SECURITY INSTRUCTION’S MANUAL FOR LABORATORY WORK Department of Cellular and Molecular Medicine
Department of Cellular and Molecular Medicine Faculty of Health Sciences ∙ University of Copenhagen Blegdamsvej 3 ∙ DK-2200 Copenhagen N ∙ Denmark SECURITY INSTRUCTION’S MANUAL FOR LABORATORY WORK To be handed out to all employees, guest researchers, students and trainees when they start working at the Department of Cellular and Molecular Medicine. The Security Instructions Manual is available at the homepage of the Department of Cellular and Molecular Medicine and is currently updated. The recent version of the manual is available at http://icmm.ku.dk/english/for_icmm_staff/ version: 16.07.14 Contents House rules……………………………………………………………..…………………………. 3 Members of the occupational health and safety committee (July 2014)…………………… 4 Evacuation instructions………………………………………………………………………….. 6 Alarm call instructions – personal accidebts……………………….……….………......…….. 8 Alarm instructions – fire, explosion, leakage, etc.…………………………………................ 9 Fire precautions……………………………………………………..…………………............... 10 Alarm instructions – unlawful intrusion……………………………………............................. 11 How to handle a bomb threat……………………………………………..……………………. 12 Keep the laboratory in proper order…………………….…………..…………………………. 13 Waste instructions.……………………………………..……………………………………….. 14 Electricity security..…………………………..………………………………………………….. 17 Registration of chemicals ………………………………………………………………………. 19 How to handle chemicals…………………………………………………..…………………… 19 Chemical accident…………………….……..……………………………...……………… 20 How to handle gas cylinders…………………….………………………….………………….. 21 How to handle radioactive materials…………………………………………………………... 22 Accident with radioactive substances ……….……………….…………………………. 24 Biosecurity…………………………….…………………………………………………………. 25 How to handle laboratory animals.……………………………………………………………. 26 How to handle biological agents………………………….…………………………………… 27 Accident with biological substances……………………………………………………… 29 How to handle human tissue or blood.……………….………………………………………… 30 Guidelines on cut and stab injuries when handling unfixed human tissue or blood… 31 Annexes………………………………………………………………………………………….. 32 House rules This Security Instructions Manual made by the occupational safety and health committee at The Department of Cellular and Molecular Medicine is a ‘’manual on noble and proper conduct in the laboratory’’. During the workday at the Department we are faced with a number of different challenges within such areas as technology, security and not at least good conduct, and it is imperative that all employees at the Department are well acquainted with the contents of the Manual and observe the rules to the benefit of their own and their colleagues’ safety and wellbeing. Particularly, it is the responsibility of the permanently employed scientific staff to ensure that new employees get well acquainted with this local manual on "proper conduct in the laboratory”. Ole William Petersen Head of Department Jesper Brahm Coordinator of the working environment When new employees begin to work at the Department of Cellular and Molecular Medicine they must be properly informed of the safety rules and receive careful instructions by the supervisors. The overall responsibility does always rest with the supervisor. Occupational injuries and ”near-to-injuries” are to be reported to the supervisory representative or the occupational health and safety representative of the group in question. A copy of the forwarded occupational health injury form is to be sent to the day-to-day occupational health and safety manager. We offer employees who work with human tissue or blood to be vaccinated free of charge against hepatitis B. Contact your local member of the Occupational Health and Safety Committee. Relevant information on the working environment is available at the University’s intranet https://intranet.ku.dk/employeeguide/HR/work%20environment%20and%20job%20satisfaction/ Pages/Workenvironmentandmentalhealth.aspx Eye-rinsing bottles, first aid equipment/plaster dispensers and emergency shower are available at all floors of the Department. 3 Members of the Occupational Health and Safety Committee (July 2014) The Department’s occupational health and safety committee, LAMU, consists of the chairman, the occupational health and safety coordinator and members of the occupational health and safety groups. Chairman Ole William Petersen, phone 28 75 72 84, [email protected] Occupational health and safety coordinator, Jesper Brahm, phone 2 7568, [email protected] Representative in FAMU (Faculty environment committee) Jesper Brahm, phone 2 7568, [email protected] Chemical coordinator Peter E. Nielsen, phone 2 7762, [email protected] GMO lab coordinator Hanne Cathrine Bisgaard, phone 29 62 37 25, [email protected] Isotope Coordinator Thomas Bentin, phone 2 7756, [email protected] Occupational health and safety groups A-H group A – building 18.1 Sascha Emilie Liberti, supervisor representative, phone. 26698, [email protected] Theresa Wass, occupational health and safety representative, tlf. 26761, [email protected] group B - building 18.2/22.2 Henrik Nielsen, supervisor representative, phone 2 7763, [email protected] Lotte Niels-Christiansen, occupational health and safety representative, phone: 2 7788, [email protected] group C- building 24.6 Hans Wandall, supervisory representative, phone. 23 84 01 56, [email protected] Lotte Bram, occupational health and safety representative, phone, 3 0693, [email protected] group D - building 22.4/ 24.4 Hans Rudolf Lytchoff Eiberg, supervisor representative, phone 2 7829, [email protected] Pernille Froh, occupational health and safety representative, phone: 2 7210, [email protected] group E - building 18.4 / 22.3 / symbion Hanne Cathrine Bisgaard, supervisor representative, phone 29 62 37 25, [email protected] Izabela Rasmussen, occupational health and safety representative, phone 27179, [email protected] group F - building 12.6 + glass wash Jesper Brahm, supervisor representative, phone 2 7568, [email protected] Wid Talal, occupational health and safety representative, tlf: 2 7578, [email protected] 4 group G – exercise/teaching Hanne Mikkelsen, supervisor representative, phone 2 7302, [email protected] Johnny Grandt, occupational health and safety representative, phone 2 7207, [email protected] group H - administration, building 22.1 Jesper Brahm, supervisor representative, phone 2 7568, [email protected] Mette Kjær Schou , occupational health and safety representative, phone 2 77 45, [email protected] 5 Evacuation instructions The same basic evacuation concept is applied at all faculties of the University of Copenhagen. All buildings are divided into units of a reasonable size, e.g. a floor. In every unit a green plastic folder is located centrally in the corridors, (as shown on the right-hand picture), containing a yellow waistcoat to be worn by the Evacuation Leader and an orange waistcoat for the Assembly Point Leader. Furthermore, the green plastic folder contains instructions in Danish and English for both leaders in charge of the evacuation. (Annex I +II) An evacuation is kicked-off locally or e.g. by the fire brigade, and the objective of the new evacuation concept is that two employees from each evacuation unit are to accept the roles. Unannounced evacuation drills will be held once a year (however due respect is paid to ongoing research). Your duty = our safety In each evacuation area the staff carrying out their work every day are obliged to get familiar with the evacuation plans to ensure that there is always a sufficient number of staff present with knowledge of the evacuation rules and ability to act accordingly. Thus no specific key personnel are to function as responsible Evacuation Leader and Assembly Point Leader during an evacuation situation. To ensure that the system works in every unit all permanent employees should be able to carry out the mentioned tasks. Evacuation signal If evacuation is necessary, you will be alerted by loudhailer or shouting. When alerted, please follow the evacuation instructions. (Annex I + II) Evacuation Leader The evacuation leader is usually a person close to the evacuation equipment folder at the time of an event requiring evacuation. The evacuation leader puts on the Yellow waistcoat and reads the instructions. The Evacuation leader’s role is to warn staff in the area specified on the back of the instructions and to ask them to leave the area and go to the Assembly Point. The Assembly Point is mentioned on the back of the Assembly Point Leader’s instructions. The Evacuation Leader is not to participate in any kind of rescuing work and should not take any risks, be it estimated to be dangerous to enter certain