15P

- 0213 

### Worker Protection Standard: Response to Comment Document

I. Introduction 1

The purpose of this document is to summarize and respond to the comments received on the 2

revisions to 40 CFR Part 170, the Worker Protection Standard. 3

The revisions were proposed on March 19, 2014 (79 FR 15444). EPA received substantial 4

feedback on the p roposal, including about 2,400 written comments with over 393,000 signatures. 5

Commenters included state pesticide regulatory agencies, state departments of health, farmworker 6

advocacy organizations, public health agencies, growers and grower organizations, agricultural producer 7

organizations, applicators and applicator organizations, pesticide manufacturers and their organizations, 8

personal protective equipment manufacturers, farm bureaus, crop consultants and organizations, the 9

Small Business Administratio n (SBA) Office of Advocacy, concerned citizens, and others. 10

This document generally follows the same structure as the preamble for the final rule to make it 11

easy to cross reference between the two documents. The preamble to the final rule includes a summ ary 12

of the major comments and EPA’s responses to them. 13

Here is an outline of the contents: 14

I. Introduction 15

II. General Support 16

III. General Opposition 17

IV. Context and Goals of this Rulemaking 18

A. Context of this Rulemaking 19

B. Goals of this Rulemaking 20

V. Pe sticide Safety Training for Workers and Handlers 21

A. Shorten Retraining Interval for Workers and Handlers 22

B. Establish Recordkeeping Requirements to Verify Training for Workers and Handlers 23

C. Establish Trainer Qualifications for Workers and Handlers 24

D. Expand the Content of Worker and Handler Pesticide Safety Training 25

E. Exception to full Pesticide Safety Training for Workers Prior to Entry into Treated Areas (Grace 26

Period) 27

F. Training Program Administration Requirements 28

G

. Require Employers to Provide E stablishment

- Specific Information to Workers and Handlers 29

VI. Notification 30

A. Posted Notification Timing and Oral Notification 31

B. Revise Content of Warning Sign 32

C. Warning Sign Location Revisions 33

VII. Hazard Communication 34

A. Hazard Information

– Location a nd Accessibility 35

B. Pesticide

- Specific Hazard Communications Materials

– General 36

C. Pesticide Application Information

- Content 37

D. Pesticide Application and Hazard Information

– When Information Must be Made Available 38

E. Pesticide Application and Hazard In formation

– Retention of Records 39

VIII. Information Exchange Between Handler and Agricultural Employers 40

IX. Drift

- Related Requirements 41

A. Overarching Performance Standard 42

B. Entry Restrictions to Protect Workers and Other Persons During Applications 43

C. Sus pend Applications 44Page 2 of 176 X. Establish Minimum Age for Handling Pesticides and Working in a Treated Area while an REI is in 45

Effect 46

XI. Restrictions on Worker Entry into Treated Areas 47

A. Requirements for Entry During an REI 48

B. Clarify Conditions of the “No Contact” Exception 49

C. Limit “Agricultural Emergency” Exception 50

D. Codify “Limited Contact” and “Irrigation” Exceptions 51

E. Eliminate the Option for an Exception Requiring Agency Approval 52

XII. Display of Pesticide Safe ty Information 53

A. Pesticide Safety Information Content 54

B. Location of Pesticide Safety Information Display 55

XIII. Decontamination 56

A. Clarify the Quantity of Water Required for Decontamination 57

B. Eliminate the Substitution of Natural Waters for Deco ntamination Supplies 58

C. Requirements for Ocular Decontamination in Case of Exposed Pesticide Handlers 59

D. Showers for Handler Decontamination 60

XIV. Emergency Assistance 61

XV. Personal Protective Equipment 62

A. Respirators: Fit Testing, Training, and Medic al Evaluation 63

B. Chemical

- Resistant PPE 64

C. Contaminated PPE 65

XVI. Decision not to Require Monitoring of Handler Exposure to Cholinesterase

- Inhibiting Pesticides 66

XVII

. Exemptions and Exceptions 67

A. Immediate Family 68

B. Crop Advisors and Employees 69

C. Closed Systems 70

D. Aerial Applications

— Eyewear Protection for Open Cockpits 71

E. Aerial Applications

– Use of Gloves 72

F. Enclosed Cabs

– Changes to Exceptions to PPE Requirements when Applying Pesticides from 73

Inside an Enclosed Cab 74

XVIII. General Revisions 75

A. Label vs. Labeling 76

B. Regulating Other Persons 77

C. Definitions 78

1. General 79

2. Authorized Representative 80

3. Closed System 81

4. Enclosed Space Production and Outdoor Production 82

5. Entry

- Restricted Area and Application Exclusion Zone 83

6. Hand Labor 84

7. Immediate Family 85

8. Use 86

D. Restructuring 40 CFR 170 87

E. Equivalency P rovisions 88

F. Clarifications 89Page 3 of 176 G. Anti

- retaliation M easures 90

H. Comments Relating to OSHA 91

XIX. Implementation 92

XX. Economic Analysis 93

A. Cost Assessment and Related Topic s 94

B. Benefits 95

XXI. References 96

97

II. General Support 98

A. Comments 99

Many commenters expressed general support for EPA’s proposed revisions to the WPS and 100

noted that the revised rule should help to prevent adverse health effects resulting from exposure to 101

pesticides among agricultural workers and pesticide handlers. While most commenters supported the 102

proposed changes generally, many provided comments about specific elements of the proposal that 103

should be strengthened. Man y commenters who expressed general support also raised concerns about 104

specific elements of the proposed regulation. 105

B. EPA Response 106

EPA appreciates the commenters’ general support for the proposed revisions. EPA 107

acknowledges commenters’ specific concerns a nd suggestions in the specific units of this response to 108

comments document. 109

III. General Opposition 110

A. Comments 111

Many commenters opposed EPA finalizing the proposed changes. Some commenters suggested 112

that EPA engage in a thorough evaluation of the existin g WPS, considering the changes in agricultural 113

practices and technology since the existing WPS was promulgated over 20 years ago. In addition, some 114

commenters asserted that acute incidents have declined significantly since the existing WPS was 115

implemented, demonstrating improvements in worker safety. 116

Another commenter suggested that EPA engage in a thorough review and dialogue related the 117

existing WPS with state regulatory agencies and the regulated community to enhance the effectiveness 118

of the current WPS and to develop alternative proposals. This commenter also requested that any 119

changes to the WPS provide state regulatory agencies flexibility in structuring and enforcing certain WPS 120

provisions to better reflect the diversity of agricultural operations in their states. 121

A few commenters expressed concern that EPA used outdated data on the demographics of 122

farmworkers when more current data are available. A commenter noted that EPA relied on information 123

from the Department of Labor’s (DOL) National Agricultur al Worker Survey (NAWS) from 2005, although 124

a more recent data set is available to the public. 125

Several commenters argued that EPA’s characterization of the existing WPS and need for the proposed 126

changes implies that EPA has been ineffective at regulating pesticides. Commenters also asserted that 127

the proposed rule indicates a belief on EPA’s part that pesticide labels are inadequate. Commenters 128

alleged that the label provides necessary protections and that by revising the WPS EPA is ignoring the 129

protections inherent in the labeling. Lastly, commenters argued that the proposal overlooks the 130

exte nsive worker protection stewardship programs of states, registrants, professional applicators, 131

producers, and the regulated community. 132

B. EPA Response 133Page 4 of 176 EPA disagrees with the commenters’ request not to promulgate revisions to the WPS. EPA 134

already engaged stakeholders extensively, in both formal and informal consultations, to evaluate the 135

existing WPS. EPA engaged in a National Assessment of the Pesticide Worker Safety Program, convened 136

a workgroup of the Pesticide Program Dialogue Committee, convened a Small Business Advocacy Review 137

(SBAR) Panel, and participated in many meeting with stakeholders to discuss the existing rule and to 138

accept suggestions for i mprovements. Stakeholders consulted included grower organizations, 139

farmworker organizations, cooperative extension services, commodity organizations, healthcare 140

providers, state regulatory agencies, federal agencies, pesticide manufacturers and distributer s, and 141

individual workers, handlers, and growers. In addition, EPA encouraged comments from all stakeholders 142

on the proposed changes to the WPS, and considered those comments in developing a final rule. 143

EPA discussed the changes over time in the regulatio n of pesticides in both the proposed and 144

final regulations. EPA acknowledges that agriculture has changed over time and technology has 145

advanced. However, the WPS is focused on protecting workers and handlers from pesticide exposure 146

through a generally appl icable regulation that applies regardless of the agricultural practices or 147

technology used. Changes in agricultural practices and technology, such as using pesticides with a lower 148

application rate or shorter REI, applying pesticides using drift reduction t echnology, or mixing and 149

loading using a closed system, are additional ways to reduce potential exposure to workers and 150

handlers. However, these measures do not replace or negate the need for the protections provided 151

under the WPS. 152

EPA notes that some dat a show that incidents of occupational pesticide exposure in agriculture 153

have declined over time. Many factors may have contributed to this reduction, including 154

implementation of the WPS, registration of lower risk pesticides, and adoption of safer applicat ion 155

technology. However, avoidable and preventable incidents continue to affect workers and handlers; EPA 156

intends to further reduce the number and severity of incidents occurring through updating the 157

protections in the WPS. 158

EPA disagrees with commenters ’ suggestion to engage in additional review and dialogue with 159

state regulatory agencies and the regulated community instead of finalizing the revised WPS, because 160

EPA already conducted a significant National Assessment of the Pesticide Worker Safety Program to 161

evaluate implementation of the existing WPS and to request suggestions for improving its effectiveness. 162

The National Assessment of the Pesticide Worker Safety Program resulted in a variety of suggestions to 163

improve the existing WPS, which came from the many stakeholders who participated in the process. EPA 164

took actions following the assessment process to improve implementation of the existing WPS by : 165

• Revising and developing improved outreach and compliance assistance materials (including 166

a revised How to Comply with the WPS manual released in 2005) 167

• Improving guidance and expanding training for enforcement inspectors, and increasing 168

oversight by EPA regional offices 169

• Improving training materials for train

- the

- trainer programs 170

• Expanding funding of pesticide incident monitoring 171

• Revising grant guidance to states for improved enforcement tracking, incident monitoring 172

and program reporting 173

While EPA was able to take some actions to improve the existing WPS immediately following the 174

National Assessment process, o ther recommendations require regulatory change to implement. For 175

example, expanding the content of worker and handler pesticide safety training and requiring respirator 176

fit testing consistent with OSHA and National Institute for Occupational Safety and Hea lth ( NIOSH ) 177Page 5 of 176 requirements require EPA to revise the requirements of the existing WPS. Given the many opportunities 178

for stakeholders to engage with EPA prior to publication of the proposed rule and to provide comments 179

during the public comment period, EPA re jects commenters ’ request for further review and dialogue 180

between EPA, state regulatory agencies, and the regulated community prior to publishing a final rule. 181

EPA notes that nationally consistent implementation of the WPS is a necessary underpinning of 182

t he pesticide regulatory decisions made by EPA. EPA will work with state regulatory agencies on 183

enforcing the WPS. Additionally, EPA has incorporated an equivalency provision in the final rule to allow 184

states to request EPA to review portions of their laws protecting workers and handlers to determine if 185

they are equivalent to the protections offered under the WPS. 186

EPA agrees with commenters that the farmworker demographic data used in the preamble to 187

the proposed rule was from 2005, and notes that the pream ble to the final rule uses the most current 188

data available from NAWS. 189

EPA disagrees with commenters’ assertions that the proposed changes to the WPS imply that 190

EPA has been ineffective at regulating pesticides. EPA believes that the current system for reg ulating 191

pesticide products is generally adequate, and that pesticides can be used safely and effectively when the 192

labeling is followed. EPA relies on the complementary relationship between the labeling and the WPS, 193

which is referenced as part of labeling, to protect workers and handlers. EPA’s proposal to improve the 194

WPS protections does not mean that EPA believes pesticide registration and labeling are not effective. 195

Rather, EPA’s registration decisions and labeling language requirements are predicated on the premise 196

that employers, workers and handlers are complying with the important workplace protections, training, 197

and hygiene measures specified in the WPS. If the existing WPS does not ensure that the assumed 198

protections are occurring, e.g., workers are entering treated areas before the REI expires or experiencing 199

pesticide exposure through drift from products applied according to labeling requirements, then EPA 200

must review the existing regulation to address these shortcomings and to ensure that the basis on which 201

the labeling decisions rest is sound. 202

EPA disagrees with comments that labeling alone provides sufficient protection to workers and 203

handlers. Under FIFRA’s authority, EPA has implemented measures to protect workers, handlers, other 204

persons, and the environment from pesticide exposure in two primary ways. First, EPA includes product

205

specific use instructions and restrictions on individual pesticide product labeling. These instructions and 206

restrictions are the result of EPA’s stringent registratio n and reevaluation processes and are based on 207

the risks of the particular product. Since users must comply with directions for use and restrictions on a 208

product’s labeling, EPA uses the labeling to convey mandatory requirements for how the pesticide must 209

b e used to protect people and the environment from unreasonable adverse effects of pesticide 210

exposure. Second, EPA enacted the WPS to expand protections against the risks of agricultural 211

pesticides without making individual product labeling longer and much more complex. The WPS is a 212

uniform set of requirements for workers, handlers and their employers that are generally applicable to 213

all agricultural pesticides and are incorporated onto agricultural pesticide labels by reference. Its 214

requirements complement the product

- specific labeling restrictions and are intended to minimize 215

occupational exposures generally. 216

EPA has included in the preamble to the final rule a discussion of EPA’s regulation of pesticides, 217

including a summary of the data required and the p rocess for evaluating the data to determine whether 218

to register a product and what, if any, labeling

- based risk mitigation measures are necessary. The final 219

rule preamble also includes a discussion of the complementary relationship between pesticide labeli ng 220

and the WPS. 221Page 6 of 176 EPA recognizes that a number of stewardship activities may support worker and handler safety. 222

However, because pesticide registration and labeling decisions depend on assurance that specific 223

protections are being provided to workers and ha ndlers, it is not possible to rely on voluntary 224

stewardship programs alone. To ensure that workers and handlers receive the protections assumed 225

when EPA reviews data and establishes risk mitigation measures during the pesticide registration and 226

registratio n review processes, EPA must establish enforceable requirements under the WPS. 227

228

IV. Context and Goals of This Rulemaking 229

A. Context for this Rulemaking 230

1. Statutory authority . Enacted in 1947, FIFRA established a framework for the pre

- market 231

registration and regulation of pesticide products; since 1972, FIFRA has prohibited the registration of 232

pesticide products that cause unreasonable adverse effects. FIFRA makes it unlawful to use a pesticide 233

in a manner inconsistent with the labeling and gives EPA’s Administrator authority to develop 234

regulations to carry out the Act. FIFRA’s legislative history indicates that Congress specifically intended 235

for FIFRA to protect workers and ot her persons from occupational exposure directly to pesticides or to 236

their residues (Ref. 5). 237

Under FIFRA’s authority, EPA has implemented measures to protect workers, handlers, other 238

persons, and the environment from pesticide exposure in two primary ways . First, EPA includes specific 239

use instructions and restrictions on individual pesticide product labeling. These instructions and 240

restrictions are the result of EPA’s stringent registration and reevaluation processes and are based on 241

the risks of the parti cular product. Since users must comply with directions for use and restrictions on a 242

product’s labeling, EPA uses the labeling to convey mandatory requirements for how the pesticide must 243

be used to protect people and the environment from unreasonable adver se effects of pesticide 244

exposure. Second, EPA enacted the WPS to expand protections against the risks of agricultural 245

pesticides without making individual product labeling longer and much more complex. The WPS is a 246

uniform set of requirements for workers, handlers and their employers that are generally applicable to 247

all agricultural pesticides and are incorporated onto agricultural pesticide labels by reference. Its 248

requirements complement the product

- specific labeling restrictions and are intended to minim ize 249

occupational exposures generally. 250

2. EPA’s regulation of pesticides . EPA uses a science

- based approach to register and re

- evaluate 251

pesticides, in order to protect human health and the environment from unreasonable adverse effects 252

that might be caused by pesticides. The registration process begins when a manufacturer submits an 253

application to register a pesticide. The application must contain required test data, including 254

information on the pesticide’s chemistry, environmental fate, toxicity to humans and wildlife, and 255

potential for human exposure. EPA also requires a copy of the proposed labeling, including directions for 256

use and appropriate warnings. 257

Once an application for a new pesticide product is received, EPA conducts an evaluation, which 258

includ es a detailed review of scientific data to determine the potential impact on human health and the 259

environment. EPA considers the risk assessments and results of any peer review, and evaluates potential 260

risk management measures that could mitigate risks tha t exceed EPA’s level of concern. In the 261

registration process, EPA evaluates the proposed use(s) of the pesticide to determine whether it would 262

cause adverse effects on human health, non

- target species, and the environment. In evaluating the 263

impact of a pes ticide on occupational health and safety, EPA considers the risks associated with use of 264

the pesticide (occupational, environmental) and the benefits associated with use of the pesticide 265

(economic, public health, environmental). However, FIFRA does not req uire EPA to balance the risks and 266Page 7 of 176 benefits for each audience. For example, a product may pose risks to workers, but risk may nevertheless 267

be reasonable in comparison to the economic benefit of continued use of the product to society at 268

large. 269

If the appli cation for registration does not contain evidence sufficient for EPA to determine that 270

the pesticide meets the FIFRA registration criteria, EPA communicates to the applicant the need for 271

more or better refined data, labeling modifications, or additional us e restrictions. Once the applicant has 272

demonstrated that a proposed product meets the FIFRA registration criteria and any applicable 273

requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 321 et seq. , EPA 274

approves the registration s ubject to any risk mitigation measures necessary to meet the FIFRA 275

registration criteria. EPA devotes significant resources to the regulation of pesticides to ensure that each 276

pesticide product meets the FIFRA requirement that pesticides not cause unreason able adverse effects 277

to the public and the environment. 278

When EPA approves a pesticide, the labeling generally reflects all risk mitigation measures 279

required by EPA. The risk mitigation measures may include requiring certain engineering controls, such 280

as t he use of closed systems for mixing pesticides and loading them into application equipment to 281

reduce potential exposure to those who handle pesticides; establishing conditions on the use of the 282

pesticide by specifying certain use sites, maximum application rate or maximum number of applications; 283

or establishing REIs during which entry into an area treated with the pesticide is generally prohibited 284

until residue levels have declined to levels unlikely to cause unreasonable adverse effects. Because users 285

must comply with the directions for use and use restrictions on a product’s labeling, EPA uses the 286

labeling to establish and convey mandatory requirements for how the pesticide must be used to protect 287

the applicator, the public, and the environment from pestic ide exposure. 288

Under FIFRA, EPA is required to review periodically the registration of pesticides currently 289

registered in the United States. The 1988 FIFRA amendments required EPA to establish a pesticide 290

reregistration program. Reregistration was a one

- ti me comprehensive review of the human health and 291

environmental effects of pesticides first registered before November 1, 1984 to make decisions about 292

these pesticides' future use. The 1996 amendments to FIFRA require that EPA establish, through rule 293

making, an ongoing “registration review” process of all pesticides at least every 15 years. The final rule 294

establishing the registration review program was signed in August 2006 (Ref. 16). The purpose of both 295

re

- evaluation programs is to review all pesticides reg istered in the United States to ensure that they 296

continue to meet current safety standards based on up

- to

- date scientific approaches and relevant data. 297

Pesticides reviewed under the reregistration program that met current scientific and safety 298

standards were declared “eligible” for reregistration. The results of EPA’s reviews are summarized in 299

