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Controlling toxic substances 2012

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  • http://www.epa.gov/opp00001/regulating/laws/fqpa/fqpa_implementation.htm

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  • 1. Controlling Toxic SubstancesRegulation of toxic substances requires rule makers to cope with the problem ofscientific uncertaintyHow is a regulatory agency to determine whether a chemical is “safe”?
  • 2. Table 8.03
  • 3. How the risk is determined?1. Hazard Identification, aims to determine the qualitative nature of the potential adverseconsequences of the contaminant (chemical, radiation, noise, etc.) and the strength ofthe evidence it can have that effect. This is done, for chemical hazards, by drawing fromthe results of the sciences of toxicology and epidemiology. For other kinds ofhazard, engineering or other disciplines are involved. 2. Dose-Response Analysis, is determining the relationship between dose and theprobability or the incidence of effect (dose-response assessment). The complexity of thisstep in many contexts derives mainly from the need to extrapolate results fromexperimental animals (e.g. mouse, rat) to humans, and/or from high to lower doses. Inaddition, the differences between individuals due to genetics or other factors mean thatthe hazard may be higher for particular groups, called susceptible populations. (seefigures) 3. Exposure Assessment, aims to determine the amount of a contaminant (dose) thatindividuals and populations will receive. This is done by examining the results of thediscipline of exposure assessment. As different location, lifestyles and other factors likelyinfluence the amount of contaminant that is received, a range or distribution of possiblevalues is generated in this step. Particular care is taken to determine the exposure of thesusceptible population(s).4. Risk Characterization, the results of the first three steps above are then combined toproduce an estimate of risk (e.g. magnitude of the public health problem). Because of thedifferent susceptibilities and exposures, this risk will vary within a population.
  • 4. Figure 8.18
  • 5. Figure 8.17
  • 6. How the risk is determined?1. Hazard Identification, aims to determine the qualitative nature of the potential adverseconsequences of the contaminant (chemical, radiation, noise, etc.) and the strength ofthe evidence it can have that effect. This is done, for chemical hazards, by drawing fromthe results of the sciences of toxicology and epidemiology. For other kinds ofhazard, engineering or other disciplines are involved. 2. Dose-Response Analysis, is determining the relationship between dose and theprobability or the incidence of effect (dose-response assessment). The complexity of thisstep in many contexts derives mainly from the need to extrapolate results fromexperimental animals (e.g. mouse, rat) to humans, and/or from high to lower doses. Inaddition, the differences between individuals due to genetics or other factors mean thatthe hazard may be higher for particular groups, called susceptible populations. (seefigures) 3. Exposure Assessment, aims to determine the amount of a contaminant (dose) thatindividuals and populations will receive. This is done by examining the results of thediscipline of exposure assessment. As different location, lifestyles and other factors likelyinfluence the amount of contaminant that is received, a range or distribution of possiblevalues is generated in this step. Particular care is taken to determine the exposure of thesusceptible population(s).4. Risk Characterization, the results of the first three steps above are then combined toproduce an estimate of risk (e.g. magnitude of the public health problem). Because of thedifferent susceptibilities and exposures, this risk will vary within a population.
  • 7. Risk perception is an important aspect ofrisk acceptance. Our perception does notusually coincide well with reality. •People tend to downplay certain risks and emphasize others that suit their own agendas •Most people do not think in terms of (or understand) probabilities •Influenced by own experience •Exaggerated view of own abilities •Media bias •Irrational fear/distrust for unfamiliar technologies or processes
  • 8. Scientific Uncertainty•problem inherent to regulating toxic and hazardous substances•while you may be able to demonstrate an effect at a particular dosage with amodel animal in the lab, or show a trend for people who have been exposed, it ismore difficult to decide on a dosage or exposure level with no effect on humans orthe environment•How do you decide what rate of exposure is an acceptable risk? Is this the samefor the whole population?•In the US EPA and OSHA use risk assessment to determine the "acceptable risk”
  • 9. Scientific Uncertainty•Ethyl Corporation v. United States EPA (1977) •"Undoubtedly certainty is a scientific ideal - to the extent that science can even be certain of its truth. But certainty in the complexities of environmental medicine may be achievable only after the fact, when scientists have the opportunity for leisurely and isolated scrutiny of an entire mechanism…. Awaiting certainty will often allow for only reactive, not preventative regulation. Petitioners suggest that anything less than certainty, that any speculation, is irresponsible. But when statutes seek to avoid environmental catastrophe, can preventative, albeit uncertain decisions legitimately be so labeled?” •In Ethyl Corp. v. EPA (1976), the U.S. Court of Appeals for the District of Columbia Circuit held that the EPA could regulate a substance even though it could not be proved that the substance was harmful. The court said the EPA could proceed if it could show a significant risk of harm. The ruling in this case has been incorporated in the Clean Air Act.
