Attachment B: List of Editorial Comments

Chapter 1

p. 1-17, line 30: “Reasonableness” may not be the best descriptor; wouldn’t “rigor” be a better term?

p. 1-20, line 15: Are the worker populations at the respective sites truly “equal”? Is there any intent to pursue local hiring in preference to other approaches?

Chapter 2

p. 2-6, line 18: “Biomolecule Production Core. This operational service is responsible for developing SOPs for propagation and titration of all BSL-4 pathogens that will be used in the NEIDL.”

Not clear why the Biomedical Production Core will develop SOPs for titration of BSL-4 pathogens. Is this not a normal practice for the researchers?

P.2-7, line 19: “Specimen Processing Core. This service supports NEIDL investigators in studying emerging infectious diseases by handling the collection and storage of animal specimens and cultures in the appropriate biocontainment setting (e.g., BSL-2, BSL-3).”

Who will be responsible for the storage of BSL-4 materials, and where will that be done?

p.2-8, line 11: “The BAS controls or monitors environmental and other 11 operational parameters (temperature, humidity, flow, and pressure values) for individual areas or 12 rooms, fire suppression, and liquid waste treatment.”

Will the BAS also control the lighting in animal rooms?

P.2-10, line 7: “All electrical conduit, plumbing, piping, supply and exhaust ducts and miscellaneous 7 penetrations are sealed at the point of penetration into the high biocontainment laboratories (BSL-3 and BSL-4).”

“High containment” = BSL-3; “maximum containment” = BSL-4. This should be used throughout the report.

P.2-12, line 4: “In general, biological indicator vials are placed inside biocontainment bags containing the material to be processed in the autoclave. If the autoclave does not reach the programmed temperature, the spores will subsequently grow, and change the color of a pH-sensitive chemical in the growth medium.”

Consider the following: In order to incubate the biological indicator, it has to be removed from the biohazard bag. If the spores should grow (indicating incomplete decontamination), then someone (plus the local area where the bag was opened outside of containment) will be



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Attachment B: List of Editorial Comments Chapter 1 p. 1-17, line 30: “Reasonableness” may not be the best descriptor; wouldn’t “rigor” be a better term? p. 1-20, line 15: Are the worker populations at the respective sites truly “equal”? Is there any intent to pursue local hiring in preference to other approaches? Chapter 2 p. 2-6, line 18: “Biomolecule Production Core. This operational service is responsible for developing SOPs for propagation and titration of all BSL-4 pathogens that will be used in the NEIDL.” Not clear why the Biomedical Production Core will develop SOPs for titration of BSL-4 pathogens. Is this not a normal practice for the researchers? P.2-7, line 19: “Specimen Processing Core. This service supports NEIDL investigators in studying emerging infectious diseases by handling the collection and storage of animal specimens and cultures in the appropriate biocontainment setting (e.g., BSL-2, BSL-3).” Who will be responsible for the storage of BSL-4 materials, and where will that be done? p.2-8, line 11: “The BAS controls or monitors environmental and other 11 operational parameters (temperature, humidity, flow, and pressure values) for individual areas or 12 rooms, fire suppression, and liquid waste treatment.” Will the BAS also control the lighting in animal rooms? P.2-10, line 7: “All electrical conduit, plumbing, piping, supply and exhaust ducts and miscellaneous 7 penetrations are sealed at the point of penetration into the high biocontainment laboratories (BSL-3 and BSL-4).” “High containment” = BSL-3; “maximum containment” = BSL-4. This should be used throughout the report. P.2-12, line 4: “In general, biological indicator vials are placed inside biocontainment bags containing the material to be processed in the autoclave. If the autocla ve does not reach the programmed temperature, the spores will subsequently grow, and change the color of a pH- sensitive chemical in the growth medium.” Consider the following: In order to incubate the biological indicator, it has to be removed from the biohazard bag. If the spores should grow (indicating incomplete decontamination), then someone (plus the local area where the bag was opened outside of containment) will be 20

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potentially contaminated. This is why the biological indicator is placed in “dummy” bags to mimic the contents of the biohazard bag. p. 2-12, line 26: “A Class III BSC, is illustrated in Figure 2-4.” Figure 2-4 is a centrifuge; a Class III BSC is not shown. This figure is also referred to (appropriately) in the next section on centrifuges. The figure should be moved and a picture of a Class III BSC added at Figure 2-4. P.2-14, line 10: “Ultra-low temperature freezers (Figure 2-5) provide long-term protection and storage for valuable samples of biohazardous materials.” An important feature (not mentioned in the draft report) is that such storage freezers need to be equipped with locks for biosecurity. p. 2-16, line 29: “The IBC coordinates its application procedures with two other offices, Research Occupational Health Program (ROHP), to ensure that research personnel have adequate occupational health monitoring, training on safe work practices, exposure control emergencies, and use of PPE.” What is the second office? Only ROHP is listed. p. 2-17, line 12: 2.1.4.3 Standard Operating Procedures and Training Generic question: Who reviews/approves SOPs? p. 2-19, line 15: “Such materials are biological samples needing further analysis…” What is the SOP for removing samples “for further analysis”? Where will that be done? Will they be irradiated? It would be helpful to describe this. Appendix A p. A-6, lines 4-8: Several of the items referenced are not “codes,” but “guidelines” based on best practices and principles of biocontainment. p. A-10, line 18: “… (e.g., an escape bottle air apparatus).” Please describe. p. A-18, line 8: “Work being performed within high-level biocontainment areas will be monitored by systems to ensure that at least two authorized persons are in each area at all times to ensure safety and minimize risk of an individual initiating a malevolent or unauthorized act.” Excellent procedure. 21

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p. A-26, line11-12: “Gas decontamination will be considered for large pieces of equipment (e.g., penning, BSCs, carts) because gases pass between barriers of biocontainment.” This does not make sense. Please clarify. Chapter 3 p. 3-15, line 7- 8: “The disease occurs worldwide and in the US in animals. There are a significant number of naturally occurring cases reported in the US annually.” The first sentence should be reworded as follows: “The disease occurs in animals worldwide and in the US.” What does “significant” mean? Can a specific number or range be provided? p. 3-17, line 24-25: “A vaccine was available for both military and civilian use that was offered to laboratory workers; however, currently, there are no FDA-approved vaccines available for F. tularensis.” This sentence suggests that the vaccine for laboratory workers is no longer available, but this is not the case. A non-FDA approved tularemia vaccine is still available for lab workers from the special Immunizations Program at Fort Detrick, MD. Chapter 9 Case fatality rate (CFR) should be used instead of mortality rate in the discussions in this chapter. 22