Evaluation Of Mosquito Control Pesticides

Transcription

1 Evaluation Of Mosquito Control Pesticides Dana Vogel Director of the Health Effects Division Office of Pesticide Programs U.S. EPA AMCA 20 th Annual Conference Washington D.C.

2 Overview EPA s Mission for Pesticides Pesticide Risk Assessment Overview Re-evaluating Mosquito Control Pesticides at EPA Discussion/Questions 2

3 Risk Assessment Overview: Basic Approach* Risk is a function of toxicity and exposure and is considered as follows: *From the National Research Council s Risk Assessment in the Federal Government: Managing the Process,

4 Hazard Identification The process quantifies toxicity of a pesticide Considers various types of exposure Battery of studies required Many types of health effects considered e.g., developmental, reproductive, cancer, neurological, etc. Well established testing guidelines Different species, durations All applicable lifestages Outcomes are: Endpoint (the toxic effect of concern) Point of Departure (dose for risk assessment) 4

5 Defining a Level of Concern Typically at levels where we do not anticipate any effect at 100 times (or more, depending) lower than the POD Series of factors (each up to 10) to account for the following: for use of animal data to apply to humans (inter-species) sensitivity among people varies (intra-species) protect children unless evidence shows not needed (FQPA) others can be applied for missing data Applied in different combinations depending upon scenario 5

6 Types of Exposures Considered Oral Food, Drinking water, Incidental ingestion (mouthing behavior in children) Dermal Occupational (e.g., applying, harvesting) Residential (e.g., homeowner use, children on lawns) Spray Drift (e.g., lawn contact from adulticides) Inhalation Applying pesticide Bystander (those around applications) 6

7 How Risks Are Calculated Risks are generally expressed in several ways but focus here is for adulticide use Adulticide risks are expressed as margin of exposure (MOE) MOE = POD (e.g., NOAEL)/Exposure Compared to the level of concern (LOC) MOEs < LOC raise a potential concern Indicates a need for possible mitigation and/or further evaluation 7

8 Approach For Adulticide Risks Consider exposures for those in treated areas Residents in their yards children playing outside Use peer reviewed methods and monitoring data to: Predict how much pesticide ends up in areas which can result in exposure Aerial AgDisp model Ground monitoring data Exposures are then determined for adults and children using standard methods Consider applicable application guidance Ground and aerial application methods Label guidance such as spray type (droplets) and aircraft release height 8

9 What Do These Represent? 9 Under actual use conditions, there is a range of exposures. The calculated values represent what would be extremely high exposures in this range in order to be protective. Based On Label Information, The Premise Is: Individuals live in directly treated area Pesticide application evaluated in a way most conducive to highest possible exposure Maximum amount applied Extremely calm weather, little dispersion Droplets are largest allowed, more deposition-bigger objects fall faster Plane height is lowest allowable, less chance to move out of area Nothing to impede drift Focus is most highly exposed population-children 1-2 years old Dermal exposure Rigorous play on lawns immediately after treatment, high skin exposure No residue decline Incidental Oral exposure High rate of contact and transfer each time hands contact the mouth All conditions must be met simultaneously to experience the calculated risk

10 Impact of Possible Risk Reduction Options Aerial Mosquitocide Results Including Sensitivity Analysis MOEs Risk Estimate Scenarios Day 0 Day 1 Day 2 Day 3 Current Label Parameters 100 foot release 100% aerial deposition 60 µm droplet 300 foot release 41% aerial deposition 60 µm droplet Adult dermal 1< 2 years Dermal + HtM Adult dermal 1< 2 years Dermal + HtM (570) (280) Sensitivity Analysis To Characterize Risks 820 3,400 (1400) 410 1,700 (680) 1,400 5,800 24, ,900 12,000 3,400 14,000 60,000 1,700 7,200 30,000 Inhalation Day , foot release 26% aerial deposition 50 µm droplet Adult dermal 1< 2 years Dermal + HtM 1,300 5,300 (2,200) 650 2,700 (1100) 5,400 23,000 94,000 2,700 11,000 47,000 5, foot release 18% aerial deposition 45 µm droplet Adult dermal 1< 2 years Dermal + HtM 1,900 7,800 (3200) 940 3,900 (1,600) 7,800 33, ,000 4,000 16,000 68,000 Release Height and Droplet Size Are Critical MOE = Margin of Exposure; Range represents estimated risk based on the highest and lowest turf residues. Values in parenthesis are averages. Dermal/Oral LOC = 1000; Inhalation LOC =3000 6,600 10

11 Re-Evaluation of Mosquito Pesticides At EPA Registration Review Mosquito Control Pesticides in Registration Review Public Participation in Registration Review Registration Review Challenges 11

12 Pesticide Re-evaluation at OPP Mandated by law EPA creates a framework for implementing law Laws have evolved over time Before 1972, efficacy was only standard for registration, now statute is risk-benefits based Reregistration began in 1988, completed in 2008 Registration review began in 2007, completion date of 2022 Ensure pesticides continue to meet statutory standard of no unreasonable adverse effects Function under FIFRA, which is a risk/benefit statute Involve sound science, transparency and public involvement Scientific Advisory Panel (SAP) Public involvement and transparency 12

