Environmental Biotechnology PDF

Environmental Biotechnology BIOT6008 The role of Environmental Protection Agency (EPA) Dr MaryAnne Hurley Biopharmaceutical Waste Biopharmaceutical companies are regulated in terms of WASTE. Environmental Protection Agency (EPA)...

Environmental Biotechnology BIOT6008 The role of Environmental Protection Agency (EPA) Dr MaryAnne Hurley Biopharmaceutical Waste Biopharmaceutical companies are regulated in terms of WASTE. Environmental Protection Agency (EPA) 2  What is EPA? The EPA is an independent public body, under the Department of the Environment, Climate and Communications.  Set up in 1993  Consisting of five offices What is EPA? 1. Office of Environmental Enforcement – Implementation and enforcement of environmental legislation 2. Office of Environmental Sustainability – achievement of a well regulated, climate-resilient, resource- efficient and environmentally engaged society. 3. Office of Evidence and Assessment – main source of scientific evidence and advice on environment 4. Office of Radiation Protection and Environmental Monitoring – implementation of a range of legislation relating to chemicals, establishment and monitoring of pollutants 5. Office of Communications and Corporate Services – support function of staff in the EPA  What is EPA? The EPA operates from a number of sites across the Republic of Ireland. The Headquarters are located in Johnstown Castle Estate, County Wexford. Additional offices are located in: Dublin Inniscarra, County Cork Castlebar, County Mayo Monaghan Kilkenny Athlone, County Westmeath Limerick What does EPA do? See here: Youtube What is their overall strategy? What are their values? What are their 5 strategic outcomes? What does EPA do?  Responsible for protecting and improving the environment  Committed to protecting people and the environment from the harmful effects of radiation and pollution.  Plays key roles in environmental regulation, provision of knowledge and advocacy for the environment.  Provides environmental data, assessments and evidence to inform decision making  Implements effective regulation and environmental compliance systems Main responsibilities EPA Responsibilities 1. Licensing 2. National Environmental Enforcement 3. Water Management 4. Monitoring, Analysing and Reporting on the Environment 5. Regulating Ireland’s Greenhouse Gas Emissions 6. Environmental Research and Development 7. Strategic Environmental Assessment 8. Radiological Protection 9. Guidance, Accessible Information and Education 10. Awareness Raising and Behavioural Change Responsibilities 1. LICENSING The EPA licences and regulates the following to ensure they do not endanger human health/ harm the environment:  Waste Facilities e.g. landfills, incinerators, waste transfer stations  Large scale industrial activities e.g. pharmaceutical, cement manufacturing, power plants  Intensive agriculture e.g. pigs, poultry  The contained use and controlled release of Genetically Modified Organisms (GMOs)  Sources of ionising radiation e.g. x-ray and radiotherapy equipment, industrial sources  Large petrol storage facilities  Waste water discharges  Dumping at sea activities 9 Responsibilities 2. NATIONAL ENVIRONMENTAL ENFORCEMENT  Conducting an annual programme of audits and inspections of EPA licensed facilities.  Overseeing local authorities’ environmental protection responsibilities.  Supervising the supply of drinking water by public water suppliers.  Working with local authorities and other agencies to tackle environmental crime by coordinating a national enforcement network, targeting offenders and overseeing remediation.  Prosecuting those who flout environmental law and damage the environment  Promoting compliance and enforcing producer responsibilities (e.g. WEEE)  Enforcing regulations 10  Responsibilities 3. WATER MANAGEMENT  Monitoring and reporting on the quality of rivers, lakes, transitional and coastal waters of Ireland and ground waters; measuring water levels and river flows.  National coordination and oversight of the Water Framework Directive.  Monitoring and reporting on Bathing Water Quality 11  Responsibilities 4. MONITORING, ANALYSING AND REPORTING ON THE ENVIRONMENT  Monitoring air quality and implementing the EU Clean Air for Europe (CAFÉ) Directive.  Independent reporting to inform decision making by national and local government (e.g. periodic reporting on the State of Ireland’s Environment and Indicator Reports).  Collecting and reporting national statistics on waste generation and management 12  EPA Licensing  Industrial activities are important for Ireland’s economy but can also have a significant impact on the environment:  Produce emissions of various substances into the air, water and land.  