Human Health Risk Assessment Manual



Human Health Risk Assessment ManualVersion 1.0? Australian Pesticides and Veterinary Medicines Authority 2018ISSNXXXXXX (electronic)ISBN XXXXXX (electronic)Ownership of intellectual property rights in this publicationUnless otherwise noted, copyright (and any other intellectual property rights, if any) in this publication is owned by the Australian Pesticides and Veterinary Medicines Authority (APVMA).Creative Commons licenceWith the exception of the Coat of Arms and other elements specifically identified, this publication is licensed under a Creative Commons Attribution 4.0 Australia Licence. This is a standard form agreement that allows you to copy, distribute, transmit and adapt this publication provided that you attribute the work.A summary of the licence terms is available from licenses/by/3.0/au/deed.en. The full licence terms are available from licenses/by/3.0/au/legalcode.The APVMA’s preference is that you attribute this publication (and any approved material sourced from it) using the following wording:Source: Licensed from the Australian Pesticides and Veterinary Medicines Authority (APVMA) under a Creative Commons Attribution 4.0 Australia Licence. In referencing this document the Australian Pesticides and Veterinary Medicines Authority should be cited as the author, publisher and copyright owner.Use of the Coat of ArmsThe terms under which the Coat of Arms can be used are set out on the Department of the Prime Minister and Cabinet website (see .au/pmc/publication/commonwealth-coat-arms-information-and-guidelines).[If third-party information is utilised or web-linked within the corporate document use the disclaimer section below]DisclaimerThe material in or linking from this report may contain the views or recommendations of third parties. Third party material does not necessarily reflect the views of the APVMA, or indicate a commitment to a particular course of action. There may be links in this document that will transfer you to external websites. The APVMA does not have responsibility for these websites, nor does linking to or from this document constitute any form of endorsement. The APVMA is not responsible for any errors, omissions or matters of interpretation in any third-party information contained within this ments and enquiries regarding copyright:Director Public Affairs and CommunicationAustralian Pesticides and Veterinary Medicines AuthorityPO Box 6182KINGSTON ACT 2604 AustraliaTelephone: +61 2 6210 4988Email: communications@.au.This publication is available from the APVMA website: .au.Contents TOC \o "1-3" \h \z \u 1Human Health Risk Assessment PAGEREF _Toc526415663 \h 31.1Assessing risks to human health PAGEREF _Toc526415664 \h 31.1.1Human health hazard assessment PAGEREF _Toc526415665 \h 31.1.2Human health exposure assessment PAGEREF _Toc526415666 \h 41.1.3Human health risk assessment PAGEREF _Toc526415667 \h 41.2Managing risks to human health PAGEREF _Toc526415668 \h 42Regulatory Framework PAGEREF _Toc526415669 \h 53hazard Assessment PAGEREF _Toc526415670 \h 64health standards PAGEREF _Toc526415671 \h 84.1ADI PAGEREF _Toc526415672 \h 84.2ARfD PAGEREF _Toc526415673 \h 94.3Poisons standard and labelling PAGEREF _Toc526415674 \h 104.4Selection of a NOAEL for risk assessment PAGEREF _Toc526415675 \h 105exposure assessment PAGEREF _Toc526415676 \h 115.1Exposure study data relevant to proposed product PAGEREF _Toc526415677 \h 115.2Occupational exposure PAGEREF _Toc526415678 \h 115.3Public exposure PAGEREF _Toc526415679 \h 125.3.1Accidental exposure PAGEREF _Toc526415680 \h 125.3.2Exposure during domestic use PAGEREF _Toc526415681 \h 125.3.3Bystander exposure PAGEREF _Toc526415682 \h 125.4Post-application exposure PAGEREF _Toc526415683 \h 125.4.1Public post-application exposure PAGEREF _Toc526415684 \h 125.4.2Occupational post-application exposure PAGEREF _Toc526415685 \h 136risk assessment PAGEREF _Toc526415686 \h 146.1Occupational risk assessment PAGEREF _Toc526415687 \h 146.1.1Risk from repeat exposure PAGEREF _Toc526415688 \h 146.1.2Risk from re-entry/re-handling exposure PAGEREF _Toc526415689 \h 156.2Public risk assessment PAGEREF _Toc526415690 \h 156.2.1Risks from residues in food PAGEREF _Toc526415691 \h 156.2.2Accidental exposure risks PAGEREF _Toc526415692 \h 166.2.3Risks associated with product use (domestic) PAGEREF _Toc526415693 \h 166.2.4Bystander risks associated with product use PAGEREF _Toc526415694 \h 167risk management PAGEREF _Toc526415695 \h 177.1Occupational risk management PAGEREF _Toc526415696 \h 177.1.1Risk management for use of the product PAGEREF _Toc526415697 \h 177.1.2Risk management for re-entry or rehandling PAGEREF _Toc526415698 \h 177.2Public risk management PAGEREF _Toc526415699 \h 177.2.1Risk management measures for exposure to the general public PAGEREF _Toc526415700 \h 178Abbreviations PAGEREF _Toc526415701 \h 189Glossary PAGEREF _Toc526415702 \h 20Human Health Risk AssessmentAssessing risks