TRANSPORTATION OF CLINICAL WASTE
TRANSPORTATION AS BULK OR IN PACKAGES, THE FACTS EXPLORED
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’.
Then, 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 expert from the UK for The Transportation of
Dangerous Goods 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 13 th revised
edition of the UN Model Regulations in July 2002.
There follows a summary of where we are now as an industry.
Background
The expert from the United Kingdom draws the attention of the Sub-Committee to
the long established practice permitted in UK domestic transport of transporting
clinical waste in plastics bags by road in freight containers or road vehicles. This
was deemed to be transport in packages. The safety record of such transport
was good and industry practice for the safe handling of this material in transport
addressed suitable additional conditions of transport. We believe that a number
of other countries permitted similar conditions in their own domestic transport
arrangements. However, to align with current UN provisions reflected in
European regional land transport agreements, and applied to domestic transport
regulations in EU Member States, clinical waste in packages can now only be
permitted in rigid, leak-proof packagings, including Intermediate Bulk Containers
(IBC’s) and Large Packagings ((LP’s) Packing Instructions P621, IBC620 and
LP621).
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.
During debate at the last session of the sub-committee it was said that such
provisions were not necessary because no international transport of clinical
waste took place. However, it should be noted that the Basel Convention on the
Trans-Boundary Movement of Hazardous Waste does address the transport of
infectious substances, including clinical waste. The Model Regulations
themselves state quite clearly in paragraph 2 of the section concerning the
nature, purpose and significance of the Recommendations (page 1 of the Model
Regulations) that they are presented in a form suitable for the development of
national, as well as international, regulations.
Some confusion arose in debate because part of the UK proposal required that
clinical waste be contained within leak-proof plastics bags. It should be
emphasised that this requirement stems from the UK’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 UK 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 UK believes
that it’s previously widely used, and demonstrably safe, method of containment
within plastics bags adequately fulfills this function. The UK proposes that, rather
than attempt to introduce into the Model Regulations some newly defined generic
concept of secondary containment, a requirement that clinical waste must be
contained as a minimum within a UN type tested plastics bag be introduced.
However, this is one of several conditions of bulk transport and is not a means of
transporting clinical waste in packages.
Proposal
The expert from the United Kingdom thus proposes the following:
In the Model Regulations
Amend the title of Section 4.3.2 to include Division 6.2
Add a new paragraph 4.3.2.4 for UN 3291 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 [and other health-care
generated dangerous wastes].
(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 leakproof.
(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.
UNCOE could not reach an agreement on this proposal during the meeting in
July 2002.
Following the lack of agreement by all Nations at the UNCOE meeting in July
2002, the HSE consulted the clinical waste industry in August 2002. A meeting
was held at HSE Offices, London to discuss the way forward. The minutes of the
meeting are detailed below.
Aim of Meeting
The aim of the meeting was to discuss the development of a paper to the UN
Sub-Committee of Experts on the Transport of Dangerous Goods (UNCOE)
proposing new provisions for the carriage of clinical waste (UN 3291) in bulk to
be incorporated in the 13th revised edition of the UN Model Regulations.
Background
A paper had already been put to UNCOE in July that proposed changes to newly
agreed provisions covering the transport of dangerous goods in bulk in the UN
Model Regulations. 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 1995. 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 us to issue a certificate of exemption anticipating the coming into
force of the provisions in RID/ADR.
It was explained that a version of the paper had been discussed at a meeting of
UNCOE in July but the paper had not been agreed mainly because of lack of
time and concerns expressed about the proposed conditions applied to transport
in bulk. DfT nevertheless felt pursuing this approach was the most likely to yield
results, particularly if the paper could be revised taking account of the concerns
of both industry and those expressed at the UNCOE meeting in July, with an eye
to co-ordinating with the American proposals.
Discussion
There was discussion of an alternative approach which sought to change the UN
Model Regulations to recognise the use of sacks as type approved packaging
provided the sort of conditions of carriage set out in the paper for bulk transport
were applied. This would allow the quantity threshold limits to be applied to other
requirements such as placarding; such requirements applied straightaway when
carriage was in bulk. However, it was agreed that success was doubtful given
that previous UK attempts to allow for sacks as type approved packaging had
met with almost complete rejection. As a result, it was agreed the approach set
out in the draft UN paper represented the approach most likely to succeed.
Discussion then centred on what changes should be made to the draft paper. It
was agreed that the paper should be revised to cover the following points:

To separate the requirements for UN 3291 from those of UN2900;

(b) should omit the reference to “sheeted” bulk containers. There was
some discussion about the use of the word “watertight” with agreement
that industry guidance could amplify this point;

(c) and (d) should be amended to make clear that bulk containers can
be used to transport clinical waste in type approved rigid packaging at
the same time as clinical waste in bulk (ie in bags);

(e) should be amended to allow greater flexibility in the means of
segregating bags and rigid packagings from one another;

(f) should include in square brackets a mention of other health-care
generated dangerous wastes to allow other wastes such as radioactive
wastes to be transported with clinical waste;

a further condition should be added which required any container to be
cleaned and, if necessary, disinfected or decontaminated where any
clinical waste has been spilled or has leaked;
delete the condition which required manual handling of clinical waste to be kept
to a minimum. This was better contained in guidance and could be covered in
the revision of the Safe Disposal of Clinical Waste.
Action
It was agreed that the paper would be revised in the light of the above and
circulated for quick comment prior to the deadline (6 September) for submission
to the UNCOE meeting in December. If the paper was agreed at this meeting
DfT would ensure that it is discussed at the joint RID/ADR meeting next March
and would take forward the possibility of agreeing an MSA.
Summary
The result of all of the discussions between the HSE and UNCOE is that clinical
waste (UN3291) can be transported in “bulk” in vehicles provided that it is
segregated from clinical waste in rigid containers (including LP’s) and other
Groups of clinical waste (e.g. Groups C, D, and E).
Thus, the UN approved clinical waste sack continues to be a viable option for the
transportation of Group A clinical waste.
Transportation as bulk is defined as clinical waste (UN 3291) in loose yellow
plastic sacks, whereas, transportation in packages is defined as the transport of
clinical waste (UN 3291) in rigid containers (e.g. one-way burn containers or
LP’s).