The U.S. Army Medical Research and Materiel Command (USAMRMC) Requires Grant Recipients

U.S. Army Medical Research and Material Command (USAMRMC) Safety Requirements and Grant Application Assistance The University of Iowa Date(s) Revised: 11/2009

The U.S. Army Medical Research and Materiel Command (USAMRMC) requires grant recipients to follow specific safety standards and notification requirements. This instruction guide is intended to provide assistance to investigators applying for USAMRMC grants. The requirements are also applicable when applying for grants through the Congressionally Directed Medical Research Programs (CDMRP). It will also assist with maintaining ongoing grant requirement compliance.

The USAMRMC grant requirements include a facility safety plan, a Certificate of Environmental Compliance, and assurance by both individual investigators and The University of Iowa that safety programs are in place and hazards have been identified and controlled.

General information on USAMRMC grants application requirements are obtained from UI Division of Sponsored Programs, from USAMRMC (http://www.usamraa.army.mil/pages/baa_paa/mrmcbaalist.cfm) or CDMRP https://cdmrp.org/ ).

INSTRUCTIONS The steps below show you how to prepare the health, safety and environmental portion of the application.

1. Complete “Form A. Research Health and Safety Hazard Assessment.” This form is intended to guide you through the identification of safety and health hazards that may be associated with your proposed research project. The form also lists the Health and Safety Programs that address each hazard. Include a date and initial for each program addressing a hazard associated with your project. You are required by USAMRMC to communicate the project hazards to UI Environmental Health & Safety (EHS) and, in step 3 below, you are required to sign an assurance that you are responsible for all safety and health aspects of your project. Alternately, you may use Form A as an explanatory guide to complete Form B.

Form A. is an internal form and is not submitted with the grant application. If you have questions, contact LuAnn Hiratzka at EHS (LuAnn 335-7564; EHS 335-8501).

2. Complete “Form B. University of Iowa Principal Investigator Health and Safety Assurance.” This is an internal form submitted only to EHS. With this Principal Investigator Assurance form, the investigator declares that safety programs are in place to address hazards associated with the research being planned or conducted. Contact EHS with any questions.

3. You will be requested by USAMRMC (or CDMRP) to complete “Form C. Principal Investigator Assurance”. Depending on how you submit your application, you may be required to submit it with an online application or you may be contacted later by the funding organization. A sample form is included with these instructions for your review. (Note that in the first and fourth bulleted paragraphs, you are assuring that you have involved and will report to the Facility Safety Director/Manager; this refers to UI EHS.)

4. Contact the University’s Environmental Compliance Manager (Michael Valde, 335-6190) to arrange a meeting to discuss the environmental impacts of your research project and obtain a signed copy of “Form D. Certificate of Environmental Compliance”. You will be requested to submit this form with your application to USAMRMC. It will be included with your application materials and a sample form is included here for your review. Be prepared to discuss the questions on “Form E. Environmental Compliance Assessment” with the Environmental Compliance Manager. Form E is an internal form that will allow proper assessment of the environmental aspects of your project. Once the “Certificate of Environmental Compliance” is signed, return it to the Division of Sponsored Programs. 5. Send a copy of the following completed documents to EHS for review – 1. Form A. Research Health and Safety Hazard Assessments (optional), 2. Form B. The University of Iowa Principal Investigator Health and Safety Assurance (required); 3. Form C. Principal Investigator Assurance (required). An EHS representative will contact you to schedule and conduct a lab/area site visit, discuss proposed research activities, and to discuss the facility safety plan. Your research project will be discussed again during your annual EHS bio/chemical lab review visit.

3. Once the USAMRMC grant is funded, the PI is required to notify EHS of any changes in the research activities that may involve new or different health, safety, or environmental impacts. A status notification is required to be submitted to EHS annually by June 30th of each year. The status notification assists EHS with preparation of the Facility Safety Plan Annual Status Report required by USAMRMC. Complete “Form F. Research Safety Plan Status Report” and submit to EHS – 100 EHS, Attention LuAnn Hiratzka, or via e-mail to [email protected] by June 30th of each year. A reminder will be sent to you to complete Form F. Form A – Research Health and Safety Hazard Assessment – Submit to EHS Only.

