Importation of Embryos From Ruminants and Swine From Countries Where Rinderpest or Foot-and-Mouth Disease Exists

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 98

[Docket No. 94-006-1]

Importation of Embryos From Ruminants and Swine From Countries

Where Rinderpest or Foot-and-Mouth Disease Exists

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations to allow, under

specified conditions, the importation of embryos from all ruminants,

including cervids, camelids, and all species of cattle, and from swine

from countries where rinderpest or foot-and-mouth disease exists. The

regulations currently provide for importing only embryos from certain

species of cattle in countries where rinderpest or foot-and-mouth

disease exists. Research now indicates that embryos from all species of

cattle, from ruminants other than cattle, and from swine, which are

produced, collected, and handled under certain conditions in countries

where rinderpest or foot-and-mouth disease exists, could be imported

with virtually no risk of introducing communicable diseases of

livestock into the United States. This action would make additional

sources of genetic material available to domestic animal breeders.

DATES: Consideration will be given only to comments received on or

before August 7, 1995.

ADDRESSES: Please send an original and three copies of your comments to

Docket No. 94-006-1, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

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. Roger Perkins, Staff Veterinarian,

Import/Export Animals, National Center for Import and Export, VS,

APHIS, Suite 3B05, 4700 River Road Unit 39, Riverdale, MD 20737-1231.

Telephone: (301) 734-8170.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 98 (referred to below as the

regulations) govern the importation of animal germ plasm so as to

prevent the introduction of contagious diseases of livestock or poultry

into the United States. Subpart A of part 98 applies to ruminant and

swine embryos from countries free of rinderpest and foot-and-mouth

disease (FMD), and to embryos of horses and asses. Subpart B applies to

certain cattle embryos from countries where rinderpest or FMD exists.

Subpart C applies to certain animal semen. Subpart B currently allows

for the importation of embryos from cattle (Bos indicus and Bos taurus)

from countries where rinderpest or FMD exists only if embryos are

produced, collected, and handled under certain conditions. However,

research 1 has demonstrated that the same conditions would

effectively ensure that embryos from all species of cattle, and from

swine, and from ruminants other than cattle, including camelids and

cervids, can also be imported into the United States from countries

where rinderpest or FMD exists without significant risk of introducing

these diseases.

\1\ Information about pertinent research may be obtained from

the Animal and Plant Health Inspection Service, Veterinary Services,

National Center for Import-Export, 4700 River Road Unit 38,

Riverdale, Maryland 20737-1231.

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At this time, only Bos indicus and Bos taurus cattle embryos may be

imported into the United States from countries where rinderpest or FMD

exists. The available gene pool for swine and ruminants other than

cattle cannot be enlarged by using embryos from animals in countries

where rinderpest or FMD exists. Because of this, U.S. livestock

interests, except cattle-related interests, [[Page 29782]] cannot fully

participate in the growing international market in germ plasm.

Therefore, we are proposing to amend the regulations in subpart B

to allow embryos from all ruminants, including cervids and camelids,

from countries where rinderpest or FMD exists, to be imported into the

United States under the same conditions under which Bos indicus and Bos

taurus cattle embryos may be imported from those countries into the

United States. Also, we are proposing to amend the regulations in

subpart B to allow embryos from swine from countries where rinderpest

or FMD exists to be imported into the United States under conditions

that are the same as those for Bos indicus and Bos taurus cattle

embryos, except with respect to the specific diseases for which we

would screen.

Under our proposed regulations, the ``General prohibitions'' in

Sec. 98.12, which now apply only to Bos indicus and Bos taurus cattle

embryos, would be amended to cover embryos from all ruminants,

including camelids and cervids, and swine. In addition, import permits

and health certificates would be required for all ruminant and swine

embryos, just as they are now required for Bos indicus and Bos taurus

cattle embryos (see Secs. 98.13 and 98.14). Collection, processing, and

handling requirements for all ruminant and swine embryos would also be

the same as those now in place for Bos indicus and Bos taurus cattle

embryos (see Secs. 98.16, 98.17 and 98.18). In addition, requirements

concerning arrival and inspection at the port of entry and embryos

refused entry would be the same for all ruminant and swine embryos as

those now in place for Bos indicus and Bos taurus cattle embryos (see

Secs. 98.19 and 98.20).

