IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 1 (23)Rev. 11 Annex

ANNEX

Current practices and proposals for generation, assessment and accessibility of hazard data

{This Annex has not yet been fully reviewed by the Working Group. A few comments have been directly entered without any proposal for how they will be handled – this will have to await the full review comments that are anticipated in November 2002.

It was earlier decided that quality aspects should be included, and a matrix should show the relation between type of data and producer of data. These directions have not yet been implemented.}

This Annex elaborates some reasons for proposing the recommendations in the Decision document Rev 11, and technical details behind the recommendations. It should be read in conjunction with the Decision document, the contents of which are not necessarily repeated here.

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 2 (23)Rev. 11 Annex

ContentsA. Abbreviations..........................................................................................................................3

B. Scope.......................................................................................................................................31. Delineation of the issues.....................................................................................................3

a) Types of chemicals..........................................................................................................3b) Types of data...................................................................................................................3c) Accessibility....................................................................................................................4

2. Relationship of this priority for action with others.............................................................43. Steps in the chain leading to risk management...................................................................4

C. Current situation on data, their quality and interpretation..............................................51. Hazard data/information needs and uncertainties...............................................................52. How should chemicals be prioritised for data accessibility and/or data generation?..........5

a) Priority setting for acquiring inherent hazard information.............................................53. Hazard data generation........................................................................................................7

a) Minimum amount and type of information for an initial hazard assessment for existing high production volume chemicals.........................................................................................7b) Other examples of data generation..................................................................................8c) New industrial chemicals................................................................................................9d) Quality (validity and adequacy) of hazard data..............................................................9e) Format of hazard data....................................................................................................10f) Accelerated generation of provisional [short-term, interim, conditional] data.............11

4. Efforts to minimise the use of animals in the development of hazard data......................11a) Developments with respect to validation......................................................................11b) Potential development of SIDS testing.........................................................................12c) Potential progress on alternative methods.....................................................................12d) Recommended testing strategies...................................................................................13

5. Hazard data/information accessibility...............................................................................15a) Who needs (or wants) access?.......................................................................................15b) What is accessibility?....................................................................................................15c) Language, Costs of access to information....................................................................15d) Sufficiency of existing databases..................................................................................15e) Protection of proprietary rights.....................................................................................15f) Information beyond inherent hazards............................................................................16g) List of data bases currently accessible..........................................................................18

6. What are the roles of industry and governments?.............................................................22

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 3 (23)Rev. 11 Annex

A. AbbreviationsSDS: Safety Data Sheet, MSDS: see SDSSIDsMAD Mutual Acceptance of DataGLP Good Laboratory PracticeSIAPSIARQSARSAR….

B. ScopeThe Annex discusses

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).

1. Delineation of the issuesa) Types of chemicals

The principles in this Priority for Action for making information available and accessible should be applied to all chemicals in commerce, as should considerations of animal welfare. However, only for industrial chemicals does this Annex go into detail with respect to test systems, prioritisation and possible approaches to generate and make accessible information. Different international organizations exist to consider the hazard and safety of:

pesticides (http://www.fao.org/ag/guides/subject/t.htm ; http://www.oecd.org/oecd/pages/document/displaywithoutnav/0,3376,EN-document-notheme-1-no-no-29297-0,00.html#title0 )

pharmaceuticals (http://www.ich.org/ ), veterinary pharmaceuticals (http://www.codexalimentarius.net/), cosmetics (http://www.cir-safety.org/ - primarily U.S.), and food additives (http://www.codexalimentarius.net/ ).

b) Types of dataMuch chemical safety information is easily available on the Internet, on broad compilations such as the Global Information Network on Chemicals, http://www.nihs.go.jp/GINC/webguide/csinfo.html.This includes the following types of data that are related to the subject of this paper, but are not discussed since they are not within the mandate for detailed treatment:- Production information: production statistics, product registers- Emission data- Exposure data- Risk assessment reports- Risk management information and risk management principles such as given in Chemical

Safety Cards.Such data are to a large extent the subject of other IFCS Priorities for Action.

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 4 (23)Rev. 11 AnnexSome information that does not pertain to inherent hazards is however discussed since it helps prioritise the selection of chemicals for data generation, (e.g. production volume) or assists in attaining what the mandate terms “interpretation leading to conclusions about the

degree of hazard or risk involved”, (e.g. exposure or risk information).

c) AccessibilityThe Annex also discusses the manner in which the hazard data identified above are accessible to anyone (government authorities, workers, consumers including manufacturing industries, the general public, non-governmental organisations, and other stakeholders) interested in such information, with the level of technical detail adapted to the needs and comprehension of the different target groups.

2. Relationship of this priority for action with othersIt is clear that Priority for Action A3 is to focus on the accessibility of hazard data. In order to implement A3, it is also clear that interpreting and communicating these hazard data 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 - http://www.who.int/ifcs/forum3/f3-finrepdoc/Priorities.pdf :

A1 – Development of harmonized approaches for performing and reporting health and environmental risk assessments

A2 – Hazard evaluations should be carried out in accordance with international methods and the resulting information be made available to the public in a timely manner.

B1 – Development of a harmonized system for classification and labeling of chemicals (critical hazard communication tool). This refers to the Globally Harmonized System for the Classification and Labelling of Chemicals (http://www.unece.org/trans/main/dgdb/dgsubc4/c42001.html).

IFCS Program Area C – focusing on information exchange on toxic chemicals and chemical risks.Specifically, C3 – To provide “all relevant parties with safety information on the hazardous properties of chemicals in an easy-to-access, easy-to-read, and easy-to-understand format”.

3. Steps in the chain leading to risk managementHazard data generation strategies often include

Screening to define extent of testing, possibly iterative Production of hazard information summaries Checking of information quality and completeness Interpretation to for instance decide upon hazard classification.

Once information on inherent hazards is available, it may be used, often together with exposure information, to inform decisions about risk management. {Based on Canada}This is outside of the scope of this Annex.

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 5 (23)Rev. 11 Annex

C. Current situation on data, their quality and interpretation

1. Hazard data/information needs and uncertaintiesMany chemicals in commerce are without adequate safety screening data and hazard information {cite the various hazard data availability studies showing there are not much data out there on hpvs} Increasing evidence of harm due to exposure to varied types of chemicals, and heightened public awareness of chemical safety issues, have caused an increasing interest in acquiring hazard data.

