|
16 October 2008
[Federal Register: October 16, 2008 (Volume 73, Number 201)]
[Rules and Regulations]
[Page 61325-61332]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc08-1]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
[[Page 61325]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 331
9 CFR Part 121
[Docket No. APHIS-2007-0033]
RIN 0579-AC53
Agricultural Bioterrorism Protection Act of 2002; Biennial Review
and Republication of the Select Agent and Toxin List
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Agricultural Bioterrorism Protection
Act of 2002, we are amending and republishing the list of select agents
and toxins that have the potential to pose a severe threat to animal or
plant health, or to animal or plant products. The Act requires the
biennial review and republication of the list of select agents and
toxins and the revision of the list as necessary. This action
implements the findings of the second biennial review of the list.
DATES: Effective Date: November 17, 2008.
FOR FURTHER INFORMATION CONTACT: For information concerning the
regulations in 7 CFR part 331, contact Ms. Cassie Armiger, Program
Analyst, Select Agent Program, PPQ, APHIS, 4700 River Road Unit 2,
Riverdale, MD 20737-1231, (301) 734-5960.
For information concerning the regulations in 9 CFR part 121,
contact Dr. Frederick D. Doddy, Staff Veterinarian, Animals, Organisms
and Vectors, and Select Agents, NCIE, VS, APHIS, 4700 River Road Unit
39, Riverdale, MD 20737-1231, (301) 734-5960.
SUPPLEMENTARY INFORMATION:
Background
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 provides for the regulation of certain biological
agents and toxins that have the potential to pose a severe threat to
both human and animal health, to animal health, to plant health, or to
animal and plant products. The Animal and Plant Health Inspection
Service (APHIS) has the primary responsibility for implementing the
provisions of the Act within the Department of Agriculture (USDA).
Plant Protection and Quarantine (PPQ) select agents and toxins are
those that have been determined to have the potential to pose a severe
threat to plant health or plant products. Veterinary Services (VS)
select agents and toxins are those that have been determined to have
the potential to pose a severe threat to animal health or animal
products. Overlap select agents and toxins--i.e., those determined to
have the potential to pose a severe threat to public health and to
animal health or animal products--are subject to regulation by both
APHIS and the Centers for Disease Control and Prevention (CDC), which
has the primary responsibility for implementing the provisions of the
Act for the Department of Health and Human Services (HHS).
Subtitle B (which is cited as the ``Agricultural Bioterrorism
Protection Act of 2002'' and referred to below as the Act), section
212(a), provides, in part, that the Secretary of Agriculture (the
Secretary) must establish by regulation a list of each biological agent
and each toxin that the Secretary determines has the potential to pose
a severe threat to animal or plant health, or to animal or plant
products. Paragraph (a)(2) of section 212 requires the Secretary to
review and republish the list every 2 years and to revise the list as
necessary.
In determining whether to include an agent or toxin on the list,
the Act requires that the following criteria be considered:
The effect of exposure to the agent or toxin on animal or
plant health, and on the production and marketability of animal or
plant products;
The pathogenicity of the agent or the toxin and the
methods by which the agent or toxin is transferred to animals or
plants;
The availability and effectiveness of pharmacotherapies
and prophylaxes to treat and prevent any illness caused by the agent or
toxin; and
Any other criteria that the Secretary considers
appropriate to protect animal or plant health, or animal or plant
products.
On August 28, 2007, in accordance with the Act, we published in the
Federal Register (72 FR 49231-49236, Docket No. APHIS-2007-0033) a
proposal \1\ to amend and republish the list of select agents and
toxins that have the potential to pose a severe threat to animal or
plant health, or to animal or plant products.
---------------------------------------------------------------------------
\1\ To view the proposed rule and the comments we received, go
to http://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0033.
---------------------------------------------------------------------------
We solicited comments concerning our proposal for 60 days ending
October 29, 2007. We received 41 comments by that date. On November 16,
2007, we published a notice in the Federal Register (72 FR 64540) to
reopen the comment period for an additional 15 days to allow interested
persons additional time to prepare and submit comments. We received an
additional 21 comments by the December 3, 2007, close of the reopened
comment period, for a total of 62 comments. The comments we received on
the proposed rule were from academic institutions, professional
associations, corporations, nonprofit organizations, individuals, and
representatives of State and Federal Government agencies. The comments
are discussed below.
PPQ Select Agents and Toxins
The list of PPQ select agents and toxins in 7 CFR 331.3 has
included entries for Candidatus Liberobacter asiaticus and Candidatus
Liberobacter africanus. In our proposed rule, we proposed to add
Candidatus Liberobacter americanus to the list and to remove the entry
for Candidatus Liberobacter asiaticus.
