# Economic Analysis of the

Bulk Pesticide Container Design and Residue

Removal Standards

June 1, 2006

### Executive Summary of the Economic Analysis of the Fi nal Pesticide Container Design and

Residue Removal Standards

The Environmental Protection Agency (EPA) is fi nalizing the standards fo r pesticide container design and residue removal as required under Sec tion 19 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The final standa rds include design and la beling requirements for non-refillable and refillable pestic ide containers to ensure that

1. containers are strong and durable;

2. minimize human and environmental exposure during container handling;

3. facilitate container disposal and recycling; 4. minimize cross-contamination of pesticid es distributed in ref illable containers; 5. codify safe refilling management practices; 6. encourage the us e of refillable containers to reduce container disposal problems; and 7. provide instructions for proper cleaning of pesticide containers.

The improvements made in the design of pesticid e containers and the removal of residues from containers prior to disposal as a result of the final pesticide co ntainer standards are expected to benefit pesticide users, non-users and the environment through a reduction in exposure to pesticides from unintended pesticide container spills and leaks.

The total annual cost of compliance with the fi nal standards to the regulated industries (i.e., pesticide registrants, agricultura l pesticide refillers, and swimmi ng pool applicators) is estimated
at $8.4 million. This estimate is based on an exam ination of the current level of compliance of pesticide containers with the final standards, an d the cost of moving from the current level of compliance to the final standards. The cost to pesticide registrants is estimated at $5.6 million per year. None of the more than 1,800 pestic ide registrant companies (including 1,658 small businesses as defined by SBA) subject to the fina l standards are estimated to be significantly impacted by compliance with the final standards (t he ratio of the cost of compliance to current industry average revenues for all businesses is es timated to be less than 0.02 percent). Pesticide registrants are responsible for ensuring that pesticide containers are designed in accordance with the final container design and labeling standa rds, and for following the pesticide container refilling requirements for pesticide containers in the agricultural and industrial/commercial/governmen t pesticide markets.

Agricultural pesticide refillers and swimming pool applicators are responsible for following the pesticide container refilling requ irements for containers in the agricultural pesticide market and pool chemicals market, respectively. The estimat ed annual cost of comp liance with the final pesticide container standards for pesticide refillers is $2.6 million. For swimming pool applicators, the estimated annual cost of co mpliance is $0.2 million. As is the case with pesticide registrants, none of the estimated 16,79 5 agricultural pesticide refilling businesses (of which16,642 are small businesses as defined by SBA) and 322 swimming pool supply companies (of which 305 are small businesses as defined by SBA) are estimated to be significantly impacted by compliance with the final standards (the ratio of the cost of compliance to current industry average reve nues for all businesses in each industry is es timated to be less than 0.01 percent)

### The human health-related benefits expected as a result of the final pesticide container standards

include a reduction in the estima ted number of unintentional c ontainer-related pesticide human exposures of an estimated 610 to 768 incidents per year. This amounts to an estimated $264,051 to $332,311 in avoided costs of illness per year. The non-human health-related benefits expected

as a result of the final rule include a cost savings of $4.5 million from the disposal of nonrefillable containers as nonhazardous rather than hazardous material, because of compliance

with the container standards. We are unable to quantify other non-health re lated benefits of the final rule, but they include a reduction in the number of unintentional pesticide exposures to terrestrial and aquatic wildlife, and avoided costs of prope rty damage/spill cleanup costs from pesticide container-related spills.

The pesticide container design and residue removal standards were proposed in 1994. In response to public comments submitted on the propos ed standards, a number of changes were made to the proposed pesticide container desi gn and residue removal standards, and these changes are reflected in the final rule. The ch anges result in a reduction in the total estimated cost of compliance with the pe sticide container standards by as much as 80 percent from the proposed rule (which was originally estimat ed at $40.1 million to $55.5 million per year for compliance with the proposed standards (EPA preferred option), compared to $8.4 million for the current final standards). The lower estimated costs are due in part to the exemption in the final rule of household pesticide product labels from containing language requiring triple rinsing of nonrefillable pesticide containers prior to disposal. As a result of this change, no end user impacts are estimated in the final rule, which were estimated at more than $8 million in the proposed rule impact analysis. Other significant changes in the regulations for the final rule,

which led to decreased costs for the industries im pacted by the rule includ e reference to and the adoption of existing Department of Transportation (DOT) standa rds in the regulations, and the

relaxation of the residue removal standard fo r nonrefillable containers from 99.9999 percent to 99.99 percent.

In general, the expected benefits of the pest icide container standards are similar between the proposed and final rule. Due to the availabilityof more detailed data on pesticide containerrelated human exposures, the estimated number of pesticide container-related human exposure incidents avoided as a result of the pesticide co ntainer standards declined from an estimated 1,650 to 2,250 incidents avoided per y ear as a result of the proposed standards, to an estimated 610 to 768 incidents avoided per year as a result of the final standards. And, due to the change in the scope of the pesticide container standards, which resulted in fewer nonrefillable containers affected by the final rule, the nonr efillable container disposal be nefits (from reduced hazardous waste) declined by more than 30 percent from the proposed to the final rule.

### Page i 

## Contents

1.0 Introduction............................................................................................................... ............... 1 1.1 Need for Regulation........................................................................................................ 2 1.2 Regulatory Background of the Final Rule...................................................................... 3 1.3 Scope of the Economic Analysis for the Final Pesticide Rule ....................................... 5

1.4 Estimated Costs and Benefits of the Final Rule ............................................................. 5 1.4.1 Costs Summary................................................................................................... 6 1.4.2 Benefits Summary ............................................................................................ 11

1.5 Limitations of the Final Rule Economic Analysis........................................................ 11

2.0 Final Rule Standards and Comparison of th e Costs and Benefits of the Final and the Proposed Rule Standards ....................................................................................................... 1 3

2.1 Final Rule Standards..................................................................................................... 13 2.2 Changes in Pesticide Container Design and Residue Removal Standards from the Proposed to the Final Rule............................................................................................ 16 2.3 Response to Comments to the Proposed Standards...................................................... 18 2.4 Comparison of the Estimated Costs and Bene fits of the Final and Proposed Standards

............................................................................................................................... ....... 19

3.0 Pesticide Container Compliance Profile................................................................................ 23

3.1 Introduction ............................................................................................................... ... 23

3.2 Pesticide Container Universe........................................................................................ 28 3.3 The Implications of the Scope of the Regulations on the Container Estimates ........... 33 3.3.1 Manufacturing Use Products and Pl ant-Incorporated Protectants.................... 35

3.3.2 Antimicrobial Pesticide Products ..................................................................... 35 3.3.3 Non-Exempt Products Sold or Distri buted in Non-Refillable Containers: Toxicity Categories I and II.............................................................................. 37 3.3.4 Non-Exempt Products Sold or Distri buted in Non-Refillable Containers:

Restricted Use Products.................................................................................... 38 3.3.5 Non-Exempt Products Sold or Distri buted in Non-Refillable Containers: Toxicity Categories III and IV That Are Not Restricted Use Products............ 39 3.3.6 Summary of Pesticide Container Scope Criteria .............................................. 39 3.4 Regulatory Compliance Baseline ................................................................................. 44 3.4.1 Regulatory Compliance Rates fo r Non-Refillable Containers ......................... 44 3.4.2 Regulatory Compliance Rates for Refillable Containers ................................. 50 3.4.3 Regulatory Compliance Rates for Refilling Activities..................................... 55

4.0 Pesticide Container Stan dards Cost Analysis........................................................................ 58

4.1 Introduction ............................................................................................................... ... 58 4.2 The Basic Framework of the Cost Analysis ................................................................. 59 4.3 Characteristics of the Regul ated Entities That Are Inputs to the Cost Analysis .......... 62 4.4 Estimating the Costs of Complying with the Final Regulations .................................. 64

4.4.1 Estimate the Number of Pesticide Co ntainers in Each Market Sector ............. 65

4.4.2 Estimate the Number of Pesticide Contai ners in Each Market Sector That Fall Within the Scope of the Container Rule........................................................... 65

4.4.3 Allocate Containers That Fall Within th e Scope of the Rule in Each Market

Sector to Each of the Size Classes.................................................................... 66

### Page ii 4.4.4 For Each Regulation Under the Pesticid e Container Rule, Estimate the Number

of Containers That Fall Within the Scope of the Rule That Are Out of Compliance with That Regulation.................................................................... 67 4.4.5 For Each Regulation Under the Cont ainer Rule, Estimate the Number of Containers That Fall Within the Scope of the Rule That Are Out of Compliance with That Regulation – for the Average Registrant in Each Combination of

Market Sector and Size Class ........................................................................... 70 4.4.6 Estimate the Cost, in Each Year of a 20-Year Period, of Bringing Containers into Compliance................................................................................................ 70

4.4.7 Calculate the Present Discounted Value of the 20-Year Stream of Costs........ 74

4.4.8 Calculate the Annualized Cost of Complying with Each Regulation .............. 75 4.4.9 Estimate the Annualized Cost of Comply ing with All Regulations per Average Regulated Entity in Each Combination of Market Sector and Size Class – Assuming No Waivers...................................................................................... 81 4.4.10 Estimate the Annual Cost of Complyi ng with All Regulations per Average Regulated Entity in Each Combination of Market Sector and Size Class – Allowing for Waivers ....................................................................................... 83 4.5 Estimating the Costs of Compliance with Refilling-Related Regulations ................... 86

4.5.1 Allocate Refillable Containe rs That Fall Within the Scope of the Rule in Each

of the Relevant Market Sectors to E ach of the Regulated Refilling Entity Categories Within the Market Sector ............................................................... 87 4.5.2 Estimate the Number of Refillings per Y ear That Fall Within the Scope of the Rule for Each Category of Regulated Entity for Each Refillable Container Type

88 4.5.3 Estimate the Number of Refillings per Y ear That Fall Within the Scope of the Rule for Pesticide Refillers in Each Size Class Within Each Refiller Category

88 4.5.4 For Each Refilling-Related Regulation Under the Pesticide Container Rule, Estimate the Number of Refillings per Year That Fall Within the Scope of the Rule That Are Out of Compliance with That Regulation................................. 89 4.5.5 For Each Refilling-Related Regulation Under the Pesticide Container Rule, Estimate the Number of Refillings That Fall Within the Scope of the Rule That Are Out of Compliance with That Re gulation – for the Average Regulated Entity in Each Combination of Refiller and Size Class.................................... 90 4.5.6 Estimate the Cost, in Each Year of a 20-Year Period, of Bringing Refillings into Compliance................................................................................................ 91

4.5.7 Calculate the Present Discounted Value of the 20-Year Stream of Costs........ 93 4.5.8 Calculate the Annualized Cost of Comp lying with the Refilling Regulations. 94

4.6 The Total Annual Costs of the Rule ............................................................................. 95 4.7 Impact Analysis .......................................................................................................... 10 2 4.8 Sensitivity Analysis .................................................................................................... 105

5.0 The Human and Non-Human Health Be nefits of the Final Standards ................................ 116

5.1 Introduction ............................................................................................................... . 116

5.2 Human Health-Related Benefits: Estimate d Annual National Cases and Valuation of

Pesticide Product-Related Illn esses and Injuries Potentially Avoided by the Standards

............................................................................................................................... ..... 117

### Page iii 5.2.1 Summary of Approach.................................................................................... 118 5.2.2 Derivation of the Annual Percentage of Pesticide Illnesses Potentially Avoided

as a Result of the Container Desi gn and Residue Removal Regulations ....... 118

5.2.3 Profile of Annual National Pesticide Exposure Cases.................................... 123 5.2.4 Extrapolation to Estimate of Nationwid e Cases Potentially Avoided from the Container Design and Residue Removal Standards ....................................... 128 5.2.5 Valuing Avoided Pesticide Product-Re lated Illnesses as a Result of the Container Regulations .................................................................................... 131

5.3 Non-Human Health-Related Benefits of the Pesticide Container Regulations .......... 143 5.3.1 Non-Refillable Container Disposal Benefits .................................................. 143

5.3.2 Environmental Effects Avoided Due to Container-Related Pesticide Exposures

153 5.3.3 Property Damage/Spill Cleanup Costs Avoided ............................................ 154 5.4 Summary of the Benefits of the Final Standards........................................................ 157

References..................................................................................................................... .............. 158



## Appendixes

Appendix A. Compliance Costs for th e Pesticide Container Standards .................................... 162

A.1 Non-Refillable Container Costs.................................................................................. 164

A.1.1 Residue Removal Standard............................................................................. 164 A.1.2 Administrative Requirements - Recordkeeping ............................................. 171

A.2 Refillable Container Costs.......................................................................................... 174 A.2.1 Administrative Requirements......................................................................... 174 A.2.2 Standard for Container Marking..................................................................... 177 A.2.3 Standards for Openings .................................................................................. 181

A.2.4 Bulk Container Standards............................................................................... 184 A.3 Refilling Compliance Costs........................................................................................ 185 A.4 Cost of Label Requirements ....................................................................................... 188

A.5 Waiver Costs............................................................................................................... 192
Appendix B. Compliance Profile Estimation Details ................................................................ 193 B.1 Assumptions and Procedure for Convert ing Pesticide Volume and Weight into

Number of Refillable C ontainers in Use .................................................................... 193 B.2 Number of Refillables in Use by the P ool Industry: A Separate Discussion and

Consideration.............................................................................................................. 195

Appendix C. Regulation-Specific Cost Schedules..................................................................... 196

Appendix D. Profile of Industries Regulated by the Pesticide Container Regulations ............. 210 D.1 Pesticide Registrants................................................................................................... 211 D.1.1 Pesticide Registrants’ NAICS Codes ............................................................. 212 D.1.2 Analysis of Large Pesticide Registrants ......................................................... 213 D.1.3 Analysis of Small Pesticide Registrants ......................................................... 214 D.1.4 Container Profile for Registrants by Market Sector and Size Category......... 216 D.2 Agricultural Pesticide Refillers .................................................................................. 218 D.3 Swimming Pool Market.............................................................................................. 220

### Page iv Appendix E. 1994 Proposed Rule Container Standards Costs and Benefits ............................. 223 E.1 Estimated Cost of Proposed Rule Container Standards.............................................. 223 E.2 Estimated Benefits of the Propos ed Rule Container Standards.................................. 226

Appendix F. Nationwide and State Regulations and Standards for Pesticide Containers......... 228 F.1 Department of Transportation Hazardous Materials Regulations .............................. 228 F.2 United Nations Recommendations on the Transport of Dangerous Goods................ 229 F.3 Mid America CropLife Association (MAC PA): MACA-75 Manufac turer Specification and User Guidelines for Portable Agrichemical Tanks.............................................. 231 F.4 Container Population Affected by the c ontainer regulations and the Three Major National Regulations/Standards ................................................................................. 232 F.5 Detailed Comparison of the Pesticide Container Regulations and the Three Major Regulations/Standards ................................................................................................ 236 F.5.1 Design Standards ............................................................................................ 236 F.5.2 Permanent Markings....................................................................................... 236 F.5.3 Dispensing Capability..................................................................................... 237

F.5.4 Closures .......................................................................................................... 237 F.5.5 Residue Removal Design Standard ................................................................ 237 F.5.6 Production Testing.......................................................................................... 237 F.5.7 Production Retesting....................................................................................... 238 F.5.8 Reconditioning................................................................................................ 238

F.5.9 Waiver ............................................................................................................ 238 F.5.10 Recordkeeping................................................................................................ 239 F.5.11 Refilling.......................................................................................................... 239 F.5.12 Labeling.......................................................................................................... 240 F.6 Existing EPA Policy Applicable to Pesticide Containers........................................... 260 F.6.1 Child-Resistant Packaging (40 CFR Part 157)............................................... 260 F.6.2 Consumer Labeling Initiative ......................................................................... 260 F.6.3 Bulk Pesticide Enforcement Policy ................................................................ 261 F.7 State Regulations and Standards................................................................................. 265 F.7.1 Container Design and Performance Standards ............................................... 265 F.7.2 Refilling Requirements................................................................................... 265

F.7.3 Transfer of Pesticides Between Containers.................................................... 266

F.7.4 Residue Removal Procedures ......................................................................... 266 F.7.5 Container Collection and Disposal Procedures .............................................. 266 F.7.6 Pesticide Storage Guidelines .......................................................................... 267

Appendix G. Comparison of the Final Containe r Regulations with the 1994 Proposed Container Regulations .................................................................................................................... ...... 273 G.1 Scope ...................................................................................................................... .... 273 G.2 Design Standards ........................................................................................................ 274 G.3 Permanent Markings................................................................................................... 275 G.4 Dispensing Capability................................................................................................. 275

G.5 Closures ................................................................................................................... ... 275 G.6 Residue Removal Design Standard ............................................................................ 275 G.7 Design Qualification Testing...................................................................................... 276 G.8 Production Testing and Periodic Retesting ................................................................ 276 G.9 Reconditioning............................................................................................................ 2 77

### Page v G.10 Waiver .................................................................................................................... .... 277

G.11 Certification............................................................................................................. ... 277 G.12 Recordkeeping............................................................................................................ 2 77 G.13 Refilling................................................................................................................. ..... 278 G.14 Labeling.................................................................................................................. .... 278
Appendix H. Characterization of Unintentiona l Human Pesticide and Antimicrobial Exposures

and Health Effects in the TESS Database............................................................................ 287

H.1 General Characterization of Unintent ional Human Pesticide and Antimicrobial Exposures.................................................................................................................... 28 7

H.2 Characterization of Health Effects Associ ated with Unintentional Human Pesticide and Antimicrobial Exposure Cases ................................................................................... 288

Appendix I. Benchmark Costs for Physician O ffice Visits by Current Procedural Terminology, Fourth Edition (CPT-4) Code .............................................................................................. 293

Appendix J. Case Summaries of 1999 California Incidents That Would Have Been Prevented by the Container Regulations.................................................................................................... 29 4
Appendix K. Pesticide Container and Refilli ng Requirements Cost Analysis Tables ............... 307

### Page vi 

## Tables and Figures

Table 1.1. The Types of Expected Benefits fr om the Container Design and Residue Removal Regulations and Their Sources ................................................................................................ 3

Table 1.2. Overview of the Rule Requirements............................................................................. 6

Table 1.3. Quantified Costs and Benefits of the Rule Requirements (2005$)............................... 7

Table 1.4. Estimated Annual Cost of Compliance a 

### with the Final Container Design and Residue Removal Standards for the Average Regulated Entity (2005$) .............................................. 9

Table 1.5. Estimated Annual Cost of Complianc e with the Pesticide Container Design and Residue Removal Standards by Standard a 

### ............................................................................ 10

Table 1.6. Estimated Benefits A ssociated with the Final Pestic ide Container Design and Residue Removal Regulations (2005$) a 

### ............................................................................................. 11
Table 2.1. Annual Compliance Cost Comp arison Between the Final and Proposed

Pesticide Container Standards (2005$).................................................................................. 19

Table 2.2. Comparison of Human Health-Related and Non-Human Health-Related Benefits for the Proposed and Final Container Standards (2005$) ........................................................... 20

Table 3.1. Market Sector Equivalent Between the Current Analysis and the 1993 EPA Proposed Container Rule RIA.............................................................................. 25

Table 3.2. Generalization of Impacts of Pesticid e Container Regulations on Regulated Entities26

Table 3.3. SBA and EPA Alternative Definitions of Small and Large Businesses Affected by the Pesticide Container Regulations............................................................................................ 27

Table 3.4. Estimated Number of Non-Refillable Pesticide Containers in Use by Major Market

Sectors........................................................................................................................ ............ 30

Table 3.5. Estimated Number of Refillable Pesticid e Containers in Use by Major Market Sectors

32
Table 3.6. Estimated Number of Swimming Pool Chemical Refillable Containers Affected by the Pesticide Container Regulations ...................................................................................... 33

Table 3.7. Summary of Regulatory Scope................................................................................... 34

Table 3.8. Percentage of Pesticide Containers Affected by the Final Rule Scope Criteria ......... 38

Table 3.9. Estimated Number of Non-Refillable Pesticide Containe rs Affected by the Pesticide Container Regulations a 

### .......................................................................................................... 41

Table 3.10. Estimated Number of Refillabl e Pesticide Containers Affected by the Pesticide Container Regulations a 

### .......................................................................................... 43

Table 3.11. Overview of th e Container Regulations.................................................................... 44

Table 3.12. Regulatory Compliance Rate s for Non-Refillable Containers a 

### ............................... 45
Table 3.13. Regulatory Compliance Ra tes for Refillable Containers.......................................... 53

Table 3.14. Repackaging/Refilling Re quirements and Responsibility ........................................ 56

Table 4.1. Types of Regulated Entities by Market Sector ........................................................... 59

Table 4.2. Overview of Regulated Entities and Types of Regulat ions with Which They Must Comply ......................................................................................................................... ......... 60

Table 4.3. Intersection of the Pesticide Cont ainer Regulations and Regulated Entities.............. 61

### Page vii Table 4.4. Types of Containers Considered in the Analysis........................................................ 62

Table 4.5. Estimated Numbers of Regulated En tities by Market Sector and Size Class............. 64

Table 4.6. Percentages of Total Revenue in Each Size Class...................................................... 64

Table 4.7. Number of Containers by Market Sector, and Number and Percentages that Fall Within the Scope of the Container-Relate d Regulations Under the Container Rule............. 66

Table 4.8a. Estimated Numbers of Non-Refilla ble Containers Out of Compliance with the Container-Related Regulations a 

### ............................................................................................ 68

Table 4.8b. Estimated Numbers of Refillable Cont ainers Out of Compliance with the ContainerRelated Regulations a 

### ............................................................................................................. 69
Table 4.9a. Total (Undiscounted) Costs a 

### of Complying with All Regulations for Non-Refillables Under the Container Rule (2005$) b 

### ....................................................................................... 73
Table 4.9b. Total (Undiscounted) Costs a 

### of Complying with All Regulations for Refillables Under the Container Rule (2005$) b 

### ....................................................................................... 74
Table 4.10a. Estimated Annual Cost of Comply ing with Each Container Regulation for NonRefillable Containers for the Average Registrant by Market Sector and Size Class (Interest Rate = 3 percent) (2005$) a 

### ..................................................................................................... 77
Table 4.10b. Estimated Annual Cost of Comp lying with Each Container Regulation for Refillable Containers for the Average Registrant by Market Sector and Size Class (Interest Rate = 3 percent) (2005$) a 

### .................................................................................................... 78
Table 4.10c. Estimated Annual Cost of Comply ing with Each Container Regulation for NonRefillable Containers for the Average Registrant by Market Sector and Size Class (Interest Rate = 7 percent) (2005$) a 

### ..................................................................................................... 79
Table 4.10d. Estimated Annual Cost of Comp lying with Each Container Regulation for Refillable Containers for the Average Registrant by Market Sector and Size Class (Interest Rate = 7 percent) (2005$) a 

### ..................................................................................................... 80

Table 4.11a. Total Annualized Costs Over a 20-Y ear Period of the Pesticide Container Rule for the Average Registrant: Total Without a Waiver (Interest =3 percent)................................. 82

Table 4.11b. Total Annualized Co sts Over a 20-Year Period of th e Pesticide Container Rule for the Average Registrant: Total Without a Waiver (Interest =7 percent)................................. 82

Table 4.11c. Total Annualized Costs Over a 20 Y ear Period of the Pesticide Container Rule for the Average Registrant: Total With a Wa iver (Interest Rate = 3 percent) ............................ 84

Table 4.11d. Total Annualized Co sts Over a 20 Year Period of th e Pesticide Container Rule for the Average Registrant: Total With a Wa iver (Interest Rate = 7 percent) ............................ 84

Table 4.12. Container-Related Standards and Waivers ............................................................... 85

Table 4.13. Estimated Annual Pestic ide Container Refilling Rates ............................................ 89

Table 4.14. Estimated Numbers of Refilling St eps (or Requirements) per Year Out of Compliance with Refilling-Re lated Requirements (2005$) .................................................. 90

Table 4.15. Total Compliance Costs a 

### Related to Refilling Requirements for Refillable Containers (2005$) b 

### .............................................................................................. 93
Table 4.16a. Estimated Annual Cost of Comp lying with the Refilli ng-Related Container Regulations for the Average Refiller by Refiller Category and Size Class (Interest = 3 percent) (2005$) a 

### ............................................................................................... 94

### Page viii Table 4.16b. Estimated Annual Cost of Comp lying with the Refilli ng-Related Container Regulations for the Average Refiller by Refiller Category and Size Class (Interest = 7 percent) (2005$) a 

### ............................................................................................... 95

Table 4.17a. Total Annual Costs of the Pesticide Container Rule for Regulated Entities (Interest Rate = 3 percent) (2005$)...................................................................................................... 97

Table 4.17b. Total Annual Costs of the Pesticide Container Rule for Regulated Entities (Interest Rate = 7 percent) (2005$)...................................................................................................... 99

Table 4.18a. Total Annual National Cost of Each Regulation Under the Pe sticide Container Rule (Interest Rate = 3 percent) (2005$)...................................................................................... 101

Table 4.18b. Total Annual Nationa l Cost of Each Regulation Unde r the Pesticide Container Rule (Interest Rate = 7 percent) (2005$)...................................................................................... 102

Table 4.19a. Ratio of Annual Compliance Cost to Annual Revenue for the Average Regulated Entity (Interest Rate = 3 percent) (2005$)........................................................................... 103

Table 4.19b. Ratio of Annual Compliance Cost to Annual Revenue for the Average Regulated Entity (Interest Rate = 7 percent) (2005$)........................................................................... 104

Table 4.20. Annual National Cost of Regulation Under the Pesticide Container Rule (2005$) 106

Table 4.21. “Low-End” and “High-End” Assumptions for Sensitivity Analysis...................... 108

Table 4.22. Total Annual Costs of the Pesticide Container Rule fo r Regulated Entities: Using “Low End” Assumptions (Interest Rate = 3 percent) (2005$) ............................................ 110

Table 4.23. Total Annual National Cost of Each Re gulation Under the Pesticide Container Rule: Using “Low End” Assumptions (Inte rest Rate = 3 percent) (2005$).................................. 112

Table 4.24. Total Annual Costs of the Pesticide Container Rule for Regulated Entities: Using “High End” Assumptions (Interest Rate = 3 percent) (2005$)............................................ 113

Table 4.25. Total Annual National Cost of Each Regulation Under the Pesticide Container Rule: Using “High End” Assumptions (Inte rest Rate = 3 percent) (2005$) ................................. 115

Table 5.1. The Types of Expected Benefits fr om the Container Design and Residue Removal Regulations and Their Sources ............................................................................................ 117

Table 5.2. Number of Reporte d Total, Intentional, and Pine Oil-Related Illnesses a 

### in

California’s Pesticide Illness Surveillance Program in 1999 .............................................. 120

Figure 5.1. Flow Chart of 1999 California Depa rtment of Pesticide Regulation (CDPR)

Pesticide-Related Incidents.................................................................................................. 12 2
Table 5.3. Profile of Unintentional Pesticide Exposures by Reason of Exposure..................... 125

Table 5.4. Guidelines for Field Definition of Clinical Effect Relationships to Exposure......... 126

Table 5.5. Frequency of Clinical Effects “Relat ed” to Unintentional Pesticide Product Exposures

127

Table 5.6. Detailed Distribution of Clinical Effects “Related” to Unintentional Pesticide Product Exposures Among Patients Experiencing With Concomitant” Pesticide Exposures .......... 127

Table 5.7. Percent Distribution of Clinical Effects Among Patients Experiencing Effects

“Related” to Unintentional Pe sticide Product Exposures.................................................... 128

Table 5.8. Estimated Frequency of Clinical Effects for Avoidabl e Cases as a Result of the Container Regulations ......................................................................................................... 1 30

### Page ix Table 5.9. Estimated National Number of Avoi dable Clinical Effects as a Result of the Container Regulations ......................................................................................................... 1 31
Table 5.10. Expected Number of Avoidable Illnesses as a Re sult of Container Regulation by Severity of Clinical Effect ................................................................................................... 1 32
Figure 5.2. Components of the Health Benefits Valuation for the Container Design and Residue Removal Regulations........................................................................................................... 1 34
Table 5.11. Medical Outcome by Management Site for Pesticide Product-Related Unintentional Exposures, TESS, 2001 a 

### ..................................................................................................... 135
Table 5.12. Duration of Clinical Effect by Me dical Outcome for Pesticide Product-Related Unintentional Exposures, TESS, 2001 a 

### .............................................................................. 136
Table 5.13. Benchmark Evaluation and Management Costs for Physician Office Visit for an Established Patient Requiring an Expanded, Pr oblem-Focused Evaluation, Adjusted to 2005

Dollars a



### ............................................................................................................................... . 137
Table 5.14. Outpatient Physician Un it Costs by Medical Outcome .......................................... 137

Table 5.15. Mean Hospitalizati on Charges and Length of Stay for Injuries/Poisonings from HCUP 1994, Adjusted to 2005 Dollars a 

### ............................................................................. 138
Table 5.16. Inpatient Hospitalization Unit Costs....................................................................... 138

Table 5.17. Socioeconomic Data Used to Ca lculate Indirect Cost of Illness ............................ 139

Table 5.18. Value of a Day of Full Productivity........................................................................ 140

Table 5.19. Average Clinical Eff ect Duration and Indirect Cost of Illness by Medical Outcome

141

Table 5.20. Value of Annual Avoided Pesticide- Related Cases as a Result of the Container Regulations (2005 dollars) a 

### ................................................................................................. 142
Table 5.21. Non-Refillable Containers Subjec t to the Labeling Requirements and Their Associated Weights ............................................................................................................. 145

Table 5.22. Non-Refillable Containers Included in the Scope of the Non-Health Benefits Analysis ....................................................................................................................... ........ 147

Table 5.23. Number of Non-Ref illable Containers Diverted from the Hazardous Waste Stream

to the Non-Hazardous Waste St ream After the Promulgation of the Labeling Requirements

150

Table 5.24. Non-Discounted Benefits Associat ed with the Diversion of Non-Refillable

Containers from the Hazardous Waste Stream to the Non-Hazardous Waste Stream (2005$)

152

Table 5.25. Characteristics of Potential Pesticid e-Related Chemical Spills Recorded in the ARIP

156

Table K-2b. Number of Contai ners Out of Compliance for the Average Registrant, by Requirement, Market Sector, and Entity Size (Refillable Containers)................................ 313



## Appendix Tables

Table A-1. Compliance Cost s Associated with the Container Standards.................................. 164

### Page x Table A-2. Estimated Number of Active Registrations (Formulati ons) per Registrant by Size Category: Current Versus Proposed Rule............................................................................ 165

Table A-3. Estimated Number of Active Regi strations per Registrant Size Category.............. 166

Table A-4. Estimated Number of Active Product s Subject to the Residue Removal Standard. 167

Table A-5. Estimated Number of Active Product s Subject to the Residue Removal Standard by Registrant Size Category ..................................................................................................... 16 8
Table A-6. Comparison of the Estimated Number of Active Registrations (Formulations) per Average Registrant by Size Category.................................................................................. 168

Table A-7. Non-Refillable Container Re sidue Removal Compliance Cost Inputs and Assumptions................................................................................................................ .. 169

Table A-8. Non-Refillable Container Resi due Removal Compliance Costs (2005$) ............... 171

Table A-9. Non-Refillable Container Reco rdkeeping Cost Inputs and Assumptions ............... 173

Table A-10. Non-Refillable Cont ainer Recordkeeping Costs ................................................... 174

Table A-11. Refillable Container Admini strative Cost Inputs and Assumptions...................... 176

Table A-12. Refillable Container Administrative Costs (2005$) .............................................. 177

Table A-13. Refillable Container Marki ng Cost Inputs and Assumptions (2005$) .................. 179

Table A-14. Refillable Contai ner Marking Costs (2005$) ........................................................ 180

Table A-15. Cost Inputs and Assumptions for Refillable Container Openings (2005$)........... 183

Table A-16. Refillable Contai ner Openings Costs (2005$)....................................................... 184

Table A-17. Bulk Container St andards Compliance Costs........................................................ 185

Table A-18. Refilling Requirement Cost Inputs and Assumptions (2005$).............................. 187

Table A-19. Refilling Requi rement Costs (2005$).................................................................... 188

Table A-20. Labeling Requirement Cost Inputs and Assumptions (2005$).............................. 191

Table A-21. Labeling Requi rement Costs (2005$).................................................................... 192

Table C-1. Undiscounted Cost of Complying with the Residue Removal Standards for

Nonrefillable Containers Under the Current Rule ............................................................... 196

Table C-2. Undiscounted Costs of Complyi ng with Recordkeeping Requirements for

Nonrefillable Containers U nder the Container Rule ........................................................... 198

Table C-3. Undiscounted Costs of Complying with the Cont ainer Marking Standards for

Refillable Containers Under the Container Rule................................................................. 200

Table C-4. Undiscounted Costs of Complying with the Standards of Openings (for LiquidMinibulk Containers Only) for Refillable Containers Under the Container Rule............... 202

Table C-5. Undiscounted Costs of Complying with the Bulk Cont ainer Standards for Refillable

Containers Under the Container Rule.................................................................................. 204

Table C-6. Undiscounted Costs of Complying with Administrative Requirements for Refillable

Containers Under the Containment Rule............................................................................. 206

Table C-7. Undiscounted Costs of Complyi ng with the Labeling Requirements for All

Containers Under the Container Rule.................................................................................. 208

Table D-1. Estimated Number of Pesticide Re gistrants Affected by the Pesticide Container Regulations .................................................................................................................... ...... 212

### Page xi Table D-2. Most Common NAICS Codes Associated with Sample of 804 Pesticide Registrants

213

Table D-3. Economic Profile of Pes ticide Registrants by Entity Size....................................... 215

Table D-4. Procedure Used to Establis h Market-Specific Regulated Entities........................... 217

Table D-5. Economic Profile of Agricultur al Pesticide Refiller s by Entity Size ...................... 219

Table D-6. Economic Profile of Swimming Pool Supply Companies by Entity Size ............... 222

Table E-1. Summary of Annual Revenue Requirements (ARR) and ARRs as a Percentage of Sales for Representative Formulating Faciliti es in Each Market Sector Under Regulatory Options 1, 2, and 3 and Scenarios 1 and 2 for the Proposed Pestic ide Container Standards (2005$)........................................................................................................................ ......... 224
Table E-2. Summary of Annua l Revenue Requirements (ARR) and ARRs as a Percentage of Sales for Representative Agricultural Refilli ng Facilities in Regulatory Options 1, 2, and 3 for the Proposed Pesticide Container Standards (2005$) .................................................... 225

Table E-3. Total Cost (Annual Revenue Requirement or ARR) of the Proposed Pesticide Container and Labeling Standards....................................................................................... 226

Table E-4. Estimated Benefits of the Pr oposed Container and Labeling Standards.................. 227

Table F-1. Grouping Criteria for Administration Through Oral Inge stion, Dermal Contact, and

Inhalation of Dusts and Mists.............................................................................................. 230

Table F-2. Scope of Container Regulations Versus Scope of Other National Regulations and

Standards...................................................................................................................... ........ 233
Table F-3. Comparison of C ontainer Regulations with Ot her National Regulations and

Standards...................................................................................................................... ........ 242
Table F-4. Comparison of Container Regul ations with Other EPA Policies.............................. 263

Table F-5. Eight-State Analysis of Pesticide Container Guidelines.......................................... 268

Table G-1. Comparison of Fina l Container Regulations with Proposed Container Regulations

280
Table H-1. Percent Distribution of Age of Exposure Case by Reason of Exposure ................. 287

Table H-2. Percent Distribution of Exposur e Chronicity to Reason of Exposure..................... 288

Table H-3. Profile of Uninten tional Pesticide and Antimicrobial Exposures by Medical Outcome

289
Table H-4. Percent Distribution of Age of Expo sure Patient by Symptom Severity of Medical Outcome Among “With Concomitants” Exposure Cases ................................................... 290

Table H-5. Duration of Clinical Effect s by Symptom Severity Among Those “With Concomitant” Cases Exhibiting Minor, M oderate or Major Medical Outcomes................ 291

Table H-6. Percent Distribution of Symptom Severity of Medical Outcome by Management Site Among “With Concomitant” Exposure Cases..................................................................... 291

Table H-7. Percent Distributi on of Management Site by Age of “With Concomitant” Exposure

Patient ........................................................................................................................ .......... 292
Table I-1. Benchmark Costs for Physician Offi ce Visits by Current Pr ocedural Terminology, Fourth Edition (CPT-4) Code .............................................................................................. 293

### Page xii Table J-1. Number of Cases in California in 1999 Considered by EPA as “Very Likely” or “Possibly” Preventable by the Container Regulations......................................................... 294

Table J-2. Case Summaries of In cidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly” Preven ted by the Container Regulations ............................... 296

Table K-1a. Number of Containers Within the Scope of the Rule by Container Type, Entity Size,

and Market Sector: Nonrefillable Liquid Pesticide Containers........................................... 307

Table K-1b. Number of Containers Within the Scope of the Rule by Container Type, Entity Size,

and Market Sector: Nonrefillable Solid Pesticide Containers ............................................. 308

Table K-1c. Number of Containers Within the Scope of the Rule by Container Type, Entity Size,

and Market Sector: Refillable Liquid Pesticide Containers ................................................ 310

Table K-1d. Number of Containers Within the Scope of the Rule by Container Type, Entity Size,

and Market Sector: Refillable Solid Pesticide Containers................................................... 311

Table K-2. Number of Contai ners Out of Compliance for the Average Registrant, by Requirement, Market Sector, and Entity Size ..................................................................... 312

Table K-3. Number of Refillable Containe rs by Type of Refilling Entity ................................. 314

Table K-4a. Annual Refillings per Refiller Cu rrently Not in Compliance with Inspection Requirement by Container Type, Ent ity Size, and Market Sector ...................................... 315

Table K-4b. Annual Refillings per Refiller Curr ently Not in Compliance with Container Cleaning Requirement by Container Type , Entity Size, and Market Sector....................... 316

Table K-4c. Annual Refillings per Refiller Cu rrently Not in Compliance with Container Tracking (Recordkeeping) Requirement by Container Type, Entity Size, and Market Sector

317

Table K-5a. Present Discounted Value of Contai ner Rule Compliance Costs, 3% Discount Rate

318

Table K-5b. Present Discounted Va lue of Container Rule Complia nce Costs, 7% Discount Rate

319

### Page 1 

## Economic Analysis of the Final Container Rule

1.0 Introduction

The U.S. Environmental Protection Agency (E PA) is imposing require ments under the Federal Insecticide, Fungicide and Roden ticide Act (FIFRA) for pesticide container design. EPA is also establishing procedures, standards, and label language to facilitate removal of pesticides from containers prior to disposal. Additionally, EPA is imposing requirements for bulk pesticide containment and procedures for container refil ling operations. These re gulations are necessary to implement statutory authority requiring EPA to develop regulat ions for the safe storage and disposal of pesticides as a means of pr otecting human health and the environment.

Sections 19(e) and (f) of FIFRA grant EPA broad authority to establish st andards and procedures to assure the safe use, reuse, storage, and dis posal of pesticide containe rs. FIFRA Section 19(e) requires EPA to promulgate regulations for “the design of pesticide containers that will promote the safe storage and disposal of pesticides.” Th e regulations must ensure, to the fullest extent practicable, that the containers:
(1) Accommodate procedures used for removal of pe sticides from the containers and rinsing of

the containers.
(2) Facilitate safe use of the containers, including elimina tion of splash and leakage.
(3) Facilitate safe disposal of the containers.
(4) Facilitate safe refill and reuse of the containers.

FIFRA Section 19(f) requires EPA to promulga te regulations “prescri bing procedures and standards for the removal of pesticides from containe rs prior to disposal.” The statute states that the regulations may:
(1) Specify, for each major type of pesticide cont ainer, procedures and standards for, at a minimum, triple rinsing or the equi valent degree of pesticide removal.
(2) Specify procedures that can be implemented pr omptly and easily in various circumstances

and conditions.
(3) Provide for reuse, whenever practicable, or disposal of rins e water and residue.
(4) Be coordinated with requirements imposed under the Resource Conservation and Recovery Act (RCRA) for rinsing containers.
Section 19(f) also provides that EPA, in its di scretion, may exempt products intended solely for

household use.

Section 19(h), titled “R elationship to Solid Waste Disposal Act,” specifies that nothing in

Section 19 shall diminish the authorities or re quirements of RCRA. Also, the Food Quality Protection Act (FQPA) of 1996 amended Section 19(h) of FIFRA to add an exemption for certain antimicrobial pesticides.

The following economic analysis (EA) is one of two economic analyses that estimate the costs and benefits of compliance with th e regulations for the safe storage and disposal of pesticides. It estimates the costs and benefits of compliance with the pesticide cont ainer design and residue removal requirements of the final rule, includi ng the container refilli ng requirements and the

### Page 2 label language requirements for pesticide contai ner residue removal. The second EA provides estimates of the costs and benefits of comp liance with the bulk pesticide containment requirements of the final rule. 1



### The EA for pesticide container design and residue removal is organized into five chapters. The first two chapters present the regulatory backgrou nd of the final rule, a description of the final pesticide container standards, a nd a summary of the results of th e EA. Chapter 3 presents an analysis of pesticide container compliance with th e final container standards. Chapter 4 presents the analysis of the estimated costs of complia nce with the final container standards. And Chapter 5 presents the estimated benefits of co mpliance with the final container standards. A detailed description of the scope of the EA is presented in Section 1.2.

1.1 Need for Regulation

The container design and residue removal standards are largely pollution prevention regulations that will safeguard workers, such as loaders, mixers, and applicators, and the environment by reducing the risk of exposure to concentrated pesticides. The improvements in pesticide container designs will enhance th e safe handling, dispensing, use, and residue removal efficiency of pesticide containers. The impr ovement in procedures and/or c ontainer designs will also help facilitate the “clean rinsing” of em ptied containers either prior to disposal or recycling, or prior

to reuse. There are numerous types of human hea lth-related benefits and non-human healthrelated (environment-related) benefits that will stem from such improvements because of relatively fewer expected spills, leaks, and othe r risks associated with exposure (e.g., handling by workers during disposal, discharges to the e nvironment, and potential public exposures).

Table 1.1 summarizes the various ty pes of expected benefits (i .e., improved worker safety, improved public health, reduced environmental risk, and other effects) resulting from the proposed container design/residue removal regulations . It also characterizes the sources of the expected benefits. Other than human health -related and environment-related benefits, the regulation will have other effects such as property damage, personal liability effects, and insurance costs. In addition, there are likely to be cost savings from the disposal of rigid nonrefillable containers as non-hazardous rather th an hazardous waste as a re sult of the regulations,

and a reduction in the number of environmenta l effects and property damage/spill cleanup costs

as a result of the c ontainer regulations.

1 Two separate economic analyses are co nducted for the rule primar ily because the standards for pesticide containers

and the standards for containment of bulk pesticides are different, and, as a result, require two distinct economic analyses. That is, because the standards regulate different structures (containers vers us bulk containment), and different industries (registrants, agricultural refillers , and swimming pool supply companies for the container standards; agricultural refillers and commercial pesticide applicators for the bulk containment standards), different assumptions and inputs will be used in the EA for each se t of standards. Rather than creating a single, lengthy document containing two different economic analyses, the Agency chos e to write a separate document for each EA.

### Page 3 Table 1.1. The Types of Expected Benefits from the Container Design and Residue Removal Regulations and Their Sources

Expected Benefit Source of Expected Benefit

Human Health-Related Benefits

Improved Worker Safety • Reduced accidental spills

• Fewer leaks

• Less dripping

• Less frequent container stress failure (durability, formulation/container degradation)

• Reduced personal sickness and injury

• Improved worker productivity

Improved Public Health • Less risk of exposure to spills and leaking/dripping

• Less contamination of surface water and groundwater sources

• Less personal injury fr om accidental spills and chronic contamination

sources

Non-Human Health-Related Benefits

Reduced Environmental Risk • Reduced accidental spills

• Fewer chronic accumulations of chemicals in loading/mixing/cleaning areas

• Reduced risk of harm from pesticide residues to terrestrial and aquatic wildlife including sensitive and critical habitats

• Less disposal of hazardous containers in landfills

Other Effects • Reduced property damage

• Reduced risk of personal injury and liability

• Lower costs for personal liability insurance

• Reduced disposal costs for cleaner containers

• Reduced loss of product from spills and leaks



### 1.2 Regulatory Background of the Final Rule

In a Notice of Proposed Rulemaking (NPRM) issued on February 11, 1994 (59 FR 6712), EPA proposed standards for pesticide containers a nd containment structures. The proposal included requirements for non-refillable and refillable contai ners that would ensure the safe use, refill, reuse, and disposal of the containers. The pr oposal also included st andards for containment structures, which would promote safe storage of pesticides in bulk contai ners. Additionally, the proposed rule contained amendments to the labe ling regulations in 40 CFR Part 156 to ensure adequate levels of residue removal from containers.

The public comment period for the NPRM cl osed on July 11, 1994. EPA received about 1,900 pages of comments from more than 200 comment ers, including many trade associations and individual companies from the pesticide ma nufacturing, pesticide retail, and container manufacturing industries as well as many state regulatory agencies.

EPA received many comments during the public comme nt period on a few issues. In particular, comments addressed the scope of the container standards and the relationship between the 1994 proposed rule and the Department of Transpor tation (DOT) standards for hazardous materials packaging. A third issue arose from the 1996 passage of the FQPA, which amended Section 19(h) of FIFRA to add an exemption for certain antimicrobial pesticides. To solicit comment on

### Page 4 EPA’s interpretation of the new statutory language on exempting an timicrobial pesticides and to reopen comment on the scope of the container re gulations and an approach for incorporating DOT’s standards, EPA published a supplemental notice in the Federal Register on October 21, 1999 (64 FR 56917, EPA 1999). The notice also provided an alternative definition of small

business for certain sectors of the pesticide industry. The purpose of the alternative definition was for use in analyzing the potential impacts to sm all businesses that were presented as part of the economic analysis. 2



### The public comment period for the supplem ental notice closed on March 20, 2000. EPA

received comments from about 70 respondents, including many trade associations and individual companies from the pesticide manufacturing, pes ticide retail, and cont ainer manufacturing industries as well as many st ate regulatory agencies.

On June 30, 2004, EPA reopened the comment period for 45 days to solicit public input on any policies, market practices, technolo gy, or other issues re lating to this rule’s requirements that would not have been available, or could not have been addre ssed at the time of either the proposed rule in 1994 or the s upplemental notice in 1999. While EPA has attempted to stay current on developments in pesticide container and containment structure policies, regulations, technology, and practices, the Agency believed that it was appropriate to solicit input from the regulated community, state regulators, and others to ensure that we are fully aware of the current state of the pesticide container and containment universe before fi nalizing the pes ticide container and containment regulations. The comment period generated 50 comments mainly from pesticide manufacturers, state regulatory agencies , and agricultural pesticide dealers. (See the preamble to the proposed rule and Section 2.3 of this document for a more complete discussion of comments received by EPA.)

Prior to 1995, recommendations rega rding procedures for storage a nd disposal of pesticides and pesticide containers were listed under 40 CFR Part 165. On June 19, 1995, as part of the federal government’s initiative to streamline regulations , Part 165 was deleted as unnecessary (60 FR 32094) because it contained recommendations rather than requirements. Subpart A of Part 165 covered the scope and definitions in the recomme ndations. Subpart B dealt with EPA’s disposal of suspended and canceled pesticides, and EPA ha s completed disposal of all pesticides for which it was responsible under those regulati ons. Subparts C and D contained recommended procedures for storage and disposal of pesticid e containers. Subparts A, B, C, and D were superseded by the passage of the Resource C onservation and Recovery Act in 1976. FIFRA Section 19, as revised in 1988 and 1996, contains authority for EPA in the area of pesticide storage and disposal, and the fi nal pesticide container and cont ainment regulations promulgated are being inserted into a newly established Part 165.

2 As discussed by EPA in the 1999 Supplemental Notice on Standards for Pesticide Containers and Containment (EPA, 1999b), the alternative definition disaggregates small businesses as defined by the Small Business Administration (SBA) into three size cat egories: small-small, medium-small, and large-small businesses. EPA is concerned that using an overly broad definition of small business in the economic analysis of the regulations may result in significant economic impacts on smaller entities that will be camouflaged when combined with information about potential impacts on facilities that meet the SBA size standard for small business but are not typical of a small business in that industry sector. (See Chapter 3 for industry-specific small business definitions.)

### Page 5 1.3 Scope of the Economic Analysis for the Final Pesticide Rule

The EA conducted for the final pes ticide container standards estimat es the costs and benefits of compliance with four sets of standards, incl uding: (1) container de sign standards for nonrefillable containers; (2) contai ner design standards for refillable containers; (3) repackaging (refilling) standards for refillable containers; and (4) standards for container labeling for all containers. The components of the final pesticide container standards EA include:
(1) A profile of the regulated community. This includes specific economic characteristics of each industry regulated under th e container regulations—such as North American Industry Classification System (NAICS) codes, the average company size, revenues for the average company, total industry revenues, the distribution of firms be tween small and large—to be used to estimate the costs and impacts of the container standards. (See Chapter 3.)
(2) A profile of the containers not in compliance with the final pesticide container design and residue removal requirements. The profile contai ns the estimates and anal ysis of the baseline estimated number of containers, the number of containers covered under the scope of the regulations, and the number of containers not in compliance with the regulations. (See Chapter 3.)
(3) An analysis of the cost of compliance with the final pesticide container design and residue removal requirements. The analysis include s the methodology for cal culating the costs of compliance and the estimates of the costs for standards related to: (a) refillable and non-refillable containe rs—how containers must be constructed, permanently marked, and labeled to ensure safety; (b) refilling—what activities (i.e., container inspection, rinsing, and recordkeeping) are required to ensure that the act of refilling cont ainers does not pose safety or health problems.
The estimated costs are presented at different levels of aggregation for all regulated industries, each industry, a repr esentative facility in each industry, and for each standard. (See Chapter 4.)
(4) An analysis of the small business impacts of compliance with the final pesticide container standards for each regulated industry. Thes e impacts are presented using both the Small Business Administration (SBA) definition of a sm all business, and the alternative definition of a small business adopted specifically for this rule. 3 

### Impacts are estimated as the proportion of increased facility costs to cu rrent facility revenu es. (See Chapter 4.)
(5) An analysis of the human and non-human health-re lated benefits of compliance with the final pesticide container standards. The quantified human health-rela ted benefits are estimated as the cost savings from eliminating containe r-related human exposure incidents. The quantified non-human health-rela ted benefits are estimated as the cost savings from disposing of non-refillable containers as non-ha zardous rather than haza rdous material. (See Chapter 5.)

1.4 Estimated Costs and Benefits of the Final Rule

The pesticide container regulati ons specify a number of standa rds that create costs to the regulated community of bringing containers into compliance with the container standards, as

well as benefits to humans and the environmen t. Improvements in the design and removal of

3 See footnote 2.

### Page 6 residues from containers will benefit humans and the environment by reducing exposures to pesticides from pesticide cont ainers. Table 1.2 provides a su mmary of the final pesticide container design and residue removal standards, which will be described in more detail in Chapter 2.

As is evident from the table, there are a numbe r of requirements common to both non-refillable and refillable containers (i.e., DOT standards and some labeling) , and a number of requirements specific to non-refillable contai ners (i.e., container dispensing cap ability, standardized closures, residue removal, and some labeling) and refillab le containers (i.e., seri al number marking, oneway valves/tamper-evident devices, bulk container requirements, refilling requirements, and some labeling). The EA addresse s each standard sepa rately in regards to pesticide container compliance and the estimated cost of compliance.

Table 1.2. Overview of the Rule Requirements

Non-Refillable

Containers Refillable Containers Refilling Pesticide

Products Labels

1. DOT container design, construction, and marking

standards

2. Container dispensing capability

3. Standardized closures

4. Residue removal

5. Recordkeeping 1. DOT container design, construction, and marking

standards

2. Serial number marking

3. One-way valves or tamper-evident devices

4. Bulk container requirements 1. Pesticide registrants (see Section 3.1) develop

information

2. Registrants and others comply with specified

conditions

3. Refillers (registrants and others) obtain and follow registrant information, and clean, inspect, and label containers before refilling

them 1. Identify container as nonrefillable or refillable (all labels)

2. Statements to prohibit

reuse and offer for recycling; batch code (all non-refillable containers)

3. Cleaning instructions (some non-refillable containers)

4. Cleaning instructions before final disposal (all refillable containers)

5. Leave blank spaces for

net contents and

establishment number (some refillable containers)

Source: Final Container Rule.



### The following two subsections summarize the estimated costs (including small business impacts) and benefits, respectively, of compliance with the final pesticide container standards. Chapters 4 and 5 present the analysis of the estimated co sts and benefits of co mpliance with the final pesticide container standards.

1.4.1 Costs Summary

The total annualized costs of the pesticide cont ainer design and residue removal requirements are estimated to be approximately $8.4 million and $8.5 million at 3 percent and 7 percent discount rate respectively, 4 

### while the total estimated annualized benefits range from $4.7 million to $4.8

4 The total estimated costs are nearly the same at both 3 pe rcent and 7 percent because th e majority of the costs of compliance (as discussed in Chapter 4) are attributed to the container-related standards (i.e., standards for residue removal, recordkeeping, container markings, closures, bulk containers, certification, and labeling), which incur most

### Page 7 million (depending on the discount rate used) 5 

### (see Table 1.3). The estimated non-human healthrelated benefits account fo r more than 90 percent of the quant ified total benefits of compliance with the requirements of the rule.

Assuming 610–768 human health-related illness and injuries potenti ally avoided as a result of the container regulations (see Ch apter 5), the total cost per avoided case ranges from $10,896 to $13,718 (Table 1.3).

Table 1.3. Quantified Costs and Benefi ts of the Rule Requirements (2005$)

Cost/Benefit Category Annualized Cost/Benefit at a

3% Discount Rate Annualized Cost/Benefit at a

7% Discount Rate

Total Cost $8,367,385 $8,449,929

Total Benefits $4,735,981–$4,804,240 $4,235,280–$4,296,452

Human Health-Related Benefits $264,051–$332,311 $236,635–$297,807

Non-Human Health-Related Benefits $4,471,929 $3,998,645

Total Cost Per Avoided Hu man Health-Related Case

Number of Cases Avoided 610–768 Cases 610–768 Cases

Total Cost Per Avoided Case $10,896–$13,718 $11,003–$13,852



### Table 1.4 provides a summary of the estimated a nnualized cost of compliance with the final container design and residue removal standards (at a 3 percent discount rate) for the average entity and totaled for each of the regulated industries (i.e., pest icide registrants, agricultural pesticide refillers, and swimming pool s upply companies), across all market sectors 6 

### for each entity size category (i.e., large, large-small, medium-small, and small-small). The costs include the estimated cost of compliance with the st andards for residue removal, recordkeeping, container markings, container openings, bulk cont ainers, labeling, and repackaging. The other standards (i.e., DOT packaging, c ontainer closures, and containe r dispensing) do not have any

costs associated with them due to the availability of containers compliant with these standards as discussed in Chapter 3.

The estimated costs are highest for pesticide regi strants, accounting for mo re than 70 percent of the total cost of compliance. Pesticide registrants are primaril y responsible for the pesticide container-related standards (i.e., residue remova l, recordkeeping, container markings, container openings, bulk containers, and labeling), although they do have some repackaging responsibilities (i.e., inspection, cleaning, and recordkeepin g) in both the agricultural and industrial/commercial/ government markets. Th e estimated costs for agricultural pesticide refillers and swimming pool supply companies, which are responsible for the pesticide container refilling requirements in th eir associated markets, are significantly less (Table 1.4).

of their costs in the first year of compliance. The refillin g-related requirements (contain er inspection, cleaning, and recordkeeping before each refill), which re present a smaller proportion of total co sts, are estimated to be nearly the same each year.

5 For ease of presentation, the estimates using only the 3 pe rcent discount rate will be presented in the text of the document. Chapters 4 and 5 present in tabular format the estimated costs and benefits of compliance with the final container standards, respectively, at both the 3 percent and 7 percent rates.

6 The market sectors analyzed include the agricultural, industrial/commercial/government (I/C/G), and home and garden (H&G) market sectors. See Chapter 3 for a description of each market sector.

### Page 8 Table 1.5 provides a summary of th e total estimated annua l cost of compliance by final pesticide

container standard. As a resu lt of assumed pesticide container compliance, no costs of compliance are estimated for meeting the DOT packaging standards, closure standards, and standards for container dispensing capability for non-refillable containers, and the DOT packaging standards for refillable containers. Approximately 16 percent of the cost of compliance is attributed to compliance with the residue removal standards. The refilling-related standards and labeling standards account for 38 percent and 27 percent of the total cost of compliance, respectively.

### Page 9 Table 1.4. Estimated Annual Cost of Compliance a 

### with the Final Container Design and

Residue Removal Standards for the Average Regulated Entity (2005$)

Cost for the Average Regulated Entity b Cost over All Regulated

Entities b, c

Regulated Entity Number of

Entities Interest Rate =

3% Interest Rate =

7% Interest Rate =

3% Interest Rate =

7%

Pesticide Registrants

Small $1,806 $1,936 $2,993,825 $3,209,477

Large-Small 166 $5,434 $5,975 $903,024 $992,891

Medium-Small 495 $2,613 $2,854 $1,293,158 $1,412,186

Small-Small 997 $800 $807 $797,642 $804,400

Large 146 $17,967 $19,078 $2,623,114 $2,785,386

Total d $5,616,939 $5,994,863

Agricultural Pesticide Refillers

Small $88 $80 $1,464,350 $1,330,876

Large-Small 251 $871 $764 $218,684 $191,692

Medium-Small 2395 $267 $237 $640,191 $566,418

Small-Small 13996 $43 $41 $605,474 $572,767

Large 153 $7,255 $6,336 $1,110,296 $969,709

Total d $2,574,646 $2,300,585

Swimming Pool Supply Companies

Small $19 $20 $5,808 $6,034

Large-Small 14 $34 $33 $474 $458

Medium-Small 117 $23 $24 $2,732 $2,755

Small-Small 174 $15 $16 $2,602 $2,821

Large 17 $10,000 $8,732 $169,993 $148,448

Total d $175,800 $154,481

Total Cost Across All Regulated Industries e $8,367,385 $8,449,929

a See Chapter 4 for information on calculations and estimated costs.

b For pesticide registrants, average entity costs and costs for all entities by entity size are averaged across all market sectors (see Chapter 4).

c For each industry, costs across all entities are found by multiplying the average entity cost by the number of entities of that size. May not be equal to the multiplication of the numbers in the table due to rounding.

d Total equals the sum of the cost over all regulated entities for each industry.

e Total Cost Across All Regulated Industries equals the sum of Total for each industry.

### Page 10 Table 1.5. Estimated Annual Cost of Compliance with the Pesticide Container Design and Residue Removal Standards by Standard a

Annual National Cost

(3% Interest Rate)

Standard Interest Rate = 3 percent Interest Rate = 7 percent

For Non-Refillable Containers

DOT Packaging Standards - hazardous material $0 $0

DOT Packaging Standards - non-hazardous

material $0 $0

Closure Standards $0 $0

Standards for Container Dispensing Capability $0 $0

Residue Removal Standards $1,465,967 $1,343,068

Other Administrative Requirements - recordkeeping $202,617 $210,575

For Refillable Containers

DOT Packaging Standards - hazardous material $0 $0

DOT Packaging Standards - non-hazardous

material $0 $0

Standards for Container Markings $241,402 $227,685

Standards for Openings (for liquid minibulks 7
only) $261,018 $291,648

Bulk Container Standards $574,504 $641,923

Other Administrative requirements - recordkeeping $138,849 $136,753

For Refilling $3,198,256 $2,849,969

For Labeling $2,252,148 $2,715,685

Cost of Waivers $32,624 $32,624

Total National Annual Cost $8,367,385 $8,449,929

a See Chapter 4 for information on calculations and estimated costs.



### As discussed later in Chapter 4, small businesses are not estimated to be significantly impacted by compliance with the final container design and residue removal requirements. The estimated costs of compliance for small businesses in each of the regulated industries, as a proportion of their current revenues, are estimated to be le ss than 1 percent. Using the Small Business Administration (SBA) definition of small busin esses, the costs of compliance for small businesses are estimated to be less than 0.02 perc ent of the current aver age entity revenues. According to the alternative small business definiti on used in this analysis (which further divides small businesses into large-small, medium-small, and small-small business), 8 

### no small business

is estimated to incur costs that account for mo re than 0.04 percent of current average entity

revenues.

7 Minibulks are bulk containers of liquid pesticide greater than 55 gallons but less than 500 gallons and dry pesticide containers greater than 100 pounds and less than 400 pounds in capacity.

8 See footnote 2.

### Page 11 1.4.2 Benefits Summary

Table 1.6 presents the human and non-human hea lth-related benefits of the final pesticide container standards as discussed in Chapter 5. The estimated annual human health-related benefits of compliance with the final containe r standards are estimated to range from $264,051 to $332,311 due to the cost savings fr om avoiding 610–768 container-relate d incidents as a result of

the final container standards. The estimate d annual non-human health -related benefits of compliance with the final container standards are estimated to range from $4.0 million to $4.5

million. These benefits are estimated as the cost savings from disposal of non-refillable pesticide containers as non-hazardous material, rather than hazardous material, as a result of the final pesticide container regulations. Additional, non- quantified benefits include the reduction in the

number of environment-related incidents of exposure, and avoided property damage/spill cleanup costs, which suggest that the social value of the benefits is higher than the quantified amount (see Chapter 5 for a more detailed discussion).

Table 1.6. Estimated Benefits Associated with the Final Pesticide Container Design and Residue Removal Regulations (2005$) a

Benefit Category Type of Benefit Estimated Benefits

Avoided cases • 610–768 cases annually (= $264,051–$332,311 in annualized health benefits)

• Additional 1,945 to 2,449 cases annually with “possible” cases (= an additional $841,644 million to $1,059,240 in annualized health benefits)

Improved worker safety • Possible health benefit; lost productivity valued as part of

health benefits from avoided casesHuman HealthRelated

Benefits

Improved public health • Possible health benefit; continued benefit of avoided cases throughout the compliance schedule

Tipping fee cost savings for

non-refillable containers • $4,471,929 (3% discount rate)–$3,998,645 (7% discount rate) in annualized cost savings

Environment-related effects • Damage reduction from fewer exposures of terrestrial and aquatic wildlife, including those in sensitive and critical habitats, to pesticides and residues Non-Human

Health-Related

Benefits

Avoided property damage/spill cleanup costs • Pesticide container rules will prevent property damage and/or

reduce the costs associated with unintended, container-related pesticide releases

a See Chapter 5 for the discussion of human health -related and non-human h ealth-related benefits.



### 1.5 Limitations of the Final Rule Economic Analysis

Conducting the EA for the final pesticide contai ner standards required extensive information. For example, in determining the baseline level of pesticide container co mpliance with the final standards, information had to be obtained on: (1) the number of existing refillable and nonrefillable containers, by contai ner type, size, and end-use mark et; (2) the number of existing

refillable and non-refillable containers that fall under the scope of the co ntainer rule; and (3) the

number of refillable and non-refillable containers that fall under the scope of the container rule and that are in compliance with each container design and residue remova l standard. To obtain the information necessary to complete the analysis, EPA relied on the regulatory impact analysis (RIA) conducted for the proposed container design and residue removal standards (EPA, 1993).

### Page 12 Contacts with industry experts and various state and federal agency personnel (including EPA personnel), as well as a review of the literature, were us ed to estimate, verif y, and update the data throughout the report to the extent possible. 9 

### We make every attempt to clearly state the assumptions throughout the analysis, and we presen t a sensitivity analysis in Chapter 4. The sensitivity analysis presents the costs of complia nce with the container standards using lower and upper bounds on the assumptions used in the EA.

In summary, Chapter 1 has presented the statut ory basis for the promulgation of the pesticide container standards final rule, a summary of th e regulatory history of the standards, and a summary of the results of the EA . The next chapter continues w ith the introduction to the final pesticide container standards; pr esenting the final pesticide cont ainer design and residue removal standards, the changes in the standards from the proposed to the final standards, the response to comments to the proposed standards, and the econo mic impacts (i.e., the change in the costs and benefits of compliance) of the changes from the proposed to the final standards. The final three chapters (Chapters 3, 4, and 5) pr esent the analysis of the costs and benefits of compliance with the final pesticide c ontainer standards.

9 The RIA for the proposed standards for pesticide container design and residue removal was a major source of the

data used in the EA for the final standards. EPA verified and updated the majority of the data used. However, it was infeasible to reconstruct some of the data, and EPA therefore used the data as presented in the RIA for the proposed container standards.

### Page 13 

## 2.0 Final Rule Standards and Comparison of the Costs and Benefits of the Final and the Proposed Rule Standards

Chapter 1 presented the regulatory history of th e pesticide container a nd bulk containment rule, an analysis of the scope of the EA, and a summar y of the results of the EA. In Chapter 2, the final pesticide container design and residue removal standards are presented. These are the standards for which pesticide container compliance is determined in Chapter 3, and for which we

estimate the costs and benefits of compliance in Chapters 4 and 5, respectively. Chapter 2 also presents a description of the changes made in th e pesticide container standards from proposed to final, and presents a comparison of the costs a nd benefits of compliance estimated for the final and proposed container standards.

2.1 Final Rule Standards

Until now, the design of containers holding pesticides has been guided only by an interrelated combination of nationwide recommendations, 10 

### federal regulations, 11 

### and state regulations and standards. (See Appendix F for complete discussion of these standards.) These recommendations, regulations, and standards form the basis for the final rule for pesticide container design and residue removal. Given the la rge set of standards alr eady in existence, this rule is primarily a harmonizing and consolida tion exercise, and EPA estimates that most containers are in compliance with many aspects of the rule because containers are already meeting a variety of other standards, as discus sed in more detail in the pesticide container compliance profile presented in Chapter 3.

The pesticide container standards as described below are the end re sult of revisions made to the 1994 proposed standards for pesticide containers, based on the public comments submitted and discussions with a number of interested part ies, including other EP A offices, government agencies, and the regulated community (see Sec tion 2.2 for a discussion of the changes in the standards from proposed to final and Appendix G for a comparison of the proposed and final pesticide container standards.) Th e first seven standards presented apply to certain non-refillable and refillable containers (as specified for each standard), while the eighth standard (the repackaging standard) applies only to refillable containers, and the final labeling standard applies to all containers. The final pesticide contai ner design and residue removal standards are as

follows:

(1) Pesticide Container Design Standards

The final container standards a dopt a subset of the Departme nt of Transportation Hazardous Materials Regulations (DOT HM R) packaging standards at the Packing Group III level for pesticides not classified as DOT hazardous materi als. Pesticides that are classified as DOT hazardous materials must comply with all applicable DOT regulations. For the purpose of enforcing the pesticide containe r regulations, the final rule identifies the DOT requirements for all three packing groups that are “equivalent” to the Packing Group III re quirements applicable to products that are not DOT hazardous materials. Under the regulations, sale or distribution of

10 United Nations (1999); Mid America Crop Protection Association (MACA, 1999 and 1986).

11 Department of Transportation Hazardous Materials Regulations (DOT HMR) (49 CFR Parts 107-179).

### Page 14 pesticides in containers not meeting all of th e standards (the specifi cally listed ones in the pesticide regulations and the adopted DOT pack aging standards) is prohibited. Both nonrefillable and refillable pesticide co ntainers must meet these standards.

(2) Pesticide Container Permanent Markings

The regulations for non-refillable pesticide containe rs and refillable pestic ide containers refer to and adopt the DOT standards, which include marking requirements. Additionally, the regulations require a serial num ber or other identifying code fo r each refillable container.

(3) Pesticide Container Dispensing Capability

The regulations stipulate that li quid pesticide non-refillable cont ainers with a capacity greater than 20 liters (5.3 gallons) be designed to el iminate splash and leakag e during normal pouring of the contents. No dispensing capability require ments are specified for refillable pesticide

containers.

(4) Pesticide Container Closures

Four closures are specified for non-refillable ri gid containers having a capacity greater than 3.0 liters for liquid agricultural pesticides, and th e final standard should not overlap with the Child-Resistant Packaging requirements. Liquid minibulk refillable containers (refillables) require a one-way valve, tamper-evident device, or both on each opening. Liquid bulk refillables must be equipped with a pressure-relieving devi ce and locking shutoff valve, and cannot have external sight gauges.

(5) Pesticide Container Residue Removal Design Standard and Procedures

With regard to non-refillable containers, the regu lations specify that every registrant test three containers from each rigid container/dilutable fo rmulation combination to determine that the containers are capable of achieving a “four-9s” laboratory performance standard (a reduction of the original active ingredient concentrate to 0.01 per cent in a fourth rinse, equivalent to 99.99 percent removal). Percent removal represents the percentage of the original concentration of the active ingredient in the pesticide product when compared to the concentration of that active ingredient in the fourth rinse according to a formula.

(6) Pesticide Container Standards Waiver

The regulations include procedures for allo wing a compliance waiver from adopting the specified DOT requirements for both non-refillable and refillable containers. In addition, for non-refillable containers, the regu lations provide for waivers from the standard closure, container dispensing, and residue removal standards.

(7) Pesticide Container Recordkeeping

The regulations require several types of recor dkeeping. The first addresses the documentation

that the container used meets each aspect of the non-refillable container design standards. For non-refillables, the period extends for as long as the container design ty pe is used with the registered pesticide pr oduct, plus 3 years.

### Page 15 The second type of recordkeeping requirement in volves records kept by the registrants regarding repackaging. The registrants are required to k eep copies of the contra cts or authorizations, residue removal procedures for refilling, and list of acceptable containers for the current operating year and for 3 years thereafter.

The third type of recordkeeping involves refillers keeping copies of the documents identified in the previous paragraph for the registrants for th e current operating year a nd for 3 years thereafter (as with the registrant recordkeeping).

The fourth type of recordkeeping involves information the refillers have to record when they repackage and when they receive refillable contai ners. Refillers must record three pieces of information when a pesticide is repackaged. No recordkeeping is required when a refillable

container is received. These reco rds must be kept for 3 years.

(8) Pesticide Container Refilling

Registrants who directly sell or di stribute pesticide products in ref illables or sell or distribute pesticide products to refillers for repackaging are held responsible for providing instructions and documentation for refilling. Refillers who repackag e pesticide products into refillable containers for distribution or sale must comply with th e refilling residue remova l procedure developed by registrants and can repackage any quantity of a pesticide product into a refillable container up to the rated capacity of the container. In addition, refillers must inspect th e exteriors and interiors

of the containers to ensure that the containers meet the necessary criteria for container integrity, required markings, and openings. Refillers must also clean each refillable container according to the residue removal procedure for pesticide prod uct refilling (supplied by the registrant) before repackaging the product, unle ss certain criteria are met.

(9) Pesticide Container Labeling

The scope of the labeling requirement includes all labels for all pesticide products, not just those that fall within the scope of the non-refillable co ntainer, refillable container, and repackaging (refilling) regulations. However, the final regulations exempt hous ehold products from the residue removal instructions. Labels may includ e blank areas to allow a refiller to put any amount of product into a refillab le and designate on the label the amount and to add its EPAdesignated number for the refilling establishment. Other information to be included on the label is a description of the containe r type giving its intended purpose (such as a refillable or nonrefillable statement) and detailed residue rem oval instructions. The regulations state that household products are exempt from requiring residue removal inst ructions on their labels and that durable permanent marking (versus permanent marking) is acceptable.

The level of required compliance for a pesticide pr oduct to these standards is not the same for all products. While the labeling stan dards apply to all pesticide pr oducts, there is a subset of pesticide products that are not subject to the pesticide non-refillable and refillable container design standards and refilling standards. The level of compliance with these requirements depends on a number of factors, such as th e type of product (e.g., end-use, manufacturing, antimicrobial), toxicity of the product, and use of the product. Chapte r 3 provides a complete description of the scope of the pesticide container requirements.

### Page 16 2.2 Changes in Pesticide Container Design and Residue Removal Standards from the Proposed to the Final Rule

The final pesticide container design and residue removal standards differ significantly from the 1994 proposed standards. The final standard s are narrower in scope than the proposed regulations, exempt certain anti microbial pesticides, require le ss stringent container design and residue removal requirements, and adopt some of the Department of Transportation (DOT) hazardous materials regulations. As a result, the estimated economic impacts on the regulated community under the final standards are differe nt from the estimated economic impacts under the proposed standards.

EPA received approximately 1,900 pages of comm ents from more than 200 commenters (e.g., trade associations, pesticide manufacturers, pe sticide retailers, and many state regulatory agencies) on the proposed rule. In response, two significant issues we re readdressed, and the comment period was reopened in 1999. The two i ssues were: (1) the sc ope of the container standards; and (2) the relations hip between the 1994 proposed rule and the DOT standards for hazardous materials packaging. In the final rule (as discussed below), EPA has revised the scope

of the container standards to be risk-based w ith exemptions, and has adopted many of the design and construction standards that would apply to DOT Packing Group III materials. These and other changes made to each standard are as fo llows. (See Appendix G for additional information on the changes from the proposed to the final rule.)

(1) Scope of the Pesticide Container Design and Residue Removal Standards

Regarding the scope of the pesticide containe r design and residue removal regulations, the proposed regulations generally affected all cont ainers used to packag e pesticide products, without regard to industry, use, risk, or cont ainer type and size. Only manufacturing use products were exempt from the proposed regulat ions. The final rule exempts manufacturing use products, plant-incorporated protectants, a nd certain antimicrobial products from the nonrefillable container, refillable container, a nd repackaging (refilling) regulations. All other products are subject to the container-related re gulations, although the numb er of non-refillable container standards is greatly reduced for some products. As proposed, all pesticide products (except household products) are subj ect to the container labeling re quirements in the final rule.

(2) Pesticide Container Design Standards

The proposed regulations included some very gene ral design standards, but also included some specific tests, such as a drop te st for minibulk containers. The final standards specify some DOT HMR packaging standards for pesticides classified as DOT hazardous materials. Pesticides that

are not classified as DOT hazardous materials are required to be packaged in accordance with the specified design and construction standards th at would apply to a DOT Packing Group III

material.

(3) Pesticide Container Permanent Markings

The proposed standards required many more specifi c permanent markings for non-refillable and

refillable containers. For example, non-refillables requi red the EPA registration number and name and a symbol or code of materials used to make the container, a nd refillables required the statement, “Meets EPA standards for refillable c ontainers.” The final re gulations, as described

### Page 17 above, refer to and adopt the DOT standards for non-refillables and refillables (which specify certain markings), and require a serial number or other identifying code for each refillable

container.

(4) Pesticide Container Dispensing Capability

The proposed regulations stipulated that liquid cont ainers be designed to eliminate the splash and leakage during normal pouring of th e contents, closing or resea ling the container, and during storage and cleaning of the cont ainer. The final regulations regarding pouring are the same except that they apply only to non-refillables liqu id containers with a capacity greater than 20 liters (5.3 gallons). The proposed requirement to reseal completely was not finalized because an equivalent requirement is included in the adopted DOT standards.

(5) Pesticide Container Closures

The proposed and final standards for container closures are the same.

(6) Pesticide Container Residue Removal Design Standard

With regard to non-refillable containers, the prop osed regulations specifie d that registrants must demonstrate that each rigid/di lutable container/formulation co mbination achieved a “six-9s” laboratory performance standard (a reduction of the original ac tive ingredient concentrate to 0.0001 percent in a fourth rinse, equivalent to 99.9999 percent removal). The final regulations require that every registrant test three containers from each rigid container/dilutable formulation

combination to determine that the containers are capable of attaining at le ast 99.99 percent removal of each active ingredient in the fourth rinsate after a triple rinse.

(7) Pesticide Container Design a nd Residue Removal Standard Waiver

The proposed regulations permitted a waiver for standard closures and the residue removal standard only (non-refillable containers), whil e the final regulations include provisions for both

non-refillable and refillable containers to waiv e adoption of the subset of DOT standards, and, for non-refillables, the standard closure, contai ner dispensing, and residue removal requirements.

(8) Pesticide Container Certification

The proposed rule required registrants to certify th at the non-refillable and refillable containers

used for the distribution or sale of pesticides meet the container design standards. The final rule does not require certification.

(9) Pesticide Container Recordkeeping

The proposed and final regulations require simila r types of recordkeepin g, although the final rule requires fewer records and decreases the length of time that many of the records must be kept.

(10) Pesticide Container Refilling

The proposed and final regulations contain near ly the same requirements for the refilling of pesticide containers, including spec ific guidelines for registrants and refillers. However, the final rule changes two of the condi tions to: (1) require a contract between the parties (rather than

### Page 18 a contract or an authorization as proposed); a nd (2) allow repackaging at an end user location under certain circumstances (rat her than requiring the repack aging to be conducted at a registered establishment as proposed).

(11) Pesticide Container Labeling

The proposed and final regulations for container la beling are similar, but the final regulations are generally more flexible because they provide a ra nge of specific statements. While the proposed regulations required the residue re moval instructions on all rigid non-refillable containers with dilutable products, the final regulations exem pt household containers and allow for durable container markings (rather than only permanent as proposed).

2.3 Response to Comments to the Proposed Standards

As previously mentioned, EPA received appr oximately 1,900 pages of comments from more than 200 commenters in response to the proposed pest icide container standard s. The majority of

the comments received were directed toward th e proposed container standa rds and their effect on the regulated industries, resulting, in part, in the changes to the proposed standa rds as described in the previous section. Only a relatively sm all portion of the comments submitted in response to the proposed container standards were directed toward the regulatory impact analysis (RIA) conducted for the proposed container standards. As a result, there were few changes made in the assumptions used to calculate the costs of comp liance from the proposed to the final container

standards based on the comments submitted. Rath er, the differences between the proposed and final rule economic analyses (EAs) primarily refl ect changes made in the scope and requirements

of the container standards.

There are two exceptions. The first is the cons ideration of the swimming pool industry in the final EA. This industry was not considered se parately in the RIA fo r the proposed container

standards. As a result of comments subm itted by the swimming pool industry, which provided a reasonable justification for being considered separately, 12 

### the EA for the final standards considers swimming pool supply companies rela tive to the refilling st andards. The other exception is the calculation of the indirect, non-he alth benefits in the RIA associated with the

movement from non-refillable to refillable contai ners. In the proposed rule, these indirect benefits (see Section 2.4) were estimated, a nd, in response, a number of comments were submitted by the regulated industry questioning th e magnitude of these benefits. Although EPA

still maintains that there could be a shift from non -refillables to refillable containers as a result of the final pesticide contai ner standards, EPA acknowledges that there is more uncertainty in the assumptions made in the analysis of indirect bene fits and the magnitude of these benefits than is made evident in the proposed rule RIA. As a result, the EA for the final pesticide container standards does not attempt to qua ntify these indirect benefits.

12 The swimming pool industry, which includes pool, spas, hot tubs, and whirlpools, succes sfully argued that it is unique because it uses and refills a large number of small refillables (an estimated 1 million 1- or 2.5-gallon containers).

### Page 19 2.4 Comparison of the Estimated Costs and Benefits of the Final and Proposed

Standards

As described in Section 2.2, EPA made a numbe r of significant cha nges to the pesticide container standards from the proposed to the final st andards. As a result, there are differences in the level of compliance with these standards for ex isting containers, leading to differences in the estimated costs and benefits of compliance with the pesticide container standards between the proposed and final rule. Tables 2.1 and 2.2 pr esent the estimated costs and benefits of compliance for the final and proposed pesticide container standards.

Table 2.1. Annual Compliance Cost Compar ison Between the Final and Proposed Pesticide Container Standards (2005$)

Cost Item Compliance Cost for Final

Container Standards a Compliance Cost for Proposed

Container Standards b

Total Cost of Compliance $8.4 million $40.1 to $55.5 million

Total Cost of Compliance by Regulated Industry

Pesticide Registrants $5.6 million $27.3 to $37.3 million

Agricultural Pesticide Refillers $2.6 million $4.7 million

End Users No Analysis Completed $8.2 to $13.6 million

Swimming Pool Supply Companies $0.2 million No Analysis Completed

Total Cost of Compliance by Standard

Container-Relat ed Standards c $2.9 million $22.2 to $32.2 million

Refilling-Related Standards d $3.2 million $4.7 million

Labeling Standards $2.3 million $13.3 to 18.7 million

a See Chapter 4 for the cost analysis of the pesticide cont ainer regulations. Figures presented here are calculated using a 3% discount rate. Figures for both 3% and 7% discount rates are presented in Chapter 4.

b Based on the costs estimated for Regulatory Option 2 in the proposed rule RIA for pesticide containers, which was EPA’s preferred option in the proposed rule. The range of cost estimates results from the consideration of two scenarios under each regulatory option (see Appendix E).

c The container-related standards include DOT packaging standards and recordkeeping standards for refillable and non-refillable containers; closure standards, standards fo r container dispensing, and residue removal standards for non-refillables; and standard s for container marking, openings, and bul k containers for refillable containers.

d The refilling-related standards include the inspection, cleaning, and recordkeeping of refillable containers.

### Page 20 Table 2.2. Comparison of Human Health-R elated and Non-Human Health-Related Benefits for the Proposed and Final Container Standards (2005$)

Benefit Category Final Container Standards a Proposed Container Standards b

Human Health-Related Benefits

Avoided Cases • 610 to 768 cases annually (= $264,051 to $332,311 in annualized health benefits per year)

• Additional 1,945 to 2,449 cases annually with “possible” cases (= an additional $841,644 to $1,059,240 in annualized health benefits) • 1,650 to 2,250 acute illnesses annually

Improved Worker Safety • Possible health benefit; lost productivity valued as part of health

benefits from avoided cases • Reduced personal sickness and injury

• Improved worker productivity Improved Public Health • Possible health benefit; continued benefit of avoided cases throughout the compliance schedule • Less personal injury from accidental spills and chronic

contamination sources

Non-Human Health-Related Benefits

Non-Refillable Container Disposal Benefit (2005$) • $4.5 million per year • $5.6 to $6.9 million per year

Non-Refillable to Refillable

Container Benefit • Not quantified • $36 to $109 million per year

a See Chapter 5 for the pesticide container regulations huma n health related and non-human health related benefits analysis. Figures presented here are calculated using a 3% discount rate. Figures for both 3% and 7% discount rates are presented in Chapter 5.

b Proposed container rule RIA (EPA, 1993, pg. XIV-3). See Appendix E.



### The total cost of compliance with the final standa rds is estimated to be significantly lower than

the estimated total cost of co mpliance with the proposed standa rds (see Table 2.1). This is primarily the result of the cha nges in the container standards fr om the proposed to final rule. One of the significant changes be tween the proposed and final pest icide container rule is the elimination of the labeling standard requiring ho usehold users to triple rinse non-refillable containers prior to disposal. The estimated co st of this requirement accounts for a significant portion of the difference between the final and proposed container standards in terms of estimated total cost and estimated labeling standa rds cost, and all of the difference between the end user costs (which are not expected in the final rule without the labeling requirement for household users to triple rinse cont ainers prior to disposal).

The difference in costs between the final and pr oposed rule for pesticide registrants (and the container-related standards, for which the pestic ide registrants are respon sible) is attributed primarily to the changes in the container standard s from the proposed to final rule. Change in residue removal standards, which are now applicab le to only flowable concentrate products, has significantly reduced the total cost of the rule. In addition, reduction in the estimated time to inspect, clean, and record information for refillable containers and the elimination of certification requirements also account for the difference be tween the total estimated costs for pesticide refillers (and the refilling-related standards) to comply with the final container standards versus the proposed container standards. Swimming pool supply companies face similar costs for refilling; however, this industry was not addressed in the proposed rule RIA. The proposed rule RIA for pesticide containers estimated costs to refill containers for agricultural refillers only, ignoring not only the swimming pool indus try, but also some agricultural and

### Page 21 industrial/commercial/government product refilli ng responsibilities (and therefore increased costs of compliance) for pesticide registrants.

Table 2.2 presents the estimated human health-related and non-hum an health-related benefits of compliance with the final and proposed container st andards. Both analyses estimate the number of potentially avoided illnesses. In addition, there were other human health-related benefits discussed qualitatively in the proposed regula tions, such as improved worker safety and improved public health, which remain relevant to the final regulations. In the RIA for the proposed container standards, the avoided cases were es timated by extrapolating 1988–1989

California incident data to the na tional level. For that analys is, the number of cases per year

found to be attributable to cont ainer-related problems in California was assumed to represent approximately 10 percent of the nation’s total, resulting in a total a nnual estimate of 1,650 to 2,250 potentially avoided cases. In the EA for the fi nal standards, it is similarly assumed that the percentage of illnesses related to pesticide pr oducts occurring in California in 1999 would not differ significantly from the United States as a wh ole. However, unlike the proposed regulations, this ratio is applied to nationa l data on pesticide exposures, rath er than extrapolating it to a

national estimate. The EA for th e final container standa rds also estimates dollar benefits for the potentially avoided cases as a re sult of the final cont ainer standards, which was not done in the RIA for the proposed container standards. The to tal human health-related be nefits calculated in the final rule EA ($264,051 to $332,311 pe r year) are estimates of the co sts avoided as a result of estimated avoided cases of pesticide illness. Th e analysis considers costs including outpatient costs, inpatient costs, the value of lost pr oductivity, and the value of premature mortality.

The only quantified non-human h ealth-related benefits calculated in the EA for the final pesticide container standards is the annual cost-saving benefit asso ciated with the diversion of

non-refillable containers from the hazardous wa ste management stream to the solid (nonhazardous) waste stream. This a nnual benefit was also calculated in the RIA for the proposed pesticide container standards. The differences between the resu lts of the two analyses stems from the changes in the scope criteria in the final rule, leading to a smaller number of containers

estimated to be diverted from the hazardous to no n-hazardous waste stream in the final rule EA, and, as a result, lower estimated dollar benefits.

In addition to the non-refillable container dispos al benefits, the RIA for the proposed container

standards estimated indirect benefits associated with the switch from use of non-refillable

containers to refillable containe rs, which was expected (not require d) as a result of the container standards. The types of indir ect cost savings estimated as a result of the switch to refillable containers include: (1) contai ner cost savings, (2) containe r disposal cost savings, and (3) substantial labor savings associated with tr iple rinsing of used non-refillable pesticide

containers. The sum of indirect benefits wa s estimated to range from $36 million to $109 million. These benefits are not quantifie d in the final container standards EA.