to human healthProtecting the health and safety of people from risks associated with agvet chemicals involves both the assessment and the management of risks.The assessment of risk is conducted in three steps:The hazard assessment determines how inherently dangerous a chemical is to human health using primarily toxicity studies on animals, in vitro studies (tests on tissue or cell cultures) and human exposure data if available.The exposure assessment determines the way and the extent to which the users, works or the public may be exposed to an agvet chemical. The overall risk assessment sums up the overall level of risk. Human health hazard assessmentThe term hazard refers to the intrinsic property of a chemical or biological agent to cause harm to humans. All chemical and biological agents have the capacity to cause harm in particular circumstances, however, this may never be realised under normal use. The nature of this harm varies from negligible to severe and can be immediate or long-term.Hazards associated with chemicals are generally identified in standardised toxicity studies conducted in suitable laboratory animals and, in some cases, tests on tissue or cell cultures (otherwise known as in vitro assays). Controlled studies in humans may sometimes be available, although this is generally uncommon for agvet chemicals. Wherever possible, the use of laboratory animals is minimised and in vitro studies are used instead to identify the hazards.The toxicity studies required will depend on the nature of the chemical and the manner of its use. These studies generally follow international practice such as those published by the OECD and VICH. Whether or not standard protocols are followed, all studies are expected to comply with quality control benchmarks such as Good Laboratory Practice (GLP) (OECD, 1997 revision).Human health exposure assessmentAssessing the potential exposure risk to agvet chemicals involves understanding the different ways that people can be exposed (exposure scenarios) and then measuring or modelling the extent of the exposure.Human exposure can occur through several pathways:Ingestion of small amounts of agvet chemicals can occur through the consumption of food or water that has been treated with chemicals, or dermal contact then touching foods, the mouth or putting treated material directly in the mouthinhaled air: airborne particles of agvet chemicals can be breathed in by workers preparing or using these products (eg by spray drift). The public may be exposed by inhalation while using a home or garden product. The public can also be inadvertently exposed to spray drift or vapours from agricultural use of pesticides or from their use in public placesskin or eye contact: agvet chemicals can be absorbed through the skin or eyes of people preparing or using these products—either at work or in the home or garden. Workers may be exposed to agvet chemicals during their preparation and use, but they can also be exposed when entering treated areas or handling treated crops or animals. Workers are generally exposed at higher levels than the public and may be required to use protective clothing and equipment to reduce the potential health risk. Regulators consider the extent of exposure for adults and children in relation to products used in the home eg flea collars and fly sprays.Human health risk assessment Risk assessment integrates the information from the hazard assessment and the exposure assessment to estimate the likely health risks associated with the various exposure scenarios. Potential human health risks are generally determined by comparing exposure to the established health standards.Managing risks to human healthHuman health risks are generally considered in two contexts: risks to public health (generally through the consumption of treated food, the use of agvet chemicals in a home garden or people coming into contact with treated surfaces and animals) and risks in the workplace. Regulatory FrameworkThe Agricultural and Veterinary Chemicals Code (Agvet Code), scheduled in the Agricultural and Veterinary Chemicals Code Act 1994 (the Act), provides the basis for using risk analysis to regulate activities with agricultural and veterinary chemicals (agvet chemicals) in Australia.The objective of the Code is for the evaluation, approval, and control of the supply, of active constituents for proposed or existing agricultural chemical products or veterinary chemical products; and the evaluation, registration, and control of the manufacture and supply, of agricultural chemical products and veterinary chemical products.The decision on whether to approve an active constituent or an agvet product is made by the Australian Pesticides and Veterinary Medicines Authority (the APVMA), an independent statutory office holder established by the Act.The Act mandates that APVMA implement the Code in a manner that reflects ‘established best-practice principles for the assessment and