7 INF
IFCS
Chemical Safety for Sustainable Development
IFCS/FORUM-V/7 INF
Original: English
5 September 2006
FORUM V
Fifth Session
of the
Intergovernmental Forum on Chemical Safety
Budapest, Hungary
25 - 29 September 2006
************************************
TOOLS AND APPROACHES FOR APPLYING PRECAUTION
IN THE CONTEXT OF CHEMICALS SAFETY
Prepared by: FSC Working Group
Secretariat: c/o World Health Organization, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland
Tel: +41 (22) 791 3873/3650; Fax: +41 (22) 791 4875; Email: ifcs@who.int; Website: www.ifcs.ch
Intergovernmental Forum on Chemical Safety
Fifth Session - Forum V
25 - 29 September 2006
IFCS/Forum-V/7 INF
FORUM V PLENARY OPEN INFORMATION/DISCUSSION SESSION ON
TOOLS AND APPROACHES FOR APPLYING PRECAUTION
IN THE CONTEXT OF CHEMICALS SAFETY
Presentation - Abstracts
Tools and Approaches for Applying Precaution in the Context of Chemicals Safety:
Introduction
Franz Xaver Perrez
International Affairs Division - Head of Section Global Affairs
Federal Office for the Environment, Switzerland
PRIO- A tool that facilitate for enterprises to practise precaution
Johanna Lissinger Peitz
Senior Technical Officer, Risk Reduction Division, Swedish Chemicals Inspectorate
U.S. EPA, Office of Pollution Prevention and Toxics (OPPT)
Chemical Reviews and Tools Case Study
John Shoaff
International Team
Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, USA
Case study: Precaution as applied in Nicaraguan pesticide control, and the chilling effect of
a regional trade and integration agreement
Jesus Marin Ruiz,Director
CIVATOX, Nicaragua
Case studies applying precautionary approaches (PAN Asia Pacific)
Romy Quijano, Pesticide Action Network
Alliance Boots - Chemicals in Consumer Products, A Precautionary Approach
Stephen Johnson
Sustainable Development Manager, CSR Support
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Tools and Approaches for Applying Precaution in the Context of Chemicals Safety: An
Introduction
By Franz Xaver Perrez*
Table of Content:
1. Introduction .........................................................................................................................4
2. Background: Origins of the Concept of Precaution ............................................................4
3. Issues surrounding the application of precaution................................................................5
(a) Elements of the Concept:...............................................................................................5
(b) Main “Challenges” to a Common Understanding of the Concept: ...............................7
(i) Principle versus Approach .........................................................................................7
(ii) Precaution as Risk Management Tool or as Broader Overarching Principle ...........7
(iii) Precaution and Trade ...............................................................................................8
(c) Status in International Law of the Concept: ..................................................................8
4. Current international instruments relevant for applying precaution in the context of
chemicals safety ......................................................................................................................9
5. General Commonalities with regard to the Concept of Precaution. .................................10
6. Conclusions .......................................................................................................................11
Annex: References to precaution in selected key international instruments .......................13
*
Dr. Franz Xaver Perrez, deputy head of the International Division and head of section Global
Affairs of the Swiss Agency for the Environment, Forests and Landscape; J.S.D. 1998 (NYU
School of Law); LL.M. 1996 (NYU School of Law); additional studies at University of Bern
School of Law and Université de Paris II. Formerly legal counsel to the Department of Public
International Law, Swiss Department of Foreign Affairs and legal advisor in the State Secretariat
for Economic Affairs, Switzerland. He has published several articles and books on international
environment law and policy, trade and environment, and precaution.
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1. Introduction
This presentation intends to provide an overview on the background and issues surrounding the
application of precaution in chemicals management efforts. It will also present current
international instruments (both voluntary and legally binding) for applying precaution in the
context of chemicals safety. It is important to note that the purpose of this overview is not to
provoke a debate about different interpretations and definitions of the concept of precaution, but
to provide the context for the session’s objective of exploring how different interpretations of
precaution have been implemented in different countries.
The presentation is made in personal capacity, not on behalf of any government or institution. It is
not intended to represent the opinion of the IFCS or of the working group that was preparing this
agenda item. While trying to be as “neutral” and “objective” as possible, it nevertheless reflects
my personal view.
2. Background: Origins of the Concept of Precaution
Precaution has become one of the most hotly debated concepts adopted at the 1992 UNCED in
Rio:
o
Some consider precaution to be a key tool to address global environmental problems and
a symbol for effective environmental protection.
o
Others are concerned that the concept may be misused to undermine the importance of
relying on sound science in regulatory decision making, or to disguise protectionist trade
measures.
The concept of precaution is a response to the growing appreciation of the scientific uncertainties
about causes and effects with regard to environmental degradation. It evolved based on the
recognition that the consequences and possible risks of certain activities or substances cannot
always be determined with scientific certainty and that the consequences of not taking a
preventive measure early enough could be irreversible. As such, it “pierces the veil” of the
concept that an environmental measure should only be adopted if there is scientific certainty that
the measure is necessary. Moreover, as there is always some scientific uncertainty in connection
with environmental regulation, one view of precaution is that it is intended to address those
situations where there is more uncertainty than usual.
The concept of precaution has evolved within national legislation before entering the international
arena. At a national level, precaution – or taking preventive action in the face of uncertain risks –
is well known and applied domestically in areas such as environment, occupational safety and
health, by most if not all countries either explicitly or implicitly.
Internationally, precaution was invoked in the early 1980’s in connection with the protection of
the marine environment of the North Sea. However, while several international instruments make
reference to precaution prior to the adoption of the Rio Declaration, the Rio Declaration of 1992
is generally seen as the entry point into and basic reference for precaution in international
instruments and policy.
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3. Issues surrounding the application of precaution
(a) Elements of the Concept:
The concept of precaution provides guidance in the decision making and in the development and
implementation of policies with regard to risk management in the light of scientific uncertainties.
Some countries view precaution as describing a variety of approaches that may be undertaken in
response to scientific uncertainty.
Precaution as stipulated by Principle 15 of the Rio Declaration indicates that “[i]n order to protect
the environment, the precautionary approach shall be widely applied by States according to their
capabilities. Where there are threats of serious or irreversible damage, lack of full scientific
certainty shall not be used as a reason for postponing cost-effective measures to prevent
environmental degradation.”
According to Rio Principle 15, the concept of precaution
o
relates to the protection of the environment;
o
requires a threat of serious or irreversible damage;
o
there must be scientific uncertainty – it seems that the scientific uncertainty must relate to
the risk of a potential damage and / or the necessity to adopt protective measure;
o
precautionary measures must be cost-effective – it seems that cost-effectiveness means
that the measure must be reasonable to achieve a particular goal; and
o
Rio Principle 15 does not require precautionary action in situations of lack of full
scientific certainties but it allows for such action.
o
Moreover, States shall widely apply precaution according to their capabilities.
Within the academic discussion of precaution different conclusions have been drawn from Rio
Principle 15. Thus, precaution is seen:
o
as a duty to avoid risk;
o
as a requirement to adopt an approach which ensures that errors are made on the side of
excess environmental protection rather than on the side of estimated assimilative capacity
of the environment;
o
as a duty to substitute more dangerous with less dangerous substances;
o
as a shift of the burden of proof to those creating risks;
o
as a concept requiring states to cooperate in order to prevent environmental degradation
in the light of scientific uncertainty; or
o
as a variety of approaches that may be undertaken in response to scientific uncertainty.
It is important to note that while there is agreement on the language and thus the elements of Rio
Principle 15, no general agreement exists with regard to one or several of these conclusions.
However, the focus of this IFCS-Session on tools and concrete examples of application of
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precaution may well show that there is actually an agreement on or that there are common
elements in approaches to the application of the concept.
Since Rio, the concept of precaution has been referred to and further concretized in numerous
international instruments and decisions, namely:
o
the Cartagena Biosafety Protocol;
o
the Stockholm POPs Convention;
o
the Johannesburg Plan of Implementation which was adopted at the WSSD in 2002;
o
the Overarching Policy Strategy of SAICM which was adopted in February 2006.
It is important to note that all these instruments and decisions explicitly refer to and confirm the
relevance of Rio Principle 15.
Not only environmental agreements but also the WTO agreements are relevant for precaution.
While several provisions of the WTO-agreements deal indirectly with precaution, e.g. by
accepting that countries have the right to adopt measures necessary for the protection of the
environment or human health, the WTO Agreement on Sanitary and Phytosanitary measures (SPS)
explicitly allows in case of insufficient scientific evidence the adoption of provisional measures if
there is pertinent information of a possible risk. A state that implements such provisional
precautionary measures has the obligation to seek additional information necessary for the
assessment of the risks and to review such precautionary measures within a reasonable period of
time.
