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Recommendations

The recommendations arising from the assessment of formaldehyde are made for occupational health, public health, and environmental protection. The critical issues that have been taken into consideration in formulating these recommendations are summarised in the preamble for each of these areas.



Recommendations for Occupational Health and Safety




Preamble

It is best occupational health and safety (OHS) practice to follow the hierarchy of controls when a risk assessment indicates a potential risk to workers’ health due to use of chemicals in the workplace.


The hierarchy of controls are:


  1. Elimination




  1. Substitution




  1. Engineering controls




  1. Safe work practices (Administrative practices)




  1. Personal protective equipment

When deciding on the best way to control a risk, start at the top of the hierarchy of controls, i.e. investigate if the risk can be eliminated first, for example, by changing the way the work is done, or by using safer substances. This is the most effective way to control a hazard. If these methods are not possible, use engineering or administrative controls to reduce or minimise the risk. The final approach is to use appropriate personal protective equipment if the risk needs further control.


In addition, personal monitoring should be conducted where a workplace assessment indicates a potential risk to health due to exposure to hazardous chemicals, particularly, workplaces with possible high exposure to the chemical.
Based on the known hazards and risks of formaldehyde, the hierarchy of controls should be implemented to manage occupational exposure to formaldehyde.
Specifically for formaldehyde, it is noted that:


  • The best available LOEL for non-cancer effects in humans is 0.5 ppm for sensory irritation;




  • Formaldehyde in solution is a strong skin sensitiser;




  • Formaldehyde may cause nasal cancer by inhalation;




  • The predicted risk for respiratory tract cancers is less than 1 in a million workers at occupational exposure levels ≤0.6 ppm;




  • The occupational risk characterisation identified concerns in a number of use scenarios, particularly in embalming and medicine-related industries;




  • The current Australian occupational exposure standard is 1 ppm time-weighted average (TWA), and 2 ppm short-term exposure limit (STEL);

The following recommendations are made:



Recommendation 1. Occupational hazard classification (OASCC)




  1. Based on the hazard assessment, formaldehyde should be classified as: R23/24/25 toxic by inhalation, in contact with skin and if swallowed R34 causes burns

R43 may cause sensitisation by skin contact
R49 may cause cancer by inhalation (Carcinogen, Category 2)
Compared with the current hazard classification for formaldehyde in the Hazardous Substances Information System of the Office of the Australian Safety and Compensation Council (OASCC), only classification for carcinogenicity has been changed (from Category 3).


  1. Based on the NOHSC’s Approved Criteria for Classifying Hazardous Substances

(NOHSC, 2004), the appropriate risk phrases for mixtures containing formaldehyde are:
Risk Phrase Concentration Cut-off
R49 ≥0.1% to <0.2%
R49, R43 ≥0.2% to <3%
R49, R43, R36/38, R20/21/22 ≥3% to <10%
R49, R43, R34, R20/21/22 ≥10% to <25%
R49, R43, R34, R23/24/25 ≥25%



Key:

R20/21/22 Harmful by inhalation, in contact with skin and if swallowed R23/24/25 Toxic by inhalation, in contact with skin and if swallowed R34 Causes burns

R36/38 Irritating to eyes and skin

R43 May cause sensitisation by skin contact

R49 May cause cancer by inhalation

It is recommended that this classification be included in the Hazardous Substances Information System (HSIS) as soon as possible.



Recommendation 2. National occupational exposure standard (OASCC)




    1. It is recommended that OASCC (formerly NOHSC) lower the current occupational exposure standard for formaldehyde. Based on the hazard assessment for




formaldehyde, NICNAS recommends that the new standard be 0.3 ppm (0.36 mg/m3) 8h TWA and 0.6 ppm (0.72 mg/m3) STEL. The recommended new standard offers adequate worker protection for extended shifts. The documentation to support the recommended exposure standard is in Appendix 16, which will serve as an attachment in the OASCC Regulatory Impact Statement when the proposed exposure standard is released for public comment. The OASCC should consider the recommended exposure standard as a matter of priority, with a view to declaration of a new standard within 12 months.
Australian monitoring studies, whilst limited, indicate that in some sectors, particularly workplaces manufacturing pressed wood products and mortuary and forensic/hospital and pathology laboratories, exposure levels are likely to regularly exceed the proposed new health-based exposure standard. These data need to be considered by OASCC in their development of a new occupational exposure standard and the timing of its implementation, noting such issues will be subject to further consultation with stakeholders under the OASSC exposure standard setting process.


