Homeland Security Watch

News and analysis of critical issues in homeland security

April 28, 2009

Swine flu: legal and policy framework

Filed under: General Homeland Security — by Philip J. Palin on April 28, 2009

There have been 40 confirmed diagnoses of H1N1 virus in the United States. The CDC is updating this number and providing additional information at: http://www.cdc.gov/swineflu/index.htm (The CDC has indicated an official update will be forthcoming at 1:00 pm eastern.  Numbers will increase and various numbers will be reported.  For consistency I will stick with the CDC official count as shown on their webpage.)

The Acting Secretary of Health and Human Services has taken statutory action as follows:

As a consequence of confirmed cases of Swine Influenza A (swH1N1) in California, Texas, Kansas, and New York, on this date and after consultation with public health officials as necessary, I, Charles E. Johnson, Acting Secretary of the U.S. Department of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, 42 U.S.C. § 247d, do hereby determine that a public health emergency exists nationwide involving Swine Influenza A that affects or has significant potential to affect national security. (April 26,2009)

In Mexico the suspected death-toll from swine flu has increased to at least 149. The government has closed all schools — pre-school to post-graduate — nationwide.  (See San Francisco Chronicle for more.)  (Again, numbers will increase, reports will vary.)

The World Health Organization has increased its alert level to Phase 4 in a six step pandemic warning system.  Phase 4 is meant to communicate that, “verified human-to-human transmission of an animal or human-animal influenza reassortant virus able to cause community-level outbreaks. The ability to cause sustained disease outbreaks in a community marks a significant upwards shift in the risk for a pandemic… Phase 4 indicates a significant increase in risk of a pandemic but does not necessarily mean that a pandemic is a forgone conclusion.” (The alert level link above provides helpful detail.)

In accordance with the Homeland Security Act of 2002,  Homeland Security Presidential Directive 5, and the National Response Framework, the Secretary of Homeland Security has been identified the Principal Federal Official (PFO) for Domestic Incident Management.  At the Sunday White House briefing John Brennan, the President’s Special Assistant to the President for Homeland Security and Counterterrorism said, “Secretary Napolitano, who is the principal federal official for domestic incident management with responsibility for spearheading our efforts.”

According to the National Response Framework, the Principal Federal Official acts “to facilitate Federal support to the established ICS Unified Command structure and to coordinate overall Federal incident management and assistance activities across the spectrum of prevention, preparedness, response, and recovery.” (my emphasis)

Wednesday the Senate Committee on Homeland Security and Governmental Affairs will hear testimony from Secretary Napolitano regarding coordination of the federal response to swine flu. 

Is the foregoing accurate?  In terms of existing law, regulation, policy, and strategy what else is of equal importance?  Is the Public Health Service Act the law that is most applicable here?  Are there other laws especially germane to the task ahead?  How about HSPD-21?  Is it being used?  If so, how?  If not, why not?  The question does not assume a right-or-wrong answer.  How about the PKEMRA?

It seems to me that this blog’s best contribution is trying to capture what is happening in the policy-and-practice nexus.  Can we discern how prior investment in law, regulation, policy and strategy is paying-off now?  If it is paying-off, how and why?  If it is not paying off, how and why?  Good or bad (and let’s not miss the good news) what does this tell us about effective law-making, rule-making, policy-making and strategizing?

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7 Comments »

