Topic I: Chemical Regulation and Control

Chemical Regulation and Control Workgroup

Three sub-topics were addressed in the working group dealing with Occupational Safety and Health aspects of chemicals: 1) regulation of mixtures, 2) respiratory protection and 3) training programs. Before discussing the sub-topics, the EU and US delegations gave some background information on their respective legal framework for chemicals.

US legal framework:

With the Occupational Safety and Health Act of 1970, Congress created the Occupational Safety and Health Administration (OSHA) to ensure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance. The OSH Act covers employers and their employees either directly through federal OSHA or through an OSHA-approved state program. State programs must meet or exceed federal OSHA standards for workplace safety and health.

Only 30 comprehensive standards on individual chemicals have been adopted in 40 years. Another 400 occupational exposure limits were adopted in 1972 under special authority in the Act to adopt existing Federal standards. Most of the limit values were derived from data available before the 1970's, and are considered outdated. There was a consensus among the US delegation that the "hazard by hazard" approach of the federal OSH regulatory framework poses challenges. OSHA is currently working on an Injury and Illness Prevention Program standard that may help to establish a broader approach to chemical protection. In addition, the OSHA Hazard Communication Standard (HCS) requires chemical manufacturers and importers to evaluate the health and physical hazards of all chemicals, and to provide information about their identities, hazards, and protective measures through labels on containers, safety data sheets, and worker training. The HCS is currently being revised to align it with the Globally Harmonized System (GHS) on classification and labeling.

The Toxic Substances Control Act of 1976 provides the Environmental Protection Agency (EPA) with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. Certain substances are generally excluded from TSCA, including, among others, food, drugs, cosmetics and pesticides. Legislative efforts are currently being made to revise TSCA.

EU legal Framework:

After the implementation of the framework directive in 1989, two pieces of EU legislation were adopted to address chemicals at work: the Carcinogens and Mutagens Directive in 1993 and the Chemical Agents Directive in 1998. They lay down minimum requirements for the protection of workers from risks to their safety and health arising, or likely to arise, from the effects of chemical agents that are present at the workplace or as a result of any work activity involving chemical agents. Under this legislation, employers must determine whether any hazardous chemical agents are present at the workplace and assess the risks arising from them. If there are risks, they must take a hierarchy of measures to prevent and reduce those risks (suppression, substitution, risk control, collective and individual protection). Substitution of carcinogens or mutagens (cat 1A and 1B) with safer alternatives is mandatory when it is technically possible without regard to the cost.

The REACH regulation was adopted in 2006 and lays down the rules for manufacturing, importing marketing and using chemicals in the EU. It requires manufacturers and importers of chemicals to register them with the European Chemicals Agency (ECHA). For hazardous substances at tonnage over 10 t/y, a Chemical Safety Report should be provided as proof that they can be used safely. For chemicals of very high concern included in the Authorisation list, applicants must also get authorisation for each use in order to continue marketing them. An estimated 30,000 or so substances will have to be REACH-registered.

The CLP Regulation adopted in 2009 is the new European Regulation on Classification, Labeling and Packaging of chemical substances and mixtures. The legislation introduces throughout the EU a new system for classifying and labeling chemicals, based on the United Nations' Globally Harmonized System (UN GHS). Under the CLP regulation companies have also to notify ECHA of the classification and labeling of all hazardous substances they place on the market, no matter what the production volume.

The added value of REACH and CLP for occupational safety & health was discussed in the group. At EU level, synergies are expected with the Carcinogens & Mutagens Directive and with the Chemical Agents Directive. The data generated by REACH and CLP should help employers performing their risk assessment and complying with the hierarchy of control measures. The quality of Safety Data Sheets (SDS) should be improved with additional information like the exposure scenario, improved Risk Management Measures, "uses advised against" or the DNELs (derived no effect levels) covering all identified uses. It is anticipated, as a result of REACH and CLP implementation, a reduction in the occupational diseases linked to hazardous chemicals exposure in the EU. At global level, some benefits are also expected in the management of chemical risks, thanks to the new data generated by REACH (information on hazards and ways of reducing the risks). The public availability on the ECHA website of non-confidential data on chemicals and the inventory of classification & labeling should also help better chemicals management worldwide. Finally, the authorisation and restrictions procedures under REACH should also be an incentive for the substitution of the very high concern substances since all importers in the EU have also to comply with REACH.