management of risk, based on science’. To do this, APVMA’s regulatory scientists must balance regulatory effort and regulatory burden with the risk that agvet chemical use will present to the health and safety of human beings, animals and the environment.The APVMA must be satisfied under s14 of the Agricultural and Veterinary Chemicals Code Act 1994 that:the proposed use of the product meets the safety criteria with respect to s5A(1)(a) and (b) the requirements of s5A(3)(a) (i), (v), (vi) & (vii); s5A(3)(b) (i), (ii), (iii) & (vi); and 5D(1) (a) - (e)are met.hazard AssessmentAssessment is made as to what effects the active constituents and its formulated product have, what is the mechanism and how this is applicable to humans. Information relating to the chemistry of the active and formulation includes what the compound is, the fate of the chemical in the human body, any residue metabolites and the type of metabolism studies that have been undertaken. Assessments consider the following areas:toxicokinetics and metabolism–the absorption, distribution, metabolism and elimination (ADME) of the chemical in the mammalian bodyacute toxicity – oral, dermal, inhalation, skin irritation, eye irritation, skin sensitisation, respiratory tract irritationshort-term/sub-chronic exposure - repeat dose exposure involving daily dosing for several weekschronic/carcinogenicity – exposure running for 12 months or over the whole of life in rodent speciesreproductive toxicity – dosing of test animals to ascertain effects on fertility and pregnancydevelopmental toxicity studies – studies in animals during foetal development to ascertain effects on the foetus and infants. To look for birth defectsGgnotoxicity – the effect of an agvet chemical on DNA and chromosomes and are based on both in vitro (cells and tissue culture) and in vivo (in a living organism) studiesneurotoxicity – investigate the effect on the growth, development and function of the nervous system, including the brainmetabolites – the effects of by-products of the particular agvet chemical produced in the bodymechanistic – investigations that help to determine how and why an agvet chemical has and effect in the bodyImmunotoxicity – exposure that indicate whether an agvet chemical causes any effects in the immune system.In reviewing the studies, the following approach is used:test substance and isomers, and their impuritiesdoes the study meet GLP requirements and did it follow internationally recognised test guidelines eg OECDhow was the test substance administered eg oralwhat was the objective of the study and the depth of analysis that was undertakensex and number of animals in each group giving a placebo or the test substanceduration, dosage levels and frequencydemonstration of impact throughpharmacokinetics (Absorption, distribution, metabolism, elimination)observations and findingsconsideration of the MOA and establishing toxicological endpoints eg NOAEL LOAEL In undertaking the analysis, consideration is given to determining whether there are adverse vs non-adverse effects. This is through understanding if it is based on an adaptive or pathological response, transient or reversible, minor magnitude or frequency, specific response of an organ or system and secondary or general toxicity.A key quantitative output from the studies is the identification of the highest dose/concentration tested that does not cause any significant adverse effects that are of a toxicological concern.health standardsHealth Based Guidance Values (HBGV) are generally established when the use of an agvet chemical is likely to result in residues being found in the diet. Where appropriate, an ADI and/or and ARfD may be established. These HBGVs are dependent on studies in animals or humans where an NOAEL was determined. These NOAELs may also be used in the exposure assessments.ADIThe ADI for humans is the level of intake of a chemical that can be ingested daily over an entire lifetime without appreciable risk to health. It is calculated by dividing the overall NOAEL for the most sensitive toxicological endpoint from a suitable study (typically an animal study) by an appropriate uncertainty (safety) factor. The magnitude of the uncertainty factor is selected to account for uncertainties in extrapolation of animal data to humans, intraspecies variation, and the completeness of the toxicological database.Studies from the toxicological database for the active constituents are researched. These studies may include short-medium term, reproduction studies, developmental studies, chronic studies and carcinogenicity studies.A NOAEL will need to be determined to establish the ADI. Information may be summarised that has relevant NOAELs from various toxicity studies with the active component. The summarised information will include the study duration, species and route, doses used, NOAEL, LOAEL and toxic end points. The assessment will ascertain which of these studies are considered