[Federal Register Volume 62, Number 92 (Tuesday, May 13, 1997)]
[Rules and Regulations]
[Pages 26211-26219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12397]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 308, 310, 381, and 416

[Docket No. 93-016T]
RIN 0583-AC28


Pathogen Reduction; Hazard Analysis and Critical Control Point 
(HACCP) Systems; Technical Corrections and Amendments

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: FSIS is making technical corrections and amendments to the 
final rule, ``Pathogen Reduction; Hazard Analysis and Critical Control 
Point (HACCP) Systems,'' published on July 25, 1996. This document 
responds to technical and scientific questions raised in the final rule 
regarding E. coli testing and to issues discussed at the ``Technical 
Conference Regarding E. coli Verification Testing,'' the ``Pathogen 
Reduction/HACCP National Implementation Conference,'' and the 
``Regional Implementation Conferences.'' Also, this document clarifies 
ambiguities brought to FSIS' attention and provides guidance on various 
technical issues. Additionally, this document corrects inadvertent 
omissions and addresses minor editorial oversights.

EFFECTIVE DATE: June 12, 1997.

ADDRESSES: Reference materials cited in this docket will be available 
for public inspection in the FSIS Docket Room, Room 3806, 1400 
Independence Ave SW, Washington, DC 20250 from 8:30 a.m. to 1:00 p.m. 
and from 2:00 p.m. to 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Ms. Patricia Stolfa, Assistant Deputy 
Administrator, Office of Policy, Program Development and Evaluation, 
(202) 205-0699.

SUPPLEMENTARY INFORMATION:

Background

    On July 25, 1996, FSIS published a final rule, ``Pathogen 
Reduction; Hazard Analysis and Critical Control Point (HACCP) 
Systems,'' (61 FR 38806). The new regulations (1) require that each 
establishment develop, implement, and maintain written sanitation 
standard operating procedures (Sanitation SOP's); (2) require regular 
microbial testing for generic E. coli by slaughter establishments to 
verify the adequacy of the establishments' process controls for the 
prevention and removal of fecal contamination and associated bacteria; 
(3) establish pathogen reduction performance standards for Salmonella 
that slaughter establishments and establishments producing raw ground 
products must meet; and (4) require that all meat and poultry 
establishments develop and implement a system of preventive controls 
designed to improve the safety of their products, known as HACCP 
(Hazard Analysis and Critical Control Points).
    With respect to the generic E. coli testing requirement, a number 
of questions were posed in the final rule, especially about how the 
requirement would be applied and what testing results might indicate in 
establishments that slaughter livestock.
    Responses to those questions were received through written 
comments; through presentations and discussions at a public meeting 
convened by FSIS on September 12-13, 1996, specifically to discuss the 
generic E. coli testing requirement; at a national implementation 
conference in Washington, DC, September 30--October 3, 1996; and six 
subsequent regional implementation conferences occurring on October 15, 
17, 22, 24, November 7 and 13, 1996, and at numerous briefings 
presented by FSIS representatives to a variety of audiences. 
Additionally, FSIS held the conference, ``Sanitation Standard Operating 
Procedures (Sanitation SOP's) and E. coli Testing Requirements,'' on 
January 23, 1997.
    Through these comments and meetings, a number of technical 
questions have arisen which indicate the need for further 
clarification. Some of these have required a change in the

[[Page 26212]]

regulation; others simply require further technical guidance.

Technical Amendments

Sanitation Standard Operating Procedures

    Questions were raised at the public meetings about the corrective 
actions an establishment might take in response to Sanitation SOP 
failures. Commenters suggested that the Agency make it clear that, in 
certain cases, improving the execution of the existing Sanitation 
SOP's, instead of revising the Sanitation SOP's, would be appropriate 
corrective action. In response to this concern, FSIS is amending 
section 416.15(b) to clarify that satisfactory corrective actions can 
include appropriate improvements in the execution of Sanitation SOP's.

