Biohazards and Select Agents

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Purpose

All grant applications that come to the NIH are reviewed for biohazard and select agent concerns to ensure that research is conducted in a safe manner. ONETOX represents the NINDS on all NIH Office of the Director committees and initiatives to keep the scientific community safe from biohazards during NIH-funded research. ONETOX also provides NINDS staff with expertise on issues related to biohazards before and during funded research, as well as information on how to determine if proposed biological and chemical agents are potential biohazards.

Definitions

Biohazards

Biohazards are biological organisms or their products (such as toxins) that pose a threat to human health. Reviewers are asked to identify potential biohazards and other hazards such as radioactivity, dangerous chemicals, or recombinant DNA that are known in their professional community to pose a particularly significant risk to research personnel and/or the environment and to determine whether proper handling procedures and adequate protections are addressed.

The NIH requires that all extramural and intramural research have materials and procedures in place to prevent hazards to research personnel and/or the environment. Biohazards not only include hazardous biological materials such as viruses, bacteria and fungi but also chemicals that could pose a risk to human health and the environment when handled improperly. Some highly toxic chemicals are recognized for their potential risk when used in research. Other chemicals that are less toxic and used routinely research still have the potential for harm if the researcher is exposed to high enough doses. The NIH Division of Occupational Health and Safety (DOHS) in the Office of the Director maintains the NIH’s policies for storing, working with, and disposing of hazardous biological material in the research environment. 

Select Agents

Select agents and toxins are biological agents and toxins that could pose a severe threat to public health and plant health, or to animal or plant products. The U.S. lists of Select Agents and Toxins are maintained by the Departments of Health and Human Services and Agriculture and can be found within the Federal Select Agent Program. 

Additionally, ONETOX represents NINDS on NIH committees and initiatives related to Select Agents and Dual-Use Research Concerns by providing the NINDS research community and NINDS staff with resources and expertise on how to determine if there are concerns related to the use of Select Agents and if there are Dual-Use Concerns.

Dual Use Research of Concern

The NIH Office of Science Policy manages the Dual-Use Research of Concern program. Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. The United States Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

 

Biohazards Application Considerations

The NIH Division of Occupational Health and Safety (DOHS) in the Office of Research Services maintains the NIH’s policies for storing, working with, and disposing of hazardous biological material in the research environment. Please consult and refer to these resources and additional institutional guidelines as you prepare this section of your application.

Applicants should describe the proper handling procedures and adequate protections throughout the application:

  • R&R Other Project Information Form: Appropriately answer the Section 4. Environmental Questions.
  • Approach: Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised.
  • Facilities and Other Resources Attachment: Describe any special facilities used for working with biohazards and any other potentially dangerous substances.
  • Note: Information about select agents must be described in the Select Agent Research Attachment.
 
NIH Biohazards Guidance


The NIH Division of Occupational Health and Safety (DOHS) in the Office of Research Services maintains the NIH’s policies for storing, working with, and disposing of hazardous biological material in the research environment.

 
CDC Biosafety Guidance

The CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) is an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective.

Select Agents Application Considerations

Applications involving research using Select Agents are required to provide additional information beyond the information provided for biohazards.

All domestic and foreign grants, cooperative agreements, and contracts that possess, use, or transfer select agents comply with NINDS and federal select agent policies as described here. See also the NIH Grants Policy Statement, Section 4.1.24.1.1: Select Agents. 

  1. Check if the work you plan involves a select agent or toxin. Use the Federal Select Agent Program’s list of Select Agents and Toxins, which also lists exclusions, restricted experiments, and permissible toxin amounts.
     
  2. Describe the select agent use including restricted experiments in your application’s Research Plan (for grants and cooperative agreements) or Technical Proposal (for contracts). Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised.
     
  3. Include a “Select Agent Research” attachment if your proposed activities involve the use of select agents at any time during the proposed project period, either at the applicant organization or at any performance site. A full discussion on the use of select agents should appear in the Select Agent Research attachment. Although no specific page limitation applies to this section, be succinct. Attach this information as a PDF file. Also, see the NIH's Format Attachments page. Information to include in the Select Agent Research attachment:
  1. Identify the select agent(s) to be used in the proposed research.
  2. Provide the registration status of all entities* where select agent(s) will be used. If the performance site(s) is a foreign institution, provide the name(s) of the country or countries where select agent research will be performed.
    • *An “entity” is defined in 42 CFR 73.1 as “any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity.”
  3. Provide a description of all facilities where the select agent(s) will be used:
    • ldentify the select agent(s) to be used in the proposed research.
    • Describe the procedures that will be used to monitor possession, use, and transfer of select agent(s).
    • Describe plans for appropriate biosafety, biocontainment, and security of the select agent(s).
    • Describe the biocontainment resources available at all performance sites.
    • Excluded Select Agents
      • If the activities proposed in the application involve only the use of a strain(s) of select agents which has been excluded from the list of select agents and toxins as per 42 CFR 73.3, the select agent requirements do not apply. Use this “Select Agent Research” attachment to identify the strain(s) of the select agent that will be used and note that it has been excluded from this list. The CDC maintains a list of exclusions, which is available on the Select Agents and Toxins Exclusions website.
      • Applying for a select agent to be excluded: If the strain(s) is not currently excluded from the list of select agents and toxins but you have applied or intend to apply to HHS for an exclusion from the list, use this section to indicate the status of your request or your intent to apply for an exclusion and provide a brief justification for the exclusion.
 
Select Agent Guidance

The CDC/USDA Federal Select Agent Program oversees the possession, use and transfer of select agents and toxins, which pose a threat to public, animal or plant health. The program provides personnel and plan guidance when using select agents and toxins.

 
CDC Biosafety Guidance

The CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) remains an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective.

 

 
Looking for NINDS funding opportunities related to Select Agent Research?

The NINDS Office of Neural Exposome and Toxicology (ONETOX) supports research and provides resources to advance knowledge of internal and external exposures that affect brain and nervous system health (Neural Exposome), leads research related to chemical threats, and provides resources that promote chemical safety.

Related Resources

 
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