Rev. sci. tech. Off. int. Epiz., 1988, 7 (2), 255-267.
Current USDA licensing requirements
for recombinant DNA-derived
animal biological products *
D.A. ESPESETH, P.L. JOSEPH, G.P. SHIBLEY and C.G. GAY **
Summary: For licensing purposes there are three categories of biotechnology
products: inactivated recombinant DNA-derived products and monoclonal
antibodies, live micro-organisms modified by adding or deleting genes, and live
vectors carrying recombinant genes which code for immunizing antigens. The
authors outline the organization and functions of the Veterinary Services
Biotechnology Committee, the Committee on Biotechnology in Agriculture, the
Agriculture Biotechnology Recombinant DNA Advisory Committee, the
Biotechnology and Environmental Coordination Staff and related organizations.
Proposals to expand regulatory authority and to avoid overlapping reviews are
discussed.
KEYWORDS: Biological products - Biotechnology organizations - Legislation - Licensing - USA - Vaccines.
Government
The establishment of appropriate procedures for regulating biotechnology products
is a national and international issue which has been debated extensively in the United
States. This debate has intensified as more new products have been developed for
commercial release. The question of how to regulate the new products has generated
a diversity of opinions. On the one hand, the scientific community has tended to take
the position that the new products, when properly characterized and evaluated prior
to release, pose no risk to public health or the environment. On the other hand, some
consumer interest groups have indicated a concern that new recombinant D N A
(rDNA)-derived micro-organisms, plants, animals or other products proposed for
release could have considerable effects on our environment and therefore should be
rigidly controlled or prohibited from release. Regulatory agencies have been faced
with the difficult task of developing a system that will protect the public interest yet
be flexible and efficient in its review of products, so as not to inhibit development
of this new technology. Such a system must also provide the opportunity for peer
review and public notification of the decision-making process.
Several actions have been taken in the United States in an attempt to define the
appropriate balance in these parameters and to establish a regulatory system acceptable
to the public. This paper will discuss the process, as established within the United
States Department of Agriculture (USDA) and more specifically within the Veterinary
* Presented at the XXIII World Veterinary Congress, Montreal, Canada, August 16-21, 1987.
** Veterinary Services, Animal and Plant Health Inspection Service, United States Department of
Agriculture (USDA), Federal Building, Hyattsville, Md. 20782, USA.
256
Services (VS) of the Animal and Plant Health Inspection Service (APHIS). The effects
of recent changes in the Virus-Serum-Toxin Act (VSTA) on the control of conventional
and r D N A veterinary biological products will be reviewed. The impact of proposed
changes in the National Institutes of Health (NIH) guidelines and the effect of recent
administrative changes within U S D A on the review of conventional and r D N A
products by Veterinary Services will also be discussed.
Regulation of rDNA-derived products is based o n the principle that these new
products are not significantly different from similar products produced by
conventional methods. T h u s , existing statutes provide a basic network of agency
jurisdiction over both research and products. This existing network has been used
to form a coordinated framework for regulating biotechnology products and research
in the United States.
Current authorities and regulatory jurisdictions for biotechnology products were
defined in two Federal Register publications. A proposed coordinated framework
for regulating biotechnology was published on 31 December 1984. This was followed
o n 26 J u n e 1986 by a document describing the regulatory policies of the individual
Federal departments and the policies for review of research conducted or supported
within these departments.
To coordinate and develop a policy for implementing these authorities, an
interagency science coordinating mechanism — the Biotechnology Science
Coordinating Committee (BSCC) - was established in October 1985 (Fig. 1).
Biotechnology Science
Coordinating Committee
NSF
EPA
Department of Agriculture
FDA
Committee o n
Biotechnology
in Agriculture
Science and
Education
NSF
EPA
FDA
NIH
=
=
=
=
Marketing and
Inspection
Service
National Science Foundation
Environmental Protection Agency
Food and Drug Administration
National Institutes of Health
FIG. 1
Biotechnology in Agriculture.