With regard to the WTO SPS agreement, it is important to note that while some see the SPS
provisions allowing for the adoption of provisional measures in situations of scientific uncertainty,
others argue that the SPS agreement is not precautionary in nature as it generally requires
measures to be based on scientific evidence and as provisional SPS-measures are seen as
“emergency measures” which must be reviewed within a reasonable period of time and
substantiated with a risk assessment, a requirement which can be challenging especially for
developing countries.
At the same time, these instruments and decisions seem to further develop, within the scope of
their application, some of the elements established by Rio Principle 15:
o
The WTO Agreement on Sanitary and Phytosanitary measures (SPS Agreement), the
Cartagena Biosafety Protocol and the Stockholm Convention on Persistent Organic
Pollutants expand the application of precaution beyond environmental measures to
measures for the protection of human health. In this context it should be noted that some
countries view that the Cartagena Protocol does not extend precaution beyond
environmental measures but allows consideration of human health effects that arise
secondarily from environmental effects or conditions.
o
The Convention on Biological Diversity, the SPS Agreement and the Cartagena Biosafety
Protocol do not use the very general formulation of Rio Principle 15 that there must be a
“threat of serious or irreversible damage” but use different criteria such as “threats of
significant reduction or loss of biological diversity”, “pertinent information” that there
might be a risk, or “potential adverse effects … on the conservation and sustainable use
of biodiversity”. Other agreements such as the UNFCCC do use the “serious and
irreversible damage” standard found in Rio Principle 15.
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o
Moreover, non of these instruments requires that precautionary measures must be costeffective – at the same time, it is important to note the desirability for all policy
instruments, not only those based on precaution, to be cost-effective and proportional.
o
In addition, new elements have been developed such as the SPS-requirement that
precautionary measures should be provisional and the obligation to “seek to obtain the
additional information necessary for a more objective assessment of risks” and to review
precautionary measures within a reasonable period of time.
o
While some countries view these differences from Rio Principle 15 as evidence that the
concept of precaution is an expanding/evolving principle, other countries view these
differences as evidence that precaution refers to a variety of approaches that are
individually tailored to particular circumstances of scientific uncertainty.
(b) Main “Challenges” to a Common Understanding of the Concept:
As indicated, the purpose of this overview is to provide the context for the session’s objective of
exploring how different interpretations of precaution have been implemented in different
countries, and not to provoke a debate about those different interpretations. In order to provide
this context, I will briefly address some of the main differences or challenges to the concept:
(i) Principle versus Approach
Precaution as a principle which evolves over time or as an approach chosen in specific situations:
o
while some see precaution as a single concept which can be defined, which has
generally agreed elements and criteria for its applications, and which evolves and
becomes more concrete over time,
o
others see it as an approach which is chosen to be relevant on a case-by-case basis in
specific circumstances.
This different perception of precaution as a principle or an approach explains many of the
differences that emerge with regard to precaution during international negotiations. However, by
focusing on concrete examples of how precaution is applied at the national level and by
discussing concrete experiences and lessons learnt rather than abstract definitions, this difference
may become less relevant.
(ii) Precaution as Risk Management Tool or as Broader Overarching Principle
Precaution as risk management tool or as a broader overarching principle. Two of the
approaches to precaution may be described as follows:
o
While an “European” approach would clearly see precaution as part of risk
management and not use the term “precaution” for the normal scientific caution used
during a risk assessment;
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another approach would argue that precaution is a broader overarching principle that
gives guidance in all steps of decision making, including in the context of risk
assessment.
This difference may also be one of the reasons why agreement is difficult to reach on the content
of the concept of precaution.
(iii) Precaution and Trade
Probably one of the main challenge for precaution is the application of the concept in situations
involving international trade:
o
on the one hand, it is clear – and generally agreed – that precaution must not be used
as a discriminatory and/or protectionist trade barrier: precaution must only be used to
pursue a desired level of protection of environmental or health concerns, it must not
be used to realize hidden economic or trade interests;
o
on the other hand, in most situations a combination of interests and reasons lead to a
certain decision and it is difficult to separate and identify each motivation
individually;
o
moreover, there is of course the attraction to try to use the concept as a pretext to veil
other interests;
o
and as a consequence, there is the lack of trust that in a trade dispute a specific
measure was taken really merely to pursue e.g. an environmental goal, especially if
the environmental sensibility and the pursued environmental standard differ on that
issue between the trading partners or if there are undesired or perhaps even desired
economic side effects of that measure.
To address this challenge, it is important to accept that differences exist with regard to preferred
safety standards and decision making processes. And, it is very important to be transparent during
the process leading to the adoption of precautionary measures.
(c) Status in International Law of the Concept:
At the international level, there is a well known disagreement whether precaution should be
referred to as a principle or an approach:
o
Some refer to precaution as an approach in order to underline that precaution refers to
a variety of approaches to scientific uncertainty which lack the prerequisites to gain
the status of customary international law;
o
others refer to precaution as a principle in order to underline that they accept
precaution as a concept entailing certain legal implications.
With regard to substance, it has to be acknowledged that there are still several important elements
which need further clarification. Moreover, several interpretations such as those understanding
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precaution as a shift of the burden of proof or as a principle requiring state activity whenever
there is scientific uncertainty do not reflect a common agreement on the concept.
On the other hand, precaution in one form or another is widely applied at the national level
throughout the world. But some countries argue that they apply precaution as a matter of policy,
not because they view the concept as a legal one.
Within academic literature, some argue that precaution has already gained the status of a principle
of customary international law, other see it rather as a non-binding but “respected guide to
decision-making”, some see it as a descriptive of a range of approaches that could be taken in the
face of scientific uncertainty, and some find the concept as currently framed to be logically
incoherent. However, there seems to be a growing tendency in academic literature to see
precaution as being in the process of crystallizing into a rule of international customary law.
Finally, the normative and politically binding or authoritative value of Rio Principle 15 is
generally accepted and the reaffirmation of the common commitment to and acceptance of Rio
Principle 15 in several decisions and instruments is an expression of an existing consensus on the
political force and legal relevance of Principle 15.
Thus, it can be concluded that despite existing different views on a few specific elements, there is
broad agreement on some key elements of the concept of precaution, namely those included in
Rio Principle 15, and also on its relevance for policy making.
4. Current international instruments relevant for applying precaution in the context of
chemicals safety
This section will summarize the reference of some of the most relevant chemicals related
international agreements and instruments. However, it is important to note that instruments such
as the Biodiversity Convention or the Climate Change Convention may also be relevant for
chemicals safety policies.
The Montreal Protocol of 1987 affirms the determination of the Parties to protect the ozone
layer by taking precautionary measures to control equitably total global emissions of substances
that deplete it, with the ultimate objective of their elimination on the basis of developments in
scientific knowledge, taking into account technical and economic considerations and bearing in
mind the developmental needs of developing countries (Preamble).
The Bamako Convention of 1991 requires that each Party shall strive to adopt and implement
the preventive, precautionary approach to pollution problems which entails, inter alia, preventing
the release into the environment of substances which may cause harm to humans or the
environment without waiting for scientific proof regarding such harm. And, Parties shall cooperate with each other in taking appropriate measures to implement the precautionary principle
to pollution prevention through the application of clean production methods, rather than the
pursuit of a permissible emissions approach based on assimilative capacity assumptions (Art.
4.3(f)). Thus, according to the Bamako Convention, precaution is also relevant for the protection
of human health. Moreover, potential damage does not have to be “serious” or “irreversible” and
precautionary
measures
should
be
appropriate,
not
cost-effective.
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The IFCS Bahia Declaration and the associated Priorities for Action beyond 2000 underline
the commitment to Rio Principle 15. Specifically, the Priorities for Action state that “Control of
chemicals and pollution control initiatives should be closely integrated and the precautionary
approaches, as outlined in principle 15 of the Rio Declaration, should be applied.” Thereby, “[t]he
full range of risk reduction options should be considered, including encouraging, in particular,
replacing more dangerous chemicals with less dangerous ones or using alternative processes.”
The Stockholm POPs-Convention of 2001 acknowledges that precaution underlines the
concerns of the parties and is embedded within this convention (Preamble). Reminding the
precautionary approach as set forth in Rio Principle 15, it stresses that the objective of the POPs
Convention is to protect human health and the environment from POPs (Art. 1). In determining
best available techniques, precaution should be born in mind (Annex C, para B). Moreover, lack
of full scientific certainty shall not prevent a proposal for listing new substances from proceeding
and the COP shall decide in a precautionary manner whether to list a chemical (Art. 8.7 and 8.9).
