GF-2687 HERBICIDE Environmental Protection Authority Public Hearing 17 th December 2015, Wellington.

GF-2687HERBICIDE

Environmental Protection Authority

Public Hearing

17th December 2015, Wellington

| 2GF-2687: EPA Hearing, December 2015

Outline

About us

GF-2687 (Paradigm™)

Halauxifen-methyl (Arylex™ Active)

Florasulam

Benefits of GF-2687

Safety of aerial applications

Risk assessment considerations

Conclusion


About us



Florasulam

Benefits of GF-2687



Conclusion

| 4

Dow AgroSciences

GF-2687: EPA Hearing, December 2015

A Global R&D Based Agricultural Company

We: Discover, develop, register and commercialize innovative technologies for crop protection and seeds

that aid the production of food and fiber

Industry Agriculture

Headquarters Indianapolis, USA

Presence Facilities in >40 countriesProducts in >130 countries

Type Wholly Owned Subsidiary

Owner The Dow Chemical Company

Company Size > 9000 employees, ~ 2000 in R&D

2014 Revenue US$ 7.3 Billion

R&D Investment Approx. US$560 Million

Founded 1897


● Each new molecule requires 8 years of R&D and spends >2 years under

regulatory review globally (a 10 year time frame).

● Each new molecule represents an average US$250 million of investment

(~100million on standard global regulatory studies).

● Only a few companies have this capability globally (Dow AgroSciences,

Syngenta, Bayer CropScience, BASF, DuPont).

● These molecules provide modern solutions to the challenges facing agriculture

More effective on target pest, diseases and weeds

Lower doses

Safer in the environment

Safer to handle

Helping with resistance to older chemistries

Importance of Investment in agrichemicals

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Dow AgroSciences in New Zealand


In 2014 we celebrated 70 years in New Zealand.

Waireka Field Research Station

New Plymouth site

Herbicides (77%)

Insecticides (11%)

Fungicides (6%)

Other (6%)


Sustainability Commitment (Dow Chemical)


Achieving sustainability goals

Spinetoram (2008): semi-synthetic insecticide, retains the favorable environmental benefits of spinosad while replacing organophosphate pesticide

Sentricon™ Termite Colony Elimination System (2000): Replaces widespread application of pesticides in the soil around houses and buildings.

Spinosad (1999): environmentally friendly natural insecticide derived through the fermentation of a natural soil organism, which provides the performance that organic growers have come to trust.

Methoxyfenozide (1998): mimics the natural substance that controls molting in caterpillar pests.

Among others:

Arylex (2015): Best Formulation Innovation

Isoclast (2014): Best New Crop Protection Product

Enlist Duo (2013): Best Formulation Innovation (contains Drift Reduction Technology)

Spinetoram (2010): Best New Crop Protection Product

Isoclast (2014)

http://www2.epa.gov/green-chemistry/basics-green-chemistry


Product Stewardship

Using the Guiding Principles of Responsible Care®, we are committed to making health, safety and environmental protection an integral part of the design, production, marketing, distribution and use of our products.


About us



Florasulam

Benefits of GF-2687



Conclusion


Add text

GF-2687

GF-2687 Wettable granule formulation containing:• 200 g/kg halauxifen-methyl (Arylex)• 200 g/kg florasulam

Target crop Cereals (wheat, barley, triticale)

Target weeds Broadleaf weeds

Application rate

25 g/ha, i.e.• 5 a.e./ha halauxifen-methyl and• 5 g a.i./ha florasulam

No of appl. 1 2

Application timing

Between 3 leaf and flag leaf fully unrolled

• 1st application between 3 leaf and end of tillering

• 2nd application prior to flag leaf fully unrolled

Application method

Broadcast: ground and aerial

Withholding periods

Grain & straw – not requiredForage – 7 days

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New Zealand grain production

Wheat Barley

Source: Te Ara, Encyclopedia of New Zealand, 2007.

In 2014• WHEAT

• 48,000 ha• 413,000 tonnes

• BARLEY• 59,000 ha• 406,000 tonnes

Source: 2014 Agricultural Production Statistics, Statistics New Zealand



EPA assessment of GF-2687

● Toxicity: 6.5B (skin sensitisation) 6.9B (specific target organ toxicity – liver effects in rats in the 90-day

dietary study, LOAEL ~50 mg/kg bw/day)“The estimated exposure of operators to both active ingredients during mixing, loading and application is below the AOEL even without the use of personal protective equipment.” (E&R)

● Ecotoxicity: 9.1A – toxic to aquatic plants 9.2A – toxic to terrestrial plants

The risks will be managed by appropriate label statements.


