SANDRA L. JAMME, SLJ BUSINESS SERVICES, LLC EH&S CONSIDERATIONS FOR BIOTECH FACILITIES START-UPS CAL STATE UNIVERSITY EAST BAY TUESDAY, OCTOBER 25,

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SANDRA L. JAMME, SLJ BUSINESS SERVICES, LLC EH&S CONSIDERATIONS FOR BIOTECH FACILITIES START-UPS CAL STATE UNIVERSITY EAST BAY TUESDAY, OCTOBER 25, 2016

EH&S Considerations for Biotech Facilities Start-ups EH&S is an essential component that starts early in the process and can define a tenant improvement project. Effectively navigate requirements for biotech facility start-ups by understanding the interdependencies of construction, design, schedules, and safety to successfully deliver complex and time-sensitive projects.

Agenda Tenant Improvement (TI) Design Through Construction Relocation Readiness Destination Preparation Origin Preparation Site Closures Lessons Learned

TI Design Through Construction Key Stakeholders Executive Management Investors Users Real Estate Executive Define Requirements and Site Selection Location Employee Base & Similars Building (Feasibility, MEP and Accessibility) Property Management Identify Proper Zoning

TI Design Through Construction

TI Design Through Construction Design Architect with Applicable Experience Generate Block Plans for Utilization and Adjacencies Facilities Conducts Due Diligence Programming to Develop Basis of Design (BOD) Schematic Drawings (SDs) Site plan, floor plans, sections, elevations, renderings Design Drawings (DDs) Floor plans with full dimensions, door and window details and materials Construction Drawings (CDs) All pertinent information required to price and build

TI Design Through Construction Planning & Architectural Considerations for EHS Determine Control Zones for Constructability ***Coordinate with Multi-Tenant Buildings Identify Use and Generate Hazardous Materials Inventory Statement (HMIS) Validate Applicable Use Requirements (ie Biological, Chemistry, Radiation, Vivarium, NMR) Constructed Safety Components Eyewash & Safety Showers Fire Extinguishing Including Sprinklers, Preaction, Class D Chemical Fume Hoods or Vented BSCs Waste Station Collection Areas Egress & Assembly Area Identification Seismic Requirements

TI Design Through Construction Calif. Fire Code Physical Hazard Classifications Maximum Daily Average Daily Maximum In-Use Amount in Amount in Input Quantity in Input CBC Quantity in Units Input Units Input Units Units Input Unit Location Control Area Code Material Name CAS Number Material Assumptions Interior CA-1 2-Propanol 67-63-0 I9516 Interior CA-1 Ammonia Solution 7664-41-7 Sigma-Aldrich Product 499145 Interior CA-1 Methyl alcohol 67-56-1 Interior CA-1 Acetone Interior CA-1 Interior Hazardous Material? Maximum HazMat Quantities Flammable Liquids (gal): Quantity in CBC Units CBC Unit Flam IA California Fire Code Health Hazard Classifications: Combustible Liquid Class (gal): Flam IB Flam IC Comb II Oxidizer Class (lbs) Comb IIIB Comb IIIA (gal or lbs) Oxid 4 Oxid 3 Unstable - reactive (lbs) Oxid 2 Oxid 1 Unst 4 Unst 3 Unst 2 Unst 1 Water Reactive Class (lbs) WR 3 Flammable Oxidizing Cryo-Ox Corr-sol WR 2 WR 1 Corr-liq 5 5.00L Yes 1.32Gallons 10 10.00L Yes 2.64Gallons 34860 10 10.00L Yes 2.64Gallons 67-64-1 270725 1 1.00L Yes 0.26Gallons Ethanol 64-17-5 24102 12 12.00L Yes 3.17Gallons CA-1 Ethanol 64-17-5 24102 10 10.00L Yes 2.64Gallons Interior CA-1 Acetic Acid 64-19-7 320099 12 12.00L Yes 3.17Gallons Interior CA-1 Formaldehyde 50-00-0 F8775 500 500.00ML Yes 0.13Gallons Interior CA-1 Phenol, chloroform P1944 1 1.00L Yes 0.26Gallons Interior CA-1 Paraformaldehyde F8775 1 1.00L Yes 0.26Gallons 30525-89-4 Other Classes Cryogenic Highly Oxidizing Corrosive Corrosive Corrosive Highly Toxic (cf at Toxic (cf at Flamm Gases (cu ft at NTP) (gal) (lbs) (gal) (cf at NTP) Toxics (lbs) NTP) Toxic (lbs) NFP) Solid (lbs) Other High Tox- High ToxFlamm Corr-gas s&l gas Toxic-s&l Toxic-gas Solid Other

