biopesticide registrations...
TRANSCRIPT
Biopesticide Registrations Implications
Nina Wilson – Gowan Company Ft Collins, CO April 2017
Biopesticides – Reduced Risk Pest Control not just for organic acres
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Industry Needs for Global Regulatory Framework • Timely and predictable
label with no barriers to exportation
• Clear understanding of requirements & process with flexibility commensurate with risk
• Quantify expectations
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Regulatory authorities are required to make safety assessment- statutory obligation under sovereign law
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Registrants demonstrate through data and scientific rationales: Toxicity x Exposure= Risk
Science + law = Registrations & some surprises
Organic Designation= Marketing Program
Regulatory Harmonization Expectations
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(Data requirements) + (Assessment) = Label & MRL (exemption)
(
1 bureaucracy + 1 bureaucracy ≠ simplified process
Science + Law + Policy = not a linear thought process
Organic Designation – naturally derived/not a safety assessment
Harmonized? Not Harmonized
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US
Defined criteria with stand-alone unit to facilitate registrations above conventional timelines
South American
Harmonized OECD guidance with national programs
EU
Defined criteria
Africa
WHO Pesticide Evaluation Schemes
Biopesticide Harmonization -Guidance regarding protocol and conduct of studies are harmonized; -The risk assessment which determines registration and labels are sovereign creating divergent data requirements and different outcomes (MRL /tolerance or exemption from MRL)
Far East
OECD guidance but defining their own process
Biopesticide requirements are varied and dependent on the regulatory process within the country; efficacy data requirements in substantially increased cost and complexity
Biopesticide Registrations – Qualitative>Quantitative Risk Assessments
• Usually given an exemption from MRL, depending on the safety assessment and reliability of the analytical (detection) method
• Depends on data and literature (history) • No evidence of toxicity at high level • Biochemical vs microbials • More data indicates a need for a quantitative risk assessment
which requires more data and suggest need for an MRL
Exemption from MRL/tolerance – not no residues but no residues of toxicological concern “residue management”….
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Biopesticide Registration- why the complexities? • More complexed as technology pushes the registration paradigm
• Not just Bacillus thuringiensis (Bt) and well-known essential oils anymore
• Uncertainty requires more data and safety assessments • Potential of over-complication because of pesticide law complexities
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Acetic Acid=vinegar=toxicity?
Is it Natural or Organic?
Organic designations and (bio)pesticide registrations are independent assessments under different laws and authorities
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If it’s natural or organic…….. Is it a pesticide or biopesticide? Is it natural? Is it a food? Is it a safe?
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*Law > > Definitions > > Interpretation >> Claims
Potential Biopesticide
• Plant extract • Central nervous poison • Acute LD50 :200-400 mg/kg • Adverse affects: mild cerebral hyperemia, occasional
psychotic-like self mutilation, gastric ulcers, and inhibition of oogenesis; hypertrophy of the salivary glands, gastrointestinal tract, liver, heart, kidneys, and lungs; a stressor reaction in the adrenal and thymus glands; minor changes in organ water levels; an occasional death apparently from bronchopneumonia (1965 Boyd)
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Caffiene: Not a biochemical per EPA-OPP BPPD Most likely NOP compliant as a pesticide
Organic Designation or Pesticide Registration
Organic designation: • Independent and/or governmental
agency • Alternative assessment generally
based on production methods free of synthetic materials
• Needed to brand or designate product or commodity as “organic”
OMRI • determines whether individual
inputs products comply with the organic standards
(Bio)pesticide Registration: • Government agency; competent
authority • Safety assessment • Needed to legally sell and use
product as a pesticide
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Global Implications – Organic Designations
• In absence of policy, and with increasingly stricter organic rules, retailers will define their own criteria & programs creating a plethora of logos
• Organic • Sustainable • Natural
• Trade depends on reciprocal agreements or managing to the most stringent policy of the target market
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Reciprocal Agreements Exists for Organic Designations but not for Pesticide Registrations
• Usually Maximum Residue Limits (MRL) of the (bio)pesticide serve as the regulatory mechanism used for trade compliance
• (Bio)pesticides are not usually associated with MRLs
• A crop treated with a biopesticide that is not registered in X country could be allowed to be labeled as “organic” for X country
• ….. But may have different tolerance/MRL designations
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Registration Tolerance/MRL Exemption
Organic Designation (USDA NOP)
Pyrethrums Conventional No (.05-3 ppm) Yes, formulation dep.
Copper Conventional Yes Some, formulation dep.
Soap salts Conventional Yes (EU exempt) Yes, formulation dep.
Nonanoic acid (fatty acid)
Biopesticide Yes Non-food only, formulation dep.
Garlic Biopesticide Yes (EU exempt) Yes and No, formulation dep.
Azadiracthin BPPD No – (EU .01-1 PPM) No food use Canada
Yes, formulation dep.
caffeine Not registered; but not considered BPPD
Most likely not Maybe
• Harmonization of MRL exemptions • Find the “spaces” between the rules • Acceptance of studies and registration submission • Efficacy requirements redefined
Regulatory
• Harmonization of organic designation • Reciprocal agreements • Alternate assessments Organic
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Doug Pike, Cartoon stock.com