Apresentação de Susan Ferenc

991 views

Published on

Os arquivos das apresentações de eventos organizados pela AGROPEC são postados no SlideShare mediante autorização por escrito dos palestrantes.

Published in: Technology, Business
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
991
On SlideShare
0
From Embeds
0
Number of Embeds
525
Actions
Shares
0
Downloads
42
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Apresentação de Susan Ferenc

  1. 1. 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
  2. 2. 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
  3. 3. 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
  4. 4. 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
  5. 5. 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
  6. 6. 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
  7. 7. 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
  8. 8. COUNCIL OF PRODUCERS & DISTRIBUTORS OF AGROTECHNOLOGY History of ASTM / CPDA Adjuvant Standardization 1987 ASTM E-35 Call for Adj. Term Std. 1999 Dvp. & review of Certification License 2000 April 15 Deadline for Comments 1990 ASTM E-35 Adj. Terms Task Force 1998 Legal and Board review of Program 1991 Founding of the CPDA AIC 1997 Development of Std. (S-1) – (S-17) Certification Standards & Guidelines Adopted July 2000 (S-1) - (S-17) 1993-95 ASTM-E-35 E-1519-95 Adj. Terms 1996 First Adjuvant Std. Meeting
  9. 9. 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
  10. 10. 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 x x Establish efficacy or regulate the claims made by the manufacturer Provide for extensive toxicology (hazard and environmental) testing Differentiate products in the marketplace between acceptable and not acceptable
  11. 11. 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)
  12. 12. COUNCIL OF PRODUCERS & DISTRIBUTORS OF AGROTECHNOLOGY Council of Producers & Distributors of Agrotechnology Labeling and Performance Standards for Spray Adjuvants and Soil Conditioners
  13. 13. 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
  14. 14. 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
  15. 15. COUNCIL OF PRODUCERS & DISTRIBUTORS OF AGROTECHNOLOGY Certification Process • Are functionality claims defined in ASTM E-1519 or E609? – 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
  16. 16. 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?
  17. 17. 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?
  18. 18. 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?
  19. 19. 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
  20. 20. 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.”
  21. 21. 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.
  22. 22. Limited Data for One Compound Prompted EPA Action 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
  23. 23. 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
  24. 24. 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
  25. 25. 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?
  26. 26. COUNCIL OF PRODUCERS & DISTRIBUTORS OF AGROTECHNOLOGY N original row number Country ASTM Category CROP TYPE 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 13 14 15 16 17 18 19 20 21 22 23 24 25 262 264 266 274 276 278 268 270 272 280 282 284 212 217 210 215 1744 1746 1304.1 1305 1306 1307 1316.1 1317 1318 1319 1333.05 1333.06 1333.07 EU EU EU EU EU EU EU EU EU EU EU EU US US US US EU EU EU EU EU EU EU EU EU EU EU EU EU Oil Oil Oil Oil Oil Oil Oil Oil Oil Oil Oil Oil Oil Oil Oil Oil Surfactant Surfactant Surfactant Surfactant Surfactant Surfactant Surfactant Surfactant Surfactant Surfactant Surfactant Surfactant Surfactant Alfalfa green matter Alfalfa green matter Alfalfa green matter Alfalfa green matter Alfalfa green matter Alfalfa green matter Alfalfa hay Alfalfa hay Alfalfa hay Alfalfa hay Alfalfa hay Alfalfa hay Almond hull Almond hull Almond nutmeat Almond nutmeat Barley grain Barley grain Barley grain Barley grain Barley grain Barley grain Barley grain Barley grain Barley grain Barley grain Barley grain Barley grain Barley grain Residues Residues with w/o adjuvant adjuvant 0.09 0.02 0.02 5.39 0.17 0.25 0.14 0.02 0.02 3.54 0.69 0.73 2.893 1.447 0.041 0.033 3.751 6.012 3.8 5.5 6.7 12 2.2 2.0 4.1 7.3 1.7 4.5 4.9 0.03 0.02 0.02 1.42 0.2 0.43 0.06 0.02 0.02 1.33 0.6 0.71 3.947 2.103 0.038 0.014 2.624 3.098 3.6 6.3 9.7 13 1.5 1.6 2.6 6.5 1.7 3.2 4.9
  27. 27. FDA DATA ON ESTABLISHED TOLERANCE VIOLATIONS Year Category Total Samples Violations 2008 TOTAL 1,398 0 2007 Grains & Grain Products Milk/Dairy/Eggs Fish/Shellfish Fruit Vegetables Other TOTAL 143 28 45 403 672 26 1,317 0 0 0 0 5 0 5 2004 Grains & Grain Products Milk/Dairy/Eggs Fish/Shellfish Fruit Vegetables Other TOTAL Grains & Grain Products Milk/Dairy/Eggs Fish/Shellfish Fruit Vegetables Other TOTAL Grains & Grain Products Milk/Dairy/Eggs Fish/Shellfish Fruit Vegetables Other TOTAL 326 49 123 868 1,383 83 2,832 301 49 95 822 1,316 55 2,638 226 21 35 372 711 29 1,394 0 0 0 1 3 0 4 0 0 0 3 2 0 5 0 0 0 1 3 0 4 2000-2008 TOTAL 18,671 40 2006 2005 Year Category Total Samples Violations 2003 Grains & Grain Products Milk/Dairy/Eggs Fish/Shellfish Fruit Vegetables Other TOTAL 154 21 122 813 1,132 102 2,344 0 0 0 0 1 8 9 Grains & Grain Products Milk/Dairy/Eggs Fish/Shellfish Fruit Vegetables Other TOTAL Grains & Grain Products Milk/Dairy/Eggs Fish/Shellfish Fruit Vegetables Other TOTAL Grains & Grain Products Milk/Dairy/Eggs Fish/Shellfish Fruit Vegetables Other TOTAL 282 25 117 725 895 78 2,122 286 33 114 710 888 70 2,101 268 65 138 978 986 90 2,525 0 0 0 0 0 0 0 1 0 0 3 7 0 11 0 0 0 1 1 0 2 2002 2001 2000
  28. 28. 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.”
  29. 29. COUNCIL OF PRODUCERS & DISTRIBUTORS OF AGROTECHNOLOGY Thank you! Visit www.cpda.com

×