In summary, this chapter presented (1) the fi nal standards for pestic ide containers and the changes that have been made to the standards from the proposed to th e final rule, and (2) a summary of the estimated costs a nd benefits of compliance with the final and with the proposed pesticide container standards. The remaining thr ee chapters present the analysis of the costs and benefits of compliance with the final pesticide contai ner standards. The first step in this analysis

### Page 22 (Chapter 3) involves determining the level of co mpliance of pesticide containers with the final

container standards. This information feeds into the second step of the analysis (Chapter 4), which estimates the cost of compliance with the final standards. The final step (Chapter 5)

estimates the benefits to humans and the environment expected to result from compliance with the final pesticide c ontainer standards.

### Page 23 

## 3.0 Pesticide Container Compliance Profile

3.1 Introduction

This chapter presents a baseline regulatory compli ance profile of pesticide c ontainers that will be affected by the container regulations. In gene ral, the container regul ations address four categories, which include:

• Non-refillable cont ainer standards;

• Refillable container standards;

• Repackaging of pes ticide products; and

• Container labeling.

The container regulations compliance affects several types of entities across multiple pesticide market sectors. The three entities that are pote ntially affected by the c ontainer regulations are pesticide registrants, agricultura l pesticide refillers, and swim ming pool supply companies. The following is a description of each of these entities as well as a de scription of how these entities are affected by the container rule. For a more detailed description of each entity type see Appendix D.

• Pesticide registrants include all establishments engaged in the formulation and preparation of all types of pesticid es (e.g., insecticides, fungicides, and he rbicides). This regulated entity includes both pesticide manufact urers and independent formul ators who hold one or more pesticide registrations. Regist rants include those who distribu te or sell pesticides in nonrefillable containers or refillable containers dire ctly, those who distribute or sell pesticides to independent formulators or refi llers, and in some cases dire ct refiller establishments.

Pesticide registrants are basically required to ensure that all non-refillable and refillable

containers meet the container rule construc tion and design standards, develop and provide information to refillers, and ensure that labe ls include the specified information. Pesticide registrants are responsible for procedural and handling activities for approximately 10 percent of the refillables in th e agricultural market (Paulson, 2002) and all of the refillables in the industrial/commercial/gove rnment (I/C/G) market. 13 

### The primary NAICS code designation for pesticide regist rants is 325320 – Pesticide and Other Agricultural Chemical Manufacturing. 14 

### The Dun & Bradstreet (D&B) database of company information and financial data provides NAICS codes with company information where available. Registrants may serve one or more of the pest icide use market sectors (i.e., agricultural,

13 Don Paulson recently retired from Ciba /Novartis and is currently a consultant to Syngenta and CropLife America, formerly the American Crop Protectio n Association (ACPA). Mr. Paulson wa s very active in the ACPA packaging task force in the 1990s and co-surveyed the number of agri cultural pesticide containers for ACPA with Tom Gilding

between 1989 and 1996.

14 Other NAICS codes associated with pesticide registrants include: (1) 422690 – 1997 NAICS - Otr Chem & Allyd Prdct Whlslrs, (2) 422910 1997 NAICS – Farm Supplies Wholesalers, (3) 325612 – Polish and Other Sanitation Good Manufacturing, (4) 325998 – All Other Miscellaneous Chemical Product and Preparation Manufacturing, (5) 325188 – All Other Basic Inorganic Chemical Manufacturing, (6) 453998 – All Other Miscellaneous Store Retailers (except Tobacco Stores), and (7) 325412 – Pharma ceutical Preparation Manufacturing. (See Appendix D.)

### Page 24 industrial/commercial/government, and/or home a nd garden). (See below for a discussion of each market sector.)

• Agricultural pesticide refillers include only independent agricultura l market sector refillers. The agricultural pesticide refiller entity is generally an agricultural chemical dealer (or retailer) who supplies pesticide products to farmer s or other end users in refillable containers for large-scale application, alt hough it could also be a distributor. Agricultural pesticide refillers are subject to container refilling re quirements each time a refillable container is repackaged. Generally, this regu lated entity is responsible fo r inspecting, ri nsing, relabeling containers prior to reuse, and maintaining approp riate records. It is estimated that 90 percent of agricultural pesticid e product is distributed or sold by ag ricultural pesticid e refillers, and the remaining 10 percent is distributed or sold directly by regi strants (Paulson, 2002).

Agricultural pesticide refillers are gene rally represented under NAICS 422910 – Farm Supplies and Wholesale Sector, which consists of “establishments primarily engaged in wholesaling farm supplies, su ch as animal feeds, fertili zers, agricultural chemicals, pesticides, plant seeds an d plant bulbs” (U.S. Department of Commerce, 1997).

• Swimming pool supply companies include registrants and other companies that repackage sodium hypochlorite, an antimicrobial used in pools and spas. Swimming pool supply companies are affected by certain requirements in the final rule for repackaging (refilling) sodium hypochlorite. These companies must meet certain refilling requirements, but not all. Refillables are required to be inspected, cleaned, and properly labeled. Swimming pool repackagers must maintain certa in records, but not all. C opies of the residue removal procedures for refilling and description of accepta ble containers must be on file, but a record

of certain information recorded each time a container is refi lled (e.g., product, amount) is not required. A primary NAICS code for sw imming pool supply companies is 453998 – All

Other Miscellaneous Store Retaile rs (except Tobacco Stores).

Other entities handle pesticide containers but are not regulated under the fina l rule. For example, agricultural commercial applicators and self-appli cators (farmers) routinel y use combinations of

non-refillable and refillable containers. These entities typically do not redistribute or resell refillable containers or provide refilling services other than for self-application or self-use; therefore, these entities will not be subject to th e final refilling requirements. As a result, these entities are not included in this industry profile.

It is difficult to estimate the impact of the container regulations on e nd users or consumers of pesticide containers. The cont ainer regulations do not includ e specific requirements for end
users or consumers. However, the labeling requirements for pest icide registrants require that certain information, including proper residue remova l procedures prior to disposal, be included on pesticide labels. The impact of these labe ling requirements on end users and consumers is

uncertain. Information on the current residue re moval practices of end users and consumers is not readily available; thus, estimating the change in behavior associated with the container rule labeling requirements is also unavailable. We assume the labeling requirement impact on end users or consumers is indirect and negligible.

### Page 25 The container regulations are associated with three major market sectors of pesticide use: agricultural, I/C/G, and home a nd garden (H&G). The market sectors used in the compliance profile are consistent with EPA’s Pesticides Industry Sales and Usage: 2000-2001 Market

Estimates report (EPA, 2002b) and the Economic Profile of the U.S. Pesticide Industry (EPA, 2000a). The agricultural sector forms the largest market for conventional pesticides, with herbicides used most commonly, followed by ins ecticides and fungicides. The I/C/G sector includes use of pesticide products by professiona l applicators at I/C/G facilities, on military bases, in hospitals, for janitorial use, and in homes and gardens. The H&G sector represents pesticide products formulated for ho usehold use in and around the home.

The market sectors considered in this analysis di ffer slightly from the market sectors considered in the proposed container rule RIA (EPA, 1993). Table 3.1 illustrates how the market sectors considered in this analysis compare with the market sectors used previously.

Table 3.1. Market Sector Equivalent Between the Current Analysis and the 1993 EPA Proposed Container Rule RIA

Current Analysis Proposed Container Rule RIA

Agricultural Agricultural

Industrial/Commercial/Government Industrial

Institutional

Swimming Pool Supply Companies a Not considered separately

Home & Garden Household

a Swimming pool supply companies are subject to a subset of the refilling requirements. Swimming pool supply companies must meet certain refilling requirements, but not all. Refillables are required to be inspected, cleaned (unless specified conditions in § 165.170 are met), and properly labeled. Swimming pool supply companies must maintain certain records, but not all. Copies of the residue removal procedures for refilling and description of acceptable containers must be on file (§165.218(a)), bu t a record of certain info rmation recorded each time a container is refilled (e.g., product, amount) is not requ ired (§165.218( b)). Swimming pool supply companies could be considered part of both the I/C/G and H&G markets. For the purposes of this analysis, however, swimming pool supply companies were considered separately for the re fillable container and repackaging requirements. For nonrefillable containers, the containers holding sodium hypochlorite for swimming pool use are included with the

estimates of containers in the I/C/G and H&G markets.



### Table 3.2 illustrates which regulat ed entities are responsible for which container regulations. Table 3.2 is not intended to be comprehensive; ra ther, it is designed to provide a brief overview showing how each of the regulated entities identif ied and characterized in this chapter will be affected by the container rule.

Table 3.3 illustrates the SBA and EP A alternative small business defi nitions for entities affected by the container regulations. A small entity is defined as:

• A small business according to the Small Busi ness Administration (SBA ) regulations at 13

CFR 121.201. The SBA defines small businesse s by category of business using NAICS codes. Not all companies within a given regulat ed entity have registered under the same

NAICS code. The SBA definition is based on th e primary NAICS code or codes that best represent(s) the regulated entity.Page 26Table 3.2. Generalization of Impacts of Pesticide Container Regulations on Regulated EntitiesContainer Rule ActivitiesPesticideRegistrantsAgriculturalPesticideRefillersSwimming PoolSupplyCompaniesNon-Refillable ContainersEnsure that all containers meet asubset of DOT packaging standards9Ensure that liquid product containers dispense properly and have standard closures9Ensure that containers meet the residue removal standard for dilutable pesticides in rigid containers9Refillable ContainersEnsure that containers meet a subset of DOT packaging standards9Mark containers with a serial number9Ensure that a one-way valve and/or tamper-evident device is in place for liquid minibulks9Ensure that a vent, gauge, and shutoff valve are in place for liquid bulk containers9Meet repackaging conditions9a99Develop cleaning procedures for repackaging9aInspect, clean, and ensure proper labeling of containers9a99bMaintain records9a99cLabeling StandardsEnsure that labels include specified information9aRefilling requirements affect pesticide registrants for 10 percent of the total refillable containers in the agricultural market sector and all of the containers inthe I/C/G market sector. Available data are insufficient to differentiate pesticide registrantsthat also repackage I/C/G market pesticide products from those thatdo not. Therefore, pesticideregistrants are held accountable.bSwimming pool supply companies must meetcertain refilling requirements, but not all.Refillables are required to be inspected, cleaned (unless specifiedconditions in §165.170 are met), and properly labeled.cSwimming pool supply companies must maintain certain records, but not all. Copies of the residue removal procedures for refilling and a description ofacceptable containers must be on file (§165.218(a)), but a record of certain information recorded each time a container is refilled (e.g., product, amount) is notrequired (§165.218(b)).Page 27Table 3.3. SBA and EPA Alternative Definitions of Small and Large Businesses Affected by thePesticide Container RegulationsSBA Definitions EPA Alternative DefinitionsRegulated EntityPrimary NAICS Code(s) SizeDefinition(13 CFR Part 121)Size DefinitionSmall-Small 1 to 19 employeesMedium-Small 20 to 99 employeesSmall 500 or fewer employeesLarge-Small 100 to 500 employeesPesticide Registrants 325320 – Pesticide and OtherAgricultural ChemicalManufacturingLarge 501 or more employees Large 501 or more employeesSmall-Small 1 to 9 employeesMedium-Small 10 to 49 employeesSmall 100 or fewer employeesLarge-Small 50 to 100 employeesAgriculturalPesticide Refillers422910 – Farm SupplyWholesalersLarge 101 or more employees Large 101 or more employeesSmall-Small 1 to 9 employeesMedium-Small 10 to 49 employeesSmall Maximum revenues of $6.0millionaLarge-Small 50 or more employeesSwimming PoolSupply Companies453998 – All OtherMiscellaneous Store Retailers(except Tobacco Stores)Large Revenues greater than $6.0millionaLarge Revenues greater than $6.0millionaaThe SBA small business size standard is no more than $6 million in revenue for NAICS 453998. The analysis divided the SBA small businesses into thethree EPA alternative small business size categories regardless ofemployee or revenue totalsonce the regulated entity passedthe SBA-defined small businessscreening.

### Page 28 • A small governmental jurisdiction that is a government of a city, county, town, school district, or special di strict with a populat ion of less than 50,000.

• Any small, not-for-profit enterprise that is independently owned and operated and is not

dominant in its field.

This economic analysis (EA) evaluates an altern ative definition of small entities or businesses potentially affected by the cont ainer regulations. As discusse d by EPA in the 1999 Standards for

Pesticide Containers and C ontainment Proposed Rule Suppl emental Notice (EPA, 1999), the alternative definition disaggregates the SBA-defined small businesses into three size categories: small-small, medium-small, and large-small busine sses. EPA is concerned that using an overly

broad definition of small business in the EA of the container regul ations may result in significant economic impacts on smaller entities that will be camouflaged when combined with information about potential impacts on facili ties that meet the SBA size standard for small business but are not typical of a small business in that industry sector. Table 3.3 represents each affected industry by the SBA definition of small business and the a lternative definition used in this analysis.

Two industry sectors considered in the 1999 Suppl emental Notice were pesticide formulators and agrichemical dealers. These regulated enti ties correspond with pes ticide registrants and agricultural pesticide refillers, respectively, in th is EA. We have also developed an alternative small business definition that disaggregates the SBA-define small businesses into small-small, medium-small and large-small businesses for the swimming pool supply companies.

The remainder of this chapter is divided into three sections. Sec tion 3.2 describes how we estimated the total universe of pesticide cont ainers in use for the three market sectors (agricultural, I/C/G, and H&G). Section 3.3 illu strates how we applied the scope criteria to the total universe of pesticide containers to estima te how many containers are ultimately affected by the container regulations. Secti on 3.4 examines the extent to which pesticide containers are already in compliance with various co mponents of the container regulations.

3.2 Pesticide Container Universe

An estimate of the current number of non-refillable and refillable containers in the agricultural, I/C/G, and H&G markets is based on data from the following sources:

• 1996 agricultural pesticide container survey by the American Crop Protection Association (ACPA, 1997).

• Container number estimates derived from a 1989 pesticide container survey conducted by the pesticide industry. The groups that participat ed include the National Agricultural Chemicals Association (NACA), the Mid America CropLif e Association (MACA), the International Sanitary Supply Association (ISSA), and the Chemical Special ties Manufacturers Association (CSMA).

• Non-refillable cont ainer numbers from 2001 and 1991 su rveys conducted by the American Chemistry Council (formerly the Chem ical Manufacturers Association).

• Information and best professi onal judgment from industry an d association representatives (EPA, 2005, and Paulson, 2002).

### Page 29 Because of the pesticide use diversity among the major pesticide markets, the number of containers is estimated separately for each ma rket. The general approach we took was to summarize the number of containers by type from the appropriate source(s) and adjust container numbers as appropriate to re flect current use levels base d on 2001 information and best professional judgment (EPA, 2005). Tables 3.4 a nd 3.5 illustrate the estimated number of nonrefillable and refillable containers, respectivel y, that are currently in use. Table 3.6 gives estimates of the number of swimming pool chem ical containers affected by the container regulations. A more detailed discussion of how the estimates were derived for refillable containers can be found in Appendix B.

### Page 30 Table 3.4. Estimated Number of Non-Refilla ble Pesticide Containers in Use by Major Market Sectors

Container Size Category Agricultural a Industrial/

Commercial/

Government b Home &

Garden c Total

Liquid Pesticide Products

30-55 Gallons

Plastic 309,100 1,600,000 0 1,909,100

Steel 115,500 2,320,000 0 2,435,500

5 Gallons

Plastic 58,100 14,048,000 0 14,106,100

Steel 28,800 960,000 0 988,800

1 To < 5 Gallons

Plastic 27,877,500 21,072 ,000 28,000,000 76,949,500

Steel 0 1,440,000 8,000,000 9,440,000

< 1 Gallon

Plastic 1,007,000 20,560,000 104,000,000 125,567,000

Steel 0 160,000 12,000,000 12,160,000

Glass 0 240,000 8,000,000 8,240,000

Water Soluble Packets

PVA 544,600 0 0 544,600

Barrier 82,200 0 0 82,200

Bag-In-Box 500 260,000 0 260,500

Aerosol Cans 0 23,200,000 200,000,000 223,200,000

Other Sizes 0 0 0 0

Subtotal 30,023,300 85,860,000 360,000,000 475,883,300

Dry Pesticide Products

> 100 lb Bulk 429,500 0 0 429,500

56-100 lb Bags 0 0 0 0

45-55 lb Bags

Plastic 1,849,200 0 0 1,849,200

Paper 8,161,000 0 0 8,161,000

11-44 lb Bags 0 1,120,000 39,500,000 40,620,000

Plastic 3,764,900 0 0 44,384,900

Paper 2,216,600 0 0 2,216,600

1-10 lb Bags

Plastic 328,900 0 0 328,900

Paper 5,730,200 0 0 5,730,200

Jugs

2.5 gallons 26,400 0 0 26,400

1 quart to < 2.5 gallons 2,273,000 370,000 500,000 3,143,000

### Page 31 Table 3.4 (Continued). Estimated Number of Non- Refillable Pesticide Containers in Use by Major Market Sectors

Container Size Category Agricultural a Industrial/

Commercial/

Government b Home &

Garden c Total

PVA 44,070,700 1,300,000 0 45,370,700

Barrier 11,879,100 430,000 0 12,309,100

Fiber Drums

> 30 pounds 12,300 1,280,000 0 1,292,300

< 30 pounds 129,600 0 0 129,600

Other Sizes 3,442,200 0 0 3,442,200

Subtotal 84,313,600 4,500, 000 40,000,000 128,813,600

Total - Non-Refillables 114,336,900 90,360,000 400,000,000 604,696,900

Percentage of Non-Refillables 18.91% 14.94% 66.15%

a Current estimates of the number of non-refillable containers in the agricultural market were taken from the most recent (1996) ACPA Containe r Survey (ACPA, 1997). Number of cont ainers has been rounded to the nearest hundred for purposes of this table. Actual container estim ates surveyed are used thro ughout the pesticide container compliance profile (Chapter 3) and cost analysis (Chapter 4). EPA (2005) determined that the 1996 ACPA Container Survey results were reasonable and should be used based on correspondence with Tom Gilding of CropLife America (formerly ACPA).

b Current estimates of the number of non-refillable containe rs in the I/C/G market were based on the combined total number of containers for the industrial and institutional market sectors used in the proposed container rule RIA (EPA, 1993). EPA solicited comments from the American Ch emistry Council (ACC) and ISSA in May 2001 to aid in updating the I/C/G non-refillable container estimates . The ACC received inform ation on the number of containers used by 11 out of 40 member companies. This information was used to modify the current estimated number of containers in the I/C/G market sector. As a result, EPA made the following changes in the estimated number of non-refillable container estimates for the I/C/G market sector (EPA, 2005):

• Bag-in-box: Two companies reported 133,162 bag-in-box containers. Since only a small number of companies reported using these containers, this estimate was doubled and rounded down to 260,000.

• One quart to < 2.5 gallon plastic: Two companies reported 184,617 containers in this category. This estimate was doubled and rounded to 370,000.

• Water soluble PVA packets and barrier packs: Three companies reported 65 3,305 water soluble PVA packets. This estimate was doubled and rounded to 1,300,000. The number of barrier packs was calculated based on a ratio of three PVA packets to one barrier pack, resulting in an estimated 430,000 barrier packs.

c Current estimates of the number of non-refillable containe rs in the H&G market were based on the total number of

containers in the household market sect or used in the proposed container ru le RIA (EPA, 1993). EPA received the following qualitative feedback from John DiFazio of Cons umer Specialty Products Association (CSPA) with regard

to the current number of H&G non-refillable c ontainers in use versus the 1993 estimates:

• Liquid non-refillables: (1) 1 to <5 gallon plastic - about the same; (2) <1 gallon plastic - about the same; (3) <1 gallon steel - much less; and (4) aerosol cans - about the same.

• Dry non-refillables: (1) 11 to 44 pound plastic bags - a bit less; (2) 1 to 10 pound paper bags - a bit more; (3) 1 quart to <2.5 gallon plastic - a bit less; and (4) subtot al for dry non-refillables - more, possibly much more. As a result, the following non-refillable container estimate modifications were made:

• <1 gallon steel: Assumed that “much less” reduced the estimate for this category from 24,000,000 to 12,000,000.

• Flexible bags (see note “d” below): Assumed that “a bit less” 11 to 44 pound plastic bags combined with “a bit more” 1 to 10 pound paper bags increased the estimate fo r this category from 28,000,000 to 40,000,000, with 500,000 of this total allocated to the “1 quart to <2.5 gallon plastic” size category specifically and the remaining 39,500,000 allocated to flexible bags with no size criteria specified.

d As with the proposed container rule RIA (EPA, 1993), no size criteria are specified for flexible bags. For the purposes of this analysis, all of the flexible bags for the market sector were allocat ed to the “11 to 44 pound paper/plastic bags” category.

### Page 32 Table 3.5. Estimated Number of Refill able Pesticide Containers in Use by Major Market Sectors

Container Size Category Agricultural a I/C/G b Home &

Garden c Total

Liquid Pesticide Products

Retail Bulk Tanks (>500 Gal)

Plastic 12,060 7,200 0 19,260

Steel 1,340 800 0 2,140

Large Tanks (251-500 Gal)

Plastic 1,170 8,400 0 9,570

Steel 130 2,800 0 2,930

126-250 Gallons

Plastic 34,800 9,000 0 43,800

Steel 6,700 1,000 0 7,700

61-125 Gallons

Plastic 172,600 9,000 0 181,600

Steel 57,600 1,000 0 58,600

26-60 Gallons

Plastic 48,800 2,920 0 51,720

Steel 4,000 4,380 0 8,380

5-25 Gallons

Plastic 127,900 0 0 127,900

Steel 99,800 0 0 99,800

Other Sizes 0 0 0 0

Subtotal 566,900 46,500 0 613,400

Dry Pesticide Products

Retail Bulk Tanks (> 4,000 lbs) 175 0 0 175

Large Tanks (2,501-4,000 lbs) 5,425 0 0 5,425

101-2,500 lb Bags 13,300 0 0 13,300

< 100 lb Bags 677,800 0 0 677,800

Other Sizes 0 0 0 0

Subtotal 696,700 0 0 696,700

Total - Refillables 1,263,600 46,500 0 1,310,100

Percentage of Refillables 96.45% 3.55% 0.00%

Note: See Table 3.6 for estimates of the number of swimming pool chemical containers in use.

a Current estimates of the number of refillable containers in the agricultural market were based on converting the formulated volume (gal) and formulated weight (lbs) of pesticides reported in the 1996 ACPA Container Survey (ACPA, 1997) to the number of refillable containers in us e. The non-bulk container estimates were rounded to the nearest hundred, and the bulk containe r estimates were rounded to nearest multiple of five. See Appendix B.

b Current estimates of the number of refillable containers in the I/C/G market were based on the combined total number of containers for the industrial and institutional market sectors used in the proposed container rule RIA (EPA, 1993). EPA solicited comments from the ACC and ISSA in May 2001 to aid in updating the I/C/G refillable container estimates. No changes to the estimated numbe r of refillable containers were warranted, based on responses from the ACC and ISSA.

c The analysis assumes that there are no refillable cont ainers in the H&G market.

### Page 33 Table 3.6. Estimated Number of Swi mming Pool Chemical Refillable Containers Affected by the Pe sticide Container Regulations

Container Size Category Number of Containers a

Liquid Pesticide Products

Retail Bulk Tanks (>500 Gal)

Plastic 1,620

Steel 180

Bulk Tanks (251-500 Gal)

Plastic 4,680

Steel 520

126-250 Gallons

Plastic 0

Steel 0

61-125 Gallons

Plastic 0

Steel 0

26-60 Gallons

Plastic 140,000

Steel 0

5-25 Gallons

Plastic 70,000

Steel 0

Other Sizes b 1,000,000

Total – Refillables 1,217,000

a Estimates are based on comments to the 1999 Supplemental Notice submitted by relevant trade associations (i.e., the Chlorine Institute, National Spa and Pool Institute, and Swimming Pool Chemical Manufacturers Association) that provide the average number of refillings and volume. Based on the comments, the number of refillings was assumed to be 8. A smaller refilling ra te of 4 was assumed for larger containers. This refilling rate was used with the data on volume from the comments (38 million gallons of sodium hypochlorite in use for pools in spas annually) to arrive at the total

number of containers.

b Other sizes include relatively smaller, 1- or 2.5-gallon plastic containers known to be

in use.



### 3.3 The Implications of the Scope of the Regulations on the Container Estimates

The regulations specify which pesticide products are and are not subject to the regulations (40 CFR Part 165 Subparts C, D, and E). The cont ainer scope criteria are relatively complex, but some of the key points are briefly summarized here and in Table 3.7:

### Page 34 Table 3.7. Summary of Regulatory Scope

Pesticide Products NOT Subject to the Pesticide Container Regulations

Non-Refillable and Refillable Containers The following three categories of pesticide products are not subject to the non-refillable container, refillable container, and repackaging regulations:

(1) Manufacturing use products (MUPs); (2) Plant-incorporated protectants (PIPs); and (3) Antimicrobial pestic ide products that satisfy all four of these criteria:

• It is an antimicrobial pesticide, as defined in FIFR A Section 2(mm), or it has antimicrobial properties, as defined in FIFRA Section 2(mm)(1)(A), and is subject to a tolerance or a food additive regulation.

• Its label includes directions for use on a site in at least one of the 10 antimicro bial product use categories identified as “household, i ndustrial, or institutional.” a

• It is not a hazardous waste when it is intended to be disposed, as defined in 40 CFR Part 261.

• EPA has not specifically found that the product must be subject to the container provisions to prevent an

unreasonable adverse effect on the environment.

Pesticide Products Subject to th e Pesticide Container Regulations

Non-Refillable ContainersOther than MUPs, PIPs, and exempt antimicrobial products, a pesticide product sold or distributed in a nonrefillable container is subject to all of the non-refillable container regulations if it satisfies at least one of the following criteria: b

(1) It meets the criteria of Toxicity Category I; (2) It meets the criteria of Toxicity Category II; or (3) It is classified for restricted use (as set out in 40 CFR parts 152.160–152.175).

If a product (other than MUPs, PIPs, and exempt antimicrobia ls) does not meet any of th ese criteria, the product is subject to only the basic DOT requirements in 49 CFR 173.24.

Refillable Containers and Repackaging Other than MUPs, PIPs, and exempt antimicrobial products, a pesticide product sold or distributed in a refillable

container is subject to the refillable container and repackaging regulations.

Pesticide Products Subject to the Pesticide Container Labeling Standards

All pesticide products are subject to the new labeling standards.

a The “household, industrial, or institutional” antimicrobi al product use categories are: (1) food handling/storage establishments premises and equipment; (2) commercial, institutional, and industrial premises and equipment; (3) residential and public access premises; (4) medical premises and equipment; (5) human drinking water systems; (6) materials preservatives; (7) industrial proce sses and water systems; (8) an tifouling coatings; (9) wood preservatives; and (10) swimming pools.

b The residue removal standard affects a smaller subset of Toxicity Category I , II, and restricted use products because it is applicable to only flowable concentrate products.



### (1) The non-refillable container

, refillable container , and repackaging regulations do not apply to the same subset of pesticid e products, although the structure of the non-refillable container regulations is different.

(2) For the non-refillable co ntainer regulations, only “higher-ri sk” products are s ubject to all of the non-refillable container requ irements. The “lower-risk” pr oducts are subject only to the basic DOT requirements. In particular:

### Page 35 (a) A product is subject to all non-refillable cont ainer requirements if it is classified in at least one of the following categories: (1) Toxi city Category I, (2) T oxicity Category II, or (3) Restricted Use Product. 15



### (b) All other products (those in Toxicity Category III or IV that are not restricted use products) must comply only with the basic DOT requirements in 49 CFR 173.24.

(3) For the refillable container and repackaging regulations, antimicrobial products that are used only in swimming pools (and closely related sites su ch as hot tubs, spas, or whirlpools) are exempt from some of the standards.

(4) The new labeling standards apply to all pesticide products.

The remainder of this section discusses how the container regulations’ scope affects the estimate

of the number of containers affected by the regulation.

3.3.1 Manufacturing Use Products and Plant-Incorporated Protectants

Manufacturing use products (MUPs) and plant-incorporated protec tants (PIPs) are explicitly exempt from the pesticide container regulations. MUPs are any products intended (labeled) for formulation or repackaging into other pesticid e products and therefore assumed to be excluded from estimates of the pesticide c ontainer universe. PIPs are subs tances that plants produce for protection against pests. These substances and the genetic material necessary to produce them are pesticides under FIFRA if humans intend these substances to prevent, repel, or mitigate any pest. Bags of seed or other containers cont aining PIPs are assumed to be excluded from the estimates of the pesticide container universe ba sed on the scope of the data sources used. In particular, the 1996 ACPA Container Survey (ACPA, 1997) used as the basis for the agricultural

market container estimates did not assess containe rs containing PIPs. Therefore, it is assumed

that none of the containers cons idered in this analysis will be affected by the MUP or PIP exemptions.

3.3.2 Antimicrobial Pesticide Products

The container rule’s antimicrobial exemption app lies only to containers in the I/C/G and H&G markets. EPA (2005) determined that 27.7 percent of the total number of c ontainers in each of the two markets (and distributed by container ty pe) would be antimicrobi al product containers. 16


### Additionally, EPA (2005) identif ied the number of antimicrobial products subject to the container regulations (1,350 products or 29.8 pe rcent of the total number of antimicrobial products [4,528]), and the number of antimicrobial products that are exempt from the regulations (3,178 products, or 70.2 percent of th e total number of antimicrobial products). As a result, it is

15 The residue removal standard affects a smaller subset of Toxicity Category I, II, and restricted use products because it is applicable to only flowable concentrate products.

16 The estimate of the total number of antimicrobial product containers is based on the estimated usage of antimicrobial pesticides in the H&G and I/C/G markets. The estimate of 27.7 percent assumes that the total number of antimicrobial product containers is in the same proportion as the number of antimicrobial products subject to the regulations. The estimate is calculated by multiplying 29.8 percent, the percentage of antimicrobial products subject to container regulations (EPA, 2005), by the total amount of antimicrobial usage, and dividing this value by the total usage of pesticides: antimicrobial, conventional (e.g., herb icides, insecticides), and ot her (e.g., petroleum oil).

### Page 36 assumed that approximately 8.25 percent (.277 * .298) of all I/C/G and H&G non-refillable and

refillable containers are antimicrobial products subject to all the container regulations.

EPA’s attempt in the 1999 Supplemental Notice (E PA, 1999) to partially exempt antimicrobials used in swimming pools from some refillable cont ainer requirements was drafted to apply to products that were eligible for exemption. EP A acknowledges that some of the products that were intended to be partially exempted from the refillable containe r standards are hazardous wastes when they are disposed. They are therefore not eligible for the antimicrobial exemption from the container rule. In other words, the partial exemption from the refillable container standards as described in the Supplemental Noti ce would not have applied to the products for which it was intended to provide relief. Antimicrobial products that were not eligible for exemption would have had to comply with the full set of c ontainer regulations.

As stated in the Supplemental Notice, EPA ac knowledges that applying some of the refillable container standards (specificall y, the serial number marking, one-way valves or tamper-evident devices, and recordkeeping) to sodium hypochlor ite used in swimming pools would disrupt the current refillable container system for these prod ucts and would probably cause the refillables to be replaced by millions of single-use, non-refill able containers. EPA believes that adding millions of pounds of these non-refillable containers to the waste stream is inconsistent with the goals of Section 19(e) of FIFRA, particularly the goal that the regulations facilitate the safe refill and reuse of containers. Therefore, in the Supplemental Notice, EPA attempted to create a partial exemption from the refillable container standards for these products.

Based on comments and an analysis of which antim icrobial pesticides may be hazardous waste when they are disposed, EPA is revising the pa rtial exemption in the final rule so that it accomplishes EPA’s intended goal. The partial ex emption will apply to “antimicrobial” products

that are:

• Distributed in ref illable containers;

• Subject to the contai ner regulations; and

• Used in swimming pools, spas, hot tubs, and whirlpools.

EPA is limiting the scope of the reduced set of refillable container standards to products used only in swimming pools, spas, hot tubs, and wh irlpools because commenters on the proposed container rule and the Supplemental Notice made a convincing case that a pplying the full set of refillable container regulations to the refillab le containers servici ng these sites would be burdensome. A significant factor was the large amount of detail about the refillable containers used for distributing pool chemicals (generally 1- or 2.5-gallon plastic containers), the large amount of product distributed in th ese containers, and the system that the pesticide registrants had in place for managing these containers.

The estimated number of refillabl e containers in the swimming pool industry is not readily available. Comments to the 1999 Supplemental No tice submitted by relevant trade associations (i.e., the Chlorine Institute, National Spa and Pool Institute , and Swimming Pool Chemical Manufacturers Association) were considered in the process of determining a reasonable number

of refillable containers of various sizes used by the estimated 305 small and 17 large swimming

### Page 37 pool supply companies (or companies that routin ely refill containers fo r distributing sodium hypochlorite for pool disinfection). Table 3.6 illustrates the estim ated number of swimming pool chemical refillable containers subject to the container regulations.

3.3.3 Non-Exempt Products Sold or Distri buted in Non-Refillable Containers: Toxicity Categories I and II

The scope criteria for the container standards lim it the universe of non-refillable containers that are affected by all of the non-refi llable container requirements. Pesticide products classified in Toxicity Category I or II are s ubject to all of the non-refi llable container regulations.

Based on an analysis of pesticid e registration data in an Office of Pesticide Programs database and literature searching, we estim ated the percentage of pesticid e active ingredients (PAIs) in Toxicity Categories I and II used in the agricultural, I/C/G, a nd H&G markets. The pounds of PAIs applied in each market sector was based on 1999 information compiled for the “Pesticide Industry Sales and Usage: 1998 and 1999 Market Estimates” report (EPA, 2002b). We crosschecked all PAIs comprising 0.05 percent or great er of the pounds applied in the agricultural market, and all I/C/G and H&G PAIs, to determin e their toxicity category and whether the PAI

was also classified for restricted use. In the agricultural market, it is estimated that Toxicity Category I and Toxicity Category II PAIs account for 28.7 percent and 22.9 percent of the total pounds applied, respectively. In the I/C/G market , Toxicity Category I an d II PAIs account for an estimated 28.4 percent each of the pounds applie d. In the H&G market, Toxicity Category I and II PAIs account for an estimated 18.5 percen t and 45.7 percent of the total pounds applied, respectively. It is assumed that the relati ve percentage of the pounds applied for PAIs categorized as Toxicity Category I or II is applicable to the number of pesticide containers affected by the container regulations according to the toxicity scope cr iteria (see Table 3.8).

### Page 38 Table 3.8. Percentage of Pesticide Containers Affected by the Final Rule Scope Criteria

Pesticide Container Final Rule Scope Criteria Agricultural (%) Industrial/Commercial/ Government (%) Home & Garden (%)

Pesticide Products NOT Subject to the Pesticide Container Regulations

Manufacturing Use Products 0 0 0

Plant-Incorporated Protectants 0 0 0

Antimicrobials a 0 8.25 8.25

Pesticide Products Sold or Distri buted in Non-Refillable Containers Subject to All of the Non-Refillable Container Regulations b

Toxicity Category I 28.7 28.4 18.5

Toxicity Category II 22.9 28.4 45.7

Restricted Use Products 12.9 5.2 3.0

a The antimicrobial exemption only applies to containers in the I/C/G and H&G markets. EPA (2005) determined that 27.7 percent of the total number of containers in each of the two markets (and distributed by container type) would be antimicrobial product containers. Additionally, EPA (2005) identified the number of antimicrobial products subject to the container regulations (1,350 products or 29.8 percent of the total number of antimicrobial products [4,528]), and the number of antimicrobial products that are exempt from the regulations (3,178 products, or 70.2 percent of the total number of antimicrobial products). As a result, approximately 8.25 percent (.277 * .298) of

all I/C/G and H&G non-refillable and ref illable containers were assumed to be antimicrobial products subject to all the container regulations.

b The container rule scope criteria limit compliance with all of the non-refillable container regulations to non-exempt products that meet the Toxicity Category I, Toxicity Category II, and/or restricted use criteria. Other non-exempt products sold in non-refillable contai ners (those in Toxicity Categories III and IV that are not restricted use products) must comply only with the basic DOT packaging standards in 49 CFR 173.24. These products are considered separately because they are not subject to the full set of n on-refillable container requirements.



### 3.3.4 Non-Exempt Products Sold or Distri buted in Non-Refillable Containers:

Restricted Use Products

Pesticide products classified for restricted use are also subject to all of the non-refillable container regulations. The same data set and as sumptions used to evaluate PAI toxicity were used to develop the percentage of pesticide containers affected by the restricted use nonrefillable container scope criter ia. PAIs and/or pesticide pro ducts ranging in toxicity (i.e., Toxicity Categories I thr ough IV) may be classified for restricted use. Those PAIs that did not meet the scope criteria based on toxicity (Toxi city Categories III and IV) were separated from those that were affected by the c ontainer regulations (Toxicity Cate gories I and II). Each of the PAIs in the Toxicity Categories II I and IV were evaluated to determ ine if they were classified for restricted use. In the agricultural market, Toxicity Category III and Toxicity Category IV restricted use products account for an estimated 12.9 percent of the tota l pounds applied. In the I/C/G and H&G markets, Toxicity Category III a nd Toxicity Category IV restricted use products account for an estimated 5.2 percent and 3.0 perc ent of the pounds applied in each of these markets, respectively. 17 

### It is assumed that the relative percentage of PAIs categorized as Toxicity Category III or IV substa nces and classified for restrict ed use were applicable to the number of pesticide containers affected by the container regulations according to the restricted use scope criteria (see Table 3.8).

17 Pesticide usage in the H&G market includes some applications by lawn care professionals and pest control operators, who may be certified pesticide applicators and can, therefore, apply restricted use pesticides.

### Page 39 3.3.5 Non-Exempt Products Sold or Distri buted in Non-Refillable Containers: Toxicity Categories III and IV That Are Not Restricted Use Products

Pesticide products classified in Toxicity Cate gories III and IV that are not restricted use products are not subject to the full set of non-refi llable container requirements. Instead, these products are subject only to the basic DOT re quirements in 49 CFR 173.24. These products are not subject to the other non-refillable containe r requirements, such as the container closure, container dispensing, and residue removal standards. Also, these products are not subject to the other DOT requirements that are adopted by the pesticide container regulations.

3.3.6 Summary of Pesticide Container Scope Criteria

Table 3.8 summarizes the percentage of non-refillable and refillabl e containers affected by the container scope criteria. As stated in Sections 3.3.1–3.3.4, the pe rcentage of pesticide products subject to the container scope criteria was applied to the estimated number of containers for each size category.

We estimated the number of containers that are affected by the container regulations out of the total universe of pesticid e containers based on the percentage of containers affected by the scope criteria listed in Table 3.8. For example, for “1 to <5 gallons” plasti c non-refillables in the agricultural sector, we estimated the number of containers affected by the container rule as:

(0.287 + 0.229 + 0.129) * 27,877,500 = 17,980,988 containers

where:

• “27,877,500” is the total number of containers in use in this size cate gory (see Table 3.4.);

• “(0.287 + 0.229 + 0.129)” represents th e percentage of containers subject to the container regulations based on the Toxicity Category I, To xicity Category II, and restricted use product classifications, respectively.

For the I/C/G and H&G markets, the same consider ations as for the agricultural market sector applied for determining the number of containers subject to the container regulations with one exception. In these market sectors, we considered antimicrobial pesticide containers separately from non-antimicrobial pesticide containers. Th erefore, the number of containers containing antimicrobials subject to the c ontainer regulations was added to the number of non-antimicrobial pesticide containers that met the container ru le scope criteria based on Toxicity Category I, Toxicity Category II, and restrict ed use product classifications. Fo r example, for I/C/G “30 to 55 gallon” plastic non-refillables, we estimated the nu mber of containers affected by container rule

as:

(1,600,000 * 0.277 * 0.298) + {(0.284 + 0.284 + 0.052) * [1,600,000 * (1 - 0.277)]} = 848,711 containers

### Page 40 where:

• “1,600,000” is the total number of 30 to 55 gallon plastic non-refillable containers in use in the I/C/G market (see Table 3.4);

• “0.277” is the percentage of containers that hold antimicrobials;

• “0.298” is the percentage of antimicrobials that are subjec t to the containe r regulations; and

• “(0.284 + 0.284 + 0.052)” represents th e percentage of containers subject to the container regulations based on the Toxicity Category I, To xicity Category II, and restricted use product classifications, respectively.

We calculated the number of pesticide containe rs affected by the scope criteria for each nonrefillable and refillab le container size category. Tabl es 3.9 and 3.10 detail the number of nonrefillables and refillables, respectively, that are within the scope of the container regulations and are potentially affected by the regulations.

As mentioned earlier, all products are subject to the refillab le container and repackaging regulations. As a result of this requirement, the number of refillable containers in the agricultural market sector affected by the contai ner regulations as displa yed in Table 3.10 is the same as in Table 3.5, which establishes the baselin e number of refillable pesticide containers in use. However, certain antimicrobial products in the I/C/G market sector (in fact, 70.2 percent of antimicrobial products, as previous ly discussed) are exempt from the container regulations. As a result of this exemption, the numbe r of refillable containers in the I/C/G market is less than the

baseline for I/C/G refillable cont ainers as described in Table 3.5. For example, in the baseline, there are an estimated 7, 200 refillable liquid plastic retail bulk tanks in th e I/C/G market sector. Due to the antimicrobial exemption, an estimate d 5,800 containers of this type fall under the scope of the regulations. The calculation is as follows:

(7,200 * 0.277 * 0.298) + [7,200 * (1-0.277)] = 5,800.

### Page 41 Table 3.9. Estimated Number of Non-Refillabl e Pesticide Containers Affected by the Pesticide Container Regulations a

Size Category Agricultural Industrial/

Commercial/

Government Home &

Garden Total

Liquid Pesticide Products

30-55 Gallons

Plastic 199,434 848,711 0 1,048,145

Steel 74,518 1,230,631 0 1,305,149

5 Gallons

Plastic 37,496 7,451,684 0 7,489,181

Steel 18,594 509,227 0 527,821

1 to < 5 GALLONS

Plastic 17,986,536 11,177 ,527 15,909,183 45,073,245

Steel 0 763,840 4,545,481 5,309,321

< 1 Gallon

Plastic 649,731 10,905,939 59,091,250 70,646,921

Steel 0 84,871 6,818,221 6,903,092

Glass 0 127,307 4,545,481 4,672,787

Water Soluble Packets

PVA 351,374 0 0 351,374

Barrier 53,012 0 0 53,012

Bag-In-Box 303 137,916 0 138,219

Aerosol Cans 0 12,306,312 113,637,020 125,943,332

Other Sizes 0 0 0 0

Subtotal 19,370,998 45,543 ,965 204,546,636 269,461,599

Dry Pesticide Products

> 100 lb Bulk 277,097 0 0 277,097

56-100 lb Bags 0 0 0 0

45-55 lb Bags

Plastic 1,193,113 0 0 1,193,113

Paper 5,265,477 0 0 5,265,477

11-44 lb Bags 0 1,120,000 39,500,000 0

Plastic 2,429,134 594,098 22,443,311 25,466,543

Paper 1,430,124 0 0 1,430,124

1-10 lb Bags

Plastic 212,196 0 0 212,196

Paper 3,697,147 0 0 3,697,147

Jugs

2.5 gallons 17,020 0 0 17,020

1 quart to < 2.5 gallons 1,466,578 196,264 284,093 1,946,935

### Page 42 Table 3.9 (Continued). Estimated Number of No n-Refillable Pesticide Containers Affected by the Pesticide Container Regulations a

Size Category Agricultural Industrial/

Commercial/

Government Home &

Garden Total

Water Soluble Packets

PVA 28,434,409 689,578 0 29,123,987

Barrier 7,664,424 228,091 0 7,892,515

Fiber Drums

> 30 pounds 7,925 678,969 0 686,894

< 30 pounds 83,628 0 0 83,628

Other Sizes 2,220,893 0 0 2,220,893

Subtotal 54,399,166 2,387, 000 22,727,404 79,513,570

Total - Non-Refillables 73,770,164 47,930,965 227,274,040 348,975,169

Percentage of Non-Refillables 21.14% 13.73% 65.13%

a Estimates based on the container rule scope criteria (see Section 2.3) applied to the total universe of non-refillable containers (see Section 2.2).

### Page 43 Table 3.10. Estimated Number of Refillable Pesticide Containers Affected by the Pesticide Container Regulations a

Container Size Category Agricultural Industrial/

Commercial/

Government Swimming

Pool Industry b Home &

Garden Total

Liquid Pesticide Products

Retail Bulk Tanks (>500 Gal)

Plastic 12,060 5,800 1,620 0 19,480

Steel 1,340 644 180 0 2,164

Large Tanks (251-500 Gal)

Plastic 1,170 6,767 4,680 0 12,617

Steel 130 2,256 520 0 2,906

126-250 Gallons

Plastic 34,800 7,250 0 0 42,050

Steel 6,700 806 0 0 7,506

61-125 Gallons

Plastic 172,600 7,250 0 0 179,850

Steel 57,600 806 0 0 58,406

26-60 Gallons

Plastic 48,800 2,352 140,000 0 191,152

Steel 4,000 3,528 0 0 7,528

5-25 Gallons

Plastic 127,900 0 70,000 0 197,900

Steel 99,800 0 0 0 99,800

Other Sizes c 0 0 1,000,000 0 1,000,000

Subtotal 566,900 37,458 1,217,000 0 1,821,358

Dry Pesticide Products

Retail Bulk Tanks (>4,000 lbs) 175 0 0 0 175

Large Tanks (2,501-4,000 lbs) 5,425 0 0 0 5,425

101-2,500 lb Bags 13,300 0 0 0 13,300

Fiber Drums 677,800 0 0 0 677,800

Other Sizes 0 0 0 0 0

Subtotal 696,700 0 0 0 696,700

Total – Refillables 1,263,600 37,458 1,217,000 0 2,518,058

Percentage of Refillables 50.18% 1.49% 48.33% 0.00%

a Estimates based on the container regulations scope crite ria (see Section 2.3) applied to the total universe of refillable containers (see Section 2.2 and Table 3.5).

b Assumed estimates based on comments to the 1999 Supplemental Notice submitted by relevant trade associations (i.e., the Chlorine Institute, National Spa and Pool Institute, and Swimming Pool Chemical Manufacturers Association).

c Other sizes include relatively smaller, 1- or 2.5-gallon plastic containers.

### Page 44 3.4 Regulatory Compliance Baseline

Table 3.11 provides an overview of the pesticid e container regulatory re quirements broken down by various components of the rule.

Table 3.11. Overview of the Container Regulations

Non-Refillable

Containers Refillable Containers Repackaging Pesticide

Products Labels

All Non-Exempt

Products (1) Basic DOT packaging standards (49 CFR 173.24)

All Non-Exempt Products Meeting Scope

Criteria (1) DOT container design, construction, and marking

standards (2) Container dispensing capability (3) Standardized closures (4) Residue removal (5) Recordkeeping Non-Exempt Products (1) DOT container design, construction, and marking

standards (2) Serial number marking* (3) One-way valves or tamper-evident devices* (4) Bulk container requirements

* Swimming pool antimicrobial products are not subject to these requirements. All Non-Exempt

Products (1) Pesticide registrants develop information (2) Registrants and others comply with specified

conditions (3) Refillers (registrants and others) obtain and follow registrant information, and clean, inspect, and label containers before refilling

them*

*Swimming pool antimicrobial products are not subject to several of these requirements. All Products (1) Identify container as

non-refillable or refillable

All Products in NonRefillable Containers (1) Statements to prohibit

reuse and offer for recycling; batch code

Some Products in NonRefillable Containers (1) Cleaning instructions

All Products in Refillable

Containers (1) Cleaning instructions before final disposal

Some Products in

Refillable Containers (1) Leave blank spaces for

net contents and

establishment number



### 3.4.1 Regulatory Compliance Rates for Non-Refillable Containers

The regulatory components and compliance rate s affecting non-refillab le containers are discussed below. The regulatory components a ffect three different sets of non-refillable containers; all non-exempt produc ts (Section 3.4.1.1), all non-exemp t products meeting the scope criteria (Section 3.4.1.2), and all products (Section 3.4.1.3). Table 3.12 summarizes the container rule regulation compliance rates for non-refillable containers.

3.4.1.1 All Non-Exempt Products

All non-exempt products sold or distributed in no n-refillable containers must comply with the basic DOT packaging requirements in 49 CFR 173.24. It is assumed that all containers comply with these requirements, which establish minimum standards for container integrity, compatibility, and filling limits.Page 45Table 3.12. Regulatory Compliance Rates for Non-Refillable ContainersaDOTPackagingStandardshazardousmaterialsb(§165.60-64)DOTPackagingStandards –nonhazardousmaterialsc(§165.60-64) Closure Standardsd, e(§165.66)Standards for container dispensingcapabilityf, g, h(§165.68)Labelingrequirements(Sec.156)Otheradministrativerequirements(recordkeeping)Small-Small EstablishmentsAgriculture 100.0% 100.0%100.0% 95.0% 90.0%100.0% 81.5% 35.0% 50.0% 0.0% 0.0%I/C/G 100.0% 100.0%N/A N/A N/A100.0% 81.5% 35.0% 50.0% 0.0% 0.0%Home & Garden 100.0% 100.0%N/A N/A N/A100.0% 80.5% 50.0% 0.0% 0.0%Medium-Small EstablishmentsAgriculture 100.0% 100.0%100.0% 95.0% 90.0%100.0% 81.5% 35.0% 50.0% 0.0% 0.0%I/C/G 100.0% 100.0%N/A N/A N/A100.0% 81.5% 35.0% 50.0% 0.0% 0.0%Home & Garden 100.0% 100.0%N/A N/A N/A100.0% 80.5% 50.0% 0.0% 0.0%Large-Small EstablishmentsAgriculture100.0% 100.0%100.0% 95.0% 90.0%100.0% 81.5% 35.0% 50.0% 0.0% 0.0%I/C/G100.0% 100.0%N/A N/A N/A100.0% 81.5% 35.0% 50.0% 0.0% 0.0%Home & Garden100.0% 100.0%N/A N/A N/A100.0% 80.5% 50.0% 0.0% 0.0%Large EstablishmentsAgriculture100.0% 100.0%100.0% 95.0% 90.0%100.0% 81.5% 35.0% 50.0% 0.0% 0.0%I/C/G100.0% 100.0%N/A N/A N/A100.0% 81.5% 35.0% 50.0% 0.0% 0.0%Home & Garden100.0% 100.0%N/A N/A N/A100.0% 80.5% 50.0% 0.0% 0.0%aIn many cases, a regulation is not applicable to particular typesof containers in a particularmarket sector. For example, theclosure standards for non-refillablesare applicable only to containers that hold at least 1 gallon and that hold liquid products in the agricultural market sector.bUnder the container rule, both containersfor hazardous materials and non-hazardous materials must comply with the DOT standards for containers for hazardousmaterials. The costs of complying with the DOT standards for containers holding hazardous materials are therefore attributed to the DOT standards and not thecontainer rule.cFor non-hazardous materials, we assume thatDOT-compliant containers canbe purchased on the market at prices comparable to non-compliant containers. Wealso assume that within the compliance period, regulated entities will exhaust their inventory ofnon-compliant containers andreplace them with compliantcontainers at no extra cost. This assumption was based on inputs from container manufactures that indicated that only DOT-compliant containers are sold.Accordingly, we assume that all non-compliant containerswill be out of use by the time the rule goes into effect.dThe closure standards are not applicable toI/C/G and H&G establishments. They are alsonot applicable to liquid containers less than 1 gallon in capacity, watersoluble packets, bag in boxes, and aerosol cans. Theyare also not applicableto dry product containers.Page 46Table 3.12 (Continued). Regulatory Compliance Rates for Non-Refillable ContainersaeThe first percentage represents the compliance rate for liquid containers 30 to 55 gallons. The second percentage represents the compliance rate for liquidcontainers of 5 gallons, and liquid containers in the “other sizes” category. The third percentage represents the compliance rate for liquid containers 1 to <5gallons.fThe standards for container dispensing capability are not applicableto liquid containers 30 to 55 gallons, water soluble packets, bag in boxes, and aerosol cans.They are also not applicableto dry product containers.gFor agricultural and I/C/G establishments: The first percentagerepresents the compliance rate for liquid containers of 5 gallons. The second percentagerepresents the compliance rate for liquid containers 1 to lessthan 5 gallons. The third percentage represents the compliance rate for liquid containers less than 1gallon. The fourth percentagerepresents the compliance rate for liquidcontainers in the “other sizes” category.hFor H&G establishments: The first percentage represents the compliance rate for liquid containers of 5 gallons. The second percentage represents thecompliance rate for liquid containers less than 5 gallons. The third percentage represents the compliance rate for liquid containers in the “other sizes” category.

### Page 47 3.4.1.2 All Non-Exempt Products Meeting Scope Criteria

Non-exempt products are subject to all of the foll owing non-refillable contai ner regulations if the product is classified as Toxicity Category I, Toxicity Category II, or restricted use.

Department of Transportation (DOT) Standards

Products sold or distributed in non-refillable containers must meet a subset of the DOT Hazardous Materials Regulations (HMR), whic h establish standards for container design, construction, and marking. Pesticide products that are not DOT hazardous materials must comply with some of the general packaging re quirements and the non-bulk and bulk packaging standards for Packing Group III (the least stringent requirements). Pesticide products that are DOT hazardous materials must comply with all of DOT’s regulations. For purposes of the container regulations, EPA is sp ecifically adopting the same kind of DOT requirements as for the non-DOT hazardous materials, but for the product’s packing group.

EPA estimates that approximately 35 percent of pesticide products in use fall under the DOT

definition of a hazardous material and theref ore meet the DOT requirements (EPA, 1999). We assume that 35 percent of all pesticide containe rs in the three major ma rkets and for each size category are DOT hazardous materials. Therefore, these containers are already in compliance with the container regulations.

It is assumed that the remaining 65 percent pr oducts sold or distri buted in non-refillable

containers contain DOT non-hazardou s material. It is assumed th at these containers are also already in compliance with the Packing Group III re quirements. This assumption is consistent with the proposed EPA container rule RIA which assumed that most of the containers in use were DOT-compliant and that nearly all contai ners in production were also DOT-compliant. This assumption was also validated for the fi nal EPA container rule EA through additional discussions with pesticide regist rants, refillers and industry expe rts. Compliance with the DOTrelated standards was high for the proposed rule, and, given the increasing av ailability and use of DOT-compliant containers, it is assumed in the fina l rule that those containers that were out of compliance have either been replaced or will be replaced with compliant containers within the compliance period.

Container Closures for Liquid Pesticide Products

To further allow for the safe use of pesticide co ntainers, the container ru le requires that rigid

non-refillable containers that have a capacity of at least 3.0 liters (0.79 gallons) and are used to hold liquid agricultural pesticides have one of fo ur standardized closur es. Container closure requirements are not required for rigid non-refi llables in the I/C/G or H&G markets. The container closure compliance rate for affected agricultural non-refillab les is based upon an assumption that EPA made for the propos ed container rule RIA (EPA, 1993):

• 100.0 percent compliance for “30 to 55 gallon” containers;

• 95.0 percent compliance for “5 gallon” and “other” size containers; and

• 90.0 percent compliance for “1 to <5 gallon” containers.

### Page 48 Container Dispensing Capability

The container regulations state that non-refillable containers of 20 liters (5.3 gallons) or smaller for liquid products must allow the contents to be poured without glugging and with minimal dripping. The major factors that reportedly a ffect pesticide dispensing are the design of the container opening, and the design and placement of the container handle. The container dispensing capability compliance rate for affect ed non-refillables is based upon assumptions that EPA made for the proposed container rule RIA. 18 

### Since there are no new data with which to update these assumptions, the assumptions are left in place. Therefore, the following compliance

rates are assumed for all of the affected liquid non-refillables:

Agricultural Market

• 100.0 percent compliance for “5 gallon” containers;

• 81.5 percent compliance for “1 to <5 gallons” containers;

• 35.0 percent compliance for “<1 gallon” containers; and

• 50.0 percent compliance for “other” size containers.

I/C/G Market

• 100.0 percent compliance for “5 gallon” containers;

• 81.5 percent compliance for “1 to <5 gallons” containers;

• 35.0 percent compliance for “<1 gallon” containers; and

• 50.0 percent compliance for “other” size containers.

H&G Market

• 100.0 percent compliance for “5 gallon” containers;

• 80.5 percent compliance for “1 to <5 gallons ” and “< 1 gallon” size containers; and

• 50.0 percent compliance for “other” containers.

Residue Removal Standards

The container regulations specify a residue remova l standard for rigid containers for flowable concentrate products that meets the Toxic Category I or II crite ria and/or are classified for restricted use. The regulations specify a test prot ocol that requires every registrant to test three containers from each rigid container/dilutable fo rmulation combination to determine that the containers are capable of attain ing at least 99.99 percent removal of each active ingredient in the fourth rinsate after a triple rinse.

It is assumed that the average establishment, rega rdless of size or market sector, uses three rigid container types per formulation, based on an assu mption EPA made in its Container Rule RIA. The residue removal standards, how ever, are applicable to only flowable concentrate products. The representative number of existing and new fo rmulations is assumed to vary by registrant

size. It is assumed that there are 0.25 existing and new formulations for the large registrants, 0.20 existing and formulations for th e large-small registrants, 0.10 ex isting and new formulations for

18 Refer to the Proposed Container Rule RIA (EPA, 1993), Table G-7, Non-refillable rigid containers: Compliance with container dispensing requirements for all three regu latory options, except as note d otherwise, “percent of plastic containers in market that m eet requirement” and the table footnotes for information to substantiate the assumptions used in this analysis.

### Page 49 the medium-small registrants and 0.05 existing and new formulations for the small-small registrants that will be subj ect to the residue removal st andards (see Appendix A).

Not all existing container/formulations will be tested because test data conforming to the residue removal protocol on a different non-refillable cont ainer/formulation may be used to demonstrate that a non-refillable container meets the residue removal standard (“me-too” scenario). In the proposed container rule RIA, EPA assumed that a lower range of 50 percent of all the container

formulation combinations will be tested and an upper range of 100 percent of all such

combinations will be tested. In the final ec onomic analysis, the midpoint of this range, 75 percent, is used since the extent to which “me-toos” will apply is not known.

It is also assumed that a certain number of container/formulation co mbinations will fail the initial residue removal test, requiring a second test using a container car efully selected from the open market and expected to rinse more readily. Based on a study conducted for EPA, EPA assumed in the proposed container rule RIA that 13 perc ent of small, medium, and large agricultural containers and 3 percent of small and medium industrial/institutiona l/household containers would not pass a triple-rinse test where 99.999 per cent (“five-9s”) of a given formulation would be removed after rinsing (EPA, 1993 and 1992b). The 99.99 percent (“four-9s”) standard in the final rule is expected to have a much lower initi al failure rate. Testing data summarized in the final rule preamble show that one out of the 79 c ontainer/formulation combin ations tested did not reach the four-9s level. However, since the residue removal standards apply to only flowable concentrate products, in the final economic anal ysis, a higher (30 perc ent) failure rate is

assumed. This is based on the failure rate of flowable concentrate container/formulation combinations in the study of 79 container/form ulation combinations tested (see Appendix A).

For all other container/formulation combinati ons, the final economic analysis assumes a 2 percent failure rate for all containers (all markets and all sizes of facilities).

Recordkeeping

For each pesticide product that is distributed or sold in non-refillable containers that meet the scope criteria, pesticide registrants must maintain certain r ecords to show compliance with the

non-refillable container standards. It is assumed that none of the pesticide registrants are currently maintaining these records.

3.4.1.3 All Products

Labeling

The new labeling standards apply to all pesticide products. Therefor e, the labeling compliance rates are applicable to all pest icide registrants selli ng or distributing pesticide products in nonrefillable containers. The pesticide contai ner regulations modify the label requirements in 40

CFR Part 156. The new standard s require statements that:

• Identify a container as non-refillable;

• Prohibit the reuse or refilling of a non-refillable container;

• Provide a recycling statement fo r non-refillable containers;

### Page 50 • Provide a lot number or ot her identification code on non -refillable containers; and

• Provide residue removal instru ctions on some containers. 19



### All of these statements are to be grouped and appear under the h eading, “Storage and Disposal.”

It is assumed that no non-refillab le containers are labeled with a ll of the required statements at

this time.

3.4.2 Regulatory Compliance Rates for Refillable Containers

Each of the regulatory components and complian ce rates affecting refill able containers is discussed below. The regulatory components aff ect all non-exempt products sold or distributed in refillable containers, except for labeling requirements, which affect all refillable containers. Antimicrobial pesticides used in swimming pool s are subject to a re duced set of these requirements. The H&G market does not include re fillable containers and is not affected by the

refillable contai ner regulations.

DOT Standards

All non-exempt products sold or distributed in re fillable containers must meet a subset of the DOT Hazardous Materials Regulations (HMR), wh ich establish standards for container design, construction, and marking. Pesticide products that are not DOT hazardous materials must comply with some of the general packaging re quirements and the non-bulk and bulk packaging standards for Packing Group III (the least stringent requirements). Pesticide products that are DOT hazardous materials must comply with all of DOT’s regulations. For the purpose of the container regulations, EPA is sp ecifically adopting the same kinds of DOT requirements as for the non-DOT hazard materials, but for the product’s packing group.

EPA estimates that approximately 35 percent of non-exempt pesticide products in use meet the

DOT definition of a hazardous material and are therefore in compliance with the DOT requirements (EPA, 1999b). It is as sumed that 35 percent of all pe sticide containers in the three major markets and for each size categ ory are DOT hazardous materials.

The remaining 65 percent of non-exempt products sold or distributed in refillable containers are not DOT hazardous materials. However, it is assumed that containers used for the DOT nonhazardous materials are in compliance with the Packing Group III requirements. This assumption is consistent with the proposed EPA container rule RIA which assumed that most of the containers in use were DOT-compliant and that nearly all containers in production were also DOT-compliant. This assumption was also valid ated for the final EP A container rule EA through additional discussions with pesticide regi strants, refillers and industry experts. Compliance with the DOT-related standards wa s high for the proposed rule, and, given the increasing availability and use of DOT-compliant containers, the final ru le assumed that those containers that were out of compliance have either been replaced or will be replaced with compliant containers with in the compliance period.

19 Residue removal instructions are required on the labels of all refillable containers and on the labels of rigid nonrefillable containers holding dilutable pr oducts that are not for residential use.

### Page 51 Standards for Container Markings

The container regulations require that non-exempt pesticide products that ar e sold or distributed in refillable containers be durably marked with a serial number or othe r identifying code (using techniques including stamping, embossing, burning, or printing). The information must be visibly located on the outside part of the container. We assu me that none of the pesticide registrants are durably marking refillable cont ainers with a serial number at this time.

Standards for Openings

The container regulations limit access to the inte rior of liquid minibulk containers by requiring that each opening of a liquid minibulk containe r other than a vent have a one-way valve, a tamper-evident device, or both. EPA believes th at one-way valves and tamper-evident devices will give repackagers reasonable assurance of the previous contents of the containers. Most agricultural minibulks and small volume returnable containers supplied by or purchased from registrants are equipped with either a one-way valve or a ta mper-evident device (EPA, 1992b) and are therefore expected to be in compliance in the baseline. Agricultural minibulks obtained on the open market, rather than from registrants, usually lack tamper-evide nt devices or one-way valves, so refillers must add them (or something similar). The standards for openings are not applicable to bulk tanks.

The standards for the openings compliance rate for affected refillables is based on assumptions that EPA made for the proposed container rule RIA (EPA, 1993) 20 

### :

• 65.0 percent compliance for minibulk containe rs in the agricultural market; and

• 10.0 percent compliance for minibulk containers in the I/C/G mark et (assumes that tote bins are minibulks, but small volume returnables in the I/C/G market are not minibulks).

Bulk Container Standards

The container regulations includ e a general integrity standard for all bulk containers and, for liquid bulk containers, require vents and lockable valves and prohibit external sight gauges. The bulk container standards compliance rate is based upon assumptions that EPA made for the proposed container ru le RIA (EPA, 1993):

• 100.0 percent compliance for dry bulk containers;

• 75.0 percent compliance for liquid plastic bulk containers in the agricultural market;

• 20.0 percent compliance for liquid steel bulk co ntainers in the agri cultural market; and

• 5.0 percent compliance for I/ C/G liquid bulk containers.

Labeling

The new labeling standards apply to all pesticide products. Therefor e, the labeling compliance rates are applicable to regist rants selling or distributing pe sticide products in refillable containers. The pesticide contai ner regulations modify the labeli ng requirements in 40 CFR Part 156. The new standards for refillables require statements that:

20 Refer to the Proposed Container Rule RIA (EPA, 1993) Tables VII-8 and VII-9 and the table footnotes for information to substantiate the assumptions used in this analysis.

### Page 52 • Prohibit users of refillable containers from re filling such containers with substances other than pesticides; and

• Provide residue removal instructions.

All of these statements are to be grouped and appear under the he ading, “Storage and Disposal.”

It is assumed that none of the re fillable containers ar e labeled with all of the container rule’s required statements at this time.

Other Administrative Requirements

For each non-exempt pesticide product that is di stributed or sold in refillable containers, pesticide registrants must prepare and keep record s of the repackaging-rela ted documents. It is assumed that none of the pesticide registra nts are currently keep ing these records.

The regulatory compliance rates for refillable containers are summarized in Table 3.13. 21 

### The compliance rates affect pesticide registrants selling or distributing refillable containers containing non-exempt pesticide products. It is assumed that the container standards for refillables in the swimming pool industry are unaffected by the container regulations because they are either partially exempt from or already in compliance with the applicable standards (EPA, 2002c). This assumption is based on co mments received from pool supply companies, industry associations, and an antimicrobial ma nufacturer, who pointed out many positive aspects

of the refillable containers th ey currently use, including: they are durable and appropriately sized; they meet applicable DOT standards; ther e is a deposit system that leads to nearly 100 percent return of the containers; the compa ny inspects and, if necessary, reconditions the containers before refilling them; an applicator can tell if the container has been tampered with when removing the cap; and their one-gallon cont ainers are of the “no-glug” design. It is assumed that swimming pool chemicals are not in compliance with the new labeling requirements in 40 CFR Part 156.

21 We used the compliance rates presented in this table to calculate the total number of containers not in compliance by regulation, which we then multiplied by the unit cost of regulation to develop total cost.Page 53Table 3.13. Regulatory Compliance Rates for Refillable ContainersDOT PackagingStandardshazardousmaterialsa(§165.110-114)DOT PackagingStandards –non-hazardousmaterialsb(§165.110-114)Standardsforcontainermarkingc(§165.116)Standards foropenings (forliquidminibulksonly)d, e(§165.118)Bulk container standardse, f(§165.120)Labelingrequirements(§156)Otheradministrativerequirements –refillingdocumentsSmall-Small EstablishmentsAgricultural 100.0% 100.0% 0.0% 65.0% 100.0% 75.0% 20.0% 0.0% 0.0%I/C/G 100.0% 100.0% 0.0% 10.0% 100.0% 5.0% 0.0% 0.0%Swimming PoolSupply Companies100.0% 100.0% 100.0% 100.0% N/A N/A N/A 0.0% 0.0%Home & Garden N/A N/A N/A N/A 100.0% N/A N/A N/AMedium-Small EstablishmentsAgricultural 100.0% 100.0% 0.0% 65.0% 100.0% 75.0% 20.0% 0.0% 0.0%I/C/G 100.0% 100.0% 0.0% 10.0% 100.0% 5.0% 0.0% 0.0%Swimming PoolSupply Companies100.0% 100.0% 100.0% 100.0% N/A N/A N/A 0.0% 0.0%Home & Garden N/A N/A N/A N/A 100.0% N/A N/A N/ALarge-Small EstablishmentsAgricultural 100.0% 100.0% 0.0% 65.0% 100.0% 75.0% 20.0% 0.0% 0.0%I/C/G 100.0% 100.0% 0.0% 10.0% 100.0% 5.0% 0.0% 0.0%Swimming PoolSupply Companies100.0% 100.0% 100.0% 100.0% N/A N/A N/A 0.0% 0.0%Home & Garden N/A N/A N/A N/A 100.0% N/A N/A N/ALarge EstablishmentsAgricultural 100.0% 100.0% 0.0% 65.0% 100.0% 75.0% 20.0% 0.0% 0.0%I/C/G 100.0% 100.0% 0.0% 10.0% 100.0% 5.0% 0.0% 0.0%Swimming PoolSupply Companies100.0% 100.0% 100.0% 100.0% N/A N/A N/A 0.0% 0.0%Home & Garden N/A N/A N/A N/A 100.0% N/A N/A N/AaUnder the container regulations, both containers for hazardous and non-hazardous materials must comply with the DOT standards for containers forhazardous materials. The costs of complying with the DOT standards for containersholding hazardous materials are therefore attributed to the DOT standardsand not to the container regulations.Page 54Table 3.13 (Continued). Regulatory Compliance Rates for Refillable ContainersbFor non-hazardous materials, we assume thatDOT-compliant containers canbe purchased on the market at prices comparable to non-compliant containers.We also assume that within the compliance period, regulated entities will exhaust their inventory of non-compliant containers and replace them with compliantcontainers at no extra cost.cThe standards for container markings are not applicable to I/C/G plastic containers from 5 to 25 gallons and to I/C/G liquid containers under the “other sizes”category.dThe standards for openings (for liquid minibulks only) are not applicable to retail bulk tanks, and to dry product containers.These standards are also notapplicable to I/C/G liquid containersunder the “other sizes” category.eThe bulk container standards are only applicable to retail bulk tanks.fFor bulk containers in the all markets, the first percentage represents the compliance rate for dry bulk containers. For the agricultural market, the secondpercentage refers to liquid plastic bulk containers and the third percentage refers to liquid steel bulk containers. For the I/C/G market the percentage refers toall liquid bulk containers.

### Page 55 3.4.3 Regulatory Compliance Rates for Refilling Activities

The container regulations establish procedural an d handling standards to ensure that containers are refilled legally and safely. Registrants have certain responsibilities to develop information, and, if a different company (such as a retailer) repackages their produ ct into refillab le containers,

to ensure that certain conditions are met. The person who is actually doing the refilling— regardless of whether it is the registrant or another company— must obtain the registrant’s information; comply with certain conditions; an d clean, inspect, and ensu re proper labeling of

the refillable containers.

It is assumed that the refilling requirements fo r 90 percent of the total number of agricultural refillables under the scope of the container rule are attributed to agricultural pesticide refillers and the remaining 10 percent are attributed to pesticide regist rants (Paulson, 2002). 22 

### All refilling requirements in the I/C/G market are attr ibuted to pesticide regi strants because there is no readily available information to differentiate an industry sector that repackages pesticide products in the I/C/G market that is also not a registrant for products in that sector. All refilling requirements in the swimming pool industry are attributed to re gistrants and swimming pool supply companies.

The standards for establishments that repackag e pesticide products into refillable containers (refillers) require that these enti ties inspect, clean, and keep certa in records about the refillable containers that they re fill (§165.198–§165.218). Using prof essional judgment based on consultations with pesticide registrants, refille rs, and industry experts, we estimated that 60 percent of establishments insp ect refillables before refilli ng, 92 percent properly clean the container before refilling, and none of the esta blishments currently im plements recordkeeping

that meets the standards.

Based on comments from pool supply companies, industry associations, and an antimicrobial manufacturer, EPA has determined that swimmi ng pool supply companies in general inspect containers before refilling (EPA, 2002c). For this analysis, we assumed that 95 percent of

refillable containers in the sw imming pool industry are properly in spected prior to refill. EPA

has also determined that refillables in the swim ming pool industry will probably not have to be cleaned prior to refilling because specifie d conditions (§165.170) will be met and certain recordkeeping requirements do not apply (§165.178(b)) (EPA, 2002c). We assumed that all of the refillables in the swimming pool industry are already in compliance with the applicable cleaning and recordkeeping requirements.

Table 3.14 summarizes the containe r rule refilling requirements fo r entities handling pesticide products that are repackaged into refilla ble containers for sale or distribution.

22 We used these assumptions to allocate the total number of containers in each size and type category to the different markets (e.g., pestic ide registrants, agricultural pesticide refillers). For example, out of the estimated 12,060 plastic bulk containers in the agricultural market, 10,854 (90 percent) are attribut ed to agricultural pesticide refillers. We then used these numbers to develop estimates of number of containers in not in compliance and finally to estimate the cost of compliance by registrants.Page 56Table 3.14. Repackaging/Refilling Requirements and ResponsibilityRequirementRegistrants Who Distributeor Sell in RefillableContainersRegistrants Who Distributeor Sell to Outside Refillersfor RepackagingRefillers Who AreNot the Registrants of the Product(Outside Refillers)Ensure product integrity Yes Yes YesDevelop written documents describing: (1) how to cleancontainers and (2) acceptable containersYes Yes NoComply with conditions to allow an outside refiller torepackage your product (e.g., provide contract orauthorization)aNo Yes NoComply with conditions to allow you to repackage aregistrant’s product (e.g., obtain contract or authorization)aNo No YesHave documents available at refilling establishmentbYes No YesBe a registered producing establishmentbYes No YesRepackage product only into acceptable containerbYes No YesRepackage up to rated capacity of containerbYes No YesNo limits on size of containerbYes No YesIdentify product previously in container to determine theappropriate cleaning procedurebYes No YesClean containerb,cYes No YesVisually inspect containerb,cYes No YesLabel containerbYes No YesRecordkeepingcYes Yes YesCompliance period 5 years 5 years 5 yearsaThe conditions for a registrant to allow a refiller that is not part of the registrant’s company to repackage a product include(a) the repackaging results in no changein the pesticide formulation; (b) the refiller is a registeredproducing establishment; (c) the registrant and refiller enter into a written contract for the refiller torepackage the pesticide product and to use the product’s label; (d) the product is repackaged only into refillable containers that comply with the regulations; and(e) there are no changes to the pesticide label (other than adding the appropriate net contents and EPA establishment number).bThe repackaging regulations do not specifically apply these standards to registrants who distribute or sell to refillers that are not part of their company forrepackaging. In this case, the registrant is not actually repackaging the product into refillable containers, which is the activity that these requirements are intended toaddress. The table therefore indicates “no” for these registrants. However, some of these requirements apply because of otherregulations. For example, theseregistrants are required to be registered producing establishments by 40 CFR Part 167.In addition, a registrant may also repackage product directly into refillablecontainers as described in the previous column, and those requirements would thus apply.cAntimicrobial products that are used only in swimming pools (andclosely related sites such as hot tubs, spas, or whirlpools) are exempt from the portions of thecleaning and inspecting requirements that relate to serial numbersand one-way valves/tamper-evident devices and from some of the recordkeeping.

### Page 57 In summary, this chapter presente d the level of compliance of pest icide containers with the final

container standards. We calcu lated the number of pesticide co ntainers affected by the scope

criteria for each non-refillable a nd refillable container size category for all the market sectorsAgriculture, I/CG and H&G. We also described the regulatory compliance baseline that presents the percentage of containers expected to be in compliance with the requi rements of the container rule. This provides an estimate of the number of containers not in complia nce, which we use in the cost analysis presented in the next chapter (Chapter 4).

### Page 58 

## 4.0 Pesticide Container Standards Cost Analysis

4.1 Introduction

This chapter describes the methods and the results of the analysis of the costs of the container regulations. Section 4.2 defines th e basic framework of the analys is: the categories of regulated entities considered, the market sectors examine d, the container types included, the specific regulations covered, and the broad assu mptions that underlie the analysis. 23 

### Section 4.3 describes those characteristics of the regulated en tities that are inputs to the cost analysis: the number of regulated entities and, for each category of regulated entity, the percentage of total

annual revenue in each size class. Section 4.4 describes the method for estimating the costs incurred by pesticide registrants of complying with the container-r elated regulations. Section 4.5 describes the method for estimating the costs incurre d by pesticide refillers (a broad category that includes several categories of re gulated entities, described in Section 4.2 below) of complying with the refilling-related regulations.

The estimates of total annualized compliance cost, both by regulated entity and by regulation, are presented in Section 4.6. The tota l annualized costs of the pesticid e container rule are calculated across all regulati ons contained within it, for:

• The average regulated entity – in each combination of entity type, market sector, and company size class;

• All regulated entities – in each combination of entity type, market sector, and company size class;

• The average pesticide registrant with a “rep resentative share” in each market sector; 24



### • All pesticide registrants (across all market sectors) in each company size class;

• All pesticide registrants across all mark et sectors and company size classes;

• All regulated entities within each category co mplying with refilling-related regulations; and

• All regulated entities.

These results are shown in Tabl es 4.17a and 4.17b in Section 4.6. Regulated entities in this analysis are companies rather than individual facilities. In additi on to costs per regulated entity, costs are calculated by regulation, as shown in Tables 4.18a and 4.18b.

The impact of the container regulation on the av erage regulated entity in each regulated entity type is measured as the ratio of its annual complia nce cost to its annual revenue. The results of the impact analysis, for each combination of ma rket sector and size class, are presented in Section 4.7. The subcategories of the “small” size category are aggregated for the Small Business Regulatory Enforcement Fairness Act (SBREFA) analysis of impact. Finally, in

23 Specific assumptions made at different points in th e analysis are detailed in the appropriate sections.

24 The cost analysis estimates the complia nce costs of an average pesticide regi strant in each market sector, as well as the compliance costs of an average pesticide registrant that works in all three ma rket sectors. The average pesticide registrant that works in all three market sectors is assumed to have the same distribution of containers

across market sectors as the distribution of pesticides (by volume) across market sectors. That is, if the distribution of pesticide usage by volume is 40 percent, 30 percent an d 30 percent in the agricultural, I/C/G, and H&G markets, respectively, then the distribution of containers by an average pesticide registrant who for example has 100 containers will be 40, 30, and 30 for the three markets, respectively.

### Page 59 Section 4.8 the results of two sens itivity analyses are presented—one that uses a set of “low-end” input values (i.e., input values th at will result in lower-cost estimat es) and one that uses a set of “high-end” input values (i.e ., input values that will resu lt in higher-cost estimates).

4.2 The Basic Framework of the Cost Analysis

There are two broad sets of regulations under the pesticide container rule. One set of regulations pertains to pesticide containers themselves—how they must be constructe d, marked, and labeled to ensure safety. The regulated entities that mu st comply with these regulations are the pesticide registrants. The other set of regulations concer ns the refilling (or repackaging) of (refillable) pesticide containers, specifying what must be done to ensure that the act of refilling a pesticide container does not pose safety or health probl ems. The regulated entities (broadly termed “pesticide refillers”) that must comply with th is set of regulations are agricultural pesticide refillers, swimming pool supply companies, and some pesticide registrants (in particular, pesticide registrants in two of the three mark et sectors plus the sw imming pool industry). Descriptions of each of these ca tegories of regulated entities can be found in Section 3.1 and Appendix D.

To the extent possible, we estimated costs for re gulated entities separately by the market sectors in which they operate. The categorization of re gulated entities by market sector is shown in

Table 4.1.

Table 4.1. Types of Regulated Entities by Market Sector

Agricultural

Sector Industrial/

Commercial/

Government (I/C/G) Sector Swimming

Pool Industry Home & Garden (H&G) Sector (Households)

Pesticide Registrants 9 9 9 9

Agricultural Pesticide Refillers 9

Swimming Pool Supply Companies 9 a

a Swimming pool supply companies could be considered part of both the I/C/G and H&G markets. However, for the purposes of this analysis, we considered swimming pool supply companies separately.



### The types of containers covered under the contai ner regulation are broa dly categorized as nonrefillable and refillable containe rs. Because the set of regulations pertaining to the activity of refilling obviously involves only refillable contai ners, only regulated ent ities that engage in refilling must comply with them. A broad overv iew of the regulated ent ities and the sets of regulations with which they must comply is pr ovided in Table 4.2. A more detailed overview, identifying the pesticide container standards w ith which the different regulated entities must comply, is given in Table 4.3. 25

25 See Chapter 2, Chapter 3, and Appendix G for a more detailed description of the final pesticide container

standards.

### Page 60 Table 4.2. Overview of Regulated Entities and Types of Regulations with Which They Must Comply

Regulated Entity Regulation of Pesticide

Containers (Non-Refillables and Refillables) Regulation of Refilling (Refillables)

Pesticide Registrants:

In the Agricultural Sector 9 9

In the I/C/G Sector 9 9

In the Home & Garden Sector 9

In the Swimming Pool Industry 9 9

Agricultural Pesticide Refillers 9

Swimming Pool Supply Companies a 9

a Swimming pool supply companies are subject to a subset of the refilling requirements. Swimming pool supply companies must maintain certain records, but not all. Swimming pool supply companies must meet certain refilling requirements, but not all. Refillables are required to be inspected and cleaned (unless specified conditions in §165.170 are met) but not do not need to be relabeled. Copies of the residue removal procedures for refilling and description of acceptable containers must be on file (§165.218(a)), but a record of certain information recorded each time a container is refilled (e.g., product, amount) is no t required (§165.218(b)). Swimming pool supply companies could be considered part of both the I/C/G and H&G markets. For the purposes of this analysis, however, we considered swimming pool supply companies separately.Page 61Table 4.3. Intersection of the Pesticide Container Regulations and Regulated EntitiesPesticide Container Regulations Pesticide RegistrantsAgriculturalPesticide RefillersSwimming PoolSupply CompaniesNon-Refillable ContainersEnsure that containers meet a subset of DOT packaging standards9Ensure that liquid product containers dispense properly and have standard closures9Develop residue removal procedures for dilutable pesticides in rigid containers9Refillable ContainersEnsure that containers meet a subset of DOT packaging standards9Mark containers with a serial number9Ensure that a one-way valve and/or tamper-evident device isin place for liquidminibulks9Ensure that a vent, gauge, and shutoff valve are in place for liquid bulk containers9Meet repackaging conditions9a99bDevelop cleaning procedures for repackaging9aInspect, clean, and properly label containers9a99bMaintain records9a99bLabeling StandardsEnsure that labels include specified information9aRefilling requirements affect pesticide registrants for 10 percent of the total refillable containers in the agricultural market sector and all of the containers inthe I/C/G market sector. Available data are insufficient to differentiate pesticide registrantsthat also repackage I/C/G market pesticide products from those thatdo not. Therefore, pesticideregistrants are held accountable.bSwimming pool supply companies must meetcertain refilling requirements, but not all.Refillables are required to be inspected and cleaned (unless specifiedconditions in §165.170 are met) but not do not need to be relabeled. Swimming pool supply companies must maintain certain records, but not all. Copies ofthe residue removal procedures for refillingand description of acceptable containers must be on file(§165.218(a)), but a record of certain information recordedeach time a container is refilled (e.g., product, amount) is not required (§165.218(b)).

### Page 62 Containers within the broad categories of non-re fillable and refillable containers are further subdivided by size and material ty pe, as shown in Table 4.4.

Table 4.4. Types of Containers Considered in the Analysis

Containers for Liquid Products Containers for Dry Products

Non-Refillables

30 - 55 gallons, plastic 56 - 100 lb. bags, paper/plastic

30 - 55 gallons, steel 45 - 55 lb. bags, plastic

5 gallons, plastic 45 - 55 lb. bags, paper

5 gallons, steel 11 - 44 lb. bags, plastic

1 - <5 gallons, plastic 11 - 44 lb. bags, paper

1 - <5 gallons, steel 1 - 10 lb. bags, plastic

< 1 gallon, plastic 1 - 10 lb. bags, paper

< 1 gallon, steel 2.5 gallon jugs

< 1 gallon, glass 1 qt. - < 2.5 gallon jugs

Water soluble packets – PVA packets Water soluble packets – PVA packets

Water soluble packets – barrier packs Water soluble packets – barrier packs

Bag in box > 101 lb. bulk containers

Aerosol can > 30 lb. fiber drums

< 30 lb. fiber drums

Other

Refillables

Bulk Tanks (> 500 gallons), plastic Bulk (> 4,000 lbs.), paper/plastic

Bulk Tanks (> 500 gallons), steel Large (2,501 - 4,000 lbs.), paper/plastic

Large Tanks (251 - 500 gallons), plastic 101 - 2,500 lbs., paper/plastic

Large Tanks (251 - 500 gallons), steel Fiber drums

126 - 250 gallons, plastic Other sizes

126 - 250 gallons, steel

61 - 125 gallons, plastic

61 - 125 gallons, steel

26 - 60 gallons, plastic

26 - 60 gallons, steel

5 - 25 gallons, plastic

5 - 25 gallons, steel

Other sizes



### 4.3 Characteristics of the Regulated Entities That Are Inputs to the Cost Analysis

Regulated entities are divided into two size classes: small and larg e. As discussed in Chapter 3, for this analysis, the “small” category is furthe r sub-divided into “small-small,” “medium-small,” and “large-small.” 26 

### We estimated costs for several of the cost categories listed above (e.g.,

26 This analysis considers an alternative definition to the Small Business Administration’s (SBA’s) definition of small business for the industries potentially affected by the final pesticide container regulations. The analysis

### Page 63 costs for the average regulated entity in each co mbination of entity type, market sector, and size class) using the following two characteri stics of regulated en tities as inputs:

• The number of entities in each combination of market sector and size class; and

• The breakdown of total revenue by size class (i.e., the percentage of total revenue attributed to large establishments and to small-small, medium-small, and large-small establishments).

We used the number of entities in a combinati on of market sector a nd company size class to

calculate the number of contai ners out of compliance with e ach regulation under the container

rule per average regulated entity in that combination of market sector and size class. For example, there are estimated to be 26,703 1 to <5 gallon plastic non-refilla ble containers out of compliance with the standards for container disp ensing capability among “large-small” pesticide registrants in the agricultural sector. 27 

### There are 66 such pesticide registrants, so the average

number of containers out of co mpliance with that regulation per “large-small” registrant in the agricultural sector is 402 (=26,703/66). 28



### We used the percentage of total revenue attributed to regulated en tities in a given size class to

allocate the number of containe rs that fall within the scope of the container rule within each market sector to the different size classes (s ee Section 4.4.3). For ex ample, 0.8 percent of revenue among pesticide registrants is associated with “large-small” establishments. Using this as a proxy for the distribution of containers that fall under the scope of the rule, the analysis assumed that 0.8 percent of all such containers were registered by “large-small” establishments

in each market sector.

