Meeting New Challenges : BiofuelsMeeting New Challenges : Biofuels and other industrial uses

Phil Macdonald Plant and Biotechnology Risk Assessment UnitPlant and Biotechnology Risk Assessment Unit

Brasilia, Brazil, August 16, 2010

© 2007 Her Majesty the Queen in right of Canada (Canadian Food Inspection Agency), all rights reserved. Use without permission is prohibited.

ObjectivesObjectives

Biofuels and industrial use crops look at what’s newBiofuels and industrial use crops- look at what s new and what’s the same?

Introduce an approach to deal with some of the riskIntroduce an approach to deal with some of the risk assessment challenges posed by the “green economy” and evolving science – a “harmonized risk assessment approach”pp

Case study and pilot projects- using the tools of risk assessment

Next steps and lessons learned

2

OriginsOrigins

The 2004 Auditor General’s report on the regulation of PNTS highlighted gaps in the risk assessments of ornamental PNTs, particularly among the imports of new species

New species arose and issue again with the strong message to developers from Government to move molecular farming from well characterized crops to more exotic platformsfrom well characterized crops to more exotic platforms, including species new to Canada or never really extensively cultivated (eg. Camelina sativa )

The “Green Economy” has also pushed the use of new cropsThe Green Economy has also pushed the use of new crops to the forefront for potential use as biofuels (Miscanthus giganteus, willow, poplar)

3

OriginsOrigins

New approaches and new solutions were required to dealNew approaches and new solutions were required to deal with these challenges

Required the combination of the experience of biotech risk assessors with the pest risk assessment experience of weedassessors with the pest risk assessment experience of weed risk assessors- areas that have always existed as separate disciplines

Thi bi ti b i t th b th h d thThis combination brings together both approaches under the IPPC umbrella while remaining consistent with the Cartegena Protocol on Biosafety

4

October 3rd, 2008 issue of Science:

“This is one of the first times such a large and diverse group of internationally recognised scientists have spoken with one voice on the issue. The 23 authors are some of the world's

5

issue. The 23 authors are some of the world s top ecologists, agronomists, conservation biologists and economists.”

Companies are Looking for Innovative Opportunities to Expand Their Markets

6

Looking for Opportunities with BiofuelsLooking for Opportunities with Biofuels

7

And Putting Together wide Reaching g g gPartnerships

8

On the Immediate Horizon

Field trials of Miscanthus giganteus in Canada this spring for biofuel production- traits for more efficient use of water and changes in cell wall composition

Camelina sativa- (false flax) with altered oil for industrial lubricants and fuel oils in field trials and pre commercial development stagespre-commercial development stages

Western and eastern provinces of Canada interested in exploiting opportunities for new industrial cropsp g pp p

(castor bean, Camelina, Russian dandelion ( Taraxacum kok-saghyz)

9

On the Immediate Horizon• Canada is actively fostering innovation and partnerships in

i ltagriculture • The Agriculture Bioproducts Innovation Program (ABIP) was

created to foster the exploitation of agricultural biomass, “ in the f bi d t bi f l biareas of bioproproducts, biofuels.. bioenergy,

biopharmaceuticals etc” with and investment of approximately $25 million to fund 6 research networksTh CFIA i t i th I d t i l Oil d N t k ki• The CFIA is a partner in the Industrial Oilseed Network working on Camelina

“MIAMI, March 25, 2010 — Biofuels market researchers at Biomass Ad i j t d t d th t billi ll f C li bi f lAdvisors projected today that one billion gallons of Camelina biofuel would be produced for the aviation and biodiesel sectors by 2025, creating 25,000 new jobs – producing over $5.5 billion in new revenues and $3 5 billion in new agricultural income for U S and Canadianand $3.5 billion in new agricultural income for U.S. and Canadian farmers.”

• Our partners are pushing hard for innovation in agriculture in Canada risk assessors need to meet the challenge to ensure

10

Canada, risk assessors need to meet the challenge to ensure that innovation proceeds safely and responsibly

Therefore…Therefore…The Plant and Biotechnology Risk Assessment Unit (PBRA)

has started developing a harmonized approach to riskhas started developing a harmonized approach to risk assessment for both intentional and unintentional introductions of plants into the Canadian environment

Which types of plants might undergo a harmonized assessment?

