61036 Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Proposed Rules

processing can demonstrate a

compelling need by submitting a

statement certified by the requester to be

true and correct to the best of such

person’s knowledge and belief and that

satisfies the statutory and regulatory

definitions of compelling need.

Requesters shall be notified within ten

(10) calendar days after receipt of such

a request whether expedited processing,

or an appeal of a denial of a request for

expedited processing, was granted. As

used in this section, compelling need

means:

(1) That a failure to obtain requested

records on an expedited basis could

reasonably be expected to pose an

imminent threat to the life or physical

safety of an individual; or

(2) With respect to a request made by

a person primarily engaged in

disseminating information, urgency to

inform the public concerning actual or

alleged Federal Government activity.

Dated: November 7, 1997.

Solly Thomas,

Executive Director.

[FR Doc. 97–29914 Filed 11–13–97; 8:45 am]

BILLING CODE 6727–01–P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Part 94

[Docket No. 97–086–1]

Changes in Disease Status of Belgium,

France, Greece, Luxembourg,

Portugal, and Spain

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to declare

Luxembourg and Portugal free of

rinderpest and foot-and-mouth disease;

Greece free of rinderpest; France,

Greece, Luxembourg, and Spain free of

exotic Newcastle disease; Portugal free

of African swine fever; and Belgium,

France, and Portugal free of swine

vesicular disease. These proposed

actions are based on a request from the

European Commission’s Directorate

General for Agriculture and on our

review of the supporting documentation

supplied with that request. These

proposed actions would relieve some

restrictions on the importation into the

United States of certain animals and

animal products from those countries.

However, because of the status of those

countries with respect to other diseases,

and because of other factors that could

result in a risk of introducing animal

diseases into the United States, the

importation into the United States of

animals and animal products from those

countries would continue to be subject

to certain restrictions.

DATES: 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. 97–086–1, 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. 97–086–1. 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: Dr.

John Cougill, Staff Veterinarian,

Products Program, National Center for

Import and Export, VS, APHIS, 4700

River Road Unit 40, Riverdale, MD

20737–1231, (301) 734–8695; or e-mail:

jcougill@aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 94

(referred to below as the regulations)

prohibit or restrict the importation of

specified animals and animal products

into the United States in order to

prevent the introduction of various

animal diseases, including foot-andmouth disease (FMD), rinderpest, exotic

Newcastle disease (END), African swine

fever (ASF), hog cholera, swine

vesicular disease (SVD), and bovine

spongiform encephalopathy (BSE).

These are dangerous and destructive

communicable diseases of ruminants,

swine, and poultry.

In this document, we are proposing to

declare Luxembourg and Portugal free of

FMD and rinderpest; Greece free of

rinderpest; France, Greece, Luxembourg,

and Spain free of END; Portugal free of

ASF; and Belgium, France, and Portugal

free of SVD. We are proposing these

actions in response to a request

submitted to the Animal and Plant

Health Inspection Service (APHIS) in

July 1997 by the European

Commission’s (EC’s) Directorate General

for Agriculture. With its request, the

EC’s Directorate General for Agriculture

provided supporting documentation

that included information about the

capability of each country’s veterinary

services, laboratory and diagnostic

procedures, vaccination practices, and

the administration of laws and

regulations to ensure against the

introduction of the diseases of concern

into each country through the

importation of live animals, meats, and

animal products.

Since this request was received and

reviewed by APHIS, we have published

a final rule and policy statement in the

Federal Register that establish

procedures for recognizing regions,

rather than only countries, for the

purpose of importing animals and

animal products into the United States,

and that establish procedures by which

regions may request permission to

export animals and animal products to

the United States under specified

conditions, based on the regions’

disease status (see 62 FR 56000–56033,

October 28, 1997, Dockets 94–106–8 and

94–106–9). The final rule is scheduled

to become effective on November 28,

1997. The request from the EC

addressed by this proposed rule is not

a request to recognize regions, rather

than countries, nor a request to establish

new import conditions based the

disease status of any region. Therefore,

as we explained we would do in our

final rule and policy statement on

regionalization, we have handled and

evaluated this request in the traditional

framework of recognizing a country as

free or not free of a specified disease. If

this proposed rule is adopted, the

current regulations regarding

importation of animals and animal

products from regions ‘‘free’’ of a

specified disease will apply.

Luxembourg and Portugal Free of

Rinderpest and FMD

Section 94.1(a)(1) of the regulations

provides that rinderpest or FMD exists

in all regions of the world except those

listed in § 94.1(a)(2), which have been

declared to be free of those diseases.