As mentioned above, the IFCS has paid much attention to the generation of hazard data, and one of the IFCS Priorities for Action (A2) states that hazard evaluations should be carried out in accordance with international methods and the resulting information be made available to the public in a timely manner. Several examples of ongoing programs are mentioned below.

The development of hazard data, whether by actual experimentation or through predictions using computer models, necessarily involves some level of uncertainty, sometimes amounting to several orders of magnitude. This uncertainty may or may not be quantifiable. In any case, it should be recognized that such uncertainties exist and should be evaluated during the course of using hazard data. The tolerable uncertainty depends on the intended use of the data. It should be assured that the data requirement is closely linked to meeting an identified assessment need on the most efficient and effective basis possible and recognising data source (including test system) alternatives. Tiered testing schemes are common which gradually reduce the uncertainties. An initial test set, dependent on the outcome, may thus be followed by more comprehensive testing, until it is considered that the basis for the intended decision is sufficient.

The purpose of this document is to propose how relevant data can become available to the public and authorities in the shortest possible time-frame. Schematically, more comprehensive information gathering concerning inherent hazards would reduce uncertainty but require more time, indicating the need for a trade-off between uncertainty and timely availability..

2. How should chemicals be prioritised for data accessibility and/or data generation?

a) Priority setting for acquiring inherent hazard informationSeveral factors are relevant for prioritising chemicals with little or no hazard data to determine which ones should have their data gaps filled first. Production volume is used in several existing systems for priority setting, but also e.g. toxicologically observed human health effects, and actual or estimated high persistence in the environment as well as bioaccumulation potential have been used, as the following examples show:

In the United States, prioritisation is based on a variety of factors, including, among others, production volume (e.g., HPV program where priority is given to roughly 2,800 HPV substances, with production volume being an agreed though imprecise surrogate for potential exposure), monitoring of human tissue, releases, other indicators of potential exposure including the nature of the chemical’s use (e.g., in children’s products, consumer products, occupational settings, in research and development), available risk information, whether the substance is “new” or “existing,” and, as a general matter, the adequacy of the available data for the relevant need.

The proposed new European Union system also relies on production volume to prioritize by requiring high volume chemicals to be registered by the end of 2005, intermediate volume

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chemicals by the end of 2008 and the rest by 2012. Generally, testing requirements at the lower volumes focus 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. In additions, a more thorough review procedure is anticipated for carcinogenic, mutagenic or reprotoxic substances, and persistent organic pollutants.

In Canada, under the Canadian Environmental Protection Act (CEPA), the federal government must categorise by September, 2006, the approximately 23,000 chemicals on the Domestic Substances List, a listing of chemicals in Canadian commerce, to identify for subsequent assessment those which may present to individuals in Canada the greatest potential for exposure, or are persistent or bioaccumulative and inherently toxic to human beings or to non-human organisms. Subsequent assessment will identify priorities for testing. Results of all assessments must be made public; for Priority Substances, timeframes for completion are also specified in the legislation. The programme to systematically prioritise for assessment all Existing Chemicals in Canada is described onhttp://www.hc-sc.gc.ca/exsd-dse http://www.ec.gc.ca/substances/ese/eng/esehome.cfm

In Russia criteria for prioritization include ability to cause acute and chronic poisonings; ability to induce occupational diseases; proven carcinogenicity, genotoxicity, teratogenicity, embryotropic effect, endocrine disrupture; persistence, aggregate state, solubility in fats, ability to absorption through lungs, mucous membrane and dermal integument; production volume of more than 1000t/y. For new substances not studied yet the criteria for ranking priority are 1. Chemical structure and properties similar to those of known toxicants; 2. Positive responses in short-term animal testing or in alternative model testing.

A matrix, as shown below, can represent such factors. In essence, it can be seen as a system based on production volume with modifying factors if they are known or are available. These modifying factors include – with suggested criteria supplied here for discussion purposes only:

production volume (systems already in place) – OECD definition whether used in closed systems – OECD definition chemicals with high occupational exposure potential (large number of workers, high

exposures) known releases from production sites PBT characteristics uses with high exposure potential (e.g., wide consumer uses) Quantitative or qualitative structure-activity relationships ((Q)SAR) effects to both human health and the environment.

There are a large number of factors that could be important in setting priorities (e.g., various types of models and their associated uncertainties: a longer list is given in the decision document, subsection IIIA). However, incorporation of these elements will greatly complicate the prioritisation process.

Any workable system of prioritisation is thus likely to be quite flexible and pragmatic in approach. Table X gives an example that incorporates several features – which assess human health only - that exist or are being explored in national, regional or OECD work.

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Table X. Conceptual model of a system for prioritising chemicals for hazard data generation The basic factor is production volume but the modifying factors need to play a role.

Modifying Factor to Production Volume

Production Volume

Prioritization LevelH M L

Special Haz. PropertiesSuspected (PBCMRH)

Yes H XM XL X

No H XM XL X

Use Information* Intermed.(closed)

H X? X?M X? X?L X

Occupational H XM XL X? X?

Consumer H XM XL X? X?

[In discussing actions, it may be useful to categorise chemicals according to their use, rather than to their effects. This could be done at different levels of detail and may facilitate the access to and understanding of data.]

3. Hazard data generation There is no global standard for a hazard data set for chemical substances, but there are similarities in the extent of dossiers required in different countries, and a screening data set has been developed within the OECD. This section describes hazard information requirements in terms of amount and type of information and the quality and format of these data.

a) Minimum amount and type of information for an initial hazard assessment for existing high production volume chemicals

The OECD countries and their chemical industries are working together to investigate High Production Volume chemicals (HPV = > xxx ton / year) to prioritise chemicals to determine whether further work is necessary given available hazard information relative to human health and environment. The basis for the assessment is a set of data called Screening Information DataSet (SIDS). The SIDS includes the following “elements” or “endpoints” to represent a minimum amount of information to describe the hazard of a chemical: physicochemical properties [water solubility, melting point, boiling point, vapor pressure, octanol:water partition coefficient]; environmental fate properties [photodegradation, biodegradation, hydrolysis, estimation of distribution and transport in the environment]; ecotoxicity [acute toxicity tests with aquatic vertebrates, invertebrates, and plants] and human health effects [animal studies for acute and repeat-dose toxic effects, effects on the gene and chromosome, effects on reproduction, and effects on development of the fetus].

