Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Rules and Regulations 61005

(E) A copy of all certifications

required under paragraph (p) of this

section.

(v) Access to records required to be

maintained under paragraph (p) of this

section must be restricted to officials of

the national government of the region of

origin, representatives of the United

States Government, and persons

maintaining the records.

(vi) The operator of the slicing/

packaging facility must have signed a

cooperative service agreement with

APHIS prior to receipt of the whole drycured hams, pork shoulders, or pork

loins for slicing and packaging, stating

that all hams, pork shoulders, or pork

loins sliced and packaged at the facility

for importation into the United States

will be sliced and packaged only in

accordance with this section.

(vii) The operator of the slicing/

packaging facility must be current, in

accordance with the terms of the

cooperative service agreement signed

with APHIS, in paying all costs for an

APHIS representative to inspect the

establishment, including travel, salary,

subsistence, administrative overhead,

and other incidental expenses.

(viii) The slicing/packaging facility

must allow the unannounced entry into

the establishment of APHIS

representatives, or other persons

authorized by the Administrator, for the

purpose of inspecting the establishment

and records of the establishment.

(ix) Workers at the slicing/packaging

facility who handle pork or pork

products in the facility must shower and

put on a full set of clean clothes, or wait

24 hours after handling pork or pork

products that are not eligible for

importation into the United States,

before handling dry-cured hams, pork

shoulders, or pork loins in the slicing/

packaging facility that are intended for

importation into the United States.

(x) Pork products intended for

importation into the United States may

not be in the slicing/packaging facility

at the same time as pork products not

intended for exportation to the United

States.

(2) Slicing and packaging and

labeling procedures. (i) A full-time

salaried veterinarian employed by the

national government of the region of

origin must inspect each lot of whole

dry-cured hams, pork shoulders, and

pork loins at the slicing/packaging

facility, before slicing is begun, and

must certify in English that it is eligible

for importation into the United States in

accordance with this section; and

(ii) Either a full-time salaried

veterinarian employed by the national

government of the region of origin, or,

if the national government of the region

of origin recognizes a local consortium

as responsible for product quality, a

representative of that local consortium,

must certify in English that he or she

personally supervised the entire process

of slicing and packaging each lot of drycured hams, pork shoulders, and pork

loins at the slicing/packaging facility;

that each lot of dry-cured hams, pork

shoulders, and pork loins was sliced

and packaged in accordance with the

requirements of this paragraph; and that

the sliced and packaged pork ham,

shoulder, or loin is the same dry-cured

ham, pork shoulder, or pork loin

certified under paragraph (p)(2)(i).

(iii) The sliced and packaged drycured pork ham, pork shoulder, or pork

loin must be labeled with the date that

processing of the meat under paragraph

(i) of this section began, and with the

date the meat was sliced and packaged.

(Approved by the Office of Management and

Budget under control number 0579–0015)

Done in Washington, DC, this 7th day of

November 1997.

Charles Schwalbe,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 97–29989 Filed 11–13–97; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Part 130

[Docket No. 96–089–1]

Import/Export User Fees; Exemptions

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Interim rule and request for

comments.

SUMMARY: We are amending the user fee

regulations to provide that user fees are

not charged for veterinary diagnostic

services in the following cases: 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)

or in support of zoonotic disease

surveillance when there is a significant

risk to human health; and when

veterinary diagnostic reagents are

distributed within the United States for

testing for foreign animal diseases. In

addition, we are eliminating the user fee

for export health certificates that are

requested and reviewed, but not

endorsed. We are making these changes

to eliminate confusion, clarify when

certain user fees apply, and eliminate an

unnecessary user fee.

DATES: Interim rule effective November

7, 1997. Consideration will be given

only to comments received on or before

January 13, 1998.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 96–089–1, Regulatory

Analysis and Development, PPD,

APHIS, suite 3C03, 4700 River Road

Unit 118, Riverdale, MD 20737–1238.

Please state that your comments refer to

Docket No. 96–089–1. Comments

received may be inspected at USDA,

room 1141, South Building, 14th Street

and Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing to

inspect comments are requested to call

ahead on (202) 690–2817 to facilitate

entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Ms.

Donna Ford, Section Head, Financial

Systems and Services Branch, Budget

and Accounting Division, M&B, APHIS,

4700 River Road Unit 54, Riverdale, MD

20737–1232, (301) 734–8351.

SUPPLEMENTARY INFORMATION:

Background

User fees to reimburse the Animal and

Plant Health Inspection Service (APHIS)

for the costs of providing veterinary

diagnostic services, and import-related

and export-related services for live

animals and birds and animal products

are contained in 9 CFR part 130.

Sections 130.14 through 130.18 list the

various veterinary diagnostic services

for which user fees are charged and the

associated user fees.

We are proposing to amend 9 CFR

part 130 (the regulations) to provide that

user fees will not be charged for

veterinary diagnostic services listed in

§§ 130.14 through 130.18 in the

following cases: (1) When veterinary

diagnostic services are provided in

connection with Federal programs to

control or eradicate diseases or pests of

animals in the United States (program

diseases) or in support of zoonotic

disease surveillance when there is a

significant risk to human health; and (2)

when veterinary diagnostic reagents are

distributed within the United States for

testing for foreign animal diseases. In

addition, we are eliminating the user fee

listed in § 130.20(d) for export health

certificates that are requested and

reviewed, but not endorsed.

Veterinary Diagnostic Services

Veterinary diagnostics is the work

performed in a laboratory to determine

if a disease-causing organism or
61006 Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Rules and Regulations

chemical agent is present in body

tissues or cells and to identify those

organisms or agents. Services in this

category include performing laboratory

tests at the National Veterinary Services

Laboratories (NVSL) and providing

diagnostic reagents and other veterinary

diagnostic materials and services.

