prn8099 - Number 19, August 1998
Info-Power against Hazardous Chemicals
Come August this year, the Occupational Safety and Health (Classification, Packaging and Labelling of Hazardous Chemicals) Regulations 1997, is expected to be enforced. This is certainly a long awaited move so that the occurrence of industrial accidents in this country which stands at 10 per 1,000 workers could see further improvement. Although the overall number of industrial accidents is said to have dropped by 50 per cent, the enforcement of the above Regulations is definitely another step in the right direction.
The Regulations is the fourth set of regulations made under the Occupational Safety and Health Act 1994 (Act 514). The purpose of the Regulations is to provide a legal framework for a large group of chemicals, commonly known as ‘industrial chemicals.’ They are largely not regulated by any legal instrument with respect to classification, packaging and labelling requirements.
In the absence of these requirements, industrial chemicals which are used, handled, transferred or stored are frequently not labelled with respect to their identity and potential risk to health and safety of workers. There were instances where chemicals have been transported to the end-users at the workplace as well as the community at large without adequate or no information whatsoever on the hazardous properties, exposing the end-users to undue risks.
What is apparent in such situations is the fact that such unnecessary exposures are preventable. Equally important to note is the fact that information is pivotal in preventing them from happening. As much as information is crucial in treating chemical-related cases; its usefulness is equally vital if preventive actions are to have any meaningful impact. For example, information stipulated by the Regulations is pivotal in any programme of preventive education be it for the workers, employers, professionals or the lay public; similar information is also essential if we want to create a level of awareness for more effective follow-up preventive activities. Information too is necessary in the drafting up of long-term plans and strategies, including monitoring and interventions. Thus the understanding of the Regulations can be overemphasised (see Review).
However not just the issue of information per se, but more importantly the question of accuracy, reliability and expediency of data, as well as their accessibility and availability to all those who require them. In short, it relates to the issue of the quality of information to be utilised in the attempt to improve the overall health care status given today’s pace of development. This is imperative if viewed within the context of the challenges of Vision 2020, whereby Malaysia is to be not only a nation that is information-rich, but at the same time, stands proud of its health and health care status. After all, ‘good’ data and information is very much a prerequisite to ‘good’ health.
Information invariably is vital resource, especially when there are risks involved. In fact it is the workers’ and the people’s rights to know. Many accidents related to poor information have occurred which affected their health, safety and productivity of workers and the public.
Moreover, with rapid industrialisation and urbanisation currently taking place in the country, occupational diseases as well as those related to environmental pollution are fast becoming more common. It was revealed lately that the number of industrial mishaps, especially deaths, at the workplace has been increasing since 1990, some undoubtedly involving hazardous chemicals. And in majority of these cases, it can almost be assumed that the proper preventive actions are either not fully understood or have been totally neglected. The first step in overcoming such a situation is by making the appropriate information more readily available. This should be case following the implementation of the Regulations.
Similarly, there is already an increasing concern over the quality of information related to chemical safety. Given the fact that the workers today are more exposed to an even larger assortment of industrial chemicals and wastes, the problem of work-related diseases is also said to be looming. Noxious fumes, gases and other pollutants spewed into the atmosphere are known to affect health in a multitude of ways especially for those suffering from asthma and other respiratory illnesses, as well as causing undue irritations to the skin and eyes. At times, the damage could go beyond the workplace affecting the population at large as examplified in Table 1. We only need to keep reminding ourselves of the various tragedies involving industrial chemicals that occur in recent years in Malaysia to have a fair idea of the dimension that would continue to confront us in the near future if we continue to be careless and irresponsible.
In this context, the enforcement of the Regulations ought to be supported by all parties. Among other aspects, it clearly stipulates the responsibility of all concern especially the suppliers of chemicals (manufacturers, formulators, etc.) to:
- classify chemicals according to their hazardous properties,
- pack the chemicals in appropriate containers,
- label the containers with prescribed information, and
- provide accompanying chemical information sheet known as the Chemical Safety Data Sheet (see Review)
All these, if complied with, will go a long way in ensuring chemical safety across the board. In addition, the Department of Occupational Safety and Health (DOSH) has also come up with various guidelines and manual (see Table 5) that further clarify the implementation of the Regulations.
In a nutshell, the Regulations can significantly enhance the basic principles of safety in the use of chemicals and, if properly enforced, will prevent any untoward incident related to the use and handling of chemicals. It must however receive the cooperation of everyone involved before any positive and sustainable impact could be felt.
