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U.S. Department of Health and Human Services

About FDA

Chemical Evaluation and Risk Estimation System (CERES)

Description: Initiate development of a chemical evaluation and risk estimation system for pre- and post-market review of food ingredients. The system will enable FDA to fully leverage available data through modern computational and predictive methods for pre-market review as well as post-market monitoring of food ingredients and packaging materials.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Develop Structure Editor

1/31/2010

(3/31/2011)

(6/15/2011)

Completed 5/27/2011

B. Establish list of requirements for CERES

3/30/2010

Completed 2/26/2010

C. Gentox computational tox models

3/30/2010

Completed 3/30/2010

D. Develop high level architecture

6/20/2010

Completed 6/20/2010

E. Carcinogenicity Model developed

7/31/2010

Completed 6/30/2010

F. System Requirements external review completed

8/31/2010

Completed 8/1/2010

G. ToxML and PAFA data migrated

9/30/2010

Completed 10/25/2010

H. Chromosome Aberration Model developed and in testing

9/30/2010

Completed 10/25/2010

I. Carcinogenicity and Chromosome Aberration Model Validated

11/30/2010

Completed 12/23/2010

J. Stand up initial operational version of CERES

12/31/2010

Completed 12/23/2010

K. Completed initial testing

2/28/2011

Completed 2/25/2011

L. Apply models to all authorized food chemicals

3/31/2011

(9/30/2011)

(1/31/2014)

On Track

M. Start operational testing

4/1/2011

Completed 3/15/2011

N. Model validation of repro-dev models scheduled for completion

7/31/2011

Completed 6/15/2011

O. End operational testing

3/31/2012

(9/30/2012)

Completed 9/30/2012

P. Release of CERES Version 1, which is not a fully automated version

3/31/2012

(9/30/2012)

Completed 9/30/2012

Q. Release of CERES Version 1.1, which is a fully automated risk assessment tool

3/31/2013

(1/31/2014)

(8/30/2013)

(1/31/2014)

(8/31/2014)

Not Yet Started

R. Complete Enterprise Performance Life Cycle testing version 1.1

1/31/2014

(8/1/2014)

Not Yet Started

S. Receive authority to operate from Chief Information Officer for version 1.1

4/30/2014

(8/31/2014)

Not Yet Started

Footnotes

  • The dates in italics under the milestone due dates are modified milestone due dates which had to be updated due to real-time delays. The milestone status reflects the revised dates.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.