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IFCS Working Group on Priority for Action A3:
Hazard data generation and availability.
The Report for Forum IV is proposed to contain
 Decision document for delegates with extent according to IFCS/FSC/01.65, aiming for
about 8 pages
 Annex published only on the IFCS website, of at most 25 pages; this is where
arguments are being developed in support of what is taken to the decision document.
The FSC might wish to make the following decisions based on this version that is the eleventh
draft, Rev 11.
I.
Comment on the extent and structure of the document, in particular
a. Is it tolerable that the decision document is longer than the ideal 4-5 pages?
b. Is it appropriate to have the Annex published only on the IFCS website or should it
also be physically made available to the delegates? Annexes are not normally
translated into all IFCS languages.
II.
Give guidance for the resolution on four issues where the Working Group has not yet
been able to agree on the text. These are marked in curled brackets in the format
{Arabic number. Tentative text in grey shade (explanation of the issue)}
III.
Decide whether alternative views on some issues should be given in the final document
that goes to Forum IV, in [square brackets] to be resolved during Forum IV discussions.
The alternative is to find a way of arriving at consensus on all issues before the
document goes to Forum IV.
IV.
Comment on those parts where the Working Group has not reached agreement on the
exact wording but where there is agreement in principle, or where the issues have been
judged to have lower priority and thus have not yet been agreed. These parts are marked
by underlining and the wording has been chosen by the Chair of the Working Group
following the Group’s latest teleconference 28 October.
V.
Comment on all other parts of the decision document.
VI.
Comment on the Annex, in particular issues that have been brought before the FSC by
any of the Working Group members (for lack of time the Working Group has not
finalised its own discussions of the Annex)
VII.
Ask the Working Group to continue working according to the instructions from the FSC
and present Rev 12 to the FSC for possible final approval at a teleconference in midJanuary, and to subsequently follow-up that work to provide by 1 March 2003 a final
text to the IFCS Secretariat for translation
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Report for Forum IV
Sponsored by Sweden in collaboration with xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
I.
Issues for consideration and Actions requested of Forum IV
Over the last three decades, much has been accomplished in chemical safety, but more needs to be
done, particularly with respect to generating and making accessible hazard data on existing
industrial chemicals and to inadequate public accessibility of such data. The Bahia Declaration in
2000 contained several recommendations to this end.
One of the Priorities for Action (A3) adopted by Forum III stated:
“For all chemicals in commerce, appropriate data detailing the inherent hazards of those chemicals
should be made available to the public. Highest priority should be given to hazard information for
those chemicals that have greatest potential for substantial exposures.”
In addition, the following language was accepted at Bahia related to A3:
To implement this principle, the Forum Standing Committee should develop a proposal for
an additional Priority for Action to be discussed at Forum IV. This Priority for Action should
address:
o The role of industry in generating and assessing data;
o The role of industry and governments in making available, and easily accessible, to
the public the results of tests and their interpretation leading to conclusions about the
degree of hazard or risk involved;
o The desirability of reducing the use of animals for toxicity testing where other
methods, that may give a similar assurance of safety, are available;
o Possible approaches for ensuring that relevant data become available to the public
and authorities in the shortest possible time-frame, considering incentives and/or
restrictions that might serve this purpose.”
This report contains the FSC’s understanding of its charge and a proposal for the additional
Priority for Action.
