The Evolving Role of the EHS Manager

1. The Evolving Role of the EHS Manager Linda Markarian Director, Safety Health Environment Avecia Biotechnology, Inc. Milford, MA

2. Avecia Biotechnology, Inc. Avecia Biotechnology is the world's leading and most experienced contract manufacturer of oligonucleotide for DNA medicines • Founded in September, 2000 • 95 Employees • Manufacture Active Pharmaceutical Ingredients (API)

3. Avecia’s SHE Value We will not hurt anyone, annoy or alarm our neighbors or harm the environment

4. Avecia SHE Principles To support the SHE Value and provide the basis for a culture of positive SHE behaviour, Avecia Biotechnology: Gives safety, health and environment the first priority Obeys all laws and is a responsible corporate citizen Identifies hazards and establishes appropriate controls for risks and reduction of environmental impacts and meets all regulatory requirements in the invention, manufacture, sale and use of its products Provides customer and patient care with all products throughout the supply chain Has established the goal to eliminate all injuries, occupational illnesses and environmental incidents ·      

5. Avecia SHE Principles (Continued) Reports and investigates all incidents, then takes corrective action and shares learning Assures that employees, agents and suppliers have appropriate competence for their roles Defines SHE requirements in simple, clear terms, communicates them to all employees and secures their involvement Reports, monitors and audits all aspects of SHE performance to confirm compliance and planned continual improvement Celebrates and rewards excellence in SHE Performance Requires all employees to accept personal responsibility for their own safety and health and that of their colleagues

6. Management of Safety Health Environment Integrated program - includes Safety Health & Environmental Responsibility is LINE drive Emphasizes adherence to the 11 Principles Everyone has a responsibility

7. Organizational Structure President VP Manufacturing Director Director, SHE Director, HR Director Commercial Technical Services Safety Health Environment Management

8. Changes in SHE Management • Downsizing of workforce due to business decline; workload stays same or increases • Shift in culture toward SHE Activities • Emphasis on Safety Health Environment Management System

9. Major Environmenal & Safety Programs • Large Quantity Generator • Tier II • TUR Plan and Form S • Minor Air Permit • Industrial Wastewater Pre-treatment • Hazard Communication • Chemical Hygiene Plan • Control of Haz. Energy • EPCRA 313 (Form R) • Permit to Work

11. Six Components of SHE Management System Initial Review and Planning of Controls (Site risk register and action plan) Operations and Maintenance Procedures to ensure legal requirements met, equip. maintained, staff competence is maintained and culture supports positive SHE behavior Monitoring Set performance measures toward achievement of improvement objectives Audit Ensure by audit and corrective action compliance with Principles is in place Annual Review & Improvement Plan Conduct annual review of SHE performance, status of improvement plan, review of site risk register and generation of new improvement plan Management System Review Periodic, third party audit of SHE Management System

12. How The Work Gets Done • Improvement Plan supported by Sr. Staff Sr. Staff level: • Monthly review of performance • Quarterly review of Improvement Plan status Company wide: • Quarterly review of performance at meeting

13. How The Work Gets Done Everyone has a SHE objective And…. The annual incentive plan has a SHE component

14. How The Work Gets Done SHE Teams • Employee led • Multi-disciplined • Each have a mission statement • Clear objectives set and agreed upon by management

15. CY 2005 SHE Teams Risk Management Team (formerly the JSA team) Chemical Safety Team Emergency Response Team Toxics Use Reduction Team Compliance Team Safety Committee

16. How The Work Gets Done Consultants Used for specific, specialized projects ex. Permit preparation, Training, IH Surveys Outsourcing Used for work that doesn’t require a full-time person or intermittent times when additional staff is needed ex. Quarterly IWW sampling, new program development

17. SHE Team Success Stories Toxics Use Reduction Team Identified method to reduce acetonitrile usage when packing and upacking synthesis column Reduced potential acetonitrile usage by 3,200 gallons/year Won internal Avecia Award

18. SHE Team Success Story Job Safety Analysis Team Conduct analysis of tasks/procedures, identify potential hazards & reduce/eliminate hazards through recommendation Conducted 78 Job Safety Analyses in CY2004 ! Managed the closure of all action items Won internal Avecia Award

19. Benefits of SHE Management System • Reduces fire-fighting • Empowers & educates employees to do the right thing • Helps support line management of SHE • Allows more time for strategic work