The regulations in § 94.1(b) prohibit,

with certain specific exceptions, the

importation into the United States of

any ruminant or swine, or any fresh,

chilled, or frozen meat of any ruminant

or swine, that is from any region where

rinderpest or FMD exists, or that has

entered a port in or otherwise transited

a region where rinderpest or FMD

exists. Furthermore, the regulations in

§ 94.2 restrict the importation of fresh,

chilled, or frozen products other than

meat, and milk and milk products, of

ruminants or swine that originate in or

transit a region where rinderpest or

FMD exists. Additionally, the

importation of organs, glands, extracts,

and secretions of ruminants or swine

originating in a region where rinderpest
Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Proposed Rules 61037

or FMD exists is restricted under the

regulations in § 94.3, and the

importation of cured or cooked meat

from a region where rinderpest or FMD

exists is restricted under the regulations

in § 94.4. Finally, the regulations in 9

CFR part 98 restrict the importation of

ruminant and swine embryos and

animal semen from a region where

rinderpest or FMD exists.

We will consider declaring a region to

be free of rinderpest and FMD if, among

other things, there have been no cases

of those diseases reported there for at

least the previous 1-year period and no

vaccinations for rinderpest or FMD have

been administered to swine or

ruminants in that region for at least the

previous 1-year period. There has never

been a reported case of rinderpest in

Luxembourg or Portugal, and the last

reported cases of FMD in Luxembourg

and Portugal occurred in 1964 and 1984,

respectively. Both Luxembourg and

Portugal have prohibited vaccinations

for rinderpest and FMD since 1991.

We have reviewed the documentation

submitted by the EC’s Directorate

General for Agriculture in support of its

request that Luxembourg and Portugal

be declared free of rinderpest and FMD.

Based on that documentation, we

believe that Luxembourg and Portugal

qualify to be designated as free of

rinderpest and FMD. Therefore, we are

proposing to add Luxembourg and

Portugal to the list in § 94.1(a)(2) of

regions declared free of rinderpest and

FMD. This proposed action would

remove the rinderpest- and FMD-based

prohibition on the importation from

Luxembourg and Portugal of live

ruminants and fresh, chilled, or frozen

meat from ruminants and would relieve

restrictions on the importation, from

these two countries, of milk and milk

products from ruminants. However, the

importation of fresh, chilled, or frozen

meat and edible products other than

meat (excluding gelatin, milk, and milk

products) from ruminants that have

been in Portugal would continue to be

restricted under § 94.18 because

Portugal is listed in § 94.18 as a region

in which BSE exists. Additionally, the

importation from Luxembourg and

Portugal of live swine and fresh, chilled,

or frozen meat from swine would

continue to be restricted under § 94.9 of

the regulations because these countries

have not been declared free of hog

cholera.

We are also proposing to add

Luxembourg and Portugal to the list in

§ 94.11(a) of regions declared free of

rinderpest and FMD that are subject to

special restrictions on the importation

of their meat and other animal products

into the United States. The regions

listed in § 94.11(a) are subject to these

special restrictions because they: (1)

Supplement their national meat supply

by importing fresh, chilled, or frozen

meat of ruminants or swine from regions

that are designated in § 94.1(a) as

infected with rinderpest or FMD; or (2)

have a common land border with

regions designated as infected with

rinderpest or FMD; or (3) import

ruminants or swine from regions

designated as infected with rinderpest

or FMD under conditions less restrictive

than would be acceptable for

importation into the United States.

Both Luxembourg and Portugal

supplement their national meat supplies

by the importation of fresh, chilled, or

frozen meat of ruminants and swine

from regions designated in § 94.1(a)(1)

as regions in which rinderpest or FMD

exists. Furthermore, both Luxembourg

and Portugal import live ruminants and

swine from regions not recognized as

being free of FMD under conditions less

restrictive than would be acceptable for

importation into the United States. As a

result, even though we propose to

designate Luxembourg and Portugal as

being free of rinderpest and FMD, the

meat and other animal products

produced in these countries may be

commingled with the fresh, chilled, or

frozen meat of animals from a region in

which rinderpest or FMD exists,

resulting in an undue risk of

introducing rinderpest or FMD into the

United States.