Plants intended for cultivation that may be regulated such asPlants intended for cultivation that may be regulated such as hybrid plants with novel traits, plants with novel traits with no counterparts in Canada, change-in-use plants (biofuels), cultivation of non-crop plants for pharmaceutical production (Artemesia annua over-expressing artemisinin )

The proposed approach has been already seen international acceptance when presented at the ISBGMO in Wellington, New Zealand

11

Environmental Release Assessments ( d f PNT )

• Risk assessment considers relative safety of the

(used for PNTs)

product once it is released in the environment both short and longer term

• ComparativeComparative• Information from applicant is compared to

information known about the biology of the counterpartcounterpart

• Science-based• Builds on previous knowledge

i e what is already known about a new protein? Is• i.e. what is already known about a new protein? Is there a history of safe use?

• Case by case basisD d t it d i

12

• Depends on trait and species

Environmental Assessment Criteria

Environmental assessment uses a “familiar” counterpart as a referencecounterpart as a reference

• relies on “substantial equivalence to define the threshold of risk”

• these concepts are borrowed from OECD food safety assessment criteria and applied to environmental safety assessmentto environmental safety assessment

• Concept continues to be developed by the OECD for the environmental perspectivep p

• very effective for crops and traits we know well

Biology DocumentsBiology Documents

• Currently used as basis for comparison to d t i b t ti l i ldetermine substantial equivalence• Agriculture has an impact• Does the addition of this trait cause a greater g

impact?• Example: Canada grows 10-12 million acres of

canola each year – this has an impact on bi di itbiodiversity

• Macroscopic perspective - Does the impact of a herbicide tolerance gene in canola cause a greater impact on bi di it ?biodiversity?

• Microscopic perspective - A canola plant has thousands of genes – what is the impact of an additional gene?What are the trait(s) conferred by the gene(s)?

14

• What are the trait(s) conferred by the gene(s)?

Methodology for a Pest Risk Assessment

Q li i R i hi h di lQ li i R i hi h di l•• Qualitative Ratings, high, medium, lowQualitative Ratings, high, medium, low•• Give ratings a numerical value, combine to give Give ratings a numerical value, combine to give

overall ratingoverall ratingoverall ratingoverall rating•• Consistency of ratings important, so provide Consistency of ratings important, so provide

guidelines and standards with assessmentguidelines and standards with assessmentgu de es a d sta da ds t assess e tgu de es a d sta da ds t assess e t•• new tools like AWRA can speed the process new tools like AWRA can speed the process

•• Assessments can be either for a commodity or Assessments can be either for a commodity or yyfor a specific pestfor a specific pest

15

Pest Specific PRAp

Establish the identityEstablish the identity•• Establish the identityEstablish the identity•• Consider geographic range and regulatory Consider geographic range and regulatory

status status •• What is the likelihood of introductionWhat is the likelihood of introduction•• Economic Importance/Consequences of Economic Importance/Consequences of

IntroductionIntroductionIntroductionIntroduction•• Establishment PotentialEstablishment Potential•• Natural Spread PotentialNatural Spread Potential•• Potential Economic ImpactPotential Economic Impact•• Potential Environmental ImpactPotential Environmental Impact

16

LMO/PNT & Plants as Pests Approaches

Ri k tLMO/PNT Plants as Pests

Risk assessment paradigm

Plants new to a PRA areaModified plants Typical

Absolute approach: Categorization (QP or not QP);W d i k t (t tComparative approach:

Plants new to a PRA areaModified plants ypplants

Weed risk assessment (text-based); Rapid Risk Assessment (spreadsheet based)

Comparative approach:Info in biology documentCompared Wrt 5 pillars:•Weediness/invasiveness Risk

assessment (spreadsheet-based)•Prob. Entry•Prob. Establishment•Prob Spread

•Gene flow•Plant pest potential•Non-targets

assessment tools

Prob. Spread•Pot. Econ. Consequences•Pot. Env/soc consequences

•Biodiversity

“relative safety”“h i k i it”

Risk t

17

y“how risky is it”assessment

endpoint

LMO/PNT & Plants as Pests Approaches

• Key step in the risk assessment approaches is to look at weediness and invasiveness

• This applies to new plant platforms, new plants imported for cultivation and accidental imports

F bi h di i l h i fi ld i l• For biotech crops traditional approach is field trials to generate data and evaluate performance against the unmodified counterpart p