  • 10. Precautionary Principlesays that when an activity raises threats of harm to human health or theenvironment, precautionary measures should be taken even if the risks are not fullyunderstood. By this principle, for example, we shouldnt mass-market newchemicals, new cars or new childrens toys until were sure they are safe. These are fourwidely accepted tenets of precautionary action: 1. People have a duty to take steps to prevent harm. If you suspect something bad might happen, you have an obligation to try to stop it. 2. The burden of proof of carelessness of a new technology, process, activity, or chemical lies with the proponents, not with the general public. 3. Before using a new technology, process, or chemical, or starting a new activity, people have an obligation to examine a full range of alternatives, including the alternative of not using it. 4. Decisions using the precautionary principle must be open and democratic and must include the affected parties.An important element of the precautionary principle is that its most meaningfulapplications pertain to those that are potentially irreversible.European Union has adopted this precautionary principle as the basis of itsenvironmental policy.In the U.S. historically there has been opposition to doing this. Why might this be? Doyou agree?
  • 11. The Toxic Substances Control Act (TSCA) is a United States law, passedby the United States Congress in 1976, that regulates the introductionof new or already existing chemicals. It grandfathered most existingchemicals, in contrast to the Registration, Evaluation and Authorizationof Chemicals (REACH) legislation of the European Union.TSCA specifically regulates polychlorinated biphenyl (PCB) products.Contrary to what the name implies, TSCA does not separate chemicalsinto categories of "toxic" and "non-toxic". Rather it prohibits themanufacture or importation of chemicals that are not on the TSCAInventory (or subject to one of many exemptions). Chemicals that arelisted on the TSCA inventory are referred to as "existing chemicals".Chemicals not listed are referred to "new chemicals".Generally, manufacturers must submit premanufacturing notification tothe U.S. Environmental Protection Agency (EPA) prior to manufacturing(or importing) new chemicals for commercial purposes. There arenotable exceptions, including one for research and development, andfor substances regulated under other statutes such as the FederalFood, Drug, and Cosmetics Act and the FederalInsecticide, Fungicide, and Rodenticide Act.New chemicals notifications are reviewed by the Agency and if theAgency finds an "unreasonable risk to human health or theenvironment", may regulate the substance in a variety of ways, fromlimiting uses or production volume to an outright ban.
  • 12. TSCA: Toxic Substances Control Act 1976OPPT: Office of Treatment of New Pollution Treatment of Old ChemicalsPrevention and Chemicals Toxics
  • 13. OPPT: Office of Pollution Prevention and Toxics in charge of implementation of the 3 major policies of the TSCA 3) Government authority must 2) Government must have be exercised so as to not 1) Data on environmental adequate authority to prevent "impede unduly or createeffects of chemicals must be unreasonable risk of injury to unnecessary barriers to developed by industry health or the environment technology while fullfilling the primary purpose of the act"
  • 14. Treatment of Old Chemicals Chemical Substance Inventory In 1986, 18,000 chemicals on its inventory with no information on toxic effects for 79%; less than one up to 50 chemicals can be on the fifth have been tested for short- Currently, >84,000 chemicals listed"high priority" list for a given year term effects, and less than one- tenth for long term, reproductive or mutagenic effects
  • 15. Treatment of New Chemicals Premanufacturing Notice (PMN) - "section 5 notice” 90 day notice in advance of manufacture or importation of a new chemical for sale or use in commercedetailed description of use and distribution of the chemical If there are to be restrictions including disposal; also within 5 days of receipt EPA 1995 study of PMNs showed on the use of the chemical the requires a review of all must publish the PMN in the that 67% lacked toxicity data EPA is must act to limit use available test data with federal register and 85% had only limited data within 45 days respect to human health and environmental effects considered weak legislation since it does not call for testing, but rather justreporting testing data that are available
