Expert Consultation on Nutrient Risk Assessment for Determination of Safe Upper Levels for Nutrients held on 4th December, 2015 by International Life Sciences Institute, India.
This document discusses nutritional requirements and how nutrient needs are determined. It explains the Dietary Reference Intakes (DRIs) which include Adequate Intake (AI), Estimated Average Requirement (EAR), Recommended Dietary Allowance (RDA), and Tolerable Upper Intake Level (UL). The EAR is the daily intake level to meet needs of half the population. The RDA meets the needs of 97-98% of people. The AI is used when an RDA is not available. The UL is the highest daily intake unlikely to cause adverse health effects. Nutrient standards help determine Daily Values and Acceptable Macronutrient Distribution Ranges.
The DRI Committee establishes nutrient recommendations based on scientific evidence, including the Estimated Average Requirement (EAR), which is the intake that meets half the population's needs. The Recommended Dietary Allowance (RDA) is set higher than the EAR to meet 97-98% of people's needs. For nutrients without an EAR, Adequate Intake (AI) reflects average intake. Tolerable Upper Intake Levels (UL) indicate maximum safe intake amounts to avoid toxicity.
This document summarizes key concepts about dietary reference intakes (DRIs) and guidelines. It discusses how DRIs such as the recommended dietary allowance (RDA) and estimated average requirement (EAR) are established based on scientific evidence and are meant to meet nutritional needs of healthy populations. It also describes the adequate intake (AI) value which is based on observed intakes and may exceed the RDA, as well as the tolerable upper intake level (UL) which indicates a highest daily intake unlikely to cause adverse health effects. Dietary guidelines provide qualitative advice to the public about diet and disease prevention by implementing DRIs through food programs and education.
Nutritional Requirements are standards developed by agencies to prevent deficiency diseases and reduce chronic diseases. These standards include the Estimated Average Requirement, Recommended Dietary Allowance, Adequate Intake, and Tolerable Upper Intake Level, which define daily nutrient needs. Determining energy needs through the Estimated Energy Requirement is important because percentages on nutrition labels are based on a 2000 calorie diet, but needs vary by age, gender, activity level and more. Assessing macronutrient balance through the Acceptable Macronutrient Distribution Ranges can also indicate dietary balance.
This document discusses Dietary Reference Intakes (DRIs), which are nutrient-based reference values used to assess dietary needs. DRIs include the Estimated Average Requirement, Recommended Dietary Allowance, Adequate Intake, Tolerable Upper Intake Level, and Acceptable Macronutrient Distribution Ranges. The Recommended Dietary Allowance is set at the EAR plus two standard deviations to cover 98% of the population's needs. Examples of vitamin C and calcium DRIs are provided to illustrate how the values are determined based on scientific studies and potential for toxicity.
RDA stands for Recommended Dietary Allowance and refers to the average daily intake level of a nutrient sufficient to meet the requirements of nearly all healthy individuals. An Adequate Intake is established when evidence is insufficient to determine an RDA. RDAs were first developed during World War II to investigate nutrition issues related to national defense. Requirements for calories, protein, fat, vitamins and minerals are provided for different age groups, including adults, children, pregnant and lactating women.
The document discusses recommended dietary allowances (RDA) which define sufficient intake levels of essential nutrients for healthy individuals. RDA was first established in India in 1944 and has since been revised periodically. It is important because many Indians suffer from malnutrition. RDA depends on factors like age, sex, activity level, and physiological state. The document provides RDA values for energy, protein, fat, minerals, and other nutrients for different groups in India including infants, children, adults, pregnant/lactating women, and workers with different activity levels. RDA is used to establish food labeling guidelines, modify clinical diets, and design feeding programs.
The document defines key terms used in Dietary Reference Intakes including Estimated Average Requirement (EAR), Recommended Dietary Allowance (RDA), Adequate Intake (AI), Tolerable Upper Intake Level (UL), Estimated Energy Requirement (EER), Acceptable Macronutrient Distribution Range (AMDR), Total Fibre, Dietary Fibre, Functional Fibre, Physical Activity Level (PAL), and provides reference values for vitamins A, D, E, and K for different life stages.
This document discusses nutritional requirements and how nutrient needs are determined. It explains the Dietary Reference Intakes (DRIs) which include Adequate Intake (AI), Estimated Average Requirement (EAR), Recommended Dietary Allowance (RDA), and Tolerable Upper Intake Level (UL). The EAR is the daily intake level to meet needs of half the population. The RDA meets the needs of 97-98% of people. The AI is used when an RDA is not available. The UL is the highest daily intake unlikely to cause adverse health effects. Nutrient standards help determine Daily Values and Acceptable Macronutrient Distribution Ranges.
The DRI Committee establishes nutrient recommendations based on scientific evidence, including the Estimated Average Requirement (EAR), which is the intake that meets half the population's needs. The Recommended Dietary Allowance (RDA) is set higher than the EAR to meet 97-98% of people's needs. For nutrients without an EAR, Adequate Intake (AI) reflects average intake. Tolerable Upper Intake Levels (UL) indicate maximum safe intake amounts to avoid toxicity.
This document summarizes key concepts about dietary reference intakes (DRIs) and guidelines. It discusses how DRIs such as the recommended dietary allowance (RDA) and estimated average requirement (EAR) are established based on scientific evidence and are meant to meet nutritional needs of healthy populations. It also describes the adequate intake (AI) value which is based on observed intakes and may exceed the RDA, as well as the tolerable upper intake level (UL) which indicates a highest daily intake unlikely to cause adverse health effects. Dietary guidelines provide qualitative advice to the public about diet and disease prevention by implementing DRIs through food programs and education.