Coordinated framework
NIH
257
This Committee provides a context for the sharing of information concerning
scientific developments among various agencies and the coordination of biotechnology
policy on a national level. Members of the BSCC are senior policy officials from
USDA, Health and H u m a n Services, Environmental Protection Agency, and National
Science F o u n d a t i o n . T h e BSCC is currently chaired by Dr David Kingsbury of the
National Science Foundation (Assistant Director of Biological, Behavioral and Social
Sciences).
Within the U S D A a n additional coordinating structure has been developed. The
Office of Agriculture Biotechnology (OAB) was established by Secretary of Agriculture
Richard Lyng in July 1986 (Fig. 2). This office performs three functions:
Science a n d E d u c a t i o n
Office of Agriculture
Biotechnology Staff
Cooperative State
Research Service
Agriculture
Biotech & r D N A - Advisory C o m m i t t e e
Extension Service
Office of G r a n t s &
P r o g r a m Systems
N a t i o n a l Biological
I m p a c t Assessment
Program
Agricultural
Research Service
National
Agricultural Library
FIG. 2
The Office of Agriculture Biotechnology Staff
1. It provides staff support for the Committee on Biotechnology in Agriculture
(CBA), which is the policy-making group in Agriculture.
2. It also provides staff support for the Agricultural Biotechnology Recombinant
D N A Advisory Committee (ABRAC) which reviews USDA-funded research proposals
or when requested, license applications.
3. It acts as a repository of biotechnology information received from U S D A
agencies responsible for the review of applications, and the issue of permits or licenses.
The Biotechnology and Environmental Coordination Staff (BECS) was established
in July 1985 to coordinate the development and implementation of biotechnology
policy and the coordination of biotechnology regulatory activities in U S D A (Fig. 3).
It also provides advice and council to p r o g r a m staffs in preparing environmental
documents required by the National Environmental Policy Act (NEPA) of 1969, and
reviews these documents before being sent outside A P H I S .
258
Marketing and Inspection Services
F o o d Safety Inspection
Service
APHIS
Agricultural Marketing
Service
Biotechnology &
Environmental
Coordinating Staff
Veterinary
Services
Plant Protection
and Quarantine
VS Biotechnology
Committee
FIG. 3
Regulatory agencies
VS has extended this coordinating structure by establishing a Veterinary Services
Biotechnology Committee (Tables I and II). This committee considers the development
and application of new biotechnology policy related to the mission of VS, and provides
recommendations to the Deputy Administrator. The committee is chaired by the
Associate Deputy Administrator, VS, and has members representing VS P r o g r a m
Planning and Development, VS Biologics Staff, Agriculture Research Service, F o o d
Safety and Inspection Service, National VS Laboratories, National Institutes of Health
(NIH) - Recombinant D N A Advisory Committee, F o o d and Drug Administration,
and the Office of the General Counsel (OGC). This committee reviews proposed rule­
making, m e m o r a n d a , and other policy-making documents concerning biotechnology
before publication, and also reviews Environmental Assessments (EA) prepared by
the VS Biologics Staff before agency authorization of shipment of live recombinant
vaccines for use outside contained premises.
In establishing the VS Biotechnology Committee, VS has become intimately
involved in biotechnology issues and policy-making, primarily because of its
responsibility for regulating veterinary biological products under the Virus-SerumToxin Act of 1913. VS has regulated the import and interstate movement of veterinary
biological products under this act for over 70 years. As new production technologies
have emerged, the agency has had to respond with new regulatory procedures. The
development of new procedures applicable to recombinant-derived products is but
the most recent change.
It has been, and still is the attitude of the agency that new biotechnology products
do not differ significantly from products produced by conventional methods. The
emphasis is on the product and its intended use rather t h a n the method used in
development. Each product must be considered on a case-by-case basis.
