Ecotoxicology – TERA

Ecotoxicology

Our unique non-profit status and scientific neutrality have allowed us to achieve an equally strong reputation across the public sector, including international, federal, state, and municipal government agencies. TERA often partners with other private consulting firms, governmental agencies, and non-profit NGO's on large-scale health and environmental research and regulatory programs.

Aquatic and Terrestrial Ecotoxicology and Risk Assessment, including: Aquatic Bioavailability Assessment; Environmental Fate and Transport (PBT Assessment), and Exposure Determination
Broad Experience with Diverse Chemistries: Commodity, Specialty, and Consumer Product Ingredients; Agrochemicals Actives and Inerts; Pharmaceutical Actives; Industrial Wastes, Mixtures, and By-Products
Literature Review; Data analysis; Database Development and Management
Product Development / Product Stewardship Support
Green Chemistry and Sustainability Assessments of New Chemicals and Products
Chemical Hazard Ranking and Scoring for Green Certification and Design for Environment

Technical Public Relations Communications of Chemical Safety Information for Consumers and Suppliers
Expert Peer Review and Peer Consultation of Chemical Safety Profiles
Industrial Site Cleanup Management
Environmental Study Placement and Management at Testing Laboratories
Regulatory Compliance Services
Strategic Regulatory Consultations on Chemical Issues Management
Data Readiness Evaluation and Gap Analysis for Chemical Registrations
Chemical Classification and Labeling for Safety Data Sheets for OSHA, GHS, and CLP Compliance
Dossier Preparation for TSCA PMNs and SNURs, Pharmaceutical and Pesticide Registrations
Cleanup and Compliance Standards for New and Existing Chemicals

For more information on our Ecotoxicology or Ecological Risk Assessment Program, please contact Michael Dourson at 513-542-7475 x 105 or dourson@TERA.org.

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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.