Therefore, we are proposing that meat

and other animal products of ruminants

and swine and the ship stores, airplane

meals, and baggage containing these

meat or animal products imported into

the United States from Luxembourg and

Portugal be subject to the restrictions

specified in § 94.11 of the regulations, in

addition to other applicable

requirements of the U.S. Department of

Agriculture’s Food Safety and

Inspection Service (FSIS) at 9 CFR

Chapter III. Section 94.11 generally

requires that the meat and other animal

products of ruminants and swine be: (1)

Prepared in an inspected establishment

that is eligible to have its products

imported into the United States under

the Federal Meat Inspection Act; and (2)

accompanied by an additional

certificate, issued by a full-time salaried

veterinary official of the national

government that is responsible for the

health of the animals within the

exporting region, assuring that the meat

or other animal products have not been

commingled with or exposed to meat or

other animal products originating in,

imported from, or transported through a

region where rinderpest or FMD exists.

Greece Free of Rinderpest

Although Greece does not appear to

qualify to be declared free of both

rinderpest and FMD, the EC’s

Directorate General for Agriculture has

requested that Greece be declared free of

rinderpest. As noted above with regard

to both rinderpest and FMD, we will

consider declaring a region to be free of

rinderpest if, among other things, there

have been no cases of the disease

reported there for at least the previous

1-year period and no vaccinations for

rinderpest have been administered to

swine or ruminants in that region for at

least the previous 1-year period. There

has not been a reported case of

rinderpest in Greece since 1926, and

vaccinations for that disease have been

prohibited in Greece since 1991.

We have reviewed the documentation

submitted by the EC’s Directorate

General for Agriculture in support of its

request that Greece be declared free of

rinderpest. Based on that

documentation, we believe that Greece

qualifies to be designated as free of

rinderpest. We are, therefore, proposing

to amend § 94.1(a) to designate Greece

as a region free of rinderpest. To do so,

we are proposing to add a new

paragraph § 94.1(a)(3) in which Greece’s

status as a region free of rinderpest

would be designated.

However, because Greece would be

declared free of rinderpest only, and not

FMD, the prohibitions and restrictions

found in §§ 94.1(b), 94.2, 94.3, and 94.4

on the importation from Greece of

ruminants and swine, and fresh, chilled,

or frozen meat of ruminants and swine;

products other than meat; milk and milk

products; organs, glands, extracts, and

secretions; and cured or cooked meat of

ruminants or swine would continue to

apply.

France, Greece, Luxembourg, and

Spain Free of END

Section 94.6(a)(1) of the regulations

provides that END is considered to exist

in all regions of the world except those

listed in § 94.6(a)(2), which have been

declared to be free of END. The

importation into the United States of

any carcasses, or parts or products of

carcasses, of poultry, game birds, or

other birds that are from a region where

END is considered to exist, or that have

been imported from or moved into or

through any region where END is

considered to exist, is subject to the

restrictions contained in § 94.6(c). In

addition, the importation into the

United States of eggs (other than

hatching eggs) laid by poultry, game

birds, or other birds that are from a

region where END or Salmonella
61038 Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Proposed Rules

enteritidis (SE) phage-type 4 is

considered to exist or that have been

imported from or moved into or through

any region where END or SE phage-type

4 is considered to exist is subject to the

restrictions contained in § 94.6(d).

Poultry eggs for hatching imported from

a region where END exists must be

quarantined in accordance with

§ 93.209(b).

We will consider declaring a region to

be free of END if there have been no

reported cases of the disease in that

region for at least the previous 1-year

period. There has been no documented

case of END in France, Greece, or Spain

during the reporting period that began

in 1994, and there has been no reported

case of END in Luxembourg since 1995.

APHIS has reviewed the

documentation submitted by the EC’s

Directorate General for Agriculture in

support of its request that France,

Greece, Luxembourg, and Spain be

declared free of END. Based on that

documentation, we believe that France,

Greece, Luxembourg, and Spain qualify

to be designated as free of END.

Therefore, we are proposing to amend

§ 94.6(a)(2) by adding France, Greece,

Luxembourg, and Spain to the list of

regions declared free of END. This

proposed action would relieve the

restrictions of § 94.6(c) on the

importation of carcasses, or parts or

products of carcasses, of poultry, game

birds, or other birds from those

countries, and would relieve the ENDspecific restrictions of § 94.6(d)(1)(ix) on

the importation of eggs (other than

hatching eggs) laid by poultry, game

birds, or other birds from those

countries. This proposed action would

also relieve the quarantine requirements

of § 93.209(b) for poultry hatching eggs

imported from France, Greece,

Luxembourg, and Spain.

