Environmental Conditions Laboratories (for commercial use) Group

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1 GBR No. 20 Environmental Conditions Laboratories (for commercial use) Group ERA regulates the environmental impact of enterprises through two key mechanisms. Smaller scale activities are regulated through a set of General Binding Rules (GBRs) which apply to all enterprises within a common group (e.g. Laboratories Group). Larger scale activities are regulated through an Environmental Permit issued on an individual basis by ERA. Certain enterprises of limited environmental significance (e.g. insurance companies) are exempt from control through a GBR or Permit. The environmental conditions set out in this General Binding Rule (GBR) are aimed at improving the environmental performance of laboratories carrying out commercial operations. GBR Conditions and Permits All laboratories, except those that are not utilised for commercial purposes (i.e. schools, research labs, etc.) (NACE code 80.42) will require a registration under the General Binding Rule (GBR) system. Any complexes of commercial laboratories or any such premises with a discharge to sea, surface water or land will require an environmental permit The Environmental Conditions in this GBR: Apply immediately on start-up of operations by new enterprises; Apply to an existing enterprise from 6 months after first notification of the GBR; Do not override the requirements of any other legislation, including any possible need for development consent; Will be enforced through ERA inspections and penalties; Apply until such time as they may be superseded for individual enterprises by the requirements of an Environmental Permit, other legal requirements or the amendment of this GBR. Operators have an obligation to understand and implement the requirements of the GBR. An explanation of these conditions and practical and detailed advice on their implementation is given in the ERA Guidance Note No. 20. Final April

2 1. General Requirements 1.1. The conditions and obligations of this GBR are without prejudice to any other regulation, code of practice, conditions or requirements requested by other Authorities or entities, including but not limited to, Occupational Health and Safety Authority, Transport Malta and the Regulator for Energy and Water Services The conditions and obligations of this GBR are without prejudice to any valid and approved, pending or any other development permits that are going to be submitted or issued on this site, any planning regulations, planning limitations or any provisions listed in the Environment Protection Act (CAP. 549; Act I of 2016) All businesses have a responsibility to protect the environment. All activities should be carried out in accordance with a proper management system that reduces risks of pollution, accidents and incidents. The operator shall become familiar with his legal obligations and good environmental practice Staff shall be made aware of the importance of environmental protection and receive appropriate training as specified in the Guidance Note Sites of operation shall be maintained in a tidy condition, free from litter and waste (whether arising from own activities or external sources) Any activity that threatens protected habitats or species is prohibited, unless that activity has received a specific permit from ERA The Operator shall be responsible for the drafting and implementation of a laboratory management plan. This plan shall include: Rules on personal laboratory apparel, personal behaviour inside the laboratory, and personal protection practices including details on the correct use of protective personal apparel and equipment; Procedures concerning laboratory housekeeping practices, environmental monitoring, waste management and disposal, management of spillages or accidents which may arise, and the handling of laboratory equipment, glassware, and chemical and biological agents and materials; Procedures concerning chemical procurement and storage; Procedures concerning record keeping, including inventorying of chemical, biological agents, and laboratory equipment; and maintenance of records concerning accidents and spillages. Final April