259
TABLE I
Organization
of the VS Biotechnology
Committee
Chairman:
• Associate Deputy Administrator, VS
Executive Secretary:
• Veterinary Biologics Staff representative
Members:
• Assistant Deputy Administrator, Program Planning and Development
• Senior Staff Veterinarian, Veterinary Biologics Staff
• Representatives from:
BECS FSIS NVSL
FDA
ARS NIH-RAC
Ad-Hoc (EPA, CVM, CDC, OGC, etc.)
BECS
FSIS
NVSL
FDA
ARS
NIH-RAC
CVM
CDC
EPA
OGC
=
=
=
=
=
=
=
=
=
=
Biotechnology and Environmental Coordinating Staff
Food Safety and Inspection Service
National Veterinary Services Laboratories
Food and Drug Administration
Agricultural Research Service
National Institutes of Health - Recombinant DNA Advisory Committee
Center for Veterinary Medicine
Centers for Disease Control
Environmental Protection Agency
Office of the General Counsel
T A B L E II
Functions
of the VS Biotechnology
Committee
•
•
•
•
Coordinate and review biotechnology issues and policy.
Review VS biotechnology regulatory policies and procedures.
Review and recommend procedures for implementing VS biotechnology policy.
Review and refer issues involving departmental and agency biotechnology policy to
APHIS BECS.
• Review biotechnology issues referred to VS from BECS and other agencies and
recommend response by the Deputy Administrator.
• Interact with APHIS BECS.
• Consider other issues as directed by the Deputy Administrator.
For the purposes of licensing under the VSTA, veterinary biological products
derived by recombinant-DNA techniques or developed from hybridomas are classified
into three broad categories, depending on the biological characteristics of the new
products and on safety aspects (Table III). This approach is very similar to the one
used for conventional veterinary biologies.
260
TABLE
Categories
of hybridoma
III
and rDNA-derived
animal
biologics
Category I:
• Inactivated rDNA-derived viral vaccines
• Inactivated rDNA-derived bacterial products
• Viral, bacterial or other subunit products
• Monoclonal antibody (hybridoma)
Category II:
• Vaccines containing live organisms modified by gene insertion or deletion
Category III:
• Vaccines using live vectors to carry r-derived foreign genes
Category I comprises inactivated products prepared from recombinant D N A derived vaccines, viruses, bacterins, bacterin-toxoids, virus subunits, or bacterial
subunits (Table IV). These nonviable or killed products pose no risk to the environment
and present no new or unusual safety concerns. Monoclonal antibody (hybridoma)
products used prophylactically, therapeutically, or as components of diagnostic kits
are also included in this category (Tables V and VI).
T A B L E IV
Category
I-A:
Bacterins
Product
Code
No.
Licensed
Firm
Estab.
No.
Date
Licensed
E. coli bacterin
for swine
26R8.56
Norden Labs
189
16 July 1984
E. coli bacterin
for swine
26R8.44
Salsbury Labs
195
23 Dec. 1982
E. coli bacterin
for swine
2648.08
Salsbury Labs
195
5 Oct. 1983
E. coli bacterintoxoid for swine
7850.00
Norden Labs
189
15 Mar. 1983
E. coli bacterintoxoid for swine
7900.R0
Norden Labs
189
29 June 1984
Category II comprises products containing live micro-organisms that have been
modified by adding or deleting one or more genes (Table VII). Deleted genes may
code for virulence, oncogenicity, enzyme activity, or other biochemical functions.
Added genes may result in the expression of unique marker antigens or the production
of novel biochemical by-products. Precautions must be taken to ensure that this
261
TABLE V
Category
I-B-l:
Therapeutic
or prophylactic
use
Product
Code
No.
Licensed
Firm
Estab.
No.
Date
Licensed
E. coli monoclonal
antibody for newborn
cattle
3525.00
Molecular
Genetics, Inc.
