Ecological Risk Assessment Data Quality Considerations - PowerPoint Presentation

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Ecological Risk Assessment Data Quality Considerations

Thomas SteegerEnvironmental Fate and Effects DivisionEPA Office of Pesticide Programs

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U.S. Environmental Protection Agency

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Office of Chemical Safety and Pollution Prevention (OCSPP) Mission

 To protect human health and the environment from potential risks from pesticides and toxic chemicals.

U.S. Environmental Protection Agency

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Office of Pesticide Programs (OPP)

OPP regulates the manufacture and use of all pesticides (including insecticides, herbicides, rodenticides, disinfectants, sanitizers and more) in the United States and establishes maximum levels for pesticide residues in food.  

U.S. Environmental Protection Agency

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Office of Pesticide Programs (OPP)

OPP implements:Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)Pesticide Registration Improvement Extension Act (PRIA 3)

Along with key parts of the Food Quality Protection Act (FQPA)Federal Food, Drug and Cosmetic Act (FFDCA); and,Endangered Species Act

U.S. Environmental Protection Agency

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Office of Pesticide ProgramsU.S. Environmental Protection Agency

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Director

Associate Director

Catherine Aubee

Deputy Director

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Environmental Fate and Effects DivisionConduct ecological risk assessments

Environmental fate assessmentsEcological effects assessmentsRisk characterizationsGenerate drinking water numbers for human health risk assessmentDevelop tools/methods for advancing science of risk assessment.

U.S. Environmental Protection Agency

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Ecological Risk Assessment Guidance

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https://www.epa.gov/sites/production/files/2014-11/documents/eco_risk_assessment1998.pdf

https://www.epa.gov/sites/production/files/2014-11/documents/ecorisk-overview.pdf

https://nepis.epa.gov/Exe/ZyPDF.cgi/91012PC3.PDF?Dockey=91012PC3.PDF

Standard evaluation procedures and guidance documents.

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Ecological Risk Assessment ProcessPlanning and Scoping Process

Phase I Problem formulationWhat is at risk and what needs to be protectedPhase II AnalysisUse CharacterizationEnvironmental Fate CharacterizationEffects CharacterizationPhase III Risk Characterization

Risk EstimationRisk DescriptionU.S. Environmental Protection Agency

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Analysis (Phase II)

U.S. Environmental Protection Agency

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Exposure Characterization

Environmental Fate Data

Persistence;

Mobility;

Residues of Concern;

Aquatic Exposure Estimates;

Terrestrial Exposure Estimates

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Data Requirements

U.S. Environmental Protection Agency

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Good Laboratory Practices Standards (GLP: 40CFR160)

Ensures the quality and integrity of test data submitted to the Agency in support of a pesticide product registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), section 5 of the Toxic Substances Control Act (TSCA)EPA conducts inspections as part of its GLP program:

to monitor compliance with the regulationsto assure that studies submitted to the Agency in support of a pesticide registration or under a testing consent agreement for an industrial chemical were done with integrity, are of good quality and valid

GLP defines procedures for:

Quality assurance

Standard operating procedures (SOPs)

Data retention/Storage

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Environmental Fate Data (40CFR158)

U.S. Environmental Protection Agency

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CFR identifies required (R) and conditionally required (CR) degradation, metabolism, mobility and dissipation studies.

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Phase II Analysis

U.S. Environmental Protection Agency

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Effects Characterization

Ecological Effect Data

Acute/chronic Freshwater/Marine Fish

Acute/chronic Freshwater/Marine Invertebrate

Benthic Invertebrate

Acute/subacute/chronic Avian

Acute/chronic mammalian

Acute/chronic adult/larval bee

Terrestrial Plant

Aquatic Plant

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Avian and Mammalian Data (40CFR158)

U.S. Environmental Protection Agency

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CFR identifies required (R) and conditionally required (CR) terrestrial animal data

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Aquatic Organism Testing (40CFR158)

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CFR identifies required (R) and conditionally required aquatic animal data.

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Sediment (40CFR158)

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CFR identifies conditionally required (CR) benthic invertebrate data.

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Terrestrial and Aquatic Plant Data (40CFR 158)

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CFR identifies required (R) and conditionally required (CR) aquatic and terrestrial plant data.

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Pollinator Data (40CFR158)

U.S. Environmental Protection Agency

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CFR identifies required (R) and conditionally required (CR) terrestrial invertebrate data

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Pollinator Data (cont’d)

U.S. Environmental Protection Agency

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OECD TG 213

OECD TG 237

OECD TG 245

OECD GD 239

OECD GD 75

Non-guideline data used to assess potential risks to honey bees (

Apis mellifera

).

