Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Rules and Regulations 61007

clarifying that policy in the regulations.

Therefore, this rule should have no

impact on entities whether they are

large or small.

Under these circumstances, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this action will not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12372

This program/activity is listed in the

Catalog of Federal Domestic Assistance

under No. 10.025 and is subject to

Executive Order 12372, which requires

intergovernmental consultation with

State and local officials. (See 7 CFR part

3015, subpart V.)

Executive Order 12988

This rule has been reviewed under

Executive Order 12988, Civil Justice

Reform. This rule: (1) Preempts all State

and local laws and regulations that are

inconsistent with this rule; (2) has no

retroactive effect; and (3) does not

require administrative proceedings

before parties may file suit in court

challenging this rule.

Paperwork Reduction Act

This rule contains no information

collection or recordkeeping

requirements under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.).

Regulatory Reform

This action is part of the President’s

Regulatory Reform Initiative, which,

among other things, directs agencies to

remove obsolete and unnecessary

regulations and to find less burdensome

ways to achieve regulatory goals.

List of Subjects in 9 CFR Part 130

Animals, Birds, Diagnostic reagents,

Exports, Imports, Poultry and poultry

products, Quarantine, Reporting and

recordkeeping requirements, Tests.

Accordingly, 9 CFR part 130 is

amended as follows:

PART 130—USER FEES

1. The authority citation for part 130

continues to read as follows:

Authority: 5 U.S.C. 5542; 7 U.S.C. 1622; 19

U.S.C. 1306; 21 U.S.C. 102–105, 111, 114,

114a, 134a, 134b, 134c, 134d, 134f, 135, 136,

and 136a; 7 CFR 2.22, 2.80, and 371.2(d).

§ 130.20 [Amended]

2. Section 130.20 is amended by

removing paragraph (d) and

redesignating paragraph (e) as paragraph

(d).

3. A new § 130.49 is added to read as

follows.

§ 130.49 Exemptions.

(a) Veterinary diagnostics. User fees

for veterinary diagnostic services,

including, but not limited to, tests and

diagnostic reagents specified in

§§ 130.14 through 130.18, are not

charged under the following conditions:

(1) When veterinary diagnostic

services are provided in connection

with Federal programs to control or

eradicate diseases or pests of livestock

or poultry in the United States (program

diseases);

(2) When veterinary diagnostic

services are provided in support of

zoonotic disease surveillance when the

Administrator has determined that there

is a significant threat to human health;

and

(3) When veterinary diagnostic

reagents are distributed within the

United States for testing for foreign

animal diseases.

(b) [Reserved].

Done in Washington, DC, this 7th day of

November 1997.

Charles Schwalbe,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 97–29990 Filed 11–13–97; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 310, 381, and 417

[Docket No. 97–056DF]

RIN 0583–AC40

Pathogen Reduction; Hazard Analysis

and Critical Control Point (HACCP)

Systems—Sample Collection—

Technical Amendments and

Corrections: Direct Final Rule

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Direct final rule.

SUMMARY: FSIS is making technical

corrections and amendments to the final

rule, ‘‘Pathogen Reduction; Hazard

Analysis and Critical Control Point

(HACCP) Systems,’’ published on July

25, 1996. In response to worker safety

concerns, FSIS will permit samples

collected for generic E. coli testing of

turkeys to be collected by sponging two

sites. Samples may still be collected by

the whole bird rinse procedure (shaking

turkeys in a bag containing a buffer

solution). FSIS will also permit

chickens and turkeys to be taken from

the end of the slaughter line if it is

impracticable to take a whole bird from

the end of the chilling process.

Additionally, FSIS is amending the

regulations to add the performance

standard for Salmonella in fresh pork

sausage, which was unavailable at the

time the rule was published, and correct

a minor editorial oversight.

DATES: This rule will be effective on

January 13, 1998, unless adverse or

critical comments are received on or

before December 15, 1997. If adverse or

critical comments within the scope of

the rulemaking are received, FSIS will

issue timely notice in the Federal

Register.

