CDC Guidance: Compliance with Select Agent Regulations For Labs Handling Specimens Containing Ebola Virus

 

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`Select agents’ are those  pathogens that have been deemed to pose a significant biological hazard, and among those, Tier 1 select agents are considered `biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public confidence, and pose a severe threat to public health and safety:’

As you might have already guessed, the various species of Ebolavirus are Tier 1 select agents, which makes everything contaminated (by blood, sweat, feces, urine, etc.) by an Ebola infected patient potentially a select agent – and subject to rigorous safety regulations – as well.

Everything from blood samples drawn for testing, to used bed linen, could potentially pose a biohazard – and if it fell into the wrongs hands – potentially a bio-weapon, as well.

 

Understandably there have been concerns over how hospitals are to handle, and account for, potentially virus contaminated items under the various laws that are in place ( see SARS Virus Placed On Select Agents List for more background).

Today the CDC has released some interim guidance on these issues.

 

Interim Guidance Regarding Compliance with Select Agent Regulations for Laboratories Handling Patient Specimens that are Known or Suspected to Contain Ebola Virus

Ebola virus is regulated as a “select agent” in accordance with the HHS Select Agent regulations (42 CFR Part 73). Given below, in question and answer format, is guidance on how to apply the select agent regulations to activities associated with the diagnosis and care of individuals suspected of having an infection with Ebola virus. All questions concerning this guidance, and other aspects of the Ebola response should be submitted to:

Centers for Disease Control and Prevention
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Atlanta, GA 30333
800-CDC-INFO
(800-232-4636)
TTY: (888) 232-6348
Contact CDC–INFO

Ebola Virus

Is Ebola virus a select agent?

Yes, Ebola virus is listed as a select agent. Biological agents that the Department of Health and Human Services (HHS) has determined to have the potential to pose a severe threat to public health and safety, such as Ebola virus, are regulated under the HHS Select Agent regulations (42 CFR Part 73).

A current list of select agents and toxins can also be found at: http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html.

Ebola virus is also listed as a Tier 1 agent. (A subset of select agents and toxins have been designated as Tier 1 because these biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public confidence, and pose a severe threat to public health and safety).

Entities that possess, use, or transfer Tier 1 select agents and toxins must adhere to the additional requirements detailed within the Select Agent Regulations: http://www.selectagents.gov/Regulations.html.

Is genetic material from the Ebola virus regulated as a select agent?

No. Nucleic acids that cannot produce infectious forms of a select agent (such as from the Ebola virus) are not regulated as a select agent.

Patient and Specimen Management Issues

Is  waste generated during delivery of care to Ebola virus-infected patients subject to select agent regulations (42 CFR Part 73)?

As long as facilities treating Ebola virus-infected patients follow the CDC’s “Infection Prevention and Control Recommendations for Hospitalized Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S. Hospitals” or equivalent actions, waste generated during delivery of care to Ebola virus-infected patients would not be subject to select agent regulations (see the exclusion provision 42 CFR § 73.3(d)(1)). However, this exclusion would not apply to any facility that intentionally collected or otherwise extracted the Ebola virus from waste generated during the delivery of patient care.

Are specimens collected from a patient suspected to have Ebola infection covered by the select agent regulations?

No, specimens would not be subject to the Federal select agent regulation until identified as containing Ebola virus by viral isolation.

How do select agent regulations apply to specimens that have tested positive by molecular methods?

The select agent regulations would not apply until the specimen that has tested presumptively positive using molecular methods has been proven to contain live-infectious Ebola virus by virus isolation.

Any specimens that are confirmed by virus isolation to contain live-infectious Ebola virus must be reported to DSAT immediately by telephone (404-718-2000), Email (lrsat@cdc.gov), or FAX (404-718-2096) and be followed up with APHIS/CDC Form 4 within seven days of the initial report.

Are specimens from a patient confirmed by viral isolation to contain Ebola virus covered by the select agent regulations?

Yes. If live-infectious Ebola virus is confirmed, any diagnostic or clinical specimens (e.g., blood, urine, tissue, and other body fluids) that are kept would be covered by the regulations and would have to be destroyed, decontaminated, or transferred to a registered select agent facility within seven days of notification that live-infectious Ebola virus was detected. Specimens that were collected but not kept, e.g. blood collected for routine patient care and then decontaminated or destroyed after testing, are not subject to the regulations.

After the patient has been determined to no longer be infected with Ebola virus, specimens taken after that point are not subject to the select agent regulations.

Is the APHIS/CDC Form 2 required to transfer specimens from a patient confirmed by viral isolation to contain Ebola virus?

Yes, APHIS/CDC Form 2 would be required to request prior authorization for the transfer of the identified select agent.

Would the APHIS/CDC Form 4 need to be completed for reporting specimens that are confirmed by viral isolation to contain the Ebola virus?

Yes. For reporting the isolation of the Ebola virus from the clinical sample, only one APHIS/CDC Form 4 should be completed for each patient.

