Importation of Fetal Bovine Serum

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 95

[Docket No. 89-174-1]

Importation of Fetal Bovine Serum

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to remove the prohibition on the importation

into the United States of fetal bovine serum from countries in which

foot-and-mouth disease or rinderpest exists, and to establish

conditions under which fetal bovine serum from those countries can be

imported without presenting a significant risk of introducing disease

into this country. We believe this action would provide additional

sources of fetal bovine serum for use in this country without

presenting a significant disease risk.

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

before April 26, 1994.

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

Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, room 804,

Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782. Please

state that your comments refer to Docket No. 89-174-1. 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 H. Gray, Senior Staff

Veterinarian, Import-Export Products Staff, National Center for Import-

Export, Veterinary Services, APHIS, USDA, room 756, Federal Building,

6505 Belcrest Road, Hyattsville, MD 20782, (301) 436-7885.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 95 govern importation into the United

States of certain animal byproducts, including blood serum and other

blood products. Blood serum is that part of blood that is left after

the blood cells are removed.

Fetal bovine serum (FBS) is that part of the blood from bovine

fetuses that is left after the blood cells are removed. It is used in

tissue culture media, to produce various pharmaceuticals and biological

products, such as vaccines, and cannot be derived synthetically.

Research laboratories and biologics manufacturers need a reliable,

affordable, safe, and continuous supply of pathogen-free FBS. At times,

the supply of domestically produced FBS is inadequate for the needs of

the United States. Although FBS is available from outside the United

States, many countries where FBS is available are countries in which

foot-and-mouth disease (FMD), rinderpest, or bovine spongiform

encephalopathy (BSE) exists. To guard against the introduction of these

diseases into the United States, FBS is prohibited importation from

countries where these diseases exist.

The prohibition on the importation of FBS from countries where BSE

exists is set forth in 9 CFR 95.4. The prohibition on the importation

of FBS from countries where FMD or rinderpest exists is set forth in 9

CFR part 94, which regulates, among other things, the importation into

the United States of certain animal products to prevent the

introduction into the United States of certain diseases. Section 94.2

prohibits, among other things, the importation of fresh, chilled, or

frozen products, derived from ruminants, from countries in which FMD or

rinderpest exists. Under this provision, the importation of FBS from

countries in which either of these diseases exists is prohibited.

Foot-and-mouth disease and rinderpest virus in FBS is destroyed by

gamma radiation. However, we do not know of any method of treating FBS

that destroys the BSE agent and retains a usable product. We,

therefore, propose to amend the regulations by adding a new Sec. 95.17

to allow FBS to be imported under certain conditions, including

treatment by irradiation in the United States, from countries in which

FMD or rinderpest exists but in which BSE does not exist.

Under this proposal, preparing FBS for export from such countries

would involve three steps. First, blood would be collected from bovine

fetuses at a certified slaughtering plant, as explained below. Then,

FBS would be derived from the blood through removal of the blood cells.

Finally, the FBS would be processed by filtering, also as explained

below. Each of these steps would be required to take place in the

country from which the FBS is collected and exported. This helps ensure

that the blood and FBS are not diverted to a country in which BSE

exists and are not commingled with blood or FBS containing the BSE

agent.

Under Sec. 95.17(b) of this proposal, FBS could be imported from a

country in which FMD or rinderpest exists (as listed in current

Sec. 94.1), but in which BSE does not exist (countries in which BSE

exists are listed in current Sec. 94.18), provided, among other things,

that the blood from which the FBS is derived is collected at a

slaughter plant that is certified by the Food Safety and Inspection

Service (FSIS) of the U.S. Department of Agriculture as eligible to

export meat products into the United States under the Federal Meat

Inspection Act (21 U.S.C. 601 et seq.) and the regulations in 9 CFR

327.2. To attain the eligibility described above, the facility may not

commingle meat products from the country in which it is located with

meat products of other countries. This would help ensure that the blood

collected at the establishment is not commingled with blood from a

country in which BSE exists. The strict standards for sanitation and

inspection required of such establishments, would further help

guarantee that FBS derived from blood collected there is free of BSE.

