WASHINGTON D.C. 20460
                                                                OFFICE OF THE ADMINISTRATOR
                                                                 SCIENCE ADVISORY BOARD

                                        May 28, 2009


The Honorable Lisa P. Jackson
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, D.C. 20460

Subject: Consultation on a Revision of the Environmental Response Technical Assistance
        Document For Bacillus anthracis Intentional Releases

Dear Administrator Jackson:

       The EPA Science Advisory Board (SAB) Homeland Security Advisory Committee
augmented with additional experts held a public meeting to provide a consultation for the EPA's
Office of Solid Waste & Emergency Response's Office of Emergency Management about its
planned revision of the Environmental Response Technical Assistance Document For Bacillus
anthracis Intentional Releases (BA-TAD). This document was prepared by a multi-agency Task
Force of the National Response Team's Weapons of Mass Destruction Subcommittee, and was
originally produced in 2003 and slightly revised in 2005. An earlier conference call, in planning
for this meeting, resulted in a letter report from the SAB, available at the SAB Web  site.

       The SAB Committee is grateful for these opportunities to provide input to the task force's
vital work at these formative stages. Its members submitted written comments in response to the
five charge questions that are appended in this letter.  In concluding discussions, they identified
several key issues for the task force's consideration as it formulates its strategy. Those key
issues include:

•  Planning for responses to intentional releases of Bacillus anthracis must be robust
   enough to cover the range of plausible scenarios  The current draft BA-TAD focuses on
   the recurrence of an envelope-borne attack, with indoor releases in facilities that could,
   conceivably, be secured quickly and abandoned for extended periods.  Attention to the details
   of such an attack is valuable, because it allows the development of specific guidance.
   However, plans developed for that scenario do not have clear extensions to other scenarios,
   such as attacks on:  (a) water supplies; (b) outdoor areas, where decontamination is infeasible;
   (c) ventilation systems; (d) facilities where human activity ensures extensive cross-
   contamination; and (e) the wide-area situation that the revised draft BA-TAD aims to

   address.  If the task force cannot address other scenarios, the document should clearly state
   its limited scope and, as a consequence, limited value to the potential users.

•  Communication is central to the BA-TAD's implementation and must be treated
   systematically.  Many critical communications outlined in the BA-TAD can be evaluated
   empirically to the standards of peer-reviewed scientific publication prior to an attack. The
   lack of such empirical evaluation demonstrating the communications' adequacy will
   needlessly  imperil Americans' well-being and faith in their government. Such
   communications must address: (a) anthrax risks, treatment, diagnosis, and precautions; (b)
   decontamination standards and residual risks; (c) uncertainties, regarding the scope of a
   possible  attacks; (d) the information that people need for effective decision making; (e) clear
   directives where those are required; and how they should do it; and (f) procedures and
   protective measures for workers. The science of communication is nowhere evident in the
   planning effort, as pointed out in our letter dated November 5, 2008.  Opinion is no substitute
   for evidence, when evaluating communications.

•  The document must be evaluated for its usability.  Particular concerns were raised about
   whether users could quickly and confidently: (a) determine whether their needs were outside
   the document's scope; (b) identify information relevant to different phases of a response; (c)
   find guidance for situations in which the nature of an attack is uncertain; and (d) address
   issues that  are officially beyond their responsibility (e.g., decontamination standards), but
   cannot be easily deferred. Usability testing should involve individuals who vary
   appropriately in their knowledge of microbiology, testing procedures, legal constraints, and
   local communities. An interactive version of the document might serve training and
   operational purposes.

•  The document should be more realistic about how well response teams will function
   An attack may bring together individuals and agencies with no previous interactions or
   unresolved differences in their procedures and experience.  Specific concerns include
   potential conflicts in: (a) selecting and applying decontamination standards - especially for
   surfaces; (b) assessing the extent and magnitude of exposure; (c) balancing public health and
   law enforcement demands; (d) using limited testing capacity (e.g., characterizing known
   hotspots  better vs. providing the reassurance  needed to reoccupy clean areas); (e) disposing
   of contaminated materials and water; (f) selecting dispersion models; and (g) listening to
   stakeholder concerns. Alerting users to these potential problems allows them to anticipate
   and address them, by creating more realistic coordination plans.

   Because this was a consultation, there will be no formal report from the SAB. We hope these
comments and recommendations are helpful to EPA as the Agency continues the important work
of revising the current BA-TAD guidance.


                                Dr. Baruch Fischhoff, Chair
                                Homeland Security Advisory Committee

cc:    Dr. Deborah L. Swackhamer
      Chair, Science Advisory Board

      Enclosure 1: Committee Roster
      Enclosure 2: Individual Comments from Committee Members
      Enclosure 3: EPA Charge Questions to the Panel

                        Enclosure 1: Committee Roster

                    U.S. Environmental Protection Agency
                            Science Advisory Board
     Homeland Security Advisory Committee (HSAC) Augmented for the
     Consultation on a Revision of the Environmental Response Technical
       Assistance Document For Bacillus anthracis Intentional Releases


Dr. Baruch Fischhoff, Howard Heinz University Professor, Department of Social and Decision
Sciences, Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh,


**Dr. William Bellamy, Vice President, Water Supply and Treatment, CH2M Hill, Englewood,

Dr. Vicki Bier, Professor, Department of Industrial Engineering, University of Wisconsin,
Madison, WI

***Dr. Mary Durfee, Associate Professor and Assistant Provost for Academic Improvement,
Social Sciences Department, Michigan Technological University, Houghton, MI

Dr. David S. Ensor, Senior Fellow, RTI International, Research Triangle Park, NC

Dr. Lynda Knobeloch, Senior Toxicologist, Wisconsin Department of Health Services,
Madison, WI.

Dr. Paul J. Lioy, Deputy Director and Professor, Environmental and Occupational Health
Sciences Institute, Exposure Sciences Division, UMDNJ - Robert Wood Johnson Medical
School, Piscataway, NJ

Dr. Lee D. McMullen, Water Resources Practice Leader,  Snyder & Associates, Inc., Ankeny,

**Dr. Royal Nadeau, President, The Eco-Strategies Group, Allamuchy, NJ

** W. Kip Viscusi,  University Distinguished Professor, Owen Graduate School of
Management, Department of Economics and the Law School, Vanderbilt University, Nashville,

*Dr. Daniel C. Walsh, Adjunct Professor at Lament Doherty Earth Observatory of Columbia
University and Chief,  New York City Superfund and Brownfield Cleanup Program , New York
State, Long Island City , NY

Dr. Rae Zimmerman, Professor of Planning and Public Administration, Director, Institute for
Civil Infrastructure Systems, Robert F. Wagner Graduate School of Public Service, New York
University, New York, NY


*Dr. John Bartlett, Professor, Division of Infectious Diseases, School of Medicine, Johns
Hopkins University Medical Institute, Baltimore, MD

Dr. Christina Egan, Director, Biodefense Laboratory, Wadsworth Center, New York State
Department of Health,  Albany, NY

Dr. Philip Hanna, Associate Professor, Microbiology & Immunology, Medical  School,
University of Michigan, Ann Arbor, MI

Dr. Denise Pettit, Lead Scientist, Analytical Services, Molecular Detection and
Characterization, Virginia Division of Consolidated Laboratory Services, Richmond, VA

Dr. James Rogers, Branch Chief, Microbiological Analysis and Data Branch, Microbiology
Division, Office of Public Health Science, Washington, DC

Mr. Edward Hanlon, Designated Federal Officer, U.S. Environmental Protection Agency,
Science Advisory Board Staff, Washington, DC

* Participated via teleconference during the April 21, 2009 meeting.

** Unable to attend the April 21, 2009 meeting

*** Unable to attend the April 21, 2009 meeting but submitted their reviews for consideration

        Enclosure 2: Individual Comments from Committee Members
Dr. John Bartlett	             Page 7
Dr. Vicki Bier	             Page 10
Dr. Mary Durfee	             Page 11
Dr. Christina Egan	             Page 13
Dr. David S. Ensor	            Page 18
Dr. Lynda Knobeloch	             Page 19
Dr. Paul J. Lioy	             Page 23
Dr. L.D. McMullen	            Page 24
Dr. Denise Pettit	             Page 25
Dr. James Rogers	             Page 28
Dr. Daniel C. Walsh	            Page 29
Dr. Rae Zimmerman	            Page 33
Dr. Baruch Fischhoff	             Page 40
  References for Dr. Fischhoff:
        "Strategic Plan for Risk
        Communication at the Food and
        Drug Administration (FDA)"
        Draft: April 15, 2009, U.S.
        Department of Health and Human
        Services, Food and Drug
        Administration	   Page 41
        "Draft Agenda, FDA Risk
        Communication Advisory
        Committee, April 30-May 1,
        2009 Meeting"	  Page 63

                               Comments from Dr. John Bartlett

       Please note that I am an infectious disease physician so my review focuses based on that

  A) General Comments
       I reviewed the document and have some comments to pass on.  Please note that I am an
infectious disease physician so my review focuses on my background.
       An overview is that the document is good but the two major areas of concern are:
              1) the assumption that this will be a mail attack and
              2) no mention of engagement with the regional health system.

  B) Specific Comments to the 2003/2005 draft Environmental Response Technical
Assistance Document For Bacillus anthracis Intentional Releases (BA-TAD)

Section 4.1 Discovery
       There may be too much emphasis on the letter mechanism of distribution.  Please include
other scenarios such as contamination of food and water (such as the chocolate contamination in
South Africa) or an aerosol via a ventilation system (similar to the B. thuringiensis in Canada).  I
worry that we think too narrowly about letter because that is our major frame of reference. The
document really needs to address multiple types of building exposures.
The recommendations are to leave the area and close the doors. Sources of aerosols should be
shut down including air conditioners, heaters and other sources of ventilation.

Section 4.6 Identification of exposed personnel:
       The statement is to consult a local plan and/or appropriate medical experts. This seems
very open ended.  Someone will need to make some rapid decisions and that really needs to be
an authority on anthrax.  It may be an identified local expert, but there needs to be clarity in who
gets called and what.  Information is essential.  I suggest the local health department or the CDC
for contact with an anthrax expert. If this is a credible exposure there will need to be rapid
institution of antibiotics for those exposed and Abx plus PPE for those who enter for cleaning,
for evidence, etc.

Chapter:  Health and Safety
    A few points worth emphasizing are the following:
    •  I urge liberal use of antibiotics if there is credible evidence of anthrax. Doxycycline and
       cipro used in 2001 were generally well tolerated and apparently 100% effective (since
       none of the 5,000 exposed persons who took it acquired anthrax). Main issues are
       children and pregnant women who will not be in the clean-up but may have been
    •  Workers and others need to know anthrax is not transmitted from person-to-person so
       their families and other contacts are safe (very important message).
    •  The PPE plan is fine - but N95 masks must be fit, tested,  individualized and don't work
       well with face hair. This part of prevention is a potential  problem.
    •  For hygiene - alcohol-based cleaning is poor vs. spores. Preferred - soap and water.

Section 5.4 Medical program
   A major concern based on the 2001 experience is the communication with the regional health
care system, especially in Washington DC. Please remember that the first case was identified by
a private physician by gram stain, and the NY cutaneous case was a private MD group puzzled
by the child's lesion. All care was in local hospitals. Local doctors will see most of the cases
(worried or well) and take relevant phone calls.  The problem was communication with that
sector. Local physicians need to know who is at risk, and what to do. This applies to those
responsible for clean-up as well.
   •   There needs to be a system to rapidly deliver antibiotics for those exposed and those who
       will be exposed by clean-up.  The best record I know is the NYC Health Department
       which had an auditorium, used a simple form, had a physician available (but ran it with
       midlevel nurses) and gave out cipro or doxy to 1000 people with a put-through time of 10
   •   The antibiotics to use are the four approved by the FDA for anthrax - cipro, levofloxcin,
       doxycycline and penicillin. It is  said that Russia engineered resistance, but that is not
       verified. I think you can count on these, know well what can be used when the first strain
       is tested (because they will all be the same) and resistance development by B.  anthracis is
       unlikely.  Side effect to these drugs are common but serious  side effects are rare.

Table 5.1 - Medical tests need to include chest x-ray and blood cultures.

Table 5.2 - Not sure about the emphasis on immune deficiency.  This pathogen does not need the

Section 5.4 Post exposure
       The option to go 100 vs. 60 days was confusing - who and why.
       In 2001, the recommendation was to give the antibiotic 60 days or 100 days, and to
consult your physician. There was also the vaccine option.  Patients asked their physicians who
didn't know anything about anthrax and  had never seen a case.  So they said "who and why" (for
100 days) and no one knew except for the primate data. My point is that the treating doctor does
best with specific  guidance when it comes to a rare disease that is lethal in 45% of the cases. I
think the problem here is that we really don't have supporting data.  I think I would go 100 days,
especially if it was well tolerated or the exposure was high risk.
Section 5-3 Medical monitoring:  Who will be doing this?

Section 6.1 Sampling plan:  Might state that nasal cultures of exposed persons should or should
not be done due to the confusion on this point in 2001.

Section 9.2.3 Communication:  This is a critical facet of the plan based on the prior experience.
It must be someone with great credibility and knowledge of the specifics of the outbreak.

Safety Data Sheet
       The drug susceptibility line suggests penicillin is inappropriate for inhalation anthrax
"since mortality remains high". Penicillin was not advocated due to penicillinas production by

the 2001 strain, but that was extra cautious and probably not very important. The fact is the
mortality is high for anthrax treated with the recommended antibiotics (45% for 2001).
          •   With hand washing it may be important to mention friction.
          •   Medical surveillance: What immunologic techniques?

Anthrax Guidance
Occupational Exposure:  OSHA
   The document is generally good based on my understanding of anthrax.  A few
   •   There is a lot of information on mail exposures and prevention but little on these types of
       anthrax spores in food, water, outside air (that enters building selectively) and spores in
       the ventilation system. (Note that mail exposure accounts for #9-12, but other exposures
       are barely mentioned).
   •   Antibiotics (#16) need a better review. In the document they are not indicated "unless
       there is strong or compelling evidence . . . of exposure" and you should "discuss this with
       your healthcare provider". There needs to be greater clarity here since  private MDs will
       need guidance and please note that the antibiotics are highly effective, resistance by B.
       anthracis is very unlikely  and serious side effects are rare. (I am not advocating broad
       scale use - the recommendation is clarity and perspective on this issue.
   •   There is reference to "an employee who tests positive for anthrax exposure" (#28). Nasal
       cultures were done in the HART Building episode in 2001, but I thought this was
       discouraged. It would be good to have clarity on what microbiology should be done in
       the event of possible exposure.