    1. Anecdotal information provided to NICNAS indicates that, in practice, occupational exposure standards (TWAs and STELs) appear to be misinterpreted. For example, industry has advised that it is their understanding that workplaces need to operate at half the level of an exposure standard to ensure compliance with the standard. To address this, it is recommended that the OASCC and state and territory workplace safety authorities develop and disseminate clear guidance on the application of national exposure standards in the workplace.



Recommendation 3. Use of formaldehyde in spray and aerosol products (Industry)

It is recommended that activities involving spraying of formaldehyde or products containing formaldehyde only be carried out in a controlled manner using adequate engineering controls and other suitable protection. If such controls or protection cannot be provided for an activity, spraying should not be permitted.



Recommendation 4. Hazard communication (Industry)

It is recommended that suppliers and employers take note of the new hazard classification in regards to carcinogenicity (Category 2 - may cause cancer by inhalation) and amend Material Safety Data Sheets (MSDS), labels and training materials accordingly.


It is recommended that all manufacturers, suppliers and employers review their hazard communication, paying particular attention to the following points:
MSDS (see Sample MSDS, Appendix 14):


      • correct identification of health hazards, especially skin sensitisation, corrosiveness, and carcinogenicity;

      • correct information on the concentration cut-offs for mixtures containing formaldehyde;

      • first aid advice, including the advice that vomiting should not be induced; and




      • include the Australian occupational exposure standard.



Labels:



  • correct signal word;







    • include emergency procedures; and




    • correct first aid statements.



Recommendation 5. Specific recommendations for the embalming industry (Industry)

    • It is recommended that the Australian Funeral Directors Association (AFDA) and the Australian Institute of Embalming (AIE), together with the registered training organisations for embalming industry, the Funeral Industry Development Australia (FIDA) and Mortuary and Funeral Educators (MFE), use the information in this report to 1) update information on formaldehyde in their training materials for embalmers; 2) develop a specific guideline for controlling non-infectious hazards such as hazardous chemicals (including formaldehyde) for embalmers. The development of any materials and guidelines should be in consultation with relevant stakeholders such as state/territory authorities and organisations representing the workers;

    • The following workplace controls are recommended:

      • Employers of embalming industry should consider replacing high concentration formalin products with low concentrations or less hazardous or formaldehyde-free products, if available;

      • Effective ventilation is a critical control measure for embalmers. It is recommended that the embalming industry ensure that a ventilation system is in place and is effective at maintaining exposure levels below the recommended national exposure standard of 0.3 ppm (TWA) and

0.6 ppm (STEL); and

      • Embalmers should pay particular attention to the type of personal protective equipment (PPE) used during embalming. Relevant Australian standards and/or guidance from manufacturers in selecting and use of PPE should be followed. Respirators should be used in situations where high formaldehyde levels and high frequency exposures may be encountered which may be above the occupational exposure standard, such as embalming post-mortem bodies;

    • NICNAS will prepare a Safety Information Sheet in consultation with industry, organisations representing the workers and relevant state/territory government organisations, specifically for safe use of formalin products in the embalming industry. It is recommended that employer industry associations and unions distribute this information widely to their members and workers.



