History of safe use as applied to the safety assessment of novel foods and foods derived from genetically modified organisms

Very few traditional foods that are consumed have been subjected to systematic toxicological and nutritional assessment, yet because of their long history and customary preparation and use and absence of evidence of harm, they are generally regarded as safe to eat. This ‘history of safe use’ of traditional foods forms the benchmark for the comparative safety assessment of novel foods, and of foods derived from genetically modified organisms. However, the concept is hard to define, since it relates to an existing body of information which describes the safety profile of a food, rather than a precise checklist of criteria. The term should be regarded as a working concept used to assist the safety assessment of a food product. Important factors in establishing a history of safe use include: the period over which the traditional food has been consumed; the way in which it has been prepared and used and at what intake levels; its composition and the results of animal studies and observations from human exposure. This paper is aimed to assist food safety professionals in the safety evaluation and regulation of novel foods and foods derived from genetically modified organisms, by describing the practical application and use of the concept of ‘history of safe use’.     

Sleep related upper airway obstruction in a cohort with Down's syndrome.

The prevalence of sleep related upper airway obstruction (UAO) was studied in a cohort of 34 children with Down''s syndrome from a geographically defined area. Thirty two (94%) of the children, ranging in age between 0.1 and 4.9 years (median 1.4), underwent full clinical assessment for UAO including parental questionnaires and overnight tape recordings of chest wall movements and arterial oxygen saturation (SaO2). Compared with controls, children with Down''s syndrome had (a) an increased incidence of stridor and chest wall recession during sleep, (b) an increased frequency of a pattern on inspiration indicating increased upper airway resistance, (c) a reduced baseline oxygen saturation (having excluded recordings on four children with potential for right to left intracardiac shunting), and (d) an increased number of episodes with SaO2 less than or equal to 90% despite continued chest wall movements. At their initial assessment seven children (22%) had evidence of UAO. The 18 youngest children (less than or equal to 1.7 years) underwent repeated recordings and clinical assessment until they had all reached 2 years of age. A further three were found to have developed UAO. Sleep related UAO is a common problem in children with Down''s syndrome, occurring in 10 of 32 (31%) of this population based sample.     

The role of endogenous opiates in athletic amenorrhea

We hypothesized that menstrual disturbances in female athletes arise from opioid-induced abnormalities in gonadotropin and/or prolactin (PRL) secretion. To investigate this hypothesis, we measured luteinizing hormone, follicle-stimulating hormone, and PRL levels in eumenorrheic and amenorrheic athletes during thyrotropin-releasing hormone and gonadotropin-releasing hormone tests at baseline, after naloxone infusions, after exercise to exhaustion, and after similar exercise during naloxone infusions. Contrary to our hypothesis, amenorrheic runners did not have significant alterations in basal, postexercise, or stimulated hormone levels compared with eumenorrheic runners. In addition, opioid blockade by naloxone did not enhance gonadotropin release by amenorrheic athletes.     

Otoacoustic emissions as a screening test for hearing impairment in children

Transient evoked otoacoustic emissions (TEOAEs) are low amplitude sound waves produced by the healthy cochlea. They can be recorded with a microphone in the external ear. TEOAEs are abolished by hearing losses of 30 dB or more. The feasibility of using TEOAEs as a screening test for hearing loss in children was studied. TEOAE recordings were attempted in 56 children attending an audiology clinic. Recordings were possible from both ears in 52 children; of these 104 ears, 32 had hearing deficits of 30 dB or more. Hearing status was compared with the results of six TEOAE screening criteria. All criteria had a sensitivity of 1.00. Four standard TEOAE criteria yielded specificities of 0.46-0.58. Two new criteria derived from analysis of limited frequencies from the TEOAE waveform gave specificities of 0.76 and 0.82. It can be concluded that, when appropriate pass/fail criteria are employed, TEOAEs are a feasible screening test in children.     

Anabolic and catabolic mediators of intestinal protein turnover: a new experimental approach

Studies on regulation of protein turnover in skeletal muscle have revealed the important contributions of protein synthesis and catabolism to tissue protein balance, and have identified a host of specific anabolic and catabolic stimuli and biochemical mechanisms that regulate these processes. This knowledge is critical to current efforts designed to promote anabolism and limit atrophy. Of the tissues with a potentially large contribution to whole-body amino acid metabolism, protein turnover of the intestine stands out as being poorly understood. The intestine is subject to complexities in regulation of its metabolism that are not apparent for other tissues. The study of intestinal protein turnover also entails some important technical challenges. We recently developed an in-situ experimental system for study of intestinal mucosal protein synthesis with the following unique features: multiple observations within an animal; controlled delivery of nutritional stimuli to the apical side, basolateral side, or both; and luminal delivery of tracer in a flooding dose for determination of protein synthesis. We have begun to use the system to test the specific roles of individual luminal nutrients in regulation of mucosal protein synthesis. We have also used protease gene expression as an index of potential regulation of catabolic pathways.     

Ruptured right coronary artery aneurysm presenting as a myocardial mass

Rupture of a coronary artery aneurysm may result in a contained hematoma and an intramyocardial mass. We present a case of a contained coronary artery aneurysm rupture presenting as a mass in the right ventricle. The mass was suspected in a preoperative transthoracic echocardiogram and identified at the time of elective coronary artery bypass surgery. We discuss the pathophysiology, clinical presentation, diagnostic features, and management of this uncommon clinical presentation.     

Serum dioxin concentrations and menstrual cycle characteristics

2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD) is a widespread industrial environmental contaminant. Animal studies suggest that TCDD exposure alters the estrus cycle. Twenty years after a 1976 industrial explosion in Seveso, Italy, the authors interviewed female residents to determine whether there was an association between TCDD exposure and current menstrual cycle characteristics. The authors analyzed serum samples collected soon after the explosion to quantify individual TCDD levels. Among women who were premenarcheal at the time of the explosion, a 10-fold increase in serum TCDD level was associated with a lengthening of the menstrual cycle by 0.93 days (95% confidence interval (CI): -0.01, 1.86) and a reduction in the odds of scanty menstrual flow (adjusted odds ratio = 0.33, 95% CI: 0.10, 1.06). However, among women who were postmenarcheal at the time of the explosion, TCDD was not associated with menstrual cycle length (adjusted beta = -0.03 days, 95% CI: -0.61, 0.54) or scantiness of flow (adjusted odds ratio = 1.36, 95% CI: 0.70, 2.64). In both menarche groups, TCDD levels were associated with decreased odds of having irregular cycles (adjusted odds ratio = 0.46, 95% CI: 0.23, 0.95) but were not related to days of flow (adjusted beta = 0.16 days, 95% CI: -0.08, 0.41). These results are consistent with effects of TCDD on ovarian function noted in some animal species and with greater sensitivity to TCDD during development.