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America Crop Protection Regulations: United States, Canada, Brazil


US Pesticide Product Registration Overview 2018Main Crops; Legal System; Data Requirements and Protection; Task Forces; Top 30 Companies and Top 100 Retailers; Biopesticides; Documentation

Agrow US Pesticide Product Registration Overview 2018 Contents

Agribusiness Intelligence © 2018 Informa UK www.agribusinessintelligence.informa.com 1

Contents

Executive Summary .................................................................................................................... 5

List of Abbreviations ................................................................................................................... 6

1. Overview of Crops and Pesticide Use in the U.S. ............................................................. 8

1.1 Geography ................................................................................................................................................. 8

1.2 Climate ...................................................................................................................................................... 8

1.3 Agricultural Meteorology .......................................................................................................................... 8

1.3.1 Planted Areas of Major Crops ..................................................................................................... 10

1.4 Farmers, Farms, Farm Size, and Main Crop Acreages ............................................................................. 10

1.5 Grain Exports ........................................................................................................................................... 14

1.6 Agrochemical Market in the United States ............................................................................................. 14

1.6.1 Maize ........................................................................................................................................... 15

1.6.2 Soybean ....................................................................................................................................... 16

1.6.3 Cotton.......................................................................................................................................... 17

1.6.4 Cereals ......................................................................................................................................... 18

1.6.5 Multinational Company Involvement in the U.S. ........................................................................ 20

2. Regulation and Legal System of Pesticide Registration in the United States ................. 21

2.1 The United States Environmental Protection Agency (EPA) ................................................................... 21

2.1.1 Office of Pesticide Programs (OPP) ............................................................................................. 21

2.2 Laws and Regulations of Pesticide Registration ...................................................................................... 24

2.2.1 Introduction ................................................................................................................................ 24

2.2.2 The Principle Laws Regarding Pesticide Registration (40 CFR) .................................................... 24

2.2.3 State Pesticide Regulatory Agencies ........................................................................................... 40

2.3 Registration categories ........................................................................................................................... 41

2.3.1 Registration for a Pesticide Product ............................................................................................ 41

2.3.2 Supplemental Registration to Distribute a Product Registered by Someone Else ...................... 41

2.3.3 Amending the Registration of a Product Already Registered with the EPA ................................ 42

2.3.4 Unconditional/Conditional Registration...................................................................................... 42

2.4 Pesticide Registration Process in the United States ................................................................................ 44

2.4.1 Overview of the Pesticide Registration Process .......................................................................... 44

2.4.2 Obtaining an EPA Company or Establishment Number .............................................................. 45

2.4.3 Pre-Registration Meeting ............................................................................................................ 48

2.4.4 Electronic Submission of Pesticide Applications ......................................................................... 48

2.4.5 Completeness Reviews ................................................................................................................ 49

2.4.6 Transfer of Product Registrations ............................................................................................... 51

3. Data Requirements for Pesticides Registration .............................................................. 52

3.1 Conventional chemical pesticides ........................................................................................................... 52

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3.1.1 Data requirement ........................................................................................................................ 52

3.1.1.1 Fee Payment ................................................................................................................. 52

3.1.1.2 Cover Letter .................................................................................................................. 53

3.1.1.3 Application form ........................................................................................................... 53

3.1.1.4 Confidential Statement of Formula .............................................................................. 53

3.1.1.5 The identity of the applicant ........................................................................................ 53

3.1.1.6 Product Chemistry data requirements ......................................................................... 54

3.1.1.7 Toxicity requirement data ............................................................................................ 62

3.1.2 Information Requirements of Label ............................................................................................ 64

3.1.2.1 Background ................................................................................................................... 64

3.1.2.2 Purpose ......................................................................................................................... 64

3.1.2.3 Scope ............................................................................................................................ 64

3.1.2.4 The format for Submitting Labels ................................................................................. 64

3.1.3 Time Schedule of Various Applications ....................................................................................... 66

3.1.3.1 Content screen review - 21 days .................................................................................. 66

3.1.3.2 Preliminary Technical Screen - 45 ~ 90 days................................................................. 67

3.1.3.3 In-Depth Review of Data - Data Deficiencies or Need for Additional Information

Identified ...................................................................................................................... 68

3.2 Biochemical pesticides ............................................................................................................................ 70

3.3 Antimicrobial pesticides .......................................................................................................................... 76

4. Data Protection/Compensation ...................................................................................... 78

4.1 Overview of Data Protection ................................................................................................................... 78

4.2 The process of Data Protection Application ............................................................................................ 78

5. Task Forces ...................................................................................................................... 80

5.1 Pesticide Handlers Exposure Database (PHED) ....................................................................................... 80

5.2 Agricultural Handler Exposure Task Force (AHETF) ................................................................................. 81

5.3 Agricultural Re-entry Task Force (ARTF).................................................................................................. 84

5.4 Outdoor Residential Exposure Task Force (ORETF) ................................................................................. 86

6. Analysis of EPA Registered Pesticides ............................................................................. 89

6.1 Top 30 companies by number of technical product registrations with the EPA ..................................... 89

6.2 Product types .......................................................................................................................................... 90

6.3 Product toxicities .................................................................................................................................... 90

6.4 Number of approvals by year .................................................................................................................. 90

7. Appendix ......................................................................................................................... 92

7.1 Top 100 agrochemicals retailers ............................................................................................................. 92

7.2 Form 8570-1 ............................................................................................................................................ 96

7.3 Form 8570-4 ............................................................................................................................................ 98

7.4 Form 8570-34 ........................................................................................................................................ 100

7.5 Form 8570-35 ........................................................................................................................................ 101

7.6 Form 8570-27 ........................................................................................................................................ 104


Agrow US Pesticide Product Registration Overview 2018 Contents


List of Figures

Figure 1: The most lucrative food crop map in the U.S......................................................................................... 9

Figure 2: Acreage from major field crops (million acres), long-term projections ............................................... 10

Figure 3: The total number of farms in the USA from 2000 to 2016 .................................................................. 11

Figure 4: The pesticide market values ($m) of main crops in the U.S. (2016) .................................................... 14

Figure 5: Flowchart of the registration process .................................................................................................. 45

Figure 6: Number of technical product registrations with the EPA by the top 30 companies............................ 89

Figure 7: Number of technical product registrations with the EPA by pesticide type ........................................ 90

Figure 8: Number of technical product registrations with the EPA by signal word ............................................ 90

Figure 9: Number of technical product registrations with the EPA by year........................................................ 91

List of Tables

Table 1: Crop Area Planted and Harvested in United States (2016 and 2017) .................................................. 12

Table 2: Top 10 herbicide active ingredients used on maize in the U.S. (2016) ................................................ 15

Table 3: Top 10 insecticide active ingredients used on maize in the U.S. (2016) .............................................. 15

Table 4: Top 10 fungicide active ingredients used on maize in the U.S. (2016) ................................................ 16

Table 5: Top 10 herbicide active ingredients used on soybean in the U.S. (2016) ............................................ 16

Table 6: Top 10 insecticide active ingredients used on soybean in the U.S. (2016) .......................................... 17

Table 7: Top 10 fungicide ingredients used on soybean in the U.S. (2016) ....................................................... 17

Table 8: Top 10 insecticide active ingredients used on cotton in the U.S. (2016) ............................................. 18

Table 9: Top 10 herbicide active ingredients used on cotton in the U.S. (2016) ............................................... 18

Table 10: Top 10 herbicide active ingredients used on wheat in the U.S. (2016) ............................................... 19

Table 11: Top 9 insecticide active ingredients used on wheat in the U.S. (2016) ............................................... 19

Table 12: Top 10 fungicide active ingredients used on wheat in the U.S. (2016) ................................................ 19

Table 13: Leading agrochemical companies in the USA (2016) ........................................................................... 20

Table 14: Product Chemistry Data Requirements................................................................................................ 61

Table 15: Experimental Use Permit Toxicity Data Requirements ........................................................................ 63

Table 16: Registration Division - New Products ................................................................................................... 68

Table 17: Biochemical Pesticides Product Chemistry Data Requirements .......................................................... 71

Table 18: Biochemical Residue Data Requirements for Specific Uses ................................................................. 72

Table 19: Biochemical Pesticides Human Health Assessment Data Requirements ............................................. 73

Table 20: PRIA Fee Category Table - Biopesticides Division - New Products ....................................................... 74

Table 21: Microbial Pesticides Product Analysis Data Requirements .................................................................. 76

Table 22: Microbial Pesticides Toxicology Data Requirements ........................................................................... 77

Table 23: Top 100 agrochemicals retailers .......................................................................................................... 92


Agrow US Pesticide Product Registration Overview 2018 Executive Summary


Executive Summary

This report provides general guidance on pesticide product registration in the United States and illustrates the

current registration system and process under the direction of the United States Environmental Protection

Agency (EPA), the legislation of pesticide regulation, and data requirements of the registration.

Chapter 1 describes agriculture in the United States with respect to geography; climate; meteorology; the

constitution/demographics of farmers and farms; the evolution of farming equipment, practice, and

technology; crop production in terms of planted area and market share; and grain exports. The principal field

crops and companies involved in the U.S. agrochemical market is then discussed. The chapter concludes by

illuminating the dynamic and ever-evolving relationships between crop production, agrochemical product use,

and the agrochemical market through case studies of maize, soybean, cotton, and cereals.

Chapter 2 explains broadly the purpose and functions of the EPA, state pesticide regulatory agencies and

pesticide registration categories, and more specifically the principal laws regarding pesticide registration.

Through reviewing the federal and state laws, the content, format, and requirements of the applications for

various pesticide registration categories are discussed. The 5-step registration process is described in detail and

well-illustrated in a flow chart. Additional tools/resources for guidance when completing the registration

process are provided.