parts of the area. 6 The Assembly Point Leader The Assembly Point Leader is usually a person close to the evacuation equipment folder at the time of an incident which requires evacuation of the area. The Assembly Point Leader puts on the orange waistcoat and reads the instructions for the Assembly Point Leader. The role of the Assembly Point Leader is to collect information concerning the evacuated areas from the Evacuation Leader when they meet at the assembly point, such as: have people left the area? Is there any smoke/fire in certain parts of the area or other important issues for the rescuing. The information should be passed on to the arriving Incident Commander from the police or fire brigade. An evacuation video is available at: http://sund.ku.dk/for_ansatte/driftsafdelingen/evakuering/video (Adobe flash player) 7 Alarm Call instructions – Personal accident In case of any casualties • Call the Emergency Service, dial 1 -1 - 2 Inform: o What has happened (e.g. a person injured by a fall) o Where has it happened: Building, department, floor, room The Panum Institute Blegdamsvej 3 (during the construction work the main entrance is at Nørre Allé 20) 2200 Copenhagen N o Are there any casualties (how many) o Who is calling o The caller’s phone number Limit the extent of the accident (prevent it from escalating) Rescue people in danger – provide first aid – and warn other people of the danger Call the guard from the Surveillance Center at Panum, so they may guide the paramedics, phone 353 27028. 8 Alarm call instructions – Fire, Explosion, Leakage etc In case of a fire, an explosion or a chemical leakage, etc. • Call the ”Surveillance”, Campus Service Sund Dial 353 27028, or 353 27029 Inform about: • What has happened (e.g. fire) • Where has it happened: Building, department, floor, room The Panum Institute Blegdamsvej 3 (during the construction work the main entrance is at Nørre Alle 20) 2200 Copenhagen N • The number of casualties • The name of the caller • The caller’s phone number Rescue people in danger – warn other people who might be in danger Extinguish the fire, if possible, using the fire equipment available at the location. Limit the extent of the fire or explosion or leakage by closing doors or gates. Stop admission of smoke/vapours, e.g. through open windows in case of a leakage etc. Note! In case of fire, an explosion accident, or a chemical leakage, it is crucial to contact the”Surveillance”, the Campus Service Sund 35 32 70 28. 9 Fire precautions Escape routes (corridors and doors) should be checked regularly to ensure that they are not barred. Furthermore, control that no fire proof doors are kept open with a wedge, etc. Know the location of the fire-fighting equipment Carbon dioxide extinguishers (CO2 extinguishers), water fire extinguishers, fire blankets, emergency showers should be available at every floor. Even in case of minor fires the alarm instructions must be followed, but if you can handle the situation, you may use the fire-extinguisher equipment at the same time, if the rules below are followed: Burning liquids: Use carbon dioxide extinguishers – never water. Electric installations on fire: Cut off electricity. Use carbon dioxide extinguishers – never water. Wood, paper, carton, textiles etc. on fire: Use water fire extinguisher. Peoples’ clothes on fire: If possible, smother the flames with a fire blanket, towel, jacket or things alike (not laboratory coats etc. made of synthetic materials) and quickly help the person to a shower with lukewarm water. Help the person to remove all clothes (shoes too) AT ONCE, while the person is in the shower. The showering should be done previously or simultaneously with calling the ambulance. Fire If evacuation is necessary, you will be alerted by: Loudhailer or shouting When alerted, please follow the evacuation instructions (Annex I+II). In case of fire an estimate must be made of the capacity to extinguish the fire locally using the appliances available on the floor or if the fire brigade should be called and the floor evacuated. Subsequent to calling the fire brigade, call the Surveillance, Campus Service Sund, phone 35 32 70 28. The fire fighting appliances available on the floor should be obligatory knowledge for everybody on the floor. Likewise the Digital fire fighting school course by Trygfonden. It is available on the internet http://ku.powerlearn.dk/ 10 Alarm instructions – unlawful intrusion etc. In case of demonstrations, unlawful intrusion, vandalism, threats of violence or violence etc. • Call the ”Surveillance Unit”, Campus Service Sund, Dial 353 27028 Inform: • What has happened (e.g. unlawful intrusion) • Where has it happened: Building, department, floor, room The Panum Institute Blegdamsvej 3 (during the construction work the main entrance is at Nørre Allé 20) 2200 Copenhagen N • The number of casualties • The name of the caller • The caller’s phone number Rescue people in danger – alert other people who might be in danger Stop the accident, if possible Limit the accident by locking relevant doors/gates etc. NOTE: In case of demonstrations, unlawful intrusion, vandalism, threats of violence it is important to contact the Surveillance”, Campus Service Sund. In case of casualties, please press 112 to contact the police or ambulance. 11 How to handle a bomb threat Nearly all bomb threats are received via the telephone. In case you receive a bomb threat, please follow the procedure below: • Keep the caller on the line as long as you can and attempt to obtain as much information as possible. Ask for the message to be repeated to confirm it. Write down all information received. • Ask for the precise location of the bomb and for the time of detonation. • Ask what the bomb looks like – is it a parcel – what kind of bomb is it. • Ask why the bomb was placed there and who is responsible for it. • Listen closely to the voice – is it a male or a female voice – calm or excited - accent or dialect - or anything else identifying the caller. • Pay special attention to background noises, such as traffic, music, talk – eventually of great importance. • Do not hang up after the call – a clue to the location of the caller. • Promptly contact the Surveillance, Campus Service Sund, phone no. 353 27028. Use another phone if possible. 12 Keep the laboratory in proper order The following rules are to be followed: • Used glass wares should be removed and chemicals etc. returned to their proper place after use. • Tidy up at once, when an experiment is finished. • Spilled substance must be removed by the person having spilled it. Pay special attention to the area around the scales. • Everything dropped on the floor must be picked up by the person having dropped it. This applies to everything from paper to pipette tips. • All solvents, samples etc are to be labelled with contents, name and date. • Hazardous substances and solvents must be labelled with name, contents, R & S sentences and danger symbols, if any. http://www.chemie.fu-berlin.de/chemistry/safety/r-saetze_en.html http://www.onsafelines.com/new-international-coshh-symbols.html • Use fume cupboards if your work produces smelly and toxic fumes. • If liquids are spilled in centrifuges, fractionating collectors etc, clean the apparatus properly at once. • Centrifuges must not be used without careful instructions of the user. Rinse the centrifuge heads with water after use and return them to their proper place. • Use face screen if you are working with vacuum equipment uncovered by wire netting. • Clean scales, microscopes and spectrophotometers after use, and remove things brought along with you. • Do not borrow anything from another laboratory without asking. Borrowed things should be returned immediately after use. 13 Waste instructions All waste should be disposed of according to the following rules: Hospital and Biological waste ( clinical risk waste) Infected non-autoclaved waste Including blood-stained or purulent soaked, still moist dressings, bandages, cotton wads, etc. Disposable gloves, serum remains, microbiological cultures, diagnostic kits in non-closed containers and cytostatic contaminated syringes, glass, infusion equipment (the complete set) and screens for extractor cabinets for preparation of cytostatics and other contaminated equipment. - To be packed into yellow plastic bags being closed in the laboratory. Organs and tissue remains, etc Dead animals used in infectious research experiments, dead animals with human infectious diseases and other dead animals that are not accepted at the incinerator according to the rules of the Danish Veterinary and Food Administration. - To be packed into yellow plastic bags being closed in the laboratory. Sharp and pointed articles Hypodermic needles and scalpels should be