[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
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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...............
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Total............................... 13 2,015 3,840 148,944 6,946
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\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