A toxicological assessment of and mushroom powders.

and are among the many mushrooms known for their long history of use in traditional medicine. Wildcrafted sources of mushrooms including and can be limited from a scarcity and quality perspective, but solid fermentation processes in cultivation settings can provide an efficient way to deliver whole mushroom preparations of a consistent composition. Despite the historical use of these mushrooms, few published reports have explored their potential subchronic oral toxicity or genotoxicity, either from specific components or whole mushroom preparations.

Evaluating the performance of Bayesian geostatistical prediction with physical barriers in the Chesapeake Bay.

The Chesapeake Bay is one of the most widely studied bodies of water in the United States and around the world. Routine monitoring of water quality indicators (e.g.

Comprehensive safety assessment of serendipity berry sweet protein produced from Komagataella phaffii.

Serendipity berry plant (Dioscoreophyllum cumminsii (Stapf) Diels) is the source of a naturally sweet protein referred to as monellin. The safety of serendipity berry sweet protein (SBSP) containing single polypeptide monellin (MON) expressed in Komagataella phaffii (formerly Pichia pastoris) and produced via precision fermentation was examined comprehensively through assessments of in vitro and in silico protein digestion, in silico allergenicity, in vitro genotoxicity (reverse mutation and mammalian micronucleus assays), and 14-day and 90-day oral (dietary) toxicity studies in rats. There was no indication of allergenicity for SBSP in the in silico analyses.

A toxicological assessment of spermidine trihydrochloride produced using an engineered strain of Saccharomyces cerevisiae.

Spermidine is a polyamine consumed in the diet, endogenously biosynthesized in most cells, and produced by the intestinal microbiome. A variety of foods contribute to intake of spermidine along with other polyamines. Spermidine trihydrochloride (spermidine-3HCl) of high purity can be produced using an engineered strain of Saccharomyces cerevisiae.

Lack of genotoxicity potential and safety assessment of 4-(2-hydroxyethyl) morpholine present as an impurity in pharmaceuticals and nutritional supplements.

4-(2-Hydroxyethyl) morpholine (HEM) is widely used as a building block of macromolecules in the manufacture of pharmaceuticals and dietary supplements and could remain as an impurity in the finished products. An evaluation of HEM was conducted to identify endpoints that could be used to determine the point-of-departure (POD) for use in assessing the potential risk from exposure to HEM. No oral repeated dose toxicological studies of appropriate duration were found for HEM.

Gestational Health Outcomes Among Pregnant Women in the United States by Level of Dairy Consumption and Quality of Diet, NHANES 2003-2016.

Objectives: Diet is an important factor in gestational health. Many pregnant women have suboptimal diets and dairy foods are an excellent source of key nutrients. The aim of this work was to investigate the relationships between dairy consumption (cup equivalents/day) or diet quality assessed using the Healthy Eating Index-2015 and gestational diabetes mellitus (GDM) or gestational weight gain (GWG) among pregnant women in the United States (US).

Glyphosate and neurological outcomes: A systematic literature review of animal studies.

Studies of nervous system effects of glyphosate, a widely used herbicide, have not been critically examined. The aim of this paper was to systematically review glyphosate-induced neurotoxicity literature to determine its usefulness in regulatory decision-making. The review was restricted to mammalian studies of behavior, neuropathology, and neuropharmacology; and other biochemical studies were considered supplementary information.

Adequacy and Sources of Protein Intake among Pregnant Women in the United States, NHANES 2003-2012.

Limited information is available on protein intake and adequacy of protein intake among pregnant women. Using data from a sample of 528 pregnant women in the National Health and Nutrition Examination Surveys (NHANES) 2003-2012, usual intake of protein (g/day and g/kg body weight (bw)/day) and prevalence of intake below the Estimated Average Requirement (EAR) by trimester of pregnancy were calculated using the National Cancer Institute method. Percent contributions to protein intake by source (i.

A case-control analysis of traceback investigations for Vibrio parahaemolyticus infections (vibriosis) and pre-harvest environmental conditions in Washington State, 2013-2018.