Many commenters supported the proposed delisting of Candidatus
Liberobacter asiaticus, but opposed the proposed listing of Candidatus
Liberobacter americanus, arguing that the presence of citrus greening
disease in Florida makes both plant pathogens unlikely agents of
bioterrorism. A
[[Page 61326]]
majority of those commenters also recommended that that Candidatus
Liberobacter africanus should also be removed from the list of PPQ
select agents and toxins for that same reason. Those commenters pointed
out that in the field there are no apparent differences in the biology
of the three plant pathogens and that there are few, if any,
established polymerase chain reaction primers available to distinguish
among them. Only one commenter supported the proposed listing of
Candidatus Liberobacter americanus based on the assertion that it is
more readily transmittable than Candidatus Liberobacter asiaticus;
however, we are unaware of any evidence to support that specific
assertion.
In response to the points raised by these commenters, we have
reevaluated the available science. We agree with the commenters that it
is difficult to distinguish between the three plant pathogens. In fact,
in the Citrus Health Response Program developed by APHIS and Florida
regulatory officials in consultation with the Florida citrus industry
and other stakeholders, the management responses for the three
bacterial species are identical. Further, we agree that the presence of
citrus greening disease in Florida makes them unlikely agents of
bioterrorism, as does the long latency period of the disease.
Therefore, in this final rule, in addition to delisting Candidatus
Liberobacter asiaticus as proposed, we are also removing Candidatus
Liberobacter africanus from the list of PPQ select agent and toxins and
have decided not to list Candidatus Liberobacter americanus as we had
originally proposed.
The list of PPQ select agents and toxins has included an entry for
Xanthomonas oryzae pv. oryzicola. In our proposed rule, we proposed to
remove the pathovar designation (pv. oryzicola) from the currently
listed organism and thus regulate both pathovars of Xanthomonas oryzae
(i.e., both oryzicola and oryzae).
Several commenters argued that the proposed removal of the pathovar
designation from Xanthomonas oryzae pv. oryzicola is unnecessary
because the exposure of Xanthomonas oryzae pv. oryzae in the United
States carries low risk for significant and ongoing damage, and
effective management practices and treatments make establishment
unlikely. Most of these commenters also recommended that we remove both
pathovars from our list.
We agree that there are effective response and recovery plans in
development for treatment and management of these pathovars (oryzicola
and oryzae). However, we do not believe that this alone is a sufficient
reason to remove these agents from the list of select agents and toxins
at this time. Both pathovars represent a significant risk to U.S. rice
production. Until we obtain more scientific information to allow us to
better evaluate the potential consequences of removing the pathovars
from the list of select agents and toxins, and until we have identified
an effective test that can quickly and conclusively distinguish between
the pathovars, we intend to regulate all pathovars of Xanthomonas
oryzae as proposed. As more information becomes available, we will be
in a better position to reevaluate the commenters' recommendations.
The list of PPQ select agents and toxins has included an entry for
Peronosclerospora philippinensis. We proposed to add Peronosclerospora
sacchari as a synonym of that organism because recent scientific
research has shown that these two organisms are the same.
One commenter did not agree with our proposed addition of
Peronosclerospora sacchari as a synonym and cited evidence that
Peronosclerospora philippinensis and Peronosclerospora sacchari may
have differing host ranges to support his position.
The evidence cited by the commenter is not sufficient to convince
us that we should not add Peronosclerospora sacchari as a synonym of
Peronosclerospora philippinensis. While we do not believe there is
currently sufficient science to confirm the potential speciation
pointed to by the commenter, we are open to reconsidering the issue as
new data are published.
We proposed to add Phoma glycinicola (formerly Pyrenochaeta
glycines), which causes red leaf blotch of soybean, to the list of PPQ
select agents and toxins.
One commenter was opposed to listing Phoma glycinicola as a select
agent. The commenter stated that the pathogen is not conducive to
widespread movement, effective chemical treatments are available, and
the advanced knowledge of plant pathology required to isolate the
pathogen makes it unsuitable as a potential weapon of terrorism.
However, much of the evidence cited by the commenter was anecdotal and
did not provide an adequate basis for not including this aggressive
fungus, which is not currently present in the United States, on the
list of PPQ select agents and toxins. Therefore, we are adding Phoma
glycinicola to the list of PPQ select agents and toxins as proposed. We
will review this listing in the future and would consider removing this
pathogen from the list of PPQ select agents and toxins should new
scientific information become available to support such an action.
We proposed to add Phytophthora kernoviae to the list of PPQ select
agents and toxins based, in part, on our identification of this
pathogen as a serious threat to the nursery industry and woodland
areas.
One commenter argued that Phytophthora kernoviae should not be
listed as a select agent based on evidence that it is primarily a
forest pathogen and has not been found in the nursery industry as
initially believed; accordingly, the effects of exposure on the
production and marketability of plant products would be minimal.
Further, the commenter stated that evidence suggests that the current
regulatory systems and surveys for Phytophthora ramorum could be
effectively applied toward the control of Phytophthora kernoviae.
We agree with this commenter's point that current regulatory
systems and surveys for Phytophthora ramorum could be effectively
applied toward the surveillance for Phytophthora kernoviae. Based on
this consideration and due to a clearer understanding of the
epidemiology of Phytophthora kernoviae that suggests a reduction in the
initially determined host range of the pathogen, we have decided that
Phytophthora kernoviae should not be listed as a select agent. We note
that a plant pest permit issued under our regulations in 7 CFR part 330
will still be required for the importation or interstate movement of
Phytophthora kernoviae, however.