Appendix D describes the data sources and proce dures we used to characterize representative regulated entities for each market sector and size category. In genera l, Dun & Bradstreet financial data were matched to the representative list of companies for each regulated entity type, and the companies were profiled based on the SBA definition of small and large businesses and EPA’s alternative definitions of small businesses (see Appendix D).

disaggregates the SBA-defined small businesses into three cat egories: small-small, medium-small, and large-small. EPA is concerned that using an overly broad definition of small business in the economic analysis of the container regulations may result in significant economic impacts on smaller entities that will be camouflaged when combined with information about potential impacts on facilities that meet the SBA size standard for small business but are not typical of a small business in that industry sector.

27 We calculated the number of plastic non-refillable containers out of compliance for the container dispensing capability among “large-small” pesticide registrants in the agricultural sector by multiplying the total number of non-refillable containers affected by the container regula tions (17,986,536, see Table 3.9) and multiplying it by the percentage of containers among the “large-small” containers (0.8%), which was obtained from the distribution of total revenues across the pesticide registrant company size categories. Out of the 144,339 (17,986,536*0.08) containers, 81.5% are expected to be in compliance with the container dispen sing standards (see Table 3.12) which gives 26,703 containers not in compliance (144,339*0.185).

28 Discrepancy is due to rounding. The inputs to the calculation shown here (26,703 and 66) are rounded. The output, 402, is based on the unrounded numbers.

### Page 64 Table 4.5 presents the estimated numbers of regulated entitie s by market sector and size

category. 29 

### The percentages of total revenue in each size class within a regulated entity type are given in Table 4.6. 30



### Table 4.5. Estimated Numbers of Regulated En tities by Market Se ctor and Size Class

Size Classes

Market Sector Small-Small Medium-Small Large-Small Large All Size Classes

Pesticide Registrants

Agricultural 399 198 66 58 722

I/C/G 299 148 50 44 541

Home & Garden 299 148 50 44 541

Total 997 495 166 146 1,804

Agricultural Pesticide Refillers

Agricultural 13,996 2,395 251 153 16,795

Total 13,996 2,395 251 153 16,795

Swimming Pool Supply Companies

Total 174 117 14 17 322



### Table 4.6. Percentages of Total Revenue in Each Size Class

Size Classes Regulated Entity Type Small-Small Medium-Small Large-Small Large

Pesticide registrants 0.2% 0.4% 0.8% 98.6%

Agricultural pesticide refillers 18.0% 25.8% 9.1% 47.0%

Swimming pool supply companies 0.2% 0.7% 0.2% 98.9%



### 4.4 Estimating the Costs of Comply ing with the Final Regulations

This section describes the method of estimating th e costs of complying with the set of containerrelated regulations incurred by the average pestic ide registrant. For a given combination of market sector and size class, the analysis proc eeds through the following series of steps to a final

estimate of the cost to the aver age pesticide registrant in that market sector/size class per container-related regulation:

• Estimate the number of containers in the market sector;

• Estimate the number of those containers that fall within the scope of the container rule;

• Estimate the number of those containers that ar e associated with pesticide registrants in the size class;

29 The number of regulated entities in each size category is distributed across the market sector based on the amount of pesticide product used in each market sector (see Appendix D for details). The 2001 pesticide use estimates that the agricultural, I/C/G, and H& G sectors used 40 percent, 30 percent, and 30 percent of pesticides, respectively. Based on these percentages, the number of registrants in the large size category (146) th at are in the agricultural

sector is calculated as 0.40*146 = 58.

30 The revenue ratio for each pesticide registrant size category is based on the per size category total revenue compared to the revenue for the total universe of registra nts based on the PPIS sample data set (see Appendix D for details).

### Page 65 • For each regulation under the container rule, estima te the number of those containers that are out of compliance with the regulation;

• Estimate the number of containers ou t of compliance with each regulation per average registrant in the market sector/size class;

• Estimate the cost, in each year of a 20-year period, of bringing t hose containers into compliance, and the present discounted value of that 20-year stream of costs, using a 3 percent discount rate and a 7 percent discount rate; and

• Annualize this present discounted value, using a 3 percent interest rate and a 7 percent

interest rate.

The steps are described below in the order in which they were carried out in the analysis.

4.4.1 Estimate the Number of Pesticide Co ntainers in Each Market Sector

The cost analysis begins by using the number of pesticide containers of each type within each market sector, separately for non-refillable and refillable containers, as described in Chapter 3.

4.4.2 Estimate the Number of Pesticide Contain ers in Each Market Sector That Fall Within the Scope of the Container Rule

As discussed in Chapter 3, not all containers fa ll within the scope of the full set of container regulations. 31 

### For the next step in the cost analysis, we estimate the number of containers, within each combination of container type and market sector, that fall with in the scope of the rule. The process of estimating the number of containers that fall within the scope of the container rule in each market sector is described in Chapter 3. The estimated numbers of containers (across all container types) in each market sector, and the estimated numbers and percentages that fall within the scope of the container rule, are presen ted, separately for non-ref illables and refillables,

in Table 4.7.

31 The scope criteria apply the full set of non-refillable container regulations to non-exempt products that meet the Toxicity Category I, Toxicity Category II, and/or restricted use criteria. The basic DOT packaging standards in 49 CFR 173.24 apply to all non-exempt products that are distributed/sold in non-refillable containers.

### Page 66 Table 4.7. Number of Containers by Market Sector, and Number and Percentages that Fall Within the Scope of the Container-Rela ted Regulations Under the Container Rule

Agricultural

Sector I/C/G Sector Home &

Garden

Sector Swimming

Pool Industry a Total

Non-Refillables

Number of containers c 114,336,894 90,360,000 400,000,000 0 604,696,894

Number of containers within the scope of the container rule 73,770,164 47,930,965 227,274,040 0 348,975,169

Percentage of containers within the scope of the container rule 64.5% 53.0% 56.8% 0 57.7%

Refillables
Total number of containers 1,263,600 46,500 0 1,217,000 2,527,100

Number of containers within the scope of the container rule b 1,263,600 37,458 0 1,217,000 2,518,058

Percentage of containers within the scope of the container rule 100.0% 80.6% --- 100.0% 99.6%

a The swimming pool industry is part of the I/C/G and H&G sectors, but is analyzed separately for the refillable container analysis. Most refillables are in complian ce with the regulations, except the labeling and other administrative requirements, b ecause these containers stor e DOT hazardous materials.

b Swimming pool refillers are subject to a subset of the ref illing requirements. Swimming pool refillers must meet certain refilling requirements, but not all. See Table 3.1 footnote for more detail.

c See Tables 3.4 and 3.9 for non-refillables and Tables 3.5 and 3.10 for refillables.



### 4.4.3 Allocate Containers That Fall Within the Sc ope of the Rule in Each Market Sector

to Each of the Size Classes

To allocate those containers that fall within the sc ope of the container rule to pesticide registrants

within each of the different si ze classes, it is assumed that th e percentage of total revenue (among all pesticide registrants) associated with establishmen ts in a given size class is a reasonable proxy for the percentage of containers registered by registra nts in that size class. This allocation of containers to size classes by percen tage revenue was applied to each of the market sectors, and within each market sector, to each container type. For example, of the 73,770,164 non-refillable containers in the ag ricultural sector that fall within the scope of the container rule (see Table 4.7), 0.8 percent (see Table 4.6), or 591,993, are assumed to be registered by largesmall pesticide registrants. 32 

### Of the 73,770,164 non-refillable cont ainers in the agricultural sector that fall with the scope of the cont ainer rule, 199,434 are 30–55 gall on plastic containers for holding liquid products. Of those, it is a ssumed that 0.8 percent, or 1,600 containers, are registered by large-small pestic ide registrants (see Table K-1). 33 

### By the end of this step in the analysis, all containers that fall within the scope of the container rule ar e allocated to pesticide registrants in each combination of market sector and size class.

32 Percentages given here are rounded. The numbers are based on the unrounded percentages, and are therefore slightly different from what would be obtained if the rounded percentages had been used.

33 Table K-1 contains estimates of the number of contai ners by container type for each container and facility size

category.

### Page 67 4.4.4 For Each Regulation Under the Pesticide Container Rule, Estimate the Number of Containers That Fall Within the Scope of the Rule That Are Out of Compliance with That Regulation

Many containers are already in compliance with one or more of the regulations under the pesticide container rule and theref ore do not need to be brought into compliance. For this step of the cost analysis, the compliance rates estimated for each type of container in each combination

of market sector and size class are used. Th e estimation of compliance rates is described in Chapter 3.

The number of containers of a given type within a given combination of market sector and size class that are out of comp liance is just the number of containers of that type in that combination

of market sector and size class that fall within the scope of the rule multiplied by one minus the corresponding compliance rate. Fo r example, it is estimated that 35 percent of non-refillable plastic containers for holding liquid products smal ler than one gallon registered by large-small establishments in the agricultural sector ar e in compliance with the dispensing capability requirement (§165.68 of the rule). It is estimated that 5,214 containers of that type in large-small establishments in the agricultural sector fall within the scope of the rule. The estimated number of containers of that type in that combination of market sector and si ze class that are out of compliance with the dispensing capabil ity requirement is (1 - 0.35)*5,214 = 3,389.

The rates of compliance with the final pesticid e container regulations by container type are described in Chapter 3. Tables 4.8a (for non-refillables) and 4.8b (for refillables) give the numbers of containers (over all types) estima ted to be out of compliance with each of the container-related regulations unde r the pesticide container rule.Page 68Table 4.8a. Estimated Numbers of Non-Refillable ContainersOut of Compliance with the Container-Related RegulationsaDOT PackagingStandards –hazardousmaterialsb(§165.60-64)DOT PackagingStandards – nonhazardousmaterialsc(§165.60-64)ClosureStandards(§165.66)Standards forcontainerdispensingcapability(§165.68)LabelingrequirementsOther administrativerequirements –recordkeepingSmall-Small EstablishmentsAgriculture 0 0 3,418 7,115 139,972 139,972I/C/G 0 0 0 17,904 90,944 90,944Home & Garden 0 0 0 33,636 431,230 431,230Medium-Small EstablishmentsAgriculture 0 0 7,975 16,600 326,568 326,568I/C/G 0 0 0 41,771 212,183 212,183Home & Garden 0 0 0 78,476 1,006,105 1,006,105Large-Small EstablishmentsAgriculture 0 0 14,456 30,092 591,993 591,993I/C/G 0 0 0 75,722 384,638 384,638Home & Garden 0 0 0 142,259 1,823,837 1,823,837Large EstablishmentsAgriculture 0 0 1,775,609 3,696,028 72,711,631 72,711,631I/C/G0 0 0 9,300,532 47,243,200 47,243,200Home & Garden0 0 0 17,473,004 224,012,868 224,012,868Total Number of ContainersAgriculture 0 0 1,801,458 3,749,834 73,770,164 73,770,164I/C/G0 0 0 9,435,929 47,930,965 47,930,965Home & Garden0 0 0 17,727,375 227,274,040 227,274,040Total Containers0 0 1,801,458 30,913,138 348,975,169 348,975,169aIn many cases, a regulation is not applicable to particular typesof containers in a particularmarket sector. For example, theclosure standards for non-refillablesare applicable only to containers that hold at least 1 gallon and that hold liquid products in the agriculture sector. In allcases in which a regulation was notapplicable, a compliance rate of 100% was used, sothat there would be 0% “out of compliance.”bUnder the container rule, both containersfor hazardous materials and non-hazardous materials must comply with the DOT standards for containers forhazardous materials. The costs of complying with the DOT standards for containersholding hazardous materials are therefore attributed to the DOT standardsand not the container rule.cFor non-hazardous materials, we assume thatDOT-compliant containers canbe purchased on the market at prices comparable to non-compliant containers. Wealso assume that within the compliance period, regulated entities will exhaust their inventory ofnon-compliant containers andreplace them with compliantcontainers at no extra cost.Page 69Table 4.8b. Estimated Numbers of Refillable Containers Out of Compliance with the Container-Related RegulationsaDOT PackagingStandards –hazardousmaterialsb(§165.110-114)DOT PackagingStandards –non-hazardousmaterialsc(§165.110-114)Standards forcontainermarking(§165.116)Standards foropenings (forliquidminibulks only)(§165.118)Bulkcontainerstandards(§165.120)LabelingrequirementsOtheradministrativerequirements –refillingdocumentsdSmall-Small EstablishmentsAgricultural 0 0 2,398 367 8 2,398 2,398I/C/G 0 0 72 396 15 2,380 2,380Home & Garden 0 0 0 0 0 0 0Medium-Small EstablishmentsAgricultural 0 0 5,594 856 18 5,594 5,594I/C/G 0 0 168 924 35 5,553 5,553Home & Garden 0 0 0 0 0 0 0Large-Small EstablishmentsAgricultural 0 0 10,140 1,551 33 10,140 10,140I/C/G 0 0 304 1,676 63 10,067 10,067Home & Garden 0 0 0 0 0 0 0Large EstablishmentsAgricultural 0 0 1,245,469 190,497 4,028 1,245,469 1,245,469I/C/G0 0 37,374 205,796 7,720 1,236,458 1,236,458Home & Garden0 0 0 000 0Total Number of ContainersAgriculture 0 0 1,263,600 193,270 4,087 1,263,600 1,263,600I/C/G0 0 37,919 208,792 7,832 1,254,458 1,254,458Home & Garden0 0 0 000 0Total Containers0 0 1,301,519 402,062 11,919 2,518,058 2,518,058aIn many cases, a regulation is not applicable to particular typesof containers in a particular market sector. In all cases inwhich a regulation was not applicable, acompliance rate of 100% was used, so that there would be 0% “out of compliance.”bUnder the container rule, both containersfor hazardous materials and non-hazardous materials must comply with the DOT standards for containers forhazardous materials. The costs of complying with the DOT standards for containersholding hazardous materials are therefore attributed to the DOT standardsand not the container rule.cFor non-hazardous materials, we assume thatDOT-compliant containers canbe purchased on the market at prices comparable to non-compliant containers. Wealso assume that within the compliance period, regulated entities will exhaust their inventory ofnon-compliant containers andreplace them with compliantcontainers at no extra cost.dOther administrative requirements relate to preparing and keeping records of the repackaging-related documents. The costs related to these requirements areincluded here (rather than the repackaging regulation) because these costs are solely the registrant’s costs —not refillers’ costs.

### Page 70 4.4.5 For Each Regulation Under the Cont ainer Rule, Estimate the Number of Containers That Fall Within the Scope of the Rule That Are Out of Compliance with That Regulation – for the Average Registrant in Each Combination of

Market Sector and Size Class

For each combination of container type, market s ector, and size class, the number of containers out of compliance with each container regulat ion is divided by the number of pesticide registrants in that combination of market sector and size class (see Table 4.5). This yields an

estimate of the number of containe rs of each type that are out of compliance with each regulation for an “average registrant” in each market sector-size class combination. 34 

### For example, there are an estimated 836,533 plastic 30–55 gallon non -refillable containers for liquid products registered by large establishments in the I/C/G se ctor that are out of compliance with the labeling requirements (see Table K-2). 35 

### There are estimated to be 44 large establishments in the I/C/G

sector. It is therefore estimate d that the number of plastic 30–55 gallon non-refillable containers for liquid products that are out of compliance with the labeling requirements for the average large pesticide registrant in th e I/C/G sector is 836,533/44 = 19,099. 36



### 4.4.6 Estimate the Cost, in Each Year of a 20-Ye ar Period, of Bringing Containers into Compliance

There are two dimensions to the cost calculati ons. First, compliance costs may be fixed or

variable. 37 

### (See Table A-1 of Appendix A for a descripti on of the type of cost associated with each container standard.) Fixed costs do not depe nd on the number of containers that must be brought into compliance with the regulation, whereas variable costs do. Fi xed costs include, for example, the cost of a filing cabinet or the cost of initial testing of each combination of container type and pesticide formulation. A fixed cost wa s estimated for each regulation, as described in detail in Appendix A.

Total variable cost increases with each cont ainer brought into compliance. The marginal variable cost curve was assumed to be horizontal; that is, there was assumed to be a constant unit variable cost, so that the vari able cost incurred by bringing N containers into compliance is N times the variable cost of bringing one containe r into compliance. A unit variable cost was estimated for each regulation, as de scribed in detail in Appendix A.

The second dimension of the cost calculations is the time dimension. Some costs are incurred only once (e.g., at the beginning of the period of time over which costs may be incurred), whereas other costs are incurred in each year of the period. The distinction between fixed costs

and variable costs is not the same as the distin ction between one-time cost s and annual costs. Some fixed costs may occur year after year, wher eas some variable costs may occur only once, at the beginning of the cost period. For example, th e cost of testing combin ations of non-refillable

34 An “average registrant” in a market sector-size class combination is assu med to have the same combination of container types as the market sector -size class combination as a whole.

35 Table K-2 presents estimates of the number of contai ners by container type for each container and facility size

category.

36 Discrepancy is due to rounding. The inputs to the calculation shown here (836,533 and 44) are rounded. The output, 19,099, is based on the unrounded numbers.

37 For some regulations there are only fixed costs (e.g., all container-related regulations for non-refillables have only fixed costs); for some, there are only variable cost s; and for some there ar e both (see Appendix A).

### Page 71 containers and pesticide formul ations is a fixed cost (it does not depend on the number of nonrefillable containers subject to the regulations), but it is assumed to be incurred in each year, as

new formulations are introduced. The cost of bringing liquid mini bulk containers into compliance with the standards for openings is a va riable cost (it increases as the number of liquid minibulk containers increases), but it occurs only once, at the beginni ng of the cost period.

Unless a pesticide registrant is able to obtain a waiver releasin g it from the responsibility to comply with a given container re gulation, the annual cost of co mplying with the regulation is found by:

• Calculating the cost in each year of the 20-year period;

• Calculating the presented di scounted value of the resul ting stream of costs; and

• Annualizing this present discounted value.

Pesticide registrants will have 3 years in whic h to bring their non-refill able containers into compliance with regulations under th e rule. It is assumed that the compliance costs associated

with non-refillables will be incurr ed beginning at the end of the th ird year. Pesticide registrants will have 5 years in which to bring their refillab le containers into compliance with regulations under the rule. It is assumed that the complia nce costs associated w ith refillables will be incurred beginning at the end of the fifth year. In calculating the present discounted value of the costs of a regulation, all costs are discounted back to the beginning of the first year of the 20- year period.

The costs incurred in a single year are the fixed cost s (if any in that year) plus the variable costs (if any in that year). If:

• F

n 

### denotes the fixed cost of comp lying with the regulation in the n th year ( n =1, ..., 20);

• UVC

n 

### denotes the unit variable cost of complying with the regulation in the n th year; and

• N denotes the number of containers out of compliance with the regulation annually, 38



### then the cost of complying with the regulation in the n th year is:

F

n 

### + UVC

n 

### * N

.

Both fixed and unit variable costs, however, ma y differ for pesticide re gistrants in different market sectors and/or different size classes, and the cost analysis attempted to capture those differences whenever possible. For example, co st of testing to ensure compliance with the residue removal standard depends on the number of formulations, which tends to vary with the

size of the establishment. The number of ex isting formulations for the average large establishment, for example, is estimated to be 0.25, whereas the number of existing formulations for the average small-small establishment is onl y 0.05 (see Appendix A, Table A.6). This results in greater testing costs for the av erage large pesticide registrant th an the average small-small one.

38 The number of containers to which the unit variable cost must be applied, if variable costs are annual, is assumed not to change over the 20-year period.

### Page 72 In addition, the type of containe r could affect the unit variable cost of compliance. The simple formula above is therefore made more specific as follows: The cost of complying with the i th regulation for the average pesticide registrant in the j th market sector and the k th size class in the

n th year of the 20-year period is



# ∑

= 

### ∗ + = M

m ijkmn ijkmn ijkn ijkn 

### N UVC F CC

1 

### ) ( ,

where:

• CC ijkn 

### denotes the cost of complying with the i th regulation for the average pesticide registrant in the j th market sector and the k th size class in the n th year;

• F ijkn 

### denotes the fixed cost of complying with the i th regulation for the average pesticide registrant in the j th market sector and the k th size class in the n th year;

• M denotes the number of container types;

• UVC ijkmn 

### denotes the unit variable cost, specific to the m th container type, of complying with

the i th regulation for the average pesticide registrant in the j th market sector and the k th size

class in the n th year; and

• N ijkmn 

### denotes the number of containers of the m th type that are out of compliance with the i th regulation for the average pesticide registrant in the j th market sector and the k th size class in

the n th year (assumed not to change over the n years).

For example, the unit (per-contai ner) variable cost of meeting the bulk container standards for

refillable containers is estimated to be $856 (regardless of contai ner type or market sector). There is no fixed cost. The average large establishment in the agricultural sector has 51 plastic “large” bulk tanks and 18 steel “large” bulk ta nks out of compliance w ith the bulk container standards. The cost to the average large establ ishment in the agricultural sector of complying with this regulation in year 3 is, then, 39



### $0 + (51)*($856) + (18)*($856) = $43,571 + $15,492 = $59,063

The 20-year schedules of costs associated with non-refillables and refillables, for the average pesticide registrant in each combin ation of market sector and size cl ass, is shown in Tables 4.9a and 4.9b, respectively. Regulation-specific cost sc hedules for the average pe sticide registrant in

each combination of market sector and size class are shown in Appendix C. (Note: There are no costs for those regulations not s hown in the tables in Appendix C due to assumed 100 percent compliance. In other words, for non-refillable co ntainers no costs are associated with the DOT packaging standards, container closure standa rds, and standards for container dispensing capability. For refillable containers, no costs ar e associated with the DOT packaging standards.)

39 Discrepancy is due to rounding. The inputs to the calculation shown here (51 and 18) are rounded. The output, $59,063, is based on the unrounded numbers.

### Page 73 Table 4.9a. Total (Undiscounted) Costs a 

### of Complying with All Regulations for Non-Refillables Under the Container Rule (2005$) b

Year c

Establishment 3 4 - 20

Large-Small Establishments

Agricultural $58,808 $2,274

I/C/G $58,808 $2,274

Home & Garden $58,808 $2,274

Medium-Small Establishments

Agricultural $27,096 $1,166

I/C/G $27,096 $1,166

Home & Garden $27,096 $1,166

Small-Small Establishments

Agricultural $4,424 $598

I/C/G $4,424 $598

Home & Garden $4,424 $598

Large Establishments

Agricultural $92,638 $2,814

I/C/G $92,638 $2,814

Home & Garden $92,638 $2,814

a Costs are rounded to the nearest dollar.

b Costs for the following regulations are included: residue removal standards, recordkeeping requirements, and labeling requirements.

c The compliance period for non-refillables is 3 year s. The analysis assumes that costs are incurred beginning at the end of the third year.

### Page 74 Table 4.9b. Total (Undiscounted) Costs a 

### of Complying with All Regulations for Refillables Under the Container Rule (2005$) b

Year c

Establishment 3 4 - 20
Large-Small Establishments
Agricultural $2,153 $126

I/C/G $2,194 $102

Home & Garden N/A N/A

Medium-Small Establishments
Agricultural $988 $63

I/C/G $996 $59

Home & Garden N/A N/A

Small-Small Establishments
Agricultural $565 $45

I/C/G $566 $44

Home & Garden N/A N/A Large Establishments
Agricultural $155,894 $3,819

I/C/G $161,637 $455

Home & Garden N/A N/A

a Costs are rounded to the nearest dollar.

b Costs for the following regulations are included: container marking standards, standards for openings, bulk container standards, and recordkeeping requirements.

c The compliance period for refillables is 5 years. The an alysis assumes that costs are incurred beginning at the end of the fifth year.



### 4.4.7 Calculate the Present Discounted Value of the 20-Year Stream of Costs



### In order to determine the total cost of complyi ng with a regulation over th e period of analysis, in this case 20 years, we could simply sum all th e costs incurred regardless of the year in which they were incurred. However, when costs are in curred is very important. Economic theory holds that given a choice, people would rather cons ume goods and services now rather then in the future. All else being equal, regulatory options that create benefits now and incur costs later are preferred to options that incur co sts now and create benefits later. Therefore, we must take this into account when comparing the costs and be nefits of alternativ e regulatory options.

We accomplish this by discounting any costs that will be incurred in the future. The amount by which we discount future expenditures is known as the social discount rate. We conducted our analysis using both a 3 percent a nd 7 percent social discount rate.

### Page 75 The present discounted value (pdv) of the 20-year stream of comp liance costs associated with the

i th regulation for the average pesticide registrant in the j th market sector and the k th size class is



# ∑

= 

### + = 20

1 

### ) 1 (

n n ijkn pdv ijk 

### d CC CC



### where d is the discount rate.

For example, costs to meet the residue removal st andard begin in year 3 and go through year 20. In year 3, there are fixed costs associated with the existing containers; in subsequent years there

are fixed costs associated with containers for ne w products. The compliance cost associated with existing containers for a small-small pesticide regist rant in the agricultural sector, for example, in year 3 is $494. The compliance cost associated with new containers in each subsequent year (years 4–20) is $479. Using a 3 percent discount rate, and discounting back to the beginning of year 1, the present discounted value of the str eam of costs associated with the residue removal standard for a small-small pesticid e registrant in the ag ricultural sector is $6 ,993. Since all costs are discounted back to year 1, th is $$6,993 is the cost to society as if all costs were incurred in year 1. 40



### 4.4.8 Calculate the Annualized Cost of Complying with Each Regulation



### As mentioned above, the present discounted value of the costs of a regula tion tells us how much it would cost to comply with a regulation if all costs were incurred in the first year of implementation. In order to discuss the cost per year of complying with a regulation, we must annualize the present discounted valu e of costs over the period of analysis, in this case 20 years. If the present discounte d value is like paying cash upfront for a house in year 1, then the annualized cost is the mortgage payment that woul d be required to pay off a mortgage equal to the present discounted value at a rate of interest equal to the discount rate. Annualization provides a “per year” cost fo r each regulatory option so that we can compare costs across regulatory options that require expenditures at diffe rent times. Also, later on we will be able to compare the annualized costs and be nefits of each regulatory option.

The present discounted value of the costs of complying with a regulatory option is annualized over the 20-year period, using the same discount rate used to obtain present discounted values.

The annualized (ann.) cost of complying with the i th regulation for the average pesticide registrant in the j th market sector and the k th size class is calculat ed using discount rate r, as: 41

pdv ijk ann ijk 

### CC

r r r CC ∗ ⎟ ⎟ ⎠ ⎞ ⎜ ⎜ ⎝ ⎛

+

− ∗ + =

− 

### ] ) 1 ( 1 [ ] 1 [ 20 .



### The estimated annual cost of complying with each regulation for the average registrant in each

combination of market sector and size class is shown in Tables 4.10a (f or non-refillables) and

40 See Table K-5 for presented discounted cost by market and by type of cost –fixed and variable.

41 The procedure for annualization is based on the guidelin es for economic analyses that are published by EPA (EPA, 2000b).

### Page 76 4.10b (for refillables) assuming a discount rate of 3 percent, and Tables 4.10c and 4.10d assuming a discount rate of 7 percent. 42 

### As displayed in the tables, the highest cost of compliance is associated with the residue rem oval because of the testing procedure, and the labeling standards because all the containers are assumed to be not in compliance.

42 When compared to residue removal standards, much of the other administrative costs and labeling costs are incurred in the initial year. Therefore, the annualized co sts for labeling and administrative requirements are higher at the 7 percent discount rate. The medium-small registrants and small-small registrants have low upfront year 1-5 costs (relative to ongoing year 6-20 cost s) associated with residual removal requirements. Therefore, the annualized costs for these registrants are higher at the 3 percent discount rate than at the 7 percent discount rate.Page 77Table 4.10a. Estimated Annual Cost of Complying with Each Container Regulation for Non-Refillable Containers for theAverage Registrant by Market Sector and Size Class(Interest Rate = 3 percent) (2005$)aDOT PackagingStandards –hazardousmaterials(§165.60-64)DOT PackagingStandards – nonhazardousmaterials(§165.60-64)ClosureStandards(§165.66)Standardsfor containerdispensingcapability(§165.68)Residueremovalstandards(§165.70)Otheradministrativerequirements –recordkeepingLabelingrequirementsbSmall-Small EstablishmentsAgricultural$0$0$0$0$456$88$190I/C/G$0$0$0$0$456$88$190Home & Garden$0$0$0$0$456$88$190Medium-Small EstablishmentsAgricultural$0$0$0$0$913$131$1,491I/C/G$0$0$0$0$913$131$1,491Home & Garden$0$0$0$0$913$131$1,491Large-Small EstablishmentsAgricultural$0$0$0$0$1,825$161$3,314I/C/G$0$0$0$0$1,825$161$3,314Home & Garden$0$0$0$0$1,825$161$3,314Large EstablishmentsAgricultural$0$0$0$0$2,282$161$5,302I/C/G$0$0$0$0$2,282$161$5,302Home & Garden$0$0$0$0$2,282$161$5,302aRounded to the nearest dollar.bUnlike the other requirements, the labeling requirement is assumed to result in one fixed cost (and no variable costs) that covers labeling of both nonrefillable and refillable containers. Therefore, although the costs given in this table are listed under “non-refillables,” they actually includethe (fixed) costsof labeling templates for all containers.Page 78Table 4.10b. Estimated Annual Cost of Complying with Each Container Regulation for Refillable Containers for the AverageRegistrant by MarketSector and Size Class(Interest Rate = 3 percent) (2005$)aDOT PackagingStandards –hazardousmaterials(§165.110-114)DOT PackagingStandards – nonhazardousmaterials(§165.110-114)Standards forcontainermarking(§165.116)Standards foropenings (forliquid minibulksonly) (§165.118)Bulk containerstandards(§165.120)Otheradministrativerequirements –recordkeepingLabelingrequirementsbSmall-Small EstablishmentsAgricultural$0$0$1$1$1$59---I/C/G$0$0$0$0$2$59---Home & GardenN/AN/AN/AN/AN/AN/A---Medium-Small EstablishmentsAgricultural$0$0$5$5$4$83---I/C/G$0$0$0$1$11$83---Home & GardenN/AN/AN/AN/AN/AN/A---Large-Small EstablishmentsAgricultural$0$0$27$29$24$125---I/C/G$0$0$3$3$61$125---Home & GardenN/AN/AN/AN/AN/AN/A---Large EstablishmentsAgricultural$0$0$3,807$4,084$3,325$125---I/C/G$0$0$356$428$8,495$125---Home & GardenN/AN/AN/AN/AN/AN/A---aRounded to the nearest dollar.bThe costs resulting from the labeling requirement are listed in Table 4.10a since, unlike the other requirements, these are assumed to result in one fixedcost (and no variable costs) that covers labeling of both non-refillable and refillable containers.Page 79Table 4.10c. Estimated Annual Cost of Complying with Each Container Regulation for Non-Refillable Containers for theAverage Registrant by Market Sector and Size Class(Interest Rate = 7 percent) (2005$)aDOT PackagingStandards –hazardousmaterials(§165.60-64)DOT PackagingStandards –non-hazardousmaterials(§165.60-64)ClosureStandards(§165.66)Standards forcontainerdispensingcapability(§165.68)Residueremovalstandards(§165.70)Otheradministrativerequirements –recordkeepingLabelingrequirementsbSmall-Small EstablishmentsAgricultural$0$0$0$0$418$91$229I/C/G$0$0$0$0$418$91$229Home & Garden$0$0$0$0$418$91$229Medium-Small EstablishmentsAgricultural$0$0$0$0$836$137$1,798I/C/G$0$0$0$0$836$137$1,798Home & Garden$0$0$0$0$836$137$1,798Large-Small EstablishmentsAgricultural$0$0$0$0$1,672$166$3,996I/C/G$0$0$0$0$1,672$166$3,996Home & Garden$0$0$0$0$1,672$166$3,996Large EstablishmentsAgricultural$0$0$0$0$2,091$166$6,393I/C/G$0$0$0$0$2,091$166$6,393Home & Garden$0$0$0$0$2,091$166$6,393aRounded to the nearest dollar.bUnlike the other requirements, the labeling requirement is assumed to result in one fixed cost (and no variable costs) that covers labeling of both nonrefillable and refillable containers. Therefore, although the costs given in this table are listed under “non-refillables,” they actually include the (fixed)costs of labeling templates for all containers.Page 80Table 4.10d. Estimated Annual Cost of Complying with Each Container Regulation for Refillable Containers for the AverageRegistrant by MarketSector and Size Class(Interest Rate = 7 percent) (2005$)aDOT PackagingStandards –hazardousmaterials(§165.110-114)DOTPackagingStandards –non-hazardousmaterials(§165.110-114)Standards forcontainermarking(§165.116)Standards foropenings (forliquidminibulksonly)(§165.118)Bulk containerstandards(§165.120)Otheradministrativerequirements –recordkeepingLabelingrequirementsbSmall-Small EstablishmentsAgricultural$0$0$1$1$1$58---I/C/G$0$0$0$0$3$58---Home & GardenN/AN/AN/AN/AN/AN/A---Medium-Small EstablishmentsAgricultural$0$0$5$6$5$83---I/C/G$0$0$0$1$13$83---Home & GardenN/AN/AN/AN/AN/AN/A---Large-Small EstablishmentsAgricultural$0$0$26$33$27$122---I/C/G$0$0$2$3$68$122---Home & GardenN/AN/AN/AN/AN/AN/A---Large EstablishmentsAgricultural$0$0$3,592$4,564$3,715$122---I/C/G$0$0$334$478$9,492$122---Home & GardenN/AN/AN/AN/AN/AN/A---aRounded to the nearest dollar.bThe costs resulting from the labeling requirement are listed in Table 4.10a since, unlike the other requirements, they are assumed to result in one fixed cost (andno variable costs) that covers labeling ofboth non-refillable and refillable containers.

### Page 81 4.4.9 Estimate the Annualized Cost of Complying with All Regulations per Average Regulated Entity in Each Combination of Market Sector and Size Class – Assuming No Waivers



### In the absence of any waivers, the total annualized cost of complying with all container-related regulations for the average pesticide registrant in the j th market sector and the k th size class is



# ∑

= 

### = I

i ann ijk ann jk 

### CC waiver o w CC

1 . . 

### ) / ( ,

where i is the number of such regulati ons. With one exception, regulations are directed at either

refillable containers or non-refillables. Even for regulations that are essentially the same for non-refillables and refillables (e.g., administra tive requirements – recordkeeping), the cost analysis assumes that any fixed costs incurred for non-refillables are separate from those

incurred for refillables (e.g., it is assumed that a separate f iling cabinet is purchased for each set of records). The exception is th e labeling requirement, which result s in only fixed costs that are not incurred separately for non-refi llable and refillable containers.

The total annualized cost of complying with all regulations, in the absence of any waivers, for the average pesticide registrant in the j th market sector and the k th size class can then be

rewritten as:

) ( ) ( ) ( ) / (

.

1 .

1 . . 

### labeling CC r CC nr CC waiver o w CC ann jk N

i ann ijk N

i ann ijk ann jk r nr 

# ∑ ∑

= = 

### + + =



### where:

• N

nr



### denotes the number of container-related re gulations for non-refi llable containers;

• N

r 

### denotes the number of container-related regulations for refillable containers;

• denotes the annualized cost of complying with the i th regulation for nonrefillables, for the average registrant in the j th market sector and the k th size class;

• denotes th e annualized cost of complying with the i th regulation for refillables, for the average registrant in the j th market sector and the k th size class; and

• denotes th e annualized cost of complying wi th the labeling requirements for the average registrant in the j th market sector and the k th size class.

The total annualized comp liance cost without waivers, acros s all regulations, for the average registrant in the j th market sector and the k th size class is shown in Ta bles 4.11a and 4.11b. At 3 percent, costs of compliance without a waiv er range from as high as $19,807 ($20,642 at 7 percent) for large registrants to $796 ($800 at 7 percent) for small-small registrants. As described in Tables 4.10a and 4.10b, the majority of the cost is associat ed with compliance with the residue removal and labeling requirements. 43

43 When compared to large-small and large registrants, small-small and medium-small registrants have low upfront year 1-5 costs (relative to on going year 6-20 costs) associ ated with the residual removal requirements. Therefore, the annualized costs for the medium-small and small-small registrants are higher at the 3 percent discount rate than at the 7 percent discount rate, while the opposite is true for the large-small and large registrants. 

### ) (

. 

### nr CC ann ijk



### ) (

. 

### r CC ann ijk



### ) (

. 

### labeling CC ann ijk

### Page 82 Table 4.11a. Total Annualized Costs Over a 20-Y ear Period of the Pesticide Container Rule for the Average Registrant: Tota l Without a Waiver (Interest =3 percent)

Establishment Annualized Cost
Large-Small Establishments
Agricultural $5,506

I/C/G $5,492

Home & Garden $5,426

Medium-Small Establishments
Agricultural $2,633

I/C/G $2,631

Home & Garden $2,618

Small-Small Establishments
Agricultural $796

I/C/G $795

Home & Garden $793 Large Establishments
Agricultural $19,087

I/C/G $17,149

Home & Garden $7,870



### Table 4.11b. Total Annualized Costs Over a 20 -Year Period of the Pesticide Container Rule for the Average Registrant: Tota l Without a Waiver (Interest =7 percent)

Establishment Annualized Cost
Large-Small Establishments
Agricultural $6,041

I/C/G $6,030

Home & Garden $5,956

Medium-Small Establishments
Agricultural $2,870

I/C/G $2,867

Home & Garden $2,854

Small-Small Establishments
Agricultural $800

I/C/G $799

Home & Garden $797 Large Establishments
Agricultural $20,642

I/C/G $19,077

Home & Garden $8,772

### Page 83 4.4.10 Estimate the Annual Cost of Complyin g with All Regulations per Average Regulated Entity in Each Combination of Market Sector and Size Class – Allowing

for Waivers



### EPA may modify or waive the requirements for some but not all of the cont ainer-related Regulations. For non-refillables, EPA may:

• Modify or waive the requirements of the DOT packaging standards for non-hazardous materials (§165.60) and for hazardous materials (§165.62);

• Approve a non-standard closure (i.e., a closure not lis ted in §165.66);

• Modify or waive the container dispensing standards (§165.68); and

• Modify or waive the residue removal standard (§165.70).

For refillables, EPA may modify or waive the requirements of the DOT packaging standards for non-hazardous materials (§165.110) and for hazardous materials (§165.112).

The total annualized compliance cost, across all re gulations, for the average registrant in the j th

market sector and the k th size class when a waiver has been obtained is shown in Tables 4.11c and 4.11d. The standards, and their potential to be waived, are summarized in Table 4.12. As expected, given the range of standards that can be waived (in particular, the residue removal standard), costs are lower for the registrant that obtains a waiver compared to the registrant that does not obtain a waiver (see Tables 4.11a and 4. 11b). With a waiver, costs of compliance range from $17,167 at 3 percent ($18,914at 7 percent) for large registrants, to $698 at 3 percent ($740 at 7 percent) for small-small registrants.

### Page 84 Table 4.11c. Total Annualized Costs Over a 20 Year Period of the Pesticide Container Rule for the Average Registrant: Total With a Waiver (Interest Rate = 3 percent)

Establishment Annualized Cost

Large-Small Establishments

Agricultural $4,042

I/C/G $4,028

Home & Garden $3,962

Medium-Small Establishments

Agricultural $2,082

I/C/G $2,080

Home & Garden $2,067

Small-Small Establishments

Agricultural $701

I/C/G $701

Home & Garden $698

Large Establishments

Agricultural $17,167

I/C/G $15,229

Home & Garden $5,950



### Table 4.11d. Total Annualized Costs Over a 20 Year Period of the Pesticide Container Rule for the Average Registrant: Total With a Waiver (Interest Rate = 7 percent)

Establishment Annualized Cost

Large-Small Establishments

Agricultural $4,731

I/C/G $4,719

Home & Garden $4,646

Medium-Small Establishments

Agricultural $2,395

I/C/G $2,393

Home & Garden $2,379

Small-Small Establishments

Agricultural $744

I/C/G $743

Home & Garden $740

Large Establishments

Agricultural $18,914

I/C/G $17,348

Home & Garden $7,043

### Page 85 Table 4.12. Container-Related Standards and Waivers

Standard May It Be Modified or

Waived?

Non-Refillables

DOT packaging (design, construction, and marking) standards – for non-hazardous materials (§165.60) Yes

DOT packaging (design, construction, an d marking) standards – for hazardous materials (§165.62) Yes

Closure standards (§165.66) Yes

Standards for container dispensing capability (§165.68) Yes

Residue removal standards (§165.70) Yes

Recordkeeping (§165.86) No

Labeling (§156.144(d)) a Yes

Refillables

DOT packaging (design, construction, and marking) standards – for non-hazardous materials (§165.110) Yes

DOT packaging (design, construction, an d marking) standards – for hazardous materials (§165.112) Yes

Standards for marking (§165.116) No

Standards for openings (§165.118) No

Standards for bulk containers (§165.120) No

Labeling (§156.144(d)) a Yes

a The regulations specify that the label requirements can be modified or waived. Fo r the purposes of the cost analysis, we assume that the label requirements are more likely to be modified than completely waived, so it is assumed that registrants still incur the cost of changing the pesticide label. Therefore, label waivers are not included in the waiver cost analysis.



### The cost analysis assumes that:

• Pesticide registrants will apply for a waiver onl y if they are reasonably certain of getting it;

• Five percent of registrants will apply for a waiver;

• All those who apply wi ll get the waiver;

• If a requirement is waived, the cost of meeting the requirement is zero; and

• There is a cost to apply for a waiver.

The total annualized cost of complying with the c ontainer rule for the average pesticide registrant

in the j th market sector and the k th size class who applies for and ge ts a waiver can be written as:

) ( ) ( ) ( ) ( ) / (

. . . . 

### labeling CC waiver C r CC nr CC waiver w CC ann jk

S m jk ann ijk

S i ann ijk ann jk

r nr 

# ∑ ∑

∈ ∈ 

### + + + =



### where:

• S

nr 

### is the set of container-relate d regulations for non-refillable containers for which a waiver cannot be obtained;

### Page 86 • S

r 

### is the set of container-related regulations for refillable containers for which a waiver cannot be obtained;

• C jk 

### ( waiver ) is the cost of applying for a waiver fo r the average pesticide registrant in the j th

market sector and the k th size class; and

• All other components on the ri ght-hand side of the equati on are as described above.

The expected annualized cost for the average pesticide registrant in the j th market sector and the

k

th size class, given that p jk



### percent of all pesticide registrants in the j th market sector and the k th size class apply for and obtain waiv ers (which relieve them of the responsibility of complying with some but not all regulations), is:

) / ( ) 1 ( ) / ( ) (

. . . 

### waiver o w CC p waiver w CC p CC E ann jk jk ann jk jk ann jk 

### ∗

− + ∗ =



### As noted above, it is assumed that p jk



### = 0.05 for all j and k ; that is, 5 percent of pesticide registrants apply for and receive a waiver. 44 

### The cost of the waiver is an estimated $362 (see Appendix A). The expected cost to a large-small agricultural pesticide registrant, for example, using the estimates of total annualized costs w ith and without a waiver at 3 percent found in Tables 4.11a and 4.11c, respectively, would be:

(0.05)*($4,042) + (1-0.05)*($5,506) = $5,433 45



### Total expected annualized costs ( across all container-related regulat ions), given that waivers are available for some regulations, are given in Tabl es 4.17a and 4.17b in Section 4.6, where total expected costs for both container-related and refilling-related regulations are summarized.

4.5 Estimating the Costs of Compliance with Refilling-Related Regulations



### The method use to estimate the cost s of complying with the set of refilling-related regulations incurred by the average pesticide refiller is ba sically the same as the method of estimating the costs of complying with the set of container-related re gulations. For a given pesticide refiller category/size class (e.g., large agricultural pes ticide refillers), the analysis proceeds through the following series of steps to a final estimate of th e cost to the average pesticide refiller in that refiller category/size class per refilling-related regulation:

• Estimate the number of refillable containers in the relevant market sector;

• Estimate the number of those that fa ll within the scope of the rule;

• Estimate the number of those that are refilled by pesticide refillers in the refiller category (this is an issue only for the agricultural sector , in which there are two categories of pesticide refillers – agricultural pesticide refillers and agricultural pesticide registrants);

44 The assumption that the probability of applying for and getting a waiver is the same for all market sectors and size classes is made in the absence of sufficient information to the contrary.

45 The difference between this estimated cost ($5,433) and the estimate of cost provided in Table 4.17a ($5,477) is the annual cost of complying with the refilling-related re gulations for an average large-small agricultural pesticide registrant ($44) (see Section 4.5).

### Page 87 • Using annual refilling rates estimated for each di fferent type of refillable container refilled by each category of pesticide refiller, estimate th e total number of refill ings per year in each refiller category;

• Estimate the number of refillings per year in each refiller category/size class;

• For each refilling-related regulation under the ru le, estimate the number of those refillings that are out of compliance with the regulat ion in each refiller category/size class;

• Estimate the number out of co mpliance with each regulation per average refiller in each refiller category/size class;

• Estimate the cost, in each year of a 20-year period, of bringing those refillings into compliance, and the present discounted value of that 20-year stream of costs, using a 3 percent discount rate and a 7 percent discount rate; and

• Annualize this present discounted value, using a 3 percent interest rate and a 7 percent

interest rate.

This section describes the method of estimating th e costs of complying with the refilling-related regulations under the pesticide co ntainer rule for the average re filling entity. The steps are

described in the order in which th ey were carried out in the analysis. The first two steps in the process (estimating the number of refillable pe sticide containers in ea ch market sector and estimating the number of refillable pesticide containe rs in each market sector that fall within the scope of the rule) were already ca rried out for the analysis of th e costs of the container-related regulations, and are described abov e in Sections 4.4.1 and 4.4.2. The description of methods presented here begins at the third step.

4.5.1 Allocate Refillable Containers That Fall Wi thin the Scope of the Rule in Each of

the Relevant Market Sectors to Each of the Regulated Refilling Entity Categories

Within the Market Sector



### The agricultural and I/C/G sectors have regulated en tities that will have to comply with the set of refilling-related regulations under the pesticide container rule (see Tabl es 4.2 and 4.3). H&G containers, however, are not refilled, so this mark et sector does not enter into the refilling cost analysis. In the I/C/G sector, I/C/G pesticide registrants make up the only refiller category. Therefore, 100 percent of all refillable containers of each type in the I/C/G market sector that fall within the scope of the rule were allocated to I/C/ G pesticide registrants for this part of the cost analysis.

Although swimming pool supply companies are consid ered to be in the I/C/G and H&G sectors, we treat them separately. As described in Chapter 3, refillable containers associated with swimming pool supply companies were not included in the data us ed to estimate the number of containers in the I/C/G market. Therefore, th e refillables associated with swimming pool supply companies were estimated differently and are treate d differently in the cost analysis because they are subject to a portion of the refilling requireme nts only. That is, the number of refillable containers of each type, and the number that fa ll within the scope of the rule, refilled by swimming pool supply companies were calculated separately. Therefore, the swimming pool industry is treated as its own market sector, and all of the refillable containers that fall within the scope of the rule in the swimming pool i ndustry are allocated to swimming pool supply companies.

### Page 88 Within the agricultural sector there are two refiller categories:

• Agricultural pesticide refillers; and

• Agricultural pesticide registrants.

It is estimated that 90 percent of the refillable cont ainers that fall within the scope of the rule in the agricultural sector are refilled by agricultural pesticide refillers, and 10 percent are refilled by agricultural pesticide registrants (see Table K- 3). More details about this assumption are provided in Chapter 3.

4.5.2 Estimate the Number of Refillings per Ye ar That Fall Within the Scope of the Rule for Each Category of Regulated Entity for Each Refillable Container Type



### Table 4.13 lists the estimated annual refilling rates (number of refill ings per container per year). Refilling rates for the agricultural sector are based on information provided by Paulson (2002). Refilling rates for the I/C/G sector are transferred from assumptions made in the proposed

container rule RIA for small volume refillable containers (EPA, 1993, Appendix G). Refilling rates for the swimming pool industry (antimic robial pesticide supply companies) are approximately twice the rate (eight times per y ear) used in the proposed container rule RIA. This is based on professional judgment and comme nts submitted to EPA. The relative amount of sodium hypochlorite used and the number of refill able containers needed to meet demand in the pool treatment industry are considered.

4.5.3 Estimate the Number of Refillings per Ye ar That Fall Within the Scope of the

Rule for Pesticide Refillers in Each Si ze Class Within Each Refiller Category



### The same size classes that were applied to pesticid e registrants were also applied to the different refiller categories, as shown in Table 4.5 a bove. Analogous to the method used to allocate

containers within each market sector to the diffe rent size classes, the analysis assumed that the percentage of total revenue (among all pesticide re fillers in a given catego ry, such as agricultural pesticide refillers) associated w ith pesticide refillers in a give n size class is a reasonable proxy for the percentage of refillings by pesticide refillers in that size class. This allocation of refillings to size classes by percentage revenue wa s applied to each category of pesticide refiller, and within each refiller category, to each container type. For ex ample, there are assumed to be 54,810 refillings of 126-250 gallon plastic contai ners for holding liquid products per year by agricultural pesticide refillers. 46 

### Of those, we assume 9.1 percent (see Table 4.6), or 5,009 refillings, to be refillings by large-small agricultural pesticide refillers. 47 

### Across all sizes and types of container, there are assumed to be 2,083, 500 refillings per year by agricultura l pesticide

refillers. 48 

### Of these, 9.1 percent, or 190,397, are attributed to larg e-small pesticide refillers. By the end of this step in the analysis, all refillings that fall within the scope of the container rule are allocated to each combination of pestic ide refiller category and size class.

46 The number of refillings in each c ontainer type category is the product of the number of containers in that category and refilling rate per container. For the 126–50 ga llon plastic container category for agricultural refillers, 31,320 containers * 1.75 refillings per year per container = 54,810 refillings per year.

47 Percentages given in the text are rounded. The numbers here are based on the unrounded percentages, and are therefore slightly different from what would be obtained if the rounded percentages had been used.

48 The total number of re fillings for each refiller class is the sum of the number of refillings ov er all container type categories.

### Page 89 Table 4.13. Estimated Annual Pesticide Container Refilling Rates

Estimated Annual Refilling Rate

Refillable Container Type Agricultural

Pesticide

Refillers a Agricultural

Pesticide Registrants a I/C/G Pesticide Registrants b Swimming Pool Industry –

Antimicrobial Applicators c

Containers for Holdin g Liquid Products

5 - 25 gallon, plastic or steel 2.25 2.25 4 8

26 - 60 gallon, plastic or steel 1.75 1.75 4 8

61 - 125 gallon, plastic or steel 1.75 1.75 4 N/A

126 - 250 gallon, plastic or steel 1.75 1.75 4 N/A

Large (251 - 500 gallons) 1.25 1.25 4 4

Bulk (> 500 gallons) 1.25 1.25 4 4

Other 1.75 1.75 4 8

Containers for Holding Dry Products

< 100 lbs. 1.75 1.75 4 N/A

101 - 2500 lbs. 1.75 1.75 4 N/A

Large (2501 - 4409 lbs.) 1.25 1.25 4 N/A

Bulk (> 4409 lbs.) 1.25 1.25 4 N/A

Other 1.75 1.75 4 N/A

a Agricultural sector refilling rates are based on Paulson (2002).

b I/C/G refilling rates based are based on assumptions in the proposed container rule RIA (EPA, 1993, Appendix G).

c Estimates are based on comments to the 1999 Supplemental Notice submitted by relevant trade associations (i.e., the Chlorine Institute, National Spa and Pool Institute, and Swimming Pool Chemical Manufacturers Association) that provide the average number of re fillings. Based on the comments, the nu mber of refillings was assumed to be 8. A smaller refilling rate of 4 was assumed for larger containers.



### 4.5.4 For Each Refilling-Related Regulation Under the Pesticide Container Rule, Estimate the Number of Refillings per Ye ar That Fall Within the Scope of the Rule That Are Out of Compliance with That Regulation



### As with the container-related regulations, it is es timated that for each ref illing-related regulation, some percentage of refillings are already in co mpliance with the regula tion and therefore do not need to be brought into compliance. This step of the cost analysis of refi lling-related regulations relied on compliance rates estimated for refillings of each type of refillable container in each combination of refiller category and size class. The estimation of compliance rates is described in Chapter 3.

The number of refillings of a given type of ref illable container within a given combination of pesticide refiller category and size class that are out of compliance with a given regulation is just the number of refillings of that type of container in that combination of refiller category and size class that fall within the scope of the rule mu ltiplied by (1 - the corresponding compliance rate). For example, it is estimated that, among large agricultural pesticide re fillers, 60 percent of refillings of 126–250 gallon plastic refillable co ntainers for holding liquid products are in compliance with the requirement to inspect the cont ainer before refilling. There are estimated to

### Page 90 be 25,767 refillings per year of that type of cont ainer by large agricultural pesticide refillers that fall within the scope of the rule. It is estimated that the number of refill ings of that type of container by large agricultural pesticide refillers that are out of compliance with the requirement to inspect the container before re filling is (1 - 0.6)*25,767 = 10,307.

The numbers of refillings (of all types of refillable containers) estimated to be out of compliance with each of the refilling-related regulations unde r the pesticide container rule is given in

Table 4.14.

Table 4.14. Estimated Numbers of Refilling Steps (or Requirements) per Year Out of Compliance with Refilling-Related Requirements (2005$)

Requirement to Inspect Container

Before Refilling Requirement to

Clean Container Before Refilling Recordkeepin g with Each Refilling
Agricultural Pesticide Refillers
Small-Small 150,077 30,015 375,191
Medium-Small 215,367 43,073 538,418
Large-Small 76,159 15,232 190,397
Large 391,797 78,359 979,494
Agricultural Pesticide Registrants

Small-Small 176 35 439

Medium-Small 410 82 1,025
Large-Small 743 149 1,858
Large 91,271 18,254 228,178
I/C/G Pesticide Registrants

Small-Small 114 23 284

Medium-Small 265 53 663
Large-Small 481 96 1,202
Large 59,073 11,815 147,682
Swimming Pool Supply Companies

Small-Small 996 0 0

Medium-Small 3,449 0 0
Large-Small 829 0 0

Large 480,126 0 0



### 4.5.5 For Each Refilling-Related Regulation Under the Pesticide Container Rule, Estimate the Number of Refillings That Fall Within the Scope of the Rule That Are Out of Compliance with That Regulati on – for the Average Regulated Entity

in Each Combination of Refiller and Size Class



### For each combination of refillable container type, re filler category, and size class, we divide the number of refillings out of compliance with each refilling-related regulation (see Table 4.14) by the number of pesticide refillers in that combin ation of refiller category and size class (see Table 4.5). This yields an estimate of the number of refillings of each type of refillable container that is out of compliance with each regulation for an “average pesticide refiller” in each refiller type-

### Page 91 size class combination. 49 

### For example, there are an estim ated 2,061 refillings of 126–250 gallon plastic containers for holding liqui d products by large agricultural pe sticide refillers that are out of compliance with the requirement to clean the container before refilling. There are estimated to be 153 large agricultural pestic ide refillers. It is therefor e estimated that the number of refillings of 126–250 gallon plastic containers for holding liquid products that are out of compliance with the requirement to clean the container before refilling for the average large agricultural pesticide refiller is 2,061/153 = 13.5 (see Table K-4b). 50



### 4.5.6 Estimate the Cost, in Each Year of a 20-Year Period, of Bringing Refillings into Compliance



### The estimation of the costs of bringing refill ings into compliance with refilling-related regulations follows the same pattern as the estima tion of costs for container-related regulations. Compliance costs may be fixed or variable. Fixed costs do not depend on the number of refillings that must be brought into compliance with the regulati on, whereas variable costs do. The only fixed cost associated with refilling requir ements is the cost of a file cabinet, estimated at $229.65. (See Appendix A for compliance cost figures.)

Total variable cost increases with each refilling brought into compliance. As with the containerrelated variable costs, the marginal variable cost curve was assumed to be horizontal; that is,

there was assumed to be a constant unit variable cost, so that the variable cost incurred by bringing N refillings into compliance is N times the variable cost of bringing one refilling into compliance. The variable costs associated with refilling are the costs of inspecting, cleaning, and recording certain information about refillable containers when refilling. We estimate a unit variable cost for each regulation, as described in detail in Appendix A.

The second dimension of the cost calculations is the time dimension. Some costs are incurred only once (e.g., at the beginning of the period of time over which costs may be incurred),

whereas other costs are incurred in each year of the 20-year period.

The cost of complying with a refilling -related regulation is calculated by:

• Calculating the cost in each year of the 20-year period;

• Calculating the presented di scounted value of the resul ting stream of costs; and

• Annualizing this present discounted value.

Waivers are not available for the refilling-relate d regulations. Pesticide refillers will have 5 years in which to bring their refillings into compliance with regulati ons under the rule. The analysis assumes that refilling-related compliance costs will be incurred beginning at the end of the fifth year. In calculating th e present discounted value of the costs of a regulation, all costs are discounted back to the beginning of the first year of the 20-year period.

49 An “average refiller” in a refiller category/size class combination is assumed to refill the same combination of refillable container types as the refiller cat egory/size class combination as a whole.

50 Table K-4 presents information for each combination of container type, container si ze, market type, and entity

size.

### Page 92 The cost of compliance with th e three refilling requirements—to inspect, clean, and record

information about refillable containers when refil ling—were combined togeth er into a single cost

estimate. The calculation of these costs is carried out in the same way as the cost of complying

with a container-related regulation. The only difference is that the unit is now a refilling rather than a container. The costs incurred in a single year are the fixed costs (if any in that year) plus the variable costs (if any in that year). If

• F

n 

### denotes the fixed cost of complying with the refilling regulations in the n th year ( n =1, ..., 20);

• UVC

n 

### denotes the unit variable cost of comply ing with the refilling regulations in the n th year; and

• N denotes the number of ref illings out of compliance w ith the regulation annually; 51



### then the cost of complying with the refilling regulations in the n th year is:

F

n 

### + UVC

n 

### * N.

As with container-related compliance costs, it is possible that both fixed and unit variable costs differ for pesticide refillers in different refill er categories and/or size classes. There was insufficient information to capture any such differe nces in this cost analysis. (Total variable costs will vary, however, because the numbers of refillings varies across refiller categories and size classes.) It is also possi ble that unit variable or fixe d costs could differ by refillable container type, but as with possible differences ac ross refiller categories and/ or size classes, there was insufficient information to capture any such possible differences.

Therefore, although in theory the calculati on of the cost of complying with the i th regulation for the average pesticide refiller in the j th refiller category and the k th size class in the n th year of the 20-year period would follow the same basic pa ttern as for container-related compliance costs (shown in Section 4.4.6),



### CC F UVC N ijkn ijk ijkmn ijkmn

m M



### = +

= 

# ∑ ( *)

1 

### ,

in practice, a simpler formula is used, in which only the number of refillings varies by refiller category and/or size class and regu lation, and the unit variable co st varies for the regulation.

The cost of complying with the three refilling re quirements is just the fixed cost (it was assumed that a single file cabinet would suffice for all three refilling regul ations) plus the three variable

costs. Each unit variable cost was estima ted by estimating the time required to meet the regulation (e.g., the time it takes to clean a refi llable container before refilling) and multiplying by the hourly wage rate. For example, we estim ate that it takes one minute, or 0.0167 hour, to inspect a container before refilli ng. We estimate the labor cost per hour to be $29.13. The unit variable cost of inspection is, then, 0.0167 x $29.13 = $0.4865. There are estimated to be 90 refillings out of compliance with the inspection regulation for the average medium-small

51 The number of refillings to which the unit variable cost mu st be applied, if variable costs are annual, is assumed not to change over the 20-year period.

### Page 93 agricultural pesticide refiller each year. The annual (undiscounted) variable cost of meeting the inspection regulation for the average medium-small agricultural pesticide refiller is therefore
$0.49 x 90 = $43.78.

The 20-year schedule of costs for the three re filling regulations combined for the average pesticide refiller in each market sector/refilling category/size class is shown in Table 4.15. Due to the significantly larger number of containers refilled by the la rge registrants compared to the small registrants, costs of compliance are estimated to be significantly higher in each year for the large registrants.

Table 4.15. Total Compliance Costs a 

### Related to Refilling Requirements for Refillable Containers (2005$) b

Year c

Establishment 5 6-20 Large-Small Establishments
Agricultural Pesticide Refillers $1,408 $1,178 Agricultural pesticide registrants $273 $43 I/C/G – Pesticide registrants $267 $37 Swimming Pool Supply Companies $258 $29

Medium-Small Establishments
Agricultural Pesticide Refillers $579 $349 Agricultural pesticide registrants $238 $8 I/C/G – Pesticide registrants $237 $7 Swimming Pool Supply Companies $244 $14

Small-Small Establishments
Agricultural Pesticide Refillers $271 $42 Agricultural pesticide registrants $231 $2 I/C/G – Pesticide registrants $231 $1 Swimming Pool Supply Companies $232 $3
Large Establishments
Agricultural Pesticide Refillers $10,174 $9,944 Agricultural pesticide registrants $6,300 $6,070 I/C/G – Pesticide registrants $5,468 $5,238 Swimming Pool Supply Companies $13,942 $13,712

a Costs are rounded to the nearest dollar.

b Compliance with the refilling requirements involves both fixed and variable costs.

c The compliance period for non-refillables is 5 years. The analysis assumes that costs are incurred beginning at the end of the fifth year.



### 4.5.7 Calculate the Present Discounted Value of the 20-Year Stream of Costs



### The present discounted value of the 20-year stre am of compliance costs associated with the refilling regulations for the aver age pesticide refiller in the j th refiller category and the k th size

class is:



### CC CC

d jk pdv jkn

n

n 

### = +

= 

# ∑ ( ) 1 1 20

### Page 94 where d is the discount rate. Two di scount rates were considered: 3 percent and 7 percent. Table K-5 shows the present discounted value of each y ear’s costs refilling requirement costs for each the average pesticide refiller in each mark et sector/refilling category and size class.

4.5.8 Calculate the Annualized Cost of Comp lying with the Refilling Regulations



### The present discounted value of the cost of complying with the refi lling regulations was annualized over the 20-year peri od, using two interest rates (r) that were assumed to be the same

as the two discount rates used to obtain present discounted values (that is, when the discount rate was assumed to be 3 percent, the interest rate wa s also assumed to be 3 percent, and similarly for 7 percent). The annualized cost of complyi ng for the average pesticide refiller in the j th refiller category and the k th size class is calculated using interest rate r as

.

The estimated annualized cost of complying with the three refilling-related regulations (combined) for the average refiller in each comb ination of refiller ca tegory and size class is shown in Tables 4.16a (at 3 percent interest) a nd 4.16b (at 7 percent interest). As discussed earlier, due to the significantly larger number of containers refilled by the large registrants compared to the small registrants, the estimated annual cost of compliance is estimated to be significantly higher for large registrants.

Table 4.16a. Estimated Annual Cost of Complying with the Refilling-Related Container Regulations for the Average Refiller by Refiller Category and Size Class (Interest = 3 percent) (2005$) a

Refiller Category / Size Class Cost of Requirements to Inspect, Clean, and Track Container Before Refilling

Agricultural Pesticide Refillers

Small-Small $43

Medium-Small $267
Large-Small $871

Large $7,255

Agricultural Pesticide Registrants

Small-Small $14

Medium-Small $19
Large-Small $45

Large $4,434

I/C/G Pesticide Registrants

Small-Small $14

Medium-Small $18
Large-Small $40

Large $3,828
Swimming Pool Supply Companies

Small-Small $15 

### CC r

r r CC jk ann jk pdv

. 

### [ ]*[ ( ) ] *

= + −+

⎛
⎝ ⎜ ⎞
⎠ ⎟

− 

### 1 11 20

### Page 95 Medium-Small $23
Large-Small $34

Large $10,000

a Costs for all three refilling-related requirements are ag gregated. Some costs are higher at the 7 percent discount rate while the others are higher at the 3 percent discount rate depending on whether the costs incurred in the initial year is high. If the initial year costs are hi gh then the typically the cost estimate is higher for the 7 percent discount rate and vice versa. For example, the large swimming pool supply companies face a high cost in the initial year while the small-small agricultural pesticide refiller f aces low initial year costs. Accordingly, the cost at the 7 percent discount rate is higher for the large former, while the opposite is true for the latter.



### Table 4.16b. Estimated Annual Cost of Complying with the Refilling-Related Container Regulations for the Average Refiller by Refiller Category and Size Class (Interest = 7 percent) (2005$) a

Refiller Category / Size Class Cost of Requirements to Inspect, Clean, and Track Container Before Refilling

Agricultural Pesticide Refillers

Small-Small $41

Medium-Small $237
Large-Small $764

Large $6,336

Agricultural Pesticide Registrants

Small-Small $16

Medium-Small $20
Large-Small $42

Large $3,874

I/C/G Pesticide Registrants

Small-Small $15

Medium-Small $19
Large-Small $38

Large $3,345
Swimming Pool Supply Companies

Small-Small $16

Medium-Small $24
Large-Small $33

Large $8,732

a Costs for all three refilling-related requirements are aggregated.



### 4.6 The Total Annual Costs of the Rule



### We calculated the total annual costs of the pe sticide container rule, across all regulations contained within it, for:

• The average regulated entity – in each combination of entity type, market sector, and size class;

• All regulated entities – in each combination of entity type, market sector, and size class;

• The average pesticide registrant with a “rep resentative share” in each market sector;

• All pesticide registrants (across all ma rket sectors) in each size class;

• All pesticide registrants across all market sectors and size classes;

### Page 96 • All regulated entities within each category co mplying with refilling-related regulations; and

• All regulated entities.

The cost of complying with each of the contai ner-related and refilling- related regulations under the rule, for the average regulated entity in each combination of re gulated entity category, market sector, and size class are given above in Tables 4.10a–4.10d and 4.16a and 4.16b, respectively. The estimation of costs across all regulations for the average regulated entity is described in Sections 4.4 and 4.5. The sets of regulations to which each regulated en tity category is subject

are summarized in Table 4.2. The numbers of re gulated entities in each category of regulated entity for each combination of market sector and size class are given in Table 4.5. The information in all these tables is synthesized in Tables 4.17a and 4.17b, which summarize the annualized costs across all regulations for each type of regulated entity and across all regulated entities, at 3 percent interest and 7 percent intere st, respectively. In general, as displayed in Tables 4.17a and 4.17b (and as discussed earlier), costs are also higher for the average large entity than for the average small entity, and the costs are higher fo r large entities when considered over all entities. The exceptions in clude the large-small registrants, which have a similar number of regulated entities to large re gistrants, making their costs smaller over all regulated entities; and large agricultural pestic ide refillers, which have higher costs over all entities, despite a relatively small number of entitie s in this market sector and size. At 3 percent and 7 percent, the total cost of compliance ove r all regulated entities is estimated to be $8.4 million and $8.5 million, respectively. With a 3 percent discount rate, pesticide registrants account for nearly $5.6 million (or almost 70 percen t) of the total cost of compliance, while agricultural pesticide refiller s and swimming pool supply compan ies account for less than $2.6 million and $180,000 of the total cost of compliance, respectively.

### Page 97 Table 4.17a. Total Annual Costs of the Pesticid e Container Rule for Regulated Entities (Interest Rate = 3 percent) (2005$)

Regulated Entities For the Average Regulated

Entity Number of Regulated

Entities Over All Regulated

Entities
Pesticide Registrants
Large-Small
Agricultural $5,477 66 $364,061

I/C/G $5,459 50 $272,139

Home & Garden $5,352 50 $266,825
Average Across Market

Sectors a $5,434

National Total Across Market Sectors $903,024

Medium-Small
Agricultural $2,625 198 $519,462

I/C/G $2,621 148 $389,096

Home & Garden $2,591 148 $384,601
Average Across Market

Sectors a $2,613

National Total Across Market Sectors $1,293,158

Small-Small
Agricultural $805 399 $321,217

I/C/G $805 299 $240,698

Home & Garden $788 299 $235,727
Average Across Market

Sectors a $800

National Total Across Market Sectors $797,642
Large
Agricultural $23,425 58 $1,367,998

I/C/G $20,881 44 $914,608

Home & Garden $7,774 44 $340,508
Average Across Market

Sectors a $17,967

National Total Across Market Sectors $2,623,114

National Total Across Market Sector s and Size Categories $5,616,939
Agricultural Pesticide Refillers
Large-Small $871 251 $218,684

Medium-Small $267 2,395 $640,191

Small-Small $43 13,996 $605,474
Large $7,255 153 $1,110,296

National Total Across Size Categories $2,574,646

### Page 98 Table 4.17a (Continued). Total Annual Costs of the Pesticide Container Rule for Regulated Entities (Interest Rate = 3 percent) (2005$)

Swimming Pool Supply Companies – Antimicrobial Applicators
Large-Small $34 14 $474

Medium-Small $23 117 $2,732

Small-Small $15 174 $2,602
Large $10,000 17 $169,993

National Total Across Size Categories $175,800

National Total Across All Regulated Entities $8,367,385

a The average pesticide registrant across market sectors is assumed to have the same distribution across market sectors as the distribution of pesticides across market sectors (by volume of pesticide) in the pesticide industry

as a whole: Agricultural sector: 40 percent Industrial/commercial/govt. sector: 30 percent Home & Garden sector: 30 percent

### Page 99 Table 4.17b. Total Annual Costs of the Pestic ide Container Rule for Regulated Entities (Interest Rate = 7 percent) (2005$)

Regulated Entities For the Average Regulated Entity Number of Regulated

Entities Over All Regulated

Entities
Pesticide Registrants
Large-Small
Agricultural $6,018 66 $399,987

I/C/G $6,003 50 $299,243

Home & Garden $5,891 50 $293,661
Average Across

Market Sectors a $5,975

National Total Across Market Sectors $992,891

Medium-Small
Agricultural $2,865 198 $567,135

I/C/G $2,863 148 $424,939

Home & Garden $2,830 148 $420,112
Average Across

Market Sectors a $2,854

National Total Across Market Sectors $1,412,186

Small-Small
Agricultural $813 399 $324,089

I/C/G $812 299 $242,890

Home & Garden $794 299 $237,420
Average Across

Market Sectors a $807

National Total Across Market Sectors $804,400
Large
Agricultural $24,430 58 $1,426,696

I/C/G $22,335 44 $978,272

Home & Garden $8,685 44 $380,418
Average Across

Market Sectors a $19,078

National Total Across Market Sectors $2,785,386

National Total Across Market Sector s and Size Categories $5,994,863
Agricultural Pesticide Refillers
Large-Small $764 251 $191,692

Medium-Small $237 2,395 $566,418

Small-Small $41 13,996 $572,767
Large $6,336 153 $969,709

National Total Across Size Categories $2,300,585

### Page 100 Table 4.17b (Continued). Total Annual Cost s of the Pesticide Container Rule for Regulated Entities (Interest Rate = 7 percent) (2005$)

Swimming Pool Supply Companie s – Antimicrobial Applicators
Large-Small 

### $33 14 $458

Medium-Small 

### $24 117 $2,755

Small-Small 

### $16 174 $2,821
Large $8,732 17 $148,448

National Total Across Size Categories $154,481

National Total Across All Regulated Entities $8,449,929

a The average pesticide registrant across market sectors is assumed to have the same distribution across market sectors as the distribution of pesticides across market sectors (by volume of pe sticide) in the pesticide industry as

a whole: Agricultural sector: 40 percent Industrial/commercial/govt. sector: 30 percent Home & Garden sector: 30 percent

### Page 101 Costs are presented by regulation in Tables 4.18a and 4.18b. Approximately 16 percent of the cost of compliance is attributed to compliance wi th the residue removal st andards. The refillingrelated standards and labeling standards account for 38 percent and 27 percent of the total cost of compliance, respectively.

Table 4.18a. Total Annual National Cost of Each Regulation Under the Pesticide Container Rule (Interest Rate = 3 percent) (2005$)

Regulation Annual National Cost

For Non-Refillable Containers

DOT Packaging Standards - hazardous material a $0

DOT Packaging Standards - non-hazardous material a $0

Closure Standards a $0

Standards for container dispensing capability a $0

Residue Removal standards a $1,465,967
Other administrative requir ements – recordkeeping $202,617

For Refillable Containers

DOT Packaging Standards - hazardous material a $0

DOT Packaging Standards - non-hazardous material a $0
Standards for container markings $241,402
Standards for openings (for liquid minibulks only) $261,018

Bulk container standards $574,504
Other administrative requir ements – recordkeeping $138,849

For Refilling $3,198,256

For Labeling $2,252,148

Cost of Waivers $32,624

Total National Cost Annually $8,367,385

a Incorporates waivers for 5 percent of pesticide registrants.

### Page 102 Table 4.18b. Total Annual National Cost of Each Regulation Under the Pesticide Container Rule (Interest Rate = 7 percent) (2005$)

Regulation Annual National Cost

For Non-Refillable Containers
DOT Packaging Standards - hazardous material a $0

DOT Packaging Standards - non-hazardous material a $0

Closure Standards a $0

Standards for container dispensing capability a $0

Residue Removal standards a $1,343,068

Other administrative requir ements – recordkeeping $210,575

For Refillable Containers

DOT Packaging Standards - hazardous material a $0

DOT Packaging Standards - non-hazardous material a $0

Standards for container markings $227,685
Standards for openings (for liquid minibulks only) $291,648

Bulk container standards $641,923

Other administrative requir ements – recordkeeping $136,753

For Refilling $2,849,969

For Labeling $2,715,685

Cost of Waivers $32,624

Total National Cost Annually $8,449,929

a Incorporates waivers for 5 percent of pesticide registrants.



### 4.7 Impact Analysis



### The impact of the pesticide contai ner rule on a regulated entity is measured as the ratio of that entity’s annual cost of complying with the rule to its annual revenue. The impacts of the rule are estimated using both a 3 percent interest rate and a 7 percent interest rate. Estimated impacts are given for the average regulated entity in each co mbination of market sector and size class in

Tables 4.19a and 4.19b. For all regulated entities (at both 3 percent and 7 percent) the annual

cost to revenue ratio is less than 0.02 percent. The highest ratios are associated with the small pesticide registrants. Agricu ltural pesticide refillers and sw imming pool supply companies have annual cost to revenue ratios very close to zero.

### Page 103 Table 4.19a. Ratio of Annual Compliance Cost to Annual Revenue for the Average Regulated Entity (Interes t Rate = 3 percent) (2005$)

Regulated Entities a Annual Cost For the Average

Regulated

Entity b Annual Revenue For the Average Regulated Entity c Annual CostRevenue Ratio For the Average Regulated Entity
Small Pesticide Registrants Agricultural $1,817 $9,439,902 0.02%

I/C/G $1,813 $9,439,902 0.02%

Home & Garden $1,784 $9,439,902 0.02% Large-Small Pesticide Registrants Agricultural $5,477 $52,676,100 0.01%

I/C/G $5,459 $52,676,100 0.01%

Home & Garden $5,352 $52,676,100 0.01% Medium-Small Pesticide Registrants Agricultural $2,625 $9,758,400 0.03%

I/C/G $2,621 $9,758,400 0.03%

Home & Garden $2,591 $9,758,400 0.03% Small-Small Pesticide Registrants Agricultural $805 $2,075,800 0.04%

I/C/G $805 $2,075,800 0.04%

Home & Garden $788 $2,075,800 0.04% Large Pesticide Registrants Agricultural $23,425 $7,363,740,000 0.00%

I/C/G $20,881 $7,363,740,000 0.00%

Home & Garden $7,774 $7,363,740,000 0.00% Agricultural Pesticide Refillers

Small $88 $1,985,935 0.00% Large-Small $871 $22,705,400 0.00%

Medium-Small $267 $6,730,300 0.00%

Small-Small $43 $802,500 0.01% Large $7,255 $191,604,900 0.00% Swimming Pool (Ant imicrobial) Supply Companies

Small $19 $1,537,432 0.00% Large-Small $34 $5,266,697 0.00%

Medium-Small $23 $2,620,614 0.00%

Small-Small $15 $509,031 0.00% Large $10,000 $2,511,092,910 0.00%

a Average cost for the small size categor y is calculated by adding the cost for the small-small, medium-small, and large-small categories and dividing the sum by the total num ber of companies in the small size category. Similarly, the average revenue for the small size category was calculated by adding the total revenue for each of its component size categories and dividing the sum by the total number of companies in the small size category.

b Annual cost of the average regulated entity is calculated by dividing the total cost for the regulated entities by the total number of entities under the scope of the rule.

c Annual average revenue for the average regulated entity is calculated by dividing the total revenue by the total

number of entities.

### Page 104 Table 4.19b. Ratio of Annual Compliance Cost to Annual Revenue for the Average Regulated Entity (Interes t Rate = 7 percent) (2005$)

Regulated Entities a Annual Cost For the Average

Regulated

Entity b Annual

Revenue For the Average

Regulated

Entity c Annual CostRevenue Ratio For the Average Regulated Entity
Small Pesticide Registrants Agricultural $1,947 $9,439,902 0.02%

I/C/G $1,944 $9,439,902 0.02%

Home & Garden $1,912 $9,439,902 0.02% Large-Small Pesticide Registrants Agricultural $6,018 $52,676,100 0.01%

I/C/G $6,003 $52,676,100 0.01%

Home & Garden $5,891 $52,676,100 0.01% Medium-Small Pesticide Registrants Agricultural $2,865 $9,758,400 0.03%

I/C/G $2,863 $9,758,400 0.03%

Home & Garden $2,830 $9,758,400 0.03% Small-Small Pesticide Registrants Agricultural $813 $2,075,800 0.04%

I/C/G $812 $2,075,800 0.04%

Home & Garden $794 $2,075,800 0.04% Large Pesticide Registrants Agricultural $24,430 $7,363,740,000 0.00%

I/C/G $22,335 $7,363,740,000 0.00%

Home & Garden $8,685 $7,363,740,000 0.00% Agricultural Pesticide Refillers Small ag. pesticide refillers $80 $1,985,935 0.00% Large-Small ag. pesticide refillers $764 $22,705,400 0.00% Medium-Small ag. pesticide refillers $237 $6,730,300 0.00% Small-Small ag. pesticide refillers $41 $802,500 0.01% Large ag. pesticide refillers $6,336 $191,604,900 0.00% Swimming Pool (Ant imicrobial) Supply Companies Small swimming pool supply companies $20 $1,537,432 0.00% Large-Small swimming pool supply companies $33 $5,266,697 0.00% Medium-Small swimming pool supply companies $24 $2,620,614 0.00% Small-Small swimming pool supply companies $16 $509,031 0.00% Large swimming pool supply companies $8,732 $2,511,092,910 0.00%

a Average cost for the small size categor y is calculated by adding the cost for the small-small, medium-small, and large-small categories and dividing it by the total number of companies in the small size category. Similarly, the average revenue for the small size category was calculated by dividing the total revenue for each of its component size category and dividing it by the tota l companies in this size category.

b Annual cost of the average regulated entity is calculated by dividing the total cost for the regulated entities by the total number of entities under the scope of the rule.

c Annual average revenue for the average regulated entity is calculated by dividing the total revenue by the total

number of entities.

### Page 105 For purposes of the analysis under the Small Bu siness Regulatory Enforcement and Fairness Act (SBREFA), we combined the three sub-categorie s of small businesses within the “small” size class (i.e., large-small, medium-small, and small- small) into a single “s mall” size class for each regulated entity type in Tables 4.19a and 4.19b. A threshold for regulations potentially causing significant impacts to small businesses is an an nual cost to revenue ratio of greater than 1 percent. As is evident from these tables, in no case are annual compliance costs for the average small regulated entity expected to exceed 0.02 pe rcent of annual average revenue. As a result, significant impacts on small businesses are not expect ed as a result of the container regulations. The ratio is highest among small entities for small pesticide registrants, at 0.02 percent. Small agricultural pesticide refillers and small swimming pool supply comp anies are estimated to have annual revenue to cost ratios very close to zero.

We found similar results using the alternative defi nition of small businesses used in the EA. The impacts to small businesses using the alternative definition, in terms of the annual revenue to cost ratio, are estimated to be no more than 0.04 percent. As with the SBA-defined small entities, the highest ratio is measured for sma ll pesticide registrants— ranging from a ratio of 0.01 percent for large-small registrants to 0.04 pe rcent for small-small registrants. The annual

cost to revenue ratio does not ch ange using the alternative defi nition of small business (versus the SBA definition) for small agricultural pest icide refillers and sm all swimming pool supply companies. Redefining the small pesticide regist rant has provided more information in regards to the impacts expected across the spectrum of small businesses impacted by the container regulations, but the impacts still remain below the threshold of causing a significant impact to

small businesses.

4.8 Sensitivity Analysis



### Many of the assumptions present in the preceding cost analysis discussion (and presented in detail in Appendix A) are inherently uncertain, th ough every effort has been made to use the best available data to inform our assumptions. Despite efforts to minimize the uncertainty, uncertainty remains. It is important, therefore, to attempt to characterize the impact that this uncertainty has on the magnitude of the total regulatory compliance costs we have estimated for the container regulations.

To test the sensitivity of total cost estimates to the assumptions in the analysis, compliance costs

have been recalculated based on a suite of lower- and upper-bound assumptions that bound the central cost estimate presented in the primary an alysis. The lower-bound suite of assumptions is composed of adjustments to the primary assumpti ons that lower the overal l container regulations compliance cost. The upper-bound suite of assump tions is composed of adjustments to the primary assumptions that increase the overall comp liance cost for the container regulations. We calculated the resulting upper- and lower-bound costs in the sa me manner as described in the preceding sections. We used a 3 percent discount rate to calculate the present discounted value

of costs and in the annua lization of those costs.

### Page 106 Parameters were selected for sensitivity analysis based on the following two criteria:

(1) Total costs appear particularly se nsitive to a given assumption; and
(2) We have a reasonable idea regarding what th e lower and upper bounds of a given assumption

should be.

The sensitivity analysis is summarized in Table 4. 20. As compared to the total cost estimate of $8.4 million (3 percent discount rate) and $8.5 mi llion (7 percent discount rate), the “low-end” total cost is $4.9 million, while the “high-end” estimate is $11.0 million. 52 

### The low-end total cost estimate is 42 percent lower than the total cost under primary assumptions, while the high-end estimate is 32 percent higher.

Table 4.20. Annual National Cost of Regula tion Under the Pesticide Container Rule (2005$)

Sensitivity Scenario Annual Cost Nationally

3% discount rate $8,367,385

7% discount rate $8,449,929

Low (3% discount rate) $4,852,818

High (3% discount rate) $11,043,774



### The underlying suites of “low-end” and “high-end” assumptions are given in Table 4.21. The detailed breakdown of resulting costs are shown in Tables 4.22 and 4.23, based on the “low-end” suite of assumptions, and in Tables 4.24 and 4.25 based on the “high-end” suite of assumptions.

These tables show the same set of total cost resu lts that were shown for the primary analysis in Tables 4.17a, 4.17b, 4.18a, and 4.18b.

In order to assess the sensitivity of the cost estimates to the different assumptions, we calculated the percentage reduction in total costs associatedwith a change in each assumption for the “lowend” assumption. We find that the largest percen tage reduction in cost is because of changes in the labeling requirements (22 percent). Under th e primary cost assumption we assume that 50 percent of the label changes are “routine” and incur only one-third of the label change cost and 50 percent of the label changes are “necessary” and incur all the label change cost, while in the “low-end” cost assumptions we assume that all label changes are “routine.” Since the labeling change cost is high, ranging from $205 for a “routine” change small-small establishments to $5,069 for a “necessary” change for all establishments except the small-small, changes in the assumptions about the number of entities for which this is a “routine” or a “necessary” change have a fairly significant implication on the cost.

The assumption about the percentage of container/formulations combinations that will be exempt from residue removal testing because of sim ilarities to other container/formulations combinations (“me-toos”) led to a 4 percent re duction in cost. Changi ng the percentage of containers that pass the initial residue removal te st from 30 percent to 0 percent reduced the cost by 5 percent. Reducing the labor time assumpti ons by 25 percent for th e refilling compliance criteria reduces the cost by 9 percent, while for standards for container markings and

52 Both cost estimates are based on a 3 percent discount rate.

### Page 107 administrative requirements for both non-refillable s and refillables, the reduction in labor time assumptions by 25 percent reduces the cost by less than 2 percent.

In addition to the above assumption, we also cons idered the sensitivity of the cost analysis to changes in the assumption about the time it takes to inspect containers. The analysis assumes that on average it takes about 1 minute to inspect containers. Gi ven that a relatively larger number of containers are small, this seems reas onable. When we change the inspection time to 5 minutes, the total cost estimate increases to $10.5 m illion, which is a significant increase. It is not clear, however, that 5 mi nutes is a more reasonable assumption for the amount of time it takes to inspect containers. Alt hough it is conceivable th at in reality large c ontainers take about

5 minutes and smaller containers take less, we did not have data to support different inspection

times for different container sizes.

### Page 108 Table 4.21. “Low-End” and “High-End” As sumptions for Sensitivity Analysis

Regulation “Low-End” Cost Assumptions Primary Cost Assumptions “High-End” Cost Assumptions

Non-Refillable Sensitivity Tests

Residue Removal

Standard -

Percent of Containers

Retested a All containers pass the

initial residue removal

test. 30% of the containers pass the

initial residue removal test. 50% of the containers pass the residue removal

test.

Residue Removal

Standard -

“Me-Toos” b 50% of all

container/formulations combinations exempt

from residue removal testing. 25% of all

container/formulation combinations exempt from residue removal testing. No container/formulation combinations exempt

from residue removal testing.

Administrative Requirements - Recordkeeping c Reduce labor time assumptions by 25%. Large and Large-Small

Establishments: 40 hours for existing container/formulation

combinations and 4 hours for

new container/formulation

combinations.

Medium-Small

Establishments: 36 hours for existing

container/formulation

combinations and 3 hours for

new container/formulation

combinations

Small-Small Establishments: 24 hours for existing

container/formulation

combinations and 2 hours for

new container/formulation

combinations Increase labor time assumptions by 25%.

Refillable Sensitivity Tests

Administrative Requirements - Recordkeeping c Reduce labor time assumptions by 25%. Large and Large-Small

Establishments: 31 hours for existing container/formulation

combinations and 4.4 hours

for new container/formulation

combinations.