Background: Vibrio parahaemolyticus is a major cause of seafood-borne illness. It is naturally prevalent in brackish waters and accumulates in shellfish. Vibriosis cases are rising globally, likely due to rising temperatures.

Cardiovascular Healthcare Cost Savings Associated with Increased Whole Grains Consumption among Adults in the United States.

Little is known about the potential health economic impact of increasing the proportion of total grains consumed as whole grains to align with Dietary Guidelines for Americans (DGA) recommendations. Health economic analysis estimating difference in costs developed using (1) relative risk (RR) estimates between whole grains consumption and outcomes of cardiovascular disease (CVD) and a selected component (coronary heart disease, CHD); (2) estimates of total and whole grains consumption among US adults; and (3) annual direct and indirect medical costs associated with CVD. Using reported RR estimates and assuming a linear relationship, risk reductions per serving of whole grains were calculated and cost savings were estimated from proportional reductions by health outcome.

A systematic review of post-harvest interventions for Vibrio parahaemolyticus in raw oysters.

Background: Non-cholera Vibrio bacteria are a major cause of foodborne illness in the United States. Raw oysters are commonly implicated in gastroenteritis caused by pathogenic Vibrio parahaemolyticus. In response to outbreaks in 1997-1998, the US Food and Drug Administration developed a nation-wide quantitative microbial risk assessment (QMRA) of V.

Examination of different definitions of snacking frequency and associations with weight status among U.S. adults.

Snacks, while widely consumed in the United States (U.S.), do not have a standard definition, complicating research to understand associations, if any, with weight status.

Health Care Costs and Savings Associated with Increased Dairy Consumption among Adults in the United States.

Background: The purpose of this study is to estimate the impact on health care costs if United States (US) adults increased their dairy consumption to meet Dietary Guidelines for Americans (DGA) recommendations.

Methods: Risk estimates from recent meta-analyses quantifying the association between dairy consumption and health outcomes were combined with the increase in dairy consumption under two scenarios where population mean dairy intakes from the 2015-2016 What We Eat in America were increased to meet the DGA recommendations: (1) according to proportions by type as specified in US Department of Agriculture Food Intake Patterns and (2) assuming the consumption of a single dairy type. The resulting change in risk was combined with published data on annual health care costs to estimate impact on costs.

Estimated daily intake and safety of FD&C food-colour additives in the US population.

A refined exposure assessment was undertaken to calculate the estimated daily intake (EDI) of the seven FD&C straight-colour additives and five FD&C colour lakes ('synthetic' food colours) approved in the United States. The EDIs were calculated for the US population as a whole and specific age groups, including children aged 2-5 and 6-12 years, adolescents aged 13-18 years, and adults aged 19 or more y. Actual use data were collected from an industry survey of companies that are users of these colour additives in a variety of products, with additional input from food colour manufacturers.

Considerations when using longitudinal cohort studies to assess dietary exposure to inorganic arsenic and chronic health outcomes.

Dietary arsenic exposure and chronic health outcomes are of interest, due in part to increased awareness and data available on inorganic arsenic levels in some foods. Recent concerns regarding levels of inorganic arsenic, the primary form of arsenic of human health concern, in foods are based on extrapolation from adverse health effects observed at high levels of inorganic arsenic exposure; the potential for the occurrence of these health effects from lower levels of dietary inorganic arsenic exposure has not been established. In this review, longitudinal cohort studies are evaluated for their utility in estimating dietary inorganic arsenic exposure and quantifying statistically reliable associations with health outcomes.

World Health Organization estimates of the global and regional disease burden of four foodborne chemical toxins, 2010: a data synthesis.

Background Chemical exposures have been associated with a variety of health effects; however, little is known about the global disease burden from foodborne chemicals. Food can be a major pathway for the general population's exposure to chemicals, and for some chemicals, it accounts for almost 100% of exposure.  Methods and Findings Groups of foodborne chemicals, both natural and anthropogenic, were evaluated for their ability to contribute to the burden of disease.

