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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 
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[[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