• Weediness and invasiveness not really much of an issue for crops with comparators or for the “1st

generation crops

•What about new species or potential “fitness” traits in 2 d ti f bi t h

18

2nd generation of biotech crops

A Harmonized Approachpp1. Harmonizing Biology Documents and Weed Fact Sheets:

Biotech Biology Document + Plant Health Weed Fact Sheet = Plant Biology Document

2. Harmonizing Plant Risk Assessment Approaches:

Biotech Envtl Release Assessment + Plant Health Weed Risk Assessment =

H i d Ri k A t f l t f l tiHarmonized Risk Assessment for plants for planting

19

PBRA Plant Biology Document

BERAWRA Document

1. General Administrative Information 4. Biology (cont’d)

WRAOverlap

1.1 Background1.2 Scope

2. Identity2.1 Names2 2 Family

g4.4 Gene flow during commercial seed production4.5 Gene flow during biomass production4.6 Cultivated [crop] as a volunteer weed

4 6 1 Cultural/mechanical control2.2 Family2.3 Synonyms2.4 Common name(s)2.5 Taxonomy and genetics2.6 General description

4.6.1 Cultural/mechanical control4.6.2 Chemical control4.6.3 Combined control4.6.4 Biological control

4.7 Means of movement and dispersal3. Geographical Distribution

3.1 Origin and history of introduction3.2 Native range3.3 Introduced range3.4 Potential range in North America

5. Related Species5.1 Inter-species/genus hybridization5.2 Potential for introgression of genetic information into relatives5.3 Summary of the ecology of relatives3.4 Potential range in North America

3.5 Habitat4. Biology

4.1 Reproductive biology4.2 Breeding and seed production4 3 C lti ti d

5.3 Summary of the ecology of relatives6. Impacts

6.1 Economic impacts6.2 Environmental impacts

7. Potential Interaction with Other Life Forms8 R f

20

4.3 Cultivation and use as a crop 8. References

Plants for Planting Risk A t

BERAWRA Assessment

3. Unconfined Environmental Release Assessment3.1 Description of the Novel Trait

3 1 1 The Trait Itself

Executive Summary1. Initiation

1 1 Background

WRAOverlap

3.1.1 The Trait Itself3.1.2 Development Method 3.1.3 Stable Integration into the Plant Genome

3.2 Criteria for the Unconfined Environmental Release Assessment

3 2 1 Potential to Become a Weed of

1.1 Background1.1.1 Initiation Point(s)1.1.2 Brief History of Request

1.2 Identification of the PRA Area1.3 Information

1.3.1 Previous PRA1 3 2 Available Weed Fact Sheets/Pest Fact 3.2.1 Potential to Become a Weed of

Agriculture or Be Invasive of Natural Habitats3.2.2 Potential for Gene Flow to Wild Relatives and Its Consequences 3.2.3 Altered Plant Pest Potential 3.2.4 Potential Impact on Non-Target Organisms

1.3.2 Available Weed Fact Sheets/Pest Fact Sheets/Pest Alerts etc.1.3.3 Current Regulatory Status

2. Weed Risk Assessment2.1 Categorization2.2 Probability of Introduction and Spread

2 2 1 Probability of Entry (Rating = XXXX) Organisms3.2.5 Potential Impact on Biodiversity 3.2.6 Stewardship Requirements (if applicable)

3.3 Criteria for the Livestock Feed Assessment 3.3.1 Potential Impact on Livestock Nutrition3 3 2 Potential Impact on Livestock and

2.2.1 Probability of Entry (Rating = XXXX)2.2.2 Probability of Establishment (Rating = XXXX)2.2.3 Probability of Spread (Rating = XXXX)

2.3 Potential Economic Consequences2.3.1 Potential Economic Consequences (Rating = XXXX) 3.3.2 Potential Impact on Livestock and

Workers/Bystanders4. Bibliography5. Appendices

5.1 Appendix 1: Administrative and Tracking Information5 2 Appendix 2: Rating Guidelines

(Rating = XXXX)2.3.2 Potential Environmental and Social Consequences (Rating = XXXX)

2.4 Conclusion2.4.1 Calculation of Overall Risk Ratings2.4.2 Summary of Risk and Uncertainty Ratings

21

5.2 Appendix 2: Rating GuidelinesRatings2.4.3 Conclusion Regarding Endangered Areas2.4.4 Discussion of Overall Risk and Uncertainty

