0 Lead Content of Children's and Adult Jewelry Products: Consolidated Studies Jennifer L. Druhan Richard P. Maas Steven C. Patch UNC Asheville Environmental Quality Institute Technical Report # 03 111A September 2003 1 I. INTRODUCTION Lead is a heavy metal used in a variety of common manufacturing and industrial processes. The metal is both extremely malleable and at the same time in elastic, making it both easy to use and mechanically strong. As a result, traditional sheeting, as well as pipes and joints used in building material were often lead based. Lead acid batteries make use of the metals' conductivity and resistance to corrosion. Further uses of lead include, but are not limited to, use as a gasoline additive to increase octane rating, as cable sheathing for telephone and power lines, as the basis of wire and imitation jewelry, as a principal component in mechanical bearings and as a pigment in paints ( 1).

In the United States, " lead poisoning" in children was first identified as a clinical disorder in the 1920s. However, the condition was thought to be associated with poor quality housing, and as such lead poisoning did not become a major issue until the 1960s ( 2). Finally, in 1978 the first of a variety of legislation limiting the use of lead in consumer products was introduced in the United States. The United States Environmental Protection Agency estimates that in the same year between three and four million children in the U. S. lived with elevated blood lead levels ( 3).

Today we better understand the toxic effects of long term low level lead exposure to children, which may result in brain damage, IQ and reading deficits, hyperactivity, and other behavioral problems. Prolonged exposure of adults to lead may also cause difficulties in pregnancy, high blood pressure, nerve disorders and muscle and joint pain ( 4). Furthermore the medical community has come to understand that only very low levels of lead are required to cause health problems, and the officially defined threshold level of lead poisoning is now only 10 micrograms of lead per deciliter of blood. A recent study by Lanphear et al found measurable learning deficits in association with BLLs as low as 2.5ug/ dL ( 5), while an even more recently Canfield et al found an IQ difference of 7.4 points between children with BLLs of 1.0ug/ dL and 10.0 ug/ dL ( 6). Lead has been prohibited or severely restricted in most consumer products including gasoline, paint for use in housing, and in food packaging, which has reduced the amount of lead related health problems significantly. Nonetheless, there are still approximately 890,000 children living in the United States alone with elevated BLLs. The need to identify and restrict further sources of lead exposure, especially to children, is clear ( 7).

Despite the fact that many major sources of lead exposure, such as lead based paint, have been phased out, there continue to be a variety of lead sources available through which poisoning could occur. The purpose of this study is to consider the lead contamination associated with metallic imitation jewelry, including pieces intended specifically for children. Approximately 120 pieces of metallic jewelry acquired from various nation wide retail stores located in California were tested for total lead content. Considering the fact that some of these jewelry pieces were rings designed to sit on a person's hand or earrings meant to be worn through the skin, the hazard of lead content in these pieces becomes especially significant. For example, a child wearing a metallic ring may use that hand to handle their food as they are eating, or may put the ring directly in their mouths. As reported earlier ( 1), imitation jewelry has traditionally been made using lead because it gives weight to the pieces and is easily manufactured. Despite this knowledge, no significant studies into the exposure of individuals to lead through common jewelry items have yet been published, and no national restrictions exist in the manufacturing and sale of these items, even when intended specifically for children. 2 II. METHODOLOGY Jewelry pieces were purchased from a variety of retail stores located in California by the California based non profit organization, As You Sow, and shipped under appropriate chain of custody documentation to the Environmental Quality Institute ( EQI) laboratory, where all analyses were conducted. Four separate shipments of jewelry pieces were sent and received. A total of 285 jewelry items from 20 different stores were included in this study. The first shipment contained 42 items from seven locations ( Table 1). In the second round of testing, 30 items were sent from four of the seven locations in the first analysis, as well as four items from two new locations ( Table 2). A third round of samples contained 44 pieces from eight retail stores ( Table 3). The final round of samples shown in Table 4 consisted of 169 pieces which included additional items from 13 of the stores already tested, as well as items from three new locations. Items shown in Tables 1 and 2 appeared to be generally oriented towards youth, given their description and place of purchase. The items shown in Table 3 and 4 were taken to represent a sample of jewelry intended for both youth and adults, given their general descriptions and place of purchase.

Table 1   Lab Identification Number, Description and Place of Purchase of First Round of Jewelry Received 1/ 31/ 03 Lab ID# Description Store Name C 1 a metal butterfly hairclips Claire's Boutique C 1 b " " " C 1 c " " " C 2 13" " silver" ring w/ bumpy outside surface Claire's Boutique C 3 metal bracelet w/ rose on top, coppery pink hue Claire's Boutique C 4 a necklace w/ " bronze" cord & " bronze" piece w/ purple stone attached Claire's Boutique C 4 b " " " C 5 bracelet charm " silver" w/ red heart Claire's Boutique C 6 " silver" ring that says " Love", size 8 Claire's Boutique C 7 a blue dolphin " Best Friends" pendants Claire's Boutique C 7 b " " " C 8 expandable " silver" w/ heart " crystal" bracelet Claire's Boutique C 9 a 5" " copper" necklace w/ pendant Claire's Boutique C 9 b " " " C 10 " silver" bracelet w/ pink heart Claire's Boutique C 11 size 7 pair of " golden" rings Claire's Boutique C 12 a " Best Friend" silver pair necklace Claire's Boutique C 12 b " " " C 13 size 6 " silver" mood ring Claire's Boutique M 1 Bronze looking ring w/ inlayed " stones" made by Ellemenno Mervyn's M  2 Silver looking piece with blue inlayed " stones" on leather string Mervyn's M 3 bronze looking piece with flesh colored " stones" inlayed on leather string Mervyn's M 4 red beaded necklace w/ " silver" heart pendant Mervyn's M 5 flower pendant w/ " silver" backing on leather string Mervyn's 3 M 6 turquoise beaded necklace w/ " silver" pendant w/ turq stones inlayed Mervyn's M 7 " silver" ring w/ colorful stones inlayed in flower pattern Mervyn's M 8 a " silver" chain belt w/ coins attached Mervyn's M 8 b " " " W 1 " silver" choker with light blue ' stone' center Walmart # 1 W 2 " silver" necklace w/ hanging pendant w/ sapphire stone setting Walmart # 1 W 3 " silver" toe rings w/ purple Walmart # 1 W 4 cuff bracelet " silver" twisted metal pattern Walmart # 1 G 1 " silver" stretch bracelet in diamond shape w/ sapphire inlayed stones Gottschalk's G 2 " silver charm bracelet set w/ attachable charms cheerleader Gottschalk's G 3 " silver" charm bracelet set w/ attachable charms dance Gottschalk's G 4 " silver" charm bracelet w/ star & blue bead charms Gottschalk's K 1 heart ring w/ pink " silver" stones Big Kmart K 2 " Best Friends" necklaces w/ cherries Big Kmart K 3 Joe Boxer toe rings " silver" imprinted w/ patterns Big Kmart K 4 Teddy Bear necklace & earrings " silver" Big Kmart T 1 ankle bracelet w/" silver" medallions Target T 2 " silver" ring w/ large pink stone in center Target T 3 " silver" rings w/ blue sapphire inset Target T 4 heavy " silver" bracelet w/ connected rectangles Target WM 1 necklace grey metal w/ 1 pendant saying ' forever' with heart, other saying ' love' Walmart # 2 WM 2 key ring in heart shape w/ inscription Walmart # 2 WM 3 a bracelet w/ coin charms Walmart # 2 WM 3 b " " "