Portugal Free of ASF

Section 94.8 of the regulations states

that ASF exists or is reasonably believed

to exist in all the regions of Africa; in

Brazil, Cuba, Haiti, Malta, and Portugal;

and on the island of Sardinia, Italy.

Paragraph (a) of § 94.8 provides that no

pork or pork products may be imported

into the United States from a region

where ASF exists unless the pork or

pork product meets certain specified

conditions. Also, § 94.17 provides, in

part, that dry-cured pork products may

be imported into the United States from

a region where ASF exists if the drycured pork products meet the

conditions specified in that section.

In addition to the restrictions on pork

and pork products contained in the

regulations in part 94, live domestic

swine from a region where ASF exists

may not be imported into the United

States because the regulations in 9 CFR

93.505(a) require, among other things,

that live domestic swine be

accompanied by a certificate showing

that the entire region of origin of the

swine is free of ASF and other specified

diseases. The importation of swine

casings from regions where ASF exists

is likewise prohibited by 9 CFR 96.2(a)

unless the swine casings originated in a

region free of ASF and were processed

in the region where ASF exists at a

facility that meets the criteria of

§ 94.8(a)(3)(iv) of the regulations.

We will consider declaring a region

free of ASF if there have been no

reported cases of the disease in that

region for at least the previous 1-year

period. The last case of ASF in Portugal

occurred in 1993.

APHIS has reviewed the

documentation submitted by the EC’s

Directorate General for Agriculture in

support of its request that Portugal be

declared free of ASF. Based on that

documentation, we believe that Portugal

qualifies to be designated as free of ASF.

Therefore, we are proposing to amend

§ 94.8 by removing Portugal from the list

of regions in which ASF exists or is

reasonably believed to exist. This

proposed action would result in the

importation of pork and pork products

from Portugal no longer being subject to

the restrictions found in § 94.8 of the

regulations. Another effect of this

proposed action would be that the

importation of swine casings that

originated in or were processed in

Portugal would no longer be subject to

the restrictions in 9 CFR 96.2(a).

However, Portugal is still considered

to be affected with hog cholera, so the

importation of pork and pork products

from Portugal would remain subject to

the restrictions in § 94.9 for hog cholera.

Similarly, the importation of dry-cured

pork products from Portugal would

continue to be subject to the regulations

in § 94.17 due to hog cholera. In

addition, the importation of pork and

pork products from Portugal would

continue to be subject to the restrictions

in § 94.11 because, as discussed above

with respect to our proposal to declare

Portugal free of rinderpest and FMD,

Portugal would be listed in § 94.11(a) as

a region that has been declared free of

rinderpest and FMD, but from which the

importation of all meat and other animal

products is restricted due to the nature

of its requirements for importing animal

products from with regions affected

with rinderpest or FMD or because they

have a common land border with a

region affected with rinderpest or FMD.

Finally, declaring Portugal free of ASF

would not relieve any of the current

restrictions in 9 CFR part 93 on the

importation into the United States of

live swine from Portugal because

Portugal remains affected with hog

cholera.

Belgium, France, and Portugal Free of

SVD

Section 94.12(a) of the regulations

provides that SVD is considered to exist

in all regions of the world except those

listed in § 94.12(a), which have been

declared to be free of SVD. Paragraph (b)

of § 94.12 provides that no pork or pork

products may be imported into the

United States from a region where SVD

exists unless the pork or pork product

meets certain specified conditions and

is not otherwise prohibited importation

into the United States by the

regulations.

We will consider declaring a region to

be free of SVD if there have been no

reported cases of the disease in that

region for at least the previous 1-year

period. The last cases of SVD in

Belgium, France, and Portugal were

reported in 1993, 1983, and 1995,

respectively.

APHIS has reviewed the

documentation submitted by the EC’s

Directorate General for Agriculture in

support of its request that Belgium,

France, and Portugal be declared free of

SVD. Based on that documentation, we

believe that Belgium, France, and

Portugal qualify to be designated as free

of SVD. Therefore, we are proposing to

amend § 94.12(a) by adding Belgium,

France, and Portugal to the list of

regions declared free of SVD. This

proposed action would relieve certain

restrictions on the importation of pork

and pork products from those countries.

However, Belgium, France, and

Portugal are still considered to be

affected with hog cholera, so pork and

pork products from those countries

offered for importation into the United

States would remain subject to the

restrictions in § 94.9 for hog cholera.