We have performed a nucleic acid extraction on a sample from a confirmed Ebola patient. Is the extracted nucleic acid covered by the select agent regulations?

No. The nucleic acid of the Ebola virus is not infectious therefore it is not a select agent.

What safety precautions should I use to perform routine medical testing for patients suspected or known to contain the Ebola virus?

Please refer to “Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Persons Under Investigation for Ebola Virus Disease” for guidance regarding safety precautions.

What should be done if there is a potential exposure to blood, body fluids and other infectious materials to a patient suspected or known to contain the Ebola virus?

Please refer to “Infection Prevention and Control Recommendations for Hospitalized Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S. Hospitals” for guidance regarding occupational exposures.

If the patient confirmed to have contracted Ebola has died as a result of virus, would the patient’s body be considered a select agent?

No. The patient’s body would not be considered a select agent. Select agents in their naturally occurring environment are not subject to the regulations; this includes a human that was naturally infected with a select agent.

SARS Virus Placed On Select Agents List

 

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A story this morning from Helen Branswell of the Canadian Press on new regulations for working with the SARS virus, but first, a little background.

 

In May of 1995 a lab technician from Lancaster, Ohio – using a credit card and and a fake letterhead – ordered a quantity of Yersinia pestis (the bacteria that causes plague) from a mail order biomedical supply firm in Maryland.

 

Although 3 vials were shipped to him, the company grew suspicious and alerted federal authorities. He was eventually convicted of mail fraud – and placed on 18 months probation - since he misrepresented himself as working for a government laboratory.

 

Around the same time, halfway around the world, a Japanese cult called Aum Shinrikyo unleashed a Sarin gas attack on five subway trains in Tokyo. In all - 13 people were killed, another 54 serious injured – while hundreds more were affected.

 

When the cult’s headquarters was raided, police reported finding explosives, along with  chemical and biological agents, including  anthrax and Ebola cultures.

 

Suddenly, the threat of homegrown biological terrorism had grown very real. In response, Congress passed Section 511 of the Antiterrorism and Effective Death Penalty of 1996.

 

This legislation was the first step on the road to creating the CDC’s Select Agent Program, which today `oversees the activities of possession of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products’

 

For more, we go to the CDC’s Select Agent Program Brochure.

 

This Act directed the U.S. Department of Health and Human Services (HHS) to establish a list of biological agents and toxins that could threaten public health and safety, procedures for governing the transfer of those agents, and training requirements for entities working with these “select agents.”

HHS delegated the authority to implement this Act to the Centers for Disease Control and Prevention (CDC), which then established the CDC Select Agent Program. The Division of Select Agents and Toxins in the CDC Office of Public Health Preparedness and Response oversees this program.

9/11 and increased regulation of select agents

Following the anthrax attacks of 2001, Congress significantly strengthened oversight of select agents by passing the following acts:

• USA PATRIOT Act (Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001; Public Law 107-56): Restricted  access to select agents
  
• Bioterrorism Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Public Law 107-188): Increased safeguards and security measures as well as oversight of the possession and use of select agents

 

Essentially, in order to be able to acquire or work with certain toxins and biological agents, you had to be registered and approved entity by the HHS.

 

 

Fast forward to this past week – when by chance, a SARS-like coronavirus detected in two patients from the Middle East was making big news – and two years after it was first requested by the CDC, the SARS virus was added to the Select Agents list.

Here is the story from Helen Branswell, that also has details on how Canada deals with these types of biological materials, and some quotes from Michael Osterholm of CIDRAP.

 

U.S. government names SARS a select agent, restricting labs that work on virus

Friday, 05 October 2012 02:15 Helen Branswell, The Canadian Press

The Centers for Disease Control has added SARS to the list of select agents in the United States, a move designed to try to ensure the virus stays within the confines of highly regulated laboratories.

 

The addition, which the CDC first proposed over two years ago, was given legal status this week when the revised select agent list was published in the U.S. Federal Registry.

 

The timing of the move is both ironic and co-incidental.

(Continue . . .)

 

Although the SARS epidemic of 2002-2003 was eventually brought under control, the virus infected roughly 8,000 people, killing nearly 800. 

 

Since then, while there have been no recurrences from the wild, three separate lab accidents in 2003 and 2004 resulted in the infection of at least 13 people.

 

SARS, or a variation on the SARS-Coronavirus, could wreak havoc were it to emerge once more from the wild, or be accidentally (or intentionally) released.

 

And many worry that - with the technology of today – cheaper, faster, and more capable than anything that could be imagined back in 1995, the ability of malevolent bio-hackers working out of their basements to create new, and dangerous organisms has never been greater.

 

While once we only had to worry about nature serving up an occasional biological curve ball, increasingly that ability – by design or by error - is becoming available to human hands all around the world.

 

Which makes the regulation and control of the most dangerous of these toxins and biological organisms a top priority of many governments around the world.