Reregistration Eligibility Decision (RED) documents. The last RED was completed in 2008. Often before a 300

pesticide could be determined “eligible,” additional risk re duction measures had to be put in place. For a 301

number of pesticides, measures intended to reduce exposure to handlers and workers were needed and 302

are reflected on pesticide labeling. To address occupational risk concerns, REDs include mitigation 303

measures s uch as: Voluntary cancellation of the product or specific use(s); limiting the amount, 304

frequency or timing of applications; imposing other application restrictions; classifying a product or 305

specific use(s) for restricted use only by certified applicators; requiring the use of specific PPE; 306

establishing specific REIs; and improving use directions. During this process, EPA also encouraged 307

registrants to find replacements for the inert ingredients of greatest concern. As a result of EPA’s 308

reregistration effort s, c urrent U.S. farm workers are not exposed to many of the previously used inert 309

ingredients that were of the greatest toxicological concern. 310

EPA’s registration review program is a recurring assessment of products against current 311Page 8 of 176 standards. EPA will revi ew each registered pesticide at least every 15 years to determine whether it 312

continues to meet the FIFRA standard for registration. Pesticides registered before 1984 were 313

reevaluated initially under the reregistration program. These and pesticides initiall y registered in 1984 314

or later are all subject to registration review. 315

In summary, EPA’s pesticide reregistration and registration reviews assess the specific risks 316

associated with particular chemicals and ensure that the public and environment do not suf fer 317

unreasonable adverse effects from those risks. EPA implements the risk reduction and mitigation 318

measures identified in the pesticide reregistration and registration review programs through 319

amendments to individual pesticide product labeling. 320

3. WPS. T he WPS regulation is incorporated by reference on certain pesticide product labeling 321

through a statement in the agricultural use box. The WPS provides a comprehensive collection of 322

pesticide management practices generally applicable to all agricultural pes ticide use scenarios in crop 323

production, complementing the product

- specific requirements that appear on individual pesticide 324

product labels. 325

The risk reduction measures of the WPS may be characterized as being one of three types: 326

Information, protection a nd mitigation. To ensure that employees will be informed about exposure to 327

pesticides, the WPS requires that workers and handlers receive training on general pesticide safety, and 328

that employers provide access to information about the pesticides with which workers and handlers 329

may have contact. To protect workers and handlers from pesticide exposure, the WPS prohibits the 330

application of pesticides in a manner that exposes workers or other persons, generally prohibits workers 331

and other persons from being in areas being treated with pesticides, and generally prohibits workers 332

from entering a treated area while an REI is in effect (with limited exceptions that require additional 333

protections). In addition, the rule protects workers by requiring employers to noti fy them about areas 334

on the establishment treated with pesticides, through posted and/or oral warnings. The rule protects 335

handlers by ensuring that they understand proper use of and have access to required PPE. Finally, the 336

WPS has provisions to mitigate ex posures if they do occur by requiring the employer to provide to 337

workers and handlers with an ample supply of water, soap and towels for routine washing and 338

emergency decontamination. The employer must also make transportation available to a medical care 339

f acility if a worker or handler may have been poisoned or injured by a pesticide and provide information 340

about the pesticide(s) to which the person may have been exposed. 341

EPA manages the risks and benefits of each pesticide product primarily through the l abeling 342

requirements specific to each pesticide product. If pesticide products are used according to the labeling, 343

EPA does not expect use to cause unreasonable adverse effects. However, data on incidents of adverse 344

effects to human health and the environm ent from the use of agricultural pesticides show that users do 345

not always comply with labeling requirements. Rigorous ongoing training, compliance assistance and 346

enforcement are needed to ensure that risk mitigation measures are appropriately implemented i n the 347

field. The framework provided by the WPS is critical for ensuring that the improvements brought about 348

by reregistration and registration review are realized in the field. For example, the requirement for 349

handlers to receive instruction on how to use the pesticide and the application equipment for each 350

application is one way to educate handlers about updated requirements on product labeling to ensure 351

they use pesticides in a manner that will not harm themselves, workers, the public or the environment. 352

In addition, the REIs are established through individual product labeling, but action needs to be taken at 353

the use site to ensure that workers are aware of areas on the establishment where REIs are in effect and 354

given directions to be kept out of the treat ed area while the REI is in effect. The changes to the WPS are 355

designed to enhance the effectiveness of the existing structure of protections and to better realize 356Page 9 of 176 labeling

- based risk mitigation measures at the field level. 357

B. Goals of This Rulemaking 358

Discussions with stakeholders over many years, together with EPA’s review of incident data, led 359

EPA to identify several shortcomings in the current regulation that will be addressed by this final rule. As 360

discussed in Unit IV.A., EPA uses both product

- spec ific labeling and the WPS to effectuate occupational 361

protections for workers and handlers. EPA engages in ongoing reviews and reassessments of pesticide 362

products to ensure they continue to meet the standard of not causing unreasonable adverse effects to 363

hu man health and the environment. The WPS must be updated to ensure that the rule continues to 364

complement the labeling

- based protections and to address issues identified through experience with 365

the WPS, and review of incident data and stakeholder engagement. 366

1. Purpose of the WPS. The WPS is intended to reduce the risks associated with occupational 367

pesticide exposure to workers, handlers and their families, and to protect others and the environment 368

from risks of pesticide use in agricultural production. The rule makes employers of workers and handlers 369

responsible for providing protections to workers and handlers on their establishments. By imposing this 370

obligation, EPA seeks to ensure those who make pesticide use decisions (employers) internalize the 371

effects of their decision making rather than passing on the costs associated with these decisions (risks of 372

pesticide exposure) to others (workers and handlers). 373

As noted in Unit IV.A., the components of the WPS generally can be grouped into three 374

categories: Inf ormation, protection, and mitigation. Employers must provide workers and handlers with 375

information needed to protect themselves, others, and the environment from pesticides and pesticide 376

residues through pesticide safety training, pesticide application and hazard information, and access to 377

labeling. Employers must provide protections to workers and handlers during and after applications in 378

order to minimize potential for exposure. Finally, employers must be prepared to mitigate exposures 379

that do occur by pr oviding supplies for washing and emergency decontamination, and emergency 380

transportation to a medical facility if necessary. These elements are necessary to implement product

381

specific labeling requirements effectively. For example, pesticide safety trainin g informs workers that 382

areas treated with pesticides are off limits for entry for a certain period after the application, i.e., a 383

product

- specific REI, and that their employers will inform them of where and when REIs are in effect and 384

entry into the treate d areas is prohibited. In some instances, employers must provide further protection 385

by posting warning signs at treated areas while REIs are in effect to remind workers to keep out of the 386

treated areas. For handlers, training informs them about basic pesti cide safety and handling precautions 387

and reducing the potential to expose themselves or others. In addition, the employer must provide 388

information for each application, informing the handler about the product

- specific labeling restrictions 389

and requirements

. 390

In summary, the WPS works in conjunction with product labeling to protect workers and 391

handlers from occupational pesticide exposure. The rule imposes on the employer the responsibility for 392

providing protections to workers and handlers and to ensure they have access to information necessary 393

to protect themselves and others during and after pesticide application. 394

2. Surveillance data. When EPA promulgated the existing rule, it used existing data on 395

occupational pesticide

- related incidents to estimate that that approximately 10,000 to 20,000 incidents 396

of physician

- diagnosed (not hospitalized) pesticide poisonings occurred in the WPS

- cov ered workforce 397

annually. For this rulemaking, EPA estimates that about 1,810 to 2,950 acute pesticide exposure 398

incidents occur annually on agricultural establishments that potentially could be prevented by the WPS. 399

This substantial drop in the estimated nu mber of incidents shows that the existing rule and efforts by 400

employers, workers and handlers have made great accomplishments in reducing pesticide exposure for 401Page 10 of 176 workers and handlers. Pesticide use in agriculture is safer than it was 20 years ago. 402

Current occupational health incident surveillance data show, however, that avoidable incidents 403

continue to occur. For example, some of the occupational pesticide illnesses reported to state health 404

agencies have occurred when workers entered a treated area before the REI expired. Although 405

employers are obligated to warn workers to keep out of treated areas and to ensure that workers 406

receive training on and information about treated areas, incidents continue to occur. Another example 407

of potentially avoidable exposur e is spray drift. Labeling instructs handlers to apply pesticides in a 408

manner that does not contact other persons, but pesticide drift continues to cause exposure incidents. 409

In addition to surveillance data, studies also show that pesticide residues are br ought home by workers 410

and handlers on their bodies and clothing (known as “take

- home exposure”), creating an exposure 411

pathway for family members. 412

This rulemaking is intended to reduce avoidable incidents by improving information, 413

protections, and mitigat ions for workers and handlers without imposing unreasonable burdens on 414

employers. Although EPA cannot quantify the specific reduction in incidents from any single change to 415

the regulation, taken together, EPA estimates that the final rule will result in an annual reduction of 416

between 540 and 1,620 acute, health

- related incidents. In addition, EPA expects that the final rule will 417

help reduce chronic health problems among workers and handlers by reducing daily pesticide 418

exposures, and thereby improving qualit y of life throughout their lives, resulting in a lower cost of health 419

care and a healthier society. (See Unit II.C.) Units V. through XIX. describe the final regulatory 420

requirements and their potential to reduce avoidable incidents. The Economic Analysis f or this 421

rulemaking provides an estimate of the costs of the requirements and a quantitative and qualitative 422

discussion of the potential benefits, including avoiding acute pesticide

- related illnesses in workers and 423

handlers (Ref. 1). 424

3. Demographics of wor kers and handlers . In addition to the complexity of the science issues 425

involving pesticide use, variability of pesticide use patterns and incomplete information about 426

occupational pesticide

- related illnesses and injuries, the diversity of the labor populat ion at risk and the 427

tasks they perform makes it challenging to ensure that workers and handlers are adequately protected. 428

According to the most recent public data set available from the DOL ’s NAWS for 2011

- 2012, 64% 429

of agricultural workers in the United St ates were born in Mexico and 6% in Central and South America 430

(Ref. 6). A majority (69%) of all survey respondents speak Spanish as their primary language (Ref. 6). 431

Approximately 65% of this population speaks a little or no English; 38% cannot read English at all and 432

another 30% can only read English “a little” (Ref. 6). Many have received only some formal education; 433

on average, the highest grade completed by foreign

- born workers was seventh grade (Ref. 6). 434

Approximately 17% of the survey respondents were c lassified as migrant, having traveled at 435

least 75 miles in the previous year to find a job in agriculture (Ref. 6). Only 17% of respondents lived in 436

housing provided by their employer and 55% rented housing from someone other than their employer 437

(Ref. 6). In general, agricultural workers surveyed by NAWS do not have access to employer

- provided 438

health insurance

– in 2011

- 2012, only 21% of farmworkers reported having the option for employer

439

provided health insurance (Ref. 6). USDA research, based on NAWS data , also reports that workers have 440

difficulty entering the health care system to receive treatment (Ref. 7). Cost was a significant barrier for 441

two

- thirds of farmworkers, while about a third listed language barriers as an impediment to receiving 442

care. Most w orkers fear that seeking treatment will result in losing their job because someone will 443

replace them while they are getting treatment or the employer will label them as troublemakers and 444

dismiss them. The problem is more severe among undocumented workers because they fear seeking 445

treatment will lead to deportation or other adverse legal action (Ref. 7). A USDA report indicates that 446Page 11 of 176 the factors mentioned previously contribute to the disadvantaged status of hired workers in agriculture 447

(Ref. 7). 448

The NAWS f ound that 19% of workers and handlers surveyed earned less than $10,000 annually 449

from agricultural work, and another 39% earn between $10,000 and $20,000 annually. Over 55% of 450

respondents reported a total family income below $22,500 (Ref. 6). 451

Both the exi sting WPS and the changes included in the final rule seek to eliminate some of the 452

potential barriers to achieving effective protection of these persons by requiring training in a manner 453

that workers and handlers can understand, requiring the employer to e nsure that handlers understand 454

relevant portions of the labeling before handling a pesticide, and expanding training to provide 455

information on seeking medical care in the event of a pesticide exposure and highlighting the anti

456

retaliation provisions of the WPS. 457

4. Summary of the final rule. The final rule amends the WPS by: 458

• Requiring pesticide safety training at one

- year intervals and a mending the existing pesticide 459

safety training content. 460

• Requiring recordkeeping for pesticide safety training. 461

• Eliminatin g the “grace period” that allowed workers to enter a treated area to perform WPS 462

tasks before receiving full pesticide safety training. 463

• Establishing a minimum age of 18 for handlers and early

- entry workers

. 464

• Establishing requirements for specific training a nd notification for workers who enter an 465

area under an REI. 466

• Restricting persons’ entry into certain areas surrounding application equipment during an 467

application. 468

• Clarifying requirements for supplies for routine washing and emergency decontamination. 469

• Requi ring employers to post warning signs around treated areas when the product applied 470

has an REI greater than 48 hours and allowing the employer to choose to post the treated 471

area or give oral notification when the product applied has an REI of 48 hours or le ss (unless 472

the labeling requires both types of notification). 473

• Requiring employers to maintain and make available copies of the SDSs for products used on 474

the establishment. 475

• Requiring employers to provide application information and SDSs to designated 476

representatives making the request on behalf of workers or handlers. 477

• A dding elements to the requirement to maintain application

- specific information. 478

• Adopting by cross reference certain OSHA requirements for employers to provide training, 479

fit testing and medical evaluations to handlers using products that require use of 480

respirators. 481

• Requiring employers to provide supplies for emergency eye flush at all pesticide mixing and 482

loadin g sites when handlers use products that require eye protection. 483

• Maintaining the immediate family exemption and ensuring it includes an exemption from 484

the new minimum age requirements for handlers and early

- entry workers. 485

• Expanding the definition of “immedi ate family” to allow more family

- owned operations to 486

qualify for the exemptions to the WPS requirements. 487

• Revising definitions to improve clarity and to refine terms. 488Page 12 of 176 • Restructuring the regulation to make it easier to read and understand. 489

Units V. through X VIII. discuss the final rule requirements and elements considered in the 490

proposal but not included in the final rule. Unit XIX. discusses implementation of the final regulatory 491

requirements. Each of these Units generally describes the existing rule, propos al and final regulatory 492

requirements (where appropriate), and summarizes the major comments received and EPA’s responses. 493

EPA has grouped the discussion of the final rule and elements considered in the proposal but 494

not included in the final rule as follo ws: 495

• Unit V: Pesticide Safety Training for Workers and Handlers. 496

• Unit VI: Notification. 497

• Unit VII: Hazard Communication. 498

• Unit VIII: Information Exchange Between Handler and Agricultural Employers. 499

• Unit IX: Drift

- Related Requirements. 500

• Unit X: Establish Mini mum Age for Handling Pesticides and Working in a Treated Area while 501

an REI is in Effect. 502

• Unit XI: Restrictions on Worker Entry into Treated Areas. 503

• Unit XII: Display of Pesticide Safety Information. 504

• Unit XIII: Decontamination. 505

• Unit XIV: Emergency Assistanc e. 506

• Unit XV: Personal Protective Equipment. 507

• Unit XVI: Decision not to Require Monitoring of Handler Exposure to Cholinesterase

508

Inhibiting Pesticides. 509

• Unit XVII: Exemptions and Exceptions. 510

• Unit XVIII: General Revisions. 511

• Unit XIX: Implementation. 512

V. Pesticide Safety Training for Workers and Handlers 513

A. Shorten Retraining Interval for Workers and Handlers 514

1. Current rule and proposal. The existing WPS requires employers to ensure that workers and 515

handlers are trained once every five years. EPA proposed to esta blish an annual retraining interval for 516

workers and handlers in order to improve the ability of workers and handlers to protect themselves and 517

their families from pesticide exposure. 518

2. Final rule. In the final rule, EPA has adopted the proposed requirem ent for workers and 519

handlers to receive full pesticide safety training annually. The final regulatory text for these 520

requirements is available at 40 CFR 170.401(a) and 170.501(a). 521

3. Comments and responses. 522

Comments. 523

Several farmworker advocacy groups, public health organizations and academics, public health 524

agencies, and PPE manufacturers supported full, annual training, stating that the more frequent training 525

would improve workers’ and handlers’ ability to protect themselves and their families, and th at annual 526

training would be simple to track administratively. Many of these commenters stated that annual safety 527

training would be comparable to training required by OSHA in other industries. 528

Agricultural producer organizations, growers, pesticide produce rs, the SBA Office of Advocacy, 529

farm bureaus, and state pesticide regulatory agencies expressed concern for the burden annual training 530Page 13 of 176 would place on agricultural employers. Some stated that farmworkers would be insulted by the 531

repeated trainings, and aske d for evidence that increased training would lead to reduced pesticide 532

exposure. Some of these entities , including the SBA Office of Advocacy, recommended an initial in

533

depth training for new workers followed annually by a shortened “refresher” training. A similar 534

suggestion was to require initial in

- depth training for workers and handlers, followed by four years of 535

refresher training, with an in

- depth training every fifth year. Some states suggested training every two 536

or three years, or allowing each sta te to set its own training interval, to parallel the state’s pesticide 537

applicator recertification interval. A few states recommended a system where the training timeframe is 538

based on the calendar year, to allow flexibility for employers. For example, under this proposal, an 539

employee trained in March 2014 could be retrained as late as December 2015. This suggestion would 540

extend the permitted interval between worker and handler trainings to as long as two years. Comments 541

from pesticide industry organizations suggested that the frequency of worker safety training be 542

commensurate with an individual workers’ tasks, previous training, and experience. 543

One commenter provided a specific alternative. The SBA Office of Advocacy reiterated the 544

comments of the SB AR Panel, convened in 2008. The SBAR Panel report recognized the importance of 545

training workers and handlers to remind them of the safety principles, but recommended that EPA 546

consider flexibilities for small establishments. Specifically, the SBAR Panel sugg ested that EPA consider a 547

reduced training frequency where all of the following conditions are met: ( 1 ) no new workers a re hired 548

during the interval; ( 2 ) no new or different pesticide applications a re made as compared to the previous 549

year, and ( 3 ) the work ers and handlers were trained on the establishment previously. Small 550

establishments requesting this flexibility would need to document their compliance with these 551

conditions. The comment from SBA stated that EPA almost always follows the Panel consensus 552

r ecommendation, and highlights that EPA should discuss the recommendations and final position. 553

