CONSUMER EXPOSURE

No one can afford to run all the tests even on one material. Yet the test or tests chosen may not be related to a contemplated use. This has lead to an enormous amount of duplication of time-consuming exposures. Consideration has been given to means of... 

Though only an estimate, a maximum consumer exposure has been established at approximately 37 mg/person/day when DOSS is used as a food additive. In medical use maximum consumption of 200 mg/day is suggested [76]. The pharmacological and side effects of DOSS have been studied by many authors [77-81]. 

Additionally, organotin-catalysed silicones have been used in products such as coatings on baking paper (for use in food preparation), and this use is considered in more detail in the consumer exposure assessment (section 6). Information provided by the Centre Europeen des Silicones (CES, 2002b) indicated that organotin-catalysed silicones are used in only a small proportion of baking paper produced in the EU ... 

Table 19 Worst-case consumer exposure to organotin compounds (adults). ...

Based upon the various sources of adult consumer exposure to organotin compounds (section 6) and the TDI values derived above, it is possible to estimate the relative exposure from the various organotin compounds expressed as a percentage of the TDI values. The exposure calculations in section 6 were based on a realistic worst-case exposure assessment. Table 26 presents the results of this risk characterization. 

Table 27 presents the results of the child consumer exposure scenario in the same manner as for the adult scenario. Again, the exposure from each source is expressed in relation to the TDI. 

ECHA (2010) Guidance on information requirements and chemical safety assessment -Chapter R.15 Consumer exposure estimation. Version 2... 

The dangerous properties of acute toxicity, irritation, corrosivity, sensitisation, repeated-dose toxicity and CMR are evaluated in terms of their potential toxic effects to workers, consumers and man exposed indirectly via the environment, based on the use for each stage in the lifecycle of the substance from which exposure can occur. Risk assessment is also required if there are reasonable grounds for concern for potential hazardous properties, e.g., from positive in vitro mutagenicity tests or structural alerts. The risk assessment involves comparing the estimated occupational or consumer exposure levels with the exposure levels at which no adverse effects are anticipated. This may be a quantitative risk assessment, based on the ratio between the two values, or a qualitative evaluation. The principles of human health risk assessment are covered in detail by Illing (a.30) and more briefly in Chapter 7 of (73). 

A detailed review is presented of the literature on cutaneous reactions to rubber, the aspects covered including latex allergy, irritant contact dermatitis and allergic contact dermatitis. The adverse cutaneous reactions to rubber occurring following industrial and occupational or consumer exposure to rubber chemicals or products or to natural rubber latex proteins are discussed. 261 refs. 

Phenol has been measured in effluents (up to 53 ppm), ambient water (from 1.5 to >100 ppb), drinking water (not quantified), groundwater (from 1.9 to >10 ppb), rain (0.075-1.2 ppb), sediment (>10 ppb), and ambient air (0.03-44 ppb). Occupational exposures occur through inhalation and dermal exposure air concentrations monitored in various workplaces range from 0.1 to 12.5 mg/m3 (0.03-32 ppm). Occupational as well as consumer exposure may also occur through dermal contact with phenol or phenol-containing products. 

A number of diseases are recognized as being, or presumed to be, allergic in nature. These include asthma, rhinitis, conjunctivitis, allergic contact dermatitis, urticaria (a condition in which red or pale, itchy, and swollen areas appear on the skin, often called hives ), and food allergies. In this section, the endpoints discussed are those traditionally associated with occupational and consumer exposure. Photosensitization is potentially important but its mechanism of action is poorly understood, so it has been considered but not discussed in detail. 

An OECD Guidance Document on Reporting Summary Information on Environmental, Occupational and Consumer Exposure (OECD 2003b) provides guidance for the reporting of summary exposure information (quantitative and qualitative), which can be used in various chemical assessment programs. 

Three formats for reporting summary information on environmental, occupational, and consumer exposure to agents are provided, together with guidance for completing and using the formats. The... 

Reliable, measured values are preferred, and should be used when available. Measured values or estimates of water solubility and vapor pressure are important in evaluating whether a chemical will dissolve in water or exist as a vapor at ambient temperature, and are used to estimate worker and consumer exposures. Measured data or estimates of biodegradation, sorption, and volatilization potential are used to predict removal in wastewater treatment. Information on decay rates in the... 

