[Federal Register Volume 62, Number 212 (Monday, November 3, 1997)]
[Proposed Rules]
[Pages 59305-59310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29027]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 310 and 381

[Docket No. 97-004P]
RIN 0583-AC32


Generic E. coli Testing for Sheep, Goats, Equine, Ducks, Geese 
and Guineas

AGENCY: Food Safety and Inspection Service.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
require establishments slaughtering sheep, goats, horses, mules, and 
other equines, and establishments slaughtering ducks, geese, and 
guineas to sample and test carcasses for generic E. coli. This proposal 
extends the sampling and testing requirements already applied to 
establishments that slaughter cattle, swine, chickens, and turkeys. 
Regular microbial testing by slaughter establishments is necessary to 
verify the adequacy of the establishment's process controls for the 
prevention and removal of fecal contamination and associated bacteria.

DATES: Comments on the proposed regulations must be received on or 
before January 2, 1998.

ADDRESSES: Please send an original and two copies of comments to: FSIS 
Docket Clerk, DOCKET No. 97-004P, Room 3806, 1400 Independence Ave., 
SW, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Ms. Patricia Stolfa, Assistant Deputy 
Administrator, Office of Policy, Program Development, and Evaluation, 
FSIS, Room 402 Annex Building, Washington, DC 20250-3700; (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 cattle, swine, chicken, and 
turkey establishments to verify the adequacy of the each 
establishment's process control 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).
    At present, all inspected establishments that slaughter cattle, 
swine, chickens or turkeys must sample and test carcasses for generic 
E. coli. These establishments must develop sampling plans and sample at 
specified frequencies, locations, and sites. They must maintain records 
of results and evaluate the results using either the m/M criteria 
developed in FSIS' baseline studies or, if m/M criteria are not 
available, statistical process control techniques. Establishments 
defined as ``very low volume'' may sample at an alternative frequency. 
Also, establishments operating under HACCP may develop alternative 
sampling frequencies if certain requirements are met. The Pathogen 
Reduction/HACCP final rule and the ``Pathogen Reduction/HACCP; 
Technical Amendments and Corrections'' rule (62 FR 26211) provide 
detailed information about the need for these requirements.
    FSIS now is proposing to extend these sampling and testing 
requirements to sheep, goats, horses, mules and other equines, defined 
as livestock in 9 CFR 301.2(qq), and to ducks, geese and guineas, 
defined as poultry in 9 CFR 381.1(b)(40). All establishments 
slaughtering sheep, goats, horses, mules or other equines would be 
required to meet the sampling and testing requirements in 9 CFR 310.25. 
Similarly, establishments slaughtering ducks, geese and guineas would 
be required to meet the sampling and testing requirements in 9 CFR 
381.94. These establishments would only be required to test sheep, 
goats, equines, ducks, geese, or guineas if they primarily slaughter 
these types of livestock or poultry. FSIS considers the livestock or 
poultry an establishment slaughters in the largest number to be that 
establishment's primary type of livestock or poultry slaughtered.

Sampling Frequencies and Definitions For Very Low Volume Establishments

    For the Pathogen Reduction/HACCP final rule, FSIS used a 
methodology to select sampling frequencies so that in the subgroup of 
establishments accounting for 99 percent of total production for each 
type of livestock or poultry, the 5 percent of establishments with the 
highest production volume would each conduct a minimum of 13 E. coli 
tests, one complete test ``window'', each day. Under these frequencies, 
90 percent of all cattle, 94 percent of all swine, 99 percent of all 
chickens, and 99 percent of all turkeys would be slaughtered in 
establishments conducting a minimum of one E. coli test per day. 
Additionally, FSIS concluded that all establishments, except those 
defined as very low volume establishments, must conduct sampling at a 
frequency of at least once per week to provide a minimum, adequate 
basis for process control verification.
    FSIS developed alternative sample frequencies for establishments 
defined as ``very low volume.'' If there are published m/M criteria for 
the type of livestock or poultry primarily slaughtered, the 
establishment must sample that type of livestock or poultry at a 
minimum frequency of once per week starting the first full week of 
operation after June 1 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 primarily slaughtered, a very low volume establishment must 
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. This provision will be eliminated once m/M criteria are 
developed for the primary type of livestock or poultry slaughtered.
    FSIS permits very low volume establishments to test at this 
frequency, in part, because of their relatively simple and stable 
production environments. Also, FSIS assumed that the total risk of 
exposure to enteric pathogens from products produced at such 
establishments would be small and roughly proportional to the amount of 
products produced. FSIS requires these establishments to begin testing 
in June because it is most important for these establishments to 
conduct testing during the summer months, when there is a seasonal peak 
in the occurrence of foodborne diseases attributable to the major 
bacterial pathogens.
    The final rule noted that very low volume cattle and swine 
establishments account for only 1.5 percent and 1.3 percent of overall 
production,

