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Airborne Partciualtes

The REACH (Registration, Evaluation, and Authorization of CHemicals) regulation is significantly impacting chemical manufacturers and importers, requiring them to disclose downstream user information, publish detailed toxicological data, and conduct thorough health risk assessments for chemicals along the entire life cycle from production and use to recycling and disposal.

ChemRisk®'s REACH services include:

  • Dossier preparation and data management
  • Only representative
  • Registration
  • Completion of Chemical Safety Reports
  • Human and environmental risk assessment
Dossier preparation & data management/ Only representative
Through our partner REACHLaw Ltd. Helsinki, Finland, we are in the position to offer Only Representative (OR) services to US manufacturers under REACH, independently from other actors in the supply chain. ChemRisk® supports the collection of data for registration from the customer, and can assist with development of scientific information to be used in registration (including toxicology studies, and exposure characterization). The OR service package includes all registration services, notably pre-registration of phase-in substances, representation in pre-SIEF, SIEF and Consortia and preparation and submission of registration. Customer benefits: Protect your confidential business information, enable you to concentrate on your core business, and comply with minimal effort.

Registration
Together with our partner REACHLaw Ltd. in Helsinki Finland, we manage registration under REACH for US-headquartered manufacturers. Depending on the companies’ specific needs, REACHLaw Ltd. can either act as an Only Representative (OR) or support their EU subsidiaries as registrants in REACH (pre-)registration, whereas ChemRisk® supports the collection of data for (pre-)registration from the customer and provides risk assessment and toxicology support as needed. For EU subsidiaries, an initial risk analysis can be conducted to identify the associated risks and liabilities. Customer benefit: Access to leading expertise in the United States, coupled with strong support in the EU.

Completion of Chemical Safety Reports
ChemRisk®’s true strength lies in our technical expertise with all aspects of conducting Chemical Safety Assessments (CSAs) to be included in the Chemical Safety Report (CSR). For each chemical manufactured or imported into the EU in quantities greater than 10 metric tons per year, a CSA must be prepared by the manufacturer or importer and this assessment must be documented in the registrant’s CSR as part of the registration dossier. The CSR is a compilation of the hazard and exposure assessments and risk characterization conducted for each chemical in order to identify appropriate risk management measures (RMMs). ChemRisk®’s experience in each of these areas is extensive and described in the following sections.

REACH - Hazard Assessment
Hazard assessments performed in accordance with the REACH require an evidence- based approach which is reliable, robust and transparent. ChemRisk® has over 20 years of experience in conducting hazard assessments for chemicals including metals, VOCs and those classified as persistent, bioaccumulative and toxic (PBT). Our experience allows us to quickly and accurately identify key toxicology studies of relevant health endpoints as well as assess additional studies appropriate for inclusion in a “weight of evidence” discussion. We are proficient with IUCLID software having entered data and utilized the software for multiple assessments. Through assessment of physiochemical properties, we have classified and labeled chemicals in terms of their potential to be hazardous to human health and the environment. Further, where necessary, we have conducted research to fill data gaps related to dose response and health endpoints in order to calculate predicted no-effect concentrations (PNECs). Our experience has shown that transparent and clearly documented hazard assessments greatly increase the likelihood of prompt regulatory and stakeholder consensus and are a key factor in efficient finalization of reviews.

REACH - Exposure Assessment
The broad range of exposure scenarios required under REACH include the registrant’s own industrial or professional use and all identified uses of the substance alone or in a preparation in the supply chain. For over 20 years, ChemRisk® scientists have developed comprehensive exposure scenarios that address the full range of media (air, water, soil and sediment), target groups (vulnerable sub-populations including children and pregnant women, consumers and workers) and routes of exposure (oral, inhalation, and dermal) required under REACH. We have published over 200 papers describing methodologies for the use of models, empirical data, simulation studies or surveys to characterize exposures attributable to the workplace, indoor and outdoor ambient environment, articles and other consumer products. Our extensive experience allows us to make realistic predictions of exposures for chemicals that have complex and multiple sources of exposure through analysis of the available data and the latest research in the field of exposure assessment.

REACH - Risk Characterization
Under the constructs of REACH, a risk characterization is required to understand the risks associated with each exposure scenario identified for a given chemical. ChemRisk®, through a rich history in risk assessment, has a wealth of experience in characterizing risks associated with a wide variety of chemicals, preparations, or articles in both humans and environmental compartments. In addition to our practice in risk assessment from a traditional standpoint, we also have the tools and experience available to initiate the biomonitoring-based risk characterization. ChemRisk®’s familiarity with both qualitative and quantitative risk assessment lends itself well to characterizing risks according to the REACH guidelines. In the past, ChemRisk® has conducted complicated risk assessments similar to those required under REACH for chemicals or preparations, resulting in quantitative estimates of human health risks for both workers and the general population, and ecological receptors. In addition, ChemRisk® has also had the opportunity to qualitatively determine the risks associated with the use of a variety of products, including whole article assessments for which no screening criteria typically exist.

