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Science Panel Report FDA 10-28-08

Science Panel Report FDA 10-28-08

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Published by zrecommends
An FDA advisory committee blasts the agency for its assessment of Bisphenol-A.
An FDA advisory committee blasts the agency for its assessment of Bisphenol-A.

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Published by: zrecommends on Oct 29, 2008
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05/09/2014

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FDA Science Board Subcommittee on Food Contact Applications of BPA
1
FDA
 
S
CIENCE
B
OARD
S
UBCOMMITTEE ON
B
ISPHENOL
A
 
SCIENTIFIC
 
PEER-REVIEW OF THE DRAFT ASSESSMENT OFBISPHENOL AFOR USE IN FOOD CONTACT APPLICATIONS
S
UBMITTED TO
:SCIENCE
 
BOARD
TO THE
FDADRAFTO
CTOBER
31,
 
2008
M
ARTIN
A.
 
P
HILBERT
,
 
P
H
.D.(C
HAIR
,
 
M
EMBER
,
 
S
CIENCE
B
OARD
)P
ROFESSOR OF
T
OXICOLOGY
&
 
S
ENIOR
A
SSOCIATE
D
EAN FOR
R
ESEARCH
 U
NIVERSITY OF
M
ICHIGAN
S
CHOOL OF
P
UBLIC
H
EALTH
 G
ARRET
F
ITZGERALD
,
 
M.D.(M
EMBER
,
 
S
CIENCE
B
OARD
)Professor of Pharmacology & ChairUniversity of Pennsylvania School of MedicineP
HILIP
J.
 
B
USHNELL
,
 
P
H
.D.Research ToxicologistNeurotoxicology DivisionNational Health and EnvironmentalEffects Research LaboratoryOffice of Research andDevelopment, USEPAA
NTONIA
M.
 
C
ALAFAT
,
 
P
H
.D.
 
Lead Research ChemistNational Center for Environmental HealthCenters for Disease Control and PreventionH
OWARD
H
U
, M.D.Professor of Environmental Health Sciences & ChairUniversity of Michigan School of Public HealthH
OWARD
R
OCKETTE
,
 
P
H
.D.
 
P
ROFESSOR OF
B
IOSTATISTICS
&
 
C
HAIR
 U
NIVERSITY OF
P
ITTSBURGH
S
CHOOL OF
P
UBLIC
H
EALTH
 J
OHN
J.
 
V
ANDENBERG
,
 
P
H
.D.
 
A
SSOCIATE
D
IRECTOR FOR
H
EALTH
 N
ATIONAL
C
ENTER FOR
E
NVIRONMENTAL
A
SSESSMENT
O
FFICE OF
R
ESEARCH AND
D
EVELOPMENT
,
 
USEPA
 
 
FDA Science Board Subcommittee on Food Contact Applications of BPA
2
C
ONTENTS
 
E
XECUTIVE
S
UMMARY
3C
HARGE
Q
UESTIONS AND
F
INDINGS
5S
UMMARY
13A
CKNOWLEDGEMENTS
14L
ITERATURE
C
ITED
14A
BBREVIATIONS
15
A
PPENDIX
1:
 
P
UBLIC
M
EETING
N
OTICE
 
16
A
PPENDIX
2:
 
I
NVITED
P
ANEL
R
OSTER
 
17
 
 
FDA Science Board Subcommittee on Food Contact Applications of BPA
3
E
XECUTIVE
S
UMMARY
 PROCESS
The Science Board provides advice primarily to the Commissioner of the USFDA andother appropriate officials on specific complex and technical issues as well as emerging issueswithin the scientific community. This temporary Subcommittee was established by the ScienceBoard and consists of two members of the Science Advisory Board and five scientists drawnfrom academia and government agencies. The focus of this Subcommittee is the scientific peer-review of the draft assessment prepared by the FDA of bisphenol A for use in food contactapplications. Members of the subcommittee were selected by the Science Board for theirexpertise in scientific disciplines relating specifically to the issues assessed in the FDA draftsafety assessment (Attached). It is the purpose of the Subcommittee to provide advice and makepreliminary recommendations regarding the FDA draft safety assessment for subsequent actionby the full Board.A public meeting (Appendix 1) was held on September 16, 2008 at the Rockville Hiltonat which the Subcommittee received from FDA (Drs. Tarantino, Baily and Twaroski) a review of the process and scientific methodologies employed in preparing the draft safety assessment of bisphenol A. Dr. John Bucher, Deputy Director of the National Toxicology Program (NIH-NIEHS) presented the approach used by the NTP in arriving at their own assessment of thesafety of bisphenol A (i.e., NTP Brief). The final formal oral presentation by Dr. Frederick vomSaal (University of Missouri-Columbia) provided the Subcommittee with an overview of theconclusions of the Chapel Hill Bisphenol A Expert Panel and of the areas in which that Paneldiffered from the FDA in its assessment of the toxicity and potential risks from exposure tobisphenol A. Open public hearings were followed by discussion between the Subcommittee andan invited Panel that focused on interpretation of BPA research studies and data gaps related tothe draft safety assessment (Appendix 2).
SPECIFIC FINDINGS OF THE SUBCOMMITTEE
 
Bisphenol A is present in food contact applications resulting in dietary exposure of BPAto infants, children and adults. The Subcommittee agrees with the focus of the draftassessment on dietary exposures to children, because they are likely to have both greaterexposures and susceptibility than adults as a function of food consumption patterns,metabolism, vulnerability of developing systems and other factors. Nevertheless, it is theopinion of the Subcommittee that the FDA assessment would be strengthened byconsidering cumulative exposures and differential risk in neonates.
 
The draft FDA exposure assessment has important limitations including that it lacks anadequate number of infant formula samples and relies on mean values rather thanaccounting for the variability in samples.
 
The draft FDA report does not articulate reasonable and appropriate scientific support forthe criteria applied to select data for use in the assessment. Specifically, theSubcommittee does not agree that the large number of non-GLP studies should beexcluded from use in the safety assessment.

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