[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
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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 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)
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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.
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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
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\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.
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(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