Recommendation 6. Specific recommendations for forensic/hospital mortuaries and pathology laboratories (Industry)

    • It is recommended that the Royal College of Pathologists of Australasia (RCPA), National Institute of Forensic Science (NIFS), Australian Forensic Medicine Managers Association (AFMMA), and other relevant associations and training organisations use the information in this report to 1) update information on formaldehyde in training materials for these industries; 2) develop a guideline for controlling hazardous workplace chemicals including

formaldehyde. The development of any materials and guidelines should be in consultation with relevant stakeholders such as state/territory authorities and organisations representing the workers;



  • The following workplace controls are recommended:

    • Use of local exhaust ventilation at each specimen station;

    • Relocate specimen vats to areas with isolated ventilation or use local exhaust ventilation over the vats;

    • Avoid the need for dilution of concentrated formalin products by purchasing diluted formalin products;

    • Ensure effective ventilation, especially in areas where formaldehyde levels may be high, such as exhaust ventilation in storage areas, and down draught arrangements at dissection areas; and

  • NICNAS will prepare a Safety Information Sheet in consultation with industry, organisations representing the workers and relevant state/territory government, specifically for safe use of formalin in forensic/hospital mortuaries and pathology laboratories. It is recommended that employer industry associations and unions distribute this information widely to their members and workers.



Recommendation 7. Compliance with state and territory legislation (Government)

It is recommended that state and territory OHS authorities review the compliance of workplaces with the workplace controls recommended in this report, including occupational exposure standard, MSDS and labels. Reviews should be conducted at an appropriate interval to allow for the adoption by industry of the recommended workplace controls, and should target industries with potential for high formaldehyde exposure, such as the embalming industry.



Recommendation 8. Communication (Government and industry)

NICNAS will prepare a Safety Information Sheet for formaldehyde in consultation with industry, organisations representing the workers, and relevant state/territory government, aimed primarily at workers in general who use formaldehyde products. It is recommended that state/territory jurisdictions and organisations representing the workers distribute this information widely.



Recommendations for Public Health




Preamble

Noting that:




  • The best available LOEL for non-cancer effects in humans is 0.5 ppm for sensory irritation;




  • Formaldehyde in solution is a strong skin sensitiser;




  • Formaldehyde may cause nasal cancer by inhalation;




  • Respiratory tract cancer risk estimates for the general public (including children) are low based on worst-case exposure scenarios;




  • Formaldehyde concentrations in indoor air are generally higher than outdoor levels;




  • Limited monitoring data indicate that mobile homes and possibly relocatable buildings have higher levels of formaldehyde, primarily due to use of large quantities of formaldehyde-emitting materials;




  • Currently there is no national indoor air standard or guidance value for formaldehyde;




  • The direct and indirect exposure of the general public via cosmetic and consumer products is expected to be widespread and repeated. Overseas countries, such as the European Union (EU), have restrictions on use of formaldehyde in cosmetic products; and




  • Based on the hazard profile of formaldehyde, it is prudent to eliminate or reduce formaldehyde exposure to the public wherever possible.

The following recommendations are made:



Recommendation 9. Indoor air guidance value (Government)

NICNAS recommends an indoor air guidance value of 80 ppb (sampling over a short duration). This guidance value is based on sensory irritation, an acute effect. Therefore, the sampling duration should be short (such as hourly). This value will provide guidance for the public and regulatory authorities so that the results of monitoring studies can be considered and action taken where appropriate.


This recommendation, together with the full report, will be forwarded to the Australian Government Department of the Environment and Heritage (DEH) and the Environment Protection and Heritage Council (EPHC) for consideration in setting an indoor air standard or guidance value for formaldehyde in the future.

Recommendation 10. Standards Australia (Non-government organisation)

It is recommended that Standards Australia




    • adopt and/or develop a standard(s) for mobile homes and relocatable buildings which includes guidance on ventilation and use of pressed wood products that meet the revised Australian Standards in regards to formaldehyde emission limits;




    • adopt and/or develop applicable method(s) for the sampling and analysis of formaldehyde in indoor air; and




    • adopt international testing and labelling practices for assessing emissions of formaldehyde from materials, which allow for testing to low emission levels as provided in other countries such as Japan.