We proposed to add Rathayibacter toxicus, a bacterium that causes
gumming disease in ryegrass, to the list of PPQ select agents and
toxins.
One commenter supported the proposed listing, but recommended that
APHIS develop a reliable diagnostic tool to differentiate between
Rathayibacter toxicus and the related, non-toxic species Rathayibacter
rathayi. This commenter stated it is critically important to be able to
distinguish between the two species for the purposes of cooperative
pest surveys and for phytosanitary certification purposes. We agree
that it is important to develop a diagnostic tool to distinguish
between these two species and note that the USDA's Agricultural
Research Service is conducting an ongoing research project focused on
the identification, molecular characterization, and detection of
[[Page 61327]]
foreign and newly emerging domestic bacteria (including Rathayibacter
toxicus). However, this is not a basis for not including Rathayibacter
toxicus on the select agent list.
Overlap and VS Select Agents and Toxins
We proposed to remove 10 of the 20 overlap select agents and toxins
from the list in 9 CFR 121.4(b). Specifically, we proposed to remove
three bacteria (Botulinum neurotoxin producing species of Clostridium,
Coxiella burnetii, and Francisella tularensis), a fungus (Coccidioides
immitis), a virus (Eastern equine encephalitis virus), and five toxins
(Botulinum neurotoxins, Clostridium perfringens epsilon toxin,
shigatoxin, staphylococcal enterotoxin, and T-2 toxin).
One commenter was opposed to the removal of botulinum neurotoxins
and botulinum neurotoxin producing species of Clostridium from the list
of overlap select agents and toxins. The commenter argued that the
presence of a select agent in the environment does not minimize the
potential for its use as a weapon of bioterrorism, which would result
in clear economic and societal consequences.
We do not minimize the fact that botulinum neurotoxins and
botulinum neurotoxin producing species of Clostridium can present a
significant health risk to livestock; indeed, these neurotoxins are
some of the most lethal substances known to animals, and could cause
the death of many animals in large herds. However, we do not agree that
the intentional use of botulinum neurotoxins would have a significant
impact on U.S. export trade in animals and animal products, or have a
long-term impact on U.S. agriculture. Based on evidence that
transmissibility from animal to animal is negligible and that,
historically, outbreaks of botulism occur periodically in the United
States, we have determined that botulinum neurotoxins are a poor
agroterrorism weapon, and we should, therefore, remove botulinum
neurotoxins and botulinum neurotoxin producing species of Clostridium
from the list of overlap select agents in our regulations in Sec.
121.4(b). It should be noted, however, that botulinum neurotoxins and
botulinum neurotoxin producing species of Clostridium will continue to
be regulated by the CDC under its select agent and toxins regulations
in 42 CFR part 73 due to their potential threat to human health.
One commenter asked that we clarify which strains of vesicular
stomatitis virus (VSV) APHIS considers to be exotic.
Although we did not propose to make any changes in the regulations
with respect to VSV, we agree that it would be helpful to clarify which
subtypes of VSV we consider to be exotic. Two major serotypes of VSV,
New Jersey (VSV-NJ or VSNJV) and Indiana (VSV-IN1 or VSIV), have been
reported to cause classical vesicular stomatitis disease in
agriculturally significant animals (i.e., cattle, horses, and swine)
throughout the Americas. Two subtypes of the Indiana serotype, Cocal
(VSIV-IN2 or VSIV-2) and Alagoas (VSV-IN3 or VSIV-3), cause vesicular
disease in livestock in Brazil and Argentina. In the United States, VSV
has not become established, but domestic outbreaks of VSV caused by
VSV-NJ and VSV-IN1 occur sporadically in cycles. Therefore, we have
clarified in the regulations that the listed VS select agent
``vesicular stomatitis virus (exotic)'' refers to Indiana subtypes VSV-
IN2 and VSV-IN3.
Two commenters involved in the development of veterinary biological
products noted that 4 of the 10 overlap select agents and toxins that
APHIS had proposed to remove from its list in Sec. 121.4 were agents
that the veterinary biologics industry uses to manufacture licensed
veterinary biologics or uses in product research and development.
Noting that the veterinary biologics industry has a well-established
relationship with APHIS' Center for Veterinary Biologics (CVB), the
commenters were concerned about what may happen when APHIS no longer
has a role in regulating those agents as select agents or toxins. The
commenters suggested that:
The agents should be removed from the CDC select agent
list to mirror their delisting by APHIS;
CDC should exempt the use of the agents in the manufacture
of veterinary biologics by CVB-licensed facilities and their
investigation use under CVB supervision;
APHIS should keep the agents on the overlap list; or
CDC should utilize APHIS/CVB for oversight and inspection
of CVB-licensed firms.
