1. Chapter 5 Environmental Health and Safety

2. Objectives 1.Understand the importance of effective EHS processes in biomanufacturing 2.Describe EHS regulatory and non-regulatory requirements related to biomanufacturing 3.Understand the role of these regulations and requirements in EHS efforts 4.Understand general types of hazards associated with biomanufacturing operations and processes 5.Describe the major components of an EHS program and their purpose in preventing injuries in a biomanufacturing setting

3. EHS Programs  Hazards – actions, materials or situations that can harm or kill people, destroy products/equipment/buildings, threaten a nearby community, and/or impact the environment  Purpose of program – to eliminate or reduce hazards

4. Potential Hazards  Chemical  Biological  Physical  Ergonomic  OSHA and EPA enforce regulations also  Programs established using a risk-based approach and risk management

5. Regulatory Requirements and Guidance

6. Occupational Safety and Health (OSH) Act  OSH Act  Enacted by Congress in 1970  General Duty Clause  Laid the groundwork for establishment of OSHA  Mission is to prevent workplace related injuries, illnesses and deaths  Electrical safe work practices, confined spaces, bloodborne pathogens, hearing protection, and control of exposures to hazardous materials and agents

7. US Environmental Protection Agency (EPA)  EPA  Created in 1970 by US Congress  Established to conduct research, monitoring, standard- setting and enforcement activities in an effort to ensure environmental protection

8. Centers for Disease Control and Prevention (CDC)  Centers for Disease Control and Prevention(CDC)  Works to identify and define preventable health problems  Efforts focused on developing, testing and publishing criteria specifically focused on disease prevention and control

9. CDC (Continued)  Centers for Disease Control and Prevention(CDC)  1. Biosafety in Microbiological and Biomedical Laboratories (BMBL)  Established biosafety levels and associated prudent biosafety practices  2. Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets  Contains biological containment guidance

10. National Institute for Occupational Safety and Health (NIOSH)  NIOSH (National Institute for Occupational Safety and Health  Specific guidance for preventing workplace illnesses and injuries

11. Local, State, Regional Regulatory Requirements / Guidance  Other guidance  Local, state and regional agencies  Typically more restrictive than federal requirements

12. Hazard Recognition and Identification  Hazard – a potential source of harm, loss or damage and poses a threat to life, health, property or environment

13. Labels Communicate Hazards

14. NFPA vs. HMIG  Both systems have three color-coded fields to indicate the flammability (red), health (blue), and reactivity (yellow) hazards associated with the material.  Both use a system of five numbers, ranging from 0 to 4, to indicate the severity of hazard, with 0 being the least and 4 being the most hazardous.

15. Hazard labels NFPA vs. HMIS  Differ in the fourth, white field  special handling in the NFPA system  protective equipment in the HMIG system  HMIS is intended as an HCS compliance tool  employees who must handle hazardous chemicals in the workplace are the intended audience  NFPA was designed for first responders.  numbers assigned in the NFPA system assume that a fire, spill, or emergency is present  Excellent Example: NO WATER ! !

16. HMIG White Field

17. NFPA White Field

18. Comprehensive EHS Program  Helps to  communicate hazards  identify practices necessary to minimize exposure and prevent injuries  outline emergency responses  serve as the basis for employee training  help to demonstrate the basis for regulatory compliance initiatives

19. Components of a Biomanufacturing EHS Program  Accident reporting and investigation  Biological and chemical inventory  Blood-borne pathogens  exposure control plan  Communication  promote open dialog between employees and members of leadership  Confined space entry  program that includes a written permit process  Emergency action plans  must address responses to spills, injuries, illnesses, fires and other events; evacuation routes must be identified

20. Components of a Biomanufacturing EHS Program (continued) Employee responsibilities Ergonomics and human factors Fire prevention/protection – include inspection, testing and maintenance of fire protection systems such as alarms, sprinklers, fire barriers and exit routes; storage and management of flammable and combustible materials Fleet safety – Safe transportation practices Hearing protection Industrial hygiene – Science of anticipating, recognizing, evaluating, and controlling workplace conditions that can cause illness or injury

21. Components of EHS Program: Hazards and Safeguarding  Hazard Communication (HAZCOM)  Ensure that information concerning hazardous agents are made available to employees  Hazard labeling on containers, warning signs for the workplace, and MSDS’s  Lockout-Tagout (LOTO)  Control of hazardous energy, by isolating an energy source (such as electricity or hydraulics) from a piece of equipment  Protects workers when performing certain tasks, such as maintenance Machinery safeguarding – Protect workers from the point of operation for a machine/piece of equipment Process safety – Written information to be compiled to enable the employer and employee to identify and understand the hazards posed by the process

22. Components of EHS: Management, Tracking, and Performance  Management of Change (MOC)  Methodology to update specific procedures and practices  Materials handling and management  Measure to track performance  Facilities EHS performance  Natural Disaster response and recovery  Waste management  Regulatory compliance element  Procedures for accumulating, storing, and shipping solid hazardous waste  If effluent discharge or airborne emission are acceptable, must be defined by plant permits

23. Components of EHS: PPE, Recordkeeping, Security, and Training  Personal protective equipment  Summarize when PPE is required; identify PPE selection, inspection, use, testing, wearing, storage, maintenance and disposal methods  Recordkeeping  Respiratory protection  Security  Training  Identify requisite training efforts necessary; how training will be provided; training frequency for each topic  New employees, when changes occur in the operation, as a result of performance deficiencies, and when new hazards are identified  Training records maintained