The importation of live swine, except

for wild swine, from Belgium, France,

and Portugal would likewise continue to

be prohibited due to hog cholera in

accordance with § 94.10. Similarly, drycured pork products from Belgium,

France, and Portugal would continue to

be subject to the regulations in § 94.17

due to hog cholera. In addition, pork

and pork products from Belgium,

France, and Portugal would continue to

be subject to the restrictions in § 94.11

because Belgium, France, and Portugal

are among the regions listed (or, in the

case of Portugal, would be listed) in

§ 94.11(a) that have been declared free

of rinderpest and FMD, but from which

the importation of all meat and other
Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Proposed Rules 61039

animal products is restricted due to the

nature of their requirements for

importing animal products from regions

affected with rinderpest or FMD or

because they have a common land

border with a region affected with

rinderpest or FMD. (Portugal is not

currently on the list in § 94.11(a), but, as

discussed above, we are proposing to

add Portugal to that list as part of our

proposal to declare Luxembourg and

Portugal free of rinderpest and FMD.)

We are also proposing to amend

§ 94.13 by adding Belgium, France, and

Portugal to the list of regions that have

been declared free of SVD, but from

which the importation of pork and pork

products is restricted. The regions listed

in § 94.13 are subject to these

restrictions because they: (1)

Supplement their national pork supply

by importing fresh, chilled, or frozen

pork from regions where SVD is

considered to exist; (2) have a common

border with regions where SVD is

considered to exist; or (3) have certain

import requirements that are less

restrictive than are acceptable to the

United States.

Belgium, France, and Portugal all

supplement their national pork supplies

by importing fresh, chilled, or frozen

pork from regions where SVD is

considered to exist. In addition, France

has a common land border with Italy,

which is designated in § 94.12(a) as a

region where SVD exists. Furthermore,

Belgium, France, and Portugal have

certain import requirements that are less

restrictive than are acceptable to the

United States. As a result, even though

Belgium, France, and Portugal appear to

qualify for designation as regions free of

SVD, there is potential for pork and

pork products produced in Belgium,

France, and Portugal to be commingled

with fresh, chilled, or frozen pork from

a region where SVD exists. This

potential for commingling constitutes an

undue risk of introducing SVD into the

United States.

Therefore, we are proposing that pork

and pork products, as well as any ship’s

stores, airplane meals, and baggage

containing such pork, offered for

importation into the United States from

Belgium, France, or Portugal be subject

to the restrictions specified in § 94.13 of

the regulations and to the applicable

requirements contained in the FSIS

regulations at 9 CFR chapter III. Section

94.13 requires, in part, that pork and

pork products, except those treated in

accordance with § 94.12(b), be: (1)

Prepared in an inspected establishment

that is eligible to have its products

imported into the United States under

the Federal Meat Inspection Act; and (2)

accompanied by a foreign meat

inspection certificate and a certification

issued by a full-time salaried veterinary

official of the national government that

is responsible for the health of the

animals within the exporting region,

stating that certain precautions have

been taken so that the pork or pork

product has not been commingled with

or exposed to animals, pork, or pork

products originating in, or transported

through, a region in which SVD is

considered to exist.

Miscellaneous

In §§ 94.3 and 94.4, reference is made

to articles ‘‘originating in any region

designated in § 94.1.’’ Although the

intent of those sections is to restrict the

importation of certain articles from

regions where rinderpest or FMD exists,

the phrase ‘‘designated in § 94.1’’ could

also be interpreted as referring to those

regions declared free of rinderpest and

FMD, since those regions are listed in

§ 94.1(a)(2). To make the intent of those

two sections clear, we are proposing to

amend those sections so that they refer

to ‘‘regions where rinderpest or footand-mouth disease exists, as designated

in § 94.1.’’ We would also amend

§§ 94.1(c) and 94.11(a), where reference

is made to § 94.1(a); for the sake of

accuracy, those paragraphs should

specifically refer to § 94.1(a)(2).

Executive Order 12866 and Regulatory

Flexibility Act

This proposed rule has been reviewed

under Executive Order 12866. For this

action, the Office of Management and

Budget has waived its review process

required by Executive Order 12866.

This proposed rule would amend the

regulations in part 94 by declaring

Luxembourg and Portugal free of

rinderpest and FMD; Greece free of

rinderpest; France, Greece, Luxembourg,

and Spain free of END; Portugal free of

ASF; and Belgium, France, and Portugal

free of SVD.

