61002 Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Rules and Regulations

1Since the proposed rule was published, we have

amended our regulations for importing animals and

animal products to refer to regions, rather than

countries. See the paragraph headed

‘‘Miscellaneous,’’ elsewhere in this Supplementary

Information section.

PART 927—WINTER PEARS GROWN

IN OREGON, WASHINGTON, AND

CALIFORNIA

1. The authority citation for 7 CFR

part 927 continues to read as follows:

Authority: 7 U.S.C. 601–674.

2. The part heading is revised to read

as follows:

PART 927—WINTER PEARS GROWN

IN OREGON AND WASHINGTON

3. Section 927.4 is revised to read as

follows:

§ 927.4 Pears.

Pears means and includes any and all

of the Beurre D’Anjou, Beurre Bosc,

Winter Nelis, Doyenne du Comice,

Forelle, and Seckel varieties of pears,

and any other winter pear varieties or

subvarieties that are grown in the

production area and are recognized by

the Control Committee and approved by

the Secretary.

4. Section 927.10 is revised to read as

follows:

§ 927.10 Production area.

Production area means and includes

the States of Oregon and Washington.

§ 927.11 [Amended]

5. In § 927.11, paragraph (e) is

removed.

§ 927.20 [Amended]

6. Section 927.20 is amended by

removing the number ‘‘14’’ in the first

sentence and adding in its place the

number ‘‘12’’, and removing the word

‘‘seven’’ each time it appears in the

third sentence and adding in its place

the word ‘‘six’’.

§ 927.33 [Amended]

7. In § 927.33, paragraph (a) is

amended by removing the word ‘‘ten’’ in

the first sentence and adding in its place

the word ‘‘nine’’; and adding the words

‘‘telecopier or other electronic means,’’

and a comma after the word ‘‘mail’’ in

paragraph (b) first sentence.

Dated: November 7, 1997.

Thomas A. O’Brien,

Acting Administrator, Agricultural Marketing

Service.

[FR Doc. 97–29927 Filed 11–13–97; 8:45 am]

BILLING CODE 3410–02–P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Part 94

[Docket No. 96–066–2]

Importation of Sliced and PrePackaged Dry-Cured Pork Products

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Final rule.

SUMMARY: We are amending our

regulations to allow dry-cured pork

products that have been sliced and

packaged prior to shipment to the

United States to be imported into the

United States under specified

conditions. This action will relieve

some restrictions on the importation of

pork into the United States without

presenting a significant risk of

introducing any serious communicable

diseases of animals.

EFFECTIVE DATE: December 15, 1997.

FOR FURTHER INFORMATION CONTACT: Dr.

Julia Sturm, Supervisory Staff Officer,

Products Program, National Center for

Import and Export, VS, APHIS, Suite

3B66, 4700 River Road Unit 40,

Riverdale, MD 20737–1231, (301) 734–

3277; or E-mail: jsturm@.aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 94

(referred to below as the regulations)

govern the importation into the United

States of specified animals and animal

products to prevent the introduction of

various animal diseases, including

rinderpest, foot-and-mouth disease,

bovine spongiform encephalopathy, hog

cholera, African swine fever, and swine

vesicular disease, into the United States.

These are dangerous and destructive

communicable diseases of ruminants

and swine.

Under the regulations, certain animal

products—whole hams, pork shoulders,

and pork loins—from regions where

foot-and-mouth disease, rinderpest,

African swine fever, hog cholera, or

swine vesicular disease exists may be

imported into the United States only

under certain conditions. To be eligible

for importation, these products must

have been dry-cured and otherwise

handled in accordance with procedures

specified in § 94.17 of the regulations.

However, the regulations have not

allowed these same products to be

eligible for importation if they have

been sliced and packaged prior to

shipment. We have prohibited the

importation of sliced and packaged drycured hams, pork shoulders, and pork

loins because of the difficulty in

verifying the origin of the meat and how

it has been processed. Without this

information, we cannot easily determine

whether the meat has been treated and

otherwise handled in a manner that

ensures it is free of disease agents.

On April 14, 1997, we published in

the Federal Register (62 FR 18055–

18059, Docket No. 96–066–1) a proposal

to allow presliced and prepackaged drycured pork to be imported into the

United States under certain conditions

from countries 1 where foot-and-mouth

disease, rinderpest, swine vesicular

disease, African swine fever, and hog

cholera exist. The proposed conditions

were designed to ensure that the origin

of the pork and the method of

processing could be verified.