Chapter 3 addresses registration data requirements, from the identity of applicants and their authorized agents

to the specific composition of their pesticide product(s), and proposed labelling depending on whether the

product is classified as a conventional chemical pesticide, a biopesticide, or an antimicrobial. This chapter also

discusses the current fee payment and registration time schedules.

Chapter 4 explains the purpose and extent of data protection measures as well as compensation procedures

for generic products applicants. Specifically, the methods of complying with data requirements for an

application are examined and the applicable forms are listed/linked for reference.

Chapter 5 describes the aims, history, and development of two databases—the Pesticide Handlers Exposure

Database, and its subsequent reformulation AHED, as well as the three task forces responsible for their

creation and maintenance. The history and mandate of each task force and a list of their member companies

are provided in this chapter.

Chapter 6 summarizes the number of technical product registrations with the EPA, in relation to product types

and toxicities, the top 30 companies with the EPA, and product approvals by year, from 1948 to 2017.


Chapter 1 Agrow US Pesticide Product Registration Overview 2018


1.3.1 Planted Areas of Major Crops

The market for GM seeds (seed sales including technology fees) amounted to $12,548 million in 2016, a 4.1%

increase from the previous year and an equivalent to 61.5% of the global market. Growing conditions were

favourable with sufficient rainfall and moderate temperatures in the Midwest and the Plains and few negative

effects from the El Niño event during the summer. Climate contributed to record yields and production for

both maize and soybeans during the year. Crop prices remained low. However, soybean prices were more

favourable than maizes. Usage of corn in ethanol production increased again, with ethanol output reaching

record levels. In comparison with 2015, the planted areas of soybean (+1.2%), maize (+7.4%), cotton (+17.7%),

sugar beet (+0.3%) and rice (+19.8%) all increased. However, a decline was recorded in the planted areas of

canola (-1.2%), sunflower (-14.7%), and cereals (-10.1%). Acreages from major field crops (million acres, long-

term projections) are graphed in Figure 2.

Figure 2: Acreage from major field crops (million acres), long-term projections

Source: Data source: USDA Agricultural Projections to 2027

1.4 Farmers, Farms, Farm Size, and Main Crop Acreages

Agriculture and agriculture-related industries contributed $992 billion to the U.S. gross domestic product (GDP)

in 2015 (a 5.5% share). The output of America's farms provided $136.7 billion of this sum - about 1% of GDP.

The overall contribution of the agriculture sector to GDP was even more significant than this figure because

related industries relied on agricultural inputs like food and materials used in textile production to contribute

added value to the economy.

Over 313,000,000 people live in the United States. Of that population, less than 1% claim farming as an

occupation (and about 2% live on farms). Around 45% of farmers claim to farm as their principal occupation,

SAMPLE


Agrow US Pesticide Product Registration Overview 2018 Chapter 1


1.6.1 Maize

In 2016, the U.S. maize area increased by 7.4% to 35.1 million hectares with many farmers favouring corn over

soybean due to higher domestic prices. Thus the U.S. market for maize herbicides increased by 5.6% to $1,288

million. Mesotrione, for example, increased revenues for Callisto (Syngenta), while atrazine gained shares due

to increased sales for Acuron, Syngenta’s herbicide introduced in 2015. GM varieties have a much more

significant market share in the U.S. than in other countries, with the nation’s herbicide-tolerant maize area in

2016 accounting for approximately 93% of the total market. The leading herbicides for corn are tabulated in

Table 2.

Table 2: Top 10 herbicide active ingredients used on maize in the U.S. (2016)

Active Ingredients Market Value ($m)

Mesotrione 208.11

S-Metolachlor 173.31

Glyphosate 166.83

Acetochlor 160.98

Atrazine 128.95

Dicamba 62.37

Diflufenzopyr 55.08

Isoxaflutole 51.12

Clopyralid 45.85

Flumetsulam 29.99

The maize insecticide market in the U.S. fell by 0.5% to $365 million in 2016 despite the increase in planted

area, which can be attributed in part to increased adoption of stacked gene maize varieties. The most

considerable shift in the market had been a result of soil insecticides - soil applied to seed treatment products,

providing an alternative for corn rootworm control. The top 10 insecticides used on corn in the U.S. are shown

in Table 3.

Table 3: Top 10 insecticide active ingredients used on maize in the U.S. (2016)


Thiamethoxam 120.71

Clothianidin 110.39

Tefluthrin 56.41

Bifenthrin 23.74

Propargite 8.07

Terbufos 7.66

Imidacloprid 7.33

Spiromesifen 7.24

Chlorpyrifos 5.39

Cyfluthrin 5

SAMPLE


Chapter 1 Agrow US Pesticide Product Registration Overview 2018


reportedly one of the most supported sectors in U.S. agriculture, and hence changes in support could have a

negative impact on the cotton sector.

Table 8: Top 10 insecticide active ingredients used on cotton in the U.S. (2016)


Thiamethoxam 31.12

Acephate 25.03

Abamectin 16.25

Imidacloprid 15.53

Dicrotophos 13.28

Chlorantraniliprole 7.41

Sulfoxaflor 7.31

Acetamiprid 5.11

Novaluron 4.11

Chlorpyrifos 3.96

The cotton herbicide market in the U.S. steadily increased since 1996. However, the introduction of Roundup

Ready cotton and variable acreages negatively impacted herbicide market values since then. Due to the high

uptake of Roundup Ready cotton, glyphosate advanced to become the leading herbicide used on cotton in the

U.S. market. However, repeated usage of glyphosate culminated in the development of resistant weeds,

notably ragweed, which led to other products, primarily flumioxazin, gaining sales. The leading products in the

U.S. cotton herbicides market are shown below (Table 9). The most important cotton herbicide markets were

in Texas, Georgia, Mississippi, and Arizona.

Table 9: Top 10 herbicide active ingredients used on cotton in the U.S. (2016)


Glyphosate 36.21

Flumioxazin 17.45

Trifluralin 16.19

S-Metolachlor 14.79

Diuron 13.33

Acetochlor 11.03

Glufosinate 9.44

Fluometuron 9.4

Pyrithiobac 8.16

Pyroxasulfone 7.14

1.6.4 Cereals

In the U.S., the cereal herbicide market is led by chlorsulfuron, followed by bromoxynil, glyphosate, pinoxaden,

metsulfuron, dicamba, fluroxypyr, clopyralid, and pyrasulfotole.

SAMPLE




(b) Non-liquid chemical sterilants. A non-liquid chemical sterilant, except ethylene oxide that meets the criteria

of § 152.6(a)(2) with respect to its claims and § 152.6(a)(3) with respect to its use sites is exempted from

regulation under FIFRA.

[53 FR 15977, May 4, 1988, as amended at 66 FR 37814, July 19, 2001; 66 FR 64764, Dec. 14, 2001; 72 FR 61027,

Oct. 26, 2007]

§ 152.25 Exemptions for pesticides of a character not requiring FIFRA regulation.

The pesticides or classes of pesticides listed in this section have been determined to be of a character not

requiring regulation under FIFRA, and are therefore exempt from all provisions of FIFRA when intended for use,

and used, only in the manner specified.

(a) Treated articles or substances. An article or substance treated with or containing, a pesticide to protect the

article or substance itself (for example, paint treated with a pesticide to protect the paint coating, or wood

products treated to protect the wood against insect or fungus infestation) if the pesticide is registered for such

use.

(b) Pheromones and pheromone traps. Pheromones and identical or substantially similar compounds labeled

for use only in pheromone traps (or labeled for use in a manner which the Administrator determines poses no

greater risk of adverse effects on the environment than use in pheromone traps), and pheromone traps in

which those compounds are the sole active ingredient(s).

(1) For the purposes of this paragraph, a pheromone is a compound produced by an arthropod which, alone or

in combination with other such compounds, modifies the behavior of other individuals of the same species.

(2) For the purposes of this paragraph, a synthetically produced compound is identical to a pheromone only

when their molecular structures are identical, or when the only differences between their molecular structures

are the stereochemical isomer ratios of the two compounds, and its toxicological properties are not

significantly different from a pheromone.

(3) When a compound possesses many characteristics of a pheromone but does not meet the criteria in

paragraph (a)(2) of this section, it may, after review by the Agency, be deemed a substantially similar

compound.

(4) For the purposes of this paragraph, a pheromone trap is a device containing a pheromone or an identical or

substantially similar compound used for the sole purpose of attracting and trapping or killing target arthropods.

Pheromone traps are intended to achieve pest control by removal of target organisms from their natural

environment and do not result in increased levels of pheromones or identical or substantially similar

compounds over a significant fraction of the treated area.

(c) Preservatives for biological specimens. (1) Embalming fluids.

(2) Products used to preserve animal or animal organ specimens, in mortuaries, laboratories, hospitals,

museums and institutions of learning.

SAMPLE




completeness reviews (21-day content screen, preliminary technical screen and in-depth review of data) and

transfer of product registrations. The main purpose of each step and the flowchart of the entire registration

process are shown below (Figure 5):

Figure 5: Flowchart of the registration process

2.4.2 Obtaining an EPA Company or Establishment Number

What is an EPA Company Number?

A “company number” is a unique identifier assigned to a company that wishes to register a pesticide (e.g.,

herbicide, rodenticide, or antimicrobial) with the U.S. Environmental Protection Agency (EPA). These

companies are commonly called registrants.

A "company number" is also necessary for a company that plans to “produce” pesticides or devices. Such

production requires the company to obtain a “Pesticide-Producing or Device-Producing Establishment

Number.” The company number is part of the establishment number.

How to Request a Company Number

The registrant must submit a signed letter on company letterhead to request a company number and establish

an official address with the EPA. The EPA will direct all future correspondence to the official address. The

registrant must keep this official address record up-to-date (see Section 3 below).

