Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Proposed Rules 59305

Done in Washington, DC, on: October 24,

1997.

Thomas J. Billy,

Administrator.

[FR Doc. 97–29034 Filed 10–31–97; 8:45 am]

BILLING CODE 3410–DM–P

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.

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,
59306 Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Proposed Rules

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
Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Proposed Rules 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
59308 Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Proposed Rules

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

Production category

Number

of establishments

Training

for aseptic sampling

Sampling

plan development

Sample

collection

and analysis (recurring)

Recording and

review

(recurring)

Exclusively Sheep or Goats with Annual Production over 6,000 ................................. 8 $2,418 $5,120 $192,360 $8,970

Exclusively Sheep or Goats with Annual Production under 6,000 .............................. 3 806 1,920 1,872 87

Primarily Sheep or Goats with Annual Production over 6,000 .................................... 24 ................ ................ 70,272 3,277

Equine ........................................................................................................................... 8 2,418 5,120 11,256 525

Total ....................................................................................................................... 43 5,642 12,160 275,760 12,859

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

Production category

Number of

establishments

Training

for aseptic sampling

Sampling

plan development

Sample

collection

and analysis (recurring)

Recording and

review

(recurring)

Ducks and Geese only-Costs Included in FRIA ......................................................... 6 $2,015 $3,840 $3,744 $175

Ducks and Geese only-Costs not Previously accounted for ...................................... 5 (included

in the 6

above)

................ ................ 54,744 2,553
Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Proposed Rules 59309

TABLE 2.—COSTS FOR IMPLEMENTING GENERIC E. COLI SAMPLING PROGRAMS FOR DUCK, GOOSE, AND GUINEA

ESTABLISHMENTS—Continued

Production category

Number of

establishments

Training

for aseptic sampling

Sampling

plan development

Sample

collection

and analysis (recurring)

Recording and

review

(recurring)

Establishments Currently Required to test Chickens or Turkeys .............................. 7 ................ ................ 90,456 4,218

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

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:

§ 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) * * *
59310 Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Proposed Rules

1A 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.

(i) * * *

(ii) Sample collection. The

establishment must collect samples

from all chilled livestock carcasses,

except those boned before chilling (hotboned), which must be sampled after

the final wash. Samples must be

collected in the following manner: 1

(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:

§ 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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 97–CE–79–AD]

RIN 2120–AA64

Airworthiness Directives; American

Champion Aircraft Corporation 7, 8,

and 11 Series Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes to

adopt a new airworthiness directive

(AD) that would apply to American

Champion Aircraft Corporation (ACAC)

7, 8, and 11 series airplanes, excluding

Model 8GCBC airplanes. The Federal

Aviation Administration (FAA)

previously proposed similar AD action

for the ACAC Model 8GCBC airplanes.

The proposed AD would require

installing inspection holes on the top

and bottom wing surfaces, repetitively

inspecting the front and rear wood spars

for damage, repairing or replacing any

damaged wood spar, and installing

inspection covers. Damage is defined as

cracks; compression cracks; longitudinal

cracks through the bolt holes or nail

holes; or loose or missing rib nails. The

proposed AD results from a review of

the service history of the affected

airplanes that incorporate wood wing

spars. The review was prompted by inflight wing structural failures on ACAC

Model 8GCBC airplanes, and revealed

several incidents where damage was

found on the front and rear wood spars

on the affected airplanes. The actions

specified by the proposed AD are

intended to prevent possible

compression cracks and other damage in

the wood spar wing, which, if not

detected and corrected, could

eventually result in in-flight structural

failure of the wing with consequent loss

of the airplane.

DATES: Comments must be received on

or before January 8, 1998.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Central Region,

Office of the Regional Counsel,

Attention: Rules Docket No. 97–CE–79–

AD, Room 1558, 601 E. 12th Street,

Kansas City, Missouri 64106. Comments

may be inspected at this location

between 8 a.m. and 4 p.m., Monday

through Friday, holidays excepted.

Service information that applies to the

proposed AD may be obtained from

American Champion Aircraft

Corporation, P.O. Box 37, 32032

Washington Avenue, Highway D,

Rochester, Wisconsin 53167. This

information also may be examined at

the Rules Docket at the address above.

FOR FURTHER INFORMATION CONTACT: Mr.

William Rohder, Aerospace Engineer,

FAA, Chicago Aircraft Certification

Office, 2300 E. Devon Avenue, Des

Plaines, Illinois 60018; telephone (847)

294–7697; facsimile (847) 294–7834.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested persons are invited to

participate in the making of the

proposed rule by submitting such