We are proposing to require in Sec. 95.17(b)(1) of this proposal

that the FBS be derived from blood in the same country in which the

blood is collected. As set forth in proposed Sec. 95.17(b)(3)(ii), the

blood would also have to be certified as having been collected from

fetuses: (1) Whose dams have passed ante mortem and post mortem food

safety inspections, conducted by a salaried veterinarian employed by

the national government of the country of origin in which the cattle

were slaughtered; and (2) whose dams did not originate from and had

never transited a country in which BSE exists. The first requirement

would help ensure that the FBS is free of diseases that might pose a

health risk to livestock in the United States. The second requirement

would provide added assurance that the FBS does not come from a fetus

whose dam is affected with BSE. Because of the lengthy incubation

period for BSE, in many cases 5 years or more, we believe it is

necessary to require that the dam never have been in a country in which

BSE exists.

Each slaughter plant that is certified by FSIS in a foreign country

has an FSIS-issued establishment number. We are proposing to require

that this number be included on the certification regarding the blood

collected, discussed above. We are also proposing that this

certification accompany the blood to the facility where it is processed

to produce FBS, and then accompany the FBS to the United States. We

believe these requirements are necessary to facilitate the traceback of

FBS in cases where its origin may be in question, and to ensure that

the blood from which it was processed was collected at an FSIS-

certified establishment.

Proposed Sec. 95.17(b)(3)(iii) would require that, after

collection, the blood be shipped in leak-proof containers to a

processing facility in the country in which the blood was collected. We

are proposing that Sec. 95.17(b)(4) of this proposal require that pre-

importation processing include filtering the FBS through a 0.45 micron

or smaller filter. Filtering helps to break up large particles in the

serum, making later irradiation to kill the FMD and rinderpest viruses

more even and, therefore, effective. We are further proposing in

proposed Sec. 95.17(b)(5) to prohibit the commingling of FBS with serum

other than FBS collected at certified slaughtering establishments in

the country in which the processing facility is located. Serum other

than FBS, even that from a newborn calf, poses a significantly greater

risk of containing disease agents at high levels, for which irradiation

would be less effective.

Paragraphs 95.17(b) (6) and (7), as proposed, would require the

importer of the FBS to obtain an import permit from the Animal and

Plant Health Inspection Service (APHIS), and would require that the FBS

be shipped to the United States in leak-proof containers from the

country in which it was processed. Section 95.17(b)(7) would require

that each container be identified by lot number. In Sec. 95.1, we would

define lot to mean FBS that is processed by filtering in the same

production run and under the same conditions, and that is given an

identification number at the time it is processed.

Upon arrival at the port of entry in the United States, the

shipment of FBS would have to be inspected by an APHIS inspector, to

confirm its identity, origin, and eligibility for importation into the

United States. The shipment would then have to be placed under an

official United States Department of Agriculture seal indicating

agency-approved inspection, and be moved from the port of entry to an

APHIS-approved irradiation facility1 to be irradiated.

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\1\The names and addresses of approved irradiation facilities

may be obtained from, and requests for approval may be made to, the

Administrator, c/o the Import-Export Products Staff, VS, APHIS,

USDA, room 756, Federal Building, 6505 Belcrest Road, Hyattsville,

MD 20782.

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Under Sec. 95.17(c) of this proposal, an irradiation facility would

be approved by APHIS after: (1) An APHIS inspector has inspected the

facility and has determined that the irradiation facility has storage,

sterilization, and recordkeeping capabilities adequate to comply with

the regulations; and (2) the owner or operator of the irradiation

facility has entered into a compliance agreement with APHIS. By

entering into a compliance agreement, the owner or operator would

notify APHIS of his or her intent to comply with the regulations.

As set forth in proposed Sec. 95.17(c)(2), the compliance agreement

would require the owner or operator of the irradiation facility to

notify APHIS, no later than the next business day after arrival of the

imported FBS, of its arrival, origin, quantity, and scheduled date of

irradiation. This would enable APHIS to confirm that the FBS had not

been diverted after inspection at the port of importation. The owner or

operator would also be required to store FBS that has not been

irradiated in an area that is separate from irradiated FBS, in order to

avoid commingling of treated and untreated material.