In addition, other, existing data on a chemical are assembled using published and/or peer reviewed scientific literature. The requirement to complete any individual data of the SIDS by further testing

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 8 (23)Rev. 11 Annexdepends on the quality and quantity of data available. All collected data are compiled into a SIDS Dossier using IUCLID software as preferred format (International Uniform Chemical Information Database).

The SIDS Dossier is used to put together a SIDS Initial Assessment Report (SIAR), which presents and assesses key information relevant to hazards. The SIAR is reviewed and discussed by member states in a particular meeting, the SIDS Assessment Meeting (SIAM). The conclusion and recommendation of this scientific review is presented in an executive summary; SIDS Initial Assessment Profile (SIDS Profile).

In an attempt to consider new information on how hazards – especially in a screening-level analysis – are identified, the OECD has recently considered using both structure-activity relationship (SAR) analyses and the use of chemical categories to reduce the time, money, and animals used in hazard testing.

SAR is based on using prior experimental knowledge to inform or predict estimates of a particular hazard endpoint for a chemical without having to do an experiment. SAR computer models exist for many health and environmental endpoints (http://www.ndsu.nodak.edu/qsar_soc/ ).

Treating similar chemicals as a category allows for the testing of one or more category members with the results applicable to all category members. OECD guidance on SAR (LINK) and categories (LINK) are available.

Sometimes less than the SIDS testing for an individual chemical may be defensible, for instance if information is available concerning isomers that have a similar structure-activity profile or concerning closely related homologues, or if the exposure potential is limited, depending on production or use scenarios, with chemical intermediates as a case in point.

b) Other examples of data generationCanada. Under the Canadian Environmental Protection Act (CEPA), the federal government must categorise by September, 2006, the approximately 23,000 chemicals on the Domestic Substances List, a listing of chemicals in Canadian commerce to identify for subsequent assessment, those which may present to individuals in Canada, the greatest potential for exposure, or are persistent or bioaccumulative and inherently toxic to human beings or to non-human organisms. Subsequent assessment will identify priorities for testing

European Union. A proposal within the European Union requests registration of basic information for around 30,000 substances (all existing and new substances exceeding a production volume of 1 t) {legislation proposals are expected to be discussed towards the end of 2002 and considerable clarity should be reached in time for the final discusasaionsa by the FSC in the beginning of 2003}

ICCA. The global chemical industry launched, through the International Council of Chemical Associations (ICCA), a global initiative on High Production Volume (HPV) chemicals at its Board meeting on 3 October 1998. (http://www.cefic.org/activities/hse/mgt/hpv/hpvinit.htm]

The chemical industry has undertaken to provide, as a first step, harmonised, internationally agreed data on the intrinsic hazards of and initial hazard assessments for approximately 1,000 HPV substances by the end of 2004. The information, i.e. a Screening Initial Data Set Dossier (SIDS Dossier), a SIDS Initial Assessment Report (SIAR) and a SIDS Initial Assessment Profile (SIAP), will be submitted to the OECD as part of its refocused HPV Chemicals Programme.

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The cost of generating data and the work to draft the assessments will be shared, whenever possible, by ICCA member companies in international consortia.

Japan. The government of Japan is responsible for data generation of existing chemicals, and has started a 5-year national programme to generate data and assess risks, in addition to industry’s voluntary initiative.

Russia. A fundamental risk assessment of chemicals has been carried out in 5 Russian industrial cities with the use of international methodology, mainly based on EPA (USA) methodology adapted to the Russian regulatory documents.

United States. The US EPA HPV Challenge Programme began in 1998 in the United States and is expected to yield basic screening level data for 2,155 high production level chemicals, noting that there is an overlap between the industry and US EPA effort. (See “Data Collection and Development on High Production Volume (HPV) Chemicals,” 65 FR 81686, December 26, 2000, at http://www.epa.gov/fedrgstr/EPA-TOX/2000/December/Day-26/t32498.pdf )

Complementing in many ways these two efforts to generate “screening level” data is a second US voluntary program focused on identifying the need for and generating upper tier or “confirmatory” test data on 20 high volume chemicals which have been detected in human tissues. (See “Voluntary Children’s Chemical Evaluation Program,” 65 FR 81700, December 26, 2000, at http://www.epa.gov/fedrgstr/EPA-TOX/2000/December/Day-26/t32767.pdf).

c) New industrial chemicalsNew industrial chemicals notification and assessment schemes have been established in the majority of OECD Member countries, creating a range of notification and assessment requirements. While they have been instrumental in reducing risks of chemicals to human health and the environment, the diversity of schemes and requirements between the countries brings complexity both to industry and government. One of the recommendations of the 1996 OECD Workshop on Sharing Information about New Industrial Chemicals Assessment (the report is available in Portable Document File) was to encourage sharing of information about new industrial chemicals notification and assessment. The OECD's New Industrial Chemicals Information Directory is one of the follow-up activities of the above workshop: http://www1.oecd.org/ehs/NewChem/index.HTM [USEPA: Should new chemicals even be considered here? – because the focus is data generation and public accessibility for existing chemicals…]

d) Quality (validity and adequacy) of hazard dataThere are at least two ways to assess the quality of hazard data: (1) the validity of the test system used to generate data; and (2) the adequacy of the resulting information to address the question at hand. A hierarchy for the validity of a test system should be employed when choosing input data for hazard assessments. Priority should be given to:

1. Measured data derived using OECD test guidelines/protocols2. Measured data derived from other acceptable methods3. Extrapolation/Interpolation from measured data on structurally similar chemicals (i.e. closest

analogues)4. Reliable QSAR estimation. Some hazard data are based on physico-chemical properties

whereas others are produced using in-vitro testing. In the absence of relevant data for a

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substance, estimates can be made based on extrapolations from the properties of similar substances, using similarities in chemical structure. Such extrapolation using QSAR have been used mainly for screening purposes for new chemicals, particularly in aquatic ecotoxicology.

5. Expert judgement. This would be used when the methods described above may not be available and intuition, experience and knowledge would determine whether the information is appropriate to describe a hazard endpoint. For example, if a study was performed that did not use any acceptable guidelines and there were no close structural analogues, but the information suggested either a high or low hazard potential then expert judgment would be needed to determine whether another test would be necessary.

6. Default values [USEPA and ICCA: Default values don’t belong in a section on generating hazard data. They are used as “safety, modifying, or uncertainty factors” in risk assessments. Identifying a hazard value by default is not possible – the only way to do it is to either measure it or estimate it (covered by 1-5 above)].

