[Federal Register Volume 64, Number 228 (Monday, November 29, 1999)]
[Rules and Regulations]
[Pages 66547-66553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30602]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 310 and 381

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


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

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is requiring 
establishments that slaughter sheep, goats, horses, mules, and other 
equines, and establishments that slaughter ducks, geese, and guineas, 
to sample and test carcasses for generic E. coli. This final rule 
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.

EFFECTIVE DATE: January 25, 2000.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director, 
Regulation Development and Analysis Division, Office of Policy, Program 
Development, and Evaluation, FSIS, Room 112 Annex Building, Washington, 
DC 20250-3700; telephone (202) 720-5627.

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 establishments that slaughter 
cattle, swine, chicken, and turkey to verify the adequacy of 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, a Hazard Analysis and Critical Control Point (HACCP) system.
    At present, all inspected establishments that slaughter cattle, 
swine, chickens or turkeys must sample and test carcasses for generic 
E. coli. These establishments have developed sampling plans and sample 
at specified frequencies, locations, and sites. They 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 Corrections and Amendment'' final rule (62 FR 26211) provide 
detailed information about the need for these requirements.
    On November 3, 1997, FSIS published a proposed rule in the Federal 
Register (62 FR 59305) proposing to extend the sampling and testing 
requirements for generic E. coli to meat establishments that slaughter 
sheep, goats, and equines and to poultry establishments that slaughter 
ducks, geese, and guineas. FSIS believes that regular microbial testing 
by all 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.

[[Page 66548]]

Comments

    FSIS received five comments during the public comment period that 
ended January 2, 1998. Two of the commenters are members of the meat 
industry, and two commenters represent industry trade associations. The 
fifth commenter is from the Ministry of Agriculture of a major U.S. 
trading partner. None of the commenters expressed any opposition to 
extending the generic E. coli sampling and testing requirements to 
minor species, and one commenter found both the costs and hours 
necessary for implementation to be reasonable.
    The principal areas of disagreement with the proposed rule dealt 
with sampling/testing rates and sites. One of the commenters proposed 
that the sampling for sheep and goats be done less frequently than for 
cattle and swine. Another commenter disagreed with the application of 
the 1 per 300 sampling frequency and proposed an ovine sampling rate of 
1 per 810 as being more appropriate for establishments that slaughter 
large numbers of sheep and lambs.
    The sampling/testing site was another area about which there was 
disagreement with the proposal. One commenter expressed a preference 
for a single sampling site rather than the three sites proposed by 
FSIS. Another commenter disagreed with the proposed sampling sites and 
recommended that alternative sites be described in the final rule to 
accommodate different dressing systems.
    The flank, brisket, and rump are the same sites that were used by 
FSIS when conducting the baseline studies for cattle and swine. FSIS' 
decision not to change sites is based on the fact that there are no 
available data to demonstrate that one-site sampling will provide 
results comparable to the baseline survey data.
    Moreover, it is appropriate, under HACCP, that the same three sites 
be used for sampling all livestock carcasses. The Agency's 
understanding of the minor species' dressing practices is that these 
three sites are the most likely places where contamination would be 
found. Although species-specific data are not currently available, 
researchers at Colorado State University (CSU) are conducting sampling 
analysis at three locations on lamb carcasses: the leg (rump, for 
beef), flank, and breast (brisket, for beef). The Agency will consider 
amending the regulations if the CSU data indicate a persuasive need to 
considering other sampling sites. With regard to frequency of sampling/
testing, FSIS proposed a maximum limit of 13 samples per day, as was 
done with poultry.
    One commenter recommended a smaller template for lamb carcasses, 
such as an area between 3 x 3 inches and 5 x 5 inches. In response to 
this recommendation, FSIS agrees that a smaller template is reasonable 
for sheep and goats, smaller species than livestock species, and will 
specify a 5 x 10 cm template in its sampling procedures.

