™trademark of dow agrosciences llc profume is a restricted ... · profume is a restricted use...

®™Trademark of Dow AgroSciences LLCProFume is a Restricted Use Pesticide.Always read and follow label directions.


Regulatory Update forProFume® Gas Fumigant

®™Trademark of Dow AgroSciences LLCProFume and Vikane are federally Restricted Use Pesticides.Always read and follow label directions.

Dave BarnekowDave BarnekowMethyl Bromide and Alternatives in Food Plants: Past, Methyl Bromide and Alternatives in Food Plants: Past,

Present, and FuturePresent, and Future“Practical pest management methods for 2010 and beyond”“Practical pest management methods for 2010 and beyond”


Topics

ProFume®® Registration Status Sulfuryl Fluoride Registration Review Schedule UpdateExpected Data Requirements

Special IssuesProposed Label AmendmentsClimate Change


ProFume®® Registration Status

Global Status update USA Status update


ProFumeProFume®® Global Registration StatusGlobal Registration Status 2003 - First global registration in Switzerland for use in

flour mills Since then, ProFume has been registered in an

additional 16 countries 2004 – USA, Italy, UK, Germany & Austria 2005 – Belgium 2006 – Canada & France 2007 – Ireland, Spain, Trinidad and Tobago, Mexico, Australia 2009 – Greece, Turkey 2010 – (anticipated) Portugal and the Netherlands


ProFumeProFume®® Global Registration StatusGlobal Registration Status 2006 – CODEX Alimentarius Commission approved MRLs for

sulfuryl fluoride for international trade 2007 – European Union Annex I listing of Directive 98/8/EC

(Biocide) of the active ingredient sulfuryl fluoride for PT 8 (wood preservation)

2008 – European Union set t-MRLs (Maximum Residue Limits) for sulfuryl fluoride and fluoride in various commodities(Annex III of 396/2005/EC)

2009 - European Union Annex I listing of Directive 98/8/EC (Biocide) of the active ingredient sulfuryl fluoride for PT 18 (food processing facilities)

2010 - European Annex I listing of Directive 91/414 (plant protection); vote for inclusion is planned for May 2010


Registration Status of ProFume® ® -- USAUSA

2004 Registration Grain Processing Facilities, Stored Cereal Grains,

Dried Fruits and Tree Nuts First Establishment of Food Residue Tolerances

2005 Registration Food Processing Facilities Established Tolerances for food commodities in

Food Processing Facilities 2009 Initiated Registration Review (June)

Oct 2009 to Jun 2014 - Case Development Oct 2014 to 2015 - Registration Review Decision


Registration Review ProcessMilestone Date

Opening the Docket

Open Docket for Preliminary Work Plan (PWP) Jun 2009Public Comment Period - PWP Jun - Aug 2009Case Development

Final Work Plan Oct 2009Issue DCI Jul – Sep 2010Registrant Data Submission Jul – Sep 2012Preliminary Risk Assessment (RA) Jan – Mar 2014Public Comment Period - RA Apr – Jun 2014Registration Review Decision (RRD)

Public Comment Period - RRD Oct – Dec 2014Final RRD and begin post-decision follow-up 2015


Anticipated Data-Call-In (DCI) Ecological Risk

Avian Plant

Human Health Risk Toxicity Studies Exposure Studies Product Use Information

Environmental Fate Henry’s Law Constant


ProFume® Label - Future Change


Why Change the ProFume® Label

Two drivers for ProFume Label Changes Managing Fluoride Dietary Risk Address confusion in the industry

what and how much can be fumigated during a “facility fumigation”

Not for the management of food adulteration Tolerances are established


Dietary Risk Assessment - Fluoride

Established Tolerances Challenged EPA addressing the challengeDow AgroSciences providing Additional dietary exposure data Market driven refinements to the dietary

exposure and risk assessment


Comparison of Fluoride Exposure Estimates –

U.S. General PopulationExposure (mg/day)

% RfDSulfuryl Fluoride Cryolite Background

FoodDrinking Water Total

EPA (2006) 0.667 0.049 0.476 1.883 3.075 38%Dow AgroSciencesRefined

0.065 0.049 0.377 2.029 2.51 31%

Fluoride exposures from use of ProFume® gas fumigant constitute a very small portion of total fluoride exposure as calculated through a market use refined dietary assessment.

%RfD based on 8.0 mg/day


ProFume® Label Changes

Adjust the commodity list to reflect risk assessment refinements

Development of language that:Remove ambiguity in label directions Clears definition of

Food Fumigation (commodity)Facility Fumigation (space)Pet Foods

Defines in facility fumigations, what and how much


Regulatory and Policy Landscape – Climate Change

Background International DomesticFederalState


Climate Change - GWP Background

The GWP compares the energy absorbing ability of a gas to a reference gas on a Kg per Kg basis, usually on a 100 year time frame.

