Enhanced Poultry Inspection

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\

---------------------------------------------------------------------------

\1\Study conducted by USDA, FSIS, Science and Technology. The

study is available for review at the Hearing Clerk's Office.

---------------------------------------------------------------------------

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\

---------------------------------------------------------------------------

\2\Study conducted by USDA, FSIS, Science and Technology. A copy

of this study is available in the office of the FSIS Hearing Clerk.

---------------------------------------------------------------------------

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\

---------------------------------------------------------------------------

\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.

---------------------------------------------------------------------------

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.

---------------------------------------------------------------------------

\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\

---------------------------------------------------------------------------

\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\

---------------------------------------------------------------------------

\7\Study conducted by the Rhone-Poulenc Company. The study is

available for review at the Hearing Clerk's Office.

---------------------------------------------------------------------------

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\

---------------------------------------------------------------------------

\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\

---------------------------------------------------------------------------

\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.

---------------------------------------------------------------------------

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\

---------------------------------------------------------------------------

\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

---------------------------------------------------------------------------

\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

---------------------------------------------------------------------------

\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.

---------------------------------------------------------------------------

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.

---------------------------------------------------------------------------

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\

---------------------------------------------------------------------------

\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.

---------------------------------------------------------------------------

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\

---------------------------------------------------------------------------

\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.

---------------------------------------------------------------------------

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.

---------------------------------------------------------------------------

\22\Agriculture Outlook, Economic Research Service, USDA, AO-198

(July 1993), pp. 33-36.

---------------------------------------------------------------------------

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/

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