[Federal Register Volume 62, Number 220 (Friday, November 14, 1997)]
[Rules and Regulations]
[Pages 61007-61009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29929]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 310, 381, and 417

[Docket No. 97-056DF]
RIN 0583-AC40


Pathogen Reduction; Hazard Analysis and Critical Control Point 
(HACCP) Systems--Sample Collection--Technical Amendments and 
Corrections: Direct Final Rule

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Direct 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. In response to 
worker safety concerns, FSIS will permit samples collected for generic 
E. coli testing of turkeys to be collected by sponging two sites. 
Samples may still be collected by the whole bird rinse procedure 
(shaking turkeys in a bag containing a buffer solution). FSIS will also 
permit chickens and turkeys to be taken from the end of the slaughter 
line if it is impracticable to take a whole bird from the end of the 
chilling process. Additionally, FSIS is amending the regulations to add 
the performance standard for Salmonella in fresh pork sausage, which 
was unavailable at the time the rule was published, and correct a minor 
editorial oversight.

DATES: This rule will be effective on January 13, 1998, unless adverse 
or critical comments are received on or before December 15, 1997. If 
adverse or critical comments within the scope of the rulemaking are 
received, FSIS will issue timely notice in the Federal Register.

ADDRESSES: Send an original and two copies of adverse written comments 
within the scope of the rulemaking to: FSIS Docket Clerk, DOCKET # 97-
056DF, Room 102, Cotton Annex, 300 12th Street, SW, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250-3700. Reference materials cited in this docket will be available 
for public inspection in the FSIS Docket Room from 8:30 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 final rule required all slaughter establishments to test 
for generic E. coli at a frequency based on production volume to verify 
that plants are meeting the established performance criteria. In the 
preamble to the final rule, FSIS solicited comments and information on 
a number of technical issues concerning the protocols for generic E. 
coli testing and announced that conferences would be held to discuss 
these issues.
    The first conference was held on September 12 and 13, 1996. 
Participants discussed issues such as testing frequency, sampling 
procedures, and revision of the testing protocol to better account for 
differing establishment characteristics. In light of these comments, 
FSIS published the May 13, 1997, final rule ``Pathogen Reduction; 
Hazard Analysis and Critical Control Point (HACCP) Systems--Technical 
Amendments and Corrections'' (62 FR 26211). The final rule made some 
changes to the E. coli testing requirements.
    On May 8, 1997, FSIS held a follow-up conference ``Technical 
Conference: Review of E. coli Testing.'' A panel of

[[Page 61008]]

industry and academia representatives made presentations about the on-
going generic E. coli verification testing by establishments and 
discussed their observations and views. In response to information 
provided at the conference, FSIS is amending the sample collection 
procedures for turkeys and allowing flexibility for the collection of 
poultry to be sampled.
    Currently, turkeys randomly selected for sampling must be rinsed in 
a buffer solution. The rinsing technique involves shaking a whole 
turkey carcass in a bag containing the buffer solution. Prior to the 
meeting, FSIS was aware of concerns regarding this process. At the 
meeting, commenters raised the issue and presented data that supports 
an alternative means of sample collection.
    The primary concern regarding the current sampling technique for 
turkeys is the physical difficulty of shaking large turkeys (i.e., 
those that are 15 to 20 pounds). Also, some commenters have stated that 
the size of the turkeys makes it difficult to prevent sample 
contamination when the buffer solution is decanted from the sampling 
bag into the sample bottle for transportation to the laboratory. At the 
conference, data was presented which indicated that a sponging 
technique is more practical, and provides accurate and reliable results 
for microbiological sampling.
    FSIS agrees that shaking turkeys in the bag may be difficult for 
individuals taking the sample and that sample contamination may occur. 
Because of the lack of data in support of an alternative method, FSIS 
has not previously adopted another sample collection method for 
turkeys. However, after reviewing the data presented at the conference, 
FSIS has determined that a sponge method for the collection of turkey 
samples is effective. Therefore, FSIS will amend the Pathogen 
Reduction/HACCP final rule to permit establishments to sample turkeys 
by sponging the back and thigh or to continue using the whole bird 
rinse procedure.
    Data collected using the sponge technique will be evaluated using 
statistical process control techniques as required in the May 13, 1997, 
technical amendments final rule. FSIS has begun to develop m/M criteria 
for turkey samples collected by the sponge method and will release data 
from this baseline quarterly so that establishments can use them for 
statistical process control techniques. FSIS also is in the process of 
developing m/M criteria for cattle and swine samples collected by the 
sponge method. The results from FSIS's first quarter of the study is as 
follows: for cattle m=negative and M=1; for swine m=.1 and M=100.
    Commenters also expressed concern about the difficulty in taking 
whole birds from the end of the chilling process, after the drip line, 
because the birds on the drip line are often high off the ground and 
hard to reach. FSIS understands this concern. In the technical 
amendments final rule, FSIS provided establishments with the option of 
taking birds from the end of the slaughter line for carcasses that are 
hot-boned. With this rule, FSIS is amending the regulations to permit 
birds to be taken at the end of the slaughter line for carcasses, if 
sampling at the end of the drip line is impracticable.
    In the pathogen reduction/HACCP final rule, FSIS stated that it was 
in the process of developing a Salmonella performance standard for 
fresh pork sausages. That work has been completed and the performance 
standard will be added to the regulations. The performance standard is 
30% (percent positive for Salmonella), the number of samples tested (n) 
equals 53, and the maximum number of positives to achieve the standard 
(c) equals 18. The methodology used to develop this performance 
standard was the same as for the other ground products. To further 
explain how the performance standard was developed, FSIS is making 
available copies of the paper ``Estimation of Salmonella Prevalence in 
25-gram Portions of Fresh Ground Pork'' in the FSIS Docket Room.
    Lastly, FSIS is making a technical correction to 9 CFR 417.2(e). 
The section should reference the Poultry Products Inspection Act (PPIA) 
and the Federal Meat Inspection Act (FMIA). FSIS inadvertently omitted 
references to sections 21 U.S.C. 456 and 463 of the PPIA and only 
referenced sections 21 U.S.C. 608 and 621 of the FMIA. Therefore, 
references to the PPIA authority will be added to this section.
    FSIS expects no adverse public reaction resulting from this change 
in regulatory language. Therefore, unless the Agency receives adverse 
or critical comments within the scope of this rulemaking, or a notice 
of intent to submit adverse comments within the scope of this 
rulemaking within 30 days, the action will become final 60 days after 
publication in the Federal Register. If adverse comments within the 
scope of the rulemaking are received, the final rulemaking notice will 
be withdrawn and a proposed rulemaking notice will be published. The 
proposed rulemaking notice will establish a comment period.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been determined to be not significant and, 
therefore, has not 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 
amendment do not change the cost and benefit estimates and impact 
assessments presented in the FRIA.