In addition, as set forth in proposed Sec. 95.17(c)(2), the owner

or operator would be required: (1) To use a dosimeter to confirm

completion and dose of treatment; (2) to release the product to the

importer only after review of the dosimeter to confirm that the serum

received the required dosage; (3) to maintain records of irradiated FBS

for at least 2 years and make them available to APHIS inspectors upon

request during normal business hours; and (4) to allow APHIS inspectors

to make unannounced inspections of the facility. These requirements

would enable APHIS to confirm that FBS treated at the facility has

received a dosage of radiation sufficient to inactivate any FMD or

rinderpest virus that might have been present.

Under Sec. 95.17(d) of our proposal, approval of an irradiation

facility, and the compliance agreement required for approval, would be

effective for one year. To renew approval, irradiation facilities would

have to renew the compliance agreement, and undergo reinspection, on an

annual basis. Section 95.17(e) of the proposed regulations includes

criteria for denial or withdrawal of approval of a facility and for the

cancellation of a compliance agreement, and procedures by which an

owner or operator could appeal such a denial, withdrawal, or

cancellation.

Under Sec. 95.17(b)(9) of our proposal, the FBS would have to be

irradiated with a minimum of 2.2 megarads of gamma radiation at dry ice

temperature. Research has determined that 2.2 megarads of gamma

radiation at dry ice temperature is adequate to inactivate any FMD and

rinderpest virus present.2 The FBS could not be released until the

irradiation process was completed.

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\2\Literature regarding this research can be obtained by writing

to the person listed under FOR FURTHER INFORMATION CONTACT.

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Section 95.17(b)(10) of this proposal would require that, upon

completion of the irradiation, a certificate of treatment for each lot

of FBS be issued to the importer by the irradiation facility. The

certificate would have to include the following information: The USDA

import permit number; the country of origin of the FBS; the lot number

of the FBS; the quantity of irradiated FBS in the consignment; and the

date the FBS was irradiated. Importers, as well as irradiation

facilities, would be required to keep FBS treatment certificates for 2

years, and would be required to make them available during normal

business hours to APHIS inspectors upon request. The information on

these documents would prove valuable in the event of a disease outbreak

to confirm that imported FBS was treated as required by the

regulations.

Miscellaneous

We are proposing to revise the definition of inspector in

Sec. 95.1. Currently, inspector is defined as an inspector of

Veterinary Services. However, Veterinary Services is just one unit of

APHIS responsible for conducting inspections under the regulations. We

are, therefore, proposing to define inspector as an APHIS inspector. We

are also proposing to add a definition of fetal bovine serum, to read

``that part of the blood from bovine fetuses that remains after the

blood cells are removed.''

We are also proposing to redesignate footnote numbers in part 95 to

conform with Federal Register style guidelines, and are removing a

duplicative footnote. We are also proposing to make a nonsubstantive

change to the definition of Animal and Plant Health Inspection Service.

Addition of Regulatory Authority

Under this proposed rule, Secs. 136 and 136a of title 21 of the

United States Code (21 U.S.C. 136 and 136a) are being added to the

authority citation for part 95. Sections 136 and 136a concern

additional inspection services and the collection of fees for

inspection services.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866.

In accordance with 5 U.S.C. 603, we have performed an Initial

Regulatory Flexibility Analysis regarding the impact of this proposed

rule on small entities. This proposed action may have a significant

economic impact on a substantial number of 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 comments concerning potential impacts. 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 contagious, infectious, or communicable disease of

animals from a foreign country into the United States. Under specified

conditions, this proposed rule would allow the importation of FBS from

countries in which FMD or rinderpest exists, but in which BSE does not

exist. We believe that FBS can be imported from such countries under

specified conditions without presenting a significant disease risk.