Honey bees serve as a surrogate for non-

Apis

bees.

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Data Requirements

Studies to generate data in response to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements are conducted under, and the results evaluated in accordance with, a series of internationally harmonized and scientifically peer-reviewed study protocols. 

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Test Guidelines

EPA's test guidelines for pesticides and toxic substances specify EPA-recommended methods to generate dataFor each of the 40CFR158 data requirements, there are EPA Test Guidelines.These protocols are designed to maintain a high standard of scientific quality and ensure that study results can be repeated.

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Ecological Effects Test Guidelines

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https://www.regulations.gov/document?D=EPA-HQ-OPPT-2009-0154-0018

https://www.regulations.gov/document?D=EPA-HQ-OPPT-2009-0154-0016

The OCSPP 850 test guidelines specify conditions, study designs and data/measurement endpoints and may identity study validity criteria.

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Data Evaluation Records (DERs)

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DERs document the Agency’s understanding of the study data.

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Data Evaluation Records (DERs)

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DER templates contain specific conditions identified in test guideline.

Those conditions are compared to what are reported in the study.

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Statistical Verification

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DERs record study author results; however, EPA also conducts an independent statistical analysis of the raw data.

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Verification/Review

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Reviewer signature block

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Open Literature Guidance

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These protocols

 are designed to maintain a high standard of scientific quality and ensure that study results can be repeated.

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Ecological Toxicity Data Evaluation

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Based on an agreement with the U.S. Fish and Wildlife Service and National Marine Fisheries Service (collectively referred to as the "Services"), OPP uses the Environmental Protection Agency's (EPA) Ecotoxicity Knowledgebase (ECOTOX) as its search engine to obtain relevant data on the ecotoxicological effects of pesticides.

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Open Literature Ecological Toxicity Data

U.S. Environmental Protection Agency

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Screening, Review and Documentation Decision Tree.

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ECOTOX Minimum Open Literature Criteria

Toxic effects related to single chemical exposure;Toxic effects are on an aquatic or terrestrial plant or animal species;There is a biological effect on live, whole organisms;

Concurrent environmental chemical concentration/dose or application rate is reported; and,There is an explicit duration of exposure.

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Additional OPP Open Literature Criteria

Toxicology information is reported for a chemical of concern to OPP;The article is published in the English language;The study is presented as a full article;The paper is a publicly available document;

The paper is the primary source of the dataA calculated endpoint is reported;Treatment(s) are compared to an acceptable control;The location of the study (e.g.,

 laboratory vs. field) is reported; and

The tested species is reported and verified.

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Open Literature DERs

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Chemical Name

Ecotox Record Number and Citation:

Purpose of Review

Description of Use in Document (QUAL, QUAN, INV)

Summary of Study Findings

Methods

Results

Rationale for Use:

Comments/Limitations of Study

Description of Use in Document (QUAL, QUAN, INV):

Reviewers

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Data Quality

The principles articulated in these documents are consistent with the agency’s policy and procedural guidance for ensuring and maximizing the quality of information, 

Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency.

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Risk Assessment Peer Reviews

Intra-branchInter-branch (Review Panel)EFED Management ReviewInter-DivisionInter-Agency

Public ProcessRegistrantsPublic CommentsFIFRA Scientific Advisory Panel

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Risk Characterization

U.S. Environmental Protection Agency

35Core Principles of Risk Characterization

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ransparency (methods/key assumptions/limitations)

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larity (plain language; brevity)

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onsistency (adheres to EPA policy/guidance)

R

easonableness (scientifically sound; and consistent with the state of the science; best available information)

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Assess the effect of pesticides on bees

2011: Interim Guidance on Honey Bee Data Requirements2012: Pollinator Risk Assessment Framework White PaperDeveloped in collaboration with Health Canada’s Pest Management Regulatory Agency and the California Department of Pesticide Regulation.

2014: Final EPA Guidance on Risk Assessments for Pollinating BeesHarmonized guidance; served as template for Mexico and Australia.

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https://www.epa.gov/sites/production/files/2014-06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf

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Assess the effect of pesticides on bees

2016 Guidance on Exposure and Effects Testing for Assessing Risks to BeesTier 1Adult acute contact/oral;Adult chronic 10-day;Larval acute; and,

Larval chronic 22-dayTier IISemi-field (tunnel; feeding) Colony; and,Residues in pollen/nectar.Tier III

Full-field Colony

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https://www.epa.gov/sites/production/files/2016-07/documents/guidance-exposure-effects-testing-assessing-risks-bees.pdf

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Tiered Risk Assessment Process

Screening-level risk estimates based on Tier 1 acute and chronic laboratory studies with adult and larval bees.