Medium-Small

Establishments: 21 hours for existing

container/formulation

combinations and 2.5 hours

for new container/formulation

combinations

Small-Small Establishments: 11 hours for existing

container/formulation

combinations and 2 hours for

new container/formulation

combinations Increase labor time assumptions by 25%.

### Page 109 Table 4.21. “Low-End” and “High-End” As sumptions for Sensitivity Analysis

Regulation “Low-End” Cost Assumptions Primary Cost Assumptions “High-End” Cost Assumptions

Standards for Container Marking c Reduce labor time assumptions by 25%. It takes 5 minutes to mark

each container. Increase labor time assumptions by 25%.

Refiller Sensitivity Tests

Refilling Compliance

Criteria d Reduce labor time assumptions by 25%. For each refill, it takes 1 minute to inspect, 10 minutes to rinse, and 2 minutes to

record information about a

container. Increase labor time assumptions by 25%.

Facility-Level Sensitivity Tests

Labeling Requirements e Assume that all label changes during the compliance period are “routine” changes and incur only one-third of the label change cost. Assume that 50% of label changes are “routine” and incur only one-third of the label change cost, and 50% of label changes are “necessary”

and incur all of the label change cost. Assume that all label changes during the compliance period are “necessary” and incur all of the label change cost.

a Primary cost assumption based on final container regulations that require containers to achieve only a four-9s standard. It is assumed that all containers will pass the four-9s standard as a lower bound. The high-end assumption is based on a container’s ability to achieve a six-9s standard. See EPA (1993, p. IX-13).

b In the proposed container rule RIA, EPA made a lower cost assumption that 50 percent of container/formulation combinations would be exempt from residue removal testin g because of similarities to other container/formulation combinations (“me-toos”). EPA’s upper cost assumption stated that all container/formulations would be tested. These high- and low-end cost assumptions are retained he re and use the mid-point between the two as the primary cost assumption. See EPA (1993, p. IX-13).

c Labor times used in the primary analysis are based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, p. IX-13). It is assumed that plus or minus 25 percent of the labor time used in the primary analysis is a reasonable uncertainty bound.

d Using professional judgment, based on estimates made by EPA in the proposed container rule RIA as a baseline (EPA, 1993, p. IX-13), the labor tim es associated with the primary cost assumptions are estimated.

e The primary cost assumption is based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pp. X-1 through X-7). We believe a reasonable lowe r cost assumption is that all label changes during the compliance period are considered “routine” (therefore incurring only one-third the cost of changing a label). A reasonable high-end cost assumption is that all labe l changes during the compliance period are considered “necessary” (therefore incurring the total cost of changing a label). The prim ary analysis assumes that during the compliance period 50 percent of label changes are routine and the rest are necessary.

### Page 110 Table 4.22. Total Annual Costs of the Pesticid e Container Rule for Regulated Entities: Using “Low End” Assumptions (I nterest Rate = 3 percent) (2005$)

Regulated Entities For the Average Regulated

Entity Number of Regulated

Entities Over All Regulated

Entities
Pesticide Registrants
Large-Small Agricultural $1,745 66 $115,978

I/C/G $1,734 50 $86,438

Home & Garden $1,635 50 $81,496
Average

Across Market

Sectors a $1,709

National Total Across Market Sectors $283,912

Medium-Small
Agricultural $884 198 $174,928

I/C/G $882 148 $130,895

Home & Garden $850 148 $126,118
Average

Across Market

Sectors a $873

National Total Across Market Sectors $431,941

Small-Small
Agricultural $384 399 $153,067

I/C/G $383 299 $114,671

Home & Garden $367 299 $109,788
Average

Across Market

Sectors a $379

National Total Across Market Sectors $377,527
Large
Agricultural $15,778 58 $921,459

I/C/G $14,249 44 $624,126

Home & Garden $2,185 44 $95,699
Average

Across Market

Sectors a $11,242

National Total Across Market Sectors $1,641,283

National Total Across Market Sectors and Size Categories $2,734,662

Agricultural Pesticide Refillers
Large-Small ag. pesticide refillers $657 251 $164,824 Medium-Small ag. pesticide refillers $267 $204 2,395 Small-Small ag. pesticide

refillers $36 13,996 $499,340 Large ag. pesticide refillers $5,445 153 $833,217

National Total Across Size Categories $1,985,265

### Page 111 Table 4.22 (Continued). Total Annual Costs of the Pesticide Container Rule for Regulated Entities: Using “Low E nd” Assumptions (Interest Rate = 3 percent) (2005$)

Regulated Entities For the Average Regulated

Entity Number of Regulated

Entities Over All Regulated

Entities Swimming Pool Applic ators – Antimicrobial Applicators Large-Small swimming pool applicators $29 14 $401 Medium-Small swimming pool applicators $21 117 $2,427 Small-Small swimming pool applicators $14 174 $2,514 Large swimming pool applicators $7,503 17 $127,549

National Total Across Size Categories $132,891

National Total Across All Regulated Entities $4,852,818

a The average pesticide registrant across market sectors is assumed to have the same distribution across market sectors as the distribution of pesticides across market sectors (by volume of pe sticide) in the pesticide industry as

a whole: Agriculture sector: 40 percent Industrial/Commercial/Govt.: 30 percent Home and Garden: 30 percent

### Page 112 Table 4.23. Total Annual National Cost of Each Regulation Under the Pesticide Container Rule: Using “Low End” Assumption s (Interest Rate = 3 percent) (2005$)

Regulation Annual National Cost

For Non-Refillable Containers
DOT Packaging Standards - hazardous material a v DOT Packaging Standards - non-hazardous material a $0

Closure Standards a $0

Standards for container dispensing capability a $0

Residue Removal standards a $708,913
Other administrative requir ements – recordkeeping $151,963

For Refillable Containers
DOT Packaging Standards - hazardous material a $0

DOT Packaging Standards - non-hazardous material a $0
Standards for container markings $181,065
Standards for openings (for liquid minibulks only) $261,018

Bulk container standards $574,504
Other administrative requir ements – recordkeeping $109,480

For Refilling: $2,458,094
For Labeling: $393,188
Cost of Waivers: $14,594

Total National Cost Annually $4,852,818

a Incorporates waivers for 5 percent of pesticide registrants.

### Page 113 Table 4.24. Total Annual Costs of the Pesticid e Container Rule for Regulated Entities: Using “High End” Assumptions (I nterest Rate = 3 percent) (2005$)

Regulated Entities For the Average Regulated Entity Number of Regulated

Entities Over All Regulated

Entities

Pesticide Registrants:
Large-Small
Agricultural $8,227 66 $546,825

I/C/G $8,201 50 $408,850

Home & Garden $8,087 50 $403,165
Average Across

Market Sectors a $8,177

National Total Across Market Sectors: $1,358,840

Medium-Small
Agricultural $3,874 198 $766,744

I/C/G $3,869 148 $574,358

Home & Garden $3,838 148 $569,658
Average Across Market Sectors a $3,862

National Total Across Market Sectors: $1,910,760

Small-Small
Agricultural $974 399 $388,510

I/C/G $973 299 $291,083

Home & Garden $956 299 $286,024
Average Across Market Sectors a $969

National Total Across Market Sectors: $965,617
Large Agricultural $29,842 58 $1,742,799

I/C/G $26,285 44 $1,151,286

Home & Garden $12,135 44 $531,518
Average Across Market Sectors a $23,463

National Total Across Market Sectors: $3,425,603 National Total Across Market Sectors and Size Categories: $7,660,820 Agricultural Pesticide Refillers
Large-Small ag. pesticide

refillers $1,086 251 $272,544 Medium-Small ag. pesticide refillers $331 $331 2,395 Small-Small ag. pesticide refillers $51 $51 13,996 Large ag. pesticide refillers $9,066 153 $1,387,376

National Total Across Size Categories: $3,164,027

### Page 114 Table 4.24 (Continued). Total Annual Costs of the Pesticide Container Rule for Regulated Entities: Using “High End” Assumpti ons (Interest Rate = 3 percent) (2005$)

Swimming Pool Applicators – Antimicrobial Applicators
Large-Small swimming pool applicators $39 14 $548 Medium-Small swimming pool applicators $26 117 $3,037 Small-Small swimming pool applicators $15 174 $2,690 Large swimming pool applicators $12,496 17 $212,436

National Total Across Size Categories $218,710

National Total Across All Regulated Entities $11,043,557

a The average pesticide registrant across market sectors is a ssumed to have the same dist ribution across market sectors as the distribution of pesticides across ma rket sectors (by volume of pesticide) in the pesticide industry as a whole: Agriculture sector: 40 percent Industrial/Commercial/Govt.: 30 percent Home and Garden: 30 percent

### Page 115 Table 4.25. Total Annual National Cost of Each Regulation Under the Pesticide Container Rule: Using “High End” Assumptions (Interest Rate = 3 percent) (2005$)

Regulation Annual National

Cost

For Non-Refillable Containers
DOT Packaging Standards - hazardous material a $0

DOT Packaging Standards - non-hazardous material a $0

Closure Standards a $0

Standards for container dispensing capability a $0

Residue Removal standards a $1,403,140
Other administrative requirements – recordkeeping $253,271

For Refillable Containers
DOT Packaging Standards - hazardous material a $0

DOT Packaging Standards - non-hazardous material a $0
Standards for container markings $301,743
Standards for openings (for liquid minibulks only) $261,018

Bulk container standards $574,504
Other administrative requir ements – recordkeeping $167,730

For Refilling $3,938,418
For Labeling $4,111,108
Cost of Waivers $32,624

Total National Cost Annually $11,043,557

a Incorporates waivers for 5 percent of pesticide registrants.

### Page 116 

## 5.0 The Human and Non-Human Health Ben efits of the Final Standards

5.1 Introduction



### The container design and residue removal standards are largely pollution prevention regulations that will safeguard workers, such as loaders, mixers, and applicators, and the environment by reducing the risk of exposure to concentrated pesticides. First, the proposed improvements in pesticide container designs will enhance the safe handling, dispensing, use, and residue removal efficiency of pesticide containers. Second, th e improvement in procedures and/or container designs will help facilitate the “c lean rinsing” of emptied containe rs either prior to disposal or recycling, or prior to reuse. There are numerous types of human health-r elated benefits and nonhuman health-related (environment-related) benefits that will stem from such improvements because of relatively fewer expected spills, leaks, and other risks associated with exposure (e.g., handling by workers during disposal, discharges to the environment, and potential public exposures).

Table 5.1 summarizes the various types of expected benefits (i .e., improved worker safety, improved public health, reduced environmental risk, and other effects) resulting from the proposed container design/residue removal regulations . It also characterizes the sources of the expected benefits. Besides human health-related and environment-related benefits, there are other effects such as property damage, personal liability effects, and insurance costs that

contribute to the overall benefits assessment. Due to limitations in the data available on these benefits, there is a high degree of uncertainty concerning both the number and average cost (including unquantifiable compone nts of loss such as pain a nd suffering) of both container design and residue removal problems. As a result, the costs of all of the expected benefits cannot be quantified. However, data do exist to qua ntify some of the expected benefits of the regulations. Section 5.2 discu sses the method and estimates of the number of pesticide-related illnesses and injuries potentially avoided as a result of the pesticide container regulations and presents the estimated value of these avoided i llnesses and injuries. Section 5.3 discusses and estimates the cost savings from the disposal of rigid non-refillable containers as non-hazardous

rather than hazardous waste as a result of th e regulations, and discusses the potential for a

reduction in the number of environmental effect s and property damage/spill cleanup costs as a result of the container regulations.

### Page 117 Table 5.1. The Types of Expected Benefits from the Container Design and Residue Removal Regulations and Their Sources

Expected Benefit Source of Expected Benefit

Human Health-Related Benefits

Improved Worker Safety • Reduced accidental spills

• Fewer leaks

• Less dripping

• Less frequent container stress failure (durability, formulation/container degradation)

• Reduced personal sickness and injury

• Improved worker productivity

Improved Public Health • Less risk of exposure to spills and leaking/dripping

• Less contamination of surface water and groundwater sources

• Less personal injury fr om accidental spills and chronic contamination

sources

Non-Human Health-Related Benefits

Reduced Environmental Risk • Reduced accidental spills

• Fewer chronic accumulations of chemicals in loading/mixing/cleaning areas

• Reduced risk of harm from pesticide residues to terrestrial and aquatic wildlife including sensitive and critical habitats

• Less disposal of hazardous containers in landfills

Other Effects • Reduced property damage

• Reduced risk of personal injury and liability

• Lower costs for personal liability insurance

• Reduced disposal costs for cleaner containers

• Reduced loss of product from spills and leaks



### 5.2 Human Health-Related Benefits: Estimate d Annual National Cases and Valuation

of Pesticide Product-Related Illnesses a nd Injuries Potentially Avoided by the

Standards



### In this section, the annual nationwide number and value of pesticide-relate d illnesses and injuries potentially avoided as a result of the pesticide container design and residue removal regulations

is estimated. The calculations involved in the results and the underlying methodology used in

the derivation of the national estimate is de scribed. Section 5.2.1 describes the overall methodological approach used. This is followed in Section 5.2.2 by a discussion of the state data used to derive the percentage of pesticide illnesses potentially re lated to the container design and

residue removal standards. Section 5.2.3 desc ribes the annual national number of pesticide exposures and resulting illnesses to which the stat e data were applied. Section 5.2.4 discusses the extrapolation of the state data to estimated pesticide i llnesses nationwide and provides a discussion of these findings. Fina lly, Section 5.2.5 describes the approach to valuing the avoided illnesses by estimating the direct and indirect costs for several severity levels of illness. More detailed information on the gene ral and health-related characteristics of the Toxic Exposure Surveillance System (TESS) exposure data subs et underlying our discussi on in Section 5.2.3 can be found in Appendix H, and additional data on direct costs for physician visits, relevant to Section 5.2.5, is listed in A ppendix I. The detailed case summ aries from California in 1999 that we used in the analysis (Section 5.2.2) to determ ine the percentage of pest icide illness potentially related to the container regulati ons are located in Appendix J.

### Page 118 5.2.1 Summary of Approach



### The first step in estimating the number of illnesses expected to be avoided as a result of the container design and residue removal regulations required identifying the available surveillance

data on the number of toxic subs tance related illnesses. Afte r reviewing the available toxic substance surveillance systems, we selected TESS for estimating the number of injuries and illnesses associated with pesticide exposure pe r year. TESS is a comprehensive surveillance system developed in 1983 by the American Asso ciation of Poison Control Centers (AAPCC) to track acute illness and injury related to toxi c substances. The system contains detailed toxicological information on poison exposures reported to more than 60 poison centers around the country, capturing an estimated 98.8 percen t of all poison exposur es reported to poison centers in the United States. We requested a detailed report from AAPCC (2002) describing “unintentional” exposures to fungicides, herbic ides, insecticides, rode nticides, non-pine oil disinfectants, and anti-algae pa ints to estimate the annual num ber of unintentional pesticide illness cases expected per year. For the purposes of this analysis, we will refer to these conventional and antimicrobial pesticide s ubstance categories as “pesticide products.”

Given the estimated annual national illnesses asso ciated with pesticide products in the TESS data, we estimated the percentage of those cases that may have resulted from incidents related to

containers and residue removal. The percentage to be appl ied to the annual number of unintentionally caused pesticide product illnesses from TESS was based on EPA’s examination of state-level case history data from California. EPA exam ined case summaries from the Pesticide Illness Surveillance Program (PISP) da tabase maintained by the California Department of Pesticide Regulation (CDPR) for 1999 and estimated the number of cases that are “very likely,” “possibly,” and “unlikely” to be avoided as a result of th e regulations (CDPR, 2001a,b). The estimates of cases that were “very likely” to be avoided as a result of the regulations were used to calculate the ratio of pesticide containe r design/residue-related cases to total pesticide product incidents in California. We applied this state-level propor tion to the United States as a

whole to estimate the annual national number of avoided pesticide product illnesses that are expected as a result of the container design and residue removal regulations.

We purchased a single report from TESS itemizi ng the exposures involving the TESS pesticide product categories described above. We selected the product categor ies to most closely resemble the pesticide products covered in the California database. In pa rticular, the active ingredients considered by CDPR as antimicrobials were de termined to be covered by the TESS categories queried. Therefore, the percentage of pesticide-related illnesses avoided as a result of the regulations, estimated for Californi a, could be applied to the nati onal number of pesticide-related illnesses queried from TESS. The potential illnesses avoided from the container design and residue removal regulations desc ribed are therefore attributable to both antimicrobial and conventional pesticide products.

5.2.2 Derivation of the Annual Percentage of Pest icide Illnesses Potentially Avoided as a Result of the Container Design and Residue Removal Regulations



### CDPR conducts ongoing surveillance of people and the environment to detect the potential for pesticide exposure as part of its pesticide safe ty program. CDPR’s PISP has required mandatory reporting of pesticide illnesses since 1971, ma king it the most comprehensive monitoring

### Page 119 program in the country. Under a California state statute, physicians are re quired to report any suspected case of pesticide-relate d illness or injury to the local health officer within 24 hours of examining the patient.

In addition, CDPR reviews doctor’s reports for workers’ compensation claims under the pesticide illness surveillance program. Staff members investigate any claim that mentions (1) pesticides as a possible cause of illness or inju ry or (2) unspecified chemicals if the setting is one in which pesticide use is likely. CDPR also works with the California Poison Control System to facilitate reporting of pesticid e-related illnesses by health care workers.

To estimate the percentage of unintentional pesticide product illnesses potentially avoided as a result of the container regulati ons, it is first necessary to de termine the number of unintentional pesticide product-related illnesses in Californi a. In 1999, CDPR reported 1,201 episodes in which the pesticide exposure was at least a pos sible contributing factor to illness or injury. 53 

### The

number of intentional cases o ccurring in California, however, is not readily available in a

summary report.

We examined the case summaries for a subset of the 1,201 CDPR cases in 1999, corresponding to a query on particular activity patterns. 54 

### Sixteen potential cases of intentional ingestion were identified among this subset, 15 of which were conventional pesticides and one antimicrobial. The 1999 CDPR summary table of pesticide-relate d illnesses summarized by activity and type of exposure reports that 35 of the 1,201 total incidents occurred as a result of ingestion (CDPR, 2001b). Of the 35 cases, only 10 would have been excluded in the subset examined, corresponding to “routin e indoor” and “routine outdoor” activities. 55 

### Assuming that (1) pesticide ingestion would be the only means of inten tional exposure and (2) none of the ingestion exposures occurring during “rou tine indoor” and “routine outdoor” ac tivities were intentional, the 16 intentional incidents identified from case reports should reflect the total number of intentional pesticide-related illnesses in the CDPR database. Using these assumptions, it was estimated that for 1999, 1,185 of the pesticide ca ses in California were due to unintentional

exposures.

53 1999 incident data is representative of the other years fo r which data have been analyzed relative to the container regulations. In 1999 there were 16 container related cas es while from 1995-1999 ther e were on an average 15

container related cases.

54 A total of 489 case summaries resulted from EPA’s query of the 1999 CDPR incident database. The query was for incidents from the following field “activities,” during wh ich EPA believes container-related illnesses are likely to

occur: (1) Occupational: Mixer/loader, aerial (code 111); Mixer/loader, ground (112); Mixer/loader, hand (113); Applicator, hand (123); Applicator, other (124); Repair/maintenance (160); Exposed to concentrate (182); Emergency response (183); Other (199) (2) Non-Occupational: Application (220); Other (299).

55 The CDPR incident database defines routine indoor and outdoor activity in the following way: (1) Routine indoor activity: Conducts activities in an indoor environment with minimal expectation for exposure to pesticides. This includes people in offices and businesses, residential structures, etc., who are not handling pesticides. (2) Routine outdoor activity: Conducts activities in an outdoor environment with minimal expectation for exposure to pesticides. This excludes field workers in agricultural fields. This includes gardeners who are not handling pesticides.

### Page 120 Furthermore, since pine oil will not be subject to the regulations, and since it was not included in the revised TESS query, the cases in 1999 that involved pine oil must also be excluded. In the 1999 CDPR summary table of pestic ide-related illnesses summarized by pesticide, it is reported that seven cases involved pine oil (CDPR, 2001a). However, the single an timicrobial intentional case identified above also involved pine oil; theref ore, an additional six cases were ultimately excluded from the total number of unintentional pe sticide product-related illnesses in California. The breakdown of pesticide product cas es is summarized in Table 5.2.

Table 5.2. Number of Reported Total, Inte ntional, and Pine Oil-Related Illnesses a 

### in

California’s Pesticide Illne ss Surveillance Program in 1999

Description Number of Cases

Total Cases a 1,201

Intentional, antimicrobial pesticide case 1

Intentional, conventional pesticide cases 15

Pine oil cases 6

Total Unintentional Pesticide Product Cases 1,179

a Only those cases in which the relationship between pes ticide exposure and illness is designated as “possible,” “probable,” or “def inite” are included.



### To estimate the number of potentially avoided case s as a result of the rule, EPA examined the full set of 1999 CDPR cases summaries with rega rds to the container design and residue removal

standards and whether or not an antimicrobial chem ical would be subject to the regulations. The likelihood that an incident would have been pr evented by the regulations was categorized into three groups:

• V = very likely the incident would have b een prevented by the container regulations;

• P = possible the incident would have been prevented by the contai ner regulations; and

• U = unlikely the incident would have been prevented by the container regulations. 56



### EPA estimated that seven conventional pesticid e illnesses and nine antimicrobial pesticide illnesses would be subject to and were “very likely” to be prevented by the regulations. These cases represent 1.36 percent of the 1,179 incidents in California that were due to unintentional, non-pine oil exposures. A flow chart showing the distribution of CDPR cases is presented in Figure 5.1.

In addition to the 16 incidents designated as “v ery likely” avoided by the rule, 51 incidents were are designated by EPA as “possibl y” avoided: 15 conventional pe sticide illnesses “possibly”

56 An example of each category of likelih ood (very likely, possibly, and unlikel y, respectively) that an incident would have been prevented by the container regulations:

Case 1999-511 (glyphosate): While preparing to spray weeds, a homeowner pulled up on the plunger of a ready-touse glyphosate container. The plunger handle broke off, allowing glyphosate to spray up into his face. He felt irritant symptoms, so he showered and sought medical attention.

Case 1999-56 (cypermethrin): A courtesy clerk dropped a can of insectic ide as she returned it to the shelf. When she picked it up, it exploded in her face. She washed but developed symptoms 30 minutes later.

Case 1999-932 (methyl bromide): Two workers tried to remove the custom locking caps from a methyl bromide cylinder and replace it with a standard cap before returning the cylinder to th e dealer. The valve was opened and released methyl bromide.

### Page 121 avoided as a result of the regul ations; 30 non-exempt antimicrobial illnesses “possibly” avoided as a result of the regulations; a nd six antimicrobial illnesses that would “very likely” be avoided if subject to the regulations, but for which it is unclear from the information provided if they are subject to the regulations.Page 122Figure 5.1. Flow Chart of 1999 CaliforniaDepartment of Pesticide Regulation(CDPR) Pesticide-Related Incidents1201 total CDPR illness “possibly”, “probably” or “definitely” relatedto pesticide exposure.385antimicrobialrelated illnesses815 nonantimicrobialrelated illnesses1 (pine oil) casefrom intentionalexposure +379 cases fromunintentionalexposure15 cases fromunintentionalexposure800 cases fromintentionalexposure331 cases“unlikely”related tocontainerdesign andresidueremoval39 cases“possibly”related tocontainerdesign andresidueremoval9 cases “verylikely” relatedto containerdesign andresidueremovalstandards7 cases“unlikely”related tocontainerdesign andresidueremoval15 cases“unlikely”related tocontainerdesign andresidueremoval778 cases“unlikely”related tocontainerdesign andresidueremoval30/1179 = 2.54% casesinvolving non-exemptantimicrobials possiblyprevented by thecontainer regulations6/1179 = 0.51% casesinvolving antimicrobialsbut whether subject tocontainer regulationsand/or insufficientinformation16/1179 = 1.36%pesticide andantimicrobials-relatedillnesses occurring inCA potentially avoidedby the container design15/1179 = 1.27%pesticide relatedillnesses potentiallyavoided by thecontainer design andresidue removal

### Page 123 These 51 incidents are potentially avoided as a re sult of the regulations and if included in the analysis, would increase the per centage of unintentional pesticid e product cases by 4.33 percent (51 of 1,179 cases). For the purposes of extrapolating California da ta to the national analysis and valuing the avoided cases, only t hose cases identified as “very lik ely” avoided by the regulations are included (16 of 1,179 cases). It is important to note, however, that additional benefits would be realized if a portion of these “possible” cases are also avoided as a re sult of the regulations.

In estimating the percentage of pesticide pr oduct-related illnesses pot entially avoided, no adjustment was made for the propo rtion of pesticide users (e.g., end users, pesticide formulators, pesticide registrants) already in compliance with the new regulations. Although some percentage of pesticide users will already be in compliance, it was assumed that any pesticide user already in compliance should not experience illnesses relate d to container design an d residue removal. Consequently, any container-related illnesses captured by CDPR’s database should reflect entities that are not in compliance and, theref ore, potentially avoided as a result of the regulations.

In addition, no adjustment was made based on th e percentage of containers covered by the regulations due to toxicity cate gory. We assumed that those cont ainer-related exposures resulting in illnesses and physician visits would have hi gh enough toxicity levels to be covered by the regulations. To the extent to which some of the illnesses observed in the CDPR database were due to pesticide containers ex cluded by the regulations, the potential benefits could be

overstated.

5.2.3 Profile of Annual National Pesticide Exposure Cases



### In the previous section, it was estimated from the California PISP database for 1999 that approximately 1.36 percent (16 of 1,179 unintenti onal conventional or an timicrobial pesticide cases) of illnesses related to pe sticide products occurring in Califo rnia were likely to have been

avoided as a result of the c ontainer design and residue removal standards. To estimate the number of illnesses to which this proportion may tr anslate nationwide, this ratio is applied to the

annual number of unintentional conventional and antimicrobial pesticid e-related illnesses occurring across the country. 57 

### To determine the number of injuries and illnesses related to pesticide products throughout the United States on an annual basis, an annual detailed report of 2001 TESS data was acquired from the American Association of Poison Control Centers (AAPCC, 2002). Since TESS is a national survei llance system database in which reports of

human exposures are recorded, the number of e xposure cases that resulted in illness was determined before applying the ratio. This overall methodology is described below in more detail, including the query of TESS exposure data submitted (Section 5.2.3.1) and the estimated number of illnesses resulting fr om pesticide-related unintentiona l exposures (Section 5.2.3.2).

5.2.3.1 TESS Database Query



### After reviewing the format of the findings published in the annual summary, a detailed 2001 TESS report was requested from AAPCC of “ unintentional” exposures to the following

57 In using this methodology, it is assumed that the ra tio for California would not differ significantly for the United

States as a whole.

### Page 124 conventional and antimicrobial pesticide substa nce categories. As desc ribed earlier, for the purposes of this analysis th ese substances are referred to as “pesticide products”:

• Fungicides;

• Herbicides;

• Insecticides;

• Rodenticides;

• Non-pine oil disinfectants; and

• Anti-algae paints.

These categories are determined by AAPCC, and more detailed examples of included substances are identified in the annual summary published in the American Journal of Emergency Medicine (Litovitz et al., 2002). The illnesses resulting from exposures in which these substances are implicated were made compatible with thos e evaluated in CDPR’s PISP by excluding cases involving pine oil. Similarly, because intentiona l cases were excluded from the California dataset

in order to estimate the number of potentially avoided cases, the underlying reason for the exposure was required to be “unint entional.” Therefore, it was requested that these data be limited only to those resulting from “unintenti onal” exposures among all other reasons for poison. 58



### In 2001, unintentional exposures accounted for 85.2 percent of all reported human poison exposures (1,931,841 cases out of 2,267,979 reported) . Exposures labeled as “intentional” were involved in 11.6 percent, “other” for 0.7 per cent, “adverse reaction” for 2.2 percent, and “unknown” for 0.4 percent of total overall exposur es. The specific definitions associated with unintentional reasons of exposure are described in Table 5.3.

From the entire TESS database in 2001, of the substances most frequently involved in human exposures, pesticides 59 

### accounted for 4 percent of the total number of overall toxic exposures. Among the substances most frequently involved in exposures of children under 6 years of age, pesticides also represented 4 percent of the total. This was slightly higher, at 4.5 percent of the total number of exposures, in adults over 19 year s old. By limiting the search criteria for the TESS query, the detailed frequency and distri butional information was evaluated just among accidental pesticide poisonings for the specific cate gories of pesticide products expected to be regulated under the rule. The re sults of the TESS query showed th at in 2001, pesticide products were implicated in 80,978 unintentional exposur es. These cases will be referred to as “unintentional exposures to pest icide products.” The breakdown of these uninten tional pesticide exposure cases by reason is provided in Table 5.3.

58 Other reasons for exposure in TESS were: (1) intentional (e .g., suicidal, abuse, misuse); (2) other (e.g., malicious, contaminant/tampering); (3) adverse reacti on (e.g., drug, food ); and (4) unknown.

59 The pesticide group includes fungicides, herbicides, in secticides, repellents, and rodenticides as itemized in Litovitz, et al. (2002). Repellents were excluded from the query made by EPA.

### Page 125 Table 5.3. Profile of Unintentional Pestic ide Exposures by Reason of Exposure

With

Concomitants a Without

Concomitants b Exposure

Reason Description Number Percent Number Percent

General Any exposure not specifically defined below 65,766 81.21% 63,809 82.15%

Environmental Any passive, non-occupational exposure that results from contamination of air, water, or soil (usually but not always caused by man-made contaminations) 6,571 8.11% 6,005 7.73%

Occupational Any exposure that occurs as a direct result of the person being on the job or in the workplace 2,625 3.24% 2,271 2.92%

Therapeutic

Error An unintentional deviation from a proper therapeutic regimen that results in the wrong dose, incorrect route of administration, administration to the wrong person, or administration of the wrong substance (only exposures to medications or products substituted for medications are included) 603 0.74% 573 0.74%

Misuse Improper or incorrect use of a nonpharmaceutical substance (exposure unplanned or not foreseen by the patient) 5,018 6.20% 4,694 6.04%

Bite/Sting All animal bites and stings, with or without

envenomation 56 0.07% 21 0.03%

Food Poisoning Suspected or confirmed food poisoning and ingestion of food contaminated with microorganisms 42 0.05% 18 0.02%

Unknown Exposure determined to be unintentional but

exact reason is unknown 297 0.37% 281 0.36%

Total 80,978 100.00% 77,672 100.00%

Source: AAPCC (2002, Report 7 “Reason” and p. 8 “Field Definitions”).

a “With Concomitants” indicates that a pesticide substan ce was implicated in the exposure case but could have involved another substance which may or may not have been another pesticide.

b “Without Concomitants” indicates that only one pesticide substance was implicated in the exposure.



### The majority (77,672 of 80,978 cases or 95.92 per cent) of unintentional pesticide exposures in 2001 involved only a single pesticide product substan ce. These cases of exposure are detailed in

the “Without Concomitants” column in Table 5.3. The remaining fracti on (4.08 percent) of unintentional pesticide e xposures in 2001 involved more than a single substance, but at least one pesticide product. These cases ar e reflected in the column “With Concomitants” along with the majority of cases without concomitants, to equa l the total number of uni ntentional exposures to pesticide products for 2001 (80,978). Therefore, the column “With Concomitants” indicates exposures in which a pesticide substance was implicated, but a nother substance, which may or may not have been another pesticide product, may also have been involved. Since the exposure cases without concomitants only involve a single pe sticide product, we cons idered restricting the analysis to those incidents. Ho wever, we did not belie ve that this would be appropriate since a pesticide product is still implicated in the exposur e incident despite the po ssible co-occurrence of another substance. Therefore, subseque nt estimates are based on the data that included

concomitants.

### Page 126 The unintentional reason categories were also reviewed to determ ine if the corresponding cases were suitable for this analysis. When we compared the definitions of reason categories, the “therapeutic error” and “bite/sting” categories initially appeared to be inappropriate for the objective of this analys is; however, when the data for unint entional exposures were reviewed without concomitants, the implication of pe sticide products in the exposures was not dramatically altered (e.g., ther apeutic error comprises 0.74 percen t of all unintentional exposures to pesticide substances under bot h scenarios). Therefore, these categories are included in this analysis. In the discussion below regarding the estimation of annual illnesses related to conventional and antimicrobial pesticides from reported exposure cases, the overall figure of 80,978 cases of exposure with concomitants is used.

5.2.3.2 Annual National Illnesses Resulting from Unintentional Human Pesticide Product Exposure Cases



### This section describes the number of illnesses used as the national estimate to which the California-derived proportion of container-related illnesses was applied to total illnesses. As described above, TESS is a national surveillance database for exposur es to toxic substances. In this section, the evaluation of the proportion of these exposures that resulted in illness is described. Although the query was limited to pe sticide products, not all the observed illnesses were a result of the pesticide. Three categories are used to describe th e relationship between the

clinical effect observed and the exposure in TESS: “related,” “not related,” and “unknown if related.” For the purposes of this analysis, since we are interested in the number of illnesses that result from these exposures, we evaluated the ca ses in which the clinical effects were labeled “related” to the pesticide exposur e as a “low-end” scenario estima te, and the cases in which the

clinical effects were labeled “r elated” plus those labeled “unknow n if related” as a “high-end” scenario estimate. The guidelines used to assess the relationship be tween observed clinical effects and unintentional exposur es to pesticide products are summarized in Table 5.4.

Table 5.4. Guidelines for Field Definition of Clinical Effect Relationships to Exposure

Exposure-Clinical Effect Relationship Selection Criteria

Related • Timing of clinical effect is reasonable for reported exposure;

• Severity of effect is consistent with reported exposure;

• Effect is consistent with anticipated substance toxicity;

• Clinical assessment of relationship was made by a physician.

Not related • Effect was pre-existing or began prior to the exposure, and was not augmented or worsened as a result of the exposure, or

• Effect can be ascribed to a documentable alternative etiology.

Unknown if Related • Relationship between exposure and effect cannot be reasonably ascertained;

• Effect has never been ascribed to the particular substance, but an alternative etiology cannot be conclusively established;

• Effect is not expected ba sed on reported exposure;

• Knowledge of patient’s history (e.g., concomitant illnesses, other medications) is not adequate to allow a determination of the relationship between the exposure and the effect.

Source: AAPCC (2002, “Field Definitions,” p. 8).

### Page 127 Of all the cases presented, 75.93 percent exhibited no clinical effects related to the pesticide exposure, 14.34 percent of patie nts exhibited one clinical e ffect, 6.40 percent showed two clinical effects, and 3.33 percent sustained three or more clinical effects (Table 5.5). Therefore, of the 80,978 exposure cases reported, 19,492 victim s exhibited clinical e ffects related to the pesticide exposure. This estimate represents the “low-end” scenario estimate of the total annual national cases of pesticide illnesses. To verify the initial assumption to use the number of unintentional exposures to pesticide products with concomitants as the basis of this analysis, the frequency distribution for the c linical effects among exposures without concomitants was also examined. When the frequency of clinical effects is evaluated among exposures without concomitants, a similar pattern of distri bution of clinical effects is present.

Table 5.5. Frequency of Clin ical Effects “Related” to Unintentional Pesticide Product Exposures

With Concomitants Without Concomitants Number of

Clinical Effects

Observed Number of Patients Percentage of

Patients Number of

Patients Percentage of

Patients
0 61,486 75.93% 59,543 76.66%
1 11,614 14.34% 11,024 14.19%
2 5,181 6.40% 4,790 6.17%
3 1,820 2.25% 1,586 2.04%

4 567 0.70% 488 0.63%

5 or more 19,492

310 0.38% 241 0.29%

Total 80,978 100.00% 77,672 100.00% Source: AAPCC (2002, Report 12 “Frequency of Clinical Effects - Related”).



### There were 31,504 clinical effects observed am ong patients who were determined to have an illness “related” to the unintentional exposure. In total, these 31,504 clinical effects were observed for the 19,492 exposure cases that resulted in a related illness. This pattern is a result of the information highlighted in Table 5.5 a nd detailed in Table 5.6, where 11,614 patients sustained a single clinical effect, 5,181 patients had two effects, 1,820 e xhibited three effects, 567 suffered four effects, and 310 cases resulte d in five or more clinical effects.

Table 5.6. Detailed Distribution of Clinical E ffects “Related” to Unintentional Pesticide Product Exposures Among Patients Experiencing With Concomitant” Pesticide Exposures

With Concomitants Number of Clinical

Effects Observed Number of Patients a Percentage of Patients Number of Observed

Clinical Effects “Related” to Exposures b

1 11,614 59.58% 11,614

2 5,181 26.58% 10,362

3 1,820 9.34% 5,460

4 567 2.91% 2,268

5 or more 310 1.59% 1,800

Total 19,492 100.00% 31,504

a Number of patients with observed clinical effect from Table 5.5.

b Number of “related” clinical e ffects corresponding to the number of patients from note (a) above.

### Page 128 Table 5.7 shows the distribution of the 31,504 cl inical effects observed among patients who were

determined to have an illness related to the un intentional pesticide produ ct exposure. Of the

cases in which some clinical effect related to a pesticide exposure was observed (approximately 24 percent of the total exposur es overall from Table 5.5 above: 19,492 ÷ 80,978 = 0.24), the majority of patients suffered ocular (26.95 percent) , gastrointestinal (24.06 percent), and dermal (17.28 percent) health effects.

Table 5.7. Percent Distribution of Clinical Ef fects Among Patients Experiencing Effects “Related” to Unintentional Pesticide Product Exposures

Clinical Effect Number of Observed

Clinical Effects

“Related” to Exposures a Percent Number of Observed

Clinical Effects

“Unknown if Related” to Exposures a Percent

Cardiovascular 410 1.30% 185 2.27%

Dermal 5,445 17.28% 995 12.22%

Gastrointestinal 7,581 24.06% 2,700 33.15%

Hematologic/Hepatic 42 0.13% 24 0.29%

Neurological 3,122 9.91% 1,788 21.95%

Ocular 8,491 26.95% 323 3.97%

Renal/Genitourinary 32 0.10% 21 0.26%

Respiratory 3,735 11.86% 624 7.66%

Miscellaneous 2,646 8.40% 1,484 18.22%

Total 31,504 100.00% 8,144 100.00%

Source: AAPCC (2002, Report 13 “Dis tribution of Clinical Effects”).

a Number reflects clinical effects and not the number of e xposure cases, since a single patient can sustain multiple clinical effects (frequency distribution for multiple clinical effects is shown in Table 5.5 and detailed in Table 5.6).



### Table 5.7 also shows the number of observed clinical effects am ong patients in which the effect was “related” or “unknown if related” to the pe sticide exposure. It is believed that these

“unknown if related” cases should be considered in the analysis since it is known that a pesticide product was involved, but it is unclear from the report whether the exposure was responsible for the illness. However, while the available TE SS data showed that 31, 504 “related” clinical effects corresponded to 19,492 exposures cases, si milar data are not av ailable for the “unknown

if related” effects. For these clinical effects, only 8,144 effects were “unknown if related” to the exposure. Below an approach is described fo r estimating the number of “unknown if related” illnesses, using the ratio of illn esses to effects from the “related” cases. Including “unknown if

related” cases with the “related” cases could serve as a “high-end” estimate for the annual

number of avoided unintentional pesticide illnesses expected nationwide as a result of the container design and residue removal regulations , since it is unclear wh at proportion of these cases are truly a result of the pesticide exposure.

5.2.4 Extrapolation to Estimate of Nationwi de Cases Potentially Avoided from the Container Design and Residue Removal Standards



### This section describes the method for deriving th e frequency of cases a nd number of clinical

effects avoided as a result of the container re gulations. The number of cases avoided is estimated by applying the percentage of pesticide illnesses determined to be container-related

### Page 129 (1.36 percent as calculated in S ection 5.2.2) to the number of cas es resulting in illness in TESS that are (1) known to be “relat ed” to pesticide expos ure (“low-end” estimate) and (2) known to be “related” plus “unknown if related” to the exposure (“high-end” scenario). From Section 5.2.3.2 above, we determined that the number of nationwide illnesses resulting from unintentional pesticide-relate d exposures was estimated to be 19,492. Assuming that 1.36 percent of these illnesses ar e related to container design or residue problems, the number of potentially avoided cases with clinical effects is 265. In 2001, 64 poison centers participated in TESS, reporting more than 2 million human exposure cases, which represent an estimated 98.8 percent of all poison exposures reported to poison centers in the United States. If it is assumed that these cases represent 98.8 percent of the number of illnesses potentially avoided from the container design and residue removal re gulations, then the “low-end” scenario number would be 268 (265 * 1.012 = 268, where the scaling factor of 1.012 is the inverse of 98.8 percent). The estimated frequency of associated clinical effects for th ese 268 illnesses (based on the frequency distribution in TESS for all uninten tional, pesticide product -related illnesses) is provided in Table 5.8. 60



### As a “high-end” estimate of cases avoided, we included those cases in TESS where some pesticide exposure was reported but it is unclear if the pesticide was responsible for the illness. As discussed earlier, the available TESS data for this subset of “unknown if related” cases were limited to the number of clinical effects, rather than the number of cases. Since one case may result in more than one clinical effect, the us e of this data would ove restimate the number of cases avoided. In order to extrapolate the numbe r of cases from the number of clinical effects for this subset, we applied the ratio of cases to clinical effects for thos e illnesses known to be “related” to pesticide exposur e (0.62, calculated as 19,492 re lated exposures cases to 31,504 clinical effects = 0.62) to the “unknown if related” cases (8, 144 “unknown if related” clinical effects * 0.62 = 5,039 “unknown if related” cases). This was added to the number of “related” cases to determine an upper bound of 24,531 as the total number of pesticide-related cases in TESS for the “high-end” scenario:

19,492 “related” cases + 5,039 “unknown if rela ted” cases = 24,531 “high-end” cases

The same percentage (1.36 percent) and scaling factor (1.012) were ap plied to generate the “high-end” estimate of 337 (24,531 “high-end” pesticide-related cases * 1.36 percent of these illnesses are related to container design or re sidue problems * 1.012 scaling factor = 337 cases) of the number of cases potentially avoided by the regulations, as shown in Table 5.8.

Table 5.8 also presents the dist ribution of the estimated number of clinical effects per avoided case. This estimate was generated by applying the frequency distribution observed in TESS for illnesses known to be “related” to pesticide exposures (see Table 5.6) to the estimated number of avoided cases. By doing so, it is assumed that the frequency of clinical effects for pesticide illnesses resulting from container design/residue issu es is the same as for all pesticide-related illnesses. The assumption is also made that for those cases in which it is unclear that pesticides are the implicated agent, the same number of clinical effects would be observed per case.

60 If possible container-related cases are included the “low -end” and “high-end” estimate of associated clinical effects is 853 and 1074 respectively. See Appendix J.

### Page 130 Table 5.8. Estimated Frequency of Clinical Eff ects for Avoidable Cases as a Result of the Container Regulations

Number of Cases Avoided b Number of Clinical

Effects per Case Percent of Cases with

Clinical Effect a “Low-End” Scenario c “High-End” Scenario d

1 59.58% 160 201

2 26.58% 71 90

3 9.34% 25 31

4 2.91% 8 10

5 or more 1.59% 4 5

Total 100% 268 337

Notes: Numbers are scaled by a factor of 1.012 to reach 100 percent coverage of the national population. Frequencyspecific estimates may not sum to totals due to rounding.

a Derived from Table 5.5 and as shown in Table 5.6.

b Distribution of number of cases avoided (e.g., with 1, 2, 3, 4, 5 or more clinical effects per case) are calculated from the total number (268 and 337 in “low-end” and “high- end” scenarios, respectively), using the percentage of

cases with different numbers of clinical effects.

c From cases “related” to exposure.

d From cases “related” and “unknown if related” to exposure.



### Table 5.9 shows the estimated number and type of avoided clinical eff ects as a result of the regulations. In order to estimat e the number of clinical effect s potentially avoided, the number of cases avoided was scaled by a factor of 1.616. This represents the ra tio of clinical effects “related” to exposures in TESS to the total number of cases re sulting in those effects (31,504 “related” clinical effects to 19, 492 “related” exposure cases = 1. 616). Therefore, on average, a pesticide product-related illness results in 1.616 clin ical effects as defined in TESS. By applying

this ratio to the number of cases avoided as a result of the regulation, it is assumed that the container-related illnesses, on average, result in the same number of clinical effects per case as all pesticide-related illnesses. It is also assume d that the relative distribu tion of types of clinical

effects are the same for container-related case s. The clinical brea kdown of the potentially

avoided clinical effects shown in Table 5.9 was derived using the distributions in Table 5.7 for

“related” and “unknown if re lated” cases, respectively. The nu mber of clinical effects avoided per year is estimated to be in the range of 433 to 545. These correspond to the estimated range of 268 to 337 potentially avoidable pesticide pr oduct illness cases as a result of the rule. 61



### The approach to scaling estimates of potential ly avoided cases based on the reported population coverage of TESS is discussed above. In addi tion, although CDPR takes many steps to ensure that the data collected are as comprehensive as possible, it is inevitable that some illnesses related to pesticide products go unreported or undiagnosed. For th e purposes of this analysis, if some cases are overlooked by CDPR, the percentage estimated and applied to the TESS data is not necessarily biased. As long as the proportion of those unreported or undiagnosed cases that are related to container design or residue problems is no differe nt from the proportion reported by CDPR, then an unbiased percentage estimate will be obtained.

61 If possible cases are included the number of clinical e ffects avoided for “low-end”, “unknown if related” and “high-end” scenario are 1379, 357 and 1736 respectively. See appendix J.

### Page 131 Table 5.9. Estimated National Number of Avoida ble Clinical Effects as a Result of the Container Regulations

Clinical Effect Number of Clinical

Effects Avoided

“Low-End” Scenario a, b Number of Clinical

Effects Avoided

“Unknown if Related” to Exposures a, b Number of Clinical

Effects Avoided “High-End” Scenario b

Cardiovascular 6 3 8

Dermal 75 14 88

Gastrointestinal 104 37 141

Hematologic/Hepatic 1 <1 1

Neurological 43 25 67

Ocular 117 4 121

Renal/Genitourinary <1 <1 <1

Respiratory 51 9 60

Miscellaneous 36 20 57

Total 433 c 112 c 545

Note: Clinical effect-specific estimates may not sum to totals due to rounding.

a Distributions of clinical effects shown here were derived from the total number of clinical effects calculated (see note (b) below), using the percentages shown in Table 5.7. (e.g., for the “low-end” scenario, 433 cases * 1.30 percent of total “related” effects are cardiovascular = 6 cardiovascular eff ects; for the “high-end” scenario, 112 cases * 2.27 percent of total “unknown if related” eff ects are cardiovascular = 3 cardiovascular effects added).

b “ Low-end” scenario clinical effects ar e represented by those effects “related ” to the pesticide exposure, while the “high-end” scenario includes those “rel ated” and those “unknown if related” to the pesticide exposure. If possible

cases are included the number of clinical effects avoided for “low-end”, “unknown if related” and “high-end” scenario are 1379, 357 and 1736 respectively.

c Number of cases avoided from Table 5.8 are scaled by a factor of 1.616 to estimate the number of clinical effects resulting from those reported cases (e .g., for the “low-end” scenario, 268 cases * 1.616 = 433 clinical effects).



### Another point to consider is the mechanism by which the data are collected for the TESS database. Since case reports are collected thr ough reporting to poison co ntrol centers across the country, it is possible that acute il lnesses and injuries are more lik ely to be reported than chronic effects resulting from the exposure. Similarly, clinical effects were generally recorded at the time of the poison report and may have been lo st in follow-up and therefore gone unreported if the victim developed symptoms s ubsequent to the initial report. Since the estimate of avoidable

cases and related clinical effects was based on these reports, the actual number of related illnesses may have been higher (see Appendix J for a description of these exposures potentially lost to follow-up).

5.2.5 Valuing Avoided Pesticide Product-Related Illnesses as a Result of the Container Regulations



### This section describes the appro ach to the quantitative valuation of the cases of pesticide product illness that may be potentially avoided as a resu lt of the container design and residue removal regulations. In order to estimate the potential co st savings from these avoided cases of pesticide product-related illness, th ese cases are first characterized into general illness se verity categories for which the average costs for outpatient physic ian visits, inpatient hospitalizations, lost productivity, and premature mortality is derived. In using this methodology, we made use of the additional data available in the TESS report that provide insight into the type or degree of

### Page 132 outcome/clinical effects observed for exposure cases. A profile of medical outcome severity as reported in TESS is presented in Appendix H.

5.2.5.1 Avoided Pesticide Product-Related Illnesses by Severity Level



### The potentially avoided cases calculated above are classified into th e following TESS outcome categories (see Table 5.10 and Appendix H):

• Minor effect: 

### patient developed some signs or symptoms as a result of the exposure but they were minimally bothersome and generally resolved with no residual disability or disfigurement;

• Moderate effect: 

### patient exhibited signs or symptoms as a result of the exposure that were more pronounced, more prolonged, or more of a systemic nature than minor symptoms (usually some form of treatment is indicated);

• Major effect: 

### patient exhibited signs or symptoms as a result of the exposure that were lifethreatening or resulted in significant residual disabil ity or disfigurement; and

• Death: 

### patient died as a result of the exposure or as a direct complicat ion of the exposure.

Table 5.10. Expected Number of Avoidable Illne sses as a Result of Container Regulation by Severity of Clinical Effect

TESS With Concomitants Potential Cases Avoided from Regulations

Medical Outcome/Severity Number of Cases Percentage a, b “Low-End”

Scenario a “High-End”

Scenario a

No Effect 18,385 56.14% 343 431

Minor Effect 12,084 36.90% 225 284

Moderate Effect 2,164 6.61% 40 51

Major Effect 111 0.34% 2 3

Death 2 43.86%

0.01% 268

<1 c 337

<1 c

Total 32,746 100.00% 610 d 768 d

a Numbers have been rounded for presentation purposes.

b Percentages were calculated to equal 100 percent for the five medical outcome categor ies using their associated number of cases from Table H-3 (Appendix H), since complete data were known for these five categories.

c 0.04 deaths were estimated for the “Low-End” scenario and 0.05 deaths for the “High-End”.

d Totals were calculated assuming that the potential illnes ses avoided as a result of the container regulations in Section 5.2.4 (268 for the “low-end” scenario and 337 fo r the “high-end” scenario) constitute the minor effect, moderate effect, major effect, and death severity categories: e.g., 268 ÷ 43.86% = 610. The breakdown by severity category was then calculated using this derived total.



### In addition, a “no effect” categor y is included (“no effect” repres ents a patient who reported an exposure but developed no signs or symptoms as a re sult of exposure). In theory, cases that did not result in any observed c linical effect should not be associat ed with any potential medical cost savings. However, TESS data show that, in re ality, some proportion of those exhibiting “no

effect” did visit a health care f acility and therefore incurred me dical costs (shown below). In addition, there are likely to be costs associated with lost productivity for the time and anxiety

associated with a call to a poison control center.

### Page 133 Table 5.10 presents the expected number of overa ll avoided cases as a result of the container design and residue removal regulations, when cases both with and without a ny clinical effect are considered. Note that the “low-end” and “high- end” scenario estimates from Section 5.2.4 of 268 and 337 cases, respectively, correspond to the following four medical outcome categories: minor effect, moderate effect , major effect, and death.

The “no effect” cases, in which no clinical effect was observed, are not a component of the 268

to 337 cases calculated in Secti on 5.2.4 above, since the Californ ia incident data from CDPR cover only pesticide exposures that resulted in symptoms. In order to estimate the number of avoided exposure cases that did not result in clini cal effects, the expected number of these cases is calculated based on the per centage distribution of medical outcome/severity observed across the entire TESS database of pesticide-related ex posures (see Appendix H). This calculation is based on the information provide d in Table H-3, which presen ts the cases according to the severity of the medical outcome, evaluating only the categories “No Effect,” “Minor Effect,” “Moderate Effect,” “Major Eff ect,” and “Death.” Using the act ual number of cases reported to TESS for these categories, the proportion of cases that each medical outcome category

contributes to the total is recalc ulated, as presented in Table 5.10. 62 

### As a result of this recalculated distribution, it is estimated that 43.86 percent of exposures resulted in clinical effects (including minor, moderate, and major eff ects, and death), and 56.14 percent of exposures resulted in “no effect,” as shown in Table 5.10. 63 

### For the “low-end” scenario, we estimated that 268 illnesses would be avoided by the rule. Assu ming that the ratio between exposures with clinical effects and exposures w ith “no effect” from TESS holds true in this subset, the number of cases with “no effect” avoided by the rule can be estimated as follows:



### 343 % 14

. 56 % 86

. 43

268

= ⇒ = x x

Using this methodology, it is assumed that the dist ribution of severity of effect (ranging from “no effect” to “death”) for exposures related to cont ainer design and residue removal is no different than for all exposures to pesticide products resulting in calls to poison control centers nationwide. Data are not available to suggest that the subset of cont ainer-related pesticide

62 After examining the medical outcome descriptions show n in Table H-3, we recalcu lated the distribution among only the first 5 categories (no effect, minor effect, moderate effect, major effect, and death) to use in this calculation of illness severity. We decided not to use the percenta ge distribution for all the categories shown in Table H-3 because sufficient information on the outcome of the expos ure was not available for the remaining categories. For example, for the category “ no follow-up, potentially toxic,” we were not able to assign a reasonable medical outcome category to value based on the uncertainties presented in its description: “Patient was lost to follow-up, refused to follow-up or was not followed but the exposu re was significant and may have resulted in a moderate, major, or fatal outcome.” Similarly, for the “unrelated effect” category, we are not c oncerned with cases for which the exposure was not responsible for the medical outcome. Since we want to categorize the medical outcome of exposure in order to value the benefits, we decided that including such cases would not be representative of the exposure cases. Instead, we assumed that the distributio n for those cases in which th e medical outcome was known is representative of the outc omes from all exposures.

63 The “no effect” category shown in Table H-3 differs from the 75.93 percent with zero clinical effects shown in

Table 5.5 because the latter shows the number of clinical eff ects known at the time of the poisoning incident report. Alternatively, the medical outcome info rmation presented in Table H-3 describes the known effect resulting from the incident. However, it is possible that the “no follow-up” categories in Table H-3 may or may not have had clinical effects, or could have had clinical effects later. This information is not known.

### Page 134 illnesses typically result in more or less severe illn esses than any other pesticide exposure. If this assumption is not true, the benefits calculated here could be over- or understated due to an overor underestimate of the severity of health effects avoided.

5.2.5.2 Unit Costs for Morbidity and Mortality by Severity Level



### The valuation of health benefits associated with reduced pesticide-related morbidity and mortality focuses on direct costs for outpatient visits and inpatient hospitalization stays, indirect costs of lost productivity, and premature mortalit y based on the “value of a statistical life” (VSL) approach (see Figure 5.2). The value of reduced morbidity is estimated below using TESS data on the likelihood of pesticide produc t-related cases of va rying severity leve ls seeking medical care. These data are then used to generate un it costs associated with physician visits, hospital stays, and lost productivity for each level of clini cal severity. Subsequent ly, the total value of reduced morbidity associated with the container rule is estimated by applying these costs to the number of avoided cases by level of severity and summing across se verity levels. The premature mortality valuation is performed by first genera ting a VSL estimate in year 2005 dollars and then applying the number of premature deaths (or the probability of premature mortality), estimated in the previous section, to this VSL.

Figure 5.2. Components of the Health Benefi ts Valuation for the Container Design and Residue Removal Regulations

Outpatient

Costs Value of

Premature Mortality Value of Lost Productivity Inpatient

Costs

Total Health Benefits



### Medical Care Utilization

In order to estimate direct costs for medical care utilization, the un it costs per outpatient physician visit and inpatient hospita lization stay were derived. Th e unit costs per visit were then converted to unit costs per pestic ide case for each severity level ot her than death (no effect, mild, moderate, and major) to reflect the probability of visiting a health care facility. The following equation presents the method used to ge nerate unit costs by severity level:



### ) ( HCFvisit P UnitCost UnitCost visit per severity 

### × =

where:

UnitCost severity 

### = the unit cost per case for a particular severity level;

UnitCost per visit 

### = the unit cost per health care visit; and

### Page 135 P(HCFvisit) = the probability of visiting a health care facility for a particular severity level.

TESS provides data on health care f acility visits for clinical effects associated with pesticiderelated exposure. Table 5.11 presents the di stribution of health care visitation by medical outcome/severity. In TESS, a health care facili ty is defined as “any hospital-based ward or emergency department, free-standing emergency medi cal clinic (emergicenter), first aid station, physician’s office, or clinic.” Therefore, it is not possible to disti nguish between outpatient physician visits, emergency room visits, and in patient hospitalization st ays. As would be expected, as the clinical effect severity level increases, the pr oportion of cases requiring health care facility visits increases as well.

Table 5.11. Medical Outcome by Management Site for Pesticid e Product-Related Unintentional Exposures, TESS, 2001 a

Management Site b

Medical Outcome/Severity Non-Health Care Facility Health Care Facility Refused Referral c

No Effect 76.86% 22.58% 0.56%

Minor Effect 67.30% 30.32% 2.38%

Moderate Effect 24.45% 70.65% 4.91%

Major Effect 9.52% 86.67% 3.81%

Death 0% 100% 0%

Source: Adapted from AAPCC (2002, Report 39 “Medical Outcome by Management Site”).

a Excludes those cases with management site designated as “other” and “unknown.”

b Represents row percent.

c Although refused referral cases are th ose that should have received health care facility treatment, they did not and

therefore did not incur medical care costs. It is not clear whether some of th ese cases ultimately received treatment

at a later time.



### The proportion of cases visiting health care facilitie s in Table 5.11 were used to adjust outpatient physician visit unit costs for each level of clinical e ffect severity. For hosp italization stays, it is assumed that only cases with major clinical e ffects require inpatient treatment. Table 5.12 presents TESS data on the duration of clinical effects by medical outcom e/severity. For cases with minor effects, 74 percent lasted less than eight hours and 88 percent less than one day. Similarly, 43 percent of cases with moderate effects lasted less than eight hours and 63 percent less than one day. On the contra ry, 59 percent of cases with major clinical effects lasted one or more days and 30 percent lasted three or more days . As a result, it is assumed that only cases with major effects would incur hospitalization inpa tient costs and the unit cost per hospitalization stay is converted to a unit cost per major effect case in the same way as described for outpatient

visits. Table 5.12 is also used to estimate the in direct cost of lost productivity, described in the section titled “Lost Productivity” below.

### Page 136 Table 5.12. Duration of Clinical Effect by Medical Outcome for Pest icide Product-Related Unintentional Exposures, TESS, 2001 a

Medical Outcome/Severity b Duration of

Clinical Effects Minor Effect Moderate Effect Major Effect

# 2 Hours 53.84% 18.34% 6.82%

2-8 Hours 20.60% 24.19% 9.09%

8-24 Hours 13.70% 20.33% 25.00%

1-3 Days 6.99% 17.94% 29.55%

3-7 Days 3.30% 12.49% 11.36%

1 Week - 1 Month 1.24% 4.66% 6.82%

>1 Month 0.30% 1.70% 5.68%

Anticipated Permanent 0.03% 0.34% 5.68%

Source: Adapted from AAPCC (2002, Report 23 “Dur ation of Clinical Effects by Medical Outcome”).

a Excludes those cases with “unkno wn” duration of clinical effect.

b Represents column percent.



### Outpatient Costs

To estimate outpatient unit costs, we obtained ph ysician visit benchmark fees from the online division of Intellimed, a private corporation that provides analytical softwa re with inpatient and outpatient databases to health care-related organizations. 64 

### Evaluation and management costs are provided by Current Procedural Terminology, Fourth Edition (CPT-4) code, an American

Medical Association classification used for defini ng outpatient treatment. Costs are available for new and established patients, based on the type of evaluation and management received. For this analysis, it is assumed that patients visit th eir current physician for evaluation and management based on a focused problem. Appendix I provides a list of benchmark costs for varying levels of complexity of care for both new and established patients.

Table 5.13 provides the current cost estimate for a physician visit of an established patient for an expanded, problem-focused evaluation, updated to 2005 dollars. The cost, $39.35, represents only the evaluation and management costs. Diag nostic and medicinal cost s are not included in this estimate and would be more likely to vary by level of severity. These costs would add to the

estimates of direct medical costs avoi ded due to the container regulations.

64 Formerly the Medical Cost and Quality Assistance (M ECQA) Web site, the Web site can now be accessed at www.myhealthscore.com.

### Page 137 Table 5.13. Benchmark Evaluation and Manageme nt Costs for Physician Office Visit for an Established Patient Requiring an Expanded, Problem-Focused Evaluation, Adjusted to 2005 Dollars a

CPT-4 Code Brief Description Cost b

99213 Established patient requiring: 1. Expanded, problem-focused history 2. Expanded, problem-focused examination 3. Medical decision-making of low complexity $39.35

a Cost data obtained from online division of Intellimed (Intellimed, 2002) See Appendix I for benchmark costs for other CPT-4 codes.

b Cost is updated to year 2005 from year 2000 by scaling based on Medicare Physician Fee Schedule conversion factors. See AAMC (1999) for the year 2000 conversion factor and AAPMR (2004) for the year 2005 conversion

factor.



### Using the health care facility utilization data fr om TESS, reported in Table 5.11, the outpatient physician unit costs per case by level of clinical severity are estimated. Table 5.14 presents the adjusted unit costs for cases with no clinical effect, minor eff ect, moderate effect, and major effect. The adjusted unit cost s range from $8.89 for “no effect ” to $34.11 for “major effect.”

Table 5.14. Outpatient Physician Unit Costs by Medical Outcome

Medical Outcome/Severity Unit Cost a

No Effect $8.89

Minor Effect $11.93

Moderate Effect $27.80

Major Effect $34.11

a Unit costs represent the cost per cas e and are calculated by multiplying the benchmark cost in Table 5.13 by the percentage of cases visiting health

care facilities in Table 5.11.



### Inpatient Costs

Hospital utilization data we re obtained from the Healthcare Co st and Utilization Project (HCUP), a series of databases compiled by the Agency for Healthcare Research and Quality (AHRQ). 65


### HCUP contains patient-level health care data on costs and quality of health services, treatment outcome, and access to health care collected through state data organizations, hospital associations, private data organizations, and th e federal government. Unit cost estimates for hospital stays were obtained from the HCUP-3 Nationwide Inpatient Sample (NIS) Release 3 (AHRQ, 1994), which contains a ll 1994 discharge records from a 20-percent sample of U.S. community hospitals from 17 states.

Table 5.15 presents mean length of stay and mean charges for diagnosis-related group (DRG) 455, “other injury, poisoning, t oxic effect diagnosis w/o CC,” 66 

### updated to 2005 dollars using an

65 Formerly called the Agency for Health Care Policy and Research (AHCPR), part of the U.S. Department of

Health and Human Services.

66 CC as defined AHCPR (1994) “(Complications, Comorb idities). Patients who are more seriously ill tend to require more hospital resources than patients who are less seri ously ill, even though they are admitted to the hospital

### Page 138 adjustment based on the Consumer Price In dex (CPI-U) for “med ical care services”. 67 

### DRGs are a classification of hospital cas e types into groups expected to have similar hospital resource use. Therefore, DRG 455 should provide a reas onable approximation of the charges associated with treatment of pesticide-related illness.

Table 5.15. Mean Hospitalization Charges and Length of Stay for Injuries/Poisonings from HCUP 1994, Adjusted to 2005 Dollars a

Diagnosis-Related

Group (DRG) DRG Description Mean Length of Stay Mean Charges

455 Other injury, poisoning & toxic effect diagnosis w/o complications or

comorbidities 1.64 $6,856

a Data obtained from HCUP-3 Nationwide Inpatient Sample (NIS) Release 3 AAPMR (2002) Updated to 2005 dollars using CPI-U for “medical care serv ices” (Bureau of Labor Statistics, 2005).



### Using the health care facility utilization data from TESS, reported in Table 5.11, and assuming that only cases with major effects will have i npatient hospital stays, th e inpatient unit costs per severity level case by severity level are estima ted (see Table 5.16). The unit cost for “major effect” is $5,942, representing th e average charge for a hospital stay across all “major effect” cases, based on the percentage of “major eff ect” cases that visit a health care facility (86.67 percent from Table 5.11).

Table 5.16. Inpatient Hospitalization Unit Costs

Medical Outcome/Severity Unit Cost a

No Effect $0

Mild Effect $0

Moderate Effect $0

Major Effect $5,942

a Unit cost for “major effect” is th e average cost across all “major effect” cases. Unit costs represent the cost per case and are calculated by multiplying the benchmark cost in Table 5.15 by the percentage of cases visiting health care facilities in Table 5.11.



### Lost Productivity

For the purposes of this analysis, a “lower-productivity day” is de fined as a day when activity is restricted and the person may be less productive in the performance of normal activities (i.e., work, housekeeping, leisure). In order to calcul ate the value lost due to a lower-productivity day, it is first necessary to estimate the value of a day of full productivity and then estimate the magnitude of reduced productivity associated with each severity level. The socioeconomic data

were collected from the U.S. Bureau of Labor Statistics and U.S. Bureau of the Census to calculate average number of hours spent on work, housekeeping, leisure, and sleep, as presented in Table 5.17. Using these data, the value of a day of full productivity can be calculated as

for the same reason. Recognizing this, the DRG grouper sp lits certain DRGs based on the presence of secondary diagnoses for specific complications or comorbidities (CC).”

67 CPI-U for Medical Care Services http://data.bls.gov/cgi-bin/surveymost?cu

### Page 139 presented in Table 5.18. From a review of the pesticide exposure cases in California that were potentially avoidable as a result of the container standards, th e majority of instances occurred during occupational activities. Therefore, the in direct cost of illness reflects estimated activity patterns for a typical working ad ult on any particular day.

Table 5.17. Socioeconomic Data Used to Calculate Indirect Cost of Illness

Data Value

Average hours an employed person works per week 33.8 a

Average hours housekeeping per week (male) 13.4 b

Average hours housekeeping per week (female) 28.3 b

Number of males aged 16 years and over in the U.S. 111,256,354 c

Number of females aged 16 years and over in the U.S. 117,365,320 c

Average hours people aged 16 years and over spend housekeeping per week 21.0

Median hourly earnings (all workers) $16.41 d

Median hourly earnings (service, private household female) $9.62 d

2002 Effective Tax Rate (includes federal, state, and FICA) 29.1% e

a Bureau of Labor Statistics (2005).

b Research Triangle Institute (1994).

c U.S. Census Bureau (2004).

d Bureau of Labor Statistics (2004) (adjusted to 2005 usin g inflation rate): Median hourly earnings (all workers) calculated as $657 in 2005 median weekly earnings for all workers 16 years and over (inflated from $638 in 2004 median weekly earnings using an inflation rate of 1.029), divided by 40 hours of work per week. Median hourly earnings (service, private household female) calculated as $385 in 2005 median weekly earnings (inflated from $374 in 2004 median weekly earnings using an inflation rate of 1.029), divided by 40 hours of work per week.

e Tax Foundation (2005).



### Economic theory dictates that the gross wage rate is the best indicator of the value of production associated with an hour of work. As show in Table 5.18, the average gross wage rate in the United States is $16.41 per hour. Therefore, each hour of lost work due to illness will be valued at $16.41. Since housekeeping is a non-market ac tivity, no market value exists with which to value the loss to society when hous ekeeping activity is lost due to illness; an implicit value must

be determined. Most cost of illness studies us e the average after-tax wage for private household workers as a proxy (see Tolley et al., 1994; Resear ch Triangle Institute, 1994). This value is calculated as $6.82 per hour, as shown in Table 5.18. Finally, an hour of leisure is valued at the average after-tax wage rate of $11.64 per hour.

In order to estimate the reduction in productivity resulting from a pesticide exposure potentially avoidable from the regulations, the TESS data on the duration of illness by medical outcome/severity were used (see Table 5.12). For each severity level, an average duration of clinical illness was generated a nd the proportion of a day spent w ith the illness was calculated. This proportion was applied to the value of a day of full productivity to estimate the indirect cost of illness. Therefore, the loss in productivity is directly proportional to the time spent with the

illness.

### Page 140 Table 5.18. Value of a Day of Full Productivity

Activity Hours/Day Hourly Value Total Value

Work 4.8 a $16.41 $79.26

Housekeeping 3.0 a $6.82 c $20.50

Leisure 8.2 b $11.64 d $95.03

Sleep 8.0 $0.00 $0.00

Total Value of a Day of Full Productivity $194.80

a For work, based on the weekly estimate in Table 5.17 divided by 7 days per week; for housekeeping, based on the number of hours people aged 16 years and over spend on housekeeping per week (21.0 hrs/wk), divided by 7 days per week.

b Leisure time is the time left per day after work, housekeeping, and assuming 8 hours of sleep (24 hours per day - 4.8 hours work - 3.0 hours housekeeping - 8.0 hours sleeping = 8.2 hours leisure).

c Housekeeping rate is based on the median hourly earnings for service, private household female (shown in Table 5.17) less income tax (average of 29.1 percent for 2005).

d Leisure rate is based on the median hourly earnings for all workers (shown in Table 5.17) less income tax (average of 29.1 percent for 2005).



### To determine the average duration of clinical illn ess for each severity level in TESS, a weighted average of the exposure durations was calculated based on the fre quency distribution of clinical

effect duration. Two scenarios were calculated: a “l ow-end” scenario based on the midpoint of the duration category and a “h igh-end” scenario based on the upper bound of the duration category. Two clinical effect duration categor ies (“>1 month” and “anticipated permanent”) were unbounded, and we assumed that the “>1 mont h” category stretched from 1 to 3 months and the “anticipated permanent” category was assumed to last 1 y ear for the “upper-bound” estimate and one-half of a year for the “lower bound.” 68



### In addition, data on duration of clinical effects were not av ailable for “no effect” group. However, since approximately 25 percent of these cases visited health care facilities (see Table 5.11) it was assumed that these 25 percent expe rienced reduced productiv ity for the shortest clinical effect duration group (< 2 hours) and the remaining 75 pe rcent experienced no reduced productivity. Table 5.19 provides the average clinical effect durations and indirect unit costs associated with the “low-end” and “high-end” scenarios.

68 Although the “anticipated permanent” category may reflect conditions that last indefinitely, since we do not know the nature of the permanent clinical effect, it is uncl ear that this will result in permanent lost productivity.

### Page 141 Table 5.19. Average Clinical Effect Du ration and Indirect Cost of Illness by Medical Outcome

Medical Outcome/Severity Scenario b Average Duration of Clinical Effect (Days) c Unit Cost for Lost Productivity Day d

Low-End 0.01 $1.83 No Effect a

High-End 0.02 $3.67

Low-End 0.9 $179.82 Minor Effect

High-End 1.4 $279.88

Low-End 3.7 $717.35 Moderate Effect

High-End 5.9 $1,146.56

Low-End 16.4 $3,192.25 Major Effect

High-End 29.9 $5,817.81

a Data on duration of clinical effect were not availabl e for “no effect” group. Ho wever, since approximately 25 percent of these cases visited health care facilities it was assumed that these 25 percent experienced reduced productivity for the shortest clinical effect duration group (<2 hours) and th e remaining 75 percent experienced no reduced productivity.

b The “low-end” scenario uses the midpoint of the range of clinical effect duration to calculate the average duration, and the “high-end” scenario uses the upper end of the range.

c Average duration of clinical effect for all except the “No Effect” case is based on a weighted average of the durations presented in Table 5.12. The category “>1 month” was assumed to be 1-3 months (where the midpoint = 60 days) and the category “anticipated permanent” was assumed to be 1 year (where the midpoint = 182.5 days) for the low-end estimate and one half year for the high-end estimate. For example, the low-end estimate of average duration of clinical effect is calculated by multiplying the mid-point of average duration in the first column in Table 5.12 with the corresponding percentage of Minor Effect cases (calculating the sum of products of column 1 and column 2 in Table 5.12).

d The unit cost is the indirect cost in terms of lost productivity associated with the average duration of clinical illness for a particular severity level. For example, the unit cost for lost productivity day was calculated by multiplying the value of a productive day ($194.80) with the average durati on of clinical effect (0.0 1). The average duration of

clinical effect is rounded off therefore the value for unit cost is less than the simple multiplication of average duration and value of a productive day.



### Premature Mortality

A “value of a statistical life” (VSL) was used to estimate a value of the potential reduction in fatalities from pesticide-related illnesses. EP A's Office of Air and Ra diation’s (OAR) work on

the value of a statistical life has been wi dely cited throughout the Agency. Recently, OAR responded to a recent SAB opinion about the previous VSL estimate used ($4.8 million in 1990 dollars) and changed the estimates (EPA,2004):

“The mean value of avoiding one statistica l death is assumed to be $5.5 million in 1999 dollars. This represents a central value consistent with the range of values suggested by recent meta-analyses of the wage-risk VSL literature. The

distribution of VSL is ch aracterized by a confidence interval from $1 to $10 million, based on two meta-analyses of the wage-risk VSL literature. The $1 million lower confidence limit represents the lower end of the interquartile range from the Mrozek and Taylor (2002) meta-analysis. The $10 million upper confidence limit represents the upper e nd of the interquartile range from the Viscusi and Aldy (2003) meta-analysis (EPA,2004).”

### Page 142 For this benefits analysis, EPA used the VSL estimate of $5.5 million (in 1999 dollars), updated to the base year of the analysis (2005). Using CPI data for all items from the Bureau of Labor Statistics, this estimated VSL was calcu lated to be $6.42 million in 2005 dollars. 69



### In this analysis, it is estimated that less than one pesticide-related death (0.04 to 0.05 deaths) will be avoided as a result of the container regulations each year (see Table 5.10). A reduction in

0.04 deaths can be seen as four deaths avoided over a 100-year peri od. This can also be viewed as a reduction in mortality risk for ever y person in the United States of 1.27 x 10 -10 

### , based on the 2004 U.S. Census estimate of 294 million people in th e United States. This estimate of avoided mortality is applied to the year 2005 value of a statis tical death to estimate a range of $240,000 to $301,000 for annual avoided premature mortality as a result of the regulations (see Table 5.20).

Table 5.20. Value of Annual Avoided Pesticide-Re lated Cases as a Result of the Container Regulations (2005 dollars) a

Medical

Outcome/ Severity Scenario Avoided

Cases c Outpatient

Costs d Inpatient

Costs e Lost Productivity f, g Premature Mortality Total h

Low-end 343 $3,045 -- $628 -- $3,674 No effect

High-end 431 $3,833 -- $791 -- $4,623

Low-end 225 $2,688 -- $40,512 -- $43,200 Minor effect

High-end 284 $3,383 -- $50,984 -- $54,367

Low-end 40 $1,122 -- $28,941 -- $30,062 Moderate

effect High-end 51 $1,412 -- $36,422 -- $37,834

Low-end 2 $71 $12,297 $6,606 -- $18,973 Major effect

High-end 3 $89 $15,479 $8,314 -- $23,878

Low-end <1 -- -- -- $239,542 $239,542 Death b

High-end <1 -- -- -- $301,465 $301,465

Low-end 610 $6,926 $12,297 $76,686 $239,542 $335,451 Total

High-end 768 $8,716 $15,476 $96,510 $301,465 $422,167

a All cost estimates are rounded to the nearest dollar.

b Estimated deaths avoided as a result of the container rule are 0.04 for the lower-bound estimate and 0.05 for the upper-bound estimate. The value of avoided mortality is the same as the value of a reduction in four deaths or five deaths over a hundred-year period, respectively.

c See Table 5.10 for derivations.

d Outpatient costs are equal to the number of avoided cases times the per case outpatient cost (see Table 5.14). Costs may not add due to rounding.

e Inpatient costs are equal to the number of avoided cases times the per case inpatient cost (see Table 5.16). Costs may not add due to rounding.

f Lost productivity costs are equal to the number of avoi ded cases times the per unit cost of lost productivity (see Table 5.19). Costs may not add due to rounding.

g Lost productivity estimates are based on the “low-end” estima te of indirect cost of illness, as described in the “Lost Productivity” subsection of Section 5.2.5.2. The value of the “high-end” estimates for lost productivity are not shown here, but can be calculated using the unit costs from Table 5.19.

69 $5.5 million in 1999 dollars was adjusted using the Consumer Price Index-All Urban Consumers (CPI-U), U.S. All items, base period 1982-84=100, series ID CUUR0000SA0 from the Bureau of Labor Statistics (2005), as follows: 194.6 (April 2005 index) ÷ 166.6 (1999 index) * $5.5 million = $6.42 million.

### Page 143 h If possible container-related cases are in cluded the “low-end” and “high-end” benefit estimates are $1,069,249 and $1,345,657 respectively.



### 5.2.5.3 Total Value of Avoided Pesticide Product-Related Illnesses



### In Section 5.2.5.1 above, the annual number of cas es of pesticide-related illnesses avoided as a result of the container regulations by level of severity was estimated. The value of these avoided cases are calculated by applying the unit costs by severity level estimated for outpatient physician visits, inpatient hospita lization stays, and lost produc tivity to the avoided cases of morbidity and the value of a statistical life to the avoided premature mort ality estimate. Table 5.20 presents the annual health benefits valu ation estimates for each of the endpoints and severity levels described above. The value of avoided pe sticide-related illnesses is provided for the “low-end” and “high-end” estimates of cases avoided, described in Section 5.2.4 above.

It is estimated that 610 to 768 cas es could have been avoided as a result of the container design and residue removal regulations each year , corresponding to approximately $335,451 to $422,167 in annual health benefits. If the 51 “possi ble” cases in Californi a are included, which increases the percenta ge of total pesticide product-rela ted cases potentially avoided by 4.33 percent, the annual health benefits woul d be an additional $1.07 million to $1.35 million annually (corresponding to an additional 1,946 to 2,449 cases). 70



### Since the compliance period for the rulemaking is either 3 or 5 years depending on the type of container involved, we assume that 50 percent of average annual benefits will begin to accrue in year 3 and the remaining 50 percent of average a nnual benefits will begin to accrue in year 5. Given the compliance schedule, th e annualized benefit over a 20-year period of analysis at a 3 percent discount rate is $264,051 for the lo w-end scenario and $332,311 for the high-end scenario. Similarly, the annualized benefit ove r a 20-year period of analysis at a 7 percent discount rate ranges from $236, 635 (low-end scenario) to $297,807 (high-end scenario). If possible cases are included the annualized benefit for the low-end and high-end scenario are $841,664 and $1,059,240 respectively at the 3 pe rcent discount rate, and $754,274 and $949,259 respectively at the 7 percent discount rate.

5.3 Non-Human Health-Related Benefits of the Pesticide Container Regulations



### This section describes the inputs and assumptions used to calcul ate the non-human health-related benefits associated with the pesticide container re gulations. For this analysis, three direct benefit categories are considered: benefits associated wi th the disposal of non-refillable containers (Section 5.3.1), benefits associated with re duced environmental and ecological incidents (Section 5.3.2), and the benefits associated with avoided cleanup costs and property damage (Section 5.2.3).

5.3.1 Non-Refillable Container Disposal Benefits



### The pesticide container regulations will directly affect the use and disposal practices of rigid

non-refillable containers for two r easons. First, rigid non-refillable pesticide containers that fall

70 See Appendix J for detailed information of the “possible” cases, defined by EPA as cases that may have possibly been prevented by the container regulations.

### Page 144 within the scope of the cont ainer regulations will be required to meet residue removal

standards. 71 

### Second, all rigid non-refillable pesticid e containers that are not exempt under the new labeling requirements must have labels that include the applicable in structions for removing pesticide residues from the contai ner prior to container disposal (§156.146). Benefits therefore

should be related to containers that will m eet the residue removal and/or the labeling requirements that did not do so previously. However, the residue removal standards are applicable to only certain flowable concentr ate formulations and it is not clear how many

containers should be tied to these formulations . Since we cannot accurately estimate the number

of containers associated with reside removal standards we are conserva tively not including the

containers diverted from the waste stream as a re sult of this standard in the benefits estimate. This implies that the benefits es timate will understate the true estim ate of benefits from the rule.

In the regulatory impact analysis (RIA) that EPA conducted for the proposed version of the pesticide container rule (E PA, 1993), EPA made a number ofassumptions regarding nonrefillable containers and their use that we retain in this analysis. It assumed that the number of non-refillable containers appropriately managed a nd disposed of will increase after promulgation of the final rule because of (1) the presence on container labels of speci fic rinsing information regarding how and when a triple rinse must be conducted due to the labeling requirements, and (2) an increased likelihood that landfills once hesitant to accept appropriately managed pesticide containers as solid waste would now do so instead of treating them as hazardous.

Though appropriate container management and dis posal would result in fewer environmental damages, such as fewer pesticide residues in soil, surface and ground water, and fewer healthrelated damages over time (See Sec tion 5.3.2), due to limitations in the data available, estimates of all of these potential benefits cannot be ma de. Instead, the differen ce in cost between the disposal of non-refillable pesticide containers th at, before the rule, were disposed of as hazardous waste, and the disposal of non-refillable pestic ide containers that, af ter the rule, would be disposed of as non-hazardous waste is calculate d as a quantified measur e of the environmental benefits of the container regulations. Because hazardous waste treatment is more costly than non-hazardous, the resulting cost savings is a di rect benefit related to the regulations.

The benefits associated with the diversion of non-refillable pesticide containers from the hazardous waste stream (where waste treatment is more expensive) into the solid waste stream are calculated in a number of step s. Each step is discussed in the order in which it was carried out in the analysis.

5.3.1.1 Step 1: Determine Which Contain er Types Are Subject to the Labeling Requirements



### There are a number of non-refillab le container types that are consid ered in the estimation of costs associated with the pesticide c ontainer regulations. These include containers that hold dry and

71 The residue removal requirements apply to only flowable concentrate products that are non-antimicrobial and non-exempt antimicrobial that are included under the Toxic Category I or II criteria and/or are classified for restricted use and that are dilutable and packaged in ri gid containers. The final regulations require that every registrant test three contai ners from each rigid containe r/dilutable formulation combin ation to determine that the containers are capable for attaining at least 99.99 percent removal of each active ingredient in the fourth rinsate after the triple rinse (see Chapter 3).

### Page 145 liquid pesticides, plastic and stee l containers of varying sizes, wa ter-soluble packets, bag-in-box containers, aerosol cans, paper a nd plastic bags, glass jugs, fiber drums, and “other” containers. Not all of these containers are subject to the labeling requirements, how ever, since only rigid containers can be triple rinsed. Table 5.21 displays the container types and sizes that are subject to the labeling requirements.

Table 5.21 also displays the wei ghts associated with the containers. Weights are needed to

calculate the volume of containers that are no lo nger treated as hazardous waste. Weights for plastic containers are based on information gathered by the 2001 High-Density Polyethylene (HDPE) Container Survey, conducted by the Agri cultural Container R ecycling Council (ACRC, 2001). All other container weight s are transferred from the propos ed container rule RIA (EPA, 1993).

Table 5.21. Non-Refillable Containers Subjec t to the Labeling Requirements and Their Associated Weights

Container Size Weight - Plastic (lbs.) a Weight - Steel/Other (lbs.) b

Container Type: Liquid Products

< 1 Gallon 0.15 0.5

1 to < 5 Gallons 0.54 1.38

5 Gallons 3 6

30 - 55 Gallons 23 42.5

Container Type: Dry Products - Jugs

Quart to < 2.5 Gallons N/A 0.6

2.5 Gallons N/A 1.5

a Source: ACRC (2001).

b Source: proposed container rule RIA (EPA, 1993, Table XIV-5).



### 5.3.1.2 Step 2: Determine the Number of Cont ainers Included in the Scope of the Non-Health Benefits Analysis



### The residue removal requirements apply to onl y flowable concentrat e products that are nonantimicrobial and non-exempt antimicrobial that are included under the Toxic Category I or II

criteria and/or are classified for restricted us e and that are dilutable and packaged in rigid containers (see Chapter 3 for a complete discussi on). As mentioned above, since we are unable to accurately determine the number of containers associated with the flowable concentrate products/formulations, we are not including the containers diverted from the waste stream as a

result of this standard in the estimate.

The container labeling requireme nts apply to all pesticide pr oducts except those that are

considered residential/house hold use pesticide products. 72 

### Non-refillable c ontainers subject to the labeling requirements must meet the following criteria:

72 The total universe of containers is based on the total number of containers in use from Chapter 3.

### Page 146 • Container does not hold a dilu table product that meets the T oxic Category I or II criteria

and/or is classified for restri cted use (this includes antimicrobi al containers exempt from the residue removal requirements); and

• Container does not hold a resi dential/household use product.

It is assumed that all containers used in th e home and garden (H&G) market sector are for residential and household purposes only and are therefore exempt from the labeling requirements. The containers in the H&G market sector are therefore excluded from consideration under this category. The total num ber of non-refillables included in the universe of containers subject to the labeling re quirements is presented in Table 5.22.Page 147Table 5.22. Non-Refillable Containers Included inthe Scope of the Non-Health Benefits AnalysisContainer Type: Liquid ProductsContainer Type:Dry Products30-55 Gallons 5 Gallons 1 To < 5 Gallons < 1 Gallon JugsPlastic Steel Plastic SteelPlastic Steel Plastic Steel Glass 2.5 Gallons 1qt-2.5 GalNumber of Containers Subjectto the Labeling RequirementsaAgriculture 309,104 115,496 58,116 28,819 27,877,458 0 1,007,023 0 0 26,379 2,273,060I/C/G 1,600,000 2,320,000 14,048,000 960,000 21,072,000 1,440,000 20,560,000 160,000 240,000 0 370,000H&G 0 0 0 0 0 0 0 0 0 0 0Total 1,909,104 2,435,496 14,106,116 988,819 48,949,458 1,440,000 21,567,023 160,000 240,000 26,379 2,643,060aThe container labeling requirements apply to all pesticide products except those that are considered residential/household use(H&G market) pesticide products.See Table 3.4.