                             Comments from Dr. Vicki Bier

       I have some substantive comments on risk communication:
       The advice given on risk communication is extremely generic, and could apply to almost
any hazard. Surely, after the anthrax attacks of 2001, we know more about risk communication
for anthrax IN PARTICULAR.
       For example, many people clearly have an incorrect mental model that anthrax is
contagious. This causes much higher levels of fear than may be justified by a particular event.
After all, if a disease is highly  contagious (like smallpox, for example), then even five cases
might be enough to start a major epidemic. For diseases like anthrax, which are not spread
primarily by infectious contact with sick people, the chance of starting an epidemic is much less;
people should be worried less about current infections spreading, and more about whether
additional attacks are credible. It would seem like a reasonable minimum standard to expect that
guidance on risk communication for anthrax should include that information, and some field-
tested communication materials on how to overcome the flawed mental models.
       For a more challenging problem, consider the following. In 2001, many people around
the country had what turned out in retrospect (and realistically were probably knowable even at
the time) to be excessive levels of concern, as judged by the number of people around the
country who called emergency-response teams for relatively innocuous packages or white
powders. At the same time, the postal workers in D.C. received false reassurances that they were
at low risk; two died as  a result. Are there ways to avoid this imbalance of concern?
       Perhaps it's too much to expect that we could SIMULTANEOUSLY reduce excessive
concern among people at low risk, and ALSO  increase levels of concern about people at higher
risk; that would be a tough challenge. However, can't we at least provide guidance to reduce the
risk of giving out false reassurances? For example, might there have been a subconscious class
bias at work among the  epidemiologists and risk communicators (reassuring postal workers that
they were not at high risk, because they weren't prominent enough to be targets of intentional
anthrax attacks)? Are there ways to at least reduce overconfidence about judgments of
reassurance (e.g., telling people that "We think you are not at risk, but if you still want to take
protective measures, here are some steps that can't hurt, and might be helpful")? The answers to
some of these questions might not be known yet, but are they researchable at a realistic level of
effort? Given that we had two deaths basically due to failures of risk communication, this would
seem to be a reasonable goal.

                           Comments from Dr. Mary Durfee

       The document is aimed at the FOSC, who coordinates the response to an actual or
suspected anthrax incident. Most of the coordination, if I understand the documents correctly, is
with other government agencies, including state and local personnel. The document outlines
main steps for identifying, decontaminating, checking the decontamination, and communicating
results. While primarily aimed at an indoor release, the charge to the HSAC is to give guidance
on outdoor releases. Also, the HSAC has been asked to comment on the communications plan.
       The Chair of the committee, Dr. Fischhoff asked for comments in the following general
       Professionals who will be concerned with how well the charge questions are answered
and how well individuals being protected by professional judgments will be served.
       It is unclear if the communications are primarily with professional people or can include
communications with elected officials.  The communications would, presumably, take rather
different turns to these two types of officials, even as all communications would be structured by
the TAD  and the efforts at the site.
   The FOSC would be communicating in a highly centralized structure with many potential
organizational contacts.
   A.  There is no evidence that the impact of organizational structure for the emergency has
       been factored into the brief comments on communications. At best it says the FOSC has
       a public affairs officer (PAO) who will take care of things.  In a highly centralized
       command  structure, the FOSC will give information to the PAO from above and will
       expect solid information from the PAO back up. Is there any evidence from any situation
       that procedures are clear on this?
   B.  Even if the structure of the response is centralized, the reality, reiterated throughout the
       document, will be operations in a much more fluid set of jurisdictional rules. There is
       clarity in the document on what to do about storing and labeling materials for transport,
       but very little else. Is there a quick guide on who to call at local, county, and state levels?
   C.  How will the FOSC be expected to guide the PAO's communications with these
       subnational governmental units?
   D.  There seems to be no real consideration, at least in this document, to how the FOSC will
       relate each major stage of the response to different agencies and to the public's concerns.
       The immediate fear of workers will be supplanted by those who have been in the
       building. People will object to the materials being transported through their
       neighborhoods.  While tons of hazardous wastes roll by communities every day, public
       awareness will be sensitized to movements of anthrax waste.

   Dr. Fishhoff asked that we offer ideas for improvement.
       What mental models do citizens have of anthrax?  This needs to be studied in advance, so
   that the entire response team can develop effective communications strategies.  A more
   advanced project would be to see if their models change when localized to real  locations in
   which they live and work on a daily basis. Beyond that, there are powerful network analysis
       We can see from the one public comment that elements of the public will have a very
   high standard for clean up, one that may just not be achievable. The FOSC should have a
   guide to help understand this in order to provide relevant, authoritative guidance in the
   centralized structure to the Public Affairs Officer.

   It would be a good idea to have ways of explaining why the use of some normally
dangerous chemicals are permitted in this context.  I suspect (but can't cite you literature)
that both public officials and the public would be accepting, at least at first.  But this should
be on the list of things the FOSC has a passing understanding of in order to be more
   I would urge much more clarity on the existing SOPs for communicating between
Federal agencies and between the Federal government and subnational units. I do not believe
the FOSC can execute the technical details well without at least a general understanding of
   Dr. Flshhoff also asked if we saw any gaps. I wonder about the advice at 8.2 Notification
of Waste and Recycling Service Providers. What will you say to these handlers who may
already have contaminated material?  How does information from the waste and recycling
providers get back to the FOSC.
   I look forward to learning how the meeting went.

                           Comments from Dr. Christina Egan

       Attached please find some comments on Charge Question 4. I will also have additional
comments that I will present at the April 21st and 22nd meeting.
       Charge Question #4:  "What are possible cleanup strategies for minimizing risk to
       facilitate re-occupancy in industrial, commercial and residential buildings where a zero-
       culturable- spore decontamination goal was not achieved?"

       The clean-up strategies that are used must include a carefully design risk assessment and
analysis. This is critical for re-occupancy of any area.  It must include an analysis of the
population that will  be occupying the space. For example, if the area to be considered is a
critical infrastructure site, such as a health-care setting, the clean-up strategy would have to differ
significantly than a strategy used in an industrial setting or outdoor setting due to the population
of immuno-comprimised individuals that could have significantly greater health risk than the
average population.  A detailed discussion of the components of performing this risk analysis
should be included in the TAD.

       In addition, clean-up strategies for the most likely scenarios as described in
http://www.osha.gov/SLTC/etools/anthrax/response.html should be included in the TAD
(Localized exposure to a white powder (such as a contaminated letter or package sent through
the mail; Contamination of a closed air supply (such as the ventilation system of a building;
Broad contamination of outdoor air (such as release of anthrax spores via a crop duster or similar
aircraft; and Contamination of a commercial food or beverage source (which would cause
gastrointestinal or oropharyngeal disease)).  The TAD does not need to contain specific details,
but a discussion of the important considerations for each type of scenario should be included as
the focus of this document has broadened from just an indoor release.

       Since 2001 there has been significant advances in research involving various methods of
decontamination that poses less health risk and is non-destructive when certain methods. Some
of the 2001 anthrax  contaminated buildings and areas have been utilized in this research. One
method that has been successfully used in research laboratories working with anthrax and other
highly infectious pathogens has been  studied for use outside the laboratory. EPA first reviewed
data related to the safety and effectiveness of using paraformaldehyde for inactivation of Bacillus
anthracis spores in relation to a request by the U.S. Department of Justice (DOJ) to
decontaminate a large mail sorting and stamping device located at its mailroom in Landover,
MD. Available data indicated that paraformaldehyde would reduce bacterial spore populations
under specific conditions including concentration, pH, and contact time.  EPA determined that
the product could be used safely and effectively, and that no unreasonable adverse effects would
occur from the requested uses
(http://www.epa.gov/pesticides/factsheets/chemicals/paraformaldehyde_factsheet.htm.) On
February 14, 2002, EPA also issued a crisis exemption to allow the U.S. Department of State
(DOS) to treat up to 200,000 diplomatic mail pouches with  paraformaldehyde, subject similar
conditions as the DOJ crisis exemption. The use of this product as a clean-up strategy should be
included in the TAD.

       The EPA also granted 2 crisis exemptions under FIFRA for use of vapor hydrogen
peroxide in decontamination of a mail facility in VA in 2003 and a building in the Naval Yard in
Washington D.C. in 2002. EPA (Environmental Protection Agency). Pesticides: Topical and
chemical fact sheets: vaporized hydrogen peroxide. 2006 Nov 26.  Hydrogen peroxide based
products such as Oxonia Active (EPA Registration Number 1677-129), KX-6049 (EPA
Registration Number 1677-158), Actril Cold Sterilant (EPA Registration Number 52252-7), and
Spor-Klenz Ready to Use (EPA Registration Number 52252-7-1043  have been issued
exemptions for use.  EPA also issued a crisis exemption for the unregistered product Virex STF,
which contains only hydrogen peroxide. These products have been utilized in the medical
community for sterilization of surgical instruments with success and have data to show that some
of these products may be beneficial in residential, commercial and industrial settings, especially
in areas containing critical infrastructure.

       EPA issued two crisis exemptions (February 14, 2002 and February 27, 2003) to the
University of Florida and Cobra Termite Control for the limited sale, distribution, and use of
methyl bromide.
http://www.epa.gov/pesticides/factsheets/chemicals/methylbromide_factsheet.htm. The data for
these studies helped demonstrate the efficacy of methyl bromide in inactivating surrogate
bacillus anthracis spores during structural fumigation. Although further research is needed to
address other issues such as how to reduce and remove methyl bromide after fumigation the use
of this decontaminant should be included in the BA-TAD.
       The current thoughts on a acceptable level of decontamination of Bacillus anthracis
spores has been greatly debated, but the standard of practice that has been utilized is a zero-
culturable spore or no spores present in an environment. Clean-up strategies for re-occupation of
sites that are going to move away from this practice or policy of zero-culturable spore levels
should be also be included for discussion.  The use of a zero-spore level has lead to hugely
expensive clean-up operations that are cost prohibitive. In recent cases in CT and NY in which
low level contamination was observed as a result of processing animal hides for drum making,
residential and industrial spaces were decontaminated as well as an automobile, in the case of the
NY inhalational anthrax case. In these settings, especially sites that are not in urban setting
could utilize an acceptable level of reduction in spore number in order to avoid destruction of
personal items etc. The concept of using a decrease in spore number or activity rather than the
zero-culturable-spore level is appropriate for certain settings and is utilized for various other
EPA classified pests.  When evaluating the efficacy  of decontaminants for prions, a decrease in
prion activity is used rather than a zero-level of activity as measured by infectivity studies.

       This charge question is a difficult one.  The use of appropriate clean-up strategies is
dependent on individual circumstances surrounding  each event and must be done in consultation
with appropriate local, state, and federal agencies. It would be helpful in developing a
comprehensive response to this question to review the new draft chapter that was mentioned in
the white paper which is devoted to clean-up strategies. I look forward to reviewing the draft of
the new document to comment on the additional chapters added for clean-up strategies.

(a) Identify the professionals who will be primarily concerned with how well that charge
question is answered and the individuals whose welfare those professionals are entrusted with

       While the focus of this document is to serve as a resource tool for the Federal On-Scene
Coordinators (FSOCs), a number of other professionals will be concerned with the resulting
document.  They include public health epidemiologists and laboratorians,  environmental health
personnel, first responders, health care personnel, all of which will be involved in developing an
appropriate strategy for decontamination. In addition, the general public will also be effected by
the response developed to this question.

(b) Identify any major gaps in the issues that the draft TAD addresses, in terms of providing the
information and resources needed by these professionals and those whom  they serve.
       It is difficult to determine the major gaps that are missing without  a thorough review of
the most current working version TAD.  Since this document has undergone a significant change
in focus (new target audience), each chapter must be carefully redesigned  for that purpose.  Is an
additional resource document for other groups involved  in a response to anthrax contamination
going to be developed?  The white paper details several  important changes or revisions that seem
to be appropriate. However, the document does not comment on how the  FSOC will interact
with the various agencies.  For example,  there is a review of potential federal agencies that will
be involved in a response to an anthrax release, but does detail how the FSOC will interact will
local and state partners or a discussion of pre-planning or communication  with these entities pre-

   1)  White paper- Page 3 under intent states that this document is a technical resource
       document and the charge questions and the title state it is a technical assistance
       document. This inconsistency and clarification of the difference between a resource and
       assistance document should be clarified.

   2)  Chapter 2 should also include a discussion of state agencies involved in a response and
       how the FOSC interacts with state and local groups. The BA TAD should contain
       background info on the roles and  responsibilities of a FOSC for those that are not familiar
       or are new to this role.  It  should also include pre-event planning and communication
       with federal, state, and local partners.
              Under 2.2.7, the Laboratory Response Network should be discussed. The  Select
       Agent Program regulates transfer and possession of select agents, this statement should
       be modified.
              Under 2.2.8, there should  be mention of the FBI WMD Coordinator who are
       tasked with responding to local and state biothreat incidents.

   3)  Chapter 4, 4.1, the characteristics listed for suspicious packages are criteria that are
       applicable for bombs and  not for biological substances. This should be modified to
       contain criteria for biological substances.
              This chapter should include information on covert discoveries of anthrax, which
       would be probably be through the healthcare facilities or emergency medical services or
       public health laboratories  or departments.
              4.4 does not reflect the actions that are currently performed in response to  a
       potential biothreat event.  A credible threat assessment is performed with law
       enforcement, the FBI WMD Coordinator, and sometimes local and state public health and

   not with federal agencies.  This section should also state the importance of notification of
   the LRN lab when there is a suspicion that a sample may be collected.
          4.5 should be changed to remove names of individuals and include a title or job
   duty of the individual that can provide information for contractors with 24/7 contact

4) Chapter 5 should include current recommendations recently published  bout PPE to be
   used in responding to a biological threat event from NIOSH as well as ACIP reference
   for vaccination of first responders. I am note sure of the value of the tables in Chapter 5
   especially 5.2 and 5.3.  I don't think it adds a lot of additional information than is
   presented in the text.
 should also include information on the importance of having individuals
   involved in an anthrax response immediately communicate potential exposure to anthrax
   to physicians and other healthcare personnel. All team members and response personnel
   should also communicate this information to family members to relay to healthcare

5) Chapter 6 should include the validated ASTM sampling standard  for indoor sampling and
   outdoor use.  Also should remove the use of immunoassay from the document or make a
   stronger statement discouraging the use of these tests and clarify the use of PCR (should
   be used be for identification and not for characterization).
          In 6.1 there is information presented about evaluating packages for hazards, this
   information should be in Chapter 4, not in Chapter 6.
          In 6.2, real-time monitoring should be more clearly defined; does this refer to
   particle counters or real-time rtPCR instruments? Additionally, these types of monitors
   have not been validated.
          6.2.4 is very vague, additional information should be included.  It is unclear what
   the purpose of this section is.
          In Table 6.1, under wet wipe, 8 square feet is used, should this be inches and not
   feet? Under wet swab, laboratories are referred to  as Level A and  B. Need to define this.
   If using LRN, this is older terminology and should be removed. Should include
   references for each of the various sampling methods, not sure if all of them are validated.
          In 6.4.1, CDC and FBI have made statements that hand-held immunoassays
   should not be used.  This section should be modified to state that HHA should not be
          In 6.4.2 PCR should not be used for characterization, it can't distinguish between
   live spores and DNA from inactivated spores. This section needs to be modified to
   include a more comprehensive review of the technology and pros  and cons. Some of the
   terminology is not used correctly.