1. Workplace handling of mixtures

The focus of research on chemicals, as well as the development of risk assessment methods, control strategies and regulatory approaches, has been mainly on individual chemical substances. However, workers are rarely exposed to a single substance. Workplaces include the use of many purposely made mixtures (e.g., paints); complex mixtures such as petroleum streams; and the mixed exposures that occur from using chemicals in close proximity to each other. While there are some well-documented situations that reveal the antagonist, additive or synergistic effects of some combined exposures, there is generally little known about these types of exposure situations. Risk management measures do not systematically take into account the interaction between substances.The design of workplace controls focuses primarily on individual chemical substances, and rarely reflects a thoughtful approach to considering all of the contaminants in a workplace, or the effects on workers of mixing them together.

Situation in the US:

From a regulatory perspective, mixtures are usually addressed by OSHA in relation to the individual chemical substances being regulated. Where OSHA has a substance-specific standard, it will generally indicate the percentage of the material required in a mixture to be subject to the rule. For example, 29 CFR 1910.1003, which regulates 13 carcinogens, exempts mixtures below specified percentages of either 0.1 or 1 percent by weight or volume (the rule specifies the cut-off for each covered carcinogen). These cut-offs are thus de minimis exemptions for mixtures of the regulated substances.

OSHA also has PELs for some complex mixtures in the workplace. In this situation, the PEL applies to the mixture as a whole, rather than to the individual components. Examples include coal tar pitch volatiles; petroleum distillates; and grain dust. OSHA's PEL for crystalline silica also recognizes that it is generally found in dust with other components.

OSHA also has mixtures' formulae (29 CFR 1910.1000(d)) to apply where there is a mixture of more than one component that has an OSHA permissible exposure limit (PEL). There aren't very many situations where all of the components of a mixture have a PEL, and these formulae often have little practical application in the workplace. The formulae allow OSHA to determine whether the exposure limits are exceeded where employees are exposed to a mixture of regulated substances. Where there is a mixed exposure of chemicals that affect the same organ system, and have an additive effect, OSHA can assess this using a formula. The Agency also recognizes that in some situations mixed exposures may have a synergistic effect.

The Agency's Hazard Communication Standard (HCS) requires information be provided on labels and safety data sheets (SDS) for mixtures used in workplaces. If a mixture has been tested to determine its hazardous effects, then this information must be provided. However, given that this does not occur very often, the HCS further assumes for untested mixtures that they have the same health hazards as their components that are present in concentrations greater than one percent (or 0.1% for carcinogens). For physical hazards, chemical manufacturers or importers can assess whether the components have the same effect in the mixture using whatever data or objective information they have available to them. The Agency is in the process of revising the HCS to align it with the GHS, and these mixture cut-offs are expected to be changed during this process.

The SDSs for mixtures are also required to provide recommended work practices for safe handling and use of the products. All of this information can help an employer assess the risks in the workplace where such products are used, and determine the appropriate control measures. However, the recommended control measures on such SDSs are frequently not specific to the mixture, and do not provide sufficient information for the downstream employer to choose the appropriate approach. For example, while permeability of individual chemical substances may be tested on different types of materials for protective apparel such as gloves, it is unlikely that a mixture has been tested in the same way. The effects of mixing several substances together may result in a completely different permeability characteristic, and the data on an individual component may be irrelevant to worker protection.