Quality and mutual acceptance of newly generated data can be ensured by using for new tests OECD Test Guidelines and working under OECD Good Laboratory Practice conditions.

The requirements for data adequacy (level of detail, tolerable uncertainty etc) depend on the intended use of data, such as regulatory decisions to control or screen or to provide information to the public. There are often uncertainties in the data. Such uncertainties must be fully communicated to allow authorities, stakeholders, and the general public to make informed decisions about the information. There is a need for flexibility and a dialogue between the data producer, the data assessor and the data user.

Guidance on the quality and adequacy of hazard data is available in OECD SIDS Manual for investigation of HPV chemicals, which is presently undergoing revision. Any new SIDS testing must be performed according to internationally acceptable test guidelines and Good Laboratory Practice (GLP).

Finally, it is important that test data reflect the conditions of all IFCS regions, for example, where a chemical is manufactured, imported, used, or otherwise is present. Test methods and data have been largely developed in and are most relevant to the more temperate climatic regions. The cooperation of developing countries and countries with economies in transition should be sought to ensure that relevant inherent hazard data, required to assess human and environmental risks are developed. Additional data that are generated and accessible with test conditions or species different from those used in current test methods may be warranted. Many OECD Test Guidelines do offer flexibility for testing, although there remains a need for efforts to develop test guidelines that allow enhanced assessment of specialized environments (e.g., coral reefs, tropics, etc.).

[Certification, good assessment practice, ]

e) Format of hazard dataOnce hazard data have been identified and its validity and adequacy accepted, the next important step is to determine the appropriate format for presenting the information to authorities, stakeholders, and the public. Each of these audiences might have a different format need. The spectrum of possibilities includes the release of the full technical report to the issuance of a short summary highlighting the main points. Of course, the format chosen would dictate the necessary content of the information. There is a need to further harmonise terminology and data formats,

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 11 (23)Rev. 11 Annexincluding tools appropriate for extracting information from a databank, such as the chemical data compilation format IUCLID (International Uniform Chemical Information Database).

An example of an existing format that provides hazard data to interested parties is the posting of “robust summaries” by industry participants in the U.S. HPV Challenge Program (http://www.epa.gov/opptintr/chemrtk/viewsrch.htm). The summaries present the facts and are meant for a technical audience with sufficient detail provided so the reader does not need to go to the full study report. They are also used in the abovementioned SIDS dossier, and OECD has developed guidance for each hazard endpoint in the SIDS.

Whatever format is used, it is important that the audience (government authorities, stakeholders [technical and non-technical], and the general public]) be identified. In addition, information on the hazard data generation methods should be supplemented by information on the transparency of the process and avoidance of conflicts of interest that might influence the outcome. Participation of interested stakeholders should be encouraged.

f) Accelerated generation of provisional [short-term, interim, conditional] data

From EU WP: The precautionary principle will be invoked whenever the risk assessment process isunduly delayed and where there is an indication of unacceptable risk. In particular,should a producer of a given substance delay the filing of information or test results, thecentral entity would be entitled to conclude the assessment. It would then pass thedossier to the Commission with a recommendation to apply the precautionary principleand to proceed to risk management measures to the possible extent of a total ban.[USEPA and ICCA: not relevant here, going beyond a “first-cut” approach (it is more of a chemicals policy)]

4. Efforts to minimise the use of animals in the development of hazard data

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. Though much remains to be done in pursuing Russell and Burch’s Three Rs of replacement, reduction, and refinement, noteworthy progress has been made. Public and private alternatives centres have been established in several countries; the Three Rs approach has been incorporated into animal welfare legislation in Europe, North America, Australia, and elsewhere; and ECVAM [weblink], ICCVAM [weblink], and the OECD have favourably evaluated a number of alternative methods.

a) Developments with respect to validationIn addition to past activities, there are also current and ongoing efforts to advance the Three Rs. For example, validation is a key issue in gaining scientific and regulatory acceptance of new alternative methods. In this context, validation is the process of assessing the reliability and relevance of a test for a specific purpose. The principles and processes for validating new toxicological methods have been developed over the last 10 to 15 years and are still evolving. Validation is a relatively new field of toxicology because it was developed to address the recent emergence of alternative methods; historically, new animal-based tests were not subjected to a formal process of validation. An influential OECD workshop held in Solna, Sweden in 1996 developed the ‘Solna principles’ for validating non-animal methods. A follow-up OECD conference was held in Stockholm, Sweden in March, 2002 to develop practical guidance on addressing validation principles and criteria and conducting validation studies. (Also addressed were activities associated with regulatory acceptance and independent peer review.) Unlike

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 12 (23)Rev. 11 Annexprevious conferences, ‘Solna II’ addressed both animal-based as well as non-animal methods. Consequently, the conference applied the validation principles such as a ‘prediction model’, previously applied only to in vitro methods, to new and updated animal-based methods. Although there were some concerns about the phrase ‘prediction model,’ there was clear support for the concept, i.e., defining how to translate the results of a test into a prediction of the toxicity of concern.

The official report from the Stockholm meeting has not been finalized, but it is expected to facilitate the revision and completion of an OECD guidance document on validation. The document will be helpful in moving forward with new testing programmes, such as the one for endocrine disruption, that are expected to involve both in vitro and in vivo methods.

The application of validated alternative methods to the testing of existing chemicals in the USA and European Union has been extensively discussed. Proposals for the further development and validation of alternative tests and testing strategies have been made, including a combined strategy for testing of chemicals and investing in alternatives that would enable the EU to move forward without relying on animal testing.

b) Potential development of SIDS testingThe target for applying alternative methods to the HPV chemical testing programmes of the OECD, US EPA, and others is the Screening Information Data Set (SIDS). The SIDS battery addresses mammalian toxicity, ecotoxicity, and environmental fate. SIDS testing for mammalian toxicity is the area of primary relevance to the effort to replace, reduce, and refine animal testing, and this is what is emphasized here. However, it should be noted that the ecotoxicity component of the SIDS battery includes tests in fish that examine toxicity and/or lethality, and consequently these tests too should be viewed as candidates for alternative procedures; in post-SIDS work testing with birds may also be considered.

