Mn  Good Thn Even Better Removn from September   Introducton nd Summr In  countr wth pproxmtel  mllon new cses of sexull trnsmtted nfectons STIs ech er hlf of them mon erolds condoms re n essentl prt
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Mn Good Thn Even Better Removn from September Introducton nd Summr In countr wth pproxmtel mllon new cses of sexull trnsmtted nfectons STIs ech er hlf of them mon erolds condoms re n essentl prt

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Mn Good Thn Even Better Removn from September Introducton nd Summr In countr wth pproxmtel mllon new cses of sexull trnsmtted nfectons STIs ech er hlf of them mon erolds condoms re n essentl prt




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Presentation on theme: "Mn Good Thn Even Better Removn from September Introducton nd Summr In countr wth pproxmtel mllon new cses of sexull trnsmtted nfectons STIs ech er hlf of them mon erolds condoms re n essentl prt"— Presentation transcript:


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Mn  Good Thn Even Better Removn from September 2014
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Introducton nd Summr In  countr wth pproxmtel 19 mllon new cses of sexull trnsmtted nfectons (STIs) ech er, hlf of them mon 1524-er-olds, condoms re n essentl prt of protectn nd

promotn sexul nd reproductve helth for people of ll es Condoms re the onl product vlble tht smultneousl protects nst STIs nd prennc, re hhl effectve when used correctl nd consstentl, nd re reltvel low-cost, mn them n essentl

sexul helth product for mn people Nevertheless, even  ood thn cn be mproved In 2010, the World Helth Ornzton (WHO) nd the Unted Ntons Populton Fund (UNFPA) recommended tht mnufcturers mnmze the presence of ntrosmnes,  clss of crcnoenc chemcls, n mle ltex condoms

Whle the detectble level of ntrosmnes n condoms s lower thn those found n food, wter, nd other consumer oods nd does not dmnsh the helth benefts, effcc, nd sfet of condoms ther presence s unnecessr nd m contrbute to our overll exposure to these chemcls Snce ntrosmnes cn be

redl removed from the condom mnufcturn process nd severl tpes of condoms re lred vlble tht do not lech ntrosmnes condoms wthout detectble levels of ntrosmnes should be the new norm There hs been lttle follow up testn to see f the WHO nd UNFPA recommendton hs been mplemented Thus, the

Reproductve Helth Technoloes Proect (RHTP), wth fundn from the co-founders of  condom compn nd n conuncton wth the Center for Envronmentl Helth (CEH), commssoned testn to determne f condoms vlble n the US relesed ntrosmnes nd, f so, whether those mounts exceeded

nterntonl stndrds set for other products Worn wth CEH, RHTP nlzed the results of the condom testn nd compred the level of ntrosmnes relesed wth exposure stndrds for ntrosmnes estblshed b the Europen Unon (EU) nd b the Stte of Clforn Our stud reveled  wde

Mn  Good Thn Even Better Removn from
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rne of mrton of ntrosmnes n the condoms we tested, from 0 to 443 prts per bllon (ppb), wth  thrd of the condoms exceedn the EU stndrds nd one condom exceedn Clforns stndrds We detl our

fndnsbelow The use of condoms should not be reduced or undermned becuse of the presence of ntrosmnes n some condoms Indeed, 2001 stud found tht the rs of tumors from ntrosmnes n condoms ws exceednl low And the helth benefts of condoms ncludn prennc preventon, HIV/AIDS preventon, nd protecton from  wde

rne of other STIs ncludn the Humn Ppllomvrus (HPV), whch cn cuse cervcl cncer fr outweh the potentl helth rss of exposure to ntrosmnes tht some condoms on the mret m pose Tht sd, n unnecessr or extrneous exposure to ntrosmnes should be

mnmzed Ntrosmnes cn be removed from condoms wthout mpctn the effcc, relblt, or sfet of condoms nd thus mnufctures should me ever effort to elmnte ntrosmnes from ther products Reproductve Helth nd Chemcl Exposures Althouh reducn exposures to