Higher-tier studies with honey bee colonies may be required pending the outcome of the Tier 1 analysis, whether risks can be mitigated, and risk manager need for additional refinement.

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Refining Test Methods

EPA is working with its regulatory counterparts through the Organization for Economic Cooperation and Development (OECD) and with researchers internationally through the International Commission on Plant-Pollinator Relationships (ICP-PR) to ensure the development of suitable methods for evaluating the effects of pesticides on both honey bees and non-

Apis bees.OPP is engaged in a retrospective analysis of honey bee exposure and effects data to better target testing needs for pesticides and to address uncertainties regarding the extent to which honey bees are suitable surrogates for both exposure and effects to honey bees and other species of bees (referred to as non-

Apis

bees)

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Non-

Apis bee exposure workshop in 2017 (academia; government; industry.EPA is continuing to rely on honey bees as a surrogate for non-Apis bees; however, when available, data on non-Apis bees are considered on a case-by-case basis to determine the extent to which honey bees are not suitable surrogates.

Data on non-Apis bees used qualitatively to characterize potential hazard to non-target organisms.Quality of the non-Apis

bee studies considered using the same standards as those applied to other taxa.

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Non-

Apis

Bee Testing

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Mitigating Risks

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EPA and USDA have been working with the Honey Bee Health Coalition to identify potential

varroacides;Match grant funded through the Foundation for Food and Agricultural Research;Consortium of Land Grant Universities, USDA, University of València (Spain).Land Grant University testing new formulation of oxalic acid-saturated towels.

EPA is monitoring research efforts to evaluate potential varroacides and understand mechanisms of resistance to these products.

Varroacide

Testing

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Best Management Practices

OPP has worked directly with the California Almond Board in the development of their BMPs.OPP serves as an

ex officio member of the Honey Bee Health Coalition (HBHC) Steering Committee and has worked with the Coalition on the multiple projects intended to increase communication, cooperation and collaboration between beekeepers, growers and applicators; projects include commodity-specific BMPs; includes BMPs for beekeepers.OPP has worked with the Pollinator Partnership’s North American Pollinator Protection Campaign (NAPPC) and the HBHC on the development of certified pesticide application training materials for continuing education credits.

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Stakeholder Outreach

OPP posted responses to frequently asked questions (FAQs; https://www.epa.gov/pesticides/new-frequently-asked-questions-honeybee-toxicity-testing-registrants-and-contract) regarding the conduct of bee exposure and effects studies. 

The FAQs are intended to better ensure that the studies will have utility to EPA. 

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Reducing use of products toxic to bees in crops with commercial pollination

EPA’s Policy to Mitigate the Acute Risk to Bees from Pesticide Products issued January 12, 2017

Two Mitigation StrategiesLabel restrictions for contract pollination services;

Prohibits pesticide applications when bees are brought onsite under contracted pollination services; and,

Also provides some flexibility for growers in some circumstances.

Managed Pollinator Protection Plans (MP3; includes colonies not under contracted pollination services).

Intended to increase communication between stakeholders to reduce exposure of honey bee colonies to pesticides;

May include additional measures to reduce exposure and enhance habitat for non-

Apis

bees and other pollinators.

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State and Tribal Pollinator Protection Plans

EPA continues to encourage development of Managed Pollinator Protection Plans (MP3) and Pollinator Protection Plans (P3s) for States and Tribes.States have engaged stakeholders (growers, applicators and beekeepers)Most (48) states have plans;

The majority of plans are voluntary.Tribal Nations working with the Tribal Pesticide Program Council (TPPC) to develop Pollinator Protection Plans (P3s) with a focus on native pollinators

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Pesticide Program Dialogue Committee (PPDC) recommended development of a survey instrument.

In cooperation with the Pesticide Program Dialogue Committee, state lead agencies assisted in development of a survey; recommendations were provided to EPA on the use of the survey as a means of evaluating the effectiveness of managed pollinator protection plans.Survey questions include measures of communication, development of best management practices (BMPs)/standard operating procedures (SOPs); education/outreach; stakeholder engagement; and, measures of behavior change/progress.

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Evaluating the Effectiveness of Managed Pollinator Protection Plans (MP3s)

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Questions?U.S. Environmental Protection Agency

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Disclaimer: The views expressed in response to questions may not reflect the position of the U.S. EPA and/or the U.S. Government.