ADDRESSES: Send an original and two

copies of adverse written comments

within the scope of the rulemaking to:

FSIS Docket Clerk, DOCKET # 97–

056DF, Room 102, Cotton Annex, 300

12th Street, SW, Food Safety and

Inspection Service, U.S. Department of

Agriculture, Washington, DC 20250–

3700. Reference materials cited in this

docket will be available for public

inspection in the FSIS Docket Room

from 8:30 to 4:30 p.m., Monday through

Friday.

FOR FURTHER INFORMATION CONTACT: Ms.

Patricia Stolfa, Assistant Deputy

Administrator, Office of Policy, Program

Development and Evaluation, (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

final rule required all slaughter

establishments to test for generic E. coli

at a frequency based on production

volume to verify that plants are meeting

the established performance criteria. In

the preamble to the final rule, FSIS

solicited comments and information on

a number of technical issues concerning

the protocols for generic E. coli testing

and announced that conferences would

be held to discuss these issues.

The first conference was held on

September 12 and 13, 1996. Participants

discussed issues such as testing

frequency, sampling procedures, and

revision of the testing protocol to better

account for differing establishment

characteristics. In light of these

comments, FSIS published the May 13,

1997, final rule ‘‘Pathogen Reduction;

Hazard Analysis and Critical Control

Point (HACCP) Systems—Technical

Amendments and Corrections’’ (62 FR

26211). The final rule made some

changes to the E. coli testing

requirements.

On May 8, 1997, FSIS held a followup conference ‘‘Technical Conference:

Review of E. coli Testing.’’ A panel of
61008 Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Rules and Regulations

industry and academia representatives

made presentations about the on-going

generic E. coli verification testing by

establishments and discussed their

observations and views. In response to

information provided at the conference,

FSIS is amending the sample collection

procedures for turkeys and allowing

flexibility for the collection of poultry to

be sampled. Currently, turkeys randomly selected

for sampling must be rinsed in a buffer

solution. The rinsing technique involves

shaking a whole turkey carcass in a bag

containing the buffer solution. Prior to

the meeting, FSIS was aware of

concerns regarding this process. At the

meeting, commenters raised the issue

and presented data that supports an

alternative means of sample collection. The primary concern regarding the

current sampling technique for turkeys

is the physical difficulty of shaking

large turkeys (i.e., those that are 15 to

20 pounds). Also, some commenters

have stated that the size of the turkeys

makes it difficult to prevent sample

contamination when the buffer solution

is decanted from the sampling bag into

the sample bottle for transportation to

the laboratory. At the conference, data

was presented which indicated that a

sponging technique is more practical,

and provides accurate and reliable

results for microbiological sampling. FSIS agrees that shaking turkeys in

the bag may be difficult for individuals

taking the sample and that sample

contamination may occur. Because of

the lack of data in support of an

alternative method, FSIS has not

previously adopted another sample

collection method for turkeys. However,

after reviewing the data presented at the

conference, FSIS has determined that a

sponge method for the collection of

turkey samples is effective. Therefore,

FSIS will amend the Pathogen

Reduction/HACCP final rule to permit

establishments to sample turkeys by

sponging the back and thigh or to

continue using the whole bird rinse

procedure. Data collected using the sponge

technique will be evaluated using

statistical process control techniques as

required in the May 13, 1997, technical

amendments final rule. FSIS has begun

to develop m/M criteria for turkey

samples collected by the sponge method

and will release data from this baseline

quarterly so that establishments can use

them for statistical process control

techniques. FSIS also is in the process

of developing m/M criteria for cattle and

swine samples collected by the sponge

method. The results from FSIS’s first

quarter of the study is as follows: for

cattle m=negative and M=1; for swine

m=.1 and M=100.