envronmentl toxns m seem fr removed from  conventonl reproductve rhts end, t s one of the most mportnt thns we cn do n the lon term to protect our reproductve helth nd the helth of our fmles Mountn scentfc evdence ndctes tht our everd

envronment from the r we brethe to the shmpoo we use cn expose us to toxc chemcls tht netvel mpct reproductve helth nd fertlt Toxc chemcls cn ffect our reproductve helth b reducn sperm content nd qult, mpedn ovrn functon, nfluencn

brest nd prostte development, nd ltern fetl development nd prennc outcomes, to nme  few B the sme toen, we lso wnt to ensure tht contrceptve nd other reproductve helth technoloes re s reen s possble 6 Ths pproch cn nclude mnmzn the envronmentl

mpcts of the processes b whch contrceptves re mde, mreted, delvered, nd used, nd t cn lso nclude reducn n potentl exposures to toxns from contrceptves themselves durn use or follown dsposl Wht Are Ntrosmnes Ntrosmnes re  clss of chemcl compounds

tht form when ntrtes nd mno cds combne About 300 tpes of ntrosmnes hve been tested nd 90 percent hve been found to be crcnoenc Reserch shows ntrosmnes cn dme DNA repr processes nd cuse humn cells to mutte, potentll cusn cncer Durn the

mnufcturn process of condoms, ntrosmnes cn form n smll qunttes when ntroen oxdes n the r nterct wth resdue from chemcls used to speed up the rubber mnufcturn process Tpcll, three tpes of ntrosmnes re found n condoms N-ntrosodmethlmne


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(NDMA), N-ntrosodethlmne (NDEA), nd N-ntrosobutlmne (NDBA) 10 In ddton to condoms, ntrosmnes re found n  vret of rubber products ncludn blloons, loves, bb bottle npples, nd pcfers, s well s n some processed mets such s hot dos nd cooed

bcon, some tpes of cheese, drnn wter, nd tobcco smoe 11 Wh Ntrosmnes n Condoms M Rse Concerns The nture of condom use s unque compred to other tpes of ntrosmne exposure Orl exposure s the prmr route of exposure for most ntrosmnes 12 Althouh some condoms re used orll, t s not the

prmr route of exposure durn tpcl use Condoms re ntended for close contct wth the sn nd wth the mucous membrnes of the entl Mucous membrnes found n entl re sem-permeble tssue nd cn be dmed, rrtted, nd penetrted b snthetc

chemcls much more esl thn the surfce of the outer sn 13 Vnl nd vulvr tssues n prtculr re more senstve nd permeble thn the sn on the rest of the bod Vnl wlls contn mn blood nd lmphtc vessels, whch enble chemcls to trnsfer

drectl nto the crcultor sstem wthout frst ben metbolzed 14 Moreover, other prts of the bod tht come nto contct wth condoms such s the hed of the pens, the nner ler of the pens foresn, the urethr, the nus, nd the rectum re lso mucous membrnes We re not wre of reserch comprn

orl nd vnl bsorpton of the ntrosmnes found n condoms However, some compounds, such s the hormone estrdol, re better bsorbed vnll thn orll 15 In ddton, reserchers hve shown tht bsorpton of  tpe of ntrosmne not tpcll found n condoms ws

equvlent whether throuh the sn or orll 16 Whle both men nd women re exposed to low levels of ntrosmnes from condoms tht contn the substnce, t s estmted tht more s bsorbed throuh the vn thn the pens 17 Even ssumn s we dd n ths stud tht 100 percent of the ntrosmnes

leched b  condom durn use re bsorbed b the vn or rectl wll, the exposures re low compred to other sources of exposure such s food, bproducts of dsnfectn our wter, tobcco smoe (frst- nd second-hnd), Worer Helth Concern bout exposure to ntrosmnes s not lmted to users of condoms Condom

fctor worers m lso be exposed, nd t much hher levels In fct, t ws n ncrese n the ncdence of cncer mon worers n the Amercn rubber ndustr tht frst lerted scentsts to the presence of ntrosmnes n rubber products Condom fctor worers, especll those