packed into special hypodermic needle boxes which are properly closed. Subsequent to packaging the above kinds of waste should be disposed of in the container for Clinical Risk Waste, room 6.01.47A or 12.01.47A (next to the goods lift, floor 01). Dead animals and tissue waste (non infectious) Dead animals, tissue waste and blood-stained paper waste should be packed into yellow plastic bags and disposed of in the freezer in room 6.01.47 and 12.01.47 (next to the goods lift, floor 01), and in the room next to the goods lift at floor 01, building 24 (the key is available in 22.4). Yellow plastic bags are available next to the freezer. When working at the Department of Experimental Medicine (Department of Animal Experiments) dead animals can be delivered there according to a previous arrangement. Chemical waste All chemical waste is collected and grouped strictly according to content: Waste group O: Waste group K: Waste group Z: Waste group T: Waste group X: Waste group A: Waste group B: Waste group C: Waste group H: Organic peroxides, strongly oxidizing substances or if the waste react with water during the formation of flammable or acid gasses. Mercurial waste. Miscellaneous waste in small packaging. Pesticides or emptied pesticide boxes Only inorganic substances. Only mineral oil products, e.g. lubricating oil. Halogen and sulphurous organic substances. Organic >50% solvent. Organic < 50% solvent/ solid substances. Subsequently the waste can be delivered in the Panum Service Yard on Mondays, 10 to 11 am. Waste groups for concentrated chemicals are available on the chemical instructions at “Kemibrug” (Chemistry Use) . http://www.kemibrug.dk/?lang=en 14 Jars from “Kommunekemi” (The Danish National Company for incineration of hazardous waste) should be equipped with a declaration of contents. Print labels from https://intranet.ku.dk/arbejdsmiljoe/kemiskarbejdsmiljoe/kemiaffald/affaldsetiketter/Sider/default. aspx Glass and bottles Glass waste is divided into three categories: glass for recycling, glass for depositing and chemical contaminated glass packaging. Glass for recycling (wine bottles, alchohol bottles, preserving jars) is collected in bottle containers at floor 01(Annex III). As a principal rule all types of glass used for foodstuffs can be recycled. The glass should be cleaned containing no remains of food, as it is manually sorted at the recycling centre. Glass for depositing is collected in the green containers at floor 01 (Annex III). As the container will be deposited items such as porcelain, flower pots, pottery, window glass, mirrors, clean laboratory glass etc may also be disposed in the glass container. Glass containing chemicals or pesticides which cannot be cleaned are as far as possible to be used for storing of chemical waste to be sent to “Kommunekemi”. Otherwise they should be packed as chemical waste for “Kommunekemi” and disposed of in the Panum Service Yard on Mondays, 10 to 11 am. Battery waste Used batteries are disposed of in specific containers. Paper Ordinary paper, newspapers, magazines, writing paper, photocopies, computer paper, remains from punching and the like - and telephone directories with the green Nordic Swan label can be recycled. But not telephone directories without the Nordic Swan label, laminated paper ware, such as milk and juice cartons, greaseproof paper or carbon paper. Containers for recycled paper are available next to the photocopying machines, and in many offices. Empty the containers into the recycling paper container located at the goods lift at floor 01 (Annex III). Cardboard Various cardboard, corrugated cardboard and cardboard from production, packing, shipment etc. But not newspapers, weekly magazines, plastic film, milk cartons and other laminated cardboard parts and the like. Empty cardboard boxes should be stripped of plastic and foam remains, folded up and disposed of in the cardboard container located beside the goods lift on floor 01. 15 Some catalogues, books etc. have a glued on back. They can, however, be recycled as paper, but special treatment is required and therefore they are collected separately. If the back is cut off with a knife the catalogues and books can be disposed of as recycled paper. Clipped catalogues can be recycled at once as paper. Books and catalogues with glued on backs are disposed of in a special “cage” located in the Panum Goods Yard. Radioactive waste During work distinguish between: • Solid, inactive waste (< 0,01 MBq/kg): Standard refuse collection Low level radioactive waste: Solid, including biological waste: Clinical Risk waste (see above) Liquid, aqueous (< 0,1 MBq/l): Drain. High level radioactive waste: RISØ (National Laboratory for Sustainable Energy). It is important to distinguish as the price increases considerable with the degree of radioactivity. • Fluid scintillation counting waste may be disposed of as Clinical Risk waste (see above) provided - according to the environment legislation - the composition of the solution does not preclude this (e.g. Ultima Gold and Opti-Fluor from Packard) and provided that the radioactivity is lower than the limits mentioned below . Fluid scintillation glass should be packed into yellow plastic bags with absorbing material (vermiculite, paper etc.). • Radioactive waste should always be disposed of in closed yellow plastic bags. Use a monitor to check the surface activity. The dose rate must not exceed 5 microSv/hour • Solid waste should always be disposed of in yellow bags as Clinical Risk waste (see above). Solid waste volume should be minimized as much as possible (expensive disposal). Radionuclide groups 2 (I-125) 3 (C-14, P-32) 4 (H-3, S-35, Cr-51) Maximum radioactivity amount per bag 5 MBq 50 MBq 500 MBq If the waste contains gamma emits (I-125) it is deposed of in the lead bin for decay. If the waste contains beta emits (P-32, S-35) it is disposed of in one of the aluminium bins in Type B isotope laboratories (room 12.3.45). Make sure that there is a yellow plastic bag in the bin before disposing of any waste. The disposal takes place according to agreement with RISØ. • Liquid waste, to be disposed of via the drain per month per isotope permission (first to be diluted to < 0,1 MBq/l): Radionuclide group 2: Radionuclide group 3: Radionuclide group 4: 5 MBq (I-125) 50 MBq (C-14, P-32) 500 MBq (H-3, S-35, Cr-51) Liquid waste which is not to be disposed of via the drain should be filled into waste bottles. Note the name, isotope, activity amount and date, and information about other relevant substances in the waste. Waste bottles should be stored shielded for decay, if the half-life period is less than 20 days. To be disposed of in agreement with RISØ. 16 Electricity security Generally An electric current may pass through your body with a mortal effect if you touch two conducting materials simultaneously, (e.g. metal or liquid, etc.) with a potential difference > 64 V. The most common cause of accident is if you with one hand touch a device with error disruptive voltage from the power supply and you put your other hand or foot on an earthed thing. The risk is eliminated if all that you can touch at the same time is either earthed or insulated (nonconducting). As the laboratories contain a great number of earthed materials (piping systems, steel tables, devices), the probability of being in contact with ”earth” is immense. Consequently, all conducting surfaces which - with or without defects - may touch live device parts should be either insulated or earthed. NB! Specific, stringent rules apply for electric measuring on humans and animals (electrodes, thermometers, infusion pumps, etc.) and special requirements exist for the set-up and the physical surroundings. Important advice The mains lead The mains lead, including the plug, is the most important element to check from an electricity security point of view. If the safety device (the terminal point wedging the lead firmly in the plug) is slacked, then the risk of accident is vast – For example the earthed lead may thus be cut off – but the device may still work anyway without the safety earth connection on crucial spots. If the worst comes to the worst a slacked earth lead in the plug may touch the phase pin and thus create a deadly current on the whole device surface. Do not pull at the mains lead when removing the plug, but clasp the plug itself. In particular that is important in the Panum building where the plugs often are extremely firmly positioned in switches and panels. Dampness Water is more or less conductive, but sufficiently to cause accidents. Saline solutions are better electric conductors than pure water. Even though the ground fault circuit interrupter should switch off supply in error situations, you should not count on the fact that