ANIMAL USE IN RESEARCH Potential Project Hazards Health/Safety Program that Addresses the Hazards Completed Initial Animal Welfare 1. Possess IACUC-Approved Protocols per UI Animal Research. and 2. Complete USMRMC protocols and information at Caretaker http://www.usamraa.army.mil/pages/baa_paa/mrmcbaalist.cfm Hazards 3. Complete Appropriate Training BIOLOGICALS Potential Project Hazards Health/Safety Program that Addresses the Hazards Completed Initial Biological Agents 6. Biosafety Plans and Procedures in Place as per UI Biological Safety Manual. 7. Bloodborne Pathogens Control Plan Template. Bloodborne Pathogens 8. Bloodborne Pathogens Safety Training. 10. rDNA Registration. Recombinant DNA 11. Procedures as per UI’s rDNA Guidelines 13. Must Possess CDC Registration. Select Agents 14. Procedures as per UI’s Requirements for Select Agent Use. CHEMICALS Potential Project Hazards Health/Safety Program that Addresses the Hazards Completed Initial Allergens (latex, animal, enzyme, etc.) 16. Chemical Hygiene Plan in written form for each lab. Anesthetic Agents 17. Lab Chemical Safety Training. Flammable 18. Site-Specific Lab Safety Topics (topics checklist found within online Lab Carcinogens Chemical Safety Training) Compressed Gases Corrosive Neurotoxins Other Toxics Reactive Reproductive Toxins Shock Sensitive ENVIRONMENTAL and WASTE MANAGEMENT Potential Project Hazards Health/Safety Program that Addresses the Hazards Completed Initial Biological Waste 19. Comply with UI Environmental Policy and Responsibilities. Chemical Waste 20. Implement EHS Waste Management Procedures. Radiological Waste 22. Possess a certificate of environmental compliance signed by the UI Environmental Compliance Officer (Form D included with USMRMC grant Environmental Compliance proposal forms and with this procedure). Contact Mike Valde, UI Environmental Compliance Manager, at 335-6190. GENERAL LAB SAFETY Potential Project Hazards Health/Safety Program that Addresses the Hazards Completed Initial

General Lab Safety Procedures 23. Lab Safety Procedures in place per the Chemical Hygiene Plan. 24. Emergency Preparedness Procedures in place per the Chemical Hygiene Plan. 25. Potential electrical/fire hazards for project addressed – see fact sheet.

Personal Protection Equipment 28. Complete Written Certification of PPE Hazard Assessment. 29. Complete Basic PPE Compliance and Awareness Training Course. (PPE) 30. Complete Site-specific PPE compliance and awareness instruction.

33. Must have a Respiratory Protection Program in place. 34. If necessary, complete the UI’s Respiratory Program template. This includes Respirator Use respirators and dust masks used for exposure control or comfort use. 35. Complete appropriate training. IONIZING RADIATION – Human Use Potential Project Hazards Health/Safety Program that Addresses the Hazards Completed Initial Brachytherapy Sources 38. UI and/or Iowa Department of Public Health Registration and Authorization. Diagnostic X-ray Machines 39. Compliance with Radiation Protection Guide for Medical Use of Radioactive Linear Accelerators (LINAC) Materials and Radiation-Producing Machines. Radiopharmaceuticals 40. Appropriate Radiation Safety Training.