In any case, the emerging challenges remains directed at building a comprehensive data set and information pool especially in situations where there has been very little data collected or the total lack of it. Where there is already substantial information being kept there may need to be a mechanism of how it can be shared in particular where more than one agencies are involved. In the process doing so, while ‘secrecy’ has its place, it must not be allowed to overshadow the common good that could be derived in making such information more available.
It remains our fervent hope therefore that with the coming into force such Regulations not only will the welfare of the workers and indeed the consumers at large be further protected, it will also promote the sharing of quality information in advancing the principles of chemical safety for all, nationwide.
What is a Life Cycle of a Chemical?
The existence of a chemical can be conveniently divided into at least five phases. Collectively these are often referred to as the Life Cycle of a Chemical. These are the phases of:
- production (extraction & formulation)
- use, and
Disasters involving industrial chemicals can occur at any one of the phases. For example the infamous Bhopal disaster took place at the production phase more specifically at the point of manufacturing (see also Table 1 below). Because each of the life cycle affords the opportunity for chemical accidents, it is important that due care be taken at every stage of the life cycle. In fact, no chemical is completely immune from the possibility of being involved in a related incident, although some may be more prone at the various phases depending on the chemical entity. Moreover, in some cases, some of the above phases may be absent from the life cycle and this if anything will complicate the situation further.
For this reason alone, the need for adequate and objective information about the various aspects of the chemicals cannot be overemphasised. As such the legal framework accorded under the Occupational Safety and Health (Classification, Packaging and Labelling of Hazardous Chemicals) Regulations 1997 can further promote the principles of chemical safety in the workplace as well as the community. Through proper implementation of such Regulations, Malaysians could begin to look forward to better public health and the environmental protection in the near future.
Occupational Safety and Health (Classification, Packaging and Labelling of Hazardous Chemicals) Regulations, 1997
The Regulations, one of the series under the Occupational Safety and Health Act 1994 (Act 514) will soon come to force. For effective implementation the understanding of the Regulation is important. Below is a review of some of the salient features of the Regulations.
What is a ‘hazardous chemical’?
A HAZARDOUS CHEMICAL is a chemical which possesses any of the following, based on two major aspects namely:
- physico-chemical properties
- extremely flammable
- highly flammable
- adverse health effects
- very toxic
What are the criteria used for the above classification?
Some of the criteria used are as summarised in Table 1 & 2.
What is the scope of application of the Regulations?
The Regulations shall apply to a supplier of any hazardous chemical for use at work except any hazardous chemical which is:
- defined as a radioactive material under the Atomic Energy Licensing Act 1984;
- defined as a pesticide under the Pesticides Act 1974;
- listed as a poison in the Poison List Order 1993, except for chemicals which are classified therein as industrial and laboratory poisons;
- defined as a drug under the Sale of Drugs Act 1952;
- listed as a schedule waste in the First Schedule of the Environmental Quality (Schedule Wastes) Regulations 1989; and
These Regulations also do not apply to the transportation of any hazardous chemical by rail, road, inland waterway, sea or air, as well as to any ha-zardous chemical in transit which is stored at a bonded warehouse.
What are the duties of a those supply ‘hazardous chemicals’?
Under the Regulation a supplier is responsible for at least four (4) basic duties:
Duty 1: Classify the Chemicals
A supplier should classify a hazardous chemical according to the specific nature of the risk involved based on the categories of hazards mentioned above.
The detailed procedure for classification is described in the Guidelines on the Classification of Hazardous Chemicals and Preparations (DOSH, 1997).
A limited number of hazardous chemicals are listed in Appendix VII of the Guidelines to assist suppliers in classifying pure or single-ingredient chemicals or multi-ingredient mixtures. There are two types of information fields contained in the Appendix:
- chemical identification which consist of three fields, namely the chemical name, CAS and the United Nation numbers, and
- hazard classification data which consist of three fields, namely concentration cut-off levels, risk phrases and safety phrases.
Duty 2: Packaging Requirements
A supplier should ensure that a hazardous chemical is supplied in packa-ging which satisfies the following requirements:
- if the packaging is a container, the container must be so designed and constructed so that the contents cannot escape unless there is a requirement for it;
- the packaging materials are not susceptible to adverse attack by the contents;
- the packaging and fastening (if provided) are strong and sturdy to meet the normal stress and strain of handling; and
- containers with replaceable fastening devices are so designed that the packaging can be repeatedly fastened without the contents escaping.
A supplier must also ensure that once any package which is initially closed with a seal is opened, the seal is broken and cannot be repaired.