An Annex with detailed technical information is available on the IFCS web page
http://www.who.int/ifcs/fsca3wg/]
Actions requested of Forum IV
Forum IV is requested to take the following actions
A. {1. Encourage governments and industry world-wide to make all existing information relevant
to hazard identification publicly available and used according to established procedures, and to
adopt the OECD SIDS as a minimum set of hazard data for chemicals of potential concern to be
applied with flexibility (issues involved are:
 utilising all existing data, e.g. from poison centres, not only test/SIDS data that may even be
unnecessary; compare III B Recommendations on Additional data
 supporting that additional data from other stakeholders be considered according to established
procedures
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standardising a minimum set of data
using tiered approaches according to data needs/priority, e.g. having lower demands on
chemicals produced in smaller quantities; compare III B Recommendations on Appropriate
hazard data)};
B. Promote the fulfilment of existing commitments by industry to make available and generate
hazard data for High Production Volume (HPV) chemicals;
C. Encourage governments, industry and other non-governmental organisations to cooperate with
the Organization for Economic Cooperation and Development (OECD) and other, non-OECD
countries to prioritise work on such hazard data for identified HPV chemicals not otherwise
addressed under existing commitments
D. Assist governments, particularly developing countries and countries with economies in
transition, in prioritising work on such data for chemicals in commerce other than HPV, by:
i. Endorsing where possible the use of existing high quality inventories of chemicals in
commerce as a starting point to estimate production and import volumes for national
prioritisation purposes, and as a second step the establishment of national inventories, to be
periodically updated
ii. Promoting the systematic identification, collection and sharing of existing hazard
information on chemicals to better assess the information needs and to avoid duplicative
testing, for both economic and animal use reduction purposes, using an international
repository of such information as a tool, while refining existing or developing improved
approaches (based on criteria other than/in addition to production volumes) for setting
priorities for data generation so that highest priority is given to chemicals most likely to
result in significant adverse effects; and
iii. Assisting non-OECD countries in identifying and nominating priority substances for the
generation and availability of hazard information under OECD programs.
E. Support that advancements in hazard identification and other relevant approaches that reduce
the use of animals for toxicity testing should be used to generate new data or information, where
practical and consistent with good scientific practice, available for scrutiny by interested
stakeholders
F. Encourage OECD to lead the work and collaborate with governments, industry, and other
interested parties in developing a standard, central repository of hazard data and/or links to
publicly available databases that would be (as much as possible) free of charge and easily available
(e.g., via the Internet), while requiring that essential health, safety and environmental information
is not withheld under confidentiality restrictions
G. Encourage all parties to develop appropriate information to interpret the data for public use and
national decision-making.
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Contents
I.
Issues for consideration and Actions requested of Forum IV ........... 2
II. Background and scope ........................................................................ 5
A.
1.
2.
3.
4.
Issues for consideration ....................................................................................................... 5
Links to the World Summit for Sustainable Development ................................................ 5
Advantages of global consistency and global collaboration .............................................. 5
FSC Working group activities ............................................................................................ 6
Relationship with other priorities for action ...................................................................... 6
1.
2.
3.
4.
Delineation of the mandate .................................................................................................. 6
Categories of chemicals in focus ........................................................................................ 6
Substances in focus, not preparations or manufactured goods ........................................... 6
Inherent hazards in focus .................................................................................................... 7
“Should be made available to the public” .......................................................................... 7
B.
III.
Current situation and recommendations ......................................... 7
A.
How should chemicals be prioritised for data accessibility and/or data generation? .... 7
B.
Hazard data generation ....................................................................................................... 8
C.
Efforts to minimise the use of animals in the development of hazard data .................... 9
D.
Hazard data/information accessibility ............................................................................. 10
E.
What are the roles of industry and governments? .......................................................... 11
IV.
Terminology ..................................................................................... 12
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II.
Background and scope
A. Issues for consideration
The FSC has developed proposals according to the request from Forum III mentioned in Section I.
1. Links to the World Summit for Sustainable Development
After the Priorities for Action were adopted by Forum III their role has been reinforced by the
World Summit for Sustainable Development in Johannesburg in September 2002. Its adopted Plan
of implementation aims 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. This would include actions at all levels to further
develop a strategic approach to international chemicals management based on the Bahia
Declaration and Priorities for Action beyond 2000 of the Intergovernmental Forum on Chemical
Safety (IFCS) by 2005. The plan goes on to encourage the collection and use of additional
scientific data. It recommends the use of tools such as







policies to improve the products and services provided, while reducing environmental and
health impacts;
consumer information tools;
investment in cleaner production and eco-efficiency;
cost-effective examples in cleaner production, eco-efficiency and environmental management;
exchange of best practices and know-how on environmentally sound technologies between
public and private institutions;
public procurement policies that encourage development and diffusion of environmentally
sound goods and services; and
environmental impact assessment procedures.
Such tools depend for their application on the availability of hazard data.
