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Food and
Drug Administration
Science Board to the Food and Drug Administration
October 31, 2008
BRIEFING INFORMATION
FDA
Charge to Subcommittee
BPA Subcommittee Report
FDA Letter to Chair (Oct. 29, 2008)
Draft Assessment of Bisphenol A for use in food contact applications
Full Reference List for BPA Draft Assessment
Memos, some redacted, referenced in the Draft Assessment
Bisphenol-A Status Summary Report
Carcinogenesis Bioassay of Bisphenol-A (CAS No. 80-05-7) in F344 Rats and B6C3F, Mice (Feed Study)
Memo regarding Migration Data for Bisphenol-A from can enamels to infant formula concentrates
Update on cumulative exposure to BPA for infants from epoxy-based container coatings and polycarbonate (PC) bottles in contact with infant formula
Reviews of the developmental neurotoxicity potential
Final TDERs for studies reviewed under contract with ICF Consulting (Contract No. 223-96-2302) for Food Additive Master File No. 580 under Work Asstgnment 2000-19 (ICF 419), Task Numbers 3, 4, 5, and 6
“Bisphenol A – Effects on onset of puberty in female and prostate and urinary tract in male rodents
FAP 9Z4681 (MATS #1070 M2.0 and 2.1): National Environmental Trust; submission of 5/13/99. Migration of di(2-ethylhexyl) adipate from polyvinyl chloride cling film and bisphenol-A from can coatings and polycarbonate baby bottles and tableware
Final TDERs for studies reviewed under contract with ICF Consulting (Contract Number 223-96-2302) for Food Additive Master File No. 580 under Work Assignment 2000-20 (ICF 020) Tasks Number 1 ,2 and 3
Review of Two-Generation Reproductive Toxicity Evaluation of Bisphenol A Admmistered in the Feed to CD-1 Swiss Mice, RTI Identification Number 65C-09301.000.003/0209301 000.003; Submitted to FMF 000580, Volumes I-VIII
Bisphenol A - Review of studies conducted by Vom Saal et al, Nagel et al, and MPI Research
Table of NOAELS and LOAELS from Bisphenol A Toxicity Studies in FMF 580
Compact Summary of Bisphenol A (BPA) Pharmacokinetics
Review of study entitled "Three-Generation Reproductive Toxicity Evaluation of Bisphenol A in the Feed
to CD (Sprague-Dawley) Rats"
Identity of Can Coating on Powder Infant Formula cans
Cumulative exposure estimates for bisphenol A (BPA), individually for adults and infants, from its use in epoxy-based can coatings and polycarbonate (PC) articles
CEDI of Bisphenol A
Charge to the Science Board
BPA Science Board Report (Added 11/10/08)
FDA Letter to Chair (December 3, 2008) (Added 12/15/08)
Additional Background Briefing Documents for other portions of the Science Board meeting
Background Document for Overview of Current Methods for Detection of Contaminants in FDA Regulated Products-1
Background Document for Overview of Current Methods for Detection of Contaminants in FDA Regulated Products-2
Background Document for Overview of Current Methods for Detection of Contaminants in FDA Regulated Products-3