[[Page 59306]]

respectively. Very low volume chicken and turkey establishments account 
for .05 percent and .1 percent of overall production, respectively.
    FSIS proposes to require sheep, goat, and equine establishments to 
sample at the same frequency now required for cattle, one test per 300 
carcasses. Similarly, FSIS proposes to require duck, geese, and guinea 
establishments to sample at the same frequency now required for 
turkeys, one test per 3,000 carcasses. FSIS also proposes to require 
sheep, goat, equine, duck, geese, and guinea establishments, except 
those defined as very low volume establishments, to conduct sampling at 
a frequency of at least once per week to provide a minimum, adequate 
basis for process control verification.
    FSIS is proposing to require sheep, goat, equine, duck, geese, and 
guinea establishments defined as ``very low volume'' to 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. At this 
time, baseline studies have not been conducted to develop m/M criteria 
for sheep, goats, equine, ducks, geese, and guinea. When m/M criteria 
is developed for any of these types of livestock or poultry, FSIS would 
require sampling at a minimum frequency of once per week starting the 
first full week of operation after June 1 until a series of 13 tests 
has met those m/M criteria.

Sheep and Goats

    In fiscal year 1993, 93 establishments primarily slaughtered sheep 
and goats. FSIS is proposing that sheep and goat establishments sample 
at a frequency of one test per 300 carcasses or at least once a week, 
whichever is greater, unless they are very low volume establishments. 
At this sampling frequency, 85 percent of all sheep and goats would be 
slaughtered in establishments conducting a minimum of one E. coli test 
per day. A very low volume sheep or goat slaughter establishment would 
annually slaughter no more than 6,000 head. Based on fiscal year 1993 
data, 61 of the 93 establishments would be classified as very low 
volume and account for 1.9 percent of total sheep and goat production.

Equine

    In fiscal year 1995, eight establishments slaughtered equine under 
Federal inspection for human food. These eight establishments 
slaughtered only equine. The Agency is proposing that horse, mule, or 
other equine establishments sample at a rate of one per 300 carcasses 
or at least once a week, whichever is greater, unless they are very low 
volume establishments. Very low volume equine establishments would 
annually slaughter no more than 6,000 equines. Two of the equine 
establishments, slaughtering 5.6 percent of overall production, would 
be classified as very low volume.

Ducks, Geese, and Guineas

    In fiscal year 1995, there were 12 establishments slaughtering 
primarily ducks and two establishments slaughtering primarily geese. 
FSIS is not aware of any federally inspected establishment currently 
processing guineas. FSIS is proposing that establishments slaughtering 
ducks, geese, and guineas sample at a frequency of one test per 3,000 
carcasses or at least once a week, whichever is greater, unless they 
are very low volume establishments. At this frequency, 96 percent of 
all ducks would be slaughtered in establishments conducting a minimum 
of one E. coli test per day. Very low volume duck, geese or guinea 
establishments would slaughter no more than 60,000 ducks, geese, or 
guineas, respectively, a year.
    In FY 1995, 25 establishments slaughtered 19.2 million ducks. Only 
12 establishments primarily slaughtered ducks. These establishments 
produced 98.7 percent of all ducks slaughtered under Federal 
inspection. One of the 12 establishments produces less than .2 percent 
of ducks slaughtered and would be defined as a very low volume duck 
establishment.
    Eight establishments under Federal inspection slaughtered 159,000 
geese in FY 1995. Only two establishments primarily slaughtered geese 
and only one of these establishments slaughters more than 60,000 geese.

