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COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
CPDA ADJUVANT CERTIFICATION
PROGRAM AND THE IMPACTS OF
ADJUVANTS ON ACTIVE INGREDIENT
RESIDUES ON FOOD
Agricultural Adjuvants in Brazil
December 9, 2013
Brasilia, Brazil
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Why Build a Program?
• Late 60s through mid 80s
– Predominantly a pre-emergence herbicide market
– Adjuvant usage focused on formulations
• Mid to late 80s to current
– Transition to post emergence herbicides
– Explosion in the need for adjuvants to enhance herbicide performance
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Late 80s - CPDA Addresses Issue
• Adjuvants not registered like pesticides
• Limited use of standardized definitions
• Undefined product functionality claims
• Failure of some products to correctly warn of safety and handling issues
• Inconsistent composition
• Variable performance
• Use of incorrect products or use rates
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
The Consequences!
• Consumer confusion / frustration
• Open to increased regulatory scrutiny
• Certain states began to develop adjuvant regulations
• CPDA – let’s get pro-active and develop Adjuvant Standards
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Adjuvants Commonly Used in Agriculture
• Adjuvants used to support biological efficacy
Surfactants (non-ionic surfactant – NIS, ionic, blends)o Penetrating agents, dispersing and emulsifying agents
Oils (modified seed oil – MSO; crop oil concentrate – COC)o Petroleum, vegetable, paraffinic & combinations; aid penetration of plant
cuticle, reduce evaporation, reduce surface tension
• Utility adjuvants used for other purposes
Water conditioning, softening or buffering agents
Foam control agents
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Adjuvant Standards: Concepts and Principles
(1) Voluntary and self-certifying program
(2) Benefit end-users and pesticide manufacturers
(3) Encourage pesticide manufacturers to promote and recommend CPDA Certified Adjuvants
(4) Adjuvant manufacturers must promote the value of Certified Adjuvants to consumers
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Adjuvant Standards: Concepts and Principles
(5) Initial Certification activities were focused on developing standards and guidelines for labels
(6) ASTM was utilized as the source for standardized definitions and, when available, test methods to document functionality claims in the Certification Program
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification
Standards
& Guidelines
Adopted July 2000
(S-1) - (S-17)
1997
Development
of Std. (S-1) –
(S-17)
1998
Legal and
Board review
of Program
1999
Dvp. & review
of Certification
License
1987
ASTM E-35
Call for Adj.
Term Std.
1990
ASTM E-35
Adj. Terms
Task Force
1996
First Adjuvant
Std. Meeting
1991
Founding of the
CPDA AIC
1993-95
ASTM-E-35
E-1519-95
Adj. Terms
History of ASTM / CPDA Adjuvant Standardization
2000
April 15
Deadline for
Comments
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Benefits of CPDA / ASTM Adjuvant Standardization Efforts
• The standardization of more than 70 terms
• Development of standardized methods for: Tank Mix Compatibility, Nonvolatile Matter of Agricultural Adjuvant Solutions by Thermogravimetry, Agricultural Acidifiers, Effectiveness of Foam Control Agents, Relative Extensional Viscosity of Agricultural Spray Mixes.
• Developing methods for: Water Conditioning Agents, Drift Reduction, Humectancy
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Adjuvant Standards
• The adjuvant standards were intended to: Establish minimum guidelines for good product stewardship
Establish use of EPA approved inerts in adjuvant formulations
Establish good product communication guidelines (MSDS, product labeling, and hazard identification)
Support product functionality claims by meeting ASTM definitions for function
Give end user useful information so they can make an informed choice
• The adjuvant standards were not intended to:x Establish efficacy or regulate the claims made by the manufacturer
x Provide for extensive toxicology (hazard and environmental) testing
x Differentiate products in the marketplace between acceptable and not acceptable
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Standards are based on ….
• Regulatory and function guarantees (S1-S3)
• Safety (S4 - S7)
• Testing guidelines (S8 - S10)
• Methodology and labeling (S11 - S15)
• Product stewardship (S16 - S17)
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Council of Producers & Distributors of Agrotechnology
Labeling and Performance Standards for Spray Adjuvants and Soil Conditioners
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process
• Product name
– Primary license
– Sub-license• If sub-license – list name of primary product being sub-licensed
• Product type (NIS, COC, etc.) must be defined in ASTM E-1519 or E-609
• Submit copy of current label
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process
• Submit summary of toxicity studies
– Dermal, oral and eye irritation mandatory
– LD-50 in each category required
• Submit MSDS
• Complete company information
• Sub-license – List name and address of sub-licensee as it appears on the label
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process
• Are functionality claims defined in ASTM E-1519 or E-609? – They must be!