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.

Final Rules

List of Subjects

9 CFR Part 310

    Meat inspection, Microbial testing.

9 CFR Part 381

    Poultry and poultry products, Microbial testing.

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

PART 310--POST MORTEM INSPECTION

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

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

    2. Section 310.25 is amended by revising Table 2 in paragraph 
(b)(1) to read as follows:


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

* * * * *
    (b) * * *
    (1) * * *

[[Page 61009]]



               Table 2.--Salmonella Performance Standards               
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                                                               Maximum  
                                   Performance                number of 
                                    standard     Number of    positives 
        Class of product            (percent      samples     to achieve
                                  positive for  tested  (n)    standard 
                                   Salmonella)                   (c)    
----------------------------------------a-------------------------------
Steers/heifers..................           1.0           82            1
Cows/bulls......................           2.7           58            2
Ground beef.....................           7.5           53            5
Hogs............................           8.7           55            6
Fresh pork sausages.............          30             53          18 
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a Performance Standards are FSIS's calculation of the national          
  prevalence of Salmonella on the indicated raw product based on data   
  developed by FSIS in its nationwide microbiological data collection   
  programs and surveys. (Copies of Reports on FSIS's Nationwide         
  Microbiological Data Collection Programs and Nationwide               
  Microbiological Surveys used in determining the prevalence of         
  Salmonella on raw products are available in the FSIS Docket Room.)    

* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    3. 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

    4. Section 381.94 is amended by revising paragraph (a)(2)(ii) to 
read as follows:


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

    (a) * * *
    (2) Sampling requirements.
    (ii) Sample collection. A whole bird must be taken from the end of 
the chilling process. If this is impracticable, the whole bird can be 
taken from the end of the slaughter line. Samples must be collected by 
rinsing the whole carcass in an amount of buffer appropriate for that 
type of bird. Samples from turkeys also may be collected by sponging 
the carcass on the back and thigh.1
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    \1\ A copy of FSIS's ``Guidelines for Escherichia coli Testing 
for Process Control Verification in Poultry Slaughter 
Establishments'' and ``FSIS Turkey Microbiological Procedures for 
Sponge Sample Collection and Methods of Analysis'' are available for 
inspection in the FSIS Docket Room.
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* * * * *

PART 417--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) 
SYSTEMS

    3. The authority citation for part 417 continues to reads as 
follows:

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


Sec. 417.2  Hazard Analysis and HACCP Plan.

    4. Section 417.2 is amended by revising paragraph (e) to read as 
follows:
* * * * *
    (e) Pursuant to 21 U.S.C. 456, 463, 608, and 621, the failure of an 
establishment to develop and implement a HACCP plan that complies with 
this section, or to operate in accordance with the requirements of this 
part, may render the products produced under those conditions 
adulterated.

    Done at Washington, DC, on November 4, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-29929 Filed 11-13-97; 8:45 am]
BILLING CODE 3410-DM-P