2. Advantages of global consistency and global collaboration
There already exist successful examples of harmonisation such as for testing, assessment methods,
dossiers, and classification and labelling, many of which have been promoted by the IFCS.
Facilitation of global consistency and global collaboration in data generation and accessibility
would have several advantages:
 Improved safe use of chemicals with respect to human health and the environment via:
facilitated access (and generation where appropriate); wider input on priorities for data
accessibility (and generation where appropriate) and standards or mechanisms for data
availability (e.g., data adequacy guidance), generation (test guidelines) and accessibility;
broader sharing of existing data and information on ongoing data development; better
informed hazard/risk assessment/communication and risk management; increases in
information available to users of substances and those otherwise potentially exposed, etc
 Minimised use of laboratory animals for testing via broader focus on/input into the
development and implementation of alternative testing methodology, and avoidance of
duplicative or unnecessary testing.
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Economy of testing and assessment; as an example, it has been estimated that the OECD
co-ordination of chemical safety assessment and management in its entirety is saving
member states and industry 50 million USD annually
Reduced barriers to trade
3. FSC Working group activities
The Forum Standing Committee has developed the present proposal with the aid of a Working
Group. Besides teleconferencing and electronic mail, the Working Group has had two
(Ronneberga, Sweden in September, 2001 and Ottawa, Canada in March, 2002) and the FSC two
(Trinidad and Tobago, October, 2001 and Bangkok; November 2002) face-to-face meetings.
4. Relationship with other priorities for action
It is clear that Priority for Action A3 is to focus on the accessibility of hazard information. In order
to implement A3, it is also clear that interpreting and communicating this hazard information are
important and necessary and will be reflected in the new, proposed Priority for Action. However,
it is important to also recognize the existence – and potential overlap –with other Priorities for
Action (see Annex Section B2 for details).
B. Delineation of the mandate
1. Categories of chemicals in focus
The recommendations that follow in Section III are to a large extent applicable to all chemicals in
commerce. However, certain classes of chemicals may already be covered with respect to some of
these recommendations. For instance, many countries or regions have requirements concerning the
generation and availability of information for pesticides, and pharmaceuticals are generally subject
to strong controls.
For industrial chemicals, in contrast, several ongoing national or international programs address the
need to make available more information. To attain the mentioned advantages of safety, minimised
laboratory animal use, economy and reduced barriers to trade, this report considers test systems,
prioritisation and possible approaches to generate and make accessible information for industrial
chemicals.
Other chemicals may also need to be addressed in some of these respects, e.g. cosmetics,
pharmaceuticals, veterinary pharmaceuticals and food additives. In particular, there is a need to
improve the accessibility of information on active ingredients of pesticides. These other chemicals
are however not treated in depth for several reasons
 historically IFCS activities have focused on industrial chemicals, and pesticides? as has the
participant/ stakeholder expertise involved and the legislative infrastructure of certain
participating governments;
 the FSC recommendation made to Forum III that “Priorities for Action” be more focused; and
 a need to keep the report practically manageable.
2. Substances in focus, not preparations or manufactured goods
The chemical substances are used as such or in marketed preparations or mixtures, and as
constituents of manufactured goods other than preparations. The FSC recognises that information
on preparations and goods is essential for risk management, but it is dealt with elsewhere, for
instance by IFCS in Priority C3 on any hazardous material put into circulation. The FSC proposes,
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therefore, and in the interest of focus, that the present Priority for Action deal only with chemical
substances as defined above.
3. Inherent hazards in focus
The FSC proposes that “appropriate data detailing inherent hazards” refer to
 the type of hazard data (i.e., endpoint such as physicochemical property, environmental fate
property, and ecological and health effect information);
 the quality of such data (a hierarchy of validity from tests following internationally
recognized guidelines, to lesser known test protocols, to the use of estimation procedures to
represent hazard) including estimates of uncertainties; and
 the format of such data (i.e. available full test data, test summaries, or some appropriate
format that would meet the needs of the intended audience).
4. “Should be made available to the public”
The FSC proposes that “should be made available to the public” refer to the manner in which the
hazard data identified above is accessible to anyone (government authorities, workers, consumers
including manufacturing industries, the general public, non-governmental organisations, and other
stakeholders) interested in such information.