### Page 148 5.3.1.3 Step 3: Estimate the Number of Non-Refi llable Containers Diverted from the

Hazardous Waste Stream to the Non-Hazardous Waste Stream After Promulgation of the Labeling Requirements



### To calculate this benefit category, the percentage of containers that will be appropriately rinsed and disposed of under the container rule needs to be estimated, as does the percentage of total

containers that will c ontinue to be inappropriately dispos ed of (without having been properly

rinsed or with a container desi gn that does not rinse clean). For lack of better data, these percentage estimates are based on educated extrapolat ions taken from the proposed container rule RIA (EPA, 1993). The proposed container rule RIA estimated its pre -regulation rinse rates based on information from the following sources:

(1) The rinsing behavior observed in a late 1970s study (as reported by Taylor, undated) and two other surveys (Ozkan, 1991, and EPA, 1992a) related to agricultural pesticide

use 

### . The Taylor study suggested th at 35 percent of farmer applic ators triple rinse pesticide containers and only 18 percent of custom app licators triple rinse. The Ozkan study found that more than 90 percent of farmer-pesticide users in Wayandot Count y, Ohio, rinsed their empty pesticide containers at least once, though only 45 percent regularly rinsed three times. EPA reported that a 1988 South Dakota farmer survey of pesticide applicators in seven counties indicated that 55 percent of the fa rmers rinsed their empt y containers, although many of them only once or twice. Across studi es, it was therefore obs erved that between 45 percent and 82 percent of farmer applicator s do not triple rinse. Though the rinsing

behaviors were based on observations taken fr om the agricultural sector, we applied these rinsing rates to the other markets as well.

(2) The percentage of agricultural and industrial /institutional containers not meeting the proposed standard (at that time a six-9s sta ndard) after a triple rinse, as observed in a 1992 study (EPA, 1992c). 

### The study tested the percentage of containers not meeting a five9s standard. The study finds that 13 percent of the containers tested at small, medium, and large agricultural facilities and 3 percent of the containers tested at small and medium

industrial/institutional faci lities did not meet a five-9s requirement for residue removal. The final rule requires containers pass only four-9 s standard. Based on the residue removal data in the preamble to the final rule that shows that only 1 of the 79 container/formulation combinations failed to meet the four-9s standard, a 2 percent failure rate is applied in this analysis.

The proposed container rule RIA acknowledged that it was likely that th e proportion of farmers not triple rinsing was less than the upper bound of the observed range of rinsing behaviors (between 45 percent and 82 percent). The RIA therefore estimated that in the baseline, 50 percent of all containers were ri nsed inadequately or not rinsed at all and should be considered hazardous prior to the labeling and residue remo val requirements. The other 50 percent of containers were therefore rinsed adequately and considered non-haza rdous waste. After promulgation of these requirements, however, the proposed container rule RIA estimated that 20 percent of all containers would remain hazardous ( due to improper rinsing or no rinsing at all).

Transferring these assumptions to the current anal ysis, it is therefore a ssumed that 30 percent of

those containers listed in Table 5.22 that are s ubject to the labeling requirements will be rinsed

### Page 149 properly after promulgation of the rule. However, non-refillable containers that comply with the labeling requirements may still be designed in such a way that inappropriate levels of pesticide

residues remain in the containers even after a triple rinse. Based on the EPA container/formulation residue removal testing study (EPA, 1992c), a tw o percent failure was

found across all container formulations to achieve th e four-9s level. Therefore, an estimated 28 percent of containers listed in Table 4.22 that are subject to the labeling requirements will no longer be hazardous waste when dispos ed of [# of containers * 0.28]. 73



### For example, applying this 28 percen t factor to the number of elig ible 5-gallon plas tic containers used in the agricultural market (58,116) yields 16,272 containers that will no longer be hazardous waste (see Table 5.23). Table 5.23 presents, by c ontainer size and market sector, the number of

non-refillable containers that will be converted from hazardous to non-hazardous waste after the promulgation of the pesticide c ontainer labeling requirements.

73 Based on assumptions made in the proposed container rule RIA (EPA, 1993), we assume that 50 percent of all containers are considered hazardous prior to the labeling requirements. After promulgation of these requirements, however, only 20 percent of all containers will remain hazar dous (due to improper rinsing, no rinsing, etc.). Because these containers only have to comply with the labeling requirements, a number of rigid containers holding dilutable pesticides may be designed in such a way that inappropriate levels of pesticide residues remain in the containers even after a triple rinse. The cost anal ysis assumed that 2 percent of container/formulation combinations for all sizes and all market categories would not pass the residue removal test. That assumption is applied here, subtracting 2 percent from the 30 percent of containers no longer considered hazardous due to the labeling requirements. In other words, 28 percent of containers listed in Table 5.22 that are subject to only the labeling requirements will no longer be hazardous waste when disposed of [# of containers * 0.28].Page 150Table 5.23. Number of Non-Refillable Containers Diverted from the Hazardous Waste Stream to the Non-Hazardous WasteStream After the Promulgationof the Labeling RequirementsContainer Type: Liquid Products Container Type: DryProducts30-55 Gallons 5 Gallons 1 To < 5 Gallons < 1 Gallon JugsPlastic Steel Plastic Steel Plastic Steel Plastic Steel Glass 2.5Gallons1qt-2.5GalNumber of Containers Diverted from the HazardousWaste Stream After Compliancewith Labeling RequirementsaAgriculture86,549 32,339 16,272 8,069 7,805,688 0 281,966 0 0 7,386 636,457I/C/G448,000 649,600 3,933,440 268,800 5,900,160 403,200 5,756,800 44,800 67,200 0 103,600H&G0 0 0 0 0 0 0 0 0 0 0Total534,549 681,939 3,949,712 276,869 13,705,848 403,200 6,038,766 44,800 67,200 7,386 740,057aBased on assumptions made in the proposed container rule RIA (EPA, 1993), we assume that 50 percent of all containers are considered hazardous prior to thelabeling requirements. After promulgation ofthese requirements, however, only 20 percent of all containers will remain hazardous (due to improper rinsing, norinsing, etc.). Because these containers only have to comply with the labeling requirements, a number of rigid containers holding dilutable pesticides may bedesigned in such a way that inappropriate levels of pesticide residues remain in the containers even after a triple rinse. Thecost analysis assumed that 2 percentof container/formulation combinations forall sizes and all market categories would not pass the residue removal test. That assumption is applied here,subtracting 2 percent from the 30 percent ofcontainers no longer considered hazardousdue to the labeling requirements. In other words, 28 percent ofcontainers listed in Table 5.22 that are subject to only the labeling requirements willno longer be hazardous waste when disposed of [# of containers * 0.28].

### Page 151 5.3.1.4 Step 4: Calculate the Benefits Associated with the Diversion of

Non-Refillable Containers from the Hazardous Waste Stream to the

Non-Hazardous Waste Stream



### Recall that this benefit category is based on the difference in co st between the disposal of nonrefillable pesticide contai ners that, before the rules, were di sposed of as hazardous waste, and the disposal of non-refillable pestic ide containers that, after the rules, would be disposed of as nonhazardous waste. Because hazardous waste dispos al is more costly than non-hazardous waste disposal, the benefit is the resulting co st savings per ton of container waste.

Now that the number of non-refillable containe rs converted from hazardous to non-hazardous waste after the promulgation of the labeling requi rements has been estimated (Table 5.23), the

number of containers must be converted to a total weight (in pounds) per container category. By multiplying the total number of containers that are no longer hazardous by each container size’s listed weight in Table 5.21, the total weight of containers no l onger considered hazardous can be estimated. For example, multiplying the tota l number of non-hazardous 5-gallon plastic containers subject to the la beling requirements (3,949,754) by the assumed weight of a representative 5-gallon plasti c container (3 pounds) equals 11,849,137 pounds, or 5,925 tons, of 5-gallon plastic containe rs that can now be disposed of as non-hazardous waste in sanitary landfills (see Table 5.24).

The dollar benefits associated with the dive rsion of waste from h azardous facilities to nonhazardous landfills are based on the difference in pe r ton tipping fees associ ated with each type

of waste treatment. We estimated non-hazar dous (solid) waste tipping fees based on average tipping fees in 13 states. 74 

### The average across states wa s $58/ton (2005$). Hazardous waste tipping fees of $233/ton (2005$) we re taken from the proposed container rule RIA (EPA, 1993) and adjusted for inflation to 2005 dollars. The cost savings achieved by diverting containers

from the hazardous waste stream to the so lid waste stream is therefore $175/ton.

Total non-discounted benefits across all cont ainer sizes equal $5,687, 420 annually (2005$). Benefits begin in the fourth year after promulga tion, allowing for a 3-year compliance period for both the labeling and residue removal requirements. Table 5.24 presents the benefits in terms of tipping fee cost savings for each container type a nd size as well as the total benefits for this direct benefit category.

For the 20-year regulatory period we consider in this analysis, dire ct non-health benefits occur in each year from years 4 to 20. Discounting this stream of annual benefits, summing across years, and annualizing over a 20-year pe riod yields a discounted annua lized benefit of $4,471,929 using a 3 percent discount rate and $3,998, 645 using a 7 percent discount rate.

74 States included: CA, CT, IA, IL, MA, ME, MN, NH, NY, PA, RI, VT, WI. Sources: IA, IL, MI, MN, WI (Lovell, 2001); CA (CA IWMB, 2002); CT, MA, ME, NH, NY, RI, VT (Watson, 2002); PA (PA DEP, 1997).Page 152Table 5.24. Non-Discounted Benefits Associated withthe Diversion of Non-Refillable Containers from theHazardous Waste Stream to the Non-Hazardous Waste Stream (2005$)Container Type: Liquid ProductsContainer Type:Dry Products30-55 Gallons5 Gallons1 To < 5 Gallons< 1 GallonJugsPlasticSteelPlasticSteelPlasticSteelPlasticSteelGlass2.5 Gal1qt-2.5 GalTotal Weight of Containers Diverted from the Hazardous Waste StreamTotal (lbs) 12,294,630 28,982,402 11,849,137 1,661,216 7,401,158 556,416 905,815 22,400 33,600 4,432 1,110,085Total (tons) 6,147 14,491 5,925 831 3,701 278 453 11 17 2 555Tipping Fee Cost Savings (Hazardous Waste Disposal vs. Solid Waste Disposal) of $175/ton (2005$)aTotalb$1,078,731 $2,542,916 $1,039,643 $145,755 $649,378 $48,820 $79,476 $1,965 $2,948 $389 $97,399Total Non-Discounted Benefits (Summed Across Container Type and SizeCategories)$5,687,420aSolid waste tipping fees based on averagetipping fees in 13 states. The averageacross states was $58/ton (2005$). Hazardous waste tipping fees of $233/ton(2005$) were taken from the proposed container rule RIA (EPA, 1993) and adjusted for inflation to 2005 dollars. The cost savings achieved by divertingcontainers from the hazardous waste stream tothe solid waste streamis therefore $175/ton.bTotals may not add due to rounding.

### Page 153 5.3.2 Environmental Effects Avoided Due to Container-Related Pesticide Exposures



### The failure or mishandling of pesticide containe rs and the resulting exposure to pesticides pose significant risks to the environment. Once th e pesticide container ru les are promulgated, however, the risk of such exposures will decrease due to reduced accidental spills, fewer leaks, less dripping, less frequent container stress failure, and proper rinsing prior to container disposal.

The direct non-health benefit that results is th erefore the damage reduction from fewer exposures of terrestrial and aquatic wildlife, including those in sens itive and critical habitats, to pesticides and residues. Unfortunately, a quantitative meas ure of the avoidance of such environmental damages related directly to the pesticide contai ner regulations is very difficult to estimate.

The extent to which pesticide-related environmen tal incidents occur in the United States is not well documented. The primary clearinghouse fo r the reporting of such incidents is the Ecological Incident Information System (EIIS), a database maintained by the Ecological Fate

and Effects Division of the Offi ce of Pesticide Programs at EPA. The two primary sources of incident reports that are submitted to the EIIS are reports filed by pesticide registrants and government agencies. The container rule requires that pesticide regist rants or manufacturers report to EPA any information related to known adve rse environmental effect s due to releases of their registered pesticides. Many of these ecol ogical incidents are prob ably not observed or reported, however.

For example, the California Department of Pestic ide Regulations (CDPR) is thought to be at the forefront of state agencies in terms of pesticid e tracking, management, monitoring, and reporting. However, very few ecological in cidents that occur in Californ ia are logged into the CDPR’s database of priority investigations—the only st atewide database that tracks such events (EPA, 2005). In California, pesticide-re lated releases are initially i nvestigated by county agricultural commissioners. If a particular release is deemed to meet “priority investigation status,” it is referred to the CDPR and logged into the databa se of priority investigations. An annual summary of all priority investiga tions, if any, is then provided to EPA for input into the EIIS. For non-health incidents, the current thresholds for categorizing an environmental incident as a priority investigation in California include:

Animals and Wildlife: Any pesticide incident wi th associated level of mortality that exceeds the following: Non-Target Birds: 50 Non-Target Fish: 500 Listed Endangered or Threatened Species: 1 Domesticated, Game, or Other Non-Target Animals: 5

As one can see from the priority investigation cr iteria, it is likely that many pesticide-related

incidents occur but never warrant priority investigation status. California maintains no records of such incidents, and of the records it does main tain and submit to EPA, only three spill-related environmental incidents were reporte d between 1968 and the present.

The spill/leak-related incidents are singled out in the EIIS since th ey are the incidents most likely to be avoided by the promulgation of the pesticid e container regulations. Within the EIIS, there have been 43 spill/leak-related aquatic and terrest rial environmental incidents reported since its

### Page 154 inception in 1992 (with reports dating back to 1968) . In total, 15 states have submitted spillrelated environmental incident reports with vary ing degrees of severity. Incidents have ranged from an unknown number of sp ecies incapacitated to thousands of acute cases of animal mortality. Species affected in clude minnow, trout, catfish, larg emouth bass, salmon, blue crab, banded water snake, American allig ators, egrets, wood storks, and turkey vultures to name only a few. Of the spill-related incidents, however, the cause of only a handful can be categorized as potentially container-related.

In fact, of the 43 spill-related incidents in the EI IS database that had suffi cient description in the incident report, only five could be considered container relate d. They are summarized as

follows:

• Chlorpyrifos termicide leaked while a technician was repairing a tank. A significant quantity spilled onto the driveway. The technician wash ed the spilled chemical into a storm drain, which ran into a public duck pond resulting in a possible fish kill. The total number of species affected was not reported (EIIS #I001849-001).

• In California, approximately 100,000 carp and tr out were killed as the result of endrin pesticide containers being discarded n ear an artesian well (EIIS #B0000-225-01).

• A 5-gallon can of Hydrothol 191 (endothall) wa s found dripping in a drain near Richvale, California. More than 1,000 fish were killed, mostly carp (EIIS #B0000-231-03).

• A fish kill occurred on a creek in Sangamon County, Illinois, due to a leaking sight valve on a 1,000 gallon tank. The type of pes ticide was not reported (EIIS #I0000659-001).

• A fish kill occurred in a creek in Baton Rouge, Louisiana, due to a leaking 55-gallon drum of 2,4-D and bromacil and a leaking 55-gallon drum of degreaser. Approximately 600 fish were killed along 1.6 miles of the creek (EIIS #I004668-001).

The extent of national pesticide container-related environmental incidents reported in the EIIS is likely to be an underestimate of the actual number of container-related incidents. Therefore, caution should be taken in using EIIS to char acterize the number and si ze of national containerbased pesticide-related incidents that could be avoided once the containe r rules are in place. Though this type of benefit is not quantified in the current analysis , it should be noted that such benefits are likely to exist in associat ion with the pesticide container rule.

5.3.3 Property Damage/Spill Cleanup Costs Avoided



### For the same reasons we are unable to estimate the benefits associated with avoided environmental incidents (a lack of data from whic h to relate container-re lated spills to property damage and the related costs of cleanup), we ar e unable to draw any c onclusions regarding the extent to which the pesticide container rules wi ll prevent property dama ge or reduce the costs associated with unintended, container-related pesticide releases.

Data does exist, however, that tracks hazardous mate rial releases. One primary database is the

Accidental Release Informati on Program (ARIP) database, maintained by the Chemical Emergency Preparedness and Prevention Office (CEPPO) within the Office of Solid Waste and Emergency Response (OSWER), which contains 4,946 incident records from between 1986 and 1999. Most recently, EPA used the ARIP data and findings in support of the development of regulatory guidance for chemical accident pr evention as mandated by the Risk Management

### Page 155 Program Rule (written to implement secti on 112(r) of the amended Clean Air Act). EPA discontinued the ARIP program in 1999 when EP A completed its regulatory guidance effort.

EPA administered the ARIP to le arn about the causes and conseque nces of accidental releases of

hazardous substances from fixed facilities and the actions that have been or could have been effective in preventing them from occurring. EPA used select releases collected in the Emergency Response Notification System database for the ARIP questionna ire, targeting those

accidental releases at fixed fac ilities that resulted in off-s ite consequence or environmental damage. Unfortunately, a search of the database yielded no definitive pesticide container-related

accidental releases.

We queried the database to extr act all potential pesticide-related releases. We limited the search to the following SIC Codes:

2879 Pesticides & Agricultural Chemicals 2869 Industrial Organic Chemicals 2819 Industrial Inorganic Chemicals 2865 Cyclic Organic Crudes & Intermediates

2833 Medicinal Chemicals & Botanical Products 5261 Retail Nurseries & Lawn Supply Stores 5191 Farm Supplies 2491 Wood Preserving 2049 Food Preparations

There were 142 incidents recorded in the ARIP data base associated with these SIC codes. Only 27 of these 142, however, were incidents related to “storage vessels” or “valves” that were caused by “equipment failure” rath er than “operational error.” 75 

### Table 5.25 lists characteristics

of these 27 incidents.

75 The cause of release for 5 of the 27 incidents was not id entified in the ARIP database. We therefore included these incidents in the “equipment failure” category.

### Page 156 Table 5.25. Characteristics of Potential Pe sticide-Related Chemical Spills Recorded

in the ARIP

Spills 6

Vapor Releases 17

Spills and Vapor Releases 4

Total 27

No Environmental Effects Recorded (Field Left Blank) 15

No Environmental Effects (Field Marked None) 9

Environmental Effects (Soil Contamination or Other) 3

Total 27

Injuries Recorded (Facility Employees, Contractors, General Public, and/or Responders) 7

No Injuries (Fields Marked Zero) 20

Total 27

Number of Facilities that Provided Cleanup Cost Information 8

Average Cleanup Cost (2000$) $22,231

Minimum Cleanup Cost (2000$) $1,438

Maximum Cleanup Cost (2000$) $126,432

Primary Product or Service Pestic ides & Chemicals; Organic & Inorganic Chemicals & Pesticides; Agricultural Chemicals; Agricultural Products; Wood Preservation; Nursery Items (Fertilizer, Pesticides & Garden Tools); Medicinal Chemicals and Botanical Products; Manufacturing of Human Health Products, Pesticides, & Agricultura l Chemicals; Industrial Organic Chemicals; Industrial Inorganic Chemicals

Chemicals Released Sulfuric Acid, Nitric Acid, Methyl Chloride, Nitrogen Dioxide, Chlorine, Ammonia, Toluene, Hydrogen Chloride, Carbon Tetrachloride, Phosphoric Acid, Creosote, Ethylene Oxide, Ammonium Hydroxide



### With the level of detail provided by ARIP, it is di fficult to determine if a particular release would or would not be avoided due to the promulgati on of the pesticide cont ainer regulations. We therefore provide the ARIP releases to demonstrate that chemical spills and other unintentional

releases occur and that there is a cost associated with their cleanup. However, we are unable to draw any conclusions regarding the extent to wh ich pesticide registrants and refillers will avoid cleanup costs due to the pesticide container regulations. Furtherm ore, it is impossible to draw any conclusions regarding the representativeness of the facilities surveyed by ARIP compared to the universe of all facilities that experience chemical releases. The criteria for selecting incidents to survey changed over time, and in the last few years of the survey (between 1997 and 1999), the ARIP survey effort scaled back its data coll ection efforts to only nine incidents surveyed per year, due to Paperwork Reduction Act requirements . We therefore cannot extrapolate the ARIP release information to represent a more broad estimate of potential pesticide container-related spills throughout the United States.

### Page 157 5.4 Summary of the Benefits of the Final Standards



### As discussed above, the container design and re sidue removal standard s are largely pollution prevention regulations that will safeguard work ers and the environment by reducing the risk of exposure to concentrated pesticid es. There are numerous types of human health-re lated benefits

and non-human health-related benefits that wi ll stem from such improvements because of relatively fewer expected spills, leaks, and other risks associated with exposure (e.g., handling by workers during disposal, discharges to the e nvironment, and potential public exposures).

The expected benefits resulting from the proposed container design/residue removal regulations include: reduced pesticide-related illnesses and in juries, the cost savings associated with the disposal of rigid non-refillable containers as non-hazardous rather than hazardous waste, and the reduction in the number of accidental pesticide spills . Due to data limitations, we were only able to monetize the benefits associated with the first two benefit categories.

The largest monetary benefit of the container standards is the d ecrease in disposal costs of nonrefillable containers. La rge numbers of non-refillable containers that are currently disposed of in

hazardous waste landfills will now be able to be disposed of in sanitary landfills at a much reduced cost ($175/ton). This savings results in an annualized benef it of $4,471,929 using a 3 percent discount rate and $3,998,645 us ing a 7 percent discount rate.

The new standards will also have a positive effect on human health. It is estimated that 610 to

768 cases of illness will be avoided as a resu lt of the container design and residue removal regulations each year. Assuming a 3 percent discount rate, this results in an annualized benefit of $264,051 (“Low-End” scenario) to $332,311 (“High-E nd” scenario). At a 7 percent discount rate, the health benefits range from $236, 635 to $297,807. If the 51 “possible” cases in California are included, which in creases the percentage of tota l pesticide produc t-related cases potentially avoided by 4.33 percent, the annual health benefits could be at five times this amount.

Therefore, the total monetized benefits of th e container design and residue removal standards range from $4,735,980 to $4,804,240 at a 3 perc ent discount rate and $4,235,280 to $4,296,452

at a 7% discount rate.

The new container design and residual removal st andards will also result in a decrease in the number of accidental pesticide spills that occur each year. This will have two benefits. First, large pesticide spills can have a significant effect on the enviro nment. Second, by reducing the number of pesticide spills, the new standa rds will decrease response and clean up costs associated with these spills. We investigated several data sources to document the cause, environmental effect, and response and clean up costs associated with accident al pesticide spills. Although we were able to document that the ne w standards will likely prevent some future pesticide spills, and that these spills do have negative environmen tal consequences and result in clean-up costs, the data do not allow us to estima te the magnitude of these benefits. Though this type of benefit is not quantified in the current analysis, due to data limitations, these data are proof that such benefits are likely to result from the new standards.

### Page 158 

## References

Agency for Healthcare Research and Quality (AHC PR). 1994. Statistics from the Health Care Utilization Project-3 Nationwide I npatient Sample (NIS) Release http://www.ahcpr.gov

Agricultural Container Recycling Council (A CRC). 2001. Non-Refillable HDPE Container Survey: Totals for All Participating Companies (45).

American Academy of Physical and Medicine an d Rehabilitation (2002), Medicare fee schedule

www.aapmr.org.

American Association of Poison Contro l Centers (AAPCC). 2002 (October). TESS Unintentional Exposures to Insecticides, Herbic ides, Fungicides, Rodenticides, Non-Pine Oil Disinfectants, and Anti-Algae Paints, 2001

.

American Crop Protection Associ ation (ACPA). 1997 (July 16). ACPA Container Number

Tabulation. Provided to EPA at meeting.

Association of American Me dical Colleges (AAMC). 1999 (N ovember 2). “Physician Fee Schedule Updates and Policy Changes for Calendar Year 2000: Final Rule.” http://www.aamc.org/advocacy/library/teachphys/phys0006.htm

.

Bach. 1992 (March 11). Personal co mmunication. Miles Incorporated.

Bartenhagen, Carl. 1992 (August 18, April 7, Fe bruary 19, February 13, and January 28).

Personal communication. Monsanto.

Bureau of Labor Statistics. 2005 (May). C onsumer Price Index – All Urban Consumers. http://data.bls.gov/cgi-bin/surveymost?cu

.

Bureau of Labor Statistics. 2002. Labor Force Statistics from the Current Population Survey. http://stats.bls.gov

.

California Department of Pesticide Regulation (CDPR) Pesticide Illness Surveillance Program (PISP). 2001a (February 15). “Pesticide-Relat ed Illnesses/Injuries Reported by California Physicians, Summarized by Pesticide(s), Type of Illness and Degree of Relationship, 1999.” http://www.cdpr.ca.gov

California Department of Pesticide Regulation (CDPR) Pesticide Illness Surveillance Program (PISP). 2001b (February 15). “Pesticide-Related Illnesses/Injuries Reported by California Physicians, Summarized by Activity and Type of Exposure, 1999.” http://www.cdpr.ca.gov

California Environmental Protection Agency (Cal EPA), Worker Health and Safety Branch. 1998 (September 28). “Pesticide Safety Inform ation Series A: Engi neering Control in Agricultural Setting (Closed Systems, Encl osed Cabs, Water Soluble Packaging).” http://www.cdpr.ca.gov/docs/whs/pdf/hs713.pdf

.

### Page 159 California Integrated Waste Management Board (CA IWMB). 2002. 1995 to 2000 Summaries of Solid Waste Tippi ng Fees Surveys. http://www.ciwmb.ca.gov/la ndfills/tipfees/tfsums.htm

.

Intellimed. www.MyHealthScore.com (formerly www.mecqa.com , the Medical Cost and Quality Assurance Web site). 2002. Physician cost query for “outpatient visit.” October.

Litovitz, T.L., et al., 2002 (September). “2001 Annual Report of the American Association of

Poison Control Centers Toxic E xposure Surveillance System.” American Journal of Emergency

Medicine , 20(5).

Lovell, David L. 2001 (December). Municipal Solid Waste Landfill Tipping Fees, Surcharges and Taxes in WI and Neighboring States. Me morandum to Representative Spencer Black. Wisconsin Legislative Council.

Midwest Agricultural Chemicals Association, Inc. (MACA, now the Mid America CropLife Association). 1992 (July). MACA-75 (Amended) Manufacturer Specification and User Guidelines: For Liquid Pesticides and Othe r Agri-Chemicals not Subject to U.S. DOT Specification Packaging . Sioux City, IA: Midwest Agricult ural Chemicals Association, Inc.

Midwest Agricultural Chemicals Association, Inc. (MACA, now the Mid America CropLife Association). 1986 (December). MACA-75 Manufacturer Specification and User Guidelines: For Liquid Pesticides and Other Agri-Chemi cals not Subject to U.S. DOT Specification Packaging . Sioux City, IA: Midw est Agricultural Chemical s Association, Inc.

Ozkan, H. Erdal. 1991. Personal letter to Ja nice Jensen, Pesticide Management and Disposal Staff, U.S. Environmental Protection Agency. Department of Agricultural Engineering, Ohio State University, Columbus, OH.

Paulson, Don. 2002 (October 15). Personal communication.

Pennsylvania Department of Environmental Protection (PA DEP). 1997. Average Landfill Tipping Fees for Municipal Solid Wa ste in Pennsylvania 1985-1996. http://www.dep.state.pa.us

Research Triangle Institute (R TI). 1994 (June). “Health Ca re Costs and Productivity Losses Averted Due to Superfund: Draft Final Report fo r the US Environmental Protection Agency.”

Research Triangle Institute (RT I). 1989 (September). “Pesti cide Container Design Impact Analysis: Standards for Pesticide Bulk Storage and Transfer.” Research Triangle Park, NC.

Snyder Industries, Inc. 1992 (February 3). F acsimile from Bill Anderson. Lincoln, NE.

Tax Foundation. 2002 (April). “Special Report: America Celebrates Tax Freedom Day.”

### Page 160 Taylor, A.G. Undated (likely 1987 or 1988). An Overview of Pesticide Disposal Issues in Illinois. Prepared for presentation at the Pest icide and Pest Manageme nt Conference, Sheraton International Hotel, Rosemont, IL.

Tolley, G., D. Kenkel, and R. Fabian (eds). 1994. Valuing Health for Policy: An Economic Approach . University of Chicago Press, Chicago.

United Nations Committee of Experts on the Transport of Dangerous Goods. 1999. United Nations Recommendations on the Transport of Dangerous Goods. Eleventh Edition. p. 98.

U.S. Department of Commerce. 2000. Bureau of Census. 2000. Census 2000.

U.S. Department of Commerce. 1997. Bureau of the Census. Economic Census, 1997.

U.S. Department of Transportation (DOT). 1996. “Overview of Hazardous Materials Regulations.” http://hazmat.dot.gov/pubtrain/regs.htm.

U.S. Department of Transportation (DOT). Deadrick, Pam. 1992 (March 16, March 12, and February 22). Personal comm unication. Washington, DC.

U.S. Environmental Protection Agency. 2005 EPA Staff Research on Container and Containment Regulation

.

U.S. Environmental Protection Agency. 2004 “Benef its of the Proposed Inter-State Air Quality Rule,” http://www.epa.gov/inters tateairquality /tsd0175.pdf.

U.S. Environmental Protection Agency (EPA), Office of Pesticide Programs. 2002a (May). Issue Paper: “Antimicrobial Exemption from th e Pesticide Container a nd Containment Rule.”

Internal use document.

U.S. Environmental Protection Agency (EPA), Office of Pesticide Programs. 2002b (August). “Pesticide Industry Sales and Usage: 1998 a nd 1999 Market Estimates .” EPA-733-R-02-001.

U.S. Environmental Protection Agency (EPA), Office of Pesticide Programs. 2002c (August). “Draft Response to Comment Document for the Antimicrobial Exemption.”

U.S. Environmental Protection Agency (EPA). 2000a (October). Economic Profile of the U.S. Pesticide Industry. Revised Draft document submitted to the Office of Pesticide Programs.

U.S. Environmental Protection Agency (EPA). 2000b (September). Guidelines for Preparing Economic Analyses . Chapter 7. EPA 240

- 

### R-00-003.

U.S. Environmental Protection Agency (EPA). 1999 (October). “Standards for Pesticide Containers and Containment; Proposed Rule Supplemental Notice.” Federal Register 64:56917-

56944.

### Page 161 U.S. Environmental Protection Agency (EPA), Of fice of Pesticide Programs. Fitz, Nancy. 1998a (September). “Overview of Packaging/ Stewardship Trends in the United States.” Washington, DC.

U.S. Environmental Protection Agency (EPA ). 1998b (July). “Characterization of Antimicrobial Pesticides.” Washington, DC.

U.S. Environmental Protection Agency (EPA). 1996. “Consumer Labeling Initiative: Notice of Project Initiation.” Federal Register (61:12011).

U.S. Environmental Protection Agency (EPA). 1994. “Standards for Pesticide Containers and

Containment.” Federal Register (59:6712)

U.S. Environmental Protection Agency (EPA), Office of Pesticide Programs. 1993 (September). Regulatory Impact Analysis: Proposed Contai ner Design and Residue Removal Regulations

Under the Federal Insectic ide, Fungicide and Rodenticide Act as Amended, 1988 . Washington,

DC.

U.S. Environmental Protection Agency (EPA), Office of Pesticide Programs, Pesticide Management and Disposal Staff. Fitz, Nancy. 1992a. Facsimile to DPRA Incorporated including information on a 1988 South Dakota Farm Survey.

U.S. Environmental Protection Agency (EPA), Of fice of Pesticide Programs. 1992b. “Container Study: Report to Congress.” EPA 540/09-91 116, May.

U.S. Environmental Protection Agency (EPA), Office of Water. 1992c. “Economic Impact Analysis of Proposed Effluent Limitations Guidelines and Standa rds for the Pesticide Manufacturing Industry.” Washington, DC.

U.S. Environmental Protection Agency (E PA), Office of Pesticide Programs. 1992d (September). “States of the States Report: Pest icide Storage, Disposal and Transportation.”

U.S. Environmental Protection Agency (EPA), Office of Pesticide Programs. 1983. Label Improvement Program–Storage and Disposal Label Statements. PR Notice 83-3.Washington, DC. Cited in EPA (1993) “Regulatory Impact An alysis: Proposed Container Design and Residue Removal Regulations Under the Federal Insec ticide, Fungicide and Rodenticide Act as Amended, 1988.”

Watson, Duncon. 2002. “Comparing the Bottom Line.” http://www.tmclark.com/recycle/bottomline.html

.

### Page 162 

## Appendix A. Compliance Costs for the Pesticide Container Standards

The inputs used to estimate fixed and unit variable compliance costs associated with the pesticide container rule are based upon inform ation taken from four sources:

(3) The Proposed Container Rule Regulato ry Impact Analysis (RIA) (EPA, 1993). 

### The assumptions used in that analysis were based on informal surveys of and consultations with pesticide registrants, refillers, and industry e xperts. The proposed container rule RIA also went through a review and comment period. The cost assumptions from the proposed EPA container rule are used as the primary source of cost information for the current analysis.

(4) An informal survey of registran ts, refillers, and industry experts. 

### Where possible, cost assumptions transferred from the proposed EPA container rule RIA are updated with up-todate information collected from an informal survey of registrants, refillers, and industry

experts.

(5) Public comments. 

### Public comments to the 1994 proposed rule, 1999 Supplemental Notice (EPA, 1999), and 2004 comment period provided in formation and data in support of the assumptions made and data used in the economic analysis.

(6) Best professional judgment. 

### In cases where new information was not available, but a revision of the proposed EPA c ontainer rule assumptions seem ed warranted, we used best professional judgment to estimate certain cost inputs.

The following section describes the source of each cost input and presents, in tabular form, the value of each cost assumption organized by the pa rticular container standard, the size of the establishment, and the establishment’s market sector.

Costs associated with the container standards are characterized in three ways. There are compliance period costs, capital costs, and recurring costs.

• Compliance period costs are asso ciated with actions regulated entities must undertake to come into compliance with a particular regulati on. It is assumed that affected entities will wait until the end of the compliance period to ta ke these actions. The compliance periods for the various regulation categories are:

- Non-refillable c ontainers: 3 years; - Refillable containers: 5 years; - Refilling or repackaging: 5 years; and - Labeling: 5 years.

• Capital costs can be thought of as a one-time purchase of equipment and/or materials related to the compliance of a particular regulation. It is assumed that any capital equipment that must be acquired is purchased at the end of the compliance period.

• Recurring costs are those that re gulated entities will incur on an annual or intermittent basis once the regulations are promulgate d. Therefore, costs start in the first year after the end of the compliance period.

### Page 163 Not all pesticide container standards have costs a ssociated with them. Table A-1 displays each

of the container standards and lists whether there is a cost associat ed with compliance. If a cost is estimated related to the container standards, Ta ble A-1 describes whether that cost is fixed or

variable.

There are two reasons why a partic ular container standard would not have a cost associated with compliance. First, the container regulations state that pesticides that are considered Department of Transportation (DOT) hazardous ma terials must be packaged in containers that meet the DOT standards for hazardous materials. Therefore, any costs that regulat ed entities incur in complying with this standard fo r pesticides that are DOT hazardous materials are attributed to the DOT standards and not the container regulati ons. In other words, we consider the DOT

standards for hazardous material containers to be in the compliance baseline for DOT hazardous materials. Second, it is assumed that there ar e containers available on the market today that comply with many of the regulations listed in Table A-1. This assumption is consistent with the proposed EPA container rule RIA which assumed th at nearly all containers on the market met container closure and dispensing standards, and th at most of the containers in use were DOTcompliant and that nearly all containers in pr oduction were DOT-compliant. These assumptions

were confirmed for the final EPA container rule EA through additional discussions with pesticide registrants, refillers and industry e xperts. Compliance with the DOT-related standards was high for the proposed rule, and, given the in creasing availability a nd use of DOT-compliant containers, the final rule assumes that those cont ainers that were out of compliance have either been replaced or will be replaced with compliant containers within the compliance period at no

extra cost. 76



### For those regulations where costs are associated with compliance, there are two inputs that many of the regulations share: labor rates and an inflat ion factor. First, many of the requirements, such as the administrative requirements (recordk eeping), container inspec tion, and marking of containers, involve labor costs. For this analysis, a base hourly wage of $15.54 is used for administrative labor and $48.22 is used for profe ssional labor. These wages were calculated by averaging the hourly wage for each labor cla ss across the agricultural chemical, industrial organic chemical, and miscellaneous chemical pr oduct industries. Using these average wages, we applied a 25 percent fringe adjustment to the hourly rate a nd a 50 percent overhead adjustment to the wage plus fringe. This resu lts in an hourly rate of $29.13 for administrative labor and $90.42 for professional labor. The indu stry-specific occupational wage estimates are

taken from the Bureau of Labor Statistics’ Occupational Employment Statistics (BLS, 2000).

All costs and cost i nputs presented in th is report are in 2005$.

76 Two DOT non-hazardous materi al packing standards had costs associat ed with them in the proposed EPA container rule RIA (the nonrefillable container marking and refillable container drop test standards). For the nonrefillable container marking requirement, the proposed ru le estimated costs to mark containers with an EPA registration number and other statements. For the refillable container drop test requirement, the proposed rule RIA estimated costs to replace containers that were not in compliance with the drop test standard. The final EPA container rule EA estimates no compliance costs with thes e requirements because it is assumed that nearly all pesticide containers meet the DOT standards.

### Page 164 Table A-1. Compliance Costs Associated with the Container Standards

Container Standard Cost Associated with Compliance? Cost Type/

Reason for No Cost

DOT Packaging Standards -

Hazardous Material No. Costs attributed to the DOT standards, not the container regulation standards.

DOT Packaging Standards –

Non-Hazardous Material No. Containers that meet the

standards are available on the open market at no extra cost.

Closure Standards No. Containers that meet the

standards are available on the open market at no extra cost.

Standards for Container Dispensing Capability No. Containers that meet the

standards are available on the open market at no extra cost.

Residue Removal Standards Yes. Fixed.

Administrative Requirements - Recordkeeping Yes. Fixed.

Standards for Container Marking Yes. Variable.

Standards for Openings Yes. Variable.

Bulk Container Standards Yes. Variable.

Inspection and Cleaning Standards Yes. Variable.

Language Changes Yes. Fixed.



### A.1 Non-Refillable Container Costs

A.1.1 Residue Removal Standard



### The cost of complying with the final standards for the removal of residues from non-refillable

containers is attributed to the cost of ensuri ng that each non-refillable container design type and pesticide formulation combination meets the residue removal standard. The container regulations propose that every regi strant test three containers fr om each rigid container/dilutable

formulation combination to determine that the co ntainers are capable of attaining at least 99.99 percent removal of each active ingredient in the four th rinsate after a triple rinse. In the proposed container rule RIA, EPA estimated that it costs $3,425 to conduc t the residue removal test using three containers, which is transf erred to the current analysis. 77



### In addition to the testing cost, it is necessa ry to know how many ri gid container/dilutable formulation combinations there are per establis hment to calculate the total residue removal compliance cost. It is assumed that the averag e establishment, regardless of size or market sector, uses three rigid containe r types per formulation, based on an assumption EPA made in its proposed container rule RIA. In an informal su rvey of pesticide registrants for the final rule economic analysis (EA), we determined that th is was a reasonable assumption. Of nine responses across small, medium, and large registra nts, four registrants in dicated that on average

77 Values quoted from the proposed container rule RIA have been updated to 2005$ to make them comparable with values in this economic analysis.

### Page 165 they used three containers to package each of their formulations (from a range of 1 to 12 container types per formulation).

To develop the representative number of formulations for large and small registrants, the analysis begins by examining the active registrations for large companies, based on company registration

information from EPA’s Pesticide Product Info rmation System (PPIS) database and Dun & Bradstreet data for determining company si ze. We downloaded the necessary container regulation Section 3 Product Informa tion Files from the PPIS Web site (http://www.epa.gov/opppmsd1/PPISdata/) and then uploaded the files in to a Microsoft Access database. We removed inactive registrations (and corresponding company data) from the database, and as a result, iden tified 1,804 registrants holding 16,407 active registrations (or formulations).

Based on the large pesticide registrant profile (see Appendix D), we matched approximately 4,600 registrations with the 146 large pesticide regi strants identified in the industry profile. As a result, we calculated that each large registra nt had on average 32 active registrations. We distributed the approximately 11,700 remaini ng active registrations (approximately 16,400 - 4,600) among the small registrants using best professional judgment by assigning on averagemore registrations to large-small companies (20) than medium-small companies (9) and smallsmall companies (3). Table A-2 summarizes the estimated number of registrations per company in each size category based on the approach describe d. The table also lists the assumptions made on the number of active registrations per registra nt size category for the proposed rule, which was significantly higher due to less specific data available on the number of active registrations.

Table A-2. Estimated Number of Active Regist rations (Formulations) per Registrant by Size Category: Current Versus Proposed Rule

Size Category Estimated Number of Active Registrations (Formulations) per Registrant Proposed Rule Estimate

of the Number of Active Registrations (Formulations) per Registrant a

Large Registrants 32 b 430

Large-Small Registrants 20 430

Medium-Small Registrants 9 60

Small-Small Registrants 3 16

a Estimates taken from the proposed container rule RIA (EPA, 1993).

b Calculated by dividing the total number of active registrations (4,575) by the estimated number of registrants in each size category (146) and rounding the result up to the nearest integer (31.3 to 32).



### As shown in Table A-3, by multiplying the number of active registrations per registrant by the number of registrants in each size category (see Table D-3) , the total number of active registrations (15,438) and the percen t of active registrations per size category can be calculated.

This number is less than the actual number of active registrations (16,407) due to rounding in the per registrant size category.

### Page 166 Table A-3. Estimated Number of Active Regi strations per Registrant Size Category

Size Category Estimated Number

of Active Registrations per Registrant a Number of Registrants in Size Category b Number of

Active Registrations per

Size Category Percentage of

Active Registrations per

Size Category

Large Registrants 32 146 4,672 30%

Large-Small Registrants 20 166 3,320 22%

Medium-Small Registrants 9 495 4,455 29%

Small-Small Registrants 3 997 2,991 19%

Total c (Registrants or Active Registrations) NA 1,804 15,438 100%

a See Table A-2.

b See Table D-3.

c May not add due to rounding. The estimated 15,438 products are less than the estimated total number of registrations based on EPA data due to rounding in per registrant estimates.



### However, not all active registrati ons are subject to the residue re moval standard. Only products that are subject to the full set of non-refillab le container standards and that are flowable concentrate products in rigid co ntainers are subject to the residue removal standard. The products that are subject to the full set of non-refillable contai ner standards are those products that are not specifically exempt a nd that are: (1) classified in T oxicity Category I or II, and/or (2) are restricted use products (RUPs). Of th e products that meet thes e criteria, only products

that are formulated as flowable concentrates and th at are packaged in rigid containers (i.e., not in bags) are subject to the residue removal standard.

An analysis of total number of products formulated as flowable concentrat es that are Toxicity Category I and II and RUPs provides an estimate of the number of active registrations that are subject to the residue re moval standard. Based on an analys is of EPA product registration data on the number and type of registered produc ts, an estimated 105 (rounded up to 110) active registrations (products) are subjec t to the residue removal standard (Table A-4). The analysis first identified from EPA product registration data the total number of registered Toxicity Category I, II, III, and IV products, restricted use products, and antimic robial products (column one of Table A-4). The analysis then estimated the percentage of these products that are subject

to the residue removal standard (column two of Table A-4) by selecting from the EPA product registration data only those produc ts formulated as flowable concentrates (346) and studying their labels to determine which of these produc ts are Toxicity Category I and II and RUPs. Based on this analysis, an estimated 3 percent of Toxicity Category I, 3 percent of Toxicity Category II, and 6 percent of RUPs in Toxicity Category III/IV are subject to the residue removal standard (Table A-4). None of th e identified flowable concentrate products are antimicrobial products.

### Page 167 Table A-4. Estimated Number of Active Products Subject to the

Residue Removal Standard

Product Category Number of

Products in Category a Percentage of Products Subject to Residue

Removal Standard b Number of Products Subject to Residue

Removal Standard c

Toxicity Category I (non-antimicrobial) 1,434 3% 43

Toxicity Category II (non-antimicrobial) 1,585 3% 48

Restricted Use Product in Toxicity Category III/IV (non-antimicrobial) 225 6% 14

Antimicrobial Products that are subject to

non-refillable container standards d 1,350 0% 0

Total 4,594 NA 105 e

a Based on information from EPA pesticide product databases.

b Information on the percentage of active products subject to the residue removal standard was estimated by identifying all active flowable concentr ate registrations and studying their labe ls to determine which products are Toxicity Category I and II and/or RUPs. This column repr esents the estimated percentage of the registered products that are Toxicity Category I and II and RUP flowable concentrates in rigid containers.

c The number of products subject to the residue removal standard is calculated by multiplying the number of products in each category by the corresponding percentage of the sample subject to the residue removal standard.

d None of the 346 active registered flowable concentrate products are antimicrobial products.

e The number of products subject to the residue removal standard is rounded to 110 products in the analysis.



### Based on this information, Table A-3 can be ame nded to include the esti mated number of active registrations (formulations) subjec t to the residue removal standard per registrant (Table A-5).

This information is calculated by distributing the estimated 110 products subject to the residue removal standard among the four registrant size categories according to the same percentages as in Table A-3, and dividing the resulting value by th e number of registrants in that size category. The result is a significant reduction in the numbe r of active registrations subject to the residue removal standard. For example, for the average large registrant, the estimated number of active registrations subject to the resi due removal standard drops from 32 to 0.23 (rounded up to 0.25) when considering only those produc ts specifically subjec t to the residue rem oval standard. This value suggests that not every large registrant has an existing regist ration that will be subject to the residue removal standard. However, on averag e, across all registrants, each registrant has one-quarter of an existing regi stration subject to the residue removal standard. Table A-6 provides a comparison of the di fferent estimates of the number of active registrations, considering all active registrations (column th ree of Table A-6), and considering only active registrations subject to th e residue removal standard (column two of Table A-6).

### Page 168 Table A-5. Estimated Number of Active Products Subject to the Residue Removal Standard by Registrant Size Category

Size Category Percentage of

Active Registrations per

Size Category a Number of Active Registrations Subject

to Residue Removal

Standard per Size Category b Number of Registrants in Size Category c Number of Active Registrations Subject to Residue

Removal Standard per Average Registrant d

Large Registrants 30% 33 146 0.23

Large-Small Registrants 22% 24 166 0.14

Medium-Small Registrants 29% 32 495 0.06

Small-Small Registrants 19% 21 997 0.02

Total (Registrants or Active Registrations) NA 110 1,804 NA

a See Table A-3.

b Equal to the percent of active registration per size category times the total number of active registrations (110). This analysis assumes that the number of active registrations subject to the residue removal standard is distributed by registrant size category in the same proportion as all active registrations.

c See Table D-3.

d Equal to the number of active registration subject to the residue removal standard divided by the number of registrants in each size category.



### Table A-6. Comparison of the Estimated Numb er of Active Registrations (Formulations) per Average Registrant by Size Category

Size Category Estimated Number of Active Registrations (Formulations) Subject to the Residue

Removal Standard

per Registrant a Estimated Number of Active Registrations (Formulations) per Registrant c

Large Registrants 0.25 32

Large-Small Registrants 0.20 20

Medium-Small Registrants 0.10 9

Small-Small Registrants 0.05 3

Total Registrants NA NA



### The proposed container rule RIA assumed that the number of new formulations per registrant per year that require testing was two for all entity sizes except small-small registrants, for which the RIA assumed one new formulation that requires testing each year. No new data are available with which to update the assumption about the number of new products per year. However, since there are so few existing registrations that are subject to the residue removal standard, this assumption must be adjusted to reflect the chan ges in the scope of the requirements from the proposed to the final rule. In the absence of data, the final ru le EA makes the assumption that the number of new formulations subject to the resi due removal standard per registrant per year is the same as the number of existing formulations subject to the residu e removal standard per registrant. That is, for the final rule, it is assumed that there are 0.25 new formulations per registrant per year that require testing (or one every 4 years) for the la rge registrants; 0.20 new formulations per registrant per ye ar that require testing (or one every 5 years) for the large-small

### Page 169 registrants; 0.10 new form ulations per registrant per year th at require testing (or one every 10 years) for medium-small registrants; and 0.05 ne w formulations per regi strant per year that require testing (or one every 20 years) for the small-small registrants (Table A-7).

Table A-7. Non-Refillable Container Re sidue Removal Compliance Cost Inputs and Assumptions

Establishment Type Testing

Cost (2005$) a Container Types per

Formulation a Existing

Formulations b New

Formulations b Percent

Retested c “Me-Too”

Scenario d

Large-Small Establishments Agriculture $3,425 3 0.2 0.2 30% 75%
I/C/G $3,425 3 0.2 0.2 30% 75%
Home & Garden $3,425 3 0.2 0.2 30% 75%

Medium-Small Establishments Agriculture $3,425 3 0.1 0.1 30% 75%
I/C/G $3,425 3 0.1 0.1 30% 75%
Home & Garden $3,425 3 0.1 0.1 30% 75%

Small-Small Establishments Agriculture $3,425 3 0.05 0.05 30% 75%
I/C/G $3,425 3 0.05 0.05 30% 75%
Home & Garden $3,425 3 0.05 0.05 30% 75%
Large Establishments Agriculture $3,425 3 0.25 0.25 30% 75%
I/C/G $3,425 3 0.25 0.25 30% 75%
Home & Garden $3,425 3 0.25 0.25 30% 75%

a Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993: pg. IX-13). Costs were updated to 2005 dollars, and other assumptions were revised based on new data and discussions with industry experts.

b Revised number of existing formulations per establishm ent based on analysis of the PPIS active registration

database. The same value is estimated for new formulations.

c The percent retested is based on residue removal testing studies of different container/formulation combinations. The retesting value is equal to the difference between the number of flowable concentrate container/formulation types failing the four-9s and five-9s standard.

d The “Me-Too” Scenario refers to the percentage of fo rmulations that will be tested—i.e., 25 percent of the container/formulation combinations are assumed not to be tested as a result of using test data from different container/formulation combinations that passed the protocol to demonstrate that these container/formulation combinations pass as well.



### Not all container/formulation combinations subject to the residue removal standard will be tested, however. In the proposed container rule RIA, EPA made this assumption because test data conforming to the residue removal protocol on a differe nt non-refillable container/formulation combination may be used to demonstrate that a non-refillable container

meets the residue removal standard. This is refe rred to as the “me-too” scenario. Because EPA did not know the extent to which “me-toos” applie d, they assumed a lower range of 50 percent of

all container/formulation combinations will be tested and an upper rang e of 100 percent of all such combinations will be tested. For this analys is, the midpoint of the range, 75 percent, is used since the extent to which “me-toos” will apply is not known.

### Page 170 It is also assumed that a certain number of container/formulation co mbinations will fail the initial residue removal test, requiring a second test using a container car efully selected from the open market and expected to rinse more readily. Based on a study conducted for EPA, EPA assumed in the proposed container rule RIA that 13 perc ent of small, medium, and large agricultural containers and 3 percent of small and medium industrial/commercial/government containers would not pass a triple-rinse test where 99.999 per cent (five-9s standard) of a given formulation

would be removed after rinsi ng (EPA, 1992b). The proposed rule requires containers to pass only a four-9s standard (99.99 percent removed afte r rinsing). The preamble to the final rule

summarizes the residue removal data from tests conducted using a standard testing procedure to test currently used formulations and container designs. The data s how that all 26 of the flowable

concentrate container formulations tested met the four-9s standard. However, 7 of the 26

container/formulation combinations tested (or 27 percent) failed to meet the five-9s standard. Because of the relatively large difference between the number of tests that meet the four-9s and the five-9s standards, we assume the differe nce (30 percent, rounded up from the 27 percent failure rate in the study) as the failure rate in th e EA. In other words, the EA for the final rule assumes a 30 percent retesting rate due to failure in the first test for all registrant company sizes and market segments. It is assumed that all c ontainer/formulation combinations pass the retest.

Table A-7 displays the unit cost inputs and associated assumptions that comprise the residue removal standard compliance costs in this analysis. Table A-8 presents the compliance and

annual costs associated with the residue removal st andard. The costs associated with the testing of existing container/formulation combinations are considered to be compliance period costs

incurred at the end of the th ird year (at the end of the co mpliance period for non-refillable containers), and the annual tes ting of new container/formulation combinations are annual costs incurred in each year af ter the end of the complian ce period (years 4 through 20).

To demonstrate how costs in Table A-8 are calcu lated from the information in Table A-7, the cost inputs associated with large-small agricultura l establishments are used. Initial testing costs of the existing formulations, and incurred in th e compliance period, are calculated by multiplying the number of container types per formulation (3) by the number of existing formulations (0.2). Multiplying the number of existing formulation/cont ainer combinations (0.6) by the testing cost ($3,425), and adjusting that re sult by the “me-too” adjustme nt factor (75 percent of

container/formulation combinations tested), yields an initial testi ng cost of $1,541. The retesting cost for existing container/formulation comb inations are calculated by multiplying those combinations (0.6) by the percent retested factor (30 percent). This result (0.18) is then multiplied by the testing cost ($3,425). The resulting retest cost incurred by large-small agricultural establishmen ts in the compliance period is $617. The same calculations apply for the initial testing and retesting costs for new c ontainer/formulation combinations (annual costs).

### Page 171 Table A-8. Non-Refillable Container Re sidue Removal Compliance Costs (2005$)

Establishment Type Initial Test Cost - Existing (Compliance) a Initial Test

Const - New (Annual) a Re-test Cost - Existing (Compliance) b Re-test Cost -

New (Annual) b

Large-Small Establishments Agriculture $1,541 $1,541 $617 $617
I/C/G $1,541 $1,541 $617 $617
Home & Garden $1,541 $1,541 $617 $617

Medium-Small Establishments Agriculture $771 $771 $308 $308

I/C/G $771 $771 $308 $308

Home & Garden $771 $771 $308 $308

Small-Small Establishments Agriculture $385 $385 $154 $154

I/C/G $385 $385 $154 $154

Home & Garden $385 $385 $154 $154

Large Establishments Agriculture $1,927 $1,927 $771 $771
I/C/G $1,927 $1,927 $771 $771

Home & Garden $1,927 $1,927 $771 $771

a Initial test costs are calculated as follows: (Testing Cost) * (# Containers/Formulation) * (# of Formulations [Existing or New]) * (% “Me-Toos”).

b Retest costs are calculated as follows: (Testing Cost) * (# Containers/Formulation) * (# of Formulations [Existing or New]) * (% Retested).



### A.1.2 Administrative Requi rements - Recordkeeping



### For each pesticide product that a registrant handles , the container standards require the registrant to generate and maintain a numbe r of records (listed in §165.86 of the container regulations) for as long as a particular non-refi llable container design type is used to di stribute or sell the pesticide product and for 3 years thereafter. Therefore, the costs a ssociated with this recordkeeping are attributed to the administrative labor costs and the capital cost of acquiring a

file cabinet to store the record s. File cabinet costs are base d on the average price of a fourdrawer legal file cabinet surveyed across a num ber of office supply stor es ($229.65). The labor time assumptions are based on estimates used by EP A in the proposed container rule RIA. Since no new data are available to update these recordkeeping labor time estimates, they are left in place. It is assumed that these data are reas onable, however, based on th e anticipated amount of recordkeeping required by th e container regulations.

Table A-9 displays the cost inputs and assumptions that comprise the labor-related recordkeeping costs. Hours represent the total amount of time it takes to fulfill the recordkeeping requirements. For existing container/formulati on combinations, the labor time is spent at the end of the compliance period (3 years for non-refillable container requirements). For new container/formulation combinations, the labor ti me is spent in each year (years 4 through 20) after the end of the compliance period. Note that the labor time assumptions change between establishment size categories, since the number of formulations handled by each establishment depends on the size of that establishment (see Table A-6 for the number of formulations by establishment type). The more container/fo rmulation combinations, the longer it takes to

### Page 172 complete the recordkeeping requirements. It is also assumed that administrative personnel will fill out the required paperwork. Therefore, the ad ministrative cost of labor is applied in this analysis.

Table A-10 presents the capital, compliance, and annual costs for the residue removal standard. The cost associated with the acqui sition of a file cabinet ($229.65) is considered a capital cost

that establishments incur at the end of th e 3-year compliance period for the non-refillable container regulations. Generati ng the paperwork necessary for existing container/formulation combinations is a compliance period cost also incurred at the end of the 3-year compliance period. The annual generation and maintenance of paperwork for new container/formulation

combinations is an annual cost that establishm ents incur each year be tween years 4 through 20.

To demonstrate how recordkeeping costs in Tabl e A-10 are calculated from the information in Table A-9, the cost inputs associated with la rge-small agricultural establishments are used. Multiplying the administrative cost of labor ($29. 13) by the number of hours assumed that it will take a large-small agricultural establishment to fulfill its recordkeeping requirements for existing

container/formulation combinati ons (40 hours), the compliance peri od cost for the non-refillable container requirements is estimated to be $1,165. 23 for large-small agricultural establishments. Using the same procedure to calculate recor dkeeping costs for new container/formulation combinations, the administrative cost of labor ($29.13) is multiplied by the recordkeeping labor

time for new container/formulation combinations (4 hours). It is estimated to cost large-small agricultural establishments $116.52 annually to fulfill the recordkeeping requirements for new

container/formulation combinations.

### Page 173 Table A-9. Non-Refillable Container Recordkeeping Cost Inputs and Assumptions

Establishment Type Recordkeeping Labor

Time for all

Cont./Form. Combs. - Existing (hours) a Recordkeeping Labor

Time for all

Cont./Form. Combs. - New (hours) a Labor Cost/Hour - Administrative (2005$) b

Large-Small Establishments

Agriculture 40 c 4 $29.13

I/C/G 40 4 $29.13

Home & Garden 40 4 $29.13

Medium-Small Establishments
Agriculture 36 3 $29.13

I/C/G 36 3 $29.13

Home & Garden 36 3 $29.13

Small-Small Establishments
Agriculture 24 2 $29.13

I/C/G 24 2 $29.13

Home & Garden 24 2 $29.13

Large Establishments
Agriculture 40 4 $29.13

I/C/G 40 4 $29.13

Home & Garden 40 4 $29.13

a Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pg. IX-13).

b The occupational wage estimates are taken from the Bureau of Labor Statistics’ Occupational Employment statistics available on the BLS Web site, http://www.bls.gov/o es/2000, and updated
from 2002$.

c Hours represent the time it takes to generate and maintain the records associated with the nonrefillable container recordkeeping regulations in §165.86 of the FIFRA container regulations.

### Page 174 Table A-10. Non-Refillable Co ntainer Recordkeeping Costs

Establishment Type File Cabinet Cost (Capital) a Recordkeeping Cost - Existing (Compliance) b Recordkeeping Cost - New (Annual) b

Large-Small Establishments

Agricultural $229.65 $1,165.23 $116.52

I/C/G $229.65 $1,165.23 $116.52

Home & Garden $229.65 $1,165.23 $116.52

Medium-Small Establishments

Agricultural $229.65 $1,048.71 $87.39

I/C/G $229.65 $1,048.71 $87.39

Home & Garden $229.65 $1,048.71 $87.39

Small-Small Establishments

Agricultural $229.65 $699.14 $58.26

I/C/G $229.65 $699.14 $58.26

Home & Garden $229.65 $699.14 $58.26

Large Establishments

Agricultural $229.65 $1,165.23 $116.52

I/C/G $229.65 $1,165.23 $116.52

Home & Garden $229.65 $1,165.23 $116.52

a File cabinet costs are based on the average price of a fo ur-drawer legal file cabinet surveyed across a number of office supply stores.

b Recordkeeping costs (compliance peri od or annual) are calculated as fo llows: Labor Time * Labor Cost. (See Table A-9.)



### A.2 Refillable Container Costs

A.2.1 Administrative Requirements



### If a registrant distributes or sells a pesticide product in refillable c ontainers (either directly or to a refiller for repackaging), the regulations require that the registrant create certain documents and

maintain a number of records. These docum ents include, for each pesticide product, a description of acceptable containers and a writ ten residue removal pr ocedure. (See §§165.164 and 165.190.) The registrant must maintain copi es of the documents for the current operating year and 3 years after. (See §§165.176(a) and 165.194. ) The registrant must also provide copies of the documents to independent refillers (§165. 192). If the product will be repackaged by an independent refiller, the registrant must enter into a contract with the refiller and keep a copy of the contract (§§165.182 and 165.194). This kind of arrangement is currently standard operating practice because it is specified in EPA’s Bulk Pe sticide Enforcement policy. Therefore, the costs associated with the contract are not included as pa rt of this economic analysis. It is worth noting that the administrative requirement s are actually located in the repackaging regulations, but are included in the refillable container part of the cost analysis because they are borne by refillers.

The costs associated with the administrative requ irements are attributed to administrative labor costs and the capital cost of acquiring a file cabinet to store the record. 78 

### File cabinet costs are

78 This file cabinet is separate from the one used to store records associated with the non-refillable container requirements.

### Page 175 based on the average price of a four-drawer legal file cabinet surveyed across a number of office supply stores ($229.65). The labor time assumptions are based on estimates used by EPA in the proposed container rule RIA. Since no new data are available to update these recordkeeping labor time estimates, these values are left in place.

Table A-11 displays the cost inputs and a ssumptions that comprise the labor-related administrative costs. Hours represent the tota l amount of time it takes to fulfill the refillable container administrative requirements. For ex isting container/formulation combinations, the labor time is spent at the end of the complian ce period (5 years for re fillable container and repackaging requirements). For ne w container/formulation combinations, the labor time is spent in each year (years 6 through 20) af ter the end of the compliance peri od. Note that the labor time assumptions change between establishment size categories, since the number of formulations handled by each establishment depends on the size of that establishment (see Table A-6 for the number of formulations by establishment type). The more refillable container/formulation combinations, the longer it takes to complete th e administrative requirement s. Since no new data are available to refute or validate these assumptions, th ey are left in place. It is also assumed that administrative personnel will fill out the required paperwork. The administrative cost of labor is, therefore, applied in this analysis.

Table A-12 presents the capital, compliance, and annual costs for the residue removal standard. We consider the cost associated with the acquisiti on of a file cabinet ($229 .65) a capital cost that establishments incur at the end of the five-year refillable container regulations compliance period. Generating the documents necessary for existing refillable container/formulation combinations is a compliance period cost also incurred at the end of the five-year compliance period. The annual generation and maintenance of paperwork is annual cost establishments incur each year between years six through 20.

To demonstrate how administrative costs in Tabl e A-12 are calculated from the information in Table A-11, the cost inputs associated with la rge-small agricultural establishments are used. Multiplying the cost of administrative labor ($29.13) by the number of hours it is assumed that it will take a large-small agricultural establishment to: (1) develop a description of acceptable

refillable containers fo r use with each formulation (4 hours) , and (2) revise or generate the written residue removal procedures for existing re fillable containers (24 hours), it is estimated that the compliance period cost for the refillab le container recordkeeping requirements will be $815.66 for large-small agricultura l establishments. Using the same procedure to calculate recordkeeping costs for new refillable container/formulation combinations, the administrative cost of labor ($29.13) is multiplied by the e quivalent recordkeeping labor time categories for

new container/formulation combina tions (1 hour + 2.4 hours). It is estimated that it costs largesmall agricultural establishments $99.04 annually to fulfill the recordkeeping requirements for

new refillable container/formulation combinations.

### Page 176 Table A-11. Refillable Co ntainer Administrative Cost Inputs and Assumptions

Administrative Labor Time (hours)

Establishment Type List of Acceptable

Containers -

Existing a List of Acceptable

Containers -

New a Written Res.

Rem. Procedure - Existing a Written Res.

Rem.

Procedure -

New a Labor Cost/hr –

Administrative b

Large-Small Establishments

Agricultural 4 1 24 2.4 $29.13

I/C/G 4 1 24 2.4 $29.13

Home & Garden 4 1 24 2.4 $29.13

Medium-Small Establishments

Agricultural 3 0.5 16 1.5 $29.13

I/C/G 3 0.5 16 1.5 $29.13

Home & Garden 3 0.5 16 1.5 $29.13

Small-Small Establishments

Agricultural 2 0.5 8 1 $29.13

I/C/G 2 0.5 8 1 $29.13

Home & Garden 2 0.5 8 1 $29.13

Large Establishments

Agricultural 4 1 24 2.4 $29.13

I/C/G 4 1 24 2.4 $29.13

Home & Garden 4 1 24 2.4 $29.13

a Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pg. IX-13).

b The occupational wage estimates are taken from the Bureau of Labor Statistics’ Occupational Employment statistics (BLS, 2000).

### Page 177 Table A-12. Refillable Contain er Administrative Costs (2005$)

Establishment Type File Cabinet Cost (Capital) a Recordkeeping Cost - Existing (Compliance) b Recordkeeping Cost - New (Annual) b

Large-Small Establishments

Agricultural $229.65 $815.66 $99.04

I/C/G $229.65 $815.66 $99.04

Home & Garden $229.65 $815.66 $99.04

Medium-Small Establishments

Agricultural $229.65 $553.48 $58.26

I/C/G $229.65 $553.48 $58.26

Home & Garden $229.65 $553.48 $58.26

Small-Small Establishments

Agricultural $229.65 $291.31 $43.70

I/C/G $229.65 $291.31 $43.70

Home & Garden $229.65 $291.31 $43.70

Large Establishments

Agricultural $229.65 $815.66 $99.04

I/C/G $229.65 $815.66 $99.04

Home & Garden $229.65 $815.66 $99.04

a File cabinet costs are based on the average price of a fo ur-drawer legal file cabinet surveyed across a number of office supply stores.

b Recordkeeping costs (compliance peri od or annual) are calculated as fo llows: Labor Time (Design Standard Documentation + List of Acceptable Containers + Written Residue Removal Procedure) * Labor Cost.



### A.2.2 Standard for Container Marking



### Section 165.116 of the container regulations states that each refillable container must be durably marked with a serial number or other identifyi ng code that will distinguish the individual

container from all other containers . It is assumed that ink is th e preferred method of applying the serial number and that all registrants already have the equipment (for example, stencils or printers) to apply the ink. Th is assumption is based on information presented in EPA’s proposed container rule RIA. The RIA quoted a source (Bach, 1992) who stated that producers/formulators who package pesticides in refillable drums or barrels are already stenciling information on their containers before shipping and most, if not all, have stenciling equipment. It is assumed that this is still the case; most ref illable containers in the current analysis are drum or barrel sized and larger. The container ma rking costs in this analysis, therefore, are the cost of acquiring the ink, the labor time it takes to apply the serial number to the container, and the number of containers that the serial number must be applied to. Because there is no new information to replace the assump tions used in the proposed container rule RIA, with the exception of the hourly wage of labor, al l of the cost inputs and assumptions associated with this cost category are taken fr om the proposed container rule RIA.

EPA’s contacts with industry e xperts and equipment and/or suppl y vendors determined that the cost of a gallon of ink was $34.25; one gallon of ink could mark 70, 000 containers; it takes

### Page 178 approximately five minutes to add a serial number to each refillable container; and that a plastic refillable container lasts 5 years while a st eel refillable container lasts 15 years. These assumptions are used to determine the two type s of costs associated with the marking of

refillable containers: the cost a ssociated with marking existing ref illable containers and, because refillable containers wear out, th e cost of marking new containers that will need a serial number application over the course of the container regulations.

The costs associated with marking existing refi llable containers are considered a compliance period cost, incurred by establishments at th e end of the 5-year compliance period for the refillable container regu lations. Though all plastic refillable containers, and one-third of steel refillable containers, will w ear out and need replacement duri ng the compliance period, it is assumed that the total inventory of refillable containers subject to the container marking regulations will not change by the end of the compliance period. By the end of the compliance period, therefore, all refillable containers will be subject to th e container marking regulations and will need a serial number application. Though the marking of these existing containers will be phased in over the course of the 5-year complia nce period, for consistency with other compliance period costs in the analysis, it is assumed that es tablishments incur the cost of marking existing

refillable containers at the end of the compliance period in year 5.

The cost of marking new containers that will repl ace existing containers as they wear out after the compliance period are considered annual costs that establishments will incur yearly (in years 6 through 20). However, because only one-fifth of plastic containers and one-fifteenth of steel containers will require replacement each year, th e annual unit marking costs are adjusted by the

same factors.

Table A-13 displays the cost i nputs and assumptions that comp rise the container marking unit costs. Table A-14 presents the compliance peri od and annual costs associated with marking

individual containers. To demonstrate how cont ainer marking costs in Table A-14 are calculated from the information in Table A-13, the cost inputs associated with large-small agricultural

establishments are used. The unit cost associated with the ink needed to mark each container is calculated by dividing the cost of a gallon of ink ($34.25) by th e number of containers it is estimated to mark (70,000), re sulting in a cost of $0.00049 per container. The labor cost associated with the physical act of marking the c ontainers is calculated by multiplying the time it takes to mark the container (five minutes, or 8.33 percent of an hour) by th e administrative rate of labor ($29.13/hour), which equals $2.43 per cont ainer. The full ink and labor unit costs are applied to the containers subjec t to marking at the end of the compliance period, one-fifth of these unit costs are applied to the annual cost of marking plastic refillab le containers, and onefifteenth of these unit costs are applied to the an nual cost of marking steel refillable containers. The annual cost per entity range from $1 for smal l-small agricultural establishments to $3,807 for large agricultural establishments (see Table A-14).

### Page 179 Table A-13. Refillable Container Mark ing Cost Inputs and Assumptions (2005$)

Establishment Type Ink ($/gal.) a # Containers Marked/gal. a Stencil

Time/

Container

(hour) a Labor Cost/hr -

Administrative b Refillable

Container Lifespan -

Plastic a Refillable

Container Lifespan -

Steel a

Large-Small Establishments

Agricultural $34.25 70,000 0.0833 $29.13 5 15

I/C/G c $34.25 70,000 0.0833 $29.13 5 15

Home & Garden $34.25 70,000 0.0833 $29.13 5 15

Medium-Small Establishments

Agricultural $34.25 70,000 0.0833 $29.13 5 15

I/C/G c $34.25 70,000 0.0833 $29.13 5 15

Home & Garden $34.25 70,000 0.0833 $29.13 5 15

Small-Small Establishments

Agricultural $34.25 70,000 0.0833 $29.13 5 15

I/C/G c $34.25 70,000 0.0833 $29.13 5 15

Home & Garden $34.25 70,000 0.0833 $29.13 5 15

Large Establishments

Agricultural $34.25 70,000 0.0833 $29.13 5 15

I/C/G c $34.25 70,000 0.0833 $29.13 5 15

Home & Garden $34.25 70,000 0.0833 $29.13 5 15

a Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pg. IX-13).

b The occupational wage estimates are taken from the Bureau of Labor Statistics’ Occupational Employment statistics (BLS, 2000).

c Container marking is not required for refillable containe rs used for antimicrobials used in the swimming pool market, such as sodium hypochlorite. This adjustment is ma de to the number of refillable containers subject to the container marking regulations presented in the compliance profile and explained in Chapter 3 by considering the containers of swimming pool antimicrobials separately.

### Page 180 Table A-14. Refillable Cont ainer Marking Costs (2005$)

Establishment Type Unit Stencil

Labor Cost -

Plastic (Compliance/

Annual) a Unit Stencil

Labor Cost -

Steel (Compliance/

Annual) a Unit Ink Cost -

Plastic (Compliance/

Annual) b Unit Ink

Cost – Steel (Compliance

/ Annual) b Annual Cost per Entity d

Large-Small Establishments

Agricultural $2.43 $2.43 $0.00049 $0.00049 $27

I/C/G c $2.43 $2.43 $0.00049 $0.00049 $3

Home & Garden $2.43 $2.43 $0.00049 $0.00049 $0

Medium-Small Establishments

Agricultural $2.43 $2.43 $0.00049 $0.00049 $5

I/C/G c $2.43 $2.43 $0.00049 $0.00049 $0

Home & Garden $2.43 $2.43 $0.00049 $0.00049 $0

Small-Small Establishments

Agricultural $2.43 $2.43 $0.00049 $0.00049 $1

I/C/G c $2.43 $2.43 $0.00049 $0.00049 $0

Home & Garden $2.43 $2.43 $0.00049 $0.00049 $0

Large Establishments

Agricultural $2.43 $2.43 $0.00049 $0.00049 $3,807

I/C/G c $2.43 $2.43 $0.00049 $0.00049 $356

Home & Garden $2.43 $2.43 $0.00049 $0.00049 $0

a Unit labor costs (compliance period costs) associated w ith refillable container markings are calculated as follows:

Labor Time to Mark Each Container * Labor Cost. To calculate the annual labor cost of marking refillable containers, we adjust the compliance period unit cost by a factor to account for the life span of each container:

Labor Time to Mark Each Container * Labor Cost b Unit ink costs (compliance peri od costs) associated with refillable container markings are calculated as follows: Ink Cost per Gallon ÷ # of Containers Marked per Gallon. To calculate the annual ink cost of marking refillable containers, we adjust the compliance period unit cost by a factor to account for the life span of each container: (Ink Cost per Gallon ÷ # of Containers Marked per Gallon)

c Container marking is not required for refillable containe rs used for certain antimicrobials, including refillable containers filled with sodium hypochlorite, a common anti microbial used in the swimming pool industry. This adjustment is made to the number of refillable containers subject to the container marking regulations presented in the compliance profile and explained in Chapter 3.

d Average annual container marking compliance cost per firm. Annual cost is calculated by calculating the sum of the present discounted value of costs incurred from years 5 to 20, and then annualizing it using a 3 percent discount rate. The details of the calculations are presented in Chapter 4 in sections 4.5.6 through 4.5.8.

### Page 181 A.2.3 Standards for Openings



### The container regulations limit access to the inte rior of liquid minibulk containers by requiring that each opening of a liquid minibulk containe r other than a vent have a one-way valve, a tamper-evident device, or both. EPA believes th at one-way valves and tamper-evident devices will give repackagers reasonable assurance of the previous contents of the containers. Most agricultural minibulks and small volume returnable containers supplied by or purchased from registrants are equipped with either a one-way valve or a ta mper-evident device (EPA, 1992b) and are therefore expected to be in compliance in the baseline. Agricultural minibulks obtained on the open market, rather than from registrants, usually lack tamper-evide nt devices or one-way valves, so refillers must add them (or something similar). The standards for openings are not applicable to bulk tanks.

The compliance rate for the standards for the openings for affected refillables is based on assumptions that EPA made for the proposed container rule RIA (EPA, 1993) 79 

### . It is assumed that 65 percent minibulk containers are compliant in the agricultural market and 10 percent are compliant compliance for minibulk containers in the I/C/G market (assumes that tote bins are minibulks, but small volume returnables in the I/C/G market are not minibulks).

Because the compliance period for this regulation is 5 years, many refillable containers will reach the end of their life span by the time the ru le is implemented. It is assumed that these containers will be replaced by compliant containers that are available on the open market at no extra cost. Using the same refillable life span assumption that was used to estimate container marking costs, it is assumed that plastic refillab le containers must be replaced every 5 years and steel refillable containers every 15 years. As a result, no plastic refillable containers will incur the cost of modifying their container openings for the express purpose of complying with the regulation. Further, assuming that containers, which meet C ontainer Rule standards, are available on the market for no extra cost, ther e will be no compliance co sts associated with plastic containers.

Only one-third of existing steel refillable containers, however, will be replaced during the compliance period (5-year compliance period divide d by the 15-year life span). To come into compliance with the regulation, two-thirds of exis ting steel refillable containers will need to add tamper-evident devices. It is assumed that all of these containers will require the tamper-evident

modification. EPA estimated that the cost of su ch a modification, includ ing labor and materials, was $109.60. Establishments incur this cost at the end of the 5-year compliance period for the

refillable containe r regulations.

Table A-15 presents the cost inputs and assump tions used to calculate the costs for this regulation. Table A-16 presents the one-time unit variable compliance cost of this regulation. To demonstrate how opening standard unit cost s in Table A-16 are calculated from the information in Table A-15, the cost inputs associated with large-small agricultural establishments

are used. There are no unit costs associated with the opening standards for plastic refillable containers because 100 percent of plastic refill able containers will be replaced by compliant

79 Refer to the Proposed Container Rule RIA (EPA, 1993) Tables VII-8 and VII-9 and the table footnotes for information to substantiate the assumptions used in this analysis.

### Page 182 containers during the complian ce period (5-year compliance period/5-year plastic refillable lifespan = 100% plastic refillable compliance). There are unit costs associated with the opening standards for steel refillable containers, however. Only 33 percent of steel refillable containers will be replaced with compliant containers during the compliance period (5-year compliance period/15-year steel refillable lifespan = 33.33% steel refillable compliance). The unit cost of complying with the container opening standard fo r steel refillables is therefore calculated by multiplying the modification costs for existing containers ($109.60) by the percentage of steel refillable containers not in compliance with the opening standard (1 - 33.33% = 66.67%). The resultant unit cost is $73.07. To compute th e cost of the opening st andard to the average pesticide refiller in each size category and mark et sector, the average cost per steel container ($73.07) is multiplied by the numbe r of steel containers the averag e refiller is assumed to havefor each market sector and size category. The average cost per entity ranges from $1 for smallsmall agricultural establishments to $4,084 for larg e agricultural establishm ents. The details of the calculations are presented in Chap ter 4, sections 4.5.6 through 4.5.8.

### Page 183 Table A-15. Cost Inputs and Assumptions fo r Refillable Container Openings (2005$)

Establishment Type Compliance Period (yrs) Refillable

Container Lifespan -

Plastic a Refillable

Container Lifespan -

Steel a % of

Containers Not Replaced During Compliance

Period -

Plastic b % of

Containers Not Replaced During Compliance

Period

- Steel b Modification

Costs for Existing

Containers a

Large-Small Establishments

Agricultural 5 5 15 0% 67% $109.60

I/C/G c 5 5 15 0% 67% $109.60

Home & Garden 5 5 15 0% 67% $109.60

Medium-Small Establishments

Agricultural 5 5 15 0% 67% $109.60

I/C/G c 5 5 15 0% 67% $109.60

Home & Garden 5 5 15 0% 67% $109.60

Small-Small Establishments

Agricultural 5 5 15 0% 67% $109.60

I/C/G c 5 5 15 0% 67% $109.60

Home & Garden 5 5 15 0% 67% $109.60

Large Establishments

Agricultural 5 5 15 0% 67% $109.60

I/C/G c 5 5 15 0% 67% $109.60

Home & Garden 5 5 15 0% 67% $109.60

a Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pg. IX-13).

b Calculated by dividing the length of the compliance pe riod (5 years) by the assumed lifespan of a refillable container (plastic – 5 year s, steel – 15 years).

c Container marking is not required for refillable containe rs used for certain antimicrobials, including refillable containers filled with sodium hypochlorite, a common anti microbial used in the swimming pool industry. This adjustment is made to the number of refillable containers subject to the container marking regulations presented in Chapter 3.

### Page 184 Table A-16. Refillable Cont ainer Openings Costs (2005$)

Establishment Type Opening Standard Unit

Cost - Plastic (Compliance) a Opening Standard

Unit Cost - Steel (Compliance) b Annual Cost per Entity d

Large-Small Establishments

Agricultural $0.00 $73.07 $29

Industrial/Commercial/Government c $0.00 $73.07 $3

Home & Garden $0.00 $73.07 $0

Medium-Small Establishments

Agricultural $0.00 $73.07 $5

Industrial/Commercial/Government c $0.00 $73.07 $1

Home & Garden $0.00 $73.07 $0

Small-Small Establishments

Agricultural $0.00 $73.07 $1

Industrial/Commercial/Government c $0.00 $73.07 $0

Home & Garden $0.00 $73.07 $0

Large Establishments

Agricultural $0.00 $73.07 $4,084

Industrial/Commercial/Government c $0.00 $73.07 $428

Home & Garden $0.00 $73.07 $0

a Because it is assumed that all plastic refillable containe rs will be replaced with compliant containers by the end of the 5-year compliance period at no extra cost, there ar e no compliance period unit co sts associated with plastic refillable containers under this regulation.

b The unit cost of modifying a refillable steel container’s opening is calculated as follows: Modification Cost * (1 - % of Containers Replaced Du ring Compliance Period).

c Container marking is not required for refillable containe rs used for certain antimicrobials, including refillable containers filled with sodium hypochlorite, a common anti microbial used in the swimming pool industry. This adjustment is made to the number of refillable containers subject to the container marking regulations presented in the compliance profile and explained in Chapter 3.

d Average annual container opening compliance cost per firm. Annual cost is calculated by calculating the sum of the present discounted value of costs incurred from years 5 to 20, and then annualizing it using a 3 percent discount rate. The details of the calculations are presented in Chapter 4 in sections 4.5.6 through 4.5.8.



### A.2.4 Bulk Container Standards



### The bulk container standards (§165. 120) require that bulk containe rs at independent refillers’ establishments and their appurtenances be designed to resist extreme changes in temperature and be resistant to corrosion, puncture, or cracking, and that they also be capable of withstanding all operating stresses. It is assumed that the bulk co ntainers currently used by refillers, and those that exist on the market today, comply with th ese basic design requireme nts. The bulk container standards also require that liquid bulk containers be equipped with a vent or other similar device, that external sight gauges be removed from bulk containers and replaced with another type of gauge, and that the containers be equipped with a shutoff valve that can be locked closed.

After conversations with industry experts, EPA assumed in its pr oposed container rule RIA that all dry bulk containers satisfy th e bulk container standards and 75 percent of agricultural liquid

### Page 185 plastic bulk containers, 20 percen t of agricultural liquid steel bulk containers and 5 percent of all liquid bulk containers in the I/C/ G market are in compliance with the bulk container standards.

For the current analysis, it is assumed that a floa t gauge will be chosen to comply with the bulk container regulations. EPA estimated that the cost of external sight gauge removal was $68.50 per bulk tank and that the cost of float gauge installation was $787.25 ( updated to 2005$). These costs are retained in this analysis. Table A- 17 displays these one-time per-container compliance

costs. It is assumed that establishments incu r these costs at the end of the 5-year compliance period for refillable container re gulations. The annual cost per entity ranges from $1 for the small-small agricultural establishment to $8,495 for the large I/C/G establishment. The annual

cost are calculated as the sum of the present value of the costs incurred from year 5 to year 20 , annualized using a 3 percent discount rate. The details of the annualization method are presented in Chapter 4, sections 4.5.6 through 4.5.8. Th e analysis assumes that all new bulk containers purchased will be in compliance with the regulations.

Table A-17. Bulk Container Standards Compliance Costs

Establishment Type Cost of External Sight Gauge Removal (Compliance) a Cost of Float Gauge Installation

(Compliance) a Annual Cost per Entity b

Large-Small Establishments

Agricultural $68.50 $787.25 $24

Industrial/Commercial/Government $68.50 $787.25 $61

Home & Garden N/A N/A N/A

Medium-Small Establishments

Agricultural $68.50 $787.25 $4

Industrial/Commercial/Government $68.50 $787.25 $11

Home & Garden N/A N/A N/A

Small-Small Establishments

Agricultural $68.50 $787.25 $1

Industrial/Commercial/Government $68.50 $787.25 $2

Home & Garden N/A N/A N/A

Large Establishments

Agricultural $68.50 $787.25 $3,325

Industrial/Commercial/Government $68.50 $787.25 $8,495

Home & Garden N/A N/A N/A

a Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pg. IX-13).

b Average annual bulk container standards compliance cost per firm. Annual cost is calculated by calculating the sum of the present discounted value of costs incurred from years 5 to 20, and then annualizing it using a 3 percent discount rate. The details of the calculations are presented in Chapter 4 in sections 4.5.6 through 4.5.8.



### A.3 Refilling Compliance Costs



### The standards for establishments that repackag e pesticide products into refillable containers (refillers) require that these en tities inspect, clean, and record information about the refillable containers that they refi ll (§§165.160–165.176, and §§165.200–165.218). The cost to do this is primarily associated with the labor time it ta kes to conduct the inspections, cleaning, and

### Page 186 recordkeeping. Total costs also include the fixed capital cost of acquiring a file cabinet to store the required paperwork, the costs of which are the same as file cabinets acquired to store records

associated with both the ref illable and non-refillable cont ainer requirements ($229.65).

Using our best professional judgment, base d on estimates made by EPA in the proposed container rule RIA as a baseline (EPA, 1993, pg. IX-13), we estimated the labor time associated with inspecting, cleaning, and recordkeeping of a refillable container each time it is refilled. We estimated that it takes one minute to inspect the refillable container, 10 minutes to clean it, and

two minutes to conduc t the recordkeeping. 80 

### This is a reasonable assumption on the median time take given that small containers are likely to ta ke about one minute for inspection majority of the

containers are small. It is assumed that these are administrative tasks; therefore, the administrative rate of labor ($29.13/hour) is used to calculate costs. Unlike the majority of costs calculated in this analysis, the unit costs associ ated with the refilling regulations are calculated every time a container is refilled. The refilli ng rate assumptions, and a ssociated discussion, are presented in Chapter 4.

Table A-18 presents the labor time assumptions for each of the refilling requirements and the hourly wage of administrative labor . Table A-19 presents the fixe d capital cost of acquiring the

file cabinet and the unit variab le costs of complying with the inspection, cleaning, and recordkeeping requirements. The cost of the f ile cabinet is a one-time compliance period cost that refilling establishments w ill incur at the end of the 5-year compliance period for refiller regulations. The unit costs of in spection, cleaning, and recordk eeping of the containers that refilling establishments refill are considered annual costs that ar e incurred in years 6 through 20.

To demonstrate how refilling compliance cost s in Table A-19 are calculated from the information in Table A-18, the cost inputs associated with large-small agricultural establishments are used. The unit cost associated with the inspection, cleaning, and recordkeeping of each

container that is refilled is ca lculated based on the time it takes to complete each task (1, 10, and 2 minutes per refill, respectively) multiplied by th e administrative cost of labor ($29.13). The resulting unit (per refill) cost s are therefore $0.49 for containe r inspection, $4.86 for container cleaning, and $0.97 for container recordkeeping. The annual cost per entity ranges from $14 for the small-small agricultural pesticide regi strants to $10,000 for the large swimming pool companies. Annual cost is calc ulated by calculating the sum of the present discounted value of costs incurred from years 5 to 20, and then annualizing it using a 3 pe rcent discount rate. The details of the annualization proceedure are presente d in Chapter 4 in sections 4.5.6 through 4.5.8.

80 The recordkeeping involves recording the container’s EPA registration number, amount of the pesticide product distributed or sold in the refillable container, the date of the repackaging, and the serial number of the refillable

container.

