DEPARTMENT OF AGRICULTURAL
Agricultural Bioterrorism Protection Act of 2002;
2005 USDA Regulation
This rule is intended to prevent the misuse of select agents and toxins, and thereby reduce the
potential for those pathogens to harm humans, animals, animal products, plants or plant
products in the United States. Should any select agent or toxin be intentionally introduced into
the United States, the consequences would be significant. Consequences could include
disruption of markets, difficulties in sustaining an adequate food and fiber supply, and the
potential spread of disease infestations over large areas.
In any animal or plant disease outbreak, the government would incur the costs of eradication.
Industry would be affected through the imposition of domestic and foreign quarantines, which
would result in a loss of markets and destruction of animals/plants if commercial properties are
found to be infected with the disease.
Even though compensation can be paid for the destroyed property, repopulating (flocks, herds,
fields, etc.) may be time consuming with additional losses from idle capital and lost markets. In
addition, there is the potential for a disruption in the domestic food supply, whether through
contamination, consumer perception, or both. Such a disruption can have a lasting influence on
food demand and global trade.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
7 CFR Part 331 and 9 CFR Part 121
[Docket No. 02-088-4]
RIN 0579-AB47
Agricultural Bioterrorism Protection
Act of 2002; Possession, Use, and
Transfer of Biological Agents and
Toxins
AGENCY: Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
SUMMARY: We are adopting as a final
rule, with changes, an interim rule that
established regulations governing the
possession, use, and transfer of
biological agents and toxins that have
been determined to have the potential to
pose a severe threat to public health and
safety, to animal health, to plant health,
or to animal or plant products. This
action is necessary to protect animal
and plant health, and animal and plant
products. p.1
Background
On June 12, 2002, the President
signed into law the Public Health
Security and Bioterrorism Preparedness
and Response Act of 2002 (Pub. L. 107-
188). Title II of Pub. L. 107-188,
‘‘Enhancing Controls on Dangerous
Biological Agents and Toxins’’ (sections
201 through 231), provides for the
regulation of certain biological agents
and toxins by the Department of Health
and Human Services (subtitle A,
sections 201-204) and the Department
of Agriculture (subtitle B, sections 211-213),
and provides for interagency
coordination between the two
departments regarding overlap agents
and toxins (subtitle C, section 221).
Subtitle D (section 231) provides for
criminal penalties regarding certain
biological agents and toxins. For the
Department of Health and Human
Services, the Centers for Disease Control
and Prevention (CDC) has been
designated as the agency with primary
responsibility for implementing the
provisions of the Act; the Animal and
Plant Health Inspection Service (APHIS)
is the agency fulfilling that role for the
Department of Agriculture (USDA). The
Criminal Justice Information Services
(CJIS) Division of the Federal Bureau of
Investigation has been designated as the
agency with primary responsibility for
implementing the Attorney General’s
responsibilities under the Act
13242 Federal Register / Vol. 70, No. 52 /
Friday, March 18, 2005
Information about the risk
characteristics of a select agent or toxin
and safe handling practices is available
in scientific literature and other
publications (e.g., the CDC/NIH
publication, ‘‘Biosafety in
Microbiological and Biomedical
Laboratories’’). For these reasons, we are
making no change based on this
comment.
13248 Federal Register / Vol. 70, No. 52 / Friday,
March 18, 2005 / Rules and Regulations
the requirement that an entity’s security
plan be sufficient to safeguard the select
agent or toxin against unauthorized
access, theft, loss, or release (newly
designated 7 CFR 331.11(a) and 9 CFR
121.11(a)). In addition, we are amending
both sections to require that the security
plan be designed according to a sitespecific
risk assessment and provide
graded protection in accordance with
the risk of the select agent or toxin,
given its intended use. We believe these
changes will clarify the requirements
and make the text in this section
consistent with other sections in the
regulations (e.g., biocontainment/
biosafety).
13262 Federal Register / Vol. 70, No. 52 / Friday,
March 18, 2005 / Rules and Regulations
Interim
7 CFR 331.11(a)(2)(iv)(B) and
9 CFR 121.12(a)(2)(iv)(B) required that
individuals who are not approved under
§§ 331.10 or 121.11, respectively, be
allowed to conduct routine cleaning,
maintenance, repairs, and other nonlaboratory
functions only when escorted
and continually monitored.
