environmental, health, and safety considerations for start-ups€¦ · planning and architectural...

Environmental, Health, and Safety Considerations for Start-Ups

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Agenda

• Who is BSI• EHS Considerations For Biopharma Start-Ups• Safety – Programs, Training, Compliance• Environmental – Permits and Inspections• Centers for Disease Control/National Institutes for Health• Steps for Implementation

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…making excellence a habit

Around the world, BSI enables businesses like yours to turn best practices into habits of excellence

• 86,000 clients in 193 countries• 49% of the Fortune 500• 75% of the FTSE 100• x77% of the Nikkei 225 Index• 23 of the Top 25 Medical-Device

Manufacturers Certified• 50% of the Top 100 on

Glassdoor’s Best Places to Work

…making excellence a habit

We can make a difference in your business today through…

• Consulting• Training• Certifying• Auditing• Software • Knowledge/Standards

…making excellence a habit

• Environmental, Health, and Safety• Occupational Health, Safety, and

Wellness• Corporate Social Responsibility• Anti-Bribery/Corruption• Sustainability• Business Continuity• Cybersecurity and Information

Resilience• Supply Chain Solutions

We help organizations identify operational improvements across their products/services and processes

Operational Resilience:

…making excellence a habit

As supply chains span continents, the ability to mitigate risks from procurement to manufacturing, transportation and sales is critical

• Supply Chain Risk Management • Risk Mapping and Modeling Services• Compliance Program Development• Supplier Development Services • On-Site Regulatory Audit Services • Risk Intelligence Monitoring Software • Audit Compliance Management

Software

Supply-Chain Resilience:

General Considerations

• EH&S is a vital part to any company and begins early in the process• Understand the building/engineering requirements• Federal, state, and local regulations• Roles and responsibilities differ between management and employees

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Construction and Engineering Considerations

• Tenant Improvement (TI) design through construction• Relocation readiness• Destination preparation• Origin preparation• Site closures

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TI Design Through Construction

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• Key Stakeholders• Define Requirements and Site

Selection• Planning and Architectural

Considerations for EHS― Determine control zones for

constructability» Coordinate with

multi-tenant buildings

• Validate Applicable-Use Requirements

» Biological» Chemistry» Radiation» Vivarium

• Constructed Safety Components» Eyewash and shower stations» Fire extinguishing systems» Chemical fume hoods and

biological safety cabinets (BSCs)

» Egress and assembly area identification

Regulatory Considerations

• Occupational Safety and Health Administration (OSHA)― Set forth federal requirements for

employers to protect the workers

• Environmental Regulatory Agencies― EPA― Others?

• Biosafety and Health Regulations― Centers of Disease Control and Prevention

(CDC)― National Institutes of Health (NIH)

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General Duty Requirement – Section 5(A)(1)

“Each employer shall furnish to each of his/her employees, employment, and a place of employment

which are free from recognized hazards that are causing or are likely to cause death or serious physical

harm to his/her employees”

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Management Roles in Safety• Comply with all safety regulations

• Develop Job Hazard Analyses for all tasks

• Implement safety rules and procedures

• Train new and existing employees on safety

• Determine if employees are capable of operating equipment/ machinery safely

• Hold regular safety meetings with employees

• Discuss safety with each employee including complaints and concerns

• Inspect for compliance with safe work practices and conditions

• Report all accidents and incidents

• Complete thorough investigations

• Establish consequences for non-compliance

• Follow through on actions, observations, and communication

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Required Safety Programs

• OSHA and other regulatory compliance― Emergency Action Plan (EAP)― Fire Prevention― Chemical Hygiene― Hazard Communication― Bloodborne Pathogen (BBP)/Exposure

Control Program― Respiratory Protection Program― Ergonomics (not required)

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Hazard Communication• OSHA 29 CFR 1910.1200

― All chemicals produced or imported are classified properly

― Information concerning the hazards is communicated to the employees

― Consistent with United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

― Hazard Communication programs include:

» Container labeling/other forms of warning

» Safety Data Sheet (SDS)» Employee training

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https://www.advancedlabelworx.com/products/ghs-labeling-2/

Environmental Considerations

• Federal EPA• Texas Commission on Environmental Quality

― Air Permits― Radioactive Materials― Storm Water Pollution Prevention― Industrial Waste Water Discharge Permits― Hazardous Waste Management― Medical Waste/Biohazardous Waste

• Department of Transportation (DOT)

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Permits

• Wastewater• Fire department• Nuclear Regulatory Commission• Drug Enforcement Agency (DEA)• Department of Occupational Health• Environmental Protection Agency (EPA ID Number)• Association for Assessment and Accreditation of Laboratory Animal Care

(AAALAC)• Institutional Animal Care and Use Committees (IACUC)

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Health Regulations

• The Centers of Disease Control and Prevention (CDC) and the National Institutes of Health (NIH)― Provide guidelines for work with biological agents

» Viruses» Bacteria» Vector therapy

― Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Ed.

» Biosafety levels» Safe work practices

― NIH Office of Science Policy» Risk groups» Biosafety committee requirements

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Biosafety Levels – CDC

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Adapted from BMBL 5th Ed.

Risk Groups – NIH

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Institutional Biosafety Committee (IBC)

• NIH states that IBCs are “the cornerstone of institutional oversight of recombinant DNA research.”

• Also responsible for oversite of research involving:― Select agents and toxins― Blood borne pathogens― Xenotransplantation― Stem cell research― “Dual Use” research ― Nanotechnology

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Implementing a Positive Safety Culture

• Don’t want to have a “gotcha” safety environment• Implement the requirements and regulations while involving the employees

― Provides a feeling of ownership― Staff gain an understanding of why they are required to do certain tasks

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Training for Employees

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• Ergonomic Program• Hazard Assessment• Emergency Action Plan• Environmental Programs• Hazardous Materials• Personal Protective Equipment• Respiratory Protection• First Aid/CPR• Bloodborne Pathogens

• Lockout/Tagout • Workplace Hazard Assessment• Back and Lifting Safety• Accident Investigation• Fire Extinguishers• Workplace Violence• Hazard Communication• Chemical Hygiene Plan• Hazardous Waste Management

Reduce• Injuries• Illnesses• Costs• Workers-Comp cases• Insurance claims• Down time• Property damage

Increase• Productivity• Time on job• Equipment longevity• Communication• Employee confidence

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What a Safety Program Can Provide

Summary

• Federal, state, and local regulations• Hazardous materials communications• Hazardous waste considerations• Biosafety guidelines• Training• Implementing safety• Benefits of a safety program

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Questions?

BSI Contact InformationRyan Bartlett ryan.bartlett@bsigroup.comDawn Carlson dawn.carlson@bsigroup.comCathy Zadrzynski cathy.zadrynski@bsigroup.com

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Thank You!