IONIZING RADIATION – Non-Human Use Potential Project Hazards Health/Safety Program that Addresses the Hazards Completed Initial 43. UI and/or Iowa Department of Public Health Registration and Authorization. Analytical X-ray Machines 44. Compliance with Radiation Protection Guide for RAM Use in the Basic Sciences. Radioactive Materials 45. Appropriate Radiation Safety Training. NON-IONIZING RADIATION Potential Project Hazards 48. Health/Safety Program that Addresses the Hazards Completed Initial 49. Registration through EHS. Lasers 50. Compliance with Laser Safety Manual. 51. Appropriate Laser Safety Training (Medical or Non-Medical Use). Call 335-8503. MRI 54. Contact Gordon Axt, EHS, at 335-8503 or [email protected] Form B – Principal Investigator Health and Safety Assurance Form (Internal form submitted only to EHS.)

The University of Iowa Principal Investigator Health and Safety Assurance Form.

Principal Investigator Department Research Location Proposal Title

I am aware of The University of Iowa health and safety programs listed below and on Form A. I understand, will follow, and enforce the requirements of those programs applicable to my research. I will ensure that all personnel involved in my research have been trained before research begins and will follow the policies and procedures specific to my research.

I have provided a date and initial indicating that the requirements of the health and safety programs listed below and on Form A applicable to my research (those not applicable are designated as N/A) have been met. Note: You may submit a completed Form A with this assurance or complete the items below.

Program Initials Date N/A Laboratory Chemical Safety Program  Chemical Hygiene Program (general and site-specific) Biological Safety Program  Biological Agents (general)  Recombinant DNA  Bloodborne Pathogens  Select Agents Radiation Safety Program  Ionizing Radiation  Non-Ionizing Radiation (lasers, MRI) General Laboratory Safety  General Safety, Fire Prevention, Emergency Preparedness  Personal Protective Equipment Program  Respiratory Protection Program Environmental and Waste Management  Hazardous Waste Management  General Environmental Compliance Animal Use in Research (IACUC-approved protocols)

Reference – Please use the most current form included with your application materials. ATTACHMENT 4 Form C – Principal Investigator Assurance (USAMRMC Research Proposal Safety Information – Safety Program)

 I assure that I have involved the Facility Safety Director/Manager in the planning of this research proposal, discussed with him/her all aspects of the proposal that relate to occupational health and safety, and will help him/her prepare the annual Facility Safety Plan Status Report.

 I assure that I will comply with my institution’s safety program and its requirements.

 I understand that I am directly responsible for all aspects of safety and occupational health specific to my research protocol.

 I assure that I will report to the Facility Safety Director/Manager any changes in the safety or occupational health practices due to changes in my originally planned research.

 I assure that hazards associated with my research have been identified, eliminated and/or controlled.

 I assure that all Facility Safety Plan requirements are in compliance with Local, State, and Federal general industry standards.

 If applicable, I assure Biological research programs will follow the recommended guidelines established in the latest editions of the CDC-NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL); Army Regulation 385-10, Chapter 20 (Biological Safety); and DA Pam 385-69 (Safety Standards for Microbiological and Biomedical Laboratories).

Name of Principal Investigator (print)

Signature of Principal Investigator Date

Mailing Address: Street

City State Zip Code

Phone Number:

E-mail Address:

JUNE 2009

Reference – Please use the most current form included with your application materials. ATTACHMENT 3 Form D – Certificate of Environmental Compliance (CEC)

The Certificate of Environmental Compliance should be executed by the institution’s official responsible for environmental compliance. The Council on Environmental Quality (CEQ) regulations (40 CFR 1500-1508) that implement the National Environmental Policy Act (PL 91-190, as amended) require all federal agencies to examine possible environmental consequences of their proposed and ongoing actions. The U.S. Army Medical Research and Materiel Command (USAMRMC) examines all medical research and development projects, whether inside or outside the United States, for their potential environmental impacts. (Note: This form is not required for institutions which solely perform work involving proposal/protocol management, conference coordination, data mining/interpretation/entry/research, and/or classroom training; as long as the operations do not use any hazardous materials— as defined by OSHA, nor do they involve any processes which will generate medical waste – such as needles, blood stained gauze/bandages, etc.)