WM 4 key ring in shape of flower & leaf Walmart # 2 WM 5 necklaces each w/ pendant saying ' Bet Friends Forever' one blue, one pink Walmart # 2 WM 6 key ring in shape of key Walmart # 2 Table 2: Lab Identification Number, Description and Place of Purchase of Second Round of Jewelry Samples Received 3/ 11/ 03 K 5 days of the week " silver" rings w/ stickers Big K Mart K 6 earring set hoops, partial circles, hearts, butterflies, balls, white stone, all silver Big K Mart K 7 earring set flowers w/ pink, blue & purple stones, hoops w/ diff texture Big K Mart K 8 earring necklace set heart rainbow earrings & necklace Big K Mart K 9 " silver" charm bracelet w/ sanddollar, seahorse, small charms Big K Mart K 10 earring w/ attached charms made by Joe Boxer Big K Mart K 11 necklace w/ attached silver charms, flower, heart & round piece Big K Mart K 12 necklace w/' Best Friends' heart & flower pendants Big K Mart W 5 horseshoe ' Best Friends' necklace Wal Mart W 6 " silver" cross w/ red& blue stones on black leather necklace Wal Mart W 7 a 4 pack: rainbow butterfly ring, pink stone ring, heart necklace, silver ring Wal Mart W 7 b " " " W 8 2 silver necklaces " My Lucky Charms" 1 heart, one flower Wal Mart 4 W 9 flower stone necklace and earring set Wal Mart W 10 silver butterfly choker Wal Mart W 11 Panama Jack silver chain w/ round pendant Wal Mart C 14 silver hearts ring Claire's Bout C 15 metal hair clip w/ flower etching Claire's Bout C 16 butterfly bracelet Claire's Bout C 17 dolphin earring set clear, blue & black stones Claire's Bout C 18 ring w/ basketballs & flowers Claire's Bout C 19 set of 3 earrings: hearts w/ pink, clear and dark pink stones Claire's Bout C 20 2 key chains of girls w/ baseballs 1 blue & 1 pink dress Claire's Bout C 21 square earrings w/ pink stones Claire's Bout C 22 metal ring w/ pink butterflies in blue background Claire's Bout M 9 earrings w/ pink stone centers Mervyn's M 10 silver ring w/ turquoise center Mervyn's M 11 " silver" earrings w/ red & blue stones Mervyn's M 12 painted stone necklace w' silver backing on blk string necklace Mervyn's M 13 painted stone necklace w' silver backing on blue string necklace Mervyn's M 14 stretch bracelet w/ picture squares w/ metal backs Mervyn's KU 1 silver necklace w/ butterfly Kids ' R' Us KU 2 silver necklace w/ 3 hearts Kids ' R' Us KU 3 silver necklace w/ heart & matching hair clips w/ hearts Kids ' R' Us R 1 black jeweled necklace w/ pendant Ross Table 3: Lab Identification Number, Description and Place of Purchase of Third Round of Jewelry Samples Received 3/ 7/ 03 Lab ID# Description Store Name LNY 1 a metal chain bracelet w/ small heart Lerner New York LNY 1 b " " " LNY 2 metal ring w/ stone inlay Lerner New York LNY 3 Asian coin on bead and leather necklace Lerner New York LNY 4 metal oval pendant w/ stone inlay on leather necklace Lerner New York LNY 5 metalic round pendant on bead & chain necklace Lerner New York LT 1 butterfly mood ring Limited Too LT 2 heart chain bracelet Limited Too LT 3 best friends star bracelets ( 2) Limited Too LT 4 metal flower pendant on suede necklace Limited Too LT 5 metal pendant w/ pink stones on leather necklace Limited Too LT 6 a best friend heart charm bracelet Limited Too LT 6 b " " " CR 1 link bracelet w/ oval pendant Charlotte Russe CR 2 a chain link necklace Charlotte Russe CR 2 b " " " CR 3 ring w/ purple & pink gemstones Charlotte Russe CR 4 pendant on leather choker Charlotte Russe CR 5 metal ring w/ red gemstone Charlotte Russe CR 6 " silver" chain anklet w/ heart charm Charlotte Russe GU 1 silver stick necklace Group USA GU 2 round metal pendant on blue suede Group USA GU 3 metal butterfly pendant w/ stones Group USA GU 4 twist wirre w/ beads & oval pendant Group USA 5 HT 1 celtic rope necklace Hot Topic HT 2 medium shot necklace Hot Topic HT 3 kitty on a rug necklace Hot Topic HT 4 fairy pendant necklace Hot Topic EX 1 a " silver' double band cuff bracelet Express EX 1 b " " " EX 2 a ornate link bracelet Express EX 2 b " " " EX 3 " silver" bracelet of 6 square plates Express EX 4 " silver" choker Express EX 5 black oval pendant on " silver" chain Express EX 6 " silver" chain link bracelet Express WS 1 a set of 6 metalic thin bracelets Wet Seal WS 1 b " " " WS 1 c " " " WS 2 burnished silver bracelet w/ coin like chains Wet Seal WS 3 copper\ bronze cuff bracelet Wet Seal WS 4 " silver" ring w/ red gemstones Wet Seal WS 5 oval pink stone pendant on leather necklace Wet Seal WS 6 small flower pendant on leather necklace Wet Seal WS 7 butterfly pendant w\ yellow gemstones on wire necklace Wet Seal WS 8 flower stone pendant on leather necklace Wet Seal CT 1 pink rectangle pendant on beaded shain necklace Clothestime CT 2 stretch bracelet of blue stone hearts in rectangle metal links Clothestime CT 3 a oval blue stone pendant on metal hoop necklace Clothestime CT 3 b " " " CT 4 metal cuff bracelet w/ magenta stones Clothestime CT 5 purple stone pendant on wire necklace Clothestime Table # 4: Lab Identification Number, Description, and Place of Purchace of Fourth Round of Jewelry Received 8/ 7/ 03.

Lab ID# Description Store Name AT 1 bracelet of black/ silver ovals & rectangles Afterthoughts AT 2 shot bead bracelet Afterthoughts AT 3 metallic cuff bracelet with gothic cross cutouts Afterthoughts AT 4 bracelet of egg shaped links Afterthoughts AT 5 bracelet of O shaped links Afterthoughts AT 6 anklet with heart pendant Afterthoughts AT 7 antiqued cross pendant w/ black stones on beaded necklace Afterthoughts AT 8 flower pendant w/ black stones on beaded necklace Afterthoughts AT 9 round pendant w/ green stones on chain necklace w/ beads Afterthoughts AT 10 ornate design ring Afterthoughts AT 11 plain, wide, square shaped ring Afterthoughts AT 12 5 row pattern ring ( brick wall type pattern) Afterthoughts CR 7 cuff bracelet w/ large round disc Charlotte Russe CR 8 chain anklet w/ jeweled pendant & hanging beads Charlotte Russe CR 9 set of 5 square ish bangle bracelets Charlotte Russe CR 10 set of 5 rings  some ornate, some plain Charlotte Russe 6 CR 10a " " " " CR 11 ring w/ large white opalescent oval stone Charlotte Russe CR 12 flower design pendant ring w/ blue stone center Charlotte Russe CR 13 metallic necklace w/ leaves & flowers w/ stone and bead inlay Charlotte Russe CR 14 metallic flower like pendant w/ gemstones on leather necklace Charlotte Russe CR 15 heart pendant on chain necklace Charlotte Russe CR 16 star pendant on 3 chain choker Charlotte Russe CR 17 stick like pendant on wire necklace Charlotte Russe CR 18 double wire necklace w/ small square beads Charlotte Russe CR 19 chain necklace w/ blue beads Charlotte Russe EX 7 metallic rope bracelet Express EX 8 necklace w/ small oval discs Express EX 9 bracelet w/ small round discs Express EX 10 link bracelet Express EX 10a " " EX 11 red stone inlay pendant on metal chain Express EX 12 metallic chain necklace Express EX 13 multi chain necklace Express EX 14 triangle pendant on metal chain Express EX 15 Asian symbol pendant on metal chain Express EX 16 O shaped pendant on metal chain Express G 5 metallic ornate round pendant w/ multi colored inlaid stones on bead necklace Gottschalk's G 6 metallic square ish pendant w/ beads on collar of amber stones Gottschalk's G 7 black & gold tone pendant necklace on gold tone chain w/ black beads Gottschalk's G 8 painted metal bracelet & earrings set Gottschalk's G 8a " " " " " "