Comment by William R. Cumming

April 28, 2009 @ 5:44 am

Two thoughts on this as background. Human to human spread (aerosol) seems to have been documented as early as April 10th. Also at least one WHO spokesperson has been quoted repeated on NPR as stating “There is no longer opportunity for containment but only mitigation.” So guessing in complete ignorance that the system will get to level 6 eventually. The enormous economic and political impacts of that evolution and of each increase in the WHO “alerting” not “warning” system seems to be not totally understood. If it does go to level 6 we should have long passed surging medical resources in accordance with HSPD-21 that upon rereading is an utterly amazing document to have escaped into print and public by the last administration. Even tight deadlines that I really hope were met now that we are in this event.
PKEMRA of 2006 (Post Katrina Emergency Management Reform Act) became fully effective on March 31, 2007. It helped to clarify the question of “who was in charge” between the PFO concept of the HSPDs and the FCO concept of the Stafford Act (42 US Code Sections 5121 and following.) It did not do it to my satisfaction but it did indicate that unless there was a Presidential Declaration of disaster or emergency pursuant to the Stafford Act a PFO could be designated and apparently that was done orally or in writing in this instance since no Stafford Act declaration. Interestingly, and not trying to second guess or box in anyone, there is a provision in the Stafford Act (I believe Section 501 if memory serves) allowing events of particular federal interest to be declared emergencies and disasters. I could be wrong but what might be of interest here is that one General Counsel of the then independent FEMA took the position that the DOJ/OLC would have to agree in advance before such a declaration was issued. Of course despite the longing of longterm FEMA appointees and personnel to deal exclusively with natural disasters, and President Clinton instruction to do just that the first WTC attack in 1993 and the Murrah Building in 1995 were both declared Presidential Stafford Act events. So the OCC/FEMA and DHS Lawyers and DOJ/OLC lawyers better get busy on this one just in case someone asks.

Also the enactment of the Bioterrorism Preparedness and Response Act of 2002 (since amended) did provide some amendments to the Public Health Service Act mentioned by Phil above. It also had sections codified elsewhere in the US code. Hoping this helps.

Comment by anon

April 28, 2009 @ 7:07 am

You would be making an assumption there is actually a planning capability in the legal emergency management community.

Come on now!

Well at least CDC has tried. Some examples:

http://www2a.cdc.gov/phlp/docs/preinitiative_bridgegap.doc

http://www.aslme.org/cdc/gebbie.pdf

Comment by Philip J. Palin

April 28, 2009 @ 7:16 am

Relevant to reference above that we are likely to eventually reach Phase 6, Secretary Napolitano is saying that the US response is proceeding “as if” there is already a full pandemic. Helpful background on this and more is in an AP story from this morning at:

http://www.google.com/hostednews/ap/article/ALeqM5iFE9l8PfnvnjH_fPGJ5uSjTkVZtwD97RE8M04

Comment by Peter J. Brown

April 28, 2009 @ 8:14 am

The good news is that regional, state and local health officials in the U.S. including hospital personnel took the pandemic threat seriously, and despite talk to the contrary, a lot of money was made available over the past 5 years in order to improve planning and preparation. Regional planning moved ahead. Coalitions began to take shape.

Among other things, health officials in Canada took the lessons learned from the SARS outbreak and acted on them, and, they came over the border into the U.S. and spelled out what worked and what failed. In the U.S, the public health and hospital sectors could listen to the Canadians while drawing funds and guidance from the HHS Hospital Preparedness Program (HPP). In addition, HPP made a significant adjustment, in effect shifting away from its prior heavy emphasis on bioterrorism and embracing instead a broader definition of preparedeness.

Hospital drills that simulated mass casualty incidents started to effectively incorporate elements of ICS and HICS. But this is simply my opinion. Others may disagree with me. One reason is that there was a greater sense of awareness about the need for a culture shift after Katrina in particular where hospitals woke up to the fact that help might not arrive as soon as they might like during a major disaster. This awareness and concern simply started a process and identified a pathway, which brought about drills and exercises that were more realistic in terms of their scope and outcome. People still might not understand their exact roles and responsibilities. but at least there is a much more sustainable framework.

As one who has addressed hospital / clinic emergency communications during large scale incidents in the past, I came to see that while execution might not always match expectation, and while drills and exercises always seemed too short and too well orchestrated, these have changed and play a significant role as a result. I don’t know that a year from now I will feel so confident, but I saw steady progress, I saw groups of people sitting down to address organizational deficiencies and i watched improvements taking place.