Foreign registrants must designate a U.S. agent to receive correspondence and represent the registrant in

matters concerning their application. U.S. registrants may also designate an agent. (Section 2 below outlines

SAMPLE




Table 14: Product Chemistry Data Requirements

Guideline Number

Data Requirement Use Pattern Test substance to support

All MP EP

Product Identity and Composition

830.1550 Product identity and composition R MP EP

830.1600 Description of materials used to produce the product

R MP EP

830.1620 Description of production process R MP EP

830.1650 Description of formulation process R MP EP

830.1670 Discussion of formulation of impurities R MP, and possibly TGAI

EP, and possibly TGAI

830.1700 Preliminary analysis CR MP, and possibly TGAI

EP, and possibly TGAI

830.1750 Certified limits R MP EP

830.1800 Enforcement analytical method R MP EP

830.1900 Submittal of samples CR MP, PAI and TGAI EP, PAI, TGAI

Physical and Chemical Properties

830.6302 Color R MP and TGAI EP

830.6303 Physical state R MP and TGAI EP and TGAI

830.6304 Odor R MP and TGAI EP

830.6313 Stability to normal and elevated temperatures, metals, and metal ions

R MP and TGAI EP

830.6314 Oxidation/reduction: chemical incompatibility

CR MP EP

830.6315 Flammability CR MP EP

830.6316 Explodability CR MP EP

830.6317 Storage stability R MP EP

830.6319 Miscibility CR MP EP

830.6320 Corrosion characteristics R MP EP

830.6321 Dielectric breakdown voltage CR NR EP

830.7000 pH CR MP and TGAI EP and TGAI

830.7050 UV/visible light absorption R TGAI or PAI NR

830.7100 Viscosity CR MP EP

830.7200 Melting point/melting range R TGAI or PAI TGAI or PAI

830.7220 Boiling point/boiling range R TGAI or PAI TGAI or PA

830.7300 Density/relative density/bulk density R MP and TGAI EP and TGAI

830.7370 Dissociation constants in water R TGAI or PAI TGAI or PAI

830.7520 Particle size, fiber length, and diameter distribution

CR TGAI or PAI EP

830.7550 830.7560 830.7570

Partition coefficient (n-octanol/water) R TGAI or PAI TGAI or PAI

830.7840 830.7860

Water solubility R TGAI or PAI TGAI or PAI

830.7950 Vapor pressure R TGAI or PAI TGAI or PAI

SAMPLE




Figure 4: Number of technical product registrations with the EPA by year

SAMPLE




93 Short Lane Ag SupplyLess than $25 million

48 28 22 2

94 T H Agri-Chemicals, Inc.Less than $25 million

97 2 0 1

95 Wickman ChemicalLess than $25 million

87 7 3 3

96 Smith Fertilizer & GrainLess than $25 million

16 26 9 49

97 The MillLess than $25 million

20 66 10 4

98 Valley Ag SupplyLess than $25 million

38 42 9 11

99 Baltz Feed Co., Inc.Less than $25 million

32 43 21 4

100 Woolsey Brothers Farm Supply Inc.

Less than $25 million

45 41 2 12

SAMPLE


http://www.croplife.com/top100/company/short-lane-ag-supply/

http://www.croplife.com/top100/company/t-h-agri-chemicals-inc/

http://www.croplife.com/top100/company/wickman-chemical/

http://www.croplife.com/top100/company/smith-fertilizer-grain/

http://www.croplife.com/top100/company/the-mill/

http://www.croplife.com/top100/company/valley-ag-supply

http://www.croplife.com/top100/company/baltz-feed-company-inc/

http://www.croplife.com/top100/company/woolsey-brothers-farm-supply-inc/

http://www.croplife.com/top100/company/woolsey-brothers-farm-supply-inc/

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Canada Pesticide Product Registration Overview 2017Agricultural Crops; Pesticide Production; Legal System; Regulations; Data Requirements and Protection; 2016 Registrations


Agrow Canada Pesticide Product Registration Overview 2017 Contents


Contents

Contents ..................................................................................................................................... 1

Executive Summary .................................................................................................................... 5

List of Abbreviations ................................................................................................................... 6

Chapter 1: Introduction to Canadian Agriculture and Pesticide Market .................................. 9

1.1 Overview of Agriculture in Canada ........................................................................................................... 9

1.1.1 Farm area ...................................................................................................................................... 9

1.1.2 Main field cropland ..................................................................................................................... 10

1.2 Agricultural Geography ........................................................................................................................... 11

1.2.1 Spatial extent of Canadian agricultural activity ........................................................................... 11

1.2.2 Farms ........................................................................................................................................... 12

1.2.3 Main field crops ........................................................................................................................... 13

1.2.4 Horticulture ................................................................................................................................. 14

1.3 Agricultural Meteorology ........................................................................................................................ 15

1.3.1 Temperature change in Canada .................................................................................................. 15

1.3.2 Precipitation change in Canada ................................................................................................... 16

1.4 Agricultural Irrigation .............................................................................................................................. 18

1.5 Main Field and Special Crops and Their Yield.......................................................................................... 18

1.5.1 Seeded area ................................................................................................................................. 18

1.5.2 Crop Production .......................................................................................................................... 19

1.6 Pesticide Value by Crops and Product Type ............................................................................................ 20

1.6.1 Overall market ............................................................................................................................. 20

1.6.2 Herbicide market ......................................................................................................................... 22

1.6.3 Insecticide market ....................................................................................................................... 23

Chapter 2: Regulation and Legal System of Pesticide Registration in Canada ........................ 27

2.1 PMRA (Pest Management Regulatory Agency) ....................................................................................... 27

2.2 PCPA (Pest Control Products Act) ........................................................................................................... 27

2.2.1 Clause 7 of products registration or amendment ....................................................................... 28

2.2.2 Clause 8 of products registration or amendment ....................................................................... 30

2.3 Pesticide Registration Process in Canada ................................................................................................ 31

2.3.1 Overview of the pesticide registration process ........................................................................... 31

2.3.2 Pre-submission consultation ....................................................................................................... 32

2.3.3 Submission receipt ...................................................................................................................... 36

2.3.4 Screening ..................................................................................................................................... 38

2.3.5 Science review ............................................................................................................................. 38

2.3.6 Decision making & consultation .................................................................................................. 42

2.3.7 Registration ................................................................................................................................. 42

2.3.8 Re-valuation ................................................................................................................................ 43

2.3.9 Special review.............................................................................................................................. 44


Contents Agrow Canada Pesticide Product Registration Overview 2017


Chapter 3: Data Requirements for Category A Registration .................................................... 45

3.1 Data Requirements ................................................................................................................................. 45

3.2 Information Requirements of Label ........................................................................................................ 46

3.2.1 Background ................................................................................................................................. 46

3.2.2 Purpose ....................................................................................................................................... 46

3.2.3 Scope ........................................................................................................................................... 47

3.2.4 Format for Submitting Labels ...................................................................................................... 47

3.2.4.1 Start with MS Word or Open Office ............................................................................. 47

3.2.4.2 Incorporate the Track Changes..................................................................................... 47

3.2.4.3 Insert Headers .............................................................................................................. 48

3.2.5 Providing an Attestation.............................................................................................................. 49

3.2.6 Validity Period ............................................................................................................................. 49

3.2.7 Receipt and Posting of the Approved Labels ............................................................................... 49

3.2.8 Transition Period ......................................................................................................................... 49

3.2.9 Questions/Contact ...................................................................................................................... 49

3.3 Time Schedule of Category A Applications.............................................................................................. 50

Chapter 4: Data Requirements for Category B Registration .................................................... 51

4.1 Overview of Data Requirements ............................................................................................................. 51

4.2 Data Requirements of TGAI or ISP .......................................................................................................... 51

4.3 Data Requirements of MA or EP ............................................................................................................. 65

Chapter 5: Data Protection ...................................................................................................... 77

5.1 Overview of Data Protection ................................................................................................................... 77

5.2 Process of Data Protection Application ................................................................................................... 78

5.3 Clauses of Data Protection Application (Pest Control Products Regulations, Section 17) ...................... 79

Chapter 6: Overview of Pesticide Registrations in 2016 .......................................................... 86

Appendix................................................................................................................................... 89

Appendix 1 Form 6003 ........................................................................................................................................ 89

Appendix 2 Check list of document required for an application ........................................................................ 91

Appendix 3 Form 6011 ........................................................................................................................................ 99

Appendix 4 Form 6005 ...................................................................................................................................... 101

Appendix 5 Form 6023 ...................................................................................................................................... 104

Appendix 6 Data requirement of USC #14 registration in Category A .............................................................. 105

Appendix 7 Preparing Labels Using MS Word or Open Office .......................................................................... 119

Appendix 8 Examples of Different Label Component Types ............................................................................. 122

Appendix 9 Submission Process flowchart........................................................................................................ 123

Appendix 10 Data requirement of the product registration in Category B....................................................... 124

Appendix 11 Principal online resources of pest control products registration ................................................. 129

List of Figures

Total farm area and cropland area in Canada, 1921 to 2016 ......................................................... 10

Spatial Extent of Canadian Agricultural Activity, 2011 ................................................................... 11

Average farm area in acres, by province ........................................................................................ 12


Agrow Canada Pesticide Product Registration Overview 2017 Contents


Number of farms by province ......................................................................................................... 13

Main field crops (excluding hay) in acres, by province ................................................................... 14

Main horticulture farm types by value ........................................................................................... 14

Annual average temperature change, 1948 to 2014 ...................................................................... 15

Regional average temperature change, 2014 ................................................................................ 16

Annual average precipitation change, 1948 to 2014 ...................................................................... 17

Regional average precipitation change, 2014 ................................................................................ 17

Pesticide sales value (%) by different classes, 2016 ....................................................................... 21