III.
Current situation and recommendations
A. How should chemicals be prioritised for data accessibility
and/or data generation?
There are tens of thousands of chemical substances in commerce, and data accessibility and, where
appropriate, generation, must be prioritised for practical reasons. Priority for Action A3 provides
that: “Highest priority should be given to hazard information for those chemicals that have the
greatest potential for substantial exposures.” Examples of exposure-related factors to consider in
setting priorities include:
 production volume (successfully used for prioritisation in the past in multilateral and other
programs), with for instance focus for testing requirements at the lower volumes on acute
hazards (immediate or slightly delayed effects after short term exposure) while those at the
higher tonnage levels include more expensive studies on the effects of (sub-) chronic
exposure, on reproductive toxicity and on carcinogenicity;
 category of use (e.g., consumer, daily use, children’s products, in research and
development, occupational, dispersive, or closed system-type uses);
 size of potentially exposed human population
 releases to the environment;
 levels in human tissue or biological specimens
 estimated or known chemical properties, and
 persistence, bioaccumulation, and toxicity (PBT) characteristics
Other factors which may be considered in prioritising the generation and accessibility of data
include:
 type of hazard, e.g. if the substance is suspected/considered to be carcinogenic, mutagenic
or a reproductive toxicant;
 available clinical information;
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hazard potential based on available data and/or appropriate structure-activity relationship
(SAR) models;
the adequacy of the currently accessible data for whatever the relevant need is.
Some pertinent information is given in the Annex Section C 5 f. Systems for prioritisation for data
generation that are being or have been designed by several countries or regions (USA, European
Union, Canada, and Russia) are described in the Annex Section C2a.
Recommendations
As national and regional programs to systematically prioritise and assess existing substances are
introduced, it is increasingly recognized that factors other than volume of production need be
considered in setting priorities for testing. Countries and organizations such as the OECD should
be encouraged to look into refining existing or developing improved approaches (based on criteria
other than or in addition to production volumes) for setting priorities for data generation so that
chemicals most likely to result in significant exposure are targeted for toxicity testing. Existing
high quality inventories of chemicals in commerce could be used as a starting point to estimate
production and import volumes for national prioritisation purposes, and as a second step national
inventories could be established, to be periodically updated
B. Hazard data generation
Hazard data are developed or are available from conducting tests (some using animals) or using
other methods (e.g, computer estimations of hazard). Data are generally required for new
chemicals and uses, although the amount and extent of data required vary. Concern regarding the
availability of hazard data for certain existing industrial chemicals has stimulated several hazard
assessment programs, operated for instance by the ICCA, the USEPA, the European Union and
Japan (see Annex Section C3b for details). The OECD, US and certain others’ efforts have
focussed on a basic set of hazard information known as the Screening Information Data Set (SIDS)
developed by the OECD, promoting significant co-ordination, see
http://ww1.oecd.org/ehs/hpv.htm.
Recommendations
Methods of generating data. Successful data generation programs recognize data source
(including test system) alternatives, with preferences duly noted, so that in the absence of measured
data reliable estimates can be made in a cost-effective manner. One possible approach would give
priority to measured data, extrapolation, interpolation, estimates based on structure-activity
relationships, expert judgment and default values, in that order. Quality and mutual acceptance of
newly generated data can be ensured by using OECD Test Guidelines and working under OECD
Good Laboratory Practice conditions.
Data adequacy and needs. The requirements for data adequacy (level of detail, addressing
uncertainty, etc.) depend on the intended use of the data. It is important that test data reflect
insofar as possible the conditions where the chemical is manufactured, imported, or used, including
unique regional conditions. There is a need for flexibility and a dialogue between the data
producer, the data assessor, and the data user.
Appropriate hazard data. {2. The OECD should be asked to develop guidance in consultation
with relevant stakeholders on screening information requirements for chemicals in commerce other
than those produced in high volumes (related to curled bracket 1 Section I item A)}
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Transparency. Data quality can be enhanced by transparency in the process used to generate and
assess data, and in assuring clarity in the information provided (compare subsection below on
Accessibility). It is important that the process be free of real or (USEPA) apparent conflicts of
interest or undue influence.
