
provided all requirements of the Act and regulations thereunder are
met.
7. Section 381.91 would be amended by revising the last sentence of
paragraph (b)(1), by redesignating paragraph (b)(2) as paragraph
(b)(3), and by adding a new paragraph (b)(2) to read as follows:
Sec. 381.91 Contamination.
* * * * *
(b)(1) * * * All visible specks of contamination must be removed,
and, if the inner surfaces are reprocessed other than solely by
trimming, all surfaces of the carcass shall be treated with chlorinated
water containing 20 ppm available chlorine or with any compound that is
approved for poultry processing by the Food and Drug Administration and
listed in title 21 of the Code of Federal Regulations, chapter I.
(2) When reprocessing carcasses, the establishment shall:
(i) Identify all reprocessed carcasses by lot in a manner
acceptable to the inspector in charge,
(ii) Return each reprocessed lot to the processing line at a
location after viscera harvest and before the on-line/off-line carcass
inspector for reinspection, and
(iii) Comply with the general chilling time and temperature
requirements prescribed in Sec. 381.66(b)(2).
* * * * *
Done at Washington, DC, on July 7, 1994.
Patricia A. Jensen,
Acting Assistant Secretary, Marketing and Inspection Service.
[FR Doc. 94-16817 Filed 7-11-94; 8:45 am]
BILLING CODE 3410-DM-M