### Page 187 Table A-18. Refilling Requirement Co st Inputs and Assumptions (2005$)

Establishment Type Inspection Time per

Container Refill (min) a Cleaning Time per

Container Refill (min) a Recordkeeping Time per Container Refill (min) a Labor Cost/hr -

Administrative b

Agricultural Pesticide Refillers

Large-Small 1 10 2 $29.13

Medium-Small 1 10 2 $29.13

Small-Small 1 10 2 $29.13

Large 1 10 2 $29.13

Agricultural Pesticide Registrants

Large-Small 1 10 2 $29.13

Medium-Small 1 10 2 $29.13

Small-Small 1 10 2 $29.13

Large 1 10 2 $29.13

Industrial/Commercial/Government - Pesticide Registrants

Large-Small 1 10 2 $29.13

Medium-Small 1 10 2 $29.13

Small-Small 1 10 2 $29.13

Large 1 10 2 $29.13

Swimming Pool Supply Companie s - Antimicrobial Applicators

Large-Small 1 10 2 $29.13

Medium-Small 1 10 2 $29.13

Small-Small 1 10 2 $29.13

Large 1 10 2 $29.13

a Using our best professional judgment, based on estimates made by EPA in the proposed container rule RIA as a baseline (EPA, 1993, pg. IX-13), we estimated the labo r time associated with inspecting, cleaning, and recordkeeping of a refillable cont ainer each time it is refilled.

b The occupational wage estimates are taken from the Bureau of Labor Statistics’ Occupational Employment statistics (BLS, 2000).

### Page 188 Table A-19. Refilling Requirement Costs (2005$)

Establishment Type File Cabinet

Cost (Compliance) a Unit Variable

Cost of Inspection (per refill) b Unit Variable Cost of Cleaning (per refill) b Unit Variable

Cost of Recordkeeping

(per refill) b Annual Cost per Entity c

Agricultural Pesticide Refillers

Large-Small $229.65 $0.49 $4.86 $0.97 $871

Medium-Small $229.65 $0.49 $4.86 $0.97 $267

Small-Small $229.65 $0.49 $4.86 $0.97 $43

Large $229.65 $0.49 $4.86 $0.97 $7,255

Agricultural Pesticide Registrants

Large-Small $229.65 $0.49 $4.86 $0.97 $45

Medium-Small $229.65 $0.49 $4.86 $0.97 $19

Small-Small $229.65 $0.49 $4.86 $0.97 $14

Large $229.65 $0.49 $4.86 $0.97 $4,434

Industrial/Commercial/Government - Pesticide Registrants

Large-Small $229.65 $0.49 $4.86 $0.97 $40

Medium-Small $229.65 $0.49 $4.86 $0.97 $18

Small-Small $229.65 $0.49 $4.86 $0.97 $14

Large $229.65 $0.49 $4.86 $0.97 $3,828

Swimming Pool Supply Companie s - Antimicrobial Applicators

Large-Small $229.65 $0.49 $4.86 $0.97 $34

Medium-Small $229.65 $0.49 $4.86 $0.97 $23

Small-Small $229.65 $0.49 $4.86 $0.97 $15

Large $229.65 $0.49 $4.86 $0.97 $10,000

a File cabinet costs are based on the average price of a fo ur-drawer legal file cabinet surveyed across a number of office supply stores.

b The unit costs of complying with the refilling requiremen ts are calculated as follows: Labor Time (per refill) *

Labor Cost.

c Average annual refilling requirement cost per firm. Annua l cost is calculated by calculating the sum of the present discounted value of costs incurred from years 5 to 20, and then annualizing it using a 3 percent discount rate. The details of the calculations are presented in Chapter 4 in sections 4.5.6 through 4.5.8.



### A.4 Cost of Label Requirements



### The container regulations, in addition to all of the compliance requirements detailed above, will also modify the labeling requirements in 40 CFR Part 156 (Labeling Requirements for Pesticides and Devices) by adding Subpart H, entitled “C ontainer Labeling,” and by modifying §156.10 (Labeling Requirements). The new labeling regulations will require that specific statements be placed on the label or container of all pesticide products and will also provide detailed residue removal instructions on the labels of some produ cts. However, the final regulations exempt household products from the residue removal instructions.

The costs to comply with the labeling requireme nts are associated with the costs for a label change on virtually all formulated pesticide prod ucts, since much of the required information is

### Page 189 not currently found on pesticide labels. Label ch anges must be made by the end of the 3-year compliance period for the labeling regulations.

Labeling cost inputs are based on the assumptions ma de in the proposed container rule RIA. In that analysis, EPA received label change cost da ta from a number of independent small, medium, and large pesticide formulators. Averaging acr oss the responses received, EPA estimated that the label change costs for small facilities were $1,918 per label change and $5,069 per label change for medium and large fac ilities (in 2005$). These costs re present the cost of the artwork or typesetting, two proof readi ngs, and printing plates. The purc hase of the labels themselves was considered an ordinary cost of doing busin ess and was therefore not included in the label change costs. Also, the cost of disposing unus ed, non-compliant labels was not included in the label change costs because EPA assumed that each facility would be able to use up existing label inventory during the compliance period. Becau se there is no information to replace the assumptions used in the proposed container rule RIA, all of the cost inputs and assumptions associated with this cost category are ta ken from the proposed container rule RIA.

In the proposed container rule RIA, EPA assumed that because many pesticide labels routinely undergo changes every 1 to 3 years, facilities will change 50 percent of all their labels during the compliance period. 81 

### For labels that undergo a routine change, EPA assumed that the additional language required by the labe ling regulations would be incorporated at the same time. The entire cost of the label change, therefore, was not asso ciated with the labeling requirements. Instead, EPA assumed that only one-third of the cost of the artwork changes was attributed to the labeling requirements (the cost of adding text to an al ready planned label change). The remaining 50 percent of the labels were assumed by EPA to require changing during the compliance period for one reason only: to come into compliance with the labeling requirement s. Therefore, EPA attributed the full costs of changing the labe ls directly to the labeling requirements.

There are two slight differences between the curr ent analysis and the proposed container rule RIA. First, in the current analysis, the label change costs for small facilities from the proposed

container rule RIA are transferred to the small- small facilities, and the label change costs for medium and large facilities are transferred to medium-small, large-small, and large establishments. Second, the compliance period for the final labeling requirements is 3 years as opposed to the 2-year compliance period assumed in the proposed container rule RIA. Though the compliance period is now longer, there is not sufficient information to alter the proposed rule’s assumption that 50 percent of all label changes that occur during the compliance period are routine (with only one-third of the total label change cost consider ed a cost of compliance), and that the other 50 percent are the result of the need to come into compliance with the regulation (with 100 percent of the total label change cost considered a cost of compliance). This assumption is therefore retained a nd applied to the current analysis.

The number of label changes that establishm ents must make is based on the number of formulations they package. It is assumed, as in the proposed containe r rule RIA, that each formulation requires one label change. The number of existing formulations per facility is the same as that used throughout th e current analysis (see Table A-2) . Table A-20 displays the cost

81 The proposed container rule RIA assumed a 2-year compliance period, though the proposed labeling requirements did not specify a definite compliance schedule or date.

### Page 190 inputs and assumptions used to calculate the label change cost s, and Table A-21 displays the total facility-level compliance cost.

It is assumed that facilities in cur the label change costs at th e end of the compliance period for the 3-year labeling regulations. It is also assumed that once regi strants make all of the labeling changes to existing labels by the end of the comp liance period, establishments will incur no new labeling costs in the future; the artwork or t ypesetting and printing plates will have been modified to meet the labeling language requirement s and will not need future modifications as a result of the labeling regulations. Also, facilities w ill be able to incorporate this labeling text into labels of new products at no additional cost.

To demonstrate how certification costs in Table A-21 are calculated from the information in Table A-20, the cost inputs associated with larg e-small agricultural establishments are used. The facility-level cost associated w ith routine label changes for existi ng formulations is calculated by multiplying the number of formulations (20) by the percentage of label changes considered routine (50 percent). The resul ting number of existing formulati ons (10) is then multiplied by the cost of a routine label change ($479.50 per label change). Routine label changes therefore cost large-small agricultural establishments $4,795. The facility-level cost associated with necessary label changes for existi ng formulations is calculated similarly; the other half of existing formulations (10) is multiplied by the cost of a necessary label change ($5,069 per label change). Necessary label change s therefore cost large-small ag ricultural estab lishments $50,690.

### Page 191 Table A-20. Labeling Requirement Cost Inputs and Assumptions (2005$)

Establishment Type Label Cost - Routine Change a Label Cost - Necessary Change a % of Label Changes

Considered

Routine a Existing

Formulations b

Large-Small Establishments

Agricultural $479.50 $5,069 50% 20

I/C/G $479.50 $5,069 50% 20

Home & Garden $479.50 $5,069 50% 20

Medium-Small Establishments

Agricultural $479.50 $5,069 50% 9

I/C/G $479.50 $5,069 50% 9

Home & Garden $479.50 $5,069 50% 9

Small-Small Establishments

Agricultural $205.50 $1,918 50% 3

I/C/G $205.50 $1,918 50% 3

Home & Garden $205.50 $1,918 50% 3

Large Establishments

Agricultural $479.50 $5,069 50% 32

I/C/G $479.50 $5,069 50% 32

Home & Garden $479.50 $5,069 50% 32

a Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pp. X-1 through X-7). Only one-third of the total label change cost are considered rou tine cost of compliance.

b Revised number of existing formulations per establishm ent based on analysis of the PPIS active registration

database. See Table A-2.

### Page 192 Table A-21. Labeling Requirement Costs (2005$)

Establishment Type Total Cost - Routine Change (Compliance) a Total Cost - Necessary Change (Compliance) b

Large-Small Establishments

Agricultural $4,795 $50,690

I/C/G $4,795 $50,690

Home & Garden $4,795 $50,690

Medium-Small Establishments

Agricultural $2,175 $22,810.50

I/C/G $2,175 $22,810.50

Home & Garden $2,175 $22,810.50

Small-Small Establishments

Agricultural $308.25 $2,877

I/C/G $308.25 $2,877

Home & Garden $308.25 $2,877

Large Establishments

Agricultural $7,672 $81,104

I/C/G $7,672 $81,104

Home & Garden $7,672 $81,104

a Facility-level routine labeling costs are calculated as fo llows: # of Existing Formulations * % of Label Changes Considered Routine * Routine Label Change Cost.

b Facility-level necessary labeling cost s are calculated as follows: # of Existing Formulations * % of Label Changes Considered Necessary * Necessary Label Change Cost.



### A.5 Waiver Costs



### In addition to the costs associated with the co ntainer and labeling regul ations, there are costs associated with the waiver appl ications that registrants may c hoose to submit to be exempted from particular regulations. Fo r facilities that do submit a waiver, EPA assumed in the proposed

container rule RIA that it took a facility manager 4 hours to complete the waiver. We assume this is a reasonable amount of time to compose and submit a waiver for one or all regulations eligible for exemption. This labor time multip lied by the assumed hourly wage of professional labor equaled the facility-level cost of completing a waiver. EPA assumed in the proposed

container rule that this cost was the same acro ss all market sectors and facility sizes. These assumptions are retained in the current analysis , using the updated prof essional labor wage of
$90.42/hour. The total cost facilities incur when applying for a waiver is therefore labor time (4 hours) multiplied by labor cost ($90.42/hour), which equals $361.69. It is assumed that facilities will apply for waivers, and therefore incur waiver cost s, in the first year that the container rules are promulgated.

### Page 193 

## Appendix B. Compliance Profile Estimation Details

B.1 Assumptions and Procedure for Convert ing Pesticide Volume and Weight into

Number of Refillable Containers in Use



### The number of refillable containers in the agricultural market is calculated by converting the formulated volume (in gallons) and formulated we ight (in pounds) of pesticides reported in the 1996 American Crop Protection Association (ACPA) Container Survey (ACPA, 1997) into the number of refillable containers in use. We assumed the following in order to convert pesticide volume and weight used into th e estimated number of refillable containers in use for the agricultural market:

Assumed representative non-bul k container sizes per category 

### (Paulson, 2002): Liquid refillables

• 5–25 gallon plastic/steel: 15 gal ;

• 26–60 gallon plastic/steel: 45 gal , based on average between common sizes of 30 and 60 gallons;

• 61–125 gallon plastic/steel: 85 gal , based on mid-point across ra nge of sizes between 60 and 110 gallons;

• 126–250 gallon plastic: 180 gal , based on mid-point across range of sizes between 140 and 220 gallons; and

• 126–250 gallon steel: 225 gal , based on average between common sizes of 200 and 250 gallons. Dry refillables

• <100 pound non-bulks: 75 lbs , based on mid-point across rang e of sizes between 50 and 100 pounds; and

• 101–2,500 pound non-bulks: 1,100 lbs , based on mid-point across common range of sizes between 1,000 and 1,200 pounds.

Assumed refill rates 

### (Paulson, 2002):

• Small and large liquid refillables are estimated to be refilled on average 2–2.5 and 1.5–2 times annually, respectively. As a result, the refill rate for 5–25 gallon containers was 2.25 times annually and for 26–250 gallon container sizes was 1.75 times annually.

• Dry non-bulk refillables are estim ated to be refilled on aver age 1.5–2 times annually, with 1.75 used in the analysis.

• Bulk liquid and dry containers are assumed to be refilled on average 1–1.5 times annually, with 1.25 used in the analysis.

These estimates include the assumption that not all containers are refilled to capacity.

Assumed representative bulk container sizes 

### (Paulson, 2002):

• Liquid: 2,500 gallons; and

• Dry: 2,501 pounds.

### Page 194 We used the following procedure to estimate the nu mber of agricultural refillable containers in

use:

(7) Estimate the number of new, non-bulk containers: 

### Divide the formulated amount in use based on the 1996 ACPA Container Survey by th e assumed average non-bulk container size for that category and round the estimate to the neares t hundred. For example, there are an estimated 34,700 new “5–25 gallon plastic” refillables in exis tence based on a formulated volume of 519,842 gallons divided by the repres entative container size of 15 gallons (34,656 rounded to 34,700). New refillables are assumed to be filled initially by a pesticide registrant at the manufacturing or formulating facility.

(8) Estimate the number of existing non-bulk containers: 

### Refillables repackaged with pesticide product are assumed to be refilled pr imarily by agricultural pe sticide refillers. Pesticide product refilled into existing refillables is a ssumed to pass through the bulk

containers considered in the 1996 ACPA Cont ainer Survey. Therefore, the ratio of formulated volume (or weight) for a given container size cate gory versus the total non-bulk container formulated volume (or weight) was multiplied by the total liquid (or dry) formulated volume (or weight) in use and divided by the represen tative container size times the annual refill rate. For example, we es timated there are 93,200 existing “5–25 gallon plastic” refillables in use ba sed on the following equation:

(519,842/7,589,197)*45,923,755/(15*2.25)

(total volume in 5-25 gallon plastic category/total non-bulk volume) *

total liquid volume in use/(representative container size*refill rate)

(9) Sum the new and existing refillables for each size category: 

### For example, the total number of “5–25 gallon plastic” refillables in use was estimated to be 127,900 (34,700 new plus 93,200 existing containers).

(10) Estimate the number of bulk containers: 

### There does not appear to be an observable increasing or decreasing trend in the formulat ed volume and weight of annual pesticide use over the 1989 through 1996 ACPA Cont ainer Survey period. Therefore, no net change in the

number of bulk containers is assume d to have occurred since the 1996 survey.

The 1996 ACPA Container Survey bulk containe r formulated amount represents the amount of pesticides distributed from pesticide manufacturers and fo rmulators to retailers through stationary bulk containers in 1996. 82 

### The method in which the pe sticide is transported from

the manufacturer or formulator to the retailer (i.e., via tank car or tanker truck) is not important to the analysis. The number of cont ainers taken out of ci rculation annually is unknown. Based on this information, we divi ded the 1996 bulk container formulated amount by the representative bulk container size (2,500 gallons or 2,501 pounds) multiplied by the

82 The 1996 APCA Container Survey defined bulk containers as containers larger than 250 gallons.

### Page 195 refill rate mid-point estimate (1.25 times annually). As a result, the total estimated number of liquid and dry bulk contai ners in use was 14,700 and 5,600, respectively.

The estimated numbers of liquid (>500 gallons ) and dry (>4,000 pounds) retail bulk tanks (as defined in this economic analysis) are 13, 400 (12,060 plastic and 1,340 steel) and 175, respectively. These estimates were consider ed reasonable by EPA and Don Paulson (2002)

and are consistent with the estimates used for the economic analysis of the containment

rule. 83 

### Of the remaining 1,300 liquid minibulk ta nks (251-500 gallons), we assume that 90 percent (or 1,170) are plastic and 10 percent (or 130) are steel. Ther e are 5,425 dry minibulk containers assumed in the analysis (5,600 - 175).

B.2 Number of Refillables in Use by the P ool Industry: A Separate Discussion and

Consideration



### Sodium hypochlorite is an antimic robial that is exempt from cer tain container requirements (see Chapter 3). Public commenters on the 1994 proposed container rule (EPA,1994) and 1999 Supplemental Notice (EPA, 1999), including pool s upply companies, industry associations, and an antimicrobial manufacturer, sp ecifically addressed the impact that the container regulations would have on refillable containers currently used to distribute sodium hypochlorite for swimming pool/spa use. It is assu med that the estimated number of refillable containers in use in

the industrial/commercia l/government (I/C/G) and home a nd garden (H&G) markets does not include the refillables used in the swimming pool industry. This assumption is based on the comments received and EPA’s understanding of th e source data used to derive container estimates for the proposed container rule RIA an d subsequent updates to the estimates for this analysis.

Currently, based on comments to the 1999 Supplemental Notice submitted by relevant trade associations (i.e., the Chlorine Institute, Natio nal Spa and Pool Institu te, and Swimming Pool Chemical Manufacturers Association), we estimate that more than 38 million gallons of sodium hypochlorite are estimated to be distributed each year in refillable containers ranging in size from jugs (1 and 2.5 gallons) to drums (30 and 55 ga llons) to minibulks (220 and 330 gallons). The comments also suggest that the average number of re fillings and is eight. A smaller refilling rate of four was assumed for larger containers. This refilling rate was used with the data on volume from the comments (38 million gallons of sodium hypochlorite in use for pools in spas annually)

to arrive at the total number of containers.

83 A separate economic analysis is written for the requirem ents for bulk containment structures. The containment regulations apply only to stationary bulk containers at re tail facilities, custom applicators, and custom blenders, while the bulk container standards apply only to bulk containers at independent refillers.Page 196Appendix C. Regulation-Specific Cost SchedulesTable C-1. Undiscounted Costsaof Complying with the Residue RemovalStandards for Non-Refillable ContainersUnder the Current RulebEstablishment Yearc3 4 5 6 7 8 9 10Large-Small EstablishmentsAgricultural$2,158 $2,158 $2,158 $2,158$2,158 $2,158 $2,158 $2,158I/C/G$2,158 $2,158 $2,158 $2,158$2,158 $2,158 $2,158 $2,158Home & Garden$2,158 $2,158 $2,158 $2,158$2,158 $2,158 $2,158 $2,158Medium-Small EstablishmentsAgricultural$1,079 $1,079 $1,079 $1,079$1,079 $1,079 $1,079 $1,079I/C/G$1,079 $1,079 $1,079 $1,079$1,079 $1,079 $1,079 $1,079Home & Garden$1,079 $1,079 $1,079 $1,079$1,079 $1,079 $1,079 $1,079Small-Small EstablishmentsAgricultural$539 $539 $539 $539 $539 $539 $539 $539I/C/G$539 $539 $539 $539 $539 $539 $539 $539Home & Garden$539 $539 $539 $539 $539 $539 $539 $539Large EstablishmentsAgricultural$2,697 $2,697 $2,697 $2,697$2,697 $2,697 $2,697 $2,697I/C/G$2,697 $2,697 $2,697 $2,697$2,697 $2,697 $2,697 $2,697Home & Garden$2,697 $2,697 $2,697 $2,697$2,697 $2,697 $2,697 $2,697Page 197Table C-1 (Continued). Undiscounted Costsaof Complying with the Residue Removal Standards for Non-RefillableContainers Under the Current RulebEstablishment Year11 12 13 14 15 16 17 18 19 20Large-Small EstablishmentsAgricultural$2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158I/C/G$2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158Home & Garden$2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158 $2,158Medium-Small EstablishmentsAgricultural$1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079I/C/G$1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079Home & Garden$1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079 $1,079Small-Small EstablishmentsAgricultural$539 $539 $539 $539 $539 $539 $539 $539 $539 $539I/C/G$539 $539 $539 $539 $539 $539 $539 $539 $539 $539Home & Garden$539 $539 $539 $539 $539 $539 $539 $539 $539 $539Large EstablishmentsAgricultural$2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697I/C/G$2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697Home & Garden$2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697 $2,697aCosts are rounded to the nearest dollar.bCompliance with the Residue Removal Standards involves only fixed costs.cThe compliance period for non-refillables is 3 years. The analysis assumes that costs are incurred beginning at the end of thethird year.Page 198Table C-2. Undiscounted Costsaof Complying with Recordkeeping Requirementsfor Non-RefillableContainers Under theContainer RulebEstablishment Yearc3 4 5 6 7 8 9 10Large-Small EstablishmentsAgricultural$1,165 $117 $117 $117 $117 $117 $117 $117I/C/G$1,165 $117 $117 $117 $117 $117 $117 $117Home & Garden$1,165 $117 $117 $117 $117 $117 $117 $117Medium-Small EstablishmentsAgricultural$1,049 $87 $87 $87 $87 $87 $87 $87I/C/G$1,049 $87 $87 $87 $87 $87 $87 $87Home & Garden$1,049 $87 $87 $87 $87 $87 $87 $87Small-Small EstablishmentsAgricultural$699 $58 $58 $58 $58 $58 $58 $58I/C/G$699 $58 $58 $58 $58 $58 $58 $58Home & Garden$699 $58 $58 $58 $58 $58 $58 $58Large EstablishmentsAgricultural$1,165 $117 $117 $117 $117 $117 $117 $117I/C/G$1,165 $117 $117 $117 $117 $117 $117 $117Home & Garden$1,165 $117 $117 $117 $117 $117 $117 $117Page 199Table C-2 (Continued). Undiscounted Costsaof Complying with Recordkeeping Requirements for Non-Refillable ContainersUnder the Container RulebEstablishment Year11 12 13 14 15 16 17 18 19 20Large-Small EstablishmentsAgricultural$117 $117 $117 $117 $117 $117 $117 $117 $117 $117I/C/G$117 $117 $117 $117 $117 $117 $117 $117 $117 $117Home & Garden$117 $117 $117 $117 $117 $117 $117 $117 $117 $117Medium-Small EstablishmentsAgricultural$87 $87 $87 $87 $87 $87 $87 $87 $87 $87I/C/G$87 $87 $87 $87 $87 $87 $87 $87 $87 $87Home & Garden$87 $87 $87 $87 $87 $87 $87 $87 $87 $87Small-Small EstablishmentsAgricultural$58 $58 $58 $58 $58 $58 $58 $58 $58 $58I/C/G$58 $58 $58 $58 $58 $58 $58 $58 $58 $58Home & Garden$58 $58 $58 $58 $58 $58 $58 $58 $58 $58Large EstablishmentsAgricultural$117 $117 $117 $117 $117 $117 $117 $117 $117 $117I/C/G$117 $117 $117 $117 $117 $117 $117 $117 $117 $117Home & Garden$117 $117 $117 $117 $117 $117 $117 $117 $117 $117aCosts are rounded to the nearest dollar.bCompliance with the Other Administrative Requirements(recordkeeping) involves only fixed costs.cThe compliance period for non-refillables is 3 years. The analysis assumes that costs are incurred beginning at the end of thethird year.Page 200Table C-3. Undiscounted Costsaof Complying with the Container Marking Standards for Refillable Containers Under theContainer RulebEstablishment Yearc5 6 7 8 9 10Large-Small EstablishmentsAgricultural$166 $27 $27 $27 $27 $27I/C/G$15 $3 $3 $3 $3 $3Home & GardenN/A N/A N/A N/A N/A N/AMedium-Small EstablishmentsAgricultural$31 $5 $5 $5 $5 $5I/C/G$3 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/ASmall-Small EstablishmentsAgricultural$7 $1 $1 $1 $1 $1I/C/G$1 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/ALarge EstablishmentsAgricultural$23,231 $3,720 $3,720 $3,720 $3,720 $3,720I/C/G$2,072 $356 $356 $356 $356 $356Home & GardenN/A N/A N/A N/A N/A N/APage 201Table C-3 (Continued). Undiscounted Costsaof Complying with the Container Marking Standards for Refillable ContainersUnder the Container RulebYearEstablishment11 12 13 14 15 16 17 18 19 20Large-Small EstablishmentsAgricultural$27 $27 $27 $27 $27 $27 $27 $27 $27 $27I/C/G$3 $3 $3 $3 $3 $3 $3 $3 $3 $3Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/AMedium-Small EstablishmentsAgricultural$5 $5 $5 $5 $5 $5 $5 $5 $5 $5I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/ASmall-Small EstablishmentsAgricultural$1 $1 $1 $1 $1 $1 $1 $1 $1 $1I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/ALarge EstablishmentsAgricultural$3,720 $3,720 $3,720 $3,720 $3,720 $3,720 $3,720 $3,720 $3,720 $3,720I/C/G$356 $356 $356 $356 $356 $356 $356 $356 $356 $356Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/AaCosts are rounded to the nearest dollar.bCompliance with the Container Marking Standards involves only variable costs.cThe compliance period for refillables is 5 years. The analysisassumes that costs are incurred beginning at the end of the fifth year.Page 202Table C-4. Undiscounted Costsaof Complying with the Standards of Openings(for Liquid-Minibulk Containers Only) forRefillable Containers Under the Container RulebEstablishment Yearc5 6 7 8 9 10Large-Small EstablishmentsAgricultural$519 $0 $0 $0 $0 $0I/C/G$54 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/AMedium-Small EstablishmentsAgricultural$96 $0 $0 $0 $0 $0I/C/G$10 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/ASmall-Small EstablishmentsAgricultural$20 $0 $0 $0 $0 $0I/C/G$2 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/ALarge EstablishmentsAgricultural$72,555 $0 $0 $0 $0 $0I/C/G$7,605 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/APage 203Table C-4 (Continued). Undiscounted Costsaof Complying with the Standards of Openings (for Liquid-Minibulk ContainersOnly) for Refillable Containers Under the Container RulebYearEstablishment11 12 13 14 15 16 17 18 19 20Large-Small EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/AMedium-Small EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/ASmall-Small EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/ALarge EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/AaCosts are rounded tothe nearest dollar.bCompliance with the Standards for Openings (for liquid minibulk containers only) involves only variable costs.cThe compliance period for refillables is 5 years. The analysisassumes that costs are incurred beginning at the end of the fifth year. The analysis also assumesthat compliant containers can be purchased at noextra cost at the end of the compliance period.Page 204Table C-5. Undiscounted Costsaof Complying with the Bulk Container Standards for Refillable ContainersUnder the Container RulebEstablishment Yearc5 6 7 8 9 10Large-Small EstablishmentsAgricultural$423 $0 $0 $0 $0 $0I/C/G$1,080 $0 $0 $0 $0 $0Home & GardendN/A N/A N/A N/A N/A N/AMedium-Small EstablishmentsAgricultural$78 $0 $0 $0 $0 $0I/C/G$200 $0 $0 $0 $0 $0Home & GardendN/A N/A N/A N/A N/A N/ASmall-Small EstablishmentsAgricultural$17 $0 $0 $0 $0 $0I/C/G$43 $0 $0 $0 $0 $0Home & GardendN/A N/A N/A N/A N/A N/ALarge EstablishmentsAgricultural$59,063 $0 $0 $0 $0 $0I/C/G$150,914 $0 $0 $0 $0 $0Home & GardendN/A N/A N/A N/A N/A N/APage 205Table C-5 (Continued). Undiscounted Costsaof Complying with the Bulk Container Standards for Refillable ContainersUnder the Container RulebEstablishment Year11 12 13 14 15 16 17 18 19 20Large-Small EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & GardendN/A N/A N/A N/A N/A N/A N/A N/A N/A N/AMedium-Small EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & GardendN/A N/A N/A N/A N/A N/A N/A N/A N/A N/ASmall-Small EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & GardendN/A N/A N/A N/A N/A N/A N/A N/A N/A N/ALarge EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & GardendN/A N/A N/A N/A N/A N/A N/A N/A N/A N/AaCosts are rounded tothe nearest dollar.bCompliance with the Bulk Container Standards involves only variable costs.cThe compliance period for refillables is 5 years. The analysisassumes that costs are incurred beginning at the end of the fifth year. The analysis alsoassumes that bulk containers purchasedafter the five-year compliance period will be in compliance at no extra cost.dCompliance costs for Home & Garden establishments are not applicable because the number ofbulk containers in Home & Garden establishments is zero.Page 206Table C-6. Undiscounted Costsaof Complying with AdministrativeRequirements for Refillable ContainersUnder the Containment RulebEstablishment Yearc5 6 7 8 9 10Large-Small EstablishmentsAgricultural$1,133 $128 $128 $128 $128 $128I/C/G$1,133 $128 $128 $128 $128 $128Home & GardenN/A N/A N/A N/A N/A N/AMedium-Small EstablishmentsAgricultural$841 $73 $73 $73 $73 $73I/C/G$841 $73 $73 $73 $73 $73Home & GardenN/A N/A N/A N/A N/A N/ASmall-Small EstablishmentsAgricultural$550 $58 $58 $58 $58 $58I/C/G$550 $58 $58 $58 $58 $58Home & GardenN/A N/A N/A N/A N/A N/ALarge EstablishmentsAgricultural$1,133 $128 $128 $128 $128 $128I/C/G$1,133 $128 $128 $128 $128 $128Home & GardenN/A N/A N/A N/A N/A N/APage 207Table C-6 (Continued). Undiscounted Costsaof Complying with Administrative Requirements for Refillable Containers Underthe Containment RulebEstablishment Year11 12 13 14 15 16 17 18 19 20Large-Small EstablishmentsAgricultural$128 $128 $128 $128 $128 $128 $128 $128 $128 $128I/C/G$128 $128 $128 $128 $128 $128 $128 $128 $128 $128Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/AMedium-Small EstablishmentsAgricultural$73 $73 $73 $73 $73 $73 $73 $73 $73 $73I/C/G$73 $73 $73 $73 $73 $73 $73 $73 $73 $73Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/ASmall-Small EstablishmentsAgricultural$58 $58 $58 $58 $58 $58 $58 $58 $58 $58I/C/G$58 $58 $58 $58 $58 $58 $58 $58 $58 $58Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/ALarge EstablishmentsAgricultural$128 $128 $128 $128 $128 $128 $128 $128 $128 $128I/C/G$128 $128 $128 $128 $128 $128 $128 $128 $128 $128Home & GardenN/A N/A N/A N/A N/A N/A N/A N/A N/A N/AaCosts are rounded tothe nearest dollar.bCompliance with the Other Administrative Requirements (preparing certain documents and recordkeeping) involves onlyfixed costs.cThe compliance period for refillables is 5 years. The analysisassumes that costs are incurred beginning at the end of the fifth year.Page 208Table C-7. Undiscounted Costsaof Complying with the Labeling Requirementsfor All Containers Under the Container RulebEstablishment Yearc3 4 5 6 7 8 9 10Large-Small EstablishmentsAgricultural$55,485 $0 $0 $0 $0 $0 $0 $0I/C/G$55,485 $0 $0 $0 $0 $0 $0 $0Home & Garden$55,485 $0 $0 $0 $0 $0 $0 $0Medium-Small EstablishmentsAgricultural$24,968 $0 $0 $0 $0 $0 $0 $0I/C/G$24,968 $0 $0 $0 $0 $0 $0 $0Home & Garden$24,968 $0 $0 $0 $0 $0 $0 $0Small-Small EstablishmentsAgricultural$3,185 $0 $0 $0 $0 $0 $0 $0I/C/G$3,185 $0 $0 $0 $0 $0 $0 $0Home & Garden$3,185 $0 $0 $0 $0 $0 $0 $0Large EstablishmentsAgricultural$88,776 $0 $0 $0 $0 $0 $0 $0I/C/G$88,776 $0 $0 $0 $0 $0 $0 $0Home & Garden$88,776 $0 $0 $0 $0 $0 $0 $0Page 209Table C-7 (Continued). Undiscounted Costsaof Complying with the Labeling Requirements for All ContainersUnder the Container RulebEstablishment Year11 12 13 14 15 16 17 18 19 20Large-Small EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & Garden$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Medium-Small EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & Garden$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Small-Small EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & Garden$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Large EstablishmentsAgricultural$0 $0 $0 $0 $0 $0 $0 $0 $0 $0I/C/G$0 $0 $0 $0 $0 $0 $0 $0 $0 $0Home & Garden$0 $0 $0 $0 $0 $0 $0 $0 $0 $0aCosts are rounded to the nearest dollar.bCompliance with the Labeling Requirements involves only fixed costs.cThe compliance period for non-refillables is 3 years. The analysis assumes that labeling costs are incurred beginning at the end of the third year. Theanalysis also assumes no costs after thecompliance period because existing labels will be in compliance and new labeling textwill be incorporated intothe labels of new products at no additional cost.

### Page 210 

## Appendix D. Profile of Industries Regulated by the Pesticide Container Regulations

This appendix provides descriptiv e and quantitative information about the three regulated entities estimated to be affected by the current containe r regulations: (1) registrants, (2) agricultural pesticide refillers, and (3) sw imming pool supply companies. Re levant details on the economic

and financial characteristics associat ed with all regulated entities ar e discussed. This information is necessary to assess the potential impacts of regulatory compliance cost s associated with the container regulations.

Two industry sectors considered in the 1999 Suppl emental Notice were pesticide formulators and agrichemical dealers. These regulated enti ties correspond with pes ticide registrants and agricultural pesticide refillers, re spectively, in this analysis.

Tables 3.3 and 3.4 illustrate which regulated entities are responsible for which pesticide container regulations, and provide a brief overv iew showing how each of the regulated entities identified and characterized in Chapter 3 will be affected by the container rule.

Another purpose of this appendix is to identify th e small entities that are potentially affected by the container regulations. A small entity is defined as:

• A small business as defined in the Small Bu siness Administration (S BA) regulations at 13 CFR §121.201—the SBA defines small busines ses by category of business using North American Industry Classification System (NAICS) codes;

• A small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and

• Any small, not-for-profit enterprise that is independently owned and operated and is not

dominant in its field.

This economic analysis evaluates an alternative definition of small entities or businesses potentially affected by the cont ainer regulations. As discusse d by EPA in the 1999 Supplemental

Notice on Standards for Pesticid e Containers and Containmen t (EPA, 1999), the alternative definition disaggregates the SBA-defined small businesses into three size categories: small-small (SS), medium-small (MS), and large-small (LS) bus inesses. EPA is concerned that using an overly broad definition of small business in the economic analysis of the container regulations may result in significant economic impacts on sma ller entities that w ill be camouflaged when combined with information about potential impact s on facilities that meet the SBA size standard

for small business but are not typical of a small busine ss in that industry sector.

### Page 211 D.1 Pesticide Registrants



### According to §165.42, §165.92, and §165.142 of the container regulations , registrants that distribute or sell a pesticide product in non-refillable or refillable c ontainers, and/or distribute or sell pesticide products to a refill er (that is not part of the same entity) for repackaging into refillable containers, constitute a business that mu st comply with the standards. Pesticide active ingredient (PAI) manufacturers ma y or may not be subject to the container regulations because §165.46, §165.96, and §165.146 of the container regula tions indicate that the standards do not apply to manufacturing use products. Howeve r, many PAI manufactur ers are vertically integrated to pesticide formulating facilities th rough direct ownership or wholesale distribution of PAIs to independent formulat ors. Also, registrants are res ponsible for complying with the label requirements in 40 CFR Part 156.

Pesticide registrants are basically required to ensure that all non-refillable and refillable

containers meet the container construction and design standards, develop and provide information to refillers, and ensure that labels include the specified information. Pesticide registrants are responsible for pr ocedural and handling activities for approximately 10 percent of the refillables in the agricultura l market (Paulson, 2002) and all of the refillables in the I/C/G

market. 84 

### Inadequate data are available to differentiate pesticide registrants that are or are not engaged directly in pesticide refilling activities.

The total universe of affected pes ticide registrants used in this analysis was derived based on the number of unique companies holding active Section 3 and/ or Section 24 (c) pesticide registrations. EPA queried the Pesticide Product Information System (PPIS) database in July 2002 and determined that 1,956 companies with unique EPA company numbers held more than 16,000 Section 3 and 24(c) pesticid e registrations. The PPIS databa se contains information for all pesticide products registered in the United States, including registrant name and address, chemical ingredients, toxicity category, product names, distributor brand names, site/pest uses, pesticidal type, formulation c ode, and registration status.

The registrant universe was reduced by consolida ting companies that have recently merged and combining companies that are considered subsidia ries or part of a larger “parent” company. Companies were consolidated in four ways:

• We matched unique companies with EPA comp any numbers to company information and

financial data from the Dun & Bradstreet (D&B) database. The D&B data included information on the company total number of employees; most recent sales and revenue information; and primary business classifica tions—NAICS code and Standard Industrial Classification (SIC) code where po ssible. In order to link registrants in the PPIS sample data set with the D&B database, we identified each company’s Data Universal Numbering System (DUNS) number. The D&B DUNS number is a unique identifier for a single business entity, which also links together the corporate fa mily structure. Using the corresponding DUNS

84 Don Paulson recently retired from Ciba /Novartis and currently is a consultant to Syngenta and CropLife America, formerly the American Crop Protectio n Association (ACPA). Mr. Paulson wa s very active in the ACPA packaging task force in the 1990s and co-surveyed the number of agri cultural pesticide containers for ACPA with Tom Gilding

between 1989 and 1996.

### Page 212 numbers, we “rolled up” or consolidated comp anies to the Global Ultimate DUNS number or “parent” level.

• In some cases company information in D&B di d not reflect recent merg ers; therefore, we consolidated the registrant universe manually by adjusting for known company mergers. For example, Aventis CropScience was acqui red by Bayer CropScience in June 2002.

• We matched and consolidated company names for all EPA company numbers based on the likelihood that the company nu mbers actually reflect one co mpany and/or based on EPA

recommendations.

As a result, the set of 1,956 unique company num bers in EPA’s PPIS database was reduced to 1,804 unique companies. These 1,804 companies repr esent the pesticide registrant universe for this analysis. Table D-1 illustrates this process numerically.

Table D-1. Estimated Number of Pest icide Registrants Affected by the Pesticide Container Regulations

Pesticide Registrants Estimated Number of

Entities

Number of unique companies in EPA’s PPIS database holding Section 3 and/or Section 24(c) registration(s) 1,956 a

Total number of duplicate companies 243 b

Consolidated number of duplicate companies 91

Total 1,804

a As of July 2002.

b Number of all companies with unique EPA company numbers th at were consolidated based on the following criteria: (1) matching of EPA company numbers with Dun & Bradstreet DUNS and Global Ultimate DUNS numbers; (2) consolidation as a result of recent mergers and acquisitions; or (3) matching of company names associated with unique EPA company

numbers.



### D.1.1 Pesticide Registrants’ NAICS Codes



### A company’s total employees and revenue inform ation is required to break down the estimated total number of affected pesticid e registrants into entity size categories according to SBA and EPA alternative definitions of company size specif ications and to determine the impact of the container regulations on pesticid e registrants. The company size specifications are based on the SBA definition for the primary NAICS code for pesticide registrants.

To confirm the primary NAICS code designation for pesticide registrants, we counted the number of pesticide registrants associated with each NAICS codes, which were available from D&B for 804 (out of an estimated 1,804 total) pe sticide registrants. The eight most common sixdigit NAICS codes designated in D&B for the set of registrants (399 out of 804) are presented in

Table D-2. A total of 184 six- digit NAICS codes are associated with at least one of the 804 registrants.

### Page 213 Table D-2. Most Common NAICS Codes As sociated with Sample of 804 Pesticide Registrants

NAICS

CODE Count of

NAICS

Code U.S. Industry Title SBA Threshold

325320 a 88 Pesticide and Other Agricultural Chemical Manufacturing 500 employees

422690 84 1997 NAICS - Otr Chem & Allyd Prdct Whlslrs 100 employees

422910 65 1997 NAICS - Farm Supplies Wholesalers 100 employees

325612 62 Polish and Other Sanitation Good Manufacturing 500 employees

325998 30 All Other Miscellaneous Chemical Product and Preparation Manufacturing 500 employees

325188 27 All Other Basic Inorganic Chemical Manufacturing 1,000 employees

453998 22 All Other Miscellaneous Store Retailers (except Tobacco Stores) $6 million in revenue

325412 21 Pharmaceutical Prepara tion Manufacturing 750 employees

a NAICS code 325320 was considered th e primary NAICS code associated with pesticide registrants in the proposed container rule RIA (EPA, 1993). The 325- NAICS series is used to designate types of “Chemical Manufacturing”

industries.



### D.1.2 Analysis of Large Pesticide Registrants



### Company information on some pesticide registra nts is unknown or unavailable. However, D&B data are more likely to be available for large companies than for small companies, based on the way D&B collects company financial information and on the availability of the required data.

To estimate the total number of large pesticid e registrants, we assumed that D&B data are available for all large firms. 85 

### A total of 146 companies were c onsidered to be large based on the company’s defined NAICS code a nd associated SBA definitions. This estimate was derived by collecting information from the D&B database for companies at the parent company level as of November 2002. In some cases a company identi fied with a unique DUNS number is ultimately part of a larger “parent” company, a corpora tion that owns more than 50 percent of another company, at the Global Ultimate DUNS number leve l. We identified the parent company in D&B using the Global Ultimate DUNS number asso ciated with each company listing. Global

Ultimate DUNS numbers in the D&B database are the highest parent company level containing revenue and employee number information.

Additionally, we made m odifications to the large pesticid e registrant universe based on knowledge of the industry. For example, at the time of analysis in fall 2002, D&B contained

financial information for both Aventis and Ba yer CropScience. Bayer CropScience recently acquired Aventis, and these companies are now consolidated. This and other modifications

85 D&B data for certain large pesticide registrants may not be readily available, and all parent companies considered to be large may not have been identified. In addition, mergers and acquisitions may slightly reduce the number of large registrants considered in the analysis. Given this un certainly, it is assumed that the estimated number of large pesticide registrants is reasonable.

### Page 214 condensed the number of large pesticide registrants slightly. Table D-3 illu strates the results of the large pesticide registrant economic profile. The average revenue for a large pesticide registrant is estimated to be $6,882 million with an average number of employees of approximately 19,300.

D.1.3 Analysis of Small Pesticide Registrants



### We generated a random sample of firms from th e PPIS database to determine the breakdown of the remaining 1,658 firms, which are SBA-define d small firms. A randomly selected set of 1,000 unique companies identified in PPIS as hol ding one or more Section 3 registrations was used for determining the number and financial characteristics of small pesticide registrant

entities. Because PPIS data do not contain information on the financ ial aspects of the registrants, we matched the 1,000 randomly selected firms w ith company information and financial data

from D&B.

We identified DUNS numbers for 853 of the 1,000 firms in the PPIS sample data set using firm name, address, and primary line of business. The additional identifiers, beyond firm name, were necessary in many cases where D&B listed severa l companies with the same name. Of the 853 registrants in the PPIS sample data set, only 615 companies had sufficient information on total revenue and number of employees to be included in this analysis.

We queries the D&B database using the DUNS num bers of the 615 potentially affected entities to retrieve the ultimate parent company name (i.e., Global Ultimate DUNS number), annual sales, total employees, and primary NAICS code. 86



### Based on total employees and financial data from D&B, we determined the entity size and average sales revenue of pesticide registrants in the PPIS sample data set as illustrated in Table D-3. We identified a total of 568 unique parent companies, of which 449 or 79 percent were considered small businesses by SBA definitions. Of the SBA-defined small pesticide registrants, approximately 60 percent (270) were small-sma ll, 30 percent (134) were medium-small, and 10 percent (45) were large-small, based on EPA’s alternative small business definitions.

86 All financial information in this industry profile is summarized at the global ultimate parent company level. The global ultimate parent is the highest-level firm within the company’s structure. For example, a major pesticide manufacturer may be headquartered in Chicago, but ha ve facilities in Memphis and St. Louis. The company information from PPIS may list the Memphis or St. Louis facility locations, and/or the D&B database may include company financial information from facility level up to the global ultimate parent company level. D&B data may make it possible to determine that all three of thes e locations are owned by the same parent company.Page 215Table D-3. Economic Profile of Pesticide Registrants by Entity SizePPIS Registrant DataaPesticide RegistrantsEntity SizeCategoryDefinitionTotalCompaniesPercentage ofSmallCompaniesTotal Revenuefor AllCompanies(million)AverageRevenue perCompany(million)AverageNumber ofEmployeesper Company Total EntitiesTotal Revenuefor AllEntities(million)bPercentage ofTotal RevenueSBA-Defined SizesLarge 501 or moreemployees146 NA $1,075,106 $7,364 19,266 146 $1,075,106 98.6%Small 500 or feweremployees449cNA $4,239 $9.44 39 1,658 $15,651 1.4%Total NA NA NA NA NA 1,804d$1,090,757 100.0%EPA Alternative Small Business SizeseLarge-Small 100 to 500employees45 10.0% $2,370 $52.68 217 166 $8,753 0.8%Medium-Small 20 to 99employees134 29.8% $1,307 $9.76 44 495 $4,829 0.4%Small-Small 1 to 19employees270 60.1% $561 $2.08 8 997 $2,070 0.2%Total 449 NA $4,239 $9.44 39 1,658 $15,651 1.4%aSufficient Dun & Bradstreet company information and financial data were assumed to be available for all SBA-defined large pesticide registrants, based on the set of1,804 unique pesticide registrants identified as having one ormore Section 3 or Section 24(c) pesticide registrations. The total number of pesticide registrants that metthis criteria and were considered to be large companies was 146. For SBA-defined small businesses, a random sample of 1,000 unique pesticide registrants was used todevelop the economic profile. A total of 565 unique parent companies were identified as having sufficient financial information at the Global Ultimate DUNS numberlevel to be included in the analysis, of which 449 or 79 percent were considered small businesses by SBA definitions.bCalculated as the average revenue per company multiplied bythe total number of entities for the respective size category.cSBA-defined small businesses identified out of a random sample of 1,000 unique companies with one or more active Section 3 orSection 24(c) registrations.dNumber of all companies with unique EPAcompany numbers that were consolidated based on the following criteria: (1) matching of EPA company numbers with D&BDUNS and Global Ultimate DUNS numbers; (2) as a result of recent mergers and acquisitions; (3) matching of company names associated with unique EPA companynumbers; or (4) recommended by EPA to be consolidated based on nearly identical name matching and/or prior knowledge.eEPA discussed alternative definitions of small businesses for some industry sectors in the 1999 Supplemental Notice on Standards for Pesticide Containers andContainment (EPA, 1999). EPA is concerned that using an overlybroad definition of small business in the economic analysis ofcontainer regulations may result insignificant economic impacts on smaller entities that will be camouflaged when combined with information about potential impacts on those facilities that meet the SBAsize standard for small business but are not typical of a small business in that industry sector.

### Page 216 The relative percentages for the EPA alternative small business categories from the sample of 449 small pesticide registrants with sufficient D& B data were applied to the total universe of 1,658 small registrants from the PPIS database. As a result, the SBA-defined small pesticide registrant universe was estimated to include 997 small-small registrants, 495 medium-small registrants, and 166 large-small registrants, based on the EPA alte rnative small business

definitions.

The D&B data for the 449 unique small companies with sufficient financial data were used to determine size (by SBA definition) and to estimate average or typical annual revenue to generate the economic profile for potentially affected small pesticide regi strant entity size categories (SBA-defined and EPA alternative definitions fo r small businesses). The data from the random sample of small pesticide registrants are summar ized in Table D-3 and the economic profile is applied to the total uni verse of 1,658 small pesticide registrants.

D.1.4 Container Profile for Registrants by Market Sector and Size Category



### The procedure for mapping pesticide containers and associated regul atory requirements to pesticide registrants is shown in Table D-4. To the extent that certain antimicrobials are exempt from consideration, the number of containers associated with each pesticide registrant size category and ultimately with individual representati ve entities will vary. The container profile is used to estimate the average number of containers for a given size category and type that can be associated with a given pesticide registrant size (by SBA large and small definitions and by EPA

alternative definitions for small businesse s) and market sector (agricultural, industrial/commercial/government, and home and garden).

The procedure described in step s 3 and 4 of Table D-4 was duplic ated for all non-refillable and

refillable container types and sizes. In the pesticide contai ner regulations cost analysis (Chapter 4), the number of containers associated with each representative entity size category of pesticide registrants is used in combination with the regulation compliance rates (see Chapter 3) to derive costs of compliance and anticipat ed SBA small business impacts.

### Page 217 Table D-4. Procedure Used to Establis h Market-Specific Regulated Entities

Step 1. Distribute the pesticide registrants across ma rket sectors (agricultural, I/C/G, and H&G) based on volume of pesticides used by each sector according to the Pesticide Industry Sales and Usage: 2000 and

2001 Market Estimates (EPA, 2002b).

Example: 2001 total pesticide use is as follows: 40% agricultural, 30% I/C/G, and 30% H&G. Accordingl y, the number of pesticide registrants by size and market sector

is as follows:

SS MS LS Large

Agricultural 399 198 66 58

I/C/G 299 148 50 44

H&G 299 148 50 44 From EPA’s pesticide use and sales report, we know the amount of pesticide product used in each market sector. The total amount of pesticide product considered includes conventional pesticides, other pesticides, and an EPA estimate of 29.8 percent of the antimicrobial products (wood preservatives, chlorine/hypochlorites, and specialty biocides) subject to the container regulations. The total number of SS, MS, LS, and large pesticide registrant entities is distributed among market sectors, based on the relative amount of the assumed pesticide product subject to the container regulations used by each sector in 2001. Total 997 495 166 146

Step 2. Derive total revenue by pesticide registrant size category and determine the revenue ratio for each pesticide registrant size catego ry by market sector to the tota l revenue for that market sector.

Sum the total revenue for SS, MS, LS, and large pesticide registrants based on PPIS sample data set analysis results for average revenue by pesticide registrant size category. Multiplying the average revenue by the total number of registrants in each category yields the total. Example: Total revenue for SS, MS, LS, and large firms in the PPIS sample data set were $2,070 million, $4,829 million, $8,753 million, and $1,075,106 million, respectively.

Total Revenue (million) Revenue Ratio

SS

$2,070 0.2%

MS $4,829 0.4%

LS $8,753 0.8%

Large $1,075,106 98.6% Determine the revenue ratio for each pesticide registrant size category based on the total reve nue per size category compared to the revenue for the total universe of registrants. The revenue ratios for the registrant size categories are applicable

to each market sector.

Total $1,090,757 100.0%

Step 3. Distribute the containers th at are affected by the container regu lations in each size/type category into entity size categories for each market sector (agricultural, I/C/G, and H&G).

Example: The 199,434 potentially affected 30–55 gallon plastic non-refillable containers in the agricultural market sector are distributed

as follows:

SS MS LS Large For each liquid and dry product pesticide container size category, apply the revenue ratio to allocate the containers to SS, MS, LS, and large entities for each market sector. Repeat example procedure to the right for every container category (size, type, material).

Agricultural 378 883 1,600 197K

Step 4. Determine the number of containers per repres entative pesticide registrant by entity size for each

market sector.

Example: Using the above example, the number of plastic 30-55 gal. containers for the Agricultural (market sector) firms is as

follows:

SS MS LS Large Calculate the number of cont ainers for an average (or representative) pesticide registrant for each size category in each market sector by dividing the number of each type of container in each market sector (step 3) by the number of companies in each market sect or (step 1). Repeat example procedure to the right for every container category (size, type, material). Agricultural 1 4.5 24 3,389

Numbers may not add due to rounding.

### Page 218 D.2 Agricultural Pesticide Refillers



### The agricultural pesticide refiller entity is analogous to agricultural chemical dealers who generally supply pesticide products to farmers or other end users in re fillable containers for large-scale application. Agricultural pestic ide refillers are subject to the repackaging requirements each time a pesticide is repackaged into a refillable container. Generally, this regulated entity is responsible for inspecting, ri nsing, and properly labeling containers prior to reuse, and maintaining appropriate records.

Agricultural pesticide refillers repackage and su pply the majority of pesticides to farmers and other agricultural end users. It is estimated that 90 percent of agricultural pesticide product

distributed in refillable containers is distributed or sold by agricu ltural pesticide refillers, and the remaining 10 percent is distributed or sold dire ctly by registrants (Pau lson, 2002). Agricultural pesticide refillers are generally represente d under NAICS 422910 (Farm Supplies and Wholesale Sector), which consists of “establishments primar ily engaged in wholesaling farm supplies, such as animal feeds, fertilizers, agricultural chemi cals, pesticides, plant seeds and plant bulbs” (U.S. Department of Commerce, 1997).

This analysis considers only ag ricultural pesticide refillers, even though the regulations do not prohibit refilling by companies other than regist rants in non-agricultural markets. To represent current business practices, we assumed that all pe sticides in the I/C/G market are repackaged by the registrants and that there are no refillables used in the H&G market/

We extracted the revenue and employee data directly from the D&B database for all establishments with NAICS 422910 designations to generate the industry pr ofile for agricultural pesticide refillers. It is assumed that the financial information extracted from D&B for the

NAICS 422910 market sector is representative of the agricult ural pesticide refiller entities subject to the container regulat ions. As a result, we pulle d 24,360 records from the D&B database, with 21,599 establishments having suffic ient financial data to be included in the analysis. We consolidated these data by Domes tic Ultimate DUNS number in order to aggregate facilities by parent company designation, resu lting in a total of 12,511 unique companies identified. In a few instances where discrepanc ies arise in revenue and employee information at the Domestic Ultimate DUNS level, we used th e maximum values for the D&B data fields “Employees Total” and “Sales Volume (US$)” associated with each Ultimate DUNS number.

We then broke down the D&B sample data set into small and large entity size according to the SBA small business definition for NAICS 422910 (i .e., SBA defines a small business for NAICS 422910 as having 100 employees or fewer). As illust rated in Table D-5, 99 percent of the 12,511 unique parent companies we identified were co nsidered small by the SBA definition. Based on the EPA alternative small business definitions pr esented in Table 3.3, approximately 83 percent were small-small, 14 percent were medium-small, and 2 percent were large-small (see Table D-5). 87

87 Regulated facilities in this analysis are co mpanies rather than individual facilities.Page 219Table D-5. Economic Profile of Agricultural Pesticide Refillers by Entity SizeD&B Sample Data Set for NAICS 422910Agricultural PesticideRefillersEntity SizeCategory DefinitionTotalCompaniesPercent ofTotalCompaniesTotalRevenue forAllCompanies(million)Percent ofTotalRevenueAverageRevenue perCompany(million)AverageNumber ofEmployeesper CompanyTotalEntitiesaTotalRevenue forAll Entities(million)bSBA-Defined SizesLarge 101 or moreemployees114 0.9% $21,842 47.1% $191.60 448 153 $29,322Small 100 or feweremployees12,397 99.1% $24,670 52.9% $1.99 6 16,642 $33,050Total 12,511 100.0% $46,416 100.0% $3.71 10 16,795c$62,372EPA Alternative Small Business SizesdLarge-Small 50 to 100employees187 1.5% $4,246 9.2% $22.71 71 251 $5,700Medium-Small 10 to 49employees1,784 14.3% $12,006 25.9% $6.73 19 2,395 $16,118Small-Small 1 to 9employees10,426 83.3% $8,341 18.0% $0.80 3 13,996 $11,232Total 12,397 99.1% $24,670 52.9% $1.99 6 16,642 $33,050aThe percentage of total companies in the D&B sample data setwas applied to the estimated number of agricultural pesticide refillers used in the analysis.bThe average revenue of agricultural pesticide refillers for each entity size categorywas multiplied by the total number of entities for the given size category.cEPA estimate based on state estimates where available; otherwise,SIC 5191.02 + 5191.14 from the American Business InformationLists of 9 Million Businesses, 1990.The same total number is estimated as presented in the 1999 Supplemental Notice on Standards for Pesticide Containers and Containment (EPA, 1999).dEPA discussed alternative definitions of small businesses for some industry sectors in the 1999 Supplemental Notice on Standards for Pesticide Containers andContainment (EPA, 1999). EPA is concerned that using an overlybroad definition of small business in the economic analysis ofthe container regulations may result insignificant economic impacts on smaller entities that will be camouflaged when combined with information about potential impacts on those facilities that meet the SBAsize standard for small business but are not typical of a small business in that industry sector.

### Page 220 Based on information collected by EPA (see footnote c to Table D-5), it was determined that no one NAICS code was unique to agrichemical d ealers or agricultural pesticide refillers. Therefore, the economic profile for the sample of 12,511 companies was applied to the total universe of 16,795 agricultural pesticide refillers. The estimated number of agricultural pesticide refillers poten tially affected (16,795 companies) is ba sed on the information presented in the 1999 Supplemental Notice (EPA, 1999) and the proposed container rule RIA. This estimate is

considered to be a reasonable estimate for th e current total number of entities potentially

affected.

The number and types of refillable containers associated with agri cultural pesticide refillers that are subject to the repackaging regulations are assumed to be approximately 90 percent of the total for each container size categor y (Paulson, 2002). We duplicat ed the procedure described in steps 3 and 4 of Table D-4 to determine the numbe r of refillable containe rs associated with a representative agricultural pesticide refiller in each SBA and EPA alternative size category. The

total number of containers that fall within the scope of the container re gulations is presented by market sector in Chapter 4 (Table 4.7).

D.3 Swimming Pool Market



### EPA has determined that certain antimicrobi al products are exempt from the container regulations (EPA, 2002a). Contai ner requirements for antimicrobial products that are subject to the rule will primarily affect pesticide registrant s. However, applicator s of sodium hypochlorite used to disinfect pool and spa water (i.e., swimming pool supply companies) have been identified as regulated entities th at will be required to comply with some refillable container and repackaging requirements. Refillable containers for the products must comply with the adopted

DOT standards and bulk container standards (if applicable), bu t not the marking or one-way valve/tamper-evident device requirements. Sw imming pool supply companies must meet certain refilling requirements, but not all. Refillables are required to be inspected and cleaned (unless specified conditions in §165.170 ar e met) and must be properly labeled. Swimming pool supply companies must maintain certain records, but not all. Copies of the residue removal procedures for refilling and description of acceptable containers must be on file, but a record of certain

information recorded each time a container is refi lled (e.g., product, amount) is not required. The partial set of repackaging (refilling) requirements and co mpliance rates are detailed in Chapter 3.

A readily available data source that could be used to charact erize the swimming pool chemical industry impacts associated with the container regulations does not exist. There is no current NAICS code that is specifically devoted to the swimming pool supply industry. Additionally, the Chlorine Institute, National Spa and Pool Institute, and the Swimming Pool Chemical

Manufacturers Association were una ble to provide adequate information. Based on EPA data, we generated a list of 472 company names asso ciated with registered sodium hypochlorite products. The primary NAICS code associat ed with these compan ies is 453998 (All Other Miscellaneous Store Retailers [except Tobacco Stores] – 7.6 percent), and 235990 (All Other Special Trade Contractors – 5.9 percent). To keep SBA small/large business distinctions from becoming too complex, we used establishmen t records with the most common NAICS code designation to characterize the sw imming pool chemical industry.

### Page 221 We consolidated the establishment records with the same Domestic Ultimate DUNS number to estimate the number of potentially affected sw imming pool supply companies (322) at the parent company level. All parent companies having su fficient revenue and employee data were divided into small and large businesses based on the SBA small business size standard for NAICS 453998, which is no more than $6 million in revenue. Once the D&B parent companies were grouped into small and large SBA defined size categories, we di vided the SBA small businesses

into the three EPA alternative small business size categories based on the criteria presented

earlier in Table 3.3.

Table D-6 illustrates the number of affected swimming pool supply companies, by size, and the financial information associated with the averag e company for each given entity size category. The total number of swimming pool supply compan ies subject to the refilling requirements is 322, with nearly all (94.7 pe rcent) of those en tities considered SBA small businesses.

Information is not readily available to estim ate which swimming pool chemical companies use

refillable containers for sodium hypochlorite. Therefore, it is assumed that all swimming pool chemical companies identified will likely be subject to the repackaging requirements. The

number of refillable containers associated wi th representative swi mming pool supply companies were found for each size category based on steps 3 and 4 described in Table D-4. The total

number of containers that fall within the scope of the contai ner regulations is presented by market sector in Chapter 4 (Table 4.7).Page 222Table D-6. Economic Profile ofSwimming Pool Supply Companiesaby Entity SizeD&B/InfoUSA Data Set for 472 Selected Companieswith Registered Sodium Hypochlorite ProductsbEntity SizeCategoryDefinitionTotal CompaniesPercentage ofTotalCompaniesTotal Revenue forall Companies(millions)Percentageof TotalRevenueAverageRevenue perCompanyAverageNumber ofEmployeesper CompanySBA-Defined SizescLarge Revenues greater than $6.0 million 17 5.3% $41,445 98.9% $2,437,954,281 12,119Small Revenues up to $6.0 million 305 94.7% $455 1.1% $1,492,653 13EPA Alternative Small Business SizesdLarge-Small 50 or more employees 14 4.4% $72 0.17% $5,113,298 70Medium-Small 10 to 49 employees 117 36.3% $298 0.71% $2,544,285 20Small-Small 1 to 9 employees 174 54.0% $86 0.21% $494,205 4Totale322 NA $41,900 NA $130,125,720 652aCurrently, only refillable containers usedin the pool chemical industry are considered. These are primarily used for repackaging sodium hypochlorite for commercialand residential pool servicing.bBased on EPA analysis of sodium hypochlorite pesticide registrations.cThe SBA small business size standard is no more than $6 million in revenue for NAICS 453998. The analysis divided the SBA small businesses into the three EPAalternative small business size categories regardless of employee or revenue totals once the regulated entity passed the SBA-defined small business screening.dEPA has not previously proposed alternative definitions of small businesses for swimming pool supply companies. However, EPAis concerned that using an overlybroad definition of small business in the economic analysis ofthe container regulations may result in significant economic impacts on smaller entities that will becamouflaged when combined with information about potential impacts on those facilities that meet the SBA size standard for small business but are not typical of a smallbusiness in that industry sector.eNo employee or revenue data were available for 140 companiesout of the initial 472 companies considered. As a result, thesecompanies have not been included in thissummary table. In addition, 10 companies in the data collectedwere also removed from consideration because they proved to beduplicates of anotherrecord (i.e., theywere found to have the same Domestic Ultimate parent company).

### Page 223 

## Appendix E. 1994 Proposed Rule Co ntainer Standards Costs and Benefits

E.1 Estimated Cost of Proposed Rule Container Standards



### Three regulatory options are ev aluated in the proposed cont ainer and labeling standards: (1) Regulatory Option 1, a low st ringency option, (2) Regulatory Option 2, representing EPA’s proposed minimum standards, and (3) Regulatory Op tion 3, a more stringent option. Under all three options, non-refillable containers must meet general integrity standards; must be marked with the EPA registration number of the pes ticide and the name, sym bol, or code of the material(s) from which the containe r is constructed; must be desi gned so that the container pours in a continuous, coherent stream (doesn’t gl ug), drippage is eliminated, and the container recloses securely; and must have one of four sta ndardized closures to en courage and expedite the use of closed handling systems (if the container is used to hold a pesticide labeled for use in the production of an agricultural commodity). In addition, under Regulatory Option 1, each

container/formulation combination must meet a five-9s (99.999 percent) residue removal standard following a prescribed protocol for testin g and analyzing the rinsat e from a fourth rinse. Under Regulatory Options 2 and 3, a more stringent residue rem oval standard of six-9s (99.9999 percent) must be met. Under Regulatory Option 3, non-refillable containers with a capacity of greater than 5 gallons that are us ed to contain liquid pesticides ar e prohibited; any such container

must be a refillable container and must meet the standards for refillable containers. And finally,

certain certification and recor dkeeping requirements are consiste nt among all three regulatory options. We analyzed two different scenarios und er all three regulatory options, with Scenario 1 assuming that 50 percent of all non-refillable/dilutable formulation combinations will be tested for the residue removal standard, whereas Scenario 2 represents a works-case analysis in that 100 percent of all container/formulation combinations are assumed to be tested for the standard.

Additional requirements for refillable containe rs include, under Regulatory Option 1, no drop tests; under Regulatory Option 2, all minibulk refillable containers must undergo a drop test of 2.6 feet to 3.9 feet, depending on whether the pesticide containe d is dry or liquid; and under Regulatory Option 3, all minibulk refillable containers refillable containers must undergo drop tests per DOT standards, as well as a vibrati on test, lifting device test , stacking device test, hydrostatic test, and leakage test. Additional requ irements for registrants include certification, recordkeeping requirements, and provision of ce rtain materials to refilling establishments, including written residue removal procedures and a written list of acceptable refillable containers for each product. Requirements for refilling estab lishments relative to refillable containers are the same under all three regulatory op tions, including obtaining specified authorization/information from the registrant(s ), container inspection procedures, repackaging procedures, and recordkeepi ng/inspection requirements.

Table E-1 and Table E-2 summarize the estimated costs of the proposed container standards for representative formulator and refiller facilities by market, respectively. Both the annual cost and annual cost as a proportion of annual sales are summarized for all three regulatory options and

for both scenarios in the Tables. Table E-3 summa rizes the total costs of the proposed container standards. Costs are aggregated by regulatory option and scenario for all facilities for both the container and labeling standards.

### Page 224 Table E-1. Summary of Annual Revenue Requirements (ARR) a 

### and ARRs as a Percentage of Sales for Representative Formulating Facilities in Each Market Sector Under Regulatory Options 1, 2, and 3 b 

### and Scenarios 1 and 2 c 

### for the Proposed Pesticide Container Standards (2005$)

Regulatory Option 1 Regulatory Option 2 Regulatory Option 3

ARR ARR/sales ARR ARR/sales ARR ARR/sales Market/Representative Formulator Facility Type ($000) (%) ($000) (%) ($000) (%)

Scenario 1

Agricultural Market Small Agricultural Facility $33 0.6 $35 0.64 $94 1.71 Medium Agricultural Facility $126 0.46 $135 0.49 $223 0.81 Large Agricultural Facility 1 $726 0.19 $796 0.21 $913 0.24 Large Agricultural Facility 2 $801 0.21 $871 0.23 $988 0.26 Large Agricultural Facility 3 $3,331 0.87 $3,401 0.89 $3,518 0.92 Large Agricultural Facility 4 $822 0.21 $892 0.23 $1,009 0.26

Industrial Market Small Industrial Facility $45 0.82 $46 0.84 $304 5.55 Medium Industrial Facility $184 0.67 $190 0.69 $703 2.56

Institutional Market Small Institutional Facility $40 0.72 $41 0.75 $197 3.6 Medium Institutional Facility $133 0.49 $139 0.51 $451 1.65

Household Market Small Household Facility $37 0.67 $38 0.7 $38 0.7 Medium Household Facility $128 0.47 $134 0.49 $134 0.49

Scenario 2

Agricultural Market Small Agricultural Facility $72 1.3 $77 1.4 $135 2.47 Medium Agricultural Facility $228 0.83 $248 0.91 $336 1.23 Large Agricultural Facility 1 $1,313 0.34 $1,452 0.38 $1,569 0.41 Large Agricultural Facility 2 $1,389 0.36 $1,528 0.4 $1,645 0.43 Large Agricultural Facility 3 $3,919 1.02 $4,058 1.06 $4,175 1.09 Large Agricultural Facility 4 $1,409 0.37 $1,549 0.4 $1,653 0.43

Industrial Market Small Industrial Facility $75 1.37 $79 1.44 $337 6.15 Medium Industrial Facility $279 1.02 $292 1.07 $805 2.94

Institutional Market Small Institutional Facility $70 1.28 $74 1.35 $230 4.19 Medium Institutional Facility $228 0.83 $241 0.88 $553 2.02

Household Market Small Household Facility $67 1.23 $71 1.3 $71 1.3 Medium Household Facility $223 0.81 $236 0.86 $236 0.86

a One method for analyzing uneven cost streams is to calculate their equivalent, constant-level cost per year. This equivalent cost is referred to as the annual revenue requi rement (ARR) because the presen t value of such an annual revenue stream would just offset or equal the present value of the cost stream.

### Page 225 Table E-1 (Continued). Summary of Annual Revenue Requirements (ARR) a 

### and ARRs as a Percentage of Sales for Representative Form ulating Facilities in Each Market Sector Under Regulatory Options 1, 2, and 3 b 

### and Scenarios 1 and 2 c 

### for the Proposed Pesticide Container Standards (2005$)

b Regulatory Option 1:

• Five-9s residue removal standard for non-refillables

• No drop test required for refillables

• Other EPA-proposed requirements. Regulatory Option 2:

• Six-9s residue removal standard for non-refillables

• Other EPA-proposed requirements. Regulatory Option 3

• Six-9s residue removal standard for non-refillables

• Non-refillables greater than 5 gallo ns prohibited for liquid pesticides

• Extensive container integrity tests for container design

• Other EPA-proposed requirements.

c Scenario 1: 50% of container/formulation combinations tested for residue removal. Scenario 2: 100% of

container/formulation combinations tested for residue removal.



### Table E-2. Summary of Annual Revenue Requirements (ARR) a 

### and ARRs as a Percentage of Sales for Representative Agricultural Refil ling Facilities in Regulatory Options 1, 2, and

3 b 

### for the Proposed Pesticide Container Standards (2005$)

Regulatory Option 1 Regulatory Option 2 and 3 Representative Agricultural Refilling Facility ARR ($) ARR/Sales (%) ARR ($) ARR/Sales (%)

Small Refilling Facility $314 0.013 $637 0.026

Medium Refilling Facility $618 0.008 $1,263 0.016

Large Refilling Facility $1,491 0.005 $2,999 0.01

a One method for analyzing uneven cost streams is to calculate their equivalent, constant-level cost per year. This equivalent cost is referred to as the annual revenue requi rement (ARR) because the presen t value of such an annual revenue stream would just offset or equal the present value of the cost stream.

b Regulatory Option 1:

• No drop test required for refillables

• Other EPA-proposed requirements. Regulatory Option 2: Other EPA-proposed requirements. Regulatory Option 3:

• Extensive container integrity tests for container design

• Other EPA-proposed requirements.

### Page 226 Table E-3. Total Cost (Annual Revenue Requi rement or ARR) of the Proposed Pesticide Container and Labeling Standards

Container Standards Labeling Standards

Regulatory Option/

Scenario a Formulating Industry (million $) Refilling Industry (million $) Formulating Industry (million $) End User b
(million $) Total ARR (million $)

Regulatory Option 1

Scenario 1 $21.4 $2.6 $5.1 $8.2 $37.3

Scenario 2 $30.4 $2.6 $5.1 $13.6 $51.6
Regulatory Option 2

Scenario 1 $22.2 $4.7 $5.1 $8.2 $40.1

Scenario 2 $32.2 $4.7 $5.1 $13.6 $55.5
Regulatory Option 3

Scenario 1 $87.8 $4.7 $5.1 $8.2 $105.8

Scenario 2 $97.8 $4.7 $5.1 $13.6 $121.1

a Regulatory Option 1:

• Five-9s residue removal standard for non-refillables

• No drop test required for refillables

• Other EPA-proposed requirements. Regulatory Option 2:

• Six-9s residue removal standard for non-refillables

• Other EPA-proposed requirements. Regulatory Option 3:

• Six-9s residue removal standard for non-refillables

• Non-refillables greater than 5 gallo ns prohibited for liquid pesticides

• Extensive container integrity tests for container design

• Other EPA-proposed requirements.

Scenario 1: 50% of container/formulation combinations tested for residue removal. Scenario 2: 100% of

container/formulation combinations tested for residue removal

b For end users only, Scenarios 1 and 2 are not defined as in Footnote a. Rather, Scenario 1 assumes a 60% compliance rate by end users for triple rinsing certain contai ner that have a triple rinse requirement for the first time, and Scenario 2 assumes a 100% compliance rate for triple rinsing the same universe of containers. Household end users account for approximately 85% of the total cost under each scenario, and institutional end users account for approximately 15%.



### E.2 Estimated Benefits of the Proposed Rule Container Standards



### The RIA for the proposed container and labeling standards estimates both direct and indirect benefits (See Chapter 5 for detail s). The direct benefits (see Ta ble E-4) include: (1) health- and environment-related benefits resulting from a re duction in the incidents of container failure and the risks posed by accidental spills of pesticide, leaks, dripping, and the residue remaining in pesticide containers; (2) a quantitative estimate of disposal-related benefits resulting from lower

costs for non-refillable containe r disposal as non-hazardous wast e after triple rinsing (versus disposal as hazardous waste); and (3) several add itional categories of qualitative benefits (e.g., increased worker productivity a nd reduced property damage).

The estimated indirect benefits are associated with the switch from use of non-refillable

containers to refillable containe rs, which are expected (not require d) as a result of the container standards. The types of indir ect cost savings estimated as a result of the switch to refillable containers include: (1) contai ner cost savings, (2) containe r disposal cost savings, and (3) substantial labor savings asso ciated with triple rinsing of used non-refillable pesticide

### Page 227 containers. The sum of indirect benefits is estimated to range from $36.4 million to $109.1 million with a midpoint of $72.8 million.

Table E-4. Estimated Benefits of the Pr oposed Container and Labeling Standards

Benefits Estimated in the Proposed Container Rule

RIA Type of Benefit Estimated Benefits

Health- and EnvironmentRelated Effects EPA estimated that 1,650 to 2,250 acute illness incidents caused by container design/residue removal problems could potentially be avoided annually throughout the United States. In addition, a potentially significant number of unreported acute pesticide poisoning incidents and environmental incidents may

be avoided.

Non-Refillable Container Disposal Effects $5,649,880 to $6,904,800 Direct Benefits

Other Container Design/Residue Removal and Labeling Effects In addition to these quantitative benefit estimates, several additional categories of benefits were qualitatively presented, including potential reductions in liability/insurance costs, increased worker productivity, creation of a lower at-risk work environment, and the potential for reduced property damage from pesticide accidents and improved pesticide management.

Refillable Container Cost-Saving Effects $29,535,145 to $88,605,435

Refillable Container Disposal Cost-Saving

Effects $545,945 - $1,637,835 Indirect Benefits

Refillable Container Labor-Saving (Rinsing)

Effects $6,280,765 - $18,842,295

### Page 228 

## Appendix F. Nationwide and State Re gulations and Standards for Pesticide

Containers

This section will examine the following nationwide regulations or standards:

• U.S. Department of Transportation (DOT) Hazardous Materials Regulations (HMR) (i.e., 49 CFR Parts 107-179);

• United Nation (UN) Recommendations on the Tr ansport of Dangerous Goods (UN, 1999);

• Mid America CropLife Association: MACA- 75 Manufacturer Specifications and User Guidelines for Liquid Pesticides and Othe r Agri-Chemicals Not Subject to U.S. DOT Specification Packaging (MACA, 1992); and

• Existing EPA policy applicable to pesticide containers.

UN recommendations and the MACA-75 specifica tions, which are voluntary, are included because research has shown that the majority of container manufacturers produce containers meeting one or both of these standards. These are viewed by major container manufacturers as necessary rather than optional standards.

Regulations affecting containers and packaging that have been specifically excluded are the

Resource Conservation and Recove ry Act (RCRA) regulations (40 CFR §261.7(b)(3)). Because the container regulations a ddress the usage rather than disposal of containers, there is very little overlap with the RCRA regulations. The only overlap occurs at th e time of container disposal. It is EPA’s intent that containers that are triple rinsed as provided in the container regulations will meet the requirements for “empty” under RCRA at 40 CFR §261.7(b)(3). While there is no specific final residue removal standard for refillabl e containers, users will likely meet one of the removal requirements at §261.7(b) if their contai ner holds a hazardous waste and they wish to avoid regulation under RCRA.

This appendix is organized into seven sections. The first three sections (F.1, F.2, and F.3) present a brief overview of the three ma jor regulations/standards (DOT HMR, UN recommendations, and MACA-75 specifications, respectively). Secti on F.4 describes the container population affected by each of the th ree major regulations/sta ndards. Section F.5 presents the requirements of the major regulations/standards as they compare with the container regulations. Section F.6 presents a summary of existing EPA policie s and regulations that affect the baseline container regulation compliance rate. The final section (F.7) presents a summary of existing state regulations and standards for pesticide containers.

F.1 Department of Transportation Hazardous Materials Regulations



### The DOT HMR apply to the interstate (and in some cases, intrastate) transportation of hazardous materials in commerce (DOT, 1996). In gene ral, the DOT HMR specify requirements for packaging, classification, handling, transport, h azard communication, and incident reporting of

hazardous materials. The HMR are enforced by the Federal Highway Administration, the Federal Aviation Administration, the Federal Railro ad Administration, and the U.S. Coast Guard.

The DOT HMR hazard class definitions are generally aligned with nine risk classes used in the

UN recommendations described in the next subsection. Under this classification system,

### Page 229 pesticides primarily fall under Hazard Class 6, Division 6.1, although some may also meet the

criteria for flammable material s (RTI, 1989). Hazard Class 6 uses a definition related to oral, dermal, and inhalation toxicity, similar to th at for the UN recommendations. The HMR also contain 20 UN performance-oriented packagi ng standards for non-bulk containers. These requirements contain general standards for specifi c types of packaging such as plywood drums, plastic drums and jerricans, 88 

### fiber drums, and steel jerricans. In addition, there are testing standards that apply to all non-bulk packaging types. Th ese requirements follow the UN

recommendations for non-bulk cont ainers and include the following tests: drop, leakproofness, hydrostatic pressure, and stacking. Non-bulk pa ckaging used for hazardous materials in the United States must also be capable of withstanding a vibration standard that is not included in the

UN recommendations.

The HMR prescribe various performance levels in packaging hazardous materials based on the level and nature of hazards posed by the material to be packaged. All packaging, regardless of type, must be designed so that under normal conditions of transport, no contents will be released. Also, the containers must be designed so that the effectiveness of the packaging will not be substantially altere d by temperature.

The DOT HMR requirements apply regardless of wh ether the container is refillable. If a container is refillable, it must also meet the reuse provisi ons found at 49 CFR §173.28, which require inspections before reuse, and the follo wing provisions for non-bul k containers: retesting of liquid packaging for leakproofness, durable marking, and minimum thickness criteria for metal and plastic drums and jerricans. The DOT HMR also contain requirements regarding the reconditioning and remanufactur ing of non-bulk packaging.

Portable tanks are subject to 49 CFR §173.32, wh ich addresses “Qualificat ion, maintenance and use of portable tanks other than Specification IM portable tanks.” Th ese provisions contain recordkeeping, retesting, and container/material compatibility requirements, some of which are required by tank specification (e.g ., DOT Specifications 56, 57, and 60). There are special requirements for containers constructed before May 15, 1950, as well as provisions addressing deteriorated, damaged, and unused tanks. There ar e also additional requirements for these tanks at 49 CFR §§173.32a, 173.32b, and 173.32c addre ssing the approval of Specification IM portable tanks, the periodic testing and inspection of these tanks, and requirements regarding

their use.

F.2 United Nations Recommendations on the Transport of Dangerous Goods



### The UN Recommendations on the Transport of Dangerous Goods were developed by the UN Committee of Experts on the Transport of Dangerous Goods (1999). While these recommendations address dangerous goods that are shipped internationally, they also affect containers shipped domestically. Many pack aging manufacturers are beginning to follow portions of these recommendations for containe rs shipped domestically. Additionally, some companies ship both domestically and internatio nally, and the containers used meet both the UN

recommendations and the DOT HMR discussed in the previous subsection. The DOT design

88 A jerrican, as defined by the DOT HMR, is a metal or plastic “packaging” of rect angular or polygonal crosssection (49 CFR 171.8).

### Page 230 specification packaging system was accepted in international trans port under transitional provisions which expired on December 31, 1990; after that date, the packaging for most hazardous materials in international transport we re required to conform to the UN standards (55 FR 52404). As of October 1996, UN performance- oriented packaging standards added to the DOT Hazardous Materials Regulations (HMR) by HM -181 were fully in effect (Deadrick, 1992; 55 FR 52408 and 52473-52474).

The UN recommendations classify dangerous goods in to nine risk classes. For each class, there is a set of criteria; any substan ce meeting those criteria is consid ered in that class. Class 6— Poisonous (toxic) and Infectious Substances—i s the class where many pesticides would fall. 89 

### A material is a Class 6 poison if it is “liable to e ither cause death or serious injury or to harm human health if swallowed, inhaled or by sk in contact” (UN Committee of Experts on the Transport of Dangerous Goods, 1999, p. 97). Di vision 6.1 specifically addresses poisonous (toxic) substances; Chapter 2.6 in the gui dance document on the UN recommendations (UN Committee of Experts on the Transport of Da ngerous Goods, 1999), which addresses Division 6.1, includes a section that allows shippers of pesticides to determine which of three Packing Groups is appropriate for their material. Many of the pesticides listed ar e insecticides because they tend to be more toxic to humans than either herbicides or fungicide s. The three Packing Groups—I, II & III—are based on to xicity classifications: the leth al dose to 50 percent of the sample population (LD 50 

### s) for oral and dermal activity and th e lethal concentration to 50 percent of the population (LC 50 

### ) for inhalation activity. Packing Gr oup I contains the most toxic materials. The criteria for these groups are shown in Table F-1.

Table F-1. Grouping Criteria for Admi nistration Through Oral Ingestion, Dermal Contact, and Inhalation of Dusts and Mists

Packing Group Oral Toxicity LD 50 (mg/kg) a Dermal Toxicity

LD 50 (mg/kg) a Inhalation Toxicity by

Dusts and Mists

LC 50 (mg/l) b

I ≤ 5 ≤ 40 ≤ 0.5

II >5-50 >40-200 >0.5-2

III c Solids: >50-200 Liquids: >50-500 >200-1,000 >2-10

Source: UN Committee of Experts on the Transport of Dangerous Goods (1999).

a Lethal dose to 50% of the sample population.

b Lethal concentration to 50% of the sample population.

c Tear gas substances should be included in Packing Group II even if their toxicity data correspond to Packing Group III values.

89 Some may meet the criteria for a flammable substance an d be placed in either Class 3 - Flammable liquids or Class 4 - Flammable solids, or possibly Class 8 - Corrosives (RTI, 1989; EPA, 2005).

### Page 231 The UN recommendations contain standards for two different container size groups:

• Non-bulk packaging, which has a net mass of 882 lbs (400 kgs) or less, and whose capacity is 119 gals (450 L) or less, and

• Intermediate bulk containers (IBCs), which are rigid or flexible portable packagings with a capacity of not more than 500 gals and are not included in non-bulk packaging. 90



### The recommendations for both non-bulk containe rs and IBCs include permanent marking, construction standards, and performance tes ting—including drop, leakproofness, hydraulic pressure, and stacking tests. IBCs must also meet bottom lift and top lift testing. There are also special tests that flexible containers (e.g., bags) must meet (UN Co mmittee of Experts on the Transportation of Dangerous Goods, 1999).

F.3 Mid America CropLife Associ ation (MACPA): MACA-75 Manufacturer Specification and User Guidelines for Portable Agrichemical Tanks



### The Mid America CropLife Association has adopted the MACA-75 standards for the conglomerate of regional crop prot ection associations represented at the national level. MACPA was formerly known as the Midwest Agricultur al Chemicals Association (MACA); hence the

MACA-75 standards have retained their title by recogni tion of the association’s former name. These specifications were developed by MACA ’s Bulk Pesticide Task Force Committee, because MACA recognized that the majority of pesticides sold were not considered DOT

hazardous material. 91 

### The lack of regulation could result in certain tanks (especially minibulks) being used to transport pesticid es even though the tanks were not of a design or construction that allowed for safe movement over the highway (MAC A, 1986). The eventual consequences of this lack of regulation could be envi ronmental pollution, severe gove rnment regulation, bad publicity, and potentially large civil liabil ities to the pesticide industry. To avoid these consequences, MACA developed the MACA-75 tank specifications , which apply to containers of 60 to 660 gallons. While MACA is only one of several regi onal agricultural chemical associations across the country, its tank specifications and user gui delines have become accepted nationally and are the standards used by many container manuf acturers (MACA, 1992, 1986; Bartenhagen, 1992; Snyder Industries, 1992).

The MACA-75 specifications include general construction requirement s regarding minimum strength, openings that allow for internal visu al inspection, and handli ng characteristics (tiedown/loading design features). Standards are al so included to address appurtenances, closures, plumbing connected to the tank, and emergency pr essure relief devices. Tanks designed under MACA-75 specifications must m eet a series of qualification tests, including vibration, leakproofness, drop, lifting device, base support structure, stacki ng, and hydrostatic testing.

90 In the UN Recommendations on the Transport of Dangerous Goods (UN, 1999) no lower limit is given for IBCs, but the definition of IBCs states “other than those [non- bulk packagings] specified in Chapter 6.1.” Thus, it would appear that the IBC’s lower capacity limit is 450 L.

91 At the time the MACA standards were developed, DOT used a different classification system from the nine hazard classes introduced by HM -181. Then, pesticides considered DOT h azardous materials were mostly classified as Class B poisons, flammable liquids, or combustible liquids. EPA felt that the number of pesticides covered was 20-25 percent of all pesticides; HM-181 has probably incr eased the number of pesticides included. Herbicides still comprise a major portion of those pesticides not covered because they tend not to be as toxic to mammals as many

insecticides.

### Page 232 F.4 Container Population Affected by the container regulations and the Three Major National Regulations/Standards



### To better understand the compliance baseline, we compared the aff ected pesticides and pesticide container populations of the three major regulations/standards (i.e., DOT HMR, UN

Recommendations on the Trans port of Dangerous Goods, and MACA-75 Guidelines) to the container regulations. Table F-2 summarizes th e affected container population for the three major sets of regulations/standards.

