NIAID Select Agent Policy for Foreign Institutions

Questions and Answers Table of Contents

Policy Implementation

Why does NIAID impose U.S. standards on biomedical research abroad? What are the consequences?

NIAID-supported researchers abroad must comply with U.S. laws, regulations, and policies for research.

Though some research partners overseas may have concerns about complying with U.S. requirements, others have found our policies helpful. For example, researchers in non-U.S. labs may view the CDC inspection report as a resource for improving the biosafety and biosecurity of their laboratories. (However, NIH cannot provide additional funding if the report identifies deficiencies.)

Why do foreign institutions have to follow NIAID select agent policy?

The U.S. Congress, which funds NIH, expects appropriated dollars to be spent and programs to be executed lawfully. Further, NIAID is helping to ensure that its funded researchers conduct their work safely and securely.

Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, U.S. institutions that perform research with select agents must be inspected for biosafety and biosecurity. These inspections provide for a level of safety and security to prevent unwarranted access to pathogenic organisms and toxins and ensure a negligible risk to the public.

Until WHO develops worldwide biosafety and biosecurity standards, NIAID requires review and possible inspection of foreign sites performing research that involves select agents.

To work safely with select agents, facilities of a foreign research site must meet certain requirements. Do these requirements refer to U.S. standards or those of the foreign country?

A responsible official from the foreign institution must certify that the facility meets the requirements of the local institution for working safely with select agents. NIAID does not impose U.S. law on foreign institutions. The purpose is to ensure safety, security, and responsibility of all parties.

Can U.S. inspectors require more for my BSL-4 lab than what is stated in the regulations of my country?

Only foreign laboratories receiving NIAID awards are inspected. U.S. government employees with experience in select agent research or policy review inspection results along with the select agent policies of the foreign institution.

If they find deficiencies based on CDC requirements (or USDA requirements in the case of plants and animals), the review group can recommend a restriction on the award, prohibiting funding until issues are resolved.

Can a U.S. PI modify his or her plan of work so that the select agent term does not have to be applied at the foreign site?

A U.S. PI should consult an NIAID program officer and grants management specialist before making changes. Some changes require prior approval, especially changes in scope.

What is the procedure for transporting select agents between international sites or between domestic and international sites?

A permit from CDC or USDA is required for transporting select agents in the U.S. A permit issued to a domestic institution does not apply to a project's foreign subcomponent.

For international sites receiving NIH funds, transportation procedures and requirements must be equivalent to those for U.S. institutions. For NIAID projects, NIAID representatives must inspect the foreign site for possession, use, transport, and training procedures.

What is the role of the U.S. awardee in ensuring that a foreign subcontractor complies with the select agent term?

Though not part of the site visit team, the U.S. awardee is involved in all communication with the foreign subcontractor and helps ensure that information is submitted as quickly as possible.

The quickest communication occurs when the subcontractor works directly with staff in NIAID's Office of International Extramural Activities to prepare documents for submission. The U.S. investigator is copied on all correspondence but can choose to have all information go through him or her, which may slow down the process.

Pre-inspection Documents

Do I need to include all required information regarding the possession, use, and transfer of select agents with my application?

No. Send them to NIAID after you get your Notice of Award. We prefer that you send them as a complete package, but if that is not possible or would cause significant delays, send the completed APHIS/CDC Form 1 with the signature of the responsible institutional official as soon as possible.

Who is responsible for preparing certified translations of a country's select agent rules and regulations?

The foreign institution translates rules and regulations into English.

Inspection Procedure

How will a site visit be organized, when will it take place, and how many inspectors will there be?

CDC inspectors acting on behalf of NIAID will organize the inspection, which will occur after we receive a completed APHIS/CDC Form 1, and the responsible official and PI agree on a date. There will be two or three inspectors, depending on the complexity of the laboratories and number of different select agents at the site.

As a subcontractor on an Ebola project who's been asked to collaborate on another project, do I need to be inspected twice?

If you are working in the same laboratory in the same location, your laboratory (along with your institution's select agents policies) needs to be inspected only once for the Ebola projects. If you begin research with a different agent, you will need a second inspection.

If I'm awarded a five-year grant for a select agent project in my country, will one inspection suffice for the whole project period? What if I'm awarded another select agent grant?

An initial site visit is required for each new award; subsequent visits are conducted every three years. In most cases a second site visit will be needed only if the award uses a new select agent or lab.

