Vol. 9, No. 1 (December 2004) – Preface
The Health and Environmental Risk Assessment (HERA) of LAS
Today, both regulators and the general public rightly demand greater transparency of hazard assessment data on chemicals, including information on the potential risks posed by the ingredients of products used in the home. There is now a call for these data to be published, so that the need for more information, if required, can be debated in public.
Recognizing these societal concerns, a unique European partnership between the makers of household cleaning products (AISE)1 and the chemical industry (Cefic)2 that supplies the raw materials was launched in 1999 to carry out human and environmental risk assessments on ingredients of household cleaning products (HERA). This is a voluntary initiative that aims to demonstrate, in an open and transparent way, that it is possible to effectively deliver risk assessments of chemicals used in household products using existing data and a common risk assessment framework.
The HERA process is intended to support a risk-based approach to proposed legislation on chemicals in the European Union, and may serve as a pilot for the application of the same process in other industries and/or geographical areas.
HERA provides a more in-depth assessment than either the Organization for Economic Cooperation and Development (OECD)3 high production volume (HPV) chemical assessment program4 or the U.S. Environmental Protection Agency (EPA) HPV Challenge Program. The OECD program is primarily a hazard assessment in which only minimal exposure information is required, although additional exposure information may be provided.5 The U.S. EPA HPV Program is primarily an assessment of available hazard data, although in this case as well, exposure information may be provided.6 In contrast, HERA requires human and environmental exposure assessments, since these are essential for risk assessments.
HERA is similar to the OECD and EPA HPV programs in that formal guidance documents have been prepared – and are available on the Internet – describing the procedures used to assess substances in these programs. For instance, the HERA methodology is fully described in a guidance document available at the HERA website ( www.heraproject.com) and is based on the European Union’s Technical Guidance Document on risk assessment.
HERA, like the OECD and EPA HPV assessment programs, includes a review process to ensure independent expert review. For HERA, a substance team consisting of supplier and downstream user experts prepares the assessment, which is posted on the HERA website for public comment. The assessment is then reviewed by an independent expert panel of scientists and the revised assessment is posted to the HERA website for further public comment and review.
The HERA expert panel is headed by a distinguished professor who also chairs the European Union Task Force on Risk Assessment Procedures. Other members of the panel hold professorships at universities in Belgium, Italy, the Netherlands and the United Kingdom.
Because of the open-ended public review period, no HERA document can be considered “final” because it is still open for additional public comment and updating based on new research.7
These formalized assessment procedures and outside expert review processes ensure that the public can have high confidence in the documents that are produced.
Because of the importance of these documents, we are very pleased to include in this issue the entire HERA LAS risk assessment document, version 2.0. This version of the LAS HERA has been revised and updated from the preliminary version posted for public comment to the HERA website in July 2002. The updated version takes account public comments and comments from the external advisory panel on both the environmental and human health aspects of the assessment.
The HERA risk assessment of LAS was produced by a substance team consisting of manufacturers of LAB/LAS (ECOSOL)8 and a representative of downstream users. The LAS substance team also acknowledges the assistance of the members of the HERA Human Health9 and Environmental10 task forces and the Industry Coalition for the EPA-OECD SIDS Assessment of LAS.11
The risk assessment includes a characterization of LAS, environmental and human health assessments and a risk assessment as well as an executive summary. The environmental assessment concludes that LAS is safe for man and the environment.
Based on the rigorous assessment procedures used, the extensive array of expertise involved in producing the documents and the outside review process, the public can indeed have high confidence in the conclusions from this assessment.
John E. Heinze, Ph.D.
1. Association Internationale de la Savonnerie, de la Détergence et des Produits d’Éntretien (International Association for Soaps, Detergents & Maintenance Products)
2. European Chemical Industry Council
3. OECD’s 30 member countries include: Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Korea, Luxembourg, Mexico, the Netherlands, New Zealand, Norway, Poland, Portugal, the Slovak Republic, Spain, Sweden, Switzerland, Turkey, the United Kingdom and the United States
4. The OECD program is called the SIDS program for the Screening Information Data Set (SIDS) that comprises the dossier of information required for each assessment
5. The SIDS assessment of linear alkylbenzene (LAB) was accepted by OECD in 1995 and the assessment documents revised in 2002. A link to the combined documents may be found on the OECD website by going to the SIDS Information homepage ( http://cs3-hq.oecd.org/scripts/hpv/Index.asp) and searching for CAS number 123013, one of the numbers for LAB. Clicking on the entry found by the search (“Benzene, dodecyl-“), leads to an information page on LAB.
6. A HPV Challenge Program assessment of LAB sulfonic acids, intermediates in the production of LAS, may be found at http://www.epa.gov/chemrtk/linalkbz/c14485tc.htm.
7. See for instance the Zeolite A assessment on the HERA website at http://www.heraproject.com/RiskAssessment.cfm
8. ECOSOL is the European Council on Studies on LAB-LAS, a Cefic sector group formed by Petresa, Sasol Italy and Wibarco. See www.lasinfo.org.
9. BASF, Bayer, CIBA, Clariant, Colgate-Palmolive, Degussa-Hüls, Henkel, McBride, Procter & Gamble, Eurocor, Shell Chemicals, Unilever.
10. AISE, BASF, CIBA Specialty Chemicals, Clariant, Dow Corning, Henkel, Petresa, Proctor & Gamble, Eurocor, Rhodia, Sasol Germany, Sasol Italy, Shell Chemicals, Solutia Services International, Solvay, Unilever.
11. CLETSA, Cognis, Colgate, Dial, Huntsman, Kao, Lion, Mitsubishi Chemicals, Nippon Petrochemical, Petresa, Procter & Gamble, Quimica Venoco, Repsol YPF, Sasol North America, Stepan, Tayca, Unilever, assisted by Compliance Services International and John Adams Associates.