Pork and Pork Products and Swine

Although this proposed rule would

declare Luxembourg and Portugal free of

rinderpest and FMD; Greece free of

rinderpest; Belgium, France, and

Portugal free of SVD; and Portugal free

of ASF, all those countries are still

considered affected with hog cholera,

and Greece is still considered to be

affected with FMD. Because of this, this

proposed rule would not lead to any

substantive relaxation of restrictions

imposed on the importation of pork and

pork products and live swine from those

countries, as these products would

continue to be restricted based on the

presence of hog cholera and, in the case

of Greece, FMD. Therefore, the effect of

this proposed rule on the importation of

pork and pork products and live swine

would be minimal, and thus the

potential impact on the domestic

producers of pork and pork products

and swine would be minimal.

Ruminants and Ruminant Products

This proposed rule would declare

Greece free of rinderpest, but that

country is still considered to be affected

with FMD. Similarly, Portugal would be

declared free of rinderpest and FMD,

but that country is still considered to be

affected with BSE. Because imports of

ruminants and ruminant products from

regions with FMD and BSE are

restricted, this proposed rule would not

lead to a substantive change in the

restrictions imposed on the importation

of ruminants and ruminant products

from Greece and Portugal.

By declaring Luxembourg free of

rinderpest and FMD, this proposed rule

would reduce the restrictions placed on

the importation of ruminants and

ruminant products from Luxembourg.

However, that proposed change in

disease status should have a minimal

effect on the amount of ruminants and

ruminant products imported into the

United States from Luxembourg.

The cattle industry in Luxembourg is

very small relative to the U.S. domestic

market. Cattle and buffalo inventories

for 1996 were more than 103 million

head in the United States (‘‘Agricultural

Statistics,’’ 1997), compared to fewer

than 3.4 million in Belgium and

Luxembourg (those two nations are

reported collectively in the United

Nations’ Food and Agriculture

Organization (FAO) Yearbook). Also, of

the 2 million cattle and calves that were

imported into the United States in 1996,

more than 99 percent were from Canada

and Mexico. Sheep and goat inventories

are also much smaller in Luxembourg

than in the United States. According to

the FAO, there were 8.9 million sheep

and 2 million goats in the U.S. in 1995,

as opposed to 150,000 sheep and 9,000

goats in Belgium and Luxembourg. The

United States is also a strong net

exporter of sheep and goats, with 48,792

head imported and 397,395 head

exported in 1996 (‘‘World Trade Atlas,’’

June 1997). Of the sheep that the United

States does import, more than 99

percent are from Canada and Mexico

(‘‘World Trade Atlas,’’ June 1997).

Luxembourg exported no live ruminants

to the United States in 1996. In fact,

there were fewer than 100 cattle, sheep

and goats imported from the European

Union in 1996. Western Europe is not a

significant source of live ruminants for

the United States, and any importation

of live ruminants from Luxembourg as
61040 Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Proposed Rules

a result of this proposed rule likely

would be negligible.

The effect of this proposed rule on the

importation of ruminant meat and meat

products should also be minimal. The

1995 production of beef, veal, mutton,

lamb and goat meat for Belgium and

Luxembourg was approximately 3

percent of the U.S. production of 11.6

million metric tons for that year (‘‘FAO

Yearbook,’’ 1995). The United States

imports only a small portion of its

overall supply of these products, an

amount equal to about 6 percent of

production. In addition, the United

States imports very little ruminant meat

and meat products from Luxembourg or

from Western Europe in general.

Moreover, nearly 85 percent of the

imports that come into the United States

are from Australia, Canada, and New

Zealand. Because we believe that it is

unlikely that Luxembourg would export

a significant portion of its comparatively

small meat production exclusively to

the United States, any effect on

domestic prices or supplies would

likely be negligible.

The importation of dairy products

from Luxembourg into the United States

should be at most minimally affected by

this proposed rule. Dairy product

production in Luxembourg is small

relative to that of the United States.

Milk production in Belgium and

Luxembourg was less than 5 percent the

size of U.S. production in 1995 (‘‘FAO

Yearbook,’’ 1995). For dairy products in

general, we believe that it is unlikely

that Luxembourg would redirect a

significant portion of its production

exclusively to the United States, which

is a significant net exporter of those

products. Belgium and Luxembourg do

export significant quantities of butter

and dried milk, but those products may

currently be exported to the United

States under the current regulations.

Therefore, the impact on domestic dairy

producers should be minimal.

The potential effect of this proposed

rule on the importation into the United

States of ruminant embryos and animal

semen would also likely be minimal.

The United States is a net exporter of

both bovine semen and cattle embryos.