G 9 gold tone love bird pin w/ green and blue gemstones Gottschalk's GU 5 wire collar necklace with crystals Group USA GU 6 wire necklace with wire rings & cat eye pendant Group USA GU 7 long drop earrings w/ black inlaid beads Group USA GU 8 gold tone wire necklace w/ 9 hanging sticks Group USA GU 9 square wire hoop earrings Group USA GU 10 16 chain silver tone necklace Group USA GU 11 2 chain crossover silver tone necklace Group USA GU 12 multi ring pendant on chain Group USA GU 13 ornate pendant on rope necklace Group USA HT 5 Celtic ( biohazard) symbol on shot bead necklace Hot Topic HT 5a " " HT 6 skull & crossbones link bracelet Hot Topic HT 7 skull pendant on rubber necklace Hot Topic HT 8 coffin pendant on bead necklace Hot Topic HT 9 ankh symbol pendant on cord necklace Hot Topic HT 10 antique siam ring  ornate w/ red gemstone Hot Topic HT 11 bike chain bracelet Hot Topic HT 12 Y shaped necklace of stars w/ red gemstones Hot Topic HT 13 anklet of starts w/ red gemstones Hot Topic 7 HT 14 heart pendant on chain necklace Hot Topic K 13 Osbourne's pendant on metal bead chain Big Kmart K 14 three square pendants on leather choker Big Kmart K 15 small jeweled round pendant w/ drop on metal chain Big Kmart K 16 necklace duo set  oval links & small chain w/ balls Big Kmart K 17 bracelet w/ 3 large flower charms/ pendants w/ beads Big Kmart K 18 gold tone chain necklace w/ red & black beads Big Kmart K 19 set of 3 pairs of hoop earrings Big Kmart K 20 metallic and black wood bead necklace Big Kmart K 21 large link chain necklace Big Kmart KU 4 soccer/ dance/ cheer pendant necklaces trio set Kids ' R' Us KU 5 flower pendant on leather necklace Kids ' R' Us KU 6 heart pendant on pink beaded necklace Kids ' R' Us KU 7 blue heart " dance" pendant necklace & matching barrettes set Kids ' R' Us KU 8 soccer pendant necklace Kids ' R' Us KU 9 pink heart on plate pendant w/ pink metallic necklace Kids ' R' Us KU 10 red megaphone pendant necklace Kids ' R' Us KU 11 set of 8 barrettes Kids ' R' Us LNY 6 large asian coin pendant w/ beads on leather cord Lerner New York LNY 7 flower shaped pendant w/ inlaid stones on leather necklace Lerner New York LNY 8 necklace of three metallic chains strung w/ 5 oval beads Lerner New York LNY 9 drop pendant w/ large purple stone on chain necklace Lerner New York LNY 10 multiple small oval discs linked together, on a chain necklace Lerner New York LNY 11 set of 8 bangle bracelets, 3 w/ beads Lerner New York LNY 12 metal & stone sticks on wire necklace Lerner New York LNY 13 O shaped pendant on rope necklace Lerner New York LNY 14 ring w/ oval pink stone Lerner New York LNY 15 large oval pink stone pendant on wire necklace Lerner New York LNY 16 large link bracelet w/ heart pendant Lerner New York LNY 17 small square tubes ( approx 1") strung on 3 wire chains Lerner New York LT 7 tiny flowers on wire necklace Limited Too LT 8 soccer ball charm bracelet Limited Too LT 9 heart mood pendant on cord necklace Limited Too LT 10 ornate butterfly pendant on cord necklace Limited Too LT 11 letter " A" charm bracelet Limited Too LT 12 charm bracelet Limited Too LT 13 hoop earring trio set Limited Too LT 14 two bracelet set  " best" & " friends" Limited Too LT 15 " Cheer" pendant on leather necklace Limited Too LT 16 soccer star bracelet and charms set Limited Too N 1 round mosaic pendant w/ beads on beaded necklace Nordstrom N 2 silver tone round piece on larger gold tone pendant & chain Nordstrom N 3 ornate cross w/ pink & purple gemstones on chain w/ beads Nordstrom N 4 round pendant w/ etched design on beaded necklace Nordstrom N 5 ring w/ pink design under clear sphere Nordstrom N 6 tiny silver tone beads on a stretchy band bracelet ( set of 16) Nordstrom N 7 painted flower pendants on stretchy bracelet of beads & stones Nordstrom 8 N 8 rectangle pieces w/ beads & stones on stretchy bracelet Nordstrom N 9 silver tone locket on chain w/ beads Nordstrom N 10 earrings w/ 3 hearts design Nordstrom N 10a " " " " "

N 11 charm bracelet ( piano, trumpet, violin, computer, ILU charms) Nordstrom N 12 painted pink cursive S pendant on metal chain Nordstrom N 13 guitar pick pendant necklace  painted black star on blue Nordstrom N 14 small round pendant w/ stone on wire beaded necklace Nordstrom N 15 round pendant w/ etched black design on beaded necklace Nordstrom N 16 wide ring w/ X type design Nordstrom R 2 round pendant with inlaid stones on beaded necklace Ross R 3 flower pendant with inlaid stones on beaded necklace Ross R 4 earrings of multiple small coins Ross R 5 ornate earrings  dangling hoop with multiple discs Ross R 6 necklace & earrings set  stone in metalic pendant Ross R 7 square pendant necklace & earrings set Ross R 8 anklet & toering set w/ blue stones Ross R 9 purple beaded necklace & purple stone toering set Ross R 10 chain link bracelet w/ charm and earrings Ross R 11 gold metallic squarish hoops duo earrings set Ross T 5 double wire necklace w/ small square ish beads Target T 6 round pendant on rope & chain necklace Target T 7 intricate chain necklace Target T 8 cross shaped pendant w/ gemstones on metal chain choker Target T 9 multiple wire necklace w/ white stones Target T 10 large cross w/ gemstones on metal chain necklace Target T 11 bronze tone vintage necklace large pendant w/ beads on collar Target T 12 bronze tone vintage bracelet ornate rectangles linked w/ beads Target T 13 oar shaped pendant necklace Target T 14 chain bracelet w/ large oval white stone pendant/ charm Target T 15 gold tone & silver tone headband set Target T 15a T 16 wide chain strung w/ one metal bead Target T 17 double chain necklace  each w/ one O shaped pendant Target T 18 round pendant on chain necklace w/ stones Target TU 1 "# 1 Grandma" pendant on rope necklace Toys ' R' Us TU 2 " Alison" pendant on bracelet Toys ' R' Us W 12 multi stone ring Wal Mart W 13 purple & pink stone inlaid butterfly ring Wal Mart W 14 silver tone ring with black engraved design Wal Mart W 15 thumb ring duo set Wal Mart W 16 silver tone ornate cross pendant Wal Mart W 17 gold and silver tone link bracelet Wal Mart W 18 silver tone cuff bracelet w/ stars & moons design Wal Mart W 19 silver tone bracelet with blue stone inlaid charms Wal Mart WS 9 scalloped cross w/ stones on metal chain Wet Seal WS 10 " SEXY" choker necklace Wet Seal 9 WS 11 large hoops duo earring set Wet Seal WS 12 trio adjustable toe rings Wet Seal WS 13 disk on wire necklace Wet Seal WS 14 small disks on metal necklace Wet Seal WS 15 wire necklace w/ beads Wet Seal WS 16 earrings  4 oval ish pieces w/ chain connection Wet Seal WS 17 rhinestone peace symbol on wire necklace Wet Seal WS 18 large link chain choker necklace Wet Seal WS 19 earrings  3 square hoops Wet Seal WS 20 cross pendant on pink cord necklace Wet Seal WS 21 ornate metal cross shape on metal chain Wet Seal WS 22 swirl pendant on wire necklace Wet Seal WS 23 cuff hinge bracelet Wet Seal Upon arrival at the EQI laboratory, each individual piece of jewelry was placed in its own plastic bag along with any accompanying tags or packaging and was labeled with an individual identification number ( Tables 1, 2, 3 and 4). Jewelry analysis for lead content of all four shipments was conducted in an identical manner. A sample was obtained from each piece by clipping a small section of metal off with a pair of handheld pliers. Due to the irregularity of the jewelry items, there was some discretion involved in choosing the section of metal to sample in each case. Most jewelry pieces included a metal setting around a central jewel or stone, and such pieces were always sampled from the edge of the metal setting. Other jewelry pieces were sampled by clipping off a substantial section of metal, while thin wire, non metal components and paintcovered areas were strictly avoided. Some jewelry pieces contained more than one substantial section of metal that appeared different from the other sections. In these cases multiple samples from the same jewelry piece were taken. Assayed sections of metal varied in weight between roughly 0.10 and 1.0 grams.

Each metal sample was placed in a clean, labeled 500mL or 1L plastic bottle to which 20mL of 50% ( v/ v) nitric acid ( HNO3) was added, and the bottles were left uncapped to fume for 24 hours. Once samples were dissolved in the acid, 500mL of deionized water was added to each bottle before being capped and shaken. Samples were analyzed for lead content using flame atomic absorption spectroscopy ( FAAS) following NIOSH method 7082. Lead detection on FAAS has an expected detection limit of about 0.05mg/ L and sensitivity of about 0.5mg/ L ( 8). The lower reporting level for these particular analyses was 0.20 mg/ L, which corresponds to a lead content between roughly 0.01% and 0.10% depending on the weight of the original sample.

II RESULTS AND DISCUSSION Table 5 shows the assayed section location and weight, dilution factor, lead content in mg/ L, and the final percent weight of lead for each sample in the first round of testing ( Table 1). Table 6, 7 and 8 show the same information for samples listed in Table 2, 3 and 4, respectively. Those concentrations that were reported as less than the lower reporting level ( 0.02 mg/ L) are represented in weight percent as the reported value or less, and are considered 0.0% for any subsequent calculations. 10 Table 5: Lab Identification Number, Location and Weight of Sampled Section, Dilution Factor and Lead Content in mg/ L and % Pb for Samples Received 1/ 31/ 03.