6) Chapter 9 should include communications and outreach to underserved and special needs
   populations, workplace preparedness etc. These types of strategies  should also include
   testing of communications such as with pre and post-tests, surveys,  focus groups.
   Communications need to be created in multiple languages and can't just be information
   to be distributed but these plans should contain action steps for people to take.  The
   public health community has been developing communication and outreach to multiple

       partners and should be included in the development of these communications. Many of
       these messages have already been developed in the public health community.

    7)  Appendix E, Section 5a, Laboratory Coordination should be corrected; there are several
       errors in the first paragraph.

Additional References:
       Phillip N. Price, Michael D. Sohn, Kristina S.H LaCommare and Jennifer A. Me Williams. Framework for
Evaluating Anthrax Risk in Buildings. Environ. Sci. Technoi, 2009, 43 (6), pp 1783-1787




                           Comments from Dr. David S. Ensor

       My comments are general impressions at this point.
       Unfortunately, in the defense and security world we don't have the luxury to select the
mode of attack.
       It would be helpful to the HSAC to know if other assistance documents have been or are
being developed for other biological agents. There is always the possibility that the material may
be a biological agent, but not anthrax. Much of the guidance might be similar for other
biological agents, in particular on how to manage the situation. However if no other guidance is
available on other biological agents it might be useful for the document to offer comments to
provide insights for broader application.
       Section 4.1 is based solely on the assumption that agent will be delivered as a package.  It
is probably the most popular method and the precedent set in the cases after 9/11. Perhaps, the
document should sensitize those responsible for security of the possibility that other delivery
methods are possible and offer/reference some tips for detection. The mode of attack in an
indoor space will affect the spatial distribution of agent.
       Finally, a document of this size and with the possibility of use under stressful  conditions
should have a keyword index to allow rapid search.

                         Comments from Dr. Lynda Knobeloch

Charge Question #1:  Given the intent that the BA-TAD serves as a technical assistance versus
technical methodology or resource document, what tools and strategies should be addressed in
preparing the FOSC to successfully manage and oversee the components of a response (i.e.,
characterization, decontamination, disposal, and clearance) to an intentional indoor release of B.
anthracis in industrial, commercial and residential buildings?

       Reviewer comments:  Although the federal coordinators will likely not have primary
responsibility for conducting a criminal investigation of an intentional release of anthrax, he/she
must be knowledgeable regarding this aspect of the government's response since preservation of
the crime scene, timely securing of on- and off-site evidence, and interviewing of possible
witnesses and suspects are all essential if the perpetrators are to be identified and prosecuted.
Increased screening of people leaving the area may also be necessary. The ability to do this will
require almost immediate sharing of information with the appropriate federal and local law
authorities.  The TAD should address these aspects of the initial response to an event.

 Other elements I would anticipate seeing in the TAD include:

   Strategies for securing and evacuating the building(s) involved.

       Criteria for determining the need to evacuate
                 •   At what point is this done?
                 •   When  is a threat of contamination deemed credible?
                 •   Who will be  evacuated?
                 •   How will the building be secured during the investigation and clean-up?
                 •   Who can have access to the building during the investigation.
                 •   A log of everyone in the building at time 0 and throughout the sampling
                     and clean-up period should be kept with  contact information.

   Sampling protocols should be discussed including the following topic areas:
          •   Statistically valid sampling techniques
          •   The most time and cost effective sampling methods and tools
          •   If real time monitoring methods, if available.
          •   Guidelines for the number of air, dust and/or wipe samples needed for building(s)
              of different sizes.
          •   Guidelines for the establishment of contamination versus safe zones.
          •   A listing of approved laboratories with addresses and phone numbers.
          •   PPE or prophylactic medications for workers involved in sampling and clean-up.

   Appropriate decontamination methods should be described including:
          •   The most effective decontamination methods for an indoor environment
          •   The process of disposing of contaminated furnishings, floor coverings, etc.
          •   Post-decontamination sampling protocols
          •   Criteria for re-entry

   Communication protocols should be described including how to prepare for and conduct:
          •  Briefings with local and federal officials
          •  Press interviews
          •  Communication with the affected community
          •  Appropriate use of cell phones and electronic communications
          •  Clearance of sensitive information that could impact criminal investigation

Charge Question #2:  Given the intent that the BA-TAD serves as a technical assistance versus
technical methodology or resource document, what tools and strategies should be addressed in
preparing the FOSC to successfully manage and oversee the components of a response (i.e.,
characterization, decontamination, disposal, and clearance) to an intentional outdoor or wide-
area release of B. anthracis?

   Reviewer comments: See above comments some of which  apply to both indoor and outdoor
releases.  Since  containment, confirmation, and investigation of a suspected outdoor release of B.
anthracis spores are inherently very difficult, and because these events pose a unique threat to the
general public, it is essential that the TAD provides FOSCs with a detailed and rigorous protocol
for responding to these events. The TAD should provide guidance on criteria for evacuation and
rapid establishment of safe and unsafe zones.  In addition, the TAD should describe statistically
rigorous sampling protocols, a listing of approved laboratories, and sample shipping methods.

Elements I would anticipate seeing in the TAD include:

       Threat Characterization and Analysis
                 •  Protocol for assessing a threat or report  of anthrax contamination
                 •  How is the threat verified or discounted?

       Securing and evacuating the area
                 •  Methods used to secure the site should be defined.
                 •  If a large area, such an  open shopping area or amusement park needs to be
                    secured, how is this accomplished? How is the perimeter defined?
                 •  What type of evidence  is needed to enforce an evacuation?
                 •  How will an evacuation be carried out and enforced?
                 •  Who should be evacuated?
                 •  What agency will enforce the evacuation?
                 •  Where should evacuees go if they cannot return to their homes?
                 •  What are the criteria for declaring the area safe?
                 •  Re-entry criteria should be defined in the TAD.
                 •  Who enforces an evacuation?

                 •  Protocol for statistically valid sampling  should be defined?
                 •  Can real time monitoring be done?
                 •  What sampling tools are appropriate?

                 •  How many air, soil and wipe samples are needed?
                 •  A listing of approved labs should be provided.
                 •  Can samples be combined to reduce cost and time?
                 •  PPE/prophylaxis for clean-up workers should be explained in the TAD.

       Decontamination strategies and tools.
                 •  The TAD should provide guidance on the appropriateness of
                    decontaminating prior to sampling or before sample analysis can be
                    completed. If possible, the TAD should identify the most effective
                    decontamination methods and tools for a variety of outdoor settings and
                 •  Prevention of offsite transport of BA spores should be discussed.
                    Can vehicles or personal items leave the site without being

       Disposal methods for contaminated solid and liquid waste should be
       discussed, including:
                 •  Where does the waste go?
                 •  What treatment, packaging and labeling is needed prior to disposal?

       Communication protocols should be described including how to prepare for briefings
       with local and federal officials, press interviews, business  owners, and meetings with the
       affected community.  The appropriate use of cell phones and electronic communications
       should be discussed as well as the process of protecting sensitive information that could
       compromise a criminal investigation.
Charge Question #3:  Are there worker health and safety issues, particular to B. anthmcis, this
document should address?

       Reviewer comments: Because of its ability to persist in the environment for long periods
of time and cause serious, life-threatening infections, anthrax contamination poses a unique
threat to the safety of workers.  As we learned from the 2001 event, government office workers
and mail  carriers died as a result of our inability to identify contamination in their work places
and prevent them from being exposed to bacillus spores; or to identify them as 'at risk' and
provide them with PPE and/or prophylactic antibiotics or vaccines. The TAD should provide
FOSCs with guidelines they can use to protect and track people who work in areas of suspected
or confirmed contamination and ensure their protection.  In addition to decontamination of the
workplace, worker protection can be accomplished using a combination of strategies including
re-assignment of non-essential workers to an alternative workplace, the use of PPE and
prophylactic medications by essential workers such as those involved with the investigation and
clean up, and the use of medical surveillance and screenings to ensure rapid diagnosis and
treatment of infections.

Charge Question #4:  For critical infrastructures or wide-area locations, a "zero-culturable-spore"
decontamination goal may not be achievable.  What are possible cleanup strategies for
minimizing risk to facilitate re-occupancy in industrial, commercial and residential buildings
where a "zero-culturable-spore" decontamination goal was not achieved?

       Reviewer comments: In cases where clean-up cannot provide 'zero culturable spore'
conditions, sealants and air filtration can help to prevent re-suspension of spores.  Hard surface
floors, for example, can be coated with urethane to encapsulate spores and foam caulking
products can be used to seal cracks and crevices.  HEPA vacuums can be used to clean soft
surfaces. Furnishings, floor coverings, and electronic devices that cannot be decontaminated
should be replaced. Repeated treatments with chlorine dioxide, radiation, or other approved
disinfectants should be done to reduce the spore counts to background levels.

Charge Question #5:  The FOSC would, in a B. anthracis event, be functioning within the
Incident Command System which typically includes a centralized communication structure with
specific roles and responsibilities. The BA-TAD will address the key issues pertinent to the
cleanup of environmental contamination with B. anthracis.
   •   What recommendations does the SAB-HSAC have for scientifically-sound
       communications to be included in the BA-TAD?
   •   More specifically, for the purposes of the BA-TAD, what recommendations does the
       SAB-HSAC have for the content of these communications?

   Reviewer comment:  The BA-TAD should prepare FOSCs to share as much factual
information as they have with the exception of sensitive information that is critical to a criminal
investigation or prosecution. The public and media can be expected to ask the typical Who,
What, Where, Why and When questions. In addition, they will want to know about risks to the
environment, general public, and workers and about the outcome of any testing that has been
completed. They may also have questions about disruptions of their daily activities.  The BA-
TAD should help FOSCs prepare for such questions and prevent factual errors and vague or
misleading statements. In addition,  the TAD should specify types of information that could
compromise a criminal investigation since that information may need clearance before its
release.  The TAD might provide templates for fact sheets that could quickly be amended for
specific situations.  Separate fact sheets for medical responders and the general public may be

                            Comments from Dr. Paul J. Lioy

       Dr. Lioy submitted a manuscript published on Anthrax entitled: "Mechanistic Modeling
of Emergency Events: Assessing the Impact of Hypothetical Releases of Anthrax"; S. S.
Isukapalli; P. J. Lioy; and P. G. Georgopoulos; Society for Risk Analysis, Vol. 28, No. 3, pages
723-740 (2008).  Dr. Lioy noted that this manuscript deals with a situation beyond finding a
package or letter with anthrax laden dust in an office. Dr. Lioy also noted he was puzzled that
the document received by the Committee for review was limited to a letter or package anthrax
incident.  He further noted there was limited or no information about "outdoor releases" and
response in this document.

                           Comments from Dr. L.D. McMullen

Charge Question #4

   For critical infrastructures or wide area locations, a "Zero-Culturable-Spore" (ZCS)
decontamination goal may not be achievable.

   •   What are possible cleanup strategies for minimizing risk to facilitate re-occupancy in
       industrial, commercial and residential buildings where a "ZCS" decontamination goal
       was not achieved?

   This question requests advice in two areas:  1) critical infrastructure and 2) wide-area
locations. It seems to me that the approach taken for each may be significantly different.  As
such, my discussion will be to separate them.
   Critical infrastructure may have many different definitions.  It may include health care
facilities, public safety, telecommunications, energy, water, wastewater, etc. However, for re-
occupancy were a "ZCS" decontamination goal was not achieved, the list could be narrowed to
only those facilities where there is minimal redundancy and have a significant impact on public
health. This will vary from city to city and locations within a city. In general, most health care
facilities, public safety, and energy facilities have adequate redundancy or can ration available
resources until adequate decontamination can be completed.  Telecommunications also fall into
this area with cellular technology being able to move portable facilities into a particular area
until the fixed systems are decontaminated. Wastewater treatment usually does not have
redundant facilities due to the design of gravity collection systems.  If these facilities are out of
service for a period of time, there is potential for environmental damage. However, the threat to
public health would be minimal.  The one infrastructure which is difficult to replace is drinking
water.  Many cities do not have full redundant treatment facilities at multiple locations. When a
treatment plant is lost and a city's water supply is lost or reduced significantly. Public health is
compromised not only from lack of drinking water, but as important, the movement of sanitary
wastes and fire protection. Therefore, water treatment infrastructure will need to be operated
before a "ZCS" decontamination.
   Most water treatment plants have automatic/remote control that can be remoted to a safe
location.  Critical chemical delivery can also be handled in a short period of time. However,
strategies for maintenance activities will have to be developed.  There should be a period of time
to develop this since there is normally redundancy within a water treatment plant that would
allow a period of time before a required re-entry to the plant. The more interesting question is
how to treat the water to make it safe. It does not seem reasonable to assume that this can be
done in a short time due to the resistance of the spores to normal water treatment systems.
   The second question deals with wide  area locations.  This is by far the more difficult question
to address. It seems a "washdown" with water by rain or manual washing is the approach that
can be used, but the bigger issue is what to do with all the wash water.  Due to the large volumes
and the natural runoff to streams or lakes, the major problem is the potential contamination of
source water for water treatment plants. This is the same problem as above since  normal water
treatment plants do not have the equipment to treat for B anthracis.

                            Comments from Dr. Denise Pettit

Charge Question 1: Given the intent that the BA-TAD will serve as a technical assistance
versus technical methodology or resource document, what tools and strategies should be
addressed in preparing the Federal On-Scene Coordinator (FOSC) to successfully manage and
oversee the components of a response (i.e. characterization, decontamination, disposal, and
clearance) to an intentional indoor release of Bacillus anthracis in industrial, commercial and
residential buildings?