the most appropriate for establishing the ADI. Table SEQ Table \* ARABIC 1. Sample table of summary of relevant NOAELs from studiesChemicalADI (mg/kg bw/d)NOAEL(mg/kg bw/d)YearDescriptionEpoxiconazole0.01116 April 20021 year dietary dog study; based on the absence of any treatment related effects at the highest tested dose of 1.1 mg/kg bw/d. 78 week dietary mouse study; a NOAEL of 0.81 mg/kg bw/d was based on reduced bodyweight gain and increased liver weight at the higher dose (36 mg/kg bw/d)Steptomycin (and dihydostreptomycin)0.055 (JECFA ’97)28 June 20012 year dietary rat study; a NOAEL of 5mg/kg/bw/d was based on decreased body weight gains at the next highest dose of 10 mg/kg bw/d dihydrostreptomycinThe ADI can be established by using the appropriate NOAEL (expressed as mg/kg bw/d) and applying an uncertainty factor (nominally 100 consisting of a 10 fold uncertainty factor for inter-species variation and a second 10 fold factor for variation within a human population).ARfDThe ARfD is the estimate of the amount of a substance in food, expressed on a milligram per kilogram body weight basis that can be ingested over a short period of time, usually in 1 meal or during 1 day, without appreciable health risk to the consumer on the basis of all known facts at the time of the evaluation.The approach in setting the ARfD is based on:evaluating the total data set on the test substance and establishing whether there are any demonstrable toxicological effects from a single dose on a test animal or humanselecting appropriate end-points for establishing an ARfD – toxicological end points most relevant for a single (day) exposure (or in the absence of a single dose study use of a repeated-dose toxicity study), select the most relevant study based on the endpoints, identify the NOAELs for the end points.Endpoints relevant to the ARfD includes:acute toxicity studies including behavioural effectsdevelopmental effects effects on organ function including clinical chemistry and haematologyneurotoxicityimmunotoxicity.If an ARfD needs to be established, it will based on the lowest appropriate NOAEL with an uncertainty factor, nominally 100 for intraspecies (10 fold uncertainty factor) and interspecies (10 fold uncertainty factor).Poisons standard and labellingRequirements from the Poisons Standard are assessed on a case by case basis. Reference is made to .au/scheduling-medicines-poisonsThe APVMA is required to approve a label for the container for the product. The Agricultural and Veterinary Chemicals Code (Agvet Code) prescribe the approval process and content requirements for labels for containers for agricultural and veterinary products. Suitability of the label is assessed based on health risks and appropriate mitigation. The APVMA must ensure that the label complies with Poisons Standard.Selection of a NOAEL for risk assessmentThe NOAEL for occupational or bystander assessments is used to estimate a Margin of Exposure (MOE). The MOE is calculated by dividing a NOAEL from an appropriate study on the active constituents with the estimated likely exposures. The studies and trials are reviewed to assess the most suitable NOAEL that best represents the potential exposure for humans based on exposure route and use pattern.The likely exposure is based on:how will the product be appliedwhat is the maximum application ratewhat is the potential route of exposure?what is the potential durationis there a potential re-entry exposure pathway or other post application exposure?In general, the lowest NOAEL in the most sensitive species is used to establish the ADI, and this may be considered the most appropriate value to use when modelling occupational or bystander exposure. Consideration will also be given when seeking the most appropriate NOAEL when the use of the agvet chemical is intermittent eg seasonal use, and what activities may occur following treatment of areas or animals.exposure assessmentExposure study data relevant to proposed productAny submitted studies which are relevant to the application are assessed. Occupational exposureWorkers may be exposed to the product when opening containers, mixing/loading, during application, and cleaning up spills, maintaining equipment and entering treated areas. The level of exposure in these situations is highly variable. In all cases, it is necessary to consider whether special clothing or equipment is necessary to reduce the likely extent of exposure.The main routes of exposure to the product may include dermal, ocular and inhalational. Exposure during useCurrently, The US EPA Pesticide Handler Exposure Database (PHED) Surrogate Exposure Guide (1998) is used to estimate exposure where there is an absence of worker exposure data from in-field use. Scenarios from PHED are assessed to determine the most suitable scenario for the proposal application. The parameters that are considered in estimating worker exposure includes:maximum application rate, concentration, treatment