Nutritional Requirements are standards developed by agencies to prevent deficiency diseases and reduce chronic diseases. These standards include the Estimated Average Requirement, Recommended Dietary Allowance, Adequate Intake, and Tolerable Upper Intake Level, which define daily nutrient needs. Determining energy needs through the Estimated Energy Requirement is important because percentages on nutrition labels are based on a 2000 calorie diet, but needs vary by age, gender, activity level and more. Assessing macronutrient balance through the Acceptable Macronutrient Distribution Ranges can also indicate dietary balance.
This document discusses Dietary Reference Intakes (DRIs), which are nutrient-based reference values used to assess dietary needs. DRIs include the Estimated Average Requirement, Recommended Dietary Allowance, Adequate Intake, Tolerable Upper Intake Level, and Acceptable Macronutrient Distribution Ranges. The Recommended Dietary Allowance is set at the EAR plus two standard deviations to cover 98% of the population's needs. Examples of vitamin C and calcium DRIs are provided to illustrate how the values are determined based on scientific studies and potential for toxicity.
RDA stands for Recommended Dietary Allowance and refers to the average daily intake level of a nutrient sufficient to meet the requirements of nearly all healthy individuals. An Adequate Intake is established when evidence is insufficient to determine an RDA. RDAs were first developed during World War II to investigate nutrition issues related to national defense. Requirements for calories, protein, fat, vitamins and minerals are provided for different age groups, including adults, children, pregnant and lactating women.
The document discusses recommended dietary allowances (RDA) which define sufficient intake levels of essential nutrients for healthy individuals. RDA was first established in India in 1944 and has since been revised periodically. It is important because many Indians suffer from malnutrition. RDA depends on factors like age, sex, activity level, and physiological state. The document provides RDA values for energy, protein, fat, minerals, and other nutrients for different groups in India including infants, children, adults, pregnant/lactating women, and workers with different activity levels. RDA is used to establish food labeling guidelines, modify clinical diets, and design feeding programs.
The document defines key terms used in Dietary Reference Intakes including Estimated Average Requirement (EAR), Recommended Dietary Allowance (RDA), Adequate Intake (AI), Tolerable Upper Intake Level (UL), Estimated Energy Requirement (EER), Acceptable Macronutrient Distribution Range (AMDR), Total Fibre, Dietary Fibre, Functional Fibre, Physical Activity Level (PAL), and provides reference values for vitamins A, D, E, and K for different life stages.
This document provides an overview of multi-vitamin/mineral (MVM) supplements. It defines MVM supplements and discusses their history. Americans have been taking MVM supplements since the 1940s when the first products became available. The document reviews nutrient recommendations and concerns about intakes based on current diets. It also discusses labeling changes and the types of MVM supplements available. Key points covered include common nutrients of concern, optimal intake recommendations, concerns about excess intake from supplements and fortified foods, and ensuring MVMs address nutrient deficiencies.
The Okinawa Flat Belly Tonic is a new one of a kind weight loss “tonic” supplement. It helps men and women burn fat fast using a simple 20-second Japanese tonic. IF THAT TONIC DOES NOT WORK AS GIVEN YOUR VALUABLE MONEY WILL REFUND WITH IMMEDIATE EFFECT.
This document discusses nutrition for fitness and sports. It covers key concepts about physical fitness including the benefits of physical activity, how to develop a fitness regimen using the FITT principle, and the importance of including aerobic exercise, strength training, and flexibility exercises. It also discusses how the body uses carbohydrates, fats, and proteins to fuel exercise through anaerobic and aerobic metabolism, and the advantages and disadvantages of each type of metabolism. Maintaining hydration and consuming the right foods before, during, and after exercise is also emphasized.
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This document discusses the importance of protein intake for aging individuals. It notes that longer lifespans have increased the prevalence of age-related declines in muscle mass and strength. Maintaining muscle through resistance exercise and adequate protein intake can help mitigate these effects. The document reviews studies showing that older adults may need more than the current recommended daily allowance of protein to optimize muscle protein synthesis and muscle mass. It advocates for an "optimal" protein intake of 1.2-1.5 grams of protein per kilogram of body weight per day distributed across meals to support muscle health in aging.
The document provides information on national dietary recommendations including the Recommended Dietary Allowance (RDA) and Dietary Reference Intake (DRI) which specify nutrient needs. It also discusses the Dietary Guidelines for Americans which provide recommendations on food choices, physical activity, and limiting sugars, salt and saturated fat. Key macronutrients like carbohydrates, fats, proteins, vitamins and minerals are explained along with dietary recommendations and guidelines for intake of each.
This document provides details about an instructional design project aimed at educating cardiovascular disease patients on the benefits of whole grains. The target audience is patients over 65 years old at Marlborough Hospital, which serves a large Portuguese population. Whole grains have been shown to decrease cholesterol and fiber is recommended to eat at least 3 servings daily, but Americans average less than 1 serving. The goal is to improve heart health by having patients increase whole grain intake through educational sessions using models like the Health Belief Model.