OSHA does not have a comprehensive approach to assessing the use of mixtures in a workplace, and determining the appropriate protective measures to implement. The various standards that address this issue do so in a piecemeal fashion, rather than providing a comprehensive strategy that could be implemented by an employer doing a risk assessment in a workplace. Control measures (such as recommendations for respiratory protection) are often focused on individual chemical substances as well, and do not provide guidance to employers as to how they can be applied to the common workplace situation where there are numerous mixed exposures. 

Employers have various methods to conduct workplace risk assessments-the size of the employer, and availability of technical staff, impacts how this might be done. One approach is to focus on the most hazardous chemicals in a workplace, which may lead to a strategy that controls other, less hazardous substances as well. For example, if engineering controls are designed to remove or significantly reduce exposures to a carcinogenic substance in the workplace, other substances present in the workplace air will be removed or concentrations reduced too. 

Situation in the EU:

There is no specific approach covering mixtures as such within the Health and Safety at Work EU regulation. Nevertheless chemical agents and carcinogen directives cover both substances and mixtures. The CLP (GHS transposed in EU) provides criteria for classifying the hazards of mixtures.

Nevertheless, a number of REACH requirements apply to companies who manufacture mixtures, who are required to pass on information on safe uses to downstream users they supply. . In turn, their customers may be required to pass comparable information on to their user/customer base. REACH requires provision of more comprehensive and detailed information than previously supplied, with the introduction of an extended safety data sheet, with the addition of exposure scenarios ("ES") for each use.

The procedures set out in REACH regarding information flows down supply and use chains do not mention how mixtures have to be practically managed. Due the number of substances and the percentage of hazardous substances in the preparation, it is of high importance to apply a simple and robust methodology which will be the basis for defining Risk Management Measures and adequate information and training of workers.

Efficient communication of safe use data to downstream users of preparations depends on adoption of procedures that enable the formulator of a preparation to identify and to extract key and relevant information from the detailed information he receives on the materials used in the preparation.

Guidance and a methodology for identification of so-called "critical components" in a mixture, and the subsequent development of an exposure scenario, are included in the ECHA guidance for downstream users (

This approach based on the lead substance(s) of a mixture has been proposed by the EU industry to determine the level of hazard of a mixture which is mainly based on the Dangerous Preparation Directive (DPD - dir 99/45). The proposed approach is referred to as the "DPD+ method". The method is the first tier-element of a tiered approach to the selection of the relevant substance Exposure Scenarios. These will l be used to provide the risk management measures and operational conditions to ensure the application of a preparation is safe. The "lead substance" approach is still under discussion and as not been assessed and endorsed by ECHA for the time being. It has to be supplemented by an additional assessment step if, for example, a preparation contains substances which are classified as category 1 or 2 carcinogenic, mutagenic or toxic for reproduction, or as respiratory sensitizers.

The EU & US delegations acknowledged that such a strategy may not always adequately address all of the characteristics of the other substances present, or account for synergistic or antagonistic effects from mixed exposures. Nevertheless DPD+ method is the first integrated tool for assessing exposure to mixture. In this context, it may be further assessed and refined to become robust. It would thus be helpful to have a more comprehensive approach for employers to implement. Among the possible future tools to be developed, the working group proposed to:

  1. build an inventory of Safety Data Sheet (SDS) for mixtures,
  2. draft common guidance on SDS for mixtures 

2. Training workers to use chemicals safely

Situation in the US:

Training of workers exposed to chemicals has always been considered essential by OSHA. Each substance-specific standard addressing a chemical includes training requirements. In addition, the HCS requires training about all hazardous chemicals, the information available on them in the workplace, and the interventions the employer is using to reduce chemical exposures. While occupational safety and health professionals in the US generally consider training to be a necessary and important part of their approach to chemical safety and health management, debate continues on how to present the training, how often to provide it, and how to assess its effectiveness. The National Institute for Occupational Safety and Health (NIOSH) recently released a study on the effectiveness of workplace training: "A Systematic Review of the Effectiveness of Training & Education for the Protection of Workers." This report indicated that training can have a positive effect on workers' knowledge, skills, and attitudes, but it also reveals that there are still many questions to be answered about effective training.