• Were ASTM standardized methods used?
• Is it labeled for use on food crops?
• Are the components listed in CFR 40, 180?
• Is the packaging Department of Transportation compliant?
DOT Compliant Packaging
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process
• Does it contain OSHA Regulated Hazardous Materials?
– If yes, then toxicity studies for inhalation, dermal irritation and skin sensitization are required.
• Does it list 24 hour data service?
• Are precautionary statements included?
• Is the designation of the proper product hazard signal word included?
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process
• Are aquatic uses on label?
- If yes, then a summary of the aquatic toxicity study is required
• Do active ingredients contribute to one or more of the functions defined in ASTM E-1519 of E-609?
• Does it list the % surfactant guarantee?
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process• Are components water dispersible and do they
reduce surface tension of water per ASTM Method D-1331?
• Are types of oil (if two or more) listed in descending order?
• Is the unsulphonated oil residue (UR) value listed?
• Are state labels identical with respect to all applicable Certification Standards?
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process:Completion
• Applicant advised of approval
• Sign licensing agreement and submit Certification of Compliance
• Pay appropriate fee
• Re-certify every 3 years
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
EPA Action
In 2006, EPA approved the following language to be placed on a registered pesticide product:
“When an adjuvant is to be used with this product, [name of the registrant of the pesticide] recommends the use of a Council of Producers & Distributors of Agrotechnology certified adjuvant.”
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Effects of Adjuvants on Active Ingredient Residues
• EPA Guideline 860.1500: “If the label of a product recommends addition of another ingredient such as crop oil or a specific class of surfactants, the field trials should reflect the use of that additive.”
• In 2008, EPA began selectively requiring adjuvant prohibition statements on pesticide product labels if adjuvants were not included in the residue trials.
Data Illustrating Effects of Adjuvants on Residue Levels
Average Residue, ppm Ratio Adjuvant:None
Crop PHI, days None MSO NIS MSO NIS
grape 15 0.189 0.371 0.461 2.0 2.4
grape 14 0.0426 0.0442 0.0909 1.0 2.1
grape 14 0.0364 0.0445 0.0408 1.2 1.1
peach 10 0.0639 0.106 0.114 1.7 1.8
peach 10 0.0827 0.0891 0.132 1.1 1.6
peach 10 0.122 0.142 0.101 1.2 0.8
plum 10 0.017 0.049 0.076 2.9 4.5
plum 10 0.004 0.011 0.011 2.8 2.8
plum 10 0.009 0.022 0.029 2.4 3.2
cherry 10 0.1 0.15 0.19 1.5 1.9
cherry 10 0.36 0.48 0.57 1.3 1.6
*MSO= Modified Seed Oil
**NIS= Non-ionic Surfactant
Limited Data for One Compound Prompted EPA Action
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Industry Dataset
• CPDA and CropLife America member companies provided residue trial results to examine the effect of adjuvants on residue levels
• 1800+ residue data points were collected and coded
• Data covers fungicides, insecticides, herbicides; 25 active ingredients; multiple crops; predominantly oils and surfactants; data from NAFTA countries and Europe
• 437 side-by-side comparisons of “with adjuvant/without adjuvant” were selected for initial industry analysis
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Industry Analysis:
• Ratios of “residue with adjuvant/residue without adjuvant” were generated
• Statistical analysis was done to examine the effects by: adjuvant type; active ingredient type (fungicide, insecticide, herbicide); and crop
• Found that 75% of “adjuvant:no adjuvant” ratios were <1.4
• In general, neither adjuvant type nor active ingredient type influenced ratios
• Range of variability seen is typical of residue data
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Next Steps
• Dataset submitted to EPA for further analysis
• EPA resources insufficient to conduct a full statistical analysis
• CPDA and EPA developed a statistical analysis plan and CPDA commissioned Dr. George Casella, University of Florida to conduct the analysis~ Is there an overall effect of adjuvants on the active ingredient residue
level?
~ Is the adjuvant effect the same for all crops?
~ If there is a crop effect, is the overall adjuvant by crop interaction less than the adjuvant effect?
~ If there is an effect of adjuvant, is there a difference between adjuvant types?