This document provides background information for a proposed instructional design project on whole grains and cardiovascular disease for patients at Marlborough Hospital. The target audience is patients over 65 years old with cardiovascular disease, many of whom are male and Portuguese. The goal is to improve heart health by increasing patients' intake of whole grains, which research shows can decrease cholesterol levels. The educational strategy will use verbal teaching, hands-on activities and large print handouts to motivate patients to understand what whole grains are, why they are heart healthy, how much is recommended per day, and how their current intake compares.
Death and Disease Rates of Vegetarians and Vegans – Summary of Prospective Co...Jussi Riekki
Vegetarians and vegans have lower mortality rates than the general population according to several prospective cohort studies from 1960-2014. A 1999 meta-analysis found vegetarians had a 24% lower risk of heart disease but no difference for other causes of death. A 2012 meta-analysis found lower cancer incidence and heart disease mortality for vegetarians, but no difference for other outcomes. More recent studies find vegetarian diets associated with lower risks of various diseases and all-cause mortality, with some evidence that pescatarian diets may have the lowest risks.
Nutritional Practices & Habits of Boomer Consumers: Why Active Snacking is the Most Effective Method of Nutritional Supplementation. Nutritional tools to minimize age accelerators and enhance an active and healthy functional lifestyle.
View more at http://www.GoBeneVia.com/blog
Expert Consultation on Nutrient Risk Assessment for Determination of Safe Upper Levels for Nutrients held on 4th December, 2015 by International Life Sciences Institute, India
This document discusses vitamin D requirements and the process for setting dietary reference intake recommendations. It outlines the key steps:
1) Identifying health outcomes related to vitamin D adequacy and safety based on a literature review.
2) Assessing dose-response relationships between vitamin D intake/status and outcomes.
3) Evaluating population intake levels and vitamin D status relative to reference values.
4) Characterizing public health risks based on prevalence of intakes/status outside reference values. The document provides details on how these steps were applied to set the 1997 US vitamin D DRIs and identifies areas being re-evaluated for new recommendations expected in 2010.
This document summarizes a study that estimated average dietary exposures to 37 pollutants across the United States population by combining contaminant data from foods with food consumption data. The study found that for the whole population, average exposures exceeded benchmark safety levels for arsenic, chlordane, DDT, dieldrin, dioxins, and PCBs when non-detects were treated as zero. Exposures to these same 6 pollutants also exceeded benchmarks for children under 12. The study provides a comprehensive assessment of both pesticide and industrial contaminant exposures through multiple foods for children and adults.
This document provides an overview of chemical risk assessment and toxicology as it relates to foods and food ingredients. It discusses key concepts in toxicology like dose-response relationships, factors that influence toxicity, and the absorption, distribution, metabolism and excretion of toxicants in the body. It then explains the risk assessment process and considers acrylamide as a case study, discussing its properties, levels found in various foods, and cancer bioassay results. It also reviews epidemiology studies that found no increased cancer risk from dietary acrylamide exposure.
Dr. Mary Torrence - Progress Report on Nationally Funded Antimicrobial Resist...John Blue
Progress Report on Nationally Funded Antimicrobial Resistance Research Projects - Dr. Mary Torrence, USDA, ARS, from the 2012 NIAA One Health Approach to Antimicrobial Resistance and Use Symposium, October 26-27, 2012, Columbus, OH, USA.
More presentations at:
http://www.trufflemedia.com/agmedia/conference/2012-one-health-to-approach-antimicrobial-resistance-and-use
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This document discusses concerns about inorganic arsenic in food and provides context on the issue. It notes that while arsenic is naturally occurring, it is also classified as a human carcinogen. Recent increased sensitivity in testing and media coverage has led to growing consumer awareness and concerns about levels in foods like rice and apple juice. The document reviews studies on arsenic exposure and risks from rice, as well as evaluations by expert groups like JECFA and EFSA that found mean exposures to be below levels of toxicological concern. It emphasizes that the dose is critical in determining toxicity, and environmental exposures from foods are typically far below doses shown to cause health effects.
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This document provides an overview of multi-vitamin/mineral (MVM) supplements. It defines MVM supplements and discusses their history. Americans have been taking MVM supplements since the 1940s when the first products became available. The document reviews nutrient recommendations and concerns about intakes based on current diets. It also discusses labeling changes and the types of MVM supplements available. Key points covered include common nutrients of concern, optimal intake recommendations, concerns about excess intake from supplements and fortified foods, and ensuring MVMs address nutrient deficiencies.
The Okinawa Flat Belly Tonic is a new one of a kind weight loss “tonic” supplement. It helps men and women burn fat fast using a simple 20-second Japanese tonic. IF THAT TONIC DOES NOT WORK AS GIVEN YOUR VALUABLE MONEY WILL REFUND WITH IMMEDIATE EFFECT.
This document discusses nutrition for fitness and sports. It covers key concepts about physical fitness including the benefits of physical activity, how to develop a fitness regimen using the FITT principle, and the importance of including aerobic exercise, strength training, and flexibility exercises. It also discusses how the body uses carbohydrates, fats, and proteins to fuel exercise through anaerobic and aerobic metabolism, and the advantages and disadvantages of each type of metabolism. Maintaining hydration and consuming the right foods before, during, and after exercise is also emphasized.
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This document discusses the importance of protein intake for aging individuals. It notes that longer lifespans have increased the prevalence of age-related declines in muscle mass and strength. Maintaining muscle through resistance exercise and adequate protein intake can help mitigate these effects. The document reviews studies showing that older adults may need more than the current recommended daily allowance of protein to optimize muscle protein synthesis and muscle mass. It advocates for an "optimal" protein intake of 1.2-1.5 grams of protein per kilogram of body weight per day distributed across meals to support muscle health in aging.