Flowchart of the registration process............................................................................................. 32

Assessment of risk and value process ............................................................................................ 39

Process of the risk management .................................................................................................... 41

Process of data protection application ........................................................................................... 78

Canadian registration process ........................................................................................................ 82

Number of registered technical products submitted from MNCs, 2017 ........................................ 86

Number of registered commercial products submitted from MNCs, 2017.................................... 87 List of Tables

Gross domestic product at basic prices ............................................................................................ 9

Largest field crops and hay in Canada, 2016 .................................................................................. 11

Percentage of irrigating farms by crop type and irrigation method, 2014 ..................................... 18

Seeded areas (1,000 ha) of field and special crops (in thousand of hectares) ............................... 19

The productions of field and special crops (in thousands of tons) ................................................. 19

Conventional agrochemical market performance: 2016/2021F .................................................... 20

Total market values by classes and crops in 2016 .......................................................................... 21

Top 10 active ingredients in 2015 .................................................................................................. 22

Top 10 herbicide active ingredients sold in Canada in 2015 .......................................................... 22

Top 10 herbicides on cereals in Canada, 2016 ............................................................................... 22

Top 10 herbicides on canola in Canada, 2016 ................................................................................ 23

Top 10 insecticide active ingredients sold in Canada in 2015 ........................................................ 23

Top 10 insecticides on cereals in Canada, 2016 ............................................................................. 24

Top 10 insecticides on canola in Canada, 2016 .............................................................................. 24

Top 10 fungicide active ingredients sold in Canada in 2015 .......................................................... 25

Top 10 fungicides on cereals in Canada, 2016 ................................................................................ 25

Top 10 fungicides on canola in Canada, 2016 ................................................................................ 26

Scope of products registered at PMRA ........................................................................................... 27

Category A Submission Performance Timelines in Number of Calendar Days ............................... 50

Fee for the TGAI application in category B ..................................................................................... 75

Fee of the EP application in category B .......................................................................................... 75

Category B Submission Performance Timelines in Number of Calendar Days ............................... 76

The approach of different jurisdictions to regulatory data protection .......................................... 82

The registration situation of top 10 conventional ais in Canada, 2015 .......................................... 87


Agrow Canada Pesticide Product Registration Overview 2017 Executive Summary


Executive Summary

This report provides a general guidance of pesticide product registration in Canada and illustrates the current

registration system under PMRA (Pest Management Regulatory Agency on behalf of the Minister of Health),

the legislation of pesticide regulation (Pest Control Products Act (PCPA)), and data requirements of the

registration. The registration situation of the top 10 ais has been analyzed in Chapter 6.

To illuminate the domestic pesticide market in Canada, Chapter 1 describes Canada’s agricultural status in the

aspects of geography, meteorology, irrigation and agri-food productivity. Canada’s crop protection markets are

well illustrated by sales and principal field crops.

Chapter 2 depicts the functions of PMRA and specifically focuses on the legislation of pesticide regulation

(PCPA). The registration process has been well illustrated by a flow chart.

Chapter 3 summarizes the data requirements of category A in which the terrestrial food crops registration was

employed as an example because this category is for brand new ais, thus it needs most complete registration

dossier for product registration.

Chapter 4 indicates the data requirements of category B pest control products registrations that applies to

generic product manufacturers, especially from China and India.

Chapter 5 focuses on the data compensation, which is an essential part of generic products applicants.

Chapter 6, reviews products registration situation in PMRA, including the technical and commercial products by

MNCs and analyzes the registration situation of top 10 ais sold in Canada up to end of September 2017.


Agrow Canada Pesticide Product Registration Overview 2017 Chapter 1


The top ten herbicides on cereals and canola accounted for 77% and 98% of the active values of their markets,

respectively. Glyphosate was the only one product shown in the top ten herbicides on the both of cereals and

canola with the sales of 50.24 $m and 39.19 $m, respectively. Pinoxaden valued the most on cereals with 79.76

$m (Table 10) while glufosinate was the most sold on canola (Table 11).

Top 10 herbicides on canola in Canada, 2016

Active Ingredients Active Area Treated Active Volume Active Value

(000 ha) (000 kg) ($m)

Glufosinate 5,551.44 2,777.82 99.07

Glyphosate 9,678.40 5,187.98 39.19

Clethodim 2,616.77 79.48 16.76

Imazamox 484.78 9.26 12.75

Quizalofop 631.89 32.15 6.46

Carfentrazone 483.35 11.14 4.85

Clopyralid 210.63 34.17 4.84

Ethalfluralin 61.21 68.57 2.34

Bromoxynil 249.89 35.48 1.57

Imazapyr 389.64 3.42 1.53

Top Ten Total 20,357.99 8,239.46 189.36

Grand Total 20,599.10 8,345.72 193

Top Ten % 99% 99% 98%

Source: AgrAspire, Phillips McDougall, 2017

1.6.3 Insecticide market

The PMRA sales report (2015) indicated that mineral oil was the largest product sold in 2015, followed by

hydrogen peroxide and Sulphur (Table 12).

Top 10 insecticide active ingredients sold in Canada in 2015

Active Ingredient

Mineral oil

Hydrogen peroxide

Sulphur

DEET*

Thiamethoxam

Silicon dioxide

Clothianidin

Paradichlorobenzene

Chlorpyrifos

Malathion

*Since DEET is an insect repellent, it has been grouped with the insecticides. Source: PMRA, Pest Control Products Sales Report for 2015

The top ten insecticides on cereals and canola accounted for 79% and 100% of the active values of their

markets, respectively. On cereals, the top 3 products were Thiamethoxam, Chlorpyrifos, and Imidacloprid

(Table 13). Clothianidin was the most valuable product with the sales of 77.23 $m on canola followed by the

Thiamethoxam and Cyantraniliprole (Table 14). Lambda-cyhalothrin, chlorantraniliprole, deltamethrin,

malathion, and permethrin were seen in the top 10 list on both cereals and canola.

SAMPLE


Chapter 1 Agrow Canada Pesticide Product Registration Overview 2017


Top 10 fungicides on canola in Canada, 2016

Active Ingredients Active Area Treated Active Volume Active Value

(000 ha) (000 kg) ($m)

Prothioconazole 1,137.39 146.89 40.55

Boscalid 430.26 105.41 13.18

Pyraclostrobin 472.68 45.41 9.08

Penicillium bilaii 670.29 13.41 4.51

Penflufen 5,134.40 4.61 3.99

Iprodione 162.37 79.53 3.76

Picoxystrobin 93.63 20.6 3

Fludioxonil 4,258.00 9.14 2.8

Difenoconazole 4,218.69 9.55 2.31

Fluxapyroxad 156.02 7.73 2.3

Top Ten Total 16,733.72 442.29 85.47

Grand Total 35,690.38 489.53 108

Top Ten % 47% 90% 79%

Source: AgrAspire, Phillips McDougall, 2017

SAMPLE




Decision making & consultation is to decide to accept or deny the registration of the submitted product based

on the science assessment and management of risks, or require further consultation before making the

decision;

Registration is to register the product that meets the registration criteria after the final label review;

Re-evaluation is to re-evaluate the product when the required information or procedures of registration

changed;

Special review is to initiate a review when the Minister has reasonable grounds to believe that the health or

environmental risks of the product are, or its value is, unacceptable.

Flowchart of the registration process

Source: PMRA, Canadian Pesticide Registration Process

2.3.2 Pre-submission consultation

A pre-submission consultation is a service offered at no cost by Health Canada's Pest Management Regulatory

Agency that provides regulatory guidance to registrants or applicants prior to the submission of an application

to register or amend a pest control product. The pre-submission process may also be utilized as a mechanism

for obtaining guidance on a study protocol.

SAMPLE




will identify and develop risk management options to reduce the identified risk(s) in such a manner and to such

an extent that the pesticide can be used without unacceptable risks to health and the environment. These

mitigation options will reduce exposure and could include protective clothing for applicators, buffer zones to

protect the environment, reduction of application rates, and lengthen pre-harvest intervals. The extent of

these mitigation measures cannot reduce the efficacy beyond acceptable levels. If that is the case, the product

is not registerable.

When the risks to the environment or health, or the pesticide's value are unacceptable, and the risks cannot be

mitigated through modifications of the conditions of use, then the registration of a new pesticide will be denied

and, in the context of a re-evaluation, the registration of an existing pesticide will be discontinued or its uses

will be phased out.

When the use of the pesticide is incompatible with federal policies and international agreements, such as the

TSMP, the Montreal Protocol on ozone-depleting substances and international agreements on POPs, or the use

of a pesticide would contravene other federal acts, a new pesticide can be refused and the registration of an

existing pesticide can be discontinued or its uses may be phased out.

Management of risks

The management of risks is based on the result of the assessment of risk and value to select a feasible

management strategy to facilitate the application of the pest control product and to provide the theoretic basis

for decision-making in the next step. The main steps of management of risks shows below (Figure 14):

Process of the risk management

Source: PMRA, Canadian Pesticide Registration Process

SAMPLE




3.3 Time Schedule of Category A Applications

Category A registration is for brand new ais, thus it needs the most complete registration process which

normally costs 737 days. The time schedule of category A applications is shown below (Table 19) and the

submission process flowchart is shown in Appendix 9.