Alternative Sampling Frequencies

    Establishments operating under a validated HACCP plan in accordance 
with 9 CFR 417.2(b) would be permitted to substitute an alternative 
frequency if the alternative is an integral part of the establishment's 
verification procedures for its HACCP plan. Establishments would not be 
allowed to use an alternative frequency if FSIS determines and notifies 
the establishment in writing that the alternative frequency is 
inadequate to verify the effectiveness of the establishment's process 
controls.

Sampling Plans

    Sheep, goat, equine, duck, geese, and guinea establishments would 
prepare written specimen collection procedures. The procedures would 
include the identification of employees designated to collect samples, 
the location(s) of sampling, how sampling randomness is achieved, and 
how samples are handled to ensure sample integrity. The written 
procedures would be made available to FSIS upon request.

Sampling Locations

    Sheep, goat, and equine establishments would collect samples from 
chilled carcasses. Carcasses boned before chilling (hot boned) would be 
sampled after the final wash. For ducks, geese and guineas, samples 
would be taken from the end of the chilling process, after the drip 
line. If the bird is boned before chilling, the sample would be taken 
from the end of the slaughter line instead of the end of the drip line.

Sampling Sites

    Samples from sheep, goats, and equine carcasses would be taken by 
sponging tissue from three sites, the flank, brisket, and rump. Hide-on 
carcasses would be sampled by sponging from inside the flank, inside 
the brisket, and inside the rump. Ducks, geese, and guineas would be 
rinsed in an amount of buffer appropriate to the type of bird being 
tested.

Recordkeeping

    Establishments would enter test results onto a process control 
chart or table and recorded in terms of colony forming units per 
milliliter (cfu/ml) for poultry carcasses or per square centimeter 
(cfu/cm2) for livestock carcasses. Establishments would use 
the records to evaluate test results. These records would be maintained 
at the establishment for 12 months and must be made available to 
Inspection Program employees on request. Inspectors would review 
results over time to verify effective and consistent process control.

Evaluation Criteria

    Establishments would evaluate results using statistical process 
control techniques until such time as m/M criteria are established for 
these types of livestock and poultry. FSIS intends to give high 
priority in its baseline plan to collect data that will support 
establishing m/M criteria for ducks and geese, and sheep.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been determined to be significant, and

[[Page 59307]]

therefore, has been reviewed by the Office of Management and Budget.
    The Administrator has made an initial determination that this 
proposed rule would 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).
    This proposed rule is an extension of the Pathogen Reduction/HACCP 
rule which was economically significant. Many aspects of that 
economically significant rule, such as the public health risks 
associated with pathogens present in fecal contamination and the 
potential health benefits of pathogen reduction, are applicable to this 
rule. In the Final Regulatory Impact Assessment (FRIA) (61 FR 38945, 
July 25, 1996) for the Pathogen Reduction/HACCP rule, FSIS addressed 
these areas in detail.
    By extending coverage of generic E. coli testing to additional 
types of livestock and poultry, this proposed rule would increase the 
effectiveness of pathogen reduction efforts and thereby generate 
proportional increases in predicted public health benefits. The 
benefits assessment in the FRIA was based on a proportional reduction 
assumption, that is, an assumption that a reduction in pathogens at the 
manufacturing level leads to a proportional reduction in foodborne 
illness. Public health benefits are quantified in terms of reduced cost 
of foodborne illness.
    This proposed rule would affect an estimated 101 federally 
inspected livestock slaughter establishments and a smaller number of 
State inspected livestock slaughter establishments. The total of 101 
federally inspected establishments includes 11 establishments that 
slaughter only sheep and goats, 82 establishments that slaughter cattle 
and/or swine but slaughter sheep or goats as their primary type of 
livestock, and eight establishments that slaughter equine. 
Additionally, there are 574 establishments that slaughter sheep or 
goats but are not affected because they primarily slaughter cattle or 
swine.
    This proposed rule would also affect an estimated 14 federally 
inspected poultry slaughter establishments and possibly a few State 
inspected poultry slaughter establishments. These include 12 federally 
inspected establishments that primarily slaughter ducks and two 
establishments that primarily slaughter geese. There are 14 
establishments that also slaughter ducks and/or geese but are not 
affected because they primarily slaughter chickens or turkeys. There 
are currently no establishments that slaughter guineas under federal 
inspection.

