Health and Safety Office Code of Practice The Control of Laboratory Animal Allergies LAACoPD Final November 2013 1
Contents 1 Introduction 3 2 What Is Laboratory Animal Allergy 3 3 How The Allergy Develops 3 4 The Symptoms Of Laboratory Animal Allergy 4 5 Controlling The Problem 4 6 Occupational Health Monitoring 8 7 Action In The Event Of A Suspected LAA 9 8 Tetanus Vaccination 10 9 Summary 10 10 Documents on Which This Code of Practice Is Based 10 Appendix 1: Management Of Laboratory Animal Allergy In NUI Galway 11 Appendix 2: Medical Questionnaires 12 Appendix 3: Practical guidelines to address LAA s 15 References 16 2
1. Introduction Currently in NUI Galway the management of Laboratory Animal Allergies (LAA) is based around the provision of suitable working environments, appropriate workplace ventilation, the use of individual ventilated cages where possible, the wearing of personal protective equipment, the provision of information and training to relevant staff, the review of staff absences, informal monitoring of symptoms by facility managers and the use of regular LAA screening. 2. What is Laboratory Animal Allergy (LAA)? 1. LAA is an allergic reaction which may develop as a result of repeated exposure to laboratory animals, animal matter, bedding and animal feeds. Up to 44% of people who regularly work with small mammals and insects develop allergic reactions to proteins secreted in urine, dander, or faeces. Usually this only causes nuisance symptoms such as an itchy nose or watering eyes but in up to 10% of cases serious diseases like asthma can occur. 2. All persons working with laboratory animals are at risk, even if allergy has never been a problem before. Someone who already has asthma or a history of allergic conditions like hay fever or eczema are at greater risk, but anyone working with laboratory animals could develop LAA. The risk is not confined to animal care personnel. Researchers, students, maintenance staff, personnel and anyone involved in the handling of animals, their by-products or their waste materials can be affected and they will be collective addressed as users in this policy. 3. How the allergy develops 1. Allergenic material becomes airborne whenever animals move around in their cages or are handled. Allergens such as the rat urinary allergens (RUA) and the mouse urinary allergens (MUA) can become attached to dust particles, which become airborne (aeroallergens) and can remain suspended in the air for some time after. These can be breathed in or can settle on exposed skin, hair and clothing. 2. Skin contamination or inhalation of airborne allergenic material is inevitable unless protective equipment is worn. When these allergens are absorbed across the lining of the lung or through lesions of the skin they can stimulate a response from the immune system to produce antibodies, which can trigger an allergic reaction whenever subsequent exposure to the allergen occurs. 3. The development of allergic sensitisation appears to be linked more to acute rather than chronic exposure, so even exposures of 1-2 hours per month can be dangerous if it involves high exposure work. However, the repeated simple handling of animals can also result in a significant exposure. 3
4. The symptoms of laboratory animal allergy 1. Many of the symptoms are similar to those of hay fever. These include sneezing and runny nose (rhinitis), itchy and watery eyes (conjunctivitis) and less commonly, itchy skin rash similar to a nettle rash (urticaria), cough, tightness of the chest and wheezing (asthma). Very rarely, acute collapse (anaphylaxis) can follow an animal bite or a needle stick injury. 2. It is important that symptoms of rhinitis and conjunctivitis are recognised and reported to the manager of the facility at an early stage so that measures can be taken to reduce the possibility of asthma developing subsequently. 3. Most users who suffer from LAA develop symptoms within a 2 year period and usually within 6 months of starting work. Occasionally however, symptoms can occur for the first time after several years of exposure. 5. Controlling the problem Effective control relies on: Awareness Appropriate Engineering Measures Work practices Adequate Use and Provision of Personal Protective Clothing 1. Create Awareness: Provide background information to users regarding what is LAA, how does it develop, which are the most common symptoms and how to control it. 2. Appropriate Engineering Measures can control and minimized exposure to high allergen concentrations through the use of: a. Filter-top cages b. Animal cage changing stations c. IVCs (Individually Ventilated Cages) d. Bedding Disposal Units. e. Allergen Curtains f. HVAC (Heating, ventilation and air conditioning) systems Where possible, open-top cages should be replaced with filter-top cages or IVCs. The ventilation systems in animal houses shall be designed to contain and remove aeroallergens, but they can only reduce and not eliminate exposure. Ventilation provides no protection against direct skin contact with allergenic material. In the absence of a HVAC air system, consideration should be given to using an air-cleaning unit and adopting the practices in Appendix 3 to address the issue of aeroallergens. 4
