April 23, 2008 Information Sheet: Safety of BPA-derived Can Liners. Summary

Transcription

1 April 23, 2008 Infrmatin Sheet: Safety f BPA-derived Can Liners Summary The use f bisphenl A (BPA)-derived epxy resins t make prtective catings fr metal fd and beverage packaging helps prvide safe, whlesme and nutritius fd and beverages fr peple thrughut the wrld. Human expsure t BPA frm the use f prtective liners in cans is exceedingly lw, many times lwer than the safe expsure levels set by United States and internatinal regulatry agencies, which in turn are based n cmprehensive reviews that include safety factrs f 100-fld r mre. Recent and cmprehensive reviews f the science, including lw dse studies, by regulatry agencies (including the U.S., the Eurpean Unin, Canada, Japan, Germany and the United Kingdm) have affirmed that BPAderived can liners are safe fr use in fd cntact applicatins. They are apprved fr this use by all fd regulatry agencies arund the wrld. In additin t the specific research n the safety f BPA-derived can liners, regulatry agencies have cnducted their wn research as well as assessed the available scientific data n BPA. The cnclusins f these cmprehensive and up-t-date assessments which cnsistently affirm the safety f BPA use - prvide assurance t the public that all f the available science has been cnsidered and that the safety f BPA has been thrughly examined. Use f BPA-derived Can Liners Prtects the Fd Supply The use f BPA-derived can liners helps prvide fd fr peple thrughut the wrld by maintaining the safety, whlesmeness and nutritinal value f canned fds and beverages. Canning is ne f the mst significant innvatins in the preservatin f fd in human histry. The metal fd can, nw mre than 200 years ld, remains ne f the mst recyclable, ecnmical and abve all, safe and energy-efficient mdes f fd distributin and packaging because it enables fd sterilizatin and lng-term preservatin. Due t the metal-crrding effects f fds and beverages during prcessing (ne hur at 250 F) and lng-term strage, metal cntainers and lids are cated t: Ensure the safety f canned fd by prtecting the integrity f the cntainer frm crrsin, and Prevent deleterius effects n fd quality, whlesmeness and nutritinal value due t metal migratin. In the manufacture f can liners, BPA and ther materials are reacted t frm high mlecular weight epxy plymers which are further crss linked during the curing prcess t frm a chemically resistant cating. The high nutritinal value f fds packaged using current canning technlgy, including can liners, has been demnstrated in studies cnducted at the University f Illinis 1 and the University f Massachusetts. 2 Tday s use f BPA-derived epxy resins is the result f ver 60 years f industry research t develp and prvide can liners with the safest and mst effective fd cntact perfrmance

2 Human Expsure t BPA frm Can Liners is Lw Human expsure t BPA frm use f prtective liners fr fd cans is exceeding lw, hundreds r mre times lwer than safe expsure levels set by U.S. and internatinal regulatry agencies. Fr example, a recent highly publicized survey 3 f BPA levels in U.S. canned fds reprted a gemetric mean f 2.4 micrgrams BPA per kilgram cncentrated liquid infant frmula (a BPA level equivalent t 2.4 parts per billin 4 ). Using the assumptin in the reprt that 100 percent f the infant s diet is frm cncentrated liquid frmula, the estimated BPA intake fr a three-mnth ld infant 5 is nly 0.17 micrgrams per kilgram bdy weight per day. This value is 300 times lwer than the mst up-t-date Tlerable Daily Intake, the amunt f a substance that can be ingested daily ver a lifetime withut psing a significant risk t health. This TDI (50 micrgrams per kilgram bdy weight per day) was set by the Eurpean Fd Safety Authrity 6 earlier this year after a cmprehensive review f the latest and mst reliable date and includes a 100-fld safety factr t accunt fr the extraplatin frm labratry animal studies t human health. This same survey als reprted a gemetric mean f 7.9 micrgrams BPA per kilgram fd (7.9 parts per billin 4 ) in 97 canned fds. Using the assumptin in the reprt f ne serving f canned fds per day fr life, the estimated BPA intake frm canned fds fr adults 7 is micrgrams per kilgram per day, a value that is ver 1000 times lwer than the Tlerable Daily Intake value set by the Eurpean Fd Safety Authrity earlier this year. The finding that BPA intake is 300 t ver 1000 times lwer than the TDI is reassuring and cnfirms that residual levels f BPA in canned fds d nt pse any significant risk t health. Regulatry Agency Reviews Affirm the Safety f BPA-derived Can Liners The safety f BPA-derived prtective catings in fd and beverage cntainers have undergne independent reviews f the science by multiple regulatry agencies, including the U.S. Fd and Drug Administratin, the United Kingdm Fd Standards Agency, the Research Center fr Chemical Risk Management f the Natinal Institute fr Advanced Industrial Science and Technlgy f Japan, and mst recently the Eurpean Fd Safety Authrity. Every regulatry review cnducted t date has affirmed that BPA-based can liners are apprved fr use in fd cntact applicatins and safe fr use. In the United States, the Fd and Drug Administratin, which apprved the use f BPA-derived can liners a number f years ag, cnducts peridic studies n human expsure 8 and mnitrs the extensive database f studies. Agency fficials have repeatedly affirmed that "...FDA sees n reasn t change [its] lng-held psitin that current [BPA] uses with fd are safe." 9 This mst recent assurance was prvided in Nvember 2005 by the Assciate Directr fr Science and Plicy f FDA's Office f Fd Additive Safety, wh at that time was Dr. Gerge Pauli One part per billin is the time equivalent f ne secnd in 31 years, 8 mnths. 5 Using the assumptins in the reprt that a three-mnth ld infant has a bdy weight f 6 kilgrams r 13 punds and frmula cnsumptin f 0.84 kilgrams r 30 unces per day Using the assumptins in the reprt f an adult bdy weight f 60 kilgrams r 132 punds, and using the largest adult serving size in the survey, 12.5 unces r 350 grams. 8 Biles, J. E., McNeal, T. P. and Begley, T. H. Determinatin f bisphenl A migrating frm epxy can catings t infant frmula liquid cncentrates. J Agric Fd Chem 1997; 45: Letter frm Gerge Pauli, Assciate Directr fr Science and Plicy, FDA's Office f Fd Additive Safety, t Califrnia Assemblymember Greg Aghazarian. Nvember 28, 2005.