284
8 Nov. 1983
Pseudorabies virus
monoclonal antibody
3800.00
Molecular
"Genetics, Inc.
284
16 Apr. 1987
TABLE VI
Category
I-B-2:
Used in diagnostic
kits
Product
Code
No.
Licensed
Firm
Estab.
No.
Date
Licensed
Feline leukemia
virus test kit
Feline leukemia
virus test kit
Feline leukemia
virus test kit
Equine infectious
anemia antigen
and reagent serum
E. coli K99
antigen test kit
Feline infectious
peritonitis
antibody test kit
Feline leukemia
virus antigen
test kit
Pseudorabies virus
antibody test kit
Pseudorabies virus
antibody test kit
Equine infectious
anemia ELISA anti­
body test kit
5028.00
Pitman-Moore Inc.
264
22 Aug. 1979
5028.00
AgriTech Systems,
Inc.
AgriTech Systems,
Inc.
TechAmerica
Diagnostics
313
6 June 1986
313
31 Mar. 1987
272-A
28 June 1984
284
29 Jan. 1985
272-A
21 Nov. 1984
317
30 Oct. 1985
5028.01
5515.20
5032.00
5029.00
Molecular
Genetics, Inc.
TechAmerica
Diagnostics
5028.00
Biologics
Corporation
5110.01
AgriTech Systems,
313
Inc.
AgriTech Systems,
313
Inc.
TechAmerica Group, 272-A
Inc.
5110.02
5514.00
16 Jan. 1986
16 Jan. 1986
13 June 1986
addition or deletion of specific genetic information does not impart increased
virulence, pathogenicity, or survival advantages in these organisms, greater than those
found in natural or wild-type forms. Modification must not impart undesirable new
or increased adhesive or invasive factors, colonization properties, or different survival
within the host. It is important that genes added or deleted do not compromise the
262
safety characteristics of these organisms. In most cases their safety characteristics
are improved, so that they cannot pose any new threat to h u m a n s , other animal
species, or to the environment.
TABLE V I I
Category
II: Live gene
deleted
Product
Code
No.
Licensed
Firm
Pseudorabies virus
vaccine modified live virus
1891.R0 Biologics Corp.
Estab.
No.
Date
Licensed
272
16 Jan. 1986
The genetic information to be added or deleted in this category must consist of
well-characterized D N A segments. Required licensing data may include base pair
analysis, sequence information, restriction endonuclease sites, as well as phenotypic
characterization of the altered organism. A comparison is also required between the
engineered organism and its parent strain with respect to biochemical pathways,
virulence traits, or other factors affecting pathogenicity. Current policy requires an
Environmental Assessment or decision document to be prepared before these products
can be considered for experimental field trial or licensing.
Category III consists of products using live vectors to carry recombinant-derived
foreign genes that code for immunizing antigens a n d / o r other immune stimulants.
Live vectors may carry multiple recombinant-derived foreign genes and are capable
of efficiently infecting and immunizing host animal species. Two classes of viral vectors
are currently being used, the lytic viruses (such as polyoma and SV-40) and the socalled shuttle vectors based on retroviruses. Live vectors currently being evaluated
include vaccinia virus, bovine papillomavirus, herpesviruses, adenoviruses, SV-40
virus, and yeasts. When used as live vectors of foreign genes, the new r D N A organisms
must be fully recharacterized and compared with the parent virus. Concerns for safety
to humans and animals, and impact on the environment, must be addressed in an
Environmental Assessment or Environmental Impact Statement before such products
can be considered for experimental field trial or licensing.
