Apresentação de Susan Ferenc

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



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



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



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



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



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



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



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



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



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



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

Labeling and Performance Standards for Spray Adjuvants and Soil Conditioners



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




• 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




• 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




• 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?




• 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?



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?



Certification Process:Completion

• Applicant advised of approval

• Sign licensing agreement and submit Certification of Compliance

• Pay appropriate fee

• Re-certify every 3 years



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.”



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



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



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



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?



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






7 268 EU Oil Alfalfa hay 0.14 0.06






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


15 1304.1 EU Surfactant Barley grain 3.8 3.6



18 1307 EU Surfactant Barley grain 12 13








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





Vegetables 1,383 3 Vegetables 895 0


2006 TOTAL 2,832 4 2002 TOTAL 2,122 0





Vegetables 1,316 2 Vegetables 888 7


2005 TOTAL 2,638 5 2001 TOTAL 2,101 11





Vegetables 711 3 Vegetables 986 1


2004 TOTAL 1,394 4 2000 TOTAL 2,525 2

2000-2008 TOTAL 18,671 40



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.”



Thank you!

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Apresentação de Susan Ferenc