Applicability of E coli Testing Requirement

Species Required to be Sampled and Tested for E. coli
    At the E. coli meeting, implementation conferences, and other 
briefings, numerous questions were raised about the applicability of 
the generic E. coli testing requirement. There were questions about 
whether generic E. coli testing was required for all types of 
livestock, i.e., cattle, sheep, swine, goats, horses, mules and other 
equines (9 CFR 301.2). There were questions about whether generic E. 
coli testing was required for all types of poultry, i.e., chickens, 
turkeys, ducks, geese and guineas. There were also questions about 
whether generic E. coli testing was required for all market classes of 
livestock and poultry.
    Clarification is needed because of inconsistencies in terminology 
used in the preamble and the regulatory text. For example, the preamble 
states that ``establishments that slaughter livestock or poultry will 
be required to begin sampling and testing for E. coli''(61 FR 38844). 
This statement is inconsistent with section 310.25 of the regulations 
which refers only to ``cattle and/or hogs'' and subsequently ``swine'' 
and ``market hogs.'' This inconsistency also makes it necessary to 
amend the regulations to clarify that all market classes of cattle, 
swine, chickens, and turkeys must sample and test for generic E. coli.
    FSIS intends that all establishments slaughtering livestock and 
poultry sample and test for generic E. coli. However, the regulatory 
requirement codified in section 310.25(a)(1) is limited to cattle and 
swine. FSIS will propose rules in the future to carry out its goal of 
applying the generic E. coli testing requirement to other types of 
livestock, such as sheep, goats, and equines. Until that rulemaking is 
completed, only cattle and swine are required to be sampled and tested 
for generic E. coli (9 CFR 310.25(a)(1)).
    With regard to poultry, the preamble of the final rule states that 
minor species, such as ducks, geese, and guineas, would be addressed at 
a later date. The rulemaking proposal to extend the E. coli testing 
requirement to all types of livestock will also propose extending the 
requirement to all types of poultry. However, until that rulemaking is 
completed, only chickens and turkeys are required to be sampled and 
tested for generic E. coli (9 CFR 381.94(a)).
    At this time, FSIS is making technical amendments to ensure that 
the terminology in sections 310.25 and 381.94 of the regulations 
applicable to generic E. coli testing is consistent with other FSIS 
regulations promulgated under the Federal Meat Inspection Act and the 
Poultry Products Inspection Act.
    Therefore, in section 325.10(a)(1), the phrase ``cattle and/or 
hogs'' will be replaced with the phrase ``cattle and/or swine.'' In 
section 310.25(a)(2)(iii), ``Sampling frequency,'' the word ``Cattle'' 
will replace the word ``Bovines.'' In section 310.25(a)(2)(v)(A) the 
word ``cattle'' will replace the word ``bovines.'' In section 
310.25(a)(5), Table 1, the phrase ``type of livestock'' will replace 
the phrase ``slaughter class;'' the ``Steers/heifers'' and ``Cows/
bulls'' lines will become a single ``Cattle'' line having the lower 
limit, upper limit, number of samples and maximum number of marginal 
now permitted in both these slaughter classes; and ``Market hogs,'' 
will be redesignated as ``Swine.'' In section 381.94(a)(5), Table 1, 
the phrase ``slaughter class'' will be replaced with ``type of 
poultry,'' and the term ``broilers'' will be replaced by ``chickens.''
    These terminology changes also will clarify that all market classes 
of cattle or swine are categorized as ``cattle'' or ``swine,'' and that 
all market classes of chickens and turkey are categorized as 
``chickens'' or ``turkeys.''
Testing Requirements for Market Classes
    Commenters and questioners also expressed confusion and sought 
clarification about the applicability of the generic E. coli testing 
requirement when no specific m/M criteria are available. They assumed 
that if FSIS has not performed baseline studies and established m/M 
criteria for evaluation of results, the requirement would not apply. 
Commenters and questioners expressed their expectations that FSIS would 
perform baseline studies for a large variety of market classes of 
livestock and poultry, such as spent hens, sows and boars, calves, as 
well as numerous types of livestock and poultry that are slaughtered, 
dressed or chilled by non-traditional methods. At virtually every 
public meeting where generic E. coli testing was discussed, 
participants identified new livestock or poultry categories for 
baseline data collection.
    All market classes of cattle, swine, chickens and turkeys must be 
sampled and tested for generic E. coli. FSIS's initial baseline studies 
were conducted on separate market classes of cattle, swine, and 
chickens. In future baseline studies, the Agency will sample from all 
market classes of a type of livestock or poultry to develop m/M 
criteria representative of that type of livestock or poultry. The 
baseline study being developed for turkeys includes samples from all 
market classes.
    FSIS considered whether the m/M criteria for broilers could be 
applied to all market classes of chickens, such as, fowl, heavy 
broilers, and rock Cornish hens. FSIS determined that this would be 
acceptable for three reasons:
    1. The processing parameters likely to affect levels of generic E. 
coli on carcasses, such as the use of automatic eviscerating equipment 
and common bath chillers, the permitted levels of chlorine in poultry 
processing waters, and the likely handling during processing were 
essentially the same for all market classes of chickens.
    2. The m/M levels of generic E. coli on chickens are expressed as 
CFUs/ml, rather than total CFUs per carcass, and the actual values at 
the 80th and 98th percentile have been rounded to the nearest whole log 
10; both of these practices have the effect of minimizing 
variability and normalizing values.
    3. Broilers constitute the vast majority (94%) of chickens 
slaughtered in the United States. An alternative to using the broiler 
criteria for all chickens would be to conduct a baseline that includes 
all market classes. However, the preponderance of broiler results will 
mean that other market classes are highly unlikely to affect the 
criteria.
    These factors, taken together, mean that it would take very large 
differences among market classes to necessitate a change in the 
criteria found in the regulations. Accordingly, no amendment is being 
made and the criteria published in the July final rule will be 
applicable to all market classes of chickens.
    FSIS expects that cattle and swine establishments will collect 
samples by sponging carcasses. If so, they will evaluate tests by the 
use of statistical process control, discussed below, and

[[Page 26213]]