Will I need to be re-inspected if we don't "pass" the first time? How soon would a second inspection take place?

Once issues are resolved, a second inspection may be needed, depending on the nature of the deficiencies. If a second inspection is necessary, inspectors need eight to ten weeks before a return visit (HHS requires eight weeks' notice).

Will the same inspection team inspect all labs? If not, how will NIAID ensure consistency in the inspections?

CDC Select Agent Program staff determine the inspection team. There is no guarantee it will be the same team. Teams ensure consistency by using the same standards at every site in every country.

What is the shortest time between receiving my Notice of Award and having an inspection?

The shortest possible time between receipt of the Notice of Award and inspection is 10 weeks, assuming that the foreign site completes and submits the laboratory application form immediately after receipt of the notice and has no scheduling delays.

What are the criteria for performing background checks of people who have select agent access at foreign institutions?

Background checks are the responsibility of the foreign institution as part of its security risk assessments.

Foreign institutions must submit their procedure for personnel background checks or the comparable personnel security risk assessment procedure for clearing people who have access to select agents in NIAID-funded research to NIAID's Office of International Extramural Activities. The procedure must be signed by the institution's signing official.

ISARG Review and Assessment

Who is on the Interagency Select Agent Review Group committee?

Interagency Select Agent Review Group (ISARG) members include U.S. federal employees who have experience in select agent research or policies. Members include NIH scientific program, grants, and contracts staff along with employees from the CDC, Department of Justice, Department of State, and other appropriate federal agencies. The committee will meet about three times a year.

What is the ISARG committee's role, and how much freedom does it have for determining the sufficiency of an institution that does not meet all of the requirements of 42 CFR Part 73?

ISARG recommends to NIAID whether a restriction on research involving select agents should be removed from an award.

The final decision on what is "sufficient" is based on a group decision made by ISARG members. The group has sufficient information and freedom to make a thoughtful and informed recommendation. The recommendation is sent to NIAID's Division of Extramural Activities director for approval.

How do the site visit and ISARG review take into account the local jurisdiction's existing rules, policies, or laws?

The rules, policies, and laws of the foreign institution are assessed along with the inspection report for similarity to U.S. requirements.

What criteria does the ISARG committee use to determine if a foreign site's safety and security procedures are equivalent to those required in U.S. institutions?

ISARG reviews foreign institutions for comparable select agent requirements for registration, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, laboratory inspections, and notifications.

What determines a pass or fail for an inspection? What if our facility managers do not agree with the inspectors' evaluations or recommendations?

ISARG checks that foreign laboratories have facilities that meet minimum biosafety and biosecurity requirements. Managers at foreign institutions who disagree with the inspectors' evaluations can provide additional information or clarification for ISARG review.

Are minor deviations from 42 CFR Part 73 allowed or is a considerable amount of leeway permitted?

Foreign institutions that do not have a process similar to the one in 42 CFR Part 73 should provide information about applicable laws, regulations and policies, safety, security, training, and procedures to ensure that only approved and appropriate persons (approved by the foreign institution) have access to select agents.

ISARG discusses the information provided and determines what is sufficient and how much leeway can be permitted. Every situation will be considered separately but with a goal of establishing some consistency in approach.

If we can't afford expensive surveillance equipment or computer tracking systems for inventories or monitoring personnel access to freezers, can we use a paper tracking system?

Expensive surveillance equipment is not a requirement for award, but you must have minimum biosafety and biosecurity procedures. If the inspection report indicates the paper tracking system and padlocks are sufficient, that is all the laboratory needs to do.

Once your institution submits the completed inspection application, the inspection team leader will contact the PI or institutional responsible official. The team leader can answer questions about the requirements. For further information, go to CDC's Select Agent Program and USDA's Agricultural Select Agent Program.

Does a foreign institution receive a certification if a term of award is considered satisfied after ISARG review?

No. There are no certifications for foreign institutions. Rather, NIAID informs foreign institutions that they have been approved to use NIH funds for select agent work. This approval is valid for three years.

If investigators have a select agent approval certification from their country's regulatory agency, do they have to go through CDC inspection and ISARG review?

Yes. All foreign laboratories and institutions are required to have their select agent policies (or comparable policies) reviewed by ISARG.

What if my question wasn't answered here, or I'd like to suggest a question?

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