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Auckland March 7th 2013

Colin Sharpe Regulatory and Government Affairs Leader ANZ

DOW AGROSCIENCES PRESENTATION TO OPC HEARING

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Who is Colin Sharpe

• Colin Sharpe 44+ years with DAS in R&D & Regulatory Affairs in ANZ & Asia

Pacific,

> including 4 years as Crop Protection Director of CropLife Australia

> Member and/or chair of many regulatory authority and industry working groups.

> Has participated in Codex Committee on Pesticide Residues and OCED Pesticide

Working Group meetings (Regulatory harmonisation)

> Hold the Inaugural CropLife Award for Industry Contribution to Crop Protection

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Who is Dow AgroSciences

Where Does NZ fit in the Agchem global market

• Dow AgroSciences 106 year old R&D plant science company discovering and

registering new active ingredients

• Business unit of The Dow Chemical Company. 2012 turnover ~ 6 billion USD

> 7000 employees ~ 2000 engaged in R&D

• Total crop protection sales NZ = ~ $250 million – ~0.125% global sales in

2012 (~ 50 billion USD).

• DAS NZ = ~0.5% DAS global sales

• NZ is irrelevant driver for development of new active ingredients. Has to compete for

R&D funds with every other country

> Important to NZ farmers to keep older chemistry as long as the health & environmental risks are

acceptable.

> Longevity influences =new peer reviewed knowledge changed regulatory standards, civil liability,

changing community standards,

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The Journey of a new active ingredient from discovery to

registration

• 1: 100,000 potential agchem chemicals finds its way to market

• Cost ~ 250 million USD (2009 survey) – 8-10 years to first sales – 20 years

Patent from discovery

• 5 non-Japanese R&D companies discovering new actives (Dow

AgroSciences, Syngenta, Bayer, BASF, DuPont)

• Focus on a few major global crops & insignificant areas grown in NZ

> Maize, Cereals, Soybeans, Cotton, Rice, Sugarcane, Oilseed Rape

• NZ crops are a secondary add-on market if the development cost can be

justified. Only patented actives of interest due to lack of data protection. No

interest in providing studies to support actives that come under review due to

no data protection.

> Local cost ~ $300,000 per crop (residues, efficacy, crop safety, registration)

> Customer standard (“No detectable residue”} a greater hurdle than the competent

authority. Restricted application window & IPM fit

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Why is Dow AgroSciences interested in this reassessment

• Original discoverer of chlorpyrifos in the early 1960s, first sold 1970

> Over its lifetime > 5000 health and environment studies have been

conducted (more than for any other chemical)

> It has undergone numerous regulatory reviews including more than one in

EU, USA & Codex

> Information on myths and facts can be found at www.chlorpyrifos.com

> Only agricultural & horticultural uses are supported by Dow AgroSciences.

Residential use was voluntarily withdrawn by Dow AgroSciences in 2001 in

the USA and globally in 2005.

• Reason = introduction of a USA rule that children exposure potential MUST be

1000x < lowest dose showing no measurable effect in laboratory studies

• Withdrawal made mandatory in USA and some other countries including the EU

so as to include products from all registrants, but only partially or not at all in

other countries

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PAN Claim – chlorpyrifos meets the criteria for listing under the

Stockholm Convention on Persistent Organic Pollutants (POPs )

• Basis of this submission principally appears to be the promotion of an

erroneous bioaccumulation factor for chlorpyrifos. Aquatic BCF > 5000

(Hansen et al 1986) > 5000 Stockholm convention trigger

• Claim based on one manifestly flawed and unrepresentative study which is

clearly an anomaly. All other data reported in the literature (18 studies) show a

BCF most commonly in the range of between 500 and 1800.

• Evaluations since 2000 by EC, USA, Canada & Australia have determined

BCF to range between 745 and 2729

• The EU rapporteur for chlorpyrifos, Spain, has taken a look over the PAN

(Watts) paper and offered a perspective that does not support the PAN

conclusions

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Comment on the PAN ANZ submission to EPA

• OP epidemiology studies – neurodevelopmental effects at levels below cholinesterase

inhibition

> DAS is aware EPA consultant has reviewed the studies referred to by PAN and came to an

equivocal conclusion generically for OPCs

> DAS draws the Committee’s attention to 6 recently published peer reviewed reports reviewing

chlorpyrifos specificaly - were not included by the EPA consultant

> & the US EPA review that was included

> None concluded on a weight of evidence basis that a concern exists relating to

neurodevelopmental affects from exposure below that which elicits cholinesterase inhibition

1. EVALUATION OF EPIDEMIOLOGY AND ANIMAL DATA FOR RISK ASSESSMENT: CHLORPYRIFOS DEVELOPMENTAL

NEUROBEHAVIORAL OUTCOMES (Abby A. Li, Kimberly A. Lowe, Laura J. McIntosh, Pamela J. Mink) 2012