Commenters also expressed concern

about the difficulty in taking whole

birds from the end of the chilling

process, after the drip line, because the

birds on the drip line are often high off

the ground and hard to reach. FSIS

understands this concern. In the

technical amendments final rule, FSIS

provided establishments with the option

of taking birds from the end of the

slaughter line for carcasses that are hotboned. With this rule, FSIS is amending

the regulations to permit birds to be

taken at the end of the slaughter line for

carcasses, if sampling at the end of the

drip line is impracticable. In the pathogen reduction/HACCP

final rule, FSIS stated that it was in the

process of developing a Salmonella

performance standard for fresh pork

sausages. That work has been completed

and the performance standard will be

added to the regulations. The

performance standard is 30% (percent

positive for Salmonella), the number of

samples tested (n) equals 53, and the

maximum number of positives to

achieve the standard (c) equals 18. The

methodology used to develop this

performance standard was the same as

for the other ground products. To

further explain how the performance

standard was developed, FSIS is making

available copies of the paper

‘‘Estimation of Salmonella Prevalence in

25-gram Portions of Fresh Ground Pork’’

in the FSIS Docket Room.

Lastly, FSIS is making a technical

correction to 9 CFR 417.2(e). The

section should reference the Poultry

Products Inspection Act (PPIA) and the

Federal Meat Inspection Act (FMIA).

FSIS inadvertently omitted references to

sections 21 U.S.C. 456 and 463 of the

PPIA and only referenced sections 21

U.S.C. 608 and 621 of the FMIA.

Therefore, references to the PPIA

authority will be added to this section. FSIS expects no adverse public

reaction resulting from this change in

regulatory language. Therefore, unless

the Agency receives adverse or critical

comments within the scope of this

rulemaking, or a notice of intent to

submit adverse comments within the

scope of this rulemaking within 30 days,

the action will become final 60 days

after publication in the Federal

Register. If adverse comments within

the scope of the rulemaking are

received, the final rulemaking notice

will be withdrawn and a proposed

rulemaking notice will be published.

The proposed rulemaking notice will

establish a comment period.

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 has determined

that this final 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).

The Pathogen Reduction/HACCP final

rule included a Final Regulatory Impact

Assessment (FRIA) (61 FR 38945). The

technical corrections and amendment

do not change the cost and benefit

estimates and impact assessments

presented in the FRIA.

Executive Order 12988

This final rule has been reviewed

under Executive Order 12988, Civil

Justice Reform. In this final rule: (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

The Pathogen Reduction/HACCP final

rule included a paperwork analysis (61

FR 38862) prepared in accordance with

the Paperwork Reduction Act. FSIS has

determined that the technical

corrections and amendments in this rule

do not change any information

collection burden hours.

Final Rules

List of Subjects

9 CFR Part 310

Meat inspection, Microbial testing.

9 CFR Part 381

Poultry and poultry products,

Microbial testing.

For 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 Table 2 in paragraph (b)(1) to

read as follows:

§ 310.25 Contamination with

microorganisms; pathogen reduction

performance standards for Salmonella.

* * * * *

(b) * * *

(1) * * *
Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Rules and Regulations 61009

1A copy of FSIS’s ‘‘Guidelines for Escherichia

coli Testing for Process Control Verification in

Poultry Slaughter Establishments’’ and ‘‘FSIS

Turkey Microbiological Procedures for Sponge

Sample Collection and Methods of Analysis’’ are

available for inspection in the FSIS Docket Room.

TABLE 2.—SALMONELLA PERFORMANCE STANDARDS

Class of product

Performance

standard

(percent

positive for

Salmonella) a

Number of

samples

tested

(n)

Maximum

number of

positives to

achieve

standard

(c)

Steers/heifers ......................................................................................................................................... 1.0 82 1

Cows/bulls .............................................................................................................................................. 2.7 58 2

Ground beef ........................................................................................................................................... 7.5 53 5

Hogs ....................................................................................................................................................... 8.7 55 6

Fresh pork sausages .............................................................................................................................. 30 53 18

aPerformance Standards are FSIS’s calculation of the national prevalence of Salmonella on the indicated raw product based on data developed by FSIS in its nationwide microbiological data collection programs and surveys. (Copies of Reports on FSIS’s Nationwide Microbiological

Data Collection Programs and Nationwide Microbiological Surveys used in determining the prevalence of Salmonella on raw products are available in the FSIS Docket Room.)