A notice of proposed actions under N I H guidelines for research involving
recombinant D N A molecules was published in the Federal Register on 19 December
1986. This notice proposed a revision of sections I-B and III-A-2 of the guidelines
concerning experiments, which would require R A C review, and N I H and Institutional
Biosafety Committee ( I B C ) approval before initiation. This proposal would exempt
research involving "deletion derivatives not otherwise covered by these guidelines"
from N I H review or approval. It is also proposed that in the definition of r D N A
the word " f o r e i g n " would be clarified by the footnote: " R e a r r a n g e m e n t s involving
the introduction of D N A from different organisms or different strains of an organism
will be considered recombinant D N A . Deletions, single-base changes and
rearrangements within a single genome will not involve the introduction of foreign
D N A and therefore would not be considered recombinant DNA". Further, it proposed
that releases into the environment would not require N I H review and approval for
organisms resulting from "deletion derivatives and single base changes not otherwise
covered by the guidelines" and "rearrangements and amplification within a single
263
genome. Rearrangement involving the introduction of D N A from different strains
of the same organism would not be covered by this e x e m p t i o n " . T h e proposed
modification of Section III-A-2 also provides a clear, concise and much needed
clarification of the position whereby the term "deliberate release" essentially describes
or suggests a dangerous event a n d is therefore inappropriate for describing the use
of r D N A products outside contained premises. The proposal to describe such release
as " p l a n n e d i n t r o d u c t i o n " under accepted scientific practices in which there is
adequate evidence of biological a n d / o r physical control of the recombinant organism
is consistent with the U S D A position concerning release.
If these proposed changes in the N I H guidelines are accepted and finalized, VS
may need to consider amending its current classification scheme for r D N A products
in favor of a scheme with only two categories (Table VIII).
TABLE V I I I
Proposed categories of
hybridoma
and rDNA-derived
animal
biologics
Category I:
• Inactivated rDNA-derived viral vaccines
• Inactivated rDNA-derived bacterial products
• Viral, bacterial, or other subunit products
• Monoclonal antibody (hybridoma)
• Vaccines containing live organisms modified by gene insertion or deletion (no
introduction of "foreign" DNA)
Category II:
• Vaccines using live vectors to carry r-derived foreign genes
• Vaccines containing live organisms modified by gene insertion or deletion (introduction
of "foreign" DNA)
Category I could consist of rDNA-derived inactivated products, monoclonal
antibody products, and virus or bacterial subunits as defined for the current category
I, and live products containing organisms resulting from deletions, single base changes
and rearrangements within a single genome. It m a y be appropriate that a categorical
exemption be requested from compliance with the National Environmental Policy
Act ( N E P A ) for products in this category since they would be exempt from N I H
review. If exempted from N E P A , release of these products would require only
demonstration of purity, safety, potency and efficacy as required presently under
the VSTA for conventional live products. D a t a submitted to establish environmental
safety for the live products in this category could be documented in a decision
document instead of preparing an Environmental Assessment (EA).
Category II would include live vectors carrying one or more foreign genes coding
for immunizing antigens a n d / o r drugs, and organisms resulting from rearrangements
and amplifications involving the introduction of D N A from different organisms or
different strains of the same organism. This category would include the current
category III products plus the true recombinant products in the current category II.
264
Concerns for safety to humans and animals as well as environmental impact would
have to be addressed in an E A or Environmental Impact Statement before these
products could be considered for experimental field use or licensing.
In the regulation of r D N A veterinary biologics, as with other rDNA-derived
products, public concern has focused on procedures for regulating release of these
products from containment. Concern has been expressed regarding the adequacy of
current law to require review and evaluation of r D N A products prior to release, to
cover all r D N A deserving attention, and to assure protection of public health and
the environment. The need for peer review, public notification, and documentation
in these decisions has also been expressed. Veterinary Services has established
procedures for regulating veterinary biological products which address all of these
concerns in a positive manner, by means of an amendment to the VSTA contained
in the Food Security Act of 1985, publication of new regulations to implement this
amendment, and implementation of new administrative procedures for the review
of products (Table IX).
