Animal and Plant Health Inspection Service

Federal RegisterApr 5, 1996

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 98

[Docket No. 94-006-2]

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: Final rule.

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SUMMARY: We are amending 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, can be imported with

virtually no risk of introducing communicable diseases of livestock

into the United States. This action will make additional sources of

genetic material available to domestic animal breeders.

EFFECTIVE DATE: April 5, 1996.

FOR FURTHER INFORMATION CONTACT: Dr. Roger Perkins, Staff Veterinarian,

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

APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231, (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 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, cannot fully participate in

the growing international market in germ plasm.

On June 6, 1995, we published in the Federal Register (60 FR 29781-

29784, Docket No. 94-006-1) a proposal 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 proposed 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.

We solicited comments concerning our proposal for 60 days ending

August 7, 1995. We received 30 comments by that date. They were from

individuals and groups involved with veterinary medicine, from a State

Department of Agriculture, and from individuals, businesses, and

associations interested in artificial insemination (AI).

Of the 30 comments received, 2 were supportive. Of the others, 23

were identical form letters. The issues raised in these comments are

discussed below by topic.

Treatment-Based Import Conditions

Most of the comments stated that our regulations for importing

embryos should be completely revised. The commenters advocated a

treatment-based approach to preventing the importation of disease via

embryos, rather than the disease prevention/disease avoidance system we

now have, which is based on serologic testing.

We have carefully considered these comments. We are constantly

reviewing our regulations to ensure that they reflect the latest proven

technology and are as effective as possible. The proposed regulations

published in June, 1995, included the regulatory changes we believe are

technically sound and most needed and desirable at this time. However,

we intend to review all the regulations in part 98. At that time, we

will consider whether we should adopt a treatment-based approach for

any diseases. If we determine that changes are warranted, we will

publish proposed regulations for public comment in the Federal

Register.

Applying Same Requirements to Other Species

Our regulations currently apply only to embryos from Bos taurus and

Bos indicus cattle from countries where foot-and-mouth disease or

rinderpest exists. Many of the commenters questioned the scientific

basis for our proposal to allow importation of other species and

expressed the belief that it would cause ``undue risk'' or that it was

``not without risk.''

Our regulations require embryos for importation to be washed.

Washing removes some disease agents. It is correct that the washing

procedures required under our regulations have not been tested for

efficacy against all disease agents specific to swine, or against all

disease agents of all species of ruminants. However, this is not

necessary as our regulations are based on serologic testing of the

donor animals. Under proposed Sec. 98.15, we would require donor dams

to be obtained from herds which have been free of all diseases of

concern for at least 1 year before embryo collection and require donor

dams to be tested and found free of all diseases of concern. In this

way we would ensure that embryos from donor animals are free of

diseases which would pose a disease threat to U.S. livestock.

Washing Embryos With Trypsin

Many of the commenters suggested we amend the regulations to

require that

[[Page 15181]]

bovine embryos be washed with trypsin. Trypsin is an enzyme. It weakens

the attachment between infectious bovine rhinotracheitis virus (IBRV)

and embryos. Washing embryos with water alone removes other disease

agents of concern to APHIS; adding trypsin allows IBRV to be removed.

Our regulations require embryos for importation into the United

States to be washed at least 10 times (see Sec. 98.17(f)(3)). The

regulations do not require washing with trypsin--any importer may use

trypsin if he or she wishes to. We do not believe it is desirable at

this time to require all embryos to be washed with trypsin. Although

trypsin offers protection against IBRV, we do not believe the cost of

requiring it to be used for all bovine embryos is justified.

Under our current regulations, however, we may require specific

embryos to be washed with trypsin. Section 98.17, paragraph (f)(6)

states: ``The Administrator may require additional measures to be taken

in processing embryos after collection (for example, adding trypsin to

the washes) if he or she determines that such measures are necessary to

ensure the embryos freedom from infectious agents that may cause

communicable diseases.'' As stated in Sec. 98.17(f)(6), circumstances

that may result in such additional measures being required include, but

are not limited to: (1) The existence of communicable diseases of

livestock, other than the diseases specifically listed, in the country

of origin, and (2) a high prevalence or an increase in the incidence of

a communicable disease in the country of origin.