The WSSD Johannesburg Plan of Implementation of 2002 renews the commitment to the
sound management of chemicals throughout their life-cycle for the protection of human health
and the environment and formulates the goal to achieve, by 2020, that chemicals are used and
produced in ways that lead to the minimization of significant adverse effects on human health and
the environment, using transparent science-based risk assessment procedures and science-based
risk management procedures, taking into account the precautionary approach as set out in Rio
Principle 15 (JPOI, Chapeau Para 23). Thus, the WSSD JPOI refers to precaution, as set forth in
Rio, as a policy tool to be taken into account in addressing the management of chemicals for the
protection of the environment and of human health.
Most recently, the Strategic Approach to International Chemicals Management (SAICM) of
February 2006 states that one of its objectives with respect to risk reduction is to apply
appropriately the precautionary approach, as set out in Principle 15 of the Rio Declaration, while
aiming to achieve that chemicals are used and produced in ways that lead to the minimization of
significant adverse effects on human health and the environment (OPS, § 14(e)). Thus, SAICM
similarly indicates that precaution may be relevant for management of chemicals for the
protection of the environment and of human health.
5. General Commonalities with regard to the Concept of Precaution.
Today, there seems to be some commonalities on some elements and criteria relevant for the
application of precaution – while of course it must be noted that not all elements have the same
relevance in all countries:
o
Precaution involves situations of scientific uncertainty.
o
There must be a pertinent indication that there is the possibility of a damage or harm.
o
How countries apply or use precaution depends on the domestic legislation and the
concrete circumstances.
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o
Precaution is normally seen as part of risk management – it should nevertheless be
indicated that while I would not use the term “precaution” for the normal scientific
caution used during a risk assessment, another approach would argue that precaution does
have a lot to do with the entire process of assessment and management, e.g. the fact that
how a problem is scientifically defined is relevant to whether we might see a problem.
o
The application of precaution should be based on the most comprehensive scientific
assessment possible, using the best available science.
o
All decisions related to precaution should be conducted in a transparent and open manner.
o
Intelligibility and review: there has to be an intelligible connection between the
precautionary measure and the scientific uncertainty indicating that there might be a
serious threat. Moreover, precautionary measures should be regularly reviewed in light of
new scientific findings and modified when necessary.
o
Proportionality: Precautionary measures should be – like all risk management measures –
proportional to the chosen level of protection and should take into account costs and
potential benefits.
o
Precautionary measures must not be disguised trade restrictions.
o
In certain policy areas, the concept is also applied for measures for the protection of
human health.
6. Conclusions
There are still differences on some important elements with regard to precaution, including its
legal status.
However, there are also important commonalities. Rio Principle 15 is, as of today, probably the
best general formulation of the common understanding on precaution. Other important
commonalities include that each country has the right to determine its own environmental
protection policies and that precaution must not be used as a protectionist tool.
With regard to chemicals, it is interesting to note that both international instruments and national
policies apply precaution in the area of environmental and human health policies.
Let me conclude by indicating that I have the impression that the debate on precaution has so far
been over-politicized, that it has typically focused too much on potential and hypothetical
differences rather than on the existing common understanding of core elements of the content and
the concrete application of the precaution. And the disputes on precaution seem to be sometimes
more politically motivated than founded in concrete facts. Differences with regard to the concrete
implementation of precaution do in reality not relate to the “mechanics” of the concept but to the
political decision whether in a specific situation of uncertainty protective measures should be
taken. As this decision depends on the level of risk that society considers to be “acceptable”, it is
not astonishing that differences exist on this regard.
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A more constructive approach than looking at the big policy picture of precaution and then trying
to develop a new definition of precaution would be to look at the concrete application of the
concept and to try to understand each other and to focus on tools and commonalities. This should
be the goal of this session of the IFCS.
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Convention
Montreal Protocol on Substances
that deplete the Ozone Layer
(1987)
ANNEX
References to precaution in selected key international instruments
Article
Citation
Preamble
Para 6
“Parties to this Protocol,…
Determined to protect the ozone layer by taking precautionary measures to control equitably
total global emissions of substances that deplete it, with the ultimate objective of their
elimination on the basis of developments in scientific knowledge, taking into account
technical and economic considerations and bearing in mind the developmental needs of
developing countries,”
Article 4(3)(f)
“Each Party shall strive to adopt and implement the preventive, precautionary approach to
pollution problems which entails, inter alia, preventing the release into the environment of
substances which may cause harm to humans or the environment without waiting for
scientific proof regarding such harm. The Parties shall co-operate with each other in taking
appropriate measures to implement the precautionary principle to pollution prevention
through the application of clean production methods, rather than the pursuit of a permissible
emissions approach based on assimilative capacity assumptions.”
Principle 15
“In order to protect the environment, the precautionary approach shall be widely applied by
States according to their capabilities. Where there are threats of serious or irreversible
damage, lack of full scientific certainty shall not be used as a reason for postponing costeffective measures to prevent environmental degradation.”
http://ozone.unep.org/Treaties_and_
Ratification/2B_montreal_protocol.a
sp
Bamako Convention on the Ban
of the Import into Africa and the
Control of Transboundary
Movement and Management of
Hazardous Wastes within Africa
(1991)
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http://www.londonconvention.org/B
amako.htm
Rio Declaration (1992)
http://www.un.org/esa/sustdev/docu
ments/agenda21/index.htm
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Agenda 21
(1992)
Para 32
“In order to promote and strengthen international cooperation in the management, including
control and monitoring, of transboundary movements of hazardous wastes, a precautionary
approach should be applied. There is a need to harmonize the procedures and criteria used in
various international and legal instruments. There is also a need to develop or harmonize
existing criteria for identifying wastes dangerous to the environment and to build monitoring
capacities.”
Preamble, Para 13
“CONSIDERING that the present Oslo and Paris Conventions do not adequately control
some of the many sources of pollution, and that it is therefore justifiable to replace them with
the present Convention, which addresses all sources of pollution of the marine environment
and the adverse effects of human activities upon it, takes into account the precautionary
principle and strengthens regional cooperation;”
“The Contracting Parties shall apply:
the precautionary principle, by virtue of which preventive measures are to be taken when
there are reasonable grounds for concern that substances or energy introduced, directly or
indirectly, into the marine environment may bring about hazards to human health, harm
living resources and marine ecosystems, damage amenities or interfere with other legitimate
uses of the sea, even when there is no conclusive evidence of a causal relationship between
the inputs and the effects;”
“1. For the purposes of this Annex, it shall inter alia be the duty of the Commission:
a.
to draw up programmes and measures for the control of the human activities
identified by the application of the criteria in Appendix 3;
b.
in doing so:
(i)
to collect and review information on such activities and their effects on
ecosystems and biological diversity;
(ii)
to develop means, consistent with international law, for instituting
protective, conservation, restorative or precautionary measures related
to specific areas or sites or related to particular species or habitats;”
http://www.un.org/esa/sustdev/docu
ments/agenda21/index.htm
Convention for the Protection of
the Marine Environment of the
North-East Atlantic (1992
OSPAR Convention)
http://www.ospar.org/eng/html/conv
ention/welcome.html
Art. 2.2(a)
(General Obligations)
Annex V,
Art. 3
Cartagena Protocol on Biosafety
to the Convention on Biological
Diversity (2000)
http://www.biodiv.org/biosafety/def
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Preamble, Para 4
Art. 1 (Objective)
“Reaffirming the precautionary approach contained in Principle 15 of the Rio Declaration on
Environment and Development,”
“In accordance with the precautionary approach contained in Principle 15 of the Rio
Declaration on Environment and Development, the objective of this Protocol is to contribute
to ensuring an adequate level of protection in the field of the safe transfer, handling and use
of living modified organisms resulting from modern biotechnology that may have adverse
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ault.aspx
Art. 10(6) (Decision
Procedure)
Art. 11(8) (Procedure
for living modified
organisms intended
for direct use as food
or feed, or for
processing)
IFCS Bahia Declaration on
Chemical Safety
(2000)
IFCS/Forum-V/7 INF
effects on the conservation and sustainable use of biological diversity, taking also into
account risks to human health, and specifically focusing on transboundary movements.”
“Lack of scientific certainty due to insufficient relevant scientific information and knowledge
regarding the extent of the potential adverse effects of a living modified organism on the
conservation and sustainable use of biological diversity in the Party of import, taking also
into account risks to human health, shall not prevent that Party from taking a decision, as
appropriate, with regard to the import of the living modified organism in question as referred
to in paragraph 3 above, in order to avoid or minimize such potential adverse effects.”