    1)  A description of each of the federal agencies' roles and responsibilities during an
       intentional or accidental release of B. anthracis would be useful. Since multiple agencies
       are involved with supporting the response to an environmental release, it is important for
       the FOSC to have a clear understanding of each parties' responsibility.  I have attached
       an Interagency Consortium of Laboratory Networks (ICLN) Responsibility matrix that
       may be useful with regard to laboratory testing.
    2)  The document focuses on one specific type of scenario, a small scale release such as a
       suspicious powder. Other scenarios such as a wide-scale release or contamination of
       drinking water would require a significantly different response. Therefore, incorporation
       of a variety of scenarios will better prepare the FOSC.
    3)  It would be helpful for the document to contain regulatory information pertinent to the
       response. Examples are listed below.  Since these regulations are often subject to change,
       web address references would be useful to ensure that accurate information and up-to-
       date information is used during an emergency.
          a.  Chain-of-custody procedures and forms: The  ICLN has a universal Chain-of-
              Custody form in it's document library. This document may have utility since
              collected samples will likely be analyzed by a member laboratory.
          b.  Select Agent Program guidance (http://www.selectagents.gov/). The shipment of
              samples that are highly likely to contain B. anthracis should be sent to a
              laboratory that is authorized to possess B. anthracis.
          c.  Shipping and Packaging regulation information: The shipment of potentially
              infectious materials is regulated. The following are websites were information
              can be obtained:
                  i. Current Guidelines http://www.asm.org/policy/index.asp?bid=6342
                 ii. Packing and Shipping Guidelines
                    http ://www. asm. org/ASM/files/LeftMarginHeaderLi st/DOWNLO ADFIL
                iii. FEDEXwww.fedex.com
                iv. Dangerous Goods Shipping

    4)  It may be helpful to have the document organized in a manner what would reflect the
       activities that are specific to each phase of a response. Three phases could be utilized:
          a.  Monitoring/surveillance (Detection)
          b.  Incident response (Characterization)
          c.  Remediation

5) The incorporation of sampling guidance may be useful in that it could prevent the
   inappropriate collection of samples and may help the FOSC to more appropriately direct
6) Sampling references that may be useful:
       a.  Beecher, Douglas. Aug 2006.  Forensic Application of Microbiological Culture
          Analysis To Identify Mail Intentionally Contaminated with Bacillus anthracis
          Spores.  Appl Environ Microbiol 72(8): 5304-10.
       b.  ASTM E2458-06 Standard Practices for Bulk Sample Collection and Swab
          Sample Collection of Visible Powders Suspected of Being Biological Agents
          from Nonporous Surfaces.
       c.  Emanuel, Peter. 2008. Sampling for Biological Agents n the Environment. ASM
       d.  ICLN has a sampling guidance in their document library. This may be of value as
7) It may be useful to incorporate the Point-of-Contact (POC) for various laboratory
   networks should be incorporated into the document. The ICLN has a POC for each of the
   networks. This would allow the FOSC to quickly identify resources that are in close
   proximity to the event. The Laboratory Response Network (LRN), the Environmental
   Response Laboratory Network (eRLN), and DoD labs would likely be involved in all
   scenarios. Therefore, incorporation of POCs for these labs may be a priority.
8) Biosafety information should be included in the plan to address the following:
       a.  A medical surveillance plan for those participating in investigations on- site.  The
          plan should include signs and symptoms for inhalational, cutaneous, and
          gastrointestinal anthrax and should include information about prophylaxis,
          treatment, and vaccination recommendations.
       b.  A template for workers to record symptoms for inhalational, cutaneous and
          gastrointestinal anthrax may be  a useful tool.
9) It may be useful to have a chapter that provides examples of Drills and Exercises that can
   be performed to assess the plan.
10) It may be helpful for the document to include  a question/answer section. This section
   could provide a list of historical questions/answers that the EPA has had to address in
   similar events.  For example: "When will the building be safe to reenter?"

White: capability is/can be established within Department.
Green: capability in place through agreements.
Yellow: capability not in place, agreements needed.
Caveat: Capacity includes both screening and
confirmatory analyses. Gaps in capacity,
particularly for confirmatory analysis, still exist.
                                               •  RFAs have been identified at
                                                 Department  level
                                               •  Identified agency responsible
                                                 for ensuring capability exists,
                                                 though actual capability may
                                                 exist in another Department
                                               •  MOAs/MOUs are required to
                                                 clarify supporting agency roles
                                                 and commitments to RFAs

                                             White: capability is/can be established w/in Department.
                                             Green: capability in place through agreements.
                                             Yellow: capability not in place, agreements needed.
                                                   Caveat: Capacity includes both screening and
                                                   confirmatory analyses. Gaps in capacity,
                                                   particularly for confirmatory analysis, still exist.

                           Comments from Dr. James Rogers

Chapter 4.1
       The early sections focus on letters/packages as the delivery vehicle, and that is
understandable. However, there should be direction as to how to handle different types of
delivery methods, or references to information on these (What about water, food,  spills,
environmental contamination), especially since other types of materials that can be intentionally
contaminated or involved in an incident are referred to later in the document.
       I would think that the sequestering of those exposed should occur very early in the
process (not wait until 4.6). That way you control their movement, reduce possible subsequent
exposure and can treat all at once.  And I might have missed it, but what about a decon line for
exposed personnel?

Chapter 4.2
       Most facilities have an evacuation plan in place, so it may be best to let the building
security handle this. Also, shouldn't restricting access and shutting down HVAC, etc., occur

Chapter 6.1
       This reads as though the sampling of the "package" would always occur onsite. My
experience suggests that, once an 'all clear' occurs on whether there were explosives have been
detected, the package would be transported to some high  containment facility for  examination
and evidence collection.

Chapter 6.2.6
       Is it really possible to decontaminate 100%? Also, there are studies regarding
equivalence between commercial spore strips and Bacillus anthracis regarding decontamination.
May want to specify something here.

Chapter 6.4.1
       I believe that there are a number of studies completed regarding the utility of smart
tickets. And sample prep of environmental samples for PCR. May need to review and change
this section.  Same with 6.4.2.

Chapter 6.4.4
       LRN labs have been supplemented with the FERN labs for food testing. Are there any
for water and environmental testing? DoD/Army/Aberdeen Proving Grounds does some of this.
We may want a listing of labs that can do the testing and  what type, in addition to LRN.  The
labs would certainly appreciate an early call out to determine sample capacity so that they could
prepare or redirect/defer.

                          Comments from Dr. Daniel C. Walsh

  Purpose of document
       Page 4 of the charge says BA-TAD will be a technical resource document.  Charge
question 1 says it will be a technical assistance document and not a resource document.  The
exact usage of the document is not clear. Review against the document purpose without a clear
statement of its function is incomplete.
       There are remarkable new capabilities for reference documents like the BA-TAD. Given
the almost unparalleled value of this document under stressful field conditions, I exhort EPA to
consider use of the most advanced and cutting edge forms of document design to enable the
greatest function by the user.

  What is good about document that should be carried over to next redraft:
       Interactive elements such as links to web based documents were very useful and  should
       be expanded
   .   the bulleted and detailed treatment of incident response  action presented in the appendix.
       Reads like a 1980s document but can be modified to be  more interactive with more links
       and possibly bubble information
       inclusion of phone number for access to federal agency  support (pg 13) provides for
       immediate use
       inclusion of local health professionals on the UC
   .   template for preparing anthrax HASP: great! This approach should be used more in the
       revised document. Templates and boilerplates provide more direct value in actual
       incident response.
   .   linkage to URLs
   .   the delivery of information in the appendix appears to be more usable for responders than
       the content of the main text.  Perhaps consider use of approach in main text.

What may be valuable to include
   .   more interactive document design using more advanced virtual technology enabling users
       in field conditions to enable a 'look up' of information needed
   .   capability to follow information down second or third tier information paths using a
       virtual capability
       search capability in an interactive mode
   .   use of phone numbers for critical contact are valuable within text.  However, all relevant
       phone numbers and other pertinent information should be coupled and printed together
       elsewhere in the report (appendix).  A directory of such  contact information for critical
       emergency response information providers would be valuable.

   1. The current report only addresses conventional attack scenario: a discrete release in a
controlled environment in a reasonably controlled manner. Complex conjunctive attacks need to

be considered and addressed in the CA-TAD revision. Current document essentially 'looks
back' at past known events but does not consider innovative forms of attack that could represent
the next generation of attack.  That new approaches will be used is the only clear pattern of past

  2. Linkage of conventional  attack, such as a blast, with anthrax release mechanisms should be
considered. Response to anthrax risk conjoined with large scale debris management in an open
space environment presents real response difficulty. In the early stage of WTC response, rumors
of anthrax mixed in the debris pile caused a short but strong reaction.  Such response work would
have been extremely difficult  if a conjunctive attack had been utilized.

  3. Consideration of conjunctive attacks that include conventional attack modes with release of

  4. The document needs to reach beyond the limited EPA response focus. EPA may be the lead
under many response scenarios but there are cases, particularly in large cities where local
resources are available and political will calls for local control.

  5. A more user compatible format to enable advice to be "pulled out" would be valuable.

  6. The report recognizes the complexity of the confluence of environmental  and public health
management performed in the context of a crime scene investigation. However, the document
itself does not elaborate beyond this statement.  The redraft should consider the ramifications of
such an endeavor. Efforts to minimize a public health threat may tamper with  evidence in the
crime scene and thus be halted by FBI. Such issues were  encountered in  the early stages of
WTC response.

  7. The difference in presentation of anthrax threats and response in this document compared to
that for anthrax in earlier documents reviewed by the committee is substantial.  The anthrax
threat to water supply posed specifically challenging identification and consequence
management scenarios. The revised document should address these identification, testing and
response to water supply threat scenarios,  or other wise refer to existing documents that provide
such information.

  8. Reported state level issues include environmental impacts, permits, worker safety,
transportation, impacts on public health (pg 22). State level issue for state (pg  22) can be
expanded to include issues like disposal

  9. The list of local level responsibilities is simplistic for the most likely attack scenario.  Listed
local level responsibility includes traffic control, public treatment facilities, utilities, building
codes and permits.  Most likely attack scenarios are larger cities where the impact will be
greatest.  Most large cities have much greater response capability (many have built this
capability since WTC) and may insist on a more advanced response role.  Many cities have
larger governments and consequent resources than many states.  There seems to be little appetite
for response scenarios that do not include federal government as the lead agency.

   10. The report seems to be limited to only the simplest attack scenario (a mail attack).  The
redraft should be more creative in anticipating attack scenarios.

   11. The report only generally addresses the immediate response of people in the affected area
and suggests that they "leave the area" (pg 24).  Some past reports reviewed by the committee
note that affected parties should be kept in the release location to minimize spread of anthrax.
Others suggest immediate evacuation. This should be addressed directly.

   12. The report indicates that local emergency responders are typically 'fire departments.' This
may be the case for small cities and towns but not for large cities where attacks may be most
likely. Many cities now have hazmat teams and sophisticated response capability.
Consequently, the revised report should consider the value that may be brought to the work of
these advanced, non-federal response teams.

   13. Suggest an anthrax certification program for sampling including establishing minimum

   14. Document states that it "may be necessary to expand HASP to protect community." (Pg
28).  There should always be a Community Air Monitoring Plan.

   15. Overly simplistic in incident prediction. There seems to be a disconnect with earlier
documents. More imagination needs to be applied to consider the threat scenarios that the
document's user may encounter.

   16. Actual  consequence management and cleanup and disposal are given less treatment here,
similar to other reports reviewed by the committee. Expansion of treatment for back end work is
valuable to improve use of document.

   17. Should there be more information for the health practitioner overseeing monitoring? I
think so (pg 34)

   18. Report reads at times like a general textbook with very general treatment of subject matter.
The report makes statements like "consideration should be given to the cost of transporting
material and the potential for spreading contamination." This is overly simplistic and has
virtually no value in its present form  (pg 68).  This is common in the document.  The redraft
should consider all statements from a user perspective and envision use in an emergency
response scenario, and build content accordingly.

   19. Not clear if there are methods to effectively detect anthrax in a complex medium, such as
those that might be posed by extensive amounts of debris in a conjunctive attack.

   20. The report stays very general.  For instance: "if needed a higher level of isolation can be
achieved with negative air pressure" is there no criteria to aid in making this determination?
Shouldn't this criteria be identified in the report so it can be used? (pg 70)

  21. Use of the document is not clear; as a text it provides general advice. As an immediate use
document, it seems fall short of providing high value to real time users.

  22. Process diagram may be helpful to describe process (example Pg 78).

  23. More virtual linkage with reference material is useful as a reference document

  24. Some areas with extra detail provide very good, detailed instruction. For example, on
page 79 the advice for shipping waste; useful details shown here. This should be accentuated in
the revision. Other areas only have vague and general references (more common).

  25. Pg 80 refers to best management practices onsite; what are they? They BMPs should be
fully defined. Perhaps a listing of all BMPs may be a useful form of an appendix.

  26. In Appendix A,  on discovery of an anthrax incident, there is no description of what the
people in the room should do? Do they leave or stay?

  27. Suggest the next version of the document be a crisper use manual for first response.  Good
info needs better user interface.

  Charge Document

  28. For response action technical assistance, breakdown of the event by actual steps is
recommended.  The more steps that are identified the more clarity of the presentation fin the
document and the easier for FOSC to search for needed information.

  29. Issues of scale of response  action must be addressed. This is most critical for large scale
and conjunctive attacks. Scale effects can include draw of a larger catchment of response
workers, including many that do not have appropriate training for job at hand, and those not
accustomed to using the proper protective equipment, and not inclined to do so. These effects
need to be addressed.

  30. There are major difficulties associated with large scale event that occur outdoors,
particularly those with infrastructure damage and large debris fields. These should be examined.
These include societal factors, such as inability to  control response frontier and the strong desire
to get the affected area back into normal use.

                         Comments from Dr. Rae Zimmerman

       This response primarily concentrates on risk communication, Charge Question #5:

       "The FOSC would, in a B. anthracis event, be functioning within the Incident Command
System which typically includes a centralized communication structure with specific roles and
responsibilities. The BA-TAD will address the key issues pertinent to the cleanup of
environmental  contamination with B. anthracis. What recommendations does the SAB-HSAC
have for scientifically-sound communications to be included in the BA-TAD? More specifically,
for the purposes of the BA-TAD, what recommendations does the SAB-HSAC have for the
content of these communications?"


       Communicating with the public is indirectly  a part of the scope of the BA-TAD and the
white paper about the revision. According to the white paper, the new BA-TAD "will be a
technical resource document developed specifically for use by FOSCs . . ." and "will not be
intended for use by a wider audience . . .  The wider audience would include ... the public (e.g.,
nearby residents; stakeholders) (White Paper, April 21-22, 2009, p. 4).  The earlier 2003/2005
TAD referred to communication with the public indirectly.  Its purpose was to provide "technical
information on a wide range of activities - initial actions when a potential release is discovered,
selection of personal protective equipment, evaluation of decontamination technologies,
communication with the public, etc." (TAD, p. 2) Its intended audience was stated as "first
responders  ... government agencies  .... and facility managers and owners..."  (TAD, p. 1). Thus,
although the general public is not indicated as an intended direct user of either document,
communication with the public by the intended audiences is at least mentioned as a primary
purpose at least indirectly.

       The comments below can be used to incorporate communication into the new BA-TAD
for the public as well as the Federal On Scene Coordinators (FOSCs) who are the major intended
users of the document. This is important, since FOSCs will at least indirectly  have to take
interactions with the public into account in their function of "managing response actions
associated with . . . release of B. anthracis," especially since the responsibilities now cover a
wide-area release.

       Communications need to be framed differently for managers, responders, various
involved professionals (health, transport, police, fire, etc.) and at least at community and
individual levels. In support of other HSAC member comments, the target of communications
should include the extremes - those who might underestimate and overestimate their exposure
and vulnerability to a particular attack - and everything in between.


  Types of Messages

       Facts about B. anthracis (abbreviated Anthrax)
       Messages for Effective Transmission
       Messages over Time and Place
       Actions People Are Expected to Take in Light of Exposures

   Message Content for each Type of Message

       1. Anthrax Facts

       People expect facts specific to the threat to be communicated. For Anthrax, these facts
can be organized along the following lines: likelihood of attacks, identification (when an attack
does occur what are the signs and how does the public know it is there), mechanisms by which
anthrax acts from release to ultimate effect, intermediate effects of exposure to anthrax, mode of
transmission to humans,  how will people know it affects them in particular and in what way,  and
what are the uncertainties in identifying individual risk (see separate uncertainty section #5

       Facts specific to Anthrax should include whether effects are dose dependant, portal of
entry (inhalation, ingestion, cutaneous), infectivity, the length of time symptoms appear for
different portals, availability and effectiveness of antedotes, etc. The CDC fact sheets are a
useful place to start as well as review articles, for example Ingleby et al. (2002):

       CDC. Fact Sheet: Anthrax Information for Health Care Providers.  Page last updated
March 8, 2002; Page last reviewed February 22, 2006.