the published m/M criteria in the regulations do not apply. FSIS will 
sample all market classes of either cattle or swine in its baseline 
studies to develop m/M criteria for samples collected by sponging 
carcasses.
    Cattle and swine establishments collecting samples by excising 
tissue from carcasses will use the published m/M criteria. In the 
regulations the m/M criteria for the market classes cows/bulls and 
steers/heifers are the same. FSIS contends that these m/M criteria are 
applicable for other market classes of cattle because of the similarity 
in processing parameters and the methodology used to develop the m/M 
criteria. FSIS also believes that the m/M criteria for market hogs are 
applicable to other market classes of swine for the same general 
reasons. Therefore, the published m/M criteria apply to all market 
classes of cattle and swine.
    While FSIS baseline surveys provide an appropriate national data 
base for establishment of m/M criteria, microbiological data bases with 
comparable accuracy and utility can be developed outside of FSIS. FSIS 
encourages industry members, academia, and other groups to work with 
the Agency to develop protocols for independent databases against which 
the 80th and 98th percentile definitions can be applied. In 
consultation with industry and consumer groups, FSIS may propose to 
publish these m/M values as criteria for evaluating results.
    FSIS is still in the process of developing its long-term plan for 
baseline data collection studies. The plan will identify the types of 
livestock and poultry to be included in future baseline data collection 
efforts. Tentatively, the Agency has determined that types of livestock 
and poultry identified in the regulatory definitions are top priority 
candidates for FSIS baseline studies. For livestock, FSIS is 
considering developing baseline data collection studies for sheep, 
goats, and equines. For poultry, FSIS is conducting a baseline study 
for turkeys and is considering baseline data collection for ducks and 
geese. Representatives of State inspection programs and others have 
raised questions about FSIS intentions for baseline data collection on 
the voluntarily-inspected species, such as rabbits and ratites. FSIS 
will consider these requests for baseline data in developing its long-
term plan.
Use of Statistical Process Control
    The current m/M criteria apply to all classes of chickens, and to 
cattle and swine samples collected by excising tissue from carcasses. 
The m/M criteria for turkeys are still being developed. At this time, 
cattle and swine establishments collecting samples by sponging and 
turkey establishments will use statistical process control techniques 
to evaluate E. coli test results.
    Statistical process control techniques are based on the principle 
that every product is produced by a process. All processes are subject 
to variation, which can be understood and controlled by statistical 
methods. A process that is in control is stable in terms of average 
level and degree of variation, i.e., it is predictable within limits 
and is ``doing its best.'' Control is attained, often by degrees, by 
detecting and eliminating special causes of variation, that is, causes 
not present at all times or not affecting all product output. 
Statistical process control initially involves evaluating data to 
determine process capability (the typical process performance level), 
then checking subsequent data to see whether they are consistent with 
this baseline level to ensure the process is in control and variations 
are within normal and acceptable limits. This is accomplished by 
checking for unreasonably high results, trends, etc., and looking for 
and correcting problems in the process when the signals occur.
    Specific techniques of statistical process control include time 
plots, which chart measurements over time. This is the first technique 
to use with data collected over time and analyzed for patterns. Another 
technique is the control chart, which plots data over time but also 
displays an upper control limit for specific measurements, and a 
centerline, above and below which is an equal number of sample results. 
The centerline is in effect a median average. A sample result above the 
upper control limit would indicate the likely presence of a special 
cause of variation that needs to be addressed. Results within control 
limits indicate that the process is in control. Control charts are used 
for after-the-fact analysis of process performance and to assist in 
gaining and maintaining control of a process. In most situations more 
than one type of control chart is applicable. More detailed information 
on time charts and control charts can be found in texts on statistical 
process control, under the topic ``control charts.''
    FSIS has concluded that statistical process control techniques will 
provide experience in ``process thinking'' (a central tenet of HACCP), 
develop an historical record of performance, and permit evaluation of 
the long-term stability of a process and determination of process 
capability (that is, how the process is actually working), and track 
the effectiveness of process improvement actions.
    FSIS emphasizes that the value of microbiological testing is not 
negated by the lack of national m and M criteria against which to 
evaluate results. E. coli testing is intended to provide verification 
of process control for fecal contamination within individual 
establishments. While there is utility in being able to compare 
individual establishment data with national norms (i.e., national m and 
M criteria), the intent of the rule is to have microbial testing 
integrated into the overall process control procedure that 
establishments are implementing. In this context, establishment-
specific databases, developed as establishments begin microbial 
testing, are also of value to individual establishments as a means of 
verifying their process control procedures.
    FSIS is amending section 310.25 of the regulations to require 
establishments slaughtering cattle or swine to use either a three-site 
sponging or a three-site excision sample collection technique. This 
amendment to the meat regulations is necessary because of the inability 
to develop a conversion factor for results derived from two or three-
site sample collection by sponging which correlates to the m/M criteria 
developed based on excision sampling methods used in conducting the 
baseline studies. If sponging is chosen, results must be evaluated 
using statistical process control techniques, because the m/M criteria 
derived from the baseline studies have not been validated for sample 
collection using sponging. If an establishment chooses to use the 
excision sample collection technique, results will be evaluated against 
national norms as expressed in the m/M criteria drawn from baseline 
studies. FSIS intends to give high priority in its baseline plan to 
collecting data that will support establishing m/M criteria using 
sponge sample collection techniques.
    FSIS also is amending section 381.94 of the regulations to require 
turkey establishments to evaluate results using statistical process 
control techniques. This amendment is necessary because FSIS has not 
completed the development of m/M criteria for turkeys.
    Establishments evaluating test results using statistical process 
control techniques will be subject to the regulatory provisions for 
failure to test and record (9 CFR 310.25(a)(7) and 381.94(a)(7)). Such 
establishments will not be subject to the regulatory provisions for the 
failure to meet criteria (9 CFR 310.25(a)(6) and 381.94(a)(6))

[[Page 26214]]

until such time as m/M criteria are developed and added to the 
regulations. The Agency intends to establish m/M criteria for each type 
of livestock and poultry based on national norms. Therefore, the 
requirements to utilize statistical process control techniques is 
temporary.

Sampling Frequencies

    There are three amendments related to the following topics: (1) The 
requirement that establishments sample at the greater of one sample per 
week or the published frequency for each type of livestock or bird; (2) 
the requirement that all establishments are required to sample only the 
type of livestock or poultry which they slaughter in the largest 
number; (3) adjustments to sampling directions for very low volume 
establishments that do not operate each week or operate on a seasonal 
basis. Each of these three amendments is discussed below.