  • 16. A NEW APPROACH TO CHEMICAL REGULATION (TSCA Reform)The Obama administration’s Essential Principles for Reform of Chemicals Management Legislationare intended to aid Congress during the legislative process. The principles, listed below, present theadministration’s goals for legislation that will give EPA the ability to target chemicals of concern andpromptly assess and regulate new and existing chemicals in commerce:• Chemicals should be reviewed against risk-based safety standards based on sound science andprotective of human health and the environment.• Manufacturers should provide EPA with the necessary information to conclude that new andexisting chemicals are safe and do not endanger public health or the environment.• EPA should have clear authority to take risk management actions when chemicals do not meet thesafety standard, with flexibility to take into account sensitive subpopulations, costs, socialbenefits, equity and other relevant considerations.• Manufacturers and EPA should assess and act on priority chemicals, both existing and new, in atimely manner.• Green chemistry should be encouraged and provisions assuring transparency and public access toInformation should be strengthened.• EPA should be given a sustained source of funding for implementation. http://ehstoday.com/environment/hazardous-waste/epa-jackson-framework-chemical-reform-5212/
  • 17. A NEW APPROACH TO CHEMICAL REGULATION (TSCA Reform)Although legislative reform is necessary for an effective chemicals managementprogram, Jackson said EPA is committed to strengthening the performance of the currentprogram while Congress considers new legislation. This enhanced plan includes thedevelopment of chemical action plans that outline the agency’s risk management effortson those chemicals of greatest concern. EPA has identified an initial list of chemicals forpossible risk management action and anticipates completing and posting action plans.An additional focus will be accelerating efforts to gather the information from industry thatthe agency needs to make chemical risk determinations. This will include filling thecurrent gaps in health and safety data on high production volume chemicals;enhanced, transparent, and more current reporting of use and exposure information; anda number of requirements for increased reporting on nanoscale chemical materials. Inaddition, EPA is reviewing how nanoscale materials are managed under TSCA. EPA alsois reviewing ways to increase the public’s access to information about chemicals. http://ehstoday.com/environment/hazardous-waste/epa-jackson-framework-chemical-reform-5212/
  • 18. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)The Federal Insecticide, Fungicide, and Rodenticide Act - a United States federal law that setup the basic U.S. system of pesticide regulation to protect applicators, consumers and theenvironment. The current version of FIFRA underwent a major revision in 1972 andsuperseded the Federal Insecticide Act of 1910 and the Federal Insecticide, Fungicide, andRodenticide Act of 1947. The act was amended somewhat in 1996 by the Food QualityProtection Act. In 1988, it was amended again to change pesticide registration laws and torequire reregistration of certain pesticides that had been registered before 1984.When FIFRA was first passed in 1947, it gave the United States Department of Agricultureresponsibility for regulating pesticides. In 1972, when FIFRA underwent a major revision, ittransferred responsibility of pesticide regulation to the Environmental Protection Agency andshifted emphasis to protection of the environment and public health. The 1972 version islargely still in place.
  • 19. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)FIFRA established a set of pesticide regulations: 1. FIFRA established registration for all pesticides, which is only done after a period of data collection todetermine the effectiveness for its intended use, appropriate dosage, and hazards of the particular material.When registered, a label is created to instruct the final user the proper usage of the material. If instructionsare ignored, users are liable for any negative consequences. Label directions are designed to maximize the effectiveness of the product, while protecting theapplicator, consumers, and the environment. Critics of the process point out on the one hand that theresearch to produce the label is entirely done by the manufacturer and not much checking is done on itsaccuracy. On the other hand some consider the process too strict. It costs millions of dollars and oftenseveral years to register a pesticide, which limits production only to large players. Likewise many smaller orspecialty uses are never registered, because the companies do not consider the potential sales sufficient tojustify the investment. 2. Only a few pesticides are available to the general public, and can be used by anyone who will followdirections (general use). Most pesticides are considered too hazardous for general use, and are restricted tocertified applicators (restricted use). FIFRA established a system of examination and certification both at theprivate level and at the commercial level for applicators who wish to purchase and use restricted usepesticides. The distribution of restricted pesticides is also monitored. 3. The EPA has different review processes for three categories of pesticides:antimicrobials, biopesticides, and conventional pesticides. The three categories have a similar applicationprocess, but have different data requirements and review policies. Depending on the category ofpesticide, the review process can take several years. After a pesticide is registered with the EPA, there maybe state registration requirements to consider.