Case Study - MiscanthusCase Study MiscanthusWe have used Miscanthus (a biofuel crop) as a case study

for our harmonized approach

A risk assessment from a plant health and biotech perspective was requested as well as a risk assessment orperspective was requested as well as a risk assessment or scientific advice on the potential environmental risk of large scale cultivation of Miscanthus

It is an excellent case study for a harmonized approach

Complementary expertise can be usedComplementary expertise can be usedShorter, more complete assessment than both approaches

alone

22

Pilot Project: Novel oilseedjhybrids

No issues identified in the pest risk assessment

Uncertainty in the weed risk assessment since one of the parents unknown in North America

Import usually not authorized where there is risk of weediness or invasiveness

D i i t k t fi d fi ld t i l lik it ti tDecision taken to use confined field trial like situation to mitigate risk of plant spreading in the environment while gathering data on the potential weediness

IPPC suggests field trials to address uncertainty but provides no guidance

23

Pilot Project: Novel oilseedjhybrids

Field trial proceeded under reproductive isolation based on the known biology of the parents

Provides applicant opportunity to generate agronomic data in the Canadian environment but providing guidancedata in the Canadian environment but providing guidance on how to investigate weediness and invasiveness a challenge

Field experiment ultimately failed but technical questions remain

24

LMO/PNT & Plants as Pests Approaches• Questions:• Questions:

•Can field trial models be used to assess the potential invasiveness and weediness of speciespotential invasiveness and weediness of species new to Canada? - already tried on some new oilseed crops where the weed risk assessment result was unclearresult was unclear

• Can provide a mechanism to address uncertainty in the risk assessment but how can thesein the risk assessment but how can these paramaters be measured?

• What will the counterpart be?What will the counterpart be?

• In the absence of a counterpart can we assign some absolute values to invasivenes or

25

weediness?

LMO/PNT & Plants as Pests Approaches• Questions:• Questions:

• Is it possible to consider standardized approaches that can be applied across theapproaches that can be applied across the continuum to address everything from PNT crop plants carrying fitness enhancing traits to plants new to Canada to new plant species that may benew to Canada to new plant species that may be genetically modified?

• Will this simplify the work of applicants and risk• Will this simplify the work of applicants and risk assessors in making decisions about potential invasiveness?

• Would this be a “tiered type approach”

26

Next Steps for PBRApRisk assessors in the new PBRA unit are sharing, or

have shared expertise on several files:have shared, expertise on several files:Cuphea terms and conditions for field trials (Spring 2008)Castor bean terms and condtionsDeveloped a Castor bean biology document

Miscanthus risk assessmentMiscanthus risk assessment

Russian Dandelion field trials 2010

Our combined formats will continue to be refinedOur combined formats will continue to be refinedPBRA discussed this approach at Ecology and

Management of Alien Plant Invasions (EMAPI) workshop on modeling invasiveness and has a recent publication

27

on modeling invasiveness and has a recent publication describing the method in EBR

Next Steps for CFIApThe risk assessments need the policy context- needs

to be a clear idea of what the endpoint goals willto be a clear idea of what the endpoint goals will be for the risk assessment

We may be considering plants outside of the usualWe may be considering plants outside of the usual context of “safe as”

Conversation on what constitutes acceptable management and for what risks e.g. currently potential market harm is not considered during the risk assessment

Capacity by the CFIA to risk manage these products will be a critical part of the discussion between risk managers and risk assessors

28

Next Steps for the CFIA

Continue to develop the harmonized approach to risk assessments and to continue to seek additional synergies t d th d l t f t i l i dtowards the development of a true single window

Agreement to the continued development of harmonized documents that although slightly longerharmonized documents that, although slightly longer, reflect a broader scope and meet more Program and Policy needs

29

30

31

32

ConclusionConclusion

Risk assessors at the CFIA have developed a new format for risk assessment for plants that do not fit well i t ith ti l f tinto either groups conventional formats

Plants that do not require a harmonized approach will continue to be assessed as beforecontinue to be assessed as before

A harmonized approach will help CFIA meet its regulatory obligations while enabling Canadians to accessregulatory obligations while enabling Canadians to access the benefits of the “green economy”

33

Thank ou !!Thank you !!

Questions?Questions?