The mammalian toxicity component of the SIDS battery includes five types of testing: acute systemic toxicity, repeat-dose toxicity, developmental toxicity [Visser: not a separate part of the SIDS], reproductive toxicity, and mutagenicity. For each type of toxicity, the SIDS battery includes one in vivo test and, for mutagenicity only, alternative in vitro tests. Several recent reviews (http://www.stopeuchemicaltests.com/TheWayForward.pdf ; Worth, A & Balls, M. (in press). Alternative (non-animal) methods for chemical testing: Current status and future prospects. ATLA; and Green, A, Goldberg, AM, and Zurlo, J. 2001. TestSmart-HPV chemicals: An approach to implementing alternatives into regulatory toxicology. Toxicological Sciences 63: 6-14)have evaluated the current status and future prospects of alternative methods to each of these endpoints, and provided a large number of proposals that might lead to replacement, reduction, and refinement.

c) Potential progress on alternative methodsFuture progress in developing and validating alternative methods will depend, in large measure, on the degree to which this work is supported financially. Any agency or institution that proposes a chemical testing program that is likely to involve large-scale animal use should consider pro-actively supporting alternative methods. This activity would have two overarching components (http://www.stopeuchemicaltests.com/way.html):

1. Developing, in consultation with ECVAM, ICCVAM, and other relevant bodies, a targeted strategy and timetable for the development and validation of alternative methods.

2. Funding the development and validation of these methods.

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So far the discussion has focused on either replacing or reducing animal testing. To refine such testing, humane endpoints should be employed (see e.g. OECD. 2000. Guidance Document on the Recognition, Assessment, and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Paris: Organization for Economic Cooperation and Development). These are strategies to terminate testing prior to reaching the traditional endpoint (e.g., death) in order to preclude additional suffering. Humane endpoints apply to situations in which early endpoints have been identified as surrogates for the traditional endpoints, or in which it is clear that allowing a test to continue will not yield meaningful results

Chemical testing programme should be designed and implemented to take full advantage of alternative methods. Some examples follow:

1. It might be possible to schedule some forms of testing for the later stages of a testing programme. This would be particularly appropriate for any animal test that is likely to be superseded soon by a replacement or reduction alternative. Such strategic scheduling would make it more likely that the alternative test will be readied in time for testing of the endpoint in question. For example, the U.S. EPA recommended that participants in its voluntary HPV program delay testing of individual chemicals (i.e., those not grouped into chemical categories (see d) 4, below)) until a certain date. The aim was to allow alternatives to animal-based acute systemic toxicity testing to be developed further, in the hope that such tests could be employed to at least reduce animal testing for this endpoint, if not replace it altogether.

2. Similarly, it might be possible to defer testing of chemicals that present less risk of exposure until the later stages of testing. Such deferrals would allow any alternative methods developed in the interim to be employed in the later stages of testing. This strategy is consistent with the need to prioritise chemicals for testing. Of course, chemicals with sufficiently low exposure should be dropped from testing altogether, and chemicals with special exposure features, such as closed system intermediates, may not warrant some of forms of testing (e.g., chronic testing), whether early or late in the programme.

3. It might be possible to combine multiple endpoints into a single test, where feasible and appropriate, to preclude conducting multiple tests. In the U.S. HPV program, the 28-day repeat dose study (OECD Test Guideline 407) is combined with the reproductive toxicity test (OECD TG 421) and the developmental toxicity test (OECD TG 414) into a repeat dose reproductive/developmental screen (OECD TG 422). There may be other possibilities for such combined testing, depending on the nature of the programme to be developed.

d) Recommended testing strategiesThe development and validation of alternative methods, and their appropriate implementation, constitute obvious strategies for reducing animal use in testing programs. However, other strategies can also reduce animal use in testing programs. The following design features (based on Stephens, ML, Conlee, K, Alvino, G, and Rowan, AN. (in press). Possibilities for refinement and reduction: Future improvements within regulatory testing. ILAR Journal) [are often employed] and should be considered for any emerging testing program that is likely to use animals:

1. Coordinate with similar testing programs internationally to avoid duplicative testing. For example, the OECD, ICCA, and U.S. EPA are seeking to coordinate their HPV programs to avoid duplicative testing and maximize the use of harmonized protocols.

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 14 (23)Rev. 11 Annex2. Maximize the use of pre-existing and scientifically adequate data from the published

literature, government records, industry files, etc., to minimize further testing. To a certain extent, calls for publicly available data/information on the toxicity of chemicals used in commerce can be satisfied by collecting and disseminating data that already exist. Experience gained through the U.S. EPA HPV program has shown that many of the data gaps identified in reports that gave rise to the HPV program are being filled by scouring existing sources, rather than by generating new data. Companies that have existing data on a given chemical may be more likely to come forward with that data if they receive government assurances that doing so will not subject the company to legal liability for not coming forward earlier with such data. Another mechanism for encouraging the use of all available data is for companies to make their test plans publicly available, so they can be scrutinized by stakeholders that may be aware of additional data.

3. Thoughtfully assess existing data and data gaps prior to making determinations about the necessity of conducting additional tests, in order to avoid a rote checklist approach to testing. Even when test results are not available to fill existing data gaps, there may be little reason to conduct additional testing, in light of the totality of information available on toxicity and exposure. Fill-in-the-box approaches to creating toxicity profiles should be discouraged in favor of more thoughtful assessments of the real-world impact of generating data on additional endpoints.

4. Maximize 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. Another method for generating information to fill existing data gaps relies on comparisons to structurally related chemicals. Experience has shown that such chemicals are likely to have similar toxicity profiles. When available evidence for a given chemical and its closely related chemicals suggests that such is the case, then data from the latter are often sufficient for screening purposes.

5. Thoughtfully assess existing exposure information prior to making determinations about the necessity of conducting additional tests, in order to avoid a rote checklist approach to testing. Exposure information on a given chemical may sometimes be sufficient to determine that additional toxicity testing is not warranted. For example, there may be little need to assess chemicals that are exclusively closed system intermediates for subchronic or chronic testing

6. Thoroughly analyze data submissions and test plans in order to accurately gauge the ‘knowledge gap’ for existing chemicals and the appropriateness of the proposed tests.