Sampling Frequencies For Very Low Volume Establishments

    The final rule states that very low volume establishments ``shall 
collect one sample per week starting the first full week of June and 
continuing through August of each year.'' FSIS is aware that some very 
low volume establishments do not operate every week or operate only 
seasonally. Therefore, this requirement is amended to provide 
flexibility and accommodate all very low volume establishments. The 
revised regulations require that very low volume establishments begin 
sampling the first full week they operate after June 1 and continue 
collecting one sample per week in each week they operate until they 
have met their sampling requirement.
    As discussed in the final rule, FSIS requires slaughter 
establishments to record and evaluate E. coli results in a ``moving 
window'' of 13 consecutive results, and the Agency is permitting very 
low volume establishments to conduct as few as 13 tests per year, in 
part because of their relatively simple and stable production 
environments.
    If there are published m/M criteria for the type of livestock or 
poultry a very low volume establishment slaughters in the largest 
number, the establishment must sample that type of livestock or poultry 
at a minimum frequency of once per week until a series of 13 tests has 
met those m/M criteria.
    If there are no m/M criteria for the type of livestock or poultry 
slaughtered in the largest number, a very low volume establishment must 
sample a minimum of once per week until 13 samples are collected. If 
the establishment does not slaughter their primary type of livestock or 
poultry for 13 weeks per year, the establishment must still collect one 
sample each week in which they conduct those slaughter operations. This 
provision will be eliminated once m/M criteria are developed for the 
type of livestock or poultry that is slaughtered in the greatest 
number.

One Type per Establishment

    The final rule states that if a very low volume establishment 
slaughters multiple types of livestock or poultry, the establishment 
shall collect samples from the type it slaughters in the largest 
number. FSIS intended that this provision apply to all establishments. 
However, because of an inadvertent omission, this language was not 
incorporated into the regulatory text for all establishments. 
Therefore, FSIS is amending the regulations so that each slaughter 
establishment, regardless of size, conducts generic E. coli testing on 
the type of livestock or poultry that it slaughters in the largest 
number.
    The purpose of the testing is not lot acceptance, but rather to 
provide each establishment with a microbial indication of how effective 
its sanitary dressing procedures are in preventing contamination of 
carcasses by fecal material, ingesta, and associated bacteria. The 
preamble stated that the required testing and criteria are intended to 
provide an initial basis for slaughter establishments and FSIS to begin 
using microbial testing to evaluate the adequacy of process control. To 
meet this regulatory objective, it is not necessary that all slaughter 
types be sampled. Whether the establishment slaughters one type or 
multiple types, E. coli test results provide information that 
establishments can use to verify their process controls over sanitary 
dressing.

Minimum Sampling Frequencies

    The preamble to the final rule stated that establishments, except 
for very low volume establishments, must test at the frequencies 
established in the regulations or at a minimum of at least once per 
week. This weekly minimum requirement was inadvertently not 
incorporated into the regulatory language for other than very low 
volume establishments. These technical amendments add the once per week 
minimum to the regulatory language. Under this amendment, an 
establishment slaughtering 9,000 cattle and sampling at the once per 
week minimum shall collect 52 samples, rather than 30, as required by 1 
test per 300. Obviously, the minimum of 52 assumes the establishment 
slaughters cattle each week during the year.

Sampling Sites

    Two specific questions raised in the final rule with respect to the 
technical specifications of the generic E. coli testing requirement for 
cattle and swine carcasses addressed the issue of sample sites on 
carcasses. The questions were: ``[a]re there more appropriate 
anatomical sites for microbial testing than those adopted?'' and 
``[a]re there worker safety concerns regarding sampling from difficult 
to reach carcass sites, and how can they be mitigated?''
    The final reports, ``Analysis of ARS Baseline and Sponge Data'' and 
``FSIS Comparison of Baseline Excision and Two-Site Sponge Method,'' 
describe results of data collection efforts by ARS and FSIS in cattle 
and swine establishments to compare sponge and baseline excision 
sampling methods and to seek conversion factors that would make sponge 
results comparable to baseline results. The baseline excision method 
for each slaughter class was defined in the protocol for the baseline 
study and specified the sites to sample, the area of tissue to analyze, 
and the amount of buffer to add to the tissue.
    The final rule specified sampling cattle and swine with a sponge 
from the same three sites from which FSIS collected excision samples in 
baseline studies. During the comment period, industry representatives 
expressed concerns over inefficiencies and safety hazards associated 
with sampling the rump of cattle and the ham of swine. During 
preparation of the final rule, FSIS initiated a data collection effort 
by ARS to evaluate sponge methods with one or three sites, and to seek 
conversion factors that would make sponge results comparable to 
baseline results and to the m/M values derived therefrom. In response 
to the comments on the 3-site sponge method, the Agency conducted 
further data collection to compare a 2-site sponge method with the 
baseline method.
    ARS compared the baseline method with the final rule's three-site 
sponge method and with a one-site sponge method, the one site being 
flank for cattle and belly for swine. They collected data on a total of 
280 carcasses in one cattle establishment and one swine establishment 
and presented summaries of their results at the September 12-13, 1996, 
FSIS E. coli conference. FSIS later performed further statistical 
analyses on the results in response to comments at the conference. The 
results of these analyses are described in detail in the reports, and 
summarized here.

[[Page 26215]]