n developn ntons, re often pd low wes nd re less lel to hve ccess to helth cre to ddress n wor-relted helth ssues Thus, protectn worers from unnecessr exposure to ntrosmnes s et nother reson for condom producers to chne ther mnufcturn

processes i Proksch, 104.
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nd cosmetcs 18 For nstnce, t s estmted tht  womns vere dl nte of ntrosmnes from food sources lone s pproxmtel 500 n, 19 wheres the vere exposure level mon the condoms tested n our stud ws 81 n However, becuse we

fce reulr exposure to ntrosmnes from other products, nthn tht dds to our cumultve ntrosmne exposure rses helth concerns Thus, t s mportnt tht our lfetme exposure to ntrosmnes be mnmzed wherever possble Methodolo In Februr 2014, we hd 24 20 dfferent tpes of ltex condoms

tht re sold n the Unted Sttes tested n ccordnce wth BS ISO 299412010 to determne the mount of ntrosmnes relesed b the condoms The condom test ISO 299412010 ws desned to estmte the mount of ntrosmnes to whch  condom user would be exposed durn tpcl use so s to provde n ssessment of

rs Ths mount s to be dstnushed from the totl mount of ntrosmnes tht m be contned n condom, whch s expected to be hher thn the mount relesed durn use The condoms we selected for testn vred b color, flvor, feture (e, wrmn or

tnln senston), texture (e, rbbed), nd thcness (e, ultrthn)We lso chose condoms bsed on hh n-store vlblt, lre number of unts sold n the Unted Sttes ccordn to the mret reserch compn IRI, nd wth nput from

ssue nd ndustr expertsIn ddton, we tested condoms tht were prevousl found to hve hher levels of ntrosmnes nd condoms tht re mreted s ornc or nturlWe cqured the selected condoms b purchsn them from retl phrmc chns or ordern them from

onlne condom vendors nd then shpped them to the Tun Abdul Rz Reserch Centre lbortor for testn, wth one excepton Pre-mret smples of Sustn condoms were shpped drectl from the compn to the lbortor for testn s the were not et vlble for purchse t the tme No overnn bod

hs set lmts for the levels of ntrosmnes n condoms Nevertheless, s mentoned bove, n 2010, the WHO nd UNFPA ssued udelnes for mle ltex condoms tht ncluded recommendton tht mnufcturers te steps to mnmze ntrosmnes n ther products 21 These udelnes dd not set specfc

lmts for ntrosmnes but dd provde ntcptor udnce on how to reduce or elmnte ntrosmnes from the mnufcturn process 22 It is estimated that a womans average daily intake of nitrosamines from food sources alone is approximately 500 ng, whereas the average exposure level among the condoms tested in our study was 81 ng.
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As  prox for determnn

whether the level of ntrosmnes relesed from condoms mht pose  rs to humn helth, we compred the level of ntrosmnes relesed durn the testn to two dfferent reultor stndrds Becuse the test used to determne the level of ntrosmnes relesed ws  mrton test (how much leched durn 

specfed tme perod) s opposed to how much ws contned n condoms, we used reultor stndrds tht lewse were bsed on mrton rther thn on content 23 The frst stndrd used for comprson ws the EUs EN 71-12 (ntrosmnes n tos mde of elstomers) 24 Ths stndrd sets  lmt of

05 mllrms of mrtble ntrosmnes/ per lorm of to mterl, or 50 ppb, clculted s  sum of ll mrtble ntrosmnes 25 The second stndrd used for comprson ws Clforns Sfe Drnn Wter nd Toxc Enforcement Act of 1986,

lso nown s Proposton 65 Whle not treted solel to ntrosmnes, Proposton 65 sees to reduce or elmnte exposures to chemcls tht cuse cncer, brth defects, or reproductve hrm b requrn wrnns n dvnce of those exposures 26 Under Proposton 65, the Offce of Envronmentl

Helth Hzrds Assessment (OEHHA) clcultes the dl exposure to certn ntrosmnes tht would result n one excess cncer cse per 100,000 people exposed 27 Ths s clled the no snfcnt rs level (NSRL) The NSRLs (n mcrorms (m) per d) for the three tpes of ntrosmnes found n condoms re