Category A Submission Performance Timelines in Number of Calendar Days

Category Subdivision Check Completeness in Days

MOSP Review Time in Days (Months)1

Public Consultation in Days

User Fee Review Timeline in Days (Months)1

Conventional chemical 37 655 (22) 45 655 (22)

Import MRL2 37 655 (22) n/a

Reduced-risk3, other biopesticides, non-conventionals, NSCLP4

37 555 (18.5) 45 555 (18.5)

Microbials including URMUR6

37 470 (15.5) 45 470 (15.5)

URMUR6 for conventional chemical, Reduced-risk, other biopesticides, non-conventionals, NSCLP4

37 470 (15.5) 45

Pheromones – SCLP5 including URMUR6

37 285 (9.5) 45 285 (9.5)

Joint reviews Negotiated 45 Negotiated

Submissions with atypical timelines, for example, tailgater submissions, renegotiated timelines, synchronized timelines, coordination with re-evaluations

37 or variable Variable 45 Variable

1 Review time excludes the 45-day public consultation period if applicable and time when a submission is on hold pending the applicant 2 Maximum Residue Limit 3 Reduced-risk refers to the expedited review timelines as outlined in Regulatory Directive DIR2002-02, The PMRA Initiative for Reduced-Risk Pesticides. 4 Non Straight Chain Lepidopteran Pheromone 5 Straight Chain Lepidopteran Pheromone 6 User Requested Minor Use Registration

MOSP Performance Standard = 90% of submissions to be processed within the applicable review timelines

Source: PMRA DIR2017-01 Management of Submissions Policy (https://www.canada.ca/en/health-

canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-

guidelines/regulatory-directive/2017/dir2017-01-management-submissions-policy.html).

SAMPLE


https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/regulatory-directive/2017/dir2017-01-management-submissions-policy.html





o (c) of 14 days’ duration under accelerated conditions at a constant temperature of 54 C, with

quantitative analysis for the active ingredient(s) at study commencement and after 14 days.

(ii) The study shall be conducted with the product in its commercial package or in smaller packages

of the same construction and materials.

(iii) For long-term ambient studies, the study should be carried out with sufficient replicates and

sufficient sampling frequency to establish the actual shelf-life if significant degradation occurs within

one year (i.e. the level of active is no longer within the certified limits). If significant degradation is

observed under accelerated conditions, a one-year study as described above may be required to

determine the shelf life. If a product has a shelf life of less than one year, an expiration date may be

required on the product container.

(iv) The analysis is to be conducted using a specific validated method. For EPs, the same method

used to determine the level of the active ingredient for establishing certified limits would typically be

employed. However, if the methodology differs from that provided under DACO 3.4.1, it must be

fully described as per Data Code 3.5.

(v) The storage stability report submitted in support of registration shall include the following

information:

o (a) a description of test procedures and conditions, e.g., study duration, humidity and

temperature

o (b) a description of any physical changes, e.g., phase separation or clumping, in the product and

any changes to the integrity of the packaging material during the test period, and also the

consequences, if any, of such changes for safe handling and use of the product; and

o (c) quantitative analytical data for the active ingredient at study commencement and all storage

periods. If product degradation or packaging deterioration is expected to cause the formation or

increase in content of impurities of human health or environmental concern, such impurities (as

identified in DACO 2.13.4) must also be monitored at each time point.

(vi) A surrogate study of a similar formulation may be acceptable in lieu of the storage stability

study. The formulation used for the surrogate study must be fully described to allow the

acceptability of the study to be determined.

(vii) The stability protocol must contain a test to monitor for the stability of optically pure/enhanced

active ingredient(s) towards chiral inversion or other isomerization, if applicable.

3.5.11 Flammability

EPA test guideline 830.6315

SAMPLE




Chapter 5: Data Protection

5.1 Overview of Data Protection

Data protection is designed to protect the test data that were used to support the previous pest control

products registration in a legally enforceable and fair process. The principles of data protection are to

encourage the registration of new innovative pesticides and facilitate the entry of generic pesticide products to

the Canadian market. Under the data protection regulations, the PMRA is responsible for conducting the

equivalency assessment between the generic product and the registrant’s precedent product, generating a

listing of compensable data and issuing the regulatory decision.

The test data can be cataloged into three categories including exclusive protection data, compensable

protection data, and generic data.

Exclusive protection data:

Data that support the initial registration of an active ingredient and associated end use product.

Data that support the initial registration of an adjuvant/safener.

Compensable protection data:

Data that support the registration of a pest control product whose active ingredient is already

registered, for 12 years from the date of the application.

Data that support the amendment of a registration, for 12 years from the date of the application.

Data submitted in response to a data call-in & supported a re-evaluation or special review, for 12

years after the date the data was received by the PMRA.

Foreign test data considered for a re-evaluation or special review, for 12 years after the re-evaluation

initiation date.

Generic data:

Data not meeting the criteria for exclusive or compensable protection status are considered generic

and can be used without consent and without payment of compensation.

SAMPLE




(2) On receipt of the list of compensable data, the applicant may send a copy of an agreement to the registrant

to enter into with respect to such of that data that they wish to use or rely on, by certified or registered mail or

any other method of delivery that provides proof of delivery.

Negotiation and Arbitration

Marginal note: Agreement entered into

17.9 (1) On delivery of the proposed agreement, the applicant and the registrant must enter into the

agreement and begin to negotiate the compensation payable in respect of the data that the applicant

wishes to use or rely on.

Marginal note: Negotiation

(3) If the parties fail to reach a negotiated settlement with respect to the compensation payable within 120

days after delivery of the agreement, they may continue negotiating if they both agree to do so.

Marginal note: When no negotiated settlement — notice of arbitration

17.91 (1) If the parties fail to conclude a negotiated settlement in accordance with section 17.9, the

applicant may, by notice in writing delivered to the registrant, submit the determination of the

compensation payable to binding arbitration in accordance with the agreement.

Marginal note: Parties’ offers in writing

(2) The notice must include the last offers of the parties, if they were presented in writing at the end of the

negotiation.

Marginal note: Method of delivery

(3) The notice must be delivered by certified or registered mail or any other method of delivery that provides

proof of delivery.

Marginal note: Arbitral award

(4) An arbitral award must be made within 120 days after delivery of the notice, unless the parties agree to an

extension.

Marginal note: When no offer in writing

17.92 If the registrant does not put their last offer in writing at the end of the negotiation, the applicant may

make the request referred to in subsection 17.93(1) without having to meet the conditions set out in section

17.93.

SAMPLE


Agrow Canada Pesticide Product Registration Overview 2017 Appendix


Appendix

Appendix 1 Form 6003

SAMPLE


Agrow Canada Pesticide Product Registration Overview 2017 Appendix


9 Resistance Management

statement X X X Registration Certificate

10 Product Composition

statements X X X Registration Certificate

11 Addition of tank mixes to

product labels X X X Registration Certificate

12 Addition of marketing text X X X Registration Certificate

13 Translation corrections X X X Registration Certificate

14 Disclosure labeling for list 1

formulant X X X Registration Certificate

15 Ozone depleting substance

disclosure X X X Registration Certificate

16 Allergen disclosure

statement X X X Registration Certificate

17 Effects on treated objects or

sites X X X Registration Certificate

18 Refillable container

indication X X X Registration Certificate

19 Change in container size or

net content X X X Registration Certificate

20 Removal of obsolete

information X X X Registration Certificate

21 Rotational Crops and Plant-

Back Intervals X X X Registration Certificate

22 Change in Packaging &

related statements X X X Registration Certificate

23 Product Name Change X X X Registration Certificate

24 Deleting a Use X X X Registration Certificate

25 Disposal Statements X X X Registration Certificate

26 Changes in

Rate/Timing/Number/Method X X X Registration Certificate

27 Precautions X X X Registration Certificate

4 Notification

1 Change in formulation

process

in some cases

if new source

in some cases X Registration Certificate

2 Change in nominal conc. of

a formulant X in some cases X Registration Certificate

3 Change in cert. limits of a


4 Change of Supplier of a


5 Change in the identity of a


6 Change or addition of

formulator X X X Registration Certificate

7 Change of colourants X X Registration Certificate

8 Change of Fragrances X X Registration Certificate

9 Change in source of TGAI X Registration Certificate

10 Removal of source of TGAI X X X Registration Certificate

11 Deletion of a formulation X X Registration Certificate

12 Deletion of alternate

formulant(s) X X Registration Certificate

13 Change in the pH range X X Registration Certificate

SAMPLE



Brazil Pesticide Registration Overview 2017Crops, Trade and Authorisation Processes

Agrow Brazil Pesticide Registration Overview 2017 Contents


Contents

Contents ..................................................................................................................................... 1

Abbreviations ............................................................................................................................. 6

Executive summary .................................................................................................................... 9

Chapter 1: Introduction ............................................................................................................ 10

Chapter 2: Brazilian agriculture and the pesticide market ...................................................... 12

2.1 Summary ................................................................................................................................................. 12

2.2 Introduction ............................................................................................................................................ 12

2.3 Geography ............................................................................................................................................... 12

2.3.1 Centre or Mid-West .................................................................................................................... 14

2.3.2 Northeast .................................................................................................................................... 14

2.3.3 North ........................................................................................................................................... 14

2.3.4 Southeast .................................................................................................................................... 15

2.3.5 South ........................................................................................................................................... 15

2.4 Crops ....................................................................................................................................................... 15

2.4.1 Soybeans ..................................................................................................................................... 16

2.4.2 Maize ........................................................................................................................................... 16

2.4.3 Sugar Cane................................................................................................................................... 16

2.4.4 Cotton.......................................................................................................................................... 17

2.4.5 Coffee .......................................................................................................................................... 17

2.4.6 Beans and rice ............................................................................................................................. 17

2.4.7 Other crops ................................................................................................................................. 17

2.5 Agricultural exports ................................................................................................................................. 17

2.6 The Brazil pesticide market ..................................................................................................................... 19

2.6.1 Transgenic crops.......................................................................................................................... 20

2.6.2 Pesticide imports ......................................................................................................................... 20

Chapter 3: The registration system for pesticides ................................................................... 22

3.1 Summary ................................................................................................................................................. 22

3.2 Introduction ............................................................................................................................................ 22

3.2.1 The agronomic prescription ........................................................................................................ 23

