Agricultural Biocontainment Guidance

Transcription

1 Agricultural Biocontainment Guidance Eilyn N. Fabregas, MS, RBP Agency Biosafety Officer Animal and Plant Health Inspection Service (APHIS) 4700 River Road Riverdale, MD PH:

2 Why Agriculture? Food Security - Domestic and Globally US agriculture economy - $1.25 trillion 16% of jobs in the US depend on agriculture Billions Demand for food will rise by 70 to 100 percent by 2050!!!

3 Diseases of Agricultural Concern Newly emerging diseases 2015 HPAI outbreak (USA) H5N2, and new H5N1 (both non-zoonotic to date) Wild bird reservoir 50 million birds culled 1,000 APHIS deployments 3,000 contractors $1 Billion estimated Public Health Concerns zoonotic diseases (animal-to-human) person-to-person transmission (pandemic potential) National & Global Trade Implications $$$$ Animals euthanized Consumption drops Commodity prices drop Exports decline as uninfected countries ban products from infected countries

4 Diseases of Agricultural Concern Newly emerging diseases 2015 Oriental Fruit Fly Outbreak (FL) Large variety of commercial agricultural production within a 4.5-mile radius of the OFF infestation in Miami-Dade County. avocado 68 groves guava 5 groves and approx. 70 acres banana 25 locations and approximately 25 acres annona approximately acres mamey approximately 100 acres sapodilla approximately 40 acres papaya approximately 50 acres lychee approximately 100 acres longan approximately 100 acres dragon fruit approximately 100 acres

5 US & Int l Biosafety & Biocontainment Guidance Documents (International Veterinary Biosafety Working Group) OIE Terrestrial Manual (2012 revised) (2015), 2 nd Edition

6 USDA Biocontainment Guidance Documents

7 Ag Biocontainment Guidance - Purpose Develop and maintain comprehensive biocontainment guidelines for agricultural research and diagnostic, including high and maximum containment research, on plant, livestock, and other agriculturally significant pests and pathogens. The development of evidence-based guidance will fill a gap that has been reported in a number of U.S. government reports, including the Trans-Federal Task Force on Biosafety and Biocontainment Oversight (2009)

8 2009 Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight Objective 5: Ensure comprehensive regulations and guidelines to cover emerging and agricultural agents. Recommendations - USDA to develop comprehensive biocontainment guidelines comparable to those of the BMBL to cover research on agriculturally significant pests and pathogens. Maintain rigorous and comprehensive processes for the review and updating of biosafety and biocontainment regulations and guidelines.

9 Benefits Developing comprehensive biosafety and biocontainment guidelines comparable to those of the BMBL to cover research, including high and maximum containment research, on plant, livestock, and other agriculturally significant pests and pathogens would help make biosafety and biocontainment standards for U.S. research and diagnostic activities in the agricultural sector more equivalent to those for research on human pathogens.

10 Ag Biosafety & Biocontainment BMBL 5 th Edition Guidance Ag pathogen information and containment guidelines (1 st time) Appendix E Arthropod Containment Guidelines (ACG) 1 (specific for arthropods of public health importance) 1

11 BMBL 5 th Edition - Ag Limitations Limited Ag pathogen information and containment guidelines Limited to livestock No aquatic animal or aquatic plant pathogens/pests No terrestrial plant pathogens/pests No Ag arthropod pathogens/pests Other agriculturally significant pests and pathogens No Ag Diagnostic Laboratories No Ag Quarantine Facilities Animal Plant pests and diseases NVSL, Ames, Iowa NVSL, FADDL (Plum Island Animal Disease Center) PPQ, Center for Plant Health Science & Technology High Containment GH

12 BMBL 5 th Edition Ag Limitations (cont.) BMBL Risk assessment criteria in the BMBL are designed for work with pathogens and toxins that are hazardous to human health (except for Appendix D). Ag Biocontainment Guidance Risk assessment Ag Risk Assessment 1 = Biocontainment & Environmental Protection + Worker Protection (if the agent is zoonotic) 1 Primary concern is the potential economic impact of the morbidity and mortality on agricultural species, and the international trade implications of a disease outbreak.