Lab ID# assayed section location weight ( g) dil( mL) Pb ( mg/ L) % Pb C 1 a butterfly wing 0.3550 520 < 0.20 < 0.03% C 1 b butterfly wing 0.4821 520 < 0.20 < 0.03% C 1 c butterfly wing 0.5558 520 < 0.20 < 0.02% C 2 cross section 1.1437 520 1252.23 56.93% C 3 rose petal 0.3328 520 42.90 6.70% C 4 a " bronze" chain 0.4605 520 < 0.02 < 0.02%

C 4 b " bronze" around stone 1.1773 520 1899.45 83.90% C 5 around red stone 0.8378 520 904.50 56.14% C 6 cross section 0.9578 520 1000.98 54.34% C 7 a silver chain 1.0837 520 < 0.20 < 0.01% C 7 b dolphin pendant 1.0916 520 1593.93 75.93% C 8 silver backing of heart 0.7987 520 < 0.20 < 0.02% C 9 a chain necklace 1.0517 520 < 0.10 < 0.01% C 9 b copper around stone 1.2262 520 1597.95 67.76% C 10 silver around heart 0.6066 520 64.32 5.51% C 11 cross section 0.9024 520 < 0.20 < 0.02% C 12 a silver chain necklace 0.8720 520 < 0.20 < 0.02% C 12 b Best Friend' 0.8735 520 < 0.20 < 0.02% C 13 NOT RECEIVED M 1 cross section 1.0396 520 907.99 45.42% M  2 outside edge of piece 0.6668 520 536.31 41.82% M 3 outside edge of piece 1.1314 520 1248.36 57.38%

M 4 " silver" heart pendant 0.9464 520 1.03 0.06% M 5 around flower stone 0.9769 520 780.73 41.56% M 6 " silver" pendant 0.5699 520 12.88 1.18%

M 7 cross section 1.0056 520 705.99 36.51% M 8 a chain 1.0151 520 < 0.20 < 0.01% M 8 b coin 0.4924 520 0.24 0.03% W 1 " silver" around stone 0.5346 520 0.45 0.04% W 2 silver pendant 0.9642 520 1148.37 61.93% W 3 cross section 0.7153 520 1.14 0.08% W 4 silver bracelet 0.6198 520 < 0.20 < 0.02% G 1 silver bracelet 0.8800 520 700.94 41.42% G 2 triangle charm w/ gems 0.2588 520 0.36 0.07% G 3 musical note charm 0.4640 520 0.85 0.10% G 4 " silver" edge of large star 0.3560 520 19.36 2.83% K 1 cross section 1.0124 520 927.18 47.62% K 2 " Best Friend" charm 1.2251 520 1588.73 67.43% K 3 ring w/ waves cross sect 0.4537 520 < 0.20 < 0.02% K 4 big Teddy bear 0.6265 520 845.37 70.17% T 1 " silver" circle 0.2639 520 < 0.20 < 0.04% T 2 ornamental edge 0.8537 520 2.08 0.13% T 3 one of 3 silver rings 0.7578 520 4.12 0.28% T 4 one of the rectangles 1.1182 520 1917.54 89.17% 11 WM 1 " Forever" pendant 0.7046 520 0.50 0.04% WM 2 " Heart" 0.6601 520 < 0.20 < 0.03% WM 3 a from " Elizabeth" coin 0.8044 520 1236.15 79.91% WM 3 b bracelet chain link 0.3546 520 < 0.20 < 0.04% WM 4 leaf section 0.7142 520 1.04 0.08% WM 5 pink pendant 0.3728 520 < 0.20 < 0.01% WM 6 key 0.1867 520 < 0.20 < 0.01%

Table 6: Lab Identification Number, Location and Weight of Sampled Section, Dilution Factor and Lead Content in mg/ L and % Pb for Second Round of Testing Received 3/ 11/ 03.

Lab ID# assayed section location weight ( g) dil( mL) Pb ( mg/ L) % Pb K 5 edge of pendant & band on Monday ring 0.1188 520 < 0.20 < 0.09% K 6 silver heart earring minus post 0.1050 520 < 0.20 < 0.10% K 7 piece of rough textured hoop & blue flower 0.4331 520 744.37 89.37% K 8 metal pendant of necklace & earring 0.1818 520 < 0.20 < 0.06% K 9 sandollar charm 0.5207 520 850.42 84.93% K 10 key charm 0.1960 520 211.09 56.00% K 11 heart charm 0.1706 520 219.17 66.80% K 12 " Friends" heart necklace pendant 0.3017 520 508.03 87.56% W 5 " best" metal pendant piece 0.1651 520 3.53 1.11% W 6 two point of cross pendant 0.4345 520 1.78 0.21% W 7 a edge of heart necklace pendant 0.2275 520 0.27 0.06% W 7 b band of pink stone ring 0.3126 520 < 0.20 < 0.04% W 8 metal from heart & flower pendants 0.1816 520 0.26 0.07% W 9 backside of flower on necklace 0.1650 520 0.25 0.08% W 10 lower butterfly wings 0.1913 520 0.28 0.08% W 11 pendant edge 0.2603 520 0.34 0.07% C 14 cross section of ring 0.2664 520 54.54 10.65% C 15 side of front band w/ etching 0.1661 520 < 0.20 < 0.07% C 16 butterfly wing 0.1139 520 < 0.20 < 0.09% C 17 dolphin earring 0.3395 520 603.98 92.51% C 18 outside of ring 0.1760 520 284.82 84.15% C 19 heart material around stones 0.1334 520 < 0.20 < 0.08% C 20 baseball bat of red dress, hat brim of blue 0.1751 520 158.57 47.09% C 21 outside or earring 0.5995 520 1008.99 87.52% C 22 outside section of ring 0.1364 520 170.69 65.07% M 9 edge of earring 0.2301 520 298.96 67.56% M 10 edge of ring 0.5597 520 627.21 58.27% M 11 edge of red stone 0.2538 520 300.98 61.67% M 12 edge of silver backing on pendant 0.2301 520 0.19 0.04% M 13 edge of pendant 0.1051 520 < 0.20 < 0.10% M 14 outside edge of picture pendant 0.1136 520 135.34 61.95% KU 1 butterfly pendant 0.1541 520 196.95 66.46% KU 2 edge of pendant of two hearts 0.1338 520 141.40 54.95% KU 3 edge of heart 0.2311 520 223.21 50.22% R 1 edge of pendant 0.2243 520 326.23 75.63% 12 Table 7: Lab Identification Number, Location and Weight of Sampled Section, Dilution Factor and Lead Content in mg/ L and % Pb for Third Round of Testing Received 3/ 7/ 03.

Lab ID# assayed section location weight ( g) dil( mL) Pb ( mg/ L) % Pb LNY 1 a edge of heart pendant 0.2174 520 304.01 72.72% LNY 1 b link of bracelet chain 0.3089 520 < 0.20 < 0.04% LNY 2 piece of silver bank 0.1264 520 148.47 61.08% LNY 3 edge of coin 0.6810 520 1064.54 81.29% LNY 4 edge of pendant 0.3267 520 263.61 41.96% LNY 5 edge of pendant 0.2747 520 1.06 0.20% LT 1 section of silver band 0.2533 520 < 0.20 < 0.05% LT 2 tip of heart pendant 0.1760 520 292.90 86.54% LT 3 section of silver loop above pendant 0.2471 520 370.67 78.00% LT 4 edge of metal pendant 0.5996 520 907.99 78.74% LT 5 edge of metal pendant 0.3670 520 657.51 93.16% LT 6 a edge of flat heart pendant 0.2899 520 559.54 100.37% LT 6 b piece of rounded heart pendant 0.2762 520 < 0.20 < 0.04% CR 1 edge of metal pendant 0.4575 520 726.19 82.54% CR 2 a edge of metal pendant 0.5318 520 491.87 48.10% CR 2 b piece of chain links 0.2506 520 < 0.20 < 0.05% CR 3 section of metal band 0.4489 520 0.18 0.02% CR 4 edge of metal pendant 0.1449 520 < 0.20 < 0.08% CR 5 edge of metal around stone 0.2602 520 320.17 63.98% CR 6 tip of metal heart pendant 0.1977 520 225.23 59.24% GU 1 tip of silver stick pendant 0.1734 520 260.58 78.14% GU 2 section of metal pendant 0.6023 520 542.37 46.83% GU 3 edge of butterfly pendant wing 0.5249 520 791.84 78.44% GU 4 edge of metal around stone pendant 0.3432 520 433.29 65.65% HT 1 piece of celtic symbol 0.5965 520 657.51 57.32% HT 2 one " shot" or ball from necklace 0.8576 520 < 0.20 < 0.02% HT 3 tip of rug on pendant w/ pink paint 0.3596 520 476.72 68.94% HT 4 edge of pendant 0.3873 520 468.64 62.92% EX 1 a edge of metal pendant 0.3698 520 440.36 61.92% EX 1 b section of metal band 0.6962 520 < 0.20 < 0.02% EX 2 a piece of ornate links 0.2673 520 245.43 47.75% EX 2 b piece of metal clasp 0.4515 520 451.47 52.00% EX 3 edge of one square plate 0.2922 520 300.98 53.56% EX 4 piece of choker at middle hook 0.3283 520 355.52 56.31% EX 5 piece of metal from around pendant 0.5986 520 678.72 58.96% EX 6 piece from one smooth link 0.5731 520 < 0.20 < 0.02% WS 1 a section of one ' gold' bracelet 0.5781 520 < 0.20 < 0.02% WS 1 b section of one ' silver' bracelet 0.6738 520 < 0.20 < 0.02% WS 1 c section of one ' copper' bracelet 0.6905 520 < 0.20 < 0.02% WS 2 one small silver coin 0.5684 520 < 0.20 < 0.02% WS 3 section of one smooth cuff 0.2095 520 < 0.20 < 0.05% WS 4 section from side of ring below gems 0.1502 520 285.83 98.96% WS 5 piece of metal loop above pendant 0.2286 520 301.99 68.69% WS 6 piece from metal around pendant 0.3786 520 550.45 75.60% WS 7 edge of butterfly pendant wing 0.3233 520 471.67 75.86% WS 8 piece from metal around pendant 0.5816 520 0.28 0.03% 13 CT 1 piece from metal around pendant 0.4623 520 620.14 69.75% CT 2 top of one metal rectangle 0.6841 520 1264.52 96.12% CT 3 a piece from metal around pendant 0.6177 520 761.54 64.11% CT 3 b section from metal hoop 0.1619 520 0.16 0.05% CT 4 section of outer metal cuff 0.7114 520 < 0.20 < 0.02% CT 5 metal setting around stone 0.1885 520 1.00 0.28%

Table 8: Lab Identification Number, Location and Weight of Sampled Section, Dilution Factor and Lead Content in mg/ L and % Pb for Fourth Round of Testing Received 8/ 7/ 03.