About us



Florasulam

Benefits of GF-2687



Conclusion


Halauxifen-methyl (Arylex Active)

New to New Zealand

Innovative broadleaf weed herbicide for use in cereals

Discovered by Dow Agrosciences

Announced to the public in 2013

New mode of action (arylpicolinate chemical family)

Toxicity: 6.9B (specific target organ toxicity)

Ecotoxicity: 9.1A (aquatic), 9.2A (soil)


About us



Florasulam

Benefits of GF-2687



Conclusion


Florasulam

Broadleaf weed herbicide for use in cereals

ALS herbicide (inhibits the plant enzyme, acetolactate synthase)

Discovered by Dow Agrosciences in 90s

New to New Zealand

Toxicity: no classification triggered

Ecotoxicity: 9.1A (aquatic), 9.2A (soil), 9.3C (terrestrial vertebrate)


Global regulatory status

Substance Approved in:

Halauxifen-methyl China (March 2014)Canada (June 2014)Australia (March 2015)EU (August 2015)Also: Argentina, Uruguay

Florasulam Australia, Canada, EU, USA, Japan, Algeria, China, Egypt, Ethiopia, Iraq, Israel, Kazakhstan, Kenya, Morocco, Pakistan, Russia, South Africa, Tanzania, Tunisia, Turkey

Paradigm CanadaAustralia

Other halauxifen-methyl formulations

China, EU, Argentina, Uruguay


About us



Florasulam

Benefits of GF-2687



Conclusion


Weeds v yields

No data on yield/profitability increase for GF-2687

Overall cost of weeds in NZ was estimated at $393 million in 19841

(according to the RBNZ inflation calculator, $1 in 1984 is equivalent to $2.99

purchasing power in 2015).

Overall cost of giant buttercup to the dairy industry was estimated at $156

million in 2003. Californian thistle - at $10 million in 19991.

NZ data for cereals – 5 – 55% yield loss depending on weed species and

type of cereal2

NZ has the highest yielding wheat crop in the world (up to 15 t/ha) and the

average is 9 t/ha. The wheat price in January 2015 was $325.70/t, therefore

assuming a 10% yield loss due to the weed pressure, the return per hectare

can be reduced in weedy paddocks by up to $300/ha.

Weed control plays a vital role in the overall cropping rotation.

1 “Te Ara” Encyclopedia of New Zealand2 Bourdot, G. W. and Saville, D. J. (1988) “The economics of herbicide use in cereal crops in New Zealand”, New Zealand Journal of Experimental Agriculture, Vol. 16, p. 201 – 207


Cleavers, cornbind, fumitory and others.

Weeds controlled by GF-2687


In the last six decades the vertebrate selectivity ratios of insecticides (i.e. a relative measure of toxicity to targeted insects versus non-target vertebrates) has increased by five orders of magnitude, when at the same time field rates dropped ~100 times.

Old v new chemistry

Source: Sparks, T. C. (2013) “Insecticide discovery: An evaluation and analysis”, Pesticide Biochemistry and Physiology, Vol. 107, p. 8 -17.


GF-2687 v existing alternatives - toxicity

HSNO classification

Substance

GF-2687 Bromoxynil + Mecoprop + Ioxynil

Mecoprop + Dicamba + MCPA

Fluroxypyr + MCPA + Mecoprop

6.1Acute (oral/dermal/inhal)

D D D

6.3Skin corrosivity

B

6.4Eye corrosivity

A

6.5Sensitisation

B B A

6.6Mutagenicity

6.7Carcinogenicity

6.8Reproduction

B B

6.9Target organ

B B A A


GF-2687 v existing alternatives - ecotoxicity

HSNO classification

Substance

GF-2687 Bromoxynil + Mecoprop + Ioxynil



9.1Aquatic

A A A A

9.2Soil

A A A A

9.3Terrestrial vertebrate

C C B

9.4Terrestrial invertebrate


Residue profile

Neither active is residual in the crop at harvest

Neither active significantly transfers into animal commodities

No detectable residues in grain and straw


Last but not least

New mode of action (resistance management)

Great compatibility (growth regulators, grass weed herbicides)

Wider application window

Excellent efficacy in a wide range of conditions

Excellent crop safety

Short plant back intervals

Easy to handle

Low risk to operators

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New Zealand demonstration program


Paradigm offers, in one application, control of some of my problem weeds, which require an application of previously two herbicides.

Cropping farmer

The flexibility of being able to apply Paradigm up to GS39 means it can give good control of later germinating weeds such as fumitory, cornbind & wireweed, which are becoming a particular problem in cereal rotations. Fumitory appears to become resistant to other herbicide groups in some areas.

Soil and plant agronomist

I applied Paradigm early in very cold conditions and also very late at growth stage 39 to a very heavy fumitory infestation with 100% control. This with the short plant back and low residue make this product a better herbicide than any product available to me at the moment.

Cropping farmer

Paradigm will be an important product to us because it will offer us more flexibility, safety & offers excellent control on fumitory which in the past has not been easy to control.

