UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

 WASHINGTON D.C. 20460 

OFFICE OF THE ADMINISTRATOR 

SCIENCE ADVISORY BOARD 

 May 28, 2009 

EPA-SAB-09-014 

The Honorable Lisa P. Jackson 

Administrator 

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 crosscontamination; and (e) the wide-area situation that the revised draft BA-TAD aims to 

1
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. 

2
 

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. 

Sincerely, 

/Signed/ 

Dr. Baruch Fischhoff, Chair 

Homeland Security Advisory Committee 

cc: Dr. Deborah L. Swackhamer 

Chair, Science Advisory Board 

Enclosures: 

Enclosure 1: Committee Roster 

Enclosure 2: Individual Comments from Committee Members 

Enclosure 3: EPA Charge Questions to the Panel 

3
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 

CHAIR 

Dr. Baruch Fischhoff, Howard Heinz University Professor, Department of Social and Decision 

Sciences, Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh, 

PA 

MEMBERS 

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

CO 

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, 

IA 

**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, 

TN 

4
*Dr. Daniel C. Walsh, Adjunct Professor at Lamont 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 

CONSULTANTS 

*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 

SCIENCE ADVISORY BOARD STAFF 

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 

5
 

 

__________________________________________________________________ 

 

 

 

 

 

Enclosure 2: Individual Comments from Committee Members 

Dr. John Bartlett................ 

Dr. Vicki Bier................... 

Dr. Mary Durfee................ 

Dr. Christina Egan.............. 

Dr. David S. Ensor.............. 

Dr. Lynda Knobeloch.......... 

Dr. Paul J. Lioy................. 

Dr. L.D. McMullen............. 

Dr. Denise Pettit ............... 

Dr. James Rogers............... 

Dr. Daniel C. Walsh............ 

Dr. Rae Zimmerman............ 

Dr. Baruch Fischhoff........... 

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...................... 

“Draft Agenda, FDA Risk 

Communication Advisory 

Committee, April 30-May 1, 

2009 Meeting” ..................... 

Page 7 

Page 10 

Page 11 

Page 13 

Page 18 

Page 19 

Page 23 

Page 24 

Page 25 

Page 28 

Page 29 

Page 33 

Page 40 

Page 41 

Page 63 

6
 

 

 

Comments from Dr. John Bartlett 

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

background. 

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 

exposed. 

•	 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. 

7
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 

minutes. 

•	 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 

help. 

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 

8
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 

suggestions/concerns 

•	 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. 

9
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 fieldtested 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. 

10
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 

categories: 

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 

tools 

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. 

11
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 

effective. 

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 

these. 

Dr. FIshhoff 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. 

12
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 zeroculturable- 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. 

http://www.epa.gov/pesticides/factsheets/chemicals/paraformaldehyde_factsheet.htm 

13
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 zeroculturable 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 

serving. 

14
 

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 preevent. 

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 

15
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 

information. 

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. 

5.4.2.1 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 

personnel. 

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 

used. 

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 

16
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. McWilliams. Framework for 

Evaluating Anthrax Risk in Buildings. Environ. Sci. Technol., 2009, 43 (6), pp 1783–1787 

http://www.epa.gov/pesticides/factsheets/chemicals/paraformaldehyde_factsheet.htm 

http://www.cdc.gov/niosh/docs/2009-132/default.html 

http://www.cdc.gov/vaccines/recs/acip/meetings.htm 

17
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. 

18
 

 

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 

19
 

 

 

 

 

 

 

 

 

 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 widearea 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?

 Sampling 

•	 Protocol for statistically valid sampling should be defined? 

•	 Can real time monitoring be done? 

•	 What sampling tools are appropriate? 

20
 

 

 

 

 

 

•	 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 

media. 

•	 Prevention of offsite transport of BA spores should be discussed. 

Can vehicles or personal items leave the site without being 

 decontaminated? 

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. anthracis, 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. 