area and quantity of each active constituent handled each daydermal absorption factorinhalation absorption factorbodyweight (in Australia considered to be 70 kg).The total exposure is calculated based on the level of dermal and inhalation exposure type by application method eg aerial or back pack sprayer, and whether engineering controls eg closed cab on an airblast sprayer, and/or Personal Protective Equipment (PPE) can reduce those levels of exposureReferenceexpobox/exposure-assessment-tools-lifestages-and-populations-occupational-workersPublic exposureAccidental exposureThe accidental exposure is determined based on the label instructions and likely use of the product. Consideration is given to likely risks from accidental exposure such as splash exposure or needle stick injuries, what is the potential outcome of exposure and what are the appropriate warning and/or precaution statements. Exposure during domestic useThe potential for public exposure during use is determined based on the label and likely use of the product. While similar to occupational exposure during use, it assumes limited application of hierarchy of control through approaches such as personal protective equipment (PPE).Bystander exposureApplication of the product via some methods may lead to on occasion to unintended bystander exposure, such as via chemical spray drift. This may be in the form of a single random exposure or repeat exposures of residents who reside adjacent to areas being treated with the product. Spray drift impacts are calculated as part of the APVMA risk assessment if relevant.Exposure to product residues in food may also occur. Such exposures are assessed by APVMA through residues assessment.Post-application exposurePublic post-application exposureThe most likely route of public exposure is through consumption of residues in food. Assessment of the exposure of the Australian population to residues of agricultural and veterinary chemicals in food crops and target animals is performed by the APVMA. Assessment will be made as to whether there is the potential for any risk associated with food produce though undertaking a residues risk assessment (refer to the Residues and Trade Risk Assessment Manual).Consideration is also given to potential exposure through contact with products and treated materials.Occupational post-application exposureReview is undertaken of the presented data. If there are no data, the post application risk assessment calculator (USEPA 2013) is currently used to estimate likely exposure following different activities in those treated areas or handling treated crops or animals. Assumptions associated with this exposure model will include:transfer coefficient grouptransfer coefficientdislodgeable foliar residuesdissipation rateexposure durationbody weightNOAEL.New entry exposure estimates after use of the active are determined and will include exposure based on various activities that may occur following treatment eg scouting, pruning and harvesting. risk assessmentRisk management is achieved through consideration of the hazard profile of the agvet product in conjunction with the systemic exposure expected through the use or subsequent exposure to the product according to the label instructions.The acute hazard of the product may require specific precautionary statements and contribute to the minimum engineering and/or PPE requirements, in the product’s safety directions. The product will be described though its oral, dermal and inhalational toxicity. The assessment will recommend the management requirements for each of these end point risks. Occupational risk assessmentRisk from repeat exposureAn appropriate NOAEL for the active constituent will be selected to support the product’s occupational use. A MOE is calculated by dividing a NOAEL from an appropriate study on the active constituent(s) with the estimated likely exposures. In general, a margin of exposure (MOE) of 100 or above is considered to be acceptable. The MOE takes into account both interspecies extrapolation and intraspecies variability. Table SEQ Table \* ARABIC 2. Sample MOE* values for workersEstimatesGlovesMixer/loader dermalApplicator dermalMixer/ loader InhalationApplicator InhalationTotal MOE*Estimate 1: PHED Scenarios 3 & 19: Open mixing and loading & High pressure hand wand application (30.4kg a.i/d)N325126114013Y401014426114030PPE’A’28004335466151005676PPE’B'40101632611397108Estimate 2: PHED Scenarios 3 & 20; Open mixing and loading & backpack applicationN3302691100Y413302691100PPE’A’1139122691982* Based on a NOEL of 3 mg/kg bw/d. Estimates are for workers wearing long pants and long sleeved shirt (single layer of clothing), MOE values were based on person of 70?kg bw, 3.4% dermal absorption factor during mixing/loading and application, and a 100% default inhalational absorption factor. Total MOE = 1/(1/ML MOE dermal) + (1/ML MOE inhalation) + 1/Applicator MOE dermal)+ (1/Applicator MOE inhalation)PPE’A’ consists of wearing cotton overalls over normal clothing, washable hat and chemical resistant gloves during mixing and loading and application and a respirator during application. PPE’B’ consists of wearing normal clothing with chemical-resistant gloves during mixing and loading and application, plus a washable hat and respirator during application.Based on the risk assessment, the margins of exposure (MOEs) to the active constituents are considered whether they are acceptable when appropriate levels of PPE are included in the relevant exposure scenarios.In examining the risk assessment, the margins of exposure (MOEs) to the chemical are assessed whether they are acceptable (ie >100) when appropriate levels of PPE are included in the relevant exposure scenarios (sample REF _Ref421099872 \h \* MERGEFORMAT Table 3). Table SEQ Table \* ARABIC 3. Sample PPE indicated by the repeat exposure risk assessment based on copperRisk assessment (end points)Personal protective equipment (tasks)Systemic exposureWhen preparing product for use and using the prepared product, wear cotton overalls buttoned to the neck and wrist (or equivalent clothing).If applying by spraying equipment carried on the back of the user, wear cotton overalls, over normal clothing, buttoned to the neck and wrist and elbow-length chemical resistant gloves.The risk assessment considerations outlined above for each active constituent will determine whether PPE will offer the required level of protection and may be the main driver for the proposed safety directions. Risk from re-entry/re-handling exposureAssessment is undertaken of the MOE (based on maximum application rates) estimates for the active constituent for workers re-entering treated areas based on number of days after treatment. The MOE values for different activities are compared against an appropriated occupational NOAEL. Assessment is made as to whether the MOE estimates for workers re-entering treated areas are considered acceptable (ie MOE values >100). This will be examined from day zero for any post application treatment considering all the potential activities that may present low to high exposure activities. Public risk assessmentThe potential for public exposure is based largely on the likely type of use. If the product is not intended for domestic use, then in general the risk to the public is considered to be low. Risks from residues in foodAssessment will be made as to whether there is the potential for any risk associated with food produce though undertaking a residues risk assessment (refer to the Residues and Trade Risk Assessment Manual). Accidental exposure risksThe type of use determines whether there is likely to be accidental exposure risks. This may include assessing the potential for self-injection injuries, or exposure to the active constituent through splash, accidental ingestion or contact exposure.Table SEQ Table \* ARABIC 2. Sample MOE* estimates for active ingredient for children playing on treated surfaces MOE*1 – 2 year olds2 – 3 year oldsTotaldermaloralTotaldermalOralEstimated MOE1485260234602605317314530* Based on a dermal NOAEL of 100 mg/kg bw/d and an oral NOAEL of 1.5 mg/kg bw/d. Risks associated with product use (domestic)The type of use determines whether there is likely to be exposure risks related to domestic use. This includes additional non-intended impacts such as post application exposure through contact with treated surfaces.Bystander risks associated with product useAssessment is made as to whether bystander risks (including both workers and the public) present based on the proposed use pattern and target. This may also those workers who are not the applicators of the product (for example, fruit pickers or animal handling post application). Routes for exposure are considered (dermal, inhalation, ocular etc). Parameters for assessing bystander exposure and risks may need to be further determined by the APVMA. risk managementRisk management is achieved through consideration of the hazard profile of a product in conjunction with the systemic exposure expected through use of a product according to the label instructions. recommended HBGVs – ADI and ARfD – published on the APVMA websiteguidance and restrictions on use (eg. Recommendations to be a restricted chemical product, domestic use guidance (eg pack size, toxicity profile)confirm label statements under the APVMA Ag and Vet Labelling Code and the Poison Standard – any critical comments required for safe useany engineering controlschange of use patternsPPE – safety directionsfirst aid instructionswarningsre-entry or Re-handling periods or statements.Occupational risk managementRisk management for use of the productAny risk management approaches are recommended. This will include addressing the acute risks, repeat dose risks and any recommended PPE and first aid requirements for the product. Risk management for re-entry or rehandlingAny recommended periods of non-entry