We acknowledge that there will be some entities that produce
veterinary biologics that will now possess select agents or toxins
regulated only by CDC, so the APHIS select agent program will not be
part of the inspection process at those facilities unless the facility
also possesses VS select agents or toxins. In either case, however, CVB
will continue to conduct its own compliance inspections and otherwise
exercise oversight of veterinary biologics facilities in keeping with
its responsibilities under the Virus-Serum-Toxin Act (VSTA). The
compliance inspections conducted by CVB under the VSTA are separate and
distinct from the inspections conducted under the select agent program,
and there will be no disruption or change in the way CVB conducts those
compliance inspections as a result of the removal of select agents and
toxins from the overlap list. As for the select agent program, we note
that the regulations administered by APHIS and CDC are entirely
consistent with each other, so there will be no change in security
requirements, registration procedures, restrictions, exemptions, etc.
With respect to inspections and other activities conducted under the
select agent program, APHIS and CDC have established procedures that
ensure close coordination and consistency in the regulation of select
agents and toxins. We do not, therefore, believe that it is necessary
to make any of the changes suggested by the commenters in order to
ensure the continuing efficiency and consistency of the regulation of
select agents and toxins by APHIS and CDC.
Other Comments
Several commenters argued that the cost to upgrade security at
existing facilities was prohibitive. One commenter stated that the cost
of compliance with the regulations at his facility came to almost
$150,000. Other commenters asserted that research facilities that
possess, use, or transfer a select agent or toxin would be forced to
close due to dramatic increases in the cost of research, or that
research programs will be impeded by the regulatory requirements or
even terminated because researchers and their institutions will not
want to deal with the new regulatory requirements or be liable for
violations of the regulations.
In our economic analysis for the proposed rule, we stated that an
entity that possesses a newly added agent will have to comply with the
regulations, and may therefore incur cost. We also noted that the costs
to comply with the security requirements are site-specific and will
vary accordingly. In this final rule, we reiterate that compliance with
the regulations can be achieved in a wide variety of ways, and while
some of these methods can be expensive, the regulations do not specify
how the physical security needs (limiting access to the agents) are to
be met, only that they are to be commensurate with the threat that the
select agent or toxin poses. Therefore, an entity can choose the most
cost-effective alternative to meeting those needs. Often an entity's
[[Page 61328]]
standard operating procedures for security are sufficient. Accordingly,
research facilities that possess, use, or transfer a select agent or
toxin may not be forced to close, as one commenter fears, due to an
increased cost of research.
We were required by the Act to establish, by regulation, standards
and procedures governing the possession, use, and transfer of listed
biological agents and toxins in order to protect animal and plant
health, and animal and plant products. Those standards and procedures
were established in an interim rule published in the Federal Register
on December 13, 2002, and effective on February 11, 2003. To date, the
commenters' concerns about the costs or difficulties of complying with
the regulations have failed to materialize.
Several commenters argued that the process of registering an entity
is excessively time-consuming and that the regulations entail
additional recordkeeping requirements. One commenter claimed that the
process of approval (Federal Bureau of Investigation (FBI) checks,
security plans, lab and greenhouse modifications, training, and
inspection) took more than 1 year.
Registered entities must develop and implement a written security
plan that provides graded protection in accordance with the risk of the
select agent or toxin, given its intended use, and must develop and
implement a written biosafety/biocontainment plan that is commensurate
with the risk of the agent or toxin, given its intended use. Registered
entities must also develop and implement a written incident response
plan that describes the entity's response procedures for releases,
theft, or loss of a select agent or toxin, etc. These reporting and
recordkeeping requirements have been reviewed and approved by the
Office of Management and Budget in accordance with the Paperwork
Reduction Act. As for the length of time it took the one commenter's
facility to become registered, there are a variety of factors that
could have contributed to such a lengthy process, but we are unaware of
the particular circumstances of the commenter's experience. We do note
that the necessary security risk assessment (SRA) checks are provided
free of charge by the FBI and take approximately 45 days to complete,
and that APHIS and CDC are committed to ensuring that the registration
process is conducted as efficiently as possible.
One commenter stated that we need a mechanism that would allow the
timely delisting of a newly detected select agent if it is found to be
widely distributed and ineradicable.
Given that the Administrative Procedure Act provides that an agency
may, with a showing of good cause, make a rule effective in less than
30 days and without prior opportunity for public comment, we do not
believe it is necessary for us to establish any new mechanism for
delisting or otherwise amending the regulations.
We received many comments that recommended we remove specific PPQ,
VS, and overlap select agents from the lists in 7 CFR part 331 and 9
CFR part 121. The PPQ select agents specifically mentioned were
Ralstonia solanacearum, race 3, biovar 2; Sclerophthora rayssiae var.
zeae; Synchytrium endobioticum; and Xylella fastidiosa (citrus
variegated chlorosis strain), and the VS select agents mentioned were
the bovine spongiform encephalopathy agent and Venezuelan equine
encephalitis virus. These commenters supplied detailed information to
support their position that these select agents should be delisted; in
most cases, the commenters asserted that the continued listing of
specific agents they considered low risks for bioterrorism was
prohibitive and impeded timely research. Conversely, another commenter
submitted information supporting his contention that the agents that
cause scrapie and chronic wasting disease should be added to the list
of VS select agents and toxins.