3 Internatinally, the U.K. Fd Standards Agency surveyed the levels f BPA in canned fds in Britain and cncluded, n the basis f a review by the independent Cmmittee n Txiclgy f Chemicals in Fd, Cnsumer Prducts and the Envirnment, that the levels f BPA identified in canned fds analyzed in this survey are unlikely t be f cncern t health. 10 In Japan, the Research Center fr Chemical Risk Management f the Natinal Institute fr Advanced Industrial Science and Technlgy reviewed the health hazards f BPA and prvided an assessment reprt in 2006 that cncluded lw risk frm BPA use in fd cntact applicatins. 11 The mst recent assessment f BPA-derived can liners is that f the Eurpean Fd Safety Authrity, cited abve. In cnducting this assessment, the EFSA directed the independent Scientific Panel n Fd Additives, Flavrings, Prcessing Aids and Materials in Cntact with Fd t re-evaluate the use f BPA in articles intended t cme int cntact with fd, giving particular attentin t the expsure f infants. This assessment in turn builds n the cmprehensive Risk Assessment Reprt fr BPA cnducted by the Eurpean Unin and published in 2003 and the 2002 assessment by the E.U. Scientific Cmmittee n Fd. Because f its high relevance t the safety f BPA-derived can liners, the findings f the EFSA Scientific Panel regarding claimed lw dse effects f BPA are quted here: In reviewing the earlier and the recently published studies n BPA, the Panel nted that sme studies indicated differences in behavir r reprductive parameters between cntrl and treated animals at dse levels lwer than the previusly accepted verall n bserved adverse effect level (NOAEL) f 5 milligrams per kilgram bdy weight per day. Hwever, the Panel had cnsiderable reservatins bth abut the bilgical significance f the reprted bservatins and the rbustness f the studies. The Panel nted that the changes bserved were ften nt sustained thrugh adulthd. The bilgical cnsequences f many f the changes in the affected animals are unknwn and sme, such as small increases in prstate weight, are nt cnsidered as precursrs f pathlgical change. While sme f the changes may be indicative f bimarkers f effect in very sensitive species and strains, in the light f present knwledge, they cannt be readily interpreted as adverse effects. The Panel als nted that the results f the studies reprting lw-dse effects are in cntrast t the results f ther studies using cmprehensive prtcls develped fr testing bth structure and reprductive functin in parents and ffspring and perfrmed fllwing internatinally recgnized guidelines with regard t study design and animal mdel selectin. A tw-generatin reprductive txicity study has recently been reprted in an estrgen-sensitive strain f mice administered a wide range f BPA dses in the diet. BPA administratin in the lw-dse range did nt result in changes in reprductive rgans r perfrmance and gave an verall NOAEL f 5 milligrams per kilgram bdy weight per day, with liver txicity as the mst sensitive endpint. The psitive cntrl substance, 17ßestradil, resulted in reprductive and develpmental txicity. The Panel cnsidered that lw-dse effects f BPA in rdents have nt been demnstrated in a rbust and reprducible way, such that they culd be used as pivtal studies fr risk assessment. The verall cnclusins f the EFSA Scientific Panel n BPA-derived can liners are: The Panel cncluded that the verall NOAEL f 5 milligrams per kilgram bdy weight per day, based n the results f a cmprehensive three-generatin study in the rat, is still valid, and in the