OSHA has provided voluntary training guidelines to help employers implement effective training programs ( These guidelines are drawn from the scientific literature on training, and provide general principles to follow in conducting and assessing the effectiveness of workplace training programs.

From OSHA's perspective, it has been difficult to find the right balance in training requirements in terms of specifying what needs to be addressed, and how it is to be done. Training requirements are often performance-oriented, establishing what needs to be provided in the training, but allowing employers to tailor the program to their specific workplace conditions. Since training requirements often cover a broad range of workplaces--with great variance in numbers of employees involved, the types of operations, and the workplace conditions of exposure-it is difficult to be more specific in such requirements.

Some training proponents believe that the Agency should specify the amount of time to be spent on training, as well as making many other aspects mandatory. Others indicate that some flexibility must be allowed to address differences in workplaces and workplace conditions. Neither approach has been a guarantee for effectiveness. Employers agree that training is a necessary component of workplace safety and health programs, and it has been estimated that they spend $100 billion a year providing it. Worker representatives also consider training to be an important part of a workplace program, but have not found many employer programs to be sufficient.

OSHA continues to seek information about the best approaches to training in the workplace, including what types of guidance materials would assist employers in providing effective training, as well as what types of mandatory provisions would lead to training programs that convey the needed information in a timely manner yet allow for consideration of the individual workplace conditions. This is particularly of interest in the area of chemical exposures. Some workplaces have literally thousands of chemicals, and training about these and the control programs in place in the workplace can be quite complex. In other workplaces, chemical exposures are quite limited, and an employer can effectively focus on the few chemicals present to cover them in detail. OSHA has taken the approach of addressing chemical hazard categories, rather than individual chemical substances, as being the appropriate way to deal with these differences. The chemical-specific information is always available to exposed workers on container labels and safety data sheets. Since the purpose of providing such training is to ensure not only that workers receive the information they have a right-to-know, but that they receive information they need to know to protect themselves, it is critical that it be provided in an effective and efficient manner.

Situation in the EU:

The Framework Directive provides that employers must ensure that each worker receives adequate safety and health training throughout the period of employment. More specifically, according to the Chemical Agents Directive, the employers must ensure that workers and/or their representatives are provided with:

  • the results of the risk assessment; 
  • information on the hazardous chemical agents present at the workplace; 
  • training and information on the appropriate precautions and on the personal and collective protection measures that are to be taken; 
  • access to any safety data sheet provided by the supplier.

The information must be provided in an appropriate manner and updated to take account of changing circumstances. These are minimum requirements common to all EU Member States. Each of them has to implement those principles in the National legislation and has the possibility to define the details (amount of time to be spent on training, etc.). The situation therefore varies according to the countries.

On top of the exchange of information on how training for chemical safety is organized in the US and the EU, the group also learned about two specific trade union initiatives related to workers' information and training showing the strong involvement of unions, from both sides of the Atlantic, to organize peer to peer training.

In conclusion, the EU and US delegation agreed on the need to develop more effective training strategies.

3. Respiratory Personal Protective Equipment

Situation in the US:

OSHA has a hierarchy of controls for the workplace. Employers are to use engineering controls first. Removing the contaminant from the workplace, and thus the potential for exposure, is considered to be the most effective means of control. Where this cannot achieve the appropriate levels of exposure, or where there are work operations with feasibility issues, respiratory protection and other types of personal protection may be used. Administrative controls are the last type of control to be implemented.

The concerns about respiratory protection are extensive. While the efficacy of the devices has improved over the years, a failure of them in the workplace may lead to unacceptable exposures. In addition, many of the devices rely on filtering or removing the contaminant from the breathing air so the device must be properly fitted to minimize leakage of contaminated workplace air. OSHA has found that respiratory protection can be an effective means to protect workers, but before employers may do so, they must implement a respiratory protection program for the selection and maintenance of the equipment. Thus OSHA has promulgated a respiratory protection standard (29 CFR 1910.134) which provides criteria for the selection and maintenance of respiratory protection devices, and the implementation of a program to ensure their proper use in the workplace. 

