[Federal Register Volume 74, Number 69 (Monday, April 13, 2009)]
[Rules and Regulations]
[Pages 16753-16754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8383]



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Rules and Regulations
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Federal Register / Vol. 74, No. 69 / Monday, April 13, 2009 / Rules 
and Regulations

[[Page 16753]]



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; Delay of 
Compliance Date for Newly Registered Entities

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule; delay of compliance date.

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SUMMARY: In a final rule published in the Federal Register on October 
16, 2008 (73 FR 61325-61332, Docket No. APHIS-2007-0033), and effective 
November 17, 2008, we amended and republished 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, thus implementing the 
findings of the second biennial review of that list. Among other 
changes, we changed the entry for ``Newcastle disease virus 
(velogenic)'' to read ``virulent Newcastle disease virus,'' thus 
including some non-velogenic strains of Newcastle disease virus as 
select agents. The final rule set the compliance date for entities that 
were newly required to register as entities possessing select agents or 
toxins as April 14, 2009. Since the publication of the final rule, we 
have been notified of entities that use virulent Newcastle disease 
virus and that have not previously been registered. This notice informs 
the public that we are extending the compliance date for new 
registrants to July 13, 2009, to give us additional time to determine 
how best to regulate those entities.

DATES: The compliance date for entities that are newly required to 
register is extended to July 13, 2009.

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. Freeda Isaac, Director, NCIE, VS, APHIS, 4700 River Road, 
Unit 39, Riverdale, MD 20737-1231; (301) 734-8364.

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. 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.
    Subtitle B (which is cited as the ``Agricultural Bioterrorism 
Protection Act of 2002''), 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.
    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. Among other things, we 
proposed to add some select agents and toxins to the list.
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    \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.
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    In the list of VS select agents and toxins in 9 CFR 121.3, we also 
proposed to change the entry for ``Newcastle disease virus 
(velogenic)'' to read ``virulent Newcastle disease virus,'' consistent 
with the World Organization for Animal Health (OIE) definition of the 
virus. Newcastle disease has lentogenic, mesogenic, and velogenic 
strains, the last of which are typically virulent; however, consistent 
with the OIE definition, we proposed that any Newcastle disease virus 
could be considered virulent if it has an intracerebral pathogenicity 
index in day-old chicks of 0.7 or greater or has an amino acid sequence 
at the fusion protein cleavage site that is consistent with virulent 
strains of Newcastle disease virus. This information was provided in a 
footnote to the proposed entry for ``virulent Newcastle disease 
virus.''
    We noted in the proposal that ``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 
circulated in the United States since the 1970s. In addition, entities 
most likely to be in possession of virulent Newcastle disease virus are 
already in possession of Newcastle disease virus (velogenic) and 
therefore already registered.''
    We solicited comments concerning our proposal for 60 days ending 
October 29, 2007. We reopened and extended the deadline for comments 
until December 3, 2007, in a document published in the Federal Register 
on November 16, 2007 (72 FR 64540, Docket No. APHIS-2007-0033). We 
received 62 comments by that date. None of the comments addressed the 
proposed change to the entry for Newcastle disease virus.
    In a final rule published in the Federal Register on October 16, 
2008 (73 FR 61325-61332, Docket No. APHIS-2007-0033), and effective 
November 17, 2008, we amended and republished the list of select agents 
and toxins, adding the proposed new select agents and toxins and 
finalizing the change to the entry for Newcastle

[[Page 16754]]

disease. Entities that possessed the select agents and toxins added in 
the final rule and that had not been registered were now required to 
register under the select agent regulations.
    To minimize the disruption of research or educational projects 
(e.g., teaching demonstrations) involving listed select agents or 
toxins, the final rule provided any individual or entity possessing 
newly added select agents or toxins as of the effective date of the 
final rule, November 17, 2008, with additional time to reach full 
compliance with the select agent regulations. The responsible official 
at all entities that possessed a new agent or toxin was required to 
provide notice to APHIS regarding their possession of the new agent(s) 
and toxin(s) by November 17, 2008. The final rule also stated that, by 
April 14, 2009, all previously unregistered entities must be registered 
and thus in compliance with the regulations.\2\
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    \2\ The compliance date in the final rule was originally 
published as April 14, 2008; it was corrected to April 14, 2009, in 
a correction published on October 27, 2008 (73 FR 63621).
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    Since the publication of the final rule, some entities have 
notified us that they use virulent Newcastle disease virus for bird 
vaccines, in research on cancer treatment in humans, and as a vector of 
antigenic proteins that enhance immune response to cancer and to 
diseases (e.g., influenza and avian influenza). This notice informs the 
public that we are extending the compliance date for registration of 
entities that are newly required to register to July 13, 2009, to give 
us additional time to determine how best to regulate those entities.

    Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, 371.3, and 371.4.

    Done in Washington, DC, this 8th day of April 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-8383 Filed 4-10-09; 8:45 am]
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