Thursday, January 27, 2005

Bird flu: select agents and red tape

If you want to know how badly coordinated the federal effort on bird flu is, consider this piece (from Henry Niman at Recombinomics)
US Classifies Pandemic Flu Vaccine as a Select Agent

Recombinomics Commentary
January 24, 2005

One of the more interesting facts to emerge from the University of Michigan symposium on Pandemic Influenza: Could History Repeat Itself? was the fact that the US declared the flu virus a select agent because it had been genetically modified to REDUCE its lethality.

Highly pathogenic influenza A virus, including H5N1, have a poly-basic cleavage site in the hemagglutinin protein. To make the virus less lethal and enhance virus production in eggs, several of the basic amino acids are genetically removed,.

However, the removal of these sequences placed the virus in the "select agent" category, requiring background checks and paperwork that would significantly delay development of the vaccine. WHO has been pushing for programs to delay the looming pandemic, saying [.pdf] that each day allows for 5 million more doses of vaccine to be made.

It wasn't clear how long it took to get the designation removed, but the clinical trials scheduled to begin this month are now at least 4-6 weeks away for Aventis. Chiron is stated to begin even later because they built a special testing facility for pandemic flu vaccine development.

Bird flu is looming large as the red tape flows out of Washington.
To understand exactly what this designation means practically, here are a few requirements for working with a Select Agent (from the CDC FAQ on Select Agents):
18. Who has to have a security risk assessment?

All entities (except for Federal, State, or local governmental agencies), the RO [Responsible Official of the institution], alternate RO, and all individuals with access to select agents or toxins must have an approved security risk assessment. Please see our website or the FBI website for additional information. [my emphasis]

19. Please provide us with additional guidance on security risk assessments and security requirements.

Section 73.8(b)(Security risk assessments) states that an entity may not provide an individual access to a select agent or toxin unless the individual has been approved by the Secretary of either HHS or USDA, based on a security risk assessment conducted by the Attorney General. "Access" as it is used in these regulations takes its ordinary meaning: "the freedom or ability to obtain or make use of." Anyone, including visitors, who have the freedom or ability to obtain and make use of a select agent or toxin, must be approved. Also see section 73.11(d)(1) (Security). However, the regulations do recognize that access to a select agent or toxin can, as a practical matter, be limited by either security containers or by escorts. As provided in 73.11(d)(2) regarding non-laboratory functions including routine cleaning, maintenance, and repairs, non-approved individuals will be allowed access to areas where select agents are accessible only if they are escorted and monitored by an individual who has been approved. It is the intent of the regulations that the escort will have the means and ability to prevent the non-approved individual from obtaining or making use of any accessible select agent or toxin in that area.

With regard to record keeping, Section 73.15(a) requires that an entity keep an up-to-date list of everyone who has been approved for access to select agents and toxins. Section 73.15(c)(1) requires that an entity must maintain a record of each individual who has actually accessed a select agent or toxin. Section 73.15(c)(2) requires that an entity must maintain a record of each individual who has actually accessed any area where select agents are used or stored. Depending on the circumstances, maintenance of some of the records may be manual or electronic (e.g., electronic key cards that records access to labs). The record may consist of one list or three, but each section of the regulations requires the entry of specific information. For example: For a researcher working directly with a select agent or toxin, the record must show the name of the researcher; the name of agent or toxin; if long-term storage or holding was involved, the dates of removal and returns; and, if a toxin, the quantity removed and returned. Another example: For a maintenance person doing routine cleaning of an area (i.e., a lab) in which a select agent or toxin was stored (even locked storage), the record must show the name of the person who had entered the area, the date and time the person entered and left; and, if escort is required, the name of the escort.

20. What is the general process for obtaining a security risk assessment (SRA)?

The following process applies to a new application or an amendment to an existing application.

* The entity Responsible Official (RO) submits an application or amendment that includes a Table 4B (CDC Form 0.1319/USDA Form 2044) to their lead agency (APHIS or CDC, but not both). The lead agency serves as single point of contact for an entity and is responsible for coordinating all activities and communications with respect to new applications or amendments;
* The lead agency issues back to the entity a letter with the unique Department of Justice (DOJ) identifying number for each individual listed on the Table 4B or amended 4B;
* The RO forwards to each individual their unique DOJ identifying number;
* The individual fills out FBI form (FD-961) and puts their unique identifying number in block 17;
* The individual follows all of the FBI instructions ( for submitting fingerprints; and
* The individual mails the FD-961 form and fingerprint cards as one package directly to the FBI, Criminal Justice Information Services Division (CJIS), not to APHIS or CDC.