3 1.8. An Emergency Response Plan (ERP) shall be prepared and communicated to all laboratory personnel. The ERP shall contain details of: The nature and quantity of chemicals/oils/biological agents or materials stored on site and their associated hazards; Plans and sections showing location of drains, reservoirs for fire water etc; Emergency phone numbers of the Operator, emergency personnel/facilities, supervisors, and laboratory workers. The Operator s emergency phone number shall be displayed publicly at the site; Procedures for ventilation failure, facility evacuation procedures and medical care, and procedures to be adopted in the eventuality of a spillage or accident including containment, cleanup and reporting requirements; Explanations of identity labels used to show contents of containers (including waste receptacles) and associated hazards; The location of eyewash stations, other safety and first aid equipment, emergency exits and areas where food and beverage consumption and storage are permitted; 1.9 Operator must ensure that the provisions of Article 10 of Regulation (EC) No 1005/2009 followed at all times and ensure that controlled substances except hydrochlorofluorocarbons are only placed on the market and used only for essential laboratory and analytical uses. A non exhaustive list of essential and non-essential uses is included in Commission Regulation (EC) No 291/ Any significant incident (including accidental release of liquid, solid or gaseous materials from the site that could cause environmental damage) shall be reported within 24 hours to ERA and the Civil Protection Department In the event of cessation of operations on the site, all wastes (including laboratory waste and associated equipment) and hazardous materials (including chemicals) must be removed from the site such that any pollution risk is avoided and the site is returned to a satisfactory state. The Operator shall notify the Authority immediately upon a decision being taken to cease business activity, and shall submit a decommissioning plan to the Authority for approval. Final April

4 1.11. The Authority may carry out compliance checks and inspections that vary in frequency according to the site s compliance with the conditions of this GBR. Any such checks and inspections carried out by the Authority are to be made at the Operator s financial expense The Authority s representatives are empowered to inspect every part of the site and ask for any closed or locked areas to be opened. They are also entitled to be given any proof, documentation, plans, receipts or any other records which these Authority representatives may request The Environmental Conditions in this GBR apply until such time as they may be superseded for individual enterprises by the requirements of an Environmental Permit, other legal requirements or the amendment of this GBR. 2. Waste Management 2.1. All operations concerning the management of waste are subject to the legal provisions of the Waste Regulations, 2011 (L.N. 184 of 2011 as amended, S.L ) the Waste Management (Activity Registration) Regulations, 2007 (L.N. 106 of 2007, S.L ). These regulations are reflected in relevant GBR conditions (listed in this document); 2.2. Wastes should preferably be collected for recycling/re-use. When practical, recyclable wastes should be segregated to facilitate recycling Incompatible waste/materials shall be segregated. Ignitables should be separated from oxidizers or sources of ignition, especially solvents. Acids should be separated from bases, and oxidizing agents from reducing agents. Likewise, organic and inorganic waste streams should be segregated All wastes shall be stored within a designated and controlled storage area(s) prior to ultimate disposal; wastes to be recycled shall be stored in a designated container or area and not mixed with other wastes. 2.5 The storage of Hazardous Waste shall comply with the requirements of the Waste Management (Activity Registration) Regulations, 2007 (L.N. 106 of 2007, S.L ). Hazardous waste shall be stored within a designated and controlled storage area(s). A hazardous waste storage area shall be equipped with engineering infrastructure and devices aimed to reduce the risk of spillages and environmental contamination. Such measures shall include: Bunding and/or containment pans; Portable fire extinguishers; Spill control equipment and kits; Final April

5 Access to an adequate source and volume of water to supply, automatic sprinklers, water hoses or foam producing equipment; An alarm system or similar device capable of informing the facilities in the event of an emergency The storage period for hazardous waste shall not exceed 12 months No storage of waste (other than own-site inert waste) is permitted for a period exceeding 12 months Liquid and hazardous wastes shall be stored in a labelled, closed container(s) within a designated and controlled storage area(s) prior to ultimate disposal. Wastes of different natures shall not be mixed in the same container Reject, spilled or out of date chemicals should be returned to original suppliers, wherever feasible Producers of packaging shall register with ERA and provide the required information, as well as achieve the targets set out in the relevant legislation. Documentation as evidence of such should be maintained for a period of 3 years and be made available upon request by ERA Packaging and containers containing significant residual quantities of chemicals shall be regarded as hazardous waste and shall be handled and treated accordingly On-site disposal of wastes by any means including burning, disposal to drain or surface water, burying or deposition on land is prohibited, unless specifically approved by a permit from ERA or the Water Services Corporation (WSC) The transport of waste off-site shall be by means of an authorised waste carrier (through relevant ERA permits as per S.L ) and should follow the appropriate waste transfer notification procedure Movement of hazardous waste to authorised facilities shall be covered by a valid consignment permit obtainable from ERA. Each movement shall also be covered by a consignment note obtainable from ERA Shipment of hazardous waste abroad is to follow the obligations listed in Council Regulation (EC) 1013/2006 of the European Parliament and of The Council of 14 June 2006 on shipments of waste Off-site disposal or recycling of wastes may only take place at a facility licensed for that purpose (e.g. only inert waste may be disposed of at a landfill licensed for inert waste). Final April