“Lack of scientific certainty due to insufficient relevant scientific information and knowledge
regarding the extent of the potential adverse effects of a living modified organism on the
conservation and sustainable use of biological diversity in the Party of import, taking also
into account risks to human health, shall not prevent that Party from taking a decision, as
appropriate, with regard to the import of that living modified organism intended for direct use
as food or feed, or for processing, in order to avoid or minimize such potential adverse
effects.”
I., first Para
We, the participating partners in the IFCS:
“Reaffirm our commitment to the Rio Declaration on Environment and Development
including principles on sustainable development, capacity building, access to information and
the precautionary approach,”
Introduction, Para 5
“Control of chemicals and pollution control initiatives should be closely integrated and the
precautionary approaches, as outlined in principle 15 of the Rio Declaration, should be
applied. The full range of risk reduction options should be considered, including encouraging,
in particular, replacing more dangerous chemicals with less dangerous ones or using
alternative processes.”
Preamble Para 8
“Acknowledging that precaution underlies the concerns of all the Parties and is embedded
within this Convention”
“Mindful of the precautionary approach as set forth in Principle 15 of the Rio Declaration on
Environment and Development, the objective of this Convention is to protect human health
and the environment from persistent organic pollutants.”
http://www.who.int/ifcs/documents/
forums/forum3/en/index.html
IFCS Priorities for Action
beyond 2000
(2000)
http://www.who.int/ifcs/documents/
forums/forum3/en/index.html
Stockholm POPs Convention
(2001)
Art. 1 (Objective)
http://www.pops.int/
15
Intergovernmental Forum on Chemical Safety
Fifth Session - Forum V
25 - 29 September 2006
Art. 8(7)(a)
(Listing of chemicals
in Annexes A, B and
C)
Art. 8(9) (Listing of
chemicals in Annexes
A, B and C)
Annex C
(Unintentional
Production) Part V.B
(General guidance on
best available
techniques)
Chapeau Para 23
World Summit on Sustainable
Development, Johannesburg Plan
of Implementation
(2002)
http://www.un.org/jsummit/html/do
cuments/summit_docs.html
Para 107(f)
IFCS/Forum-V/7 INF
“If, on the basis of the risk profile conducted in accordance with Annex E, the Committee
decides:
That the chemical is likely as a result of its long-range environmental transport to lead to
significant adverse human health and/or environmental effects such that global action is
warranted, the proposal shall proceed. Lack of full scientific certainty shall not prevent the
proposal from proceeding. The Committee shall, through the Secretariat, invite information
from all Parties and observers relating to the considerations specified in Annex F. It shall then
prepare a risk management evaluation that includes an analysis of possible control measures
for the chemical in accordance with that Annex;…”
“The Committee shall, based on the risk profile referred to in paragraph 6 and the risk
management evaluation referred to in paragraph 7(a) or paragraph 8, recommend whether the
chemical should be considered by the Conference of the Parties for listing in Annexes A, B
and/or C. The Conference of the Parties, taking due account of the recommendations of the
Committee, including any scientific uncertainty, shall decide, in a precautionary manner,
whether to list the chemical, and specify its related control measures, in Annexes A, B and/or
C.”
“The concept of best available techniques is not aimed at the prescription of any specific
technology, but at taking into account the technical characteristics of the installation
concerned, its geographical location and the local environmental conditions. Appropriate
control techniques to reduce releases of the chemicals listed in Part I are in general the same.
In determining best available techniques, special consideration should be given, generally or
in specific cases, to the following factors, bearing in mind the likely costs and benefits of a
measure and consideration of precaution and prevention:…”
“Renew the commitment, as advanced in Agenda 21, to sound management of chemicals
throughout their life cycle and of hazardous wastes for sustainable development as well as for
the protection of human health and the environment, inter alia, aiming to achieve, by 2020,
that chemicals are used and produced in ways that lead to the minimization of significant
adverse effects on human health and the environment, using transparent science-based risk
assessment procedures and science-based risk management procedures, taking into account
the precautionary approach, as set out in principle 15 of the Rio Declaration on Environment
and Development, and support developing countries in strengthening their capacity for the
sound management of chemicals and hazardous wastes by providing technical and financial
assistance. This would include actions at all level to:”
“Improve policy and decision-making at all levels through, inter alia, improved collaboration
between natural and social scientists, and between scientists and policy makers, including
16
Intergovernmental Forum on Chemical Safety
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IFCS/Forum-V/7 INF
through urgent actions at all level to:
…
(f) Promote and improve science-based decision-making and reaffirm the precautionary
approach as set out in principle 15 of the Rio Declaration on Environment and Development,
which states:
‘In order to protect the environment, the precautionary approach shall be widely applied by
States according to their capabilities. Where there are threats of serious or irreversible
damage, lack of full scientific certainty shall not be used as a reason for postponing costeffective measures to prevent environmental degradation’
SAICM
(2006)
Para 14(e)
(Risk reduction)
“The objectives of the Strategic Approach with regard to risk reduction are:
…
(e) Appropriately to apply the precautionary approach, as set out in Principle 15 of the Rio
Declaration on Environment and Development, while aiming to achieve that chemicals are
used and produced in ways that lead to the minimization of significant adverse effects on
human health and the environment.”
Activity 133
“Further develop methodologies using transparent science-based risk assessment procedures
and science—based management procedures, taking into account the precautionary
approach.”
http://www.chem.unep.ch/saicm/SA
ICM%20texts/SAICM%20documen
ts.htm
SAICM: Global Plan of Action
http://www.chem.unep.ch/saicm/SA
ICM%20texts/SAICM%20documen
ts.htm
17
Intergovernmental Forum on Chemical Safety
Fifth Session - Forum V
25 - 29 September 2006
IFCS/Forum-V/7 INF
PRIO
A tool that facilitate for enterprises to practise precaution
Johanna Lissinger Peitz
Senior Technical Officer, Risk Reduction Division, Swedish Chemicals Inspectorate
The Swedish Chemicals Inspectorate launched in the beginning of 2004 a web-based risk
reduction tool called PRIO. The tool is aimed at all companies with an intent to improve their
environmental work. PRIO consists of a guide and a database containing about 4000 dangerous
substances.
PRIO is intended to be used preventively to reduce risks to human health and environment from
chemicals. The aim of PRIO is to facilitate in the assessment of health and environmental risks of
chemicals so that people working as environmental managers, purchasers or product developers
can identify the need for risk reduction. To achieve this, PRIO provides a guide for decisionmaking that can be used in setting risk reduction priorities.
The recommendations for which chemicals are prioritised for risk reduction measures are based
on the environmental quality objective “A non toxic environment” adopted by the Swedish
parliament and the current proposal for the new EU-legislation, REACH. Although PRIO is based
on Swedish considerations the tool can and is already used by companies or organisations in other
countries as a source of knowledge or inspiration.
PRIO has been developed in cooperation with other authorities, industry organisation and
companies within different sectors.
The Tool
All the substances in the database have been allocated a prioritisation level; phase-out substance
or priority risk-reduction substance. The prioritisation level indicates how you should act, how
highly you should prioritise the substance in your risk-reduction work. The assessment has been
made according to the “worst” properties of the various substances, as a carcinogenic phase-out
substance may, for example, also have properties that belong to the priority risk-reduction level
(e.g. allergenic).
Each substance is accompanied by a “message” that varies according to what prioritisation level it
belongs to, as follows:
 Priority risk-reduction substance: Because of the hazardous properties of the substance, it
is particular important to consider how the substance is handled. Assess the risk for the
intended use. Consider substitution. Some of the substances are prohibited or restricted
in Sweden.
 Phase-out substances: This a substances with particular concern and according to the
Swedish environmental quality objective a non-toxic environment all newly produced
articles should not contain phase-out substances according to a specific timetable.
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Intergovernmental Forum on Chemical Safety
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25 - 29 September 2006
Phase-out substances
CMR
PBT/vPvB
Particular hazardous metals
Endocrine disrupters
Ozone-depleting substances
IFCS/Forum-V/7 INF
Priority risk reduction substances
Very high acute toxicity
Allergenic
Mutagenic Category 3
High chronic toxicity (health)
Environmentally hazardous, long-term effects
Potential PBT/vPvB
The guide part in PRIO is based on a step-by-step model with the aim to introduce a methodology
for working with the tool. The aim is to avoid that the tool is being used as a black- or grey list.
The intention is to take away the focus from single substances and instead and instead working
with a more risk based approach. The guide is built as a decision tree and by answering a set of
questions the user gets guidance on how to prioritise in their work.
In the Swedish version of the tool a new part is going to be launched during the autumn. This part
is called “chemicals in practice” and presents a structured way on how to work with risk
reduction and continuums improvement. This part has partly been developed as a response to
many of the questions from the users. The intention is to translate also this part to English.