GWP is a Normalizing Factor (CO2 equivalents) CO2 is the reference gas and assigned a GWP of 1 The GWP value is used to compare other gases to CO2

equivalents GWP is not the measure of impact on the climate

Global impact of a gas as a greenhouse gas is a function of both its GWP and and the volume of the gas found in the atmosphere


International

Kyoto Protocol (KP)Kyoto Protocol (KP) UN treaty developed to stabilize concentrations of

greenhouse gases (GHG) at reduced levels, not to ban or phase them out

Six gases or families of gases are included in the KP. The most significant are: carbon dioxide (CO2), methane (CH4) and nitrous oxide (N2O). SF is not on this list

US signed but did not ratify the KP KP expires in 2012.


International

UN Negotiations UN Negotiations –– Successor Climate TreatySuccessor Climate Treaty On-going process for past 4+ years Target: To gain global consensus on successor treaty that would be

approved by all major GHG emitting Parties Esp. US, China and India

Was scheduled to culminate in December 2009 - Copenhagen (COP 15) with new treaty

Result: Non-binding, non-specific “Copenhagen Accord” No consensus on GHG emission reduction mechanisms, goals or enforcement

UN Efforts will continue in 2010 No indication at this point of the addition of minor gases to the GHG list

within new treaty


European Perspective - 2009 European Parliament Statement

CO2eq emissions of sulfuryl fluoride would still represent a negligible share of global greenhouse gas emissions

the EU, in line with its overall strategy for the negotiations on climate change, does not, at this stage, intend to propose the inclusion of sulfuryl fluoride in a future agreement under the United Nations Framework Convention on Climate Change (UNFCCC).


SF & Climate Change


SF Atmospheric Properties Climate Change

Atmospheric Chemistry of Sulphuryl Fluoride, SO2F2. Dillon, T.J.; Horowitz, A.; Crowley, J.N. Atmospheric Chemistry and Physics 2008 8:1547-1557.

Experimental and Theoretical Study of the Atmospheric Chemistry and Global Warming Potential of SO2F2. Papadimitriou, V.C.; Portmann, R.W.; Fahey, D.W.; Mühle, J.; Weiss, R.F.; Burkholder, J.B., Journal of Physical Chemistry A 2008 112(49):12657-12666

Atmospheric Chemistry of Sulfuryl Fluoride: Reaction with OH Radicals, Cl Atoms and O3 Atmospheric Lifetime, IR Spectrum, and Global Warming Potential. Sulbaek Andersen, M.P.; Blake, D.R.; Rowland, F.S.; Hurley, M.D.; Wallington, T.J. Environmental Science and Technology 2009

Sulfuryl Fluoride in the Global Atmosphere. Mühle, J.; Huang, J.; Weiss, R.F.; Prinn, R.G.; Miller, B.R.; Salameh, P.K.; Harth, C.M.; Fraser, P.J.; Porter, L.W.; Greally, B.R.; O’Doherty, S.; Simmonds, P.G. Journal of Geophysical Research D (2009)


SF GWP in Perspective – Key Facts

The current atmospheric concentration is ~1.5 ppt Atmospheric concentration has been increasing

approximately 5% per year since 1978 Most accurate estimate of the atmospheric lifetime

is 36 ± 11 years GWP value is 4,780 (+ 30%)


SF GWP in Perspective –Potential for Increase

Annual SO2F2 Production Estimate

0

500

1,000

1,500

2,000

2,500

3,000

3,500

1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010

Year

Met

ric T

onne

s

TotalDow

1960-1975 values estimated by linear interpolation from start of production in 1960 to first available production data in 1976.

Sulfuryl Fluoride in the Global Atmosphere. Mühle, J.; Huang, J.; Weiss, R.F.; Prinn, R.G.; Miller, B.R.; Salameh, P.K.; Harth, C.M.; Fraser, P.J.; Porter, L.W.; Greally, B.R.; O’Doherty, S.; Simmonds, P.G. Journal of Geophysical Research D (2009), p. 8

Atmospheric Chemistry of Sulfuryl Fluoride: Reaction with OH Radicals, Cl Atoms and O3 Atmospheric Lifetime, IR Spectrum, and Global Warming Potential. Sulbaek Andersen, M.P.; Blake, D.R.; Rowland, F.S.; Hurley, M.D.; Wallington, T.J. Environmental Science and Technology 2009


SF Atmospheric Fate – Limited Climate Impact

Radiative forcing of SF is approximately 3.3 x10-4 W m-2

Radiative Forcing - Kyoto Gases and SF

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

CO

2

CH

4

CFC

-12

N2O

CFC

-11

HC

FC-2

2

CFC

-113

CC

l4

HFC

-134

a

CF4

(PFC

-14)

HFC

-23

HC

FC-1

42b

SF6

HC

FC-1

41b

CH

3CC

L2

HFC

-125

C2F

6(P

FC-1

16)

HFC

-152

a

SO

2F2

Gas

Rad

iativ

e Fo

rcin

g (W

/ m2)


SF – Climate Change Impact

SF is in a steady-state in the atmosphere Represents approximately 0.01% of greenhouse

gases. Current SF uses results in a diminutive

contribution to global warming Future growth of SF use will always represent a

negligible contribution to global greenhouse gas impact


Discussion

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