We will take the information provided by the commenters into
account as we continue to review our regulations and anticipate that we
will be providing an opportunity in the future for affected entities
and the general public to offer suggestions for adding or eliminating
select agents and toxins to or from the lists in our regulations. We
will use the information provided by the commenters as we consider the
potential regulatory changes that may be part of our next proposed
rule.
Miscellaneous Change
We are making one other change in this final rule. In the proposed
rule, we included an explanatory footnote to the entry for ``virulent
Newcastle disease virus'' in the proposed list of VS select agents and
toxins. This footnote read: ``A virulent Newcastle disease virus (avian
paramyxovirus serotype 1) has an intracerebral pathogenicity index in
day-old chicks (Gallus gallus) of 0.7 or greater or having an amino
acid sequence at the fusion (F) protein cleavage site that is
consistent with virulent strains of Newcastle disease virus.'' We are
replacing the word ``having'' in the proposed footnote with the word
``has.'' In addition, we are adding a sentence to further clarify the
definition: ``A failure to detect a cleavage site that is consistent
with virulent strains does not confirm the absence of a virulent
virus.'' This sentence will provide additional guidance to entities in
determining whether they possess a virulent strain of Newcastle disease
virus.
Compliance Dates
We recognize that there may be some entities that are not currently
registered under the select agents program, but that possess one of the
PPQ select agents being added to the regulations by this final rule.
The PPQ select agents we are adding to the regulations in 7 CFR part
331 are:
Xanthomonas oryzae pv. oryzae,
Peronosclerospora sacchari,
Phoma glycinicola (formerly Pyrenochaeta glycines), and
Rathayibacter toxicus.
In addition, although it is not likely, the redefinition of
Newcastle disease virus (velogenic) to virulent Newcastle disease virus
may lead to new registrants, as it is possible that additional entities
may be in possession of a virulent strain of Newcastle disease virus
that does not fit the current definition.
Accordingly, entities that currently possess one of those four
agents or a strain of Newcastle disease virus that we now define as
virulent, if they are not already registered entities, will have to
either transfer the organism to a registered entity or become a
registered entity themselves as a result of this final rule. Those
entities that choose to become registered will need time to come into
full compliance with the requirements of the regulations.
This final rule will become effective on November 17, 2008. On and
after that date, any individual or entity possessing, using, or
transferring any listed agent or toxin must be in compliance with the
provisions of each part.
However, to minimize the disruption of research or educational
projects (e.g., teaching demonstrations) involving listed select agents
or toxins that were underway as of the effective date of these
regulations, we provide that any individual or entity possessing such
agents or toxins as of the effective date (current possessors) will be
afforded additional time to reach full compliance with the regulations
in each part. Accordingly, by November 17, 2008, the responsible
official at all entities that possess a new agent or toxin must provide
notice to APHIS regarding their
[[Page 61329]]
possession of the new agent(s) and toxin(s). By April 14, 2008, all
previously unregistered entities must be registered.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be not significant for the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of
Management and Budget.
In accordance with the Agricultural Bioterrorism Protection Act of
2002, we are amending and republishing the list of select agents and
toxins that have the potential to pose a severe threat to animal or
plant health, or to animal or plant products. The Act requires the
biennial review and republication of the list of select agents and
toxins and the revision of the list as necessary. This action
implements the findings of the second biennial review of the list.
Certain pathogens or toxins produced by biological organisms that
are released intentionally or accidentally can result in disease, wide-
ranging and devastating impacts on the economy, disruption to society,
diminished confidence in public and private institutions, and large-
scale loss of life. People or livestock can be exposed to these agents
from inhalation, through the skin, or by the ingestion of contaminated
food, feed, or water. Similarly, crops can be exposed to biological
pathogens in several ways--at the seed stage, in the field, or after
harvest.
Because of its size and complexity, the U.S. food and agriculture
system is vulnerable to deliberate attacks, particularly with foreign
diseases that do not now occur domestically. The U.S. livestock
industry, with revenues of approximately $150 billion annually, is
extremely vulnerable to a host of highly infectious and often
contagious biological agents that have been eradicated from the United
States, or have never existed here. Many of these animal-targeted
agents could simply be point-introduced into herds. Given the
increasing concentration and specialization in the livestock
industries, the introduction of a VS select agent or toxin could cause
the immediate halt of movement and export of vast quantities of U.S.
livestock and livestock products. Crops, too, are vulnerable. They are
grown over very large areas (more than 75 million acres of soybeans
were cultivated in the United States in 2006, for example),
exacerbating difficulties in surveillance and monitoring.\2\
---------------------------------------------------------------------------
\2\ Making the Nation Safer: The Role of Science and Technology
in Countering Terrorism. Committee on Science and Technology for
Countering Terrorism, Division on Engineering and Physical Sciences,
National Research Council. National Academy Press (2002), and USDA
National Agricultural Statistics Service, Prospective Plantings,
March 30, 2007, Cr Pr 2-4, http://www.usda.gov/nass/PUBS/TODAYRPT/
pspl0307.txt.