Who is PRIO for?
The main target group for PRIO are small and medium sized companies handling chemicals. The
more traditionally chemical industry has not been seen as the primary target group. The content in
PRIO is also presented on different levels which means that also for people with a limited
knowledge in chemistry and risk management the tool provides useful information. Within a
company the prime target groups are environmental managers, purchaser and product developer,
PRIO also includes tips on how to exert influence on the product chain from other professions,
such as the reuse- and recovery industry, environmental auditors, eco-label organisations, finance
and regional or local authorities.
Lessons learned:
Opportunities and Challenges
A high degree of involvement from the stakeholders that will be using the tool is one of the most
important factors for success. On the other hand one of the main challenges in the work with
developing PRIO was trying to resist the pressure from all involved actors to create the perfect
tool. Most tools needs to be developed in an iterative process with the user. The challenge
however is that everyone you ask for an opinion wants you to create the perfect tool that would
solve all their problems just pressing one single button. Our experience is that such a tool will be
an impossible task and that even the simplest tool require some competence in relevant fields, a
tool is never better than its least informed user. As an authority The Swedish Chemicals
Inspectorate has an obligation to provide a generic tool that can be useful for a diverse target
group. For more specific information industry organisations are encouraged to adjust the
information in PRIO to more detailed level that suits the needs in their specific sector.
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IFCS/Forum-V/7 INF
One of the other major challenges in the work process was getting the experts involved in the
development phase to accept that things needs to be simplified in a final version. We learnt to
hold on to our guiding principle “Keep it simple” as we soon find out that the more complicated
the tool would be the fewer users it would have.
It doesn’t need to be complicated
Since the launch of PRIO in 2004 KemI has presented PRIO at several large Swedish events and
also PRIO is also frequently presented during half day seminars in Sweden. These seminars are
often hosted by the local municipality or an industry network and include a presentation in more
detail of the tool and the opportunity for the participants to test the tool in a real situation. The
response from industry on PRIO as such and on the seminars has almost only been positive.
Although there is no real evaluation available it appears like PRIO act as a strong driving force
for the risk management measures in companies. Many companies also point to the fact that
PRIO simplifies a complex task that many small and medium sized companies sees as something
too complicate to deal with. PRIO provides them with both information and knowledge but also a
base for prioritisation. It has visualised the precautionary principle and introduce a methodology
that seems to be understandable for a wide range of stakeholders.
Other relevant tools
Within the frame of dialogue “Sustainable trade” which is hosted by the Swedish government a
guide has been developed to facilitate for companies in the retail industry to formulate chemical
related product requirements to their suppliers. The focus for the guide is chemicals in articles.
The project presents a five step model that should help environmental departments or purchasers
to have proactive and a precautionary approach in the communication with the suppliers.
Conclusion
The long term goal for the Swedish Chemicals Inspectorate as an authority to develop and market
a tool like PRIO is to facilitate informed decision making taking into concern the precautionary
approach and thereby reduces risks caused by chemicals on health and environment.
For more information on PRIO: www.kemi.se/prio
For more information about Sustainable Trade www.framtidahandel.se
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Intergovernmental Forum on Chemical Safety
Fifth Session - Forum V
25 - 29 September 2006
IFCS/Forum-V/7 INF
U.S. EPA, Office of Pollution Prevention and Toxics (OPPT)
Chemical Reviews and Tools Case Study
Presentation Abstract
John Shoaff, International Teamr, Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency, USA
Introduction
While U.S. law does not specifically use the term “precaution,” decision-making in the face of
scientific uncertainty has been a feature of U.S. policy since the passage of the Federal Food,
Drug and Cosmetics Act (FFDCA) in 1906. This can also be found in various forms in other
statutes and policies, implementation of a number of environmental laws and as an integral part of
our regulatory process and scientific risk analysis. In particular, EPA has been reviewing and
regulating new and existing chemicals under the Toxic Substances Control Act (TSCA) since the
late 1970s and in the absence of complete scientific certainty.
New Chemical Review Process and Tools
EPA’s new chemicals program, under which we review proposed new chemicals prior to
commercial manufacture or importation, is a good example of decision making under conditions
of uncertainty. The review process is designed to prevent unreasonable health and/or
environmental risks before they occur and prior to a new chemical’s entrance into commerce.
EPA reviews about 1500 new chemical notices annually and has reviewed over 45,000 new
chemical submissions to date. 1 The Premanufacture Notification (PMN) review process is
designed to accommodate the large number of PMNs received, while adequately assessing the
risks posed by each substance within the 90-day review timeframe prescribed by TSCA. The
information included in PMNs is limited with more than half of PMNs containing no health or
ecotoxicity test data. Consequently, EPA uses several general approaches to address data gaps to
rapidly evaluate potential risks and make risk management decisions for new chemicals. EPA
relies upon “Structure Activity Relationships” or SAR analysis to estimate or predict physicalchemical properties, environmental fate, and human and environmental effects. A SAR is the
relationship between the chemical structure of a molecule and its properties, including
interactions with the environment and organisms. These modeling and assessment techniques
have worked well to identify problem chemicals, as indicated by the results of a 1993 study
conducted jointly by the EPA and authorities in the European Union (EU). This study showed
that our SAR-based predictions agreed with test results in about 60-90% of the cases, depending

This case study abstract is for information and illustrative purposes only and is not intended to
convey all aspects of EPA’s chemicals program, other programs or U.S. views with respect to
scientific uncertainty under U.S. law, international commitments, agreements and law.
1
Approximately 1000 of the 1500 annual notices are Premanufacture Notifications and the
remaining 500 notices are requests for review and EPA approval as “exemptions” from
premanufacture notification. Approximately 5% of PMNs are regulated by EPA and an additional
5% are withdrawn by manufacturers often in the face of potential action. Ultimately, less than
half of the new chemicals for which EPA receives PMNs enter into commerce.
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IFCS/Forum-V/7 INF
on the end point.2 EPA has also established chemical categories to further facilitate the PMN
review process.3 The presentation will touch upon some of these tools while more information
and links to additional methods and models that are utilized in our reviews follows below.
Considerations and Outcomes of Reviews
Several regulatory and non-regulatory outcomes may follow a PMN submission –




Voluntary withdrawal of the notice, often in the face of possible EPA action.
Voluntary testing action whereby a PMN submitter agrees to suspend the notice review
period and conduct hazard or environmental fate testing in response to a request from
EPA where EPA has risk concerns.
Issuance of an order to prohibit or limit activities associated with the new chemical if
EPA determines that insufficient information exists to evaluate the human health and
environmental effects of the substance, and that (1) it may present an unreasonable risk or
(2) that it will be produced in substantial quantities and may be anticipated to enter the
environment in substantial quantities or there may be significant or substantial human
exposure (TSCA §5(e) Orders). This authority authorizes regulation “pending the
development of information” and allows regulatory actions to be taken in cases where
risk “may” be present or where there is potential for substantial production and exposure.
In cases where EPA has concerns about potential exposures associated with “new” uses
(i.e., those beyond the uses described in the notice), it can issue a significant new use rule
(SNUR) that requires manufacturers, importers and processors of such substances to
notify EPA at least 90 days before beginning any activity that EPA has designated a
“significant new use.” These actions allow EPA to prevent or limit potentially adverse
exposure to, or effects from, the new use of the substance before they occur (TSCA
§5(a)(2) SNURs).
During the presentation, more detail and examples will be provided on the considerations and
potential actions above as a result of various PMN reviews including how examples relate to
decisions under conditions of uncertainty. Furthermore, we will touch on cases where testing
data received on regulated chemicals suggested that our hazard estimates were overly
conservative which resulted in our modifying the regulatory approach to better reflect risks.
Other Methods to Reduce Uncertainty and Risk
Under TSCA’s broad information-gathering authorities, EPA established an Inventory Update
Rule (IUR) in order to obtain updated basic U.S. production and importation information on
nonpolymeric organic chemicals that are listed on the TSCA inventory. The Inventory Update
Rule was recently amended to require the reporting of additional exposure-related information for
2
OECD (1994). US EPA/EC Joint Project on the Evaluation of (Quantitative) Structure Activity
Relationships (QSARS). OECD Environmental Monographs No. 88. Organization for Economic
Cooperation and Development, Paris, p. 367,
http://www.epa.gov/oppt/newchems/pubs/ene4147.pdf. U.S. EPA (1994) US EPA/EC Joint
Project on the Evaluation of (Quantitative) Structure Activity Relationships (QSARS). EPA 743R-94-001. U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics,
Washington, D.C., p. 55 (plus 15 annexes and 4 appendices),
http://www.epa.gov/oppt/newchems/tools/sar_report.pdf.