Lab ID# assayed section location weight ( g) dil( mL) Pb( mg/ L) % Pb AT 1 edge of one silver oval 0.5170 520 498.94 50.18% AT 2 1/ 2 of one shot bead 0.2609 520 0.01 < 0.00% AT 3 edge of bracelet above cross 0.1445 520 0.02 0.01% AT 4 edge of one egg link 0.6293 520 830.22 68.60% AT 5 section of one O link 0.2319 520 392.89 88.10% AT 6 tip of heart pendant 0.2925 520 310.07 55.12% AT 7 edge of cross pendant 0.2591 520 0.12 < 0.04% AT 8 piece of metal edge on pendant 0.1186 520 125.24 54.91% AT 9 metal loop at top of pendant to string chain 0.1397 520 0.37 0.14% AT 10 edge of ring 0.1241 520 142.41 59.67% AT 11 section along edge 0.1146 520 172.71 78.37% AT 12 section along edge 0.1930 520 311.08 83.81% CR 7 section of one metal cuff 0.1689 520 0.08 0.02% CR 8 tip of pendant 0.2158 520 271.69 65.47% CR 9 section of one square 0.2491 520 0.10 0.02% CR 10 section of one plain ring 0.1240 520 150.49 63.11% CR 10a section of one darker colored ornate ring 0.3574 520 440.36 64.07% CR 11 metal surrounding stone 0.1467 520 170.69 60.50% CR 12 one metal flower petal 0.2680 520 312.09 60.55% CR 13 metal backing around one leaf 0.1702 520 285.83 87.33% CR 14 edge of one petal 0.1078 520 0.07 0.03% CR 15 tip of heart 0.1125 520 6.47 2.99% CR 16 one tip of star pendant 0.2614 520 271.69 54.05% CR 17 tip of stick pendant 0.3576 520 356.53 51.84% CR 18 one square bead 0.1932 520 10.92 2.94% CR 19 section of chain 0.1120 520 0.04 0.02% EX 7 one section of rope 0.2444 520 0.05 0.01% EX 8 one oval disk 0.1855 520 0.00 < 0.01% EX 9 one round disk 0.2683 520 20.13 3.90% EX 10 section of one smooth link 0.1024 520 0.07 0.04% EX 10a section of one rough link 0.2962 520 292.00 51.26% EX 11 metal backing around pendant 0.2112 520 0.09 0.02% EX 12 link of medium chain 0.5306 520 0.00 0.00% EX 13 section of link style chain 0.3158 520 0.00 0.00% EX 14 piece of metal frame around triangle 0.1711 520 23.98 7.29% 14 duplicate EX 14 same piece as EX 14 0.1433 520 20.79 7.54% Blank 0.04 EX 15 edge of pendant 0.1749 520 230.28 68.47% EX 16 piece of O pendant 0.4337 520 72.72 8.72% G 5 edge of pendant 0.1845 520 28.27 7.97% G 6 piece of metal backing on pendant 0.1076 520 10.08 4.87% G 7 piece of gold tone metal on back of pendant 0.1651 520 13.69 4.31% G 8 piece from bracelet backing 0.2290 520 26.62 6.04% G 8a stud and post from 1 earring 0.0791 520 0.03 0.02% G 9 edge of tail feather on bird 0.1683 520 15.41 4.76% GU 5 tip of bottom plate /" wire" 0.2449 520 0.00 0.00% GU 6 section of outer ring 0.1102 520 0.09 0.04% GU 7 backing of bottom bead 0.3932 520 421.17 55.70% GU 8 gold tone metal from one stick 0.2920 520 0.07 0.01% GU 9 section of one square 0.2222 520 0.08 0.02% GU 10 section of one chain 0.2858 520 0.00 0.00% GU 11 end of one chain below X 0.3641 520 0.15 < 0.00% GU 12 piece of bottom most ring 0.1001 520 0.00 < 0.01% GU 13 bottom of pendant edge 0.4994 520 570.65 59.42% HT 5 one edge of celtic symbol 0.4342 520 621.15 74.39% HT 5a one shot bead from chain 0.2401 520 0.06 0.01% HT 6 top of one crossbone 0.6338 520 566.61 46.49% HT 7 chin of skull pendant 0.1373 520 24.53 9.29% HT 8 bottom edge of coffin lid 0.3421 520 577.72 87.81% HT 9 bottom tip of ankh symbol 0.2057 520 225.23 56.94% HT 10 metal around stone 0.4222 520 497.93 61.33% HT 11 one link section 0.5659 520 0.00 0.00% HT 12 3 of 5 tips from bottom star 0.1176 520 192.91 85.30% HT 13 metal link between 2 stars 0.1507 520 184.83 63.78% HT 14 piece of detail inside heart 0.5709 520 635.29 57.86% K 13 edge of metal pendant 0.1474 520 0.08 0.03% K 14 edge of central square pendant 0.3352 520 0.21 0.03% K 15 metal backing of ' drop' 0.1081 520 0.11 0.05% K 16 one metal link 0.3015 520 0.03 0.01% K 17 section from metal petals of one flower 0.4058 520 671.65 86.07% K 18 section of gold tone chain 0.3409 520 0.11 0.02% K 19 bottom edge of medium earring 0.1422 520 9.77 3.57% duplicate K 19 bottom edge of other medium earring 0.2802 520 13.69 2.54% K 20 one metallic section/ bead 0.8939 520 128.04 7.45% K 21 small piece of one link 0.6075 520 0.00 0.00% KU 4 upper left corner of soccer pendant 0.1958 520 0.52 0.14% KU 5 section of bottom petal 0.1864 520 25.19 7.03% KU 6 tip of heart pendant 0.1896 520 329.26 90.30% 15 KU 7 metal backing of pendant with plastic coating/ paint scrapped away 0.3693 520 516.11 72.67% KU 8 one star from side of pendant 0.3414 520 339.36 51.69% KU 9 lower left corner of metallic plate pendant 0.2644 520 0.00 0.00% KU 10 section of chain  pendant is not metalic 0.1359 520 0.02 0.01% KU 11 back of one barrette clip 0.1293 520 0.00 < 0.01% LNY 6 section from outer edge of coin 0.5823 520 563.58 50.33%

LNY 7 metal around edge of one white inlaid stone 0.1349 520 173.72 66.96% LNY 8 section of chain with beads on it 0.2093 520 0.11 0.03%

LNY 9 section of bottom of drop pendant below stone 0.3557 520 367.64 53.75% LNY 10 two oval disks 0.1670 520 0.08 0.02% LNY 11 section of one beaded bracelet 0.1139 520 0.18 0.08% LNY 12 tip of one metal stick 0.4950 520 467.63 49.12% LNY 13 piece from outer edge of O pendant 0.2576 520 288.86 58.31% LNY 14 section from band next to stone 0.3253 520 334.31 53.44%

LNY 15 piece of metal around stone, top center of pendant 0.1959 520 254.52 67.56% LNY 16 tip of heart pendant 0.1926 520 0.37 0.10% LNY 17 one square tube cut off of its chain 0.3645 520 0.12 0.02%

LT 7 one flower with inlaid ' stone' removed 0.4055 520 28.82 3.70% LT 8 metal from edge of soccer ball 0.1519 520 182.81 62.58% LT 9 metal from tip of heart 0.3494 520 393.90 58.62% LT 10 tip of lower right wing of butterfly 0.4361 520 518.13 61.78% LT 11 tip of lower corner of " A" 0.2734 520 316.13 60.13% LT 12 tip of one " shoe" charm 0.5194 520 911.02 91.21% LT 13 post/ stud from one medium earring 0.1618 520 0.00 < 0.01% LT 14 section of " best" plate 0.1232 520 189.88 80.14% LT 15 metal attachment between " cheer" & leather 0.1144 520 108.07 49.12% LT 16 half of one star shaped charm 0.3883 520 0.70 0.09% N 1 piece from metal edge of pendant 0.4372 520 501.97 59.70% duplicate N 1 piece from metal edge of pendant 0.3879 520 439.35 58.90% Blank 0.02 N 2 edge of larger gold tone pendant ( silver tone made of plastic) 0.2278 520 0.10 0.02%