We solicited comments concerning

our proposal for 60 days ending June 13,

1997. We received 13 comments by that

date. They were from importers, foreign

governments and meat processors, and

one veterinarian. The comments were

primarily positive. Several comments

suggested changes in the proposed

regulations. These suggestions are

discussed individually below.

Separation of Facilities

In our proposed rule, we required that

the slicing/packaging facility itself

would have to be in a separate building,

physically detached from any area

where pork or pork products are

handled for other purposes. This

requirement was designed to prevent

any possible contamination of the meat.

Several commenters objected to this

requirement as unnecessarily restrictive.

Commenters made various suggestions

as to how we could minimize

contamination without requiring a

separate building for the slicing/

packaging facility. Among the

suggestions were: require workers

moving from the pork processing facility

to the slicing/packaging facility to

change into either freshly laundered or

disposable clothing, including caps,

masks, gloves and footwear; require a

‘‘changing/scrub’’ room for employees;

and require ‘‘walls, doors, passageways,

etc.’’

After carefully considering these

comments, we have determined that our

proposed requirement that the slicing/

packaging facility be in a separate

building is overly restrictive. Having the
Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Rules and Regulations 61003

slicing/packaging facility in a separate

building would achieve our goal of

separating the facilities so that disease

agents cannot be transmitted from areas

in the facility where pork is cured and

dried to the slicing/packaging facility.

However, it may not be practical in all

situations, and we believe the desired

goal can be accomplished by other

means. Therefore, our final rule

(§ 94.17(p)(1)(ii)) will state that the

slicing/packaging facility may either be

in a separate, physically detached

building, or in a separate room within

the same building where the pork is

cured and dried if the slicing and

packing room has no direct access to

areas in the facility where pork is cured

and dried and if the room can be closed

off from the rest of the facility so

unauthorized individuals cannot enter.

We are not making any changes based

on the commenters’ suggestions

regarding showering and clothing for

workers. Our proposed rule included a

requirement (see § 94.17(p)(1)(ix)) that

workers in the slicing/packaging

facilities who handle dry-cured hams,

pork shoulders, and pork loins either

shower and put on a full set of clean

clothes, or wait 24 hours after handling

other pork or pork products before

handling dry-cured pork hams, pork

shoulders, or pork loins in the facility

that are intended for importation into

the United States. We believe the

commenters’ suggestions are already

covered by this requirement.

Safeguards

One commenter objected that our

proposed rule would eliminate ‘‘critical

safeguard and identification points.’’

The commenter pointed out that no

individual identification would remain

on the pork after slicing and packaging,

and that the Animal and Plant Health

Inspection Service (APHIS) would have

to rely on ‘‘paper certification’’ and

records compiled by facilities that

process, slice, and package dry-cured

pork products.

As discussed in our proposal, we

believe that the combination of

inspection and recordkeeping

requirements included in this

rulemakng will allow verification of the

meat’s origin, treatment, and handling.

Therefore, we have made no changes in

response to this comment. Our rule

provides for periodic inspections of

slicing/packaging facilities (see

proposed § 94.17(p)(1)). These include

inspections by both APHIS personnel

and personnel from the Food Safety

Inspection Service (FSIS) of the U.S.

Department of Agriculture. In addition,

our rule requires slicing/packaging

facilities to maintain specific, detailed

records on the source and identity of all

dry-cured pork they handle (see

§ 94.17(p)(1)(iv)). Access to these

records 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 (see

§ 94.17(p)(1)(v)). In addition, APHIS

representatives, or individuals

authorized by APHIS, will make

unannounced visits to inspect the

facility and the required records (see

§ 94.17(p)(1)(viii)).

Since April 1987, similar

recordkeeping and inspection

requirements have been in effect for

facilities that cure and dry whole pork

products. These products have been

imported into the United States since

1988 without problems.

We realize that the effectiveness of

our regulations is dependent to some

extent on the honesty and reliability of

others. However, this is also true in

reverse: foreign governments rely on

records maintained by U.S. producers

and processors, and on certificates

issued by APHIS. In a system of mutual

reliance, we believe the possibility of

violations is minimized.

