On Nov. 10, the U.S. Environmental Protection Agency (EPA) opened a 90-day public comment period on its Draft ORD Staff Handbook for Developing Integrated Risk Information System (IRIS) Assessments. The IRIS program is operated by EPA’s Office of Research and Development (ORD). ORD takes a multidisciplinary and decentralized approach by consulting with multiple organizational divisions. Since the 1980s, IRIS has reviewed the toxicity data on chemicals in commerce and the environment and set hazard benchmarks, including oral reference doses (RfDs), inhalation reference concentrations (RfCs) and cancer potency factors.
IRIS assessments incorporate public input and expert peer review during development. Systematic review principles are implemented to improve the rigor, transparency, and coherence of IRIS assessments. The 280-page draft IRIS Handbook outlines 13 steps and procedures for the program’s staff to develop chemical hazard assessments.
The draft handbook does not supersede existing EPA risk assessment guidelines and does not serve as guidance for other EPA programs. It is intended to be a “living document”; updates will be based on emerging science and experience gained through its application. Ongoing assessments developed with previously established procedures may not reflect all the approaches or procedures as described in the draft handbook.
EPA is accepting comments through Feb. 10, 2021. Comments may be submitted here.
Procedures for Staff Developing IRIS Assessments
The draft IRIS Handbook delineates the 13 steps and procedures for program staff to develop chemical hazard assessments, as follows:
- Scoping of IRIS assessments
- Problem formulation and development of an assessment plan
- Protocol development for IRIS systematic reviews
- Literature search, screening, and inventory
- Refined evaluation plan
- Study evaluation
- Organizing the hazard review: approach to the synthesis of evidence
- Extraction and display of study results of health effects and toxicities from epidemiology and toxicology studies
- Analysis and synthesis of human and experimental animal data
- Analysis and synthesis of mechanistic data
- Evidence integration
- Hazard considerations and study selection for deriving toxicity values
- Derivation of toxicity values
Notably, the IRIS Handbook implements recommendations and input from the National Academy of Sciences, Engineering and Medicine, EPA agency reviewers, other federal agencies, EPA’s Science Advisory Board, and workshops involving input from experts in systematic review.
IRIS Assessments Role in Risk Assessment
Risk assessment is a four-step process described by the National Research Council in 1983 as “the characterization of the potential adverse health effects of human exposures to environmental hazards.” Characterizing risk involves integrating information on hazard, dose-response, and exposure into a risk characterization.
An IRIS assessment includes the first two steps of the risk assessment process:
- Hazard identification, which identifies credible health hazards associated with exposure to a chemical, and
- Dose-response assessment, which characterizes the quantitative relationship between chemical exposure and each credible health hazard. These quantitative relationships are then used to derive toxicity values.
EPA’s program and regional offices identify human exposure pathways and estimate the amount of human exposure under different exposure scenarios (exposure assessment). Then they combine their exposure assessment with the hazard information and toxicity values from IRIS to characterize potential public health risks (risk characterization).
Contact ACA’s Riaz Zaman or Scott Braithwaite for more information.
The post EPA Seeks Comment on Draft Handbook for the Integrated Risk Information System (IRIS) appeared first on American Coatings Association.
from American Coatings Association https://www.paint.org/iris/
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