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Risk Assessments
TERA scientists combine a practitioner’s knowledge of the issues and pitfalls involved in the development of human health risk assessments, together with cutting-edge toxicology expertise, to develop state-of-the-science assessments. Our research, aimed at improving risk assessment methods particularly in the areas of dose-response and mode of action, further enhance our analyses. In solving risk problems for a diverse array of government and private sponsors, we apply a collaborative philosophy that emphasizes partnership building, allowing us to expand our pool of expertise, build on multiple perspectives, and ensure the use of the best science. These strengths form the basis for our development of independent and science-driven analyses for a range of risk assessment products such as screening-level assessments, dossiers for HPV and REACH, occupational assessments, and in-depth evaluations considering mechanistic data and using sophisticated modeling techniques.

Risk Examples

Toxicology Reviews

TERA staff have developed comprehensive toxicological reviews and risk assessments.  The following is a list of project examples for this area.

Selected Assessments  

  • Trichloroethylene (TCE) science peer consultation.
  •  Cyanide IRIS Toxicological Support Document is being drafted for U.S. EPA.
  • Soluble Nickel Salts IRIS Toxicological Support Document.
  • TERA supports risk value development for perchlorate.
  • Ammonium Perflourooctanoate Provisional Risk Values developed through peer consultation process for the State of West Virginia.
  • Draft Tetrahydrofuran IRIS Toxicological Support Document developed for private sponsor in coordination with EPA OPPTS.
  • Phenol IRIS Toxicological Support Document loaded on IRIS.
  • Atrazine Drinking Water Criteria Document being developed for EPA OW.
  • Drinking Water Criteria Documents being developed for several Drinking Water Disinfection By-products for EPA OW.

Screening Assessments

Information needs vary with the complexity of the risk management decisions to be made. Screening level assessments are an important component of proactive risk assessment for evaluating the need for more data collection, in setting priorities for more detailed evaluations, and for comparative risk ranking. 

Click here for an information sheet that describes our array of capabilities for screening level risk assessment and hazard ranking methods. 

The following are examples projects for this area. 

  • Provide toxicology and risk methods support for chemical assessment under Health Canada’s Domestic Substances List program.
  • Sustainable Futures.  Under subcontract with the U.S. EPA, provide screening level hazard assessments for non-cancer toxicity for new chemicals under pollution prevention initiatives. 
  • Screening Levels.  For a private sponsor, evaluate available toxicology data and develop equipment cleaning validation limits and screening levels for pharmaceutical ingredients.
  • For EPA-OW, participate in a project to implement a screening assessment strategy to identify priority water contaminants.
  • TERA develops methods to conduct screening assessments for the use of chemicals newly introduced to company operations, and provides comprehensive support in hazard ranking and screening.  

Product/Site Assessment

TERA provides integrated toxicology support for product safety evaluation and characterization of environmental site-related risks through our extensive network of international experts in exposure modeling.  

  • A risk communication document was developed on bromate for the International Bottled Water Association.
  • An evaluation of potential health risks from chronic exposure to emissions of Toxic Release Inventory Chemicals from power plants was conducted for Cinergy.
  • The potential for adverse effects associated with candle emissions was investigated.  Emission profiles and exposure estimates were compared to existing benchmarks to assess potential health risks associated with individual materials and the mixture of emission products.
  • An evaluation of potential risk associated with mercury exposure from breakage of compact fluorescent light bulbs was completed in collaboration with the New Zealand Ministry of Health.

Corporate Info

Resources

Our Brands

  • ITER ITER

Contacts

  • 1250 Ohio Pike, Suite 197, Cincinnati Ohio 45102
  • 513.488.1990
  • TERA@TERA.ORG

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WEEL OEL

Occupational Exposure Limits (OELs) are designed to safeguard the health of healthy workers during their careers. These limits are based on the assumption of repeated daily exposure throughout a working lifetime, typically averaged over an 8-hour workday. Their purpose is to prevent both immediate (acute) and long-term (chronic) health issues arising from workplace exposures. It’s important to note that OELs are not intended for the general public, which includes vulnerable groups like infants, the elderly, and those with pre-existing health conditions.

Workplace Environmental Exposure Levels (WEELs) are health-based guidelines for chemical hazards in the workplace. These values represent air concentrations believed to protect the majority of workers from negative health effects resulting from occupational chemical exposure.

The WEEL Process
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The development of new or revision of existing WEELs is typically assigned to voluntarily designated subcommittees. A subcommittee usually comprises 3 – 4 members from the WEEL Committee. New WEELs are developed using the OARS-WEEL administrative standard operating procedure (SOP), while existing WEELs are usually revised every 10 years, unless the availability of significant new data which may impact the existing WEEL value compels the committee to make a revision sooner. The OARS-WEEL SOP contains procedures and guidelines governing conflicts of interest, draft document preparation, literature searches, draft document review, balloting process, post-ballot WEEL documentation quality assurance scientific review, and publication.

Once a subcommittee has prepared a draft WEEL document, a review of the draft is scheduled for the next available Committee meeting. The WEEL Committee members are expected to have reviewed all such drafts prior to the meeting. If no major changes are necessary to a draft, the attending Committee membership may, by a simple majority, approve the WEEL for balloting. Alternatively, the Committee may direct the subcommittee to revise the WEEL and present it for further discussion at a future meeting. If a ballot is not approved by a two-thirds majority of non-abstaining Committee members, it is discussed at the next Committee meeting to determine the appropriate course of action. Once the WEEL is approved by a two-thirds majority of non-abstaining Committee members, copies of ballot comments are forwarded to the designated subcommittee and all substantive comments must be addressed in the final draft. If resolution of a substantive comment results in a change to the WEEL value or a change in the basis for the value, the draft must be re-balloted.

Once all comments have been addressed on a successfully balloted draft, document formatting and editorial review are performed by TERA, before the draft WEEL document is made available for public comment (usually for a period of 30 days but may be extended if the need arises). After the public comment period has elapsed, comments are addressed by the subcommittee responsible for that specific draft, after which the WEEL documentation is submitted to Toxicology and Industrial Health (TIH), a peer-reviewed medical journal that covers research in the fields of occupational health and toxicology, for publication. A thorough review of the galley proof by the scientific content quality coordinator at TERA, and proofreaders and editors at TIH is the penultimate step before eventual publication of the WEEL documentation.

The WEEL Committee

The OARS-WEEL Committee is composed of volunteer experts specializing in the scientific determination of occupational exposure levels. This committee actively seeks a balanced representation of professionals from toxicology and industrial hygiene, drawing upon a diverse range of experience from industry, government, academia, and consulting. Importantly, each member contributes to the Committee based on their individual expertise and not as an official representative of their respective employer, organization, or agency.