Legal Digest. Biosafety Laws Or Guidelines. An online repository of various articles published by our lawyers. February 2001 Rajah & Tann

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1 An online repository of various articles published by our lawyers Biosafety Laws Or Guidelines 1 Rajah & Tann 4 Battery Road #26-01 Bank of China Building Singapore Tel: Fax: eoasis@sg.rajahtann.com Website:

2 Biosafety Laws Or Guidelines Persons involved in biotechnology may have to deal with either toxic or dangerous chemicals, or lethal micro-organisms. Having proper safety measures and guidelines is critical to ensuring safety. The article looks at the requirements imposed on hospitals, laboratories and universities under Singapore law, as well as the safety and ethical issues arising from carrying out biotechnological work. Introduction The new Jackie Chan movie titled Accidental Spy deals with the development and demand for a new deadly biological weapon known as Anthrax II. While the movie is fictitious, its release coincided with an unexpected result in an Australian laboratory. Researchers from the Cooperative Research Center ( CRC ) for the biological control of pest animals discovered a potentially deadly technique that could be used to create a biological weapon aimed at humans. In an attempt to make mice and rats infertile and lessen the chance of plagues of these vermin in agricultural crops, the researchers injected the mice with a genetically altered mousepox virus. The new virus created massive amounts of a naturally occurring protein found in all animals immune systems. It was hoped that the increase in the level of this anti-viral protein would block reproduction, a process known as immuno -contraception. Instead of making the mice infertile, it suppressed their viral immune system causing the mice previously vaccinated against the disease to actually die from it. Mousepox virus is harmless to humans, and while this newly created virus poses no threat to people, the technique could be use to create viruses that would infect humans. This prompted the researchers to call for the strengthening and further implementation of the Biological Weapons Convention. The Biological Weapons Convention which entered into force in 1975, formally known as the Biological and Toxic Weapons Convention, is an international treaty signed by 162 countries, including Singapore, in an attempt to stop the development, production and stockpiling of biological and toxic weapons. Another treaty, the Chemical Weapons Convention, came into force in 1997 which seeks to outlaw the possession of chemical weapons. As a signatory and in compliance with this convention, Singapore has recently enacted the Chemical Weapons (Prohibition) Act which essentially provides that you cannot develop, produce or stockpile chemical weapons which in some cases may include biological weapons. Page 1

3 The director of the Australian CRC, Dr. Bob Seamark remarked In the course of science you sometimes make unexpected discoveries, penicillin is one example. But what happens if the discovery poses a risk to society? A similar case involving a more virulent strain of the AIDS virus occurred last year in the USA. In situations like this, it is important to have a system of biological hazard containment in place so that the hazard can go no further than the laboratory. The Advisory Committee on Infection Control of the Singapore Ministry of Health has issued an infection control manual. Under the Private Hospital and Medical Clinics Act, health care institutes are required to comply with the stipulated infection control standards. In Australia, all laboratories using any human, plant or animal microorganisms are ranked in four groups according to the risk the organisms could present to the researchers, the environment and the community. According to the level of risk, researchers are legally required to provide appropriate containment known as physical containment or PC. Thus, a PC1 facility would be used when working with organisms that pose no known threat to humans, plants or animals. A PC2 facility would be used if there is a moderate risk and the microorganisms are associated with animal plant or human disease often requiring a class I or II biological safety cabinet. A PC3 facility involves working with infectious microorganisms. The containment rules for this category are extensive and PC3 certification can only be obtained via an inspection of the facility. Most pathological laboratories in hospitals come under this classification. As you may well imagine PC4 facilities deal with highly infectious diseases and there are very few such facilities. The issue of containment while protecting the general public also protects the researchers and overlaps with issues of occupational health and safety. How researchers, laboratory technicians and cleaners handle infectious microorganisms and dispose of them can directly affect their health. Occupational health and safety is not just restricted to biohazardous materials. Laboratories are full of small amounts of chemicals, some of which are toxic. In addition, laboratories contain noisy machines or machines such as ultracentrifuges that spin samples at speeds of 100 thousand rpm which is over 800 thousand times the force of gravity. In 1998, a ultracentrifuge at Cornell University became unbalanced and exploded. The flying metal fragments damaged walls, ceiling windows and equipment. Thanks to the American occupational health and safety system, the machine was contained in a separate equipment room where no one worked and thus no one was injured. In Singapore, the Factories Act and the Radiation Protection Act deal with occupational health and safety laws. Of the two, only the Radiation Protection Act extends to laboratories and hospitals, and universities would be required to comply with this Act as well. As for the Factories Act, government officers and statutory boards may be deemed factories even if they aren t producing products for trade. By analogy, laboratories and hospitals could technically be classified as factories as they are often used to alter, clean or breakdown articles, store gas and liquefied gas. Universities, hospitals and polytechnics in Singapore should constantly be aware of their obligations under the Factories Act to implement occupational health and safety rules. In many countries around the world occupational health and safety laws have been extended to all places of employment in addition to good laboratory practice laws that specifically deal with Page 2