       CDC. Division of Foodborne, Bacterial, and Mycotic Diseases (DFBMD). Anthrax. Last
Page last modified March 2008.

       2. Designing Messages and Message Content  for Effective Transmission. How people
process communications and overcoming obstacles to message transmission is a critical aspect of
communication and the science of risk communication.  Below is a list of some of the obstacles
to effective transmission of messages and some suggestions about ways to overcome them.

       a. Message is not heard:

   Failure to Hear.  This could be a function of technology, or the physical or psychological
state of the intended recipients.

   •   Draw upon more effective technology or decentralize the message transmission closer to
       the intended recipients.
   •   Where hearing impairment is suspected, special messengers would be needed.

   Failure to Listen.
   •   Incorporate attention getting efforts.  Incorporating emotion into messages has been
       known to draw people to information about risks and to seek out ways to reduce the risks.
       This was cited in connection with arsenic in drinking water (Sunstein 2003) and the
       understanding by laypersons of the effects of SARS (Lerner et al. 2003).
   •   Use messengers people will respond to.  Messengers who are trusted are considered the
       most effective. In the context of other kinds of releases, effective messengers have been
       identified as doctors for health information (Blendon et al. 2003) and meteorologists for
       dispersion of a contaminant (Henderson 2004).

   b. Message is heard, but:

   It is Misheard or Misunderstood. A case example is instructive. A clerk misheard a person
was going to be working at a nuclear power plant as saying that the person "came to blow up the
place," but the person claims he actually said that he "hoped he wouldn't blow up the place"
because of his inexperience.  The mistake resulted in the evacuation of hundreds of employees in
a nuclear power plant for several hours. (Associated Press, April 9, 2008).
   •   Provide multiple sources of information for cross-verification.

   It is Not Comprehensible.  This may occur because of language or education barriers.
   •   Tailor messages to different audiences.
   •   Message content should be translated into different languages based even on scant
       knowledge of the population in the affected area.
   •   Formulate messages in a more easily understood format with simple easy  to understand

   It is Inaudible.  This could be a technology problem.
   •   Multiple means of transmitting messages should be tapped.

   It is Ignored.
   •   As in the case of failure to listen above, attention getting mechanisms and effective
       messengers should be tapped.
   •   In addition, however, communicating the process by which discovery, deployment of
       emergency and healthcare workers, and cleanup is being undertaken is critical to getting
       and sustaining people's attention.

   3. Messages need to be staged over time since the purpose of a message changes over
time and place relative to the point of the release

   •   Prior to any attack: no easy way to anticipate an attack, etc.
   •   At the time of discovery: alert people in the vicinity of the release that something has
   •   When exposure is suspected
   •   When clear symptoms appear

   •   Those closest to the release. As studies of the World Trade Center attacks in NYC
       revealed, those closest to a release are more likely to be more stressed (Schuster et al.
       2003) and exhibit fear and risk avoidance behavior (Fischhoff et al. 2003).
   •   The "worried well"
   •   Distant onlookers
   •   Those concerned about people they know might be affected

   4. Actions Desired

   Gear messages to what you want people to do.  Identify what activities have to be done
before, during and after an attack, noting where people should go in the event of an anthrax
attack and under what conditions.  Where actions are mentioned specifically for the general
public, communications should comprehensively cover these alternative actions, and each type
of action might need a different type of communication.  One action is  evacuation.  Another
action is having individuals get to a health facility for treatment (triage center, hospital, etc.).

   Compliance with messages that are geared  toward desired actions is the subject of a
relatively large literature. Compliance tends to be associated with prior experience with similar
risks (Lichtenberg and Zimmerman 1999), trust in the messengers discussed earlier,  etc.

   5. Uncertainty

   Uncertainty is perhaps the most critical factor in risk communication, and a failure to
confront it openly and honestly can bring down any level of trust people might have had in
managers. It will  affect how people react to and their expectations about false positives and false
negatives. Some important examples of uncertainty for Anthrax organized according to the
stages in the emergence of the threat are:
   •   Detection of the agent.  Appearance of a white powder or actual symptoms has typically
       been the trigger in most instances.  Sampling uncertainty is described in  detail in the
       2003/2005 TAD (p. 42) and has to be communicated in a way that gives the public an
       understanding of imperfect knowledge  about detecting the existence of the substance.
   •   Prophylaxis and post-exposure treatment: Supplies of vaccines are limited, and not
       sufficient for civilian use; use of vaccines can have adverse side effects;  amount of time
       needed to develop an immunity is variable (2003/2005 TAD p. 24)
   •   Defining the geographic extent of the problem.

   •   Exposure. The appearance of symptoms seems to be highly variable for the various
       forms of exposure, ranging generally from 1-7 days and longer.
          o   Symptoms appear relatively quickly (in less than a day) for Cutaneous Anthrax.
          o   For inhalation anthrax it could be as long as two months (CDC fact sheet for
              health care providers).  Also, the threshold of exposure for inhalation anthrax is
              not well known: "It is not yet known how many spores cause inhalational anthrax
              or how many spores a responder may be exposed to during environmental
              sampling or decontamination activities." (2003/2005 TAD p. 24-25).
              "Experimental data indicate that viable spores may persist in the lungs for 100
              days after exposure." [this can be a factor in the timing of antibiotic use]. The
              longer it takes for symptoms appear the more difficult it is to link symptoms to a

       6.  Process. Communicating the process for the chain of activities through which anthrax
passes as it is collected, treated, etc., e.g., goes  to wastewater treatment plants, other handling
facilities needs to be communicated so people won't leave this to their imagination.

       Concepts of Risk Communication

       Communication concepts for emergency responders to use would be very useful. A basic
primer of risk communication should be contained in the report or at least guide the risk
communication procedures the report contains, including some of the basic underlying tenets of
risk communication that have been around for years. Basic risk communication principles,
perceptions that influence communication effectiveness, and the framing of messages have been
around and have been applied for decades. These should be summarized up front.  There are
many and they are interrelated. Some of the simpler ones include: trust in messengers and the
institutions is a strong determinant of who and what messages will be listened to; people tend to
misrepresent technical information, underestimating large risks and overestimating small ones,
but this can depend on the type of risk; people will personalize risks and are most concerned with
what happens to them or those close to them and less concerned about the general public; prior
experiences will shape people's perceptions of new experiences; etc.

       A number of cases occurred during and after the 2001 Anthrax incidents that have
important lessons for risk communication, and would be useful to write up in detail.

       1. Eatontown, NJ:  Two postal workers at the USPS Monmouth Processing and
Distribution Center (PDC) are hospitalized with "suspected" anthrax exposure (eventually
disproven) potentially associated with a case in Hamilton, NJ confirmed as being infected with
anthrax.       This case, specifically about suspected anthrax (Bacillus anthracis), indicates the
influence of prior events related to post 9/11 anthrax-related deaths on people's reactions,
particularly postal workers, the need to divide audiences ("communication triage"), the critical
importance of communicating uncertainties in sampling, and other aspects of communication.

       Reference: Chess, C., J. Calia, and K. M. O'Neill. 2004. Communication triage: An
anthrax case-study. Biosecurity and Bioterrorism 2, 106-111.

       2. Reported March 2005. Washington, DC. Actions precipitated by an accidental false
negative from a testing error.
       This is an account about anthrax and risk (mis)communication - its costs and
consequences, and acting on an accidental false negative. A sampling mixup "rattled the stock
market, set the White House on alert, shut three post offices in the Washington area and led to
more than 800 people being offered antibiotics"
       Reference: Scott Shane, "Anthrax Scare Is Attributed to a Testing Error," The New York
Times, March 16, 2005. http://www.nytimes.com/2005/03/16/politics/16anthrax.html

       3. Reported March 2005. Glenshaw, PA. Actions from an intentional false negative.
       State legislator falsely accuses a political adversary of putting anthrax in his mail, setting
off an investigation.
       Reference: The Associated Press, "Lawmaker Charged in an Anthrax Scare," The New
York Times, March 31, 2005. http://www.nytimes.com/2005/03/31/national/31penn.html

       The Associated Press (2005) "Lawmaker Charged in an Anthrax Scare," The New York
Times, March 31, http://www.nytimes.com/2005/03/31/national/31penn.html

       Associated Press (2008) "Misheard Comment Leads to Evacuation in Wisconsin," New
York Times, National Briefing | Midwest, April 9,
http://www.nytimes.com/2008/04/09/us/09brfs-MISHE ARDCOMM_BRF.html

       Blendon, R.J., DesRoches, C.M., Benson, J.M., Herrmann, M.J., Taylor-Clark, K.,
Weldon, K. J. (2003) "The Public and the Smallpox Threat," The New England Journal of
Medicine, Vol. 348, No. 5, pp. 426-432.

       Chess, C., J. Calia, and K. M. O'Neill. 2004. Communication triage: An anthrax case-
study. Biosecurity and Bioterrorism 2, 106-111.

       Fischhoff, B., Gonzalez, R.M., Small, D.A., Lerner, J.S. (2003b) "Judged Terror Risk and
Proximity to the World Trade Center," The Journal of Risk and Uncertainty, Vol. 26, No. 2/3,
pp. 137-151.

       Henderson, J.N., Henderson, L.C., Raskob, G.E., Boatright, D.T. (2004) "Chemical (VX)
Terrorist Threat: Public Knowledge, Attitudes, and Responses," Biosecurity and Bioterrorism:
Biodefense Strategy, Practice, and Science, Vol. 2, No. 3, pp.  224-228.

       Ingleby, T. V. et al. (2002) "Anthrax as a Biological Weapon, 2002," JAMA, 287, pp.

       Lerner, J.S., Gonzalez, R.M., Small, D.A., Fischhoff, B. (2003) "Effects of Fear and
Anger on Perceived Risks of Terrorism: A National Field Experiment," Psychological Science,
Vol. 14, No. 2, pp. 144-150.

       Lichtenberg, E., and Zimmerman, R. (1999) "Adverse Health Experiences,
Environmental Attitudes, and Pesticide Usage Behavior of Farm Operators," Risk Analysis, Vol.
19, No. 2, pp. 283-294.

       Schuster, M.A., Stein, B.D., Jaycox, L.H., Collins, R.L., Marshall, G.N., Elliott, M.N.,
Zhou, A.J., Kanouse, D.E., Morrison, J.L., Berry, S.H. (2001) "A National Survey of Stress
Reactions After the September 11, 2001, Terrorist Attacks," New England Journal of Medicine,
Vol. 345, No. 20, pp. 1507-1512.

       Shane, S. (2005) "Anthrax Scare Is Attributed to a Testing Error," The New York Times
March 16. http://www.nytimes.com/2005/03/16/politics/16anthrax.html

       Sunstein, C. (2003) "Terrorism and Probability Neglect" Journal of Risk and
Uncertainty, Vol. 26, No. 2-3, pp. 121-136.

                        Comments from Dr. Baruch Fischhoff

      Dr. Fischhoff submitted the attached "Strategic Plan for Risk Communication at the Food
and Drug Administration (FDA)" Draft: April 15, 2009, U.S. Department of Health and Human
Services, Food and Drug Administration; and "Draft Agenda, FDA Risk Communication
Advisory Committee, April 30-May 1, 2009 Meeting." Dr. Fischhoff noted these documents
reflect how another agency is addressing a related problem.

          DRAFT- April 15, 2009
     Strategic Plan for
Risk Communication at the
       Food and Drug
           Draft: April 15, 2009
  U.S. Department of Health and Human Services
       Food and Drug Administration

                      D RAFT-April 15, 2009

                       Table of Contents
Purpose	1

Background	 1

Plan At A Glance 	 3

The Evolving Role of Risk Communication	4

Defining Risk Communication for the Future	5

Underlying Principles	6

Strategic Goals	7

      Science Goal and Associated Strategies	8

      Capacity Goal and Associated Strategies	  11

      Policy Goal and Associated Strategies	  16

Conclusion	20

                           DRAFT- April 15,  2009

                          Strategic Plan for
                 Risk  Communication at the
              Food  and Drug  Administration
The purpose of this document is to describe the U.S. Food and Drug Administration's
strategy for improving how the agency communicates about regulated products.
The strategy is intended to guide program development and research planning in a
dynamic environment where rapidly evolving technologies enable patients and
consumers to become increasingly Involved in managing their health and well-being,
We define three key goal areas—policy, capacity, and science—in which  strategic
actions can  help improve how we ourselves produce communications about the risks
and benefits of regulated products, as well as how we oversee those communications
produced by regulated entities. Box 2 on page 3 summarizes these three key goal
areas and the associated strategies on which we will focus our efforts.

FDA recognizes the importance of communicating effectively about FDA-regulated products
to achieve the agency's mission of protecting and promoting the public health. Effective
communication supports both optimal use of medical products and safe consumption of
foods to maximize health. In 1999, FDA released a  report that acknowledged risk
communication as a key component in the effective management of medical product risks.1
More recently, FDA asked the Institute of Medicine  (IOM) to investigate the agency's drug
safety efforts and to recommend improvements to its existing systems. In response, the
IOM produced the report The Future of Drug Safety: Promoting and Protecting the Health of
the Public, which  it released on September 22, 2006.2 Although the report focused on drug
safety, it highlighted communication more generally, referencing FDA's mission of "helping
the public get the accurate, science-based information they need ..."3 to use FDA-regulated
products to improve health, and recommending the formation of an advisory committee on
communication (IOM Recommendation 6.1).

Although the lOM's recommendation to create a communications-focused Advisory
Committee was directed to Congress and focused primarily on medical products, FDA
independently responded by launching its  Risk Communication Advisory Committee  in 2007
to give advice about FDA's risk communication approaches for all FDA-regulated products
(Box 1). The Committee was established to advise the agency on how it could improve its
communication policies and practices, to review and evaluate relevant research, and to
1 Managing the Risks from Medical Product Use: Report to the FDA Commissioner from the Task Force on Risk
Management, FDA, May 1999.
? See http://www.iom.edu/CMS/3793/26341/37329.aspx
3 See http://www.fda.gov/opacom/morechoices/mission.htrnl

                             DRAFT- April 15, 2009
advise on implementing communication strategies consistent with the most current
At the August 2008 Advisory Committee's meeting, members voted unanimously to accept
two resolutions:
    1.  FDA should consider risk communication as a strategic function, to be considered in
       designing FDA core processes,
    2,  FDA should engage in strategic planning of its risk communication activities.