The Final Rule

    FSIS now is extending these sampling and testing requirements to 
sheep, goats, horses, mules, and other equines, defined as livestock in 
9 CFR 301.2 (qq). All establishments slaughtering sheep, goats, horses, 
mules, or other equines now are required to meet the sampling and 
testing requirements in 9 CFR 310.25. Similarly, establishments that 
slaughter ducks, geese, and guineas now are required to meet the 
sampling and testing requirements in 9 CFR 381.94. These establishments 
will 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. Finally, this final rule also 
corrects an inadvertent inconsistency in the headings of Secs. 310.25 
and 381.94 that appeared in the proposed rule by including the phrase 
``process control verification criteria and testing'' as well as 
removing the phrase ``for Salmonella'' in Sec. 310.25.

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, or 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 complete E. coli sampling 
window per day to provide a minimum, adequate basis for process control 
verification.
    FSIS developed alternative sampling 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 of each year 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 that 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 assumes 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 Pathogen Reduction/HACCP final rule (61 FR 38842) noted that 
very low volume cattle and swine establishments account for only 1.5 
percent and 1.3 percent of overall production, respectively. Very low 
volume chicken and turkey establishments account for .05 percent and 
.01 percent of overall production, respectively.
    FSIS is now requiring establishments that slaughter sheep, goats, 
and equines to sample at the same frequency now required for cattle, 
one test per 300 carcasses. Similarly, FSIS is requiring establishments 
that slaughter ducks, geese, and guineas to sample at the same 
frequency now required for turkeys, one test per 3,000 carcasses. FSIS 
also is requiring establishments that slaughter sheep, goats, equines, 
ducks, geese, and guineas, 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 requiring ``very low volume'' establishments that slaughter 
sheep, goats, equines, ducks, geese, and guineas to collect at least 
one sample per week, starting the first full week of

[[Page 66549]]

operation after June 1 of each year, and continue sampling at a minimum 
of once each week that 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, equines, ducks, geese, and 
guineas. When m/M criteria are developed for any of these types of 
livestock or poultry, FSIS intends to 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 slaughtered primarily sheep 
and goats. FSIS is requiring that these 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 will be 
slaughtered in establishments conducting a minimum of 13 samplings each 
day or one complete E. coli test window. A very low volume sheep or 
goat slaughter establishment is one that annually will slaughter no 
more than 6,000 head. Based on fiscal year 1993 data, 61 of the 93 
establishments will be classified as very low volume and account for 
1.9 percent of total sheep and goat production.

Equines

    In fiscal year 1995, eight establishments slaughtered equines under 
Federal inspection for human food. These eight establishments 
slaughtered only equines. The Agency now is requiring that horse, mule, 
or other equine slaughter 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 are those that will annually slaughter no more than 
6,000 equines. Two of the equine establishments, slaughtering 5.6 
percent of overall production, will be classified as very low volume.

Ducks, Geese, and Guineas

    In fiscal year 1995, there were 12 establishments that slaughtered 
primarily ducks and two establishments that slaughtered primarily 
geese. FSIS is not aware of any federally inspected establishment 
currently slaughtering guineas. FSIS now is requiring establishments 
that slaughter ducks, geese, and guineas to 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 will be slaughtered in 
establishments conducting a minimum of one E. coli test per day. Very 
low volume duck, geese, or guinea establishments are those that will 
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 slaughtered primarily ducks. These establishments 
produced 98.7 percent of all ducks slaughtered under Federal 
inspection. One of the 12 establishments produces less than 0.2 percent 
of ducks slaughtered and will be defined as a very low volume duck 
establishment.
    Eight establishments under Federal inspection slaughtered 159,000 
geese in FY 1995. Only two establishments slaughtered primarily 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) will 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 will 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

    Establishments that slaughter sheep, goats, equines, ducks, geese, 
and guineas will prepare written specimen collection procedures. The 
procedures will 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 will be made available to FSIS upon request.

Sampling Locations

    Establishments that slaughter sheep, goats, and equines will 
collect samples from chilled carcasses. Carcasses boned before chilling 
(hot boned) will be sampled after the final wash. For ducks, geese, and 
guineas, samples will be taken from the end of the chilling process, 
after the drip line. If the bird is boned before chilling, the sample 
will be taken from the end of the slaughter line instead of the end of 
the drip line.

