OFVM Chemical Safety Assessment Review: Report of the CFSAN Working Group
The FDA’s Office of Foods and Veterinary Medicine (OFVM), which encompasses both the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM), must make effective and efficient use of its chemical safety resources, act to ensure the rigor and effectiveness of its chemical safety program responsibilities, and maintain and work to strengthen its national and international leadership role to meet current and future challenges in the field of chemical safety. To help accomplish these goals, OFVM initiated a review of its overall chemical safety assessment program, focusing on the scientific capacity and management of the program's multiple elements across the two centers. The review included:
- Anonymous and confidential interviews of employees involved in all elements of OFVM's chemical safety assessment program;
- Anonymous and confidential interviews with former staff as well as senior managers from other Federal agencies experienced in chemical safety assessment;
- Listening sessions with internal and external stakeholders on OFVM’s overall chemical safety assessment program; and
- Independent review by four outside consultants, who met with OFVM and senior center managers to discuss the materials, providing in four separate consultant reports their own written recommendations for OFVM’s chemical safety program.
Following delivery of the interview, listening session, and consultant reports, CFSAN's center director formed an internal Chemical Safety Working Group to review these documents and directed the group to develop a report identifying the most significant issues arising from the various documents and containing prioritized recommendations for improving the chemical safety program at CFSAN.
The working group submitted its report and recommendations, along with a plan to implement the recommendations. To view these materials, see “Report Contents” below.
It should be noted that the statements made by current or former FDA or other Federal employees, as well as statements by stakeholders and consultants in all the review materials and reports, are the expression of individual views and opinions and do not necessarily reflect the facts or agency policy or guidance, and cannot be construed as official representations of (as examples) statutes or regulations.
Update: September 2014
Since submitting the Chemical Safety Working Group report and recommendations, CFSAN, in partnership with CVM, has taken steps to improve the OFVM chemical safety program, building on its recommendations and in line with requests from Deputy Commissioner of Foods and Veterinary Medicine Michael Taylor, for a unified strategy across the two centers.
- The centers have formed an FVM Chemical Safety Report Implementation Committee to oversee implementation of recommendations from the working group report, independent consultants and listening sessions. The timeline for implementing the recommendations is dependent on the nature of each recommendation. Some are considered “short term,” meaning they can be implemented in 3 to 6 months; some are “intermediate,” meaning they may take 6 to 18 months to implement; and still others are considered “long term,” meaning they will take two or more years to implement.
- CFSAN has formed a steering committee, including CVM representation, to focus on updating and maintaining the currency of the FDA’s Toxicological Principles for the Safety Assessment of Food Ingredients, also known as the “Redbook.” The steering committee will develop a project plan to include how stakeholders will be engaged as revisions of the Redbook are developed.
- CFSAN will be forming a working group (with CVM representation) to update its 2002 Risk Analysis Framework document, which describes the process for identifying, selecting, managing, and conducting major risk assessments by incorporating both best practices and lessons learned. The group will be charged with developing a science-based SOP document for conducting chemical safety and risk assessments, designed to be followed whether cancer or non-cancer risks are being assessed. The science-based SOPs should address, for example, how susceptible populations are to be taken into account, the use of dose-response modeling, average consumer weights used in calculations, and current consumption data for exposure assessment. The working group’s charges will pertain to safety and risk assessments in both centers.
- Report (PDF - 201KB)
- Appendix 1 - Results of Chemical Safety Assessment Personnel Interviews (PDF - 1.2MB)
- Appendix 2 – FDA Foods Program Review of Chemical Safety, Capacity, and Management Report Skeleton (PDF - 936KB)
- Appendix 3 – FDA Foods Program Review of Chemical Safety Capacity and Management: Results of External Interviews (PDF - 738KB)
- Appendix 4 – Results from the Listening Sessions Conducted by CFSAN/CVM/OFVM Conducted as Part of the Chemical Safety Assessment Review (PDF - 93KB)
- Appendix 5 – Consultant Reports
- Constituent Update: FDA Takes Steps to Strengthen Program to Assess the Safety of Chemicals in Foods, Other Products
- OFVM Chemical Safety Assessment Review: Report of the CVM Working Group