    Because the lowest detectable levels (LDLs) of the sponge methods 
were well below the LDL of the baseline method, the sponge methods were 
expected to find more E. coli positives than the baseline method. The 
three-site sponge resulted in more E. coli positives than the baseline 
method for both cattle and swine. However, whereas the one-site sponge 
method found more E. coli positives for cattle, it gave less for swine 
(i.e., the difference in sites appeared to affect the prevalences found 
by the two sponge methods).
    Since the two-site sponge method had not been included in the ARS 
study, FSIS undertook comparison of this sampling method with the 
baseline method. The Agency collected data on a total of 825 carcasses 
in three cattle establishments and four swine establishments. Results 
of this effort are presented in detail in the reports and are 
summarized here.
    Once again, the sponge method was expected to result in more E. 
coli positives than the baseline method because of its lower LDL, and 
it did for all three cattle establishments sampled. However, sponging 
resulted in considerably fewer E. coli positives than the baseline 
method in three of the four swine establishments. One establishment, 
however, had 100 percent E. coli prevalence by both the two-site sponge 
and the baseline methods. That establishment also had higher levels of 
E. coli than the other swine establishments.
    In addition to the qualitative comparison of sponge and baseline 
methods in terms of prevalence, FSIS also evaluated sponge results 
quantitatively in terms of recovery of bacteria relative to the 
baseline method. It was evident from the results that the sponge 
methods generally gave lower average microbial counts than the baseline 
method.
    Where possible given the available data, FSIS evaluated recovery by 
two alternate methods suggested at the E. coli conference. However, 
there were several difficulties with getting reasonable estimates of 
recovery. First, numerous negative baseline results left recovery 
undefined for many carcasses. Second, the two recommended methods of 
defining recovery gave seriously different recovery values. Third, the 
sponge method gave appreciably more negative results for swine than the 
baseline method. All of these difficulties caused FSIS to abandon the 
effort to find a conversion factor.
    In view of these findings, FSIS has determined that, at the present 
time, the third sampling site is necessary. If data can be developed 
that support a change to fewer, more accessible sampling sites, the 
Agency is very willing to consider them. In addition, as described 
above, livestock slaughtering establishments that want to relate their 
results to national norms may use the excision technique and the m/M 
criteria associated with the baseline studies.

Sampling Locations

    Sampling location in the process is a factor for comparability of 
an establishment's results with the criteria derived from baseline 
studies. Establishments that slaughter, dress or chill types of 
livestock or poultry by using non-traditional methods, such as hot 
boning of swine and poultry and chilling of split turkey carcasses, may 
not be able to collect samples at the exact location in the slaughter 
process as was used in the baseline studies. FSIS is amending section 
310.25(a)(2)(ii) to provide for sample collection after final wash, if 
sampling chilled carcasses is not possible. Similarly, FSIS is amending 
section 381.194(a)(2)(ii) to provide for sample collection after the 
final wash, if sampling at the end of the drip line is not possible.
    Additionally, questions have arisen about whether random carcass 
sampling can only occur when carcasses are in the cooler. It is not 
FSIS's intention to limit random carcass sample selection in the 
cooler. The random sampling can be carried out before carcasses enter 
the cooler so that carcasses selected for sampling can be placed in a 
separate and convenient location in the cooler. The regulations require 
establishments to include in their written procedures how sampling 
randomness will be achieved (section 310.25(a)(2)(i)).

Technical Guidance

    This section provides technical guidance for the following areas: 
(1) definition of very low volume slaughter establishment; (2) counting 
employees to determine establishment size for HACCP implementation; (3) 
FSIS intentions on rules of practice.

Very Low Volume Slaughter Establishments

    The regulations define very low volume establishments for cattle, 
swine, chickens, and turkeys. These definitions are expressed in terms 
of the number of animals or birds slaughtered annually. Establishments 
should use 1996 slaughter data to determine whether they meet the 
definition. Livestock and poultry slaughtered under the custom 
exemption need not be counted.

Size Categories For HACCP Implementation

    For purposes of determining whether an establishment is large, 
small, or very small, FSIS has established the following guidelines for 
counting employees. These guidelines combine the Small Business 
Administration procedures for counting employees to determine 
establishment size and the FSIS definition of ``official 
establishment.'' All paid employees who work within the official 
establishment are to be counted, whether full time, part time, or 
temporary. Employees should be counted whether or not they perform 
duties related to inspected products. Employee numbers should be 
averaged over a year.
    One exception to the above guidance covers situations where 
headquarter's employees for firms with multiple establishments are 
located at one official establishment and their assigned duties are 
related to the company and not specifically to the official 
establishment where they are located. Such employees need not be 
counted. In addition, administrative staff, for example, billing and 
bookkeeping staff, working outside the official premises need not be 
counted. Unpaid family members of the owner or operator also need not 
be counted. Large firms that have employees engaged full-time in buying 
or selling products should count such staff even though they usually 
work outside the establishment.
    Establishments are very small if they have fewer than 10 employees 
or annual sales of less than $2.5 million. In calculating annual sales, 
establishments should count all sales of inspected meat and poultry 
products produced at the establishment. Inspected product excludes 
product produced under a retail or custom exemption provision. 
Furthermore, ``Pass Through'' product that is produced in another 
establishment and resold without any further processing need not be 
counted. ``Pass Through'' includes the operation referred to as 
``breaking bulk,'' if this operation involves only separating and 
resorting ``intact'' packages prepared at another establishment.

FSIS Intention Regarding Rules of Practice

    The final rule stated that, upon an establishment's failure to test 
and record, inspection would be suspended in accordance with rules of 
practice that ``will be adopted for such proceedings upon a finding by 
FSIS that one or more provisions of subparagraphs (a) (1)-(4) of this 
section have not been complied

[[Page 26216]]

with and written notice has been provided to the establishment.'' FSIS 
has determined that a separate set of rules of practice for generic E. 
coli testing is not necessary. The Agency does, however, intend to 
review and propose revisions to its rules of practice (9 CFR 335.1 and 
381.230). It plans to complete this process before the first HACCP 
implementation date, January 26, 1998. In the meantime, the Agency will 
use existing rules of practice for enforcement of Sanitation SOP's 
requirements and for enforcement actions when establishments fail to 
test and record results of generic E. coli analysis.