3. Work Practices: If the recommended work practices, which are designed to reduce the severity of exposure, are followed, particularly the use of recommended protective clothing, early detection of new cases by reporting any incidence to facility management, the adhering to cleaning and maintenance standard operating procedures that ensure minimal presence and generation of dust, and the adhering to the yearly routine LAA monitoring programme of all users working in animal facilities, the risk of contracting an allergy will be substantially reduced. When recruiting or redeploying personnel to work in an animal facility, personnel who have pre-existing allergies should be identified with a view to minimizing the risk of exacerbating the condition. If a persistent LAA develops, management in conjunction with the user will consider redeployment to alternative appropriate activities. 4. Personal Protective Equipment (PPE) The correct selection and use of PPE is essential to reducing user exposure to animal allergens. This is based on a precise assessment of the nature of the work being undertaken and the consequential generation and anticipated risk of exposure to allergens. Your attention is drawn to the University resource on PPE in Part 7 of the Safety Statement, Appendix 18 - Personal Protective Equipment (PPE) Issue Form. This will aid the documented process to demonstrate that the requirement for PPE has been assessed and that any appropriate PPE has been issued to the relevant user(s). The risk of exposure to allergens is related to the tasks being performed in the animal house and can be divided into three categories: High, Medium, and Low; see Table 1 for further details. Respiratory protection: Suitable respiratory protection must be worn when engaged in any high risk activity, i.e. any activity where there is the potential to generate large amounts of airborne allergens, or as required. It should be noted that the inhalation of any allergen may result in a significant risk of developing an allergic reaction. A number of different types of respiratory protection are suitable for use in protecting against airborne allergens. Resources to assist in the correct type are as follows: HS(G)53 Respiratory Protective Equipment at Work A Practical Guide; EN 529:2005 Respiratory protective devices Recommendations for selection, use, care and maintenance Guidance document: 5
RISK CATEGORISATION OF ANIMAL HANDLING/ANIMAL FACILITY OPERATORS TABLE Category Typical Activities Required PPE and other controls High Risk The following processes if carried out outside of laminar flow workstations: Full set of body scrubs or equivalent o Cleaning / scraping out animal cages Disposable gloves o Repeated cage transfer activities Respiratory protection o Repeated animal immunisations Good personal hygiene o All dry shaving of animals practices o Repeated handling of soiled animal bedding Head/hair protection o Repeated weaning activities o Any activity that involves the repeated handling of animals or animal products where there is a risk of large amounts of airborne particles being created Medium Risk Single physical contact process / events excluding dry shaving Animal feeding activities Any activity where there is a risk of airborne particles being created but not in large amounts as assessed by facility management or their nominee. Non contact activities but in contact with air born allergens e.g. observers of procedures or users involved in imaging or treatment preparation Low Risk Non contact activities for short period of time (visitors) and by users with no previous history of allergies e.g. animal observations; walking through facility, etc Any activity where there is little or no risk of airborne particles being created as assessed by facility management or their nominee. Users working with zebrafish and frogs. Note: These PPE requirements apply to those users who have not been previously diagnosed with any Laboratory Animal Allergy. Users known to suffer any such allergy must consult with their manager and the University Safety Office before carrying out any of the high or medium risk activities outlined above. Full upper body (neck to waist and arms) skin coverage, e.g. closed Howie coat; full set of complete body scrubs; etc. Disposable gloves Good personal hygiene practices Full upper body (neck to waist and arms) skin coverage, e.g. closed Howie coat, full set of complete body scrubs; etc. Disposable gloves when handling animals Good personal hygiene practices Whichever type is used it must bear a CE mask and conform to relevant EN standards, such as: EN132:1999 - Respiratory protective devices - Definitions of terms and pictograms; EN 133:2001 Respiratory protective devices Classification; and EN 149:2001+A1:2009 - Respiratory protective devices Filtering half masks to protect against particles Requirements, testing, marking. Copies of these resources are available from Safety Office. 6
1. The two main types of respiratory protection that may be used on a regular basis are: a. Disposable masks: Only disposable masks with at least an FFP3 rating give adequate protection against inhaling respiratory allergens in an animal house any mask with a lower rating is not suitable. This type of mask may not be suitable for persons with facial hair. Persons with facial hair may be required to use a half-face mask facial hair. b. A half facemask: Users wearing these types of mask will require fit testing and training in the correct use of the mask selected. c. Full-face protection P2/P3 (to be determined based on recently revised EH76). If you are sensitised, you may be advised to wear a different type of mask or respirator which may provide you with additional protection. 