The EU Technical Guidance Document (TGD) for risk assessment of new and existing substances and biocides (EC 2003) contains guidance on exposure assessment (Chapter 2). The core principles of human exposure assessments according to the TGD are humans may be exposed to substances in the workplace (occupational exposure), from use of consumer products (consumer exposure),... 

CEM TF. 2004. Consumer Exposure Modelling Tools. Ispra, European Commission, Joint Research Centre, Institute for Health and Consumer Protection, Physical and Chemical Exposure Unit, Exposure Modelling Sector, http //cem.jrc.it/cemdb/qstart.php... 

EU. 2004. European information system on risks from chemicals released from consumer products/aiticles. Consumer exposure modelling task force. Bmssels, European Commission, Joint Research Centre, http // www.jrc.cec.eu.int/eis-chemrisks/... 

Cadby P.H., W.R. Troy, and M.G.H. Vey (2002). Consumer exposure to fragrance ingredients Providing estimates for safety evaluation. Regulatory Toxicology and Pharmacology 36 246-252. 

The production of ort/ro-toluidine and its use as an intermediate in the production of dyes and pigments, mbber chemicals and other products may result in its release to the environment through various waste streams. The primary routes of potential human exposure to ort/ro-toluidine and its hydrochloride salt are inhalation and dermal contact. Consumer exposure may occur from residues present in commercial dyes and on textiles and via smoking (lARC, 1982 Department of Health and Human Services, 1982 Environmental Protection Agency, 1984, 1997 Department of Health and Human Services, 1999). 

The FDA has the right to conduct surveillance inspections of manufacturing facilities for the purpose of enforcement. The goal of inspections is to minimize consumers exposure to adulterated products. 5... 

Workers may be exposed to ENMs during the production, use, or recycling of industrial nanoproducts, and consumers may be exposed mainly during the use of consumer products. However, sooner or later these ENMs are likely to enter the environment and therefore assessing occupational and consumer exposure forms the basis for assessing the environmental exposure. Direct exposure of the environment to ENMs will be mainly restricted to a few applications with intended release... 

In the exposure assessment stage, qualitative and quantitative evaluation of the likely intake of drug residues through food as well as exposure from other sources are performed. Estimating consumer exposure is based on the daily consumption of a particular food commodity combined with its content of veterinary drug residues. 

The conditions under which the drug is used need to be estimated as do acceptable residues linked to the level of acceptable risk to the consumer. The acceptable level of risk, which is determined in theory at the risk management stage, has already been expressed in terms of residues by the ADI under hazard characterization. Moreover, the elements considered for hazard identification, hazard characterization, and exposure assessment make it possible, for a given form of utilization of a particular substance, to establish a profile of residues in animal tissues and to associate this with a profile of consumer exposure. Comparison of this consumer profile and ADI indicates whether the mode of utilization of the substance is acceptable or not. Analysis of the different results of residue content in animal products then provides an indication of level of residues in one or several animal tissues, making it possible to differentiate between veterinary drug applications that do or do not permit compliance with the ADI. 

The 1997 consultation addressed the topic of safety factors, which is vitally important for die protection of public health. Setting MRLs is in fact based on a series of assumptions. One assumption is that humans are at least as sensitive as the most sensitive laboratory animal to a potentially toxic residue. Another assumption is diat all the residues covered by the MRLs are as toxic as the parent substance. A third assumption is that residues free from the human gastrointestinal tract are all totally bioavailable. A fourth assumption is the safety factor used to infer an ADI from a NOEL, including the additional safety factor, generally with a value of 2, to establish a provisional ADI until further information is available to convert this into a definite ADI. Other assumptions are the overestimation of consumer exposure to drug residues and the reduction of MRL values to take account of normal conditions under which the veterinary drugs are administered. 

Exposure to benzoyl peroxide may occur in its manufacture and use as an initiator in polymer production, food bleaching and rubber curing. Consumer exposure occurs from acne medications and dental products containing benzoyl peroxide. 

The potential for consumer exposure to residues of tranquillisers and beta-agonists has been tested intensively over the past twenty years. This followed evidence of illegal drug availability and usage. These substances could have immediate effect on health if consumed in large amounts. Action was taken to protect consumers. Surveillance continues to ensure that no detectable contamination of the food supply occurs with these substances (see, for example, VMD, 1995). 

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