Diseases of Concern

One commenter objected to our listing vesicular stomatitis as a

``disease of concern'' in Sec. 98.15 of the proposed rule because

vesicular stomatitis is present in the United States. We agree that

vesicular stomatitis is present in the United States. Brucellosis and

tuberculosis, also listed in our proposed rule as ``diseases of

concern'' are also present in the United States. These are diseases for

which we have Federal or Federal-State cooperative control and

eradication programs. We want to prevent the importation of embryos

which could transmit vesicular stomatitis, brucellosis, or tuberculosis

to livestock in this country. Infected embryos imported into this

country would be additional sources of infection. This would make it

more difficult to control and eradicate these diseases in the United

States. For this reason, we are making no changes in the proposed

regulations based on this comment.

One commenter asked us to test imported embryos for diseases in

addition to those listed in the proposed regulations as ``diseases of

concern.'' Another commenter stated that scrapie should be included as

a ``disease of concern.'' This same commenter also stated that the

regulations should include safeguards to ensure that swine embryos

cannot transmit pseudorabies or any other virus.

The diseases listed in the regulations are those we consider the

most dangerous. We require serologic testing and other measures to

ensure that embryos that could transmit these diseases are not imported

(see Secs. 98.14 through 98.17 of the current regulations, and proposed

Secs. 98.15). With regard to pseudorabies, Sec. 98.15(a) of our

proposal lists pseudorabies as a disease of concern for swine. With

regard to scrapie, we have published proposed regulations designed to

ensure that embryos which could transmit scrapie are imported into the

United States under conditions where they do not pose a threat to the

health of livestock in the United States (see Docket No. 94-085-2,

published May 11, 1995, at 60 FR 25151-25162).

In addition to the diseases listed in the regulations, we test

embryos for other diseases if other diseases exist in the country of

origin that could pose a threat to U.S. livestock. For these reasons,

we do not believe our proposed regulations need to be amended based on

these comments.

On-Site Compliance

One commenter suggested we add specific on-site compliance

validation procedures to ensure that imported embryos have been

prepared and shipped properly. Other commenters stated that we need to

amend our regulations to provide for enforcement of import protocols.

We have carefully considered these comments and determined that

changes in the regulations are warranted. We are therefore amending

Secs. 98.16 and 98.17(b). Section 98.16 is amended to require that an

APHIS veterinarian inspect and approve embryo collection units as

meeting our requirements. Requirements for embryo collection units are

listed in Sec. 98.16. However, the regulations have not included any

mechanism for ensuring that the requirements are met. We believe this

deficiency in the regulations will be corrected by this amendment. We

are also amending Sec. 98.17(b) to require that an APHIS veterinarian

supervise all stages of embryo collection and processing. Section

98.17(b) provides that an ``official veterinarian'' must supervise

embryo collection. An ``official veterinarian'' is either an APHIS

veterinarian or a full-time salaried veterinarian of the national

government of the country of origin. We believe not only that an APHIS

veterinarian can best perform this function, but that when an APHIS

veterinarian supervises the work, we can better verify, on-site, that

requirements and procedures are met. We are further amending

Sec. 98.17, paragraphs (b) and (g), to specify that an APHIS

veterinarian must supervise, in person, certain procedures. Included

are collecting, pooling, freezing, and sending test samples to the

Foreign Animal Disease Diagnostic Laboratory, and collecting,

processing, and storing embryos. These are the crucial stages of embryo

collection and processing. We believe they require the closest possible

supervision to ensure that requirements and procedures are met.

Publish Import Protocols

Commenters stated that import protocols for individual countries

should be ``mentioned'' in the regulations and that APHIS should

consider all diseases present in the country of origin. Import

protocols for individual countries do take into account all diseases

that are present in that country. Import protocols are constantly

changed, sometimes daily, depending on the disease situation in that

country, the requirements of foreign governments, and many other

factors. Protocols exist for numerous countries. At the time an

importer applies for an import permit, he or she is given up-to-date

information on the particular import requirements that apply to the

embryos they wish to import. Our offices also provide current

information to anyone who calls or writes concerning the protocols for

a particular country. Under these circumstances, we do not believe the

regulations need to be changed based on these comments.

Emergency Preparedness and Post-Entry Surveillance

Several commenters stated that APHIS needs to be adequately

prepared to handle a foreign animal disease outbreak in the United

States.

Our regulations are designed to offer multiple levels of security.