21
 

 

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 BATAD 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 

helpful. 

22
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. 

23
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 reoccupancy 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. 

24
 

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-todate information is used during an emergency. 

a.	 Chain-of-custody procedures and forms: The ICLN has a universal Chain-ofCustody 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/LeftMarginHeaderList/DOWNLOADFIL 

ENAME/000000001202/PackingandShipping1-08.pdf 

iii.	 FEDEX www.fedex.com 

iv.	 Dangerous Goods Shipping 

http://www.fedex.com/us/services/options/dangerousgoods/declarationfor 

ms.html 

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 

25
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 

resources. 

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 

Press 

d.	 ICLN has a sampling guidance in their document library. This may be of value as 

well. 

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?” 

26
 

 

 

 

 

ICLN Responsible Federal Agency Matrix ICLN Responsible Federal Agency Matrix

Chemical Biological 

Lab Support to Phase of Response Lab Support to Phase of Response 

Sample matrix 

Monitoring/ 

surveillance

Incident

Response

Remediation

Forensics

Sample matrix 

Monitoring/ 

surveillance

Incident

Response

Remediation

Forensics 

Human Clinical HHS HHS FBI Human Clinical HHS HHS HHS FBI 

Environmental EPA EPA FBI Environmental Multiple Multiple EPA FBI 

Food USDA/ 

HHS 

USDA/ 

HHS 

USDA/ 

HHS FBI Food USDA/ HHS 

HHS/ 

USDA 

USDA/ 

HHS FBI 

Animal USDA USDA FBI Animal USDA USDA USDA FBI 

Plant USDA USDA USDA FBI Plant USDA USDA USDA FBI 

Drinking Water EPA EPA EPA FBI Drinking Water EPA EPA EPA FBI 

White Caveat: Capacity includes both screening and : capability is/can be established within Department. confirmatory analyses. Gaps in capacity, Green: capability in place through agreements. particularly for confirmatory analysis, still exist. Yellow 1 : capability not in place, agreements needed. 

ICLN Resp ICLN Responsible Federal ble Federal Agency Matrix 

Radiological 

Lab Support to Phase of Response 

Sample matrix 

Monitoring/

surveillance

Incident

Response

Remediation

Forensics 

Human Clinical HHS HHS FBI 

Environmental EPA DOE/ 

EPA EPA FBI 

Food USDA/ 

HHS 

USDA/ 

HHS 

USDA/ 

HHS FBI 

Animal USDA USDA FBI 

Plant USDA USDA FBI 

Drinking Water EPA EPA EPA FBI 

• 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. 

1 

27
 

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 

here? 

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. 

28
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 

29
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 

attacks. 

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 

anthrax. 

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. 

30
 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 

standards. 

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) 

31
 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. 

32
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?” 

 GENERAL COMMENTS 

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. 

33
 

 TYPES AND CONTENT OF MESSAGES 

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 

Uncertainties 

Process 

 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 

below). 

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. 

http://www.bt.cdc.gov/agent/anthrax/anthrax-hcp-factsheet.asp 

CDC. Division of Foodborne, Bacterial, and Mycotic Diseases (DFBMD). Anthrax. Last 

Page last modified March 2008. 

http://www.cdc.gov/nczved/dfbmd/disease_listing/anthrax_gi.html 

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. 

34
•	 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 

phrases. 

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. 

35
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 

Time 

•	 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 

occurred 

•	 When exposure is suspected 

•	 When clear symptoms appear 

Place 

•	 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. 

36
 

•	 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 

source. 

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. 

OTHER SUGGESTED ITEMS TO INCLUDE 

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. 

Cases 

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. 

37
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 

REFERENCES CITED 

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-MISHEARDCOMM_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 casestudy. 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. 

236-252. 

38
 

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. 

39
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. 