4 Panel s view is further supprted by the NOAEL f 5 milligrams per kilgram bdy weight in a recent tw-generatin reprductive txicity study f BPA in mice. The Panel nw cnsiders that the database cncerning reprductin and develpment has been cnsiderably strengthened and that the additinal uncertainty factr f 5, intrduced in 2002 fr the uncertainties in the database n reprductin and develpment, is n lnger required. The Panel als cncluded, in view f the well described species differences in txickinetics, shwing a lw level f free BPA in humans cmpared with rats, that a default uncertainty factr f 100 applied t the verall NOAEL frm the rdent studies can be cnsidered as cnservative. The Panel therefre established a full TDI f 50 micrgrams BPA per kilgram bdy weight, derived by applying a 100-fld uncertainty factr t the verall NOAEL f 5 milligrams per kilgram bdy weight per day. In shrt, the Eurpean Fd Safety Authrity cncluded nt nly that studies claiming lw dse effects are nt sufficiently reliable fr risk assessment, but als that the studies n lnger justify any additinal uncertainty factr beynd the standard 100-fld safety factr used fr extraplatin frm labratry animal studies t human health. Extensive Research and Review Prvides Assurance f Safety In additin t the specific research n the safety f BPA-derived can liners reviewed abve, extensive research and review f the scientific data prvides assurance t the public that all f the available science has been cnsidered and that the safety f BPA has been thrughly examined. While research and review f claimed lw dse effects have been n-ging fr ver 10 years, nly the mst recent reprts are referenced belw: In March 2005, the Japanese Ministry f Envirnment reprted the results f their wn tests n BPA, including an enhanced ne-generatin reprductive and develpmental study in lab rats. 12 BPA was tested at fur dses representing estimated human expsure levels. The Ministry f Envirnment reprted that the study fund n clear evidence f effects at any f the BPA dses tested. In January 2006, the German Federal Institute fr Risk Assessment released a statement with their views n the safety f BPA in which they nted that sme f the trials reprting lw dse effects are difficult t interpret and ccasinally they are cntradictry. 13 In June 2006, a panel f U.S. scientific experts reprted the results f their weight-f-the-evidence evaluatin f lw-dse reprductive and develpmental effects f bisphenl A. Cnsidering studies published thrugh February 2006, the panel cncluded the weight f evidence des nt supprt the hypthesis that lw ral dses f BPA adversely affect human reprductive and develpmental health. 14 In January 2007, Dr. Michael A. Kamrin f the Center fr Integrative Txiclgy f Michigan State University published a review f the available data n BPA in a peer-reviewed internatinal science Gdman, J. E., McCnnell, E. E., Sipes, I. G., Witrsch, R. J., Slaytn, T. M., Yu, C. J., Lewis, A. S., and Rhmberg, L. R An Updated Weight f the Evidence Evaluatin f Reprductive and Develpmental Effects f Lw Dses f Bisphenl A. Critical Reviews in Txiclgy, vl. 36, pages

5 jurnal. 15 The paper cncludes that these lw dse effects have yet t be established, that the studies purprted t supprt these cannt be validly extraplated t humans, and the dses at which the studies have been perfrmed are significantly higher than the levels t which humans are expsed. In April 2008, Health Canada fficials clearly stated that the very lw levels f BPA expsure experienced by mst peple presents negligible risk. 16 In April 2008, the Natinal Txiclgy Prgram (NTP) released its Draft Brief n BPA. 17 The Draft Brief presents NTP s draft cnclusins n the pssible effects f BPA n human develpment and reprductin.. The Draft Brief includes the fllwing cnclusins: Negligible cncern that expsure f pregnant wmen t BPA will result in fetal r nenatal mrtality, birth defects, r reduced birth weight and grwth in their ffspring; Sme cncern fr neural and behaviral effects in fetuses, infants, and children at current human expsures; Sme cncern fr BPA expsure in these ppulatins based n effects in the prstate gland, mammary gland, and an earlier age fr puberty in females; Negligible cncern that expsure t BPA causes reprductive effects in nn-ccupatinally expsed adults; and Minimal cncern fr wrkers expsed t higher levels in ccupatinal settings. Cnclusins The use f BPA-derived can liners helps prvide essential fd t feed the wrld by maintaining the safety, whlesmeness and nutritinal value f canned fds and beverages. Human expsure t BPA frm use f fd prtective can liners is much lwer than safe expsure levels set by U.S. and internatinal regulatry authrities. The safety f BPA-derived can liners has undergne recent scientific reviews by U.S. and internatinal regulatry agencies, wh have rejected lw dse studies as nt reliable fr risk assessment and affirmed the safety f BPA-derived can liners. Extensive research and review f the scientific data n BPA prvides assurance t the public that all f the available science has been cnsidered and the safety f BPA-derived can liners thrughly examined. 15 Kamrin, M.A The Lw Dse Hypthesis: Validity and Implicatins fr Human Risk. Internatinal Jurnal f Txiclgy, vl. 26, pages