The Guidelines for Labelling of Hazardous Chemicals describe details on packaging (DOSH, 1997).
Duty 3: Labelling
A supplier must also ensure that every packaging is labelled clearly. The label should contained the following information.
- the name of the hazardous chemical;
- the name, address and telephone number of the supplier;
- the danger symbol and indication of danger;
- the nature of risk associated with the chemical; and
- the safety precautionary measures
The dimensions of label shall be as in Table 3.
When it is not practicable to label a hazardous chemical due to the size of the container or the nature of the package, the container or package must be tagged according to the label dimensions applicable as specified in the table above.
An example of sample label for all category of chemical products containing a single hazardous ingredient is as in Figure 1.
Details on labelling and packaging can be found in the Guidelines for Labelling of Hazardous Chemicals (DOSH, 1997).
Duty 4: Furnishing CSDS
A supplier should furnish an up-to-date Chemical Safety Data Sheet (CSDS) for each hazardous chemical supplied. The information sheet should contain relevant information pertaining to the hazardous chemical or preparation which it is vital for establishing arrangements - the safe use of the chemical or preparation of work. The CSDS should be written in layman language and arranged in a format which is clear and concise, and generally acceptable to the users. It should contain the following information:
- trade or common name of the chemical and company identification with the detail of the supplier;
- composition of ingredients that identifies the hazardous chemicals;
- hazard identification;
- first aid measures;
- fire fighting measures;
- accidental release measures;
- handling and storage procedures;
- exposure control and personal protection;
- physical and chemical pro-perties;
- stability and reactivity data;
- toxicological information;
- ecological information;
- disposal information; and
- transport information
The details on preparing CSDS can be referred in the Guidelines for the Formulation of a Chemical Safety Data Sheet (DOSH, 1997).
The CSDS should aim at achieving the following objectives:
- to make users of hazardous chemicals understand safety recommendations and the rationale for these recommendations;
- to create awareness among users of hazardous chemicals of the consequences of failure to comply with the recommendations;
- to ensure that users of hazardous chemicals recognise the symptoms of overexposure; and
- to encourage the users of hazardous chemicals to provide inputs in establishing strategies and recommendations for the safe use of the hazardous chemicals.
What are the danger symbols and indications of danger specified?
The danger symbols and corresponding indications of danger used must be in accordance with regulations 7(2) of the Regulations. The former assigned to a hazardous chemical must also take into consideration its physico-chemical pro-perties and the adverse health effects.
A maximum of only two danger symbols is suggested – one represents the hazard solely to its physico-chemical properties (Part A of Schedule I of the Regulations), and the other the hazard solely due to its adverse health effects (Part B of Sche-dule I of the Regulations).
If there are two danger symbols, depending on the size, they should be placed together and located in either one of the four layouts shown:
- Top and bottom on the right hand portion of the label (Figure 2);
- Side by side at the top portion of the label (Figure 3); or
- Diagonally positioned on the right hand portion of the label (Figure 4).
- For packages containing 125 milimetres or less of an irritant, flammable, highly flammable or oxidising chemical substance, the layout as in (Figure 5).
The risk and safety phrases need not be given in the case of irritant, highly flammable, flammable and oxidising chemicals where the package contain 125 mm or less of the hazardous chemical.
Each danger symbol should cover at least one-tenth of the surface area of the label and should not be less than one square centimetre. The danger symbol is a diamond shape figure with the sides tilted a 45 degrees to the horizontal following specific dimensions and specifications as in Figure 6.
The corresponding indications of danger however are the hazard classification as determined in the Guidelines for the Classification of Hazardous Chemicals which has been included together with the danger symbols in the diamond shape figure as mentioned above.
How is information about the nature of the special risk associated with the use of the chemical incorporated?
Information to be incorporated is described by the ‘risk phrase’ also known as r-phrase. This phrase should give notice of the hazards present with the normal or reasonably foreseeable handling or use of the hazardous chemical. It should include effects of overexposure or any likely chronic effects following multiple low-level exposure. It should be placed accordingly as shown in Figures 1, 2 and 3.
The criteria for the choice of the appropriate r-phrases for each hazard are spelt out in the Guidelines for Labelling of Hazardous Chemicals. Examples of such phrases are as in Figure 1.
How is information about the safety precautionary measures associated with the use of the chemical incorporated?
Information to be incorporated is described by the ‘safety phrase’ also known as s-phrase. This phrase generally gives advice in relation to a related risk especially to give a special emphasis to a specific warning. When the s-phrase refers to personnel protective equipment, where appropriate it should specify the exact type of protective equipment needed.