Additional data. A process should be in place to allow other stakeholders to bring forward
additional data to be included in the final dossier that will be evaluated by OECD (or governmental
organizations), e.g. relating to human poisoning. All available information should be taken into
consideration to produce the hazard identification documents, subject to the above mentioned
quality constraints.
C. Efforts to minimise the use of animals in the development of
hazard data
There is agreement that the use of laboratory animals for testing should be reduced to the absolute
minimum consistent with the technical ability to adequately assess the relevant hazards. Clearly,
one way to accomplish this goal is through the development, validation, and implementation of
alternative tests that reduce, replace or refine animal use (see Annex Section C4). Other strategies
for reducing animal use in testing programs are being employed as recommended below. Many of
them have been incorporated in the U.S. voluntary HPV Challenge program (see
www.epa.gov/chemRTK).
Recommendations
Co-ordination. Co-ordinating similar testing programs internationally to avoid duplicative testing
Thoughtful initial review. Assuring, through systematic review of existing hazard data, exposure
information and clinical information, and where appropriate test plans, that the data requirement is
closely linked to meeting an identified assessment need on the most efficient (in terms of animal
numbers) and effective basis possible and recognising scientifically based data source (including
test system) alternatives (see B. Hazard data generation above and Annex C.4.d).
Use of categories. Maximising the use of scientifically appropriate categories of related chemicals
to avoid testing every representative of a series of chemicals that are likely to have similar toxicity
profiles, provided that the template chemicals are chosen with scientific rigor.
Publishing test plans. {3. Where appropriate, publishing proposed test plans and public comments
on these test plans, through the Internet or other means. (At present, this is US HPV Challenge
Program-specific and is unlikely to be practical or useful on a global scale at this time but may be
worth striving for; insertion of the words “where appropriate” might give it enough flexibility –
compare the corresponding insertion under Thoughtful initial review. The comment option would
rely on the good will of test plan submitters to assess any submitted comments in good faith, and
modify their test plans accordingly. Similarly, the national authorities are not called upon to review
the test plan comments nor post their reactions to these comments, nor work with the test plan
submitters to modify their test plans. Such authorities may or may not choose to do this, in light of
test plan comments.)}.
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D. Hazard data/information accessibility
Chemical safety can be facilitated if the public has easy access to appropriate, reliable, and
understandable hazard information, with the level of technical detail adapted to the needs and
comprehension of the different target groups. This would allow, among other things, individuals
or organizations to make informed decisions about whether to purchase, use or otherwise come in
contact with specific chemicals. Similarly, this would inform prioritisation and the nature of risk
reduction activities within governments and industry. Forum III recommended increasing the flow
of information and recognized the need to ensure that essential health, safety and environmental
information not be withheld under confidentiality restrictions.
The OECD has recommended a list of non-confidential data (see appendix to OECD Council
Recommendation C(83)98/Final in Annex Section C5e), and that robust study summaries be
publicly available.
A prerequisite for information is that data have been generated, a process benefiting from extensive
communication as discussed in IIIB.
It is also necessary that available hazard information in a broad sense is accessible to the public (as
defined in II.B.4). To a large extent this is the case if literacy and technical expertise are assumed,
as evidenced by the listings of databases in the Annex Section C5g. However, because of
differences in language, literacy and culture, much remains to be done before hazard information
can be made readily accessible to all persons.
Recommendations
Tiered extent. Wherever practicable use a tiered system for accessing hazard information at
different levels of detail, including:
 The raw toxicity data, as produced by the chemical manufacturer.
 A “Robust Summary” of the hazard information, containing enough detail to allow a
technically trained person to understand and evaluate the validity of the tests conducted and the
conclusions drawn (20-50 pages).
 A “Brief summary” of the hazard information, containing a less technical overview of the
results accessible to the literate layperson (2-5 pages)
 A very brief symbolic summary of the inherent hazards of the chemical, as well as the gaps in
hazard information for that chemical, accessible to all laypeople, including workers and others
who may have contact with the substances
Standardisation. There is a need to further harmonise terminology and data formats, including
tools appropriate for extracting information from a databank, such as the chemical data compilation
format IUCLID (International Uniform Chemical Information Database). This is essential to meet
objectives of national/regional programs to systematically prioritise and assess existing substances
and global objectives to minimize duplication and increase accessibility of data.