One level consists of requirements designed to prevent the introduction

of foreign animal diseases into the United States. The regulations in

this rulemaking are in this category. Another level consists of

requirements designed to control and eradicate livestock and poultry

diseases

[[Page 15182]]

within the United States, and to regulate the interstate transportation

of animals, including poultry, and animal products to prevent the

spread of diseases and pests. These regulations are contained in the

Code of Federal Regulations, Title 9, chapter I, subchapters B and C.

In addition, APHIS maintains a staff devoted to emergency planning and

preparedness, to contain and eradicate any outbreak of animal disease

in the United States that should occur.

For these reasons, we believe APHIS is adequately prepared to

handle an outbreak of a foreign animal disease, should that occur.

Several commenters also suggested that we include a post-entry

surveillance program as part of our regulations. As explained above,

our multi-level system of regulation is designed to ensure that foreign

animal diseases are not introduced into the United States. Our controls

on importation include requirements that we be notified of the

destination of embryos. Our domestic animal identification system,

coupled with requirements concerning interstate transportation of

animals, allow us to trace animals which may be infected with disease.

These programs have worked effectively for many years. In the case of

embryos from sheep and goats that may be affected with scrapie, we have

published proposed regulations requiring that these embryos be imported

only into flocks or herds participating in the Voluntary Scrapie Flock

Certification Program (see Docket 94-085-2, published May 11, 1995, at

60 FR 25151-25162). All animals in flocks and herds participating in

this program are under our surveillance.

Additional post-entry surveillance requirements would not appear to

increase the effectiveness of most of our programs, but would add costs

for both APHIS and for the regulated industries. We are therefore not

making any changes in this document based on these comments.

Economic Analysis

One commenter questioned the value we placed on embryos imported

into the United States. In our proposed rule of June 6, 1995 (see 60 FR

29782), we stated that cattle embryos imported into the United States

``during the past several years has averaged in the hundred of

thousands of dollars.'' This data is from the Foreign Agricultural

Trade of the United States, Fiscal Year 1994 Supplement (USDA, Economic

Service).2

\2\ Page 298 of the Foreign Agricultural Trade of the United

States, Fiscal Years 1994 Supplement includes a table showing that

cattle embryos imported into the United States were valued at

$160,000 during FY 1992, $228,000 during FY 1993, and $219,000

during FY 1994.

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Therefore, based on the rationale set forth in the proposed rule

and in this document, we are adopting the provisions of the proposal as

a final rule with the changes discussed in this document.

Miscellaneous

We are amending several sections of the regulations in part 98 to

add Office of Management and Budget (OMB) control numbers for

previously approved information collection and recordkeeping

requirements. We did not propose to amend these sections in the

proposed rule of June 6, 1995. However, adding OMB control numbers to

the regulations is a minor administrative change and does not affect

the regulations substantively.

Effective Date

This is a substantive rule that relieves restrictions and, pursuant

to the provisions of 5 U.S.C. 553, may be made effective less than 30

days after publication in the Federal Register. This rule will allow

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. This action will

make additional sources of genetic material available to domestic

animal breeders. Therefore, the Administrator of the Animal and Plant

Health Inspection Service has determined that this rule should be

effective less than 30 days after publication in the Federal Register.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. The rule

has been determined to be not significant for the purposes of Executive

Order 12866 and, therefore, has not been reviewed by the Office of

Management and Budget.

This rule allows 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.

As part of the proposed rule document published June 6, 1995, we

invited comments concerning potential effects of the proposed rule. We

stated that we were particularly interested in determining the number

and kind of small entities that might incur benefits or costs from

implementation of the rule. Other than the comment discussed above

under the heading ``Economic Analysis,'' none of the comments we

received addressed our Initial Regulatory Flexibility Analysis, and

none provided any information of the type we requested. We have

therefore based this Final Regulatory Flexibility Analysis on the data

available to us.

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 this rule change to 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 may 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 will 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 submitting a cashier's check of $32,000

for each application for the lottery), 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, will also

be realized.

This final rule contains paperwork and recordkeeping requirements.

Under this rule, import permits and health certificates will be

required for all ruminant and swine embryos, as they are now required

for Bos indicus and Bos taurus cattle embryos. These requirements have

been approved by the Office of Management and Budget.