02 m for NDEA 04 m for NDMA nd 06 m for NDBA 28 We reconze tht the comprson of ntrosmnes relesed n testn to these stndrds s not perfect For one, the EU stndrd s treted to chldren,  populton tht m be t hher rs becuse of rpd developmentl

chnes Moreover, the stndrd s prmrl concerned wth orl exposure Lewse, under Proposton 65, the studes used for clcultn the mxmum llowble dose level (MADL) for ntrosmnes re bsed on orl exposure from drnn wter 29 Whle condoms re sometmes used for orl sex,  more common

exposure s derml or epthell, 30 s noted bove Results The stud reveled  wde rne of mrton of ntrosmnes n condoms, from 0 to 443ppb (Fure 1) Sxteen of the 23 condoms 31 relesed t lest one tpe of ntrosmne NDBA ws the most common ntrosmne detected, but NDEA consdered the most potent s

demonstrted b the low NSRL under Proposton 65 ws detected t the hhest levels One of the condoms tested relesed more thn 300 ppb of NDEA Specl fetures of the condom (e, flvor, color, or thcness) dd not seem to ffect the level of ntrosmnes relesed The good news is that almost one-third of the condoms tested (7 out of 23) did not release any detectable nitrosamines.
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Figure 1: Nitrosamines Migrating from Condoms (ng/g or ppb) Condom NDMA NDEA NDBA Billy BoyBeaded Lot D420721 Not Detected Not Detected DurexAvanti Bare Lot 0010657782 Not Detected Not Detected 11 DurexExtra Sensitive, Extra Lubricated Lot0010870147 Not Detected Not Detected Not Detected FC2Female Condom Lot F5416 Not Detected Not Detected Not Detected GlydeBlueberry Lot BB15961 37 Not Detected 55 LifeStylesFlavors and Colors, Strawberry Lot106571916 Not Detected Not Detected Not Detected LifeStylesSkyn, Original Lot 1302120722 Not Detected Not Detected Not Detected

LifeStylesUltraLubePlus Lot 1211080916 Not Detected Not Detected Not Detected NVoNude Lot 1206/09 18 Not Detected 40 OneGlowing Pleasures Lot 13N714 22 Not Detected 40 PlayboyLubricated LotNWXA10-101104 15 340 88 Sir RichardsUltraThin Lot 10N3716 36 Not Detected 97 SustainProto TP/RD/PS/05/2013 LotTRL3026 Not Detected Not Detected Not Detected TrojanENZ Lot TT3150XZ3 02 19 TrojanHer Pleasure Sensations LotTT2353UZ1312 31 TrojanIntensified Charged Orgasmic Pleasure Lot TT1335BZ1311 Not Detected TrojanMagnum, Large Size Condoms, Ecstasy,

UltrasmoothLubricant LotTT3163CC 27 11 TrojanMagnum, Large Size Condoms, Lubricated LotTT3216ZZ1308 12 TrojanMagnum, Large Size Condoms, XL, Lubricated LotTT3101YC 13 67 63 TrojanPleasures, Extended LotTT3152TE Not Detected TrojanPleasures, Fire and Ice LotTT3151ZZ709 Not Detected 11 Not Detected TrojanSensitivity, Bareskin LotCZ2319L3 Not Detected Not Detected Not Detected TrojanUltra Ribbed LotTT3173UZ1512 20 48 14 * These results are accurate as of the time of testing (February 2014) and do not necessarily reflect the

nitrosamine levels of these products as currently available for sale. Testing samples were procured in December 2013. The makers of the Glyde Blueberry condom have informed RHTP that the condom tested in this study was pro duced in February 2011 and indicated that they changed their manufacturing process in 2013 to reduce the level of nitrosamines in their product to fall below current regulatory standards. However, as of the time of publication, they had not provided evidence to RHTP to substantiate that claim. The makers of One Glowing Pleasures condom have informed RHTP that testing in