Databases. The Internet should be developed as a tool for identifying and disseminating hazard
information to the intended target groups in the respective tiers, preferably using existing
databases.
Free access to databases. Access to databases should be free of charge, to the largest extent
practicable, particularly databases produced through an intergovernmental cooperation.
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Translation. {4. There is a need to translate into the national language of the user at least the
“Brief summary” of results of tests for inherent hazards. (Who should have this obligation? Is
“Brief summary” the appropriate level of detail for translation? Compare the underlined part in
Interpretation of hazard data below and Communication under E. Recommendations)}
Confidentiality. The accessibility of data must reflect the need to protect confidential business
information, such as the detailed composition of single chemical preparations, as well as national
policies concerning data protection.
Interpretation of hazard data. Work with respect to other IFCS Program Areas would further
facilitate public accessibility and communication of information of a type and format to enable risk
reduction. Examples include Area B. Harmonisation of classification and labelling (classification
and labelling, symbols) and area C, Information exchange on toxic chemicals and chemical risks
(e.g. safety information accompanying hazardous material). Many of the above recommendations
may also apply to such information. There is a need to identify the roles of industry and
governments in assessing and interpreting the information developed.
E. What are the roles of industry and governments?
The roles of governments and industry vary among countries or regions and between developed
countries and less developed countries. Governments do not systematically generate the data on
chemicals themselves but rely mainly on the chemical industry to provide the information deemed
to be necessary.
There is a trend that industry is taking more responsibility in generating data and an increasing role
in assessing data and managing chemicals. There is also increasing participation of workers and the
public in chemical safety discussions and information is now beginning to be more widely
distributed. This increasing involvement and transparency is likely to foster increased confidence
in how industry takes on its responsibility. The chemical safety infrastructure, however, is still
under development in many countries, particularly in developing countries and countries with
economies in transition.
Recommendations
Data generation. Industry should provide appropriate hazard data in a format that has been
generally accepted for the type of information presented. Governments and international
organisations should consider ways to include robust study summaries and other available hazard
data in their own assessment work.
Cost Sharing. Programmes to generate hazard data should promote the sharing of test data and
costs (e.g., through voluntary consortia) to improve efficiency and fair competition. Insofar as
possible a voluntary approach to data and cost sharing should be encouraged. The Mutual
Acceptance of Data (MAD) that is now accepted in the OECD countries should be extended to
non-OECD countries.
Central repository. Governments need to play a critical role, in collaboration with industry, in
developing a central repository (or a central location with links/pointers to applicable information)
of inherent hazard data to minimize duplication of effort and increase accessibility.
Communication. The primary responsibility lies with industry to create labelling that effectively
communicates the hazards of its products to users. Governments should make use of the available
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hazard information to develop additional regulatory and educational approaches that will
effectively communicate hazards in their local settings. Non-governmental organizations can play a
key role in this effort and should work with governments and users of the chemicals to raise
awareness of inherent hazards among users of chemical substances.
IV.
Terminology
This document uses to the largest extent possible the definitions of the Joint IPCS/OECD Project
on the Harmonisation of Chemical Hazard/Risk Assessment Terminology. Definitions of Generic
Terms uses in Chemical Hazard/Risk Assessment,
http://www.ipcsharmonize.org/terminology/index.html
In addition, some terms are particularly important and are defined here to facilitate the
comprehension of the text; different national or regional laws may have their own definitions.
Accessibility relates to available data being easy to obtain in an easily understandable format
Availability relates to the existence of data
Data includes available full test data, test summaries, and estimation of data for a substance from
known properties of others
Industry refers mainly to the industry producing chemicals; if industry refers to those using
chemicals as an input for manufacturing goods it is specifically mentioned.
Information includes data and interpretations thereof
HPV High Production Volume is defined differently in different assessment schemes but typically
refers to production volumes above 1000 tonnes per year
Products
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