The United States currently imports FBS from countries in which FMD

or rinderpest does not exist. Although official statistics are not

maintained on these imports, available estimates suggest that current

imports range from 75,000 to 130,000 liters annually. Estimates

regarding the additional quantity of FBS likely to be imported as a

result of this proposed rule are unavailable.

Under this proposed rule, FBS imported from countries in which FMD

and rinderpest exist would be subject to irradiation upon import into

the United States. Current costs for irradiation run approximately

$12.50 per liter. These costs are based on irradiation facilities

working at full capacity. Costs per liter could be higher if the

irradiation were carried out at facilities operating at less than full

capacity.

The cost of the APHIS inspections of irradiation facilities that

would be required under this proposed rule would be subject to user

fees paid by the facilities. We expect that these costs would be passed

on to importers through fees charged for irradiation. However, at

present, estimates of how many facilities would request approval to

irradiate FBS from countries in which FMD or rinderpest exists are

unavailable.

Official U.S. production data for FBS are unavailable; however,

available estimates suggest that production ranges from 200,000 to

250,000 liters annually. Fetal bovine serum is used in the United

States for research purposes, in the production of a variety of

pharmaceuticals and biological products, such as vaccines. The cost of

FBS in the United States ranges from $200 to $500 per liter.

In general, increases in imports of FBS would tend to lower U.S.

prices for the serum. Users of FBS such as research laboratories and

vaccine producers would benefit from these lower prices. Increased

revenue might accrue to FBS producers/importers if the percentage

increase in quantity sold exceeded the percentage decrease in price.

Without information on the sensitivity of demand on price (elasticity),

it is not possible to project actual changes in price.

In 1987, the last year for which U.S. Department of Commerce census

information was available, 241 establishments in the United States

produced biological products such as bacterial and viral vaccines,

toxoids, and analogous products, as well as serums, plasmas, and other

blood derivatives for human and veterinary use. Establishments using

FBS would be among these establishments. Of these 241 establishments,

32 percent employ less than 10 persons, 43 percent employ 10 to 49

persons, 13 percent employ 50 to 99 persons, 10 percent employ 100 to

499 persons, and 2 percent employ over 500 persons.

A total of 732 establishments produced pharmaceutical preparations

for both human and veterinary use in 1987. Establishments using FBS

were among these 732 firms. Of these 732 establishments, 36 percent

employed less than 10 persons, 30 percent employed 10 to 49 persons, 9

percent employed 50 to 99 persons, 17 percent employed 100 to 499

persons, and 8 percent employed over 500 persons.

This proposed rule contains paperwork and recordkeeping

requirements. Under this proposed rule, importers of FBS would be

required to apply for and receive an import permit from APHIS.

Irradiation facilities that irradiate FBS imported under this proposed

rule would be required to certify to the importer that the required

treatment was carried out. Both the irradiation facilities and the

importers of the FBS would be required to retain the records of

treatment for 2 years. A salaried veterinarian in the country from

which the FBS is imported would be required to certify that the blood

collected came from fetuses whose dams had passed ante mortem and post

mortem inspections, and whose dams were not from, and had never

transited, a country where BSE exists.

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

or to allow the importation of FBS from countries in which FMD or

rinderpest exists under conditions other than those specified in this

proposal. We do not consider taking no action a reasonable alternative,

because we believe it would unnecessarily limit the supply of FBS

available in this country. We also do not consider importation under

conditions other than those proposed a viable option, because we

believe the proposed conditions are necessary to ensure that FBS

imported into this country does not pose the risk of introducing FMD,

rinderpest, or BSE.

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) Chief, Regulatory Analysis and Development, PPD,

APHIS, USDA, room 804, Federal Building, 6505 Belcrest Road,

Hyattsville, MD 20782, 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 95

Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping

requirements, Straw, Transportation.

Accordingly, 9 CFR part 95 would be amended as follows:

PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS),

AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES

1. The authority citation for part 95 would be revised to read as

follows:

Authority: 21 U.S.C. 111, 136, and 136a; 31 U.S.C. 9701; 7 CFR

2.17, 2.51, and 371.2(d).