Technical Corrections

    FSIS is making three technical corrections to the final rule. The 
first corrects the inadvertent requirement that custom and retail 
exempt establishments, as defined in section 303.1 of the Federal meat 
inspection regulations, comply with the requirements for Sanitation 
SOP's. These establishments are required to meet general sanitation 
requirements, including those in section 308.3. When FSIS drafted the 
final rule, it amended section 308.3 to ensure that meat and poultry 
establishments not only meet the general sanitation requirements but 
also comply with the regulations in Part 416, which require Sanitation 
SOP's. However, FSIS never intended to require custom and retail exempt 
establishments to comply with Sanitation SOP's. To clarify that point, 
FSIS is amending section 308.3 to include language that explicitly 
exempts these establishments from the part 416 requirements.
    Secondly, FSIS is updating the footnotes in the ``Salmonella 
Performance Standards'' table (Table 2) in section 381.94(b)(1) of the 
poultry products inspection regulations. Footnote ``b'' states that the 
``Broiler'' data was based on partial analysis and was subject to 
confirmation upon publication of the baseline survey. The baseline 
survey is complete and published. There are no changes to the numbers 
related to broilers. FSIS is, therefore, removing footnote ``b.'' Also, 
with the deletion of footnote ``b,'' the footnote designated as ``d'' 
(an editorial oversight omitted a footnote ``c'') will be redesignated 
as footnote ``b.''
    Finally, FSIS is correcting the references in sections 325.10(a)(3) 
and 381.94(a)(3) to the AOAC International by updating the regulatory 
text and a footnote in the regulatory text to reflect the 
organization's new name and the current edition of its publication. 
Also, FSIS is clarifying what establishments must do if they intend to 
have samples analyzed by a method approved by a scientific body other 
than the AOAC International.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been determined to be significant and, 
therefore, has been reviewed by the Office of Management and Budget.
    The Administrator has determined that this final rule will not have 
a significant economic impact on a substantial number of small 
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).
    The Pathogen Reduction/HACCP final rule included a Final Regulatory 
Impact Assessment (FRIA) (61 FR 38945). The technical corrections and 
amendments do not change the cost and benefit estimates and impact 
assessments presented in the FRIA.
    The technical amendments regarding Sanitation SOP's clarify the 
regulatory language to more accurately explain what FSIS intended 
corrective actions to encompass. There is no change in regulatory 
impact or cost of Sanitation SOP's. Similarly, the regulatory 
amendments that change terminology in sections 310.25(a) and 381.94(a) 
do not affect any regulatory requirements.
    The technical amendments regarding statistical process control 
clarify how turkey establishments and livestock establishments 
collecting samples by sponging will analyze test results until m/M 
criteria are developed. This change will not affect the cost estimates.
    In the Preliminary Regulatory Impact Analysis (PRIA) for the 
Pathogen Reduction/HACCP proposed rule, FSIS concluded that for each 
microbiological sample it would take 5 minutes ``* * * to prepare the 
paperwork and review the results of the sample analysis and plot the 
results on a statistical process control chart.'' In the FRIA, the 
Agency used this 5 minute estimate as the time it takes to record a 
window of E. coli test results and compare such results with m/M 
criteria. The Agency still believes that it takes approximately the 
same amount of time to conduct either of these processes.
    FSIS has amended the regulations to clarify how sampling and 
testing must be conducted on hot-boned or hide-on product. These are 
not new requirements.
    The FRIA estimated generic E. coli testing costs using an upper 
bound estimate of 24 dollars per sample. To develop this upper bound 
estimate for E. coli sampling, FSIS examined cost estimates reported in 
the PRIA and current cost estimates for FSIS testing programs. The 
proposed rule required establishments to collect Salmonella samples by 
excising tissue from carcasses, and therefore, the cost estimate 
factored in the time it takes to sample in such a manner. Similarly, 
FSIS samples are collected by excising tissue, and FSIS cost analyses 
of its testing program reflect this fact. Because sponging carcasses 
presumably takes less time to perform than excising tissue from 
carcasses, FSIS is confident that the cost estimates reported in the 
FRIA are upper bound estimates. FSIS expects all establishments to use 
the sponging method because excising tissue takes more time and 
devalues the carcasses. However, because the cost estimates were based 
on excision, establishments choosing to excise tissue should not incur 
costs greater than 24 dollars a sample.
    The three technical amendments relating to sampling frequencies do 
not change the regulatory impact and cost to establishments. In the 
FRIA the Agency based its cost estimates on the assumption that 
establishments would sample at a minimum of 52 times a year. Also, the 
cost estimates assumed that establishments would only sample and test 
the type of livestock or poultry slaughtered in the largest number. 
Lastly, FSIS's analysis assumed that very low volume establishments 
sample and test once per week until the results show that they meet the 
published criteria.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. In this final rule: (1) all state and local laws 
and regulations that are inconsistent with this rule will be preempted; 
(2) no retroactive effect will be given to this rule; and (3) 
administrative proceedings will not be required before parties may file 
suit in court challenging this rule.

Paperwork Requirements

    The Pathogen Reduction/HACCP final rule included a paperwork 
analysis (61 FR 38862) prepared in accordance with the Paperwork 
Reduction Act. FSIS has determined that the technical corrections and 
amendments in this rule do not change any information collection burden 
hours. The paperwork and recordkeeping burden hours were developed 
using the assumptions in the FRIA, discussed above.

Final Rules

List of Subjects

9 CFR Part 308

    Meat inspection.

[[Page 26217]]

9 CFR Part 310

    Meat inspection, Microbial testing.

9 CFR Part 381

    Poultry and poultry products, Microbial testing.

9 CFR Part 416

    Meat inspection, Poultry and poultry products.

    For reasons set forth in this preamble, 9 CFR chapter III is 
amended as follows:

PART 308--SANITATION

    1. The authority citation for part 308 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53

    2. Section 308.3 is amended by revising the last sentence of 
paragraph (a) to read as follows:


Sec. 308.3  Establishments; sanitary conditions; requirements.