Federal Register / Vol. 70, No. 52 / Friday, March
18, 2005 / Rules and Regulations 13263
Training
Interim 7 CFR 331.12 (newly
designated § 331.15) required the
responsible official to provide
appropriate training in containment and
security procedures to all individuals
with access to listed agents and toxins,
while interim 9 CFR 121.13 (newly
designated § 121.15) required the
responsible official to provide
appropriate training in biosafety,
containment, and security procedures to
all individuals with access to listed
agents and toxins. Both sections
required the responsible official to
provide information and training to an
individual at the time the individual is
assigned to work with a listed agent and
toxin, and to provide refresher training
annually.
Federal Register / Vol. 70, No. 52 / Friday, March
18, 2005 / Rules and Regulations 13265
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Biosafety/Biocontainment
Biosafety and containment
requirements ensure that the
combination of work practices and
physical containment are designed to
reduce the risks of working with
infectious material and the degree of
protection is proportional to the risk
associated with the agent. Higher
biosafety levels (BSL) correspond to
greater degrees of protection. For
example, at a BSL-3 laboratory, more
emphasis is placed on primary and
secondary barriers to protect personnel
in contiguous areas, the community,
and the environment from exposure to
potentially infectious aerosols. Also,
because there is special concern for
reducing the risk of environmental
exposure to pathogens of concern to
agriculture, BSL-3-Ag adds filtration of
supply and exhaust air, sewage
decontamination, exit personnel
showers, and entity integrity testing.
While the BSL terminology is not
formally used in relation to laboratories
working with plant agents or toxins, a
parallel philosophy of matching pest
risk to biocontainment is used in theplant pest
permit system. Under this
rule, the biosafety and containment
procedures at an entity must be
sufficient to contain the agent or toxin
(e.g., physical structure and features of
the entity, and operational and
procedural safeguards).
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Friday, March 18, 2005 / Rules and Regulations
Conclusion
This rule is intended to prevent the
misuse of select agents and toxins, and
thereby reduce the potential for those
pathogens to harm humans, animals,
animal products, plants or plant
products in the United States. Should
any select agent or toxin be
intentionally introduced into the United
States, the consequences would be
significant. Consequences could include
disruption of markets, difficulties in
sustaining an adequate food and fiber
supply, and the potential spread of
disease infestations over large areas. In
any animal or plant disease outbreak,
the government would incur the costs of
eradication. Industry would be affected
through the imposition of domestic and
foreign quarantines, which would result
in a loss of markets and destruction of
animals/plants if commercial properties
are found to be infected with the
disease. Even though compensation can
be paid for the destroyed property,
repopulating (flocks, herds, fields, etc.)
may be time consuming with additional
losses from idle capital and lost
markets. In addition, there is the potential for a
disruption in the
domestic food supply, whether through
contamination, consumer perception, or
both. Such a disruption can have a
lasting influence on food demand and
global trade.
While the costs associated with this
rule could be considerable, some of
those impacts are somewhat offset. For
example, requirements such as USDA
permit requirements for biosafety and
containment and the mandate to update
security at USDA facilities were in place
prior to the implementation of the
December 2002 interim rule. The
flexibility in the rule also allows for
site-specific needs to be met in the most
cost effective manner possible. In
addition, these costs are greatly
outweighed by the benefits of
preventing an unintentional or
deliberate introduction of a select agent
or toxin into the United States. The cost
associated with outbreaks can be very
high as is demonstrated by natural
outbreaks that have occurred. Deliberate
introduction greatly increases the
probability of a select agent or toxin
becoming established and causing wideranging
and devastating impacts on the
economy, disruption to society,
diminished confidence in public and
private institutions, and possible loss of
life.
Federal Register / Vol. 70, No. 52 / Friday,
March 18, 2005 / Rules and Regulations 13277
In this final rule, newly designated 7
CFR 331.19(b) requires that APHIS or
CDC be notified immediately upon
discovery of a release of a PPQ select
agent or toxin outside the primary
barriers of the biocontainment area
while 9 CFR 121.19(b) requires that
APHIS or CDC be notified immediately
upon discovery of a release of a VS or
overlap select agent or toxin causing
occupational exposure or a release
outside the primary barriers of the
biocontainment area. The requirement
for notification of a release outside of
the primary barriers of the
biocontainment area is a clarification.