The SBA Office of Advocacy also commented that the proposal for retraining would have 554

required a higher standard for trainers, and would require employers to pro vide all workers a copy of 555

the training record, adding burden to employers. SBA Office of Advocacy note d that most small 556

businesses retrain annually due to high worker turnover, despite the five year maximum retraining 557

interval in the current rule, and re tain records of the training. 558

EPA Response . EPA considered the alternatives described for training frequency, and agrees 559

with the comments that annual training, in some form, is the appropriate interval to ensure that 560

workers and handlers receive more fr equent reinforcement of the safety principles. EPA rejected the 561

suggestion for a limited refresher training based on the difficulty both employers and regulators would 562

face in tracking multiple levels of training among a mobile workforce, the burdens of ma intaining 563

multiple forms of training materials and providing different trainings where employees are on differing 564

cycles for full and refresher training, and the fact that very little of the substantive content of the 565

required training appears to be materi al that would not need to be brought to employees’ attention 566

annually. 567

The suggestions for biennial or triennial training and allowing the states to base the frequency of 568

training for workers and handlers on their pesticide applicator recertification req uirements would 569

present similar administrative problems with tracking trainings and introduce the possibility that 570

workers or handlers would miss information needed to protect themselves. Finally, the alternative to 571

establish the frequency of training base d on the calendar year presents similar issues with tracking 572

training and needed frequency of repetition. 573

The recommendation for training to be tailored to the individual workers’ tasks, experience, and 574

prior training was rejected based on the difficulty in tracking the specific training needs with a mobile 575Page 14 of 176 workforce, the need for multiple forms of training materials, and the potential burden on employers to 576

determine specific needs for each employee. In addition, the training gives practical information t hat is 577

useful to everyone who works with or around agricultural pesticides. 578

Comments that farmworkers would resent the more frequent training do not comport with the 579

information available to the EPA. In response to the proposal, EPA received comments from 580

farmworkers related to training frequency. In one survey provided by Cabrillo, 78% of the farmworkers 581

asked how often they should receive training responded that annual training should be provided. Letters 582

from Spanish

- speaking farmworkers submitted to th e docket included similar requests for annual 583

training. 584

Commenters that asked for evidence that increased frequency of training would lead to reduced 585

pesticide exposure should refer to the discussion of evidence supporting annual training in the preamble 586

for the proposed rule. (Ref. 2

, Unit VII.A.) 587

The revisions to the WPS will not cause a significant impact on a substantial number of small 588

entities

. EPA has already certified that there is not a significant impact on a substantial number of small 589

entities which would trigger the requirement for a n SBAR Panel review. However, EPA opted to conduct 590

a SBAR Panel review to gather more information related to the impact of t he proposed regulations, and 591

included discussion of the retraining interval for workers. The recommendation from the SBAR Panel 592

regarding the retraining interval encouraged EPA to consider flexibility for less frequent training for 593

small entities. EPA agre es that the SBAR Panel recommendation could reduce burden on small entities, 594

but it would also reduce the benefit workers would receive from annual training. EPA considered the 595

recommendation for reduced training, but notes that the SBAR Panel alternative would increase 596

recordkeeping burdens for all small establishments that would

– to some degree

– offset their savings 597

from fewer trainings. The additional burden to document compliance with the SBAR Panel alternative’s 598

requirements would include recordkeepi ng documenting that : (1) no new workers a re hired during the 599

reduced training interval; (2) no new or different pesticide applications are made during the reduced 600

training interval , and (3) the specific workers were trained on the establishment within the reduced 601

training interval

. Those costs were not estimated, but EPA expects that they would be higher than those 602

estimated for the proposed recordkeeping for all workers. Based on the marginal cost reduction and 603

potential risk to workers who would not rec eive training annually, EPA believes that annual training is 604

more protective. And in any case, the revisions to the WPS will not cause a significant impact on a 605

substantial number of small entities. 606

EPA has responded to comments from SBA Office of Advoca cy and others about the burden on 607

employers from eliminating the option for certified applicators to train workers and on the proposed 608

requirement for employers to provide all workers and handlers with a copy of the training by reinstating 609

certified applic ators as trainers of workers and limiting the requirement for providing training records to 610

only requesting employees. SBA Office of Advocacy note d that most small businesses retrain annually 611

due to high worker turnover, despite the five year maximum ret raining interval in the current rule, and 612

retain records of the training. 613

B. Establish Recordkeeping Requirements to Verify Training for Workers and Handlers 614

1. Current rule and proposal . The existing WPS does not specify how an employer must verify 615

th at a worker or handler has received pesticide safety training. EPA proposed to eliminate the existing 616

voluntary training verification card system and to require employers to maintain records of WPS worker 617

and handler training for two years. EPA proposed th at the training record include, among other things, 618

the employee’s birthdate to verify minimum age for early

- entry worker or handler activities. EPA 619

proposed to require the employer to provide a copy of the record to each worker or handler upon 620Page 15 of 176 completion of the training. 621

2. Final rule. EPA has finalized the proposed requirement for employers to maintain records of 622

worker and handler training for two years. Required information for the record of worker and handler 623

training includes the trained worker’s or handler’s name and signature, the date of training, the trainer’s 624

name, evidence of the trainer’s qualification to train, the employer’s name, and which EPA

- approved 625

training materials were used. EPA has not included in the final rule the proposed requirem ent for the 626

employer to record or retain the birthdate of the employee. The final rule does not require employers to 627

automatically provide a copy of the training record to each worker and handler; instead, the final rule 628

only requires the employer to provi de a copy of the training record to the trained employee upon the 629

employee’s request. The final regulatory text for the worker and handler training recordkeeping 630

requirements appears at 40 CFR 170.401(d) and 170.501(d), respectively. 631

3. Comments and responses. 632

Comments that recordkeeping does not improve worker safety . Several farm bureaus, pesticide 633

manufacturers, and some state pesticide regulatory agencies commented that the requirement for the 634

employer to make and keep training records is for det ermining compliance but does not improve worker 635

safety. 636

A pesticide industry organization stated that there is a body of research supporting the notion 637

that better training and good supervision protect better than creating records. 638

EPA Response. EPA agrees with the comments that state that recordkeeping, in itself, does not 639

improve worker safety. However, the requirement for employers to retain documentation that training 640

has been provided is expected to improve compliance with the rule. One stat e agency indicated that 641

unless employers are held accountable, they may not take the requirement seriously. Even for those 642

employers with the strongest commitment to worker training, training records can be a useful tool to 643

track employee trainings and mak e sure their employees receive the protections provided through 644

training and are able to protect themselves. The training recordkeeping will also be used to provide 645

verification to future employers to demonstrate that a worker or handler has been properly trained. 646

Statements that the states will need to verify training are correct. FIFRA section 26 gives s tates 647

primary enforcement responsibility in regard to pesticide use violations, which include the requirements 648

of the WPS. Currently, in the absence of training records, inspectors generally rely on interviews with 649

workers and handlers to determine whether training has been provided, and have stated that it is 650

difficult to determine whether training has been provided. Workers may not consistently recall when or 651

whether they were provided training or may not be able to communicate clearly with an inspector due 652

to language differences. Please refer to the preamble of the proposed rule ( Ref. 2 , Unit VII.B.3.) for a 653

discussion of these issues. Reliance on bot h records and interviews will provide a more reliable 654

assessment of whether workers have been properly trained. 655

EPA does not agree that the recordkeeping of training is highly burdensome to employers. One 656

farm bureau commenter found the proposed recordkeep ing manageable. EPA is convinced that the 657

benefits of training and training recordkeeping exceed the burden on employers, who benefit 658

economically from worker and handler activity. 659

Comments

– support for recordkeeping. Comments from state regulatory agenc ies, farmworker 660

advocacy organizations , a grower organization, and academics in support of a requirement for 661

recordkeeping stated that it would ensure employees received the training and that it would improve 662

enforcement and compliance. One applicator orga nization and two state regulatory agencies support 663

the recordkeeping to demonstrate that a person was trained. 664

One farm bureau finds the burden for growers to be manageable. One grower stated that they 665Page 16 of 176 have maintained records of training for many years. 666

Another state regulatory agency supports employer recordkeeping of worker training, from the 667

date of employment until one year after they are either separated or retrained

, and two farmworker 668

advocacy organizations support the training recordkeeping and d istribution to employees. 669

One grower/public citizen had this to say: 670

“I track a person’s training and retraining by using a roster spreadsheet that they [workers] 671

sign...I feel the responsibility of retaining a training roster is the responsibility of the i ndividual 672

employer/employee.” 673

EPA Response. EPA agrees with the commenters that recordkeeping is necessary for the purpose 674

of compliance monitoring and to ensure that workers and handlers receive the required training. 675

Comments in opposition t o recordkeeping on basis of burden to the state or agricultural 676

employers. One state regulatory agency argued that states would have to verify the training record, 677

which would be burdensome. They noted that the state and the employer would be responsible f or 678

verify ing the training. Several farm bureaus and a pesticide manufacturer, as well as some state 679

regulatory agencies, stated that the requirement would be burdensome to employers. 680

One farm bureau stated that collecting the date of birth, the trainer’s c redentials, and the 681

training materials used, as required under the proposal, would be “time consuming and restrictive.” 682

EPA Response . EPA agrees that the state regulatory agency would need to verify training from 683

employer records. Currently, inspectors mus t rely on interviews and in some instances on the training 684

verification card to determine if a worker or handler has been trained. Using a combination of an 685

interview and comparison with the training record can provide a more reliable assessment of whethe r 686

workers and handlers have been properly trained. 687

EPA has revised the requirement to eliminate the documentation of the birth date. The 688

information describing the trainer’s credentials and the materials used for training need be captured 689

only once per specific training. EPA finds that the benefit to workers and handlers from annual training 690

and recordkeeping of training outweighs the burden on employers to collect and retain the information. 691

Comments in opposition to training records because benefits cannot be quantified. Several farm 692

bureaus and pesticide manufacturers, some grower groups, and state regulatory agencies state d that, 693

due to the burden on growers and because EPA state d that it is unable to quantify the benefits 694

associated with the traini ng records, the need for recordkeeping is not supported and should not be 695

implemented. 696

EPA Response to benefits. EPA disagrees with the contention that, because the benefits of 697

keeping records of training cannot be quantified, that the requirement is not s upported. Recordkeeping 698

increases incentive to comply with requirements. Increased compliance with the requirement to provide 699

pesticide safety training to workers and handlers should result in increased safety of workers and 700

handlers. Employers benefit fro m recordkeeping because inspectors would review documentation of 701

training rather than relying on the memory of workers and handlers about when and whether they were 702

trained. EPA directs the commenter to review Unit VII. of the preamble of the proposed rule ( Ref. 2 ) for 703

information that describes the benefits of training. One specific benefit, from an association that 704

provides safety training, is that repeating safety messages increases the adoption of improved safety 705

practices. Although these benefits, and others identified in the preamble to the proposed rule, cannot 706

be quantified, EPA finds them compelling, and that they justify the burden on employers. 707

Comments in opposition to the requirement to distribute records to all workers and handlers. 708

Several gr ower organizations, a public health organization, and two state regulatory agencies stated that 709

the proposed requirement to distribute the record to every trained worker or handler would be 710Page 17 of 176 burdensome and that most workers or handlers would not take or kee p the records. One state 711

regulatory agency commented that state lead agencies should not have to rely on the record provided 712

to the worker or handler to verify training, because state lead agencies may not be able to confirm with 713

the person who issued the record that it is valid. 714

EPA Response. EPA agrees with commenters that providing a copy of the training record to each 715

worker and handler would be unduly burdensome, and has modified the requirement. The final rule 716

requires employers to provide training r ecords to the trained employee only on the employee’s request. 717

This will reduce the burden on employers while ensuring that interested employees will be able to 718

demonstrate to future employers that they were appropriately trained. 719

Subsequent employers wou ld be responsible, as in the current rule, to decide whether the 720

provided training record was valid. If the new employer believes the provided record is falsified, the new 721

employer must provide the safety training to the employee. However, if a worker or h andler presents a 722

valid training record to an employer indicating he or she has been trained according to the rule within 723

the last year, and the employer has no reason to believe the record has been falsified, the employer 724

could retain a copy of the traini ng record as proof the worker or handler has been trained. I f a state 725

confirms that a training record is in valid, the employer must provide training to the worker or handler. 726

Comments in support of proposal to provide training records to employees. One grower 727

organization supported the requirement for training documentation to be given to all workers to prove 728

to subsequent employers that they have been trained. Many commenters recommended the record be 729

provided to the worker or handler only upon their re quest to reduce burden. 730

EPA Response. EPA agrees that the record can be useful to demonstrate to future employers 731

that workers or handlers have been trained

. EPA also agrees with commenters that not all workers or 732

handlers may want or need documentation of training. EPA has revised the final rule to reflect that the 733

training record need only be provided to workers and handlers on their request. 734

Comments opposed to requiring birthdate in the record. There were a number of comments 735

from state regulatory agen cies, one grower organization, and farmworker advocacy organizations 736

related to the proposed requirement that employers include the trained employee’s birthdate among 737

the information to be recorded to document training. EPA proposed including the trained e mployee’s 738

birthdate in the recordkeeping in order to facilitate the employer’s verification that a worker or handler 739

met the minimum age requirement for handling pesticides or entering treated areas under an REI as 740

allowed under the early entry exceptions. States and other commenters noted that a person’s birthdate 741

can be considered confidential and personal information, the distribution of which can lead to identity 742

theft. 743

Farmworker advocacy groups also expressed concern that workers would be denied 744

empl oyment based on their age. 745

EPA Response. EPA has decided the advantages of requiring the employer to record the 746

birthdate of the trained worker or handler are outweighed in this instance by concerns for protecting 747

confidential and personal information. U nder the final rule, the employer is responsible for determining 748

that each employee has met applicable the minimum age requirement. The final rule does not include 749

the proposed requirement for the employer to collect or retain specific documentation of the 750

employee’s birthdate or age. However, the employer must verify that early

- entry workers and handlers 751

meet the minimum age of 18 prior to performing those tasks. 752

In response to farmworker advocacy organization concerns regarding employers discriminating 753

on the basis of age, the revised rule eliminates the birthdate as a required element

. EPA believes that 754

the protecting persons under 18 years of age from the pesticide exposures associated with handler 755Page 18 of 176 duties and early

- entry worker tasks is more important than the possibility that employers’ inquiries into 756

age might lead to age

- based discrimination. The Age Discrimination in Employment Act (29 U

. S

. C

. 621 et 757

seq.) forbids age discrimination against people who are age 40 or older, and some states have laws t hat 758

protect younger workers from age discrimination. Employers may not direct a person under 18 years of 759

age to perform handler duties or early

- entry worker tasks

. 760

Comments opposing the provided record due to concerns for falsification. One farm bureau, a 761

state lead agency and a marketing group expressed concern for falsification of these employer

- created 762

records. One state pesticide regulatory agency stated that because many workers and handlers are 763

undocumented, there will be falsification of the record s. Another state pesticide regulatory organization 764

state d that they do not support recordkeeping on the basis that it is likely that fraudulent records will be 765

used, and because verification of the record will burden the state regulatory agency . One grower group 766

asked how the proposed record

, which would be given to the worker or handler

, would reduce 767

fraudulent records as compared to the verification card system, stating that the training record is not 768

different in that it could also be compromised. This c ommenter asserted the main change to be the 769

recordkeeping burden to the employer, and state d that if EPA cannot demonstrate how this is an 770

improvement, the current system should be retained. 771

Another state regulatory agency ask ed for the specific benefits of the proposed change, and for 772

a viable program of verification to be implemented, such as using the verification card system. Another 773

commented that state lead agencies should not have to rely on the provided record to verify training, 774

because of concern s for falsification. 775

EPA Response. The statement that the recordkeeping would force employers to falsify records 776

appears unsupported, because the WPS training record requirement does not require documentation of 777

the worker ’s or handler’s immigration status. The worker’s name is the only personal identifying 778

information required in the training record. EPA believes the requirement to provide a copy of the 779

training record to the trained employee is reasonable and will provide a dequate verification of training. 780

If the subsequent employer does not believe that the record has been tampered with or falsified , the 781

employer does not need to train the employee. If he or she is concerned that the record has been 782

tampered with and potent ially falsified, the employer may contact the previous establishment (listed on 783

the record) to verify the training, or train the employee. 784

Comments in support of a national trained employee database. Several entities supported a 785

national centralized databa se of trained workers and handlers, for a variety of purposes. A state 786

pesticide regulatory agency expressed concern for fraudulent entries on the provided training 787

document, and recommended that EPA develop a national database that trainers could maintain and 788

state regulatory agencies could access to verify the training record. A state department of health also 789

supported a centralized database of handler training, for use to determine if, in case of an incident, 790

whether the employee was trained. Another st ate pesticide regulatory agency and state department of 791

health suggested that subsequent employers could rely on the information in the database to confirm 792

whether a new employee had been trained. Several farmworker advocacy organizations supported a 793

natio nalized central database, to estimate the number of trained workers and handlers. An academic 794

supported the centralized tracking of training to help determine the efficacy of the training. 795

Another state pesticide regulatory agency would support a national database, but comment ed 796

that their inspections show that most employers provide safety training even when prospective 797

employees have verification of training, reducing the need for a federal program. 798

EPA Response. EPA discussed this alternative in the pr oposed rule ( Ref. 2, Unit VII.B). EPA 799

agrees that there may be merit in a centralized database of trained workers and handlers that may be 800Page 19 of 176 used for reference by an employer. However, EPA did not propose such a database because it is unclear 801

whether a rel iable database of national scale could be accurately populated and updated in a timely 802

manner. Issues of who would be allowed to input data, what data would be collected, how the data 803

would be authenticated, and who would be able to view the data, all pre sent significant challenges. As 804

resources permit, EPA plans to discuss with stakeholders the future feasibility, utility, and efficiency of 805

developing and implementing a centralized database of trained workers and handlers

. 806

Comments in opposition to a national trained employee database. Two state pesticide 807

regulatory agencies strongly opposed a state

- by

- state training database, commenting that workers are 808

very mobile and keeping the data accurate would be difficult. However, they recommended that EPA 809

co nsider, in consultation with the state regulatory partners and the regulated community, the benefits 810

of a national database. One state farm bureau and a grower opposed a requirement for worker and 811

handler training information to be provided to the state o r federal government for keeping in a central 812

repository. They state d that during periodic regulatory inspections, there is adequate opportunity for 813

training records to be inspected. Additional reporting burdens are not necessary. This grower also 814

stated that the documentation can be given to workers to prove to subsequent employers that they 815

have been trained, so the central database would not be necessary. A public health organization agreed 816

with EPA that the cost and incremental benefit of a central dat abase would not warrant such an 817

undertaking. They state d that the employer records will be sufficient to demonstrate compliance. 818

Another grower organization commented that a national registry for training records would be 819

very difficult to implement, stati ng that history has indicated that this type of verification system is 820

extremely difficult to maintain and ensure accuracy of the information collected. A state pesticide 821

regulatory agency commented that they did not see this providing benefits, and it wou ld be 822

burdensome. This entity preferred that the records be available when requested by the state. One state 823

agency expressed concern that there would be speculation that the data would be used to track 824

immigration status, resulting in workers’ being reluc tant to be trained. 825

EPA Response. EPA agrees with commenters that a national database of trained workers and 826

handlers would be very difficult to successfully implement and would impose unnecessary burden on 827

employers, with limited benefit. 828

Comment on the use of wallet

- sized training verification cards . A couple of state regulatory 829

agencies and many farmworker advocacy organizations, as well as a number of public citizens, 830

recommended that the worker and handler training verification system include a walle t

- sized card for 831

workers and handlers, some stating because it works best in the field. The current voluntary card system 832

relies on a wallet

- sized card that is provided by the trainer or employer directly to the worker. One state 833

pesticide regulatory agenc y stated that the cards serve the purpose of document ing workers’ training, 834

but note d that the current card would need to be modified to cover most of the required elements. A 835

farmworker advocacy organization encouraged EPA to maintain the training card, s tating that in their 836

experience, employers have asked workers to sign a piece of paper indicating they had been trained, 837

when in fact they had not. This commenter also stated that the card reinforces the importance of the 838

training. 839

One crop advisor state d that the required recordkeeping is part of a well

- managed operation, 840

and asserted the elimination of the verification card is a mistake, as they are readily accepted and 841

difficult to falsify. 842

One farm bureau stated that their farmers provide verificati on cards to their employees and 843

contend that the proposed recordkeeping would be overly burdensome. They note that date of birth, 844

trainer’s credentials, and training materials required under the proposal are “time consuming and 845Page 20 of 176 restrictive.” They strongly prefer the current training card. One state lead agency requested that EPA 846

develop a training record format that could be used by employers. 847

EPA Response. EPA recognizes that the wallet

- sized verification card is a convenient document 848

for workers, hand lers and employers. However, requiring employers to maintain training records on the 849

establishment will allow inspectors to review two years’ practices, rather than being limited to just the 850

workers and handlers currently on the establishment . Employers wo uld be required to provide the 851

information on the card because of the difficulty of imposing FIFRA requirements on trainers. The WPS 852

is applied through labeling. Since trainers are not the parties making pesticide use decisions on the 853

establishment or mak ing pesticide applications, requirements to comply with the WPS cannot extend to 854

them. 855

The information needed to ensure that the training meets the WPS requirements would be 856

difficult to fit on a wallet

- sized card. However, if all of the information was included on a wallet

- sized 857

card, it would be sufficient documentation to comply with the recordkeeping requirement. The 858

provision of a copy of the training record to the worker or handler provides information to subsequent 859

employers that is complete for pu rposes of inspection. 860

Comment on documentation of trainer qualifications . One state regulatory agency expressed 861

concern that they would have to maintain documentation of qualified trainers. They suggested that EPA 862

create and maintain a national database of qualified trainers. 863

EPA Response. The requirements for qualified trainers are not different from those in the 864

current rule; it is the responsibility of the employer to ensure the trainer has the proper qualifications. 865