Generate waste and use resources such as energy and water. EPA Authorisation of activities that could have an impact on the environment or on human health 13 Biopharmaceutical Waste Contents of Current Pharmaceutical Waste Streams and Treatment Options HAZARDOUS NON-HAZARDOUS HAZARDOUS LIQUID WASTE LIQUID WASTE MUNICIPAL SOLID SOLID WASTE WASTE Fermentation media Laboratory activities Packaging Process items Water used for cleaning Cleaning agents Empty glass bottles (GMM contact) Process buffers Disinfection Production bags Empty plastic bottles PPE Paper Plastic Food waste, etc. INACTIVATION INACTIVATION TREAT ON SITE If necessary IF POSSIBLE Recyclables Potential for Sent off recovered recycling WASTEWATER TREATMENT PLANT site for opportunities??? disposal Discharge to surface waters LANDFILL OR MUNICIPAL INCINERATOR Reduce - BOD - Nitrogen - Phosphorous 14 EPA Licensing Radiation  Ionising Radiation Regulations 2019  Environmental Data Exchange Network (EDEN)  Guidance Documents 15  EPA Industrial Licensing Two main Industrial Licences: 1. Industrial Emissions (IE) Licence 2. Integrated Pollution Control (IPC) Licence 16  EPA Industrial Licensing Integrated Pollution Control (IPC) Licensing  Required by biopharmaceutical companies operating manufacturing facilities in Ireland.  The IPC licence covers all emissions from the facility and its environmental management  Before a licence is granted, the company must satisfy the EPA that emissions from the activity do not cause a significant adverse environmental impact. 17 IPC Licence Aim of IPC licensing Prevent or reduce emissions to - Air - Water - Land - Reduce waste Use energy/ resources efficiently 18  IPC Licence Process Biopharmaceutical Company intending to operate in Ireland need to:  Apply for an Integrated Pollution Control (IPC) licence  Complete an Environmental Impact Assessment (EIA) as part of IPC license application  EIA: A statement of the effects, if any, which proposed developments, if carried out, would have on the environment  EPA will assess an EIA submitted as part of an application for an IPC 19 Licence Enforcement See here:EPA I&W enforcement report 22 v8 20 Licence Enforcement See here:EPA I&W enforcement report 22 v8 21 EPA Waste Licensing The EPA licenses: Landfills, hazardous waste disposal, ship recycling other significant waste disposal and recovery activities. EPA Waste Licence/ Permit or IPC 22 EPA Waste Licensing Other Considerations Dedicated waste storage facilities Air emissions Noise Groundwater monitoring EPA Responsibility for ensuring compliance with IPC license - achieved through audits and environmental monitoring 23 EPA GMO Notifications Discovery of genetic engineering techniques have made it possible to introduce, delete or enhance particular traits in an organism either by inserting genes from another organism or by otherwise altering its genetic make-up. Genetically Engineered Production Cells Biopharmaceutical Products Impact on waste disposal??? 24 EPA GMO Notifications Genetically Modified Organisms - the genetic material is altered in a way that does not occur naturally by mating or natural recombination’. Genetically Modified Micro-Organisms (GMMs) -bacteria, viruses, and animal and plant cells in culture. GMOs - comprise GM plants or GM animals otherwise known as transgenic plants or transgenic animals. The Environmental Protection Agency is the authority in Ireland that implements GMO Regulations on: - The contained use of Genetically Modified Organisms - The deliberate release of Genetically Modified Organisms into the environment - The transboundary movement of Genetically Modified Organisms 25 EPA GMM/ GMO Notifications Contained Use: 1. Companies must apply for first-time use of a premises for a contained use and for subsequent contained use of GMOs and GMMs 2. The EPA reviews the notification and grant consent, with or without conditions, or refuse consent. 3. Users of GMO/GMM contained use activities (other than Class 1 GMMs) must submit annual reports to the EPA 26 EPA GMM/ GMO Notifications Deliberate release Companies must apply to EPA to release the GMOs into the environment 1. For purpose other than marketing it: e.g. field trials for MG plants, human clinical trials with medicinal products containing or consisting of GMOs) 2. For the purpose of marketing it in the EU: e.g. placing on a market a product containing or consisting of a GMO such as GM starch potato, GM cut flowers etc. 27