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


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


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
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


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 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


• 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?


• 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.

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


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?

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 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

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

Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
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

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

Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
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


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!

Visit www.cpda.com

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