Under the final rule, the training record must include documentation of the trainer’s qualification. The 866

suggested option for a national database of qualified trainers presents similar issues as the national 867

trained worker database discussed above, and as resources permit, EPA will include that in the 868

stakeholder discussions a bout a national trained worker database. EPA notes that c ertified applicators 869

must possess a credential demonstrating their qualification, which can be used to show the employer 870

that the holder is qualified to be a trainer for workers and handlers. 871

Comme nts on access to the training record by an authorized representative. Several farm 872

bureau organizations, one organization representative of agricultural employers, and one pesticide 873

manufacturer organization opposed authorized representative access to trai ning records, even if the 874

authorization is in writing. These entities did not see any benefit and observed that there may be abuse. 875

EPA Response . EPA did not propose and is not finalizing a requirement to allow authorized 876

representative s access to trainin g records. Under the final rule, the designated representative ( under 877

the proposal, authorized representative) could request the application information and safety data 878

sheet ( SDS ) on behalf of a worker or handler. The final rule does not require employer s to make training 879

records available to the designated representative. 880

Comments supporting a performance standard approach instead of recordkeeping . One public 881

health organization recommended a performance standard that would weigh understanding of the 882

saf ety principles, and highlight those training approaches that were most successful. Two farmworker 883

advocacy organizations supported recordkeeping as a reliable, cost

- efficient and effective way to 884

determine compliance, but expressed concern that the quality of the training is important, and 885

supported a performance standard to measure comprehension. 886

EPA Response. Inspectors having used only a performance

- based approach to verifying training 887

find the burden of interviewing each worker or handler to determine their understanding of the safety 888

principles extremely high. Language difficulties often complicate interviews. Access to a record of 889

training, available from the employer, provides adequate information to efficiently determine a 890Page 21 of 176 threshold level of compli ance. EPA’s guidance for inspectors recommends interviews with workers and 891

handlers as part of the inspection , including to verify that training has been provided. 892

Comments opposing a performance standard to evaluate training. One state pesticide 893

regulat ory agency did not support a performance standard to evaluate training, saying it places 894

unnecessary burden on trainers to prove their competence

. 895

Although one public health organization supported post

- testing to determine comprehension 896

and retention, they recognize d the additional cost for training and supported voluntary use of post

897

training assessment by employers. 898

EPA Response. EPA agrees that use of exams to determine comprehension for compliance 899

purposes would be inappropriate with this population. Th ere is a description of the concerns with the 900

use of exams to evaluate training in the preamble for the proposed rulemaking ( Ref. 2 ). EPA agrees that 901

requiring inspectors to determine whether training was provided to a worker or handler solely through 902

int erviews and questions is inefficient, and can provide false positives and negatives. 903

Comments in support of a longer timeframe for record retention. One advocacy group 904

recommended a five year retention period for records. One public health school state d that records 905

should be kept for more than two years. A farmworker advocacy organization asserted that EPA did not 906

adequately support a shorter timeframe rather than five years for record retention, stating that chronic 907

illnesses can manifest years after th e exposure. 908

EPA Response. EPA considered a five year retention schedule for training record retention in the 909

proposal , but as noted in the preamble to the proposed rule, California and Florida have a two year 910

retention timeframe (Ref. 2). EPA received support for a two year timeframe , including from state 911

regulators who noted it would be adequate for determining compliance

. 912

Comments in support of a two year timeframe for recordkeeping. One academic organization 913

supported the two year tim eframe for retention, stating that it will improve the state’s ability to follow 914

up on referrals they make on reported pesticide illness. 915

EPA Response . EPA agrees with this comment. 916

Comments on state concerns for burden. One state regulatory agency ask ed for information 917

about how training verification will be implemented, and whether states will need to keep track of 918

training cards. They also note d that it will be difficult to verify employee age. 919

EPA Response . EPA is not implementing a mandatory train ing verification card program, so 920

states will not need to track cards. EPA plans to develop a n optional form that may be used to collect 921

the training information, but it s use will not be required under the final rule . EPA is developing detailed 922

informatio n for the states about rule implementation. The rule becomes effective 60 days after 923

publication, but the requirement for training recordkeeping will be implemented one year and 60 days 924

after publication, to give states and the regulated entities time to learn and understand the rule. 925

Regarding the minimum age requirement for handlers and early entry workers, inspectors will 926

need to ask how the employer verified the age of those employees, similar to the process used in liquor 927

stores, and consider whether the method used was reasonable. 928

Comments from industry that civil rights laws foster employer reliance on worker

- presented 929

documents

. The proposal asked whether employers would be likely to rely on training records provided 930

by the worker. A farm bureau commenter noted it is likely that employers would rely on training records 931

provided by the worker or handler, in part because employers are already accustomed to relying on 932

worker

- presented documents. They note that Federal law prohibits discrimination ag ainst any 933

individual other than an unauthorized alien, with respect to hiring, employment, etc. 8 U.S.C. 934

1324b(a)(1). The same law expressly prohibits immigration

- related discrimination by “refusing to honor 935Page 22 of 176 documents tendered that on their face reasonab ly appear to be genuine...” 8 U.S.C. 1324b(a)(6)

. A farm 936

bureau ma de the point that since employers are accustomed to rely on presented immigration

- related 937

documents, they are also likely to rely upon WPS training documents that on their face reasonably 938

a ppear to be genuine. 939

EPA Response. EPA thanks AFBF for the helpful information. 940

Comment that there may be duplicative recordkeeping . One grower organization suggests that 941

there may be duplicative recordkeeping required under Food Safety Programs. 942

EPA R esponse. Regulations under the Food Safety Modernization Act have not yet been 943

promulgated in final form by the Food and Drug Administration (FDA). EPA is not aware of duplicative 944

recordkeeping requirements under FDA’s proposed rules. 945

Comment that states have requirements for recordkeeping in place. One grower organization 946

commented that EPA should reinforce the state requirements but not place additional burden by way of 947

redundant requirements. 948

EPA Response . If state requirements pr oduce records that satisfy the WPS requirements, 949

inspectors can use those records to confirm compliance. If additional information is needed to satisfy 950

the WPS requirements, employers must record that information. Moreover, under the final rule, a state 951

o r tribe may request authority to continue implementing any provision of its existing regulations 952

(including recordkeeping requirements) that provides equivalent protection, in lieu of implementing the 953

corresponding WPS provision. 954

Comments in opposition t o training records for handlers. Several state pesticide regulatory 955

agencies stated, in similar comments, that the recordkeeping requirements for handlers are 956

unnecessary and would burden the handler employer: 957

“This section should be deleted. This exte nsive recordkeeping requirement for proof of training 958

creates an unnecessary burden and expense for the agricultural producer. The current requirements in 959

the existing rule are adequate. From a compliance standpoint, if an SLA is investigating a for

- cause 960

complaint for determination of compliance with the training requirement, examining training records 961

alone will probably not satisfy the burden of proof for a significant enforcement action. This is especially 962

true if any training records are found not to b e 100% accurate and complete for all trainees. Again, 963

adding this recordkeeping requirement creates the opportunity for technical violations without a 964

demonstrated improvement in actual protections for workers and handlers. It should also be noted that 965

sin ce the inception of the original WPS rule [the state] has not investigated a single complaint focusing 966

solely on failure to provide training. If training was not being provided, it was a case of the agricultural 967

employer not complying with any of the WPS r ule provisions.” 968

EPA Response. The recordkeeping requirements for handlers are identical to the recordkeeping 969

requirements for workers. EPA does not believe that the recordkeeping requirements for handlers 970

impose unnecessary or excessive burdens in compar ison with the expected benefits. 971

Comment on responsibility for the training record . One state pesticide regulatory agency state d 972

that only the employer, not the trainer, should have responsibility for the record. This agency add ed 973

that the record should be in paper or electronic format and retained for two years, and state d that some 974

employers have agreements with labor contractors and the rule should allow that the entity with 975

direction and control over the worker is the one with responsibility to keep t raining records. 976

EPA Response. EPA agrees that the employer is responsible for maintaining records. Trainers are 977

not directly responsible under the rule. The employer, as the entity that makes pesticide use decisions 978

on their establishment, is responsibl e for providing the protections of the rule. 979Page 23 of 176 Whether or not it might be desirable that the rule require labor contractors to keep training 980

records, EPA’s authority to promulgate and enforce the WPS is based on each agricultural pesticide’s 981

label requirin g users to comply with the WPS. Labor contractors are not typically the pesticide user, nor 982

do they typically have control over pesticide use on the establishment, and therefore would not 983

ordinarily be directly subject to the WPS requirements. The employe r may require, through terms of an 984

agreement or contract , the labor contractor or other entity to prepare records of training; however, the 985

agricultural employer is the responsible party and must demonstrate compliance. 986

The records may be in paper or ele ctronic format, but they must be made available upon 987

request for inspection purposes. 988

Comments regarding “shift” of regulatory responsibility from EPA and states to employers for 989

training verification for workers and handlers. One state regulatory agency noted that the requirement 990

for training verification represents a shift of regulatory responsibility from EPA and states to agricultural 991

employers. One organization that represents agricultural employers stated the following: 992

“... we oppose that EPA’s current proposal shifts regulatory responsibility from EPA and 993

state lead agencies to agricultural employers, adding the cost and responsibility for 994

implementing and maintaining a new recordkeeping system that are not considered in 995

the Information Collecti on Request (ICR). Additionally it is our concern that the 996

significantly increased documentation and retention requirements will put state lead 997

agencies into the position that they will be sued to require them to audit such records 998

and thus be forced to div ert scarce resources from training and enforcement to become 999

“auditors.” 1000

EPA Response . The agricultural employer is responsible, under the existing rule, to ensure that 1001

the worker or handler has been trained, according to the requirements of the rule. This final rule merely 1002

requires that the employer create a record that documents the fulfillment of that requirement. EPA 1003

expects the documentation to ease the burden on inspectors, because training can be more easily 1004

verified by reviewing a contemporaneous r ecord tha n in the absence of a training record. To the extent 1005

that this represents a shifting of burden from the states (who have primary enforcement responsibility 1006

for WPS compliance) to the employer, it is a small and reasonable burden. The ICR for the proposed rule 1007

in the docket includes estimates for the recordkeeping of training on page 31, Table 14 1008

( http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2011

- 0184

- 0105 )

. 1009

EPA does not expect that state lead agencies for pesticide enforcement will be sued to require 1010

them to audit training records; however, they are expected to enforce the WPS rule and as such, will be 1011

expected to inspect these records. 1012

Comments on workers being denied employment because of lack of training record . Two 1013

farmworker advo cacy organizations expressed concerns for employers denying employment to workers 1014

and handlers based on their inability to demonstrate that they have been trained. 1015

EPA Response . This concern is addressed by the requirement for the employer to provide a 1016

re cord of their training to the requesting employee upon request . However, if the employer cannot 1017

verify that a worker or handler has been trained, they must receive the training prior to entry into a 1018

treated area. 1019

C. Establish Trainer Qualifications for Wo rkers and Handlers 1020

1. Current rule and proposal. The existing WPS allows workers and handlers to be trained by a 1021

variety of persons, including pesticide applicators certified to use restricted use pesticides (RUPs) under 1022

40 CFR part 171, persons identified by the agency with jurisdiction for pesticide e nforcement as a trainer 1023

of certified applicators, or persons having completed an approved pesticide safety train

- the

- trainer 1024Page 24 of 176 course. In addition, persons trained as handlers under the WPS are also eligible to train workers. 1025

EPA proposed to limit eligible trainers of workers to those who complete an EPA

- approved train

1026

the

- trainer program or are designated by EPA or an appropriate state or tribal agency as trainers of 1027

certified applicators; being a certified applicator or trained as a handler under the WPS w ould not 1028

automatically qualify a person to train workers under the proposal. EPA did not propose to change the 1029

qualifications for trainers of handlers. 1030

2. Final rule. In the final rule, EPA has expanded the class of persons qualified to train workers 1031

rel ative to the proposed rule. Under the final rule, qualified trainers of workers include persons who: 1032

Have completed a pesticide safety train

- the

- trainer program approved by EPA, are designated as a 1033

trainer of certified applicators, handlers or workers by E PA or a state or tribal agency responsible for 1034

pesticide enforcement, or are certified pesticide applicators under 40 CFR part 171. Unlike the proposal, 1035

certified applicators are considered qualified to train workers under the final rule. However, consist ent 1036

with the proposal, the persons trained as handlers under the WPS are not considered qualified to train 1037

workers under the final rule. 1038

The final rule does not make any changes from the existing rule and proposal related to who is 1039

qualified to provide tr aining to handlers. 1040

The final regulatory text for worker and handler trainer qualifications is available at 40 CFR 1041

170.401(c)(4) and 170.501(c)(4), respectively. 1042

3. Comments and responses. 1043

Comments. Many of the comments, from states, grower organizatio ns, and farm bureaus, 1044

advised EPA to retain certified applicators as trainers of workers in the final rule. Several commenters 1045

stated that without certified applicators providing worker training, resources such as cooperative 1046

extension trainers would be se verely strained and there might not be adequate resources to provide 1047

annual training for workers. Several states and others noted that certified applicators possess the 1048

necessary competence to provide training to workers; in some states, they must receive training 1049

specifically for the purpose of training workers in order to meet their certification requirements. 1050

Commenters also questioned how a certified applicator could be considered qualified to train handlers, 1051

but not workers as many handlers have the sa me demographic profile as workers, some stating that the 1052

training material covered mostly the same material. 1053

Comments that supported the proposal to remove certified applicators as trainers of workers 1054

stated that certified applicators may not have the tr aining skills needed for effectively communicating 1055

with this demographic, but suggested certified applicators that may lack such skills could be effective 1056

trainers of workers by completing a training course. 1057

A few commenters opposed the proposed eliminati on of handlers as worker trainers, stating 1058

that the existing system works and that trained handlers are needed to provide training. However, there 1059

were few comments in support of retaining handlers as trainers for workers. One comment suggested 1060

that handle rs could be required to take an approved train

- the

- trainer course to ensure they can 1061

adequately train workers. 1062

One commenter stated that if a certified applicator is not qualified to train a worker, then they 1063

should not be qualified to train handlers. 1064

I n response to the question raised in the proposal for the final rule regarding retraining for 1065

trainers, a few commenters suggested that refresh training should take place every five years. One 1066

commenter stated that trainers would need to know about new pro ducts and techniques that may 1067

come on line. Comments from a state and a farm bureau opposed refresh training, expressing concern 1068

for burden. 1069Page 25 of 176 One commenter expressed concern that, if certified applicators were no longer acceptable 1070

trainers for workers , all workers would be trained as handlers to manage the additional training 1071

requirements, and they would perform handler tasks with higher risk. 1072

One commenter suggested that EPA designate a category under the Certification of Pesticide 1073

Applicators rule for WPS Trainers. Persons certified under this category would be eligible to train 1074

workers. 1075

EPA Response. EPA is persuaded by the comments that it is reasonable to expect that certified 1076

applicators can competently train workers, as well as handlers. Commenters note d that certified 1077

applicators possess knowledge of pesticide safety from their certification training and pesticide handling 1078

experience. The commenters stated that the additional burden from the proposed requirement for 1079

annual training in combination wi th the elimination of certified applicators as trainers would severely 1080

strain trainer resources and potentially result in fewer workers receiving annual training. This concern 1081

persuaded EPA to include certified applicators as qualified to train workers in the final rule. 1082

Commenters that supported the proposal to no longer qualify all certified applicators as trainers 1083

of workers recommended that they receive training to qualify as trainers. This is very similar to the 1084

proposal that would have allowed certif ied applicators to train workers if they completed a train

- the

1085

trainer course. In combination with concerns raised for burden in response to the question about 1086

refresh training for trainers, and the consistent comments from states and growers supporting ce rtified 1087

applicators as trainers of workers, EPA was convinced that certified applicators have successfully trained 1088

workers since the rule was originally implemented and should continue to be eligible to provide training 1089

to workers. 1090

In response to comments supporting handlers as trainers of workers, EPA is not convinced that 1091

they possess the skills and/or technical knowledge to convey the information. Some comments stated 1092

that the existing system works and that trained handlers are needed to provid e training. EPA believes 1093

that permitting certified applicators to train workers provides adequate numbers of trainers. Under the 1094

final regulation, any person, including a handler, is qualified to train workers after successfully 1095

completing an approved tra in

- the

- trainer course. 1096

In response to concerns that without certified applicators as trainers of workers, more workers 1097

would be given handler training and thereafter perform handler tasks with higher risk, EPA does not 1098

consider this a plausible outcome, b ut it is moot as the final rule allows certified applicators to train 1099

workers. First, EPA expects that the difference between the burdens of worker and handler training will 1100

encourage the development of appropriate worker training capacity. Second, an in crease in the number 1101

of trained handlers would not increase risk, because it would not cause an increase in the aggregate 1102

hours of handler activity; if there were an increase in the number of trained handlers, that would merely 1103

spread those hours over a la rger pool of trained handlers

. 1104

EPA agrees with the commenters that requiring refresher training for trainers would be 1105

burdensome. Although application methods and pesticides used might change over time, the pesticide 1106

safety training provides common

- sense steps that workers can take to protect themselves from 1107

exposure, and EPA does not find that these steps change significantly over time. EPA supports training 1108

for trainers and encourages them to enhance their skills, but based on comments received, has no t 1109

established a requirement under the WPS for refresher training for trainers of workers or handlers. 1110

The comment that EPA should establish a category under the Certification of Pesticide 1111

Applicators rule for certified applicators to become qualified as WPS worker trainers is moot because 1112

under the final rule, any certified applicator is authorized to train workers. 1113Page 26 of 176 In response to the question of whether a person trained as a handler is allowed to perform 1114

worker activities without separate worker trainin g, EPA agrees that a person trained as a handler is 1115

qualified to perform worker activities. The question of what would have been allowed under the 1116

proposed rule is moot. 1117

D. Expand the Content of Worker and Handler Pesticide Safety Training 1118

1. Current and proposed rule. The existing WPS requires employers to provide pesticide safety 1119

training covering specific content to workers and handlers. Under the existing rule, worker safety 1120

training content must include the following 11 points: 1121

• Where and in what for m pesticides may be encountered during work activities. 1122

• Hazards of pesticides resulting from toxicity and exposure, including acute and chronic 1123

effects, delayed effects, and sensitization. 1124

• Routes through which pesticides can enter the body. 1125

• Signs and symptoms of common types of pesticide poisoning. 1126

• Emergency first aid for pesticide injuries or poisonings. 1127

• How to obtain emergency medical care. 1128

• Routine and emergency decontamination procedures, including emergency eye flushing 1129

techniques. 1130

• Haza rds from chemigation and drift. 1131

• Hazards from pesticide residues on clothing. 1132

• Warnings about taking pesticides or pesticide containers home. 1133

• Requirements of the WPS designed to reduce the risks of illness or injury resulting from 1134

workers' occupational expo sure to pesticides, including application and entry restrictions, 1135

the design of the warning sign, posting of warning signs, oral warnings, the availability of 1136

specific information about applications, and the protection against retaliatory acts. 1137