early 2014 of the One Class- ic Select condom, which uses the same latex formulation and processing parameters as the Glowing Pleasures condom (aside from the addition of a glow pigment to the latter), showed that the Classic Select released less than 10 ppb of nitrosamines. They have added Glowing Pleasures to the list for their next round of analysis, but that testing had not occurred as of the time of publication. The makers of the Playboy Lubricated condom have provided evidence to RHTP that they have implemented changes to the manufacturing process of all their condom lines, which has

resulted in nitrosamine levels that fall below the EU standards (on file with authors). However, because the newer versions of their products have not yet been imported to the U.S., our testing results for this condom are relevant to current market conditions as of the time of publication of this report. Playboy has not indicated when the new versions will become available for sale in the U.S.
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The ood news s tht lmost one-thrd of the condoms tested (7 out of 23) dd not relese n detectble

ntrosmnes, ncludn the onl femle condom vlble n the Unted Sttes (Fure 2) Figure 2: Tested Condoms with No Detectable* Nitrosamine Migration Condom NDMA NDEA NDBA DurexExtra Sensitive, Extra Lubricated Lot0010870147 Not Detected Not Detected Not Detected FC2Female Condom Lot F5416 Not Detected Not Detected Not Detected LifeStylesFlavors and Colors, Strawberry Lot106571916 Not Detected Not Detected Not Detected LifeStylesSkyn, Original Lot

1302120722 Not Detected Not Detected Not Detected LifeStylesUltraLubePlus Lot1211080916 Not Detected Not Detected Not Detected SustainProto TP/RD/PS/05/2013 LotTRL3026 Not Detected Not Detected Not Detected TrojanSensitivity, Bareskin LotCZ2319L3 Not Detected Not Detected Not Detected *The limit of detection was taken as 1-2 ng/g. Seven of the 23 condoms tested relesed enouh ntrosmnes to exceed the level set b the EU for tos ntended for use b the mouth or b chldren under the

e of three (Fure 3) Of those seven, mrton from three ws reter thn two tmes the EU stndrd, suestn the level of ntrosmnes relesed b these condoms m be hh enouh to wrrnt concern nd quc cton b the mnufcturers to reduce ntrosmnes n those products Figure 3:

Total Migration of Nitrosamines from Condoms that Exceeded the EU Standard for Nitrosamines in Toys for Children Under Three Condom NDMA NDEA NDBA Total Nitrosamines GlydeBlueberry Lot BB15961 37 Not Detected 55 92 NuvoNude Lot 1206/09 18 Not Detected 40 58 OneGlowing Pleasures Lot13N714 22 Not Detected 40 62 PlayboyLubricated LotNWXA10-101104 15 340 88 443 Sir RichardsUltraThin Lot 10N3716 36 Not Detected 97 133 TrojanMagnum, Large Size Condoms, XL, Lubricated Lot TT3101YC 13 67 63 143 TrojanUltra Ribbed Lot TT3173UZ1512 20 48 14 82 The stud dt

suest tht one condom, Plbos Lubrcted, relesed enouh ntrosmnes to exceed both the EU stndrd nd Clforns Proposton 65 The mount of NDEA detected n ths condom (340 n/) multpled b the weht of the condom (15)
Page 10
10 ves n exposure of 510 n per use (340

n/ x 15  = 510 n of exposure per use or 51mcrorms of exposure per use) Wth n estmted vere number of uses per er of 50, vere dl exposure would then be 69 n (07 mcrorms), more thn three tmes theNSRL Dscusson Thouh the testn found tht some condoms contn levels of

ntrosmnes tht rse concerns, the results do not suest tht consumers should be dscoured from usn condoms As noted bove, the proven helth benefts of condoms ncludn HIV, STI, nd prennc preventon fr outweh the potentl helth rss of exposure to ntrosmnes from the use of some condoms on the mret