3.3 The registration agencies ........................................................................................................................ 23

3.3.1 MAPA........................................................................................................................................... 23

3.3.2 Anvisa .......................................................................................................................................... 25

3.3.3 Ibama .......................................................................................................................................... 27

3.4 Responsibilities of the registration agencies ........................................................................................... 27

3.5 Toxicological classifications ..................................................................................................................... 29

3.5.1 Anvisa .......................................................................................................................................... 29

3.5.2 Ibama .......................................................................................................................................... 30

3.5.2.1 Environmental risk potential (PPA)............................................................................ 30

3.5.2.2 Environmental risk evaluation (ARA) ......................................................................... 30


Contents Agrow Brazil Pesticide Registration Overview 2017


3.6 General characteristics of registration .................................................................................................... 31

3.6.1 The RET ........................................................................................................................................ 31

3.6.2 Other registrations ...................................................................................................................... 31

3.6.3 Maintaining documentation up-to-date ..................................................................................... 31

3.6.4 MAPA protocols .......................................................................................................................... 32

3.6.5 Registration procedure ............................................................................................................... 32

3.6.5.1 Publication in the official gazette .............................................................................. 32

3.6.5.2 Distribution of registration submissions .................................................................... 33

3.6.5.3 Technical analysis ...................................................................................................... 33

3.6.5.4 Notification of Requirements .................................................................................... 33

3.6.5.5 Irregularities and rejection of the submission ........................................................... 34

3.6.5.6 Report on agronomic efficiency and feasibility ......................................................... 34

3.6.5.7 Final consolidation ..................................................................................................... 34

Chapter 4: Data requirements for Brazilian registrations ........................................................ 37

4.1 Summary ................................................................................................................................................. 37

4.2 Hierarchy of laws in Brazil ....................................................................................................................... 37

4.3 Terminology and definitions ................................................................................................................... 38

4.4 Data requirements for different registrations ........................................................................................ 43

4.4.1 Special temporary registration for research and experimentation (RET) ................................... 43

4.4.1.1 Research and experimentation ................................................................................. 45

4.4.1.2 Types of RET .............................................................................................................. 45

4.4.2 Registration of technical product ................................................................................................ 46

4.4.3 Registration of me-too technical product ................................................................................... 49

4.4.4 Registration of a pre-mixture ...................................................................................................... 51

4.4.5 Registration of a formulated product.......................................................................................... 52

4.4.5.1 Product clones ........................................................................................................... 55

4.4.5.2 Atypical products ....................................................................................................... 55

4.4.6 Registration of a me-too formulated product ............................................................................. 56

4.4.7 Registration of a biological product ............................................................................................ 58

4.4.8 Registration of a microbiological product ................................................................................... 60

4.4.9 Registration of a semiochemical product .................................................................................... 63

4.4.10 Registration of a formulated biochemical product ..................................................................... 66

4.4.11 Registration of a domissanitary product ..................................................................................... 68

4.4.11.1 Registration of insecticides ........................................................................................ 72

4.4.11.2 Registration of rodenticides ...................................................................................... 72

4.4.11.3 Packaging and labelling ............................................................................................. 72

4.4.12 Registration of products for organic agriculture ......................................................................... 73

4.4.12.1 Establishment of a reference specification ............................................................... 74

4.4.12.2 Registration process for organic agriculture ............................................................. 74

4.5 Alterations in the registrations of crop protection products .................................................................. 77

4.5.1 Technical alterations requested only by MAPA .......................................................................... 77

4.5.2 Exclusions .................................................................................................................................... 77

4.5.3 Inclusions ..................................................................................................................................... 77

4.5.4 Limitations in use ........................................................................................................................ 78

4.5.5 New company name and tax number ......................................................................................... 78


Agrow Brazil Pesticide Registration Overview 2017 Contents


4.5.6 Alteration in address ................................................................................................................... 78

4.5.7 Transfer of title ............................................................................................................................ 78

4.5.8 Alteration in brand name ............................................................................................................ 78

4.5.9 New labels ................................................................................................................................... 78

4.5.10 Inclusion of third-party importer ................................................................................................ 79

4.5.11 Technical alterations ................................................................................................................... 79

4.5.12 Inclusion of formulator and/or manipulator for formulated product ......................................... 79

4.5.12.1 Inclusion of the manufacturer of technical product .................................................. 79

4.5.12. Inclusion of the manufacturer of the technical product in the registration of the

formulated product ................................................................................................... 79

4.5.12.3 Inclusion of the manufacturer of the third-party technical product registration in

the registration of the formulated product ............................................................... 79

4.5.12.4 Alteration in the localization of the manufacturing unit ........................................... 80

4.5.12.5 Establishment of dosages higher than those registered, increase in application

frequency, inclusion of application use, inclusion of crop in product already

registered .................................................................................................................. 80

4.5.12.6 Alteration in the production process of the TP ......................................................... 80

4.5.12.7 Recommendation of tank mix ................................................................................... 80

4.5.12.8 Alteration in formulation components ...................................................................... 81

4.5.12.9 Inclusion of aerial application .................................................................................... 81

4.5.12.10 Alteration of toxicological classification, safety interval and MRLs, environmental

classification and packaging with a different material and volume to that

approved ................................................................................................................... 81

4.5.12.11 Alterations in labels and product insert .................................................................... 81

4.6 Registration prohibitions ......................................................................................................................... 81

Chapter 5: Recent events and future trends............................................................................ 83

5.1 Summary ................................................................................................................................................. 83

5.2 Introduction ............................................................................................................................................ 83

5.3 Minor crops ............................................................................................................................................. 84

5.4 Bee concerns ........................................................................................................................................... 84

5.5 Registration priorities.............................................................................................................................. 85

5.5.1 Biological products ...................................................................................................................... 85

5.5.2 The approval process .................................................................................................................. 86

5.5.3 Establishing priorities .................................................................................................................. 86

5.5.4 Anvisa public consultations ......................................................................................................... 87

5.5.5 Priorities for 2017 ........................................................................................................................ 89

5.6 Product suspensions ............................................................................................................................... 90

5.6.1 Soybean rust fungicides .............................................................................................................. 90

5.6.2 Paraquat phase-out ..................................................................................................................... 91

5.7 Registration bottlenecks ......................................................................................................................... 91

5.8 Registration approvals ............................................................................................................................ 92

5.9 Recommendations to improve Brazil’s registration system .................................................................... 93

Appendix 1: Site links of Brazilian pesticide legislation....................................................................................... 94

Appendix 2: The toxicological classification of pesticide products according to Anvisa guidelines .................... 96


Contents Agrow Brazil Pesticide Registration Overview 2017


List of Figures

Figure 1: Map of Brazil showing main geographic regions ................................................................................... 13

Figure 3.1: Organogram of MAPA ......................................................................................................................... 24

Figure 3.2: Organogram of Anvisa ......................................................................................................................... 25

Figure 3.3: Structural organization of GGTOX, Anvisa .......................................................................................... 26

Figure 4.1: Typical flowchart of pesticide registration in Brazil ............................................................................ 37

Figure 4.2: Registration flowchart of crop protection products for organic agriculture ...................................... 75 List of Tables Table 2.1: Use and availability of land in Brazil ..................................................................................................... 13

Table 2.2: Principal crops grown in Brazil in 2016/2017 ....................................................................................... 16

Table 2.3: Brazilian agribusiness exports in 2016 ................................................................................................. 18

Table 2.4: Brazil ranking in agricultural production and exports in 2014-15 ........................................................ 18

Table 2.5: Sales of pesticides in different crops in Brazil in 2016 ......................................................................... 19

Table 2.6: Sales of different classes of pesticides in Brazil in 2016 ....................................................................... 19

Table 2.7: Sales of pesticides in Brazil by state in 2016 ........................................................................................ 20

Table 2.8: Pesticides imported by Brazil in 2016 .................................................................................................. 21

Table 4.1: Data requirements for registering a technical product ........................................................................ 47

Table 4.2: Data requirements for registering a me-too technical product ........................................................... 49

Table 4.3: Data requirements for registering a chemical formulated product ..................................................... 52

Table 4.4: Data requirements for registering a me-too formulated product based on a

me-too technical product .................................................................................................................... 56

Table 4.5: Data requirements for registering a biological control agent .............................................................. 58

Table 4.6: Necessary information for Anvisa and Ibama for the evaluation and registration of

biological control agents ...................................................................................................................... 59

Table 4.7: Data requirements for registering a microbiological product .............................................................. 61

Table 4.8: Data requirements for registering a semiochemical product .............................................................. 64

Table 4.9: Data requirements for registering a formulated biochemical product ................................................ 66

Table 4.10: Data requirements for registering a domissanitary product .............................................................. 69

Table 4.11: Toxicological data necessary for evaluating AIs not authorized by Anvisa ........................................ 71

Table 4.12: The process of risk evaluation for domissanitary products ............................................................... 71

Table 4.13: List of prohibited and restricted use AIs for domissanitary products ................................................ 72

Table 4.14: Maximum content permitted in individual packaging of domissanitary OTC products ..................... 73

Table 4.15: Data requirements for registering a crop protection product for organic agriculture ...................... 76

Table 5: Summary of registrations granted in Brazil for the period 2005-17 ....................................................... 85


Agrow Brazil Pesticide Registration Overview 2017 Executive Summary


Executive summary

Brazil is one of the largest producers and exporters of agricultural crops in the world planting a wide variety of

tropical and temperate fruits, vegetables and grain crops besides having a significant area of reafforestation

and pastures. The most important crop in area is soybeans, followed by corn and sugar cane. The pesticide

market is valued around US$10 B (ex-manufacturer level) with a large planting of transgenic crops, especially in

soybeans, corn and cotton.