6 2.16. Records shall be maintained for the disposal of all hazardous waste, including quantities, dates, contractor name and manner of disposal. The records should be maintained for a period of 2 years and be made available, upon request by ERA. 3. Emissions to Atmosphere 3.1. Air emissions shall be eliminated/ reduced and controlled through the installation of engineering controls. All processes which generate significant levels of airborne contaminants (such as odorous chemicals and toxic gases) shall have effective local collection and filtration, and shall discharge (after treatment where necessary) through a stack or vent located and/or designed in such a way as to avoid local nuisance Evaporation of solvents, especially chlorofluorocarbons (CFCs) and other volatile chemicals, for the purpose of disposal is not permitted Diesel (gas oil) used for generators and boilers shall have a sulphur content not greater than 0.1% Under abnormal operating conditions such as in the case of breakdown, the Operator shall reduce or close operations immediately until normal operation can be restored Extracted fumes and gases from fume hoods, sterilisation units and autoclaves, and/or exhaust gases from oil or solid fuel boilers/generators shall vent through stacks 3 metres above roof level and 3 metres above any habitable floor within a 25 metre radius as per provisions of the Ambient Air Quality Regulations, 2010 (L.N. 478 of 2010 as amended, S.L ) Minor exhausts, such as wall grills, should normally discharge above head height and be directed upwards The exhaust from general building ventilation (e.g. extractors or fans in walls or roofs) shall be vented in such a way as to avoid local nuisance For those activities where it can be shown to the satisfaction of ERA that the above venting requirements are not practical, sensible or necessary, stacks and vents shall be located and designed so as to minimise local nuisance in accordance with policies issued by the Planning Authority In the event of a local nuisance from emissions to air, the operator must, at the written request of ERA and within 30 working days, identify the specific cause of the nuisance and examine means for its elimination or minimisation including: Relocating/redesigning the stack(s) or vent(s) to a point where nuisance is minimised; Final April

7 Replacement of fuel by lower sulphur content or cleaner burning fuel; Preventative measures such as replacement of process materials (e.g. odorous solvents) by more environmentally sensitive compounds; Improved storage of materials; Use of additional abatement measures All abatement equipment and ducting shall be cleaned and maintained according to manufacturer product specifications in a way so as to ensure proper functioning of the equipment. This is to be carried out on a regular basis and records kept of any such maintenance The Operator shall prevent or where that is not practicable reduce fugitive emissions of substances to air from the installation. 4. Effluent Discharge 4.1. The Operator shall prepare and maintain a comprehensive inventory listing all water discharges generated by all laboratory processes. Such an inventory shall contain the sources and location of the discharges and data, including analytical data, which can be used to characterize both the chemical composition and the volume of each discharge No discharges to surface water or groundwater shall take place at the installation Rainwater shall not be discharged into the sewer. Foul sewer drains must be strictly segregated from stormwater drains. The operator shall endeavour to collect rainwater in a suitable reservoir or cistern The discharge of any type of effluent to land, stormwater drains or sea is prohibited, unless specifically approved under a permit issued by ERA All discharges to the foul sewer (other than from domestic sewage or equivalent) shall comply with the requirements of a license issued by the Water Services Corporation. Process effluents shall not be diluted prior to discharge to sewer The Operator shall provide a full description of its effluent characteristics when applying for a WSC permit Where requested by the WSC, effluent shall pass through a balancing tank to facilitate monitoring of the effluent Stormwater from areas where contamination by oil or chemicals is likely (such as loading/unloading and bunded areas) shall pass through an adequately sized interceptor. Final April