Diagnostic reagents are biological

materials used in diagnostic tests to

detect disease agents or antibodies by

causing an identifiable reaction. NVSL

also collects data and compiles statistics

on the incidence of various livestock

diseases based on the results of the

veterinary diagnostic tests.

We do not charge user fees for

veterinary diagnostic services provided

in connection with Federal programs to

control or eradicate diseases or pests

(program diseases). Examples of

program diseases are tuberculosis,

brucellosis, and pseudorabies. These

activities are covered by appropriated

funding. Our policy not to charge for

these services was specified in the

background portion in previously

published proposed and final rules

concerning user fees for veterinary

diagnostic services (58 FR 15292–15301,

Docket No. 91–021–4, March 22, 1993,

and 58 FR 38954–38961, Docket No. 91–

021–5, July 21, 1993). In this document,

we are amending the regulations to

specify that user fees are not charged for

these services.

While not specified in earlier user fee

rules, there are other activities which

we cover by appropriated funding

instead of user fees. We routinely

distribute veterinary diagnostic reagents

free of charge to laboratories throughout

the United States for testing for foreign

animal diseases. This allows these

laboratories to immediately test animals

suspected of being infected with a

foreign animal disease. The distribution

of these diagnostic reagents is covered

by appropriated funding to ensure that

we are able to identify foreign animal

diseases as quickly as possible. In this

document, we are clarifying the

regulations by specifying that this

service is exempt from user fees.

In addition, we provide veterinary

diagnostic services in support of

zoonotic disease surveillance. Zoonotic

diseases are those that affect both

animals and humans and are

communicable from animals to humans.

Examples of zoonotic diseases are

anthrax, brucellosis, leptospirosis,

rabies, salmonellosis, tuberculosis, and

vesicular stomatitis. Some of these are

program diseases and, therefore, user

fees are not charged, as stated above.

Occasionally, there are zoonotic

diseases that pose a significant threat to

human health, and a thorough

knowledge of the prevalence of the

disease in animals will directly benefit

control of the disease in humans. In

these cases, we believe that the cost of

the testing related to the zoonotic

disease surveillance should be covered

by appropriated funds. At this time,

salmonellosis is the only zoonotic

disease that falls into this second

category, and user fees are not charged

for the salmonella testing that will

provide direct benefit to control of

disease in humans. User fees are

charged for other salmonellosis testing.

Therefore, we are amending our

regulations to state that user fees are not

charged for veterinary diagnostic

services provided in relation to zoonotic

diseases when the Administrator has

determined that there is a significant

threat to human health.

We are adding a new § 130.49 to the

regulations that lists the circumstances

under which we do not charge user fees

for veterinary diagnostic services. The

exemptions will be specified as follows:

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 animals 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 risk to human health;

and

(3) When veterinary diagnostic

reagents are distributed within the

United States for testing for foreign

animal diseases.

Nonendorsed Export Health Certificates

We established a user fee for

nonendorsed export health certificates

in a final rule published in the Federal

Register on May 7, 1996 (61 FR 20421–

20437, Docket No. 92–174–2). These are

certificates that are requested from the

Animal and Plant Health Inspection

Service (APHIS) and then are reviewed

by APHIS, but either withdrawn or

returned without being endorsed. The

user fee was intended to cover the costs

of the APHIS review. We have reviewed

this user fee and have determined that

we do not need to charge for these

services because these services are

comparable to those consultation

services that we provide via the

telephone to customers requesting

information about animal or animal

product exportation requirements. Most

export health certificates that are

returned by the APHIS veterinarian for

corrective action are later resubmitted

and endorsed. The user fee for the

endorsement of these export health

certificates recovers the costs for the full

review including any consultations.

Therefore, we are removing § 130.20(d)

from the regulations and will not charge

a user fee for export health certificates

that are reviewed but not endorsed.

Immediate Action

The Administrator of the Animal and

Plant Health Inspection Service has

determined that there is good cause for

publishing this interim rule without

prior opportunity for public comment.

Immediate action is warranted to

encourage participation in programs to

control and eradicate disease and pests

of livestock or poultry, eliminate

confusion about when user fees are

charged, and to eliminate an

unnecessary user fee. These changes

will benefit users and help ensure that

veterinary diagnostic services will

continue to be requested for testing in

connection with program diseases and

zoonotic disease surveillance when

there is a significant risk to human

health.

Because prior notice and other public

procedures with respect to this action

are impracticable and contrary to the

public interest under these conditions,

we find good cause under 5 U.S.C. 553

to make it effective upon signature. We

will consider comments that are

received within 60 days of publication

of this rule in the Federal Register.

After the comment period closes, we

will publish another document in the

Federal Register. It will include a

discussion of any comments we receive

and any amendments we are making to

the rule as a result of the comments.

Executive Order 12866 and Regulatory

Flexibility Act

This rule has been reviewed under

Executive Order 12866. The rule has

been determined to be not significant for

the purposes of Executive Order 12866

and, therefore, has not been reviewed by

the Office of Management and Budget.

This rule provides that we do not

charge user fees for (1) veterinary

diagnostic services related to program

diseases, (2) veterinary diagnostic

services related to zoonotic disease

surveillance when there is a significant

risk to human health, (3) the

distribution of diagnostic reagents

within the United States used in testing

for foreign animal diseases, or (4)

services provided to review, but not

endorse, export health certificates. Our

policy, has been not to charge user fees

for these services, and we are now
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