both the ground fault circuit interrupter, the device and all the earth connections are being intact. An electric shock even as short as the interrupter’s reaction time is strong enough to be dangerous. Especially the risk exists on the laboratory steel tables normally unearthed. A device or mains lead out of order, an illicit mains distributor or a ”mains adapter” may due to faults (e.g. caused by dampness) create a voltage on the whole table without any reaction from the ground fault circuit interrupter and an accident may be the result. Keep electric devices, leads, etc away from (damp) steel tables! Unauthorized devices You are not allowed to connect ”unauthorized” devices, that are not equipped with or may be equipped with the “hospital plug “(see the chapter ”Special rules for the Department of Cellular and Molecular Medicine"). In this way you evade the security system and expose yourself and others to an additional risk. Thus any attempts made by the users to connect devices with other mains plugs e.g. by exchanging the mains plugs and by “graising” on these or by applying unauthorised extension leads will be an act contrary to the intentions. The effect will be an increased risk and noise level for yourself and others. In general: A crack in a plug, a scratch in a lead, a loose safety device (lead fastening) a peculiar state of the device, a tingling in the fingers or even a shock. 17 Have the problem solved immediately – and do not postpone the problem to the next time or next user. If there is the slightest doubt about the security of the installation or apparatus, contact your “local” electricity service (Peter Bech Jensen, [email protected]). Also contact the electricity service in connection with new purchases, preferably before the purchase to ensure that the making of the devices is correct. Specific department rules Wiring at the Panum is at many places designed for device connection via the so-called “hospital plug”, characterized by a flat phase pin, a round 0 pin and “below” a semi-round earth pin. Devices with this mains plug should comply with the noise and safety requirements. Other devices should be controlled by experts prior to the fitting of the “hospital plug” For further information, please see the “Guidelines on electricity security in the laboratory – with focus on semi-enclosure security”, (in Danish) issued by the Occupational Health and Safety Organization, Technical Administration, University of Copenhagen, April 2000. You may download the guidelines from the Occupational Health and Safety Organisation’s homepage (http://arbejdsmiljo.ku.dk/vejledninger/elsikkerhed/ in Danish) 18 Registration of chemicals All chemicals/reagents that are bought on ICMM (and the rest of the university) must be registered in a central database called Kemibrug. http://www.kemibrug.dk/?lang=en (this is a requirement from the Danish Working Environment Authority) Log in with user name: icmm and password: (if the password is not added here by handwriting contact your local occupational health and safety representative and ask for it) Under "search" choose "Only search your own organisation's database" (the database is used by several universities) You will then be able to search for data for a lot of chemicals/reagents, and if anybody at ICMM has got them in stock you will be able to see it. So please remember when someone buy chemicals/reagents in your group, they must fill out this form so everything can be registered correctly https://intranet.ku.dk/icmm/LAMO/kemibrug/Documents/Kemikalieregistrering%20i%20Kemibru g.docx (in danish - so far), Annex V Pass on the form to a member of the local Occupational health and safety group. How to handle chemicals Always read the security regulations of a chemical before using it for the first time. Security rules Several regulations and instructions by the Danish Working Environment Service concerning work with “substances and materials” have been written. They are available at the homepage of the Danish Working Environment Service (http://engelsk.arbejdstilsynet.dk/), under Regulations. It appears from the Danish Working Environment Service’s guidelines C.1.3 that a list of all hazardous substances and materials in use at the workplace should be available. Chemical coordinator at the Department of Cellular and Molecular Medicine is Peter E. Nielsen ([email protected]). Common rules for working with chemicals • Workplace instructions (chemical instructions + local procedures) should be available in the laboratory. Chemical instructions are available via Kemibrug (Chemistry Use) at the homepage http://www.kemibrug.dk/?lang=en. Kemibrug (Chemistry Use) is a cooperation between the University of Copenhagen and the Technical University of Denmark. • Laboratory coat: you are required to wear a laboratory coat when working with chemicals. Mouth pipettering and eating or drinking is of course not allowed in the laboratory. • Dangerous and poisonous substances should be stored properly (i.e. poisons locked in poison cupboard) and in the original packaging. In case of decantation and dilution label the new packaging with the name of the substance and danger symbol. • Substances which might emit dangerous fumes or dust should be handled in fume cupboards or at workplaces with fume extractors. 19 • Dilutions of strong acids and bases should be made in heat-stable glass apparatus (generation of heat). Never pour water into concentrated acid. The dilution should always be made pouring the Acid into the Water (AIW). • Use gloves during work with carcinogenic or in other ways toxic chemicals or chemicals causing local irritation; weighing of powder etc risking inhalation also use a mask and fume extractor (fume cupboard or laboratory fume extractor). Chemical accidents If a chemical is spilled use Vermacolit to absorb it and dispose of it according to the rules for other chemical waste. Vermacolit is available in the Panum Service Yard. Spilled chemicals etc. must be reported to the local Occupational Health and Safety representative and all staff at the department must be informed about the incident. In case of poisoning – contact the Poison Control Hotline at Bispebjerg Hospital (Bispebjerg Bakke 23, dial 82 12 12 12 ). http://www.bispebjerghospital.dk/giftlinjen/topmenu/english/ 20 How to handle gas cylinders Rooms with steel cylinders containing compressed gasses are to be marked. A plate with ”Gas cylinders – to be removed in case of fire” approved by the fire authorities should be put at the door of the room. When moving a gas cylinder use a cylinder trolley – a specifically designed wagon with a base plate and chain attachment. If the cylinder is to be positioned in an arrangement of apparatus it should be secured by means of retaining straps or chains on to either a table, wall etc. unless it remains chained in the cylinder trolley. Ensure that the pressure regulator (manometer) is dismantled from the cylinders before transport. Steel cylinders with compressed gasses should not be exposed to jolts, blows or heat (e.g. radiator heat or sunshine). Keep pressure regulators clean and equipped with original, flawless gaskets and do not lubricate them. This is particularly important for oxygen cylinders to avoid self-ignition of the grease and a subsequent explosion. Opening of a gas cylinder should be done slowly to ensure that the desired pressure value of the outlet increases slowly. There are different types of pressure regulators on the market – therefore see the manual before opening and closing of a gas cylinder. 