Agronomist

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Australian experience


Paradigm was slower acting than carfentrazone but the final results were impressive. The host client was very happy with the lack of crop effect compared to historical results with comparison treatments.

Agronomist, South Australia

Fantastic result achieved on the main target weed Bastardii Fumitory. The comparison treatment burnt it back and a lot of it re-shot. Paradigm was very soft on the crop, no effect at all, whereas the comparison mix burnt the crop quite badly.

Argonomist, New South Wales

Very impressive control on volunteer poppy regrowth and my grower was impressed with no adverse crop effect and ease of mixing.

Agronomist, Tasmania

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Canadian experience


You can't always wait for perfect spraying conditions on every piece of land, if we tried everything would be a mess. It gives us the flexibility to go when we need to.

Farmer, Saskatchewan

Wow! The dry formulation of Paradigm mixing was amazing! Easily the best dry formulation that I have ever used.

Farmer, Alberta

Every day is a perfect day when spraying ARYLEX!!!!Farmer, Alberta

There is nothing worse than walking a field after spraying only to find broadleaf weeds still alive. Complete peace of mind knowing the job is done tight the first time.

Farmer, Saskatchewan


About us



Florasulam

Benefits of GF-2687



Conclusion

| 31

Aerial application


A useful tool for farmers in their toolbox (indispensable in certain circumstances)

Aerial applicators undergo extensive training (including optional audited certification)

The risks have been quantified comprehensively in the EPA assessment

Significantly stricter controls apply

No evidence of adverse effects resulting from aerial applicationsInsurance Statistics (NZAAA)

• In 90s – average 25 incidents annually

• In 2006 – 2014 – average 0.6 incidents annually (2 major, neither resulting from drift)

Adverse effects reporting

• Though ACVMG (condition 82)

• Through internal procedures


About us



Florasulam

Benefits of GF-2687



Conclusion

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There are 3218 products in the

ACVMG register.

2014Introduction of a buffer zone control

Feb 2015Endangered species risk assessment

announced

1 product approved

3 products approved1 with prescribed buffer zonesGF-2687 first with prescribed buffer zones for threatened species


GF-2687 v existing alternatives – buffer zones

HSNO classification

Substance

GF-2687Halauxifen-methyl +Florasulam

Bromoxynil + Mecoprop + Ioxynil



Mandatory(Aquatic)

Threatened speciesGround: 2 mAerial: 65 m

NONEAdvisory(terrestrial)

Ground: 5 mAerial: 25 m

Threatened speciesGround: 10 mAerial: 220 m

Application rates per ha:5 g halauxifen-methyl + 5 g florasulam96–210 g bromoxynil + 288–630 g mecoprop + 96-210 g ioxynil1800-2400 g mecoprop + 56-74 g dicamba + 450-600 g MCPA140-210 g fluroxypyr + 400-600 g MCPA + 400-600 g mecoprop

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Main causes of biodiversity loss


“Collectively invasive pests pose the greatest single threat to our remaining natural ecosystems and habitats and threatened native species.”

Habitat loss and modification (forests converted to farmland, exotic forests, settlements and roads; extensive modification of wetlands, dunelands, river and lake systems, and coastal areas)

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Threatened/endangered/native species


Pesticides not among primary causes of loss of biodiversity

New methodology introduced with no industry consultation

Introduced ~2 months after first standard buffer zone control

Arbitrary safety factor

No refinement options

Lack of definition (practical considerations, i.e. how will a farmer know which buffer zone to observe?)

No proposed roll-out to currently registered products – no actual change to the exposure of endangered species to pesticides. Is there another, more effective way?

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Modelling methodology


Based on provided information results cannot be replicated.

E&R Calculated by applicant

Ground applications• Aquatic - standard• Aquatic - endangered species• Terrestrial - standard• Terrestrial - endangered species

22510

510510

Aerial applications• Aquatic - standard• Aquatic - endangered species• Terrestrial - standard• Terrestrial - endangered species

266426220

366972154

Lack of predictability

=Increased risk

in R&D investment

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Evaluation process


No reasonable timeframe for detailed discussion of E&R in the current process

Details cannot be discussed before the E&R is released

E&R is released 10 working days prior to hearing

All communication must be distributed to all stakeholders


About us



Florasulam

Benefits of GF-2687



Conclusion

| 40

Conclusion


Dow AgroSciences thank EPA for thorough risk assessment and accept all proposed controls.

However, we request the buffer zone control to be modified to set aside the buffer zones calculated for the endangered species until standard buffer zones are more uniformly implemented.

For future applications we request for the evaluation process to allow the applicant to comment on the draft E&R before it is distributed.

GF-2687 HERBICIDE Environmental Protection Authority Public Hearing 17 th December 2015, Wellington.

Documents

epa hearing

powerpoint presentation

new molecule

new zealandgf

dow agrosciencesgf

years of rd

outlineabout usgf

global rd