2. RISK ASSESSMENT: CHLORPYRIFOS DEVELOPMENTAL NEUROBEHAVIORAL OUTCOMES (Abby A. Li, Kimberly A.

Lowe, Laura J. McIntosh, Pamela J. Mink) 2012

3. INCORPORATING LOW-DOSE EPIDEMIOLOGY DATA IN A CHLORPYRIFOS RISK ASSESSMENT (Julie E. Goodman,

Robyn L. Prueitt, and Lorenz R. Rhomberg) 2012

4. EVALUATION OF EPIDEMIOLOGY AND ANIMAL DATA FOR POTENTIAL EFFECTS OF CHLORPYRIFOS ON FETAL

GROWTH OUTCOMES: IMPLICATIONS FOR RISK ASSESSMENT (Pamela J. Mink, Carole A. Kimmel, Abby A. Li) 2012

5. Review of the Toxicology of Chlorpyrifos With an Emphasis on Human Exposure and Neurodevelopment (David L. Eaton;

Robert B. Daroff; Herman Autrup; James Bridges; Patricia Buffler; Lucio G. Costa;Joseph Coyle; Guy McKhann; William C.

Mobley; Lynn Nadel; Diether Neubert; Rolf Schulte-Hermann; Peter S. Spencer) 2008

6. Dialkyl Phosphates as Biomarkers of Organophosphates: The current divide between epidemiology and clinical toxicology

(Daniel L. Sudakin and David L. Stone) 2011

7. The USA EPA Scientific Advisory Panel considered the health effects of chlorpyrifos in April 2012, including the relevance of

cholinesterase inhibition as the endpoint for risk assessment

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Comment on the PAN ANZ submission to EPA

• Chlorpyrifos is a carcinogen and developmental/reproduction toxin at

potential levels of exposure

• No competent authority agrees with this conclusion including

California

> Peer reviews of available data by Science Advisory Panels

> Not on the Proposition 65 list last reviewed Feb 2013 (annual)

• Chlorpyrifos is an endocrine disruptor

> 11 studies done under the US EPA Endocrine Disruptor Screening

Program

> By weight of evidence US EPA concluded chlorpyrifos has no potential to

interact with the endocrine system including oestrogen, androgen & thyroid

pathways

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Unacceptable exposure

• PAN claims the Californian ADI (0.0001 mkd) should be adopted to protect

children and not the Australian 0.003 mkd

• NZ max rate 1.5 kgai/ha

> Government residue monitoring 2011/12 • Spring onions 1 detection > 0.1 MRL (0.11)

• Olive oil 1 detection > 0.04 MRL (0.044) + organic oil detection < MRL

• Australian max rate 3 kgai/ha

> Government residue monitoring 2011/12 showed no detectable residues

• USA EPA ADI = 0.0003 to take care of children.

> Supports use on tree crops, vegetables, grapes, berryfruit, broadacre crops at rates

up to ~ 2 kgai/ha. Citrus up to 6 kgai/ha.

• Note ADI = daily dietary intake & incorporates 100x safety factor

> Sum of MRLs x dietary consumption for each food must be less than the ADI

• Note occupational exposure risk calculated using the AOEL = 0.01

(incorporating 100x safety factor)

> Additional 100X safety factor within the acceptable risk calculation (Margin of

Exposure)

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Comment on the PAN ANZ submission to EPA

• Approval of chlorpyrifos methyl should be revoked because residues

are found in grain products

• Only approved to be formulated for export

• No NZ registration for use therefore can not be sold in NZ

• Codex MRLs (adopted by NZ for imports) = 10 mg/kg for wheat

> MRLs are a means of checking if the product is being used according to its

label which instructs how to use the product in accordance with a risk

acceptable to competent authorities.

> Codex MRLs = globally acceptable risk

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EPA conclusion on Higher Tier field studies for bird effects risk

• Spanish review conclusion for the nominated Annex 1 use = “there are low

acute oral risks for insectivorous birds in vineyards for the dose proposed in

the new GAPs.”

> Only one use can be submitted for Annex 1 EU approval. Other uses are addressed

at the national level

> Addtional data at use rates similar to and higher than NZ’s are available but not

addressed by Spain

• EPA Conclusion from Spanish DAR

> “Unfortunately the data on which these conclusions are based or an

independent review by a regulatory authority are not available to the EPA.

Therefore the EPA is not able to review the relevance for the New Zealand

circumstances and uses”

> Will not be provided due to lack of data protection, nor will any additional

data – only summaries can be provided

> “Given the tested application rate (sic 0.36 kg/ha) which is significantly

lower than the highest approved and used application rate in New Zealand

EPA staff consider that a high acute risk to birds cannot be excluded”

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Bird risks – Field studies

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Bird risk – field studies

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EPA hazard classification amendment

• Classification of chlorpyrifos as a reproductive and developmental

toxicant on the basis of one report is of concern.

• There are many studies available that investigate the potential for

chlorpyrifos to cause reproduction and developmental toxicity.

• On a weight of evidence there is no justification for this classification.

• Not listed in California’s Proposition 65 as a

reproduction/developmental toxicant or carcinogen as of Feb 2013

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Conclusion

• The more than 5000 available peer reviewed health and environment

studies on a weight of evidence supports the EPA Staff

recommendation to

Retain approvals with additional controls