RHTP nd CEH reconze tht some people wth n nt-condom end or senstonlst bent m see to dstort the results of ths stud nd erroneousl clm tht condoms cuse cncer Anone who does so be t the med, poltcns, or dvoctes s ctn rresponsbl

nd not n the best nterests of publc helth Our perspectve on ths ssue s smlr to tht on contmnnts n brest ml The presence of chemcls n brest ml should not dscoure women from brestfeedn ther chldren On the contrr, the helth benefts of brest ml re

ndsputble, even when the potentl for exposure to envronmentl toxns exsts Lewse, condoms re stll the best w for people to protect themselves from HIV/AIDS nd other STIs Tht sd, n unnecessr or extrneous exposure to ntrosmnes should be mnmzed There s no functonl use of ntrosmnes n condoms

nd there re severl optons for removn them The WHO/UNFPA udelnes dvse mnufcturers tht ntrosmnes cn be reduced b dequtel lechn condoms, b usn mnmum mounts of ccelertors, or b choosn lterntve ccelertors 32 Furthermore, our testn results reveled tht

 ood number of condoms lred on the mret ether relesed low or undetectble levels of ntrosmnes Thus, t s possble to mnufcture qult condoms on  lre scle wth lttle to no ntrosmnes Mret chne s lso chevble For nstnce, severl ers

o when Germns best erotc compn, Bete Uhse, found out tht ts chocolte-flvored condoms contned hh levels of ntrosmnes, the compn bnned the condoms from ts sles lne 33 And some of the condom mers n ths stud hve lred beun to chne ther products to reduce or

elmnte ntrosmnes We pplud the ctons of those who hve proctvel souht to ensure tht ther products re s sfe s possble nd who hve followed the precutonr prncple of reducn consumer exposure to potentll hrmful substnces In order to encoure other mnufcturers to follow

sut, we hve nformed the mers of the products we tested of our results For those whose condoms relesed ntrosmnes, we sed them to me  plede b Februr 27, 2015 to elmnte ntrosmnes from ther products We wll publsh n updte n the The proven health benefits of condoms including HIV, STI, and pregnancy prevention far outweigh the potential health risks of

exposure to nitrosamines from the use of some condoms on the market.
Page 11
11 sprn of 2015 on n commtments or other proress mde In tht sme sprt, we ure lre-volume purchsers ncludn publc purchsers le communt nd fml plnnn helth clncs, blterl ornztons

such s the Unted Sttes Aenc for Interntonl Development (USAID) nd the Deprtment for Interntonl Development (DFID), nd lre multlterl ornztons le the WHO nd UNFPA nvolved n settn udelnes nd qult ssurnce to encoure condom mnufcturers to

elmnte ntrosmnes nd to purchse brnds tht relese undetectble levels of ntrosmnes Concluson Women nd men deserve sfe nd effectve contrceptve optons tht do not hrm or contrbute to hrmn ther helth or the envronment Althouh our exposure to ntrosmnes from some condoms s mnml

compred to other sources, ntrosmnes cn be removed from condoms wthout mpctn the effcc, relblt, or sfet of condoms nd, thus, the should be
Page 12
12 Endnotes Guttmacher Institute. Facts on Sexually Transmitted Infections in the United States. http://www. guttmacher.org/pubs/FIB_STI_US.html . Published June 2009. Accessed March 2014. World Health Organization (WHO), UNAIDS, United Nations Population Fund

(UNFPA), and Family Health International (FHI). Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 (revised 2013) (hereinafter WHO/UNFPA Male Latex Condom Specification). http://www.unfpa. org/webdav/site/global/shared/procurement/07_ resources/malecondoms_specs_procurement_2010. pdf . Published 2010. Accessed September 12, 2014. Proksch E. Toxicological evaluation of nitrosamines in condoms (hereinafter Toxicological evaluation). Int. J. Hyg. Environ. Health. 2001;204:103-110. Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J. Fertility, family planning,

and reproductive health of U.S. women: Data from the 2002 National Survey of Family Growth. National Center for Health Statistics. Vital and Health Statistics. 2005;23(25); Crain D, et al. Female reproductive disorders: the roles of endocrine- disrupting compounds and developmental timing. Fertility and Sterility. 2008;90(4):911-40; Travison TG, Araujo AB, ODonnell AB, Kupelian V, McKinlay JB. A population-level decline in serum testosterone levels in American men. The Journal of Clinical Endocrinology & Metabolism. 2007:92(1):199-201; Buck Louis, GM, Sundaram R, Schisterman E, et al.