  • 20. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)As of 1999, approximately 20,000 pesticides had been registered by EPA. In2006, 26 new pesticide products were registered, 44 were amended for 186 newuses, and 18 products were cancelled.When a pesticide is to be registered, data showing its impact are submitted to EPA.The EPA will register the pesticide when 4 factors exist:1)The pesticide’s composition is such as to warrant the proposed claims for it.2)Its labeling complies with the act3)The pesticide will perform its intended function without unreasonable risks topeople and the environment (taking into account economic, social andenvironmental costs and benefits of the pesticide)4)When used in accordance with commonly used practice, the pesticide will notcause unreasonable risk to the environmentWhat is unreasonable risk?originally primarily carcinogenicity today, reproductive, immunological and neurological effects of the pesticide, aswell as its impact on groundwater and on the growth and reproduction of wildlife andfishWhat constitutes a proper label?http://www.epa.gov/pesticides/kids/hometour/label/read.htm
  • 21. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)Registration (lasts 5 years; unless only a conditional registration)general use – most desirable for manufacturer, can be sold to anyone in anyquantityRestricted use – reserved for pesticides have the potential to have an unreasonableimpact. The unreasonable effects can be mitigated or prevented if the use and/orsale of the pesticide is restricted in some manner.most common restriction is to limit use to certified applicators who take a test “application by or under the supervision of a certified applicator”What if anything might be wrong with this aspect of the statute?exception for private applicator must take course, but not take exam What if anything might be wrong with this aspect of the statute?Other possible restrictions limited frequency of use limited locations of sale or application limitations on the pests that may be targeted limits on amount used per application
  • 22. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)Re-registration1988 amendments set up a re-registration scheme for some pesticides. Applies tochemicals developed prior to current health and safety standards (1984 FoodQuality Protection Act (FQPA); amended 1996)As of 2006 613 re-registration cases for EPA to consider 90% completed (559) 330 reregistered 229 voluntarily cancelled or deregulated
  • 23. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)Cancellation of Registrationautomatic unless renewal submitted during the 5 yr. registration period"unreasonable risk" can also justify premature cancellation; time consuming hearingprocess (2yrs) during which the product remains on the market"imminent hazard" administrator of the EPA can issue a notice to the manufacturerthat the pesticide use is being suspended within 5 days; manufacturer can requestan expedited hearing"emergency suspension" immediate action by the EPA administrator; manufacturercan have an expedited hearingWhat should be done with pesticide stocks after their registrations have beencancelled?In many cases, as long as they can use their stock, manufacturers do not protestcancellationAlthough other governments will be informed by the EPA there is no regulationmaking it illegal to sell the pesticide in another country circle of poison problem
  • 24. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)Worker Protection Standard Programhttp://www.epa.gov/oppfead1/safety/workers/principl.htm
  • 25. Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes EPA to settolerances, or maximum residue limits, for pesticide residues on foods. In theabsence of a tolerance for a pesticide residue, a food containing such a residue issubject to seizure by the government. Once a tolerance is established, the residuelevel in the tolerance is the trigger for enforcement actions. That is, if residues arefound above that level, the commodity will be subject to seizure.In setting tolerances, EPA must make a finding that the tolerance is “safe.” Safe isdefined as meaning that there is a "reasonable certainty that no harm will resultfrom aggregate exposure to the pesticide residue." To make the safety finding, EPAconsiders, among other things: the toxicity of the pesticide and its break-downproducts, aggregate exposure to the pesticide in foods and from other sources ofexposure, and any special risks posed to infants and children. Some pesticides areexempted from the requirement to have a tolerance. EPA may grant exemptions incases where the pesticide residues do not pose a dietary risk under reasonablyforeseeable circumstances.