Under the existing rule, pesticide handler safety training must include the following 13 basic 1138

safety training points: 1139

• Format and meaning of information contained on pesticide labels and in labeling, including 1140

safety information such as precautionary statements abou t human health hazards. 1141

• Hazards of pesticides resulting from toxicity and exposure, including acute and chronic 1142

effects, delayed effects, and sensitization. 1143

• Routes through which pesticides can enter the body. 1144

• Signs and symptoms of pesticide poisoning. 1145

• Eme rgency first aid for pesticide injuries or poisonings. 1146

• How to get emergency medical care. 1147

• Routine and emergency decontamination procedures. 1148

• Need for and appropriate use of PPE. 1149

• Prevention, recognition, and first aid treatment of heat

- related illness. 1150

• Safet y requirements for handling, transporting, storing, and disposing of pesticides. 1151

• Environmental concerns. 1152

• Warnings about taking pesticides or pesticide containers home. 1153

• Training on the requirements of the regulation related to handling. 1154Page 27 of 176 EPA proposed additi onal content in worker pesticide safety training including, among other 1155

things, information on the requirements for early

- entry notification and emergency assistance, how to 1156

reduce pesticide take

- home exposure, the availability of hazard communication mate rials for workers, 1157

the minimum age requirements for handling and early entry, and the obligations of agricultural 1158

employers to provide protections to workers. 1159

EPA proposed additional content in handler pesticide safety training, including the requirement 1160

for handlers to cease application if they observe a person, other than another trained and properly 1161

equipped handler, in the area being treated or the entry

- restricted area, and information about the 1162

requirement for OSHA

- equivalent training on respirator use, fit

- testing of respirators, and medical 1163

evaluation in the event a handler must wear a respirator. 1164

2. Final rule. EPA has finalized the proposed additions to and expansions of the worker and 1165

handler pesticide safety training. The final regulatory tex t for the content of worker and handler 1166

pesticide training is available at 40 CFR 170.401(c)(2)

- (3) and 170.501(c)(2)

- (3). 1167

The final rule requires employers to ensure that workers are trained on the following topics 1168

after EPA has announced the availability of training materials (see Unit XIX. for information on the 1169

timing of implementation): 1170

• The responsibility of agricultural employers to provide workers and handlers with information 1171

and protections designed to reduce work

- related pesticide e xposures and illnesses. This includes 1172

ensuring workers and handlers have been trained on pesticide safety, providing pesticide safety and 1173

application information, decontamination supplies and emergency medical assistance, and notifying 1174

workers of restricti ons during applications and on entering pesticide treated areas. A worker or handler 1175

may designate in writing a representative to request access to pesticide application and hazard 1176

information. 1177

• How to recognize and understand the meaning of the warning sign used for notifying workers 1178

of restrictions on entering pesticide

- treated areas on the establishment. 1179

• How to follow directions and/or signs about keeping out of pesticide

- treated areas subject to 1180

an REI and application exclusion zones. 1181

• Where an d in what form pesticides may be encountered during work activities and potential 1182

sources of pesticide exposure on the agricultural establishment. This includes exposure to pesticide 1183

residues that may be on or in plants, soil, tractors, application and che migation equipment, or used PPE, 1184

and that may drift through the air from nearby applications or be in irrigation water. 1185

• Potential hazards from toxicity and exposure that pesticides present to workers and their 1186

families, including acute and chronic effects, delayed effects, and sensitization. 1187

• Routes through which pesticides can enter the body. 1188

• Signs and symptoms of common types of pesticide poisoning. 1189

• Emergency first aid for pesticide injuries or poisonings. 1190

• Routine and emergency deconta mination procedures, including emergency eye flushing 1191

techniques, and if pesticides are spilled or sprayed on the body, to use decontamination supplies to 1192

wash immediately or rinse off in the nearest clean water, including springs, streams, lakes, or other 1193

sources, if more readily available than decontamination supplies, and as soon as possible, wash or 1194

shower with soap and water, shampoo hair, and change into clean clothes. 1195

• How and when to obtain emergency medical care. 1196

• When working in pesticide

- trea ted areas, wear work clothing that protects the body from 1197

pesticide residues and wash hands before eating, drinking, using chewing gum or tobacco, or using the 1198

toilet. 1199Page 28 of 176 • Wash or shower with soap and water, shampoo hair, and change into clean clothes as so on as 1200

possible after working in pesticide

- treated areas. 1201

• Potential hazards from pesticide residues on clothing. 1202

• Wash work clothes before wearing them again and wash them separately from other clothes. 1203

• Do not take pesticides or pesticide container s used at work to your home. 1204

• Safety data sheets provide hazard, emergency medical treatment and other information about 1205

the pesticides used on the establishment they may come in contact with. 1206

The responsibility of agricultural employers to do all of th e following: Display safety data sheets for all 1207

pesticides used on the establishment, provide workers and handlers information about the location of 1208

the safety data sheets on the establishment, and provide workers and handlers unimpeded access to 1209

safety da ta sheets during normal work hours. 1210

• The rule prohibits agricultural employers from allowing or directing any worker to mix, load or 1211

apply pesticides or assist in the application of pesticides unless the worker has been trained as a 1212

handler. 1213

• The resp onsibility of agricultural employers to provide specific information to workers before 1214

directing them to perform early

- entry activities. Workers must be 18 years old to perform early

- entry 1215

activities. 1216

• Potential hazards to children and pregnant women fro m pesticide exposure. 1217

• Keep children and nonworking family members away from pesticide

- treated areas. 1218

• After working in pesticide

- treated areas, remove work boots or shoes before entering your 1219

home, and remove work clothes and wash or shower before phy sical contact with children or family 1220

members. 1221

• How to report suspected pesticide use violations to the state or tribal agency responsible for 1222

pesticide enforcement. 1223

• The rule prohibits agricultural employers from intimidating, threatening, coercing, or 1224

discriminating against any worker or handler for complying with or attempting to comply with the 1225

requirements of this rule, or because the worker or handler has provided, caused to be provided, or is 1226

about to provide information to the employer or to t he EPA or its agents regarding conduct that the 1227

employee reasonably believes violates this part, and/or has made a complaint, testified, assisted, or 1228

participated in any manner in an investigation, proceeding, or hearing concerning compliance with this 1229

rul e. 1230

The final rule requires employers to ensure that handlers are trained on the following topics 1231

after EPA has announced the availability of training materials (see Unit XIX. of the preamble for 1232

information on the timing of implementation): 1233

• All conten t for worker training. 1234

• Information on proper application and use of pesticides. 1235

• Handlers must follow the portions of the labeling applicable to the safe use of the pesticide. 1236

• Format and meaning of information contained on pesticide labels and in labeling applicable to 1237

the safe use of the pesticide. 1238

• Need for and appropriate use and removal of all PPE. 1239

• How to recognize, prevent, and provide first aid treatment for heat

- re lated illness. 1240

• Safety requirements for handling, transporting, storing, and disposing of pesticides, including 1241

general procedures for spill cleanup. 1242

• Environmental concerns, such as drift, runoff, and wildlife hazards. 1243

• Handlers must not apply pe sticides in a manner that results in contact with workers or other 1244Page 29 of 176 persons. 1245

• The responsibility of handler employers to provide handlers with information and protections 1246

designed to reduce work

- related pesticide exposures and illnesses. This includes pro viding, cleaning, 1247

maintaining, storing, and ensuring proper use of all required personal protective equipment; providing 1248

decontamination supplies; and providing specific information about pesticide use and labeling 1249

information. 1250

• Handlers must suspend a p esticide application if workers or other persons are in the 1251

application exclusion zone. 1252

• Handlers must be at least 18 years old. 1253

• The responsibility of handler employers to ensure handlers have received respirator fit

- testing, 1254

training and medical eval uation if they are required to wear a respirator by the product labeling. 1255

• The responsibility of agricultural employers to post treated areas as required by this rule. 1256

EPA intends to develop the training materials that meet the final training requirements and to 1257

publish in the Federal Register a notice of their availability. To allow time for the completion and 1258

distribution of revised training materials and to allow time for trainers to become familiar with them and 1259

begin training workers and handlers, the rule extends the implementation period for training on the 1260

new requirements for two years, or until six months after EPA has made the revised training materials 1261

availab le, whichever is longer. The final requirements for the content of worker and handler pesticide 1262

safety training are available at 40 CFR 170.401(c)(2)

- (3) and 170.501(c)(2)

- (3), respectively. 1263

3. Comments and responses. 1264

Comments on training requirements

– general. Farmworker advocacy organizations, many 1265

states, and public health organizations provided support for the expanded training topics, in particular 1266

information about preventing take

- home exposure

, and medical evaluation, fit testing and training on 1267

respirator use for handlers who need to wear respirators. Some farmworker advocacy organizations 1268

commented on the importance of information about worker rights. 1269

Agricultural producer organizations expressed concern for the additional burden of the length ier 1270

training. Some states asserted that several of the handler training points are beyond the scope of the 1271

WPS and should be addressed in applicator certification only. Specifically, they requested that EPA 1272

eliminate training on environmental concerns from pesticide use; proper application and use of 1273

pesticides; and requirements for handlers to understand the format and meaning of all information 1274

contained on pesticide labels and labeling, and to follow all pesticide label directions. These 1275

commenters state d that these training points are appropriate for persons who work under the 1276

supervision of certified applicators, but they do not relate directly to worker or handler safety. Two 1277

states recommended a revision to language in the handler training topics requ iring that “all” 1278

information on the pesticide label would be required to be covered, stating that all labeling information 1279

may not be relevant to a given application. 1280

EPA Response. EPA does not agree with comments from states that the handler training to pics 1281

related to environmental concerns from pesticide use, proper application and use, requirements for 1282

handlers to understand the format and meaning of information on label ing and to follow label ing 1283

directions are beyond the scope of the WPS and may expan d the liability of handlers. First, the “Worker 1284

Protection Standard” title is descriptive, and not jurisdictional. The WPS is, in essence, a codification of 1285

material that EPA would otherwise have to require to appear on the label ing of agricultural pestici des. 1286

Thus its potential scope is as broad as EPA’s labeling authority. While there may be some point at which 1287

a prospective provision might be so tangentially related to the rest of the WPS that its inclusion in the 1288

WPS would cause excessive confusion, tha t is not the case with the provisions included in today’s final 1289Page 30 of 176 rule. 1290

In addition, this is not the first time that requirements included in the WPS have served 1291

purposes beyond the protection of agricultural workers and handlers. Section 170.210(a) of the existing 1292

rule requires that “The handler employer and the handler shall assure that no pesticide is applied so as 1293

to contact, either directly or through drift, any worker or other person , other than an appropriately 1294

trained and equipped handler” (emphasis added). Section 170.234(c) of the existing rule requires that, 1295

among other things, when application equipment is sent to non

- handlers for repair, the handler 1296

employer must assure that pesticide residues have been removed, or else warn the person who would 1297

perform the repair. The handler training point on environmental concerns from pesticide use already 1298

appears in the existing rule at 40 CFR 170.230(c)(4)(xi). In response to a similar comment on the 1299

proposal that resulted in the existing regulation, EPA st ated: 1300

One comment questioned the relevancy of environmental information in worker 1301

protection training. The Agency believes such training is relevant to worker protection. 1302

Many environmental concerns are applicable not only to the organisms in the 1303

environm ent, but also to workers and other persons who may be in that environment. 1304

Ground and surface water warnings, for example, are designed not to protect only aquatic 1305

organisms, but to protect workers and other persons who may be using the water for 1306

drinking, cooking, bathing, etc. The Agency notes that FIFRA defines “environment” as 1307

including “water, air, land, and all plants and man and other animals living therein, and 1308

the interrelationships which exist among these .” (Ref. 8). 1309

The final rule retains the re quirement for handler training on environmental concerns related to 1310

pesticide use from the current WPS. 1311

EPA does not agree that the training topic requiring handlers to receive instruction on proper 1312

application and use of pesticides is only appropriate fo r noncertified applicators making application 1313

under the direct supervision of a certified applicator. First, handlers routinely apply pesticides, and 1314

misapplication of pesticides can result in injury to persons covered by the WPS, including workers and 1315

han dlers. Training on proper use can help prevent such misapplication and consequent exposure to 1316

people. Second, relying solely on the training of noncertified applicators under direct supervision would 1317

cover only applicators using RUPs, and many agricultural use products covered by the WPS are not RUPs. 1318

To ensure that handlers under the WPS have the training to apply pesticides properly, it is necessary for 1319

them to be trained on proper use. The final rule includes the handler training topic requiring informat ion 1320

on proper application and use of pesticides. 1321

EPA does not agree with the commenters that requirements for handlers to understand the 1322

format and meaning of information on label ing and to follow labeling directions are only appropriate for 1323

noncertified applicators applying under the supervision of certified applicators. To properly handle 1324

agricultural pesticides covered by the WPS rule, handlers need to understand the information on the 1325

labeling related to safe use of the pesticide and follow the use ins tructions. Use of a product in a manner 1326

inconsistent with the labeling may cause injury or illness to the handler and to others. However, EPA did 1327

revise the handler training requirements based on commente rs concerns that the proposed training 1328

requirements were too broad. See the discussion in Unit XVIII.A. related to changes to the handler 1329

training requirements covering labels and labeling. 1330

Comments on the cost. A farm bureau expressed concern for the costs of revising and updating 1331

existing materials, quest ioning whether the additional material is necessary to further the program and 1332

whether it can be provided in a way that it can be used. 1333

EPA Response . EPA agrees that there are costs associated with the revisions to the training 1334Page 31 of 176 program, including costs to update materials, produce, and distribute them. EPA plans to revise the 1335

training materials and make them widely available, reducing the burden on employers. EPA has 1336

considered the costs to the regulated community and found them to be reasonable in the cont ext of 1337

health improvements and protections for workers, handlers, and their families. 1338

Comment on applicability of information . One commenter state d that the CDC study cited in the 1339

preamble does not reflect current practices, and that since the 1996 FQPA, there have been significant 1340

revisions to pesticide regulation. 1341

EPA Response . Families and their environment can be exposed to pesticide s by contact with 1342

residues carried on working parents’ clothing, dirt tracked into the home, or from other pathways. The 1343

transfer of residues can be minimized by the worker or handler by observing simple hygienic steps, 1344

including hand washing and removal of work boots prior to entry into the home. Studies cited in the 1345

preamble demonstrated a reduction in residues when workers observe these practices. Although the 1346

CDC study itself is from 1995, several of the studies that support improved practices to reduc e take 1347

home exposure are more recent, notably the 2000 study by Lu, et al, titled “Pesticide Exposure of 1348

Children in an Agricultural Community: Evidence of Household Proximity to Farmland and Take Home 1349

exposure Pathways,” and the Arcury study titled, “Pest icide Urinary Metabolite Levels in Urine of 1350

Children Living In Agricultural Communities (2005).” These studies found that children in homes with 1351

agricultural parents are exposed to pesticides and that changes are needed to protect them from such 1352

exposures. 1353

Although the FQPA has altered the types and amounts of certain pesticides used on certain 1354

crops in order to reduce dietary exposures, there is no evidence that it has resulted in overall reductions 1355

in worker or handler occupational exposure to pesticide s or the associated risks. 1356

Comments on topics related to reporting violations. Two commenters expressed concern for 1357

EPA’s rationale to require worker and handler pesticide safety training to include information on how to 1358

report suspected pesticide use vio lations. They objected to the rationale in part because the context 1359

used to justify this action suggested that it is an infringement of “WPS rights”, not general pesticide or 1360

FIFRA label violations. 1361

EPA Response. EPA believes the commenters have misunders tood EPA’s position. The proposal 1362

states the following related to this issue: 1363

“Farmworker advocacy organizations recommend including in the worker or handler 1364

pesticide safety training information on the rights of workers and handlers under the WPS 1365

(Ref. 36 ). The Agency agrees that workers and handlers should be aware of WPS 1366

provisions on how to report violations and the prohibition on retaliation by the 1367

agricultural employer.” (Ref. 2.) 1368

While the WPS does not use the term “rights”, various sections (particu larly section 170.7 of the 1369

existing WPS) impose certain duties upon employers in regard to their employees, and it is not 1370

unreasonable to speak of employees having certain WPS rights as a consequence of the employers’ WPS 1371

duties. However, the commenters a ppear to misconstrue the preamble statement as an endorsement 1372

of broader worker rights claims made by farmworker advocates. Regardless of what other rights 1373

workers and handlers might have, EPA’s focus is on compliance with FIFRA and its associated regulat ions 1374

and requirements. Consequently, the focus of the WPS training provision concerning reporting of 1375

violations refers to pesticide use violations (including WPS violations). 1376

Comments on “take home exposure” training . One commenter wrote at length about 1377

“ protection from pesticide take home exposure,” stating that current training already addresses the 1378

risks of pesticide residues on clothes, and this awareness could be augmented quite simply by updating 1379Page 32 of 176 current training materials. It does not warrant the at tention paid to it within the preamble . The 1380

commenter expressed concern that the tone and information provided by EPA to justify this action 1381

undermines the great strides that have been made in product safety, labeling and application. 1382

EPA Response. The e xisting point in the training informs workers and handlers to remove and 1383

wash their clothes to protect themselves from exposure to pesticide residues. The additional training 1384

point emphasizes that there are risks to worker’s families from these residues, a nd provides information 1385

on how to reduce those exposures. EPA agrees that updates to the training are necessary. 1386

Comments on handler training . One commenter recommended that NIOSH and OSHA be 1387

involved with EPA’s review of training material. They ask if t he employer can rely on outside trainers to 1388

provide the respirator training, or have these agencies approve materials. 1389

EPA R esponse . The training requirements of the WPS for handlers wearing respirators must 1390

conform to 29 CFR 1910.134. EPA plans to work with NIOSH and OSHA on the development of training 1391

material related to respirators. The final rule requires employers to ensure proper respirator training 1392

conforming to 29 CFR 1910.134 is provided for handlers required to wear a respirator ; it does not 1393

prohibit the employer from using outside trainers to provide the required respirator training. 1394

E. Exception to Full Pesticide Safety Training for Workers Prior to Entry into Treated Areas (Grace Period). 1395

1. Current rule and proposal. Except in regard to workers entering treated areas during an REI, 1396

the existing WPS permits the agricultural employer to delay providing full pesticide safety training until 1397

the end of the fifth day after the worker’s entry into a treated area, often called the “g race period,” 1398

provided that the worker receives training in a basic set of two safety points before entering the treated 1399

area (i.e., an area that has been treated or where an REI has been in effect within the last 30 days). 1400

Under this exception, the worker must receive the full safety training on the content outlined in the rule 1401

prior to the sixth day of entry into a treated area. EPA proposed to shorten the “grace period” to two 1402

days, require that full training take place before the third day of entry into a treated area, and expand 1403

the basic set of safety information to be provided prior to the worker’s first entry into a treated area 1404

under the “grace period.” 1405

2. Final rule. EPA has eliminated the “grace period” entirely. The final rule requires employer s to 1406

ensure that workers receive full pesticide safety training before entering a treated area (i.e., an area 1407

that has been treated or where an REI has been in effect within the last 30 days). 1408

3. Comments and responses. 1409

Comments. Few commenters support ed the proposed two day grace period coupled with the 1410

expanded basic safety points prior to first entry. Many agricultural producer organizations and the SBA 1411