1. One CEC (this form) must be submitted for each site conducting research under the submitted research proposal. This includes all subcontractors. 2. If you have any questions concerning the generation or applicability of a CEC, please e-mail or call (310- 619-2004) the USAMRMC Command Environmental Coordinator.

The offeror currently ____ IS ____ IS NOT (check appropriate category) in compliance with applicable national, state, and local environmental laws and regulations. (If not in compliance, attach details and evidence of approved mitigation measures.) The offeror has examined the activities encompassed within the proposed action for compliance with environmental laws and regulations. (Enter Research Proposal Title)

Principle Investigator:

The offeror states that the conduct of the proposed action:

1. WILL NOT violate any applicable national, state, or local environmental law or regulation; and 2. WILL NOT have a significant impact on the environment.

The offeror agrees that if the work required under the proposed action at any time results in a significant impact on the environment or a violation of any applicable environmental law or regulation, the offeror will immediately take appropriate action, to include notifying and/or coordinating with the appropriate regulatory agencies as required by law and notifying the Contracting/Grants Officer.

Name and Title of Official Responsible for Environmental Compliance (Printed)

Signature Date

Name of Organization (Printed)

JUNE 2009

Form E – Environmental Compliance Assessment (Internal form to be used for discussion with the UI Environmental Compliance Manager)

 Briefly describe your research project.

 Will the project include any source of emissions or exhausts to the atmosphere such as: Fume hoods Yes No Boilers Yes No Generators Yes No Sterilizers Yes No Combustion sources Yes No (list the source and the fuel)

 Will any equipment use ozone depleting substances such as freon, hydrochlorofluorocarbons, chlorofluorocarbons (e.g., chillers, freezers)

 Will you have 55 gallons or more of oil of any kind in any containers or equipment?

 If any of the following will be discharged into the sewer, check the appropriate box(es). Flammable or explosive pollutants Corrosives Solid or viscous pollutants that may cause obstructions of flow Pollutants capable of releasing fumes or vapors Pollutants of high biological oxygen demand Oil of any kind

 Will any pollutants of any kind be discharged into a surface water?

 Will hazardous waste be generated? Yes No How will it be handled and disposed of?

 Will any mercury containing equipment be used?

 Will any pesticides be used?

 Will hazardous materials be present? Yes No Has Hazardous material storage been addressed?

Meeting and Review with Environmental Compliance Manager

Signature (date) Signature (date) Form F – Research Safety Plan Status Report (Internal form submitted only to EHS)

A Research Safety Plan Status Report must be submitted annually to the Environmental Health & Safety Department (EHS) no later than JUNE 30th. Please provide a brief description of any changes in research that had safety, health, or environmental impacts during the past 12 months. (Additional pages may be attached.)

During the past 12 months:

1. Have any change(s) in Research Operation Safety Procedure(s) been made? Yes No If yes, briefly describe:

2. Have any modifications to the facility, equipment, and description (e.g., new equipment purchased, hood ventilation certification) been made? Yes No If yes, briefly describe:

3. Hazard Analysis: Have any new hazards been identified for any of the awards supported by the USAMRMC? Yes No If yes, provide a hazard analysis for each new hazard.

4. Radioactive Materials: Have any significant change(s) occurred in the use of the radioactive materials? Yes No If yes, briefly describe:

Are there any additional radioactive materials in use? Yes No If yes, list additional material(s).

I certify that all of the above statements are correct to the best of my knowledge, and I assure that the research area provides a safe environment for my employees working in accordance with UI’s health and safety programs for laboratories. I provide employee safety training and periodic laboratory inspections in an effort to minimize, eliminate, or control potential hazards to the employees and the public.

I understand that the Safety Office, USAMRMC, may conduct periodic site visits in order to ensure the indicated elements are in compliance with regulatory requirements.

Principal Investigator Date

Department Research Location

Phone Number Emergency Phone Number

Proposal Title