8 4.9. The Operator shall undertake all necessary measures and precautions to prevent spillage of raw materials, intermediates, products, waste and any other materials All process and storage areas must be appropriately contained. Any accidental release of substances shall be duly treated prior to discharge into the sewers, or disposed/recovered to the satisfaction of the Authority if treatment does not enable compliance with emission limit values in the Sewer Discharge Permit The Operator shall ensure the Sewer Discharge Permit from the Water Services Corporation is updated every year. The Operator shall abide to the provisions indicated in the Sewer Discharge Permit The Operator shall provide a full description of the laboratory s wastewater effluent characteristics when applying for a WSC permit. Substances being considered for sewer disposal must be compatible with each other and with the piping system of the sewer system The Operator shall monitor for the parameters as per Water Services Corporation requirements. The Operator shall inform the Authority of any changes to the Sewer Discharge Permit of the installation or changes made by the Water Services Corporation to monitoring requirements or frequency of monitoring All reasonable measures to minimise wastage of water should be implemented. Techniques to be employed include regular monitoring of water usage, identification of sources of high water usage, use of triggers on hoses and water efficient taps and appliances. 5. Storage 5.1. No storage of waste, equipment or materials is permitted on property outside the site premises Non-hazardous waste awaiting collection may be placed outside the site premises for a period not exceeding 12 hours Hazardous waste awaiting collection shall never be left unattended or placed outside the site premises and should be disposed of in sites permitted by ERA to receive such waste All bulk oil storage tanks shall be provided with an adequately designed bund system with an impermeable base and walls. The capacity of the bund shall be a minimum of 110% of the largest tank within the bund or 25% of the total volume of all the tanks within the bund, whichever is greater. All filling and off-take points shall be located within the bund. Final April

9 5.5. Containers for bulk storage of liquids shall be properly designed, located, labelled, bunded and maintained so as to prevent accidental spillage. Incompatible chemicals shall not be stored within the same bund Laboratory processes as well as chemical and raw material storage areas must be appropriately contained. Any accidental release of substances shall be duly treated prior to discharge into the sewers, or disposed/recovered to the satisfaction of the Authority if treatment does not enable compliance with emission limit values listed in the Sewer Discharge Permit The Operator shall prepare and maintain an inventory of all chemicals used in the laboratory which shall include chemical names, storage locations, quantities and associated hazard information. Updates to such an inventory shall be carried out as necessary 5.8. The chemicals` containers shall be appropriately labelled. This shall also apply to chemicals transferred from the manufacturer s container to a second container Material Safety Data Sheets (MSDS) shall be made available for workers on all shifts and in all locations, at all times The storage of flammable, toxic and hazardous substances and any other chemicals in stock should correspond to manufacturer specifications and MSDS sheets instructions Bulk storage tanks for liquids and associated bunding and pipe work shall be visually inspected at least once a month and certified by a warranted engineer on an annual basis. Records for such inspections should be kept for a minimum period of two years and should be made available upon request by ERA All storage of materials or waste shall take place only in locations where thorough clean-up and site reinstatement can be readily undertaken Drums and containers of paints, solvents, chemicals, oils, etc. shall be stored in designated and secure storage areas. Storage areas shall be bunded or otherwise designed so that surface and ground waters cannot be contaminated by spillages Accidental spillages of oil or other hazardous material shall receive immediate attention to prevent escape to drain, surface water or land. Spilled material shall be disposed of in sites permitted under the relevant environmental regulations to accept such waste. Kits for the collection of liquid and powder spills shall be available on site at sensitive locations The integrity of any underground storage tanks shall be examined by a qualified person at least every 5 years unless otherwise specified by Final April

10 ERA. Records of the examination shall be retained for inspection by ERA The construction of fuel tanks shall comply with relevant REWS standards The construction of new underground tanks for storage of oils and chemicals is prohibited unless specifically approved by ERA. Final April

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