21 How to handle radioactive material Responsibility for the work with radioactive Isotope coordinator at the Department is Thomas Bentin ([email protected]). Each supervisor is responsible for the work with radioactive substances within his or her own working area and together with the permanent staff, trainees, students, guest researchers, scholarship holders he or she must ensure that the work is carried out with due respect to radiation protection. Radioactive material must be properly packed and labelled. Radioactive waste is likewise to be properly labelled and disposed of (see page 16). Security rules Our security rules are “Guidance on radiation protection when working with non-sealed radioactive sources” issued by the National Board of Health and National Institute of Radiation Protection at Work in 2002 (http://www.sst.dk/Sundhed%20og%20forebyggelse/Straalebeskyttelse/Radioaktivitet/Vejlednin g_og_raadgivning.aspx) and “Executive order on the application of non-sealed radioactive sources at hospitals, laboratories etc.” (no. 954, October 23, 2000 (www.sis.dk). The laboratory manager must have received training as described in “Guidance of approval of responsible manager for non-medical application of non-sealed radioactive sources”, issued by the National Board of Health and National Institute of Radiation Protection in 2002 (www.sis.dk) Dose control Dose control rules are available in the National Board of Health’s executive order, no. 823, October 31, 1997 (http://www.sst.dk/Sundhed%20og%20forebyggelse/Straalebeskyttelse/Persondosimetri.aspx in Danish) Commen rules for working with radioactive materials • The work is to take place in rooms approved by the National Institute of Radiation Protection. At the Department three Type C’s isotope laboratories are available (responsible for the three laboratories are Thomas Bentin, Frederik Vilhardt and Jesper Brahm). Furthermore, there is access to one Type B isotope laboratory. If you want to use that laboratory contact Jesper Brahm or Carolyn Deacon. When using the laboratory you must enter your name in a register available in the small room of the isotope laboratory (room 12.3.45: Carolyn Deacon). All isotope laboratories should be equipped with a radioactivity warning sign. A record has to be made of all repeat observations for radioactive contamination of employees and surfaces in the isotope laboratories. Employees above 18 years capable of receiving radioactive doses higher than 6 mSv/year, are to be monitored by a dosimeter. Special rules apply for pregnant employees. • Stocks of radioactive material should be stored in isotope labeled refrigerators or freezers. The isotopes should be properly shielded and stock lists of stored isotopes and consumption of them should be made. • Always wear a buttoned up laboratory coat and use disposable gloves. • All work with open radioactive sources should be carried out on a plastic covered working area with absorbing paper on the top. • Working with radioactive substances, eventually causing a spill of the material, aerosols or vaporization of the radioactive substances must be carried out in plastic covered fume cupboards (see above). 22 • Only use disposable containers for isotope work, if possible. • Only bring the most needed articles from other laboratories with you. Everything must be controlled with a monitor/”wipe-test” before returned. • Never bring or use the following articles in laboratories, in which radioactive substances are being worked with: o food and drinks o tobacco o handbags o lipsticks and other cosmetics o paper tissues (disposables should be available in the laboratory). • Rings, watches and bracelets should be removed prior to the work with radioactive substances. • All solvents and dilutions of radioactive substances must be labeled with isotope, activity, name and date. Labels should be available in the laboratory. • All radioactive waste should either be disposed of as quickly as possible or stored properly for decay, clearly labeled with isotope, activity, name and date. • At the end of working hours tidy up the laboratory completely. • Subsequent to the P-32 and I-125 work use a monitor to control that the workplace, hands and laboratory coat are non-contaminated. • Wash hands properly before leaving the laboratory. • The radiation dose should be kept as low as possible. As the radiation dose is dependent on the amount of radioactive substance, radiation time, distance and shielding, the radiation dose can be kept low if: o applying as low activities as possible o handling the radioactive source as briefly as possible o increasing the distance to the radioactive source as much as possible, as the dose decreases with the square of the distance o applying shielding • Use plexi glass shielding for β-radiation (e.g. P-32) • Use lead or lead glass shielding for γ-radiation (e.g. I-125) 23 Accidents with radioactive substances The person having spilled radioactive material is obliged immediately to take good care of implementing decontamination. Pour absorbing material on the spill and avoid spreading the contamination. Subsequently, wash with a carrier solution, i.e. a non-radioactive solution of the marked spilled substance. However, in case of P-32 spill a potassium phosphate solution should be applied, or in case of I-125 a sodium iodide should be used. Afterwards use a monitor to control the contamination of the area (for P-32 or I-125) or apply a “wipe test” (i.e. counting in the scintillation counter) (for H-3, C-14 and S-35). Contamination of skin requires repeatedly rinsing with a carrier solution and careful washing with water and soap. If the skin is still contaminated contact a doctor or the emergency ward. Serious contamination (stab, cut, consumption) should be reported at once to the responsible supervisor. Serious contaminated articles (including clothes) should be disposed of as radioactive waste. Accidents with radioactive substances should be reported to one of the Department’s isotope responsible employees (Thomas Bentin and Jesper Brahm). A radioactive protection expert from the National Institute of Radiation Protection can be contacted in case of accidents with radioactive substances, phone 4943773 (24 hours surveillance). 24 Biosecurity Application of biological agents and equipment covered by a new executive order on Biosecurity. All departments working with substances or technology contained in "the Executive order, no. 981, of October 15, 2009, on securing specific biological substances, delivery systems and related materials", should apply for a permit from the Centre for Biosecurity and Preparedness (CBP) or destroy them properly. The order is an implementation of the Act of the Danish Parliament, no. 474 of May 17, 2008 on security of specific biological substances, delivery systems and related materials. Background: The Purpose of the order is to prevent that unauthorized persons get access to technology and substances for the production of biological weapons (terror). With the word technology is meant delivery systems, knowledge and data. On November 1, 2009 the Executive order no. 981 took effect. ( annex IV.) A new national authority is in charge of the order, i.e. the Centre for Biosecurity and Biopreparedness (http://www.biosikring.dk/eng/) located at the Danish National Institute, but which is an independent authority. Delivery systems Spray and mist systems, aerosol generating units. Related material Facilities for encapsulation at encapsulation level P2 or P3 (biological agents, risk groups 2 and 3) fermentors, centrifugal separators which can carry out continuous separation, filtration equipment with intersecting flow, freeze drying equipment which can be sterilized by steam, protective suits and hoods with permanently attached external air supply, chambers designed for aerosol provocation testing, biological detection systems and specific information (technical data or technical assistance), required for development, production or use of a product. Substances Include patogeneos biological agents and toxins, inoculated on plates or in stock. Human pathogens and zoonotic substances: viruses, rickettsiae, bacteria, fungi. Genetic elements from the specified bacteria/organisms and their infected host: nucleic acid sequences within and outside host. More information is available on their homepage http://www.biosikring.dk/eng/ As a supplement to the executive order, no. 981 the CBB has made an exemption list and other delimitations, see the item “Biosecurity – What is included?” A control list of biological substances, delivery systems and related materials is available in the Enclosures at the end of this manual. If you hold or apply some of the materials mentioned in the list, please ask the day-to-day occupational health and safety manager, what to do. 25 How to handle laboratory animals Work and contact with laboratory animals entails a risk of developing allergic illnesses. Allergy is especially developed towards substances (allergens) of the urine, saliva, skin and fur of the animals. Allergic illnesses can be serious and may affect the life of a person throughout a necessary and lifelong medical treatment and limitations in conduct and activities. Therefore it is important prior to the work to consider whether you are particularly predisposed and also how the risk of developing the illness can be minimized. Such a predisposition is a special risk element in connection with the work with laboratory animals and in such cases this kind of work must be warned against. On the other hand working with laboratory animals does normally not involve any particular risk in connection with pregnancy. Early allergic symptoms are usually inconveniences like itching eyes and nose and maybe also a tickling in the upper respiratory tract. Further symptoms are sneezing and bleary eyes. Sometimes a local itching skin eruption appears after being in contact with animals. When such