Under these circumstances, we

believe our regulations are adequate to

protect the health of livestock in the

United States.

Lot Numbers

One commenter suggested that we

require lot numbers to be placed on

packages of sliced pork.

When drafting the proposed rule, we

considered requiring the lot number of

the meat to appear on the label, or

requiring that meat from only one lot be

in a package. However, as we explained

in our proposed rule, current industry

practice is to label packages with the lot

number. Current industry practice is

also to package only meat from one lot

in a package. Under these

circumstances, it appears unnecessary

to include either requirement in our

regulations. However, if industry

practices change, and we believe it is

necessary to require lot numbers or to

require that only meat from one lot be

in a package, we will publish a proposal

in the Federal Register for public

comment.

Miscellaneous

On October 28, 1997, we published in

the Federal Register (62 FR 56000—

56026, Docket No. 94–106–9) a final

rule establishing procedures for

recognizing regions, rather than only

countries, for the purpose of

importation of animals and animal

products into the United States. In that

rule, scheduled to be effective on

November 28, 1997, we amended 9 CFR

part 94 to remove the words ‘‘country’’

and ‘‘countries’’ and replace them,

respectively, with the words ‘‘region’’

and ‘‘regions’’. To reflect these

intervening changes, we have therefore

adjusted the language in this rule.

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.

In accordance with 5 U.S.C. 603, we

have performed a Final Regulatory

Flexibility Act Analysis, set forth below,

regarding the economic impact of this

rule on small entities.

This final rule will amend the

regulations regarding importation of

dry-cured pork products from regions

where certain diseases of concern exist,

by providing that certain sliced and

packaged products may be imported

into the United States under specified

conditions.

We have used all available data to

estimate the potential economic effects

of allowing these sliced and prepackaged dry-cured pork products to be

imported into the United States.

However, some of the data we believe

would be helpful in making this

determination has not been available.

Specifically, data on: (1) The quantity of

specialty dry-cured hams produced

domestically; (2) the quantity of

potential imports; and (3) the degree to

which imported presliced and

prepackaged dry-cured pork products

will displace existing imported or

domestic products, is not available. In

our proposed rule, we invited

comments. However, none of the

comments we received addressed these

economic issues.

The pork products covered by the rule

are specialty products, such as Parma

hams from Italy. These products are

similar to other dry-cured pork products

consumed in the United States, some

imported from other countries and some

produced domestically. Currently, only

whole dry-cured pork hams, pork

shoulders, and pork loins are being

imported into the United States. Slightly

less than 3 million pounds of such

whole products were imported in 1995,

the most recent year for which figures

are available. Presliced and prepackaged

dry-cured pork products are not being

imported into the United States at this

time.

We estimate that fewer than 15

domestic companies produce dry-cured
61004 Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Rules and Regulations

2See footnote 14 in § 94.17(e).

pork products similar to those covered

by this final rule as a primary or major

product line. At least two of these

companies are very large, and these

types of products constitute only a small

fraction of their overall business. Of the

others, four are subsidiaries of Italian or

Swiss companies.

There are also a number of other

producers of cured and smoked hams

who may produce similar products. If

they do, this final rule could affect

them. In addition, there are

approximately 10 domestic

establishments that buy cured hams and

trim and dress them for resale. Some of

the resulting products might be similar

to the presliced and prepackaged

products covered by this rule. If so,

these businesses could also be affected

by this final rule.

This rule contains various

recordkeeping requirements, which

were described in our proposed rule,

and which have been approved by the

Office of Management and Budget.

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

In accordance with the Paperwork

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

et seq.), the information collection or

recordkeeping requirements included in

this final rule have been approved by

the Office of Management and Budget

(OMB) under OMB control number

0579–0015.

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 94

Animal diseases, Imports, Livestock,

Meat and meat products, Milk, Poultry

and poultry products, Reporting and

recordkeeping requirements.

Accordingly, 9 CFR part 94 is

amended as follows:

PART 94—RINDERPEST, FOOT-ANDMOUTH DISEASE, FOWL PEST (FOWL

PLAGUE), EXOTIC NEWCASTLE

DISEASE, AFRICAN SWINE FEVER,

HOG CHOLERA, AND BOVINE

SPONGIFORM ENCEPHALOPATHY:

PROHIBITED AND RESTRICTED

IMPORTATIONS

1. The authority citation for part 94

continues to read as follows:

Authority: 7 U.S.C. 147a, 150ee, 161, 162,

and 450; 19 U.S.C. 1306; 21 U.S.C. 111, 114a,

134a, 134b, 134c, 134f, 136, and 136a; 31

U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR

2.22, 2.80, and 371.2(d).