Persistent environmental pollutants and couple fecundity: The LIFE Study. Environ. Health Perspect. 2013;121:231-36. Vandenberg LN, Colborn T, Hayes T, et al. Hormones and endocrine-disrupting chemicals: Low-dose effects and nonmonotonic dose responses. Endocrine Review. 2012;33(3). doi:10.1210/er.2011-1050; The Collaborative on Health and the Environment. Environmental Exposures, Infertility, and Related Reproductive Disorders: An update. www.healthandenvironment. org/infertility/peer_reviewed . Published October 2011. Accessed September 12, 2014. Moore K, Townsend J, Spieler J, et al. A

greenprint for sustainable contraceptive research and development. Contraception . 2013;87:347-51. The WHO Prequalification Programme for Condoms. A Workshop for Male Latex Condom Manufacturers - Session 7, Handout 3. http://www.path.org/ publications/files/RH_condom_wrkshp_session7_ en.pdf . Hebels D. Radical Mechanisms in Nitrosamine- and Nitrosamide-Induced Whole-Genome Gene Expression Modulations in Caco-2 Cells. Toxicological Science. 2010;116:194-205. Department of Health and Human Services. Report on Carcinogens, Twelfth Edition. http://ntp.niehs.

nih.gov/ntp/roc/twelfth/profiles/nitrosamines. pdf . Published 2011. Accessed September 12, 2014; Toxicological evaluation, supra note 3. 10 Selin E. Environmental Guidelines and Regulations for Nitrosamines: A Policy Summary (hereinafter Environmental Guidelines). February 2014. CO2 Technology Centre Mongstad. http://www. tcmda.com/Global/Aminrapporter/MIT%20 nitrosamines%20report%20final.pdf . 11 Id. 12 See e.g. , Risk Specific Intake Levels For Proposition 65 Carcinogen, N-Nitrosodimethylamine, Reproductive Hazard Assessment Section, Office of Environmental Health Hazard Assessment,

California Department of Health Services (Oct. 1, 1988); Risk Specific Intake Levels For Proposition 65 Carcinogen, N-Nitrosodiethylamine, Reproductive Hazard Assessment Section, Office of Environmental Health Hazard Assessment, California Department of Health Services (Oct. 1, 1988); Risk Specific Intake Levels For Proposition 65 Carcinogen, N-Nitroso-n-Dibutylamine, Reproductive Hazard Assessment Section, Office of Environmental Health Hazard Assessment, California Department of Health Services (Nov. 1, 1988). 13 Thomas P. Behind the label: KY Jelly. Ecologist . 2007;37.8:24-25. 14 Womens

Voices for the Earth. Potential Health Effects of Toxic Chemicals in Feminine Care Products. http://www.womensvoices.org/wp content/ uploads/2013/11/Chem Fatale Report.pdf. Published November 2013. Accessed September 12, 2014. 15 Tourgeman DE, Gentzchein E, Stanczyk FZ, Paulson RJ. Serum and tissue hormone levels of vaginally and orally administered estradiol. Am. J. Obstet. Gynecol. 1999;180(6):1480-3; Sanders JM, Mathews HB. Vaginal absorption of polyvinyl alcohol in Fischer 344 rats. Hum. Exp. Toxicol . 1990;9(2):71-7. 16 Lijinsky W, Losikoff AM, Sansone EB. Penetration of rat skin by

