[Federal Register Volume 59, Number 38 (Friday, February 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4326]


[[Page Unknown]]

[Federal Register: February 25, 1994]


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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]
BILLING CODE 3410-34-P