In 9 CFR 121.19(b), we are
adding the provision for occupational
exposure to be consistent with CDC’s
regulations.
Given the risks associated with select
agents and toxins, we believe it is
necessary to be notified of all
occupational exposures. It is the entity’s
responsibility to ensure that its
employees comply with these reporting
requirements. For these reasons, we are
making no changes based on these
comments.
13268 Federal Register / Vol. 70, No. 52 /
Friday, March 18, 2005 / Rules and
Regulations
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (Pub. L. 107-188),
provides for the regulation of certain
biological agents 1 and toxins 2 that have
the potential to pose a severe threat to public
health and safety, to animal
health, to plant health, or to animal and
plant products. The Act also requires
that the Secretary of Agriculture
establish and enforce standards and
procedures governing the possession
and use of the listed biological agents
and toxins, including the establishment
and enforcement of safety requirements
for the transfer of listed agents and
toxins; the establishment and
enforcement of safeguard and security
measures to prevent access to listed
agents and toxins for use in domestic or
international terrorism or other criminal
purpose; and the establishment of
procedures to protect animal and plant
health, and animal and plant products,
in the event of a transfer in violation of
the established safety and security
measures.
1 Any microorganism (including, but not limited
to, bacteria, viruses, fungi, rickettsiae, or protozoa),
or infectious substance, or any naturally occurring,
bioengineered, or synthesized component of any
such microorganism or infectious substance,
capable of causing: (1) Death, disease or other
biological malfunction in a human, an animal, a plant,
or another living organism; (2) deterioration of food,
water, equipment, supplies, or material of any kind; or
(3) deleterious alteration of the environment.
2 The toxic material or product of plants, animals,
microorganisms (including, but not limited to,
bacteria, viruses, fungi, rickettsiae, or protozoa), or
infectious substances, or a recombinant or
synthesized molecule, whatever their origin and
method of production, and includes: (1) Any
poisonous substance or biological product that may
be engineered as a result of biotechnology produced
by a living organism; or (2) any poisonous isomer or
biological product, homolog, or derivative of
such a substance.
Federal Register / Vol. 70, No. 52 / Friday,
March 18, 2005 / Rules and Regulations 13269
42 § 73.1 Definitions.
Biological agent means any
microorganism (including, but not
limited to, bacteria, viruses, fungi,
rickettsiae, or protozoa), or infectious
substance, or any naturally occurring,
bioengineered, or synthesized
component of any such microorganism
or infectious substance, capable of
causing death, disease, or other
biological malfunction in a human, an
animal, a plant, or another living
organism; deterioration of food, water,
equipment, supplies, or material of any
kind; or deleterious alteration of the
environment.
Select agent and/or toxin means
unless otherwise specified, all of the
biological agents or toxins listed in
§§ 73.3 and 73.4.
Toxin means the toxic material or
product of plants, animals,
microorganisms (including, but not
limited to, bacteria, viruses, fungi,
rickettsiae, or protozoa), or infectious
substances, or a recombinant or
synthesized molecule, whatever their
origin and method of production, and
includes any poisonous substance or
biological product that may be
engineered as a result of biotechnology,
produced by a living organism; or any
poisonous isomer or biological product,
homolog, or derivative of such a
substance.
§ 121.1, § 331.1 Definitions.
Biological agent. Any microorganism
(including, but not limited to, bacteria,
viruses, fungi, rickettsiae, or protozoa),
or infectious substance, or any naturally
occurring, bioengineered, or synthesized
component of any such microorganism
or infectious substance, capable of
causing:
(1) Death, disease, or other biological
malfunction in a human, an animal, a
plant, or another living organism;
(2) Deterioration of food, water,
equipment, supplies, or material of any
kind; or
(3) Deleterious alteration of the
environment.
Select agent and/or toxin. A biological
agent or toxin listed in § 331.3.
Toxin. The toxic material or product
of plants, animals, microorganisms
(including, but not limited to, bacteria,
viruses, fungi, rickettsiae, or protozoa),
or infectious substances, or a
recombinant or synthesized molecule,
whatever their origin and method of
production, and includes:
(1) Any poisonous substance or
biological product that may be
engineered as a result of biotechnology
produced by a living organism; or
(2) Any poisonous isomer or
biological product, homolog, or
derivative of such a substance.
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