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This document provides details about an instructional design project aimed at educating cardiovascular disease patients on the benefits of whole grains. The target audience is patients over 65 years old at Marlborough Hospital, which serves a large Portuguese population. Whole grains have been shown to decrease cholesterol and fiber is recommended to eat at least 3 servings daily, but Americans average less than 1 serving. The goal is to improve heart health by having patients increase whole grain intake through educational sessions using models like the Health Belief Model.
This document provides background information for a proposed instructional design project on whole grains and cardiovascular disease for patients at Marlborough Hospital. The target audience is patients over 65 years old with cardiovascular disease, many of whom are male and Portuguese. The goal is to improve heart health by increasing patients' intake of whole grains, which research shows can decrease cholesterol levels. The educational strategy will use verbal teaching, hands-on activities and large print handouts to motivate patients to understand what whole grains are, why they are heart healthy, how much is recommended per day, and how their current intake compares.
Death and Disease Rates of Vegetarians and Vegans – Summary of Prospective Co...Jussi Riekki
Vegetarians and vegans have lower mortality rates than the general population according to several prospective cohort studies from 1960-2014. A 1999 meta-analysis found vegetarians had a 24% lower risk of heart disease but no difference for other causes of death. A 2012 meta-analysis found lower cancer incidence and heart disease mortality for vegetarians, but no difference for other outcomes. More recent studies find vegetarian diets associated with lower risks of various diseases and all-cause mortality, with some evidence that pescatarian diets may have the lowest risks.
Nutritional Practices & Habits of Boomer Consumers: Why Active Snacking is the Most Effective Method of Nutritional Supplementation. Nutritional tools to minimize age accelerators and enhance an active and healthy functional lifestyle.
View more at http://www.GoBeneVia.com/blog
Expert Consultation on Nutrient Risk Assessment for Determination of Safe Upper Levels for Nutrients held on 4th December, 2015 by International Life Sciences Institute, India
This document discusses vitamin D requirements and the process for setting dietary reference intake recommendations. It outlines the key steps:
1) Identifying health outcomes related to vitamin D adequacy and safety based on a literature review.
2) Assessing dose-response relationships between vitamin D intake/status and outcomes.
3) Evaluating population intake levels and vitamin D status relative to reference values.
4) Characterizing public health risks based on prevalence of intakes/status outside reference values. The document provides details on how these steps were applied to set the 1997 US vitamin D DRIs and identifies areas being re-evaluated for new recommendations expected in 2010.
This document summarizes a study that estimated average dietary exposures to 37 pollutants across the United States population by combining contaminant data from foods with food consumption data. The study found that for the whole population, average exposures exceeded benchmark safety levels for arsenic, chlordane, DDT, dieldrin, dioxins, and PCBs when non-detects were treated as zero. Exposures to these same 6 pollutants also exceeded benchmarks for children under 12. The study provides a comprehensive assessment of both pesticide and industrial contaminant exposures through multiple foods for children and adults.
This document provides an overview of chemical risk assessment and toxicology as it relates to foods and food ingredients. It discusses key concepts in toxicology like dose-response relationships, factors that influence toxicity, and the absorption, distribution, metabolism and excretion of toxicants in the body. It then explains the risk assessment process and considers acrylamide as a case study, discussing its properties, levels found in various foods, and cancer bioassay results. It also reviews epidemiology studies that found no increased cancer risk from dietary acrylamide exposure.
Dr. Mary Torrence - Progress Report on Nationally Funded Antimicrobial Resist...John Blue
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More presentations at:
http://www.trufflemedia.com/agmedia/conference/2012-one-health-to-approach-antimicrobial-resistance-and-use
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This document summarizes a study that examines consumer acceptance of food irradiation using the recreancy theorem, which focuses on consumer evaluations of societal institutions' ability to develop and manage technologies. The study surveyed 482 individuals about food irradiation at two time periods. Structural equation models showed that the recreancy theorem effectively explains trust and acceptance, with presenting alternative information relating to increased acceptance. Key determinants of trust - competence and responsibility - equally impacted trust in institutions as specified by the recreancy theorem.
This document discusses concerns about inorganic arsenic in food and provides context on the issue. It notes that while arsenic is naturally occurring, it is also classified as a human carcinogen. Recent increased sensitivity in testing and media coverage has led to growing consumer awareness and concerns about levels in foods like rice and apple juice. The document reviews studies on arsenic exposure and risks from rice, as well as evaluations by expert groups like JECFA and EFSA that found mean exposures to be below levels of toxicological concern. It emphasizes that the dose is critical in determining toxicity, and environmental exposures from foods are typically far below doses shown to cause health effects.
The document is a toxicological profile for endosulfan produced by the U.S. Department of Health and Human Services in September 2000. It was reviewed by a panel of experts in endosulfan's properties, health effects, exposure risks, and quantification of risks to humans. The profile provides a public health statement on endosulfan's toxic properties and reviews health effects by route of exposure and length of exposure based on human and animal studies. It also addresses children's health issues related to endosulfan exposure and methods for reducing toxic effects and biomarkers of exposure.
Multiple Chemical Sensitivities Report - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
This document discusses making decisions about risks from chemicals in foods when scientific information is limited. It provides context on the US legal framework for food safety and international considerations. The experts examined challenges in timely decision making with limited data. They developed a conceptual framework to guide evaluating available evidence and making balanced risk management decisions. Case studies demonstrate applying the framework and how decisions can be reinforced as more data become available.