N 3 section from bottom of cross between gemstones 0.3559 520 418.14 61.09%

N 4 section from metal around edge of pendant without gemstones 0.2892 520 73.59 13.23% N 5 section of metal band 0.1514 520 0.17 0.06% N 6 two beads from one bracelet 0.1021 520 0.00 < 0.01%

N 7 section of metal from side of one petal without any paint 0.2006 520 255.53 66.24% N 8 long ends of one rectangle without any paint 0.3517 520 445.41 65.86% N 9 section from back half of locket 0.3086 520 0.00 0.00% 16 N 10 section from sides of top heart 0.2843 520 263.61 48.22% N 10a post stud from both earrings 0.0837 520 0.09 0.06% N 11 U from ILU pendant 0.9171 520 1298.86 73.65%

N 12 O ring of pendant through which chain was hung ( no paint) 0.1843 520 0.12 0.03%

N 13 corner of pendant under paint ( paint first scrapped away) 0.4265 520 0.00 0.00% N 14 two beads from wire 0.2153 520 0.10 0.02% N 15 section from outer edge of pendant 0.4373 520 5.99 0.71% N 16 section of band 0.5929 520 0.11 0.01% R 2 bottom outside edge of pendant 0.8232 520 119.35 7.54% R 3 one petal of flower with inlaid stone removed 0.9749 520 1113.02 59.37% R 4 one small coin 0.3546 520 368.65 54.06% R 5 section of dangling hoop 0.4766 520 517.12 56.42%

R 6 section from metal edge around necklace pendant 0.4661 520 596.91 66.59%

R 7 section from metal edge around necklace pendant 0.6613 520 1012.02 79.58% R 8 section from band of toe ring 0.3915 520 336.33 44.67% R 9 section from band of toe ring 0.4660 520 45.54 5.08% R 10 metal portion of bracelet charm 0.3866 520 23.65 3.18% R 11 half of one hoop from smaller set 0.6166 520 0.19 0.02% T 5 two square ish beads 0.5562 520 30.69 2.87% T 6 section from outer edge of pendant 0.7094 520 780.73 57.23% T 7 one thin section of chain 0.5739 520 0.07 0.01% T 8 right edge of cross with inlaid stones removed 0.7649 520 573.68 39.00% T 9 section of all wires near clasp 0.1745 520 0.00 < 0.01%

T 10 bottom tip of cross below gemstones 0.7728 520 535.30 36.02% T 11 bottom edge of pendant 0.5048 520 480.76 49.52% T 12 side of one rectangle 0.5731 520 609.03 55.26% duplicate T 12 side of one rectangle 0.5304 520 831.23 81.49% Blank 0.03 T 13 tip of oar 0.5352 520 515.10 50.05% T 14 metal from around edge of oval pendant 0.6285 520 25.74 2.13% T 15 section of gold tone 0.5975 520 19.03 1.66% T 15a section of silver tone 0.7816 520 778.71 51.81% T 16 the single metal bead 0.5654 520 445.41 40.96% T 17 half of one O shaped pendant 0.7680 520 613.07 41.51% T 18 section from outer edge of pendant 0.5267 520 638.32 63.02% TU 1 right edge of pendant 0.7427 520 750.43 52.54% TU 2 4 links from chain link band 0.4028 520 0.40 0.05% W 12 section of metal band 0.4729 520 50.60 5.56% W 13 section of metal band 0.4344 520 47.41 5.68% W 14 section of ring 0.8786 520 0.79 0.05% W 15 section of plain metal ring 0.6626 520 0.27 0.02% W 16 bottom tip of cross 0.7235 520 0.34 0.02% 17 W 17 one gold & silver section without stones 0.6500 520 0.76 0.06% W 18 edge of one cuff  end 0.8293 520 0.00 0.00%

W 19 one charm with inlaid stone removed 0.7200 520 0.99 0.07% WS 9 tip of cross below stones 0.8487 520 798.91 48.95% WS 10 lower portion of " E" 0.7134 520 0.33 0.02% WS 11 section from one of smaller pair 0.3850 520 0.03 0.00% WS 12 section of plain metal ring 0.3097 520 0.00 0.00% WS 13 section of disk 0.5183 520 544.39 54.62% WS 14 one small disk 0.2892 520 0.00 0.00% WS 15 three metal beads 0.3266 520 0.36 0.06%

WS 16 bottom oval & chain connection from one earring 0.6607 520 450.46 35.45% WS 17 section of peace symbol with stones removed 0.6614 520 661.55 52.01% WS 18 half of one large link 0.7383 520 0.00 0.00% WS 19 section from outermost hoop 0.5040 520 0.00 0.00% WS 20 bottom edge of cross 0.7826 520 1.10 0.07% WS 21 bottom edge of cross 0.8556 520 1104.94 67.15% WS 22 outside edge of pendant 0.1583 520 223.21 73.32% WS 23 one metal hinge 0.1294 520 0.00 < 0.01% duplicate WS 23 one metal hinge 0.3051 520 0.00 0.00% Blank 0.04 Clearly, there is a considerable amount of lead being used in the production of most of the sampled jewelry items. Of the total 292 samples tested ( including duplicates), 162 contained at least 5% lead by weight in at least one portion of the jewelry piece. These 162 samples showed a wide range of lead weight percents, from 5% to a maximum of essentially one hundred percent lead. In fact, 123 of the 292 samples were found to contain more than 50% lead by weight. All of the twenty retail stores where jewelry was acquired yielded at least one piece with significant lead content. The mean percentages of lead by store ranged from a low of 3.8% for WalMart # 1, to a high of 53.2% for the Limited Too. Several other stores showed mean percentages near 50%, including Hot Topic, Afterthoughts, Ross and Charlotte Russe.

Overall, it is inappropriate to attempt to label certain retail stores as having higher lead content in their jewelry than others based on this data because the number of jewelry items purchased from each store varied from two to twenty three. Furthermore, those stores from which a large number of pieces were purchased showed a relatively consistent distribution of pieces with both very high lead weight percents and no detectable lead at all. The content of lead appears to vary with the nature of the particular item, such as its intended weight and appearance, more so than the place of purchase. Based on the data provided, those items categorized as children's jewelry ( Table 1 and 2) showed an overall mean lead content of 27.8%, while those pieces intended for all ages ( Table 3 and 4) had a mean lead content of 35.6%. However, these values are of little application given the wide variability of lead content. A more useful interpretation is the probability of purchasing a high lead containing jewelry item, which is roughly two out of three. Thirty six jewelry pieces tested ( 12.3%) had in excess of 75% lead. Previous EQI research on lead exposure has indicated that handling items with much lower lead weight percent 18 than these jewelry pieces ( e. g. 1 8%) results in significant transfer of lead to the skin. A handling study conducted on keys with lead contents of 1.4% to 1.9% indicated that as much as 30 µ g of lead could be transferred to the skin when handling the key for the first time ( 9). A similar EQI study testing galvanized plumbing parts ( approximately 1 2% Pb) for lead exposure involved handling an apple slice after handling the galvanized part to determine the amount of lead transferred to foodstuffs and thus subsequent ingestion. Results indicated that up to 4 µ g of lead could be transferred from the skin to the surface of food items after a single hand contact with such parts ( 10). As indicated earlier, such ingestion levels are well above the accepted maximum. The United States Consumer Products Safety Commission estimates up to 50% of lead on the hands is ultimately transferred to the mouth of a child under three years of age ( 11). The hazard associated with 3% to 100% lead jewelry items that may be worn on a finger or through the skin is readily apparent in light of these earlier studies.

IV SUMMARY and CONCLUSION Lead has historically been one of the most highly applicable metals used in the manufacturing and production of various products intended for consumer contact. We are now challenged with the problem of widespread uses of lead as we have come to realize its associated health hazards, especially to children. The jewelry analyses conducted as part of this research project demonstrate that lead is still being used excessively in the production of jewelry items, and sold directly to the customer without any form of warning. Further study of the amount of lead transferred from these items to the hands and subsequent ingestion potential for children as well as adults would enable the lead exposure from the handling of these products to be better quantified. However, those items which contain a high lead weight percent clearly pose a direct health threat to the consumer.

V. REFERENCES 19 1. Urbanowicz, Marie Anne. " The Uses of Lead Today." Lead Toxicity History and Environmental Impact. Ed. Richard Lansdown and William Yule. Baltimore: The John Hopkins University Press, 1986. 25 40.