Recommendation 11. Mobile home and relocatable building manufacturers (Industry)

Manufacturers of mobile homes and relocatable buildings should aim to minimise levels of formaldehyde in indoor air. Recommendations include:



      • design the structure to ensure that the recommended indoor air guidance value of 80 ppb is not exceeded;

      • only use low formaldehyde-emitting pressed wood products, such as those that meet the Australian Standards for formaldehyde emission limits;




        • coat or laminate untreated surfaces with materials, such as vinyl or water- resistant coatings to reduce formaldehyde emission; and

        • ventilate the buildings well before delivery and use to ensure the recommended indoor air guidance value of 80 ppb is met.



Recommendation 12. Residents/occupants of mobile homes and relocatable buildings (The general public)

The following recommendations are for the general public and are particularly relevant to current residents/occupants of mobile homes and relocatable buildings:



        • ensure adequate ventilation (exhaust ventilation, fans or window ventilation);




        • exhaust all combustion appliances directly to the outdoors;




        • purchase low formaldehyde-emitting pressed wood products, such as those that meet Australian Standards for formaldehyde emission limits;

        • where possible/practicable, ensure that furniture and fittings are manufactured from materials that are low formaldehyde emitters;

        • avoid smoking indoors; and




        • avoid high room temperatures and high relative humidity wherever possible, such as through the use of air-conditioning.



Recommendation 13. Indoor air monitoring (Government, industry and research organisations)

In order to more accurately estimate the risks to the public from indoor air exposure to formaldehyde, indoor air monitoring data should be collected, focusing on the buildings with potentially high formaldehyde levels, such as mobile homes and relocatable buildings including classrooms.



Recommendation 14. Communication (Government and industry)

To raise consumer awareness, NICNAS will prepare an Information Sheet, in consultation with industry and other government departments, for distribution to mobile building owners/residents, state and private education departments/offices, and teaching unions. It is recommended that industry, local governments, and other relevant authorities distribute the information widely.


To facilitate consumer choice and use of safer products, low formaldehyde emitting products should be labelled accordingly.

Recommendation 15. Poison Scheduling (Government)

It is recommended that the National Drugs and Poisons Schedule Committee (NDPSC) consider amending the current scheduling for formaldehyde and paraformaldehyde taking note of the following:




  1. the need to consider more restrictive categories given its potency of causing skin sensitisation and its classification for the workplace as a Category 2 carcinogen;




  1. the need for more protective cut-off values for cosmetics and personal care products containing formaldehyde. The EU cut-off values are highlighted below as representing a potential best practice model and have the following restrictions:


Formaldehyde and paraformaldehyde (as a preservative) for cosmetic use:


      • free formaldehyde at 0.2% or less in all cosmetic preparations [except oral hygiene preparations, nail hardeners and aerosol dispensers (sprays)];

      • free formaldehyde at 0.1% or less in oral hygiene preparations;







      • use of formaldehyde and paraformaldehyde in aerosol dispensers (sprays) is prohibited.



Recommendations 16. Utilisation of the health hazard assessment

(Government)
It is recommended that other government organisations, such as Agricultural Pesticides and Veterinary Medicines Authority (APVMA) and Therapeutic Good Administration (TGA), take the findings of the human health hazard assessment into consideration in future work on formaldehyde or products containing formaldehyde, noting use of formaldehyde in therapeutic and agricultural and veterinary products.

Recommendations for Environmental Protection




Preamble

Noting that:




  • The major environmental release of formaldehyde is into the atmosphere;




  • Formaldehyde is a hazardous air pollutant otherwise known as an ‘air toxic’;




  • The release and disposal of formaldehyde from industrial facilities are regulated by licence agreements; and




  • Formaldehyde in ambient air is currently being investigated by the National Environment Protection Council (NEPC), as part of their Air Toxics National Environment Protection Measure (NEPM).

The following recommendations are made:



Recommendation 17. Ambient air standard (Government)

It is recommended that NEPC take the data and findings of this report into consideration when setting an ambient air standard for formaldehyde. Evaluation of the available data in this report indicates that an ambient air standard in the order of 80 ppb (sampling over a short duration) would be warranted.



Recommendation 18. Communication (Government)

It is recommended that the Australian Government Department of the Environment and Heritage update the National Pollutant Inventory (NPI) Fact Sheet for formaldehyde in accordance with the findings of this report.





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