N-nitrosodiethanolamine and N-nitrosomorpholine. J . Natl. Cancer Inst . 1981;66(1):125-7. 17 Toxicological evaluation, supra note 3. 18 Environmental Guidelines, supra note 10. 19 Griesenbeck J, Brender J, Sharkey J, et al. Maternal characteristics associated with the dietary intake of nitrates, nitrites, and nitrosamines in women of child- bearing age: a cross-sectional study. Environmental Health. 2010;9:10. doi:10.1186/1476-069X-9-10 at 13, Table 5.
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13 20 Planned Parenthood Federation of America (PPFA), which owns one of the condoms we tested PROPER ATTIREs Basic

condom has informed RHTP that it secured a commitment from its manufacturer in May 2014 to phase out nitrosamine levels to below the limits of detection after 12 months. PPFA also has provided evidence to RHTP that condoms produced using its new manufacturing process release nitrosamines at levels that fall below the limits set by the EU and California (on file with authors). Therefore, we have omitted from the reported findings the results of our testing of what is now an outdated version of PROPER ATTIREs Basic condom. 21 WHO/UNFPA Male Latex Condom Specification, supra note 2 at 28 and

122. 22 Id 23 The U.S. Food and Drug Administration regulates the level of nitrosamines in baby bottles and nipples, but that standard is based on nitrosamine content, not exposure, and thus was not applicable to the testing we had done on condoms. See U.S. Food and Drug Administration, CPG Sec. 500.450 Volatile N-Nitrosamines in Rubber Baby Bottle Nipples (2005). 24 EN 71-12 (June 2013). This standard was set for toys made of elastomers intended for use by children less than three years old or intended to be put in the mouth. 25 Id 26 Cal. Health and Safety Code 

252495-25249.13. http://oehha.ca.gov/prop65/law/p65law72003.html . 27 Id. Under California law, if daily exposure (averaged over a lifetime) exceeds the No Significant Risk Level (NSRL), the company selling the product must provide a warning to potential consumers. 28 See Office of Environmental Health Hazard Assessment. No Significant Risk Levels (NSRLs) for Carcinogens and Maximum Allowable Dose Levels (MADLs) for Chemicals Causing Reproductive Toxicity. http://www.oehha.ca.gov/Prop65/pdf/ safeharbor070113.pdf. Published July 2013. Accessed September 12, 2014. 29 Risk Specific Intake

Levels For Proposition 65 Carcinogen, N-Nitrosodimethylamine, Reproductive Hazard Assessment Section, Office of Environmental Health Hazard Assessment, California Department of Health Services (Oct. 1, 1988); Risk Specific Intake Levels For Proposition 65 Carcinogen, N-Nitrosodiethylamine, Reproductive Hazard Assessment Section, Office of Environmental Health Hazard Assessment, California Department of Health Services (Oct. 1, 1988); Risk Specific Intake Levels For Proposition 65 Carcinogen, N-Nitroso-n-Dibutylamine, Reproductive Hazard Assessment Section, Office of Environmental Health Hazard

Assessment, California Department of Health Services (Nov. 1, 1988). 30 Epithelial tissue refers to the tissue that covers the whole surface of the body including the lining of internal and external body surfaces. See Department of Biodiversity & Conservation Biology, University of the Western Cape, Epithelial Tissues, http:// www.botany.uwc.ac.za/sci_ed/grade10/mammal/ epithelial.htm . Accessed September 12, 2014. 31 Because our results for PROPER ATTIRE are no longer relevant, see supra note 20, we are reporting our findings on 23 of the 24 condoms tested. 32 WHO/UNFPA Male Latex Condom

Specification, supra note 2 at 28 and 122. 33 German Study Says Condoms Contain Cancer-Causing Chemical. http://www.dw.de/german study says condoms contain cancer causing chemical/a 1220847 . Published May 29, 2004. Accessed September 12, 2014.
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14 Acnowldgmnts Fundn for ths reserch nd report ws provded n prt b  personl rnt from Shel nd JeffreHollender throuh donor dvsed fund of the

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womn of n e to cheve full reproductve freedom wth ccess to the sfest, most effectve, pproprte nd cceptble technoloes for ensurn her own helth nd controlln her fertlt The Center for Envronmentl Helth protects people from toxc chemcls b worn wth communtes, consumers,

worers, overnment, nd the prvte sector to demnd nd support busness prctces tht re sfe for publc helth nd the envronment