40
ORA F T - April 15, 2009 

Strategic Plan for
 

Risk Communication at the
 

Food and Drug
 

Administration
 

Draft: April 15, 2009 

u.s. Departnlent of Health and Hunlan Services 

Food and Drug Adnlinistration 

41
D R AFT - April 15, 2009 

Table of Contents 

Purpose 1 

Backgrou nd 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 

42
ORA F T - April 15, 2009 

Strategic Plan for 

Risk Communication at the 

Food and Drug Administration 

Purpose 

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. 

Background 

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 (10M) to investigate the agency's drug 

safety efforts and to recommend improvements to its existing systems. In response, the 

10M 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 dn.1g 

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 (10M Recommendation 6.1). 

Although the 10M'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. 

2 See http://www.iom.edu/CMS/3793/26341/37329.aspx 

3 See http://www.fda.gov/opacom/morechoices/mission.html 

43
ORA F T - April 15, 2009 

advise on implementing communication strategies consistent with the most current 

knowledge. 4 

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 

communication: 

•	 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. 

44
D R AFT - 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 deci.sion 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 

organizations 

Optimize FDA's policies on communicating product risks and 

benefits 

Policy Strategy 1: Develop principles to guide consistent and understandable FDA 

communications 

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 

products 

Policy Strategy 4: Assess and improve FDA communication policies in areas that have a 

major impact on public health 

45
ORA F T - 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. 

46
ORA F T - 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, 

6 National Research Council. Improving Risk Communication, National Academy Press: Washington, DC, 1989. 

47
ORA F T - Apri/15, 2009 

product advertising) FDA can have a significant effect on user knowledge and consequent 

behavior. 

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 

products. 

Risk communication is science-based 

First, FDA has a long-standing commitment to being science-based and science-Ied-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, & c.J. Atman. Risk Communication: A Mental Models Approach. Cambridge 

48
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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 needswhen, 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. 

B 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 

49
ORA F T - Apri/15, 2009 

•	 Strengthen the science that supports effective risk communication 

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

communication 

•	 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. 

50
ORA F T - 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' 

9 See http://www.fda.gov/womens/pubs.html 

51
ORA F T - 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, 

including: 

•	 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 

10 formerly known as Riskmaps 

52
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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 foodrelated 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. 

53
ORA F T - 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 

possible. 

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 nine ll 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 

public. 

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ORA F T - 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 nonspecialists. 

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 

55
ORA F T - 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 

objectives. 

Capacity Strategy 5: Increase staff with decision and behavioral science 

expertise and involve them in communication design and message 

development 

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. Fischhofe2 

asserts that effective risk communication requires the contribution of four types of 

specialists: 

• 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 publicboth 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 drugrelated 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 

http://www.fda .qov/ohrms/dockets/acf08/slides/2008-4377s1-01. pdf 

56
ORA F T - 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 Webl"1D, which will make consumer health information associated with FDAregulated 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 

organizations 

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.// 1s 

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 

l3 See http://www.fda .gov/cder/meeting/RiskComm200S/summary. pdf. 

14 See http://www.webmd.com/fda 

15 See http://www .fda .QOV /cder/meeting/RiskComm200S/summary. pdf. 

57
ORA F T - 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. 

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ORA F T - 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 

formats. 

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 

following. 

•	 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
 

information.
 

•	 How tiering or layering messages can improve communication of critical 

information. 

•	 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, 

16 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. 

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ORA F T - 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 

recalls. 

- 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. 

17 See http://www.fda.gov/cder/news/CMI/default.htm 

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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 biologics) 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 FDAregulated 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 biologics. 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 consumerdirected 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 

61
ORA F T - 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. 

Conclusion 

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. 

62
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 

Agencies 

Baruch Fischhoff, PhD., Professor, Carnegie Mellon University
 

Member Questions/Answers
 

Discussion of Science Goal and associated FDA Discussion Topics 

5:00 Adjourn for the day 

63
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 

64
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 /signed March 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)”. 

Background 

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 

65
 

 

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 

66
 

 

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 BATAD 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 

achieved? 

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. 

67