§ 94.17 [Amended]

2. Section 94.17 is amended as

follows:

a. By revising the introductory text to

read as set forth below.

b. In paragraph (d), by adding the

word ‘‘whole’’ immediately before the

word ‘‘ham,’’.

c. In paragraph (e), by adding the

word ‘‘whole’’ immediately after the

words ‘‘was processed’’; and in footnote

14, by removing the words ‘‘9 CFR part

301, et seq.’’ and adding the words ‘‘9

CFR, chapter III’’ in their place.

d. In paragraph (f), by adding the

word ‘‘whole’’ immediately after the

words ‘‘was processed’’.

e. In paragraph (g), by adding the

word ‘‘whole’’ immediately after the

words ‘‘was processed’’, and by

removing the words ‘‘within 12

months’’.

f. In the introductory text of paragraph

(h), and in the introductory text of

paragraph (i), by adding the word

‘‘whole’’ immediately after the words

‘‘was processed’’.

g. In paragraphs (j)(1), (j)(2), (j)(3), (k),

(l), and (n), by adding the word ‘‘whole’’

immediately after the first word ‘‘The’’

in each paragraph.

h. In paragraph (j)(2), by adding the

word ‘‘whole’’ immediately before the

words ‘‘dry-cured pork shoulder’’.

i. In paragraph (n), by removing the

words ‘‘trust fund agreement’’ and

adding the words ‘‘cooperative service

agreement’’ in its place each time it

appears.

j. By adding a new paragraph (p) to

read as set forth below.

§ 94.17 Dry-cured pork products from

regions where foot-and-mouth disease,

rinderpest, African swine fever, hog

cholera, or swine vesicular disease exists.

Notwithstanding any other provisions

in this part, dry-cured ham, pork

shoulder, or pork loin, whether whole

or sliced and packaged, shall not be

prohibited from being imported into the

United States if it meets the following

conditions:

* * * * *

(p) Whole hams, pork shoulders, and

pork loins that have been dry-cured in

accordance with paragraph (i) of this

section may be transported to a facility

in the same region for slicing and

packaging in accordance with this

paragraph.

(1) The slicing/packaging facility. (i)

The slicing/packaging facility 2 must be

inspected, prior to slicing and packaging

any hams, pork shoulders, or pork loins

in accordance with this paragraph, by

an APHIS representative and

determined by the Administrator to be

capable of meeting the provisions of this

paragraph.

(ii) The slicing/packaging facility

must be either in a separate, physically

detached building, or in a separate room

in the facility where the whole ham,

pork shoulder, or pork loin was drycured in accordance with paragraph (i)

of this section. If the slicing/packaging

facility is in a separate room, the room

must have no direct access to areas in

the facility where pork is cured and

dried and it must be capable of being

closed off from the rest of the facility so

unauthorized individuals cannot enter.

(iii) The slicing/packaging facility,

including all equipment used to handle

pork and pork products, such as

containers, work surfaces, slicing

machines, and packaging equipment,

must be cleaned and disinfected after

sliced and packaged pork products that

are not eligible for export to the United

States leave the facility, and before

whole dry-cured hams, pork shoulders,

or pork intended for importation into

the United States enter the facility for

slicing and packaging. Cleaning and

disinfecting must be adequate to ensure

that disease agents of concern are killed

or inactivated and that pork products

intended for importation into the United

States are not contaminated.

(iv) The slicing/packaging facility

must maintain under lock and key for a

minimum of 2 years, original records on

each lot of whole dry-cured hams, pork

shoulders, and pork loins entering the

facility for slicing and packaging under

this section, including:

(A) The approval number of the

facility where the whole ham, shoulder,

or loin was dry-cured in accordance

with paragraph (i) of this section;

(B) The date the whole ham, shoulder,

or loin started dry-curing;

(C) The date the whole ham, shoulder,

or loin completed dry-curing;

(D) The date the whole ham, shoulder,

or loin was sliced and packaged; and
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