APHIS - PPD Risk Analysis

PPD Risk Analysis Systems Plant Health Risk AssessmentRegulation and Rulemaking at APHIS : 

PPD Risk Analysis Systems Plant Health Risk AssessmentRegulation and Rulemaking at APHIS Wendy Fineblum Hall, DVM, PhD APHIS Policy and Program Development Risk Analysis Systems

Today’s presentation : 

Today’s presentation USDA APHIS PPD RAS (Risk Analysis Systems) Brief introduction to plant heath risk analysis and risk assessment Brief description of how risk analysis fits into rulemaking at APHIS

USDA Animal and Plant Health Inspection Service : 

USDA Animal and Plant Health Inspection Service

APHIS Policy and Program Development : 

APHIS Policy and Program Development

PPD Risk Analysis Systems : 

PPD Risk Analysis Systems Chief: Dr. Richard Fite Assistant Chief: Dr. Wendy Hall Multidisciplinary staff: 3 veterinarians, 4 plant pathologists, 1 agricultural engineer, 1 economist Skills: risk assessment and mitigation mathematical modeling and simulation sample design and statistical analysis

RAS activities include: : 

RAS activities include: Support programs’ risk analysis efforts Training Methods development Collaboration RA performance Review Risk mitigation Sanitary and Phytosanitary (SPS) capacity building Provide training in RA to subject matter experts from several countries

What is Risk? : 

What is Risk? Chance of something bad happening Probability * Consequences

Why do risk analysis? : 

Why do risk analysis? Support decision-making Provide transparent documentation Fulfill international and/or domestic requirements

Risk Analysis : 

Risk Analysis Risk Assessment Risk Management Risk Communication

Risk Analysis : 

Risk Analysis

Risk Analysis : 

Risk Analysis Risk Assessment Risk Management Risk Communication

What is Risk Assessment? : 

What is Risk Assessment? Method(s) of organizing evidence to answer questions: What can go wrong? (introduction and spread, scenario analysis) How likely is it to go wrong? (probability) What can happen if it does go wrong? (consequences)

According to IPPC : 

According to IPPC Pest Risk Assessment (PRA) is a “Science-based process that provides rationale for implementing phytosanitary measures for a specific area Systematic approach to decide if a pest should be managed using legislation” - www.ippc.int

Plant pests : 

Plant pests IPPC: Any species, strain or biotype of plant, animal or pathogenic agent injurious to plants or plant products - Glossary of Phytosanitary Terms, ISPM No. 5 APHIS: Any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: (A) A protozoan (B) A nonhuman animal (C) A parasitic plant (D) A bacterium (E) A fungus (F) A virus or viroid (G) An infectious agent or other pathogen (H) Any article similar to or allied with any of the articles specified in the preceding subparagraphs

How is risk assessment used? : 

How is risk assessment used? Assist decisionmaker to reach an informed decision; influences risk management Inform stakeholders Identify data gaps

Pest Risk Assessments : 

Pest Risk Assessments Three step process: Categorization of individual pests (e.g., that may enter on commodity considered for import) of concern (e.g., quarantine pests) Assessment of the likelihood of introduction and spread Assessment of the consequences of introduction and spread (economic, environmental)

Types of Risk Assessments : 

Types of Risk Assessments Typically described as Qualitative Quantitative Deterministic Probabilistic Continuum Common feature: scenario or risk pathway

Risk Assessment Tips : 

Risk Assessment Tips Guidance from risk managers Questions to answer Scope of assessment Resulting document should be transparent (risk communication) Team sport (multidisciplinary) Iterative (update with new information) Consider mitigations (sometimes in separate document) Address uncertainty

Risk Assessment at APHIS : 

Risk Assessment at APHIS Veterinary Services 11 risk factors – qualitative regionalization assessment Quantitative models Example: Importation of beef from region of Brazil that is free of FMD with vaccination Plant Protection and Quarantine Pathway pest risk assessment http://www.aphis.usda.gov/ppq/pra/ Example: Hass avocados from Mexico Weed pest risk assessment – for listing http://www.aphis.usda.gov/plant_health/plant_pest_info/weeds/weedriskassmnt99.shtml Example: Beach Vitex

Risk Analysis : 

Risk Analysis Risk Assessment Risk Management Risk Communication

Pest Risk Management : 

Pest Risk Management The evaluation and selection of options to reduce the risk of pest introduction and spread of a pest. [ISPM No. 11] Must balance appropriate level of protection from assessed risks against obligations to minimize negative trade impacts

Risk Analysis : 

Risk Analysis Risk Assessment Risk Management Risk Communication

Pest Risk Communication : 

Pest Risk Communication Occurs throughout risk analysis process Among all parties – decisionmakers, analysts, stakeholders

APHIS Regulatory Authority : 

APHIS Regulatory Authority Animal Health Protection Act prevent, control and eradicate the introduction and establishment of pests and diseases of livestock Plant Protection Act control, eradication…of plant pests or noxious weeds in order to protect agriculture, the environment and the economy

APHIS Authority: Plant Protection Act : 

APHIS Authority: Plant Protection Act Secretary may: issue regulations to prevent the introduction or dissemination of plant pests publish lists of Noxious weeds Biological control organisms act to prevent dissemination or to eradicate newly introduced plant pest or noxious weed cooperate with other Federal agencies, States, other national governments, domestic or international organizations or other associations, to carry out this title

Rulemaking at APHIS : 

Rulemaking at APHIS Rulemaking = process of creating regulation Defined by Congress (Administrative Procedure Act, 5 USC) New regulations require opportunity for public comment on proposed rule adherence to various laws and executive orders NEPA – environmental impacts USDA Reorganization Act of 1994 – risk assessment for economically significant rules Executive Order 12866 – benefit-cost analysis May NOT be ‘arbitrary and capricious’ Final rule publication Opportunities for Congressional and judicial review

Risk Assessment and Rulemaking : 

Risk Assessment and Rulemaking Purposes of risk assessment Support decision-making Provide transparent documentation Fulfill international and/or domestic requirements

Risk Assessment and Rulemaking : 

Risk Assessment and Rulemaking Risk assessment supports rulemaking International Trade (approximately 1/3 of rules published since 2001, nearly all of risk assessments) Domestic Issues (approximately 2/3 of rules since 2001) Pest and disease control and eradication Surveillance Indemnity Others

International Obligations for Risk Assessment : 

International Obligations for Risk Assessment 1994: WTO’s Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) Sanitary and phytosanitary measures must be based on risk assessment

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Thank you!Shukran!