Such a large agricultural sector in a tropical environment results in many pest and disease problems and

extensive use of pesticides to maintain productivity. There is a significant area of GMO crops in soybeans,

maize and cotton. Brazil imports most of the pesticides it uses from China, India, USA and Argentina as active

ingredients and formulated products. The marketing of pesticides requires the emission of an agronomic

prescription.

Pesticide registration is managed by three different federal agencies, the Ministeries of Agriculture, Health and

the Environment, which are responsible for evaluating product efficacy, toxicology and environmental impacts,

respectively.

The Brazilian pesticide legislation for registering different products and authorization for research and

experimentation is complex. Details are given of the requirements for registering technical, formulated, me-

too, biological, microbiological, biochemical, semiochemical and domissanitary products as well as those for

organic agriculture.

There has been a lot of recent activity by the registration agencies in an effort to modernize Brazil’s pesticide

registration system, which is one of the most bureaucratic and lengthy in the world.

Recent actions regarding Public Health Consultations, product suspensions, especially of soybean rust

fungicides and concerns about pesticide effects on bees are discussed.

Registration priorities for 2017 are given and the present bottlenecks in the registration procedure and

recommendations for modernizing the current system are presented.


Agrow Brazil Pesticide Registration Overview 2017 Chapter 2


Table 2.1 shows the use and availability of land in Brazil with 28.2% of the total currently devoted to

agricultural production with ranching and grain production being the most important. Protected areas make up

64.4% of the total land area and areas available for ranching, which are potential agricultural areas in many

cases, a further 7.4% of the total.

Table 2.1: Use and availability of land in Brazil Distribution Ha (m) % Total

Land in agricultural production 240.0 28.2

- Grains (CONAB)* 56.3 6.6

- Ranching (pastures-IBGE)* 160.0 18.8

- Planted forests (Eucalyptus, Pinus - IBGE)* 4.7 0.6

- Sugar cane (IBGE)* 9.9 1.2

- Banana, cassava, citrus, cocoa, coffee and other permanent crops (IBGE)* 9.1 1.1

Protected areas 548.0 64.4

- Conservation areas (EMBRAPA)* 133.0 15.6

- Indian lands (EMBRAPA)* 121.0 14.2

- Permanent legalized reserves (EMBRAPA)* 268.0 31.5

- Cities, roads, hydroelectric schemes, etc. 26.0 3.1

Areas available for ranching 63.0 7.4

TOTAL AREA BRAZIL 851 100

* sources of estimates

Brazil's 26 states and the Federal District (Distrito Federal) are conventionally divided into five regions (Figure

1): North (N-Norte), Northeast (NE-Nordeste), Southeast (SE-Sudeste), South (S-Sul), and Centre or Mid-West

(CW-Centro-Oeste). In 2015 there were 5,570 municipalities.

Each of the five major regions has distinct ecosystems but administrative boundaries do not necessarily

coincide with ecological boundaries, however. In addition to differences in physical environment, patterns

of economic activity and population settlement vary widely between the regions.

Figure 1: Map of Brazil showing main geographic regions

SAMPLE


https://en.wikipedia.org/wiki/States_of_Brazil

https://en.wikipedia.org/wiki/Federal_District_(Brazil)

Chapter 2 Agrow Brazil Pesticide Registration Overview 2017


Table 2.2: Principal crops grown in Brazil in 2016/2017

Crops Area (KHa) Production (KT) Yield (kg/ha)

Apples 33.8 1247.1 36872

Banana 478.5 6873.7 14364

Beans (3 harvests) 3065.3 3369.0 1099

Citrus 671.9 14813.0 22048

Coffee 1900.2 2735.8 1440

Cotton 947.7 3621.1 3821

Grapes 67.8 1318.3 19443

Maize 17308.1 92370.8 5337

Peanuts (2 harvests) 136.6 439.6 3219

Potatoes (3 harvests) 132.3 3952.4 29866

Rice 2014.3 12053.5 5984

Soybeans 33933.9 110935.3 3269

Sugar cane 9565.2 719469.6 75217

Tobacco 393.2 865.1 2200

Tomatoes 59.9 3967.5 66272

Vegetables 416.3 - -

Wheat 2093.4 5795.5 2768

Source: IBGE (https://sidra.ibge.gov.br/home/ipca/brasil)

2.4.1 Soybeans

Until the year 2000, the soybean area was around 12 m ha divided between the Centre-West and Southern

regions. This area rapidly increased after 2001 to reach 34 m ha for the 2016/17 season, with the Centre-West

responsible for 45% of the total (Mato Grosso alone is 60% of this) and the South for 34%. A new “Frontier

Area” for planting, called MAPITOBA, comprising the states of Maranhão, Piauí, Tocantins and Bahia, is

developing in the Northeast and is becoming more important.

2.4.2 Maize

Maize is grown throughout Brazil, with a summer crop (September-February), of 5-6 m ha, grown in the South

and Southeast, with subsistence maize in the Northeast, and a winter crop (January-April) of around 12 m ha,

63% of which is planted in the Centre-West, especially Mato Grosso.

2.4.3 Sugar Cane

Around 50% of the area is planted in São Paulo state and 20% in the Centre-West states, particularly Goiás. The

sugar mills can produce either sugar or ethanol as a single fuel for vehicles and also mixed with petrol.

SAMPLE




Table 2.7: Sales of pesticides in Brazil by state in 2016

Region/State % Total

SOUTH

- Rio Grande do Sul 13

- Paraná 14

SOUTHEAST

- São Paulo 14

- Minas Gerais 8

CENTRE-WEST

- Mato Grosso do Sul 6

- Mato Grosso 20

- Goiás 10

NORTHEAST

- Bahia 5

OTHER STATES 10

Total 100

Source: Sindiveg

The agrochemicals market is highly concentrated with ten companies constituting more than 80% of the total

(Syngenta, Bayer, BASF, FMC, DuPont, Dow, Monsanto, Adama, UPL and Nufarm).

Generic products account for 40% of the values of agrochemicals sold and specialties 60%.

ANDAV estimates that there are around 7,200 distributors of agrochemicals, 80% of which are resellers and

20% cooperatives. Wholesalers are relatively unimportant in Brazil.

Around 25% of sales are made by the cooperatives, 50% by resellers and 25% direct to farmers by the

manufacturers. Only 6% of sales are paid for in cash whereas 46% are made on terms of more than 241 days

(source: Sindiveg).

Smuggling of agrochemicals, mainly from Paraguay, has become increasingly important and is estimated to be

around 20% of total use according to Sindiveg.

2.6.1 Transgenic crops

Almost 50 m ha of transgenic soybean (32.7 m), maize (15.7 m) and cotton (0.7 m) were planted in the 2016/17

harvest and, to date, around 70 transgenic events have been approved for sale in Brazil.

2.6.2 Pesticide imports

Brazil imports most of the pesticides it uses, either as AI to be formulated in Brazil or as formulated product.

One third of the imports originated from China, almost 18% from the USA and 12% from India (Table 2.8).

SAMPLE




Table 4.1: Data requirements for registering a technical product Item Comments

1. Registration Application form

Personal data of applicant, legal representative, manufacturer (s), formulator(s), plus corroborating documents for legal representative; Objective of request (production, importation, exportation, handling, commercialization, use); Product class (herbicide, insecticide etc); Mode of action; AI(s) data (chemical name in English and Portuguese, IUPAC nomenclature, common name in English and Portuguese, code number in CAS registry, chemical group in Portuguese, synonyms, chemical formula and structure; Commercial product name, experimental code/ name, formulation type; Packaging type, material and capacity.

2. Technical Report (to be signed by responsible agronomist)

Proof that the petitioner company, and manufacturer(s) established in Brazil, are properly registered for this category at the State, Federal District or local agency level.

Proof of condition of legal representative of the petitioner company.

Certificate of physical-chemical analysis of product.

When available, information on the product situation, registration, authorized uses, restrictions and the reasons for them, in the country of origin.

Detailed description of the method(s) for deactivating the product, accompanied by a technical report indicating the potential reduction of components, with identification of the residues remaining and the entity in Brazil which can do this analysis.

Information from other countries on possible restrictions or prohibitions for products based on the same AI and the reason(s) for them.

Laboratory reports on the 5-batch analyses for each manufacturer.

All documents presented should be original, a certified copy or in the original to be certified by the public agency which receives them.

Registrant owner's declaration on the qualitative and quantitative composition of the product, based on laboratory reports of 5 batch analyses of each manufacturer, which should show: 1. the maximum limit of the content of each impurity with a concentration equal or higher than 0.1%. 2. The minimum limit of the AI content. 3. The maximum limit of sub-products or impurities present in concentrations less than 0.1%, when relevant toxicologically or environmentally. 4. Identification of isomers and their corresponding ratios.

Description of the effects observed of relevant impurities, e.g. toxicological effects or effects on AI stability.

Description of the analytical methodology for qualitative and quantitative determination of the AI, its impurities in concentrations higher than or equal to 0.1% and of the relevant toxicological or environmental impurities in concentrations lower than 0.1%.

Description of the analytical methodology of the principal products of degradation of the AI for monitoring and supervision purposes.

Description of the production process of the TP, including the stages of synthesis, the by-products and impurities, supplied by the manufacture, containing: 1. flowchart of the chemical reactions and the output of each stage of the process. 2. Identity of the reagents, solvents and catalysts, with their respective degrees of purity. 3. general description of the conditions which are controlled during the process (e.g.: temperature, pressure, pH, humidity). 4. description of the stages of purification, including those used to recover or recycle starting materials, intermediates or substances generated. 5. discussion on the theoretical formation of all possible impurities generated in the production process.