Sampling Sites

    Samples from sheep, goat, and equine carcasses will be taken by 
sponging tissue from three sites: the flank, brisket, and rump. The 
sponge is to be placed afterward in an amount of buffer to transfer any 
E. coli to a solution, which then is analyzed for E. coli. Hide-on 
carcasses will be sampled by sponging from inside the flank, inside the 
brisket, and inside the rump. Samples from ducks, geese, and guineas 
will be collected by taking whole birds from the end of the chilling 
process after the drip line and rinsing them in an amount of buffer 
appropriate to the type of bird being tested.

Recordkeeping

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

Evaluation Criteria

    Establishments will 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.

International Implementation

    The Federal Meat Inspection Act and the Poultry Products Inspection 
Act require that meat and poultry products imported into the United 
States be produced under an inspection system that is equivalent to the 
U.S. inspection system. In determining the equivalency of a foreign 
country's eligibility to import meat or poultry products into the 
United States, FSIS evaluates the laws, policies, and administration of 
that country's inspection system. This assessment includes on-site 
reviews of individual establishments, laboratories, and other 
facilities within the foreign system. With this final rule, countries 
that export products of sheep, goats, equines, ducks, geese, and 
guineas to the United States must implement

[[Page 66550]]

equivalent generic E. coli sampling and testing programs as a condition 
of maintaining eligibility for access to the U.S. market.
    The burden for demonstrating equivalence rests with the exporting 
country, and the United States is free to set any level of protection 
it considers appropriate to control or eliminate a foodborne hazard. 
Equivalent regulatory systems need not be identical. FSIS has 
established a level of protection that domestic establishments must 
achieve. Exporting countries may propose alternative methods of 
achieving equivalent levels of protection and are advised to consult 
with FSIS on any proposed alternatives that they believe will meet U.S. 
requirements.

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 made an initial determination that this 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).
    This final rule is an extension of the Pathogen Reduction/HACCP 
rule, which is 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 the requirement for generic E. coli testing to 
additional types of livestock and poultry, this final rule will 
increase the effectiveness of pathogen reduction efforts and 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 was made 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 final rule will 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 equines. In 
addition, there are 574 establishments that slaughter sheep or goats 
but are not affected because they primarily slaughter cattle or swine.
    This final rule also will 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 slaughter primarily ducks and two 
establishments that slaughter primarily geese. There are 14 
establishments that also slaughter ducks and/or geese, but are not 
affected because they slaughter primarily chickens or turkeys. There 
are currently no establishments that slaughter guineas under Federal 
inspection.

Executive Order 12898

    Pursuant to Executive Order 12898, ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations,'' FSIS has considered potential impacts of this final rule 
on environmental and health conditions in low-income and minority 
communities.
    This final rule extends the sampling and testing requirements 
already applied to establishments that slaughter cattle, swine, 
chickens, and turkeys. As explained in the economic impact analysis 
above, the Final Regulatory Impact Assessment (FRIA) for the Pathogen 
Reduction/HACCP final rule addressed in detail the fact that this rule 
will generally benefit FSIS, the regulated industries, and consumers. 
The final rule will not require or compel meat or poultry 
establishments to relocate or alter their operations in ways that could 
adversely affect the public health or environment in low income and 
minority communities. Further, this final rule will not exclude any 
persons or populations from participation in FSIS programs, deny any 
persons or populations the benefits of FSIS programs, or subject any 
persons or populations to discrimination because of their race, color, 
or national origin.