    (a) * * * The provisions of part 416 of this chapter apply to all 
establishments, except establishments that are exempt in accordance 
with Sec. 303.1 of this chapter.

PART 310--POST MORTEM INSPECTION

    3. The authority citation for part 310 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    4. Section 310.25 is amended by revising paragraphs (a)(1), 
introductory test (a)(2)(ii),(a)(2)(iii), (a)(2)(v)(A), (a)(3), (a)(4), 
and (a)(5) to read as follows:


Sec. 310.25  Contamination with microorganisms; pathogen reduction 
performance standards for Salmonella.

    (a) * * *
    (1) Each official establishment that slaughters cattle and/or swine 
shall test for Escherichia coli Biotype 1 (E. coli). Establishments 
that slaughter more than one type of livestock or both livestock and 
poultry, shall test the type of livestock or poultry slaughtered in the 
greatest number. The establishment shall:
* * * * *
    (2) Sampling requirements.
    (i) * * *
    (ii) Sample collection. The establishment shall collect samples 
from all chilled swine or cattle carcasses, except those boned before 
chilling (hot-boned), which must be sampled after the final wash. 
Samples shall be collected by either sponging or excising tissue from 
three sites on the selected carcass. On cattle carcasses, 
establishments shall sponge or excise tissue from the flank, brisket 
and rump, except for hide-on calves, in which case establishments shall 
take samples by sponging from inside the flank, inside the brisket, and 
inside the rump; on swine carcasses, establishments shall sponge or 
excise tissue from the ham, belly and jowl areas. 1
---------------------------------------------------------------------------

    \1\ A copy of FSIS's ``Guidelines for E. coli Testing for 
Process Control verification in Cattle and Swine Slaughter 
Establishments'' is available for inspection in the FSIS Docket 
Room.
---------------------------------------------------------------------------

    (iii) Sampling frequency. Slaughter establishments, except very low 
volume establishments as defined in paragraph (a)(2)(v) of this 
section, shall take samples at a frequency proportional to the volume 
of production at the following rates:
    Cattle: 1 test per 300 carcasses, but at a minimum one sample each 
week of operation.
    Swine: 1 test per 1000 carcasses, but at a minimum one sample each 
week of operation.
* * * * *
    (v) Sampling in very low volume establishments.
    (A) Very low volume establishments annually slaughter no more than 
6,000 cattle, 20,000 swine, or a combination of cattle and swine not 
exceeding 6,000 cattle and 20,000 total of both types. Very low volume 
establishments that collect samples by sponging shall collect at least 
one sample per week, starting the first full week of operation after 
June 1 of each year, and continue sampling at a minimum of once each 
week the establishment operates until June 1 of the following year or 
until 13 samples have been collected, whichever comes first. Very low 
volume establishments collecting samples by excising tissue from 
carcasses shall collect one sample per week, starting the first full 
week of operation after June 1 of each year, and continue sampling at a 
minimum of once each week the establishment operates until one series 
of 13 tests meets the criteria set forth in paragraph (a)(5)(i) of this 
section.
* * * * *
    (3) Analysis of samples. Laboratories may use any quantitative 
method for analysis of E. coli that is approved as an AOAC Official 
Method of the AOAC International (formerly the Association of Official 
Analytical Chemists) 2 or approved and published by a 
scientific body and based on the results of a collaborative trial 
conducted in accordance with an internationally recognized protocol on 
collaborative trials and compared against the three tube Most Probable 
Number (MPN) method and agreeing with the 95 percent upper and lower 
confidence limit of the appropriate MPN index.
---------------------------------------------------------------------------

    \2\ A copy of the current edition/revision of the ``Official 
Methods of AOAC International,'' 16th edition, 3rd revision, 1997, 
is on file with the Director, Office of the Federal Register, and 
may be purchased from the Association of Official Analytical 
Chemists International, Inc., 481 North Frederick Ave., Suite 500, 
Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------

    (4) Recording of test results. The establishment shall maintain 
accurate records of all test results, in terms of CFU/cm\2\ of surface 
area sponged or excised. Results shall be recorded onto a process 
control chart or table showing at least the most recent 13 test 
results, by type of livestock slaughtered. Records shall be retained at 
the establishment for a period of 12 months and shall be made available 
to FSIS upon request.
    (5) Criteria for evaluation of test results.
    (i) An establishment excising samples from carcasses is operating 
within the criteria when the most recent E. coli test result does not 
exceed the upper limit (M), and the number of samples, if any, testing 
positive at levels above (m) is three or fewer out of the most recent 
13 samples (n) taken, as follows:

                                  Table 1.--Evaluation of E. Coli Test Results                                  
                                                                                                                
                                                                                                       Maximum  
                                                                                         Number of      number  
          Type of livestock           Lower limit of marginal  Upper limit of marginal     sample     permitted 
                                               range                    range              tested    in marginal
                                                                                                        range   
                                      (m)....................  (M)....................          (n)          (c)
----------------------------------------------------------------------------------------------------------------
Cattle..............................  Negative a.............  100 CFU/cm \2\.........           13            3

[[Page 26218]]

                                                                                                                
Swine...............................  10 CFU/cm \2\..........  10,000 CFU/cm \2\......           13           3 
----------------------------------------------------------------------------------------------------------------
a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of
  at least 5 cfu/cm\2\ carcass surface area.                                                                    

    (ii) Establishments sponging carcasses shall evaluate E. coli test 
results using statistical process control techniques.
* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

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

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

Subpart K--Post Mortem Inspection; Disposition of Carcasses and 
Parts

    6. Section 381.94 is amended by revising paragraphs (a)(1) 
introductory text, (a)(2)(ii), (a)(2)(iii), (a)(2)(v)(A), (a)(3), 
(a)(4); and (a)(5) Table 1; by redesignating paragraph (a)(5) as 
(a)(5)(i); by adding a new paragraph (a)(5)(ii); and by removing the 
footnote b in Table 2 of paragraph (b)(1) and removing the symbol ``b'' 
as it appears after the term ``Broiler'' and redesignating footnote d 
as footnote b to read as follows:


Sec. 381.94  Contamination with microorganisms; process control 
verification criteria and testing; pathogen reduction standards.