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This document provides an overview of a presentation on international approaches to regulating antimicrobial use in food animal production. The presentation covers topics such as: a brief history of antimicrobial regulation in various countries including the US, EU, Australia, Canada, and Japan; emerging issues regarding antimicrobial resistance and the role of international organizations in regulation; and potential future areas of focus for antimicrobial resistance policy internationally, including monitoring of antimicrobial use volumes, the EU's efforts to impose its domestic regulations on trade partners, and WHO's expanded scope to include regulation of disease prevention uses of antimicrobials in animals.
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2) Reference doses (RfDs) derived from epidemiologic data generally .pdfarchanadesignfashion
2) Reference doses (RfDs) derived from epidemiologic data generally would involve fewer
uncertainty factors than those derived solely from animal data.
True or False
3) In estimating actual human exposures to an environmental hazard, risk assessors often employ
conservative, \"health-protective\" assumptions that presume people are exposed to the highest
level of hazard that can be considered credible.
True or False
4) New animal toxicity data has recently become available that strongly indicates the Reference
Dose (RfD) for a regulated chemical found in drinking water should be decreased by two-fold in
order to be protective of public health. One option regulators would have to maintain the
prevailing level of population health protection for this chemical would be reduce it\'s legally
allowable limit in drinking water by two-fold.
True or False
Solution
2) Answer: TRUE
In epidemiologic data, the Reference doses (RfDs) derived by experimenting with human
population, but in animal data , the experiments are done on those animals which genetically
mimic the human, genarally on mice, rat, monkey etc. So the Reference doses (RfDs) derived
from epidemiologic data generally have fewer uncertainty factors than those derived solely from
animal data.
3) Answer: False
Risk assessment combines what is currently known about chemical toxicity and exposure to
characterize potential health problems, but there are significant uncertainties in each step of the
process. Some uncertainties are addressed by regulatory agencies through the use of health-
protective assumptions that may result in overestimates of risk. These include assuming that
animal toxicity test results are predictive of human responses, and that there is some risk of a
carcinogenic response at even extremely low doses. These health-protective assumptions are
often criticized by chemical defenders as leading to biased risk assessments. However, there are
other uncertainties that are currently ignored in conventional risk assessment, which may result
in underestimating health risks. Important factors that could affect health outcomes are often
ignored because critical data are lacking. For example, risk assessment values are derived based
on the assumption that people are exposed to a single chemical at a time, and that there is no
significant interaction between chemicals that heightens the probability of adverse outcomes.
Variations in susceptibility to a toxic chemical between people are often ignored, even though it
is known that factors such as health status or genetic characteristics can greatly affect how
someone responds to chemical exposure.
4) Answer: TRUE.
Evaluating Health Risks in Children Associated with Exposure to Chemicals v2zq
This document summarizes the key findings from the World Health Organization's Environmental Health Criteria 237 on evaluating health risks in children from exposure to chemicals. It outlines that children are among the most vulnerable populations and environmental factors can affect their health differently than adults. It also notes that social, economic and nutritional factors influence children's susceptibility to environmental hazards. The document provides guidance for public health officials, scientists and others on assessing risks to children from chemicals by considering children's unique biological characteristics and developmental stages.
Felicia Wu
John A. Hannah Distinguished Professor
Department of Food Science and Human Nutrition
Department of Agricultural, Food, and Resource Economics
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This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
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This document discusses food labelling regulations and challenges in ASEAN countries. It provides an overview of the general labelling requirements for Indonesia, Malaysia, Thailand and Singapore, which include the product name, ingredients list, net content, expiration date and manufacturer information. There are also country-specific details regarding language, format of dates and addresses, nutrition panel requirements. While general labelling information is similar, differences exist in details. Developing a common ASEAN food label is difficult due to mandatory country requirements, but harmonizing standards across ASEAN by referring to Codex guidelines could help address this challenge.
This document discusses considerations for developing a successful functional food product for the market. It begins by outlining upcoming trends in the industry, such as emerging economies and increasing health consciousness. Next, it identifies market drivers focused on consumers, like rising incomes and increasing awareness of health. Some key challenges in product development are ensuring healthy options are easy choices and delivering health, safety and quality. Five critical success factors for products are noticeability, superiority, compatibility, practicality and lack of complexity. The document provides a checklist for successful marketing that includes offering relevant benefits and differentiating through packaging. It emphasizes the importance of filtering promises from challenges in marketing.
This document discusses considerations for developing a successful functional food product. It notes consumers are shifting from illness management to wellness promotion. Functional foods fit within a continuum from health maintenance to promotion. Developing uniqueness through customization for intended populations and new research areas like nutrigenomics, proteomics and metabolomics can aid innovation. Biomarkers directly correlate health status to exposure. Encouraging development factors include epidemiological research, technological advancements, legislation and government incentives.
This document provides an overview of best practices for ensuring readiness for food safety audits and assessments. It begins with introductions and background on the speaker, Bill McBride. The agenda then outlines topics to be covered, including an overview of food safety audits, understanding common food safety terminology, selecting the appropriate food safety standard, and what it means to be "audit ready". It also provides definitions and objectives of food safety audits. Key points made include criticisms of some auditing practices, the roles and limitations of audits, and information on standards organizations like ISO, GFSI initiatives, and the purpose of establishing the GFSI.
