James J. Jones Deputy Assistant Administrator EPA Office of Chemical Safety and Pollution Prevention

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1 James J. Jones Deputy Assistant Administrator EPA Office of Chemical Safety and Pollution Prevention EPA Organizational Structure Agency Wide Science and Risk Assessment Processes Office of Pesticide Programs Scientific Risk Assessment and Decision Making Processes Expertise Needed How risk information is included in decision making Other factors considered to make decisions Weight of the factors Acquirement and sharing of data 2 1

2 Office of Water Safe Drinking Water Act--Regulates quality of drinking water in cooperation with states. EPA must conduct a detailed risk and cost assessment and use best available peer reviewed science when developing drinking water standards. Office of Air and Radiation Clean Air Act As an example, when regulating hazardous air pollutants (HAPs), EPA establishes emission standards based on maximum achievable control technology. Office of Chemical Safety and Pollution Prevention Toxic Substances Control Act--Regulates industrial chemicals that present or will present an unreasonable risk of injury to health or the environment using the least burdensome requirements in regulating chemicals. EPA implements many different statutory standards and programs while unifying scientific risk assessment criteria, standards and processes. 3 The Office of Research and Development (ORD) coordinates agency-wide science and risk assessment issues to promote consistency. manages many forums and workgroups across the agency to promote a consistent approach to risk assessment, such as the Science Policy Council. However, due to various statutes having differing regulatory standards, many offices generate individual science assessments following consistent scientific principles throughout the agency. When one chemical is regulated by many different offices (e.g., air, water and waste), ORD generally manages the overall process to develop the specific endpoints or other scientific benchmarks. 4 2

3 Although different statutes have different standards, EPA works hard to evaluate risk in the same way. For example: Federal Food, Drug, and Cosmetic Act Risk only standard; risk drives decision Toxic Substances Control Act Unreasonable risk standard; must balance risks and benefits Safe Drinking Water Act Best practice standard; relies on detailed risk and cost assessment and best available peer reviewed science Clean Air Act In regulating HAPs, best available control technology standard; independent of risk 5 I ll focus on EPA s process for assessing risks from pesticides What is considered a pesticide? Any substance designed to prevent, destroy, repel or mitigate pests. Pesticides include diverse products such as: Insect repellents Weed killers Disinfectants and sanitizers Wood preservatives Antifoulant coatings Swimming pool chemicals Flea and tick sprays, powders, and collars Rodent baits Moth balls 6 3

4 Risk assessments are done within the management structure of OPP. There are several benefits to this: Alignment of mission Better problem formulation Accountability Expeditious Issue Resolution To ensure that the integrity of the process is not compromised, OPP uses: Peer Review Public Participation Transparency 7 EPA s Pesticide Program has a strong, diverse workforce that includes: Chemists Economists Biologists Toxicologists Botonists Chemical Engineers Epidemiologists Entomologists Geologists Plant Pathologists Veterinarians Wildlife Biologists Health Scientists Statisticians 8 4

5 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Registration of new pesticides and new uses of existing pesticides, re-evaluation of older pesticide registrations; Standard is that pesticide will not pose an unreasonable risk of harm to human health or the environment; In addition to risk, FIFRA requires consideration of a pesticide s potential benefits. Federal Food, Drug and Cosmetic Act Governs establishment of tolerances or maximum allowable levels of pesticide residues on food or feed Solely risk-based standard reasonable certainty that no harm will result from aggregate exposure to pesticide residues (continued) 9 The Food Quality Protection Act of 1996 amended FIFRA by introducing 3 new considerations to risk assessment Aggregate Risk: The same pesticide with multiple exposure pathways (e.g., present in food, drinking water, and/or household products); Cumulative Risk: Multiple pesticides that act via a common mechanism (e.g., organophosphates, triazines, or N-methyl carbamates); Additional 10x safety factor when establishing tolerances for chemicals with potential exposure to children or fetuses unless reliable data indicate that a lesser factor would be protective. EPA assesses aggregate and cumulative risks, and characterizes this information to allow risk managers to make the safety determination under FIFRA. 10 5

6 Passed in 1996, FQPA imposed a risk only standard Required assessments we d never done Required a standard we d never used Decided to approach this through: Peer Review Public Participation Transparency 11 EPA employs a tiered system for data requirements. Depending on the type of pesticide, receptor, and its intended use patterns, required data may include: Acute/Sub-Acute, Sub-chronic/Chronic Toxicity Dietary/Dermal/Absorption/Inhalation Exposure Worker/Bystander Exposure Environmental Fate and Transport (physiochemical and biological degradation, mobility, field dissipation, bioaccumulation) Product Performance Mutagenicity Pesticide Metabolism Residue and Product Chemistry Short-term Acute, Sub-acute, Reproduction, Simulated and Full Field Studies 12 6

7 EPA has broad authority to require manufacturers to develop data EPA also works with other federal agencies and consults the public literature or other sources of supporting information on the chemical 13 Ultimately, both human health and ecological risk assessments result in risk characterization. But risk isn t just a number: all the inputs resulting in the risk estimate must be considered and characterized when making a safety finding. Questions impacting risk characterizations might include: Are the hazard and toxicity databases complete; and if not, are the missing data likely to result in a higher estimated risk? Are exposure data estimates based on high-end screening estimates or models, or real-world data in which we have confidence? What other conservatisms are built into the risk estimates e.g., how likely is it that the aggregated exposures will occur together, what percentile of exposure do the risk values represent, etc.? 14 7

8 Pesticide risk assessments inform risk management decisions and allow risk managers to compare regulatory options and decide which option ensures that a pesticide s use meets the regulatory safety standard. If risk mitigation is necessary, possible options include: Changes in use patterns, including elimination of uses or lessening frequency or rates or application; Introduction of buffer zones or restrictions on applying near water bodies; Requirements for environmental monitoring; Modifying, implementing, requirements for re-entry intervals after applications or personal protective equipment; Changing statues from general use to restricted use (requiring special training); Requiring specialized application methods. As a general rule, EPA attempts to implement the least burdensome option to implement the standard. 15 8