Office of Advocacy requested that EPA retain the five day grace period in the existing rule, stati ng it is 1412

needed for flexibility in scheduling training sessions as workers arrive at various times on the 1413

establishment. Many farmworker advocacy organizations and two states recommended elimination of 1414

the grace period entirely. Several commenters recomme nded, as an alternative, adoption of the two 1415

day grace period with reduced material relative to the propos ed training required prior to first entry, 1416

because the brief training seemed onerous. Farmworker advocacy organizations that supported the 1417

elimination of the grace period cited the importance of workers having full safety information prior to 1418

entering an area with pesticide residues. One state that supported the elimination of the grace period 1419

expressed concern that this change would heighten concerns a bout the number of qualified trainers in 1420

the event that EPA would follow through on its proposal to make certified applicators ineligible to train 1421

workers. 1422

SBA’s Office of Advocacy stated that small businesses stated that a reduced grace period would 1423

req uire employers to hire workers earlier and increase the per

- hire costs. Other small businesses stated 1424Page 33 of 176 that flexibility is needed around busy schedules and to ensure continuity of operations. 1425

Two commenters from regulatory agencies in states with signific ant agricultural production 1426

stated that their programs do not allow a training grace period; in those states, workers must be trained 1427

before they can enter treated areas. Some commenters indicated that eliminating the grace period 1428

would reduce complexity o f the rule. 1429

EPA Response. While EPA recognizes the flexibility that the grace period offers agricultural 1430

employers in scheduling training sessions for workers, and the economic importance of that flexibility, 1431

EPA remains convinced that the elimination of the grace period is reasonable. The full pesticide safety 1432

training provides information that workers need to have before their exposure to pesticide treated 1433

areas so they can protect themselves. Under OSHA, training must take place at the time of the 1434

emplo yee’s initial assignment. EPA has decided that the cost of eliminating the grace period is 1435

reasonable when compared to the benefit from workers receiving the complete pesticide safety training 1436

before their first exposure to pesticides. 1437

EPA acknowledges c oncerns raised by agricultural producer organizations and state regulatory 1438

agencie s that eliminating the grace period combined with the proposal to limit who is qualified to 1439

conduct worker training could result in an inadequate number of people available t o provide worker 1440

training. The final rule allows certified applicators to continue to be trainers of workers (see Unit V.D.). 1441

As a result, EPA expects that there will be an adequate number of trainers to provide full pesticide safety 1442

training for workers p rior to their entry into treated areas. 1443

F. Training Program Administration Requirements 1444

1. Current rule and proposal. Under the existing WPS, pesticide safety training must be 1445

presented either orally from written materials or in audiovisual format. The information must be 1446

presented in a manner that the worker or handler can understand, and the trainer must respond to 1447

questions, but the existing rule does not require the trainer to be present for the entire training period. 1448

EPA proposed to retain the requ irement to provide training in an oral or audiovisual format, to require 1449

that the trainer remain present throughout the training session, and to require that the training be 1450

presented in a place that is conducive to learning and reasonably free of distract ions. 1451

2. Final rule. EPA has finalized the proposed requirements for the presentation of training. 1452

Trainers of workers and handlers must remain present during training sessions to respond to questions. 1453

The training environment must be conducive to traini ng and be reasonably free of distractions, to help 1454

ensure training quality. The final rule retains the existing requirement for pesticide safety training to be 1455

delivered either orally from written materials or by audiovisual means. 1456

The final regulatory te xt for these requirements is available at 40 CFR 170.401(c)(1) and 1457

170.501(c)(1). 1458

3. Comments and responses. 1459

Comments on use of videos. Most commenters endorsed the use of videos. Some stated that 1460

they enhance understanding of the material, especially when combined with hands

- on activities or 1461

other kinds of learning approaches. Other farmworker advocacy organizations stated that there is a lack 1462

of interac tion between the trainer and the employees trained using a video, resulting in reduced 1463

information transfer. Agricultural producer organizations and state regulatory agencies supported the 1464

use of the video, citing ease of use and effectiveness. Commenters from each category urged EPA to 1465

update the videos; a few suggested EPA evaluate different media presentations. 1466

One commenter noted that videos are preferred so the workers and handlers can see and hear 1467

the presentation. This commenter mentioned that trai nees preferred having the presenter remain with 1468

the workers to answer questions and manage distractions. 1469Page 34 of 176 Another commenter suggested that trainers use a variety of materials, including the videos, to 1470

train and cited the Food Safety training materials tha t are adapted to field situations and include flip 1471

charts, handouts, and videos. One department of agriculture recommended keeping the video because 1472

employers would not need expertise to provide the training. They suggested having two videos

, one for 1473

entry level and one for more experienced workers. Another state regulatory agency stated that the 1474

video is an essential training tool. 1475

Many other organizations

– growers, pesticide manufacturers, and farm bureaus

– supported 1476

the use of the video for training. 1477

EPA Response. EPA agrees with the commenters who consider videos to be effective and useful 1478

training materials. 1479

EPA intends to update the training videos with information about the final rule requirements. 1480

The revised videos will cover updates to the r ule as well as the existing protections. EPA recognizes that 1481

updated videos are needed for workers and handlers. 1482

Comments on the requirement for trainers to remain present during entire training session. 1483

Farmworker advocacy organizations and another com menter supported the proposal for trainers to 1484

remain present during the entire training, citing the need for them to be interactive with workers to 1485

enhance the training and facilitate discussion. One commenter, experienced in providing pesticide 1486

safety tra ining, noted that the interaction with trainees, through hands

- on training and sharing of 1487

experiences, was effective. Some agricultural producer organizations opposed the requirement, stating 1488

that it would be distracting for the video to be interrupted for questions, and there would be lost time 1489

for the trainer. One commenter suggested it would lead to larger training conferences that would 1490

discourage post

- video interaction. Some states opposed the requirement for the trainer to be present 1491

throughout the tr aining; some recommended that the trainer only needs to be available before and/or 1492

after the training if a video is used. 1493

One pesticide manufacturer organization supported requiring the trainer to remain present 1494

during the training, but other agricultura l industry organizations rejected the concept, stating that it was 1495

burdensome and unnecessary, and that the trainer was only needed at the end or beginning of the 1496

training. 1497

Workers responding to questions from an advocacy organization indicated that having persons 1498

available to answer questions was important. 1499

EPA Response. EPA agrees with the commenters that having trainers present during the entire 1500

training program could facilitate discussion and promote interaction. EPA recognizes that a video is a 1501

passiv e form of training, and has added the requirement for the trainer to be present to answer 1502

questions during the entire session to mitigate this problem. 1503

EPA disagrees that questions from the trainees would be disruptive to the training; responding 1504

to quest ions during the video would facilitate learning. A 2006 study (Burke) cited interactive training 1505

activities as a best practice for supporting training transfer. EPA is convinced that the trainer’s presence 1506

during the video enhances the training by enabling questions and discussion during the presentation

. 1507

Comments on the requirement for the training environment to be relatively free of distractions 1508

and conducive to learning. The commenters were mostly in agreement that the learning environment 1509

needs to hav e minimal distractions and be conducive to learning. Farmworker advocacy organizations 1510

and public health organizations supported the proposed requirement as a way to improve the learning 1511

environment. Two farm bureaus suggested allowing the trainer to be ab sent during the video, and to 1512

have a supervisor present to ensure the quality of the training environment. One state supported the 1513

proposed requirement for the training to be conducted in an environment reasonably free of 1514Page 35 of 176 distractions; another stated that the requirement was not enforceable. Finally, one agricultural 1515

organization described the environment where their workers receive training as taking place either on 1516

or outside their transportation bus or in the field where it is difficult to manage distrac tions, and noted 1517

that the low number of incidents is evidence that the training is effective. 1518

EPA Response. EPA agrees that the requirement for the training environment to be reasonably 1519

free from distractions and conducive to training would make it easier for workers and handlers to 1520

absorb and retain information. As discussed in the previous response, EPA disagrees with comments 1521

requesting that EPA eliminate the requirement for the trainer to be present throughout the training. The 1522

proposal and final rule establish requirements for the training location; the ultimate responsibility for 1523

ensuring the requirements are met rests with the employer. EPA recognizes that there are challenges in 1524

locating environments in agriculture that are quiet and present few dis tractions; classrooms are rarely 1525

convenient. However, EPA is requiring employers to provide a training environment that is reasonably 1526

free from distractions and conducive to training. EPA notes that the final rule does not prohibit 1527

providing training in an y specific location, such as outdoors or on a bus, as long as the environment is 1528

reasonably free from distraction and conducive to training. 1529

Other comments on training administration. Commenters from a state regulatory agency and 1530

farmworker advocacy organ ization suggested that the trainings should be in the language of the workers 1531

and/or handlers. 1532

EPA Response . EPA agrees that, ideally, trainers would provide training in the language of the 1533

workers or handlers. Agricultural workers and handlers speak man y languages, and employers may not 1534

have ready access to trainers with skills in multiple languages. The WPS requires that the training be 1535

provided in a manner that the worker or handler can understand, which allows flexibility for the trainer 1536

to use graphi cs, gestures, and examples to describe a point. The concepts from the training are 1537

relatively simple and can be communicated with the use of a narrated video or pictorial flipchart, along 1538

with demonstrations by the attending trainer. 1539

G. Require Employer s to Provide Establishment

- Specific Information to Workers and Handlers 1540

1. Current rule and proposal. The existing WPS does not clearly require employers to provide to 1541

workers and handlers establishment

- specific information on the location of decontaminat ion supplies or 1542

hazard information as part of their pesticide safety training. EPA proposed that in addition to required 1543

pesticide safety training, employers must provide workers and handlers with establishment

- specific 1544

information about the location of de contamination supplies and pesticide safety and hazard 1545

information, as well as how to obtain medical assistance. EPA proposed that agricultural and handler 1546

employers would be required to provide this establishment

- specific information to all workers and 1547

ha ndlers, including those previously trained on other establishments. 1548

2. Final rule. EPA has finalized the proposed requirement for employers to provide 1549

establishment

- specific information to workers and handlers. The final rule requires employers to 1550

provid e establishment

- specific information for workers and handlers when they enter the establishment 1551

and before beginning WPS tasks in areas where within the last 30 days a product requiring compliance 1552

with the WPS has been applied or an REI has been in effect. Content for the establishment

- specific 1553

information includes the location of the pesticide safety information, the location of pesticide 1554

application and hazard information, and the location of decontamination supplies. Employers are 1555

required to provide thi s information in a manner that the worker or handler can understand, such as 1556

through a translator, and prior to the worker or handler performing activities covered by the WPS. 1557

Lastly, this information is required even if the employer can verify that the wo rker or handler has 1558

already received the general pesticide safety training on another establishment, because the 1559Page 36 of 176 information required is specific to each establishment. The final regulatory text for these requirements 1560

is available at 40 CFR 170.403 and 170 .503(b). 1561

3. Comments and responses. 1562

Comments. Most commenters supported the addition of the establishment

- specific training, 1563

with some noting that it is currently being provided voluntarily. One farmworker advocacy organization 1564

commented that the inform ation would help workers access decontamination supplies and safety and 1565

hazard information quickly, even workers trained at other establishments. 1566

Some farm bureaus, a grower organization, and a state pesticide regulatory agency noted that 1567

employers already provide the information, and another farm bureau stated that the requirement is 1568

reasonable. 1569

One grower organization requested clarification on whether the statement in the preamble 1570

about “how to obtain emergency medical assistance” refers to emergency nu mbers on the safety 1571

poster. 1572

Two farmworker advocacy organizations responded to a question in the preamble, that asked if 1573

there are any issues related to the requirement that the information be provided in a manner the 1574

worker or handler understands. These farmworker advocacy organizations replied that the information 1575

needs to be in the worker’s or handler’s “mother tongue.” Similarly, another farmworker advocacy 1576

organization stated that the requirement must establish that the information be provided in a l anguage 1577

all workers can understand fluently; it must be delivered at an appropriate literacy level and in a 1578

culturally appropriate manner. Additionally, the commenter stated that the content must include 1579

information about buffers in the fields. 1580

One comme nter expressed concern that the training has to be EPA

- approved and must be 1581

presented in a manner the worker can understand such as through a translator, and that this could 1582

increase costs. 1583

One state regulatory agency stated that this requirement should be deleted, because the 1584

provision does not specifically address protection of workers, is not germane, and therefore should not 1585

be included in this rule. A commenter representing agricultural industry stated that employers must 1586

provide workers with information on restricted sites. 1587

EPA Response. EPA agrees with the commenters that the establishment

- specific training is 1588

necessary for workers and handlers to know where to find information on the establishment to protect 1589

themselves from pesticides and their potential effects. EPA notes that some of this information is 1590

required under the existing rule. However, EPA is convinced that consolidating the requirements for 1591

establishment

- specific training and co

- locating them with requirements for pesticide safety training will 1592

make them easier for employers to find and comply with, resulting in a higher likelihood that workers 1593

and handlers will receive the necessary information. 1594

One commenter requested clarification of the meaning of the phrase “how to obtain emergency 1595

medical assistance.” To clarify, the establishment

- specific training requirement includes the location of 1596

the safety information display , which provides contact information for emergency medical services. 1597

Once the worker or handler knows where to access the safety information, they can contact emergency 1598

medical assistance. In addition, if a worker or handler may have been exposed or displays symptoms 1599

consistent with pesticide exposure, th eir employer is obligated to provide emergency assistance under 1600

the rule. This point is covered in pesticide safety training. 1601

Two commenters were concerned that the training would have to be EPA

- approved. The 1602

worker training covered under Section 170.40 1 and the handler training under 170.501 must be 1603

approved by EPA, however, the establishment

- specific training is not required to be EPA

- approved. EPA 1604Page 37 of 176 believes the requirements themselves are self

- explanatory. Please refer to 170.403 and 170.503(b) for 1605

the regulatory language. 1606

One of the commenters expressed concern that the information had to be provided in a manner 1607

that the worker or handler can understand, such as through a translator, stating that it could increase 1608

costs. For the information to be us eful it must be provided so the worker or handler can understand it. 1609

However, EPA recognizes that there are many languages spoken by farmworkers and does not require 1610

that the information is provided in those languages. Information may be provided through videos, 1611

illustrations, and gestures in such a way as to be understood by the target audience. 1612

Regarding the comments from farmworker advocacy organizations about the need for the 1613

information to be provided in the language of the worker or handler, EPA a grees that this would be 1614

useful. However, there are many languages spoken by workers and handlers, and the burden on 1615

employers to find translators for this information, in a timely manner, would be too great. Also, the 1616

existing requirement for training to be provided so the employee can understand it has been in the rule 1617

for training for nearly 20 years without significant problem. This, combined with comments from 1618

growers that the information is already being provided, suggests that employees are receivin g the 1619

information and understanding it. Trainers may rely on videos in the language of the workers or a 1620

flipchart to share information. 1621

Regarding the comment about presenting the infor mation in a culturally appropriate way and at 1622

a literacy level that co uld be understood by the employee

, EPA expects that the location of the 1623

decontamination supplies, the safety poster, and the hazard information is not likely to be provided in a 1624

manner that would be inappropriate or difficult to understand. 1625

Regarding the comment about the employer providing information about buffers in the field

, 1626

EPA believes the commenter was referring to the application exclusion zone (previously the entry 1627

restricted area). EPA considered this requirement, but rejected it because under the final rule, it is only a 1628

requirement during the application, the temporal nature of the restriction would limit the usefulness of 1629

the information, and would be difficult to convey accurately. Finally, the annual safety training includes 1630

information on restrictions during application, so workers will know to stay away from areas during 1631

treatment. 1632

EPA disagrees with the comment that the establishment

- specific information does not 1633

contribute to worker or handler safety. As commenters have noted, knowin g where to go to 1634

decontaminate, find safety and hazard information, and learn what they were exposed to, can enable 1635

workers and handlers to reduce their exposure, find ways to avoid exposure, and react to an exposure 1636

by contacting an emergency medical faci lity. 1637

VI. Notification 1638

A. Posted Notification Timing and Oral Notification 1639

1. Current rule and proposal . The current WPS requires agricultural employers to notify workers 1640

about pesticide applications and areas on the agricultural establishment subject to an REI. Notification is 1641

required when workers are on the establishment during application or the REI and will pass within one

1642

quarter mile of the treated area. On farms, and in forests and non

- enclosed nurseries (referred to as 1643

“outdoor production” in the proposal) the agricultural employer may choose either to post warning 1644

signs at the usual points of entry around the treated area or to notify workers orally about applications 1645

that will take place on the establishment. In greenhouses and some other enclosed spaces (referred to 1646

as “enclosed space production” in the proposal), the agricultural employer must po st warning signs for 1647

all applications, regardless of the product’s REI. In cases where the product labeling requires both 1648

written and oral notification of workers, the WPS also requires this “double notification.” 1649Page 38 of 176 For outdoor production, EPA proposed req uiring agricultural employers to post warning signs 1650

where the pesticide to be applied has an REI greater than 48 hours, and to allow the option of oral 1651

warning or posted notification for products with an REI of 48 hours or less. For enclosed space 1652

producti on, EPA proposed requiring posting of warning signs only when the product applied has an REI 1653

greater than four hours, and to allow the option of oral warning or posted notification for products with 1654

an REI of four hours or less. 1655

2. Final rule . EPA has fin alized the proposed requirements to post warning signs for all “outdoor 1656

production” when a product with an REI longer than 48 hours is used, and to allow either oral or posted 1657

warnings for “enclosed space production” when a product with an REI of 4 hours o r less is used. The 1658

final regulatory text for these requirements is available at 40 CFR 170.409(a)(1)(ii)

- (v). The final rule 1659

modifies the existing requirement for employers to take down posted warning signs within three days of 1660

the expiration of the REI b y prohibiting worker entry into the area until the posted warning signs have 1661

been removed (except for early entry pursuant to 40 CFR 170.603). The final regulatory text for this 1662

prohibition is available at 40 CFR 170.409(b). 1663

3. Comments and responses. 1664

C omments in support of proposal

. Many states and some farmworker advocacy organizations 1665

and public health organizations supported the notification requirements as proposed. They noted the 1666

potential benefit to workers and employees of crop advisors of manda tory posting for the most toxic 1667

pesticides. They agreed with EPA’s assessment that additional posting would provide added protection 1668

for workers while placing a minimal burden on employers. 1669

Comments opposed to the proposal

. Several grower associations an d farm bureaus supported 1670

the proposed change in notification requirements for indoor production but opposed the proposal for 1671

additional posting for outdoor production. They noted that signs can be destroyed, removed, or 1672

relocated and that agricultural prod ucers may not return to some fields more than once per week. One 1673

grower association specifically requested that EPA clarify how enforcement would address these 1674

challenges

. Another grower association highlighted the need for clarity on how to comply with 1675

notification rules for products with multiple, activity

- based REIs. One grower association also stated 1676

that workers are fully capable of understanding oral notification and suggest focusing instead on 1677

reinforcing the existing oral notification. One indust ry association objected to the proposal on the 1678

grounds that the changes did not recognize existing practices and improvements in training, 1679

recordkeeping, supervision and other protections since the WPS was initially implemented. This 1680

commenter also noted that posting for REIs is further complicated by the additional requirement to post 1681

“no entry” buffers during application. Several grower associations stated that the proposal lacked data 1682

to support the need for increased posting or for why certain REIs we re selected over others, and that 1683

EPA underestimated the cost of field posting. 1684

Comments suggesting alternatives to the proposal

. Several farmworker advocacy organizations, 1685

health organizations, individual farmworkers and one state regulatory agency sugge sted requiring both 1686

posting signs and providing oral warnings for all pesticide applications, or at a minimum for those 1687

pesticides with an REI of 12 hours or more. Some farmworker advocacy organizations suggested 1688

mandatory posting of any treated area subje ct to an REI greater than 24 hours, and others requested 1689

that EPA require mandatory posting of any treated area subject to an REI. They reiterated EPA’s 1690

rationale that oral notification of pesticide application information is difficult to recall over multi ple 1691

days, that oral notification may not be clearly communicated due to multiple language barriers and that 1692

it is difficult to verify whether oral notification was in fact given. 1693Page 39 of 176 EPA Response . EPA considered the comments submitted and remains convinced tha t increasing 1694

workers' awareness of treated areas through additional posting will lead to an overall reduction in 1695

occupational pesticide

- related illnesses at reasonable cost. Because of the nature of pesticide exposure, 1696

the possible latency of effects, and the underreporting of pesticide incidents, it is difficult to find precise 1697

estimates of the benefits of the WPS changes. EPA took great care to not underestimate the costs of the 1698