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Nutrient Risk Assessment and Upper Intake Levels - USA_2015
1. DRIs
Dietary Reference IntakesDietary Reference Intakes
119-02
Allison A. Yates, PhD, RD
Procedures for Development of Tolerable
Upper Intake Levels for Nutrients
1994-2004
2. Today’s Presentation
Previous discussions/reports impacting
need to develop a new process for setting
reference values
Overview of US/Canada DRI Process
In-depth look at steps in developing ULs
Examples of UL derivation
3. Previous Reports that Set the Stage
for the Development ULs
1983 Risk Assessment Report—U.S. NRC
1983 Recommended Nutrient Intakes—Health
& Welfare, Canada
1991 UK Dietary Reference Values Report—
COMA
1994 Risk Assessment of Essential Elements
Report—ILSI
143-01
4. The Concept of a Safe Intake Range
Observed level of intake
Riskofinadequacy
Riskofexcess
0.5 0.5
RDA
Average
Requirement
198-01
Safe Range of Intake
1.0 1.0
Upper Safe
Deficient
Adapted from Health and Welfare, Canada, 1983; 1991 UK Report, COMA
5. DRI Framework
Reference values to meet variety of uses
Concepts of reduction of risk to chronic
disease
Reviews of other food components
In-depth rationale for functional end points
used
Open dialog with interested groups
Estimates of upper limits of intake
143-01
6. Why DRIs?
Conceptual Approach
Quantitative dietary reference values need to
address multiple users and meet multiple
needs
—Labeling
—Limits for fortification
—Assessing adequacy of diets of population
groups
One number can’t do it all if a science-based
approach is to be followed
142-02
7. Observed level of intake
UL
Riskofinadequacy
Riskofexcess
0.5 0.5
RDA
AI
EAR
Increase
Relationship of the DRIs
8. Dietary Reference Intakes
Upper Reference Levels
Subcommittee
Uses of DRIs
Subcommittee
Standing Committee on the Scientific
Evaluation of Dietary Reference Intakes
Panels
Ca, Vitamin D, Phosphorus, Mg, F
Folate, B12, Other B Vitamins, Choline
Vitamins C and E, Se, ß-carotene and Other
Carotenoids
Vitamins A and K, As, B, Cr, Cu, Fe, I2,
Mn, Mo, Ni, Si, V, Zn
Energy and Macronutrients
Electrolytes, Water
[Other Food Components]
10 years,
$US ~7.5 M
9. Flow Chart of DRI Activities—FNB/IOM Process
NRC REVIEW
UPPER
REFERENCE
LEVELS
SUBCOMMITTEE
DRI COMMITTEE-
Scientific
Evaluation of DRIs
NUTRIENT GROUP PANEL(S)
SCIENTIFIC
AND USER
COMMUNITIES
Reports Released
Recommends
Appointments to
Panel and Guides
Forwards
Drafts
Solicits
Nominees
Input USES OF DRIs
SUBCOMMITTEE
1) Holds Workshops and Meetings
2) Develops Scientific Basis for Nutrient Needs and
Sets Tentative Reference Values, Including
EARs, Variances, RDAs, AIs, and ULs
Forwards Drafts
Forwards Drafts
Develops Guidelines for use
with Emphasis on Policy,
Guidance & Education
158-01
10. DRIs
Dietary Reference IntakesDietary Reference Intakes
119-02
Allison A. Yates, PhD, RD
Development of Tolerable Upper
Intake Levels for Nutrients
1994-2004
DRI Reports 1997-2004
11. DRI Funding Provided By
United States: DHHS (Office of Disease Prevention and Health
Promotion, Food and Drug Administration, Centers for Disease
Control and Prevention, and NIH); USDA; U.S. Army
Health Canada
NGOs: the Dannon Institute; International Life Sciences
Institute
the DRI Corporate Donors’ Fund: Daiichi Fine Chemicals;
Kemin Foods; M&M/Mars; Mead Johnson Nutritionals; Nabisco
Foods Group; Natural Source Vitamin E Association; Roche
Vitamins; U.S. Borax; and Weider Nutritional Group
223-02
12. Subcommittee on Upper Reference
Levels of Nutrients
Original Subcommittee 1995+
IAN C. MUNRO, chair, CanTox, Inc.,
Mississauga, Ontario
WALTER MERTZ, Retired, USDA, Beltsville,
MD
RITA B. MESSING, Minnesota Dept of Health
SANFORD A. MILLER, Georgetown
University, Washington, DC
SUZANNE P. MURPHY, University of
California, Berkeley
JOSEPH V. RODRICKS, The Life Sciences
Consultancy, Arlington VA
IRVIN H. ROSENBERG, USDA & Tufts
University, Boston
STEVE L. TAYLOR, Univ. of Nebraska, Lincoln
ROBERT H. WASSERMAN, Cornell
University, Ithaca, NY
Additional Members 1999-2004
G. HARVEY ANDERSON,
University of Toronto
GEORGE C. BECKING, Phoenix
OHC, Kingston, Ontario
ELAINE FOUSTMAN, University of
Washington, Seattle
SUZANNE HENDRICH, Iowa
State University, Ames
RENATE D. KIMBROUGH,
Institute for Evaluating Health Risks
HARRIS PASTIDES, University of
South Carolina, Columbia
JOHN A. THOMAS, San Antonio
GARY M. WILLIAMS, New York
Medical College
219-03
13. Key Issues in the Development of a
Model for Upper Levels of Nutrients
Safety versus risk
Limitations of traditional models
Unique characteristics of nutrients
Sparse documentation of adverse effects
of chronic overconsumption
Coordinating the work of the nutrient