To that end,  FDA has developed a Strategic Plan for Risk Communication, which is described
in this document. FDA has the capacity to empower the public by providing medical
professionals, patients, and consumers with the useful information on FDA-regulated
products they need to take action, in the form they need it, and when they need it. The plan
presents FDA's strategies for risk communication and proposes ways to improve its science
base, its capacity for action, and its  policy processes. FDA takes the approach that  risk

    •   is integral to carrying out FDA's mission effectively
    •   involves two-way interaction
    «   must  be adapted to the various needs of the parties involved
    •   must  be evaluated to ensure  optimal effectiveness

Currently, FDA uses  various formats to reach multiple audiences, but the agency is
exploring which of those formats are most preferred and easily understood. Evolving
technologies  are making it possible for the public to access a broad variety of information
about FDA-regulated products. The agency must increasingly take advantage of these
technologies  to receive, analyze, and communicate important information, including risk and
benefit information.

The following strategy document lays out FDA's role in communicating the risks of regulated
product use,  defining risk communication anew for a 21st century in which evolving
technologies  have enabled the increasing involvement of patients and consumers in the
management of their health and well-being. The document defines the three key areas
(policy, capacity, and science), in which strategic action can help improve the generation
and regulation of risk communication about  regulated products. Finally, 14 specific
strategies are identified and explained  in detail.5
4 The Risk Communication Advisory Committee (RCAC) met three times in 2008 and is scheduled to meet four
times in 2009. For more on the RCAC, see http://www.fda.gov/oc/advisory/OCRCACACpg.html.
5 Note that the Plan provides a conceptual framework and FDA's commitment for improving the agency's risk
communication. Except for some examples of specific actions the agency has already begun, the Plan does not
provide a comprehensive listing of specific actions that the agency will take to implement the identified goals and
strategies.  Such actions will  be identified and selected as part of FDA's overall strategic planning effort by the new
administration over the coming year.

                     DRAFT- April 15, 2009
    Box 2: FDA Risk Communication Strategic Plan - At a Glance

Strengthen  the science that supports effective risk communication

Science Strategy 1: Identify gaps in key areas of risk communication knowledge and
              implementation and create a risk communication research agenda
Science Strategy 2: Evaluate the effectiveness of FDA's risk communication and related
              activities and monitor those of other stakeholders

Science Strategy 3: Translate and integrate knowledge gained through
              research/evaluation into practice

Expand FDA's capacity to generate, disseminate, and oversee
effective risk communication

Capacity Strategy 1: Streamline and coordinate more effectively the development of
              communication messages and activities
Capacity Strategy 2: Plan for crisis communications

Capacity Strategy 3: Streamline processes for conducting  communication research and
              testing, including evaluation

Capacity Strategy 4: Clarify roles and responsibilities of staff involved in drafting,
              reviewing, testing, and clearing messages
Capacity Strategy 5: Increase staff with decision and behavioral science expertise and
              involve them in communication design and message development

Capacity Strategy 6: Improve the effectiveness of FDA's Web site as a primary
              mechanism for communicating with  different stakeholders

Capacity Strategy 7: Improve two-way  communication and dissemination by
              strengthening partnerships with governmental and non-governmental

Optimize FDA's policies on communicating product risks and

Policy Strategy 1: Develop principles to guide consistent and understandable FDA
Policy Strategy 2: Identify consistent criteria for when and how to communicate
              emerging risk information
Policy Strategy 3: Re-evaluate and optimize policies for using partnerships and other
              leveraging activities to facilitate effective communication about regulated
Policy Strategy 4: Assess and improve FDA communication policies in areas  that have a
              major impact on public health

                            DRAFT- April 15, 2009

                         The Strategic Plan

The Evolving Role of FDA Risk Communication

FDA has seen its responsibilities increase exponentially in recent years as globalization,
emerging areas of science, evolving technologies, and people's growing interest in
managing their health and well-being have presented the agency with unprecedented
challenges and opportunities. These factors have enormous implications for the ways in
which the agency communicates the risks and benefits of the products it regulates.

In the past,  FDA's communication efforts were largely restricted to overseeing the key
vehicle for communicating risk information to the public—the labeling of FDA-regulated
products. The process of negotiating with product manufacturers about  changes to labeling
or decisions to recall a product was often lengthy. But as the Internet and emerging
technologies have both enabled and fed the public's demand for greater transparency and
communication  frequency, these protracted waiting periods have given  way to
communication  in real time. Thus, designing a contemporary risk communication strategy is
key to FDA's efforts to reposition itself to realize its potential for effective protection and
promotion of health, enabled by 21st century knowledge and technology.

Communicating the appropriate use of FDA-regulated products is crucial

An important facet  of FDA's risk communication strategy and mission has been educating
the public about the appropriate use of FDA-regulated products. Today,  however,  we
recognize that education involves more than ensuring the accuracy of product labeling; we
must communicate the context of the message so that  the words make  sense to the
audience. For example, in reviewing certain premarket  submissions,  FDA determines that a
product is safe and effective. But that decision is made within a specific  legal  context, which
is that the product  meets the legal  standard of safe and effective for its  labeled or intended
use—to  read either word as an absolute would be misleading. Whether the public—medical
professionals, consumers, patients, and caregivers—fully understands the ramifications of
the legal context within which approvals are made is questionable.

The public also may not understand the context within which FDA makes decisions about
whether recalls of particular foods or medical products are appropriate.  Consequently,
helping the public better understand both the product approval and recall processes would
naturally complement FDA's rigorous premarket reviews, postmarket changes to product
status and labeling, and compliance actions. Product users need to understand the closely
associated concepts of risk and benefit—as well as each person's role in  managing the risks
of using FDA-regulated products—to be able to act in an informed  manner in relation to
products coming on the market as well  as those being removed.

Equally important to understand is the natural tension that results from  communicating
what we know from research about a product's risks and benefits.  In research, scientists
collect evidence for a population: summary risks and benefits are therefore accurate for a
population in general, but may not  be so for a specific individual, who may react differently
from that expected  for the "average" individual.

                            DRAFT- April 15, 2009

Emergency-related communication is particularly challenging

Communicating during emergency events, such as with food recalls, presents unique
challenges. Over the course of a recall, as both FDA and the industry gather more
information, advice for consumers can change significantly. That change can result in
confusion. Once a recall  is over, effective communication is needed to ensure that
consumers can understand and be assured that it is once again possible to safely consume
the previously recalled product. There may be significant nutritional consequences should
consumers decide permanently to shun such products.

Defining Risk Communication for the  Future

In the past decades,  FDA's awareness has grown about the breadth of what constitutes risk
communication. This is consistent with the general growth  in acceptance of risk
communication as a broader process than one-way messaging about risks from experts to
non-experts.6 Risk communication that seeks to be effective needs to consider processes
and procedures in addition to content. In pursuit of a shared acknowledgment of how FDA
conceptualizes risk communication, a cross-FDA group of staff involved  in  communications
agreed on the below  working definition of FDA risk communication (Box 3).
                            Box 3: FDA Risk Communication is

      — Interactively sharing risk and benefit information to enable people to make informed
      judgments about use of FDA-regulated products

      — Providing guidance to relevant industries about how they can most effectively
      communicate the risks and benefits of regulated products
Risk communication is multifaceted

In the context of FDA's responsibilities, its risk communication activities fall into two broad
categories. The first relates to FDA's function as an information-generator. In this capacity,
FDA produces and disseminates its own information about regulated products to the press
and various stakeholders, including consumers, medical professionals (e.g., physicians,
nurses, physician assistants, pharmacists, veterinarians, hospital administrators, and health
plan managers), caregivers, patients, public health officials, and regulated industry. Such
information includes notices of product approvals, announcements and advisories about new
public health related information, notices of product recalls, and educational  information
about proper product use and safe food handling practices.

The second category relates to how the agency oversees what regulated industry says about
its products. Manufacturer- and producer-generated product information represents most of
what users hear about FDA-regulated products. This information makes up a large part of
what users know about a  product and is critical to ensuring that they use a product
appropriately to achieve maximal benefit. By enforcing the rules and providing useful
guidance to industry around product information  (labels, labeling, and in select cases,
 National Research Council. Improving Risk Communication, National Academy Press: Washington, DC, 1989.

                            DRAFT- April 15, 2009

product advertising) FDA can have a significant effect on  user knowledge and consequent
Risk communication conveys the potential for good and bad outcomes

Risk communication is about conveying the possibility of both bad and good outcomes. For
example, with respect to medical products, without the expectation of benefit, people are
unlikely to accept even a small amount of risk. With respect to foods, there are many
questions concerning the net value of particular foods or nutrients for addressing health
conditions. Further, in the absence of understanding that foods provide nutritional benefits,
members of the public may respond to a food product recall by stopping permanently their
use of that food or food  type. This would be an unintended bad outcome of a recall notice.
Therefore, risk communication  must involve describing both the risks and the benefits of
regulated products, including adequate  instructions to guide appropriate use.

Risk communication is a two-way street

FDA recognizes that risk communication with the public is  a two-way street. Without a
dialogue, FDA cannot learn the needs of its varied audiences or attempt to meet those
needs successfully. This concept of a two-way sharing of information is implicitly embedded
in FDA's provision of guidance to regulated industries. The government is committed to an
interactive process in policy development. Similarly, we believe the same should be true,
whenever possible, of risk communication.

Underlying this definition is the recognition that even if people are getting direct FDA
recommendations, it is ultimately an individual's personal choice to,  for example, purchase
a prescription drug and take or give it to their pet, pick the "right" food choice for their
health, use a medical device appropriately for a particular  patient, or avoid unnecessary
exposure to radiation. It is critical that individuals receive information that is adequate to
ensure that they make informed choices.

Underlying Principles

A number of underlying principles guide FDA's strategic planning and commitment to
activities that will improve  how the agency conveys the risks and the benefits of regulated
Risk communication is science-based

First, FDA has a long-standing commitment to being science-based and science-led—a
commitment that also includes risk communication activities. FDA fully supports using
scientific methods to design and assess communications that will ensure maximal
effectiveness. The science of risk communication and previous work in this area
demonstrate important ground rules.7  For example, it is crucial that the information in a
document be  both cognitively accessible8 and relevant to the target audience.
7 National Research Council. Improving Risk Communication. National Academy Press: Washington, DC, 1989;
Morgan, M.G., B. Fischhoff, A. Bostrom, & CJ. Atman. Risk Communication: A Mental Models Approach. Cambridge

                            DRAFT- April 15, 2009
However, having general ground rules is not enough. While there are general principles for
designing communications, they are not algorithms; we must still assess whether specific
messages are reaching and being understood by the various target audiences. To use an
analogy, consider how FDA assesses products like drugs. Previous work has established the
general principle that an effective drug will show a dose-response curve. The  dose for the
specific drug and its use in particular populations,  however, must still be assessed before
FDA can decide whether the drug is effective and how it should be administered. Risk
communication must be viewed similarly.

Risk-benefit information provides context and is tailored to audience needs

A second guiding principle is that for people to make informed decisions, they need to have
critical risk and benefit information available to them—and tailored to their specific needs—
when, where, and in the form needed  to best understand and apply this information.

Audiences have  different levels of understanding about the context in which they receive
information. For example, information that could be interpreted as representing a change in
FDA's position on a  product's overall value could be misleading or confusing to patients and
other members of the public. To enable informed decision making that  ensures the greatest
possible benefit  at the lowest possible personal risk, the complete information people
require may include not only objective facts about the risks and benefits of product use but,
when appropriate, facts about the risks and benefits of not using a particular  product.

Communications must address the possibility that people may react to  facts from  emerging
risk information  out of context, choosing actions that are not beneficial and may be harmful.
FDA recognizes that patients and consumers make the choices to take  particular actions.
One of FDA's essential roles is to ensure that its various audiences get  the information they
need to make informed choices. But audiences must also be given and  must understand the
context of that information or it will have little meaning. Thus, communications about
regulated products should include what is known and not known about  the product—and
perhaps even the limitations of that knowledge. Communications must  also be framed so
that audiences can  understand the decision-making process that led to the communication
and any recommendations.
Strategic Goals

The graphic below shows the three areas of strategic focus that form the foundation for
FDA's Risk Communication Strategic Plan:  science, capacity, and policy. Depicting these
three focus areas as intersecting circles illustrates that in practice they often overlap.
Separately and together they support improved risk communication. Some of the strategies
discussed later in this document contribute to two or even all three Strategic Goals.

The three overarching Strategic Goals that will help the agency develop a 21st century
communications model are as follows:
University Press: Cambridge, U.K., 2002; Wogalter, M.S., D.M. DeJoy, & K.R. Laughery. Warnings and Risk
Communication. Taylor & Francis. 1999.
8 Day, R.S. Comprehension of Prescription Drug Information: Overview of a Research Program, Proceedings of the
American Association for Artificial Intelligence, Argumentation for Consumer Healthcare. 2006

                         DRAFT- April 15, 2009
   •  Strengthen the science that supports effective risk communication
   •  Expand FDA's capacity to generate, disseminate, and oversee effective risk
   •  Optimize FDA's policies on communicating product risks and benefits
Strengthen the science that supports effective risk communication

FDA depends on the best and latest science to make regulatory decisions about
product safety and effectiveness (i.e., risks and benefits for consumers or patients).
FDA acknowledges that, to the extent possible, this same science-based approach
should guide our communications activities. The agency recognizes that time and
resources largely determine the extent to which it can apply science's lessons in the
communications arena. For example, we can't do external formative and evaluative
consumer research of every individual announcement before releasing it, but we
can incorporate more testing than we presently conduct. Although FDA has made
progress in providing the scientific support for some communications and
communications-related policy decisions, more needs to be done. Toward that end,
FDA has identified three basic strategies that should ensure more consistent
application of the scientific perspective to communication activities.

Science Strategy 1: Identify gaps in key areas of risk communication
knowledge and implementation, and work toward filling those gaps
It is apparent that many gaps remain  in our knowledge about the communication
needs of our various audiences. A few sample questions include the following.

                          DRAFT- April 15, 2009

   •  How much and what kind of information do physicians and patients need to
      make informed decisions on appropriate prescribing or use of a particular
      medical product?
   •  How much quantitative information on the risk of using a recalled food should
      FDA give the public?
   •  How much quantitative information should FDA provide or require
      manufacturers to provide about prescription drugs or medical devices?
   •  How much benefit information is needed about risk information to create a
      "balanced" perception of a medical product?
   •  What are the major motivators to persuade an individual to use nutrition
      facts labels for effective decision-making about weight management?

Furthermore, to  provide audiences with the context they need to understand FDA's
actions, especially  the degree to which FDA can take specific actions to  ensure
public safety, we need to better understand the public's knowledge of the scope of
FDA's authority.

With this in mind, a key action item under this strategy to strengthen FDA's risk
communication science is to create a prioritized risk communication research
agenda. This would have a dual purpose—to guide FDA's own decisions about the
risk communication research it should conduct and to facilitate academic and
private-sector research that explores risk communication issues of  interest to FDA.