Cost Analysis

    This analysis is based on the same estimates and assumptions that 
were used to develop the FRIA for the Pathogen Reduction/HACCP rule and 
include:
    (1) An average cost of $24 for collecting and analyzing a sample 
for generic E. coli.
    (2) A cost of $640 for the preparation of a sampling plan. This 
estimate is based on 25 hours at $25.60 per hour, the average wage of a 
quality control manager.
    (3) A cost of $403 per establishment for an estimated three out of 
four establishments that would require extra training for aseptic 
sampling.
    (4) An estimate of 26 sample collections annually by very low 
volume slaughter establishments. (The proposed requirement is a minimum 
of 13.)
    (5) An estimate of five minutes to record and review laboratory 
results for each sample by an employee earning $13.42 per hour.

Sheep, Goats and Equine

    Unless otherwise specified, this cost analysis is based on data 
from the Agency's Enhanced Economic Database. This database includes 
ADRS data from FY 1993. Sheep and goat production were combined in the 
Enhanced Economic Database. Although the proposed rule treats sheep and 
goats as two separate types of livestock, the cost analysis is based on 
combined sheep and goat production. This has a minimal impact on the 
accuracy of the cost estimates.
    There are 11 establishments that slaughter only sheep and goats. 
This proposed rule would extend mandatory generic E. coli testing to 
these establishments. Each of these 11 establishments would be required 
to develop a sampling plan at a cost of $640 per establishment or 
$7,040 in total. This cost would include items such as preparing a 
written plan, establishing sampling procedures, locating a laboratory 
and arranging for necessary supplies, and developing the statistical 
process control techniques to be used for analyzing results.
    This analysis assumes that eight establishments (75 percent) would 
require training in aseptic sampling at a cost of $3,224 (8 times 
$403). Three of the eleven establishments would be very low volume 
establishments and would analyze 26 samples per year for a recurring 
cost of $1,872. Based on production data and a sampling rate of one in 
300, the other eight establishments would analyze a total of 8,015 
samples annually at a cost of $192,360. Recording and reviewing costs 
for 8,015 samples would require 668 hours annually and cost $8,970. The 
annual recording and reviewing costs for the three very low volume 
establishments would be $87 (6.5 hours at $13.43 per hour).
    As discussed above, there are 82 establishments that slaughter 
cattle and/or swine but slaughter sheep or goats as their primary type 
of livestock. There would be no additional cost for 58 of these 
establishments because these 58 are now required to conduct sampling as 
very low volume cattle or swine slaughter establishments and would be 
very low volume sheep or goat establishments under the proposed rule. 
The impact on these 58 establishments would be a shift in the type of 
livestock sampled. It is assumed they can make this shift without 
additional costs for sampling plan development.
    The other 24 establishments within the 82 that slaughter both 
cattle and/or swine and sheep or goats are now required to test for 
cattle or swine. However, under this proposed rule they would have to 
conduct additional analyses based on their sheep or goat production. 
Their sheep/goat production is greater than the larger of their cattle 
or swine production. As they shift from cattle or swine to sheep or 
goats, annual sampling would increase by 2,928 samples or $70,272 per 
year. Annual recording and reviewing costs would be $3,277 (244 hours 
at $13.43 per hour).
    This proposed rule would also extend mandatory generic E. coli 
testing to 8 establishments that slaughter equines for human food. 
Based on FY 1995 ADRS data, the 8 equine establishments would be 
required to conduct 469 analyses per year. It was assumed they would 
all have to develop sampling plans ($640 each) and that six would have 
to obtain training in aseptic sampling ($403 per establishment). Two of 
the 8 equine establishments would meet the definition for a very low 
volume establishment. The total recurring cost for 469 analyses would 
be $11,256. Recording and reviewing costs would be $525 per year (39 
hours at $13.43 per hour).
    In conclusion, there are 43 federally inspected livestock slaughter 
establishments that would experience increased costs under this 
proposal. The one time up-front costs would total $17,802, $5,642 for 
training in aseptic sampling and $12,160 for sampling plan development. 
The total recurring cost for the 43 establishments would be $288,619, 
$275,760 for sample

[[Page 59308]]

collection and analysis and $12,859 for recording and reviewing test 
results.
    All the costs discussed above for sheep, goat and equine 
establishments are summarized in Table 1.