or non-handling is provided based on the assessments that have been undertaken. Public risk managementRisk management measures for exposure to the general publicRisk management is determined for public risk where there may be exposure for the public. If a product is not intended for domestic use, no additional risk management is generally not required for members of the public with regard to risks during product use or for accidental exposure in the domestic environment.AbbreviationsADIAcceptable daily intakeADMEAbsorption, distribution, metabolism and elimination ADWGAustralian Drinking Water GuidelinesAERPAdverse Experience Reporting ProgramALARAAs low as reasonably achievableAPVMAAustralian Pesticides and Veterinary Medicines AuthorityDAWRDepartment of Agriculture and Water ResourcesDEEDepartment of the Environment and EnergyEPAEnvironment Protection AgencyFAISDFirst aid instructions and safety directionsFAOFood and Agriculture OrganisationFSANZFood Standards Australia New ZealandGHSGlobally Harmonised System of Classification and Labelling of ChemicalsGLPGood laboratory practiceGMPGood manufacturing practicesHBGVHealth Based Guidance Values JECFAJoint FAO/WHO Expert Committee on Food AdditivesLOAELLowest-observed-adverse-effect levelMLSManufacturers Licensing SchemeMOAModes of ActionMOEMargin of exposureMRLMaximum residue limitNOAELNo-observed-adverse-effect levelNOELNo-observed-adverse levelNRSNational Residue SurveyOCSOffice of Chemical SafetyOECDOrganisation for Economic Co-operation and DevelopmentOGTROffice of the Gene Technology RegulatorPBTPersistent, bioaccumulative and toxicPECPredicted environmental concentrationPHEDUS EPA Pesticide Handler Exposure DatabasePOPPersistent organic pollutantsPPEPersonal Protective EquipmentRCPAn RCP may be declared if special knowledge, skills, training and equipment are needed to be able to obtain, handle or use the product. This is based on the risks posed by the product to human health, animals, plants or the environment.REIRe-entry intervalSUSMPStandard for the Uniform Scheduling of Medicines and PoisonsUSEPAUSA Environmental Protection AuthorityVICHInternational Cooperation on Harmonization of Technical Requirements of Veterinary Medicinal ProductsWHOWorld Health OrganizationWHPWithholding periodGlossaryActive constituentThe component of an agricultural or veterinary chemical product responsible for its physiological or pharmacological actionAcute toxicityImmediate toxic effects shortly after exposureAgvet chemicalsThis covers agricultural chemical products and veterinary chemical products, as defined in the Agricultural and Veterinary Chemicals Code (Agvet Code). It encompasses all chemicals regulated by the APVMAAs Low as Reasonably Achievable (ALARA)Means making every reasonable effort to minimise exposure to agvet chemicals, and reduce the use to the minimum necessary to achieve the required effectBenthicRelating to the bottom of a sea, lake or river, or resident organismsEcotoxicityToxic effects on plants and animals, both terrestrial and aquaticFAISD HandbookThe Handbook of First Aid Instructions, Safety Directions, Warning Statements and General Safety Precautions for Agricultural and Veterinary Chemicals updated each quarterGenotoxicityThe propensity to damage cellular DNA and chromosomes, resulting in mutationsHealth Based Guidance Values (HBGV)Health Based Guidance Values used in dietary risk assessmentsMaximum Residue Limit (MRL)Maximum permitted concentration of a residue, resulting from the registered use of an agricultural or veterinary chemical, usually expressed in units of mg/kg or μg/kg on a fresh weight basisOccupational exposureExposure to a chemical during use by workersOrganophosphorus (OP)A group of phosphorus-containing insecticides which act to inhibit acetylcholinesterase, an enzyme which is essential to nerve function in insects, animals and humans. Restricted chemical product (RCP)An RCP may be declared if special knowledge, skills, training and equipment are needed to be able to obtain, handle or use the product. This is based on the risks posed by the product to human health, animals, plants or the environment.Safe thresholdThe dose of a chemical that a person could have without suffering any measurable harmStandard for the Uniform Scheduling of Medicines and Poisons (SUSMP)The Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and TerritoriesUncertainty factorThe factor by which an observed or estimated NOAEL is divided to generate a standard considered safe or without appreciable riskVICHInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal ProductsVICH programA trilateral EU-Japan-USA program aimed at harmonising technical requirements for veterinary product registrationWithholding Period (WHP)The minimum time that must elapse between treating a crop or animal and availability of crop or animal product for safe human consumption ................
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