Science Strategy 2: Evaluate the effectiveness of FDA's risk communication
and related activities and monitor those of other stakeholders

It is essential to  understand our audiences' basic needs. How do we best
communicate the facts we have so that audiences will understand and use them? In
addition, effective health and risk  communication involves conducting formative and
evaluative research. Formative testing includes initial research  into audience needs
and decision strategies around particular issues,  along with  message pre-testing.
Such steps are important to ensure that audience feedback  is incorporated so as to
maximize the efficacy of the message design  process.  In this way, initial areas of
confusion and  misinterpretation can highlight aspects of a message that require
further work. Conducting evaluative research following the use of a message or tool
is also necessary—especially if using a new approach—to determine if it has been
effective in achieving its objectives, and to  clarify whether revision  is needed.
FDA uses research to test materials

FDA's Office of Women's Health (OWH) regularly uses focus groups to test the
educational materials it issues. OWH also provides those materials in multiple
languages.9 OWH works with its dissemination partners to assess the materials'
1 See http://www.fda.gov/womens/pubs.html

                         DRAFT- April 15, 2009

effectiveness on individual beliefs and behaviors. FDA's Center for Food Safety and
Applied Nutrition has similarly evaluated educational campaigns about safe food
handling practices to ensure that communication objectives are met. Surveys of
consumer food safety knowledge, attitudes, and behavior are  regularly conducted
to help determine the effectiveness of food safety campaigns and the direction of
future education programs. But evaluation is not a consistent  practice across the
agency. FDA is committed to working toward more consistency in assessing and
evaluating its own communications.

FDA is also striving to ensure that it and regulated industries,  as appropriate,
evaluate the communications and communication-related activities conducted in
response to regulatory mandates. For example, Section 901 of the Food and Drug
Administration Amendments Act of 2007 requires evaluations  be conducted to
determine whether to modify the elements of a Risk Evaluation and Mitigation
Strategy (REMS)10 for a subset of prescription drugs with serious  risks.

As a further example of ongoing efforts, in renewed dialogue between FDA's Office
of Special Health Issues (OSHI), including  its MedWatch staff, and multiple
healthcare professional organizations, FDA asked for feedback about what their
members knew about the MedWatch program's products. The agency also asked
how to improve written communications so it could help these organizations inform
their membership about emerging risks associated with medicines and medical
devices. The information gleaned from  this dialogue is providing feedback about
success to date and is guiding FDA in improving future communications.

Science Strategy 3: Translate and integrate knowledge gained through
research/evaluation into practice

Knowledge is gained through basic research, formative testing, and message or
program evaluation. However, that knowledge has no value to any organization
unless it is packaged in a  form that can be circulated and  used by those who need
it. Having formal processes in place to disseminate research results and lessons
learned within the organization will prevent the same mistakes from recurring. FDA
is committed to ensuring that knowledge acquired through research and evaluation
will be translated so as to be useful to communication designers, effectively
disseminated, and incorporated into agency communication practices.

FDA has recently completed and is analyzing data  from  a survey of physicians about
their use and perceptions  of emerging risk information on medical products,
   •  the impact of news  about emerging risks on their patients and practices
   •  when  and how they would like to receive such information
   •  what sources  they find most trustworthy
   •  the degree to which they use electronic sources
   •  the factors that influence whether they  report medical product problems and
      adverse effects
 formerly known as Riskmaps

                          DRAFT - April 15, 2009
For this information to be useful, it must be analyzed with an eye to the needs of its
audiences—in this case, FDA staff. The information must be marketed internally and
presented in a way that will best meet the requirements of relevant staffers to help
produce communication materials that reflect this new data on stakeholders' needs.
Expand FDA's capacity to generate, disseminate, and oversee
effective risk communication

Along with obtaining the scientific knowledge needed to prepare effective risk
communications and evaluate impact, FDA must be able to apply that knowledge.
Doing this effectively and efficiently requires that the operational capacity of FDA's
communications be adequate and that the processes associated with developing
and coordinating risk communications be optimal. FDA has identified seven
strategies it believes will expand  its capacity both to generate effective risk
communication and to oversee effectively the risk communication-related activities
of regulated industries.

Capacity Strategy 1: Streamline and more effectively coordinate the
development of communication messages and activities

Risk communication-related activities take place at many levels within FDA,
including within the product-focused centers, the Office of  Regulatory Affairs, and
the Office of the Commissioner. To ensure that FDA speaks with one voice, efficient
internal and external coordination are required.  In addition to coordinating
internally and with  the Department of Health and Human Services (DHHS), FDA
often shares responsibility for dealing with certain products or addressing food-
related contaminations or outbreaks with other government agencies, including,
among others, the  Centers for Disease Control and Prevention (CDC) and the U.S.
Department of Agriculture (USDA). In these cases, seamless coordination among
the agencies increases the timeliness and consistency of communications on
identical issues.

Capacity Strategy 2: Plan for crisis communications

Many crisis communication situations—especially disease outbreaks related to food
contamination—are true emergencies in which FDA and its  partners (see Capacity
Strategy 1) must develop and disseminate communications unexpectedly, swiftly,
and often on a continual basis.  In such cases, FDA is unlikely to have thoughtfully
developed and tested messages available for a specific emergency. But the agency
can apply lessons from similar past experiences as well as  its knowledge of the
products that are most vulnerable to contamination—accidental or deliberate. FDA
can use these lessons learned to develop general procedures, tentative
communication dissemination plans,  and prototype messages for various audiences
that can be adapted to specific  circumstances.

                          DRAFT- April 15, 2009

For example, FDA is analyzing data from interviews with consumers focused on
their preparedness for a food terrorism event. The agency will use this information
to develop strategies to communicate more effectively with consumers should such
an event occur. The agency is also creating an FDA call center that will improve
how the agency handles phone calls about regulated products that are received
outside of normal business hours. In  a related move, FDA is increasing its surge
capacity for managing a larger-than-normal volume  of emergency-related calls
during and outside of normal  business hours.

Capacity Strategy 3: Streamline processes for conducting required
communication  research and testing, including evaluation

FDA is committed to:
   •  conducting and encouraging others to conduct the research and testing
      needed to develop and disseminate communications according to evidence of
      how they are likely to be encountered,  attended to, understood, and acted
      upon by target audiences
   •  evaluating the degree to which a communication process was successful in
      achieving its objectives

In fact, past FDA research has informed various communication-related initiatives,
including development of:
   •  the Nutrition Facts label for foods
   •  the Drug Facts label for nonprescription drugs
   •  format revisions to prescription drug prescribing information

FDA is conducting research on both the detailed information ("brief summary")
required for inclusion in  prescription drug advertising directed to consumers, and on
how consumers interpret various statements on the front-panel display of food
labels. However, this research often takes years to develop and implement. FDA is
committed to streamlining the required processes for moving research projects
from conception to implementation so as to make these processes as efficient as

Producing effective communications requires that initial drafts be tested, preferably
with target audience members. This enables drafters to determine whether the
communication is meeting its objectives and whether there are likely to be
unintended negative effects. However, the lengthy process needed to  gain approval
for conducting research and testing can make it difficult to test communications
with more than nine11 members of the public in the time needed for rapid
communication, especially about emerging risks of regulated  products.
11 Requirements of the Paperwork Reduction Act of 1990 include the need to seek public comment and clearance
from the Office of Management and Budget when information is collected from more than nine members of the

                          DRAFT - April 15, 2009

Piloting message testing using government employees as public surrogates

Streamlining processes as much as possible is one part of this  solution. Another
part relates to FDA's policies (see also Policy Strategy 3). While FDA moves toward
these improvements, it is also piloting the feasibility of using government
employees as public surrogates to informally test messages and communication
formats before issuing messages, especially when it is critical to communicate
quickly with the public.

FDA recognizes that, scientifically, this is not an ideal solution because these
employees may not be completely representative of the agency's target audiences.
However, this approach is much more readily implemented than an external study
and allows testing prior to making the message public. There are many employees
who could be reasonable surrogates for different members of the public on a given
topic because their work lies in areas significantly different from that topic.
Additionally, using employees allows testing messages that could be difficult to test
with the  public because the information is confidential.

Capacity Strategy 4: Clarify roles and responsibilities of staff involved in
drafting, reviewing, testing, and clearing messages

Within FDA, there is a need for greater clarity about who in the communications
review chain is responsible for determining that an information piece has been
sufficiently refined for a particular target audience. FDA's messages about regulated
products are scrupulously reviewed by staff members with different types of
expertise. Depending on the product and issue, reviewers may include physicians,
pharmacists, biologists, chemists, pharmacologists, nutritionists, engineers,
communications professionals,  attorneys, compliance officers, and policy analysts.

Although the targeted audience is often patients or caregivers, it is uncommon  for
anyone from that target audience to be included in the review chain. Consequently,
messages initially designed to communicate a simple point can grow excessively
lengthy and complex. Expert staffers want to ensure that the message is
scientifically and legally precise but stakeholders have frequently told FDA that the
resulting messages are too complicated and not easily understood by non-

FDA also believes that it can improve the internal  review process by raising
reviewers' awareness about factors that must be explicitly balanced for the best
communications results. For example, reviewers could be further educated to
consider  the needs of certain vulnerable populations, including  those with limited
English proficiency, health literacy,  or limited ability to understand and use
numbers (numeracy).

Reviewers can also be educated to weigh the benefits of including highly detailed
information that provides greater precision  against the increased likelihood of
information overload. A shorter, more focused message may not address an issue's
every nuance, but it ensures that a  less literate audience will be able to understand

                          DRAFT-April 15, 2009

critical messages and recommendations. Tiering the information—providing a
shorter and simpler message first, followed by additional detailed information for
those who want it—may help achieve a balance in these competing but worthy

Capacity Strategy 5: Increase staff with decision and behavioral science
expertise and involve them in communication design and message

As a result of the issues discussed in previous sections, producing effective FDA risk
communications and ensuring that regulated  industries produce effective risk
communications have become  increasingly important  FDA functions. Fischhoff12
asserts that effective risk communication requires the contribution of four types of
   •  domain specialists
   •  risk and decision analysis specialists
   •  behavioral science specialists
   •  systems specialists

Applying this  framework to FDA staffing, it is clear that the agency has many
domain specialists—individuals with expertise in medical and physical sciences who
understand the risks and benefits data that need to be communicated to product
users.  But FDA  is not well staffed with  the risk and decision analysts needed to
identify the information that is necessary to user choices. Nor is it well-staffed with
the behavioral scientists it needs to design and evaluate messages. Finally, while
communications systems specialists are somewhat better represented within FDA,
more are needed to create and use communication channels more effectively.

Capacity Strategy 6: Improve the effectiveness of FDA's Web site as a
primary mechanism for  communicating with different stakeholders

FDA's Internet Web site is  a primary vehicle for communicating with the  public—
both directly and through the press. This is especially  so when FDA is conveying
information about new and potentially  uncertain or emerging risk information,
product recalls and warnings with significant public health consequences. FDA's
Web site provides a wealth of information about:
   •  how products are reviewed
   •  how product quality is monitored
   •  the myriad regulatory and policy actions the agency takes
   •  how external advice has been given to  FDA
   •  how FDA takes advice into account when it acts

However, the volume of information provided itself has a downside. In December
2005, FDA held a public hearing about the effectiveness of the agency's risk
communication  strategies for human drugs. Stakeholders told FDA that its drug-
related Web information  is difficult to navigate and needs to be redesigned to make
12 Presentation to Risk Communication Advisory Committee Meeting, August 14, 2008. See slide 10 at

                          DRAFT- April 15, 2009

it "more accessible and user-friendly as well as to address specific health concerns
of patients, caregivers, and healthcare professionals."13

FDA is preparing to launch a Web Content Management System that will improve
the timeliness, ease of navigation, usefulness, and usability of its Web materials. As
part of this modernization effort, FDA is also removing outdated, extraneous, and
unused materials. The agency has also begun  making changes to its Web site to
improve its information architecture.

In addition, FDA recognizes its need to explore the variety of electronic tools that
fall under the broad scope of the Internet. The agency already uses email
distribution lists, RSS feeds, podcasts, widgets, and other tools when appropriate
for a particular communication purpose.  However, the always-expanding supply of
new tools highlights the need for constant vigilance in assessing  the potential value
of these tools for improved  communication.

Forming Web partnerships to broaden  FDA information distribution

The agency has begun forming partnerships with  organizations to maximize the
distribution of FDA's information. It recognizes the current limitations of its Web
site and that many stakeholders access other sites more frequently than FDA's.
Thus, in early December 2008, FDA announced a  formal partnership arrangement
with WebMD, which will make consumer health information associated with FDA-
regulated products more accessible by having  an  FDA-focused Web page on
WebMD's site.14 The agency is pursuing other  partnership arrangements, including
with the CDC, to examine the value of social media and networking tools to
communicate time-sensitive product information expeditiously.

Capacity Strategy 7: Improve two-way communication  and dissemination
through enhanced partnering with government and nongovernment

At the December 2005 public hearing on the effectiveness of  FDA's risk
communication strategies for human drugs, some participants commented that the
agency should "concentrate on its traditional role  of providing benefit-risk
information to healthcare practitioners that would improve patient dialogue."
Participants also  advised FDA to target specific specialties and work closely with
those groups to "optimize education in risk communication."15
Improving relationships with medical professionals

FDA acknowledges that ensuring continual dialogue with medical professionals is
crucial. In fact, within the past few years, FDA has reestablished its efforts to
develop and maintain productive relationships with medical and pharmacy
13 See http://www.fda.aov/cder/meetinQ/RiskComm2005/sumrnarv.pdf.
14 See http://www.webmd.com/fda
15 See http://www.fda.gov/cder/meetinQ/RiskComm2005/summarv.Ddf.

                         DRAFT- April 15, 2009

professional organizations, and is committed to continuing this approach. The Office
of Special Health Issues (OSHI) and the MedWatch staff are working with several
organizations to devise a mechanism for targeting MedWatch safety alerts and
monthly notices of changes to the safety labeling of prescription drugs to a
subscriber subset who wish to receive selected notices. Through OSHI, FDA is
working with the American Medical  Association to develop an "FDA Specialty
Network." Among other things, this network would  target particular medical
specialties for two-way communication. OSHI is planning to pilot targeted
messaging with the American Academy of Clinical Endocrinologists, a member of
the Specialty Network.
Improving relationships with other government stakeholders

FDA also recognizes that it needs to establish and continue to improve working
relationships with other government agency stakeholders like CDC, USDA, the
Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare &
Medicaid Services (CMS), the Department of Defense (DoD), the Department of
Homeland Security (DHS), and the Veteran's Administration (VA).

Sharing early information with other stakeholders should make working
relationships more effective and place greater value on collaboration.  FDA has
already established Memoranda of Understanding with DoD and VA to improve
communication with these organizations, which  have information about and
responsibility for large numbers of patients. The agency's Planning Office's Risk
Communication Staff has also set up regular teleconferences with regulatory and
communications officials from Health Canada to improve coordination  of strategic
risk communication.

FDA and  the foods industry, through a  non-profit consortium, have collaborated
successfully on joint education efforts.  This collaboration represents another type of
partnership that FDA aims to advance.  Along with USDA and CDC, FDA is a member
of the Partnership for Food Safety Education, which also includes the Food
Marketing Institute, the Grocery Manufacturers Association,  and other industry
groups. This not-for-profit organization is the steward of the "Fight Bac" campaign
that is  designed to keep food safe from harmful bacteria through public education
about safe food handling practices.
Optimize FDA's policies on communicating product risks and benefits

The third strategic goal focuses on FDA's policies on risk communication. Applying
the results of the science goal strategies and implementing some of the capacity
strategies requires streamlining internal and externally focused FDA policies. Three
strategies under the policy goal target internal policies around FDA-generated risk
communications. The fourth strategy targets policies associated with  risk
communications that FDA oversees.