SAMPLE




4. Report on residue studies, pre-harvest interval and, when applicable, the limit of unknown residues. These tests will not be necessary for products, which when compared to formulated products already registered, have: a. the same formulation. b. the same recommended registered uses (crops and dosage rates) and the same application modes. c. application of the same quantity or less of AI during the crop cycle or season, and d. the safety interval is the same or higher. To compare already registered formulated products the dossiers must contain: a. an analytical report with a description of the analysis method and all the chromatograms, which permit a quantification of the MRLs; b. residue trials with 3 field trials in distinct areas in the same crop year or 2 field trials in the same area in 2 consecutive crop years and a 3rd trial in a different area. At least 2 trials in representative localities for post-harvest treatments. The residue studies on the registered formulated products should have been done after 11/05/2000 and studies must be done under GLP conditions. Residue field trials: a. under GLP conditions; for each formulated product, 4 field trials in 4 distinct and representative areas for each crop in the same crop year or in consecutive crop years in the same areas. For post-harvest and stored product products only 3 field trials are required and for products used exclusively in pre-planting and pre-emergence, 2 field trials. For exclusive formulated ST products, 2 trials for systemic action products and no trials are required for contact action ST products. All field trials and residue trials must be done in Brazil. Further details on field trials and laboratory analyses etc are set out in Anvisa Resolution RDC No. 4 of 18/01/2012.

5. Analytical method and its sensitivity to determine pesticide residues.

6. Results of quantitative analyses done indicating the persistence of the residues in plants, animals, in the water, soil and atmosphere.

7. Information on bio-accumulation, presistence and mobility. Other data, information or documents requested in complementary regulations, including a copy of the RET, when applicable, analytical method to determine the AI content and an accession letter for data use where applicable.

Anvisa data LD50 oral and dermal on laboratory animals

LC50 inhalatory on laboratory animals

Ocular lesions in rabbits

Dermal lesions

Dermal sensitivity

Possible mutagenic effects

Medical information as follows: clinical and laboratory data on human exposure; diagnosis confirmation for intoxication; first aid and therapeutic measures and antidotes for intoxication.

Summary of environmental effects as follows: toxicity for fish, lower aquatic organisms, birds, bees and wildlife; accumulation in food chain; environmental mobility, persistence and degradation; toxicity of degraded product.

Trials and tests to be done according to protocols published by WHO, FAO etc. (see Portaria No. 03 of 16/01/1992 published by Anvisa.

Ibama data Physical-Chemical: aspect, colour, smell, solubility/miscibility, pH, density, superficial tension of solutions, viscosity, particle distribution by size, corrosivity, thermal stability in air, flash point.

Toxicity for non-target organisms: microorganisms, algae, soil organisms, bees, microcrustacea (acute), fish (acute), birds (single dose), plants (phytotoxicity).

SAMPLE




Toxicological and environmental information on the principal degradation products of the AI, accompanied by relevant bibliography. Description of the physical state, aspect, colour of the semiochemical as well as the equipment used in its use. Information on the effects of the product on non-target organisms and the environment accompanied by relevant bibliography. Copy of RET Certificate. (Annex II of INC No.1 of 10/03/2006).

Physical-chemical properties of the product, including: degree of purity, solubility, pH, density, volatility, distribution of particles by size, stability under hot and normal conditions. (Annex III of INC No.1 of 10/03/2006).

Toxicological and ecotoxicological evaluations: when there already exist studies on the product, tests may be waived. An example would be with the Lepidoptera, where the semiochemical molecules are already well known. Tests will be requested on a case-by-case basis depending on the origin and the mode of use of the product. Evaluations are done through a series of tests divided into 3 distinct phases: Phase 1: short-term toxicological tests (DL50, CL50 etc) on various species (nutrient cycling microorganisms, earthworms, birds, rats, rabbits). Whenever one of more tests in Phase 1 gives results classified as Class 1 in terms of toxicological potential or a positive result for the mutagenicity test, the product should be submitted to Phase 2. Phase 2: Mutagenic, teratogenic and subchronic tests on mammals. Whenever the mutagenicity tests done in Phase 2 or if the Response to Cellular Immunity are positive or indicate a significant immunocellular impairment, respectively, the product should be submitted to Phase 3. Phase 3: Tests on chronic toxicity and carcinogenicity on rats/ mice. Details on the tests in Phases 1-3 are set out in Annex IV of INC No.1 of 23/01/2006. Where the results of the mutagenicity tests in Phases 1 and 2 are positive, the product will not be registered. The presentation of tests or information set out in Annex IV of INC No. 1 is waived for products used in population monitoring programmes with traps, programmes for the detection and mass trapping with traps or for devices liberating semiochemicals for mating disruption as long as they are not applied to fruits or parts of plants to be consumed and that the semiochemicals are the only AIs present.

Copy of the RET certificate

MAPA data 1. Report on physical-chemical properties.

2. Report on residue studies, safety interval, and, when applicable, the limit of unknown residues.


4. Results of quantitative analyses done indicating the persistence of residues in plants, animals, in the water, soil and atmosphere.

5. Interval of reentry of people in the treated areas.

6. Biological studies involving biochemical and acute and chronic toxicological aspects.

7. The antidote or treatment available in Brazil for cases of human intoxication.

8. Other data, information or documents requested in complementary regulations.

9. Tests and information regarding its compatibility with other products.

10. Information on bioaccumulation, persistence and mobility.

Ibama data

1. Report on physical-chemical properties. 2. Report on data showing the toxicity for microorganisms, microcrustacea, fish, algae, soil organisms, birds, plants and non-target insects.

3. Report on studies on bioaccumulation, persistence and mobility.

4. Report on studies on toxicity to higher animals.

5. Report on studies showing the mutagenic, embryo-feto-toxic and carcinogenic potential in animals.


SAMPLE




Products which attend the reference specifications are exempt from the RET and the registration of

components. However, those imported products and AIs which still do not have reference characteristics

established must have a RET in order to do research in Brazil.

CPPs approved for organic agriculture do not need an agronomic prescription.

Decree 6913/2009 defines the reference specification, i.e. specifications and minimum guarantees that the

phytosanitary products with use approved for organic agriculture should follow in order to obtain the

registration. Thus the establishment of a reference specification precedes the registration process of a CPP with

use approved for organic agriculture.

4.4.12.1 Establishment of a reference specification

COAGRE of MAPA is responsible for identifying the priority phytosanitary products for establishing reference

specifications based on the demand of the organic production network presented by the CPOrgs-UF, which are

active in each state.

The request for a reference specification should be made to the CPOrg in the applicant’s state or federal unit

and includes the request form and information on the product characteristics and production process.

The request form requests data as follows:

the applicant (name, address, contact data).

product composition: identification of the agent/BC agent, % concentration, function of the agent.

type of formulation.

recommendation of product use (biological targets, crops, dosage, number and interval of applications).

The product composition for establishing the reference specificity may be published by a joint statement of

MAPA, Anvisa and Ibama and this publication may serve as a basis for the registration of other commercial

products.

A list of the products approved for organic agriculture and those for which reference specifications have been

established is given at http://www.agricultura.gov.br/assuntos/sustentabilidade/organicos/produtos-

fitossanitarios/arquivos-especificacao-de-

referencia/SolicitaesdeEspecificaesencaminhadaspelasCPOrgs_18_07_16.pdf

Up to now MAPA has said that 27 reference specifications have been published.

4.4.12.2 Registration process for organic agriculture

A flow diagram showing the steps in registering a product for organic agriculture is given in Figure 4.2.

(http://www.agricultura.gov.br/assuntos/sustentabilidade/organicos/produtos-fitossanitarios/arquivos-

registro/Fluxogramadetalhadopararegistro.jpg )

SAMPLE


http://www.agricultura.gov.br/assuntos/sustentabilidade/organicos/produtos-fitossanitarios/arquivos-especificacao-de-referencia/SolicitaesdeEspecificaesencaminhadaspelasCPOrgs_18_07_16.pdf



http://www.agricultura.gov.br/assuntos/sustentabilidade/organicos/produtos-fitossanitarios/arquivos-registro/Fluxogramadetalhadopararegistro.jpg

http://www.agricultura.gov.br/assuntos/sustentabilidade/organicos/produtos-fitossanitarios/arquivos-registro/Fluxogramadetalhadopararegistro.jpg



This results in the maximum times for registration being much shorter than in Brazil:

Argentina – 2.5 years, Paraguay – 1.5 years, Uruguay – 9-10 months, Chile – 3 years.

In other developed countries, the maximum time for registering me-too generic and new products is also much

quicker than in Brazil:

Me-too New

USA ...................................... 1 yr 3 yrs

Australia ............................... 4 months-1 yr 2-2.5 yrs

Germany ............................... 6 yrs

France .................................. 5 yrs

Portugal/ Spain .................... 1.5 yrs

One of the main results of the long time to register a pesticide in Brazil has been the increase in the availability

of contraband products from surrounding countries, especially Paraguay, with an estimate of 20% of all the

CPPs supplied on Brazilian crops.

5.9 Recommendations to improve Brazil’s registration system

ABRAPA made the following recommendations to improve the current system for registering pesticides

in Brazil:

1. Improve the legislation based on the best regulatory practices followed in other important

agricultural countries.

2. Integrated electronic system involving MAPA, Anvisa and Ibama.

3. Reduce the bureaucracy wherever possible.

4. Improve the post-registration processes with positive lists for packaging, formulators, components etc.

5. Simplify the registration of an identical product (clone).

6. Harmonize the process based on the most efficient models used in other countries.

7. Standardize the evaluation criteria of the 3 agencies involved (MAPA, Anvisa, Ibama).

8. Improve the administrative structure and contract specialists for the 3 agencies.

9. Give power to MAPA as the leading agency in the registration process of agricultural inputs.

10. Give priority to and legalize registrations for products of agricultural importance.

11. Structure a “phase-in” programme to replace products which are withdrawn from the market.

12. Combat contraband and pirate products.

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