Regulatory Compliance - Federal Regulations
IB's partners have assisted clients in navigating Federal regulations:
Using the unique pharmacokinetics of metals, developed risk values for exposures to a series of metal compounds including lead, mercury, cadmium, and zinc.
Critically examined and used the biokinetic model for predicting blood levels and clean-up levels for lead in various media for a variety of projects.
Working with industry sectors and a major trade association, developed a strategic response to the Food Quality and Protection Act (FQPA), particularly technical issues such as aggregate exposures, cumulative risk via common modes of action, and default safety factors to distinguish between susceptibility of adult and perinatal receptors. Strategic response included preparation of white papers on specific technical issues, participation in round-table discussions with representatives of registrants and end-users of pesticides; rapporteur at public meetings; meetings with Congressional staff; discussions with legal counsel.
Prepared MSDS sheets for several small companies developing novel chemicals for use in a variety of chemical processes. The work also involved characterization of both the chemical and toxicological properties of the compound through design of standard tests.
Prepared and presented the first Margin-of-Exposure risk characterization submitted to USEPA for dioxin-like compounds.
Organized and managed a series of expert panels to provide peer-review of USEPA's reassessment of the potential human health hazards resulting from exposures to dioxin-like chemicals. Tasks included panelist identification, recruitment, preparation of draft comments to the Agency, and preparation of manuscripts submitted to the peer-reviewed literature based on the outcomes of panel deliberations.
Reviewed, critically evaluated, and summarized data on the toxic effects, background exposure levels, and risks associated with exposure to a broad range of environmental contaminants in environmental media. Much of this work was done in the context of Superfund risk assessments or state-specific regulations governing hazardous waste.
Reviewed water criteria documents for state and federal jurisdictions for a paper and pulp manufacturer. Chemicals considered included metals, chlorinated organics, biological effluents.
Provided training to environmental managers within a large petrochemical company covering all of the major USEPA regulatory initiatives.
Performed risk assessments for consumer products containing trace quantities of heavy metals and represented the companies before CPSC.