TABLE I X
Expanded
authority
for regulating
veterinary
biologics
• Intra and interstate
• Export
• Seizure and condemnation
• Establishment license based on Autogenous Product License
• Exemptions
- Products for use in Veterinary - Client Patient Relationship
— Products for use in a person's own animals
- Products prepared under approved state licensing programs
— Interim license to expire 1 January 1990
In amending the VSTA of 1913, the Food Security Act of 1985 expanded the
Department's authority over veterinary biological products in several respects. Under
the amended statute it is unlawful to ship or deliver for shipment any worthless,
contaminated, dangerous or harmful veterinary biologies intended for the treatment
of animals anywhere in or from the United States. Previously, intrastate shipments
and exports were not subject to the VSTA. T h e amendment also expanded the
Secretary's rule-making authority, authorized the inspection of any establishment
preparing animal biologies and provided new authorities of detention, seizure, and
condemnation of products. With these changes in the statutes, VS gained the b r o a d
authority needed for supervision of all biological products shipped in the United States.
To implement this new authority, several new and amended regulations have been
promulgated. Title 9 CFR, P a r t 103.3 which contains widely used provisions for the
interstate shipment of unlicensed biological products for experimental purposes, such
as field safety testing before licensing, was amended. Regulations now require
authorization from the Deputy Administrator before any shipment of an experimental
product in or from the United States, including intrastate and export shipments. These
amended regulations now permit VS to supervise all experimental uses of veterinary
biological products outside containment, whether in the United States or for export.
265
As with conventional products, r D N A products must be shown to be pure, safe,
potent and efficacious, and not worthless, contaminated, dangerous or harmful.
Assurance of safety in all products has included the responsibility to ensure that
products do not have any adverse effects u p o n the environment and d o not h a r m
animal and h u m a n health. T o ensure that safety concerns are fully respected,
regulations have also been amended to require a person wishing to import or ship
a veterinary biological product anywhere in or from the United States to provide any
additional information needed by the Deputy Administrator for a proper assessment
of the impact of products on the environment. Such additional information will apply
to live vaccines and m a y include (but is not necessarily limited to) demonstrating
nonpathogenicity and nonreversion to virulence by means of a number of backpassages
in the host animal; also studies to determine the fate of the organism when injected
into the host, and the ability of the organism to shed, transmit, and maintain itself
in a livestock population. Persons m a y also be requested to define the stability and
survival of the organism in the environment.
The organism's host range and ability to adapt to and affect other species m a y
also need to be investigated. In the case of live r D N A products (current category II
and III products) Veterinary Services will use these data to prepare a decision document
or an Environmental Assessment in accordance with the National Environmental
Policy Act. Under current policy, shipments of live r D N A products that involve release
of product outside containment will not be authorized until the completion of an
EA and the determination of a finding of no significant impact ( F O N S I ) by the Deputy
Administrator. P r o d u c t is not permitted to be shipped for release outside of
containment until 30 days after the publication in the Federal Register of a notice
of the availability of the E A and F O N S I (Fig. 4).
Environmental assessments are prepared by the VS Biologics Staff, reviewed by
the B E C Staff for compliance with N E P A and departmental biotechnology policy,
reviewed by the O G C for legal correctness, and evaluated by the VS Biotechnology
Committee for technical sufficiency and adequacy of the findings. The determination
of a F O N S I is m a d e by the Deputy Administrator only after concurrence in the E A
and findings from all parties. Implementation of the N E P A process in this manner
provides for review, documentation of the decision-making process, and notification
of the public before authorization of use of such products outside containment.
This process has been applied successfully t o recent field trials authorized for a
live recombinant-derived Pseudorabies vaccine produced by the U p J o h n C o m p a n y
and the D i a m o n d Scientific C o m p a n y . Requests to release other r D N A products are
currently under review. It is anticipated that several new r D N A products will be
authorized for use outside containment in this manner in the future.