    (a) * * *
    (1) Each official establishment that slaughters poultry shall test 
for Escherichia coli Biotype I (E. coli). Establishments that slaughter 
more than one type of poultry and/or poultry and livestock, shall test 
the type of poultry or livestock slaughtered in the greatest number. 
The establishment shall:
* * * * *
    (2) Sampling requirements.
    (i) * * *
    (ii) Sample collection. Samples shall be collected by taking a 
whole bird from the end of the chilling process, after the drip line, 
and rinsing it in an amount of buffer appropriate to the type of bird 
being tested. If the bird is boned before chilling (hot boned poultry), 
the sample shall be taken from the end of the slaughter line instead of 
the end of the drip line.1
---------------------------------------------------------------------------

    \1\ A copy of FSIS's ``Sampling Technique for E. coli in Raw 
Meat and Poultry for Process Control Verification'' is available for 
inspection in the FSIS Docket Room.
---------------------------------------------------------------------------

    (iii) Sampling frequency. Slaughter establishments, except very low 
volume establishments as defined in paragraph (a)(2)(v) of this 
section, shall take samples at a frequency proportional to the 
establishment's volume of production at the following rates:
    Chickens: 1 sample per 22,000 carcasses, but at a minimum one 
sample per each week of operation.
    Turkeys: 1 sample per 3,000 carcasses, but at a minimum one sample 
each week of operation.
* * * * *
    (v) Sampling in very low volume establishments
    (A) Very low volume establishments annually slaughter no more than 
440,000 chickens or 60,000 turkeys or a combination of chickens and 
turkeys not exceeding 60,000 turkeys and 440,000 birds total. Very low 
volume establishments slaughtering turkeys in the largest number shall 
collect at least one sample per week, starting the first full week of 
operation after June 1 of each year, and continue sampling at a minimum 
of once each week the establishment operates until June 1 of the 
following year or until 13 samples have been collected, whichever comes 
first. Very low volume establishments slaughtering chickens in the 
largest number shall collect one sample per week, starting the first 
full week of operation after June 1 of each year, and continue sampling 
at a minimum of once each week the establishment operates until one 
series of 13 tests meets the criteria set forth in paragraph (a)(5)(i) 
of this section.
* * * * *
    (3) Analysis of samples. Laboratories may use any quantitative 
method for analysis of E. coli that is approved as an AOAC Official 
Method of the AOAC International (formerly the Association of Official 
Analytical Chemists) 2 or approved and published by a 
scientific body and based on the results of a collaborative trial 
conducted in accordance with an internationally recognized protocol on 
collaborative trials and compared against the three tube Most Probable 
Number (MPN) method and agreeing with the 95 percent upper and lower 
confidence limit of the appropriate MPN index.
---------------------------------------------------------------------------

    \2\ A copy of the current edition/revision of the ``Official 
Methods of AOAC International,'' 16th edition, 3rd revision, 1997, 
is on file with the Director, Office of the Federal Register, and 
may be purchased from the Association of Official Analytical 
Chemists International, Inc., 481 North Frederick Ave., Suite 500, 
Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------

    (4) Recording of test results. The establishment shall maintain 
accurate records of all test results, in terms of CFU/ml of rinse 
fluid. Results shall be recorded onto a process control chart or table 
showing at least the most recent 13 test results, by type of poultry 
slaughtered. Records shall be retained at the establishment for a 
period of 12 months and shall be made available to FSIS upon request.
    (5) Criteria for evaluation of test results.
    (i) * * *

[[Page 26219]]



                                  Table 1.--Evaluation of E. coli Test Results                                  
                                                                                                                
                                                                                                Maximum number  
        Types of poultry           Lower limit of      Upper limit of     Number of sample       permitted in   
                                   marginal range      marginal range          tested           marginal range  
                                 (m)...............  (M)...............  (n)...............  (c)                
----------------------------------------------------------------------------------------------------------------
Chickens.......................  100 CFU/ml........  1,000 CFU/ml......  13................  3                  
Turkeys........................  N.A.a.............  N.A...............  N.A...............  N.A.               
----------------------------------------------------------------------------------------------------------------
a Not available; values for turkeys will be added upon completion of data collection program for turkeys.       

    (ii) For types of poultry appearing in paragraph (a)(5)(i) Table 1 
of this section that do not have m/M criteria, establishments shall 
evaluate E. coli test results using statistical process control 
techniques.
* * * * *

PART 416--SANITATION

    7. The authority citation for part 416 continues to reads as 
follows:

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

    8. Section 416.15 is amended by revising paragraph (b) to read as 
follows:


Sec. 416.15  Corrective Actions.

* * * * *
    (b) Corrective actions include procedures to ensure appropriate 
disposition of product(s) that may be contaminated, restore sanitary 
conditions, and prevent the recurrence of direct contamination or 
adulteration of product(s), including appropriate reevaluation and 
modification of the Sanitation SOP's and the procedures specified 
therein or appropriate improvements in the execution of the Sanitation 
SOP's or the procedures specified therein.

    Done at Washington, DC, on May 7, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-12397 Filed 5-7-97; 3:21 pm]
BILLING CODE 3410-DM-P