2. Lin Fu, Jane. " Modern History of Lead Poisoning: A Century of Discovery and Rediscovery." Human Lead Exposure. Ed. Herbert L. Needleman, M. D. Boca Raton, CRC Press, 1992. 23 43.

3. United States Environmental Protection Agency; http:// www. epa. gov/ lead/; visited on April 6, 2003.

4. United States Department of Environmental Protection. Protect Your Family From Lead in Your Home. Washington D. C., 2001.

5. Lamphear, B., et al. Cognitive Deficits Associated With Blood Lead Concentrations < 10 µ g/ L in US Children and Adolescents. Public Health Reports, 2001.

6. Canfield, Richard, et al. Intellectual Impairment in Children with Blood Lead Concentrations below 10 µ g per Deciliter. The New England Journal of Medicine, 2003.

7. United States Consumer Product Safety Commission. Guidance for Lead ( Pb) in Consumer Products. Washington D. C., U. S. Consumer Products Safety Commission, 2003.

8. National Institute for Occupational Safety and Health. Manual of Analytical Methods ( NMAM), 4th Edition. NIOSH method 7082, i. 2, August 1994.

9. Middleton, W. and Maas, R. P. Exposure to Lead Through Key Handling. Proceeds of the National Conference on Undergraduate Research ( NCUR), MT, 2000.

10. Maas, R. P., Patch, S. and Honnald, D. Lead Exposure from the Instillation and Use of Galvanized Plumbing Parts. EQI Technical Report # 01 087, 2001.

11. United States Consumer Product Safety Commission. CPSC Staff Report on Lead and Cadmium in Children's Polyvinyl Chloride ( PVC) Products. Washington D. C., U. S. Consumer Product Safety Commission, 1997.


[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Rules and Regulations]
[Pages 73973-73975]
[FR Doc No: 2021-28157]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2021-N-0855]

Medical Devices; Neurological Devices; Classification of the
Cerebrospinal Fluid Shunt System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the cerebrospinal fluid shunt system into class II (special controls).
The special controls that apply to the device type are identified in
this order and will be part of the codified language for the
cerebrospinal fluid shunt system's classification. We are taking this
action because we have determined that classifying the device into
class II (special controls) will provide a reasonable assurance of
safety and effectiveness of the device. We believe this action will
also enhance patients' access to beneficial innovative devices.

DATES: This order is effective December 29, 2021. The classification
was applicable on August 22, 2014.

FOR FURTHER INFORMATION CONTACT: Xiaolin Zheng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2674, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the cerebrospinal fluid shunt
system as class II (special controls), which we have determined will
provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation.

    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation. When FDA classifies a device into
class I or II via the De Novo process, the device can serve as a
predicate for future devices of that type, including for 510(k)s (see
section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device
sponsors do not have to submit a De Novo request or premarket approval
application to market a substantially equivalent device (see section
513(i) of the FD&C Act, defining ``substantial equivalence''). Instead,
sponsors can use the less-burdensome 510(k) process, when necessary, to
market their device.

II. De Novo Classification

    For this device, FDA issued an order on November 27, 2012, finding
the Medtronic DUETTM External Drainage and Monitoring System
(EDMS) not substantially equivalent to a predicate device and not
subject to a premarket approval application (PMA). Thus, the device
remained in class III in accordance with section 513(f)(1) of the FD&C
Act when we issued the order.
    On December 21, 2012, FDA received Medtronic Neurosurgery's request
for De Novo classification of the Medtronic DUETTM EDMS. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see section 513 (a)(1)(B) of the FD&C Act). After
review of the information submitted in the request, we determined that
the device can be classified into class II with the establishment of
special controls. FDA has determined that these special controls, in
addition to the general controls, will provide reasonable assurance of
the safety and effectiveness of the device.
    Therefore, on August 22, 2014, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
882.5560.\1\ We have named the generic type of device cerebrospinal
fluid shunt system, and it is identified as a prescription device used
to monitor and divert fluid from the brain or other part of the central
nervous system to an internal delivery site or an external receptacle
for the purpose of preventing spinal cord ischemia or injury during
procedures that require reduction in central nervous system pressure. A
cerebrospinal fluid shunt system may include catheters, valved
catheters, valves, connectors, and pressure monitors intended to
facilitate use of the shunt or evaluation of a patient with a shunt.
---------------------------------------------------------------------------

    \1\ FDA notes that the ACTION caption for this final order is
styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Cerebrospinal Fluid Shunt System Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Pyrogenicity/adverse tissue reaction...  Biocompatibility testing,
                                          Pyrogenicity testing,
                                          Labeling, Shelf-life testing,
                                          and Sterility testing.
Infection (including meningitis).......  Labeling, Sterility testing,
                                          and Package integrity testing.
Cerebrospinal fluid (CSF) leakage......  Labeling, and Non-clinical
                                          performance testing.
Over- and under-drainage                 Labeling, and Non-clinical
                                          performance testing.

     Spinal headache with and
     without CSF leakage.
     Intracranial hemorrhage...
     Hematoma (e.g., spinal,
     subdural).
     Paraplegia................
     Foreign body obstruction..
Procedural/use errors..................  Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, cerebrospinal fluid shunt systems
are for prescription use only. Prescription devices are exempt from the
requirement for adequate directions for use for the layperson under
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR
801.5, as long as the conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 820, regarding quality system regulation,
have been approved under OMB control number 0910-0073; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 882

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  882.5560 to subpart F to read as follows:

Sec.  882.5560  Cerebrospinal fluid shunt system.

    (a) Identification. A cerebrospinal fluid shunt system is a
prescription device used to monitor and divert fluid from the brain or
other part of the central nervous system to an internal delivery site
or an external receptacle for the purpose of preventing spinal cord
ischemia or injury during procedures that require reduction in central
nervous system pressure. A cerebrospinal fluid shunt system may include
catheters, valved catheters, valves, connectors, and pressure monitors
intended to facilitate use of the shunt or evaluation of a patient with
a shunt.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The device description must include a detailed summary of the
device technical parameters, including design configuration,
dimensions, engineering drawings, and a list of all components with
identification of their materials of construction.
    (2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (3) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
    (i) Simulated use testing must be conducted to characterize fluid
flow and resistance to leakage; and
    (ii) Mechanical integrity testing of all connections must be
conducted.
    (4) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the specified shelf life.
    (5) Performance data must demonstrate the sterility and
pyrogenicity of patient-contacting components of the device.
    (6) The labeling must include:
    (i) Contraindications with respect to patients who should not
receive a lumbar drain;
    (ii) A warning that the device should have 24-hour-a-day
availability of trained personnel to supervise monitoring and drainage;
    (iii) Instructions on proper device setup, positioning, and
monitoring;
    (iv) Warnings and precautions to inform the user of serious hazards
and special care associated with the use of the device;
    (v) A statement that the device is not to be reused, reprocessed,
or resterilized when open but unused; and
    (vi) Cleaning instructions for the injection sites.

    Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28157 Filed 12-28-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 10, 2007 (Volume 72, Number 68)]
[Notices]
[Page 17886]
[DOCID:fr10ap07-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL07-53-000]

FirstEnergy Generation Corp.; Notice of Filing

April 4, 2007.
    Take notice that on April 2, 2007, FirstEnergy Generation Corp.
submitted a petition requesting the Commission to disclaim jurisdiction
over passive owner participants associated with a proposed sale and
leaseback of existing generation.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on April 20, 2007.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-6678 Filed 4-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Proposed Rules]
[Pages 38152-38153]
[FR Doc No: 2015-16078]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2015-0247; FRL-9929-83-Region 4]

Approval and Promulgation of Implementation Plans; Mississippi;
Memphis, TN-AR-MS Emissions Inventory for the 2008 8-Hour Ozone
Standard

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve the portion of the state implementation plan revision submitted
by the State of Mississippi, through the Mississippi Department of
Environmental Quality, on January 14, 2015, that addresses the base
year emissions inventory requirements for the State's portion of the
Memphis, Tennessee-Mississippi-Arkansas (Memphis, TN-AR-MS) 2008 8-hour
ozone national ambient air quality standards (NAAQS) nonattainment
area. A base year emissions inventory is required for all ozone
nonattainment areas. The Memphis 2008 8-hour ozone NAAQS marginal
nonattainment area is comprised of Shelby County in Tennessee,
Crittenden County in Arkansas, and a portion of DeSoto County in
Mississippi. EPA will take action on the emissions inventories for the
Tennessee and Arkansas portions of the Area in separate actions. In the
Final Rules section of this Federal Register, EPA is approving the
State's implementation plan revision as a direct final rule without
prior proposal because the Agency views this as a noncontroversial
submittal and anticipates no adverse comments. A detailed rationale for
the approval is set forth in the direct final rule.