review panels with the subcommittees
220-02
14. Characteristics of the
Concept of Safety
Safety is:
An intellectual concept
Not an inherent biological property
A point on a continuum
221-02
UK DRV Report in 1991 had used the term
“Upper Safe Level of Intake”
15. Safety: A Point on a Continuum
+ + + +SOCIETY CULTURE POLITICS LAW ECONOMICS
UNSAFE
(0)
SAFE
(100)
222-02
SCIENCE
16. Definition of Risk
Risk is defined as the probability of an
adverse effect occurring at some specified
level of exposure
Risk assessment is a scientific exercise, not
influenced by value judgments
Risk management = approaches to take to
mitigate identified risk --- not part of risk
assessment
223-02
17. Limitations of Traditional Toxicology
Models in Use in 1994
Focused on establishing safe intakes not
tolerable upper intake levels
Reliance on animal data
Most involved the concept of establishing an
Acceptable Daily Intake (ADI) ---somewhat
equivalent to other terms such as US EPA’s
Oral Reference Dose (RfD) or US ATSDR’s
Minimum Risk Level (MRL)
224-02
18. Typical Studies Required for
Food Ingredients (Usually for Non-
Essential Additives)
Acute toxicity - 2 species
Sub-chronic toxicity - 2 species
Multi-generation studies
Teratology studies
Long-term/carcinogenicity studies - 2 species
Absorption, distribution, metabolism and
excretion studies
Genotoxicity studies - in vitro / in vivo
225-01
e.g., NAS report, Risk Assessment in the
Federal Government: Managing the Process,
1983 (The “Red Book”)
19. Calculation of Acceptable
Daily Intake (ADI)
ADI
(mg/kg bw-
man)
=
NOAEL1 (mg/kg bw-animal)
Safety Factor (usually 100)
Note: Safety Factor designed to compensate for:
a) Animal to man extrapolation
b) Intrahuman sensitivities (children, elderly, gender)
c) Differences in test population size
226-01
1No Adverse Effect Level
20. Unique Characteristics of Data on
Overconsumption of Nutrients
Absence of dose-response data
Few available human or animal chronic
studies
Few surveillance studies to establish NOAEL
Available databases have concentrated on
supplement intake, but not total
Significant differences in bioavailability,
particularly for trace elements
227-01
21. Problem Identified When Standard
Uncertainty Factors Used with
Essential Nutrients
US EPA’s RfD (oral reference dose) for zinc for
children was less than the 1989 RDA for zinc
for young boys
23. DRI UL
Tolerable Upper Intake Level--Definition
The highest daily nutrient intake level that is likely
to pose no risk of adverse health effects to almost
all individuals in the general population. As intake
increases above the UL, the potential risk of
adverse effects may increase(s). The UL is not a
recommended level of intake and is not a level that
is desirable to attain.
228-04
NOTE: Words in italics added in later DRI reports
24. UL
Tolerable Upper Intake Level
Aspects Important to Consider when
Applying to Nutrients
Limited data available due to few human studies
Depending on clinical significance of observed
adverse effects, uncertainty factor used will vary
Observed effects may vary depending on form of
intake
229-03
25. Step 1: Hazard Identification
Components
Evidence of adverse effects in humans
Causality
Relevance of experimental data
Mechanism of toxic action
Quality and completeness of the data base
Identification of distinct and highly sensitive
subpopulations
232-01
26. Step 2: Dose-Response Assessment
Components
Data selection
Identification of no-observed-adverse-effect
level (NOAEL) or lowest-observed-adverse-
effect level (LOAEL) and critical endpoint
Uncertainty assessment
Derivation of a UL
Characterization of the estimate and special
considerations
233-01
27. Step 3: Uncertainty Assessment
Depends on
Inter-individual variation in sensitivity
Experimental animal data extrapolated to
humans
LOAEL used in absence of NOAEL
Sub-chronic NOAEL used to predict chronic
NOAEL
234-01
28. UL Calculations
Almost always based on data for adults, then
typically decreased for younger age groups
LOAEL =
Uncertainty Factor
==
UL
29. Effect of Uncertainty Assessment on UL
100%
50%
RDA UL NOAEL LOAEL
100%
50%
RDA UL
NOAEL
LOAEL
RiskofAdverse
Effects
RiskofAdverse
Effects
Increasing Intake
230-03
31. Importance of Knowing Distributions
for Dietary Recommendations
Frequency
Requirement Adverse Effects
Intake
Distribution
XEAR RDA XIntake
Amount Consumed
Pop. Index
AI
197-02
SuS. Murphy, 2015
33. Example of Overlapping Requirements Distribution with
Distribution of Adverse Effects: Caries Experience and
Dental Fluorosis Index Versus Fluoride Concentration
of Drinking Water
0
1
2
3
4
5
6
7
8
0 1 2 3
2
1
CariesExperienceperChild
FluorosisIndex
Water [F], ppm
236-02
NOAEL?