Proposed changes in section I-A of the N I H guidelines, as contained in the Federal
Register Notice of 19, December 1986, also m a y have a significant impact on VS
procedures for handling r D N A products. The proposed changes would permit any
r D N A experiments, which according to the guidelines require N I H approval, to be
sent either to N I H for approval or another Federal agency which has jurisdiction
for review and approval. If submitted to and approved by another Federal agency,
experiments could proceed without the necessity for N I H review or approval. O u r
agency supports this change. It would be consistent with the development of expanded
regulatory authority in other Federal agencies. It would also help eliminate overlapping
jurisdiction and possible confusion concerning which agency an experiment should
266
Application
Veterinary Biologics Staff
O A B Notification
Quarantine
Field Trials
Restricted
Field Trials
Decision
Document
Preparation of E A
& FONSI by VS
B E C Staff
VS Authorization
VS Biotechnology
Committee
OGC
Deputy Administrator
(for signature)
Office of Agricultural
Biotechnology Notification
Federal
Register
30 day notice
Field Trials
FIG. 4
APHIS review procedures for field testing
live rDNA products
be submitted to for review and approval. At present, there is no provision or
requirement for transfer of information between N I H and other Federal regulatory
agencies. Because the review by another Federal agency serves the same purpose as
that currently conducted by N I H , it would be superfluous to require overlapping
reviews. Each Federal regulatory agency may also have unique requirements or criteria
for review not normally demanded by N I H that would also need to be addressed.
Currently, the N I H guidelines presented in Appendix L provide only the conditions
under which plants containing recombinant D N A molecules may be released into the
environment. The R A C Working G r o u p on Definitions, meeting in December 1986,
recommended the establishment of new appendices, similar to Appendix L, to include
conditions of release for genetically-engineered animals, micro-organisms other than
vaccines, and vaccines.
267
We favor the proposal by the R A C Working G r o u p on Definitions t o amend
Section III-A-2 by adding parallel sections to be written as Appendices M, N , and
O to cover (respectively) animals, micro-organisms (other than vaccines), and vaccines.
We also urge appropriate Federal, private, and public involvement in the preparation
of the criteria for these new Appendices.
Another paper provides more detailed information regarding VS guidelines for
transferring live, genetically-engineered organisms from containment t o limited field
trials.
Although further refinements and adjustments may be necessary as our knowledge
of r D N A products expands, we feel procedures for review and approval of r D N A
veterinary biological products that have been established in the United States provide
an appropriate balance of flexibility and control, and as a result, new r D N A products
should be marketed in a manner that maintains the public confidence.
*
* *
CONDITIONS D'HOMOLOGATION ACTUELLES DU DÉPARTEMENT DE
L'AGRICULTURE DES ÉTATS-UNIS POUR LES PRODUITS BIOLOGIQUES ANIMAUX
OBTENUS PAR RECOMBINAISON DE L'ADN. - D.A. Espeseth, P.L. Joseph,
G.P. Shibley et C.G. Gay.
Résumé : Aux fins d'homologation, les produits de la biotechnologie sont classés
dans trois catégories : les produits inactivés obtenus par recombinaison de l'ADN
et les anticorps monoclonaux, les micro-organismes vivants modifiés par addition
ou délétion de gènes, et les vecteurs vivants porteurs de gènes recombinants qui
permettent l'expression d'antigènes immunisants. Les auteurs présentent
l'organisation et les fonctions de la Commission de biotechnologie des Services
Vétérinaires, de la Commission sur la biotechnologie dans l'agriculture, de la
Commission consultative sur la biotechnologie de recombinaison de l'ADN en
agriculture, de l'Etat-major de coordination sur la biotechnologie et l'environnement, ainsi que des organismes qui se rattachent aux précédents. Les
propositions visant à accroître l'autorité des administrations responsables des
réglementations et à éviter le chevauchement des activités de contrôle sont
discutées.
MOTS-CLÉS : Administrations publiques - Biotechnologie - Etats-Unis
d'Amérique - Homologation - Législation - Produits biologiques - Vaccins.