[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\Literature regarding this research can be obtained by writing
to the person listed under FOR FURTHER INFORMATION CONTACT.
---------------------------------------------------------------------------
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;
---------------------------------------------------------------------------
\5\See footnote 1 to Sec. 95.4.
---------------------------------------------------------------------------
(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
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
(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