2. In Sec. 95.1, the definitions of Animal and Plant Health

Inspection Service and inspector would be revised, and definitions of

fetal bovine serum and lot would be added, in alphabetical order, to

read as follows:

Sec. 95.1 Definitions.

* * * * *

Animal and Plant Health Inspection Service (APHIS) means the Animal

and Plant Health Inspection Service of the United States Department of

Agriculture.

* * * * *

Fetal bovine serum means that part of the blood from bovine fetuses

that remains after the blood cells are removed.

* * * * *

Inspector means an APHIS inspector.

Lot means fetal bovine serum that is processed by filtering in the

same production run and under the same conditions, and that is given an

identification number at the time it is processed.

* * * * *

Sec. 95.4 [Amended]

3. In Sec. 95.4, paragraph (d)(1), footnote 2 would be removed and

its reference in the regulatory text would be changed to footnote 1.

Secs. 95.5, 95.7, 95.9, 95.26, 95.28 [Amended]

4. In part 95, footnote numbers and their references in the text

would be redesignated as follows:

a. In Sec. 95.5, paragraph (c), footnote 1 would be redesignated as

footnote 2;

b. In Sec. 95.7, paragraph (c), footnote 1 would be redesignated as

footnote 3;

c. In Sec. 95.9, paragraph (c), footnote 1 would be redesignated as

footnote 4; and

d. In Sec. 95.26, paragraph (c)(3), footnote 2 would be

redesignated as footnote 7.

Secs. 95.17 through 95.28 [Redesignated as Secs. 95.18-95.29]

5. Sections 95.17 through 95.28 would be redesignated Secs. 95.18

through 95.29, respectively.

6. A new Sec. 95.17 would be added to read as follows:

Sec. 95.17 Fetal bovine serum.

(a) Fetal bovine serum (FBS) from countries where bovine spongiform

encephalopathy exists, as listed in Sec. 94.18 of this chapter, may not

be imported into the United States.

(b) FBS from countries where foot-and-mouth disease or rinderpest

exists, as listed in Sec. 94.1 of this chapter, may be imported into

the United States only if the following conditions are met:

(1) The FBS is derived from blood in the same country in which the

blood is collected;

(2) The country in which the FBS is derived from the blood is free

of bovine spongiform encephalopathy (BSE);

(3) The FBS is derived from blood that was:

(i) Collected at a slaughter plant certified by the Food Safety and

Inspection Service of the United States Department of Agriculture as

eligible to export meat products into the United States under the

Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations

in 9 CFR 327.2;

(ii) Certified as having been collected from fetuses whose dams

were determined through ante mortem and post mortem inspections to be

eligible to be used for food, and whose dams did not originate from and

never transited a country where BSE exists. The certification and

inspections must be carried out by a salaried veterinarian employed by

the national government of the country in which the dams were

slaughtered. The certification must include the slaughter plant's FSIS-

issued establishment number; and

(iii) Shipped in leak-proof containers, accompanied by the

certification issued at the slaughter plant, to a facility within the

country where it was collected, for pre-importation processing;

(4) The FBS is processed by filtering it through a 0.45 micron or

smaller filter;

(5) The FBS is not commingled with serum other than FBS from

slaughter plants that are in the same country as the processing plant

and that are certified as described in paragraph (b)(3)(i) of this

section;

(6) The importer of the FBS obtains a United States Veterinary

Permit for Importation and Transportation of Controlled Materials and

Organisms and Vectors under part 122 of this chapter by filing a permit

application on VS form 16-3.5 The permit application must include

the name and complete street address of the irradiation facility at

which the FBS will be irradiated in the United States;

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\5\See footnote 1 to Sec. 95.4.

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(7) The FBS is shipped from the country in which it was processed

to the United States in leak-proof containers that are each identified

by lot number, and that are accompanied by the certification, or a copy

of the certification, issued at the slaughter plant in accordance with

paragraph (b)(3)(ii) of this section;

(8) Upon arrival at the United States port of entry, the FBS is

inspected by an inspector, placed under an official Department seal,

and moved from the port of entry to an irradiation facility approved in

accordance with paragraph (c) of this section;6

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\6\The names and addresses of approved irradiation facilities

may be obtained from, and requests for approval may be made to, the

Administrator, c/o the Import-Export Products Staff, VS, APHIS,

USDA, Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782.