This standard and its requirements have evolved over the years of experience OSHA has had with regard to respiratory protection and been informed by extensive research conducted by NIOSH. NIOSH is also responsible for testing and certifying respiratory protection devices for use in the workplace. Only such certified devices can be used in American workplaces.

The concept of assigned protection factors for respirators to limit the use of particular types of devices under certain conditions has been one of the key areas developed to ensure proper selection of respiratory protection. Each type of device has an assigned protection factor, and can only be used at pre-determined levels of exposure and, in the case of filtering respirators, where sufficient warning properties exist. Thus devices that rely on air filtering and proper fit can only be used at lower levels of exposure, while devices that use independent sources of clean breathing air can be used at higher levels. Where the fit of a device is key to protection, OSHA has established fit testing protocols that must be used to govern this process.

Employers often view respiratory protection as a less costly method of control, and argue for more extensive use of it rather than having to implement engineering controls. Worker representatives tend to favor engineering controls, rather than the use of respiratory protection. Respirators are often uncomfortable, hot, and difficult to work in, which leads to improper use or lack of use in some workplaces. These factors also lead to many safety and health professionals preferring to establish other types of control.

Proper use of respiratory protection in the context of an effective respiratory protection program may actually exceed the costs of engineering controls over time. OSHA believes it is critically important to ensure that respiratory protection is only used in the context of a monitored workplace situation with an appropriate respiratory protection program. The Agency continues to seek information regarding appropriate factors to consider in the implementation of such programs, as well as being interested in new devices that address some of the issues of fit and efficiency that have occurred in the past.

Situation in the EU:

The Chemical Agent Directive includes a hierarchy of measures to control and prevent chemical risks. If risks do exist, the employers have first to eliminate the risks or replace the hazardous chemical agent, second avoid or minimize the release of the hazardous chemical agent; third apply collective protection measures at the source of the risk and as a last resort use individual protective equipment.

Also, a specific piece of legislation (Directive on the use of personal protective equipment) lays down minimum requirements for the assessment, selection and correct use of personal protective equipment. The employer must provide the appropriate equipment free of charge and ensure that it is in good working order and hygienic condition. Before choosing personal protective equipment, the employer is required to assess the extent to which it complies with the conditions set out in the Directive. This includes analysis of risks which cannot be avoided by other means and definition and comparison of the requisite characteristics of the equipment. Member States shall ensure that general rules are established for the use of personal protective equipment and/or covering cases and situations where the employer must provide such equipment.

When comparing the US and EU legal framework for the use of respiratory equipments, it seems that the US has a more comprehensive system while the EU legal system is more fragmented, . In the US "fit tests" are also performed while in the EU it is only "fit checks"

In conclusion, the group found consensus on the necessity to take action to apply better the hierarchy of controls at the workplace.

4. Possible topics for future EU/US collaboration:

It appears clear that there remain many areas of mutual interest regarding chemicals in the workplace that would benefit from a discussion at the next US/EU conference on occupational safety and health. The following topics were proposed by the group:

  1. Explore the feasibility of common databases on chemicals and their uses to allow better control & prevention at the workplace. These might include: inventory of SDS, inventory of safer alternatives, common guidance on SDS for mixtures. 
  2. Explore the possibility of practical guidelines on Substitution
  3. Develop common list of substances of very high concern for priority action 
  4. Discuss risk assessment and risk reduction strategies for CMRs, endocrine disruptors, sensitizers
  5. Discuss OSH aspects of nanomaterials (eg, early risk identification, hazard communication) 
  1. Exchange & compare training strategies
  2. A discussion is also needed on how to organize and implement post conference collaboration