Chemical acceptable daily intake

Acceptable Daily Intake (ADI) An estimate similar in concept to the RfD, but derived using a less strictly defined methodology. RfDs have replaced ADIs as the USEPA s (Agency) preferred values for use in evaluating potential noiicarcinogenic health effects resulting from exposure to a chemical. 

The determination of an acceptable dose for humans involves the application of uncertainty factors to reflect the fact that, unlike the experimental animal, there is wide variability and susceptibility of response in the genetically diverse human population. Variations in gender, age, hormonal and disease status can affect the response to a chemical. In order to minimise any potential risks, uncertainty factors are applied to the NOAEL to arrive at a reduced exposure that is considered tolerable - namely the acceptable daily intake or ADI. These are usually tenfold for variations in susceptibility amongst the human population (the intra-species factor) and tenfold for the potential... 

Dose-response characterisation. Different chemicals will be associated with different toxicological end-points and the risk of any individual experiencing toxicity is related to the dose that they receive. Very often it is possible to identify a dose level below which the probability of anyone experiencing an adverse effect is veiy low or zero. For additives this is usually referred to as the Acceptable Daily Intake (ADI). 

For many substances the body s own mechanisms for de-toxification and repair mean that low doses of some chemicals can be tolerated without experiencing any adverse effects. However, once a certain threshold has been exceeded then the degree of adverse effect is related to the dose. The highest dose at which no adverse effects are observed in the most susceptible animal species is identified as the No Observed Adverse Effect Level (NOAEL). The NOAEL is used as the basis for setting human safety standards for food additive Acceptable Daily Intakes (ADIs)4... 

Some chemicals are believed to have no threshold above which toxic effects are observed. In other words, a single molecule has the potential to induce an adverse effect. The most common group of hazards in this respect are genotoxic carcinogens. Chemical carcinogens are not normally approved as food additives because an acceptable daily intake cannot be established. 

An estimate for the lowest level of toxicological concern for human exposure to a chemical is developed by dividing the appropriate NOAEL by the uncertainty factor. Historically, this estimate has been termed the acceptable daily intake (or ADI) although it has been replaced by what EPA calls the reference dose (or RfD). Both ADIs and RfDs are expressed in terms of the amount of chemical exposure per amount of body weight per day. 

The risk assessment comprises an effect assessment (hazard identification and hazard characterization) and an exposure assessment. The principles for the effect assessment of the active substances are in principle similar to those for existing and new chemicals and are addressed in detail in Chapter 4. Based on the outcome of the effect assessment, an Acceptable Daily Intake (ADI) and an Acceptable Operator Exposure Level (AOEL) are derived, usually from the NOAEL by applying an overall assessment factor addressing differences between experimental effect assessment data (usually from animal studies) and the real human exposure situation, taking into account variability and uncertainty for further details the reader is referred to Chapter 5. As a part of the effect assessment, classification and labeling of the active substance according to the criteria laid down in Directive 67/548/EEC (EEC 1967) is also addressed (Section 2.4.1.8). 

There are of course many mathematically complex ways to perform a risk assessment, but first key questions about the biological data must be resolved. The most sensitive endpoint must be defined along with relevant toxicity and dose-response data. A standard risk assessment approach that is often used is the so-called divide by 10 rule . Dividing the dose by 10 applies a safety factor to ensure that even the most sensitive individuals are protected. Animal studies are typically used to establish a dose-response curve and the most sensitive endpoint. From the dose-response curve a NOAEL dose or no observed adverse effect level is derived. This is the dose at which there appears to be no adverse effects in the animal studies at a particular endpoint, which could be cancer, liver damage, or a neuro-behavioral effect. This dose is then divided by 10 if the animal data are in any way thought to be inadequate. For example, there may be a great deal of variability, or there were adverse effects at the lowest dose, or there were only tests of short-term exposure to the chemical. An additional factor of 10 is used when extrapolating from animals to humans. Last, a factor of 10 is used to account for variability in the human population or to account for sensitive individuals such as children or the elderly. The final number is the reference dose (RfD) or acceptable daily intake (ADI). This process is summarized below. 

ADI Acceptable daily intake - "The daily intake of chemical, which during an entire lifetime appears to be without appreciable risk on the basis of all known facts at that time" Food additives, pesticides... 

Acceptable Daily Intake (ADI) The dally intake of a chemical that is considered without appreciable risk on the basis of all the facts known at the time it is defined. 

Under the proposal, residue incidents would be categorized into risk groups, which in turn would be used to determine the nature and severity of any response actions needed. Criteria for such categorizations would be determined by the impact consumption of a particular food would have on the dietary intake of consumers, measured as a proportion of the Acceptable Daily Intake. This approach recognizes that chemical residues occasionally consumed at concentrations marginally above MRL rarely present a risk to public health, whereas they may do so at higher concentrations. 

For food additives, this is normally the acceptable daily intake (ADI). The ADI is the amount of chemical to which a person can be exposed for a lifetime without suffering harmful effects. The determination of these intake values requires the use of a safety or uncertainty factor. 