Both the DOT HMR and UN recommendations co ver pesticide containers that (1) are transported, and (2) hold pesticid es that are highly toxic (i.e., LD 50 

### of 200 mg/kg or less for solids and 500 mg/kg or less for liquids) or m eet the DOT HMR/UN criteria for a flammable or

corrosive material. The DOT HMR regulate these containers, either through direct regulation or exemption, regardless of container size or whet her the container is re fillable. The MACA-75 specifications primarily affect containers that (1 ) contain liquid agricultura l pesticides of lower toxicity (e.g., most herbicides , and certain fungicides and insect icides that are not considered DOT hazardous materials) that are not DOT HMR fl ammable or corrosive materials, (2) are of sizes 60 to 660 gallons, and (3) are used in the agricultural market. Thus, based on this combination of requirements, recommendations, a nd voluntary standards, t hose containers that are currently not subject to marking, construction, or performance standards include:

• Containers of 60 gallons or less, holding liquid pesticides that are used in the agricultural market and are not DOT hazardous materials;

• Containers holding dry pesticides that are used in the agricu ltural market and are not DOT hazardous materials;

• Containers of any size holding liquid and dry pesticides that are used in non-agricultural markets and are not DOT hazardous materials; and

• Bulk containers containing any pesticides that are not transp orted. (Some states have

standards for stationa ry bulk containers.)

These containers are subject to the full effects of the final container regulat ions in that they are effectively starting from a “no standards” baseline and will become subject to the full requirements of the regulations.Page 233Table F-2. Scope of Container Regulations VersusScope of Other National Regulations and StandardsContainer RegulationsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on theTransport of Dangerous GoodsMACA-75ManufacturerSpecification and UserGuidelinesPesticidesAffected Other than manufacturing useproducts (MUPs), plant-incorporatedprotectants, and exempt antimicrobialproducts, all pesticide products aresubjectto the non-refillable containerregulations. A product is subject toall non-refillable containerrequirements if it satisfies at least oneof the following criteria:(1) It meets the criteria of ToxicityCategory I.(2) It meets the criteria of ToxicityCategory II.(3) It is a restricted use product.If it doesn’t meet any of these criteria,the product is subject to only the basicDOT requirements in the nonrefillable container regulations.Other than MUPs, plant-incorporatedprotectants, and exempt antimicrobialproducts, all pesticide productsaresubject toall of the refillablecontainer and repackagingregulations.Pesticides that meet the definition of ahazardous material in 49 CFR §171.8Those meeting UN risk classdefinitions 1–9 (i.e., most inclass 6, Division 6.1 ToxicSubstances). Includes pesticideswith oral LD50<500 mg/kg forliquids and 200 mg/kg for solids.DOT Packing Group I and IIpesticides are primarily included.Some pesticides may also meetcriteria of flammable orcorrosive material.Agricultural pesticides,with exceptions (seebelow).Page 234Table F-2 (Continued). Scope of Container Regulations Versus Scope of Other National Regulations and StandardsContainer RegulationsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on theTransport of Dangerous GoodsMACA-75ManufacturerSpecification and UserGuidelinesUnaffected The followingthree categories ofpesticide products are not subject tothe non-refillable container, refillablecontainer, and repackagingregulations:(1) Manufacturing use products;(2) Plant-incorporated protectants; and(3) Antimicrobial pesticide productsthat satisfy all four of these criteria:•The product is an antimicrobialpesticide, as defined in thecontainer regulations Section2(mm), or it has antimicrobialproperties, as defined in thecontainer regulations Section2(mm)(1)(A), and is subject to atolerance or a food additiveregulation.•Its label includes directions foruse on a site in at least one of the10 antimicrobial product usecategories identified as“household, industrial orinstitutional.”•It is not a hazardous waste whenit is intended to be disposed, asdefined in 40 CFR Part 261.•It is not specifically included inthe regulations by EPA.Pesticides thatdo notmeet the hazardousmaterial definition in 49 CFR §171.8.Those pesticides that do not meetUN risk class definitions 1-9.Liquid pesticides andother agrichemicalssubject to DOTspecification packaging.Container Type/SizeRefillable All containersfilled and refilled witheligible product more than once.No distinction between refillable and nonrefillable containers with regard to specificNo distinction between refillableand non-refillable containersNo distinction betweenrefillable and non-Page 235Table F-2 (Continued). Scope of Container Regulations Versus Scope of Other National Regulations and StandardsContainer RegulationsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on theTransport of Dangerous GoodsMACA-75ManufacturerSpecification and UserGuidelinesNonRefillableContainers that are designed andconstructed for one-time filling onlywith eligible pesticide.requirements; however, DOT refers to “reuse”of containers.with regard to specificrequirements.refillable containers withregard to specificrequirements.Non-Bulk No regulatory distinction betweennon-bulk and bulk with regard torequirements.Packaging that has: (1) a maximum capacityof 450 L (119 gallons) orless as a receptaclefor a liquid; (2) a maximum net mass of 400kg (882 pounds) or less and a maximumcapacity of 450 L (119 gallons) or less as areceptacle for a solid; or(3) a water capacityof 454 kg (1,000 pounds) or less as areceptacle for a gas as defined in §173.115.(§171.8)Net mass≤400 kgCapacity≤450 L(6.1.1.1)Does not specify.Bulk No regulatory distinction betweennon-bulk and bulk with regard torequirements.Bulk packaging means a packaging, otherthan a vessel or a barge,including a transportvehicle or freight container, in whichhazardous materials are loaded with nointermediate form of containment and whichhas:(1) A maximum capacity greater than 450 L(119 gallons) as a receptacle for a liquid;(2) A maximum net mass greater than 400 kg(882 pounds) and a maximum capacity greaterthan 450 L (119gallons) as a receptacle for asolid; or(3) A water capacity greater than 454 kg(1,000 pounds) as a receptacle for a gas asdefined in §173.115.(§171.8)IBC defined as rigid or flexibleportable packagings other thanthose specified in Division 6.1that (A) have a capacity of:(i) Not more than 3,000 L forsolids and liquids of PackingGroups (PG) II and II;(ii) Not more than 1.5 m3forsolids of PG I when packed inflexible, rigid plastics,composite, fiberboard, andwooden IBCs;(iii) Not more than 3.0 m3forsolids of PG I when packed inmetal IBCs; and(iv) Not more than 3.0 m3forradioactive material of Class 7.(1.2.1)60–660 gallons

### Page 236 F.5 Detailed Comparison of the Pesticide Container Regulations and the Three Major Regulations/Standards



### The container regulations under c onsideration include several com ponents. This section details 13 major components of the cont ainer regulations and compares them to the relevant requirements of the DOT HMR, UN recommenda tions, and MACA-75 sp ecifications. Each component is discussed separately below.

F.5.1 Design Standards



### The container regulations adopt the DOT HMR packaging standards for pesticides classified as

DOT hazardous materials. Pesticides that are not classified as DOT hazardous materials are required to be packaged in accordance with the specified design and construction standards that would apply to a DOT Packing Group III material . Under the container regulations, sale or distribution of pesticides in c ontainers not meeting the DOT sta ndards for design, construction, and markings is prohibited, and registrants are held responsible for, but are not required to report, the design standards.

The container regulations incorporate a provision similar to the DOT limited quantity exceptions that provide exceptions parallel to those in th e DOT HMR. The integrity use and compatibility standards of the DOT HMR are incorporated into the container regulation s with the exception of additional requirements in the container regulations for bulk refillable containers for appurtenances and listing of compatible containers for pesticide formulations.

The UN recommendations and the MACA-75 specifications are mu ch more specific. The UN

recommendations contain detailed construction requirements by container/material grouping. These requirements address which construction materials can be used; the design of openings and closures; seams; and, in some cases, mi nimum allowable material thickness. MACA-75 specifications are somewhat more general, but the requirements are more detailed than the container regulations and address minimum strength, handling characteristics, and draining/cleaning capability.

F.5.2 Permanent Markings



### All of the current regulations/standards examined require some form of permanent marking on each container; however, each regulation/standard va ries somewhat in the information required. The container regulation requirements for non-refillables and refillables refer to and adopt the DOT standards. Additionally, container regulati ons require a serial number or other identifying

code for each non-refillable container.

The information requirements that are common between the refillable container requirements and the regulatory/standar ds baseline are: manufacturer name or symbol, year of manufacture, and name or symbol (code) of materials the container is made from. The UN IBC recommendation calls for a marking that signifies conformity to design type . Serial number and capacity rating are required only under the EP A requirements and MACA-75 specifications.

### Page 237 F.5.3 Dispensing Capability



### The container regulations stipulate that containe rs with a capacity greater than 20 liters (5.3 gallons) need to be designed to eliminate the splash and leakage during normal pouring of the contents, closing or resealing of the containe r, and storage and cleaning of the container.

The other three regulations/recomm endations primarily mention disp ensing capability in terms of cleaning and storing. MACA-75 r ecommends that tanks be desi gned so that, when necessary, they can be totally drained.

F.5.4 Closures



### Safe use of pesticide containe rs extends to closed systems (also known as closed transfer systems). All four nationwide standards are similar in that they each discuss regulations/ recommendations for proper container closures. E ach standard specifies in some fashion that containers must be equipped with closures that will be secure and leakproof. However, EPA’s regulations are the most specific about specific closure sizes (see Table F-3 for more details).

F.5.5 Residue Removal Design Standard



### Only the MACA-75 guidelines specify a standa rd for residue removal for non-refillable

containers. The MACA-75 standard applies to bulk tanks and stat es that containers should be designed to allow the product to completely drain out of the tank. With regard to non-refillable containers, the container require ments specify that each rigid/d ilutable container/formulation combination must achieve a certain laboratory pe rformance standard (a re duction of the original active ingredient concentrate to .01 percent in a fourth rinse or equivalent to 99.99 percent removal). This specification, of course, does not guarantee that these containers will be rinsed to this level by the end user in th e field before c ontainer disposal.

While the UN recommendations, the DOT HMR, and the MACA- 75 specifications all address residue removal from refillable containers, th e container regulations are the most specific regarding how much must be removed a nd how it should be removed. The UN recommendations state only that th e container should be “purged” of its former contents before refilling; no procedures are specif ied. The DOT HMR state that be fore the container is refilled, it must “be free from incompatible residue.” The MACA-75 specifications recommend that each portable tank be kept in dedica ted service to one product “in or der to reduce contamination and content-disposal problems.” If the container must be used fo r another product, the container must be examined “to determine presence of prev ious product and then “all of the residue from the former loading” must be cleaned out.

The container regulations require that the every re gistrant test three containers from each rigid

container/dilutable formulation combination to determine that the containers are capable of attaining at least 99.99 percent removal of each ac tive ingredient in the fourth rinsate after a triple rinse.

F.5.6 Production Testing



### The container regulations do not specify producti on testing requirements. However, by adopting DOT HMR design standards, the container regula tions indirectly include production testing for

### Page 238 performance of drop, leakproofness, hydrostatic pressure, stacking, and cooperative tests (as applicable) for each new or different packaging.

For non-bulk containers, DOT HMR (or the cont ainer regulations) and UN recommendations require sampling of 3–6 containers, whereas the MACA-75 guidelines do not specify. For bulk containers, the container and DOT regulations require representa tive samples of all design types, while the UN recommendations and MACA-75 speci fications suggest using one container. The DOT HMR (or container regulat ions) filling requirements are the same as the UN

recommendations and similar to the MACA-75 specifications. Drop testing requirements for DOT (or container regulations) are similar to the UN recommendations, while the MACA-75 specifications only state that the standard is two feet.

F.5.7 Production Retesting



### Rather than directly specifyi ng, the container regulations adopt DOT HMR standards for an interval for repeating production testing. Th e product retesting intervals for DOT HMR bulk is every year, but varies according to the container specifications. For example, each IBC must be tested in accordance to the leakproofness test and visually inspected every 2.5 years. Under the UN recommendations, retesting of a particular co ntainer design must be conducted at intervals established by a “competent aut hority.” The MACA-75 specifi cations do not address product retesting for the container design.

The non-bulk DOT HMR is the only set of require ments requiring a leakproofness test before reuse of each container. The MACA-75 speci fications and the UN r ecommendations specify rerunning a leakproofness test on ta nks at least every 2 years and 2.5 years, respectively. The DOT HMR specifications for non-bulks require that each tank must be fully retested every 2

years.

F.5.8 Reconditioning



### Only the UN recommendations and the DOT HMR have specific reconditioning standards. Under the UN recommendations, containers (incl uding non-bulks) must be capable of passing all appropriate performance tests, a nd each one must undergo the lea kproofness test before it can be reused for transport. The DOT HMR contain specific requirements fo r reconditioning metal drums and require that all other reconditioned co ntainers be capable of meeting all non-bulk performance standards. A rec onditioned container must have a permanent mark representing a

certification that the reconditioned container c onforms to the DOT HMR standards for that container design.

F.5.9 Waiver



### None of the nationwide standards except the container regulations sp ecify a procedure for obtaining a waiver for all or parts of the regula tion or standard. The container regulations include procedures for allowing a waiver of co mpliance for portions of the regulation based on the registrant’s capacity to demonstrate that th e container meets or exceeds DOT standards for

hazardous materials.

### Page 239 F.5.10 Recordkeeping



### EPA container records requirements are more extensive than those of the baseline. The regulations require several types of recordkeeping. The first addresses the documentation that

the container used meets each as pect of the non-refillable contai ner design standards. For nonrefillables, the period extends for as long as the container design type is used with the registered pesticide product, plus 3 years. The second type of recordkeeping requ irement involves records kept by the registrants regarding repackaging. Th e registrants are required to keep copies of the contracts or authorizations, residue removal pr ocedures for refilling, and list of acceptable containers for the current operating year and for 3 years after.

The third type of recordkeeping involves refillers keeping copies of the documents identified in the previous paragraph for the registrants for th e current operating year a nd for 3 years after (as with the registrant recordkeepi ng). The fourth type of recordke eping involves information the refillers have to record when they repackage and when they receive refillable containers. Refillers must record three pieces of information when a pesticide is repackaged. No recordkeeping is required when a refillable contai ner is received. These records must be kept for 3 years.

The UN recommendations, the DOT HMR, a nd the MACA-75 specifications have no requirements analogous to the second type of reco rdkeeping. Relative to the first type, however,

the UN recommendations for IBCs do include reco rdkeeping provisions but only to the extent that a report should be kept of each inspection. This report shoul d be retained at least until the date of the next inspection. Testing records also are reco mmended. The MACA-75 standards are similar, stipulating written r ecords of the annual inspections. The results of the 2-year test for leakproofness must also be kept by tank serial number. The DOT HMR currently require records only for non-bulk packagi ng. These records are limited to information regarding the design qualification testing, includ ing documenting the types of test s conducted; dates; locations; packaging specifications; test specifics (e.g., drop heights, hydrostatic pressures); results; and test operators’ names or name of the person responsible for testing each packaging at each location where that packaging was manufactured; a nd at each location wher e design qualification

tests are conducted. This information must be retained for as long as the packaging is produced and for at least 2 years thereafter. Similar informa tion must be kept for periodic retesting. This information must be kept until such tests are performed successfully again and for at least 2 years

from the date of each test.

F.5.11 Refilling



### The container regulations contain a great amount of detail regardi ng refilling, including specific guidelines for registrants and refillers. For exam ple, registrants who dire ctly sell or distribute pesticide products in refillables or sell or distribute pesticide pr oducts to refillers for repackaging are held responsible for providing instructions and documentation for refilling. Refillers who package or repackage pesticide products into refi llable containers for distribution or sale must comply with the residue removal procedure for refilling developed by registrants and repackage any quantity of a pesticide product into a refilla ble container up to the rated capacity of the container. In addition, refillers must inspect the ex terior and interiors of the containers to ensure that the container meets the necessary criteria with respect to cont ainer integrity, required markings, and openings; and clean each refillable container according to the pesticide product’s

### Page 240 residue removal procedure for refi lling before repackaging the produc t, unless certain criteria are

met.

With regard to refilling, the UN and DOT regulat ions are much less detailed than the container regulations. They both specify that each package must be inspected before reuse. The MACA-75 specifications also refer to refilling recomme ndations only in terms of inspection. They

recommend that fillers examine the tank to determ ine the presence of any residue of the previous product to prevent contamination and clean out resi due of the former lading if the tank must be refilled with another product.

An inspection prior to refilling is required under the container regulations and under each of the regulations/standards included in the baseline. The container regulations and the MACA-75 standards are the most detailed with regard to how the inspection s hould be conducted. The MACA-75 standards also specify a thorough exte rior/interior inspecti on annually (or at the beginning of each use season), and on a 2-year ba sis, an inspection that includes retesting for leakproofness. The UN recommendations for non- bulk containers include inspection before each filling, and, for certain container types, (e.g., ri gid metal and plastic containers) inspections every 2.5 years to the “satisfaction of the competent authority” with rega rd to external conditions of the container and proper functioning of service equipmen t. Every 5 years, these containers are also inspected to the satisfaction of the competent authority, to determine:

• Conformance to design t ype, including marking;

• Internal and external conditions, and

• Proper functioning of service equipment.

DOT standards (both the specifications and non-bul k packaging) indicate that on inspection the

container must not show a reduction in inte grity (non-bulks) and mu st be “free from incompatible residues, rupture or other damage which reduces its [the container’s] structural integrity.” The container regulations require a tamper-evident device for containers holding liquids, and the MACA-75 standard s specify an anti-backfilling device for such containers. These devices must be checked before each refilling.

F.5.12 Labeling



### Labeling requirements were originally consider ed under the proposed cont ainer and containment regulations in the 1994 proposed container rule. In this section, la beling requirements are compared with existing standards as referenced in the 1994 Proposed Rule.

The Proposed Rule adopted PR Notice 83-3 re commendations (EPA, 1983), which provided the pesticide user certain statements and instruct ions on the container la bel for pesticide and container storage and removal. Additionally, cont ainer regulations require container labels to include the product’s intended use and registration number and cont ainer type information.

The DOT HMR require containers to be labeled with general sp ecifications pertaining to the nature of the hazard of the product. UN recomme ndations also requires a statement on the label regarding the primary and secondary risk s of the product. The DOT HMR or UN recommendations do not contain labeling specifi cations for product or container storage and

### Page 241 disposal nor a unique identifier to track the product. MACA- 75 specifications do not include labeling.

Table F-3 presents a side-by-si de comparison of the 13 requirement categories and subcategories between the container regulations and the three major regulations/standards.Page 242Table F-3. Comparison of Container Regulationswith Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRefillableRequirementNon-RefillableMinibulk BulkBulk and IBC Non-Bulk Non-Bulk IBC BulkDesignStandardsRequirementsProhibitdistribution orsale of pesticideproduct in nonrefillablecontainer unlessthe container metstandard.(§165.42)Container mustmeet DOTstandards fordesign,construction, andmarkings inaccordance withPacking GroupIII material asdefined by DOT.(§§165.60–165.64)Prohibit distribution or sale of pesticideproduct in refillable container unlesscontainer met standard.(§165.92)Container must meet DOT standardsfor design, construction, and markingsin accordance with Packing Group IIImaterial as defined by DOT.(§§165.60–165.64)Specific construction requirements for the 20packaging types, including seams, opening/closingsizes and types, compatibility of container andmaterials, construction materials (§§173 (e.g.,173.24) 178, 180)Specific constructionstandards by containertype (e.g., steel drums,plastic drums, andjerricans), including:opening size, seams,construction materials,etc.(6.1.4)(1) Resistant to orprotected fromdeterioration.(2) Constructed so thatcontents can’t escapeunder normal conditions.(3) Gaskets made ofmaterials not subject toattack by the contents ofthe IBCs.(4) All service equip.positioned or protected tominimize risk of escapeor contents owing todamage.(5) Designed to withstandinternal pressure ofcontents and stresses ofnormal handling andtransport.(6) Specific constructionrequirements bycontainer type.(7) Each IBC capable ofpassing relevantperformance tests.(6.5.1.5)Examples:(1) Constructionmaterials (1.2.1)(2) Minimum strengthrequirements (1.3.1)(3) Inspectionopenings (1.3.2)(4) Fork-liftable(1.3.3)(5) Fastening/blockingfor transport (1.3.4)(6) Pressure releasevalve (1.4.4)(7) Seal to verifytank/content integrity(1.4.5)(8) Appurtenanceprotection (1.4.3)(9) Draining/cleaningcapability(1.3.6)Page 243Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkReporting No reportingunder theseregulations.Refer tostandards underthe containerregulations6(a)(2) todetermine ifincidentsinvolvingcontainers arereportable toEPA. (§165.80)No reporting under these regulations.Refer to standards under the containerregulations 6(a)(2) to determine ifincidents involving containers arereportable to EPA. (§165.130)Each carrier that transports hazardous materials shallreport in writing to DOTwhen there has been anunintentional release of hazardous materials or anyquantity of hazardous materials has been dischargedduring transportation. (§171.16)None. A report of eachinspection of conformityto design type kept untildate of next inspection.(6.5.1.6.4(b))Not specified.Responsibility Registrants.(§165.42)Registrants. (§165.92) Manufactureror any person who performs a functionprescribed in this part shall perform that function inaccordance with this part.§178.2(a)(2)Not specified. Not specified. Not specified.Integrity - Use Not specified. Not specified. Each liquid and drybulk container andits appurtenancesmust meet thefollowingstandards:(1) Be resistant toextreme changes intemperature andconstructed ofmaterialsadequately thick tonot fail and beresistant tocorrosion, puncture,or cracking; and(2) Capable ofwithstanding alloperating stresses.(§165.120(a))Each package used forthe shipment ofhazardous materials shallbe designed, constructed,maintained, filled, itscontents so limited, andclosed, so that underconditions normallyincident to transportation:(1) Except as otherwiseprovided, there will be noidentifiable (without theuse of instruments)release of hazardousmaterials to theenvironment;(2) The effectiveness ofthe package will not besubstantially reduced; forexample, impactresistance, strength,packaging compatibility,Each package used forthe shipment ofhazardous materials shallbe designed, constructed,maintained, filled, itscontents so limited, andclosed, so that underconditions normallyincident totransportation-(1) Except as otherwiseprovided, there will be noidentifiable (without theuse of instruments)release of hazardousmaterials to theenvironment;(2) The effectiveness ofthe package will not besubstantially reduced; forexample, impactresistance, strength,Specific requirementsaccording topackaging typerelating tocontainers designed sothat they remainsecure and leakproofunder normalconditions oftransport. (6.1.4)Resistant to and protectedfrom deterioration fromexternal environment.(6.5.1.5.1)None of the contents canescape under normalconditions of transport.(6.5.1.6.2, 6.5.1.5.6)Minimum strengthrequirements andhandling requirements.(1.3)Page 244Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC Bulketc. must be maintainedfor the minimum andmaximum temperaturesencountered duringtransportation;(3) There will be nomixture of gases orvapors in the packagewhich could, through anycredible spontaneousincrease of heat orpressure, significantlyreduce the effectivenessof the packaging.(§173.24(b))(4) Additional integrityrequirements forIntermediate BulkContainers (§178.704)packaging compatibility,etc. must be maintainedfor the minimum andmaximum temperaturesencountered duringtransportation;(3) There will be nomixture of gases orvapors in the packagewhich could, through anycredible spontaneousincrease of heat orpressure, significantlyreduce the effectivenessof the packaging.(§173.24(b))Page 245Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkIntegrity -CompatibilityNot specified. Registrantsdevelop a description ofacceptable containers, which are thosethat meet the standards in Subpart Dand are compatible with the pesticideformulation. (§§165.164(b) and165.190(b))(1) Even though certain packages are specified in thispart, it is, nevertheless, the responsibility of theperson offering a hazardous material fortransportation to ensurethat such packages arecompatible with their lading.This particularly appliesto corrosivity, permeability, softening, prematureaging and embrittlement.(2) Packaging materials and contents must be suchthat there will be no significant chemical or galvanicreaction between the materials and contents of thepackage.(3) Plastic packages and receptacles must be of a typecompatible with the ladingand may not be permeableto an extent that a hazardous condition is likely tooccur during transportation,handling or refilling.Each plastic packaging orreceptacle which is usedfor liquid hazardous materials must be capable ofwithstanding without failure the procedure specifiedin appendix B of this partAlternative procedures or rates of permeation arepermitted if they yield a level of safety equivalent toor greater than that provided by paragraph§173.24(e)(3)(ii) of this section and are specificallyapproved by the Associate Administrator forHazardous Materials Safety.Construction shouldbe appropriate to itsintended use (6.1.4)IBCs and closuresconstructed withmaterials compatiblewith their contents so notliable(1) to be attacked bycontents so as to maketheir use dangerous or(2) cause contents toreact or decompose, orform harmful ordangerous compoundswith IBCs (6.5.1.5.3)Each tank must bemade of materialshaving performancecharacteristics suitableto their application(1.2.1)(4) Mixed contents. Hazardous materials may not bepacked or mixed together in the same outerpackaging with other hazardous or non-hazardousmaterials if such materials are capable of reactingdangerously with each other and causing combustionor dangerous evolution of heat;evolution of flammable, poisonous, or asphyxiantgases; orformation of unstable or corrosive materials.(5) Packagings used forsolids, which may becomeliquid at temperatures likely to be encountered duringtransportation, must be capable of containing thehazardous material in the liquid state. §173.24(e)Page 246Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkPermanentMarkingsNot specified. Serial number or other identifying codefor each container (§165.116)Each packaging represented as manufactured to aDOT specification or a UN standard must be markedon a non-removable component of the packagingwith specification markings conforming to theapplicable specification, and with the following:(1) In an unobstructed area, with letters, andnumerals identifying the standards or specification(e.g., UN 1A1, DOT 4B240ET, etc.).(2) Unless otherwise specifiedin this part, with thename and address or symbol of the packagingmanufacturer or, where specifically authorized, thesymbol of the approval agency certifying compliancewith a UN standard. Symbols, if used, must beregistered with the Associate Administrator forHazardous Materials Safety. Duplicate symbols arenot authorized.(3) The markings must be stamped, embossed,burned, printed or otherwise marked on thepackaging to provide adequate accessibility,permanency, contrast, and legibility so as to bereadily apparent and understood.(1) UN packagingsymbol(2) Code designatingtype of packaging(3) Letter ofdesignation(4) Relative densityfor which the designtype has been tested.(5) Either letter “S”denoting thatpackaging intended fortransport of solids orinner packagings orfor packagingsintended to containliquids, hydraulic testpressure whichpackaging has shownto withstand(6) Last 2 digits of theyear which packagingwas manufactured.(7) State authorizingallocation of the mark(8) Name ofmanufacturer or otherID of packaging(9) Specific markingaccording topackaging type(10) Reconditioningmarkings(6.1.3.1)(1) UN packagingsymbol.(2) Code designatingtype of IBC(3) Letter designating thepacking groups for whichthe design type has beenapproved.(4) Month and year ofmanufacture(5) State authorizingallocation of the mark.(6) Name or symbol ofmanufacturer and otherID of the IBC asspecified by competentauthority(7) Stacking test load(8) Maximumpermissible gross mass.(9) Conformity to designtype(10) Additional markingsfor certain categories ofIBCs (6.5.2.1)(1) Tank manufacturer(2) SpecificationMACA 75(3) Material ofconstruction(4) Design pressure(5) Test pressure(6) Rated gross weight(7) Volumetriccapacity(8) Serial number(9) Tare weight(10) Production date(11) Otherspecificationsaccording to tank type(2.1.1)Page 247Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC Bulk(4) Unless otherwise specified, letters and numeralsmust be at least 12.0 mm (0.47 inches) in heightexcept that for packagings of less than or equal to 30L (7.9 gallons) capacity for liquids or 30 kg (66pounds) capacity for solids the height must be at least6.0 mm (0.2 inches). For packagings having acapacity of 5 L (1 gallon) or 5 kg (11 pounds) or less,letters and numerals must be of an appropriate size.(5) For packages with a gross mass of more than 30kg (66 pounds), the markings or a duplicate thereofmust appear on the top or on a side of the packaging.(6) A UN standard packaging marking or multiplemarkings are permitted provided container meets allapplicable standards.(7) Authorized exemptions allowed.(§178.3, §178.503(a), §178.703)DispensingCapabilityIf container hascapacity of 30 Lor less & ifcontainer holds aliquid pesticide,container must:(1) Allowcontents of nonrefillablecontainer to pourout in acontinuous,coherent stream(2) Minimizedripping(§165.68)Not specified. Not specified. Closures on packagingsshall be so designed andclosed that underconditions normallyincident to transportation:(1) Except as provided inparagraph (g) of thissection, there is noidentifiable release ofhazardous materials tothe environment from theopening to which theclosure is applied; and(2) The closure is secureand leakproof.(§173.24(f))Must be leakproof (6.1.4) No contents should escape under normalconditions (6.5.1.5.2)Each tank must bedesigned so that, whennecessary, it may betotally drained (1.3.6)Page 248Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkClosuresFour closuresizes arespecified forcontainers thatmeet all of thesecriteria: (1) rigidcontainer; (2)capacity greaterthan or equal to3.0 liters (0.79gal.); (3) holdsliquidagriculturalpesticide; (4) isnot an aerosolcontainer; (5) isnot a pressurizedcontainer.(§165.66) Finalrule should notoverlap withchild-resistantpackagingrequirements.Each opening ofeach liquidminibulkcontainer musthave a one-wayvalve, a tamperevident device,or both(§165.118)(1) Each liquid bulkcontainer must A)be equipped with avent or other devicedesigned to relieveexcess pressure,prevent losses byevaporation,excludeprecipitation.(2) External sightgauges areprohibited.(3) Containerconnections exceptfor vents must beequipped with ashutoff valve whichcan be lockedclosed(§165.120(b))(1) Closures onpackagings shall be sodesigned and closed thatunder conditions(including the effects oftemperature andvibration) normallyincident totransportation-(i) Except as provided inparagraph (g) of thissection, there is noidentifiable release ofhazardous materials tothe environment from theopening to which theclosure is applied; and(ii) The closure is secureand leakproof.(2) Except as otherwiseprovided in thissubchapter, a closure(including gaskets orother closurecomponents, if any) usedon a specificationpackaging must conformto all applicablerequirements of thespecification.(§173.24 (f))§178.601(g)(5)Specific constructionstandards according totype. For example,closure device must bedesigned so it remainssecure and leakproofunder normal conditionsof transport (6.1.4)Constructed so that none of the contents canescape under normal conditions (6.5.1.5)Closure must protectagainst leakage oraccidental openingthat might be causedby vibration,corrosion,temperature, or othercircumstancesnormally encounteredduring transportationor sue. The tankstructure may be usedto provide thisprotection. (1.4.1)Page 249Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkResidueRemovalDesign StandardFor rigidcontainers withdilutablepesticide,container mustbe capable of99.99% removalof each activeingredient.Percent removalrepresents thepercent of theoriginalconcentration ofthe activeingredient in thepesticide productwhen comparedto theconcentration ofthat activeingredient in thefourth rinseaccording to aformula.(§165.70)Not specified.Not specified.Not specified.Not specified.Not specified.Not specified.Each tank must bedesigned so that, whennecessary, it may betotally drained andthoroughly drained out(1.3.6)Design StandardResponsibilityRegistrant Not applicable. Not applicable. Not applicable. Not applicable. Not applicable. Notapplicable. Not specified.Page 250Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkProcedure Conduct rinsing(triple and/orpressure) on thelabel if rigidcontainer &dilutablepesticide.Registrant develops a written residueremoval procedure for each pesticideproduct placed in a refillable containerthat is adequate to maintain productintegrity. (§§165.164(a) and165.190(a)) Before refilling, therefiller (which could be a registrant)must clean each refillable container byconducting the pesticide product’sresidue removal procedure for refillingunless certain conditions are met.(§165.170 and 165.210) Beforedisposal, conduct the rinsing procedureon the label.To be considered empty and not subject to DOTrequirements, packaging must be “sufficientlycleaned to remove any potential hazard.”(§173.29(b)(2)(ii))Must be free from incompatible residue for reuse.(§§173.28(a))Not specified.Not specified.Examine to determinepresence of previousproduct. Each portableagrichemical tankshould be kept indedicated service;however, if tank mustbe refilled withanother product, cleanout all residue of theformer lading. (2.1.2)ProcedureResponsibilityEnd userBefore refilling: registrant and refiller(which could be the registrant). Beforedisposal: whoever disposes ofcontainer, could be registrant, refiller,end user, or someone else.Not specified. Not specified. Not specified. Not specified. Not specified.ProductionTestingNo No No Yes Yes Yes Yes YesSampling No No No IBC-Samples of allintermediate bulkcontainer design types(§178.810(c))3-6 containers(§178.602)3-6 containers(6.1.5.3.1)1 container (says thesame or different IBCmay be used for eachdrop (6.5.4.9.3))1 container (1.7.1)FillingRequirementsNo No No Filled at least: solids95%, liquid-98%(§178.602, §178.810)Filled at least: solids95%, liquid-98%(§178.602)Filled to at least:solids-95%; liquid98% (6.1.5.2.1)Filled to at least: solids95%; liquid-98%(6.5.4.9.2)Filled to rated grossweight but not over98% of volume(1.7.1.2)Page 251Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkDrop Test No No No The drop test must beconducted for thequalification of allpackaging design typesand performedperiodically as specifiedin §178.601(e)Drop heights aredetermined according tothe packing group,; forliquids, if the test isperformed with water,there are specificrequirements (§178.603,§178.810)The drop test must beconducted for thequalification of allpackaging design typesand performedperiodically as specifiedin §178.601(e). Dropheights, measured as thevertical distance from thetarget to the lowest pointon the package, must bedetermined as follows:(1) For solids and liquids,if the test is performedwith the solid or liquid tobe transported or with anon-hazardous materialhaving essentially thesame physicalcharacteristic, the dropheight must bedetermined according topacking group and (2)Specific requirements iffor liquids, the test isperformed with water(§178.603(e)).If test performed withmaterials to be carriedor with anothersubstance havingessentially samephysicalcharacteristics, 0.8 m -1.8 m depending onpacking group. Otherheights will applybased on relativedensity (6.1.5.3.4)Depends on relativedensity: (1) 1.8m, 1.2 m,0.8m if relative density1.2 or (2) density *1.5m/d * 1.0m/d * 0.67mif relative density > 1.2.(6.5.4.1.3)2 ft. (1.7.1.2)Page 252Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkProductionRetestingNot specified,however DOTstandards arereferred to andadopted. (49CFR Parts 178and 180)Not specified,however DOTstandards arereferred to andadopted. (49CFR Parts 178and 180)Not specified,however DOTstandards arereferred to andadopted. (49 CFRParts 178 and 180)Manufacturer-periodicretesting §178.601(e)-Each IBC intended tocontain liquids or solidsthat are loaded ordischarged underpressure must be tested inaccordance with theleakproofness testprescribed in §178.813 ofthis subchapter andvisually inspected every2.5 years, starting fromthe date of manufactureor the date of a repair(§180.352b)The performance of thedrop, leakproofness,hydrostatic pressure, andstacking tests.(§178.601(c)(2)) Thepackaging manufacturershall achieve successfultest results for theperiodic retesting atintervals established bythe manufacturer ofsufficient frequency toensure that eachpackaging produced bythe manufacturer iscapable of passing thedesign qualification tests.Changes in retestfrequency are subject tothe approval of theAssociate Administratorfor Hazardous MaterialsSafety. For single orcomposite packagings,the periodic retests mustbe conducted at leastonce every 12 months.For combinationpackagings, the periodicretests must be conductedat least once every 24months. (§178.601(e))At intervalsestablished bycompetent authority.(6.1.5.1.3) Retestingbefore reuse every 2.5years (§173.32(e))At intervals establishedby competent authority.(6.5.4.1.4) All packagessubject to theleakproofness test withair prescribed in§178.604 must bechecked forleakproofness beforereuse. (§173.28(b)(2))Every 2 years performleak test immediatelyprior to the use seasonfor the tank. (2.1.4)At minimum, check attwo year inspectionfill with nonhazardous liquid andbe sure tank does notleak. (2.1.4)Page 253Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkReconditioningNo. However,may beapplicable todrums.No No Packagings andreceptacles used morethan once must be insuch condition, includingclosure devices andcushioning materials, thatthey conform in allrespects to the prescribedrequirements of thissubchapter. Before reuse,each packaging must beinspected and may not bereused unless free fromincompatible residue,rupture, or other damagewhich reduces itsstructural integrity.(§173.28)(1) Reconditioning ofmetal drums is: cleaning,restoring and inspecting.Packagings that havevisible signs ofdeterioration must berejected. (§173.28)(2) Reconditioning of anon-bulk packaging otherthan a metal drum or aUN 1H1 plastic drumincludes: removal offormer contents,cleaning, inspecting,replacing non-integralparts with new orrefurbished parts, andrestoring to meetstandards. (§173.28)(3) A person whoreconditions a packagingmust mark and certify thepackage before reuse.(§178.503(c)(d))d (d)The marking maydifferent than the originalbut must not identify agreater containercapacity.(4) Packagings whichhave significant defectswhich cannot be repairedmay not be reused.(§173.28c)(1) Requiresleakproofness test(4.1.1.12(2) Must be able topass all tests (4.1.1.9)(1) Requiresleakproofness test(4.1.1.12)(2) Must be able to passall tests (6.5.1.6.6)NoMiscellaneous---------------------Additional guidelinesin leakproofness(1.8.1), hydrostatic(1.7.2.2), stacking(1.7.1.5), vibration(1.7.1.1), base support(1.7.1.4), and liftingdevice (1.7.1.3).Page 254Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkWaiverYes. May beissued by EPAfor the followingreasons: (1) ifregistrantdemonstratescontainer safetystandard meetsor exceeds DOTstandards forhazardousmaterials; (2)necessary orsimilarlyprotective nonstandard closure;(3) or otherreasons asnecessary.Waiver must beobtained inwriting.(§§165.72,165.74)Yes. May beissued by EPA ifregistrantdemonstratescontainer safetystandard meetsor exceeds DOTstandards forhazardousmaterials.Waiver must beobtained inwriting.(§§165.122,165.124)Not specified. Not specified. Not specified. Not specified. Not applicable.CertificationNot required Not required. Marking on the packaging with appropriateDOT or UN markings certifies that:(1) All requirements of the DOT specificationor UN standard are met.(2) All functioned performed by or on behalf ofthe person whose name or symbol appears aspart o f the marking conform to requirementsspecified in this part. (§§178.3(a)(2), 178.2(b))A transport certificate and mark shall be issuedattesting that container design meets the standards.(5.4.1.6)A certificate and markshall be issued attestingthat design typeincluding its equipmentmeets the standards.(6.5.1.6.3)NoPage 255Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkRecordkeepingFor eachpesticideproduct,maintain recordsfor as long as thenon-refillablecontainer designtype is used todistribute or sellthe pesticideproduct and for 3years thereafter.Must keep thefollowingrecords:1) Name andEPA registrationnumber of thepesticide product2) Description ofthe design typeof the nonrefillablecontainer inwhich pesticideproduct isdistributed orsold3) copy of thecertification asdescribed in§§165.82 and165.844) Record todocumentcompliance withthe requirementfor closures in§165.665) Record todocumentcompliance withdispensingstandards in§165.68.(§165.86)Keep a copy of the certification for aslong as a refillable container is used todistribute the product and for 3 yearsafter. (§165.136)Yes, relative to testingfor IBCs. (§178.801(l))Yes, relative to testingfor refillables.(§178.601(1))Yes, relative totesting. (6.1.5.8.9)Yes, relative toinspections and tests.(6.5.4.14.4, 6.5.1.6.5)Yes, relative tomaintenance andinspection. (2.1.5,2.2.6)Page 256Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkRefillingTransferNot Applicable. Replacesthe Bulk PesticidesEnforcement Policy with §165.182 and§165.200. Provides that registrantsmay allow a refillerto prepackage theregistrant’s pesticide product into anysize refillable container and distributeor sell under the registrant’sregistration (provided all conditions ofthe rule are met). Require registrants tosubmit to EPA acknowledgement thatthey have entered into a repackagingagreement with a refiller and they areresponsible for the integrity of therepackaged product.Not specified.Not specified.Not specified.Not specified.Not specified.Responsibility -Registrant thatdistributes orsells products inrefillablecontainersNot applicable. (1) Product not adulterated or differentfrom composition described.(§165.162)(2) Registrant would be required todevelop written residue removalprocedure for refilling each pesticideproduct. (§165.164)(3) Registrant required to develop awritten list of acceptable containers foreach registered pesticide. (§165.164)(4) Refiller at establishment must useapproved container(s) (§165.166), haverequired documentation (§165.168),clean and inspect containers beforerefilling (§§165.170–165.174), andappropriately label the containers(§165.176).(5) Keep and make available to EPArecords on pesticide productsdistributed or sold and information oncontainer history and use. (§165.178)Not specified. Not specified. Not specified. Not specified. Not specified.Page 257Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkResponsibility -Registrant thatdistributes orsells products torefillers forrepackagingNot applicable. (1)Repackaging results in no change topesticide formulation and occurs at anEPA approved location. (§165.182)(2) Registrant must provide refillerwith a written contract/authorization.(§165.186)(3) Registrant responsible for productintegrity (§165.188)(4) Registrant required to providerefiller with a written residue removalprocedure for refilling each pesticideproduct before or at the time ofdistribution or sale. (§§165.190,165.192)(5) Registrant required to providerefiller with a written list of acceptablecontainers for each registered pesticide.(§§165.190, 165.192)(6) Keep and make available to EPArecords on contracts entered into withrefillers, residue removal procedure,and list of acceptable containers for thecurrent operating year and 3 years afterthat. (§165.194)Not specified. Not specified. Not specified. Not specified. Not specified.Responsibility -RefillerNot applicable. (1) Required to possess necessarywritten authorizations. (§165.200)(2) Product not adulterated or differentfrom composition described.(§165.204)(3) Refiller at establishment must useapproved container(s) (§165.206), haverequired documentation (§165.208),clean and inspect containers beforerefilling (§§165.210–165.214), andappropriately label the containers(§165.216).(4) Keep and make available to EPArecords on pesticide productsdistributed or sold and information oncontainer history and use. (§165.218)Not specified. Not specified. Not specified. Not specified. Not specified.Page 258Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkInspection Not applicable. Inspection prior to packaging orrefilling (§§165.174and 165.214)Before reuse, eachpackaging must beinspected and may not bereused unless free fromincompatible residue,rupture, or other damagewhich reduces itsstructural integrity.(§173.28,§178.601(c)(g))Refillables-inspectionprior to refill. (§173.28,§180.352) Before reuse,each packaging must beinspected and may not bereused unless free fromincompatible residue,rupture, or other damagewhich reduces itsstructural integrity.(§173.28,§178.601(c)(g))Inspection before eachfill (4.1.1.9)Before each refill.(4.1.1.9) For some typesof packaging, inspectionby a competent authorityrequired, thorough every5 years and less thoroughevery 2.5 years.(6.5.1.6.4)Before each refill;annual and 2 yr.inspections morethorough. (2.1.1, 2.1.2,2.1.4) Before loadinga product into anytank, the filler shouldperform the following:(1) verify for antiback-filling device orother filling controldevice on thedischarge opening.(2) Examine the tankto determine thepresence of anyresidue of the previousproduct to preventcontamination. Cleanout reside of theformer lading if tankmust be refilled withanother product.(3) Examine tank andsupport structure forany significantstructuraldamage(2.1.2)Page 259Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and StandardsContainer RequirementsDOT Hazardous Materials Regulations(49 CFR Parts 100-199)UN Recommendations on the Transport ofDangerous GoodsMACA-75ManufacturerSpecification andUser GuidelinesRequirementNon-Refillable Refillable Bulk andIBC Non-Bulk Non-Bulk IBC BulkLabeling(1)Identifycontainer type +recyclestatement(156.140(a))(2) Residueremovalstatement(156.144(d))(1) Reserve space for net weight ofcontents (156.10(d)(7))(2) Reserve space for EPAestablishment number (156.10(f))(3) Identify container type (156.140(b))(4) Residue removal statementExcept as specified in§172.400a, each personwho offers fortransportation ortransports a hazardousmaterial in any of thefollowing packages orcontainment devices,shall label the package orcontainment device withlabels specified for thematerial in §172.101 and§172.400Examples:(1) general labelspecifications(2) codes indicating theprimary hazard of thematerial(3) codes indicatingsubsidiary hazards(4) specific labelsaccording tohazard class or division(§172.101(g), §172.400)Labels of primary andsubsidiary risk (5.2.2.1)1. Precautionarymarkings (1.1.1)2. Marked inaccordance withapplicable provisionsof the containerregulations (1.2.1)3. Tanks designed,constructed, or testedunder these guidelinesaren’t required to belabeled or marked asprescribed by DOTHaz. Mat. Regs unlessthey contain DOTregulated hazardousmaterials (1.1.3)4. Containers over 119gallons capacity,containingcombustible liquids,must be marked andplacarded as requiredto DOT HMR (1.1.4)Not specified Not specified

### Page 260 F.6 Existing EPA Policy Applicab le to Pesticide Containers



### Existing EPA regulations, recomm endations, and programs have an effect on the baseline compliance rate of the container regulations. Three policies that are examined to estimate this effect are the child-resistant packaging requi rements already specifi ed under container regulations, the Consumer Labeling Initiative, and the Bulk Pesticide Enforcement Policy. It is important to estimate the impacts of these policies in order to determine the level of adjustments and changes that the affected market sectors will make to come into compliance under the container regulations. Each of these current pol icies affects some but not all of the components of the container regulations. Below is a summ ary of each policy and its relevant impacts on the container regulations. Following the policy su mmaries, Table F-4 provides a side-by-side comparison of the relevant compone nts of the container regulations.

F.6.1 Child-Resistant Packaging (40 CFR Part 157)



### Subpart B of 40 CFR Part 157 prescribes require ments for child-resistant packaging (CRP) of pesticide products and devices under authority of the container regulations Sections 25(a)(1) and 25(c)(3). The purpose of this regulation is to pr otect children and adults from serious injury or illness resulting from accidental ingestion or cont act with pesticides or devices regulated under the container regulations. The CRP requirements are targeted toward products that meet toxicity

criteria and are intended for residential use. Ta ble F-4 details the toxicity criteria used to determine eligibility. Pesticides classified for re stricted use or that are packaged in large sizes

are exempt.

The CRP standards are set for effectiveness, comp atibility, and durability and must be certified by EPA. Registrants must keep on record a (1) description of the container, (2) copy of the certification statement, (3) document verifying the package is child-resistant, (4) written evidence verifying that the container has been test ed, and (5) an explanation of why the container and closure are compatible in cases wher e the components are pur chased separately.

F.6.2 Consumer Labeling Initiative



### EPA’s Consumer Labeling Initiati ve (CLI) is a voluntary, coope rative partnership effort among federal, state, and local government agencies, the pesticide and cleaner industry, environmental groups, and other interested gr oups. CLI was promulgated by a Pesticide Registration (PR) Notice posted in the Federal Register (EPA,1996). The purpose of CLI is to make labels easier to read and understand on indoor insecticides, ou tdoor pesticides, and household hard surface cleaners (i.e., floor and basin, tub an d tile), some of which are registered

antimicrobials/disinfectants.

CLI has undergone two phases. Phase I began in early 1996 and ended on September 30, 1996. It was comprised of three component s: qualitative consumer resear ch, a literature review of relevant publications and reports of studies available in the public domain or provided by various stakeholders, and a review of extensive stakeholder comments solicited through the Federal Register Notice.

Phase II, which began in Octobe r 1996, resulted from this first phase of research. Phase II addressed issues that Phase I did not comple te or include, including conducting in-depth

### Page 261 quantitative consumer research, finding ways to improve labels by using clearer wording and storage and disposal information, and identify ing other information a bout ingredients that consumers want and need on labels. This phase also included the develo pment of a consumer education campaign.

Pesticide Regulation Notices are issued by EPA’ s Office of Pesticide Programs to inform pesticide registrants and other interested pers ons about important polic ies, procedures, and regulatory decisions. The labeling recommendations of the Phase I a nd II reports, some of which have been included in PR Notices, are as follows:

• Include emergency telephone numbers on product labels;

• Use common chemical names, not formal chemical names;

• Use the heading “Other Ingredients” instead of the little understood term “Inert Ingredients”;

• Use the more readily understood heading “First Aid,” instead of “Statement of Practical Treatment”;

• Include simplified, medically correct First Aid Statements;

• List only meaningful ingr edient identification;

• Provide consistent and clear direc tions for storage and disposal; and

• Specify label recommendations according to pesticide type.

The CLI affects a relatively small portion of the pe sticides included in the scope of the container regulations. This class of produc ts includes outdoor pest icides under Toxicity Categories I or II, which are not exempt as eligible antimicrobials. It appears unlikely that outdoor pesticides in Toxicity Categories III and IV, which meet container regulations , were intended for use in the scope of the CLI. The CLI targets the home and garden sector whereas the container regulations are intended for eligible containers used by all market sectors. Table F-4 below compares the requirements of the 1994 Proposed Rule regulat ions for container la beling with the CLI

recommendations.

F.6.3 Bulk Pesticide Enforcement Policy



### The Bulk Pesticide Enforcement Policy was published in July 1977 (41 FR 55932). This policy was developed to define when bulk shipments a nd transfer practices we re allowable without a separate registration. The commercial transfer of pesticides in bulk can involve changing the container at various stages of the distribution process; however, “repackaging” (“transferring a pesticide formulation from one c ontainer to another without a ch ange in the composition of the formulation or the labeling for sale or distri bution,” 40 CFR §165.3) is considered “production” of a pesticide as defined in 40 CFR §167.3. A regi stration is needed for di stribution or sale of a repackaged product. The Bulk Po licy clarifies that a se parate registration is not needed, as long as “the transfer of a regist ered product in ‘bulk’ involves only the changing of the product

container with no change:

(1) “to the pesticide formulation,
(2) to the product’s accepted labeling [with excep tions regarding information required by the policy regarding the repackaging es tablishment and package content], and
(3) to the identity of the party account able for the product’s integrity.”

### Page 262 If the above three conditions are met, the repackaged product is considered to be encompassed within the terms of the original product registra tion. The policy details when a new registration is needed and how to satisfy the third criteri on regarding “accountability ” for product integrity. Primarily, this criterion is met if the repackager has written authorization from the registrant allowing the repackager to repackage the pesticid e at a registered establishment and to use the registrant’s label.

The Bulk Pesticides Enforcement Policy is often referred to as the “55-gallon” policy because it defines the term “bulk” to mean any volume of pesticide greater than 55 gallons or 100 pounds

held in an individual container. This policy may have discou raged repackaging smaller amounts (i.e., it placed a lower limit on the quantity of pesticide that could be introduced into refillable bulk containers and on the capacity of the cont ainers because such quantities could not be repackaged without a new registration). On March 4, 1991, this policy was amended to allow the repackaging of any quantity of pesticides into refillable containers, provided that:

(4) “The container is designed and constructed to accommodate the return and refill of greater than 55 gallons liquid or 100 lb. dry materials; and
(11) Either: (a) the containers are dedicated to a nd refilled with one speci fic active ingredient in a compatible formulation, or (b) the cont ainer is thoroughly cleaned according to written instructions provided by the regist rant to the dealer prior to introducing anothe r chemical to

the container in order to avoi d cross-contamination; and
(12) All other conditions of the Ju ly 11, 1977 policy are met.”

The Bulk Pesticides Enforcement Policy does not include any contai ner construction or performance standards. With regard to labe ling and marking, the pol icy indicates that the registrant’s label must be used for the repack aged material, and this label must reflect the

establishment number of the establishment that re packaged the material and the appropriate net content statement. Permanent marking is not required.

The refillable container requirements do not ch ange the conditions unde r which repackaging a pesticide can occur without requir ing a new registration. The sa feguards specified in the Bulk Pesticides Enforcement Policy are incorporated into the final containe r regulations through the requirements regarding registrant and refilling establishment rep ackaging responsibilities. The Bulk Pesticides Enforcement Policy will be resci nded after the container regulations are final. The final regulations make the following general changes:

(5) Repackaging is allowed for any quantity of pestic ide into any size of container, as long as that container meets the standards for a refillable container, and
(6) Specific labeling, marking, design, and performa nce standards are established for refillable

containers.Page 263Table F-4. Comparison of Container Regulations with Other EPA PoliciesCategoryContainer RegulationsChild-Resistant Packaging(49 CFR Part 157)Consumer LabelingInitiative(FR 61:12011)Bulk PesticideEnforcementPolicy(40 CFR Part 167)Scope (1) The product is classified inToxicity Category I or II, or(2) The container capacity isgreater than or equal to thecontainer size criterion of 5 L (1.3gallons) or 5 kg (11 lbs), or(3) The product is intended foroutdoor use and the label includesat least one of the specifiedenvironmental statements (FR64:203, Table 5)Exempt:Antimicrobials eligiblefor exemption (FR 64:203,Table 5)(1) The product has toxicity of: 1.5 g/kg LD50oral; 2,000 mg/kg LD50 acute dermal; or 2 mg/lLC50 acute inhalation; or(2) The product is corrosive to the eye, causescorneal irritation persisting 21+ days; or(3) The product is corrosive to the skin or causessevere skin irritation at 72 hrs; or(4) EPA determines packaging could significantlyreduce serious hazard or injury. and(5) Product intended for residential use.Exempt:Product classified for restricted use orpackaged in large sizes.(1) Indoor insecticides(2) Household surfacecleaners(3) Outdoor pesticidesSome of these pesticides areregistered antimicrobials.Separateregistration is notneeded to transfer aregistered productfrom one containerto another(repackaging) aslong as thecomposition of theformulation andlabeling for sale ordistribution remainsthe same.DesignStandardsMajor component of regulationdeveloped for refillable and nonrefillable container standards(refer to Table F-3 above).(1) Effectiveness: meets specification in 16 CFR§170.20.(2) Compatibility: product does not interfere withthe child-resistant packaging or is detrimental tothe integrity of the container.(3) Durability: child-resistant packaging meetsstandards over lifetime of container.Not applicable. The container isdesigned andconstructed toaccommodate thereturn and refill of>5 gallon liquid or100 lb of drymaterial. (1991amendment to thepolicy)Certification Not required. Child-resistant packaging device must be certifiedby EPA along with compatibility with container.Not applicable. None.Recordkeeping Record of container certificationsmust be kept while container is inuse.Record of CRP and container certifications mustbe kept while container is in use.Not applicable. None.Page 264Table F-4 (Continued). Comparison of Container Regulations with Other EPA PoliciesCategoryContainer RegulationsChild-Resistant Packaging(49 CFR Part 157)Consumer LabelingInitiative(FR 61:12011)Bulk PesticideEnforcementPolicy(40 CFR Part 167)Labeling Labeling regulations pertain to:(1) For refillables, reserve spacefor net contents and EPAestablishment number.(2) Residue removal instructions.(3) Identification of containertypes.Not specified. Voluntary labelingrecommendations pertain to :(1) Simplifying andclarifying language,ingredient listings, and firstaid statements.(2) Providing useful storageand disposal information.The originalregistered labelmust be attached tothe transferredproduct. Also itmust reflect theestablishmentnumber of theestablishment atwhich the productwas transferred.

### Page 265 F.7 State Regulations and Standards



### State regulations and standards have an important role in managing pesticide containers. Just as nationwide regulations/standards affect the base line compliance rate of container regulations, state-level regulations/standards al so have an impact on the baseline compliance rate. States have developed container-related regulations vary ing from no or weak standards to stringent requirements. This suggests that adjustments to the nationwide compliance rate are necessary to compensate for variability in st ate-level contai ner regulations.

While a comprehensive state-level container st andards analysis is be yond the scope of this economic analysis, this section will discuss so me of the applicable state regulations and guidelines that focus on container performance sta ndards and the rinsing, di sposal, and storage of pesticide containers. To obtain information on state pesticide regulations, we conducted a survey of Internet literature for eight states located in different region s of the United States. The main

source of information used for this section wa s the National Agricultural Safety Database (NASD) maintained by the Centers for Diseas e Control and Prevention (CDC). The NASD includes pesticide contai ner-related articles and brochures contributed by professionals and organizations from states across the country. Additional information collected and summarized

in this section comes from st ate agencies responsible for pe sticide container standards and university extension programs providing recommendations.

The results of the eight-state analysis are summ arized in the following sections by requirement category. Following the summaries is Table F-5, which includes state-by-state details of the rinsing, disposal, and storage guideline s from the eight states evaluated.

F.7.1 Container Design and Performance Standards



### States are prohibited from impos ing any requirements for pesticid e packaging in addition to, or different from, those required under the containe r regulations (Section 14( b)). The container regulations require pesticides that are consider ed DOT hazardous materials to be packaged in

containers that meet the DOT hazardous materi als regulations, which contain performance, design, and management standards. Most, if not all, states ha ve adopted the DOT HMR in some form and, in this way, regulate pesticide cont ainers holding DOT hazardous materials. These requirements must be at least as stringent as the federal requirements.

F.7.2 Refilling Requirements



### Some states have adopted bulk pe sticide storage regulations that by definition allow repackaging

and transfer into refillable containers with the assurance that certain standards are being met. Such standards may address, depending on the state, refillable storage containers and appurtenances, secondary containment, operationa l area containment (mix ing/loading/refilling activities), security, inspection and maintenance, open burning of agrichemical containers, and

other issues. Iowa and South Dakota have effectively incorpor ated EPA’s 1977 Bulk Pesticides Enforcement Policy.

Applicators can purchase small quan tities of pesticides in containers that are refilled by the registrant. Several registrants market pesticides in these small refillable containers (e.g., 15 or 30 gallons) in compliance with both federal and state law. They do this by having the containers

### Page 266 returned to them for refilling, rather than to a dealer. Registrants are able to trace and ensure return of these containers by numbering each one and requiring a deposit.

F.7.3 Transfer of Pesticides Between Containers



### California has regulations requiri ng the use of closed systems when (1) employees handle any liquid pesticide or liquid mix or dilution of pesticide displayi ng the signal word “DANGER” on the label or (2) employees handle any minimal expos ure pesticide. California defines a “closed system” as “a procedure for removing a pesticide from its original container, rinsing the empty container and transferring th e pesticide product and dilutions and rinse solution through connecting hoses, pipes, and coup lings that are sufficiently ti ght to prevent exposure of any person to the pesticide or rins e solution” (CalEPA, 1998). Empl oyees must receive training in the proper use and safety precautions of closed systems. Employees who only handle up to one gallon of product per day in original containers of up to one gallon in size are exempted from the closed system requirement.

California has found its closed-system requirement difficult to implement because of the variety of container sizes, shapes, and materials. Additi onally, not all reusable containers are adaptable to closed systems. The container regulations do not address the use of closed systems for either the registrant or the refilling esta blishment, but the requirement fo r use of standardized closures

for non-refillable containers shoul d encourage and expedite the us e of closed systems. EPA’s final container regulations do not specify that refillable containers must conform to the use of

standardized closures.

F.7.4 Residue Removal Procedures



### A number of states have devel oped residue removal procedures fo r users. These are sometimes part of a regulatory requirement or are publis hed as recommendations in Cooperative Extension circulars or bulletins. The removal procedures va ry by state and typically include triple rinsing and/or pressure rinsing. Tabl e F-5 contains descriptions of the residue removal procedures, either required or recommended, for t hose states that have such procedures.

F.7.5 Container Collection and Disposal Procedures



### A number of states have instit uted some form of pesticide co ntainer disposal program. The primary function of these programs is to pr ovide pesticide users with a secure and environmentally controlled site for returning empt y containers, so that uncontrolled disposal and dumping of pesticide containers is reduced. These programs also help to ensure that residues have been properly removed from empty containe rs. States commonly recommend that rinsed, empty pesticide containers be disposed of in a pproved, sanitary landfills. Pesticide container

collection sites and toxic waste cleanup days are also common. South Dakota, for example, establishes 19 sites across the state during the summer for pesticide container collection. Some states, including Florida and Nebr aska, allow for some pesticide containers to be disposed of by open burning. Opening burning of pesticide containers is prohibited by state statute in Michigan. Florida and Nebraska also permit the burial of properly ri nsed pesticide contai ners in open fields, with regulations that the burial be a minimum of 18 inches deep and in a location where surface and groundwater will not be polluted. Californi a prohibits the burial of pesticide containers.

### Page 267 F.7.6 Pesticide Storage Guidelines



### Pesticide storage guidelines are similar from state to state. Generally, states recommend that pesticides and pesticide containers should be stored in a clean, dry, well-ventilated, insulated, fireproof structure that can be locked and monitored by responsible personnel. Storage guidelines commonly specify that only pesticid e and pesticide containe rs should be stored together to avoid the contamination of other prod ucts. Visible signs on all entrance points with the words “danger,” “warning,” or “keep out” ar e also recommended. Michigan has special storage guidelines for bulk pestic ides which specify permissible lo cations of storage facilities based on distance from water supplies. The Iowa State University Extension is promoting “Zero Pesticide Storage” to encourage farmers to inve ntory and properly dispose of all unneeded or unusable pesticides in 2 to 3 years.Page 268Table F-5. Eight-State Analysis ofPesticide Container GuidelinesRinsing Guidelines Disposal Guidelines Storage Guidelines SourceFLORIDATriple-rinse, or jet-rinse, applicable tometal, glass, and plastic containers, withthe exception of aerosol cans:1.Empty container into spray tankand drain in vertical position for30 seconds2.Add a measured amount of rinsewater (or other dilutant) socontainer is 1/5 to 1/4 full3.Rinse container thoroughly, pourinto tank, and drain for 30seconds.4.Repeat step three times5.Puncture container before finaldrain6.Crush pesticide containerimmediately; sell as scrap forrecycling or bury7.Bury triple-rinsed containers aminimum of 18 inches deep butwell above the ground water table(never bury in wetlands orsinkholes).Florida state law allows for some pesticide containers to bedisposed of by open burning.Strict regulations apply.Farmers may bury triple-rinsed containers on their ownproperty. Containers should be buried at least 18 inchesdeep but well above the groundwater table, and never insinkholes and wetlands. Farmers should receive permissionfrom the landowner before burying containers on rentedproperty. Non-farmers who bury empty pesticide containerson the their own property must notify their local Departmentof Environmental Regulation of the burial.Safe storage rules:1.Keep pesticides and other poisons locked in acabinet, room, or separate building designatedsolely for their storage.2.Post the cabinet, room, orbuilding with a sign,“PESTICIDES—POISONS, KEEP OUT,” orsimilar signs3.Control access to the facility to one to threehighly trusted, responsible individuals4.Never store pesticides where food, feed, seed,fertilizers, or otherproducts may becomecontaminated5.Only store pesticides intheir original containers6.Facility shall be reasonably fireproof and wellventilated; temperatures should be kept betweenfreezing and 100 degrees F7.Concrete block walls, sealed concrete floors withno floor drains, and metal shelves arerecommended over wooden structures8.Store dry pesticides on the top shelves, liquidson the lower shelves9.Electrical fixtures should be dust- and explosionproof.NASD:http://www.cdc.gov/nasd/MICHIGANTriple-rinse, or pressure-rinse,applicable to all empty pesticidecontainers. After triple-rinsing,puncture metal and plaster containers.Metal and plastic containersshould be punctured after theyare properly rinsed. Rinsed glass, metal, and plasticcontainers may be buried in approved sanitary landfills.Open burning of pesticide containers is prohibited by statestatute.Michigan has had an agricultural plastic pesticide containerrecycling program in operation since 1992. This programfacilitates grinding and recycling of clean, plastic containers.Safe storage rules:•Keep a separate structure for pesticide storage•Structure should be locked at all times andprotected from temperature extremes, highhumidity, and direct sunlight•Structure should be dark, cook, dry, wellventilated, insulated to prevent freezing, andconstructed to state and local fire codes forstoring flammable/combustible materials•Never store pesticides near feed, seed, food, orfertilizers.Storage guidelines for bulk pesticides also exist inMichigan. The guidelines specify permissiblelocations of storage facilities, based on distance fromwater supplies.NASD:http://www.cdc.gov/nasd/Michigan Departmentof Agriculture:http://www.michigan.gov/mdaPage 269Table F-5 (Continued). Eight-State Analysis of Pesticide Container GuidelinesRinsing Guidelines Disposal Guidelines Storage Guidelines SourceIOWATriple-rinse, or pressure-rinse,applicable to all empty pesticidecontainers:1.Fill container about 20 percent fullof water, replace the cap securely,and shake the container2.Pour rinse water into a spray tank3.Drain for at least 30 seconds4.Repeat two times5.Puncture all containers.Empty pesticide containers that have been properly rinsedmay be disposed of in approved landfills.The Iowa State UniversityExtension recommends thatpesticide users try to achieve “Zero Pesticide Storage”in 2 to 3 years. The following initial steps aresuggested:•Determine what pesticides are in storage; bannedpesticides such as DDT or Chlordane should bedisposed of by professionals at the next ToxicWaste Cleanup Day•Set aside all pesticides that are no longer wantedor that are unusable (unusable pesticides may beineffective or dangerous to use due to poorstorage conditions); store them properly until thenext Toxic Waste Cleanup Day.NASD:http://www.cdc.gov/nasd/KANSASTriple-rinse applicable to all emptycontainers of liquid pesticides.Wash the inside ofthe tractor withdetergent and water and change thecab’s filters when finished applyingpesticides.NASD:http://www.cdc.gov/nasd/MARYLANDTriple-rinse pesticide containers andreturn the rinsate to the spray tank.Puncture thoroughly rinsed pesticide containers so theycannot be reused.Pesticides containers may be disposed of in a licensedsanitary landfill.Pesticides should be stored in their original containersin a cool, well-ventilated,locked location away frompumps and water sources.Maryland Cooperative Extension:httphttp://www.pesticide.umd.edu/Leaflets.htmlLeaflet #9 ProtectingGroundwater fromPesticidesPage 270Table F-5 (Continued). Eight-State Analysis of Pesticide Container GuidelinesRinsing Guidelines Disposal Guidelines Storage Guidelines SourceSOUTH DAKOTAContainers must be either triple-rinsedor pressure-rinsed prior to recycling ordisposal.Triple rinse:•Remove cover from container;empty pesticide into the sprayertank; let container drip and drainfor an extra 30 seconds once it isempty•Fill the container 1/5 to 1/4 fullwith water•Secure the cover on the container•Remove cover and empty rinsateinto the sprayer tank; let containerdrip and drain for an extra 30seconds•Repeat two more times•Leave container open to air dry•Inspect container for cleanliness –pay close attention to threads andthe outside of the container (morerinsing may be necessary).Pesticide containers are collected at approximately 19 sitesacross South Dakota during the summer. Containers areinspected before acceptance.Acceptable containers arerecycled, while containers with visible residue are rejected.Applicators with unacceptable containers are asked toproperly clean and return them.A person shall not construct abulk pesticide storage facility,for the storage of more than 300 gallons, without asecondary means of containment. Plans and specificationsfor the facility must be submitted to the Secretary ofAgriculture for review and approval prior to construction.Reduce the amount of pesticides kept in storage at anyone time, storing it no longer than necessary.:•Rotate pesticide supply, using the oldest productsfirst•Store pesticides under proper conditions; mostpesticides require storage temperatures between40 and 100 degrees F under relatively dryconditions•Store in a location away from occupied areas andon an impermeable floor, such as concrete, toallow detection and containment of spills.South Dakota Department of Agriculture:http://www.state.sd.us/doa/das/pest_was.htmhttp://www.state.sd.us/doa/das/pest_sum.htmNEBRASKAAll empty pesticide containers must beeither triple-rinsed or pressure-rinsed.Triple-rinsing (applicable for plastic,non-pressurized metal, and glasscontainers):•Remove cap from container;empty remaining pesticide into thespray tank, allowing container todrain for 30 seconds•Fill container 10% to 20% full ofwater or rinse solution•Secure the pesticide container cap•Swirl liquid within the containerto rinse all inside surfaces•Remove cap; add rinsate fromcontainer to spray tank and allowto drain for at least 30 seconds•Repeat two more times•Replace cap and dispose ofcontainer properly.Nebraska has community landfills and other sites that acceptempty plastic agricultural pesticide containers that have beenpressure- or triple-rinsed.All containers are thoroughlyinspected before acceptance.Pesticide containers are divided into three groups:•Group I: combustible containers that held all pesticidesexcept for heavy metals•Group II: noncombustible containers (metal, glass, andplastic) that held all pesticides except for heavy metals•Group III: both combustible and noncombustiblecontainers used for pesticides containing heavy metals.Group I containers may be disposed of by:•Burning in a special high-temperature pesticideincinerator•Burial in a specially designated disposal landfill•Burning small quantities (50 pounds or one day’saccumulation, whichever is less) if local ordinancespermit•Burial singly in open fields atleast 18 inches below thesurface, but only in locations where surface andStorage Area Guidelines:•Store pesticides and pesticide containers in a fireresistant structure with a concrete floor and goodventilation•Post weatherproof signs stating “Danger –Pesticides, Keep Out!” or a similar warning oneach door of the facility and over all windows•Use pesticide storage area ONLY for pesticides•Good lighting–both natural and artificial–isnecessary in storage area; some liquid pesticides,for example, are subject to photodecompositionand therefore should not be stored in directsunlight•Insulate storage areas to avoid temperatureextremes•An electrically shielded exhaust-type ventilatingfan may be needed in the storage area to reducethe temperature and concentrations of toxicfumes•For storage of large quantities or pesticides, firedetector sensors and fire-fighting equipment areNebGuide, Cooperative Extension,Institute of Agriculture and NaturalResources, University of Nebraska–Lincolnhttp://www.ianr.unl.edu/pubs/pesticidesPage 271Table F-5 (Continued). Eight-State Analysis of Pesticide Container GuidelinesRinsing Guidelines Disposal Guidelines Storage Guidelines SourcePressure-rinsing (applicable for plasticand non-pressurized metal containers):•Remove cap from container;empty pesticide into spray tank,allowing container to drain for 30seconds•Insert pressure-rinser nozzle bypuncturing through the lower sideof the container•Hold container upside down overthe spray tank openings•Rinsate will run into the spraytank•Rinse for the length of timerecommended by the manufacturer(at least 30 seconds); rotate thenozzle to rinse all inside surfaces•Rinse caps in a bucket of water formore than one minute and pourthis rinse water into spray tank•Replace cap and dispose ofcontainer properly.subsurface water will not be polluted; containersshould not be buried in locations likely to be used asfuture building sites or where animals might uncoverthem while rooting or digging.Group II containers may be disposed of by:•Burial in a sanitary landfill•If group II containers are not properly•rinsed, they can only be disposed of by burial in aspecially designated landfill.Group III containers may be disposed of by:•Disposal in a sanitary landfill,if the container has beentriple-rinsed and punctured to facilitate draining•Any Group III container that is not or cannot be rinsedmust be sealed in a watertight container and buried in aspecially designated hazardous waste landfill.recommended; provide floor plan and records ofthe location and nature ofpesticides in storage tothe police or county sheriff, fire department, andpublic health department•Provide wooden pallets or metal shelves forstoring granular and dry formulations packagedin sacks, fiber drums, boxes, or other waterpermeable containers.Page 272Table F-5 (Continued). Eight-State Analysis of Pesticide Container GuidelinesRinsing Guidelines Disposal Guidelines Storage Guidelines SourceCALIFORNIAEach emptied container that held lessthan 28 gallons of a liquid pesticidediluted for use shall be rinsed by theuser at the time of use. There are tworinsing procedures:Procedure 1:•For containers smaller than 5gallons, use enough water to fillthe container 1/4 full; for largercontainers, use enough water tofill it 1/5 full•Close the container securely andagitate•Drain the solution into the mixtank; allow the container to emptycompletely•Repeat steps a minimum of 2 moretimes.Procedure 2:•Turn the empty container over andplace the opening over a nozzle;this nozzle must be located in theopening of the mix tank so theliquid will drain into the tank; thenozzle must be able to rinse allinner surfaces of the container•Turn the nozzle on and rinse untilthe water coming from thecontainer is clear; use a minimumof 1⁄2 the container volume ofwater.Other rinsing methods may be used, ifapproved by the Department ofPesticide Regulation (DPR).Dispose of all empty pesticide containers in a mannerapproved by the CalEPA, Department of Toxic SubstancesControl. Glass, plastic, and metal containers should bedisposed of in an approved disposal site. No pesticidecontainer should be buried.Disposal requirements may differ by county. In manycounties, people must possess a permit or certificate issuedby the local agricultural commissioner to dispose of rinsedcontainers.Safe storage guidelines:•Keep pesticides and empty containers underdirect personal control at all times•Acceptable pesticide storage areas include: (1) alocked, fenced area, (2) a lockable storagecompartment, (3) a locked truck or trailer withside racks (the tops of the racks should be at leastsix feet above the ground)•Keep storage areas clean, dry, ventilated, andadequately lighted•Keep pesticides and fertilizers separate in storagearea•Post warning signs on all storage areascontaining pesticides (orempty containers) withthe signal words “DANGER” or “WARNING”on the label; post signs on all directions ofapproach, if possible; sign must be readable from25 feet away.Worker Health and Safety Branch,CalEPA, “Pesticide Safety InformationSeries A”http://www.cdpr.ca.gov/docs/whs/pdf/hs1743.pdf

### Page 273 

## Appendix G. Comparison of the Fi nal Container Regulations with the 1994 Proposed Container Regulations

The final container regulations differ significantly from the 1994 pr oposed regulations. The final regulations are narrower in scope than the propos ed regulations, exempt certain antimicrobial pesticides, and adopt some of the Department of Transportation (DOT) hazardous materials regulations. As a result, the economic impact s on the regulated community will be different under the final regulations than under the proposed regulations.

EPA received approximately 1,900 pages of comm ents from more than 200 commenters (e.g., trade associations, pesticide manufacturers, pesticide retailers, and many state regulatory agencies) on the proposed rule. In response, tw o significant issues were readdressed, and the comment period was reopened in 1999. The two issues were: (1) the scope of the container standards; and (2) the relations hip between the 1994 proposed rule and the DOT standards for hazardous materials packaging. In the final rule (as discussed below), EPA has revised the scope

of the container standards to be risk-based w ith exemptions, and has adopted many of the design and construction standards that would apply to DOT Packing Group III materials. These and other changes made to each standard are as follows.

The following is a comparison of the propos ed and final container requirements under consideration by EPA for 11 major sections of the container regulations. Each category is discussed in a separate section below:

G.1 Scope



### The proposed regulations generally affected all containers used to p ackage pesticide products, without regard to industry, use, risk, or c ontainer type and size. Only manufacturing use products were exempt from the proposed regulations.

The final CONTAINER regulations a ffect a significant number but no t all of the total containers used in the pesticide industry. The scope crit eria of the final regul ations are based on the

characteristics and/or human risk associated with the pes ticide product cont ained. All manufacturing use products, all plant-incorporated protectant s, and certain antimicrobial products are not subject to the fi nal regulations. In particular, antimicrobial pesticide products that satisfy all four of the following criteria are exempt from the regulations:

• The product is an antimicrobial pesticide, as defined in the containe r regulations Section 2(mm), or it has antimicrobial properties, as defined in the containe r regulations Section 2(mm)(1)(A), and is subject to a tole rance or a food additive regulation.

• Its label includes directions for use on a site in at least one of the 10 antimicrobial product use categories identified as “househ old, industrial or institutional.”

• It is not a hazardous waste when it is intended to be disposed, as defined in 40 CFR Part 261.

• EPA has not specifically found that the product must be subject to the regulations to prevent

an unreasonable adverse effect on the environment.

As set out in the last bullet, the final regulations include a provision to require a specific antimicrobial product or group of pr oducts to comply with the cont ainer regulations if a problem

### Page 274 becomes evident. EPA may consider evidence such as use history, accident data, monitoring data, or other pertinent evidence in deciding whether the product mu st comply with the container standards to prevent an unreasonable adverse effect on the environment.

Other than MUPs, plant-incorporated protecta nts, and exempt antimicrobial products, all pesticide products are subject to the non-refillable container, ref illable container, repackaging and labeling regulations.

However, the scope of the non-refi llable container regulat ions is different in that only “higherrisk” products are subject to all of the non-refillable container re quirements. The “lower-risk” products are subject only to the basic DOT requirements. In particular:

• A product is subject to all non-refillable container requirements if it is classifi ed in at least one of the following categories: - Toxicity Category I - Toxicity Category II

- Restricted use product.

• All other products (those in Toxic ity Category III or IV that ar e not restricted use products) must comply only with the basic DOT requirements in 49 CFR §173.24.

For the refillable container and repackaging re gulations, all products (t hat are not specifically exempt) are subject to the full set of requireme nts. The only exception is that antimicrobial products used in swimming pools and closely rela ted sites are subject to a reduced number of requirements.

To estimate the number of containers affect ed by the container rule, EPA estimated the percentage of pesticide products in Toxicity Categories I a nd II, and the percentage of antimicrobial pesticides. Based on an analysis of information in an Office of Pesticide Programs database (EPA, 1998a), EPA estimated the percenta ge of pesticide products in Toxicity Category I used on agricultural crops and forestry and or namental turf/plants to be 20 and 10 percent, respectively. Toxicity Category II pesticide products were estim ated to be 15 percent used on agricultural crops and forestry a nd ornamental turf/plants. Fi fteen percent of all pesticide products used for agricultural products and forestry and ornamental turf/plants were in Toxicity Category II.

For comparison purposes, EPA estimated that 70 percent of antimicrobial pesticides eligible for exemption are classified in Toxicity Category I and 15 percent in Toxicity Category II. The antimicrobial pesticide exemption applies only to non-agricultural pesticide use. EPA estimated that an additional 10 to 20 per cent of pesticide products above and beyond those affected by the toxicity criteria would also be affected by the hazard statement scope criteria and an additional 15 to 25 percent affected by the container size cr iteria. In the end, approximately 50 to 90 percent of pesticide containers were expect ed to be affected by the scope criteria.

G.2 Design Standards



### Design standards were very general in the propos ed regulations. The final container standards adopt a subset of the Department of Trans portation Hazardous Materials Regulations (DOT

### Page 275 HMR) packaging standards at the Packing Group III level for pesticides not classified as DOT

hazardous materials. Pesticides that are cla ssified as DOT hazardous materials must comply with all applicable DOT regulations. For th e purpose of enforcing th e pesticide container regulations, the final rule identi fies the DOT requirements for a ll three packing groups that are “equivalent” to the Packing Group III requirement s applicable to products that are not DOT hazardous materials. Under the regulations, sale or distribution of pesticides in containers not meeting all of the standards (the specifically listed ones in the pestic ide regulations and the adopted DOT packaging standards) is prohibited. Both non-refillable an d refillable pesticide

containers must meet these standards.

G.3 Permanent Markings



### Proposed container regulations specified permanent marking requirements for non-refillable and

refillable containers. Non-refillables required the EPA registration number and the name, symbol, or code of materials us ed to make the container, and refillables required several pieces of information including the statement, “Meets EPA standards for refillab le containers.” The final regulations for non-refillables and refillables refer to and adopt the DOT standards, which include marking requirements. Additionally, the final regulations require a serial number or other identifying code to be durably marked on each refillable container.

G.4 Dispensing Capability



### The proposed regulations stipulated that all non-re fillable containers for liquids be designed to eliminate the splash and leakage during normal pour ing of the contents, cl osing or resealing of the container, and storage and cleaning of the c ontainer. The final regulations apply only to liquid non-refillable containers with a capacity gr eater than 20 liters (5.3 gallons) and are the same except the resealing criterion was replaced by a DOT equivalent. No dispensing capability requirements are specified in either the proposed or final container regulations for refillable

containers.

G.5 Closures



### The final requirements for container closures ar e essentially the same as the proposed closure standards. Four closures are specified for non-refillable rigid containers having a capacity greater than 3.0 liters for liqui d agricultural pesticides. The proposed and final regulations should not overlap with the child-resistant packaging requirements. Liquid minibulk refillables require a one-way valve, tamper-evident device, or both on each opening. Liquid bulk refillable containers must be equipped w ith a pressure-relieving device and locking shutoff valve and cannot have external sight gauges.

G.6 Residue Removal Design Standard



### With regard to non-refillable containers, the prop osed regulations specifie d that registrants must demonstrate that each rigid/di lutable container/formulation co mbination achieves a “six-9s” laboratory performance standard (a reduction of the original ac tive ingredient concentrate to .0001 percent in a fourth rinse or equivalent to 99.9999 percent removal). The final regulations require only a “four-9s” standard, where rigid co ntainers with dilutable pesticides must be capable of 99.99 percent removal of each active ingredient. Percent removal represents the

### Page 276 percentage of the original concentration of the active ingredient in the pesticide product when compared to the concentration of that active ingred ient in the fourth rinse according to a formula.

The final regulations require that every regist rant test three containers from each rigid

container/dilutable formulation combination to determine that the containers are capable of attaining at least 99.99 percent removal of each ac tive ingredient in the fourth rinsate after a triple rinse.

The proposed regulations required that a minimu m of 19 randomly selected containers be sampled for residue removal compliance and required the testing to be done according to the full

GLP rule.

Residue removal procedures for the final and pr oposed regulations are the same, except that household products are exempt from the resi due removal labeling requirements for nonrefillables. For non-refillable, ri gid containers with dilutable pesticides, triple and/or pressure rinsing is required prior to dis posal, and the procedure is spec ified on the pesticide label. Additionally, for refillables, registrants are required to develop written residue removal procedures for each pesticide product, and refiller s are required to follow the procedures before

each refill.

G.7 Design Qualification Testing 92



### The proposed regulations specified several contai ner design qualification te sting requirements; in particular, residue removal testing for non-refill able containers and dr op testing for refillable minibulk containers. The final regulations do not specifically require residue removal testing for non-refillable containers, although in reality the registrants will ha ve to conduct some testing to

be able to show that their containers meet th e residue removal standard. The details of the testing procedure will be included in an OPP testing guideline. The final regulations do not provide the specific details of a drop test for minibulks as the pr oposed regulations did. Instead, the final rule adopts the DOT HM R design standards for non-refillab le and refillable containers, thereby incorporating DOT’s de sign qualification te sting for drop, leakproofness, hydrostatic pressure, stacking, and cooperative tests (as appl icable) for each new or different packaging.

G.8 Production Testing and Periodic Retesting 92



### The proposed regulations did not address producti on testing or periodic retesting, whereas the final regulations require production testing and periodic retesting by adopting DOT HMR standards. Depending on the kind of container, the DOT HMR specify the retesting intervals (e.g., every 12 or 24 months for DOT non-bulk pack ages). In addition, the DOT HMR specify

92 The titles of Sections G.7 and G.8 are consistent with the DOT definitions of design qualification testing, periodic retesting, and production testing (49 CFR §178.601(c)). For the sake of completeness: “Design qualification testing is the performance of the drop, leakproofness, hydrostatic pressure, stacking, and cooperage tests, as applicable , prescribed in sections..., for each new or different packaging, at the start of production of that packaging. Periodic retesting is the performance of the drop, leakproofness, hydrostatic pressure, and stacking tests, as applicable, prescribed in sections..., at the freque ncy specified in §178.601(e) of this subpart. Production testing is the performance of the leakproofness test prescribed in §178.604 of this subpart on each single or composite packaging intended to contain a liquid.”

### Page 277 production testing (testing each and every containe r for compliance with the leakproofness test) for some types of containers.

G.9 Reconditioning



### The proposed regulations did not address reconditioning of containers. The final rule incorporates DOT requirements (such as 49 CFR §173.28) that allow and account for reconditioning.

G.10 Waiver



### The proposed rule provided for waivers from the standard closure and residue removal standards

for non-refillable containers. The final rule includes provisions for these two waivers, plus waivers from the container dispensing requirement s (for non-refillable c ontainers) and from the cross-referenced DOT requirements (for non-refillable and refillable containers.)

G.11 Certification



### The proposed regulations required registrants to certify that th e non-refillable and refillable containers used for distribution or sale of pestic ides meet the regulatory standards. As proposed,

the certification needed to c ontain information including the EP A registration number and the name of company official who certified the container. The final rule does not require

certification.

G.12 Recordkeeping



### The proposed and final regulations require several types of recordkeeping. The first addresses

the documentation that the container used meets each aspect of the EPA desi gn standards. In the proposed rule, the records for non-refillable cont ainer design specified si x pieces of information and required the records to be kept for as long as the container design type was used with the registered pesticide product, pl us 3 years. The final recordk eeping requirements are similar, although only five pieces of information must be kept. In the proposed rule, the records for

refillable containers in cluded documentation of compliance with the drop test and a copy of the certification and needed to be kept for as long as the registrant a llowed the container to be used, plus 3 additional years. The final rule doe s not include any refillable container design recordkeeping because the standards for which records were proposed are not being finalized.

The second type of recordkeeping requirement in volves records kept by the registrants regarding repackaging. The proposed rule required regi strants to keep copies of the contracts or authorizations, residue removal procedure for ref illing, and list of acceptable containers for as long as the registrant distributes or sells a product to a refiller and for 3 years thereafter. The final rule requires registrants to keep the same r ecords, but changes the time period to the current operating year and for 3 years thereafter.

The third type of recordkeeping requires refiller s to keep copies of the documents identified in the previous paragraph for the registrants. The same documents are specified in both the proposed and final regulations, a lthough the time period for mainta ining the records in the final rule was changed to the current operating year and for 3 years after (as for the registrant recordkeeping).

### Page 278 The fourth type of recordkeeping involves information that refillers have to record when they repackage and when they receive refillable cont ainers. The proposed rule required refillers to record six pieces of information each time a pestic ide was repackaged into a refillable container and four pieces of information each time a refiller received a refillable container. These records were to be kept for 3 years. The final rule maintains the same time frame, but significantly

decreases the amount of informati on that refillers must keep. In the final rule, refillers must record only three pieces of information when a pesticide is repackaged, and no recordkeeping is required when a refillable container is received.

G.13 Refilling



### The proposed and final regulations contain nearly the same requirements for refilling, including specific guidelines for registrants and refillers. For example, registrants that directly sell or distribute pesticide products in refillables or sell or distri bute pesticide products to refillers for repackaging are held responsible for providing instructions and documentation for refilling. Refillers that repackage pesticide products into re fillable containers for distribution or sale must comply with the residue removal procedure for refilling developed by registrants and can repackage any quantity of a pestic ide product into a refillable cont ainer up to the rated capacity of the container. In addition, re fillers must inspect the exterior and interiors of the containers to ensure that the container meets the necessary criter ia with respect to container integrity, required markings, and openings. Refillers must also cl ean each refillable container according to the pesticide product’s residue removal procedure fo r refilling (supplied by the registrant) before repackaging the product, unless cert ain criteria are met. Both the proposed and final regulations set out conditions for allowing regist rants and refillers to engage in repackaging. The final rule has the same general structure of these conditions, although the fi nal rule changes two of the conditions to: (1) require a contract between the parties (rather than a contract or an authorization as proposed); and (2) allow repackaging at an end user location under certain circumstances (rather than requiring the repackaging to be conducted at a re gistered establishment as proposed).

