About FDA
BPA Data Gap Analysis
Description: Evaluate BPA in rodent models to address data gaps related to potential low dose effects that have been identified by FDA/CFSAN and NTP. This analysis will help FDA assess the toxicities associated with exposure to BPA, a component in baby bottles and formula and food/water containers, and determine the appropriate safety levels for humans. This study is supported by an interagency agreement between NIEHS/NTP and FDA to support studies of mutual benefit to FDA and NIEHS/NIH.
Definition: BPA is primarily used to make plastic bottles and metal-based food and beverage cans and is an endocrine disruptor which can mimic the body’s own hormones and may lead to negative health effects. Safety levels for humans are currently under review. It appears that greatest sensitivity to BPA is in early development. A reevaluation of the safety of BPA in light of recent research (which suggests adverse effects at lower levels than previously indicated) will contribute to the development and initiation of approved protocols.
Public Health Outcome: These data will address current controversies in the risk assessment of BPA. A major goal of the study is to provide a basis to initiate interaction among FDA, NTP, and academic scientists in a follow-up 2 year study to incorporate endpoints that may improve future evaluations of endocrine active agents.
Briefing Status: ON TRACK
Prior Briefing Status: ON TRACK
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
1. Protocol concept reviewed by the TSSRC |
11/1/2009 |
Completed | 11/1/2009 |
|
2. Develop protocol and complete the peer review (1) |
3/1/2010 |
Completed | 3/1/2010 |
|
3. Obtain NCTR approval on the protocol |
6/1/2010 |
Completed | 6/1/2010 |
|
4. Begin research |
6/1/2010 |
Completed | 6/1/2010 |
|
5. Complete the assessment of research findings |
10/1/2011 (TBD) |
On Track | |
|
6. Develop draft technical report, manuscript, and/or publication (2) |
12/1/2011 (TBD) |
On Track | |
|
7. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication |
1/1/2012 (TBD) |
On Track | |
|
8. Submit the draft technical report, manuscript, and/or publication to the document tracking system for NCTR Center Director approval |
3/1/2012 (TBD) |
Not Yet Started | |
|
9. Obtain final approval of the technical report, manuscript, and/or publication |
TBD |
Not Yet Started | |
|
10. Submit final technical report, manuscript, and/or publication to a scientific journal |
6/1/2012 (TBD) |
Not Yet Started | |
|
11. Publish final technical report, manuscript, and/or publication |
10/1/2012 (TBD) |
Not Yet Started |
Footnotes
- (1) This protocol will evaluate a broad range of BPA doses in rodents treated orally during pregnancy followed by direct oral dosing of pups until they are young adults (90 days of age). The results of the study will be used to select doses for a long-term study (chronic study) that will evaluate effects into old age. In the current study, a variety of endpoints related to reproductive development, control of energy utilization (that is fat deposition), and general toxicity are being evaluated. The subsequent chronic study will involve collaboration with academic laboratories.
- (2) Manuscripts published to date: (1) Doerge, D.R., Twaddle, N.C., Vanlandingham, M., and Fisher, J.W. Pharmacokinetics of bisphenol A in adult and neonatal Sprague-Dawley rats. Toxicol. Appl. Pharmacol. 247, 158-165 (2010).; (2) Doerge, D.R., Twaddle, N.C., Vanlandingham, M., and Fisher, J.W. Pharmacokinetics of bisphenol A in adult and neonatal rhesus monkeys. Toxicol. Appl. Pharmacol. 248, 1-11 (2010).; (3) Twaddle, N.C., Churchwell, M.I., Vanlandingham, M., and Doerge, D.R. Quantification of deuterated bisphenol A in serum, tissues, and excreta from adult Sprague-Dawley rats using liquid chromatography with tandem mass spectrometry. Rapid Commun. Mass Spectrom. 24, 3011-3020 (2010).; (4) Doerge, D.R., Vanlandingham, M., Twaddle, N.C., and Delclos, K.B. Lactational transfer of bisphenol A in Sprague-Dawley rats. Repro. Toxicol. 199, 372-376 (2010).
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |
Glossary
BPA
Bisphenol A
CFSAN
Center for Food Safety and Nutrition
NTP
National Toxicology Program
NIEHS
National Institute of Environmental Health Sciences
NIH
National Institute of Health
TSSRC
Toxicology Study Selection and Review Committee
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.
