Transportation of Clinical Waste as ‘Bulk’ or in Packages

April 27, 2003

Transportation of Clinical Waste as ‘Bulk’ or in Packages

– the way forward.

Dr Nick Williams – Environmental Advisor – PHS Group plc and

Mr. Ian Pepper - Senior Regulatory Affairs Officer – Rentokil Initial plc

Background

 

In 1957 the UK signed an international treaty called "Accord Europeen relatif au transport international des marchandise dangereuses par route" which is a European agreement concerning the international carriage of dangerous goods by road, also more commonly known as "ADR". The purpose of this agreement is to provide a standardised and internationally recognised means of protecting human health and the environment from the dangers posed by the transport of dangerous goods.

The requirements of ADR are implemented via "The Carriage of Dangerous Goods by Road Regulations 1996" and "The Carriage of Dangerous Goods (Classification, Packaging and Labelling) Regulations 1996". Clinical waste is subject to these Regulations although it should be understood that "Sanpro" waste (human hygiene) is not considered to be dangerous for transportation purposes and as such is not governed by these regulations.

Although the Regulations became law in 1996, the UK was allowed a five-year derogation during which time it was to prepare for the higher standards required under this legislation. This five-year derogation ended on the 31st December 2001 and full compliance with the Regulations was required as of the 1st January 2002, or was it?

On the 4th January 2002 (only 4 days into the new regime), HSE issued a ‘consultation’ to industry regarding the future implementation of ADR 2003, and included a paragraph suggesting that the carriage of clinical waste in ‘loose’ bags was still acceptable throughout 2002. Whilst preparations had been in hand for some time, much of the capital spent by industry had only finally been committed in December – when HSE were actually writing this ‘consultation’.

In spite of strong representations from SMDSA, on the 28th February 2002 the Health and Safety Executive (HSE) issued Certificate of Exemption No 1 2002, allowing the use of type approved sacks for transport of clinical waste as inners of rigid large packaging (LP’s) or in bulk in "specially equipped vehicles" as detailed in the certificate of exemption.

Following this development, the UK approached the United Nations Sub-Committee of Experts on The Transportation of Dangerous Goods (UNCOE) with a proposal for the carriage of clinical waste (UN 3291) in bulk to be incorporated in the 13th revised edition of the UN Model Regulations in July 2002.This sought to amplify the provision in VV11 of RID and ADR which permitted the bulk carriage of clinical waste provided it was transported in "specially equipped vehicles and containers in a manner which avoids risks to humans, animals and the environment".

The rationale for seeking changes to the UN Model Regulations was that it would be easier to secure changes in UN (particularly as the Americans were also seeking similar changes) than RID/ADR. That if the proposals were agreed at the UNCOE, there was good chance that the provisions would drop down unaltered into RID/ADR in 2005. In the meantime, we would be able to use the provisions as the basis for a Multilateral Special Agreement (MSA) which, in turn, would allow the UK to issue a certificate of exemption anticipating the coming into force of the provisions in RID/ADR.

 could not reach an agreement on this proposal during the meeting in July 2002 mainly because of lack of time and concerns expressed about the proposed conditions applied to transport in bulk, and the HSE asked SMDSA, NHS, and other industry representatives to attend a hastily convened meeting in August to revise the UK position for re-submission in December.

 

 

The UK submission to UN

 

The following position was agreed, and re-submitted to the UN in December:

"The UK industry has invested heavily in developing, particularly, Large Packagings for the transport of clinical waste. However, with the adoption during this biennium of provisions addressing the transport of solid substances in bulk in containers in the Model Regulations, and recognising that bulk transport of clinical waste is permitted in European land transport agreements under conditions approved by the competent authority, the expert of the United Kingdom believes it is appropriate for the Model Regulations to address this issue too.

Some confusion arose in [previous] debate because part of the United Kingdom proposal required that clinical waste be contained within leak-proof plastics bags. It should be emphasised that this requirement stems from the United Kingdom’s belief that clinical waste, which otherwise may have the potential to generate a quantity of free liquid in transport, should not be transported loose in bulk. This reflects the need to protect the health and safety of transport workers, handlers of clinical waste and the wider community.

In order to minimise any free liquid in the bulk container, it is the view of the expert of the United Kingdom that it is necessary to introduce some form of secondary containment requirement. For reasons of ease of availability and cost efficiency for health services as the primary generators of clinical waste, the United Kingdom believes that its previously widely used, and demonstrably safe, method of containment within plastics bags adequately fulfills this function."

 

 

Proposal

 

Amend the title of Section 4.3.2 in the Model Regulations to include Division 6.2. Add a new paragraph as follows:

4.3.2.4 Bulk Goods of Division 6.2 (UN 3291)

 

(a) Only closed bulk containers [BK2] shall be permitted that in addition have a rigid roof, side walls, end walls and floor.

 

(b) Closed bulk containers, and their openings, shall be watertight by design or by the fitting of a suitable liner.

 

(c) Goods of UN 3291 containing sharp objects are not permitted in bulk and shall be contained in UN type tested and approved rigid packagings meeting the provisions of Packing Instructions P621, IBC620 or LP621.

 

(d)   Other goods of UN 3291 shall be contained within the closed bulk container in UN type tested and approved sealed leak-proof plastics bags marked as suitable for solids of Packing Group II and marked in accordance with 6.1.3.1. Rigid packagings specified in Packing Instructions P621, IBC 620 or LP621 may also be used.

 

(e)   Goods of UN 3291 carried in rigid packagings and plastics bags together in the same closed bulk container shall be adequately segregated from each other such as by suitable rigid barriers or dividers, mesh nets or otherwise securing the packagings, such that they prevent damage to the packagings during normal conditions of transport.

 

(f)   Goods of UN 3291 may not be carried together with any other dangerous goods except UN 1851, UN 3248 and/or UN 3249.

 

(g)   Goods of UN 3291 in plastics bags shall not be compressed in the closed bulk container in such a way that bags may be rendered no longer leak-proof.

 

(h)   If any goods of UN 3291 have leaked or been spilled in the closed bulk container, it may not be re-used until after it has been thoroughly cleaned and, if necessary, disinfected or decontaminated. Any other goods and articles carried in the same closed bulk container shall be examined for possible contamination. (NOTE: this provision may be more appropriately placed as a new 7.1.6.2.3)

 

Renumber the subsequent paragraphs in 4.3.2 accordingly.

 

Unfortunately, voting at UNCOE was split 7-7 and again the proposals failed to be agreed.

 

So what’s the future hold for the UK?

 

However it is important to recognize that the UN Model Regulations are effectively guidance whereas ADR/RID is mandatory, and consideration may now be given to a proposal to the ADR/RID joint meeting to incorporate the UK text into ADR as a useful explanation of VV11.

As for the future, the following comment was received from Mr. Eddie Bailey, Head of the Transport of Dangerous Goods Policy Unit at HSE:

 

"In the meantime, the conditions for the domestic carriage of clinical waste

in bulk remain those in the certificate of exemption. The certificate will

fall when the new Carriage of Dangerous Goods by Road and Rail Regulations

are in place later in 2003. However, when the time comes, the conditions

themselves will be repeated in an addendum to the HSC guidance "Safe

Disposal of Clinical Waste", amended to follow the text put to the UN as

agreed with industry. There should therefore be no disruption to carriage

practices for the foreseeable future."

 

Thus, it appears that the UN approved clinical waste sack will continue in the UK to be a viable option for the transportation of Group A clinical waste well into the future.

 

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