---------------------------------------------------------------------------
Preparedness for a biological attack against people, crops or
livestock is complicated by the large number of potential agents, the
long incubation periods of some agents, and the potential for secondary
transmission. All of these factors make vital the prevention of the
misuse of biological agents and toxins through registration, biosafety,
and security measures and the availability of incident response
capabilities.
Section 212(a)(2) of the Act requires a biennial review and
republication of the select biological agent and toxin list, with
revisions as appropriate in accordance with this law. This rule will
implement the recommendations of the second biennial review of the
list. Expected benefits and costs are examined in accordance with
Executive Order 12866. Expected impacts for small entities are also
considered, as required by the Regulatory Flexibility Act.
Benefits and Costs
This rule updates the lists of select agents and toxins contained
in the regulations in 7 CFR part 331 and 9 CFR part 121. The
regulations require registration, biosafety, incident response, and
security measures for the possession, use, and transfer of the listed
select agents and toxins. The regulations are intended to prevent the
misuse of those select agents and toxins, and therefore 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. Direct losses in agriculture could
occur as a result of the exposure, such as death or debility of
affected production animals, or yield loss for plants. Industry could
also be affected through the imposition of domestic and foreign
quarantines that result in a loss of markets. The Federal Government
and State governments would also incur costs associated with
eradication and quarantine enforcement to prevent further spread, and
in the case of intentional introduction, law enforcement. In addition,
there is the potential for a disruption in the domestic food supply,
whether through contamination, consumer perception, or both. Past food
safety incidents have shown that consumer perceptions (both domestic
and international) about an implicated food product and about the
producing country or sector's ability to produce safe food are slow to
recover and can have a lasting influence on food demand and global
trade.\3\ As such, the benefits of the rule are the avoided losses of
animals or plants that could be attacked by these organisms or toxic
materials (because of the reduced risk of release of the select agents
and reduced likelihood of exposure for susceptible animals or plants),
the avoided public and private costs of eradication, and the avoided
negative effects on products and markets.
---------------------------------------------------------------------------
\3\ Buzby, J.C. Effects of food-safety perceptions on food
demand and global trade. Changing Structure of Global Food
Consumption and Trade/WRS-01-1. Economic Research Service/USDA.
---------------------------------------------------------------------------
The costs associated with the outbreak of a select agent can be
very high, as demonstrated, for example, by the losses to agriculture
and the food chain from the foot-and-mouth disease (FMD) outbreak in
the United Kingdom (UK) in 2001. Those costs amounted to about
[pound]3.1 billion ($4.7 billion). In 1999, it was estimated that the
potential impacts of an FMD outbreak in California alone would be
between $8.5 and $13.5 billion.\4\ The bovine spongiform encephalopathy
(BSE) crisis in the UK (which has a cattle industry about one-tenth the
size of that in the United States) is another example. It has been
estimated that the total resource costs to the UK economy as a result
of BSE in the first 12 months after the onset of the 1996 crisis were
in the range of [pound]740 million to [pound]980 million ($1.2 to $1.5
billion), or just over 0.1 percent of the gross domestic product of the
United Kingdom.\5\ In addition, the UK lost its entire export market
for beef.
---------------------------------------------------------------------------
\4\ Ekboir, J.M. Potential impact of foot-and-mouth disease in
California: the role and contribution of animal health surveillance
and monitoring services. Davis, CA: Agricultural Issues Center,
Division of Agriculture and Natural Resources, University of
California, Davis, 1999.
\5\ DTZ Pieda Consulting. Economic Impact of BSE on the UK
economy. A report commissioned by the UK Agricultural Departments
and HM Treasury.
---------------------------------------------------------------------------
These are examples of consequences of natural or accidental disease
introduction. Deliberate introduction greatly increases the probability
of a select agent or toxin becoming established and causing wide-
ranging and devastating impacts on an economy, disruption to society,
diminished confidence in public and private institutions, and possible
loss of life.
[[Page 61330]]
The entities most likely to be affected by this rule include
research and diagnostic facilities, Federal, State, and university
laboratories, and private commercial and non-profit enterprises. An
entity that possesses, uses, or transfers listed select agents or
toxins is required to comply with the select agent regulations. The
regulations require registering the possession, transfer, or
destruction of select agents or toxins. In addition, the entity is also
required to ensure that the facility where the agent or toxin is housed
has adequate biosafety and containment measures, that the physical
security of the premises is adequate, that all individuals with access
to select agents or toxins have appropriate training to handle such
agents or toxins, and that complete records concerning activities
related to the select agents or toxins are maintained.