In 1996, the value of U.S. bovine semen

and cattle embryo imports was $7.7

million and $701,000, respectively,

while the value of U.S. exports of

bovine semen and cattle embryos was

$63.1 million and $12.6 million

respectively (‘‘World Trade Atlas,’’ June

1997). Given this trade balance and the

size difference between the cattle

industries of the United States and

Luxembourg, the amount imported of

each will likely be minimal.

Bird and Poultry Products

The proposed rule would declare

France, Greece, Luxembourg, and Spain

free of END. This proposed action

would relieve restrictions on the

importation of carcasses, or parts or

products of carcasses, of poultry, game

birds, or other birds from those

countries, and would relieve certain

restrictions on the importation of eggs

(other than hatching eggs) laid by

poultry, game birds, or other birds from

those countries. This proposed action

would also relieve the quarantine

requirements for poultry hatching eggs

imported from France, Greece,

Luxembourg, and Spain.

Egg production in those four countries

is considerable: In 1995, the reported

egg production in Belgium and

Luxembourg was 3,858 million; in

France, 16,911 million; in Greece, 2,600

million; and in Spain, 9,983 million

(‘‘Agriculture Statistics,’’ 1997). U.S.

production is also large, 74,280 million

in 1995. In addition, the U.S. imports

few eggs, with the total amount being

equal to less than 0.1 percent of U.S.

production. We believe that it is

unlikely that these countries would

redirect a significant portion of their

production toward such a small U.S.

import market.

Total poultry meat production in

France, Greece, Luxembourg, and Spain

in 1995 was about 3.5 million metric

tons, or about 26 percent the size of U.S.

production of 13.8 million metric tons.

However, the United States is a very

strong net exporter of poultry meat, with

imports of only 3,546 metric tons and

exports of more than 2 million metric

tons in 1996 (‘‘World Trade Atlas,’’ June

1997). Very few of the imports are from

western Europe. Moreover, more than

99 percent of U.S. poultry meat imports

originated in Canada. We do not expect

that these countries would redirect a

significant amount of poultry meat

toward such a small U.S. import market.

Impact on Small Entities

The Regulatory Flexibility Act

requires that the Agency specifically

consider the economic impact

associated with the proposed rule on

small entities. Those likely to be

affected by this proposed rule are those

entities engaged in the production of

live swine, pork and pork products, live

ruminants, meat, meat products, and

dairy products derived from ruminants,

and poultry products.

The Small Business Administration’s

(SBA’s) definition of a ‘‘small’’ cattle,

swine, or poultry farm is one whose

total sales is less than $0.5 million

annually. In 1992, 97.8 percent of cattle

and calf farms would be considered

small entities. The vast majority of the

domestic hog and pig farms qualify as

small entities (96.3 percent in 1992).

Eighty-seven percent of poultry farms

would be considered small entities in

1992 (‘‘1992 Census of Agriculture,’’

U.S. Department of Commerce, 1993).

The SBA’s guidelines state that a

‘‘small’’ producer of poultry meat

(Standard Industrial Classification (SIC)

2015, poultry slaughtering and

processing) is one employing fewer than

500 workers. In 1992, 74 percent of 591

poultry slaughtering and processing

establishments were considered small

entities. These small entities accounted

for approximately 30 percent of the total

value of shipments of the industry, $7.2

billion.

The SBA’s guidelines state that a

‘‘small’’ producer of pork and ruminant

products (part of SIC 2011 or 2013, meat

packing plants) is one employing fewer

than 500 workers. In 1992, 97 percent of

the 1,367 meat packing establishments

in SIC 2011 were considered small

entities. These small establishments

accounted for approximately 40 percent

of the total value of shipments of the

industry, $50.4 billion. Ninety-eight

percent of the 1,264 establishments in

SIC 2013 were considered small entities

in 1992. These producers accounted for

84 percent of the total value of

shipments of the industry, $19.97

billion.

Although the majority of the domestic

entities potentially affected by this

proposed rule are small, there should be

only a minimal change in the level of

imports that may compete with the

output of these small entities, and thus

there would be a minimal impact on any

domestic producer of these products,

whether small or large.

Under these circumstances, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this action would not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12988

This proposed rule has been reviewed

under Executive Order 12988, Civil

Justice Reform. If this proposed rule is

adopted: (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 Reduction Act

This proposed rule contains no new

information collection or recordkeeping

requirements under the Paperwork
Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Proposed Rules 61041

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

et seq.).

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 would be

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

would continue 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).