Basically, these workers were attempting to determine the amounts of chemicals that the human body could ingest on a daily basis without undue risk and toxicity. In the process, they found that a level of acceptable daily intake could be calculated from the toxicity of the materials expressed as an LDS0. These data are widely available on material safety data sheets and other references on which toxicity data can be found. 

The risk to health from chemicals in food can be assessed by comparing estimates of dietary exposure with recommended safe levels of exposure. For most metals and other elements, these are the Provisional Tolerable Weekly Intakes (PTWIs) and the Provisional Tolerable Daily Intakes (PTDIs) recommended by the Joint Expert Committee on Food Additives of the Food and Agricultural Organisation of the United Nations and the World Health Organisation International Programme on Chemical Safety (JECFA). The European Commission s Scientific Committee on Food has established other relevant safe levels. These are Acceptable Daily Intakes (ADIs) for chemicals added to food, and Tolerable Daily Intakes (TDIs) for chemical contaminants. The use of the term tolerable implies permissibility rather than acceptability. All the above recommendations are estimates of the amount of substance that can be ingested over a lifetime without appreciable risk, expressed on a daily or weekly basis as appropriate. 

Toxic chemical intake must be quantified in order that comparisons between different chemicals (e.g. pesticides), diets and countries can be made. Most countries in the developed world conduct surveys which involve analysing food for pesticide residues. These values are then put in context by comparing them to benchmarks of toxicity (Acceptable Daily Intake - ADI) or with trading standards (Maximum Residue Level -MRL) which are set to ensure that countries exporting food do not export excessive pesticide residues with that food. 

Australian Government (2009) Acceptable daily intakes for agricultural and veterinary chemicals. Department of Health and Ageing, http //www.health.gov.au/intemet/main/publishing.nsf/ content/ocs-adi-list.htm. Cited 22 February 2009. 

The toxicological evaluations related to human safety of chemical substances are a very complex process involving the determination of the intrinsic toxicity and hazard of the test chemicals. Subsequently, this evaluation leads to determining and establishing a no observed effect level (NOEL) the highest dose level tested experimentally that did not produce any adverse effects. This dose level then is divided by a safety factor to establish an acceptable daily intake (ADI) of the candidate chemical substance. The ADI value is normally based on current research and... 

Historically speaking, the acceptable daily intake (ADI) procedure has been used to calculate permissible chronic exposure levels for humans, based on non-carcinogenic effects. The ADI is the amount of a chemical to which a person can be exposed each day for a long time (usually for a lifetime) without suffering harmful effects. It is determined by applying safety factors that account for the uncertainty in the data, to the highest dose used in human or animal studies which has been shown not to cause toxicity (i.e., the NOAEL). 

Acceptable Daily Intake (ADI) The ADI of a chemical is the estimate of the amount of a substance in food and/or drinking water, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk to the consumer on the basis of all of the known facts at the time of the evaluation. It is usually expressed in mg of the chemical per kg of body weight (EAO/WHO, 1997). 

For chemicals such as food additives, food contaminants, and industrial chemicals the threshold, that is the dose at which toxic effects become apparent, is determined from the dose-response graph and used in the risk assessment process. The threshold value is used, together with safety factors, to determine the acceptable daily intake (ADI) of a food additive, or the tolerable daily intake (TDI) of a food contaminant, or the threshold limit value (TLV in the USA, or maximum exposure limit (MEL) in the UK), for an industrial chemical (see box for calculation). For a drug, information about the dose in animals below which there are no adverse effects will be necessary before human volunteers can be exposed in clinical trials. More extensive safety evaluation is carried out for drugs than for... 

The health and environmental effects profile for antimony oxides was prepared by the Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH, USA Acceptable daily intakes, defined as the amount of a chemical to which humans can he exposed on a daily basis over an extended period of time (usually a lifetime) without suffering deleterious effects, were 24.5, 29.3, 30.9 and 32.5 /ig day for oral exposure, for antimony, antimony trioxide, antimony tetroxide and antimony pentoxide, respectively. 

The WHO has set a temporary acceptable daily intake for saccharin, including its calcium, potassium, and sodium salts, at up to 2.5 mg/kg body-weight. In the UK, the Committee on Toxicity of Chemicals in Food, Consumer Products, and the Environment (COT) has set an acceptable daily intake for saccharin and its calcium, potassium, and sodium salts (expressed as saccharin sodium) at up to 5 mg/kg body-weight. ... 

The dose-response relationship is the basis by which regulatory bodies define under what limits humans can be exposed to potentially toxic chemicals and yet not suffer adverse effects. A number of different government bodies establish regulations to define safe exposure conditions. The acceptable daily intake (ADI) is... 

The prototypical safety assessment for food-borne compounds is the acceptable daily intake (ADI) methodology, which was first documented in 1954, and has come to be employed throughout the world. This paradigm has also been codified in the consideration of food (e.g., aspartame) and color additives (e.g.. Red Dye No. 2), and pesticides (e.g., atrazine). It is also routinely used in the consideration of incidental food-borne chemical contaminants (e.g., lead), particularly as a tool for screening out trivial incidents of exposure. This procedure specifies that an acceptable dose of a chemical may be calculated with the following equation ... 

---