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 Equines

    Unless otherwise specified, this cost analysis is based on data 
from the Agency's Enhanced Economic Database. This database includes 
Animal Disposition Retrieval System (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 final rule will extend mandatory generic E. coli testing to these 
establishments. Each of these 11 establishments will 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 will be very low volume 
establishments and will 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 will analyze a total of 8,015 
samples annually at a cost of $192,360. Recording and reviewing costs 
for 8,015 samples will require 668 hours annually and cost $8,970. The 
annual recording and reviewing costs for the three very low volume 
establishments will 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

[[Page 66551]]

will 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 will be very low volume sheep or 
goat establishments under this rule. The impact on these 58 
establishments will be a shift in the type of livestock sampled. The 
Agency is not aware of any basis to conclude that establishments could 
not make this shift without additional costs for sampling plan 
development.
    The other 24 establishments within the 82 that slaughter cattle 
and/or swine and sheep or goats are now required to test cattle or 
swine. However, under this final rule, they will 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 will increase by 2,928 samples or $70,272 per year. 
Annual recording and reviewing costs will be $3,277 (244 hours at 
$13.43 per hour).
    This final rule will also extend mandatory generic E. coli testing 
to 8 establishments that slaughter equines for human food. Based on FY 
1995 ADRS data, these eight establishments will be required to conduct 
469 analyses per year. It is assumed they will all have to develop 
sampling plans ($640 each) and that six will have to obtain training in 
aseptic sampling ($403 per establishment). Two of the eight 
establishments that slaughter equines will meet the definition for a 
very low volume establishment. The total recurring cost for 469 
analyses will be $11,256. Recording and reviewing costs will be $525 
per year (39 hours at $13.43 per hour).
    In conclusion, there are 43 federally inspected livestock slaughter 
establishments that will experience increased costs under this final 
rule. The one time up-front costs will 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 will be $288,619, 
$275,760 for sample collection and analysis and $12,859 for recording 
and reviewing test results.
    All the costs discussed above for establishments that slaughter 
sheep, goats, and equines 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
                                             Number of    Training for    Sampling     collection     Recording
           Production category            establishments     aseptic        plan      and analysis   and review
                                                            sampling     development   (recurring)   (recurring)
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Exclusively Sheep or Goats with Annual                8         $2,418        $5,120      $192,360        $8,970
 Production over 6,000..................
Exclusively sheep or Goats with Annual                3            806         1,920         1,872            87
 Production under 6,000.................
Primarily Sheep or Goats with Annual                 24   ............  ............        70,272         3,277
 Production over 6,000..................
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 final rule. This final rule 
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, will 
shift their testing program to ducks or geese. Seven of these 
establishments will have to conduct more testing because they will not 
be very low volume establishments based on their duck or goose 
production. The eighth establishment will shift from a very low volume 
establishment that slaughters chickens to a very low volume 
establishment that slaughters ducks, and it and will not incur any 
additional costs.
    In summary, under this final rule, 14 establishments will test 
ducks or geese. Two of these establishments will be very low volume 
establishments. All 14 poultry slaughter establishments affected by 
this final rule 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; 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 final rule 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 duck and geese production levels from FY 
1995, five of the six establishments slaughtering only ducks and geese 
will 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 will 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 will have to conduct more analyses under this final 
rule because they will not be very low volume establishments based on 
their duck or goose production. These seven establishments will 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 will 
total $4,218 per year.

[[Page 66552]]

    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 cost for requiring generic E. coli sampling in 
establishments that slaughter ducks, geese, and guineas are summarized 
in Table 2.

  Table 2: Costs for Implementing Generic E. coli Sampling Programs for Duck, Goose, and Guinea Establishments
----------------------------------------------------------------------------------------------------------------
                                                                                         Sample
                                             Number of    Training for    Sampling     collection     Recording
           Production category            establishments     aseptic        plan      and analysis   and review
                                                            sampling     development   (recurring)   (recurring)
----------------------------------------------------------------------------------------------------------------
Ducks and Geese only-Costs Included in                6         $2,015        $3,840        $3,744          $175
 FRIA...................................
Ducks and Geese only-Costs not                    \1\ 5   ............  ............        54,744         2,553
 previously accounted for...............
Establishments Currently Required to                  7   ............  ............        90,456         4,218
 test Chickens or Turkeys...............
                                         -----------------------------------------------------------------------
    Total...............................             13          2,015         3,840       148,944        6,946
----------------------------------------------------------------------------------------------------------------
\1\ Included in the 6 above.