* * * * *

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)(ii) to read as

follows:

§ 381.94 Contamination with

microorganisms; process control

verification criteria and testing; pathogen

reduction standards.

(a) * * *

(2) Sampling requirements.

(ii) Sample collection. A whole bird

must be taken from the end of the

chilling process. If this is impracticable,

the whole bird can be taken from the

end of the slaughter line. Samples must

be collected by rinsing the whole

carcass in an amount of buffer

appropriate for that type of bird.

Samples from turkeys also may be

collected by sponging the carcass on the

back and thigh.1

* * * * *

PART 417—HAZARD ANALYSIS AND

CRITICAL CONTROL POINT (HACCP)

SYSTEMS

3. The authority citation for part 417

continues to reads as follows:

Authority: 7 U.S.C. 450; 21 U.S.C. 451–

470, 601–695; 7 U.S.C. 1901–1906; 7 CFR

2.18, 2.53.

§ 417.2 Hazard Analysis and HACCP Plan.

4. Section 417.2 is amended by

revising paragraph (e) to read as follows:

* * * * *

(e) Pursuant to 21 U.S.C. 456, 463,

608, and 621, the failure of an

establishment to develop and

implement a HACCP plan that complies

with this section, or to operate in

accordance with the requirements of

this part, may render the products

produced under those conditions

adulterated.

Done at Washington, DC, on November 4,

1997.

Thomas J. Billy,

Administrator.

[FR Doc. 97–29929 Filed 11–13–97; 8:45 am]

BILLING CODE 3410–DM–P

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 331 and 381

[Docket No. 97–050F]

Designation of the State of Florida

Under the Federal Meat Inspection Act

and the Poultry Products Inspection

Act

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Final rule.

SUMMARY: Representatives of the State of

Florida have advised the Agency that,

because of a lack of funding, the State

of Florida will no longer continue

administering its State meat and poultry

inspection programs after November 30,

1997. The Food Safety and Inspection

Service (FSIS) is mandated by law to

assume the responsibility, previously

held by the State of Florida, for

administering the meat and poultry

inspection programs with respect to

operations and transactions within the

State of Florida. Therefore, in

accordance with the law, the Secretary

of Agriculture is designating the State of

Florida to receive Federal inspection

with respect to operations and

transactions within the State, and FSIS

is amending the Federal meat and

poultry inspection regulations by

adding Florida to the list of

‘‘designated’’ States.

DATES: This final rule will be effective

on December 2, 1997.

FOR FURTHER INFORMATION CONTACT: Dr.

William Leese, Director, Federal-State

Relations Staff, Food Safety and

Inspection Service, U.S. Department of

Agriculture, Washington, DC 20250–

3700 at (202) 720–6313.

SUPPLEMENTARY INFORMATION:

Background

Under section 301 of the Federal Meat

Inspection Act (FMIA) and section 5 of

the Poultry Products Inspection Act

(PPIA), a State may administer State

meat and poultry inspection programs

provided the State has developed and is

effectively enforcing State meat and

poultry inspection requirements at least

equal to those imposed under titles I

and IV of the FMIA and section 1–4, 6–

10, and 12–22 of the PPIA (collectively

referred to below as the titles). These

titles contemplate continuous ongoing

programs. When States can no longer

effectively enforce meat and poultry

inspection requirements at least equal to

Federal requirements, then they must be

‘‘designated’’ by the Secretary to receive

Federal inspection.

In accordance with the FMIA and

PPIA, the Secretary had determined that

the State of Florida had developed and

was enforcing State meat and poultry

inspection requirements for

establishments at least equal to Federal

meat and poultry inspection