3
For more information on chemical categories, see
http://www.epa.gov/opptintr/newchems/pubs/chemcat.htm
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IFCS/Forum-V/7 INF
higher-volume chemicals and to include reporting on inorganic chemicals. This new information,
together with the hazard information being developed by efforts in the U.S. such as the High
Production Volume (HPV) Challenge Program 4 and those by the Organization for Economic
Cooperation and Development (OECD), such as the HPV Screening Information Data Set (SIDS)
Program, will enable EPA, industry, environmental groups, and others to evaluate, better
understand, and, where necessary, take action to gather additional information or to reduce
chemical risks.
Substantial risk information notices under TSCA §8(e) is another important informationgathering tool whereby EPA screens submissions to identify chemicals for further assessment,
referral or follow-up with submitters for additional information on exposure and/or risk
management. Our presentation will discuss examples of EPA follow-up to substantial risk
notices, including a mix of voluntary approaches and regulatory action under TSCA pursued in
the face of uncertainty.
Stewardship Tools and Activities
EPA also works with companies and other stakeholders to provide chemical assessment tools,
educational and other programs that further facilitate environmental stewardship across the
lifecycle of chemicals, including where appropriate to inform substitution decisions. This is also
complementary to EPA’s new chemicals and other regulatory activities. A few examples relative
to the development, review and promotion of both safer and greener new chemicals include:
Sustainable Futures; the Pollution Prevention (P2) Framework; PBT Profiler; the Analogue
Identification Methodology (AIM); Green Chemistry and Green Engineering; Design for the
Environment (DfE) programs; and Environmentally Preferable Purchasing (EPP). These
activities contribute to improved decision making while also taking a preventive approach to
environmental protection. In lieu of a few illustrative examples of how select activities also
supplement decision making under conditions of uncertainty during our presentation, additional
background and links are included for reference below.
4
The U.S. High Production Volume Challenge Program will fill information gaps for over 93 %
of the production volume of the chemicals we track on our inventory of existing chemicals. For
more on the U.S. HPV Challenge Program and HPV Information System, see
http://www.epa.gov/chemrtk/. A related OECD effort, the Global Chemicals Portal, will be
presented and discussed along with the U.S. National Institutes of Health (NIH) World Library of
Toxicology, Chemical Safety and Environmental Health at a Side Event on Global Chemical
Database Initiatives during the IFCS Forum V. meeting and scheduled for the afternoon of 26
September.
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IFCS/Forum-V/7 INF
Information Sources:
An overview of EPA’s chemicals program and new chemicals review process may be obtained
respectively at:
http://www.epa.gov/oppt/pubs/opptabt.htm
(click on “Overview of OPPT Programs” PDF file and “Overview Appendices)
http://www.epa.gov/opptintr/newchems/
Hazard and Exposure Assessment Tools5
EPI Suite: the Estimation Programs Interface Suite of Models
A Windows®-based suite of physical/chemical property and environmental fate
estimation models. Using only a substance’s chemical structure, EPI Suite runs
estimation models for all of the basic chemical properties needed in environmental
assessment. In addition, EPI Suite runs state-of-the-art models for estimating key
transformation processes (e.g. biodegradation), and estimates both multimedia
environmental fate and fate in typical wastewater treatment systems using Mackay-type
fugacity models. This software has become one of the world’s most popular chemical
assessment tools and is widely used in industry for pre-screening of candidate substances
prior to development; in the NCP in PMN review; and in review of existing substances
such as High Production Volume (HPV) chemicals. EPI Suite is available for free
download from the internet via EPA/OPPT’s Exposure Assessment Tools and Models
website: http://www.epa.gov/oppt/exposure/pubs/episuite.htm
ChemSTEER
The Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER)
is a PC-based software program that uses the OPPT’s most current workplace exposure
and release assessment methods. The tool generates screening-level estimates of
environmental releases of and worker exposures to chemicals manufactured and used in
workplaces. An updated beta version (May 2004) of ChemSTEER is publicly available
through
OPPT’s
Exposure
internet
web
pages:
http://www.epa.gov/oppt/exposure/pubs/chemsteer.htm
5
These tools and models are developed and tested in accordance with EPA policy and guidance.
The first step involves obtaining enough data and proven scientific theory to generate the
methods, data, and equations that could be used to develop the model. If it makes sense to
develop a computerized model, then OPPT establishes the requirements for the model or
software. The next step involves developing the software and documentation, including an
iterative process of evaluating or validating the model, and comparing estimated results with
measured data. OPPT’s tools and models are widely used by scientists world wide and must meet
stringent standards for transparency, integrity, objectivity, and data quality. Following internal
peer review and testing of the software, OPPT arranges for beta testing by stakeholders and other
external parties. The software then undergoes peer review following the guidance in the EPA
Peer Review Handbook. The models undergo further evaluation during use and whenever
possible, model results are compared with “real” data to allow for a continued assessment of
model accuracy and to ensure that the methods remain up-to-date.
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E-FAST
The Exposure, Fate Assessment Screening Tool (E-FAST) is a PC-based software
program that estimates screening-level general population and consumer exposures,
environmental concentrations and aquatic exposures to chemical releases. Potential
human doses are estimated for inhalation, dermal, and ingestion exposure routes. Version
2 includes enhanced air exposure estimates, endangered species information for U.S. sitespecific
aquatic
releases,
and
expanded
documentation.
http://www.epa.gov/oppt/exposure/pubs/efast.htm
ECOSAR
The Ecological Structure Activity Relationships (ECOSAR) is a personal computer
software program that is used to estimate the aquatic toxicity of chemicals. The program
predicts the toxicity of industrial chemicals to aquatic organisms such as fish,
invertebrates and algae using (Q)SARs. ECOSAR estimates a chemical’s acute (shortterm) toxicity and, when available, chronic (long-term or delayed) toxicity. ECOSAR is
available at: http://www.epa.gov/oppt/newchems/tools/21ecosar.htm
OncoLogic Cancer Expert System
The OncoLogic Cancer Expert System is a PC-based expert system software program
that can be used to assess the potential of chemicals to cause cancer in humans based on
chemical structure, exposure scenarios, mechanistic consideration, short-term predictive
tests and expert judgment. The program captures SAR expertise in cancer hazard
identification, employs knowledge rules and decision logics, and makes semiquantitative
predictions together with underlying scientific rationale. OncoLogic is or will soon be
available at: http://www.epa.gov/oppt/newchems/pubs/sustainablefutures.htm
Stewardship Tools
Pollution Prevention (P2) Framework
The P2 Framework is an analytical framework for assessing risk(s) of chemicals when
data are lacking. The P2 Framework integrates all of OPPT’s chemical assessment
methods, including SAR techniques for estimating PChem properties, environmental fate,
human and aquatic hazards and exposure. The P2 Framework includes technical
guidance on how to interpret the results of each assessment method, and describes how
these tools are applied in an integrated manner to yield quantitative estimates of risk. The
P2 Framework can be used early-on in R&D to identify problematic chemicals, to
compare and contrast hazard/risk profiles of alternatives under consideration and to
facilitate development of safer substitutes.
Sustainable Futures
Sustainable Futures is an industry, Agency, NGO partnership dedicated to the practical
application of science and technology toward our shared goals of prevention, risk
reduction and stewardship. Sustainable Futures is the programmatic structure for
transferring the P2 Framework risk screening technology to the public together with: 1)
training in the use and interpretation of the P2 Framework risk screening methods, 2)
technical assistance, 3) regulatory relief for qualifying low hazard/low risk New
Chemical submissions, 4) assistance to small businesses, and 5) public recognition for
participating companies. SF is an example of an innovative voluntary effort that builds
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IFCS/Forum-V/7 INF
on risk screening expertise developed by EPA, and facilitates P2 and risk reduction
through
transfer
of
that
expertise
to
other
chemical
stakeholders.
http://www.epa.gov/oppt/newchems/pubs/sustainablefutures.htm
PBT Profiler
The PBT Profiler is a no cost, online PBT screening methodology that predicts a
chemical's potential persistence (P), bioaccumulation (B), and chronic aquatic toxicity (T)
values and compares the predictions to EPA's New Chemicals Program PBT criteria to
determine if the substance is a potential PBT of concern. http://www.pbtprofiler.net/
Analog Identification Methodology (AIM)
An online computerized tool called the Analog Identification Methodology was
developed to help users evaluate the potential health effects of untested chemicals
through identification of close chemical analogs that have measured data on the endpoints
of concern. AIM identifies chemical analogs through a fragment-based structural
similarity approach, and points the user to publicly available databases or other sources of
information where experimental data on the related chemical analogs can be found. AIM
is undergoing a beta test and will be publicly released in the future.