an allergic condition has developed the symptoms will appear about 10 to 20 min after the contact no matter whether the contact with the animals is direct or whether the person just stays in a room with the animals. Allergy does not develop or appear unless there has been a contact to the responsible substances from the animals. Therefore in the first place focus on limiting contact to the animals and the exposure to the allergenic substances, which they excrete: • The work with laboratory animals may only take place in special rooms designed to the purpose. • Ensure that cleaning of these rooms is optimal. • As few articles as possible should be in the room to avoid dust gathering. • Efficient ventilation removing dust is required. • Work with regular movements to avoid dust formation. • Normally a laboratory fume extractor should be available for special procedures • Use full protective suit, gloves, shoe cover and hair protection. In special cases the use of breathing mask and safety goggles may be recommended. • Wash hands after the work and apply hand cream. Other risks: The work with nearly all animals implies the risk of bites. Such wounds should be carefully cleaned. Therefore based on this risk, staff working with laboratory animals should be vaccinated against tetanus. For further information, see the manual “Work with laboratory animals” issued by the Occupational Health and Safety Unit, Technical Administration, University of Copenhagen, November 1998. http://www.ku.dk/regel/4/3/Tekst%20til%20tryk%20fors%C3%B8gsdyr.html Furthermore, see the “Guidelines on laboratory animal rooms requirements and rooms for animal experimental work” issued by the Occupational Health and Safety Unit, University of Copenhagen, November 1997. Download the manual from the homepage of the Occupational Health and Safety Unit (http://www.ku.dk/regel/4/3/Krav%20til%20dyrerum.html in Danish) 26 How to handle biological agents Security rules This chapter is primarily based on the following laws and guidelines by the National Working Environment Authority (NWEA) - "Biological Agents – Guidelines for the work with infectious microorganisms, etc. in laboratories and industrial processes” (NWEA guidelines C.0.18, Sept 2006) - “Guidelines for classification of and requirements to laboratories and laboratory areas, in which work is carried out with genetic modified organisms, class 1 and 2” (DWEA guidelines C.0.4, April 2001) - “Risk assessment of gene technology research projects etc.” (NWEA guidelines C.0.5, April 2001) - “Executive order on gene technology and working environment ” (no. 642, June 2001) All guidelines are available on the homepage of the Danish Working Environment Authority (http://arbejdstilsynet.dk/en/engelsk.aspx), “Regulations”. Laboratory work with infectious material (material containing biological agents) are subjects to the law requirements for a formal risk classification and a possible notification to the NWEA. “Biological Agents” are defined as infectious micro organisms whether they are natural or genetically modified. Therefore NWEA.C.0.18 may be considered basic common guidelines which have been enlarged with further rules for the work with genetic modified organisms (GMO) (see above). The GMO work requires an approval (based on individual application) of the specific project and of the fitting up and design of the laboratory and the procedures (“gene technology laboratory”), including a GMO work specific security manual for the employees of the laboratory. In the light of the above-mentioned specific security rules for these laboratories the GMO specific conditions are not included in this common security instructions manual for laboratory work. Notification to the DWEA concerning new gene technology laboratories is made by the supervisor in cooperation with the Department’s GMO coordinator Thrine Bisgaard (phone 2 7703, [email protected]) and GMO consultant at SUND Randi Iversen ([email protected]). Basic conditions “Biological agents” cover micro organisms (including GMOs) cell cultures and endoparasites in human beings which may cause infection, allergy or toxicity. NWEA C.0.18 states that in cell cultures it is not the culture itself that is to be considered a biological agent, but any possible agents being present in the cells. A similar consideration must apply for all other forms of biological experimental material. Each laboratory manager should consider whether the applied tissue, organ or cell type or eventually the whole experimental animal should be considered as an infectious carrier of biological agents and therefore should be included in the relevant security rules. Risk groups in outline Risk group 1: Micro organisms (MO) that may not cause any diseases for human beings. Risk group 2: MO that may cause infectious diseases for staff, with limited risk of spreading the disease to society and for which an efficient prevention and treatment exists. Risk group 3-4: MO that may cause serious disease, eventually with a great danger of spreading the disease to society and for which an efficient prevention or treatment may not exist. 27 The work with MO in the risk groups 3 and 4 requires extensive measures (including class 3 and 4 laboratories) and will not be dealt with further in this manual. The National Working Environment Authority (NWEA) has informed (June 2003) that in practice the requirements for the work with biological agents in risk group 2 is equalized with the requirements for the work with GMO in the risk group 1. General rules for the work with biological agents The extent of the MO work and risk group classification should appear from the workplace assessment (APV). Laboratory managers should be aware that the NWEA should be notified of work with biological agents from the risk group 2 to 4. The notification should be made in cooperation with the occupational health and safety consultant of the faculty. Rules for working with biological agents appear from the NWEA C.0.18 subsection 6. In the following some main features are mentioned: 1. Work with MO in the risk group 1, requires no special precautions. 2. Work with MO in the risk group 2 must only be carried out in working areas which as a minimum meet the requirements for class 2 laboratories (correspond to gene technology, class 1 laboratories). The following applies: • “The working area” to be marked can be a laboratory or a specially designed part of a laboratory. • Access to the working area should be limited for unauthorized people – no ordinary coming and going and no passing through. • A number of requirements are made for the disinfecting procedures, vector control, for cleaning easiness of working surfaces and for the positioning and keeping of infected materials or animals. • A number of requirements are made for laboratory fume extractors, especially that the air is not recirculated to the working room. • Special requirements are made for handling of waste. 28 Accidents with biological agents Accidents in the laboratory should at once be combated or relieved by means of countermeasures and reported to the supervisor. Countermeasures consist of: 1. Barring of the involved area 2. Disinfection and subsequent cleaning: apply Diversol 4% for at least 5 min before drying with cellulose or other absorbing tissue. Moreover, any liquid material is absorbed with affluent amount of tissue or cellulose (afterwards to be autoclaved) and the area disinfected. Contaminated laboratory coats, dish towels, paper, tissue, etc should be autoclaved before wash or disposal. In case of personal injury contact the casualty ward at Bispebjerg Hospital (Bispebjerg Bakke 23, phone 35312372 or 35312373). In case of an infectious material in the eye, rinse with affluent amount of sterile isotonic salt water (eye rinsing apparatus are available at all floors). Seek medical advice for further treatment. Has any infectious material come into the mouth rinse with water, spit the water out (take care of aerosol formation and surrounding splash. Seek medical advice for further treatment. In case of stab and cut injuries follow the same procedure as for handling of human tissue or blood (see page 29). 