  • 26. Food Quality Protection Act (FQPA) 1996Congress presented EPA with the enormous challenge of implementing the most comprehensive and historicoverhaul of the Nations pesticide and food safety laws in decades.Improved Health Standards for Food CommoditiesFQPA Requirement: FQPA requires a new safety standard – reasonable certainty of no harm – that mustbe applied to all pesticides used on food commoditiesAchievement: Tolerances, which are the maximum amount of pesticide residue allowed to remain on foodproducts, are set by EPA as part of the registration and reregistration processes. Under FQPA, EPA mustmake a safety finding in setting tolerances that the pesticide can be used with "reasonable certainty of noharm." To achieve the new safety standards required by FQPA, EPA has refined its risk assessment methodsand added new risk assessments, e.g. aggregate and cumulative. This task sent EPA into novel scientificinquiry and forced the development of cutting edge scientific methods and policy. As a result of EPAsstrenuous efforts and inventive solutions, all pesticide tolerances now meet the stringent health standard setby FQPA.FQPA Requirement: FQPA requires EPA to reassess all existing tolerances within 10 yearsAchievement: Pesticide tolerances that were in place as of August 1996, when the Food Quality ProtectionAct was signed, are subject to reassessment under the new safety standards of FQPA. EPA has completednearly all of this work, having reassessed 9637 or over 99% of the 9,721 tolerances required by FQPA. Thisreassessment is scheduled to be completed shortly. This complex scientific effort required the detailedreview of tens of thousands of studies and test results on toxicity, chemistry, and environmentaldata. Notably, this work resulted in the revocation or modification of almost 4,000 food tolerances.FQPA Requirement: FQPA requires EPA to set tolerances for residues resulting from uses allowed underFIFRA section 18 emergency exemptionsAchievement: EPA created a program for setting time-limited tolerances for emergency exemptions on anexpedited basis. This program, which became operational for the 1996 use season, has enabled EPA towork rapidly and efficiently with our co-regulator States. As a result, there are minimal disruptions in theemergency exemption approval process and maximum efficiency in responding to such situations. EPA hasmade approximately 500 annual decisions on emergency exemptions most years since 1996.
  • 27. FQPA Requirement: FQPA requires EPA to consider risks to infants and children when setting tolerancesAchievement: In accordance with FQPA, all tolerance decisions take into account the special susceptibilityof children to pesticides. EPA has cancelled use of several OP pesticides on many “kid” foods, such asapples, and utilizes an additional tenfold (10X) safety factor as appropriate in setting and reassessingtolerances.FQPA Requirement: FQPA requires EPA to consider all "aggregate risk” from exposure to a pesticide frommultiple sources when assessing tolerancesAchievement: Through consultation with the FIFRA Scientific Advisory Panel (SAP), the ToleranceReassessment Advisory Committee (TRAC), and the Committee to Advise on Reassessment and Transition(CARAT), EPA has developed sound scientific procedures for evaluating aggregate exposures to pesticides.These new and improved procedures have enabled EPA to conduct risk assessments that combineexposures from dietary, residential, and drinking water sources, and to ensure that exposure to pesticides infood are safe in light of the aggregate exposure.FQPA Requirement: FQPA requires EPA to consider "cumulative exposure" to pesticides that havecommon mechanisms of toxicityAchievement: EPA has identified four groups of pesticides that share a common mechanism of toxicity:organophosphates (OPs); n-methyl carbamates; triazines; and chloroacetanilides. In assessing cumulativerisks, EPA evaluates the potential for people to be exposed to more than one pesticide at a time from a groupwith an identified common mechanism of toxicity.FQPA Requirement: EPA developed science policies regarding risk assessmentsAchievement: In order to implement the new risk assessment standards, EPA had to develop new sciencepolicies. EPA met this challenge by working with the Tolerance Reassessment Advisory Committee, as wellas other committees and panels, to identify science policy issues that were key to the implementation ofFQPA and tolerance reassessment. New science policies were developed rapidly and effectively, especiallyin light of the unexplored nature of the scientific areas involved; they represent a significant aspect of EPAsachievements in regard to FQPA. The new science polices include guidelines regarding: a tenfold safetyfactor; dietary exposure and risk assessment; threshold of regulation; drinking water exposure; residentialexposure; aggregate exposure and risk assessment; cumulative risk assessment for pesticides with acommon mechanism of toxicity; cholinesterase inhibition end point; and use and usage information.