Agricultural BiocontainmentGuidance

Eilyn N. Fabregas, MS, RBPAgency Biosafety OfficerAnimal and Plant Health Inspection Service (APHIS)4700 River RoadRiverdale, MD 20737PH: 301-436-3117Eilyn.N.Fabregas@aphis.usda.gov

• “Food Security”- Domestic and

Globally

• US agriculture economy - $1.25 trillion

• 16% of jobs in the US depend on agriculture

Why Agriculture?

Demand for food will rise by 70 to 100 percent by 2050!!!

Billions

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 www.nytimes.com/2015/04/10/business/brought-by-wild-neighbors-a-deadly-flu-attacks-turkey-flocks.html?_r=0

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 10–20 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

US & Int’l Biosafety & Biocontainment Guidance Documents

OIE Terrestrial Manual (2012 revised) (2015), 2nd Edition

(International Veterinary Biosafety Working Group)

www.astmh.org

USDA Biocontainment Guidance Documents

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)1.

1www.ars.usda.gov/is/br/bbotaskforce/biosafety-FINAL-REPORT-092009.pdf

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.

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.

Ag Biosafety & Biocontainment Guidance

• 2008 - BMBL 5th Edition– Ag pathogen information and

containment guidelines (1st time)

Appendix E—Arthropod Containment Guidelines (ACG)1

(specific for arthropods of public health importance)

1 www.astmh.org

BMBL 5th 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

HighContainment GH

BMBL 5th 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

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.

Ag RiskAssessment1 =

Biocontainment&

Environmental Protection+ Worker Protection

(if the agent is zoonotic)

Ag Biocontainment Guidance -Timeline

• 2009 - 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

• 2015 - TOC was developed and published

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• www.Regulations.gov

– Evaluation of comments, adjudication, and TOC update

Table of Contents (Draft)

• Review and Public Comments– www.Regulations.gov

• ABSA International• Federal government• State government• One Health Initiative1

• Academia• International (UK, Belgium)

– Others• directly to Steering Committee

1 www.onehealthinitiative.com

Table of Contents• Animals

– Terrestrial• Livestock (including avian species)• Wildlife

– Aquaculture• Fish, shellfish

Hesy.comNova Scotia Department of Fisheries and Agriculture

5 millon feral swine($1.5 billon damages annually)

Table of Contents (cont.)• Plants

– Terrestrial• Plant diseases, arthropods,

nematodes, mollusks, and noxious weeds

– Terrestrial Pest Plants (Parasitic)

– Aquaculture• Aquatic plants

Source: Aplofl.com

Ralstonia solanacearum race 3 biovar 2

Mediterranean Fruit Fly

Pale Cyst Nematode

Geranium

Potato

Potato plant

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

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

Other• 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

Ag Biocontainment Guidance –Next Steps

• 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.

BMBL 6th Edition & AgBiocontainmentGuidance - Timeline

• Appendix D will remain as part of the 6th 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 7th edition of the BMBL will be the first edition to reference the Ag document.

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‘18-’19 ‘21-’22

BMBL 6th

(with Appendix D)BMBL 7th

&AgBioCGD