WPS changes, and is confident that the estimates in the Economic Analysis ar e reliable. 1699

EPA disagrees with commenters that assert oral notification alone would provide sufficient 1700

notification to workers. As noted in the proposal for this rule ( Ref. 2, see reference number 41), research 1701

has shown that oral instruction alone may not be an effective method of safety instruction. Because 1702

workers face challenges with literacy and understanding English, EPA believes that reducing the reliance 1703

on spoken messages and increasing reliance on a clear, graphic, posted warning would better p rotect 1704

workers from the risks of mistakenly entering a treated area before the REI expires. The most recent 1705

public data set available from the DOL ’s NAWS (2011

- 2012)

, which shows a majority (69%) of all survey 1706

respondents speak Spanish as their primary lan guage and approximately 65% speak little or no English 1707

(Ref. 5), supports the need for visual reminders to reinforce oral warnings. 1708

EPA acknowledges that compliance with the posting requirement for outdoor production could 1709

require some establishments to change their business practices or monitor posted fields more often. 1710

However, the commenter’s concern about additional requirements to post “no entry” buffers during 1711

application is based on a misunderstanding. The only additional field posting required un der this rule is 1712

when a product with an REI longer than 48 hours is used in outdoor production. Posting requirements 1713

for greenhouses have been reduced. 1714

While EPA recognizes industry improvements in training and supervision, and other efforts to 1715

protect wor kers from improperly entering fields during an REI, these efforts are not required and can 1716

vary significantly in quality from employer to employer. In addition, the preamble to the proposed rule 1717

cites two studies that support the need for additional field posting ( Ref. 2, see references numbered 11 1718

and 60 ). EPA continues to believe that occupational illnesses related to improper entry into treated 1719

fields can be reduced by more robust posting of treated areas. 1720

Enforcement of the Federal WPS is generally t he responsibility of state, tribal or territorial 1721

pesticide regulatory agencies. EPA will develop compliance monitoring strategies and guidance for the 1722

responsible enforcement agencies. In addition, EPA will develop and disseminate guidance for the 1723

regula ted community on how to interpret and comply with the rule. 1724

EPA considered additional posting requirements presented by farmworker advocacy 1725

organizations and was not convinced that the increased cost to employers to post all treated areas, or to 1726

post area s treated with products with REIs of 12 hours or greater or 24 hours or greater would result in 1727

significantly more protections than the requirement to post areas treated with products with an REI 1728

longer than 48 hours. EPA concluded that it is reasonable to expect workers to remember oral warnings 1729

regarding REIs for two work days, or about 48 hours total

, and to require employers to provide visual 1730

reminders for longer periods for the more hazardous pesticides. 1731

B. Revise Content of Warning Sign 1732

1. Current rule and proposal . The existing WPS requires agricultural employers to post warning 1733

signs with the words “DANGER,” “PELIGRO,” “PESTICIDES” and “PESTICIDAS,” at the top of the sign, and 1734

the words “KEEP OUT” and “NO ENTRE” at the bottom of the sign. A circle containing an upraised hand 1735

on the left and a stern face on the right must be near the center of the sign. EPA proposed replacing 1736

“KEEP OUT” and “NO ENTRE” with “Entry Restricted” and “Entrada Restringida,” and changing the shape 1737

containing the face and h and to an octagon (similar to a stop sign). 1738Page 40 of 176 2. Final rule

. EPA has decided not to change the text or graphic of the existing warning sign. The 1739

final regulatory text for the warning sign content is available at 40 CFR 170.409(b)(2). 1740

3. Comments and responses. 1741

Comments . Two state pesticide regulatory agencie s and several grower organizations supported 1742

the proposed changes on the grounds that "Entry Restricted" would be less confusing to workers than 1743

“KEEP OUT,” since entry is allowed under certain ci rcumstances. Many more state regulatory agencies 1744

and supporting organizations, grower associations, farmworker advocacy organizations, and public 1745

health organizations opposed changing the existing warning sign. Those commenters asserted that 1746

“KEEP OUT” sen ds a much clearer message than “Entry Restricted,” particularly to people with lower 1747

levels of literacy. They noted that the term “Entrada Restringida” is not common in Spanish, which is the 1748

first language of the majority of farmworkers in the U.S., wherea s “KEEP OUT” is simple and well 1749

understood even by people who do not speak or read English. Commenters pointed to standard 1750

readability test results confirming that “KEEP OUT” is easily understood by most six

- year

- olds, while 1751

“Entry Restricted” is placed at the grade 12

- 13 reading level and would be beyond the reading and 1752

comprehension level of the majority of farmworkers in the U.S. 1753

A number of states commented that the existing sign is sufficient. They noted that although 1754

“Entry Restricted” is more accur ate, it would be a costly change for growers that may lead to confusion 1755

and not be more protective than the language on the existing warning sign. States also commented that 1756

20 years of training and experience with the current sign is what makes it effecti ve for keeping workers 1757

out of fields under an REI. The state regulatory agencies and farmworker advocacy organizations agreed 1758

that for the predominantly low

- literacy population of farmworkers, a simpler message, along with 1759

training on the message, is more protective than the proposed wording for the warning sign. 1760

EPA Response . EPA was persuaded that the proposed changes to the warning sign would be 1761

costly for employers and not increase protections for workers as much as expected. A significant factor 1762

in EP A’s decision was the additional information presented in public comments regarding the potential 1763

lack of understanding of the term “Entrada Restringida.” EPA was convinced that eliminating the existing 1764

language, “KEEP OUT,” in favor of a technically more a ccurate sign would be less protective for the 1765

majority of workers. The goal of the warning sign is to keep workers out of areas that are treated with 1766

certain pesticides. Entry into these areas is prohibited while the REI is in effect with a few narrow 1767

exce ptions. Workers that are directed to enter treated areas under an REI and/or areas where the 1768

warning sign is posted must have received pesticide safety training, be provided additional protections, 1769

and be informed that their entry is subject to the limitat ions established for early entry exceptions in the 1770

regulation. Because EPA expects that the majority of workers would never enter treated areas during an 1771

REI, because 20 years of training and experience have familiarized workers with the message and intent 1772

of the sign, and because EPA has added additional training and protection for early

- entry workers 1773

entering treated areas while an REI is in effect, EPA agrees with commenters that the easily understood 1774

message of “KEEP OUT” is most appropriate. 1775

C. Warni ng Sign Location Revisions 1776

1. Current rule and proposal

. Under the existing rule, when signs are required for applications in 1777

outdoor production, they “shall be visible from all usual points of worker entry to the treated area, 1778

including at least each access road, each border with any labor camp adjacent to the treated area, and 1779

each footpath and other walking route that enters the treated area.” EPA proposed maintaining the 1780

existing posting requirement for outdoor production and clarifying the language to require posting be 1781

visible from “each border with any wor ker housing area within 100 feet of the treated area,” rather than 1782

“labor camps adjacent to the treated area.” 1783Page 41 of 176 2. Final rule . EPA has finalized the proposed changes to the warning sign location requirements 1784

for outdoor production. The final regulatory te xt for this requirement is available at 40 CFR 1785

170.409(b)(3)(ii). 1786

3. Comments and responses. 1787

Comments . Several state pesticide regulatory agencie s, grower organizations, and farmworker 1788

advocacy organizations supported the proposal and agreed that it wou ld support EPA’s goal of 1789

increasing clarity of the rule and enhance the ability of employers to understand their responsibilities 1790

under the regulation. Commenters in support of the change noted that “adjacent” is a vague term that 1791

may be interpreted differ ently by different people and that “labor camp” is too limited and does not 1792

technically include worker housing. They noted that clearer posting requirements could lead to better 1793

compliance and thus be a better system for keeping people living in close prox imity to treated fields 1794

safe. 1795

Some pesticide manufacturers opposed the proposal on the grounds that it is an overly 1796

prescriptive, costly, and unnecessary provision which would not provide additional protection above 1797

that already provided by the label and existing WPS. 1798

A public health organization proposed adding pesticide application information and REIs to the 1799

posting requirement near worker housing areas. One state regulatory agency suggested revising the 1800

language by stating “Each border with any worke r housing area provided by this 1801

establishment/employer within 100 feet of the treated area.” 1802

Several industry associations commented on the timing of the required posting. They noted 1803

that requiring signs to be posted prior to but no earlier than 24 hours before the scheduled application 1804

could be complicated by inclement weather, equipment malfunctions, or other unforeseen conditions 1805

that could delay a planned pesticide application. These commenters requested an exemption be written 1806

into the regulation for such delays. Another industry association objected to the requirement that 1807

“under no circumstances shall the signs remain posted and uncovered when worker entry is permitted.” 1808

They contend that employers want to remove signs as soon as possible to allow reentry and the timing 1809

provision could lead to technical violations without additional protections. 1810

EPA Response . EPA was not persuaded by the comments that the revised posting location 1811

requirement would be a significant additional burden on employers. T he requirement only clarifies 1812

where employers need to post warning signs but does not increase posting requirements beyond what 1813

was intended in the existing regulation. EPA agrees with commenters who noted that increased clarity 1814

on posting requirements wil l lead to better compliance and increase awareness of treated fields by 1815

workers who live near treated areas. 1816

EPA acknowledges that scheduled pesticide applications can be delayed by many factors. EPA 1817

considered allowing the warning signs to be posted afte r an application is complete but decided the risk 1818

of entry during applications, as well as confusion over when an application is complete, necessitated 1819

posting prior to an application. EPA did not establish an exemption that would allow warning signs to b e 1820

posted more than 24 hours in advance because of the continuing belief that the meaning of warning 1821

signs is diminished if they are posted well before the hazard exists. If inclement weather or other 1822

factors postpone an application, the regulation do es al low the signs to be covered rather than entirely 1823

removed. 1824

EPA agrees with the industry association commenter that employers will want to remove 1825

warning signs as soon as possible to allow reentry. While the three

- day standard for removal remains, 1826

the rule a lso has an exemption for signs to remain posted after the restricted

- entry interval has expired 1827

as long as certain conditions are met. 1828Page 42 of 176 VII. Hazard Communication 1829

A. Hazard Information

– Location and Accessibility 1830

1. Current rule and proposal. The existing WPS requires employers to display certain information 1831

about pesticide applications at a central location on the establishment when workers or handlers are 1832

present and an application of a pesticide requiring compliance with the WPS has been made or an REI 1833

has been in effect within the past 30 days (referred to as the “central display” requirement). 1834

EPA proposed to replace the existing requirement for the application information to be located 1835

at the central display with a requirement for employers to make the application information and 1836

additional hazard information accessible upon request by workers, handlers or their authorized 1837

representatives. 1838

2. Final rule . EPA has decided not to finalize the proposal. The final rule generally retains the 1839

existing requi rement related to the location of, and accessibility for workers and handlers to, the 1840

pesticide application information, makes some changes to the content of the required information, 1841

requires the display of hazard information, and includes the accessibili ty requirements proposed for 1842

workers, handlers, and their designated representatives (“authorized representatives” in the proposal). 1843

The employer must display the information at a place on the establishment where workers or handlers 1844

are likely to pass by (the “central display”). The information must be displayed when workers or 1845

handlers are on the establishment and an application of a WPS

- covered pesticide has been made or an 1846

REI has been in effect within the past 30 days. After this time, the information must be kept on the 1847

establishment for two years and made available to workers, handlers, or their designated 1848

representatives or any treating medical personnel. The final rule contains more specificity than the 1849

proposal, particularly in reference to the des ignated representative, where details are drawn from 1850

OSHA’s rule at 29 CFR 1910 (Ref. 17). 1851

The designated representative must provide written evidence of such designation, including the 1852

name of the worker or handler being represented, a description of the specific information being 1853

requested, including dates of employment of the employee, the dates for which the records are 1854

requested, the type of work conducted by the worker or handler during that period, a statement 1855

indicating that the representative is de signated by the worker or handler, the specific application and/or 1856

hazard information requested, a statement designating the representative to request the information 1857

on the worker’s or handler’s behalf, the date of the designation, and the printed name an d contact 1858

information for the designated representative. If the information is to be sent to the requester, 1859

direction for where that information must be sent is to be included. When the employer is presented a 1860

request that contains all of the necessary in formation specified in the regulations, the employer must 1861

provide a copy of, or access to, all of the requested information that is applicable within 15 working days 1862

from the receipt of the request. Failure to respond to the request would be a violation of the rule. The 1863

final regulatory text for this requirement is available at 40 CFR 170.311(b)(9). 1864

Workers and handlers who worked on the establishment may request, orally or in writing, the 1865

pesticide

- specific information retained by the employer. The info rmation must have been displayed 1866

while the worker or handler worked on the establishment. The employer must provide access to, or a 1867

copy of, the information within 15 days of the request. The regulatory text for this requirement is 1868

available at 40 CFR 17 0.311(b)(7). 1869

Under the requirements to provide records to workers, handlers, and designated 1870

representatives, EPA also added language similar to that found in OSHA regulations (see 29 CFR 1871

1910.1020(e)(1)(v)) to ensure that whenever a record has been previou sly provided without cost to a 1872

worker, handler, or their designated representative, the agricultural employer may charge reasonable, 1873Page 43 of 176 non

- discriminatory administrative costs (i.e., search and copying expenses but not including overhead 1874

expenses) for a reque st by the worker or handler for additional copies of the same record. 1875

Medical personnel or persons acting under their supervision may also request the pesticide

1876

specific information required to be retained in 170.311(b)( 6 ) to inform diagnosis or treatment of 1877

workers or handlers who were employed on the establishment during the time the information was 1878

required to be displayed. The request may be provided orally or in writing to the agricultural employer, 1879

and the employer m ust respond promptly to the request. The regulatory text for this requirement is 1880

available at 40 CFR 170.311(b)(8 ). 1881

Lastly, the final rule makes some changes to the content of the required pesticide application 1882

information and when it must be posted, as explained in Units VII.C. and VII.D. The final regulatory text 1883

for this requirement is available at 40 CFR 170.311(b). 1884

3. Comments and responses. 1885

Comments . The overwhelming majority of commenters requested that EPA keep the existing 1886

central display requi rement. Many comments from farmworker advocacy organizations, academic 1887

institutions, public health organizations, states, unions, a pesticide retailer association, many citizens 1888

and some members of Congress noted that they thought it was unreasonable, unre alistic and naïve to 1889

think a vulnerable population such as workers and handlers would request hazard information from 1890

their employers. These commenters cited many reasons for this position, including barriers (e.g., 1891

language differences, concern about comp romising their immigration status, intimidation, and fear of 1892

retribution, retaliation or job loss) and the power and social dynamics between employer and employee. 1893

One state remarked that their experience was workers simply do not want to draw attention t o 1894

themselves for fear of discrimination. These commenters were adamant that workers and handlers 1895

needed ready, anonymous, unhampered access to hazard information as currently provided through the 1896

central display requirement. Farmworkers themselves, in let ters and surveys, revealed that they would 1897

not feel comfortable asking the employer for information. These farmworkers insisted that employers 1898

would ignore such a request, reprimand them for halting work, or reply that the information is only for 1899

“those s praying

, ” and order them to resume working. One citizen in support of the central display 1900

requirement pointed out that no one should assume that farmworkers are aware of the dangers posed 1901

by exposure to pesticides or pesticide residues. Many commenters f rom farmworker advocacy groups, 1902

state regulatory agencies and a union noted that one benefit of keeping the requirement is that 1903

employers are already mostly complying with it, it is well accepted by the agricultural community, and 1904

workers expect to find th e information there. 1905

To improve accessibility to information, one state, a public health organization and a 1906

farmworker advocacy group suggested requiring that the displayed information include cell phone scan 1907

codes linked to pesticide use records and SDS s . A professional organization of trainers and educators 1908

suggested setting up an online site for agricultural employers to post and maintain information specific 1909

to their operation, thereby making the information available by cell phone and Internet acces s. 1910

However, one state regulatory agency has observed a problem with a system whereby pesticide 1911

application information that was called or texted into a recording system was checked once a day, 1912

resulting in the posting of incorrect information. Commenters also offered suggestions on 1913

nontraditional ways of complying with the central display requirement. For example, one state 1914

regulatory agency suggested putting the information in a binder in a work area while a public health 1915

organization suggested the use of a hard plastic sleeve to protect the information from weathering. A 1916

farmworker advocacy group suggested posting a leaflet at the worksite identifying the location of SDSs 1917

and pesticide application records, while another noted that it has seen the infor mation displayed near 1918Page 44 of 176 bathrooms, hand washing stations and time clocks at nurseries or greenhouses. 1919

State regulatory agencies requested that EPA stratify the central display requirement, but did 1920

not elaborate how. One state wanted the display requirement limited to work hours, because of their 1921

experience with nighttime vandalism of central displays. 1922

Many commenters supported the inclusion of a designated representative who could request 1923

the hazard information on behalf of a worker or handler, as long as the central display requirement was 1924

also kept. Farmworker advocacy organizations, public health organizations, unions and citizens cited 1925

OSHA’s requirements at 29 CFR 1910.1020(e)(1) that require access to exposure records for workers in 1926

other industries. Comments in support of including access to hazard information by workers’ or 1927

handlers’ designated representatives note that workers and handlers may be reluctant to request the 1928

information for themselves due to their inability to communicate effectively with, or fear of, their 1929

employer, or because they may not be able to understand the information without help. Many 1930

commenters repeated the need to access information for early diagnosis and treatment. However, 1931

commenters also discussed the benefits of h aving the information in non

- emergency situations. 1932

Specifically, having the information would allow health care providers to assess risk, educate workers, 1933

and offer preventative care to patients who are workers. Along the same lines, two public health 1934

or ganizations thought access would be helpful for incident reporting and differential diagnosis. One 1935

farmworker advocacy organization pointed to their need for information so they can knowledgeably 1936

respond during pesticide safety training to farmworkers’ qu estions about the health effects of pesticides 1937

where they work. One comment described a situation where a farmworker advocacy organization 1938

requested such information from an employer on behalf of two ill workers, but their request was denied 1939

because the w orkers themselves did not make the request. One commodity association was in support 1940

of a provision for a designated representative. One farmworker advocacy group wanted collective 1941

bargaining agents to be able to obtain records as well as designated repr esentatives. A citizen noted 1942

that a family of a worker could also need or want access to the information. 1943

In contrast, there was significant opposition from many state regulatory agencies, farm bureaus

, 1944

the SBA Office of Advocacy and the agricultural in dustry in general to the proposal for the designated 1945

representative, including growers, pesticide manufacturers, and their organizations. Comments from 1946

these groups centered on the additional burden on employers to provide the records. Many 1947

commenters als o expressed concerns that allowing access to pesticide application information by 1948

designated representatives could be abused by anti

- pesticide organizations and others, who could send 1949

people onto the establishment requesting information purportedly on beha lf of a worker or handler. 1950