TI Design Through Construction Construction Drawings (CDs) and Permits Client Awards Project to General Contractor Architect Submits Permit Set Drawings To City Plan Check & Review Comments *** Allow 4-6 Weeks Based on Project Value *** Expeditor Available in some Jurisdictions Let s Start Building!! Construction TI Project Allow 12-20 Weeks for Physical Construction and Longer for New Construction

EHS Professionals Are Critical to Minimize Business Disruption!!!

Relocation Readiness Define Scope of Work - Preparing for the Relocation Inspections with Regulatory Agencies Pre-Move Meetings with Staff Be Available Request Minimizing Chemical Orders Identify Locations and Collect Obsolete Waste Solicit Vendor to Lab Pack, Inventory and Move or Dispose of Hazardous Chemicals Support Equipment & Lab Decontamination Identify Strategies for Biologicals/ Live Cells Cold Storage Items (ie Cold Room, Freezers)

Relocation Readiness OSHA and other Regulatory Compliance, which may include: Injury & Illness Prevention Program (IIPP) Emergency Action Plan (EAP) Fire Prevention Program (FPP) Chemical Hygiene Program (CHP) Bloodborne Pathogen Program (BBP) Department of Transportation (DOT)

Relocation Readiness Permits Certified Unified Program Agency (CUPA) City or County Wastewater Fire Department Nuclear Regulatory Commission (NRC) Drug Enforcement Agency (DEA) Department of Occupational Health (DOSH or OSHA) Bay Area Air Quality Management District (BAAQMD) Environmental Protection Agency (EPA) Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) Institutional Animal Care and Use Committees (IACUC)

Relocation Readiness Site Preparation Hazard Communication at Labs and Buildings Identify and Train to Assembly Areas Post Emergency Contacts Generate and Post Evacuation Plans Procure and Stock First Aid Kits & AEDs Ensure Fire Extinguishers Are Available and Charged Confirm Safety Showers/ Eyewash Stations are Clear of Obstacles, Serviceable and Maintained

Relocation Readiness

Destination Preparation Certify Chemical Fume Hoods & Alarms Certify BioSafety Cabinets (BSCs), HEPAs, Canopies Waste Areas Identified & Prepared for Accumulation Safety Glasses & Other PPE Available Review Process Flows Seismic Bracing Conducted

Origin Preparation Identify Landlord Turn-Over Requirements Pre-Move Inspection To Confirm Testing and Other Requirements Develop Closure Plan to Comply With Requirements Submit Closure Plan to County & Landlord Implement Equipment and Lab Decontamination Plan Relocate and Remove Chemical and Biological Products Receive Sample Results and Waste Submit Closure package Essential to Timely Turn-Over

Site Closure Confirm Turn-Over Date Identify Landlord Exit Requirements Ensure All Chemicals Removed, Site Decontaminated, Tested and Results Received Turn-Over Closure Report Avoid Costly Hold-Over Costs Allow Time

Summary Define the Tenant Improvement (TI) Process Tips for Preparing for your Relocation How to Prepare the Destination Wrap Up Origin & Site Closures

Engage with Senior Management Early In Project Clearly Communicate Schedule and Expectations Manage Internal & External Resources Be Aware of Schedule Changes Talk with Local Agencies for Requirements/ Alliance Speak Up, Honest, Clear Be Involved with Regular Construction Teams Engage Employee Safety Teams

Questions Sandra L. Jamme SLJ Business Services, LLC 650.400.2051 sjamme@sljbusinessservices.com www.sljbusinessservices.com