2. Body and hand protection: these range from:- Disposable Gloves Disposable shoe covers Disposable hair caps Scrubs Anti-Mist wraparound safety goggles Animal house Lab coats Croc type shoes for exclusive use in a facility The aim of protective clothing and gloves is to eliminate or minimise direct skin contact between the animals and their bedding and users working with the animals. In this regard the wearing of clothing which does not substantially cover the wearer s legs or arms is not advised. When direct skin contact is made between a user s skin and an animal or animal matter, immediately and thoroughly wash the affected area with warm soapy water. The University hand-wash protocol for hand hygiene should be followed; this is found at http://www.nuigalway.ie/healthsaf/index.php?menu=33&page=48. a. Howie-style laboratory coats or scrubs with full-length sleeves should be worn at all times in animal holding facilities. These will provide protection from animal hair, soiled bedding, blood, faeces, urine and other animal matter, and must be kept exclusively for animal work. Dedicated scrubs or lab coats must not be worn outside the animal holding facility, and definitely not in any area where food and drink is stored or consumed. b. Full-body suits or coveralls with hoods may be required. These may be required as much to prevent the introduction of contamination from outside the animal handling facility as they do to protect the wearer while inside the facility. These coveralls should have elasticated cuffs, and preferably should be disposable. 7
c. Protective gloves are required to protect against direct contact with animals, animal matter and soiled bedding. The choice of gloves is for the animal facility manager but whichever glove type(s) is chosen it must be suitable for the purpose, comfortable for the wearer, and not, of itself, pose a hazard. In this regard, the use of disposable latex gloves, the preferred choice for many applications, has recently come into question because there is an increase in the incidence of allergies towards latex. NUI Galway Health and Safety Office has published guidelines on latex-glove allergy, at http://www.nuigalway.ie/healthsaf/index.php?menu=33&page=48. 6. Occupational Health Monitoring 1. As part of the risk assessment requirements of the Biological Agents Regulations the University must ensure, where appropriate, that users working in or planning to utilise animal holding facilities who are at risk from LAA will benefit from ongoing occupational health assessment, more commonly called health surveillance. The health of users working with laboratory animals will be regularly monitored by the University Occupational Health Physician. The purpose of health surveillance is to protect the health of individual users to assist in the evaluation of control measures, to amend current measures if required and to consider whether redeployment to other duties is necessary, if an individual user develops a persistent or severe LAA. 2. The role of occupational health in health surveillance for Laboratory Animal Allergy is to: a. Assess the health of users who will be involved in animal work. b. Periodically monitor the health of existing users in order to identify any problems at an early stage. The Occupational Health Physician in conjunction with the Health and Safety Office would then be able to advise the user and management of any necessary changes to minimise any risk to the user s health. c. Encourage any user who has work-related health concerns to self refer to the University Occupational Health Physician via the Human Resources Office. 3. At the pre-employment medical stage, prospective employees will: a. Be informed at interview stage that the position involves work with laboratory animals. b. Complete an expanded pre-employment medical to include the allergy assessment questionnaire (Appendix 2) and spirometry, before gaining access to an animal facility and as part of the access requirements. Note: There are questions on allergy on the Pre-employment Medical Questionnaire, but more expansive questions i.e. Appendix 2 is needed where there is a LAA risk. 8
4. As part of the LAA assessment process all users who engage in medium or high-risk activities (see Table above) will be required initially to complete an allergy assessment questionnaire and a spirometry test. This will set a baseline for each individual. Based on this initial testing and the results obtained further tests such as patch testing / RAST may be required if advised by the University Occupational Health Physician. Following this initial screening users will be subject to an annual questionnaire assessment and a spirometry test, or more regularly if they have a concern about their health status. A copy of the allergy questionnaire is attached in Appendix 2. At a minimum a spirometry test must be undertaken at least once every year, unless advised by the Occupational Health Physician that regular spirometry tests are not required. 5. Please note that this policy will not apply to users working with aquatic species (zebra fish or frogs) given the much lower risk of aerosolizing allergens and therefore acquiring LAA in their working environment. 6. Users who engaged in low risk activities and who only require access to an animal holding facility for a short period of time (one day, for example for training, or servicing equipment) may not be required to undergo LAA screening but must sign a visitors declaration. However this decision will be made on a case-by-case basis and in conjunction with the facility management. 