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tive science, and that further data or changed circumstances could _ and plastic medical products to Australian hospitals and medical lead to entirely different findings, several conclusions were _ centres, recently stated: “...we [Baxter HealthCare] are not in a drawn: phthalates migrating into food did nol constitute a ‘toxic’ —_ position to speak on behalf of the industry" regarding “plastics risk, and there was no need for concern over daily intake levels. products for medical use". Minimising phthalates in food was, however, highly desirable? A Baxter HealthCare suggested I contact the Medical Industry number of proposals were suggested regarding labelling regula- | Association of Australia with my questions. The MIAA could not tions for PVC film. Representatives from the plastics industry | understand Baxter's failure to answer questions relating to the stressed that self-regulation was still desirable and that proposals — products it manufactures, and, meantime, has not been able to to apply warning labels would be resisted. contact Baxter for their statement on these questions: In 1989, phthalates in PVC mattress covers were linked to cot- 1) What type of plastic/s is used for: (a) blood packaging, etc.?; death syndrome in studies by Penarth Research International. _—_(b) intravenous drip tubing, etc.?; (c) ventilator tubing and masks, Subsequent studies refuted Penarth's findings, yet phthalates, par- _—etc.? ticularly DEHP, have been implicated in fatal lung conditions in 2) Have any tests been carried out on these products (1 a,b,c) to newborns using PVC ventilators, Parents of newboms are cur- _ determine if any ‘biologically active’ substances transfer from rently advised to place their babies on their backs and remove any _ packaging, tubing, etc. to patients? plastic (PVC) toys and cot bumpers to reduce the risk of SIDS. 3) Could the findings and conclusions of such tests be made A 1989 meeting of the Australian Committee on Toxicity available? (COT) considered DEHP for the fourth time, to examine the pos- The medical industry is well aware of the migration of DEHP sibility that DEHP may be responsible for congenital birth defects into blood stored in PVC bags. Dr Max Whisson, from the when combined with chemicals like caffeine. The Committee | Research and Development Unit of the Australian Red Cross in found there was no reason for concern over human exposure and = Western Australia, has published a number of papers on the use of that no further action was required. Of interest, the United States | PVC blood bags. Concerned by the use of DEHP, Dr Whisson Food and Drug Administration (FDA) insists on a warning label found its use is based on errors in interpretation of blood cell biol- on any medical products containing : ogy. DEHP migrates readily into red DEHP. : "g blood cell platelets, somehow increas- In 1992, Australian Standard AS | = ‘The UK Mi ist of Agriculture, ing the shelf-life of blood products. 2070, "Plastics for Food Contact | Long-term exposure to DEHP in the Use", reflected the findings of the |= ~ Fisheries and F ood fot nd :, fg bloodstream may also be linked to an NHMRC's 1987 report. AS 2070 increased risk of heart attack, as contained a warning to food manu- | “J DEHP reduces contractile strength of facturers of the dangers of biologi- |’ sam le takei n since 1993, @@ the heart muscle. cally active substances (phthalates) |° including meat, fish, eggs, milk In 1992, WHO recommended that migrating into food products via |. and milk Foducte a : disposal practices for DEHP be plastic packaging or wrapping mate- improved, that steps be taken to rials, including possible "toxic" or |: Every baby | milk formula tested reduce the release of DEHP into the "chronic" effects to consumers: “It |: ‘ : environment, and that medical prod- ‘ is essential that the formulation of |: %. contained hthalates. ucts that contribute to the body burden the plastics materials is such that |= of DEHP be scrutinised to reduce any migration of substances into the exposure. food from the plastics packaging or wrapping materials is min- The UK Ministry of Agriculture, Fisheries and Food (MAFF) imised and, if migration occurs, no known toxic hazard will exist found phthalates present in every food sample taken since 1993, to the consumer of the food... Chronic effects...are possible where — including meat, fish, eggs, milk and milk products. MAFF esti- small quantities of biologically active substances transfer from mated that daily intake of phthalates in adults averaged between packaging materials and are ingested in small amounts over along _—(0.8 mg per day and up to 1.6 mg per day. Studies in 1995 found period of time." AS 2070 came into existence in 1977, yet itcon- _ high levels of phthalates in infant formula, potato chips, chocolate tained exactly the same warming as the 1992 Standard. bars, margarine, milk products and vegetable oils. Products pack- The World Health Organization (WHO) also published a report aged in paper and board, such as cakes, fats and confectionery, on DEHP in 1992. It found DEHP is readily absorbed in soil, is also contained high levels of phthalates. Gravy and vegetable more soluble in blood than water, is highly lipophilic (i.e., loves burger mix, biscuits and vegetable fat had high concentrations. fat), and is persistent, accumulating in plants and animals. | Every baby milk formula tested contained phthalates.’ The most Atmospheric pollution was identified as the major source of cont- contaminated baby milk had concentrations that gave a total daily amination, industrial areas generally having the highest levels of _ intake of 0.023 mg per kg of bodyweight. This is only four times DEHP. Blood transfusions and medical treatment using plastic lower than levels shown to reduce sperm-count in rats, Safety devices were listed as sources of involuntary human exposure to levels in humans are normally a minimum of 100 times lower DEHP, the most consistent side-effect of DEHP being testicular _ than levels shown to cause harm in animals—not four times. atrophy. In 1986 Her Majesty's Stationery Office also reported In 1995, doctors from New York's Strang-Cornell Cancer testicular atrophy in patients undergoing regular dialysis. Research Laboratory suggested that xeno-oestrogens found in A number of questions regarding the types of plastic used in _ plastics and pesticides increased breast cancer rates in women. blood bags, intravenous tubing and medical products were recent- | Women who experience early onset of menstruation, late onset of ly directed to members of the medical industry. Spokesperson for | menopause, who have no children or who do not breastfeed their the Red Cross Blood Bank, Dr Richard Kimber, stated he was _ children are considered to be in higher-risk groups for breast can- unaware of any problem associated with PVC blood bags and sug- _—cer. Breastfeeding has been shown to lower the risk of breast can- gested contacting the manufacturers. cer by reducing high oestrogen levels associated with pregnancy. The multinational Baxter HealthCare, supplier of blood bags = The Nursing Mothers Association voiced its concern about the 12 » NEXUS OCTOBER - NOVEMBER 1996