29 How to handle human tissue or blood Definition Human material consists of blood and tissue samples from healthy human people, patients, post-mortem material and human cell lines. The risk of infection is caused by RNA virus (e.g. HIV and DNA virus (e.g. Hepatitis B). The National Working Environment Authority has prepared a guideline concerning “AIDS and prevention of HIV infection” (NWEA guidance C.0.14, December 2004, http://arbejdstilsynet.dk/en/engelsk.aspx). Virus infection may result in an acute infection disease, but in the long run also an increased risk of cancer development. HIV and Hepatitis B virus are both deactivated by a number of non-ionic detergents(1%) after 10 min.; HIV is furthermore deactivated by 70% ethanol for 10 min. However, as we do not know what other non-identified infectious organisms may be found in the tissue, one of the following procedures is a minimum for making human material non infectious: • 5 minutes boiling with 1% SDS (SDS-PAGE sample buffer). • Fixation in 4% paraformaldehyd (or Bouin) followed by dehydration and paraffin fixing • Autoclaving (1200°C for 20 min), • 10 min in 5% RBS or 4% DIVERSOL (The Department offer employees who work with human tissue or blood to be vaccinated free of charge against hepatitis B. Contact your local member of the Occupational Health and Safety Committee. ) General rules for working with biological, active material • Open wounds on hands or forearms preclude working with human material. • Use disposable gloves and laboratory coat. • Use disposable materials as far as possible. • Homogenization should be done behind a screen due to formation of aerosol. • Used apparatus (e.g. centrifuges) should be cleaned with 1% VirkonR after use. Spray tables and other surfaces with 1% VirkonR and dry them. • Leave all recycled material in 1% VirkonR for at least 10 min prior to normal washing up. • To be autoclaved afterwards if sterilizing is required. • Tidy up at once after work. 30 Guidelines on cut and stab injuries when handling unfixed human tissue or blood In case of accident do the following in the order mentioned below: A 1. Promptly press blood or secretion out after a stab or cut injury. 2. Wash with water and soap. 3. Wash with surgical spirit. The above guidelines are in pursuant to the Guidelines of the Stab and Cut Injury group at the Copenhagen University Hospital, the Trauma Centre and Acute Admission. Do not wash with tincture of iodine due to the great number of people being allergic towards iodine. Instead of item 3 apply a hand disinfecting agent containing 70-85% ethanol plus a skin care remedy. B On the very day of the accident contact the casualty ward at the following address: H:S Bispebjerg Hospital Bispebjerg Bakke 23 5. Tværvej, entrance 7c, ground floor 2400 Copenhagen NV Phone: 35312373 After examination the casualty ward staff decide on the treatment which often includes vaccination, e.g. against Hepatitis B – the first of 4 vaccinations should be given at the very day of the injury. Finally instructions to the injured person’s medical practitioner concerning further treatment are handed out. C 1. As soon as possible fill in an “Occupational Health Injury Form” (green form) and send it (see C2). The form is available at this address: https://intranet.ku.dk/employeeguide/HR/work%20environment%20and%20job%20satisf action/occupationalinjuries/Pages/default.aspx A clear guidance is found on the first page of the form. 2. Make two copies of the notification form. One copy is to be kept with the local occupational health and safety group and the other copy should be forwarded to the day-to-day occupational health and safety manager (compulsory). 31 Annex I 32 Annex II 33 Annex III 34 Annex IV Kemikalieregistrering i Kemibrug ( også til afregistrering ). For KU-SUND-ICMM ( Institut for Cellulær og Molekylær Medicin ). Følgende oplysninger gives. Sæt X for registrering:___ afregistrering:___ Stofnavn: CAS nummer: Bygning/etage: Rum: Sted: Fritekst: Indkøbsdato: Ansvarlig: Forklaring til felter: Ved registrering er det vigtigt at kun rene stoffer registreres med CAS-nummer - alle andre registreres som produkter (kun med navn). • Kun "100%" væsker, gasser og faste stoffer er rene stoffer. Disse har et CAS-nummer. CAS nummer står ofte på beholderen. Hvis ikke CAS nummeret er kendt, kan dette hurtigt findes via en Google søgning på ”cas kemikalienavn”. • Alle andre (dvs. opløsninger, blandinger, fortyndinger mm.) er produkter og har ikke et CASnummer. Det er vigtigt at skrive produktnavnet korrekt - så havner produktet på rette plads i stoflisten og er søgbart via navnet. • 25% saltsyre skrives som "saltsyre 25%" • 1% Beryllium i Hexan skrives som "Beryllium 1% opløst i Hexan" Angiv Bygning som f.eks. 12.6 og rum f.eks. 12.6.31 Angiv sted som f.eks. reol, aflåst skab, gift-skab, atex-skab osv. Fritekst bruges til ekstra oplysning f.eks. Sigma produkt nr. osv. Indkøbsdato: Måned/år f.eks. Maj 2012 Ansvarlig er den der ejer kemikaliet. Andet kan aftales lokalt. Brug samme angivelse hver gang for at lette søgning i kemikaliebeholdningen. Det udfyldte skema afleveres til ansvarlig redaktør i Kemibrug lokalt på din afdeling, som vil registrere / afregistrere dit kemikalie i kemikaliebeholdningen. Send evt. det udfyldte skema på mail til den ansvarlige redaktør. 35 Annex V Annex from "Centre for Biosecurity and Biopreparedness, Executive order no. 981, of October 15, 2009 on securing of specific biological substances, delivery systems and related materials". List of biological substances, delivery systems and related materials 1. Biological substances Human pathogens, zoonoses and toxins as follows: a) Viruses, whether natural, enhanced or modified, in the form of isolated live cultures or of materials, including living materials which are intentionally inoculated or contaminated with such cultures, as follows: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. Chikungunya virus; Crimean-Congo virus (Crimean-Congo hemorrhagic fever); Dengue fever virus; Eastern equine encephalitis virus; Ebola virus; Hantaan virus; Junin virus; Lassa fever virus; Lymphocytic choriomeningitis virus; Machupo virus; Marburg virus; Monkey pox virus; Rift Valley fever virus; Tick-borne encephalitis virus (Russian spring-summer encephalitis); Variola virus; Venezuelan equine encephalitis virus; Western equine encephalitis virus; White pox (Variola minor); Yellow fever virus; Japanese encephalitis virus; Kyasanur Forest disease virus; Louping ill virus; Murray Valley encephalitis virus; Omsk haemorrhagic fever virus; Oropouche virus; Powassan virus; Rocio virus; St Louis encephalitis virus; Hendra virus (Equine morbillivirus); South American hemorrhagic fever virus (Sabia, Flexal, Guanarito); Hemorrhagic fever with lung and renal syndrome virus (Seoul, Dobrava, Puumala, Sin Nombre); 32. Nipah virus. b) Rickettsiae, whether natural, enhanced or modified, either in the form of isolated live cultures or of materials, including living materials, which are intentionally inoculated or contaminated with such cultures, as follows: 1. Coxiella burnetii; 36 2. Bartonella quintana (Rochalimaea quintana, Rickettsiae quintana); 3. Rickettsiae prowazekii; 4. Rickettsiae rickettsii. c) Bacteria, whether natural, enhanced or modified, in the form of isolated live cultures or of materials, including living materials, which are intentionally inoculated or contaminated with such cultures, as follows: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Bacillus anthracis; Brucella abortus; Brucella melitensis; Brucella suis; Chlamydia psittaci; Clostridium botulinum; Francisella tularensis; Burkholderia mallei (Pseudomonas mallei); Burkholderia pseudomallei (Pseudomonas pseudomallei); Salmonella typhi; Shigella dysenteriae; Vibrio choleræ; Yersinia pestis; Epsilon toxin produced types of Clostridium perfringens; Enterohemorrhagic Escherichia coli, serotype O157 and other verotoxin produced serotypes. d) The following toxins and sub-units of these toxins: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. Botulinum toxins; Clostridium perfringens toxins; Conotoxin; Ricin; Saxitoxin; Shiga toxin; Staphylococcus aureus toxins; Tetrodotoxin; Verotoxin and shiga-like ribosome activated proteins; Microcystin (Cyanginosin); Aflatoxins; Abrin; Cholera toxin; Diacetoxyscirpenol toxin; T-2-toxin; HT-2-toxin; Modeccin; Volkensin; Viscum album Lectin 1 (Viscumin). Note 1: No controls are imposed on botulinum toxins or conotoxins in product form, which comply with all of the following criteria: 1. they are pharmaceutical specialties for human use in the treatment of diseases; 2. they are fully pre-packaged for distribution as pharmaceutical products; 3. they are permitted by a governmental authority to be marketed as a pharmaceutical product. 