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U.S. Department of Health and Human Services

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.

Milestone DescriptionMilestone DateMilestone StatusMilestone 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

Subchronic (short-term study)

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

5. Complete the assessment of research findings

10/1/2011

Completed FY13 Q1

6. Develop draft technical report, manuscript, and/or publication (2)

12/1/2011

Completed FY13 Q3

7. Submit final technical report, manuscript, and/or publication to a scientific journal

6/1/2012

Completed FY13 Q3

Chronic (two year study)

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

8. Send initial data to collaborating academic laboratories for analysis

FY14 Q1

Completed FY14 Q1

9. Discuss progress with academic investigators

FY14 Q3

On Track

10. Complete assessment of research findings

FY15 Q3

On Track

11. Develop draft technical report, manuscript, and/or publication

TBD

On Track

12. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication

TBD

On Track

13. Submit the draft technical report, manuscript, and/or publication to the document tracking system for NCTR Center Director approval

TBD

Not Yet Started

14. Obtain final approval of the technical report, manuscript, and/or publication

TBD

Not Yet Started

15. Submit final technical report, manuscript, and/or publication to a scientific journal

TBD

Not Yet Started

16. Publish final technical report, manuscript, and/or publication

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 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

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.