Green Chemistry
EPA's Green Chemistry Program fosters the research, development, and implementation
of innovative chemical technologies that prevent pollution in both a scientifically sound
and cost-effective manner. It supports fundamental research in the area of
environmentally benign chemistry as well as a variety of educational activities,
international activities, conferences and meetings, and tool development, all through
voluntary partnerships with academia, industry, and other government agencies.
http://www.epa.gov/opptintr/greenchemistry/
Green Engineering
EPA's Green Engineering Program is introducing a "green" philosophy into
undergraduate chemical engineering programs. The program aims to develop and
maintain effective communication between educators and practicing engineers. To this
end the program has developed text books and workshops for professors.
http://www.epa.gov/opptintr/greenengineering/
Design for the Environment (DfE)
The DfE Program is a voluntary partnership program that works directly with industries
to integrate health and environmental considerations into their business decisions. DfE is
also a recognized approach that companies first adopted in the late 1980s that involves
thinking in terms of "design for" qualities or traits in products and process design. In the
environmental field, views on risk management have shifted to approaches that promote
reducing risks to human health and the environment through pollution prevention or
source reduction instead of relying on end-of-the-pipe pollution control.
http://www.epa.gov/opptintr/dfe/
Environmentally Preferable Purchasing (EPP)
EPA's Environmentally Preferable Purchasing (EPP) Program is a federal initiative that
encourages and assists Executive agencies in the purchasing of environmentally
preferable products and services. The goal of the EPP Program is to help increase the
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availability of products and services that are environmentally preferable, protect human
health, save money, and improve the overall quality of government purchases.
http://www.epa.gov/opptintr/epp/
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IFCS/Forum-V/7 INF
Case study: The precautionary principle as applied in pesticides control in Nicaragua – A
regional trade and integration agreement as the stumbling block
Ministry of Health
Poison Information, Surveillance and Advisory Centre
Jesus Marin Ruiz, Director, CIVATOX, Nicaragua
Nicaragua adopted a precautionary approach in pesticides control and occupational health
impacts surveillance which included: extensive epidemiological surveillance, scientific
assessments of health, environmental and agricultural impacts, and the implementation of a legal
framework that included an early assessment mechanism and compulsory assessments in
doubtful cases of a clear cause-effect link (exposition - illness).
The results of this interagency assessment, with the participation of industry and civil society,
led to the adoption of a regulatory decision which imposed stricter controls and banned the use
of three pesticides. More than two years after the decision was taken it had not been enforced by
the relevant authority, the Ministry of Agriculture. Following demands for active action, the
Ministry established restriction and control measures it was ill prepared to enforce. The Ministry
further claimed that since the creation of a Harmonized Pesticides Registry within the Central
American Customs Union was been discussed, no country could take any independent
regulatory action while the regional integration agreement was under negotiation.
The Nicaraguan law on Pesticides and Other Toxic Substances states that the formal registry of a
product can be reviewed when and if there is sufficient evidence of significant adverse effects
for public health, agriculture or the environment. As a result of a ten-year epidemiological
surveillance study, carried out by the Pesticides Programme of the MOH, with the support of the
Pan-American Health Organization (PAHO), twelve pesticides were identified as the main cause
of most poisoning cases registered in the country. (The pesticides epidemiological surveillance
program was carried out in all seven Central American countries).
The Ministry of Health thus requested the Ministry of Agriculture to reassess those 12 pesticides
under the provisions of Law 274 on Pesticides and Other Toxic Substances. The Minister of
Agriculture thus convened an interagency technical assessment commission with the
participation of representatives on the Ministries of Health, Agriculture and Environment. In
consultation with civil society and industry, the commission carried out a two-year assessment
and reached a technical conclusion.
In its conclusions made public on January 2004, the technical assessment commission referred to
the need to prevent future occupational and accidental poisoning cases, as well as adverse effects
to agriculture and the environment, and recommended a total ban on monocrotophos,
methamidophos, and methyl parathion, and severely restricted sales of other nine products.
Law 274 provides that the Minister of Agriculture must take action and implement the
commission’s recommendations in the sixty days following the date on which they were issued.
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Intergovernmental Forum on Chemical Safety
Fifth Session - Forum V
25 - 29 September 2006
IFCS/Forum-V/7 INF
Until April 2006 no action whatsoever had been taken to apply such recommendations and the
three products are still legally registered and sold in Nicaragua.
By the end of the first half of 2004 the Minister of Agriculture had stated the need to wait until
the conclusion of negotiations on the Central American Customs Union, under which the
Harmonized Pesticides Registry was to be discussed.
This Harmonized Pesticides Registry would supersede al relevant member countries laws and
would consider registry of a pesticide in any Central American country as valid and accepted by
all the others. The product would thus enjoy free circulation in all Union members’ territories
with no reciprocity in restrictions or prohibitions. The agreement does not clearly provide for a
new assessment mechanism for pesticides in use.
The proposed Harmonized Pesticides Registry will in fact undermine the soundest current law
on pesticides in the Region: the Nicaraguan law legally empowers civil society and the
Ministries of Health and Environment to actively participate in pesticides registration. Nicaragua
is currently the only country in the Region with technical expertise to assess pesticides health
and environmental impacts and which has, furthermore, passed a law that enables this role.
The Harmonized Pesticides Registry clearly identifies the Ministry of Agriculture as the
competent implementing agency in each country member, but does not clearly state the roles of
the Ministries of Health and Environment, or civil society, in pesticides assessment, monitoring
and control both prior to their registry and once they are circulating in the Region.
Once the Harmonized Pesticides Registry is in place, a company might register a product in a
Central American country with relatively weaker legislation compared to others and, in doing so,
the pesticide will be automatically registered for sale in all member countries of the Customs
Union.
In Central America, the Ministries of Health and Environment, together with civil society, must
be able to exert greater influence on rules and regulations being established for the Regional
Customs Union and should promote the creation of a regional centre, optimizing the
opportunities linked to the application of the precautionary principle in order to protect human
and environmental health.
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Intergovernmental Forum on Chemical Safety
Fifth Session - Forum V
25 - 29 September 2006
IFCS/Forum-V/7 INF
Case studies applying precautionary approaches (PAN Asia Pacific)
Romy Quijano, Pesticide Action Network
Community-based monitoring of pesticide impacts is based on participatory action research and is
a tool to document and create awareness of pesticide impacts on human health and the
environment. Community Pesticide Action Monitoring or CPAM provides tools for selfsurveillance and encourages organising for action. Through self-surveillance, documentation,
surveys and observations, communities, agricultural workers, farmers and rural women are able to
take action for change such as reduce the use of pesticides, adopt ecological agricultural practices,
and pressure governments for the implementation of better pesticide regulations and international
conventions pertaining to pesticides.
How the principle of precaution is applied in using the CPAM approach:
From the public interest NGO perspective, the key elements of precaution in the CPAM approach
are the following:
1.
2.
3.
4.
5.
6.
Preventive action
Community participatory action research in addressing uncertainty
Alternatives are explored, assessed and implemented
The burden of proof (of safety) is put on the polluter
A need-based approach is the major criterion in the assessment of the chemical/s
Starting premise is “no acceptable level of exposure” (elimination), acceptability of
exposure depends on need and clear preponderance of benefits over risks.
7. All relevant information is not-confidential and must be made available
8. The safety and welfare of the community is the focus of importance, not business interest
The main objective in the CPAM approach is protecting health and the environment and,
therefore, any potential adverse effect that might occur must be prevented from happening. The
CPAM approach challenges the dominant forces in the scientific community and regulatory
agencies that impose an evaluation system (risk assessment paradigm) that relies heavily on
numerical data and on the “smoking gun” type of evidence of harm that presumes the chemical to
be innocuous until proven otherwise. The CPAM relies instead on the collective wisdom of the
community in determining whether or not the chemicals they would be exposed to (or are already
exposed to without their consent) pose hazards to their health and their environment. They do this
through their own system of observation and evaluation of risks developed mainly through the
CPAM approach, which includes community organizing, education and empowerment. For
example, using CPAM, Malaysian plantation workers were organized, documented the health
effects of the sprayed pesticides on their health, and through this process, identified paraquat as a
major problem. Their conclusions were criticised by the industry and some “experts” as having no
sufficient “scientific basis” to identify paraquat as a major problem. Indeed there were many
uncertainties as far as “cause-effect” relationship is concerned pertaining to paraquat and
incidents of poisoning. However, using the principle of precaution, the plantation workers and
their support groups, including PANAP, proceeded to take action to prevent further exposure of
plantation workers to paraquat. This led to a campaign of the plantation workers together with
regional and local groups, calling for a safer working environment and justice. In 2002, the
Malaysian Pesticide Control Division banned paraquat with a phase-out period of two years.