The changes to the PPQ select agent list include the addition of
four organisms to the list, the removal of two organisms from the list,
and technical changes for organisms currently listed. An entity that
possesses a newly added agent or toxin will have to comply with the
select agent regulations, and may therefore incur costs. These
primarily involve becoming registered, maintaining an inventory of the
agents and toxins, and limiting access to the agent or toxin to those
individuals who are qualified, have a need to have access to a select
agent or toxin, and have an SRA conducted by the FBI. This rule does
not change the process for obtaining the agents or toxins (i.e., a
permit is required regardless of whether an organism is listed as a
select agent) or the bio-containment requirements as set forth in the
existing permitting process. Necessary SRA checks are performed free of
charge by the FBI and take approximately 45 days to complete. Limiting
access to the listed agents or toxins can be achieved in a wide variety
of ways. Some of these methods can be very expensive. For example,
installing new state-of-the-art electronic surveillance equipment can
run into the thousands of dollars even for a relatively small space.
However, in most instances the physical security needs can be met with
far less rigorous methods. Often an entity's standard operating
procedures for security are sufficient. Because many entities deal with
select agents or toxins in an area that is fully contained within a
larger structure, a lack of entry control equipment may not affect the
level of graded protection. It should also be noted that only that
portion of a given entity affected by select agent or toxin operations
is required to be secured. The select agent regulations do not specify
how the physical security needs (limiting access to the agents) are to
be met, only that they need to be adequate for the situation.
Therefore, an entity can choose the most cost-effective alternative to
meet those needs.
The changes should affect only a very small number of entities. The
plant pest permit database maintained by APHIS indicates that very few
entities currently possess any of the agents that are being added to
the PPQ list. It is estimated that less than a total of 10 entities
will be affected by changes to the plant list. In addition, most of the
entities that do possess the newly added agents are already registered
due to their possession of other listed select agents or toxins. After
this rule goes into effect, entities will no longer be required to
maintain records and security for those agents and toxins that are
being removed from the select agent lists by this rule. However, the
entities are still required to maintain select agent records for 3
years past the time they were regulated under 7 CFR part 331 or 9 CFR
part 121. Additionally, permits are still required under 7 CFR part 330
or 9 CFR part 122 for those agents and toxins that have been removed
from the lists. These changes should have little impact.
The changes to the VS select agent list include the removal of
agents, the redefinition of an agent, and technical changes to the
nomenclature used for some agents in the list to be consistent with
current scientific literature. The agents that will be removed are
overlap select agents and toxins regulated by both USDA and HHS. Any
entity that is in possession of the overlap select agents and toxins
that are to be removed, and that does not possess any other overlap
agents or toxins or any of the APHIS select agents or toxins, will
subsequently possess HHS-only agents and toxins and will thus continue
to be subject to select agent regulations as administered by HHS. In
addition, the organisms that will be removed from the lists of select
agents and toxins (Botulinum neurotoxin producing species of
Clostridium, Coxiella burnetii, and Francisella tularensis; the fungus
Coccidioides immitis; and Eastern equine encephalitis virus) will
continue to be subject to the regulations under 9 CFR part 122. The
redefinition of Newcastle disease virus (velogenic) to virulent
Newcastle disease virus may lead to new registrants. It is possible
that additional entities may be in possession of a virulent strain of
Newcastle disease virus that does not fit the current definition.
However, these strains have not been circulating in the United States
since the 1970s. Those entities most likely to be in possession of
virulent Newcastle disease virus are those already in possession of
Newcastle disease virus (velogenic) and therefore already registered.
Therefore, these changes should have little impact.
Alternatives Considered
The alternative to this rule would be to leave the regulations
unchanged. In this case, the lists of select agents in 7 CFR part 331
and 9 CFR part 121 would remain unchanged. However, APHIS has conducted
reviews of these lists and concluded that changes are necessary to
ensure that the lists contain those biological agents and toxins that
have the potential to pose a severe threat to both human and animal
health, to plant health, or to animal and plant products. These reviews
were conducted in accordance with the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, which requires a
biennial review and republication of the select biological agent and
toxin list, with revisions as appropriate. Therefore, this alternative
was rejected.
Conclusion
This rule will update the PPQ, VS, and overlap select agent lists.
The regulation of select agents is intended to prevent their misuse and
thereby reduce the potential for those agents and toxins to harm
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 could 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 costs of eradication.
Industry would be affected through the imposition of domestic and
foreign quarantines that result in a loss of markets and the
destruction of animals or plants found to be infected with the disease.
Even though entities may be compensated for the destroyed property,
repopulating (flocks, herds, fields, etc.) can take time, with
additional losses incurred due to 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.