   Table 1.--Costs for Implementing Generic E. coli Sampling Programs in Sheep, Goat and Equine Establishments  
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                                                                                           Sample               
                                                                 Training    Sampling    collection   Recording 
              Production category                  Number of       for         plan         and       and review
                                                establishments   aseptic   development    analysis   (recurring)
                                                                 sampling               (recurring)             
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Exclusively Sheep or Goats with Annual                                                                          
 Production over 6,000........................             8       $2,418      $5,120     $192,360       $8,970 
Exclusively Sheep or Goats with Annual                                                                          
 Production under 6,000.......................             3          806       1,920        1,872           87 
Primarily Sheep or Goats with Annual                                                                            
 Production over 6,000........................            24    .........  ...........      70,272        3,277 
Equine........................................             8        2,418       5,120       11,256          525 
                                               -----------------------------------------------------------------
    Total.....................................            43        5,642      12,160      275,760       12,859 
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Ducks, Geese and Guineas

    The ADRS data show that 28 federally inspected establishments 
slaughtered ducks and/or geese in FY 1995. FSIS is not aware of any 
establishment slaughtering guineas. Six establishments slaughtered only 
the types of poultry covered by this proposal. This proposal extends 
mandatory generic E. coli testing to six federally inspected poultry 
establishments that are not currently required to test. There are eight 
poultry slaughter establishments that currently test chickens or 
turkeys but slaughter more ducks or geese and, therefore, would shift 
their testing program to ducks or geese. Seven of these establishments 
would have to conduct more testing because they would not be very low 
volume establishments based on their duck or goose production. The 
eighth establishment would shift from a very low volume chicken 
establishment to a very low volume duck establishment and would not 
incur any additional costs.
    In summary, under this proposal, 14 establishments would test ducks 
or geese. Two of these establishments would be very low volume 
establishments. All 14 poultry slaughter establishments affected by 
this proposal were included in the Pathogen Reduction/HACCP FRIA as 
very low volume poultry slaughter establishments, that is, annual 
chicken slaughter under 440,000 and annual turkey slaughter under 
60,000. The methodology applied in the FRIA started with all 306 
poultry slaughter establishments (FY 1993 ADRS data) in the Agency's 
Enhanced Economic Database. FSIS calculated the costs for 208 
establishments processing more than 440,000 chickens annually and the 
costs for 48 establishments processing more than 60,000 turkeys 
annually. FSIS treated the remaining 50 poultry slaughter 
establishments as very low volume establishments.
    This methodology most likely overestimated costs for the FRIA 
because more recent FY 1995 ADRS data include six poultry slaughter 
establishments processing ducks and/or geese exclusively. This cost 
analysis separates the costs already addressed and the incremental 
costs of basing sampling frequency upon duck and geese production. The 
costs already addressed that are actually costs of this proposal 
include the cost of six sampling plans at $640 per plan or $3,840; 
training in aseptic sampling for five establishments at $403 per 
establishment or $2,015; sample collection and analysis costs for 156 
(6 multiplied by 26) samples per year at a cost of $24 per sample or 
$3,744; and recording and record review costs of $175. Using ducks and 
geese production levels from FY 1995, five of the six establishments 
slaughtering only ducks and geese would have to collect and analyze an 
additional 2,281 samples per year at an annual cost of $54,744. The 
recording and reviewing costs for 2,281 samples would be $2,553 
annually. The other establishment is a very low volume establishment.
    As discussed above, there are seven establishments that are 
currently required to test for chickens or turkeys as very low volume 
establishments but would have to conduct more analyses under this 
proposal because they would not be very low volume establishments based 
on their duck or goose production. These seven establishments would 
have to collect and analyze an additional 3,769 samples annually at a 
cost of $90,456. Recording and review costs at five minutes per sample 
would total $4,218 per year.
    The total cost for extending testing to ducks, geese, and guineas 
includes a one time cost of $5,855 for training and sampling plan 
development and an annual recurring sampling and recording cost of 
$155,890. The costs for implementing generic E. coli sampling for duck, 
geese and guineas are summarized in Table 2.