Health requirements would also be the same for all ruminant embryos

as are those now in place for Bos indicus and Bos taurus cattle embryos

(see Sec. 98.15). The health requirements for swine embryos would

differ only in regard to the listed diseases for which would screen.

The current regulations are designed to ensure that embryos from Bos

indicus and Bos taurus cattle are free of certain listed diseases.

These regulations, in part, address the health of the donor dam and the

herds in which it was present, the health of the animals in the embryo

collection unit with the donor dam, and the presence of specific

diseases in the locales of the embryo collection unit and of any herd

in which the donor dam was present, over the previous 12 months.

The listed diseases of concern for embryos from Bos indicus and Bos

taurus cattle are bovine spongiform encephalopathy, brucellosis,

contagious bovine pleuropneumonia, FMD, Rift Valley fever, rinderpest,

tuberculosis, and vesicular stomatitis. All of these diseases may

affect other ruminants, including cervids, all other species of cattle,

and camelids. Under our proposed regulations, all ruminant embryos

would have to meet the same health regulations as Bos indicus and Bos

taurus cattle embryos must now meet, to ensure that they are not

infected with any of these diseases. Except for brucellosis and

tuberculosis, none of these diseases are present in the United States

and we want to prevent their introduction. Brucellosis and tuberculosis

are present in the United States. However, we have programs to control

their spread and to eradicate them. Therefore, we do not want infected

embryos imported into the United States, where they could spread

infection and increase the cost and difficulty of controlling and

eradicating these diseases.

The proposed diseases of concern for swine embryos, which would be

listed in the regulations, are African swine fever, brucellosis, FMD,

hog cholera, pseudorabies, rinderpest, swine vesicular disease,

tuberculosis, and vesicular stomatitis. Except for brucellosis,

pseudorabies, and tuberculosis, these are diseases which are not

present in the United States and which may infect swine. Brucellosis,

pseudorabies, and tuberculosis are present in the United States.

However, we have programs to control their spread and to eradicate

them. We therefore do not want infected embryos imported into the

United States. Rinderpest is not normally considered a swine disease,

but we are proposing to require that swine embryos be free of

rinderpest because rare infections do occur in domestic Asiatic swine.

We are also proposing to amend part 98 to remove the definition of

cattle and add a definition of ruminant. Cervids, camelids, and all

species of cattle would be included under the proposed definition of

ruminant. Camelids are often considered to be ruminants. However, they

are not true ruminants as they do not have four stomach compartments.

There is no disease risk basis to treat them differently than true

ruminants under these regulations. Therefore, we propose to include

them under the definition of ruminant.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866.

The rule has been determined to be not significant for 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 an Initial

Regulatory Flexibility Analysis, which is set out below, regarding the

impact of this proposed rule on small entities. However, we do not

currently have all the data necessary for a comprehensive analysis of

the effects of this rule on small entities. Therefore, we are inviting

comment concerning potential effects. In particular, we are interested

in determining the number and kind of small entities that may incur

benefits or costs from implementation of this proposed rule.

In accordance with 21 U.S.C. 111, the Secretary of Agriculture is

authorized to promulgate regulations to prevent the introduction or

dissemination of any communicable disease of animals from a foreign

country into the United States. This proposed rule would allow the

importation of certain embryos from swine and ruminants, including

camelids, cervids, and all species of cattle, from countries where

rinderpest or foot-and-mouth disease exists, under restrictions that

appear adequate to prevent the introduction or dissemination of

rinderpest, foot-and-mouth disease, and other communicable diseases of

livestock.

The annual value of cattle embryos imported during the past several

years has averaged in the hundreds of thousands of dollars. We do not

expect that this proposed rule change would result in a significant

increase in cattle embryo imports, since demand will continue to be

predominantly for the Bos indicus and Bos taurus species. However,

APHIS does foresee the importation of embryos of other species, such as

water buffalo and certain breeds of sheep and goats from Africa.