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(9) At the irradiation facility, the FBS is irradiated with a

minimum of 2.2 megarads of gamma radiation at dry ice temperature;

(10) Following the irradiation, the irradiation facility issues to

the importer a certificate of treatment for each lot of FBS that

includes the following information:

(i) The USDA import permit number;

(ii) The country of origin of the FBS;

(iii) The lot number of the FBS;

(iv) The quantity of irradiated FBS in the consignment;

(v) The date the FBS was irradiated; and

(11) Importers of FBS and approved irradiation facilities must

retain FBS irradiation certificates of treatment for 2 years following

the treatment. These records must be made available to inspectors upon

request during normal APHIS business hours.

(c) An irradiation facility will be approved by APHIS when the

following conditions are met:

(1) An inspector has inspected the facility and has determined that

the facility has storage, sterilization, and recordkeeping capabilities

adequate to meet the conditions set forth in paragraph (c)(2) of this

section; and

(2) The owner or operator of the irradiation facility has entered

into a compliance agreement in which the owner or operator agrees to

comply with the following requirements:

(i) To notify APHIS no later than the next business day following

arrival of the FBS at the facility, of its arrival, origin, quantity,

and scheduled date of irradiation;

(ii) To store all FBS untreated by radiation in an area separate

from FBS that has been treated with radiation, so as to avoid

commingling of containers of treated and untreated FBS;

(iii) To use a dosimeter to confirm completion and dose of

treatment in accordance with paragraph (b)(9) of this section;

(iv) To release the product to the importer only after review of

the dosimeter to confirm that the serum received the required dose of

radiation;

(v) To maintain records of irradiated FBS for at least 2 years and

make them available to inspectors during normal business hours; and

(vi) To allow inspectors to make unannounced inspections of the

facility.

(d) Approval of an irradiation facility, and the compliance

agreement required under paragraph (c)(2) of this section, are

effective for one year, unless withdrawn or canceled under paragraph

(e) of this section. In order to renew approval, irradiation facilities

must, on an annual basis, renew the compliance agreement and undergo

reinspection.

(e) Approval of an irradiation facility may be denied or withdrawn,

and any compliance agreement entered into under this section may be

canceled, orally or in writing, if:

(1) An inspector determines that a facility or its owner or

operator does not meet or has not complied with the requirements of

this section;

(2) The operator or a person responsibly connected with the

business of the irradiation facility has committed any act involving

fraud, bribery, extortion, smuggling, or any other act involving a lack

of integrity needed for the conduct of operations affecting the

irradiation of FBS, as determined by the Administrator.

(f) For the purposes of this section, a person shall be deemed to

be responsibly connected with the business of the quarantine facility

if such person has an ownership, mortgage, or lease interest in the

facility's physical plant, or if such person is a partner, officer,

director, holder or owner of 10 per centum or more of its voting stock,

or an employee in a managerial or executive capacity.

(g) If the denial, cancellation, or withdrawal is oral, such action

and the reasons for the action shall be confirmed in writing as

promptly as circumstances allow. Any owner or operator whose facility

has been denied approval, whose facility's approval has been withdrawn,

or whose compliance agreement has been canceled, may appeal the

decision, in writing, within 10 days after receiving written

notification of the denial, withdrawal, or cancellation. The appeal

must state all of the facts and reasons upon which the person relies to

show that the approval was wrongfully denied or withdrawn, or that the

compliance agreement was wrongfully canceled. As promptly as

circumstances allow, the Administrator will grant or deny the appeal,

in writing, stating the reasons for the decision. A hearing will be

held to resolve a conflict as to any material fact. Rules of practice

concerning the hearing will be adopted by the Administrator.

Done in Washington, DC, this 18th day of February, 1994.

Patricia Jensen,

Acting Assistant Secretary, Marketing and Inspection Services.

[FR Doc. 94-4326 Filed 02-24-94; 8:45 am]

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