  Table 2.--Costs for Implementing Generic E. coli Sampling Programs for Duck, Goose, and Guinea Establishments 
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                                                                                           Sample               
                                                                 Training    Sampling    collection   Recording 
         Production category                  Number of            for         plan         and       and review
                                            establishments       aseptic   development    analysis   (recurring)
                                                                 sampling               (recurring)             
----------------------------------------------------------------------------------------------------------------
Ducks and Geese only-Costs Included    6                           $2,015      $3,840       $3,744         $175 
 in FRIA.                                                                                                       
Ducks and Geese only-Costs not         5 (included in the 6     .........  ...........      54,744        2,553 
 Previously accounted for.              above)                                                                  

[[Page 59309]]

                                                                                                                
Establishments Currently Required to   7                        .........  ...........      90,456        4,218 
 test Chickens or Turkeys.                                                                                      
                                      --------------------------------------------------------------------------
    Total............................  13                           2,015       3,840      148,944        6,946 
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Overall Summary of Cost Analysis

    This proposed rule would extend mandatory generic E. coli sampling 
requirements to 25 federally inspected establishments, 11 that 
slaughter sheep and goats exclusively, eight that slaughter equine and 
six that currently slaughter only ducks and/or geese. The nonrecurring 
up-front costs for these establishments would total $23,657. The annual 
recurring costs for collecting and analyzing 10,999 samples and 
recording and reviewing results for these 25 establishments would be 
$276,286. There are 31 establishments that currently test cattle, 
swine, chickens or turkeys that would have to increase their testing 
programs by 6,697 samples. The increase in annual recurring costs for 
these 31 establishments would be $168,223.
    The costs summarized in Tables 1 and 2 are maximum costs because 
the proposal would allow for establishments operating under a validated 
HACCP system to use sampling frequencies other than those specified in 
this proposal if the alternative sampling frequency is an integral part 
of the establishments HACCP plan. The cost estimates in Tables 1 and 2 
do not account for possible reductions in sampling frequencies.

Executive Order 12988

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

Paperwork Requirements

    Abstract: As part of microbiological testing, each slaughter 
establishment would be required to develop written procedures outlining 
specimen collection and handling. The slaughter establishments would be 
responsible for entering the results into a statistical process control 
chart or table. The data and chart would be available for review by 
FSIS upon request.
    Estimate of Burden: Agency subject matter experts estimate that it 
would take 25 hours for establishments to develop a microbial sampling 
and analysis plan. It would take an estimated 17.5 minutes to collect 
samples and 5 minutes per sample to enter data into charts, and then 
review and file the information.
    This proposal would require 25 federally inspected establishments 
to develop sampling plans. FSIS estimates that each plan would require 
25 hours to develop. Plan development for 25 establishments would 
require 625 burden hours. Fifty-six establishments would be required to 
collect samples and to record new or additional test results. These 56 
establishments would be required to collect and record and review the 
results of 17,696 analyses, annually. To collect samples at 17.5 
minutes per sample, 5,161 burden hours would be required. To record and 
review results at 5 minutes per result, it would take 1,475 burden 
hours.
    Respondents: Livestock and poultry product establishments.
    Estimated Number of Respondents: 56.
    Estimated Number of Responses per Respondent: 18,402.
    Estimated Total Annual Burden on Respondents: 7,261 hours.
    Copies of this information collection assessment can be obtained 
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection 
Service, USDA, 1400 Independence Ave, SW, Room 3812, Washington, DC 
20250-3700.
    Comments are invited on: (a) whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the Agency, including whether the information would have practical 
utility; (b) the accuracy of the Agency's estimate of the burden of the 
collection of information including the validity of the methodology and 
assumptions used; (c) ways to enhance the quality, utility, and clarity 
of the information to be collected; (d) ways to minimize the burden of 
the collection of information on those who are to respond, including 
through use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology. Comments may be sent to Lee Puricelli, Paperwork 
Specialist, see the address above, and Desk Officer for Agriculture, 
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Washington, DC 20253.
    Comments are requested by January 2, 1998. To be most effective, 
comments should be sent to OMB within 30 days of the publication date 
of this proposed rule.

