From: BULLELKMAN@aol.com Sent: Tuesday, July 01, 2003 2:03 AM To: fdadockets@oc.fda.gov Subject: Docket No. 2003N-0169 - Dental Mercury Amalgam Information Dear FDA, Below you will find additional scientific studies for the new panel to review. It is vital that the new panel realize how important this issue of mercury dental fillings is to the health and well being of millions and millions of Americans. Thank you for finally doing your job and start working to protect Americans from these toxic mercury dental fillings. Thank you, Mary Ann Newell Vancouver, WA Placental transfer of mercury in pregnant rats which received dental amalgam restorations. Takahashi Y, Tsuruta S, Arimoto M, Tanaka H, Yoshida M. Toxicology 2003 Mar 14;185(1-2):23-33 Placental to fetal transfer of mercury and fetotoxicity. Yoshida M.Tohoku J Exp Med 2002 Feb;196(2):79-88 Release of mercury from dental amalgam fillings in pregnant rats and distribution of mercury in maternal and fetal tissues. Takahashi Y, Tsuruta S, Hasegawa J, Kameyama Y, Yoshida M. Toxicology 2001 Jun 21;163(2-3):115-26 Disposition of inhaled mercury vapor in pregnant rats: maternal toxicity and effects on developmental outcome. Morgan DL, Chanda SM, Price HC, Fernando R, Liu J, Brambila E, O'Connor RW, Beliles RP, Barone S Jr. Toxicol Sci 2002 Apr;66(2):261-73. Maternal-fetal distribution of mercury (203Hg) released from dental amalgam fillings. Vimy et. al., (1990). Am. J. Physiol. 258:R939-R945. Maternal amalgam and prenatal mercury exposure. Halbach and Summer (1995). Eur. J. Pediatr. 154:498-499. Mercury burden of human fetal and infant tissues. Drasch et al., (1994). Eur. J. Pediatr. 153:607-610. Maternal-fetal transfer of metallic mercury via the placenta and milk. Yang et al., (1997). Ann. Clin. Lab. Sci. 27:135-141. Concentrations of heavy metal in maternal and umbilical cord blood. Ong et al., (1993). Biometals 6:61-66 . Concentration of mercury, cadmium and lead in brain and kidney of second trimester fetuses and infants. Lutz et. al., (1996). J. Trace Elem. Med. Biol. 10:61-67 Distribution of mercury in guinea pigs offspring after in utero exposure to mercury vapor during late gestation. Yoshida et al., (1986). Arch. Toxicol. 58:225-228. Dental amalgam and pregnancy. Drasch and Roider (1995). Geburtshilfe Frauenheilkd 55:63-65. The effect of occupational exposure to mercury vapour on the fertility of female dental assistants. Rowland et al., (1994). Occup. Environ. Med. 51:28-34. Environmental pollutants and fertility disorders. Heavy metals and minerals. Gerhard and Runnebaum (1992). Geburtshilfe Frauenheilkd 52:383-396. Heavy metals and fertility. Gerhard et al., (1998). J. Toxicol. Environ. Health 54:593-611. Impact of heavy metals on hormonal and immunological factors in women with repeated miscarriages. Gerhard et al., (1998). Hum. Reprod. Update 4:301-309. Prenatal coexposure to metallic mercury vapour and methylmercury produce interactive behavioural changes in adult rats. Fredriksson et. al., (1996). Neurotoxicol. Teratol. 18:129-134. Behavioural effects of prenatal metallic mercury inhalation exposure in rats. Danielsson et. al., (1993). Neurotoxicol. Teratol. 15:391-396. Behavioural effects of neonatal metallic mercury exposure in rats. Fredriksson et. al., (1992). Toxicology 74:151-160. Behavioral consequences of in utero exposure to mercury vapor: alterations in lever-press durations and learning in squirrel monkeys. Newland et. al., (1996). Toxicol. Appl. Pharmacol. 139:374-386. Mercury distribution in cortical areas and fiber systems of the neonatal and maternal adult cerebrum after exposure of pregnant squirrel monkeys to mercury vapor. Warfvinge et al., (1994). Environ. Res. 67:196-208. Distribution of mercury in guinea pig offspring after in utero exposure to mercury vapor during late gestation. Yoshida et al., (1986). Arch. Toxicol. 58:225-228. Effect of inorganic mercury on in vitro placental nutrient transfer and oxygen consumption. Urbach et. al., (1992). Reprod. Toxicol. 6:69-75. In vitro effect of mercury on enzyme activities and its accumulation in the first-trimester human placenta. Boadi et. al., (1992). Environ. Res. 57:96-106. In vitro effect of mercury on aryl hydrocarbon hydroxylase, quinone reductase, catecholamine-O-methyltransferase and glucose-6-phosphate dehydrogenase activities in term human placenta. Boadi et. al., (1991). Pharmacol. Toxicol. 68:317-321. Toxic effects on embryos derived from amalgam restorations containing mercury. West German considerations. Strubelt et. al., (1989). Tandlakartidningen 81:283-290. Breast-feeding exposure of infants to cadmium, lead, and mercury: a public health viewpoint. Abadin et al., (1997). Toxicol. Ind. Health 13:495-517. Total and inorganic mercury in breast milk in relation to fish consumption and amalgam in lactating women. Oskarsson et al., (1996). Arch. Environ. Health 51:234-241. Exposure to toxic elements via breast milk. Oskarsson et al., (1995). Analyst 120:765-770. The mercury concentration in breast milk resulting from amalgam fillings and dietary habits. Drexler and Schaller (1998). Environ. Res. 77:124-129. Mercury in human colostrum and early breast milk. Its dependence on dental amalgam and other factors. Drasch et. al., (1998). J. Trace Elem. Med. Biol. 12:23-27. Exposure to mercury via breast milk in suckling offspring of maternal guinea pigs exposed to mercury vapor after parturition. Yoshida et. al., (1992). J. Toxicol. Environ. Health 35:135-139. Milk transfer and tissue uptake of mercury in suckling offspring after exposure of lactating maternal guinea pigs to inorganic or methylmercury. Yoshida et. al., (1994). Arch. Toxicol. 68:174-178. Kinetics of methylmercury and inorganic mercury in lactating and nonlactating mice. Sundberg et al., (1998). Toxicol. Appl. Pharmacol. 151:319-329. Occupational mercury vapour exposure and testicular, pituitary and thyroid endocrine function. McGregor and Mason (1991). Hum. Exp. Toxicol. 10:199-203. Paternal exposure to mercury and spontaneous abortions. Cordier et. al., (1991). Br. J. Ind. Med. 48:375-381. Effect of organic and inorganic mercury on human sperm motility. Ernst and Lauritsen (1991). Pharmacol. Toxicol. 68:440-444. Autometallographic detection of mercury in testicular tissue of an infertile man exposed to mercury vapor. Keck et al., (1993). Reprod. Toxicol. 7:469-475. Hong Kong male subfertility links to mercury in human hair and fish. Dickman et al., (1998). Sci. Total Environ. 214:165-174