Another kind of toxic debt
July 30th 2009

In a report launched this year the European Agency for Safety and Health at Work (EUOSHA) suggested not enough people take into account reprotoxicants in workplace risk assessments.A subsequent HSM poll found this was likely to be because few understand what they are and where they are found. Georgina Bisby speaks to Emmanuelle Brun and Elke Schneider,project managers at the EU-OSHA’s European Risk Observatory to find out more

EU-OSHA’s report Expert Forecast on Emerging Chemical Risks - identifies the main groups of substances which could pose new and increasing risks to workers, contributing to diseases which range from allergies, asthma, and infertility to cancers. Reprotoxicants, were flagged up as an issue which posed a serious threat to health but were rarely considered in workplace risk assessments.

How should reprotoxicants be addressed through a risk assessment?

Reprotoxicants are rarely considered in workplace risk assessments and in prevention. Their proper risk management is made difficult because: hazards and effects are difficult to see and to correlate, information on reprotoxic effects of substances is still poor and specific legislation for reprotoxicants does not exist at EU level and in many Member States.

The French Afsset agency has established a first list of 50 substances which are considered as potentially reprotoxic for humans or animals. Thirty-two of these substances are classified as reprotoxic in the European Regulation for the classification, packaging and labelling of dangerous substances.

According to Directive 98/24/EC on the protection of workers’s health from chemical agents, employers in the EU must by law protect their workers from being harmed by any type of dangerous substances (DS) in the workplace, which of course implicitly includes reprotoxicants. Employers are required to protect workers’ health by assessing the risks, taking action to remove or reduce the risks, monitor the effectiveness of the preventive measures and review the assessment.

Consequently, the risks from reprotoxicants in the workplace have to be assessed and managed following the same principles as for any other dangerous substances at work.

Steps to assess the risk

Directive 98/24/ provides a hierarchy of measures to prevent or reduce the exposure of workers to dangerous substances. The procedure to follow in order to assess the risks from reprotoxicants – as well as any other dangerous substances at work – can be summarised as follow:

• Create an inventory of dangerous substances used and those generated by processes

• Collect information about possible harm. Safety Data Sheets are one information source

• Assess exposure to identified substances; analysing type, intensity, length, frequency and occurrence of exposure to all workers, including combined effects

• Draw up an action plan including control measures

Elimination, substitution and control

Directive 98/24/EC places elimination and substitution at the top of the hierarchy of control measures for protecting workers from the risks related to chemical agents:

1) Elimination: the best way to reduce the risks connected with dangerous substances is to remove the need to use those substances by changing the process or product in which the substance is used;

2) Substitution: if elimination is not possible, then the substitution, or replacement, of the hazardous substance or the process with one less dangerous under its condition of use is the next best option;

3) Control: if a substance or process cannot be eliminated or substituted, then exposure may be prevented or reduced by:

• enclosure of the emitting process;

• control of the emission by better management of the processes;

• technical solutions to minimise the concentration in the exposure zone;

• organisational measures such as minimising the number of exposed workers and the duration and intensiveness of the exposure;

• use of personal protective equipment

This means that employers are required to prevent exposure to dangerous chemicals (by elimination or substitution), and only if this cannot be done to ensure the risk to workers is reduced to a minimum by controlling exposure. Where Occupational Exposure Limits (OEL)s for a reprotoxicant have been set, just being under the limit does not necessarily mean that legal requirements are being met. Similarly, an absence of an OEL should not be taken to mean that the substance is not dangerous; in some cases it may be that a safe exposure could not be defined.

Although they are not the only workplace control measure, OELs can play an important role in risk assessment and management. When collecting information about chemicals used in the workplace, the exposure limit is a good source of information, along with safety data sheets and labels on containers of dangerous chemicals. The indicated values can also be used as monitoring tool to compare performance of control measures against set levels, giving a clear indication of how effective the measures are and whether the preventive measures are functioning correctly. This information can then be used in the review of the risk assessment.

Pregnancy and breastfeeding

An additional EU Directive is relevant to the management of risks from reprotoxicants in the workplace: Directive 92/85/EEC on the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding.

According to this Directive, the employer has the duty carried out a risk assessment of workplaces to protect pregnant and breastfeeding workers. However, workers’ notification to the employer of a pregnancy state usually occurs after the eighth week, meaning that there might be no protection against harmful exposures in the first weeks of embryo development.

Many enterprises, workers and OSH specialists, who have to deal with this issue, are looking for background information and good practice solutions. EU-OSHA offers information on the prevention of harm from dangerous substances through its website http://osha.europa.eu. This information is free to download in 22 languages includes several sector specific factsheets and case studies on dealing with hazardous chemicals.