Proposed Rule

List of Subjects

9 CFR Part 310

    Meat inspection, Microbial testing.

9 CFR Part 381

    Poultry and poultry products, Microbial testing.

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

PART 310--POST MORTEM INSPECTION

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

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

    2. Section 310.25 would be amended by revising the first sentence 
of paragraph (a)(1) introductory text, paragraphs 
(a)(2)(ii),(a)(2)(iii), and the first sentence of (a)(2)(v)(A) to read 
as follows:


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

    (a) * * *
    (1) Each official establishment that slaughters livestock must test 
for Escherichia coli Biotype 1 (E. coli). * * *.
* * * * *
    (2) * * *

[[Page 59310]]

    (i) * * *
    (ii) Sample collection. The establishment must collect samples from 
all chilled livestock carcasses, except those boned before chilling 
(hot-boned), which must be sampled after the final wash. Samples must 
be collected in the following manner: 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.
---------------------------------------------------------------------------

    (A) For cattle, establishments must sponge or excise tissue from 
the flank, brisket and rump, except for hide-on calves, in which case 
establishments must take samples by sponging from inside the flank, 
inside the brisket, and inside the rump.
    (B) For sheep, goat, horse, mule, or other equine carcasses, 
establishments must sponge from the flank, brisket and rump, except for 
hide-on carcasses, in which case establishments must take samples by 
sponging from inside the flank, inside the brisket, and inside the 
rump.
    (C) For swine carcasses, establishments must sponge or excise 
tissue from the ham, belly and jowl areas.
    (iii) Sampling frequency. Slaughter establishments, except very low 
volume establishments as defined in paragraph (a)(2)(v) of this 
section, must take samples at a frequency proportional to the volume of 
production at the following rates:
    (A) Cattle, Sheep, Goats, Horses, Mules, and Other Equine: 1 test 
per 300 carcasses, but at a minimum one sample each week of operation.
    (B) Swine: 1 test per 1000 carcasses, but at a minimum one sample 
each week of operation.
* * * * *
    (v) * * *
    (A) Very low volume establishments annually slaughter no more than 
6,000 cattle, 6,000 sheep, 6,000 goats, 6,000 horses, mules, or other 
equine, 20,000 swine, or a combination of livestock not exceeding 6,000 
cattle and 20,000 total of all livestock. * * *
* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    3. The authority citation for part 381 would continue 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 would be amended by revising paragraph 
(a)(2)(iii), and the first and second sentences of paragraph 
(a)(2)(v)(A) as follows:


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

    (a) * * *
    (2) * * *
    (iii) Sampling frequency. Slaughter establishments, except very low 
volume establishments as defined in paragraph (a)(2)(v) of this 
section, must take samples at a frequency proportional to the 
establishment's volume of production at the following rates:
    (A) Chickens: 1 sample per 22,000 carcasses, but at a minimum one 
sample per each week of operation.
    (B) Turkeys, Ducks, Geese, and Guineas: 1 sample per 3,000 
carcasses, but at a minimum one sample each week of operation.
* * * * *
    (v) * * *
    (A) Very low volume establishments annually slaughter no more than 
440,000 chickens or 60,000 turkeys, 60,000 duck, 60,000 geese, 60,000 
guineas or a combination all types of poultry not exceeding 60,000 
turkeys and 440,000 birds total. Very low volume establishments 
slaughtering turkeys, ducks, geese, or guineas in the largest number 
must 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. * * *
* * * * *
    Done at Washington, DC, on October 24, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-29027 Filed 10-31-97; 8:45 am]
BILLING CODE 3410-DM-P