7. Any user prior to being issued with a swipe access card for an animal holding facility will be required to undergo LAA screening irrespective of the work that they undertake. In some instances external contractors may be required to undergo LAA screening. 8. In the event that any of the medical tests or questionnaires raise any concerns then further testing of the individual may be required. The purpose of this further testing will be to ensure that the health of the user is not being affected by their work with or around lab animals, that adequate exposure control and treatment measures can be identified as necessary and if required to consider redeployment to other appropriate duties. It should be noted that no specific medical information gathered as part of this assessment will be disclosed to management. The Occupational Health Physician will simply provide management with a statement of fitness and advises work modification when this may be beneficial to the health of the individual concerned. 7. Action in the event of suspected LAA If you suspect that you are suffering from a LAA (e.g. if you develop eye, skin or lung irritations) then you should contact the manager of the facility and/or the Human Resources Office to arrange an immediate consultation with the Occupational Health Physician. In such circumstances the Occupational Health Physician may advise a temporary cessation of certain tasks until further tests have been conducted. If the Occupational Health Physician diagnoses a persistent or severe LAA, 9
then arrangements must be made in consultation with the employee to consider redeployment to other appropriate duties, at no detriment to the user s terms and conditions of employment. 8. Additional Measures: Tetanus vaccination: Although not directly related to LAA vaccinations should be obtained or updated before using lab animals. 9. Summary 1. If you work directly with or handle live or dead intact laboratory animals you will need to be subjected to a monitoring regime to assess your condition with regard to LAA. 2. This will involve completing a questionnaire and some simple medical tests as outlined above. This service is provided at no cost to the users and it is confidential. 3. Medical surveillance is designed to minimize the risks to you from laboratory animal allergy. It also helps the manager of the animal facility to ensure adequate control measures are implemented that help minimize the risk. 4. On-going medical surveillance will be made available to you on at least an annual basis. Immediate assessment will be provided if you notice any of the symptoms of laboratory animal allergy. 5. Your cooperation is essential in minimizing the risk by wearing personal protective equipment (gloves, lab coat and mask) and following good hygiene and working practices. 10. Documents on which this code of practice is based Safety, Health and Welfare at Work Act 2005 Safety, Health and Welfare at Work (Biological Agents) Regulations 1994/1998 Safety, Health and Welfare at Work (Chemical Agents) Regulations 2001 Working safely with research animals Health and Safety Executive 1997 Control of animal allergy Guidance note EH76 Health and Safety Executive 2002/2011 Codes of practice and guidance issued by UK universities (Exeter, Imperial, Sussex, York) 10
Appendix 1: Management Of Laboratory Animal Allergy In NUI Galway Baseline testing will be performed for all relevant userss commencing the surveillance programme All users will undergo initial health surveillance to include spirometry testing and questionnaire assessment Questionnaire will be completed annually. The need for further additional testing to be based on the results of the annual questionnaire.. Annual review Occupational Health will review all results/questionnaires Normal results No action required Changes noted from review Action required Further investigation required, e.g. Occupational Health review, blood tests, specialist consultant review, workplace assessment, allergy testing, etc Report from Occupational Health to Human Resources Office re fitness Employee fit to continue work Fitness to work with no modification of working conditions confirmed Unfit to work / *redeployment Increased frequency of medical assessment of identified condition Consultation with user and identification of additional exposure control measures Modification of working conditions required *Consultation with user on redeployment to other appropriate duties, if LAA is persistent or severe 11
Appendix 2: Medical Questionnaires 1. Personal details Surname Forenames Male/Female Surname at birth Date of Birth Nationality Staff ID number Email Contact Number School/Unit Section Status: Research Staff/Technical Staff/Postgrad Student/Academic Visitor/Other GP Name & Address: 2. Basic work information 1. Name of research group leader Telephone Number 2. Brief description of work 3. Intended duration: 4. Does your work involve handling of human tissue (including blood or serum)? Yes No 3. Work with animals 1. What animals or insects are used in your research work? 2. How many hours per month will you spend working with them? hours 3. Have you worked with laboratory animals or insects before? Yes No 3.a If yes, for how long? Years 4. Did you ever keep a mouse, rat, guinea pig, hens or rabbit as a pet? Yes No 5. When will your animal work start (date) 4. Work-related symptoms Has work with any of the above ever caused: a. Chest tightness? Yes No b. Wheezing? Yes No 12