7. Publish proposed test plans on the Internet, and allow for public comment on these plans and for the publication of the comments themselves. Data submissions or test plans may fail to provide all existing information or abide by some of animal welfare-related provisions of the programme. Consequently, the competent authorities should commit to reviewing these submissions and test plans, as well as establishing a mechanism to receive, review, and act on comments of interested stakeholders. [USEPA: Delete. This principle is very specific for the US HPV program and may not be universally practical in all settings]

Many of the foregoing principles have been incorporated in the U.S. voluntary HPV Challenge program (see www.epa.gov/chemRTK). The magnitude of the resulting reductions in animal use in this program will depend on the degree to which these principles are actually implemented by companies participating in the program. There is evidence that a number of companies have not

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 15 (23)Rev. 11 Annexfollowed these principles when drawing up their test plans (http://www.pcrm.org/issues/Animal_Experimentation_Issues/hpv_report0801.html ). Fortunately, the transparency in the US program allows interested parties to scrutinize company test plans and get an idea of how well the alternatives-related features are being implemented. Similar features, backed up by a transparent process, should be considered for any related programs.

5. Hazard data/information accessibility Chemical safety requires access to hazard information. Several issues have to be addressed, such as the needs of different target groups, methods of making information accessible, and consistency with national laws and policies concerning data protection.

a) Who needs (or wants) access?The simplest definition of who might be interested in this information is ”the public”. Of course, there are many subpopulations in the public: stakeholders and government authorities involved in chemicals and chemical management; workers, consumers, and the general public. In all cases, individuals or groups could be either technical or non-technical in terms of their ability to comprehend certain scientific aspects of the information and their needs for the data may vary.

b)What is accessibility? There are existing databases that are publicly available (for examples, see list below). Rather than create a new database, it would be best to channel new data to one or more existing databases. Thus, a platform would be needed to make the available data accessible to parties interested in the information. The FSC believes this means having the appropriate hazard data brought “to the table” in a format that has been generally accepted for the type of information presented. For example, a likely scenario would be one in which a summary for a given chemical for a given endpoint is generated by industry and “made available” – probably electronically – for inclusion in an existing database.

c) Language, Costs of access to information{Should anything be added to what is in the Decision document? We decided in Rönneberga: “The summary of test results would be possible to translate into accessible languages whereas a translation of complete test protocols would be beyond the scope of the Forum A3 mandate}

d) Sufficiency of existing databases{It is important to determine whether existing information systems would be sufficient to meet the needs should be discussed. If we go into the need for databases: System owner is responsible for legal permissions to keep the registry and for the existence of an organisation to monitor that existing rules are followed.System administrator is responsible for planning, co-ordination and follow-up. Ensures that the system is adapted to changes in activities and legislation. System operator is responsible for the daily operation and maintenance of the data bases}

e) Protection of proprietary rightsThe OECD council has addressed the issue of priorietary rights in the Recommendation of the Council concerning the OECD List of Non-Confidential Data on Chemicals, 26 July 1983 - C(83)98/Final. The Council recommends that Member countries, for purposes of assessment and for other uses relating to protection of man and the environment, facilitate the disclosure and exchange of data belonging to the OECD List of Non-Confidential Data and other data which may

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 16 (23)Rev. 11 Annexbe deemed by the Member country concerned to be non-confidential.. The list is given in an Appendix which is reproduced here:

“APPENDIX:  THE OECD LIST OF NON-CONFIDENTIAL DATA ON CHEMICALS

Certain data, of value for hazard assessment of chemicals and for other purposes connected with the protection of man and the environment, may be termed non-confidential.

In this context, "non-confidential" means that no restrictions should be put on the exchange of the data between governments nor on the disclosure of such data to the public. Proprietary Rights to data are not affected by the non-confidential status of such data. Data should be exchanged between governments on request and not as a matter of routine.

The following list is not restrictive. It is recognised, on the contrary, that in some circumstances there may be other data which are considered non-confidential both by the government and the submitter and that if these are useful for hazard assessment of chemicals, they should also be exchanged. The list below is inspired by the OECD Minimum Pre-marketing Set of Data, but is not meant to be restricted to information on new chemicals. Non-confidentiality, as defined above, applies to all chemicals.

trade name(s) or name(s) commonly used (in the United States of America, trade names or names commonly used may mean a generic name of a chemical substance);

general data on uses (the uses need to be described only broadly, like: closed or open system, agriculture, domestic use, etc.);

safe handling precautions to be observed in the manufacture, storage, transport and use of the chemical; recommended methods for disposal and elimination; safety measures in case of an accident; physical and chemical data with the exception of data revealing the chemicals identity (e.g. spectra). If the

physical and chemical data make it possible to deduce therefrom the chemical identity only ranges of values need be given;

summaries of health, safety, and environmental data including precise figures and interpretations. (The submitter of the health, safety, and environmental data should participate in the preparation of the summaries.)”

f) Information beyond inherent hazardsClassification. Global Harmonisation System for Classification and Labelling of Chemicals (GHS). In 1992, at the United Nations Conference on the environment in Rio de Janeiro, it was decided to develop a globally harmonised system for hazard classification of chemicals, labels and safety data sheets, including easily understandable symbols.The work has been co-ordinated by the Interorganisation Programme for the Sound Management of Chemicals (IOMC) Coordinating Group for the Harmonisation and Classification Systems (CG/HCCS). The United Nations Economic and Social Council (ECOSOC) has the international responsibility for implementaion and oversight of the completed GHS. The work is presently in the beginning of global implementation, and is expected to be available in 2003. The GHS is a non-mandatory recommendation available to counties to implement. The system uses a building block approach and countries are free to decide which of the building blocks will be applied in different parts of their system such as transport, workplace and consumer sectors.

The GHS refers to the intrinsic properties of hazardous chemicals. The criteria for hazard determination for health and environment are harmonised. The GHS system does not include the establishment of uniform test methods or promotion of further testing. The GHS should make use of all appropriate and relevant data including ethically obtained human data or available human experience.

http://www.ilo.org/public/english/protection/safework/ghs/index.htm

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 17 (23)Rev. 11 AnnexEU-classification of chemical substances The EU-classification of substances is regulated in Directive 67/548/EEC. All classified substances (>2570 substances) are listed in Annex I to this Directive, and the rules for classifying and labelling are described in Annex VI (printed matter).

N-Class Database Environmental Hazard Classification (www.kemi.se/nclass) (Nordic Council of Ministers) gives an overview of the work within the EU. It is continuously updated, is not part of the binding EU-regulation and contains about 7000 substances, both general industrial chemicals and active substances in pesticides. Health classification may also be found in this database.

(Sweden has a database version (in Swedish) of the Classification List (http://www.kemi.se) which gives the binding classifications for human health and the environment of 2 244 substances. Since related substances, isomers and other groups of substances often are assigned under the same substance, the number of chemical substances is, in fact, larger. This list is linked with the substance data base at the same site, so a search for a few very general substance properties also leads to information about its classification.)

Safety Data Sheets (SDS). The GHS includes also SDS. The SDS should be compiled by the supplier and should be produced for all substances and mixtures which meet the harmonised criteria for physical, health and environmental hazards under the GHS . The SDS should provide comprehensive information about the chemical to be used by workers and employers in the workplace. This is to enable the professional user of a chemical substance or preparation on the market, to take necessary measures to protect health and safety on the workplace as well as to protect the environment. The information in the SDS should be presented according to 16 headings and there is also a minimum of information limit given.

Internationally recognised standards that provide guidance to SDS are ILO standard under the recommendation 177 on Safety in the use of Chemicals at work, the International Standard Organisation (ISO), the European Union Safety Data Sheet Directive 91/155/EEC and the American National Standards Institute (ANSI) standard Z 400.1.

Companies are responsible for their SDS and may choose to publish the information e.g. on their web-site.

Production volume. Production volumes are often considered confidential business information and not easy to come by. Aggregate data e.g. for a country may be available from national product registers; there exist a handful of such registers, mainly in Europe. Regional or global production volumes are not readily available. World production of some 50 major commercial chemicals is presented annually in the journal Chemical and Engineering News. There are also organisations such as the Chemical Manufacturers Association in the United States that maintain production records. The United Nations Economic Commission for Europe has discontinued a series of comprehensive statistics covering about 70 substances in its geographical area, mainly in North America and Europe.

Emissions. Emissions of intentionally produced substances may occur at any stage of the life-cycle of the substance, from production through use and recovery or waste management. Often a large share of the total release comes from the use of manufactured goods containing the substance. The IFCS has stressed the value of emission registers/PRTRs in one of the Priorities for Action (D8). Examples of emission data include

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Annex to Report for Forum IV 18 (23)Rev. 11 Annex

the "OECD's Database on Use and Release of Industrial Chemicals" (http://appli1.oecd.org/ehs/urchem.nsf/ ) which contains Emission Scenario Documents

information on Pollutant Release and Transfer Registers, PRTR; registers from many sources is available on http://irptc.unep.ch/prtr/ and under the Århus Convention, a new instrument on emissions is under negotiation (http://www.unece.org/env/pp/prtr.htm ).

the TRI toxic chemical list in the United States (http://www.epa.gov/tri/index.htm ).

Exposures. Exposures occur via environmental media. They can be assessed via measurements or modelling. Ideally, the exposures should be assessed in terms of internal concentrations at the site in the organism where the toxic effect actually occurs. For the time being, this is largely impracticable, and resort must often be made to assessments based on external concentrations in environmental media, such as air, water, soil and sediments. In the case of human exposure, food products , consumer products and occupational settings are added. The assessment may become extremely complex, and simplifying models are often necessary. These models and tools are intended to be used by scientists and engineers familiar with exposure assessment principles. They may be helpful in

considering potential exposure when designing and selecting products and processes; and evaluating pollution prevention opportunities.

The person interested in obtaining data should first specify the purpose to be served by the data. Then, a range of sources will be necessary to consult.

The IFCS has stressed the importance of exposure information in one of the Priorities for Action (A2). Examples of available data include:

monitoring data from Europe that are relatively rich on air quality but scarce on other hazardous chemicals (http://dataservice.eea.eu.int/dataservice/available.asp?type=default&i=1 )

limited monitoring data from OECD, mainly for water http://www1.oecd.org/ehs/joint/Monitor/index.HTM.

several exposure assessment methods, databases, and predictive models iIn the United States (http://www.epa.gov/opptintr/exposure/ ); an alphabetical list is available at http://www.epa.gov/opptintr/dsalpha.htm

The US industry website http://www.chemicalawareness.org/toolkit/index.html that purports to assist interested parties in the development and communication of exposure information on chemicals

The extensive US monitoring program on human exposure to environmental chemicals (www.cdc.gov/niehs/dls/report ).

Several prototypes for screening assessments from Canada (http://www.hc-sc.gc.ca/hecs-sesc/exsd/screening.htm )

records of cases, incidents, substances and products from Poison control centres through the IPCS INTOX data base, www.intox.org

Hazard/risk assessment. An overview over activities on hazard/risk assessment within the OECD is given on http://www1.oecd.org/ehs/hazard.htm .

g) List of data bases currently accessible{Sweden is working on a list of data bases that would be accessible by links from the Annex. The list of databases is now extended in line with suggestions from the USEPA and ICCA. It is given below in its present state of development split into RISK and HAZARD data}

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 1011Hazard data generation and availability: Annex to Report for Forum IV 19 (23)Rev. 11 AnnexName Web-site Operated by Purpose/ function

- RISK-

Size Published/peer-reviewed

Access Printed material,books,

IPCS-INCHEM

www.inchem.org CCOHS and IPCS-WHO Risk characterisation, by reviews (EHC) and concise summaries of effects of chemicals (CICADS)

1000 chemicals

Yes Free No password

Yes

IPCS Safety cards (ICSC)

www.inchem.org

www.ilo.org/cis

Managed by ILO on behalf of IPCS

Health & safety information for industries and workers

1198 chemical cards

Yes Free No password,

Yes

IPCS-JECFA

www.inchem.org FAO/WHO International standards are set (Codex alimentarius) by using the evaluations based on the monographs

1000 mono-graphs

Yes Free No password

Yes

IPCS-JMPR

www.inchem.org FAO/WHO International standards are set by using the evaluations based on the monographs

200 pesticides

Yes (and GLP)

FreeNo password

Yes

IPCS-INTOX

www.intox.org Canadian Centre for Occupational Safety & Health (CCOHS) and IPCS -WHO

1) Databank: asssistance to poison centres2) Data Management System: Records of cases, incidents and products

- 1) Yes2) No

Password Pay fee

Yes

IPCS-INTOX Pesticies

www.intox.org Canadian Centre for Occupational Safety & Health (CCOHS) and IPCS -WHO

Ongoing project for establishing a global source for information on pesticide poisoning

- - Password Pay fee

-

CISDOC/CISILO

www.ilo.org/cis

International Occupational Safety and Health nformation Centre / ILO

State of the art in occupational safety and health

60 000 records

Yes Password Fee

PAN Pesticide Database

www.pesticideinfo.org Pestcide Action Network (PAN)

Identification information, regulatory status, toxicity, aquatic ecotocicity, pesticide use

6 400 pesticide active ingredients

Mainly

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 1011Hazard data generation and availability: Annex to Report for Forum IV 20 (23)Rev. 11 Annex

TO BE COMPLETED…..Name Web-site Operated by Purpose/ function

- HAZARD

Size Published/peer-reviewed

Access Printed material,books,

ATSDR http://www.atsdr.cdc.gov /toxprofiles/

ASTDR (USA)

“Toxicological profiles" for hazardous substances found at National Priorities List (NPL) sites

261 tox profiles

Yes Pay fee

Defined parties free

Yes

HSDB http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB

IUCLID http://ecb.jrc.it/existing-chemicals/

IRIS http://www.epa.gov/iris/index.html

MSDS http://www.ilpi.com/msds/index.html

Information such as physical data, toxicity, health effects, first aid, reactivity, storage, disposal

Pay fee Send for Cd-rom

NTP http://ntp-server.niehs.nih.gov/main_ pages/NTP_ALL_STDY_PG.html

Cancer, mutagenicity and repeat-dose data

Free

N-ClassDatabase Environ- mental Hazard Classification

http://www.kemi.se/nclass Nordic Council of MinistersAnd National Chemicals Inspectorate (Sweden)

Environmental hazard classification of general industrial chemicals and active substances in pesticides. Health classification may also be found

7000 substances

Yes FreeNo password

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 1011Hazard data generation and availability: Annex to Report for Forum IV 21 (23)Rev. 11 AnnexOECD Integrated HPV Database

http://cs3-hq.oecd.org/scripts/hpv/ OECD Tracks all High Production Volume (HPV) chemicals through the process of investigation in the OECD programme on the Investigation of Existing Chemicals

RTECS http://www.cdc.gov/niosh/97-119.html

EPA-TSCA

http://www.epa.gov /opptintr/tsca8e/

UNEP SIDS

http://irptc.unep.ch/irptc /sids/sidspub.html

Chemical Substances

http://konsult.prevent.se/ka3ok Prevent, Sweden Substance identification, classification, physical data, toxicology, handling…

11 912 substances

Yes Pay feeSend for Cd-rom

No

AcronymsASTDR Agency for Toxic Substances and Disease RegistryCICADSCOOHS Canadian Centre for Occupational Safety & HealthEHC Environmental Health CriteriaHSDB Hazardous Substances Data BankIPCSIUCLID International Uniform Chemical Information DatabaseINCHEMIRIS Integrated Risk Information SystemWHO World…

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Report for Forum IV 22 (23)Rev. 11

6. What are the roles of industry and governments?

The roles of governments and industry for generating and making available inherent hazard data of industrial chemicals vary among countries or regions and between developed countries and less developed countries. Governments do not usually generate the data on chemicals themselves but rely mainly on the chemical industry to provide the information deemed to be necessary to assure the safe intended use of the chemicals. There are currently several initiatives (see C3 above) designed to generate – and make publicly available – hazard data on high production volume chemicals. The one exception is Japan. Japan has started a 5-year national programme to generate data and assess risks, in addition to industry’s voluntary initiative. Recognizing that Priority for Action A3 is one in a whole program with the common goal of global chemical safety, the FSC proposes the following general guidance to industry and governments:

All stakeholders should be involved in the prioritisation process.

Industry should be responsible for the generation of needed hazard data.

Industry should consider cost sharing. Sharing of test data and the costs of testing is essential to ensure fair competition, otherwise some companies might delay testing in the hope that competitors producing the same substance would test and pick up the full costs. Anybody who generates testing data should be encouraged to share them and anyone who uses such data obliged to pay a fair and equitable contribution to the generator of the data

Industry should consider reducing the use of laboratory animals whenever possible.

Both government and industry should consider endorsing existing formats for summary sheets (e.g., the IPCS Safety Cards) for each chemical geared toward the intended audience (workers, general public, technical audience, etc.);

Both industry and government should use these summary sheets to bring together the relevant hazard information that would provide users with information for future activities.

Need for criteria for some types of classification where countries should classify, as compared to the default where industry does [via a multi-party organisation?] and governments check. Countries also to be judges if diverging views on classification. For substances of global significance: Industry to classify preliminarily, governments to hang on and develop more difficult cases.

[Sweden EDG Accessibility: Enterprises other than manufacturers and importers, e.g. Down Stream Users, should normally be able to rely on the knowledge and assessments submitted to them by their suppliers, provided that their use of a chemical has been considered in the suppliers´ analyses and assessments. Otherwise, the responsibilities of manufacturers and importers will be taken over by the Down Stream User.] [ICCA: Delete Sweden’s comment, premature]

[Sweden EDG Testing: The role, responsibility and accountability of industry (producers, importers and suppliers of chemicals) have to be clearly identified to ensure human-health and environmental safety at a high level of protection.

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IFCS Working Group on Priority for Action A3 2002-10-29 A3 Rev. 11Hazard data generation and availability: Report for Forum IV 23 (23)Rev. 11

Extensive responsibilities should be allocated to the producing/importing enterprises, concerning the generation, assessment and dissemination of knowledge/data on hazardous properties, intended/foreseen uses, emissions and exposure of individual substances. Sufficient knowledge should be available regarding all known/foreseen/significant uses of chemical substances to ensure their safe handling and use, whether handled alone or as constituents in preparations and finished articles. In particular, this requires sufficient information to enable classification and labelling.

The obligation to adhere to this general clause should apply regardless of other specific rules or guidance given in national, regional or subregional legislation. (This general duty to undertake investigations, that are as thorough as necessary in every individual case, will be needed to fully allocate the responsibility of chemical safety to industry. Without such a clause, the full allocation of responsibility to industry will not be clear and investigations, analyses and assessments other than those specifically prescribed or suggested in legislation may be seen as voluntary.) [ICCA: Delete the whole paragraph, concept not sufficiently developed ]

Governments should require industry to establish means of quality assurance of the mentioned information, such as the quality assurance code termed “Good Assessment Practice” proposed in the European Union. [ICCA: delete the part after the comma]. This is to promote public confidence in the process, to mitigate negative effects of foreseeable conflicts of interests, and to ensure that the work carried out by industry will be controllable and has been performed in accordance with current scientific knowledge and proven experience.

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