DATES: Written comments must be received on or before August 3, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2015-0247 by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2015-0247,'' Air Regulatory Management
Section (formerly the Regulatory Development Section), Air Planning and
Implementation Branch (formerly the Air Planning Branch), Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Air
Regulatory Management Section, Air Planning and Implementation Branch,
Air, Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Such deliveries are only accepted during the Regional
Office's normal hours of operation. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

Please see the direct final rule which is located in the Rules section
of this Federal Register for detailed instructions on how to submit
comments.

FOR FURTHER INFORMATION CONTACT: Tiereny Bell, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Ms. Bell can be reached at<PHONE_NUMBER> and via
electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For additional information see the direct
final rule which is published in the Rules section of this Federal
Register. A detailed rationale for the approval is set forth in the
direct final rule. If no adverse comments are received in response to
this rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a

subsequent final rule based on this proposed rule. EPA will not
institute a second comment period on this document. Any parties
interested in commenting on this document should do so at this time.

    Dated: June 18, 2015.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2015-16078 Filed 7-1-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 63 (Friday, April 1, 2011)]
[Notices]
[Page 18215]
[FR Doc No: 2011-7684]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13102-001]

Birch Power Company; Notice of Intent To File License
Application, Filing of Pre-Application Document, and Approving Use of
the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 13102-001.
    c. Dated Filed: February 2, 2011.
    d. Submitted by: Birch Power Company.
    e. Name of Project: Demopolis Lock and Dam Hydroelectric Project.
    f. Location: On the Tombigbee River, in Marengo and Sumter
Counties, Alabama. The project would occupy United States land,
administered by the U.S. Army Corps of Engineers, for a transmission
line and other ancillary facilities.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations
    h. Potential Applicant Contact: Nicholas E. Josten, 2742 Saint
Charles Avenue, Idaho Falls, ID 83404;<PHONE_NUMBER>; e-mail_
<EMAIL_ADDRESS>    i. FERC Contact: Jennifer Adams at<PHONE_NUMBER>; or e-mail at
<EMAIL_ADDRESS>    j. Birch Power Company filed its request to use the Traditional
Licensing Process on February 1, 2011. Birch Power Company provided
public notice of its request on February 5, 2011. In a letter dated
March 25, 2011, the Director of the Office of Energy Projects approved
Birch Power Company's request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, Part 402; (b) NOAA Fisheries under
section 305(b) of the Magnuson-Stevens Fishery Conservation and
Management Act and implementing regulations at 50 CFR 600.920; and (c)
the Alabama State Historic Preservation Officer, as required by section
106, National Historical Preservation Act, and the implementing
regulations of the Advisory Council on Historic Preservation at 36 CFR
800.2.
    l. Birch Power Company filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    m. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's website
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in paragraph h.
    n. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via e-mail of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: March 25, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-7684 Filed 3-31-11; 8:45 am]
BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller,

I am writing as a concerned individual consumer of electronic cigarettes to request an extension for the comment period for the Food and Drug Administration’s (“FDA”) Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Costmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a significant number of issues and questions that are extremely relevant to me, as a consumer of the very products that are proposed for regulation under the Proposed Rule. There are a couple of hundred pages that raise as many questions that I would like to have the opportunity to respond to. Considering that the FDA had many people over a period of several years work on the Proposed Rule presents me with a serious imbalance because I can not, unfortunately, dedicate months of my time to write thoughtful and helpful comments on the extremely important issues that have been presented to me. I feel it is unreasonable to ask for thoughtful and well researched response in the relatively short period that has been allowed for such. The content of the Proposed Rule is of such utmost important to people’s lives, including my own, that I do not believe it would be unreasonable to request for an extension to this period. After all, this may be our first and only chance that we, the consumers of the products subject to the Proposed Rule, can provide our feedback.

I have strong feelings about electronic cigarettes and the alternative they present to traditional combustable cigarettes. I have no reason to doubt that they have improved my life and my health in ways I had never thought were possible and even allowed me to quit smoking altogether even though that was not originally my intention when I bought my first electronic cigarette.

I believe that under 21 CFR 10.40 the FDA has the authority to extend the period for feedback and comments and has a proven history of granting such extensions on numerous occasions. I would henceforth ask that you do so here as well in order for all stakeholders to have a more reasonable opportunity to provide comments on the Proposed Rule.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

Sincerely,

Stefan Didak.


[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Notices]
[Page 49304]
[FR Doc No: 2014-19750]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL14-91-000]

NextEra Energy Partners, LP, Elk City Wind, LLC, Genesis Solar,
LLC, Northern Colorado Wind Energy, LLC, Perrin Ranch Wind, LLC,
Tuscola Bay Wind, LLC; Notice of Petition for Declaratory Order

    Take notice that on August 12, 2014, pursuant to Rule 207 and 212
of the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207 and 385.212, NextEra Energy
Partners, LP (NEP), Elk City Wind, LLC, Genesis Solar, LLC, Northern
Colorado Wind Energy, LLC, Perrin Ranch Wind, LLC, and Tuscola Bay
Wind, LLC (collectively, the Petitioners) filed a petition for
declaratory order requesting that the Commission disclaim jurisdiction,
or alternatively request approval under section 203 of the Federal
Power Act, in connection with the issuance of public securities by NEP
and related transactions, as more fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on September 11, 2014.

    Dated: August 14, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-19750 Filed 8-19-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Notices]
[Page 59007-59008]
[DOCID:fr08oc08-109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58701; File No. SR-ISE-2008-74]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to a New Order Type

October 1, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 29, 2008, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission the proposed rule change as described in Items I,
II, and III below, which items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE proposes to allow for the use of attributable orders. The
text of the proposed rule amendment is as follows, with deletions in
[brackets] and additions in italics:
Rule 715. Types of Orders
    (a)-(g) No Change.
    (f) Attributable Order. An Attributable Order is a market or limit
order which displays the user firm ID for purposes of electronic
trading on the Exchange. Use of Attributable Orders is voluntary.
Attributable Orders may not be available for all Exchange systems. The
Exchange will issue a Regulatory Information Circular specifying the
systems and the class of securities for which the Attributable Order
type shall be available.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    (a) Purpose--The Exchange proposes to modify Rule 715 (Types of
Orders) to allow for the submission of attributable orders. These
market or limit orders allow users to voluntarily display their firm
IDs on the orders.\3\ The NASDAQ Options Market, LLC (``NOM'')
currently allows its participants to submit attributable orders (See
NOM Chapter VI, Section (1)(d)(1)). The Chicago Board

Options Exchange also recently adopted the use of attributable orders
(See CBOE Rule 6.53(o)). As proposed, the Exchange may limit the
systems/processes and the class of securities for which attributable
orders will be available. Prior to turning on this functionality, ISE
will issue a regulatory circular specifying the systems and the options
classes for which the attributable order type will be available. This
proposal is responsive to requests by Exchange users who believe that
enhanced executions may be obtained if Firm ID is allowed on orders (on
a voluntary basis).
---------------------------------------------------------------------------

    \3\ A Firm ID is a 3-5 character identification code. ISE
establishes a unique Firm ID for each ISE member firm.
---------------------------------------------------------------------------

    (b) Basis--The Exchange believes the proposed rule change is
consistent with the Securities Exchange Act of 1934 (the ``Act'') and
the rules and regulations under the Act applicable to a national
securities exchange and, in particular, the requirements of Section
6(b) of the Act.\4\ Specifically, the Exchange believes the proposed
rule change is consistent with Section 6(b)(5) of the Act's\5\
requirements that the rules of a national securities exchange be
designed to promote just and equitable principles of trade, to prevent
fraudulent and manipulative acts and, in general, to protect investors
and the public interest. In particular, the proposed rule change will
allow for greater customization by providing users with an additional
order type.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    This proposed rule change does not significantly affect the
protection of investors or the public interest, does not impose any
significant burden on competition, and, by its terms, does not become
operative for 30 days after the date of the filing, or such shorter
time as the Commission may designate if consistent with the protection
of investors and the public interest. The Exchange provided the
Commission with written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing the
proposed rule change as required by Rule 19b-4(f)(6).\6\ For the
foregoing reasons, the Exchange believes the proposed rule filing
qualifies for immediate effectiveness as a ``non-controversial'' rule
change under paragraph (f)(6) of Rule 19b-4 of the Act.\7\
---------------------------------------------------------------------------

    \6\ 17 C.F.R. 240.19b-4(f)(6).
    \7\ Id.
---------------------------------------------------------------------------

    The Exchange believes the proposed rule change is non-controversial
in that it is similar to the rules of the CBOE and the NOM. Further,
the Exchange believes the proposed rule change may assist investors by
allowing market participants the benefits of attributable orders. The
Exchange also believes that the proposed rule change does not raise any
new, unique or substantive issues, and is beneficial for competitive
purposes and to promote a free and open market for the benefit of
investors.
    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2008-74 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2008-74. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2008-74 and should be
submitted on or before October 29, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-23764 Filed 10-7-08; 8:45 am]

BILLING CODE 8011-01-P