[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66751-66752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26612]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of Science Policy, Office of Biotechnology Activities; 
Recombinant or Synthetic Nucleic Acid Molecule Research: Action Under 
the NIH Guidelines for Research Involving Recombinant or Synthetic 
Nucleic Acid Molecules (NIH Guidelines)

AGENCY: NIH, Public Health Service, HHS.

ACTION: Notice of Final Action under the NIH Guidelines.

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SUMMARY: The Office of Biotechnology Activities (OBA) is updating 
Appendix B (Classification of Human Etiologic Agents on the Basis of 
Hazard) of the NIH Guidelines by specifying the risk group (RG) 
classification for two organisms: Middle East Respiratory Syndrome 
coronavirus (MERS-CoV) and Pseudomonas aeruginosa.
    Background: The NIH Guidelines provide guidance to investigators 
and local Institutional Biosafety Committees (IBCs) for setting 
containment for research involving recombinant or synthetic nucleic 
acid molecules. Section II-A, Risk Assessment, instructs investigators 
and IBCs to make an initial risk assessment based on the RG of the 
agent that will be manipulated (see Appendix B, Classification of Human 
Etiologic Agents on the Basis of Hazard). The RG of the agent often 
correlates with the minimum containment level required for experiments 
subject to the NIH Guidelines. Updating Appendix B by revising the risk 
groups for certain organisms, or adding new organisms, leads to more 
uniform containment recommendations that are commensurate with the 
biosafety risk.
    The resulting amendments are ``Minor Actions'' under Section IV-C-
1-(b)-2 of the NIH Guidelines and, therefore, will be implemented 
immediately upon publication in the Federal Register. However, the OBA 
welcomes public comment to inform any future changes to Appendix B.

DATES: Comments may be submitted to the OBA in paper or electronic form 
at the mailing, fax, and email addresses shown below under the heading 
``For Further Information.'' All comments should be submitted by 
December 6, 2013. All written comments received in response to this 
notice will be available for public inspection in the NIH OBA office, 
6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD 20892-7985, 
weekdays between the hours of 8:30 a.m. and 5:00 p.m.

FOR FURTHER INFORMATION CONTACT: If you have questions, or require 
additional information about these changes, please contact the OBA by 
email at [email protected] or by telephone at 301-496-9838. Comments may 
be submitted to the same email address or by fax to 301-496-9839 or by 
mail to the Office of Biotechnology Activities, National Institutes of 
Health, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892-7985. 
Background information may be obtained by contacting the NIH OBA by 
email at [email protected].

Middle East Respiratory Syndrome coronavirus (MERS-CoV)

    MERS-CoV is an emerging infectious disease agent that was 
originally identified in 2012 in Saudi Arabia. The virus is a member of 
the order Nidovirales, family Coronaviridae, and causes a severe 
pulmonary syndrome that is similar to what was seen with Severe Acute 
Respiratory Syndrome coronavirus (SARS-CoV). MERS-CoV has been 
identified as the cause of a severe respiratory disease in 144 
individuals, of which 62 have died (as of October 25, 2013; source: 
Centers for Disease Control and Prevention (CDC)--http://www.cdc.gov/coronavirus/mers/). The overall mortality rate of MERS-CoV infection to 
date is about four times higher than what was reported for SARS-CoV; 
although it is of note, in patients over 65 years of age, that 
mortality from infection with SARS-CoV was reported to exceed 50 
percent (based on World Health Organization (WHO) data accessed 
September 9, 2013, http://www.who.int/csr/sars/archive/2003_05_07a/en/print.html). As was the case for SARS-CoV, there are no proven 
preventive or therapeutic measures against this new virus. In addition, 
there are many unanswered questions regarding this virus, including 
questions about how the virus is transmitted. Although the incidence of 
viral infections caused by MERS-CoV remains highest in, and largely 
localized to the Arabian Peninsula (138 of 144 cases), the high 
mortality rate associated with this agent and its epidemic potential 
has led to close monitoring by the WHO (http://www.who.int/csr/disease/coronavirus_infections/faq/en/index.html).

[[Page 66752]]

    Under Appendix B of the NIH Guidelines, most coronaviruses are 
classified as RG2 viruses. Given the severity of illness seen to date, 
MERS-CoV will be added to the list of RG3 agents, as was done for SARS-
CoV. However, because little is currently known about the source, 
reservoir, and epidemiology of this virus, the RG classification will 
be reassessed if new data emerge relevant to the biosafety risks 
associated with the agent. In addition, while research with RG3 agents 
is often carried out at Biosafety level 3 containment--with appropriate 
enhancements depending upon the nature of the agent, e.g., increased 
respiratory precautions for agents that are transmissible by the 
aerosol route--the RG of an agent is not the only factor that 
determines the containment level. As stated in Section II-A of the NIH 
Guidelines (Risk Assessment) ``once the risk group of an agent is 
identified, this should be followed by a thorough consideration of how 
the agent is to be manipulated'' and there may be experiments for which 
a higher containment level is warranted. Interim Laboratory Biosafety 
Guidelines for Handling and Processing Specimens Associated with MERS-
CoV are available on the CDC Web site at the following URL: http://www.cdc.gov/coronavirus/mers/guidelines-lab-biosafety.html.

Pseudomonas aeruginosa

    Bacteria belonging to the genus Pseudomonas are ubiquitous in the 
environment. They are generally considered to be opportunistic 
pathogens, i.e., able to cause disease in individuals who are 
immunocompromised. According to the CDC, serious pseudomonas infections 
usually occur in hospitalized patients and those who are 
immunocompromised and these infections can lead to severe illness and 
death (http://www.cdc.gov/hai/organisms/pseudomonas.html). Healthy 
people can also become ill from Pseudomonas aeruginosa, especially 
after exposure to inadequately disinfected water. Per the CDC, ``Ear 
infections, especially in children, and more generalized skin rashes 
may occur after exposure to inadequately chlorinated hot tubs or 
swimming pools. Eye infections have occasionally been reported in 
persons using extended-wear contact lenses'' (http://www.cdc.gov/hai/organisms/pseudomonas.html).
    Because this bacterium generally causes mild disease in healthy 
individuals and there are antibiotics to treat such disease, the OBA 
will add it to Appendix B as an RG2 bacterium. This is consistent with 
other assessments of the RG for this pathogen by other biosafety 
guidances, including the Canadian (http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/pseudomonas-spp-eng.php) and the European Community 
(http://www.bacterio.net/hazard.html#group2) guidances.

Appendix B-II-A. Risk Group 2 (RG2)--Bacterial Agents Including 
Chlamydia.

    The following addition will be made to Appendix B-II-A. Risk Group 
2 (RG2)--Bacterial Agents Including Chlamydia:

Pseudomonas aeruginosa

    The following addition will be made to Appendix B-III-D Risk Group 
3 (RG3)--Viruses and Prions:

Middle East Respiratory Syndrome coronavirus (MERS-CoV)

    Dated: October 30, 2013.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health
[FR Doc. 2013-26612 Filed 11-5-13; 8:45 am]
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