Associations of consumption of fruits and vegetables during pregnancy with infant birth weight or small for gestational age births: a systematic review of the literature.

Maternal nutrition is recognized as one of the determinants of fetal growth. Consumption of fruits and vegetables is promoted as part of a healthful diet; however, intakes are typically lower than recommended levels. The purpose of this study was to systematically review results from studies examining the relationship between maternal consumption of fruits and vegetables during pregnancy with infant birth weight or risk for delivering a small for gestational age baby.

Egg consumption and cardiovascular disease among diabetic individuals: a systematic review of the literature.

Background: This study reviewed epidemiological and experimental evidence on the relationship between egg consumption and cardiovascular disease (CVD) risks among type II diabetes mellitus (T2DM) individuals, and T2DM risk in nondiabetic subjects.

Results: Four of the six studies that examined CVD and mortality and egg consumption among diabetics found a statistically significant association. Of the eight studies evaluating incident T2DM and egg consumption, four prospective studies found a statistically significant association.

Toxicologic evaluations of DHA-rich algal oil in rats: developmental toxicity study and 3-month dietary toxicity study with an in utero exposure phase.

DHA-rich algal oil ONC-T18, tested for subchronic, reproductive, and developmental toxicity in the rat, did not produce any significant toxicologic manifestations. Based on the absence of maternal or developmental toxicity at any dosage level, a dosage level of 2000 mg/kg/day was considered to be the no observed adverse-effect level (NOAEL) for maternal toxicity and embryo/fetal development when DHA-rich algal oil was administered orally by gavage to pregnant Crl:CD(SD) rats during gestation days 6-19. In a dietary combined one-generation/90-day reproductive toxicity study in rats, the NOAEL for F0 male and female and F1 male systemic toxicity was considered to be 50,000 ppm (highest concentration administered) and 25,000 ppm for F1 female systemic toxicity (higher mean body weight, body weight gain, and food consumption).

Toxicologic evaluation of DHA-rich algal oil: Genotoxicity, acute and subchronic toxicity in rats.

DHA-rich algal oil ONC-T18, tested in a battery of in vitro and in vivo genotoxicity tests, did not show mutagenic or genotoxic potential. The acute oral LD50 in rats has been estimated to be greater than 5000 mg/kg of body weight. In a 90-day subchronic dietary study, administration of DHA-rich algal oil at concentrations of 0, 10,000, 25,000, and 50,000 ppm in the diet for 13 weeks did not produce any significant toxicologic manifestations.

Fresh and fresh lean pork are substantial sources of key nutrients when these products are consumed by adults in the United States.

Many fresh pork products, in particular, fresh lean pork products, are nutrient-dense sources of protein and several other nutrients. The purpose of this study was to estimate nutritional contributions of fresh and fresh lean pork to adults' diets in the United States. Mean total nutrient intakes by fresh and fresh lean pork consumers on a day of recall were compared with intakes by nonconsumers to test the hypothesis that overall nutrient intakes by consumers were comparable with or better as compared with intakes by nonconsumers.

FDA'S food ingredient approval process: Safety assurance based on scientific assessment.

Fifty years ago, the Food and Drug Administration (FDA) began implementing new provisions of the Federal Food, Drug, and Cosmetic Act aimed at assuring the safety of new food additives before they enter the marketplace. Today, the agency's procedures for premarket evaluation of food additive safety have evolved into a scientifically rigorous, sound and dependable system whose objective and independent evaluations by FDA scientists assure that new food additives are safe for their intended uses before they arrive on the consumer's plate. Although controversy often surrounds food additives in the popular media and culture, and science-based challenges to FDA's decisions do arise, the agency's original safety judgments successfully withstand these challenges time and again.

The SHEDS-Wood model: incorporation of observational data to estimate exposure to arsenic for children playing on CCA-treated wood structures.

Background: Lumber treated with chromated copper arsenate (CCA) compounds has been used in residential outdoor wood structures and public playgrounds. The U.S.