Some of our relevant project experience with REACH includes:
  • Currently assisting the tire industry with exposure scenario development for each of the relevant life stages including formulation and industrial use, service life and end of life. Evaluation includes review of emissions factors and completion of example Tier 1 modeling assessments.
  • Created and performed a compliance exercise for the manufacturer of a polymer sheet to determine the status of their product as an article in accordance with REACH guidelines and to determine their potential REACH obligations.
  • Built a training module used by large chemical company to train their employees on the requirements for REACH

ChemRisk® Publications

  • Williams, E.S., Panko, J. and D.J. Paustenbach. 2009. The European Union’s REACH Regulation: A review of its history and requirements. Crit Rev Toxicol. 39(7):553-75.

  • Paustenbach, D.J. 1997. Methods for setting limits for acute and chronic toxic ambient air contaminants. Appl Occup Environ Hyg. 12(6):418-28.

  • Paustenbach, D.J., R.D. Bass, and P. Price. 1993. Benzene toxicity and risk assessment, 1972-1992: implications for future regulation. Environ Health Perspect. 101(6):177-200.

  • Paustenbach, D.J., G.P. Carlson, J.E. Christian, and G.S. Born. 1986. A comparative study of the pharmacokinetics of carbon tetrachloride in the rat following repeated inhalation exposures of 8 and 11.5 hr/day. Fundam Appl Toxicol. 6:484-97.

  • Finley, B. and D. Paustenbach. 1994. The benefits of probabilistic exposure assessment: three case studies involving contaminated air, water, and soil. Risk Anal. 14(1):53-73.

  • Finley, B.L., D.M. Proctor, P. Scott, N.W. Harrington, D.J. Paustenbach, and P.S. Price. 1994. Recommended distributions for exposure factors frequently used in health risk assessment. Risk Anal. 14(4):533-53.

  • Gaffney, S.H., E.C. Moody, M.A. McKinley, J.S. Knutsen, A.K. Madl, and D.J. Paustenbach. 2008. Worker exposure to methanol vapors during cleaning of semiconductor wafers in a manufacturing setting. J Occup Environ Hyg. 5:313-24.

  • Madl, A.K. and D.J. Paustenbach. 2002. Airborne concentrations of benzene and mineral spirits (stoddard solvent) during cleaning of a locomotive generator and traction motor. J Toxicol Environ Health A. 65(23):1965-79.

  • Paustenbach, D.J., J.M. Panko, P.K. Scott and K. M. Unice. 2006. A methodology for estimating human exposure to perfluorooctanoic acid (PFOA): A retrospective exposure assessment of a community (1951-2003). J Toxicol Environ Health. 70:28-57.

  • Paustenbach, D.J. 2000. The practice of exposure assessment: A state-of-the-art review. J Toxicol Environ Health B Crit Rev. 3(3):179-291.

  • Price, P.S., P.K. Scott, N.D. Wilson, and D.J. Paustenbach. 1998. An empirical approach to deriving information on total duration of exposure from information on historical exposure. Risk Anal. 18(5):611-9.

  • Williams, P.R.D., J.M Panko, K. Unice J.L. Brown, and D.J. Paustenbach. 2008. Occupational exposures associated with petroleum-derived products containing trace levels of benzene. J Occup Environ Hyg. 5(9):565-574.

  • Williams, P.R.D., K. Holicky, and D.J. Paustenbach. 2003. Current methods for evaluating children’s exposures for use in health risk assessment. J Children’s Health. 1(1):41-98.

  • Williams, P.R.D., P.K. Scott, P.J. Sheehan, and D.J. Paustenbach. 2000. A probabilistic assessment of household exposures to MTBE from drinking water. Hum Ecol Risk Assess. 6:827-49.

  • Finley, B.L. and D.J. Paustenbach. 1997. Using applied research to reduce uncertainty in health risks assessment: five case studies involving human exposure to chromium in soil and groundwater. J Soil Contam. 6(6):649-705.

  • Finley, B.L., K.R. Trowbridge, S. Burton, D.M. Proctor, J.M. Panko, and D.J. Paustenbach. 1997. Preliminary assessment of PCB risks to human and ecological health in the lower Passaic River. J Toxicol Environ Health. 52(2):95-118.

  • Haws, L.C., J.A. Tachovsky, E.S. Williams, L.L.F. Scott, D.J. Paustenbach, and M.A. Harris. 2008. Assessment of potential human health risks posed by benzene in beverages. J Food Sci. 73(4):T33-41.

  • Leung, H.W. and D.J. Paustenbach. 1995. Physiologically based pharmacokinetic and pharmacodynamic modeling in health risk assessment and characterization of hazardous substances. Toxicol Lett. 79:55-65.

  • Sweet, L.I. and B. Strohm. 2006. Nanotechnology -- Life Cycle Risk Management. Human & Ecological Risk Assessment, 12(3):528-551. Special Edition “Linkages between Risk and Life Cycle Assessment”. June.

  • Wilson, N.D., P.S. Price, and D.J. Paustenbach. 2001. An event-by-event probabilistic methodology for assessing the health risks of persistent chemicals in fish: a case study at the Palos Verdes Shelf. J Toxicol Environ Health. 62(8):595-642.

  • Williams, P.R.D. and D.J. Paustenbach. 2002. Risk characterization: principles and practice. J Toxicol Environ Health B Crit Rev. 5(4):337-406.

For Additional information, please contact Britt McAtee at bmcatee@chemrisk.com.com; (412) 281-6900, ext. 1026


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