[[Page 15183]]

The alternatives to this final rule are to take no action, or to

allow the importation of embryos under different conditions than those

adopted in this rule. 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 adopted a viable

option. The only available research concerns embryos handled and

treated using the methods required by this final rule. 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 rule has been reviewed under Executive Order 12778, 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 rule have been approved by the Office of Management

and Budget under OMB control number 0579-0040 and 0579-0120.

List of Subjects in 9 CFR Part 98

Animal diseases, Imports, Reporting and recordkeeping requirements.

Accordingly, 9 CFR part 98 is amended as follows:

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

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

follows:

Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 103-105,

111, 134a, 134b, 134c, 134d, 134f, 136 and 136a; 31 U.S.C. 9701; 7

CFR 2.22, 2.80, and 371.2(d).

Subpart B--Ruminant and Swine Embryos From Countries Where

Rinderpest or Foot-and-Mouth Disease Exists

Sec. 98.5 [Amended]

2. Section 98.5 is amended by adding at the end of the section the

following:

(Approved by the Office of Management and Budget under control

number 0579-0040.)

3. The heading for subpart B is revised to read as set forth above.

4. Section 98.11 is 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]

5. In the following sections, the word ``Cattle'' is removed and

the words ``Ruminant and swine'' are 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.

Sec. 98.13 [Amended]

6. Section 98.13 is amended by adding at the end of the section the

following:

(Approved by the Office of Management and Budget under control

number 0579-0040).

Sec. 98.14 [Amended]

7. Section 98.14 is amended by adding at the end of the section the

following:

(Approved by the Office of Management and Budget under control

number 0579-0040).

8. Section 98.15 is amended as follows:

a. In the introductory paragraph, by removing the word ``Cattle''

and adding the words ``Ruminant and swine'' in its place.

b. By revising paragraphs (a)(1) and (a)(2) to read as set forth

below.

c. In paragraph (a)(4), by removing the word ``cattle'' and adding

the words ``ruminants or swine'' in its place.

d. In paragraph (a)(5), by designating the first sentence as

paragraph (a)(5)(i), by designating the second sentence as paragraph

(a)(5)(ii) and revising it to read as set forth below; and by

designating the third and fourth sentences as paragraphs (a)(5)(iii)

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

e. In paragraph (a)(7), by designating the first sentence as

paragraph (a)(7)(i) and revising it to read as set forth below; and by

designating the second sentence as paragraph (a)(7)(ii).

f. In paragraph (a)(8), by designating the first sentence as

paragraph (a)(8)(i) and revising it to read as set forth below; and by

designating the second sentence as paragraph (a)(8)(ii).

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

(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

[[Page 15184]]

(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.

* * * * *

9. Section 98.16 is amended as follows:

a. In the introductory paragraph, the first sentence, by removing

the word ``Cattle'' and adding the words ``Ruminant and swine'' in its

place.

b. In the introductory paragraph, by revising the second sentence

to read as set forth below.

c. In paragraph (b), the first sentence, by removing the word

``cattle'' and adding the words ``embryo donors'' in its place.

Sec. 98.16 The embryo collection unit.

* * * The embryo collection unit may be located on the premises

where the donor dam's herd of origin is kept, or at any other location,

provided that the embryo collection unit has been inspected and

approved by an APHIS veterinarian and that the following requirements

are met:

* * * * *

10. Section 98.17 is amended as follows:

a. By revising paragraph (b)(1) to read as set forth below.

b. In paragraph (g), by adding, at the end of the first and second

sentences: ``under the personal supervision of an APHIS veterinarian''.

c. By adding at the end of the section the following: ``(Approved

by the Office of Management and Budget under control number 0579-

0040)''.

Sec. 98.17 Procedures.

(a) * * *

(b) Oversight and supervision. (1) All procedures associated with

the production of embryos for importation into the United States,

including artificial insemination, natural breeding, and cleaning and

disinfection, must be performed under the oversight of an APHIS

veterinarian. Collecting test samples, and collecting, processing, and

storing embryos, must be supervised in person by an APHIS veterinarian.

* * * * *

Sec. 98.35 [Amended]

11. Section 98.35 is amended by adding at the end of the section

the following:

(Approved by the Office of Management and Budget under control

number 0579-0040)

Done in Washington, DC, this 2nd day of April 1996.

Lonnie J. King,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 96-8471 Filed 4-4-96; 8:45 am]

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