37 Note 2: No controls are imposed on vaccines or immunotoxins e) Fungi, whether natural, enhanced or modified, either in the form of isolated live cultures or of materials, including living materials, which are intentionally inoculated or contaminated with such. 1. Coccidioides immitis; 2. Coccidioides posadasii. Genetic elements and genetically modified organisms as follows: a) Genetically modified organisms or genetic elements which contain nucleic acid sequences associated with the pathogenicity from the organisms specified under points a–c and e in the above list of biological substances. b) Genetically modified organisms or genetic elements which contain nucleic acid sequences as coding for any of the toxins specified under point d, or sub-units of toxins of these. Note 1: Genetic elements include chromosomes, genomes, plasmids, transposons and vectors, whether genetically modified or not. Note 2: For nucleic acid sequences associated with the pathogenicity from each of the microorganisms specified under points a–c and e in the above list of biological substances, each sequence is understood to be specific to the micro-organism specified, and which: a. in itself or via its transcription or translation products represents a significant risk to human health; or b. is known to make a specified micro-organism (or any other organisms in which it can be inserted or integrated in other way) more able to cause serious harm to human health. Note 3: Limitations do not apply to nucleic acid sequences which are associated with the pathogenicity from enterohemorrhagic Escherichia coli, serotype O157, and other verotoxin produced strains in addition to those which code verotoxin or sub-units thereof. 38 2. Delivery systems Spray or mist systems which are specifically designed or modified for installation on aircraft, craft which are lighter than air or unmanned aircraft, and specially constructed components for these, as follows: a) Complete spray or mist systems which, based on a liquid suspension, can produce initial drops 'VMD' of less than 50 µm at a flow velocity of more than two litres per minute; b) Spray systems or combinations of aerosol generating units which, based on a liquid suspension, can produce initial drops with a 'VMD' of less than 50 µm at a flow velocity of more than two liters per minute; c) Aerosol generating units which are specially designed for installation in the systems specified under point a and b. Note 1: Aerosol generating units are devices which are specially designed or modified for installation on aircraft, i.e. jets, rotating drum atomizers and equivalent devices. Note 2: Controls are not imposed on spray or mist systems and associated components which have been proven not to disseminate biological agents in the form of infectious aerosols. Note 3: The drop size for spray equipment or jets which are specially designed for use on aircraft, craft which are lighter than air or unmanned aircraft are measured in accordance with one of the following methods: a. doppler laser method; b. forward laser diffraction method. Note 4: 'VMD' is the volume mean diameter, and for water-based systems it is equivalent to the mass mean diameter (MMD). 3. Related materials The following equipment and technology can be immediately used in the handling of pathogenic biological materials including toxins: a) Complete facilities for biological encapsulation at encapsulation level P3 or P4. Note: The specifications in Danish Working Environment Authority Executive Order No. 864 of 10 November 1993 on biological agents and working environments apply to encapsulation level P3 and P4 (BL3, BL4, L3, L4). b) Fermentors which can be used for the cultivation of pathogenic microorganisms, viruses or which can produce toxins without deriving aerosols and which have a total capacity of minimum 20 litres. Note: Fermentors include bioreactors, chemostats and systems with continuous through flow. c) Centrifugal separators which can carry out continuous separation without the derivation of aerosols, with all the following properties: 39 1. flow velocity of more than 100 litres/hour; 2. components of polished stainless steel or titanium; 3. one or more seals in the steam containment area; 4. can be sterilized in place in the closed state. Note: Centrifugal separators include decanting vats. d) Filtration equipment with intersecting (tangential) flow and components as follows: 1. Filtration equipment with intersecting (tangential) flow, which can carry out the separation of pathogenic microorganisms, viruses, toxins or cell cultures without deriving aerosols, with both of the following properties: i: a total filtering area of at least 1 m2; and ii: can be sterilized or disinfected in place Note: In association with d.1.ii, sterilising means the elimination of all viable microbes in the equipment using physical agents (i.e. steam) or chemical agents. Disinfection means the decomposition of the potential infectivity of microbes in the equipment using germicidal chemical agents. Disinfection and sterilisation differ from hygienisation, hygienisation being cleaning procedures which are implemented to reduce microbe levels in the equipment, without this necessarily leading to the total elimination of the infectivity or viability of the microbes. 2. Filtration components with intersecting (tangential) flow (i.e. modules, elements, cassettes, cartridges or plates) with a filtering area of at least 0,2 m2 for each component and which is designed to be used in the filtration equipment with intersecting (tangential) flow specified in point. d1; Note: Controls are not imposed on equipment for reverse osmosis as specified by the manufacturer. e) Freeze drying equipment which can be sterilised by steam, with a condensation capacity of more than 10 kg/ ice in 24 hours and under 1,000 kg/ ice in 24 hours; f) The following protection and encapsulation equipment: 1. Protective suits (fully or partial) or hoods with permanently attached external air supply in stationary systems which operate under higher pressures; Note: Controls are not imposed on suits which are to be used with built-in breathing equipment. 2. Class III biological safety cabinets or isolation equipment with similar performance standards; Note: Isolation equipment includes flexible isolators, drying chambers, anaerobic chambers, glove boxes and laminar flow hoods (closed with vertical flow). 40 g) Chambers designed for aerosol provocation testing using microorganisms, viruses or toxins and with a capacity of at least 1 m3. h) Biological detection systems which have been specially developed or modified for the detection or identification by biological weapons for use in warfare and specially developed components thereof. i) Technology which can be directly used for the development of biological weapons or for attack weapon usage. The technology required for the development, production or use of products which are controlled otherwise is controlled in accordance with the provisions for these products. Technology which is required for the development, production or use of a controlled product, remains controlled even when used in a product which is not controlled. There are no controls on technology which is required as a minimum for the installation, operation, maintenance (inspection) and repair of products which are not subject to control, or which have been previously issued with a permit. There are no controls on information which is already in the public domain or represents basic scientific research, or which is required as a minimum for patent applications. Note: Technology is defined as specific information required for the development, production or use of a product. Information is 'technical data' or 'technical assistance'. 'Technical assistance' can take different forms such as instructions, skills, training, practical experience and consultant services and can include the transfer of technical data. Technical data can take the form of drawings, plans, diagrams, models, formulae, tables, design plans and specifications, manuals and instructions written or stored on other media or equipment such as diskettes, tape or ROMs. 41 Annex Vl Internet addresses: Useful information is available on the internet, e.g. in the following guidelines: National Working Environment Authority : guidelines on biological agents and working environment http://arbejdstilsynet.dk/da/regler/bekendtgorelser/b/biologiske-agenser-57.aspx (in Danish) National Working Environment Authority: C.0.18 Exposing to bacteria, fungi and other micro organisms: http: www.at.dk/sw28384.asp (in Danish) National Board of Health: Guidelines on protection against viral hepatitis: http: www.sst.dk/publ/Publ2002/hepatitis/html/index.htm (in Danish) Guidelines C.0.14 AIDS and protection against HIV infection http://www.at.dk/sw13127.asp (in Danish) Centre for Biosecurity and Biopreparedness http://www.biosikring.dk/eng/ Biological Agents – Guidelines for the work with infectious microorganisms, etc. in laboratories and industrial processes” (NWEA guidelines C.0.18, Sept 2006) http://arbejdstilsynet.dk/da/regler/at-vejledninger-mv/stoffer-og-materialer/at-vejledninger-omstoffer-og-materialer/c0-generelt-og-diverse/c018-mikroorganismer.aspx 42
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