The entities most likely to be affected by this rule are those
laboratories and
[[Page 61331]]
other institutions conducting research and related activities that
involve the use of the newly added select agents and toxins. The impact
of these changes is expected to be minimal, however. Indications are
that very few entities currently possess any of the agents or toxins
that are being added to the list of select agents and toxins. Moreover,
after this rule goes into effect, entities will no longer be required
to maintain records and security for those agents and toxins that are
being removed from the select agent lists by this rule. However, the
entities are still required to maintain select agent records for 3
years past the time they were regulated under 7 CFR part 331 or 9 CFR
part 121. Additionally, permits are still required under 7 CFR part 330
or 9 CFR part 122 for those agents and toxins that have been removed
from the lists. Other changes do not affect what select agents or
toxins are listed but rather the nomenclature by which those agents and
toxins are identified, and therefore should have no economic impact on
holders of those organisms or toxic materials.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This final rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects
7 CFR Part 331
Agricultural research, Laboratories, Plant diseases and pests,
Reporting and recordkeeping requirements.
9 CFR Part 121
Agricultural research, Animal diseases, Laboratories, Medical
research, Reporting and recordkeeping requirements.
0
Accordingly, we are amending 7 CFR part 331 and 9 CFR part 121 as
follows:
Title 7--[Amended]
PART 331--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
0
1. The authority citation for part 331 continues to read as follows:
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.3.
0
2. In Sec. 331.3, paragraph (b) is revised to read as follows:
Sec. 331.3 PPQ select agents and toxins.
* * * * *
(b) PPQ select agents and toxins:
Peronosclerospora philippinensis (Peronosclerospora sacchari);
Phoma glycinicola (formerly Pyrenochaeta glycines);
Ralstonia solanacearum, race 3, biovar 2;
Rathayibacter toxicus;
Sclerophthora rayssiae var. zeae;
Synchytrium endobioticum;
Xanthomonas oryzae;
Xylella fastidiosa (citrus variegated chlorosis strain).
* * * * *
Title 9--[Amended]
PART 121--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
0
3. The authority citation for part 121 continues to read as follows:
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.
0
4. In part 121, footnotes 1 through 14 are redesignated as footnotes 2
through 15, respectively.
0
5. In Sec. 121.3, paragraph (b) is revised to read as follows:
Sec. 121.3 VS select agents and toxins.
* * * * *
(b) VS select agents and toxins:
African horse sickness virus;
African swine fever virus;
Akabane virus;
Avian influenza virus (highly pathogenic);
Bluetongue virus (exotic);
Bovine spongiform encephalopathy agent;
Camel pox virus;
Classical swine fever virus;
Ehrlichia ruminantium (Heartwater);
Foot-and-mouth disease virus;
Goat pox virus;
Japanese encephalitis virus;
Lumpy skin disease virus;
Malignant catarrhal fever virus (Alcelaphine herpesvirus type 1);
Menangle virus;
Mycoplasma capricolum subspecies capripneumoniae (contagious caprine
pleuropneumonia);
Mycoplasma mycoides subspecies mycoides small colony (MmmSC)
(contagious bovine pleuropneumonia);
Peste des petits ruminants virus;
Rinderpest virus;
Sheep pox virus;
Swine vesicular disease virus;
Vesicular stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3;
Virulent Newcastle disease virus \1\
---------------------------------------------------------------------------
\1\ A virulent Newcastle disease virus (avian paramyxovirus
serotype 1) has an intracerebral pathogenicity index in day-old
chicks (Gallus gallus) of 0.7 or greater or has an amino acid
sequence at the fusion (F) protein cleavage site that is consistent
with virulent strains of Newcastle disease virus. A failure to
detect a cleavage site that is consistent with virulent strains does
not confirm the absence of a virulent virus.
---------------------------------------------------------------------------
* * * * *
0
6. Section 121.4 is amended as follows:
0
a. By revising paragraph (b) to read as set forth below.
0
b. By removing paragraph (d)(3).
0
c. In paragraph (f)(3)(i), by removing the words ``Botulinum
neurotoxins,'' and ``Francisella tularensis,''.
Sec. 121.4 Overlap select agents and toxins.
* * * * *
(b) Overlap select agents and toxins:
Bacillus anthracis;
Brucella abortus;
Brucella melitensis;
Brucella suis;
Burkholderia mallei;
Burkholderia pseudomallei;
Hendra virus;
Nipah virus;
Rift Valley fever virus;
Venezuelan equine encephalitis virus.
* * * * *
Sec. 121.5 [Amended]
0
7. In Sec. 121.5, paragraph (a)(3)(i) is amended by removing the words
``Newcastle disease virus (velogenic)'' and adding the words ``virulent
Newcastle disease virus'' in their place.
Sec. 121.6 [Amended]
0
8. In Sec. 121.6, paragraph (a)(3)(i) is amended by removing the words
``Botulinum neurotoxins,'' and ``Francisella tularensis,''.
[[Page 61332]]
Sec. 121.9 [Amended]
0
9. In Sec. 121.9, paragraph (c)(1) is amended by removing the words
``Botulinum neurotoxins,'' and ``Francisella tularensis,'', and by
removing the words ``Newcastle disease virus (velogenic)'' and adding
the words ``virulent Newcastle disease virus'' in their place.
Done in Washington, DC, this 3rd day of October 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-23887 Filed 10-15-08; 8:45 am]
BILLING CODE 3410-34-P