                          DRAFT- April 15, 2009

Policy Strategy 1: Develop principles to guide consistent and easily
understood FDA communications

Risk communications would be better understood and applied if internal policies
were established specifying the kind of information that should be consistently
included. For example, FDA's Risk Communication Advisory Committee has
repeatedly recommended that FDA's risk communications include both product
benefit and risk information, presented to the extent possible in quantitative

Additionally, some Committee members  have noted the need to ensure that the
public understands fully the context of approvals and recalls. For example, risk
communications about approved products may at times need to state clearly that
efficacy and risk information was established only  for the product's intended use(s)
and  might not apply if someone uses it in another way.  FDA also may need to
address how to improve public understanding of the limits of FDA's authority, at
least to the extent it is relevant to informed decision-making about regulated
products (see also the discussion in  Science Strategy 1).

Based on the information from literature, testing, and basic research, other
evidence-based principles for communication documents could address the
   •  When to include the risks and benefits of not using particular products
      associated with emerging risks.
   •  How to ensure that lower literacy  audiences are given only essential
   •  How tiering or layering messages  can improve communication of critical
   •  How to ensure the clarity of product use recommendations.
   •  How people can get additional risk communication/information.

Policy Strategy 2: Identify consistent criteria for when and how to
communicate emerging risk information

Although FDA has moved toward communicating earlier and more transparently
about emerging risks of regulated products, particularly medical products, it does
not have a comprehensive, science-based set of principles about when and how to
communicate this information.16 Therefore, the criteria that FDA uses to determine
when to communicate about regulated products are likely to be unclear to the
public. Additionally, FDA uses different types of communications to address
emerging risks for different types of regulated products. Issuing multiple
documents with similar purposes can be  confusing for stakeholders. To avoid this,
  Emerging risks of medical products refers to information about potential product risks that is still
uncertain - that is, there is either not yet a full analysis or a clear confirmation that a specific
identified risk is associated with the product in question.

                          DRAFT - April 15, 2009

the agency must clarify, both internally and externally, when and how it will
communicate about emerging risks of FDA-regulated products, and how to
standardize communication formats.

Policy Strategy 3: Re-evaluate and optimize policies for using  partnerships
and other leveraging activities to facilitate effective communication about
regulated products

It is generally accepted that critical communications should be tested prior to use
with the intended target audience. However, as discussed earlier, this process is
often time-consuming and therefore may not be feasible for crisis situations. As
Capacity Strategy 7 notes, FDA is committed to partnering with both  governmental
and  nongovernmental entities to improve the value and reach of its risk
communications. In addition to creating a more effective interactive risk
communication environment, sharing messages before issuance with organizations
representing critical stakeholders (especially when the target audience  is medical
professionals) could provide some timely feedback. However, FDA's policies on
confidentiality, ethics, and other considerations require that  acceptable parameters
be established for such interactions.

Policy Strategy 4: Assess and improve FDA communication policies in areas
of high public health impact

FDA recognizes the need to consider how to optimize policies on  its oversight of the
communications of regulated industries. This is especially critical when  industry
communications deal with issues that have a major public health impact. Some of
the areas that FDA is currently examining are listed below.

-  Modernize effective communication in a recall. FDA  issues some
   communications on recalls. However, product  manufacturers have the primary
   responsibility for most of the notices and for follow-up with wholesalers or
   retailers to decide whether recall activities are addressing the particular safety
   issue satisfactorily. FDA  is examining the impact of a recent food recall and will
   investigate the degree to which, if at all, new social media tools that FDA and
   CDC used  contributed to the recall's outcome. This investigation's results  could
   have implications for how FDA asks regulated  industry to act in future food

-  Ensure that patients get useful written information about the
   prescription drugs they use. On the basis of a congressionally mandated
   study, FDA recently determined that private-sector efforts have not  succeeded
   in meeting congressionally mandated goals to ensure that patients filling new
   prescriptions get useful written information on the  drugs they are  given.17 The
   failure of these efforts allows FDA to examine and potentially take regulatory
   action to ensure that patients get this information.
  See http://www.fda.gov/cder/news/CMI/default.htm

                       DRAFT- April 15, 2009

However, the combination of private sector-produced information and increasing
numbers of manufacturer-drafted, FDA-approved information (Medication Guides
and Patient Package Inserts) has created a potentially bewildering array of
written information  for patients—multiple formats, inconsistently distributed.
Various stakeholders have noted that the excess of information and inconsistent
content and formats could confuse patients and lead  to error. Consequently,
FDA is revisiting the current approach to the content and format of written
prescription drug information provided to patients. It is evaluating how  best to
ensure that patients getting prescription drugs (including biologies) receive the
information they need, in an optimal form and format, to use products with
maximal benefit and minimal risk.

Ensure that medical professionals get useful information about FDA-
regulated products  when and in the form  they need it. Historically, FDA
has focused on communicating with medical professionals about medical
products. As well as having primary responsibility for using  significant medical
devices and animal  drugs, these professionals  have the most influence on the
decisions that  patients make about product use, especially drug and certain
device use, and the decisions that consumers make about human and animal
nonprescription drug use. As Capacity Strategy 7 describes, FDA has recently
devoted additional resources to re-establishing and maintaining relationships
with medical and pharmacy professional groups. Part of that effort has involved
looking at how FDA  can better  provide more effective two-way communication
with these professionals. The agency is also seeking opportunities to work with
them  to make  available information that professionals need at the time  of
clinical decision-making.

Modernize the regulation of prescription drug promotion. FDA regulates
both advertisements and labeling (including approved prescribing information
and promotional materials like  mailed literature, brochures, scientific study
reprints, videos, and press releases) for prescription drugs and biologies. The
current regulations were developed when such promotional  materials were only
directed to  medical  professionals, and may create confusion when applied to
consumer-directed advertising. For example, these regulations require that FDA
enforce regulatory distinctions  in information disclosure between the two
categories of promotional materials (advertisements versus labeling), even
though such distinctions are not meaningful to a targeted consumer audience.

Other regulations require that FDA enforce identical information disclosure
requirements within each promotional material category (ads and labeling),
regardless of whether the target audience is medical  professionals or
consumers. The result is that consumer-directed advertisements generally
include highly technical information that can be difficult to sort through.

In recent years, FDA has researched  and solicited public comment on consumer-
directed prescription drug advertisements. It has issued guidance (some draft
and some final) on how advertisements directed to consumers can provide
information in  language that is  more easily understood  by this audience and still

                         DRAFT- April 15, 2009

   meet regulatory requirements. In light of direction from the Food and Drug
   Administration Amendments Act of 2007, research data, and public comment,
   FDA is  proactively developing additional guidance and devising regulations that
   will further address these communication issues to better meet the needs of
   consumers and medical professionals, and provide greater clarity for industry.

FDA considers risk communication as a strategic activity. To this end, the agency
must address its audiences' needs more effectively in planning and implementing
its own risk communications for regulated products and in its oversight of regulated
industry communications. The agency has identified the areas in which it needs to
improve and has begun:
   •  enhancing the science behind FDA risk communication
   •  expanding the agency's capacity to generate, disseminate, and oversee risk
      communication about regulated products
   •  optimizing its policies on communicating product risks and  benefits

These actions will help FDA  achieve its goals of improved public health and safety
through increasing the appropriate use of regulated products.

              FDA Risk Communication Advisory Committee
                Location: 5630 Fishers Lane, Room 1066, Rockville, MD
                                April 30-May 1, 2009
                                AGENDA (DRAFT)
April 30. 2009
 8:00 Call to Order
 8:05 Conflict of Interest Statement - Designated Federal Officer
 8:10 Introductions of Committee Members

 8:30 Introductory Remarks
      Baruch Fischhoff, Ph.D - Objective of meeting

 8:45 Strategic Planning at FDA
      Malcolm J. Bertoni, M.S., Assistant Commissioner for Planning
            Member Questions/Answers

10:00 Break

10:15 Goal:  Expand FDA's Capacity to Generate and Oversee Risk Communication
      Susan C. Winckler, RPh, Esq., Chief of Staff
            Member Questions/Answers

      Discussion of Capacity Goal and associated FDA Discussion Topics

12:00 Lunch

1:00  Open  Public Hearing

2:00  Goal:  Optimize FDA's  Policies on Communicating Product Risks and Benefits
      Jeffrey Shuren,  M.D., J.D., Associate Commissioner for Policy and Planning
            Member Questions/Answers

      Discussion of Policy Goal and associated FDA Discussion Topics

3:15  Break

3:30  Goal: Strengthen the Science Supporting Effective Risk Communication
      Nancy M. Ostrove, Ph.D., Director for Risk Communication
            Member Questions/Answers

      Perspective: Select Models for Conducting Research Needed  by Government
      Baruch Fischhoff, Ph.D., Professor, Carnegie Mellon University
            Member Questions/Answers

      Discussion of Science Goal and associated FDA Discussion Topics

5:00  Adjourn for the day

May 1.2009

 8:00  Call to Order
 8:05  Conflict of Interest Statement - Designated Federal Officer
 8:10  Introductions of Committee Members

 8:20  Prioritization of Risk Communication Research
      Nancy M. Ostrove, Ph.D., Director for Risk Communication

      Member Questions/Answers and Discussion

10:15 Break

10:30 Open Public Hearing

11:30 Lunch

12:30 Summarize what has emerged from discussion regarding FDA discussion topics

 2:30  Adjourn

            Enclosure 3: EPA Charge Questions to the Panel
SUBJECT:   Consultation on the Development of the Environmental Response
             Technical Assistance Document For Bacillus anthracis Intentional
             Releases (BA-TAD)

FROM:      Deborah Y. Dietrich, Director /signedMarch 24, 2009/
             Office of Emergency Management

TO:         Vanessa Vu, Director
             Science Advisory Board Staff Office
This is to request that the Science Advisory Board (SAB) Homeland Security Advisory
Committee (HSAC) conduct a consultation of the attached White Paper entitled "The
Development of the Environmental Response Technical Assistance Document
for Bacillus anthracis Intentional Releases (BA-TAD)".


The EPA-chaired National Response Team (NRT) comprises 18 federal agencies that
have major responsibilities for environmental protection, transportation, emergency
management, worker safety, and public health.  The Clean Water Act (CWA) provides
the authority for the establishment of the National Response System, which contains the
NRT,  Regional Response Teams (RRTs), and Federal and State On-Scene Coordinators
(OSCs). The NRT may consider and make recommendations to agencies on the training,
equipping and protection of response teams and necessary research, development,
demonstration and evaluation to improve response capabilities.

In response to the 2001 Bacillus anthracis incidents in Washington, the Weapons of Mass
Destruction (WMD) Subcommittee of the Science and Technology Committee of the
NRT developed an interim-final draft Technical Assistance Document (TAD) in 2003 for
responses to an actual or suspected terrorist release of Bacillus anthracis. In July 2005,
the NRT slightly revised the interim-final draft TAD (2003/2005 TAD).

In 2007, the NRT tasked the WMD Subcommittee with updating the 2003/2005 TAD.
The updated 2003/2005 TAD will have a new title:  Environmental Response Technical
Assistance Document for Bacillus anthracis Intentional Releases (BA-TAD). The WMD
Subcommittee conducted a chapter by chapter review of the 2003/2005 TAD to
determine what information was still accurate, what needed updating and if there were
any data gaps. A brief summary of the content of the 2003/2005 TAD chapters and the

approach the WMD Subcommittee plans for the BA-TAD is outlined in the attached
White Paper.

The NRT requested that EPA's Office of Emergency Response (OEM) seek consultative
advice from the SAB HSAC on the WMD Subcommittee's development of the BA-TAD.

The SAB HSAC held a teleconference on October 15, 2008 and was briefed by the EPA
and its partners on its progress in developing the draft BA-TAD. A Federal Register
Notice dated September 29, 2008 (73 FR 56578-56579) announced this teleconference
and provided background information on this advisory activity.

Following the teleconference on October 15, Dr. Baruch Fischhoff, Chair of the SAB
HSAC, sent a letter to Stephen L. Johnson, then EPA Administrator, dated November 5,
2008. In his memorandum Dr. Fischhoff thanked the Office of Solid Waste and
Emergency Response for seeking SAB input on the TAD. However, Dr. Fischhoff also
expressed his concern that the Agency is not focusing on the critical issue of risk
communication, citing a lack of systematic, scientific attention to communicating with
the public.  He asked that the anthrax task force clearly define the centrality of
communication to the execution of the technical activities described in the TAD and
demand the investment in scientifically sound communication. To respond to Dr.
Fischhoff s concern, the workgroup has added a specific charge to the SAB (see No. 5
below) to seek input on scientifically sound communication which would be appropriate
for this document.

Specific Request

OSWER and the WMD subcommittee request that HSAC provide advice on whether the
attached plans to prepare the BA-TAD are properly directed, and if there are any items,
issues or practical  applications that have not been considered that ought to be included
within the BA-TAD. The WMD subcommittee expects the HSAC will bring a broader
scientific perspective to the BA-TAD document. In addition, the revision is at a stage
where input from the HSAC will be most beneficial. We thank you in advance for your
participation in this important project.

  Consult Charge Questions

1.  Given the intent that the BA-TAD will serve as a technical assistance versus technical
   methodology or resource document, what tools and strategies should be addressed in
   preparing the Federal On-Scene Coordinator (FOSC) to successfully manage and
   oversee the components of a response (i.e., characterization, decontamination,
   disposal, and clearance) to an intentional indoor release of Bacillus anthracis in
   industrial, commercial and residential buildings?

2.  Given the intent that the BA-TAD will serve as a technical assistance versus technical
   methodology or resource document, what tools and strategies should be addressed in
   preparing the FOSC to successfully manage and oversee the components of a

   response (i.e., characterization, decontamination, disposal, and clearance) to an
   intentional wide-area outdoor release of Bacillus anthracis?

3.  Are there worker health and safety issues, particular to Bacillus anthracis, the BA-
   TAD should address?

4.  For critical infrastructures or wide-area locations, a "zero-culturable-spore"
   decontamination goal may not be achievable. What are possible cleanup strategies
   for minimizing risk to facilitate re-occupancy in industrial, commercial and
   residential buildings where a "zero-culturable-spore" decontamination goal was not

5.  The FOSC would, in a Bacillus anthracis event, be functioning within the Incident
   Command System which typically includes a centralized communication structure
   with specific roles and responsibilities. The BA-TAD will address the key issues
   pertinent to the cleanup of environmental contamination with Bacillus anthracis.
   What recommendations does the SAB-HSAC have for scientifically-sound
   communications to be included in the BA-TAD? More specifically, for the purposes
   of the BA-TAD, what recommendations  does the SAB-HSAC have for the content of
   these communications?

If you have any questions about this request, please contact Captain Colleen Petullo, U.S.
Public Health Service, permanently assigned to EPA, at petullo.colleen@epa.gov or
(702) 784-8004.