The criteria for the choice of the appropriate r-phrases for each hazard are spelt out in the Guidelines for Labelling Hazardous Chemical. It should be placed accordingly as shown in Figures 1, 2 and 3. Examples of such phrases are as in Figure 1.
It should also include first aid safety phrases(s) as given in the Guidelines for Labelling of Hazardous Chemicals.
What are the languages allowed on the labels?
The labels should be written in both the national language (Bahasa Malaysia) and English. The lettering in English should not be bigger than those in Bahasa Malaysia with the proper lettering sizes (see below).
Where no translation of a particular word or phrase is available in the national language, the English word or phrase may be used and the word or phrase should be in parentheses.
The letters and numerals are to be in print and should be of font size not smaller than seven (7) points. They should be black in colour.
What background colours are stipulated for the labels?
The colour is either white or a light colour, which will not camouflage the danger symbol. The background colour for the danger symbols stipulated in the Regulations is as in Table 4 below.
What additional local resources are available to support the Regulations?
As mentioned, the Department of Occupational Safety and Health provides the details to the Regulations in various guidelines (Table 5). Others usefu; resources include:
- Assessment of the Health Risks Arising from the Use of Hazardous Chemicals in the Workplace - A Manual of Recommended Practice, 1997 (Reprinted edition).
- Malaysian Standards. Labelling of Dangerous Substances, 1982.
What is the penalty provided under the Regulations?
Any person who contravenes any provision of these Regulations shall be guilty of an offence and, on conviction, be liable to a fine not exceeding ten thousand ringgit or to imprisonment for a term not exceeding one year or to both, and in the case of a continuing offence, to a fine not exceeding one thousand ringgit for each day or part of a day during which the offence continues after conviction.
References: see Table 5
Viagra Petition to USFDA
On July 1, 1998 the Public Citizen Health Research Group http://www.citizen.org/hrg petitioned the US-FDA asking for changes in the labeling for sildenafil (Viagra), the very popular drug used to treat male erectile dysfunction. The petition is based on sildenafil clinical data submitted to the FDA by Pfizer prior to the drug’s approval and on adverse drug reaction reports received by the FDA until June 30, 1998. The petition asks that sildenafil’s labelling be amended to reflect the following:
In all of the large multi-center clinical trials of Viagra, men with various medical conditions were excluded from the stu-dies. Among those excluded were people with blood pressure of less than 90/50 or more than 170/100; active peptic ulcer disease or bleeding disorder; any clinically significant baseline laboratory abnormality, need for anti-coagulants, androgens, or trazodone (an antidepressant); need for aspirin or NSAIDS and a history of peptic ulcer disease; history of retinitis pigmentosa; uncontrolled diabetes or diabetic retinopathy; stroke or myocardial infarction within 6 months, cardiac failure, unstable angina, ECG ischemia (a common finding in people with coronary artery disease); or life-threatening arrhythmia within 6 months. For none of these conditions is there an exclusion in the FDA-approved labelling for sildenafil.
Many commonly used drugs can interfere with sexual function in both men and women, causing loss of libido, or can interfere with erection or ejaculation in men, or can delay or prevent orgasm in women. Drug-related effects on sexual function may be difficult to distinguish from the effects of depression or disease, but most are reversible when drug use is stopped and sometimes when dosage is decreased.
The petition contains a list of drugs that are known to cause sexual dysfunction that was originally prepared by the editors of the Medical Letter on Drugs and Therapeutics in 1992. We have added new drugs to the list if there was evidence from published studies that they can cause sexual dysfunction.
In the first 174 adverse reactions reports received by FDA since Viagra was marketed and up 30, 1998, 75 listed one or more drugs being taken by the patient in addition to Viagra. Of these 75 reports, the other drugs were fully listed in 69 of the reports. Of these 69 adverse reaction reports, 32 (46.4%) included one or more drugs known to cause sexual dysfunction.
Of the 75 reports in which patients were using one or more drugs in addition to Viagra, in 27 or 36%, one or more drugs for the treatment of cardiovascular diseases were used, many of which were probably the diseases for which people were excluded in the pre-approval clinical trials. Some of the cardiovascular diseases (including diabetes) for which people are taking these drugs, in addition to Viagra, are themselves associated with an increased amount of sexual dysfunction. But to worsen pre-existing sexual dysfunction and then treat this with Viagra, instead of attempting to substitute another drug less likely to cause sexual dysfunction or to lower the dose of the offending drug seems to be an unwise medical decision, if indeed it is being made with full knowledge.