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