4 laboratory safety. Laboratories at universities and polytechnics are training grounds for the future workforce of the life sciences industry. To produce a professional workforce, it is important they are familiar at least with the idea of safety audits, chemical, physical and biological risk assessment and safety planing not just experimental planning. I was pleased to discover that both Singapore and Temasek Polytechnic include subjects on good laboratory practices in their biotechnology courses. Ngee Ann Polytechnic also has a section on laboratory safety in its laboratory management section but this is restricted to the Biomedical diploma. The universities have laboratories with broad occupational hazards and, therefore, it is particularly important that they are aware of laboratory safety. For example, laboratory safety training should be mandatory for all staff and students. Let s consider a hypothetical scenario. Acrylamide is a neurotoxin and a carcinogen. Ethidium bromide is a mutagen. If students are not provided with gloves when making polyacrylamide gels, or when staining DNA gels with ethidium bromide, such students may be exposed to potentially life threatening diseases such as cancer and birth defects. The proper disposal of all equipment that comes into contact with biological or toxic hazards is essential. Take another scenario where the equipment is not disposed of properly and where the laboratory cleaners, who are often untrained foreign workers, come along and take everything out of the dustbin with their bare ha nds to put in a larger waste bag. Such cleaners could come into contact with chemicals that may endanger their lives. The occupational diseases that these students and cleaners may experience 10 to 20 years down the road could have been avoided if safety procedures were implemented in these laboratories. There is one more issue of biosafety which is more ethical in nature. In most countries that do a lot of life sciences research, it is compulsory for any institution, company or place that conducts experiments on animals or humans to have an ethics committee. This ethics committee usually follows certain national guidelines and any experiments done in these institutions, companies or places on animals or humans are required to get ethical approval for the experiment. On an ethical approval form, you usually specify how many subjects will be used, why you need that many, what you will do, and what risks are involved. Ethical approval must also usually be gained for teaching purposes, if animals or humans are used. Of course, the ethical approval forms for humans are generally far more extensive. In the USA, ethical approval must be gained from the Food and Drug Administration to do experiments on humans. The new Singapore Center for Drug Evaluation requires researchers to apply for ethical approval before conducting experimental drug trials on humans. The National University Hospital and the Singapore General Hospital similarly have ethics committees. No such regulations apply to experimenters doing work with animals. Possibly the new bioethics committee will be involved in rectifying this. Australia is in the process of passing a biosafety bill that also deals with another issue of biosafety, genetic alteration of any biological systems. Under the new guidelines, researchers would be required to apply for ethical approval to do any genetic alteration and must specify what Page 3

5 they intend to do, how they will do it, why it is necessary and other similar matters that must be declared to get ethical approval. The Genetic Modification Advisory Committee of Singapore stated on 3 that it is finalising bio-safety guidelines for research institutes and laboratories to minimise the risk of any inadvertent release of genetically modified organisms in Singapore. Singapore is investing heavily in the life sciences and as we now seem to be at the beginning of a burgeoning life sciences industry, it is important that we act now in implementing comprehensive biosafety laws or regulations rather than after a mishap has occurred. People spend more than half their waking hours at work so it is important that the workplace is as safe as possible. The life sciences require professional biosafety rules if we are to have a professional workforce. This article first published in slightly modified form in The Business Times, 6. Rajah & Tann is one of the largest law firms in Singapore. It is a full service firm and given its alliances, including US premier firm Weil, Gotshal & Manges, is able to tap into a number of countries. Rajah & Tann is firmly committed to the provision of high quality legal services. It places strong emphasis on promptness, accessibility and reliability in dealings with clients. At the same time, the firm strives towards a practical yet creative approach in dealing with business and commercial problems. The information contained in this newsletter is correct to the best of our knowledge and belief at the time of writing. Specific professional advice should be sought before any action is taken. In this regard, you may call the lawyer you normally deal with in Rajah & Tann or e -mail the Knowledge Management team at eoasis@sg.rajahandtann.com Knowledge Management. All rights reserved. Page 4