13 Ag Biocontainment Guidance Report of the Trans- Federal Task Force on Optimizing Biosafety and Biocontainment Oversight 2013 ARS Biosafety Symposium Interactive Exercise Types of content useful to stakeholder community Preference for a single comprehensive guidance document covering animal and plant pests and pathogens 2013 USDA s APHIS & ARS Steering Committee; funding TOC was developed and published Timeline

14 Table of Contents Draft TOC Co-developed by ARS & APHIS Senior Management Review Public announcements APHIS and ARS Stakeholders Registries ABSA International Listserv Other Public review period 2 months Public comments captured Evaluation of comments, adjudication, and TOC update

15 Table of Contents (Draft) Review and Public Comments ABSA International Federal government State government One Health Initiative 1 Academia International (UK, Belgium) Others directly to Steering Committee 1

16 Animals Terrestrial Table of Contents Livestock (including avian species) Wildlife Aquaculture Fish, shellfish 5 millon feral swine ($1.5 billon damages annually) Nova Scotia Department of Fisheries and Agriculture Hesy.com

17 Table of Contents (cont.) Plants Terrestrial Plant diseases, arthropods, nematodes, mollusks, and noxious weeds Terrestrial Pest Plants (Parasitic) Aquaculture Aquatic plants Ralstonia solanacearum race 3 biovar 2 Geranium Mediterranean Fruit Fly Potato Pale Cyst Nematode Source: Aplofl.com Potato plant

18 Topics Animals Terrestrial Livestock Wildlife Aquaculture Fish Shellfish Laboratories (containment from lowest to highest) Animal facilities containment for both large and small species (containment from lowest to highest) of animal models Occupational Health Programs Animal health issues Animal Care and Use issues Biosafety Agent summary statements Viral, bacterial, rickettsial, archaebacterial, prion and other diseases, as well as animal/zoonotic select agents, and their impact on agriculture Decontamination, disinfection and sterilization of laboratory and traditional animal facilities, animal cadavers Veterinary Biosecurity Animal handling & restraint (chemical and physical) Animal surgery, necropsy & sampling methods Waste management (urine, feces, milk, eggs, tissues, etc.) and carcass disposal Design and Construction References for livestock and wildlife ABSL-2, ABSL-3, and BSL-3Ag Commissioning of containment systems and facilities Decommissioning of laboratories, animal facilities, and ancillary facilities/processes

19 Topics Plants Terrestrial Plant diseases, arthropods, nematodes, and noxious weeds Terrestrial Pest (Parasitic) Plants Aquaculture Aquatic plants Laboratories (containment from lowest to highest) Greenhouse and quarantine facilities (containment from lowest to highest) Occupational Health Programs Biosafety Agent summary statements Viroids, virusoids, viruses, bacterial, fungal, protozoa, nematodes, insects, and mites, as well as plant select agents, GMOs/transgenic organisms, invasive species, and parasitic plants, noxious weeds and their impact on agriculture Decontamination, disinfection, and sterilization of laboratory, greenhouse and quarantine facilities Plant Biosecurity Waste management Design and Construction References for screen houses, BL1-P through BL4-P, with or without enhancements, or greenhouses, growth rooms, fumigation chambers, and quarantine facilities Commissioning of containment systems and facilities Decommissioning of laboratories, greenhouses and quarantine facilities, and ancillary facilities/processes

20 Appendices Competencies for animal and plant pest laboratory professionals Pest control and Management Fieldwork practices Animal health, plant health, wildlife APHIS permits Veterinary Services Plant Pest Quarantine Other Other

21 Ag Biocontainment Guidance Recruit chapter writers and editors Recruit and assign SMEs to write technical sections of each chapter USG, academia, private and public sector, other Form WGs as needed to incorporate comments from public outreach efforts. Next Steps

22 BMBL 6 th Edition & AgBiocontainment Guidance - Timeline BMBL 6 th (with Appendix D) BMBL 7 th & AgBioCGD Appendix D will remain as part of the 6 th edition USDA will take the lead on revision/update of that appendix. May need to add additional requirements for ABSL-4 Ag. The Ag Biocontainment Guidance document will cover Ag agents only will reference the BMBL in regards to zoonotic agents which present a risk to humans. The 7 th edition of the BMBL will be the first edition to reference the Ag document.

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