2. Section 94.1 would be amended as

follows:

a. In paragraph (a)(1), the words ‘‘or

(a)(3)’’ would be added immediately

after the words ‘‘paragraph (a)(2)’’.

b. In paragraph (a)(2), the word

‘‘Luxembourg,’’ would be added

immediately after the word ‘‘Japan,’’

and the word ‘‘Portugal,’’ would be

added immediately after the word

‘‘Poland,’’;

c. A new paragraph (a)(3) would be

added to read as set forth below.

d. In the introductory text of

paragraph (c), the words ‘‘paragraph (a)

of’’ would be removed and the words

‘‘paragraph (a)(2) of’’ would be added in

their place.

§ 94.1 Regions where rinderpest or footand-mouth disease exists; importations

prohibited.

(a) * * *

(3) The following regions are declared

to be free of rinderpest: Greece.

* * * * *

§ 94.3 [Amended]

3. Section 94.3 would be amended by

adding the words ‘‘where rinderpest or

foot-and-mouth disease exists, as’’

immediately before the word

‘‘designated’’.

§ 94.4 [Amended]

4. In § 94.4(a), the introductory text of

the paragraph would be amended by

adding the words ‘‘where rinderpest or

foot-and-mouth disease exists, as’’

immediately before the word

‘‘designated’’.

§ 94.6 [Amended]

5. In § 94.6, paragraph (a)(2) would be

amended by adding the words ‘‘France,

Greece,’’ immediately after the word

‘‘Finland,’’; by adding the word

‘‘Luxembourg,’’ immediately after the

word ‘‘Iceland,’’; and by adding the

word ‘‘Spain,’’ immediately after the

words ‘‘Republic of Ireland,’’.

§ 94.8 [Amended]

6. In § 94.8, the introductory text of

the section would be amended by

removing the words ‘‘Malta, and

Portugal’’ and adding in their place the

words ‘‘and Malta’’.

§ 94.11 [Amended]

7. In § 94.11, paragraph (a), the first

sentence would be amended by adding

the word ‘‘Luxembourg,’’ immediately

after the word ‘‘Japan,’’; by adding the

word ‘‘Portugal,’’ immediately after the

word ‘‘Poland,’’; and by removing the

reference ‘‘§ 94.1’’ and adding the

reference ‘‘§ 94.1(a)(2)’’ in its place.

§ 94.12 [Amended]

8. In § 94.12, paragraph (a) would be

amended by adding the word

‘‘Belgium,’’ immediately after the words

‘‘The Bahamas,’’; by adding the word

‘‘France,’’ immediately after the word

‘‘Finland,’’; and by adding the word

‘‘Portugal,’’ immediately after the word

‘‘Panama,’’.

§ 94.13 [Amended]

9. In § 94.13, the introductory text of

the section would be amended by

adding the word ‘‘Belgium,’’

immediately after the words ‘‘The

Bahamas,’’; by adding the word

‘‘France,’’ immediately after the word

‘‘Denmark,’’; and by adding the word

‘‘Portugal,’’ immediately after the words

‘‘Northern Ireland,’’.

Done in Washington, DC, this 12th day of

November 1997.

Terry L. Medley,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 97–30105 Filed 11–13–97; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 77N–094W]

RIN 0910–AA01

Over the-Counter Drug Products

Containing Analgesic/Antipyretic

Active Ingredients for Internal Use;

Required Alcohol Warning

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a notice

of proposed rulemaking that would

establish alcohol warnings for all overthe-counter (OTC) drug products

containing internal analgesic/antipyretic

active ingredients labeled for adult use.

The proposed warning statements

advise consumers who have a history of

heavy alcohol use or abuse to consult a

physician for advice about the use of

OTC internal analgesic/antipyretic drug

products. A warning would be required

for all OTC internal analgesic/

antipyretic drug products marketed

under an OTC drug monograph or an

approved new drug application (NDA).

FDA is issuing this notice of proposed

rulemaking after considering the reports

and recommendations of its

Nonprescription Drugs Advisory

Committee (NDAC) and Arthritis Drugs

Advisory Committee (ADAC), public

comments on the proposed rule for OTC

internal analgesic, antipyretic, and

antirheumatic drug products, and other

available information.

DATES: Written comments by January 28,

1998. Written comments on the agency’s

economic impact determination by

January 28, 1998. The agency is

proposing that any final rule based on

this proposal be effective 6 months after

the date of its publication in the Federal

Register.

ADDRESSES: Written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Debbie L. Lumpkins, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2241.

SUPPLEMENTARY INFORMATION: