Updates and history

 

The OECD Harmonised Templates for Reporting Chemical Test Summaries (OHTs) are regularly updated and completed to cover new or revised Test Guidelines, fulfil requests for improvement from users, and extend their functionalities following information technology and chemical testing developments. 

UPDATES OF THE OECD HARMONISED TEMPLATES 

  • Changes made to all OHTs in December 2018 for update and alignment with the IUCLID 6.3 characteristics (more details in the History section below), compared to their previous version (July 2016), are available in a xls file HERE. The file also contains the migration rules, made available for the first time on the public website.
  • The major revision of the OHTs published in July 2016 resulted from a two-year work aiming to improve the templates and align them with IUCLID 6 characteristics (read the History section below). Changes are detailed in the following documents collated in a zip file: 2016-2015 OHTs major update and revision.
  • Changes brought to OHTs from 2011 to 2014, including new OHTs added to the existing Series, are available at: 2011-2014 OHTs Update Overview (Excel file).

Process for developing/revising the OECD Harmonised Templates

The draft new or revised templates undergo a thorough review process before their publication:

  1. Pre-draft (new or revised) documents are usually developed in Word format by an Ad hoc group of experts and specialists of the test guidelines and endpoint to be covered by the template. This development is co-ordinated by the OECD Secretariat. 
  2. Draft documents are circulated to the OHT Expert Group, as well as other OECD Working Parties where relevant, for comments and suggestions under written procedure. 
  3. Comments received from national authorities, industry experts and observer organisations, are taken into consideration by the Ad hoc group and the OECD Secretariat as far as possible for finalising the draft templates. Depending on the nature and the extent of the changes brought to the initial drafts, further round(s) of comments by the OHT Expert Group might be necessary. 
  4. (Final) draft templates are submitted to the OECD Joint Meeting for comments and endorsement under written procedure. 
  5. After the deadline and pending Joint Meeting agreement, the new or revised OHTs are then published on the OECD Website.

Brief history of the OECD Harmonised Templates development

December 2018: The full set of OHTs was updated by ECHA and OECD for a range of improvements and format changes, and aligning them with new characteristics of IUCLID 6.3 launched in October 2018. In particular, a new field ‘Confidential details on test material’ was added to the Test material information section of each template. Technical improvements were brought to OHT 53 Toxicity to soil microorganisms, OHT 78 Specific investigations: other studies, and OHT 90 Emissions from preservative-treated wood. The Series of OHTs 303 to 306 on Use and Exposure Information was updated for aligning the ‘Article categories’, ‘product codes’ and ‘Technical function’ with internationally-harmonised categories. A new OHT 401 on Dispersion stability of nanomaterials was added to the Environmental fate and behaviour Series (previously named ‘Degradation and accumulation’ Series).

August 2018: Update of 4 OHTs in the Series on Health Effects and 1 OHT in the Series on Effects on Biotic Systems.

December 2017: Update of 4 OHTs in the Series on Effects on Biotic Systems and 5 OHTS in the Series on Health Effects.

September 2017: Update and extension of the Series of OHTs on pesticide residue chemistry. The Series was re-organised (residues in crops and in rotational crops grouped in single files) and completed with new templates on the nature, magnitude and stability of residues in commodities. The OHTs on the metabolism in livestock and in crops/rotational crops were harmonised with corresponding MetaPath Study Summary Composers. Updates included also the addition of repeatable fields to capture (new) data reporting tables, and elements to cover the EU Biocidal Product Regulations. Some predefined tables and executive summaries were revised or added.

August 2016:  Major update of all OHTs. From 2014 to 2016, OECD and ECHA implemented a general revision process aiming to improve the whole set of templates and align then with the new characteristics of IUCLID 6 (that was launched in April 2016). Taking into account comments from users over the past years, the templates were modified in consultation with the relevant OECD expert groups. This revision provided major improvements by allowing cross-check between OHTs and harmonising elements, simplifying the template presentation and content, making them easier to use and to update in future. When publishing the full Series of revised OHTs, the website was also renovated to facilitate the access and use of the information: new presentation by OHT Series, increased use of zip files to group previous documents wherever possible, and new function linking each OECD Test Guideline covered by the OHTs to access its corresponding publication page on OECD iLibrary. A new OHT on in vivo endocrine disrupter testing in aquatic vertebrates, and 4 new OHTs on physico-chemical properties were added, together with new types of templates: OHT 201 on intermediate effects (non-apical observations during testing), and OHTs 301 to 306 to report information on the use of and exposure to chemicals. The documents showing the modifications brought to the OHTs (both in track-changed and cleared versions) and approved by the Joint Meeting in February 2015 and then July 2015 for additional changes, are collated in a zip file: 2016-2015 OHTs major update and revision.

Examples of templates that were developed and added to the evolving OHT website in previous years:

2013: Addition of 13 OHTs on physico-chemical properties specific to nanomaterials

2012: First OHT of the Series on emissions from treated articles (preservative-treated wood)

2010: Website re-organised for making available all templates with their related material and report the OECD Test Guidelines they cover (1 page per OHT)

2008: First set of OHTs on pesticide residues

2006: A set of 87 templates developed by the OECD Secretariat (on 86 endpoints or physico-chemical properties, and 1 on generic fields) was agreed by the OECD Joint Meeting and published on the OECD website. When defining the pieces of information of the templates, i.e. fields including context-sensitive help texts and picklists, a number of existing national/regional test guidelines and/or templates were taken into account, particularly:

  • OECD Test guidelines
  • NAFTA Pesticides: Evaluation templates for reviewing the scientific studies that are submitted to support applications to register pest control products in Canada and the United States
  • Templates drafted by the Working Group Data Submission Formats "Biocides and Beyond", which was established by the German Federal Environmental Agency (UBA) jointly with the European Chemicals Bureau (ECB) (Final drafts dated 17 May 2004)
  • WORD proformas provided in the Technical Notes for Guidance (TNsG) on Preparation of Dossiers and Study Evaluation under Directive 98/8/EC
  • IUCLID 4: The previous system in the EU for data entry of electronic submission of summaries of test results under the EU Existing Substances regulation and the OECD High Production Volume (HPV) Chemicals Programme
  • OECD HPV ExChem: Templates for compiling robust study summaries for submission to the OECD HPV Chemicals Programme
  • EU/New Chemicals: SNIF - Data entry screens for electronic notification of summaries on new chemicals substances

 

2004: The OECD Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology established the OECD Expert Group on Harmonising Templates which 1) reviewed the existing templates and 2) selected four endpoints representing the major areas of testing: human health, eco-toxicity and environmental fate. The first four OECD Templates were developed and agreed, covering endpoints for skin irritation, hydrolysis, repeat dose toxicity (oral) and fish acute toxicity, as well as a template grouping all generic fields (i.e. fields which occur in almost all the templates). It was also agreed to develop other templates on the remaining endpoints, with a focus on the most important ones for regulatory decisions, and to recommend the use the five existing templates as the starting point.

2003: The OECD Secretariat conducted a survey with member countries and observer Organisations on already-existing templates for chemical study reporting developed by other bodies. 

October 2002: The OECD Workshop on Electronic Tools for Data Submission, Evaluation and Exchange for the Regulation of New and Existing Industrial Chemicals, Agricultural Pesticides and Biocides recommended for the OECD to support harmonisation where possible in the reporting of chemical test results, by the use of templates and XML tags.

 

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