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Noriginal
row
number
Country ASTM Category CROP TYPE
Residues
with
adjuvant
Residues
w/o adjuvant
1 262 EU Oil Alfalfa green matter 0.09 0.03
2 264 EU Oil Alfalfa green matter 0.02 0.02
3 266 EU Oil Alfalfa green matter 0.02 0.02
4 274 EU Oil Alfalfa green matter 5.39 1.42
5 276 EU Oil Alfalfa green matter 0.17 0.2
6 278 EU Oil Alfalfa green matter 0.25 0.43
7 268 EU Oil Alfalfa hay 0.14 0.06
8 270 EU Oil Alfalfa hay 0.02 0.02
9 272 EU Oil Alfalfa hay 0.02 0.02
10 280 EU Oil Alfalfa hay 3.54 1.33
11 282 EU Oil Alfalfa hay 0.69 0.6
12 284 EU Oil Alfalfa hay 0.73 0.71
1 212 US Oil Almond hull 2.893 3.947
2 217 US Oil Almond hull 1.447 2.103
3 210 US Oil Almond nutmeat 0.041 0.038
4 215 US Oil Almond nutmeat 0.033 0.014
13 1744 EU Surfactant Barley grain 3.751 2.624
14 1746 EU Surfactant Barley grain 6.012 3.098
15 1304.1 EU Surfactant Barley grain 3.8 3.6
16 1305 EU Surfactant Barley grain 5.5 6.3
17 1306 EU Surfactant Barley grain 6.7 9.7
18 1307 EU Surfactant Barley grain 12 13
19 1316.1 EU Surfactant Barley grain 2.2 1.5
20 1317 EU Surfactant Barley grain 2.0 1.6
21 1318 EU Surfactant Barley grain 4.1 2.6
22 1319 EU Surfactant Barley grain 7.3 6.5
23 1333.05 EU Surfactant Barley grain 1.7 1.7
24 1333.06 EU Surfactant Barley grain 4.5 3.2
25 1333.07 EU Surfactant Barley grain 4.9 4.9
FDA DATA ON ESTABLISHED TOLERANCE VIOLATIONS
Year Category Total Samples Violations Year Category Total Samples Violations
2008 TOTAL 1,398 0
Grains & Grain Products 143 0 Grains & Grain Products 154 0
Milk/Dairy/Eggs 28 0 Milk/Dairy/Eggs 21 0
Fish/Shellfish 45 0 Fish/Shellfish 122 0
Fruit 403 0 Fruit 813 0
Vegetables 672 5 Vegetables 1,132 1
Other 26 0 Other 102 8
2007 TOTAL 1,317 5 2003 TOTAL 2,344 9
Grains & Grain Products 326 0 Grains & Grain Products 282 0
Milk/Dairy/Eggs 49 0 Milk/Dairy/Eggs 25 0
Fish/Shellfish 123 0 Fish/Shellfish 117 0
Fruit 868 1 Fruit 725 0
Vegetables 1,383 3 Vegetables 895 0
Other 83 0 Other 78 0
2006 TOTAL 2,832 4 2002 TOTAL 2,122 0
Grains & Grain Products 301 0 Grains & Grain Products 286 1
Milk/Dairy/Eggs 49 0 Milk/Dairy/Eggs 33 0
Fish/Shellfish 95 0 Fish/Shellfish 114 0
Fruit 822 3 Fruit 710 3
Vegetables 1,316 2 Vegetables 888 7
Other 55 0 Other 70 0
2005 TOTAL 2,638 5 2001 TOTAL 2,101 11
Grains & Grain Products 226 0 Grains & Grain Products 268 0
Milk/Dairy/Eggs 21 0 Milk/Dairy/Eggs 65 0
Fish/Shellfish 35 0 Fish/Shellfish 138 0
Fruit 372 1 Fruit 978 1
Vegetables 711 3 Vegetables 986 1
Other 29 0 Other 90 0
2004 TOTAL 1,394 4 2000 TOTAL 2,525 2
2000-2008 TOTAL 18,671 40
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Conclusions
• Casella: “There is no statistically significant effect of adjuvants on pesticide residue levels.”
• CPDA: During a 9-year period “there were only 40 tolerance exceedence violations out of 18,671 samples tested” and “there was no identifiable trend associated with crop type or active ingredient.”
• EPA Health and Effects Division: “HED has examined industry’s analysis of the effect of adjuvants on pesticide residues and has come to the conclusion that existing tolerances and risk assessments will be adequate and protective of public health, even if special field trials involving adjuvant use were not conducted.”
COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Thank you!
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