G.14 Labeling



### Labeling requirements under the final regulations are generally more flexible than the proposed regulations because they provide a range of specific statemen ts. The scope of the labeling requirement (proposed and final) includes all labels for all pesticide produc ts, not just those that fall within the container rule scope. However, the final regulations exempt household products

from the residue removal instructions. Labe ls may include blank areas, which are more specifically described in the fina l regulations, to allow a refill er to put any amount of product into a refillable, designate on the label the amount , and add its EPA establishment number. This is an option in the final rule, but was required in the proposal. Other information to be included on the label is a description of the container type (intended purpose, such as a refillable or nonrefillable statement) and detailed residue rem oval instructions. Changes between the final and proposed regulations include clarifying that dur able permanent marking is acceptable versus permanent marking, adding alternatives for the recycling and reuse statements for refillables, exempting household products from including resi due removal instructions, and several minor changes that offer greater flexibility and clarity.

### Page 279 Table G-1 presents a side-by-si de comparison of the 14 requirement categories and subcategories between the final and proposed regulations for the three major container types (non-refillable, refillable minibulk, and refillable bulk). In th e table (as in the previous discussion), only substantial changes in the requi rements are mentioned. For the purposes of this analysis, substantial changes are modifications that would change the costs and/or the assumptions made in the proposed container rule RIA. All cha nges, including those ma de for clarification purposes, are described in the preamble of the final rule.Page 280Table G-1. Comparison of Final Container Regulations with Proposed Container RegulationsFinal Container Requirements1994 Proposed Container RequirementsRefillableRefillableRequirementNon-RefillableMinibulksBulksNon-RefillableMinibulks Bulks1. ScopeThe following three categories of pesticide products are not subject to the nonrefillable container, refillable container, and repackaging regulations:(1) Manufacturing use products (MUPs),(2) Plant-incorporated protectants, and(3) Antimicrobial pesticide products that satisfy all four of these criteria:- The product is an antimicrobial pesticide,as defined in the container regulationsSection 2(mm), or it has antimicrobial properties, as defined in the containerregulations Section 2(mm)(1)(A), and issubject to a tolerance or a food additiveregulation.- Its label includes directions for use on a site in at least one of the 10 antimicrobialproduct use categories identified as “household, industrial or institutional.”- It is not a hazardous waste when it isintended to be disposed, as defined in 40CFR Part 261.- EPA has not specifically found that the product must be subject to the regulationsto prevent an unreasonable adverse effect on the environment.MUPs are exempt. All other pesticide products affected.Other than MUPs, plant-incorporatedprotectants, and exempt antimicrobialproducts, all pesticide productsaresubject tothe non-refillable containerregulations. A productis subject toallnon-refillable container requirements ifit satisfies at least one of the followingcriteria:(1) It meets the criteria of ToxicityCategory I.(2) It meets the criteria of ToxicityCategory II.(3) It is a restricted use product.If it does not meet any of these criteria,the productis subject toonly the basicDOT requirements in 49 CFR §173.24.Other than MUPs, plant-incorporatedprotectants, and exempt antimicrobialproducts, all pesticide productsaresubject toall of the refillable containerand repackaging regulations.2. Design Standards(general)Prohibit distribution or sale of pesticideproduct in non-refillable containerunless the container meets thestandards. (§165.42)Container must meet certain DOTstandards for design, construction, andmarkings in accordance with PackingGroup III material as defined by DOT.(§§165.60–165.64)Prohibit distribution or sale of pesticideproduct in refillable container unlesscontainer meets the standards. (§165.92)Container must meet certain DOTstandards for design, construction, andmarkings in accordance with PackingGroup III material as defined by DOT.(§§165.110–165.114)Same general integrity standards for bulkcontainers as proposed. (§164.120)Cannot sell or distribute pesticide in anon-refillable container unless containermeets the standards. (§165.102(a)(1)).General integrity requirements.Can’t sell or distribute pesticide in arefillable container unless containermeets the standards. (§165.124(a)(1)).General integrity requirements forminibulks. Different general integritystandards for bulk containers.Page 281Table G-1 (Continued). Comparisonof Final Container Regulations withProposed Container RegulationsFinal Container Requirements1994 Proposed Container RequirementsRefillableRefillableRequirementNon-RefillableMinibulksBulksNon-RefillableMinibulks Bulks3. Permanent MarkingsIncorporates DOT marking. Incorporates DOT marking. Also, serialnumber or other identifying code markeddurably on each container. (§165.116)Permanent only: EPA registration numberand the name, symbol, or code ofmaterial(s) used to make container.(§165.102(c))Permanent only: name of containermanufacturer, model number, date ofmanufacture, capacity, the name,symbol or code of material(s) used tomake container, serial number, and thestatement, “Meets EPA standards forrefillable containers.” (§165.124(b))4. Dispensing CapabilityIf container has capacity of 20 L or lessand if container holds a liquid pesticide,container must:(1) Allow contents to pour out in acontinuous, coherent stream, and(2) Minimize dripping.(§165.68)Not specified. Require all containers that hold liquidpesticide to:(1) Allow contents to pour in continuous,coherent stream,(2) Dispense without leaking or dripping,and(3) Once container has been resealed, notallow the pesticide to escape duringstorage or agitation.(§165.102(d))Not specified.5. ClosuresSimilar to proposed rule requirements.(§165.66)Same as proposedrule requirements.(§165.118)Same as proposedrule requirements.(§165.120(b))Four closure sizes are specified forcontainers that meet all of these criteria:(1) rigid container; (2) capacity greaterthan or equal to 3.0 liters (0.79 gal.);(3) holds liquid agricultural pesticide;(4) is not an aerosol container; (5) is not apressurized container. (§165.102(e))Final rule should not overlap with childresistant packaging requirements.Each opening ofeach liquidminibulkcontainer musthave a one-wayvalve, a tamperevident device, orboth.(§165.124(e))For liquid bulkcontainers:(1) The containermust be equippedwith a vent orother devicedesigned torelieve excesspressure, preventlosses byevaporation,excludeprecipitation.(2) External sightgauges areprohibited.(3) Containerconnectionsexcept for ventsmust be equippedwith a shutoffvalve that can belocked closed.(§165.124(f))Page 282Table G-1 (Continued). Comparisonof Final Container Regulations withProposed Container RegulationsFinal Container Requirements1994 Proposed Container RequirementsRefillableRefillableRequirementNon-RefillableMinibulksBulksNon-RefillableMinibulks Bulks6. Residue RemovalDesign StandardThe final regulationsrequire only a “four-9s”standard, where rigidcontainers with dilutablepesticides must be capableof 99.99 percent removalof each active ingredient.Percent removalrepresents the percentageof the originalconcentration of the activeingredient in the pesticideproduct when compared tothe concentration of thatactive ingredient in thefourth rinse according to aformula.The final regulationsrequire that everyregistrant test threecontainers from each rigidcontainer/dilutableformulation combination.Not specified. Not specified. For rigid containers with dilutablepesticide, registrant must demonstrate thatcontainer achieves 99.9999% removal ofeach active ingredient. Testing doneaccording to full GLP regulations.(§165.104)Testing done by sampling of a minimum19 random containers for residue removalcompliance.(§165.105(b)(1))Not specified.Page 283Table G-1 (Continued). Comparisonof Final Container Regulations withProposed Container RegulationsFinal Container Requirements1994 Proposed Container RequirementsRefillableRefillableRequirementNon-RefillableMinibulksBulksNon-RefillableMinibulks BulksProcedure Same as proposed rule requirements,but household products are exempt.Same as proposed rule requirements. Conduct rinsing (triple and/or pressure) onthe label if rigid container & dilutablepesticide.(156.144(d))Registrant develops a written residueremoval procedure for each pesticideproduct placed in a refillable containerthat is adequate to maintain productintegrity. (§§165.164(a) and165.190(a))Before refilling, the refiller (whichcould be a registrant) must clean eachrefillable container by conducting thepesticide product’s residue removalprocedure for refilling unless certainconditions are met. (§§165.170 and165.210)Before disposal, conduct the rinsingprocedure on the label. (§156.144(e))ProcedureResponsibilitySame as proposed rule requirements.Same as proposed rule requirements. End user.Before refilling: registrant and refiller(which could be the registrant). Beforedisposal: whoever disposes ofcontainer, could be registrant, refiller,end user or someone else.7. Design QualificationTestingResidue removal testing not required,but registrants will have to do sometesting to show they comply with thestandard. Incorporates DOT designqualification tests.Incorporates DOTdesignqualification tests.Incorporates DOTdesignqualification tests.Yes, required residue removal testing Yes, required droptest for minibulksNo.Sampling Three containers for residue removaltest, as described in OPP test procedure.Sampling for DOT tests as set out in theDOT regulations.As set out in DOTregulations.As set out in DOTregulations.Nineteen random containers at a minimum(for residue removal). (§165.105(b)(1))One randomcontainer; droptesting.No.Drop Test Incorporates drop test (and other tests)in DOT regulations. (49 CFR Parts 178and 180)Incorporates droptest (and othertests) in DOTregulations.(49 CFR Parts 178and 180)Incorporates droptest (and othertests) in DOTregulations.(49 CFR Parts 178and 180)No. Solids - 2.6 ft. andliquids - 3.9 ft.(§165.125(c-e))No.Page 284Table G-1 (Continued). Comparisonof Final Container Regulations withProposed Container RegulationsFinal Container Requirements1994 Proposed Container RequirementsRefillableRefillableRequirementNon-RefillableMinibulksBulksNon-RefillableMinibulks Bulks8. Production Testingand Periodic RetestingIncorporates production testing andperiodic retesting in DOT regulations.(49 CFR Parts 178 and 180)Incorporatesproduction testingand periodicretesting in DOTregulations.(49 CFR Parts 178and 180)Incorporatesproduction testingand periodicretesting in DOTregulations.(49 CFR Parts 178and 180)No. No. No.9. ReconditioningIncorporates DOT regulations thatprovide for reconditioning.(49 CFR §173.28)No. No. No. However,may be applicable todrums.No. No.10. WaiverYes. Provisions to waive: (1) adoptionof the subset of DOT standards (new);(2) standard closure requirement (asproposed); (3) container dispensingstandards (new); and (4) residueremoval standard (as proposed) if thespecified criteria are met. Waiver mustbe obtained in writing. (§§165.72,165.74)Yes. There is a provision to waiveadoption of the DOT standards if thespecified criterion is met. (New) waivermust be obtained in writing. (§§165.122,165.124)Yes. May be issued by EPA if registrantcan demonstrate that waiving compliancewith residue removal procedure does notresult in unreasonable risk. (§165.104(c))There is also the option to requestapproval of a non-standard closure, whichis ultimately a waiver (§165.102(e)(2))Not specified.11. CertificationNo No Yes. (§165.111(a)) Yes. (§165.126(a))12. RecordkeepingFor ContainerDesignRequirementsSimilar to proposed rule requirements,but copy of certification is not required.(§165.86)No recordkeeping required.For each pesticide product, maintainrecords for as long as the non-refillablecontainer design type is used to distributeor sell the pesticide product and for 3years thereafter. Must keep the followingrecords:(1) Name and EPA registration number ofthe pesticide product(2) Description of the design type of thenon-refillable container in which pesticideproduct is distributed or sold(3) Copy of the certification(4) Record to document compliance withthe requirement for closures(5) Record to document compliance withdispensing standards(6) Record to document compliance withresidue removal standard.(§165.107)For each product distributed/sold to arefiller for repackaging into refillablecontainers, maintain records for as longas a refillable container is used todistribute the product and for 3 yearsthereafter. Must keep the followingrecords:(1) Description of the refillablecontainer(s)(2) Record to document compliancewith the drop test for minibulks (ifapplicable)(3) Copy of the certification.(§165.128)Page 285Table G-1 (Continued). Comparisonof Final Container Regulations withProposed Container RegulationsFinal Container Requirements1994 Proposed Container RequirementsRefillableRefillableRequirementNon-RefillableMinibulksBulksNon-RefillableMinibulks BulksFor RepackagingRequirementsNot applicable. Registrant records: Must keep the samerecords, but for a different time period(current operating year and for 3 yearsthereafter.) (§§165.176(a) and 165.194)Refiller “informational” records: Mustkeep the same records, but for a differenttime period (current operating year andfor 3 years thereafter). (§§165.176(a)and 165.218(a))Refiller repackaging records: Each timea refiller repackagesinto a refillablecontainer for sale ordistribution, mustgenerate and maintain the following for3 years: product information; date ofrepackaging; serial number of container.(§§165.176(b) and 165.218(b))Refiller container return records: Notrequired in final rule.Not applicable. Registrant records: For as long as aregistrant distributes or sells a productto a refiller and for 3 years thereafter,the registrant must keep copies of: thecontract or authorization, residueremoval procedure for refilling, and listof acceptable containers. (§165.132)Refiller “informational” records: For aslong as a refiller distributes or sells aproduct in refillable containers and for3 years thereafter, the refiller must keepcopies of the contract or authorization,residue removal procedure for refilling,and list of acceptable containers.(§165.136(a))Refiller repackaging records: Each timea refiller repackagesinto a refillablecontainer for sale ordistribution, mustgenerate and maintain the following for3 years: product information; date ofsale; name & address of consignee;serial number of container; record ofinspection; record of cleaning.(§165.136(c))Refiller container return records: Eachtime a refiller receives a refillablecontainer, must record and maintain thefollowing for 3 years: name & addressof person providing container; serialnumber of container;date the containerwas received; product last sold incontainer. (§165.136(b))Page 286Table G-1 (Continued). Comparisonof Final Container Regulations withProposed Container RegulationsFinal Container Requirements1994 Proposed Container RequirementsRefillableRefillableRequirementNon-RefillableMinibulksBulksNon-RefillableMinibulks Bulks13. RefillingTransferNot Applicable.Same general structure as proposed rulerequirements, but the final rule changestwo of the conditions to require acontract between the parties rather than acontract or authorization and to allowrepackaging at an end user location ifconducted by a registered establishment.(§§165.182 and 165.202)Not applicable.Replaces the Bulk PesticidesEnforcement Policy with §165.129.Provides that registrants may allow arefiller to repackage the registrant’spesticide product into any sizerefillable container and distribute orsell under the registrant’s registration(provided all conditions of the rule aremet). Also establishes theresponsibilities of registrants andrefillers for various parts of the refillingprocess.Responsibility forProduct IntegrityNot applicable. Same as proposed rule requirements.(§165.162, 165.188 and 165.206)Not applicable. Both the registrant and refiller heldresponsible for integrity of therepackaged product; different butrelated roles regarding label andrepackaging. (§§165.129–165.34)Inspection Not applicable. Same as proposed rule requirements.(§§165.168 and 165.210)Not applicable. Refiller inspects prior to repackaging.(§165.134(e))14. LabelingSimilar to and more specific andflexible than proposed requirements.Additional/amended requirementsinclude:(1) Durable markings acceptable(§156.140)(2) Non-refillable statement includesalternatives for recycling and reusedirections (§156.140(a))(3) Exempt household products fromrequiring residue removal instructions.(§156.144(c)) (See residue removalprocedures above.)(4) Rinsing procedure includes “orequivalent.” (§156.146(a)) (See residueremoval procedures above.)Similar to and more specific and flexiblethan proposed requirements.Additional/amended requirementsinclude:(1) Durable markings acceptable(§156.140)(2) More specific description of use ofblank space on labels for net contentsand EPA establishment registrationnumber, and makes blank spacesoptional (“may include”) (§156.10(d)(f))(3) Container type requirement includesan alternative statement. (§156.140(b))(4) Residue removal statement(§156.156) (See residue removalprocedures above.)(1) Identify container type + recycle + donot reuse statement (§156.140(a))(2) Residue removal statement(§156.144(d)) (See residue removalprocedures above.)(1) Reserve space for net weight ofcontents (§156.10(d)(7))(2) Reserve space for EPAestablishment number (§156.10(f))(3) Identify container type(§156.140(b))(4) Residue removal statement(§156.144(e)) (See residue removalprocedures above.)

### Page 287 

## Appendix H. Characterization of Unintentional Human Pesticide and Antimicrobial Exposures and Health Effects in the TESS Database

H.1 General Characterization of Unintent ional Human Pesticide and Antimicrobial Exposures



### One of the strengths of TESS information is th at it provides a perspective on the extent of pesticide exposures occurring thro ughout the country. For example, we have information on the distribution of the age of uni ntentional pesticide exposure vi ctims by the reason of exposure (Table H-1). Generally, children less than 6 years of age comprised 54 percent of the overall exposure cases seen. Thirty-seven percent of the incidents involved adults over 19 years old, followed by young children 6 to 12 years old (6 pe rcent), and young adults 13 to 19 years old (3 percent). Overall, in children under 6 years of age most cases (64. 05 percent) were observed as a result of “general” unintentional exposure causes.

Table H-1. Percent Distribution of Age of Exposure Case by Reason of Exposure

Exposure Reason ≤ 5 Years

Old 6-12 Years

Old 13-19 Years

Old ≥ 20 Years

Old Unknown Total a

General 64.05% 5.14% 2.21% 27.83% 0.76% 81.21%

Environmental 17.12% 8.78% 4.92% 67.40% 1.78% 8.11%

Occupational 0.04% 0.04% 6.93% 91.54% 1.45% 3.24%

Therapeutic Error 22.55% 21.72% 8.13% 46.43% 1.16% 0.74%

Misuse 6.38% 7.87% 5.26% 79.97% 0.52% 6.20%

Bite/sting 19.64% 7.14% 3.57% 66.07% 3.57% 0.07%

Food poisoning 9.52% 4.76% 47.62% 38.10% 0% 0.05%

Unknown 29.29% 5.72% 5.39% 58.59% 1.01% 0.37%

Total 54.10% 5.57% 2.85% 36.62% 0.86% 100.00%

Source: AAPCC (2002, Report 31 “Reason by Age (Adults Lumped)”).

a Represents column percent where total number of cases is 80,978; other percentages represent row percent.



### As expected, adults sustained the majority (91.54 percent) of exposures occurring in occupational environments. Although adults comp rised only 36.62 percent of the overall victim population, they made up the largest proportion of exposures in each specific reason of exposure category, except for “general.”

Table H-2 below shows a similar breakdown of these unintentional e xposures categories by exposure chronicity. Of all the unintentional pesticide and antimi crobial exposures observed in 2001, the overwhelming majority (97 percent) of them were considered “acute” exposures. Chronic exposures comprised 1.4 percent of a ll unintentional pesticide and antimicrobial exposures, acute-on-chronic exposures represen ted approximately one percent, and cases in which the chronicity could not be determined accounted for 0.2 percent of overall unintentional

exposures.

### Page 288 Table H-2. Percent Distribution of Exposu re Chronicity to Reason of Exposure

Exposure Reason Acute a Acute-onchronic b Chronic c Unknown d Total e

General 98.84% 0.52% 0.50% 0.14% 81.27%

Environmental 88.66% 3.12% 7.56% 0.65% 8.11%

Occupational 88.99% 2.70% 7.20% 1.10% 3.24%

Therapeutic Error 90.05% 4.31% 5.47% 0.17% 0.74%

Misuse 95.56% 2.01% 2.21% 0.22% 6.20%

Bite/sting 94.64% 1.79% 3.57% 0% 0.07%

Food poisoning 100.00% 0% 0% 0% 0.05%

Unknown 93.60% 2.36% 2.02% 2.02% 0.37%

TOTAL 97.40% 0.93% 1.44% 0.22% 100.00%

Source: AAPCC (2002, Report 42 “Reason by Exposure Chronicity”).

a Acute: a single, repeated or continuous exposure occurring over a period of 8 hours or less.

b Acute-on-chronic: single exposur e that was preceded by a con tinuous, repeated, or interm ittent exposure occurring over a period exceeding 8 hours.

c Chronic: a continuous, repeated, or intermittent exposure to the same substance lasting longer than 8 hours.

d Unknown: unable to determine whether the exposure is acute or chronic.

e Represents column percent where total number of cases is 80,978; other percentages represent row percent.



### H.2 Characterization of Health Effects Asso ciated with Unintentional Human Pesticide and Antimicrobial Exposure Cases



### TESS data also offer some insight into the type or degree of outcome or clinical effects and the location of the activities perfor med to manage the exposure. We evaluated these data and determined the appropriate stratification with which to estimate the number of unintentional pesticide-related illnesses expected per year. This section characterizes the overall patterns seen among unintentional pesticide exposures.

The general distribution of exposure cases by me dical outcome is presented for both the “with concomitants” and “without concomitants” categories in Table H-3. In this case, the distribution of medical outcome does not vary sign ificantly between the two categories.

### Page 289 Table H-3. Profile of Unintentional Pesticide and Antimicrobial Exposures by

Medical Outcome

With Concomitants a Without

Concomitants b Medical Outcome Description Number Percent Number Percent

No effect Patient developed no signs or symptoms as a result of exposure 18,385 22.70% 17,888 23.03%

Minor effect Patient developed some signs or symptoms as a result of the exposure, but they were minimally bothersome and generally resolved with no residual disability or disfigurement 12,084 14.92% 11,295 14.54%

Moderate effect Patient exhibited signs or symptoms as a result of the exposure that were more pronounced, more prolonged, or more of a systemic nature than minor symptoms (usually some form of treatment is indicated) 2,164 2.67% 1,876 2.42%

Major effect Patient exhibited signs or symptoms as a result of the exposure that were life-threatening or resulted in significant residual disability or disfigurement 111 0.14% 87 0.11%

Death Patient died as a result of the exposure or as a direct complication of the exposure 2 0% 2 0%

No follow-up,

nontoxic No follow-up calls were made to determine the patient’s outcome because the substance implicated was nontoxic, the amount implicated was insignificant, or the route of exposure was unlikely to result in a clinical

effect 13,773 17.01% 13,612 17.52%

No follow-up,

minimal toxicity No follow-up calls were made to determine the patient’s outcome because the exposure was likely to result in only minimal toxicity of a

trivial nature 25,388 31.35% 24,482 31.52%

No follow-up, potentially

toxic Patient was lost to follow-up, refused followup, or was not followed, but the exposure was significant and may have resulted in a moderate, major, or fatal outcome 2,378 2.94% 2,229 2.87%

Unrelated effect Exposure was probably not responsible for the

effect 6,693 8.27% 6,201 7.98%

Total 80,978 100.00% 77,672 100.00%

Source: AAPCC (2002, Report 22 “Medical Outcome” and p. 6 “Field Definitions”).

a “With Concomitants” indicates that a pesticide substan ce was implicated in the exposure case but could have involved another substance that may or may not have been another pesticide.

b “Without concomitants” indicates that only one pe sticide substance was implicated in the exposure.



### We evaluated only the unintentional pesticide and antimicrobial exposures “with concomitants” to include all the cases in which a pesticide was involved. The majority of cases reported showed no effect (23 percent) or was an expos ure in which minimal toxicity concerns were involved (31 percent).

### Page 290 Table H-4 displays the severity of symptoms asso ciated with exposures distributed by age. As described earlier, young children acc ount for the majority of the exposed population (54 percent) in the 80,978 reported cases. However, from Tabl e H-4, we see that they also account for the majority of the individuals who showed no effect from the reported exposure (75 percent) as well as of the individuals involved in nontoxic expo sures (77 percent). By contrast, adults were among the majority of victims exhibiting minor, moderate, or major medical effects. More severe outcomes (“major effect”) also occurred in the adult (over 19 years old) category. Results for the exposures resulting in death appear to be equally distributed between less-than-6-yearolds and over-19-year-olds, but this is represen tative of the two deaths reported in 2001.

Table H-4. Percent Distribution of Age of Exposure Patient by Symptom Severity of Medical Outcome Among “With Concomitants” Exposure Cases

Medical Outcome ≤ 5 Years

Old 6-12 Years

Old 13-19 Years

Old ≥ 20 Years

Old Unknown Total a

No effect 74.57% 5.32% 1.68% 17.97% 0.46% 23.70%

Minor effect b 24.90% 7.15% 4.97% 62.20% 0.78% 14.92%

Moderate effect b 11.23% 3.51% 4.16% 80.18% 0.93% 2.67%

Major effect b 27.93% 5.41% 9.01% 55.86% 1.80% 0.14%

Death 50.00% 0% 0% 50.00% 0% 0%

No follow-up, nontoxic 77.02% 4.94% 1.68% 15.72% 0.64% 17.01%

No follow-up, minimal toxicity 53.39% 5.90% 3.06% 36.64% 1.01% 31.35%

No follow-up, potentially toxic 43.82% 4.12% 2.86% 45.75% 3.45% 2.94%

Unrelated effect 24.07% 4.62% 3.35% 67.00% 0.97% 8.27%

Total 54.10% 5.57% 2.85% 36.62% 0.86% 100.00%

Source: AAPCC (2002, Report 51a “Medic al Outcome by Age (Adults Lumped)”).

a Represents column percent where total number of cases is 80,978; other percentages represent row percent.

b The duration of the clinical effects observed in these outcome categories ar e highlighted in Table H-5 below.



### Table H-5 shows the tendency for increasing durati on of the clinical effects with more severe outcomes among those exhibiting minor, moderate, or major medical outcomes. Although these outcome categories were defined above in Tabl e H-3, some examples of common symptoms demonstrated in each group may include:

• Minor effect: self-limited gastrointestinal symptoms, drowsiness, skin irritation, first-degree dermal burn, transient cough;

• Moderate effect: corneal abrasion, high fever, disorientation, isolated brief seizures that respond readily to treatment; and

• Major effect: repeated seizures, respirator y compromise during in tubation, cardiac or respiratory arrest.

### Page 291 Table H-5. Duration of Clinical Effect s by Symptom Severity Among Those “With Concomitant” Cases Exhibiting Minor, Moderate or Major Medical Outcomes

Duration Minor Effect Moderate Effect Major Effect Total

≤ 2 hours 48.49% 14.93% 5.41% 43.10%

> 2 and

 8 hours 18.55% 19.69% 7.21% 18.64%

> 8 and

 24 hours 12.34% 16.54% 19.82% 13.03%

> 24 hours and ≤ 3 days 6.30% 14.60% 23.42% 7.68%

> 3 days and ≤ 1 week 2.97% 10.17% 9.01% 4.10%

> 1 week and ≤ 1 month 1.12% 3.79% 5.41% 1.55%

> 1 month 0.27% 1.39% 4.50% 0.47%

Anticipated permanent 0.02% 0.28% 4.50% 0.10%

Unknown 9.93% 18.62% 20.72% 11.32%

Total a 84.16% 15.07% 0.77% 100.00%

Source: AAPCC (2002, Report 23 “Duration of Clinical Effects by Medical Outcome”).

a Represents row percent where total number minor, moderate and major effects is 14,359; other percentages represent column percent.



### Most minor effects lasted less than 2 hours, and as expected, victims with major effects tended to experience more prolonged effects.

Table H-6 gives more insight regarding the severi ty of reported cases and the medical resources required to manage them. The majority of all unintentional pesticide exposures (77 percent) reported to poison centers were managed in a non-heal th care facility, such as at the site of the exposure (which could be the patient’s home). Tr eatment in health care facilities was involved in 20 percent of the reported cases and was recommended in a nother 1.27 percent of patients.

Table H-6. Percent Distribution of Symp tom Severity of Medical Outcome by Management Site Among “With Concomitant” Exposure Cases

Medical Outcome Non-Health

Care Facility Health Care Facility Other Refused

Referral Unknown Total a

No effect 76.57% 22.49% 0.36% 0.55% 0.03% 22.70%

Minor effect 66.44% 29.93% 1.02% 2.35% 0.26% 14.92%

Moderate effect 23.94% 69.18% 1.57% 4.81% 0.51% 2.67%

Major effect 9.01% 81.98% 5.41% 3.60% 0% 0.14%

Death 0% 100% 0% 0% 0% 0%

No follow-up, nontoxic 93.25% 6.43% 0.25% 0.03% 0.05% 17.01%

No follow-up, minimal toxicity 88.03% 10.32% 0.81% 0.37% 0.47% 31.35%

No follow-up, potentially toxic 28.17% 46.01% 3.11% 14.00% 8.70% 2.94%

Unrelated effect 61.09% 34.87% 1.00% 1.51% 1.52% 8.27%

Total 77.29% 20.10% 0.75% 1.27% 0.60% 100.00%

Source: AAPCC (2002, Report 39 “Medical Outcome by Management Site”).

a Represents column percent where total number of cases is 80,978; other percentages represent row percent.

### Page 292 Table H-4 above showed that the majority of victims experiencing minor, moderate, or major effects were over 19 years old. According to Tabl e H-6, the majority of victims with moderate and major effects are managed in a health care fa cility. Table H-7 provides the distribution of

the victims that were treated in health care faci lities, where children less than 6 years old and adults over 19 years of age were most often treat ed and released when they were evaluated at a health care facility. However, adults over 19 ye ars of age were also approximately twice as likely as children less than 6 years old to be admitted to the hospital for their exposure.

Table H-7. Percent Distribution of Manageme nt Site by Age of “With Concomitant” Exposure Patient

Management Site ≤ 5 Years

Old 6-12 Years

Old 13-19

Years Old ≥ 20 Years

Old Unknown Total a

Non-health care facility 56.75% 5.99% 2.73% 33.71% 0.81% 77.29%

Health care facility 45.80% 3.75% 3.22% 46.43% 0.79% 21.36%

Treated/released 52.01% 3.98% 2.84% 40.68% 0.48% 16.24%

Admitted, critical care 28.84% 5.03% 4.23% 61.11% 0.79% 0.47%

Admitted, non-critical care 32.50% 2.12% 7.31% 57.88% 0.19% 0.64%

Admitted, psychiatry 1.85% 1.85% 20.37% 74.07% 1.85% 0.07%

Lost to follow-up/left against

medical advice 25.33% 3.26% 3.59% 65.10% 2.72% 2.69%

Refused Referral 24.98% 2.34% 3.90% 67.90% 0.88% 1.27%

Other 34.26% 13.61% 5.90% 41.48% 4.75% 0.75%

Unknown 32.37% 5.19% 2.28% 56.02% 4.14% 0.60%

TOTAL 54.10% 5.57% 2.85% 36.62% 0.86% 100.00%

Source: AAPCC (2002, Report 45a “M anagement Site by Age - Row %”).

a Represents column percent where total number of cases is 80,978; other percentages represent row percent.

### Page 293 

## Appendix I. Benchmark Costs for Ph ysician Office Visits by Current Procedural Terminology, Fo urth Edition (CPT-4) Code

Table I-1. Benchmark Costs for Physicia n Office Visits by Current Procedural Terminology, Fourth Edition (CPT-4) Code

CPT-4 Code Brief Description Cost (Year 2000$) Cost (Year 2005$) a

99201 New patient requiring: 1. Problem focused history

2. Problem focused examination 3. Straightforward medical decision-making $30.61 $31.68

99202 New patient requiring: 1. Expanded problem focused history 2. Expanded problem focused examination 3. Straightforward medical decision-making $48.44 $50.14

99203 New patient requiring: 1. Detailed history

2. Detailed examination 3. Medical decision-making of low complexity $66.95 $69.30

99204 New patient requiring: 1. Comprehensive history 2. Comprehensive examination 3. Medical decision-making of moderate complexity $99.58 $103.07

99205 New patient requiring: 1. Comprehensive history 2. Comprehensive examination 3. Medical decision-making of high complexity $125.15 $129.54

99211 Established patient. May not require a physician. Presenting problems are minimal (5 minutes). $13.46 $13.93

99212 Established patient requiring

 2 of these 3 components: 1. Problem focused history

2. Problem focused examination 3. Straightforward medical decision-making $26.58 $27.51

99213 Established patient requiring

 2 of these 3 components: 1. Expanded problem focused history 2. Expanded problem focused examination 3. Medical decision-making of low complexity $38.02 $39.35

99214 Established patient requiring

 2 of these 3 components: 1. Detailed history

2. Detailed examination 3. Medical decision-making of moderate complexity $57.53 $59.55

99215 Established patient requiring

 2 of these 3 components: 1. Comprehensive history 2. Comprehensive examination 3. Medical decision-making of high complexity $90.83 $94.01

Source: Online division of Intellimed, accessible at www.myhealthscore.com.

a Prices provided at www.myhealthscor e.com were year 2000 dollars, as of October 23, 2002. These costs were converted to 2005 dollars by applying the Medicare Physician Fee Schedule conversion factors: [2005 conversion factor] ÷ [2000 conversion factor] = $37.8975 ÷ $36.6137 = 1.0351.

### Page 294 

## Appendix J. Case Summaries of 1999 Ca lifornia Incidents That Would Have Been Prevented by the Container Regulations

In Chapter 5, we described the state data used to derive the percentage of pesticide illnesses potentially related to the container standards. Th is section provides a more detailed view of the underlying cases in California in 199 9 that were used in the calcul ation of the percentage. First, we provide a breakdown of the cases based on th e likelihood of preventi on by the regulation and whether the pesticide involved is subject to the regulations. This is followed by individual case summaries for each of the cases used by EPA to es timate the percentage of potentially avoidable pesticide illnesses as a result of the regulation.

Table J-1 shows the number of cases associated with the incidents in California in 1999 that were considered by EPA to have been “very likel y” or “possibly” prev ented by the container regulations. Sixteen cases we re considered “very likely,” and 51 cases were considered “possible.” Table J-2 presen ts the specific case summarie s, along with two columns of information critical to the calculations described in Chapter 5.

Table J-1. Number of Cases in California in 1999 Considered by EPA as “Very Likely” or “Possibly” Preventable by the Container Regulations

Likelihood of Incident

Prevention Regulated Pesticide Category Very Likely Possibly Total

Other Pesticide 7 15 22

Antimicrobial 9 30 39

Antimicrobial (unclear whet her subject to regulations) 3 3 6

Total 19 48 67

Note: Shaded areas denote the 51 “possible” cases, which if included, would increase the annual health benefits by an additional 1,950 to 2,451 cases, as described in S ection 5.2.5.3. The three unclear antimicrobial cases are

included in the “Possible” incidents



### The first column of interest is “Reg Imp act,” which designates EPA’s evaluation of the regulatory impact. In addition to this condition of whether the in cident was likely to have been prevented by the regulations, EPA also considered whether the chemical involved was subject to the regulations (noted in the column “Product Category”). Here, EPA determined that cases involving non-antimicrobial agents were subject to the regulations (“Not A”). For the remaining cases, where the antimicrobial pesticide was known, EPA determined whether it would be subject to the regulations (“A-in” if subject to regulations, otherwise exempt and omitted from the table).

However, in six cases antimicrobial pesticides were involved, but it was not clear from the California Department of Pesticide Regulations (CDPR) information available whether the pesticide is subject to the cont ainer regulations (denoted “A ?” in Table J-2). Three of these cases were initially categorized as “very like ly” and three were “possibly” prevented by the regulations, as shown in Table J-1. Due to the limited data and the uncertainties surrounding these cases, we regrouped the three former cases as “possibly” for a conservative approach to

### Page 295 deriving the percentage of pesticide illnesses potentially related to the container design and

residue removal standards.

Additional cases avoided if possible cases are included



### Similar to calculations describe d in 5.2.4 and 5.2.5, we estimat e the additional cases avoided if the 51 “possible” cases were also consider ed. The 51 “possible” cases (from CDPR) corresponds to 4.33 percent of th e total unintentional pesticide product cases in CDPR (i.e., 51 / 1,179 = 4.33 percent). In 2001, 64 poison control cen ters participated in TESS, reporting more than 2 million human exposure cases, which represent an estimated 98.8 percent of all poison exposures reported to poison centers in the U.S. To scale up to 100 percent, we need the inverse of 98.8 percent, which is 1.012)

Avoided illnesses with clinical effects = 19,492 * 4.33% * 1.012 = 853 cases, where 19,492 is

the number of nationwide illne sses resulting from unintentional pesticide-related exposures (from TESS); used for “low-end” scenario. To ca lculate the “high-end” scenario, we go through the same steps using 24,531 (19,492 related case s + 5039 unknown if related) “high-end” cases as the basis from TESS, which results in 1,074 cases avoided.

From Table 5.10, we have that 43.86% of exposures resulted in clinical effects (including minor, moderate, major effects, and death) and 56.14% of exposures resulted in “no effect.” Assuming these same ratios between exposures with clinical effects and exposures with “no effect,” than

we can estimate the number of cases with “no effect” avoided by the rule would be:



### 092

, 1 % 14

. 56 % 86

. 43

853

= ⇒ = x x

Therefore, the total number of a dditional cases that could have b een avoided if the 51 “possible” cases were considered from the CDPR data, is 1,945 (853 + 1,092 = 1,945). This number represents the “low-end” scenario. To calculate the “high-end” scenario, we go through the same steps using 1,074 “high-end” cases re sulting in clinical effects, which results in 2,449 “high-end”

cases avoided.



### 375

, 1 % 14

. 56 % 86

. 43 074

, 1

= ⇒ = x xPage 296Table J-2. Case Summaries of Incidents inCalifornia in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly” Prevented bythe Container RegulationsCase No.CDPRRelationaProductCategorybMedical Description Pesticide(s)DaysoffWorkDaysinHospRegImpactcCommentsHANDLING CONTAINER FOR APPLICATION/USEOpening or closing container (other than drops)99-44 def A-in red, irritatedeye sodium hypochlorite 0 0 P After removing the cap to a bleach bottle, a restaurant managerpoked a hole in the inside sealcausing a drop of bleach tosplash into his eye. He flushed the eye; failed to wearprovided eye protection.99-121 pro A-in red, irritated eyes sodium hypochlorite 0 0 P According to the manager, a bus boy splashed sanitizer into hiseyes when he opened a 5-gallon sanitizer container prior toconnecting it to the dishwasher.His eyes felt irritated so a coworker drove him to the hospital.99-176 def A-in red, burning eye,blurred visionsodium hypochlorite 0 0 P Kenneltechnician flicked a drop ofbleach into her eye as shepulled the inner seal from a new bottle of bleach. She flushedher eye; failed to wear employer-provided gloves & eye wear.Handler opens container and then drops it99-840 def A-in severely painful, red& dry eyes, blurredvision, sluggishlyreactive pupilssodium hypochlorite 1 0 V As a worker poured pool chlorine into a dispensing barrel, thecontainer’s handle broke off in his hands. The container fellinto the barrel and splashed liquid chlorine onto his face. Theliquid ran down behind his goggles and into his eyes.Transfer pesticide from container, unspecified99-334 def A-in red eye, superficialcorneal burnsodium hypochlorite 0 0 P School food service worker splashed bleach in her eye whilepouring a sanitizer from a gallon container into a small spraybottle. She acknowledged havingbeen trained to wear rubbergloves & goggles, but failed to do so.99-783 def A-in scratchy, burning, redeyessodium hypochlorite 2 0 P Liquid pool chlorine sprayed into the faces of a delivery driverand his assistant when theassistant uncapped a hoseincautiously. They rinsed eyes & were taken to a hospital.Both recovered fully within 5 days.99-995 def A-in red, burning eye sodium hypochlorite 0 0 P When a camp maintenance worker poured liquid chorine into acistern to treat the camp’s drinking water, some of the liquidsplashed up into his eye.He flushed the eye and soughtmedical attention.Page 297Table J-2 (Continued). Case Summaries ofIncidents in California in 1999 Considered byEPA to Have Been “Very Likely” or “Possibly”Prevented by the Container RegulationsCase No.CDPRRelationaProductCategorybMedical Description Pesticide(s)DaysoffWorkDaysinHospRegImpactcComments99-1121 def A-in red, dry and burningeye, blurred visionsodium hypochlorite 0 0 P When a hurried correctional officer tried topour bleach from a5-gallon container into a cup, she splashed some bleach intoher eye. She failed to wearlabel-required eye protection.99-1401 def A-in burning eye sodium hypochlorite 0 0 P As employee poured disinfectant into a spa, some liquidcontacted his hand. He then touched the contaminated hand tohis eye, which began burning, so he flushed it before seekingmedical attention.Handler is exposed while mixing/loading; exposure involves the container99-719 pro A ? burning eye peroxyacetic acid 0 0 P Sterilant failed to completely drain from its packet into asterilizer when a medical technician submerged the packet inwater and cut it open. She accidentally splashed a drop ofliquid into her eye. She flushed it with water.Handler is exposed while mixing/loading;exposure involves the transfer equipment99-395 pro A-in burning, irritated skinon face, neck,shoulder; headache,brief transient eyeirritationsodium hypochlorite 0 0 P A pool chlorine delivery driver asked a swimming poolemployee to shut a valve duringthe transfer process. Whenthe employee attempted to close the valve, it broke. Liquidchlorine splashed on his body.99-613 def A-in redness, burningsensation in eye,slightly blurredvisionsodium hypochlorite 0 0 P Employee attempted to dislodge what he believed was ablockage in the disinfectant discharge tube when thedisinfectant splashed toward his face and into his eye. Heflushed the eye with water and sought medical attention.99-715 def A-in redness, stinging &burning pain in eyessodium hypochlorite 0 0 P Mobile home park manager investigated problem with poolchlorinator. During inspection, a line blew off and sprayedliquid chlorine in his face. Force of spray lifted his goggles.He had no pesticide training.99-854 def A-in irritated, burning eye sodium hypochlorite 1 0 P As a prison employee attempted to connect a bleach hose to awater treatment tank, the hose popped off and splashed bleachinto his eye. He flushed it with water and went to theinfirmary, which sent him to a doctor.Page 298Table J-2 (Continued). Case Summaries ofIncidents in California in 1999 Considered byEPA to Have Been “Very Likely” or “Possibly”Prevented by the Container RegulationsCase No.CDPRRelationaProductCategorybMedical Description Pesticide(s)DaysoffWorkDaysinHospRegImpactcCommentsHandler is exposed while mixing/loading; exposure doesnot involve the containerand/or transfer equipment99-402 def A-in burning, irritated eye sodium hypochlorite 0 0 P As a housekeeper cleaned the restroom, she poured bleach intoa bucket of water and splashed some in her eye. Shedeveloped symptoms and sought medical attention. She failedto wear the provided eye protection.99-635 def A-in red & irritated eye sodium hypochlorite 17 0 P As a meat packing plant employee filled a machine withcleaner & disinfectant, some solution splashed into his eye.He sought medical attention. He failed to wear provided eyeprotection.99-779 pos Not A itchy, red, burningrash on face and neckpropargite, adjuvant 0 0 P Worker mixed, loaded & applied propargite to a grapevineyard for 3 or 4 days. He first noticed his neck feeling hotwhile loading the propargite in the spray tank. He saw adoctor the next day when symptoms worsened.99-819 def A-in red, burning eye sodium hypochlorite 0 0 P When a custodian poured bleach into bucket, some of itsplashed into his eye. He developed symptoms and soughtmedical attention. He failed towear provided eye protection.99-865 pro Not A red, burning, itchingand papular lesion onpenisnot determined,metolachlor, trifluralin0 0 P After mixing/loading herbicides, an applicator urinated w/owashing his hands. He developed symptoms and saw a doctor2 hours later. Grower & worker have conflicting statementsabout application dates and protective gear.99-1005 def A-in burning, painful andslightly red eyesodium hypochlorite 0 0 P Veterinary assistant prepared to mop the floor of the clinic. Asshe poured bleach into the mopbucket, some splashed up intoher eye. She sought medical attention.99-1047 def A ? red, burning eye unknown 0 0 P As restaurant employee poured liquid sanitizer into water,some of it splashed up into his eye. He developed symptomsand sought medical attention. Restaurant switched to granularsanitizer.99-1135 def A-in red, burning, painfuleyesodium hypochlorite 5 0 P When a shopemployee poured bleach into a bucket, shesplashed some into her eye. She flushed it and sought medicalattention. The bucket contained cleaning towels.Page 299Table J-2 (Continued). Case Summaries ofIncidents in California in 1999 Considered byEPA to Have Been “Very Likely” or “Possibly”Prevented by the Container RegulationsCase No.CDPRRelationaProductCategorybMedical Description Pesticide(s)DaysoffWorkDaysinHospRegImpactcComments99-1146 def A-in red, painful eye sodium hypochlorite 0 0P While preparing a bleach solution to wash walls, a custodiansplashed the liquid into his eye. He flushed the eye with waterand continued work. He sought medical attention the next day.Use or application99-120 def A-in red, irritated eye sodium hypochlorite 0 0 P Amusement park worker splashed sanitizer in his eye as hepoured the liquid into a sinkof dishes. The eye remainedirritated after flushing it, so he went to a hospital emergencyroom.99-406 pro A-in red, burning eye sodium hypochlorite 0 0 P Hospital housekeeper splashed bleach in her eye whilecleaning a toilet. She flushed her eye with water beforeseeking medical attention in the hospital emergency room.99-674 def Not A mildly swolleneyelid, irritated eyepermethrin 5 0 P SPCO removed safety glasses to examine a plugged nozzle.While manipulating the nozzle, it unplugged and sprayedpermethrin into his eye. He flushed the eye with water andsaw a doctor the next day.99-682 def A-in red, burning eye,blurred vision, smallerosions over rightcorneasodium hypochlorite 1 0 P As a swimming instructor poured chlorine into the pool, someliquid splashed up into her eye. She flushed the eye & soughtmedical attention. Label instructions were almost illegible.99-713 pro A ? water & burningeyes, irritated throat,brief wheezingheadacheperoxyacetic acid 0 0 V As an LVN placeda sterilant container into a sterilizingmachine, the lid broke. She removed the container and pouredsterilizer into an adjacent sinkaccording to instructions. Sheexposed herself to fumes & developed symptoms.99-1128 def A-in burning eye sodium hypochlorite 0 0 P Pool serviceman ignored explicit company policy by failing towear provided PPE. As he poured pool chlorine into a spa,liquid splashed up into his eye. He flushed it and soughtmedical attention.Page 300Table J-2 (Continued). Case Summaries ofIncidents in California in 1999 Considered byEPA to Have Been “Very Likely” or “Possibly”Prevented by the Container RegulationsCase No.CDPRRelationaProductCategorybMedical Description Pesticide(s)DaysoffWorkDaysinHospRegImpactcCommentsMiscellaneous99-288 pro Not A red, irritated eyes adjuvant 0 0 P As employee put away a spreader-binder container, he set itdown hard, causing the material to splash up into his eyes.The cap was not screwed on tight. He rinsed his eyes withwater and went home for the day. He saw a doctor the nextday.99-320 pos Not A red, burning, painfuleyenot determined,diuron, glyphosate,oxyfluorfen, simazine0 0 P Farm worker felt something in right eye while hand-pouring aherbicide into a spray tank equipped with a boom sprayer and ahand wand. He wore safety glasses with brow and templeprotection. He is unsure what got into his eye.OTHER CONTAINER HANDLINGHandling that seems to be related to use99-196 def Not A red and burning skinon the palm of theleft handnot determined, 2,4-D,diquat, fluazifopbutyl, mecoprop? 0 V A herbicide leaked onto a homeowner’s left hand as sheadjusted the nozzle on a ready-to-use product. Her hand beganto burn so she rinsed it with water for 15 minutes beforeseeking medical attention. She failed to wear the requiredrubber gloves.99-296 pro Not A severe burning &pain in eyesglyphosate 0 0 P While holding a glyphosate container, homeownercontaminated his hand with residue on the container. Herubbed his eyes and developed symptoms. He irrigated theeyes and sought medical attention.99-689 pro Not A headache, nausea,lightheadedness,slight difficultybreathingglyphosate 4 0 p As an employee talked to an unhappy customer, he took the lidoff a hand pump sprayer and accidentally splashed some of thepesticide onto her arms. The sprayer was left in her work areawhere she smelled the fumes. She developed symptoms.Moving containers on a cart99-1048 pro A-in red, burning eye sodium hypochlorite 0 0 P While cleaning a co-worker’s cart, a janitor reached for abottle of bleach with a loosened cap. The cap came off andspilled bleach into her eye. She flushed it and was taken formedical evaluation.Page 301Table J-2 (Continued). Case Summaries ofIncidents in California in 1999 Considered byEPA to Have Been “Very Likely” or “Possibly”Prevented by the Container RegulationsCase No.CDPRRelationaProductCategorybMedical Description Pesticide(s)DaysoffWorkDaysinHospRegImpactcCommentsMiscellaneous99-340 def Not A red, irritated eyes fipronil 0 0 P Child grabbed flea treatment product from her grandfather’shands. She meant to apply it, but squirted it in her eyes whiletrying to open it. Her grandparents rinsed her eyesimmediately and took her to the emergency room.99-1177 def A-in redness, temporaryloss of visionsodium hypochlorite 3 0 P As employee changed the disinfectant container for adishwasher, some of the liquid splashed up into his eye. Heflushed it & sought medical attention. His employer providedno eye protection.STORAGEStock management99-90 def A-in red, burning eye sodium hypochlorite 1 0 V As a worker stacked liquid pool chlorine cases onto a handtruck, some liquid from the bottom of a case splashed up intohis eye. He immediately flushed his eye with water and soughtmedical attention; failed to wear provided safety glasses.99-546 def A ? nausea, headache,vomitingunknown ? 0 V As employee lifted boxes of disinfectant containers, bottomfell out of one box. Container broke upon impact and contentssplashed up into his face. He developed symptoms and soughtmedical attention the next day.99-1001 def A-in red, irritated eye,blurred visionsodium hypochlorite 0 0 V Pool chlorine leaked and wet its carton. When the storemanager moved the carton, it caught on a nail & tore. Thechlorine containers fell out and liquid splashed into his eye.He flushed it & sought medical attention.99-1105 def Not A 2 dime-sized blisterson the hand betweenfingersnot determined,chloropicrin, methylbromide0 0 P While prepping empty fumigant cylinders for return tomanufacturer, a grower placed safety cap back on a cylinder.He noticed wetness on his hand & smelled chloropicrin.Within a few hours, he noticed blisters on his hand.Leaking/broken container onshelf causes exposure99-560 def A-in red, burning, itchyeyes, temporaryblindnesssodium hypochlorite 1 0 V Liquid from a cracked disinfectant container splashed into anemployee’s eyes as he stocked shelves at a retail store. Hedeveloped symptoms & sought medical attention.Page 302Table J-2 (Continued). Case Summaries ofIncidents in California in 1999 Considered byEPA to Have Been “Very Likely” or “Possibly”Prevented by the Container RegulationsCase No.CDPRRelationaProductCategorybMedical Description Pesticide(s)DaysoffWorkDaysinHospRegImpactcComments99-580 pro Not A nausea, upsetstomachnot determined, 2,4-D,dichlorprop,mecoprop0 0 V When a customer picked up a leaking herbicide bottle from ashelf, he contaminated his hand. He bought another bottle anddrove home. While driving home, he became nauseous so hewashed his hands upon arriving home. He saw a doctor thenext day.99-610 def Not A red, burning eye metolachlor 0 0 V Shopforeman splashed a concentrated herbicide in his eyewhen he investigated a wet package. He had receivedapplicator training. After the incident, his employer directedhim to wear PPE in all dealings with chemicals.99-1354 pro A ? rough, dry skin onfingers, itchy &burning handsphenolic disinfectants 0 0 V Hospital service technician developed skin irritation throughrepeated contact with leaking containers, one of which is adisinfectant. He saw a nurse practitioner who instructed him towear protective gloves when handling containers.Container falls off shelf or is dropped after being taken from a shelf99-903 pro Not A burning eyes, nose,throat and chestMSMA 0 0 V Sales clerk dropped a bottle of herbicide while stockingshelves. Upon impact, the lid popped off and the herbicidesplashed into his face & eyes. He flushed them & soughtmedical attention.Stocking shelves or displays99-275 def A-in pain & cornealabrasion in eyesodium hypochlorite 0 0 P As employee stocked the grocery shelves with disinfectant, heaccidentally squeezed the trigger nozzle on a bottle andsquirted the disinfectant into his eye. A co-workerimmediately drove him to a medical clinic for treatment.Retail – exposure occurs at cashier/check out stand99-128 def A-in pain, irritation ineyessodium hypochlorite 1 0 V When a cashier dropped a bleach bottle, some of the liquidsplashed up into her eyes. She flushed her eyes and saw adoctor, who noted normal exam except for eyelid opening.Retail – exposure from handling returns99-56 pro Not A red, watery eyes andburning sensation ofeyes and facecypermethrin 0 0 P A courtesy clerk dropped a can of insecticide as she returned itto the shelf. When she pickedit up, it exploded in her face.She washed but developed symptoms 30 minutes later.Page 303Table J-2 (Continued). Case Summaries ofIncidents in California in 1999 Considered byEPA to Have Been “Very Likely” or “Possibly”Prevented by the Container RegulationsCase No.CDPRRelationaProductCategorybMedical Description Pesticide(s)DaysoffWorkDaysinHospRegImpactcComments99-510 def A-in red, burning, tearingeye, red eyelidssodium hypochlorite 0 0 P As grocery store employee handled a returned gallon of bleach,a loose cap allowed some to spill on a roll of tape. When shepicked up the tape, the liquid splashed into her eye. Sheflushed her eye with water.99-891 def Not A blurred vision, lightsensitivity in the eyemalathion 3 0 P Dissatisfied customer slammed a plastic bag containing abroken malathion bottle onto the returns counter causingmalathion to splatter into the cashier’s eye. She flushed hereye and saw a doctor the next day.Retail – other99-720 pro A-in mildly red, burningpain in eyecalcium hypochlorite 0 0 V When a grocery store clerk picked up a leaking bag of granularpool chlorine, some of the product blew up into her eye. Hereye began burning so a co-worker took her to a doctor.99-786 pro A-in itchy, red, burningskin on arm, sensitiveto light touch, nauseasodium hypochlorite 0 0 V Pool sanitizer spilled from a leaking bottle onto a retail clerk’sarm. She felt her skin immediately begin to burn so shewashed it with soap & water. Her skin reddened and she feltnauseous.99-889 pos A-in watery, irritated,bloodshot eyesodium hypochlorite 0 0 V Retail clerk handled a wet box of liquid pool chlorine. Shesaid it did not smell like chlorine. Later, her eye becameirritated. She flushed it with water and was sent to a doctor.99-1159 pos A-in red, burning in eye copper naphthenate 0 0V Retail clerk rubbed his eye after carrying an unopened can ofwood preservative. The eye began to burn and he flushed itimmediately with water.TRANSPORTATIONExposure while loading or unloading a vehicle99-133 pos Not A nausea,lightheadedness,slightly dry mouth,difficulty breathing,sluggishnessdiazinon 0 0 V Farm supply company driver picked up a bag of diazinonpowder. Bag split open and powder poofed up into his face.He washed face, removed shirt, developed symptoms thatnight. His family had the flu at the time.Page 304Table J-2 (Continued). Case Summaries ofIncidents in California in 1999 Considered byEPA to Have Been “Very Likely” or “Possibly”Prevented by the Container RegulationsCase No.CDPRRelationaProductCategorybMedical Description Pesticide(s)DaysoffWorkDaysinHospRegImpactcCommentsContainer leaks or spills during transport99-168 pro Not A burning testicle andabdomen skin, legnumbnesstrifluralin 0 0 P An unopened box with 2 containers fell off a truck as 2employees drove to an application site. One employeecontaminated himself with pesticide & developed symptoms.He saw a doctor 4 hours later.Transportation – accident99-1353 pro A-in red, burning eyes,difficulty breathing,burning lungs &facial skinsodium hypochlorite 0 0 P Two police officers spent 30 minutes directing traffic atvehicular accident site involvinga pool service company truck.The chemicals spilled and formed a whitish cloud to which theofficers were exposed.OTHERRepackaging - transferring pesticide from one container to another (not for application or use)99-1219 pro A-in difficulty breathing,pain upon deepbreathingcalcium hypochlorite 0 0 P As a pool maintenance worker transferred granular poolchlorine from a large container to a small one, he inhaled thefumes. He developed symptoms and sought medical attention.He smokes 4–5 packs of cigarettes per week.Spill – various causes (not drop, not moving, not falling off shelves)99-1441 pro A-in coughing, breathingdifficulty, eyeirritation, dizzinessnot determined,hydrogen chloride,sodium hypochlorite15 0 P Contractor was checking on a nearby tank when he noticed thecloud of greenish gas and shouted for people to clear the area.He reported that one of his employees also was present andexperienced similar symptoms.Mix up containers/mistake/mis-labeled containers99-541 pro A ? burning in throat,chest heaviness,transient shortness ofbreathunknown 0 0 P Someone apparently poured an unknown liquid into a brokencontainer of granular pool chlorine causing generation offumes. Upon investigating an odor complaint, a store managerdiscovered the problem, inhaled the fumes & developedsymptoms.Cleanup99-785 pos Not A nausea, sleepiness,eye irritationoxyfluorfen 0 0 P Public works employee developed symptoms after helping toclean up a herbicide spill. He went home to rest. Hissupervisor went to his home and took him for medical care.Page 305Table J-2 (Continued). Case Summaries ofIncidents in California in 1999 Considered byEPA to Have Been “Very Likely” or “Possibly”Prevented by the Container RegulationsCase No.CDPRRelationaProductCategorybMedical Description Pesticide(s)DaysoffWorkDaysinHospRegImpactcCommentsMiscellaneous household exposures99-1055 pos A-in red, irritated eye sodium hypochlorite 0 0 P When a worker added disinfectant bleach to a load of laundry,some bleach splashed up into her eye. She rinsed the eye andcontinued working. The eye still bothered her 23 days later andshe sought medical attention.SPECIFIC PESTICIDES OR CONTAINERSFogger99-284 def Not A coughing, sore throat,burning eyes, rash onheadnot determined,methoprene, piperonlybutoxide, pyrethrins,synergist? 0 V Homeowner successfully activated 2 insecticide foggers, butthe tab snapped off the third and sprayed the insecticide intoher face. She rinsed her face and eyes with a garden hose andsought medical attention. Her symptoms resolved within a fewdays.Aerosol container – exposure occurs during application (use of the container)99-1411 pos Not A nausea, vomiting,diarrhea, mildsweating, abdominalpain, possible mildtremorchlorpyrifos ? 0 P Man developed symptoms after spraying an aerosol insecticidein his room. He reportedly inhaled some as well as gettingsome on his skin.Spray bottle – spray mechanism and bottle separate, causing exposure99-511 def Not A bad taste in mouth,nauseam eyeirritationglyphosate 0 0 V While preparing to spray weeds, a homeowner pulled up on theplunger of a ready-to-use glyphosate container. The plungerhandle broke off, allowing glyphosate to spray up into his face.He felt irritant symptoms, so he showered and sought medicalattention.99-1365 pro Not A burning eyes, blurredvisionunknown 0 0 P Homeowner treated a crape myrtle with an old dormant spray,thought to contain copper & oil.When the nozzle tip came offthe hand pump sprayer, the wind blew pesticide stream into hisface & eyes. He washed up & saw a doctor.Page 306Table J-2 (Continued). Case Summaries ofIncidents in California in 1999 Considered byEPA to Have Been “Very Likely” or “Possibly”Prevented by the Container RegulationsSource: EPA (2005).a“CDPR Relation” refers to the California Department of Pesticide Regulation (CDPR) evaluation of the degree of correlation between pesticide exposure and resulting symptoms,where the term “pesticide-related” refers to cases that fall into one of the three following relationships:Definite (def): High degree of correlation between pattern ofexposure and resulting symptoms. Requires both medical evidence (such as measured cholinesterase inhibition,positive allergy tests, characteristic signsobserved by medical professional) and physical evidence of exposure (environmentaland/or biological samples, exposure history) tosupport the conclusions.Probable (pro): Relatively high degree ofcorrelation exists between the pattern ofexposure and the resulting symptoms. Eithermedical or physical evidence is inconclusive orunavailable.Possible (pos): Some degree of correlation evident. Medicaland physical evidence are inconclusive or unavailable.b“Product Category” refers to the following codes, developed and assigned by EPA regarding the type of pesticide involved and whether it is subject to the Container Regulationsgiven the information provided in the CDPR case summary:Not A: not an antimicrobial, assumed to be subject to the regulations.A-in: antimicrobial that is subject to the regulations (i.e.,antimicrobial that is “in” the scope of the regulations).A ?: antimicrobial, but it is unclear whether or not it will be subject to the regulations, either because there is not enoughinformation, or it is not clear how all of the regulatorycriteria would apply to it.c“Reg Impact” refers to whether EPA determined the incident to be “very likely” (V) or “possibly” (P) prevented by the container regulations.Page 307Appendix K. Pesticide Container and Refilling Requirements Cost Analysis TablesTable K-1a. Number of Containers Withinthe Scope of the Rule by Container Type, Entity Size, and Market Sector: NonRefillable Liquid Pesticide Containers30-55 Gallons5 Gallons1 to < 5 Gallons< 1 GallonWater SolublePacketsPlasticSteelPlasticSteelPlasticSteelPlasticSteelGlassPVAPacketsBarrierPacksBag inBoxAerosolCansSubtotal--LiquidContainersSmall-Small EstablishmentsAgricultural 378 141 71 35 34,128 0 1,233 0 0 667 101 1 036,755I/C/G 1,610 2,335 14,139 966 21,208 1,449 20,693 161 242 0 0 262 23,35086,415Home &Garden0 0 0 0 30,186 8,625 112,120 12,937 8,625 0 0 0 215,615388,107Medium-Small EstablishmentsAgricultural 883 330 166 82 79,623 0 2,876 0 0 1,555 235 1 085,752I/C/G 3,757 5,448 32,987 2,254 49,481 3,381 48,279 376 564 0 0 611 54,478201,616Home &Garden0 0 0 0 70,427 20,122 261,587 30,183 20,122 0 0 0 503,052905,494Large-Small EstablishmentsAgricultural 1,600 598 301 149 144,339 0 5,214 0 0 2,820 425 2 0155,449I/C/G 6,811 9,876 59,799 4,086 89,6986,130 87,518 681 1,022 0 0 1,107 98,756365,483Home &Garden0 0 0 0 127,669 36,477 474,198 54,715 36,477 0 0 0 911,9181,641,453Large EstablishmentsAgricultural 196,572 73,449 36,958 18,32717,728,446 0 640,408 0 0 346,332 52,251 299 019,093,042I/C/G 836,533 1,212,973 7,344,760501,920 11,017,139 752,880 10,749,44983,653 125,480 0 0 135,937 12,129,72844,890,451Home &Garden0 0 0 0 15,680,901 4,480,257 58,243,346 6,720,386 4,480,257 0 0 0 112,006,434201,611,581Page 308Table K-1b. Number of Containers Within the Scope of the Rule by Container Type, EntitySize, and Market Sector: NonRefillable Solid Pesticide Containers11-44 lbBags45 - 55 lb Bags11 - 44 lb Bags1 - 10 lb BagsJugsWater SolublePacketsBulkPaper/PlasticPlasticPaperPlasticPaperPlasticPaper2.5Gallons1 qt to< 2.5 GalPVAPacketsBarrierPacks> 101 lbSmall-Small EstablishmentsAgricultural0 2,264 9,991 4,609 2,714 403 7,015 32 2,783 53,951 14,542 526I/C/G0 0 0 1,127 0 0 0 0 372 1,308 433 0Home &Garden0 0 0 42,584 0 0 0 0 539 0 0 0Medium-Small EstablishmentsAgricultural0 5,282 23,309 10,753 6,331 939 16,367 75 6,492 125,874 33,929 1,227I/C/G0 0 0 2,630 0 0 0 0 869 3,053 1,010 0Home &Garden0 0 0 99,353 0 0 0 0 1,258 0 0 0Large-Small EstablishmentsAgricultural0 9,575 42,255 19,493 11,477 1,703 29,669 137 11,769 228,181 61,506 2,224I/C/G0 0 0 4,768 0 0 0 0 1,575 5,534 1,830 0Home &Garden0 0 0 180,104 0 0 0 0 2,280 0 0 0Large EstablishmentsAgricultural0 1,175,993 5,189,922 2,394,278 1,409,603 209,151 3,644,096 16,776 1,445,534 28,026,402 7,554,447 273,121I/C/G0 0 0 585,573 0 0 0 0 193,448 679,683 224,818 0Home &Garden0 0 0 22,121,271 0 0 0 0 280,016 0 0 0

### Page 309 Table K-1b (Continued). Number of Containers Within the Scope of the Rule by Container Type, Entity Size, and Market Sector: Non-Refillable Solid Pesticide Containers

Fiber Drums

> 30 lb < 30 lb Other Subtotal-- Dry

Containers Total

Small-Small Establishments
Agricultural 15 159 4,214 103,217 139,972

I/C/G 1,288 0 0 4,529 90,944

Home & Garden 0 0 0 43,123 431,230

Medium-Small Establishments

Agricultural 35 370 9,832 240,816 326,568

I/C/G 3,006 0 0 10,567 212,183

Home & Garden 0 0 0 100,610 1,006,105

Large-Small Establishments

Agricultural 64 671 17,822 436,544 591,993

I/C/G 5,449 0 0 19,155 384,638

Home & Garden 0 0 0 182,384 1,823,837

Large Establishments

Agricultural 7,811 82,428 2,189,025 53,618,588 72,711,631

I/C/G 669,226 0 0 2,352,749 47,243,200

Home & Garden 0 0 0 22,401,287 224,012,868Page 310Table K-1c. Number of Containers Within the Scope of the Rule by Container Type, Entity Size, and MarketSector: RefillableLiquid Pesticide Containers“Large” BulkTanksBulk Tanks(> 250 Gallons)126 - 250Gallons61 - 125 Gallons 26 - 60 Gallons 5 - 25 GallonsPlastic Steel Plastic SteelPlastic Steel Plastic SteelPlastic Steel Plastic SteelOtherSizesSubtotal--LiquidContainersSmall-Small EstablishmentsAgricultural 23 3 2 0 66 13 327 109 93 8 243 189 01,076I/C/G 14 2 22 5 14 2 14 2 270 7 133 0 1,8972,380Home & Garden 0 0 0 0 0 0 0 0 0 0 0 0 00Swimming PoolIndustry3 0 10 1 0 0 0 0 287 0 144 0 2,0522,498Medium-Small EstablishmentsAgricultural 53 6 5 1 154 30 764 255 216 18 566 442 02,510I/C/G 33 4 51 12 32 4 32 4 630 16 310 0 4,4275,553Home & Garden 0 0 0 0 0 0 0 0 0 0 0 0 00Swimming PoolIndustry12 1 33 4 0 0 0 0 996 0 498 0 7,1128,655Large-Small EstablishmentsAgricultural 97 11 9 1 279 54 1,385 462 392 32 1,026 801 04,549I/C/G 60 7 92 22 58 6 58 6 1,142 28 562 0 8,02510,067Home & Garden 0 0 0 0 0 0 0 0 0 0 0 0 00Swimming PoolIndustry3 0 8 1 0 0 0 0 241 0 120 0 1,7182,091Large EstablishmentsAgricultural 11,887 1,321 1,153 128 34,301 6,604 170,123 56,773 48,100 3,943 126,065 98,368 0558,766I/C/G 7,313 813 11,282 2,736 7,146 794 7,146 794 140,310 3,478 68,996 0 985,6511,236,458Home & Garden 0 0 0 0 0 0 0 0 0 0 0 0 00Swimming PoolIndustry1,602 178 4,629 514 0 0 0 0 138,476 0 69,238 0 989,1171,203,756

### Page 311 Table K-1d. Number of Containers Within the Sc ope of the Rule by Container Type, Entity Size, and Market Sector: Refillable Solid Pesticide Containers

Bulk (> 2,501 lbs) 101 - 2,500

lbs < 100 lb “Large”

Bulk

Tank Paper/Plastic Paper/Plastic Paper/Plastic Other Subtotal-- Dry

Containers Total

Small-Small Establishments

Agricultural 0 10 25 1,286 0 1,322 2,398

I/C/G 0 0 0 0 0 0 2,380

Home & Garden 0 0 0 0 0 0 0

Swimming Pool Industry 0 0 0 0 0 0 2,498

Medium-Small Establishments

Agricultural 1 24 59 3,001 0 3,084 5,594

I/C/G 0 0 0 0 0 0 5,553

Home & Garden 0 0 0 0 0 0 0

Swimming Pool Industry 0 0 0 0 0 0 8,655

Large-Small Establishments

Agricultural 1 44 107 5,439 0 5,591 10,140

I/C/G 0 0 0 0 0 0 10,067

Home & Garden 0 0 0 0 0 0 0

Swimming Pool Industry 0 0 0 0 0 0 2,091

Large Establishments

Agricultural 172 5,347 13,109 668,074 0 686,703 1,245,469

I/C/G 0 0 0 0 0 0 1,236,458

Home & Garden 0 0 0 0 0 0 0

Swimming Pool Industry 0 0 0 0 0 0 1,203,756Page 312Table K-2a. Number of Containers Out of Compliance for the AverageRegistrant, by Requirement, Market Sector, and Entity Size(Nonrefillable Containers)DOT PackagingStandards,Hazardous MaterialDOT PackagingStandards, Nonhazardous MaterialClosureStandardsDispensingStandardsLabeling RecordkeepingSmall EstablishmentsAgriculture 0 0 39 81 1,596 1,596Indust./Comm./Govt. 0 0 0 272 1,383 1,383Home & Garden 0 0 0 511 6,556 6,556Total0 0 39 865 9,535 9,535Small-Small EstablishmentsAgriculture 0 0 9 18 351 351Indust./Comm./Govt. 0 0 0 60 304 304Home & Garden 0 0 0 112 1,442 1,442Total0 0 9 190 2,097 2,097Medium-Small EstablishmentsAgriculture 0 0 40 84 1,650 1,650Indust./Comm./Govt. 0 0 0 281 1,429 1,429Home & Garden 0 0 0 529 6,778 6,778Total0 0 40 894 9,857 9,857Large-Small EstablishmentsAgriculture 0 0 217 453 8,906 8,906Indust./Comm./Govt. 0 0 0 1,519 7,716 7,716Home & Garden 0 0 0 2,854 36,586 36,586Total0 0 217 4,825 53,208 53,208Large EstablishmentsAgriculture 0 0 30,404 63,288 1,245,062 1,245,062Indust./Comm./Govt. 0 0 0 212,341 1,078,612 1,078,612Home & Garden 0 0 0 398,927 5,114,449 5,114,449Total0 0 30,404 674,556 7,438,123 7,438,123Page 313Table K-2b. Number of Containers Out of Compliance for the Average Registrant, by Requirement, Market Sector, and Entity Size(Refillable Containers)DOT PackagingStandards,HazardousMaterialDOT PackagingStandards, Nonhazardous MaterialLabeling RecordkeepingContainerMarkingsMinibulkContainerOpeningsBulk ContainerStandardsSmall EstablishmentsAgriculture 0.00 0.00 27.34 27.34 27.34 4.18 0.09Indust./Comm./Govt. 0.00 0.00 36.19 36.19 1.09 6.02 0.23Home & Garden 0.00 0.00 0.00 0.00 0.00 0.00 0.00Total0.00 0.00 63.53 63.53 28.43 10.20 0.31Small-Small EstablishmentsAgriculture 0.00 0.00 6.01 6.01 6.01 0.92 0.02Indust./Comm./Govt. 0.00 0.00 7.96 7.96 0.24 1.32 0.05Home & Garden 0.00 0.00 0.00 0.00 0.00 0.00 0.00Total0.00 0.00 13.97 13.97 6.25 2.24 0.07Medium-Small EstablishmentsAgriculture 0.00 0.00 28.26 28.26 28.26 4.32 0.09Indust./Comm./Govt. 0.00 0.00 37.41 37.41 1.13 6.23 0.23Home & Garden 0.00 0.00 0.00 0.00 0.00 0.00 0.00Total0.00 0.00 65.67 65.67 29.39 10.55 0.32Large-Small EstablishmentsAgriculture 0.00 0.00 152.56 152.56 152.56 23.33 0.49Indust./Comm./Govt. 0.00 0.00 201.94 201.94 6.10 33.61 1.26Home & Garden 0.00 0.00 0.00 0.00 0.00 0.00 0.00Total0.00 0.00 354.50 354.50 158.66 56.94 1.75Large EstablishmentsAgriculture 0.00 0.00 21326.52 21326.52 21326.52 3261.93 68.98Indust./Comm./Govt. 0.00 0.00 28229.63 28229.63 853.30 4698.55 176.25Home & Garden 0.00 0.00 0.00 0.00 0.00 0.00 0.00Total0.00 0.00 49556.14 49556.14 22179.81 7960.48 245.23

### Page 314 Table K-3. Number of Refillable Contai ners by Type of Refilling Entity

Number of Containers within the Scope

of the Rule Type of Refilling Entity

Liquid Dry Total

Agriculture 566,900 696,700 1,263,600

Agricultural Pesticide Refillers 510,210 627,030 1,137,240

Agricultural Pesticide Registrants 56,690 69,670 126,360

I/C/G -- Pestic ide registrants 37,458 0 37,458

Swimming Pool Industry -- Antimicrobial Applicators 1,217,000 0 1,217,000

Home & Garden 0 0 0

Total 2,388,258 696,700 2,518,058Page 315Table K-4a. Annual Refillings per RefillerCurrently Not in Compliancewith Inspection Requirementby Container Type, EntitySize, and Market SectorContainer Type: Liquid ProductsContainer Type: Dry Products

“Large” Bulk Tanks Bulk Tanks (> 250 Gallons) 126 - 250 Gallons 61 - 125 Gallons 26 - 60 Gallons 5 - 25 GallonsPlastic Steel Plastic Steel Plastic Steel Plastic Steel Plastic Steel Plastic Steel Other “Large” Bulk Tank Bulk (> 2,501 lbs) Paper/Plastic 101 - 2,500 lbs Paper/Plastic < 100 lb Paper/Plastic Other TotalAgricultural Pesticide RefillersLarge-Small2.0 0.2 0.2 0.0 8.0 1.5 39.6 13.2 11.2 0.9 37.7 29.4 0.0 0.0 0.9 3.1 155.4 0.0303.4Medium-Small0.6 0.1 0.1 0.0 2.4 0.5 11.7 3.9 3.3 0.3 11.2 8.7 0.0 0.0 0.3 0.9 46.1 0.089.9Small-Small0.1 0.0 0.0 0.0 0.3 0.1 1.4 0.5 0.4 0.0 1.3 1.0 0.0 0.0 0.0 0.1 5.5 0.010.7Large16.7 1.9 1.6 0.2 67.3 13.0 334.0 111.594.4 7.7 318.3 248.3 0.0 0.2 7.5 25.7 1311.8 0.02560.2Agricultural Pesticide RegistrantsSmall0.0 0.0 0.0 0.0 0.1 0.0 0.3 0.1 0.1 0.0 0.2 0.2 0.0 0.0 0.0 0.0 1.0 0.02.0Large-Small0.1 0.0 0.0 0.0 0.3 0.1 1.5 0.5 0.4 0.0 1.4 1.1 0.0 0.0 0.0 0.1 5.7 0.011.2Medium-Small0.0 0.0 0.0 0.0 0.1 0.0 0.3 0.1 0.1 0.0 0.3 0.2 0.0 0.0 0.0 0.0 1.1 0.02.1Small-Small0.0 0.0 0.0 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.0 0.0 0.2 0.00.4Large10.2 1.1 1.0 0.1 41.1 7.9 203.9 68.1 57.7 4.7 194.3 151.6 0.0 0.1 4.6 15.7 800.8 0.01562.9I/C/G -- Pesticide registrantsSmall0.3 0.0 0.3 0.1 0.3 0.0 0.3 0.0 0.1 0.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.01.7Large-Small1.5 0.2 1.7 0.6 1.9 0.2 1.9 0.2 0.6 0.9 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.09.6Medium-Small0.3 0.0 0.3 0.1 0.3 0.0 0.3 0.0 0.1 0.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.01.8Small-Small0.1 0.0 0.1 0.0 0.1 0.0 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.4Large208.8 23.2 243.6 81.2 261.0 29.0 261.0 29.0 84.7 127.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.01348.7Swimming Pool Supply Companies -- Antimicrobial ApplicatorsSmall0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 2.0 0.0 1.0 0.0 14.2 0.0 0.0 0.0 0.0 0.017.3Large-Small0.0 0.0 0.1 0.0 0.0 0.0 0.0 0.0 6.9 0.0 3.4 0.0 49.1 0.0 0.0 0.0 0.0 0.059.6Medium-Small0.0 0.0 0.1 0.0 0.0 0.0 0.0 0.0 3.4 0.0 1.7 0.0 24.3 0.0 0.0 0.0 0.0 0.029.5Small-Small0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.7 0.0 0.3 0.0 4.7 0.0 0.0 0.0 0.0 0.05.7Large18.9 2.1 54.5 6.1 0.0 0.0 0.0 0.0 3258.3 0.0 1629.2 0.0 23274 0.0 0.0 0.0 0.0 0.028242.9Page 316Table K-4b. Annual Refillings per Refiller Currently Not in Compliance with Container Cleaning Requirement by ContainerType, Entity Size, and Market SectorContainer Type: Liquid ProductsContainer Type: Dry Products

“Large” Bulk Tanks Bulk Tanks (> 250 Gallons) 126 - 250 Gallons 61 - 125 Gallons 26 - 60 Gallons 5 - 25 GallonsPlastic Steel Plastic Steel Plastic Steel Plastic Steel Plastic Steel Plastic Steel Other “Large” Bulk Tank Bulk (> 2,501 lbs) Pa p er/Plastic 101 - 2,500 lbs Paper/Plastic < 100 lb Paper/Plastic Other TotalAgricultural Pesticide RefillersLarge-Small0.4 0.0 0.0 0.0 1.6 0.3 7.9 2.6 2.2 0.2 7.5 5.9 0.0 0.0 0.2 0.6 31.1 0.060.7Medium-Small0.1 0.0 0.0 0.0 0.5 0.1 2.3 0.8 0.7 0.1 2.2 1.7 0.0 0.0 0.1 0.2 9.2 0.018.0Small-Small0.0 0.0 0.0 0.0 0.1 0.0 0.3 0.1 0.1 0.0 0.3 0.2 0.0 0.0 0.0 0.0 1.1 0.02.1Large3.3 0.4 0.3 0.0 13.5 2.6 66.8 22.3 18.9 1.5 63.7 49.7 0.0 0.0 1.5 5.1 262.4 0.0512.0Agricultural Pesticide RegistrantsSmall0.0 0.0 0.0 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.2 0.00.4Large-Small0.0 0.0 0.0 0.0 0.1 0.0 0.3 0.1 0.1 0.0 0.3 0.2 0.0 0.0 0.0 0.0 1.1 0.02.2Medium-Small0.0 0.0 0.0 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.0 0.0 0.2 0.00.4Small-Small0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.1Large2.0 0.2 0.2 0.0 8.2 1.6 40.8 13.6 11.5 0.9 38.9 30.3 0.0 0.0 0.9 3.1 160.2 0.0312.6I/C/G -- Pesticide registrantsSmall0.1 0.0 0.1 0.0 0.1 0.0 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.3Large-Small0.3 0.0 0.3 0.1 0.4 0.0 0.4 0.0 0.1 0.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.01.9Medium-Small0.1 0.0 0.1 0.0 0.1 0.0 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.4Small-Small0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.1Large41.8 4.6 48.7 16.2 52.2 5.8 52.2 5.8 16.9 25.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0269.7Swimming Pool Supply Companies-- Antimicrobial ApplicatorsSmall0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.0Large-Small0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.0Medium-Small0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.0Small-Small0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.0Large0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.0Page 317Table K-4c. Annual Refillings per Refiller Currently Not in Compliance withContainer Tracking(Recordkeeping)Requirement by Container Type, Entity Size, and Market SectorContainer Type: Liquid ProductsContainer Type: Dry Products

“Large” Bulk Tanks Bulk Tanks (> 250 Gallons) 126 - 250 Gallons 61 - 125 Gallons 26 - 60 Gallons 5 - 25 GallonsPlastic Steel Plastic Steel PlasticSteel Plastic Steel Plastic Steel Plastic Steel Other “Large” Bulk Tank Bulk (> 2,501 lbs) Paper/Plastic 101 - 2,500 lbs Paper/Plastic < 100 lb Paper/Plastic Other TotalAgricultural Pesticide RefillersLarge-Small4.9 0.5 0.5 0.1 20.0 3.8 99.0 33.0 28.0 2.3 94.3 73.6 0.0 0.1 2.2 7.6 388.6 0.0758.5Medium-Small1.5 0.2 0.1 0.0 5.9 1.1 29.3 9.8 8.3 0.7 27.9 21.8 0.0 0.0 0.7 2.3 115.2 0.0224.8Small-Small0.2 0.0 0.0 0.0 0.7 0.1 3.5 1.2 1.0 0.1 3.3 2.6 0.0 0.0 0.1 0.3 13.7 0.026.8Large41.7 4.6 4.0 0.4 168.4 32.4 835.1 278.7 236.1 19.4 795.6 620.8 0.0 0.6 18.7 64.3 3279.4 0.06400.4Agricultural Pesticide RegistrantsSmall0.0 0.0 0.0 0.0 0.1 0.0 0.7 0.2 0.2 0.0 0.6 0.5 0.0 0.0 0.0 0.1 2.6 0.05.0Large-Small0.2 0.0 0.0 0.0 0.7 0.1 3.6 1.2 1.0 0.1 3.5 2.7 0.0 0.0 0.1 0.3 14.3 0.027.9Medium-Small0.0 0.0 0.0 0.0 0.1 0.0 0.7 0.2 0.2 0.0 0.6 0.5 0.0 0.0 0.0 0.1 2.7 0.05.2Small-Small0.0 0.0 0.0 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.1 0.1 0.0 0.0 0.0 0.0 0.6 0.01.1Large25.4 2.8 2.5 0.3 102.8 19.8 509.8 170.1 144.1 11.8 485.7 379.0 0.0 0.4 11.4 39.3 2001.9 0.03907.2I/C/G -- Pesticide registrantsSmall0.7 0.1 0.8 0.3 0.8 0.1 0.8 0.1 0.3 0.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.04.3Large-Small3.7 0.4 4.4 1.5 4.7 0.5 4.7 0.5 1.5 2.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.024.1Medium-Small0.7 0.1 0.8 0.3 0.9 0.1 0.9 0.1 0.3 0.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.04.5Small-Small0.1 0.0 0.2 0.1 0.2 0.0 0.2 0.0 0.1 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.01.0Large522.1 58.0 609.1 203.0 652.6 72.5 652.6 72.5 211.7 317.6 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.03371.7Swimming Pool Supply Companies-- Antimicrobial ApplicatorsSmall0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.0Large-Small0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.0Medium-Small0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.0Small-Small0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.0Large0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.00.0Page 318Table K-5a. Present Discounted Value of Compliance Costsper Entity for Refilling Requirement, 3% Discount RateYear5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20Agricultural Pesticide RefillersLarge-Small$1215 $987 $958 $930 $903 $877 $851 $826 $802 $779 $756 $734 $713 $692 $672 $652Medium-Small499 293 284 276 268 260 252 245 238 231 224 218 211 205 199 193Small-Small234 35 34 33 32 31 30 29 28 28 27 26 25 24 24 23Large8776 8328 8085 7850 7621 7399 7184 6974 6771 6574 6383 6197 6016 5841 5671 5506Agricultural Pesticide RegistrantsSmall205 7 6 6 6 6 6 5 5 5 5 5 5 5 4 4Large-Small236 36 35 34 33 32 31 30 30 29 28 27 26 26 25 24Medium-Small205 7 7 6 6 6 6 6 5 5 5 5 5 5 5 4Small-Small200 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1Large5434 5084 4936 4792 4652 4517 4385 4258 4134 4013 3896 3783 3673 3566 3462 3361Industrial/Commercial/Government Pesticide RegistrantsLarge-Small230 31 30 30 29 28 27 26 26 25 24 23 23 22 21 21Medium-Small204 6 6 5 5 5 5 5 5 5 4 4 4 4 4 4Small-Small199 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1Large4717 4387 4259 4135 4015 3898 3784 3674 3567 3463 3362 3264 3169 3077 2987 2900Swimming Pool Supply Companies – Antimicrobial ApplicatorsLarge-Small223 24 24 23 22 22 21 20 20 19 19 18 18 17 16 16Medium-Small210 12 12 11 11 11 10 10 10 9 9 9 9 8 8 8Small-Small200 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2Large12026 11484 11149 10825 10509 10203 9906 9618 9337 9065 8801 8545 8296 8055 7820 7592Page 319Table K-5b. Present Discounted Value of Compliance Costs per Entity for Refilling Requirement, 7% Discount RateYear5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20Agricultural Pesticide RefillersLarge-Small$1004 $785 $734 $686 $641 $599 $560 $523 $489 $457 $427 $399 $373 $349 $326 $305Medium-Small413 233 218 203 190 178 166 155 145 135 127 118 111 103 97 90Small-Small193 28 26 24 23 21 20 18 17 16 15 14 13 12 12 11Large7254 6626 6193 5787 5409 5055 4724 4415 4126 3856 3604 3368 3148 2942 2750 2570Agricultural Pesticide RegistrantsSmall169 5 5 5 4 4 4 3 3 3 3 3 2 2 2 2Large-Small195 29 27 25 24 22 21 19 18 17 16 15 14 13 12 11Medium-Small169 5 5 5 4 4 4 4 3 3 3 3 3 2 2 2Small-Small165 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0Large4492 4045 3780 3533 3302 3086 2884 2695 2519 2354 2200 2056 1922 1796 1678 1569Industrial/Commercial/Government Pesticide RegistrantsLarge-Small190 25 23 22 20 19 18 17 16 15 14 13 12 11 10 10Medium-Small169 5 4 4 4 4 3 3 3 3 3 2 2 2 2 2Small-Small165 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0Large3899 3491 3262 3049 2849 2663 2489 2326 2174 2032 1899 1774 1658 1550 1448 1354Swimming Pool Supply Companies – Antimicrobial ApplicatorsLarge-Small184 19 18 17 16 15 14 13 12 11 10 10 9 9 8 7Medium-Small174 10 9 8 8 7 7 6 6 6 5 5 5 4 4 4Small-Small166 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1Large9940 9137 8539 7981 7459 6971 6515 6088 5690 5318 4970 4645 4341 4057 3792 3544