At present, ruminants and swine from countries where rinderpest or

foot-and-mouth disease exists can only enter the United States

following quarantine at the Harry S Truman Animal Import Center

(HSTAIC). Allowing embryos of additional ruminant species and swine to

be imported would enable importers to forgo quarantine and other costs

of importing live animals. For example, we estimate that the cost to

importers of importing approximately 500 Boer goats from South Africa

would average more than $2,000 per animal for quarantine in HSTAIC.

This does not include testing, post-quarantine clean-up expenses, and

other costs associated with importing animals through HSTAIC. In

addition, importers must undergo the inconvenience and uncertainty of

lottery selection (including putting [[Page 29783]] down either a

letter of credit or a $50,000 deposit), must bear the costs of

qualifying animals for importation through HSTAIC, and must assume the

risk that animals may not qualify for importation after quarantine.

Quarantine-related costs could easily exceed the cost of implanting an

imported embryo. Savings in transporting embryos rather than live

animals, both before and after entry into the United States, would also

be realized.

This proposed rule contains paperwork and recordkeeping

requirements. Under this proposed rule, import permits and health

certificates would be required for all ruminant and swine embryos, as

they are now required for Bos indicus and Bos taurus cattle embryos.

The alternatives to this proposed rule would be to take no action,

or to allow the importation of embryos under different conditions than

those proposed. We did not consider taking no action a reasonable

alternative, because it would, in our opinion, prohibit the importation

of embryos which pose no significant risk of disease. We also did not

consider importation under conditions other than those proposed a

viable option. The only available research concerns embryos handled and

treated as proposed in this document. Embryos handled and treated using

other methods have not been tested. We therefore have no data

demonstrating that other methods would be adequate to prevent the

importation of rinderpest, foot-and-mouth disease, and other

communicable diseases of livestock.

Executive Order 12778

This proposed rule has been reviewed under Executive Order 12778,

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

In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C.

3501 et seq.), the information collection or recordkeeping requirements

included in this proposed rule will be submitted for approval to the

Office of Management and Budget. Please send written comments to the

Office of Information and Regulatory Affairs, OMB, Attention: Desk

Officer for APHIS, Washington, DC 20503. Please send a copy of your

comments to: (1) Docket No. 94-006-1, Regulatory Analysis and

Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118,

Riverdale, MD 20737-1238 and (2) Clearance Officer, OIRM, USDA, room

404-W, 14th Street and Independence Avenue SW., Washington, DC 20250.

List of Subjects in 9 CFR Part 98

Animal diseases, Imports, Reporting and recordkeeping requirements.

Accordingly, 9 CFR part 98 would be amended as follows:

PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN

1. The authority citation for part 98 would be revised to read as

follows:

Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105,

111, 114a, 134a, 134b, 134c, 134d, 134f, 136 and 136a; 31 U.S.C.

9701; 7 CFR 2.17, 2.51, and 371.2(d).

Subpart B--Ruminant and Swine Embryos From Countries Where

Rinderpest or Foot-and-Mouth Disease Exists

2. The heading for subpart B would be revised to read as set forth

above.

3. Section 98.11 would be amended by removing the definition of

Cattle, and by adding, in alphabetical order, the following definitions

to read as follows:

Sec. 98.11 Definitions.

* * * * *

Ruminant. All animals which chew the cud, including cattle,

buffaloes, camelids, cervids (deer, elk, moose, and antelope), sheep,

goats, and giraffes.

Swine. The domestic hog and all varieties of wild hogs.

* * * * *

Secs. 98.12, 98.13, 98.14 [Amended]

4. In the following sections, the word ``Cattle'' would be removed

and the words ``Ruminant, camelid, and swine'' would be added in its

place:

a. Sec. 98.12(a);

b. Sec. 98.12(b);

c. Sec. 98.13(a); and

d. Sec. 98.14(a), the introductory text.