c. Sneezing attacks? Yes No d. Eye irritation? Yes No e. Skin rashes? Yes No f. Other symptoms? Yes No Details 5. Other hazardous work (Are you involved in other work requiring health surveillance/monitoring?) Details 6. Medical Information 1. Have you ever been affected by: a. Recurrent skin rashes (e.g. eczema, dermatitis, hives, psoriasis)? Yes No b. Asthma or recurrent bronchitis? Yes No c. Allergic rhinitis or conjunctivitis? Yes No d. Other allergic diseases? Yes No If yes, give details (dates causes if known, treatment, parts of the body affected, state whether a current problem) 2. Do you take any medicines (including non-prescription drugs) regularly? Yes No Details 3. Do you have any other health problem that may affect you in your work? Yes No Details 4. Do you smoke? Yes No 5. Have you been vaccinated against Hepatitis B? Yes No a. When? Has your antibody level been checked? Yes No b. If yes, what was the result? 13
6. Have you been vaccinated against Tetanus? Yes No When? 7. If you wish to have 24 hour BMF access, please fill in the following section. This information will not be disclosed to anyone other than the medical practitioner a. Do you have/have you ever had a medical condition that causes or could cause seizures and/or sudden collapse Yes No b. If yes is your condition currently controlled Yes No c. Do you suffer from diabetes? Yes No I also understand that, in the case of severe or persistent LAA, the Occupational Health Physician may seek approval from me to consult with my family GP or medical consultant for information relating to my medical fitness. GP s Name: GP s Address: GP s Tel. No.: I understand the nature of this consent and have been given the opportunity to ask questions. I understand if there are any personal or private details which I do not wish disclosed to my employer, I can and should indicate this to the doctor at the time of our consultation and those details will not be disclosed. If uncontrolled medical conditions are present that may disallow lone working you will have the option to disclose said condition to the BMF Director who will look at options for facilitating 24-hour access to the facility. Alternatively you can retract your application for 24-hour access. User s signature: Date: 8. Declaration I have answered all questions to the best of my knowledge. I agree to participate in the health surveillance programme for work-induced allergies. I will report any symptoms of possible allergic reactions to substances encountered in my work to my manager as soon as possible should I develop these in future. Signed Date 14
Appendix 3: Practical Guidelines Addressing LAA Issues. In the absence of a HVAC air system, consider installing a commercial air-cleaning unit. Wherever available, always use a cage changing station and a bedding disposal unit during routine animal cage maintenance. Non-contact absorbent bedding is best for combating Allergen production. In cases where the above is not suitable, choose the animal contact-bedding with greatest absorbency and which does not obstruct research requirements. This may first need careful consideration before choosing bedding. Some wood-based bedding products, while sold as dust-free, do not have good absorbency characteristics. Wear FFP3 disposable masks, latex or Nitrile disposable gloves, shoe covers and hair covers. Wear suitable lab coats or scrubs, which are restricted in use to the animal unit only. Decrease the animal density/cubic metre of room volume. Wet-sweep the floors or ideally wash floors. dry-sweeping of floors can raise any allergen contaminated dust particles into the air which can be suspended in air for 3 5 hours. Where wet sweeping is not feasible, only use a HEPA filter vacuum cleaner, if vacuum - cleaning an animal room floor. Wet-wipe the cage rack before replacing a cage. Because cleaning/scraping of cages is recognised as the task generating intense aeroallergen production, it is imperative to wear all of the following during this task: Masks, Lab coats, Wrap-around goggles, Disposable gloves If stacking cages for cleaning/scraping as part of the cage changing task, drape a damp towel/cloth or cover over the top cage before carrying the stack of cages to the cleaning area. Male mice excrete more MUA than female ones as the excretion is under hormonal control, so if feasible, choose female animals. 15
References: (1) NIOSH Publication Preventing Asthma in Animal Handlers. (2) HSE Guidance Note EH76 Control of laboratory animal allergy (3) Occupational Medicine, 2003; 53; 371-377 Prevention of laboratory animal allergy (4) Laboratory Animals (2004) 38, 25-37 The bedding of laboratory animals as a source of airborne Contaminants (5) ILAR Journal, Volume 42, No 1 Controlling Exposure to Laboratory Animal Allergens (6) Ann Occup. Hyg, Vol 46, No 1, PP 61-68, 2002 Reduction of exposure to laboratory animal allergens in research laboratory. (7) British Journal of Industrial Medicine 1992; 49:416-422 Reduction of airborne allergenic urinary proteins from laboratory rats (8) Clinical & experimental Allergy, 1997, volume 27, PP 744-751 Reduction of exposure to laboratory animal allergens in the workplace (9) British Journal of Industrial Medicine, 1986;43: 192-198 Allergy to laboratory animals in laboratory technicians and animal keepers (10) Journal of the American Association for Laboratory Animal Science, Vol 45, No 3 Control of Allergens in the Animal Room by the use of curtains (11) Animal Technology and Welfare April 2007 The effectiveness of the AiroCide system in reducing theconcentration of mouse urinary protein within the working environment 16