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Biosafety and rDNA Research Program: References

NIH rDNA Guidelines
  Full Text as PDF - Word Document (1.5 mb)
Example Procedures by BSL Level
  PDF - Word Document
MInimal Risk rDNA Experiments Descriptions:
  PDF - Word Document
Dual Use Research Guide
  PDF - Word Document
Export Administration Regulation & Commerce Control List
  Website (search terms EAR CCL)

 Sample Lab Safety SOP

   Word Document (if used, edit as appropriate for the lab/project)


Biosafety Application Forms


NIAID Emerging Infectious Diseases/ Pathogens
(NIH National Institute of Allergy and Infectiuous Disease) (2018)

Emerging infectious diseases can be defined as infectious diseases that have newly appeared in a population or have existed but are rapidly increasing in incidence or geographic range, or that are caused by one of the NIAID Category A, B, or C priority pathogens.

The NIAID Emerging Infectious Diseases/Pathogens category includes Biodefense Research and Additional Emerging Infectious Diseases/Pathogens.

NIAID Biodefense Research

NIAID Emerging Infectious Diseases/Pathogens

NIAID’s pathogen priority list is periodically reviewed and is subject to revision in conjunction with our federal partners, including the U.S. Department of Homeland Security, which determines threat assessments, and the Centers for Disease Control and Prevention, which is responsible for responding to emerging pathogen threats in the United States.

Category A pathogens are those organisms/biological agents that pose the highest risk to national security and public health because they:

Can be easily disseminated or transmitted from person to person;
Result in high mortality rates and have the potential for major public health impact;
Might cause public panic and social disruption;
Require special action for public health preparedness.

(Partial List Cat A)

Category B pathogens are the second highest priority organisms/biological agents. They:

Are moderately easy to disseminate;
Result in moderate morbidity rates and low mortality rates;
Require specific enhancements for diagnostic capacity and enhanced disease surveillance.

(Partial List Cat B)

Category C pathogens are the third highest priority and include emerging pathogens that could be engineered for mass dissemination in the future because of:

Ease of production and dissemination;
Potential for high morbidity and mortality rates and major health impact.

(Partial List Cat C)

Immunilogical Studies

(Partial List: Immunilogical Studies)

Additional Emerging Infectious Diseases/Pathogens

(Partial List: Other Pathogens/Vectors)

Category A Priority Pathogens

Bacillus anthracis (anthrax)
Clostridium botulinum toxin (botulism)
Yersinia pestis (plague)
Variola major (smallpox) and other related pox viruses
Francisella tularensis (tularemia)

Viral hemorrhagic fevers:

Junin, Machupo, Guanarito, Chapare (new in fiscal year (FY14), Lassa, Lujo (new in FY14)
Hantaviruses causing Hanta Pulmonary syndrome, Rift Valley Fever, Crimean Congo Hemorrhagic Fever
Ebola and Marburg viruses


Category B Priority Pathogens

Burkholderia pseudomallei (melioidosis)
Coxiella burnetii (Q fever)
Brucella species (brucellosis)
Burkholderia mallei (glanders)
Chlamydia psittaci (Psittacosis)
Ricin toxin (Ricinus communis)
Epsilon toxin (Clostridium perfringens)
Staphylococcus enterotoxin B (SEB)
Typhus fever (Rickettsia prowazekii)

Food- and waterborne pathogens:

Diarrheagenic E.coli
Pathogenic Vibrios
Shigella species
Listeria monocytogenes
Campylobacter jejuni
Yersinia enterocolitica
Hepatitis A
Cryptosporidium parvum
Cyclospora cayatanensis
Giardia lamblia
Entamoeba histolytica
Toxoplasma gondii
Naegleria fowleri (new in FY14)
Balamuthia mandrillaris (new in FY14)

Mosquito-borne viruses

West Nile virus (WNV)
LaCrosse encephalitis (LACV)
California encephalitis
Venezuelan equine encephalitis (VEE)
Eastern equine encephalitis (EEE)
Western equine encephalitis (WEE)
Japanese encephalitis virus (JE)
St. Louis encephalitis virus (SLEV)
Yellow fever virus (YFV)
Chikungunya virus
Zika virus

Category C Priority Pathogens

Nipah and Hendra viruses
Additional hantaviruses
Tickborne hemorrhagic fever viruses
Severe Fever with Thrombocytopenia Syndrome virus (SFTSV), Heartland virus
Omsk Hemorrhagic Fever virus, Alkhurma virus, Kyasanur Forest virus
Tickborne encephalitis complex flaviviruses
Tickborne encephalitis viruses
European subtype
Far Eastern subtype
Siberian subtype
Powassan/Deer Tick virus
Tuberculosis, including drug-resistant TB
Influenza virus
Other Rickettsias
Rabies virus
Coccidioides spp.
Severe acute respiratory syndrome associated coronavirus (SARS-CoV), MERS-CoV, and other highly pathogenic human coronaviruses (new in FY14)

Antimicrobial resistance, excluding research on sexually transmitted organisms, unless the resistance is newly emerging*
Research on mechanisms of antimicrobial resistance
Studies of the emergence and/or spread of antimicrobial resistance genes within pathogen populations
Studies of the emergence and/or spread of antimicrobial-resistant pathogens in human populations
Research on therapeutic approaches that target resistance mechanisms
Modification of existing antimicrobials to overcome emergent resistance

*Excluded Research (Sexually Transmitted Organisms) - Bacterial vaginosis, Chlamydia trachomatis, cytomegalovirus, Granuloma inguinale, Hemophilus ducreyi, hepatitis B virus, hepatitis C virus, herpes simplex virus, human immunodeficiency virus, human papillomavirus,Treponema pallidum, Trichomonas vaginalis.

Antimicrobial research, as related to engineered threats and naturally occurring drug-resistant pathogens, focused on development of broad-spectrum antimicrobials

Immunological Studies

Immunology studies that advance our understanding of host defenses applicable to the biodefense effort, for example:

Innate Immunity
Adaptive Immunity
Mucosal Immunity

Additional Emerging Infectious Diseases/Pathogens

Anaplasmosis (new in FY14)
Australian bat lyssavirus
Babesia, atypical
Bartonella henselae
BK virus (new in FY14)
Bordetella pertussis (new in FY15)
Borrelia mayonii (new in FY18)
Borrelia miyamotoi (new in FY14)
Enterovirus 68 (new in FY15)
Enterovirus 71
Hepatitis C (new in FY14)
Hepatitis E (new in FY14)
Human herpesvirus 6
Human herpesvirus 8
JC virus (new in FY14)
Leptospirosis (new in FY14)
Mucormycosis (new in FY14)
Poliovirus (new in FY15)
Rubeola (measles) (new in FY14)
Streptococcus, Group A

* This list was created for the purpose of extramural and intramural program management within the NIAID biodefense/EID mission and does not represent the complete scope of biodefense and emerging infectious disease.
** HIV/AIDS is excluded.

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    or email Neal Sullivan at or Jennifer Sutton at

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