Within the scope of the current ‘Healthy Workplace Initiative’ the Agency has developed additional specific information material on the assessment of risks from dangerous substances (e.g. a Power-Point presentation or a specific checklist) and organises seminars for small businesses in the newest EU Member States and candidate countries.

What are reprotoxicants?

Reprotoxicants are substances which can damage reproductive health; this includes adverse effects on sexual function and fertility in adults and developmental toxicity in the offspring as well as substances which have been shown to interfere with lactation.

Adverse effects on sexual function and fertility include alterations to the female and male reproductive system, adverse effects on onset of puberty, gamete production and transport, reproductive cycle normality, sexual behaviour, fertility, parturition, pregnancy outcomes, premature reproductive senescence, or modifications in other functions that are dependent on the integrity of the reproductive systems.

Developmental toxicity in the offspring includes, in its widest sense, any effect which interferes with normal development of the conceptus, either before or after birth, and resulting from exposure of either parent prior to conception, or exposure of the developing offspring during prenatal development. These effects can be manifested at any point in the life span of the organism. The major manifestations of developmental toxicity include (1) death of the developing organism, (2) structural abnormality, (3) altered growth, and (4) functional deficiency.

For example, Endocrine disruptors (sometimes also referred to as hormonally active agents) are exogenous substances that act like hormones in the endocrine system and disrupt the physiologic function of endogenous hormones. Studies have linked endocrine disruptors to adverse biological effects in animals, giving rise to concerns that lowlevel exposure might cause similar effects in human beings. Endocrine disrupting compounds encompass a variety of chemical classes, including hormones, plant constituents, pesticides, compounds used in the plastics industry and in consumer products, and other industrial by-products and pollutants.

Some are pervasive and widely dispersed in the environment. Some are persistent organic pollutants (POPs), and can be transported long distances across national boundaries and have been found in virtually all regions of the world.

In general, the level of awareness for the risks of reprotoxicants is still very low. Although reprotoxicants can cause a variety of effects on the reproductive health in both men and women, they are mostly known as a women’s health issue, and even more so as an issue for pregnant women only. In addition, toxicological and epidemiological data, as well as data on prevalence of workers’ exposure and occurrence of reproductive health disorders are scarce. The health effects from reprotoxicants sometimes develop with long latency periods making it difficult to assess and correlate the health effects to the occupational exposures – even more so in the case of health damages transferred onto the next generation and transgenerational impact.

Registration under the new chemicals legislation REACH is expected to improve the information on dangerous substances.

However, the tonnage trigger could be problematic as few data will be generated for low volume chemicals (under 1 tonne produced per year). At present, there are three additional substances proposed for identification as substance of very high concern and inclusion into the candidate list for authorization because of their reprotoxic effects: Dibutyl phthalate (DBP), Bis(2-ethylhexyl)phthalate (DEHP) and Benzyl butyl phthalate (BBP).

Where are reprotoxicants found?

Examples of reprotoxicants include:

• endocrine disruptors such as heavy metals (lead and its derivates, mercury), polychlorinated biphenyls (PCBs), phthalates (used as plasticizers and solvents in many industrial and consumer goods such as flexible PVC, adhesives, paints, nail polishes), some pesticides, etc.

• some organic solvents (e.g. toluene)

• carbon disulphide, a solvent used in the manufacture of synthetic sponges, viscose and plastic film, and in the production of many organic sulphur compounds used in particular as vulcanizing accelerators, dyes, pesticides, and pharmaceutical products

• cytostatic substances (drugs used to treat tumours), anaesthetic gases and ethylene oxide (used for disinfection in hospitals)

• glycol ethers, a group of organic solvents. Although their use has been banned in cosmetics and consumer products, they are still used in industrial products. Even if in many industrial processes they have been substituted by less toxic solvents, still the ethylene glycol derivates considered as most toxic accounted for 10% of all glycol ethers used in France in 2004 There are no formal statistics available but studies indicate that a significant percentage of workers are exposed to reprotoxicants, in particular in the chemical industry, construction, cleaning, waste processing and recycling and health care.

In France, according to the SUMER survey 2003, about 180,000 workers (1% of the workforce) are exposed to three reprotoxicants included in the survey:

• lead and its derivates (129,800 workers exposed)

• dimethylformamide (38,400)

• cadmium and its derivates (27,700)

Workers are the most exposed to these in manufacturing and maintenance jobs. Efficient collective protection measures are in place in 29% of exposure situations only.

Lead was found to be the most common reprotoxin: 130,000 workers are exposed in battery, crystal glass and pigment manufacture, the production of various alloys, and car repair in garages.

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