35. UL Adverse Effects from
1998 B-Vitamin Report
Nutrient Adverse Effect NN(L)OAEL UF Adult UL/d
Niacin1
Flushing L = 50 mg 1.5 ~35 mg
Vitamin B6 Sensory neuropathy N = 200 mg 2.0 100 mg
Folate1
Neuropathy in B12-
deficient individuals
L = 5 mg 5.0 1,000 µg
Choline
Vitamin B12
Hypotension, fishy
body odor
None identified as of
concern
L = 7.5 g 2.0 3.5 g
---
1
From supplements only
360-03
36. UL for Folate
Dose Response Assessment
Adverse Effect Selection
Possible adverse effects in the literature
— Neurological damage in Vitamin B-12 deficient
individuals
— General toxicity: mental changes, sleep
disturbances ,and GI effects of 15 mg/d
— Increased cancer of oropharynx and hypopharynx
and total cancer rates – epidemiological study
— Hypersensitivity – rare, 1 mg/d
— Intestinal zinc malabsorption
37. UL for Folate
Dose Response Assessment
Identification of NOAEL (or LOAEL)
Supplemental folate ≥ 5 mg/d ~100 reported cases
≤ 5 mg/d (0.33 to 2.5 mg/d), only 8 well-
documented
Folate supplementation maintained patients in
remission of pernicious anemia symptoms
Background intake of folate from food was not
specified in reports
38. UL for Folate
Dose Response Assessment
Uncertainty Assessment
UF chosen was 5
Why so high when there is dose-response
data available?
— Due to severity of neurological complications
— Complications are irreversible
— Only have LOAEL, not NOAEL
Not higher than 5 as have uncontrolled
observations of millions of people exposed to
1/10th the LOAEL without reported harm
41. Why Not a UL for -Carotene?
Supplemental -carotene increased the risk
of lung cancer in two major trials (doses used
20 mg/d; 30 mg/d + vit. A)
However, the data are conflicting with a third
major trial (dose 50 mg/every other day)
reporting no adverse effects with up to 12
years intervention
Therefore, conflicting data did not allow
determination of a UL
466-01
42. Plasma -Carotene Concentrations in
Large Population Studies
U.S. 5th to 95th%
0.09–0.9
(5–49)
“Threshold”
>0.4 mol/L
(>20g/dL)
1.9
(100)
5.6
(300)
3.8
(200)
7.5
(400)
Linxian
(15 mg/day)
PHS
(50 mg every
other day)
CARET
(30 mg/day)
ATBC
(20 mg/day)
Blood -carotene concentration
µmol/L (µg/dL)
468-03
43. Supplemental -Carotene and Lung
Cancer Risk
Report conclusion: “Based on evidence that -
carotene supplements have not been shown to
confer any benefit…and may cause harm in certain
subgroups (possible lung cancer risk in smokers), it
is concluded that -carotene supplements are not
advisable, other than as a provitamin A source and
for the prevention and control of vitamin A
deficiency in at-risk populations.”
467-02
45. Adverse Effects Considered in
Setting the Upper Level for Vitamin A
Bone mineral density
Liver toxicity
Teratogenicity (women of reproductive
age)
Bulging fontanel (infants)
46. Upper Levels for Vitamin A
Women of reproductive age
NOAEL (teratogenicity) = 4,500 μg/day = 3,000 μg/day
UF 1.5
All other adults
LOAEL (liver toxicity) = 14,000 μg/day = 3,000 μg/day
UF 5
47. Tolerable Upper Intake Levels for
Vitamin A (µg/day)
Life Stage UL
0–6 mo 600
7–12 mo 600
1–3 y 600
4–8 y 900 (same as RDA for adult male)
9–13 y 1,700
14–18 y 2,800
19 y 3,000
Preg, Lact See age group
49. Adverse Effects Considered for
Setting the Upper Level for Iron*
Gastrointestinal distress
Impaired zinc absorption
Cardiovascular disease
Cancer
UL = LOAEL (gastrointestinal = 70 mg/day 45 mg/day
UF distress) 1.5
*May not protect individuals with hemochromatosis
50. Critical Points in Establishing Useful
ULs
Integrate nutrient requirements analysis with evaluation
of adverse effects---can’t be isolated activities—and
must involve both nutritionists and toxicologists
Evaluate existence of food and supplement intake data
to assure that adequate exposure (intake) estimates
exist for relevant sub-population groups
Dietary guidance needs to reflect varied population
needs as well as potential adverse effects—depends on
the seriousness of the adverse effects
Risk managers determine how to incorporate risk
assessment into policy—Final Dietary Guidelines, label
values, etc.
51. 93
56
44
31
14
12
8
5
5
5
5
3
2
2
2
0 20 40 60 80 100
Vitamin E
Magnesium
Vitamin A
Vitamin C
Vitamin B6
Zinc
Folate
Copper
Phosphorus
Thiamin
Iron
Protein
Selenium
Niacin
Riboflavin
Nutrient
Percent of inadequate intakes in U.S.
compared to nutrient requirements, using
individual DRI EARs to determine prevalence
of inadequacy; WWEIA intake surveys now
include estimates from supplements as well
as food to allow comparison with ULs
21st Century Paradox in the U.S.:
Overnutrition & Malnutrition
What We Eat in America,
NHANES
Percent of Population
WWEIA 2001-2002, 1 day, 1+ y
FSRG/ARS/USDA
52. Synthesis Report Submitted as
CRD 1 for Codex Committee on
Nutrition and Foods for Special
Dietary Uses in 1998
All DRI reports are
downloadable on National
Academies Press website:
www.nap.edu
Search term: DRI
Also, 2015 Dietary Guidelines for
Americans Advisory Committee
Report from February 2015
available online; final 2015 Dietary
Guidelines Report not yet
available