5. Section 98.15 would be amended as follows:

a. In the introductory paragraph, the word ``Cattle'' would be

removed and the words ``Ruminant and swine'' would be added in its

place.

b. Paragraphs (a)(1) and (a)(2) would be revised to read as set

forth below:

c. In paragraph (a)(4), the word ``cattle'' would be removed and

the words ``ruminants or swine'' would be added in its place.

d. In paragraph (a)(5), the first sentence would be designated as

paragraph (a)(5)(i), the second sentence would be designated as

paragraph (a)(5)(ii) and revised to read as set forth below, and the

third and fourth sentences would be designated as paragraphs

(a)(5)(iii) and (a)(5)(iv), respectively.

e. In paragraph (a)(7), the first sentence would be designated as

paragraph (a)(7)(i) and revised to read as set forth below, and the

second sentence would be designated as paragraph (a)(7)(ii).

f. In paragraph (a)(8), the first sentence would be designated as

paragraph (a)(8)(i) and revised to read as set forth below, and the

second sentence would be designated as paragraph (a)(8)(ii).

The revisions read as follows:

Sec. 98.15 Health requirements.

* * * * *

(a) * * *

(1) During the year before embryo collection, no case of the

following diseases occurred in the embryo collection unit or in any

herd in which the donor dam was present:

(i) Ruminant: Bovine spongiform encephalopathy, contagious bovine

pleuropneumonia, foot-and-mouth disease, Rift Valley fever, rinderpest,

or vesicular stomatitis; or

(ii) Swine: African swine fever, foot-and-mouth disease, hog

cholera, pseudorabies, rinderpest, swine vesicular disease, or

vesicular stomatitis.

(2) During the year before embryo collection, no case of the

following diseases occurred within 5 kilometers of the embryo

collection unit or in any herd in which the donor dam was present:

(i) Ruminant: Bovine spongiform encephalopathy, contagious bovine

pleuropneumonia, foot-and-mouth disease, Rift Valley fever, rinderpest,

or vesicular stomatitis; or

(ii) Swine: African swine fever, foot-and-mouth disease, hog

cholera, pseudorabies, rinderpest, swine vesicular disease, or

vesicular stomatitis.

* * * * *

(5)(i) * * *

(ii) The donor dam was determined to be free of foot-and-mouth

disease based upon tests of the pair of serum samples. In addition, if

any of the following diseases exist in the country of origin, the donor

dam was determined to be free of these diseases based upon additional

tests of the serum samples:

(A) Ruminant: Contagious bovine pleuropneumonia, Rift Valley fever,

rinderpest, or vesicular stomatitis; or

[[Page 29784]]

(B) Swine: African swine fever, hog cholera, pseudorabies,

rinderpest, swine vesicular disease, or vesicular stomatitis.

* * * * *

(7)(i) Not less than 30 days nor more than 120 days after embryo

collection, the donor dam was examined by an official veterinarian and

found free of clinical evidence of the following diseases:

(A) Ruminant: Bovine spongiform encephalopathy, brucellosis,

contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley

fever, rinderpest, tuberculosis, and vesicular stomatitis; or

(B) Swine: African swine fever, brucellosis, foot-and-mouth

disease, hog cholera, pseudorabies, rinderpest, swine vesicular

disease, tuberculosis, and vesicular stomatitis.

* * * * *

(8)(i) Between the time the embryos were collected and all

examinations and tests required by this subpart were completed, no

animals in the embryo collection unit with the donor dam, or in the

donor dam's herd of origin, exhibited any clinical evidence of:

(A) Ruminant: Bovine spongiform encephalopathy, brucellosis,

contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley

fever, rinderpest, tuberculosis, and vesicular stomatitis; or

(B) Swine: African swine fever, brucellosis, foot-and-mouth

disease, hog cholera, pseudorabies, rinderpest, swine vesicular

disease, tuberculosis, and vesicular stomatitis.

* * * * *

Sec. 98.16 [Amended]

6. Sec. 98.16 would be amended as follows:

a. In the introductory paragraph, the first sentence, the word

``Cattle'' would be removed and the words ``Ruminant and swine'' would

be added in its place.

b. In paragraph (b), in the first sentence, the word ``cattle''

would be removed and the words ``embryo donors'' would be added in its

place.

Done in Washington, DC, this 30th day of May 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-13667 Filed 6-5-95; 8:45 am]

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