Overall Summary of Cost Analysis

    This final rule will extend mandatory generic E. coli sampling 
requirements to 25 federally inspected establishments, 11 that 
slaughter sheep and goats exclusively, eight that slaughter equines, 
and six that currently slaughter only ducks and/or geese. The 
nonrecurring up-front cost for these establishments will total $23,657. 
The annual recurring cost for collecting and analyzing 10,999 samples 
and recording and reviewing results for these 25 establishments will be 
$276,286. There are 31 establishments that currently test cattle, 
swine, chickens or turkeys that will have to increase their testing 
programs by 6,697 samples. The increase in annual 28 recurring costs 
for these 31 establishments will be $168,223.
    The costs summarized in Tables 1 and 2 are maximum costs because 
the final rule will allow for establishments operating under a 
validated HACCP system to use sampling frequencies other than those 
specified in this final rule if the alternative sampling frequency is 
an integral part of the establishment's HACCP plan. The cost estimates 
in Tables 1 and 2 do not account for possible reductions in sampling 
frequencies.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Because this rule is final, (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

    Abstract: As part of microbiological testing, each slaughter 
establishment will be required to develop written procedures outlining 
specimen collection and handling. The slaughter establishments will be 
responsible for entering the results into a statistical process control 
chart or table. The data and chart will be available for review by FSIS 
upon request.
    Estimate of Burden: Agency subject matter experts estimate that it 
will take 25 hours for establishments to develop a microbial sampling 
and analysis plan. It will 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 final rule will require 25 federally inspected establishments 
to develop sampling plans. FSIS estimates that each plan will require 
25 hours to develop. Plan development for 25 establishments will 
require 625 burden hours. Fifty-six establishments will be required to 
collect samples and to record new or additional test results. These 56 
establishments will 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 will be required. It will take 
1,475 burden hours at 5 minutes per result to record and review 
results.
    Respondents: Livestock and poultry product establishments.
    Estimated Number of Respondents: 56.
    Estimated Number of Responses per Respondents: 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, 300 12th Street, SW, Room 109, Washington, DC 20250-
3700.

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 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 the section heading, 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; process control 
verification criteria and testing; pathogen reduction standards.

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

[[Page 66553]]

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 equines: 1 test 
per 300 carcasses, but a minimum of one sample during each week of 
operation.
    (B) Swine: 1 test per 1,000 carcasses, but a minimum of one sample 
during 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 
equines, 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 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)(iii), the 
first and second sentence of paragraph (a)(2)(v)(A), and table 1 in 
paragraph (a)(5)(i) 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 a minimum of one 
sample during each week of operation.
    (B) Turkeys, Ducks, Geese, and Guineas: 1 sample per 3,000 
carcasses, but a minimum of one sample during each week of operation.
* * * * *
    (v) * * *
    (A) Very low volume establishments annually slaughter no more than 
440,000 chickens or 60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000 
guineas or a combination of all types of poultry not exceeding 60,000 
turkeys and 440,000 birds total. Very low volume establishments that 
slaughter turkeys, ducks, geese, or guineas in the largest number must 
collect at least one sample during each 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.
* * * * *
    (5) * * *
    (i) * * *

                                  Table 1.--Evaluation of E. coli Test Results
----------------------------------------------------------------------------------------------------------------
                                                                                                  Maximum number
                                               Lower limit of   Upper limit of     Number of       permitted in
              Types of poultry                 marginal range   marginal range   sample tested    marginal range
                                                    (m)              (M)              (n)              (c)
----------------------------------------------------------------------------------------------------------------
Chickens....................................         \1\ 100        \1\ 1,000               13                3
Turkeys.....................................            * NA              *NA             * NA             * NA
Ducks.......................................            * NA             * NA             * NA             * NA
Geese.......................................            * NA             * NA             * NA             * NA
Guineas.....................................            * NA             * NA             * NA            * NA
----------------------------------------------------------------------------------------------------------------
\1\ CFU/ml.
* Values will be added upon completion of data collection programs.

* * * * *
    Done at Washington, DC, on: November 18, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 99-30602 Filed 11-26-99; 8:45 am]
BILLING CODE 3410-DM-P