That said, the other good news is that GAO has been very diligent and on target over the past 3 years in particular with respect to pandemic planning issues and updates. The GAO has not always been kind as well nor willing to distort the big picture, thankfully. The GAO report issued in February is a good open and frank assessment of where things stand today. Check it out — “INFLUENZA PANDEMIC Sustaining Focus on the Nation’s Planning and Preparedness Efforts” (GAO-09-334). In the interest of brevity — I do recommend that everyone should grab a copy and study it — here are the “Results in Brief” —

What GAO Found —

GAO has conducted a body of work over the past several years to help the nation better prepare for, respond to, and recover from a possible influenza pandemic, which could result from a novel strain of influenza virus for which there is little resistance and which therefore is highly transmissible among humans.

GAO’s work has pointed out that while the previous administration had taken a number of actions to plan for a pandemic, including developing a national strategy and implementation plan, much more needs to be done.

However, national priorities are shifting as a pandemic has yet to occur, and other national issues have become more immediate and pressing. Nevertheless, an influenza pandemic remains a real threat to our nation and the world.

For this report, GAO synthesized the results of 11 reports and two testimonies issued over the past 3 years using six key thematic areas:
(1) leadership, authority, and coordination;
(2) detecting threats and managing risks;
(3) planning, training, and exercising;
(4) capacity to respond and recover;
(5) information sharing and communication; and
(6) performance and accountability.

GAO also updated the status of recommendations in these reports.

What GAO Recommends
This report does not make new recommendations. However, the report discusses the status of GAO’s prior recommendations on the nation’s planning and preparedness for a pandemic.

Leadership roles and responsibilities need to be clarified and tested, and coordination mechanisms could be better utilized. Shared leadership roles and responsibilities between the Departments of Health and Human Services (HHS) and Homeland Security (DHS) and other entities are evolving, and will require further testing and exercising before they are well understood.

Although there are mechanisms in place to facilitate coordination between federal, state, and local governments and the private sector to prepare for an influenza pandemic, these could be more fully utilized.

Efforts are underway to improve the surveillance and detection of pandemic-related threats, but targeting assistance to countries at the greatest risk has been based on incomplete information. Steps have been taken to improve international disease surveillance and detection efforts. However, information gaps limit the capacity for comprehensive comparisons of risk levels by country.

Pandemic planning and exercising has occurred, but planning gaps remain. The United States and other countries, as well as states and localities, have developed influenza pandemic plans. Yet, additional planning needs still exist. For example, the national strategy and implementation plan omitted some key elements, and HHS found many major gaps in states’ pandemic plans.

Further actions are needed to address the capacity to respond to and recover from an influenza pandemic. An outbreak will require additional capacity in many areas, including the procurement of additional patient treatment space and the acquisition and distribution of medical and other critical supplies, such as antivirals and vaccines for an influenza pandemic.

Federal agencies have provided considerable guidance and pandemic related information, but could augment their efforts. Federal agencies, such as HHS and DHS, have shared information in a number of ways, such as through Web sites and guidance, but state and local governments and private sector representatives would welcome additional information on vaccine distribution and other topics.

Performance monitoring and accountability for pandemic preparedness needs strengthening. Although certain performance measures have been established in the National Pandemic Implementation Plan to prepare for an influenza pandemic, these measures are not always linked to results. Further, the plan does not contain information on the financial resources needed to implement it.

GAO has made 23 recommendations in its reports—13 of these have been implemented and 10 remain outstanding. Continued leadership focus on pandemic preparedness remains vital, as the threat has not diminished.

Comment by William R. Cumming

April 28, 2009 @ 11:34 am

Peter posts are great! GAO has done well on Pandemics. Hope Congressional staff and members access them!

http://www.pandemicflu.gov/plan/federal/pandemic-influenza-implementation.pdf

Comment by Arnold

April 28, 2009 @ 1:34 pm

For some historical background (and potential lessons for today), the IOM released in electronic format the paper “The Swine Flu Affair: Decision Making on a Slippery Disease,” an analysis by Richard Neustadt and Harvey Fineberg of decision making during the swine flu scare of the late seventies.

http://www.iom.edu/?ID=65926

Comment by William R. Cumming

April 29, 2009 @ 10:42 am

Okay full disclosure. Helped draft immunity on Swine Flu vaccine for manufacturers.

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