13 Registration Review Successor program to reregistration FIFRA now requires review of each registered pesticide at least every 15 years to ensure it continues to meet safety standards Reviews include national Endangered Species Act (ESA) assessments and endocrine disruption screening program Must complete first cycle by 10/1/2022 Includes over 1,100 active ingredients Takes 5-7 years for each pesticide review OPP initiates 70 review cases/year 13

14 Registration Review: EPA s Role Assembles background information, prepares preliminary work plan for case Leads focus meeting with registrant(s) to discuss: Areas of uncertainty for risk assessment/decision Label clarity, use/usage information, exposure, other data Places preliminary work plan in docket and starts comment period Reviews public comments and any additional information Develops final work plan stating if new risk assessments required or additional data needed Issues data call-in (DCI), if needed 14

15 Registration Review Process and Public Participation Public Comment Opportunities Open Docket Preliminary Risk Assessment Final Risk Assessment and Proposed Interim Decision Interim or Final Decision 15

16 Registration Review: Assessment If assessment is needed, EPA will Receive and evaluate data, if needed Complete new human health and ecological risk assessment(s), if needed Consult with the Services (Fish and Wildlife Service and National Marine Fisheries Service) if necessary for endangered species concerns Make risk management decisions via Proposed Interim Decision (PID) Publish PID for comment Revise risk management decisions via Interim Decision (ID) Publish ID or final decision document Implement decisions through label amendments 16

17 Registration Review: Progress All conventional chemicals have had Preliminary and final Work Plans published Focus thru 2022 will be on: Data evaluation Risk assessment development Risk mitigation via PID and ID development 2018 schedule of risk assessments, PIDs, and IDs is available on EPA Registration Review webpage 17

18 Schedule for Mosquito Control Pesticides Many mosquito control pesticides active in Registration Review Pyriproxifen: Assessments published 2017, PID planned late 2018 Spinosad: Assessments published 2016, PID published 2017, ID in development Naled: awaiting data, EFED and HED assessments planned for 2019 Malathion: Assessments published 2016 Chlorpyrifos: Revised human health Assessment published 2016 Phenothrin (Sumithrin): EFED and HED assessments out in December 2016, PID planned for late 2018/early 2019 Prallethrin: EFED and HED assessments out in December 2016, PID planned for late 2018/early 2019 Etofenprox: EFED assessment out in December 2016, HED assessment planned for Spring 2017 Deltamethrin: EFED assessment out in 2016, HED assessment out in 2017, PID planned for late 2018/early 2019 Pyrethrins: EFED assessment out in December 2016, HED assessment out in 2017, PID planned for late 2018/early 2019 Permethrin: EFED assessment out in December 2016, HED assessment out in 2017, PID planned for late 2018/early 2019 *milestones are listed for only 18

19 Opportunities for Public Participation EPA strives to be as transparent as possible and values public input, which: Promotes greater accuracy in decisions Leads to a more robust decision Limits surprises Many opportunities for participation and consultation throughout process Especially important for mosquito control products Unique applications that can t necessarily be mitigated the same way as typical agricultural products OPP actively collaborates with a variety of stakeholders on science and policy issues 19

20 PPDC Public Health Workgroup The PPDC Public Health Working Group has met four times since the last PPDC to discuss, outline and create a recommendation to this PPDC for a Pesticide Emergency Preparedness Action Plan. The group proposed creation of a Pesticide Emergency Preparedness Action Plan, and want to share with the PPDC our progress to date on the ideas, key elements and the recommendation to the PPDC that the workgroup continues to work on. The workgroup is looking forward to hearing PPDC guidance and thoughts as we continue to move towards a specific deliverable. The purpose of the Pesticide Emergency Preparedness Action Plan is to set out a clear guide, for use by the EPA Office of Pesticide Programs to be able to respond more effectively during a pest related emergency, regarding interactions with other agencies and communication materials about pesticides. The workgroup believes that a preparedness plan would ease the way for a coordinated, sound, science-based response to emergencies that involve IPM and pesticides. The workgroup discussed past public health emergencies and some of the shortcomings in responses to them, notably the Anthrax incidents, West Nile Virus, Zika and hurricane responses. The group notes that while there is focus on disease vector control, responses are not limited to mosquitoes. Hurricane responses can include rodent and mold control, and microbial outbreaks can occur in healthcare or other facilities. Bed bugs and ticks are still also significant public health pests, should there be a major outbreak or disease occur. 20

21 AMCA Participation: Registration Review For registration review, AMCA input is very valuable in terms of: Label and use patterns will drive risk assessments More detailed use and usage information could refine assessments and ensure more accurate assessments Risk assessment, when geographic locations of use may refine ecological assessments or endangered species assessments Risk mitigation development Spray height, speed, nozzles, etc. Risk/Benefits decision, to articulate benefits if EPA needs to make risk/benefits determination 22

22 Current Challenges Completing first cycle of registration review by 2022 Over 175 risk assessments to complete Continuing to evolve science and risk assessment methods Over 240 preliminary interim decisions Develop consistent and useful risk mitigation across similar pesticides Implementing the Endocrine Disruptor Screening Program Meeting Endangered Species Act obligations Finding effective ways to engage the interested parties, particularly on niche products such as those used for mosquito control 23

23 Information on EPA s Web Site Office of Pesticide Programs Registration Review Pesticide-specific Information 24

24 Thank You!