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Intergovernmental Forum on Chemical Safety
Fifth Session - Forum V
25 - 29 September 2006
IFCS/Forum-V/7 INF
Similarly, documenting, monitoring and investigating at the local level the communities in
Kasargod District, Kerala (India), clearly identified endosulfan as the pesticide causing health and
environmental problems. Previous studies undertaken by the private entities commissioned by the
industry did not find any connection between endosulfan exposure and the illnesses observed in
the community and a government scientific body was reluctant in making any conclusion as to the
adverse effects of endosulfan because of many uncertainties. Nevertheless, the community groups,
together with the support NGOs, both locally and internationally, made a decision that endosulfan
was the primary cause of the health and environmental problems in the communities and called
for banning of endosulfan to prevent further exposure and damage to the communities. A ban on
aerial spraying of endosulfan in the state was eventually obtained through court action mainly as a
result of local action and campaigning. It is noteworthy that the court in this case also invoked
the “precautionary principle” in ruling in favour of the petitioners (affected communities).
In the above examples, uncertainty was considered a threat, unlike in the usual risk assessment
tool used by most government regulatory agencies and the industry, where in the face of
uncertainty, the chemical is given the benefit of the doubt and the “lack of evidence” of cause and
effect relationship (often because of lack of appropriate studies) is considered as evidence of
absence of harm. Using CPAM, the communities considered “lack of evidence” as no evidence of
absence (of harm), realizing that uncertainty factors often preclude demonstration of cause and
effect relationships and probabilistic characterization of risks. To be meaningfully protective,
therefore, an assessment process looking into the potential environmental and health impacts of a
chemical should consider uncertainty as a warning signal. The burden of proof of safety is put
squarely on the proponents of chemical use, requiring them to clearly demonstrate the relative
safety of the chemical, especially to vulnerable groups, showing there is real need for the
chemical, thoroughly taking into account various externalities and plausible exposure scenarios
and conditions of use, and presenting convincing evidence that benefits far outweigh the risks.
Nevertheless, CPAM attempts to address the knowledge gaps, using self-monitoring tools,
seeking help of experts from the academe and public interest NGOs, and sometimes even from
concerned government bodies to elucidate the uncertainties involved in the use of chemicals in
the community.
In some areas, the CPAM approach focuses on alternatives to chemicals, demonstrating that the
perceived “need” for the chemicals is illusory. More often than not, the need that chemicals are
supposed to address can be addressed more effectively and safely over the long term by nonchemical alternatives. For example, the use of highly toxic pesticides is often justified in terms of
increasing crop yields. However, a closer study of factors that contribute to sustainable crop
yields would reveal that pesticides are not really necessary and that an integrated, ecological
approach to plant, soil and pest management would be the better option for a sustainable crop
production that would not endanger health and the environment.
To the farmers practising sustainable agriculture, there is no uncertainty as far as diverse effects
of pesticides is concerned. To them, harm is certain to occur if synthetic chemicals are used in
agriculture. They do not need further scientific studies for them to decide on the matter. The only
way to prevent harm from pesticides, therefore, is to not to use them by practising sustainable,
ecological way of farming. Empirical data and scientific studies provide sufficient proof that toxic
chemicals are not necessary in producing food for communities and it is not necessary to accept
“allowable levels” of exposure to agrochemicals. Practising sustainable agriculture is the ultimate
application of the precautionary principle at the farmer's level.
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Intergovernmental Forum on Chemical Safety
Fifth Session - Forum V
25 - 29 September 2006
IFCS/Forum-V/7 INF
Chemicals in Consumer Products
A Precautionary Approach
Stephen Johnson, Sustainable Development Manager, CSR Support
Company information
The merger of equals between Alliance UniChem and Boots Group in July 2006 has
created an international pharmacy-led health and beauty group. Alliance Boots will build
on the existing strategies of both companies combining their complementary skills and
businesses.
The health and beauty group comprises:


approximately 3,000 retail outlets (including associates) - of which approximately
2,700 will have a pharmacy
a wholesale network of over 380 depots (including associates) serving over
125,000 outlets.
Background
The potential impact of chemicals on human health and the environment has long been
a matter of concern for manufacturers and retailers in relation to product formulation,
development and manufacture. The perceived inability of the chemical industry to
provide adequate safety data for the vast majority of chemicals on the market has been
seen as an important factor in the decision at European level to introduce more stringent
controls on the licensing of chemicals. Traditional methods of determining safety, such
as risk assessment, are also being challenged and a more precautionary approach to
the use of chemicals is being advocated. Retailers and brand owners must continue to
place safety at the top of their agenda whilst still meeting and exceeding customers’ high
expectations of their product offer.
Whilst the number of chemicals currently having their safety questioned appears to be
increasing significantly, the situation itself is not new. Manufacturers of brands like
ourselves have for many years had to face the challenge of replacing a number of
suspect chemicals, such as Chlorofluorocarbons (CFCs), Alkylphenol ethoxylates
(APEs), etc. It is also important that we learn the lessons from our previous experiences
when considering, for example, setting targets for the replacement of particular
chemicals. Whilst it might be beneficial to a company's reputation to make bold
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Intergovernmental Forum on Chemical Safety
Fifth Session - Forum V
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IFCS/Forum-V/7 INF
statements about excluding certain chemicals from their inventory, the reality is that a
programme of successful replacement can be a long and resource intensive process.
It is against this background that the way in which Boots approaches this complex issue
is described.
Boots Approach
This paper briefly describes how Boots manages the assessment of chemicals through
the application of its chemical strategy and how we apply our precautionary approach
across all the products we sell. Boots Chemical Working Group (CWG) provides the
business with an authoritative, forward-looking, coordinated approach to the
environmental, health and safety aspects of the use of chemicals. This group is made up
of internal experts from a number of disciplines covering chemistry, toxicology and
environment science.
The CWG is responsible or assessing the impact of chemicals on the products using a
variety of knowledge sources. The assessment is based on several external databases
i.e. OSPAR, CMR, SCC, KEMI Prio etc but also based on information supplied by our
supply chain & internal expert knowledge. This is still a risk assessment process rather
than a hazard assessment but is not based solely on scientific fact but also considers
consumer perception and the application of precautionary action.
Following the assessment and depending on the final result Boots may apply 3 different
substitution strategies
Strategic substitution






based on market
intelligence
and
market conditions
based on in-house
expertise
&
recommendations
from CWG
often
based
on
precaution
planned exit usually
over 3 – 10 years
cost managed
cost predicted
Phased substitution





most common way
of substituting
based on scientific
concern from CWG
often
based
on
precaution
planned exit usually
over 1 – 3 years
cost managed
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Issue
substitution






unforeseen risk
unpredicted
consumer concern
unpredicted safety
concern
rare
Most costly
Immediate
replacement/
removal
of
chemical. Possible
product recall
Intergovernmental Forum on Chemical Safety
Fifth Session - Forum V
25 - 29 September 2006
IFCS/Forum-V/7 INF
We have begun to embed our chemical strategy into bigger picture thinking of
‘sustainability through design’ with the development of an integrated sustainability
assessment tool, which encompasses all aspects of product sustainability.
Finally we will share some of the key lessons we have learnt over the past 150 years of
managing chemicals in consumer products.
Boots Chemical Strategy Key Deliverables for 2006/2007

To safeguard our customers' health and safety and protect the environment,
meeting fully the expectations and responsibilities associated with trust in the
Boots brand.

Through the utilisation of expertise from the Chemical Working Group highlight
strategic important chemicals used in Boots inventory and systematically review
their long-term implications. Ensure sustainability criteria for assessing all
chemicals is published and implemented across development activities.

Develop appropriate partnerships with expert bodies to provide Boots clear first
to market product opportunities

Develop a process for measuring the success of Boots precautionary approach
specifically considering number of materials replaced by suitable safer
alternatives

To help consumer choice and to provide the business a clear opportunity to
exploit our expert knowledge of product formulation, develop mechanisms to
provide transparency of materials currently used.
For further information visit:
Boots Chemical Website (http://www.boots-csr.com/main.asp?pid=636 )
Alliance Boots Homepage (http://www.allianceboots.com/ )
Or contact:
Stephen Johnson
Sustainable Development Manager/Scientific Advisors Manager
Alliance Boots
D90 West G13
Nottingham NG90 1BS. UK
Tel: +44 (0)115 949 3911
Email: Stephen.Johnson@Boots.co.uk
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