One farm bureau described a hypothetical situation, and gave examples of legal challenges to, and 1951

alleged harassment of, farmers by persons purporting to be worker advocates. To alleviate this concern, 1952

it was suggested by at lea st one commodity organization and one farm bureau that the designated 1953

representative be restricted to someone already associated with the farming operation, such as a 1954

foreman. 1955

There was concern expressed by commenters of the privacy of information. Some farm bureaus 1956

stated that the requirement for providing the information to a representative is a violation of farmer’s 1957

legal and privacy rights, stating that the representative could demand all information related to 1958

pesticides on that establishment. In on e state, a yearlong debate centered around whether or not to 1959

keep pesticide application information confidential. Ultimately, the state’s solution was to enhance the 1960

pesticide use information gathered by the USDA’s National Agricultural Statistics Service and still 1961

maintain the anonymity of pesticide users. 1962

Some commenters pointed out that the WPS already requires under the “emergency assistance 1963Page 45 of 176 provisions” that employers provide promptly upon request to workers, handlers or treating medical 1964

personnel, i nformation on the pesticide to which a person may have been exposed, treatment 1965

information, how the pesticide was used and circumstance s of possible exposure. One state regulatory 1966

agency suggested that EPA use USDA’s provision for making pesticide applica tor records of restricted 1967

pesticide use available to certified or licensed health care professionals, or those acting under their 1968

direction, for the treatment of any individual who may have been exposed to a n RUP . The USDA 1969

regulation ( 7 U

. S

. C

. 136i

- 1 ) als o requires that the information be made available immediately in case of 1970

a medical emergency. 1971

One association of state regulatory agencies objected because of the time and administrative 1972

burden to themselves and to agricultural employers. Another state re gulatory agency was concerned 1973

that a requirement to provide information upon request and during normal work hours meant that the 1974

agricultural employer would have to be chained to their office in case someone were to appear with a 1975

request. According to sev eral grower organizations, unless EPA requires that all records be kept in one 1976

physical location agricultural employers may need to respond more than once to a single request since 1977

various records could be kept in various places on an establishment. One s tate was concerned that if 1978

the agricultural employer were to make the information available orally or electronically, there would be 1979

no record of compliance. 1980

Some state regulatory agencies and other commenters provided recommendations to improve 1981

the proposed requirement for a designated representative. Suggested improvements included limiting 1982

the designated representative requirement to current workers and handlers or to employees who 1983

worked on the e stablishment within two years of the request, limiting access to medical personnel only, 1984

or limiting the request to a specific acute incident. Many state regulatory agencies, a farmworker 1985

advocacy organization and others recommended that the request be in written form

, on paper or 1986

electronically, and include designation of the representative by the worker or handler. One state 1987

recommended defining a time frame for provision of the information to the requester. Another state 1988

suggested that the request clea rly identify the information required to be provided to the designated 1989

representative, and the purpose of the request or intended use of the information. State regulatory 1990

agencies were concerned about the ambiguity of the requirement to fulfill a request for information no 1991

later than the end of the day of the request . A few farmworker advocacy organizations expressed 1992

concern that there was no requirement to provide information to the designated representative for 1993

free. They maintained that the information should be provided at no cost, as is the case with a similar 1994

OSHA requirement. 1995

Many of the commenters in favor of keeping the existing central display requirement explained 1996

that a central display requirement that provides information about general pesti cide safety, including 1997

symptoms of pesticide illness and the specific pesticides used on the establishment, is necessary to 1998

protect the health of workers and handlers. First, having information available in non

- emergency 1999

situations could help workers and h andlers be aware of symptoms before they occur, help them avoid 2000

exposure, and possibly enhance the reporting of illnesses. Secondly, they stated that emergency medical 2001

personnel would not have to lose critical time tracking down information instead of trea ting the ill or 2002

injured person if they could rely on accessing the information quickly from the central display. As 2003

expressed by one municipality required to post similar kinds of information, employers’ convenience 2004

should not outweigh the employees’ righ t to have the information available to them. One farmworker 2005

advocacy organization argued that a lack of current information at central displays is attributable to a 2006

lack of compliance and not problems with the requirement itself. 2007

EPA also received comme nts from one pesticide manufacturer organization, a couple of states 2008Page 46 of 176 and some farm bureaus in favor of the proposal to eliminate the existing requirement for a central 2009

display of pesticide application information. These commenters agreed with EPA’s observa tions in the 2010

preamble to the proposal that this requirement imposes a paperwork burden and that states often cite 2011

employers for technical violations of the display requirement. The commenters stated it is difficult to 2012

keep the displayed information current when application plans change, especially on large 2013

establishments. They also noted the difficulty keeping information legible when it is displayed at a 2014

central location subject to weather conditions. These commenters encouraged EPA to eliminate the 2015

existi ng central display requirement, not to finalize the proposed requirement to provide hazard 2016

communication information to workers, handlers, or their designated representative, and to require 2017

employers to only keep records of pesticide applications on their establishment. 2018

EPA Response . EPA agrees with those commenters who argued that workers and handlers must 2019

have relatively unhindered access to pesticide

- specific information, and has decided to retain the central 2020

display requirement. Although the extent an d type of barriers and employer

- employee dynamics are 2021

unique to each situation, EPA recognizes that a significant number of workers and handlers face 2022

disadvantages that can reasonably be expected to make them hesitant to ask their employers for 2023

information relating to their pesticide exposure. As stated by commenters, agricultural employers are 2024

accustomed to complying with the requirement and workers and handlers already know to find the 2025

information at the central location. EPA recognizes that it is an env ironmental justice issue and that 2026

removing the requirement would be taking a step backwards. Consequently, EPA believes that it is not 2027

reasonable to make it more difficult for an employee to obtain this information, particularly given the 2028

potential useful ness of the information if an employee may have been harmed by a pesticide. 2029

Therefore, EPA has decided to retain the requirement for the pesticide application information to be 2030

displayed at a place on the establishment where workers and handlers are likel y to pass by or 2031

congregate and has added the requirement that the SDS must also be displayed at that location. 2032

In the final rule, workers and handlers, their designated representative and any treating medical 2033

personnel may request either a copy of or acce ss to the pesticide

- specific information that was required 2034

to be displayed while the worker or handler was employed on the establishment. The records of 2035

application and SDSs must be retained for two years after the date of expiration of the REI applicable to 2036

the pesticide application. Access to the SDSs after the display period will afford workers and handlers 2037

information about the pesticides they may have been exposed to, and the hazards they may present. 2038

EPA recognizes, however, that there can be diffic ulties in complying with the central display 2039

requirement. In response to comments about the difficulty of keeping accurate information posted, EPA 2040

simplif ied the central display requirement by changing the required time frame for posting the 2041

application

- sp ecific information from before the application to within 24 hours of the end of the 2042

application. (Unit VII.D

. ) EPA expects this modification to the requirement for the timing to post the 2043

application information will reduce the burden on employers, while p roviding employees with ready 2044

access to accurate information. In response to the comments about the difficulty of maintaining a 2045

legible central display when it is subject to weather conditions, EPA notes that the central display 2046

requirement does not mandat e how or where employers post the information. Rather, the information 2047

must be displayed “where workers and handlers are likely to pass by and congregate and where it can 2048

be readily seen and read” and workers and handlers must be able to access the inform ation at all times 2049

during work hours. This does not preclude the central display from being maintained in a location 2050

sheltered from weather conditions, such as a bathroom, break area, or changing area, as long as the 2051

requirements of this section are met. Nor does it preclude the information from being displayed in a 2052

hard plastic holder or binder. In addition, the requirement for a “central” display does not limit the 2053Page 47 of 176 employer to only one location on the establishment. If workers and handlers are unlikely to congregate 2054

in one place on the establishment, there may be several locations but all of the same information must 2055

be present, accessible during work hour s and be readily seen and read. Lastly, agricultural employers 2056

may provide the information through electronic means (e.g., texts, scan codes, Internet sites), but they 2057

must also display paper copies of the application information and SDS since workers and handlers may 2058

not have regular, dependable Internet access or cellphone coverage. 2059

EPA has been co nvinced by comments in support of retain ing the option for a designated 2060

representative to access hazard information (application information and SDS) on behalf of a worker or 2061

handler. EPA agrees that including in the rule a requirement, based on OSHA’s rul e at 29 CFR 1910.1020, 2062

for employers to provide the information to a representative who has been designated to act on the 2063

behalf of the worker or handler would give workers and handlers more access to information related to 2064

pesticides used in their workpla ce. Also, EPA is aware that California and Texas regulations include 2065

requirements for employee representatives’ to be given access to hazard information for farmworkers, 2066

and comments from the Texas Department of Agriculture encouraged EPA to require the d esignation in 2067

writing and to limit access to records to the retention timeframe of two years. EPA is unaware of issues 2068

related to worker representatives having access to hazard information on behalf of workers in those 2069

states. Under this provision, worke rs and handlers may also request the information directly from the 2070

agricultural employer, either orally or in writing. 2071

In response to the many comments opposing the establishment of the authorized or designated 2072

representative based on concerns for the po tential for anti

- chemical activists fraudulently acquiring 2073

records, the final rule includes a requirement for the representative to provide to the employer 2074

documentation (written authorization) signed by the worker or handler that clearly designates that 2075

p erson to act as his or her designated representative. The information that can be obtained is limited to 2076

the application and hazard information that is required by § 170.311(b) of the final rule that was 2077

required to be displayed while the worker or handler was on the establishment, and for the dates 2078

applicable to the worker’s or handler’s dates of employment on the establishment. The employer must 2079

provide the information regardless of the worker’s or handler’s employment status on that 2080

establishment at the time of the request. 2081

Although the existing WPS requires that agricultural employers provide the pesticide application 2082

information under the emergency assistance provision, the difference is that the information can be 2083

accessed before an emergency. Medica l professionals may request the information if they suspect a 2084

chronic exposure, for example. A designated representative may request the information to be able to 2085

translate it for a worker, handler or a family member

, o r, as one commenter emphasized, to b e able to 2086

knowledgeably answer workers’ and handlers’ information about exposure during pesticide safety 2087

training. These situations would not qualify for access to the information under the emergency 2088

assistance provision. 2089

EPA was convinced by comments about the need for the pesticide specific information by 2090

medical personnel treating workers or handlers who may have been exposed to pesticides on the 2091

establishment, and has added a requirement that employers promptly provide the information to the 2092

request ing medical personnel or persons they supervise. The request may be made orally or in writing, 2093

but in either case the information that must be provided to medical personnel is the same set that must 2094

be provided to an employee or a designated representativ e. The information would help ensure that 2095

the medical considerations would include the possibility that a pesticide exposure was involved in the 2096

worker’s or handler’s illness. 2097

B. Pesticide

- Specific Hazard Communication Materials

– General 2098Page 48 of 176 1. Current ru le and proposal. The existing WPS requires employers to provide workers and 2099

handlers with specific pesticide application information, but not pesticide

- specific hazard information

, 2100

on the pesticides they may be exposed to in the workplace. 2101

EPA proposed t o require employers to provide workers and handlers with access to the SDSs 2102

and pesticide labeling for products that have been applied on the establishment and to which workers 2103

and handlers may be exposed, in addition to the pesticide application informati on already required to 2104

be made available. 2105

2. Final rule. EPA has finalized the requirement for agricultural employers to display at a central 2106

location pesticide application information and SDSs for pesticide products used on the establishment 2107

(referred to as “pesticide application and hazard information” in the final rule). The same information 2108

must be kept as records for two years from end date of the REI, and provided to designated 2109

representatives, workers and handlers, and medical personnel upon request. EPA has not finalized the 2110

proposal to require employer s to provide access to pesticide labeling. The final regulatory text for this 2111

requirement is available at 40 CFR 170.311(b). 2112

3. Comments and responses. 2113

Comments on providing safety data sheets and pesticide labeling. EPA received many comments 2114

from farmw orkers, farmworker advocacy organizations, unions, public health organizations, academics, 2115

citizens, a grower organization and a few state regulatory agencies in support of providing information 2116

on pesticide

- specific health effects to workers and handlers. Most were in favor of providing both the 2117

label and SDS. However, many commenters focused their comments on the SDSs because of their 2118

information on the health effects of pesticides. It was asserted that migrant clinicians lack farm

- specific 2119

information for pesticides, and that SDSs would help them make correct and early diagnosis for the 2120

treatment of pesticide

- related illnesses. One point expressed repeatedly in letters from and surveys of 2121

farmworkers, as well as supported by many farmworker advocacy or ganizations, was the desire of 2122

farmworkers to have specific information on what is used, what they are exposed to, and potential 2123

effects. Many farmworkers believe that agricultural employers don’t care about their health, and insist 2124

that employers need to make employee/farmworker health a priority. One farmworker advocacy 2125

organization argued the worth of providing the information if it has any possibility of helping workers 2126

recognize symptoms of exposure and to seek timely medical care. Research by one academic 2127

institution described the positive results of providing pesticide

- specific hazard information to 2128

farmworkers. First without the information, farmworkers often rely on lay knowledge and sensory 2129

perception that can often be dangerous and misleading , such as assuming that no odor means no risk. 2130

Second, there is a positive correlation between farmworkers’ access and receipt of health and safety 2131

information and their safety behavior (e.g., hand washing). Along the same lines, one state regulatory 2132

agen cy supports the belief that well

- informed people are able to make better decisions. Furthermore, 2133

according to a couple of farmworker advocacy organizations, providing such information would make 2134

farmworkers feel more vested in their work and improve emplo yer

- employee relations. 2135

On the other hand, a few grower organizations, a farm bureau, a pesticide manufacturer 2136

organization and a couple of states were against a requirement to provide labeling and SDSs. These 2137

commenters argued that EPA had not made a case strong enough to justify a need. An association of 2138

pesticide manufacturers questioned the utility of requiring SDSs when labels or label information can 2139

already be requested through the existing emergen cy assistance provision. At least one grower 2140

organization thought it would only create confusion for agricultural employers to obtain and provide 2141

SDSs since it is redundant with the OSHA Hazard Communication Standard. One state thought SDSs 2142

were too comp lex and confusing for farmworkers, and using them could result in unintended 2143Page 49 of 176 consequences. Because of the complexity, employers who are not usually qualified to teach could feel 2144

obligated to train workers on the health effects of pesticides. One commodit y organization was 2145

concerned that the information would be unduly alarming to workers without the proper context. One 2146

grower organization said they witnessed workers claiming illness based on the power of suggestion 2147

inherent in health effect information, r ather than an actual exposure. They fear misdiagnoses since 2148

symptoms of a foodborne illness, heat stress and the flu are similar to a pesticide poisoning. They also 2149

opposed display of SDSs on the grounds that while the pesticide product label poses legall y enforceable 2150

requirements on users, SDSs do not. 2151

Some farmworker advocacy organizations, public health organizations, a grower organization, a 2152

farm bureau, an academic institution, unions, a state regulatory agency and others thought it would not 2153

be muc h of a burden on agricultural employers to acquire the SDSs of pesticide products because they 2154

are easily available online or can be requested from the pesticide manufacturer or distributor. One 2155

farmworker advocacy organization gave the Washington State Ha zard Communication rule ( HC rule) as 2156

an example that it is a feasible requirement for employers to make SDSs available to employees. 2157

http://www.lni.wa.gov/IPUB/413

- 012

- 000.pdf. The Washington State HC rule applies to employers with 2158

one or more employees wh o either handle or are potentially exposed to hazardous chemicals, including 2159

pesticides, in their workplace. It requires employers to make SDSs for each chemical that employees 2160

may encounter readily accessible and easily obtained without delay during each work shift, and to 2161

ensure that employees traveling between workplaces during a work shift can immediately obtain the 2162

SDS in an emergency. Several commenters suggested that EPA consider maintaining a repository of 2163

SDSs. 2164

In contrast, a couple of grower as sociations and one state regulatory agency thought it overly 2165

burdensome for agricultural employers to obtain SDSs. One state thought it would be difficult for 2166

employers to locate the correct SDS for pesticide products. They also noted that small businesses that 2167

do not meet the OSHA threshold of 10 employees or more and private applicators would have the most 2168

difficulty since they are not already accustomed to obtaining and keeping SDSs. 2169

EPA received some comments both for and against providing pesticide p roduct labeling. Many 2170

farmworker advocacy groups and an association of pesticide manufacturers supported a requirement 2171

for the employer to provide the labeling. These commenters maintained that workers and handlers 2172

want more information on chemicals to whi ch they may be exposed. One commenter favored providing 2173

the label over the SDS because the label is the culmination of regulatory testing and specifies the use of 2174

the product so as to mitigate risks to workers, handlers and applicators, and provides envir onmental 2175

safety information for the pesticide and its use on crops. 2176

On the other hand, farm bureaus, growers and grower organizations and states opposed a 2177

requirement to provide the labeling. These commenters expressed concern that EPA is expanding its 2178

m andate by requiring agricultural employers to provide the product “labeling” when it should be limited 2179

only to the WPS portions of the “label .” They also were concerned that an agricultural employer could 2180

easily violate this requirement by not having the m ost current or correct version of the labeling, such as 2181

a specimen or technical label. They argued that workers and others could look up the label based on 2182

application

- specific information contained in the pesticide application record. 2183

EPA Response. Af ter consideration of the comments, EPA remains convinced that access to SDSs 2184

offers significant health and safety benefits to workers and handlers. SDSs contain information that is 2185

not generally included in pesticide labeling regarding chronic, development al, and reproductive toxicity 2186

that can be valuable to exposed and potentially exposed workers, and to medical personnel and others 2187

who provide treatment to an ill or injured person. Moreover, given the ubiquity of chemicals subject to 2188Page 50 of 176 the OSHA Hazard Commu nication Standard that mandates the development and distribution of SDSs, it 2189

is likely that many health care professionals are more familiar with SDSs than pesticide labeling. 2190

Requiring the SDS as part of the central display facilitates a quicker identific ation of the pesticide 2191

product used in case of an incident and may assist in diagnosis. The SDS contains information about 2192

symptoms expected in a person exposed to the chemical (immediate, delayed and chronic effects) as 2193

well as recommended treatment, wher eas the label may not include detailed information on symptoms 2194

or treatment. EPA recognizes that state pesticide regulatory agencies do not review, approve, or take 2195

enforcement action based on the information in SDSs. However, comments from farmworker advo cates 2196

indicate that workers and handlers want to have more information on health effects, which is available 2197

on SDSs and generally not available on the pesticide labeling. OSHA is requiring that all SDSs be in a 2198

standard format, making it easier to locate health information (Ref. 17). Accordingly, EPA concludes that 2199

a requirement to display and make available SDSs is an effective way to communicate pesticide hazard 2200

information important to workers and handlers. EPA notes that under the final rule workers an d 2201

handlers will learn during pesticide safety training about SDSs, the information they contain, and their 2202

availability at central display locations. This addition to the training will further reinforce workers’ and 2203

handlers’ awareness and potential use of SDSs. 2204

EPA is persuaded that access to SDSs is not a significant obstacle to requiring agricultural 2205

employers to keep and display SDS s for pesticide products used on the establishment. Agricultural 2206

employers can obtain SDSs from the distributor of the pe sticide, online, or upon request from the 2207

product manufacturer. For example, employers in industries other than agriculture

– including retailers 2208

and wholesalers of agricultural chemicals

- are required by the OSHA Hazard Communication Standard 2209

to make ava ilable SDSs to their employees. 2210

Upon consideration of the comments, EPA has decided not to require agricultural employers 2211

include the pesticide product label or labeling as part of the central display requirement. EPA recognizes 2212

the burden on employers to provide both the SDS and label or labeling in addition to the pesticide 2213

application information. As noted previously , the SDS contains the health

- related information requested 2214

in comments by worker advocates, and that would be most useful to persons providing treatment to 2215

those who may have been exposed to pesticides. EPA agrees that if necessary, the labeling for a product 2216

used for a specific application can be located using the application

- specific information th at employers 2217

are also required to post. 2218

Comments on the extent of the requirement. EPA received comments both to narrow and to 2219

expand the scope of the proposal requiring employers to maintain SDSs and make them available to 2220

employees . At least one assoc iation of pesticide manufacturers, a grower association and a few state 2221

regulatory agencies thought the existing hazard communication requirements were sufficient. Among 2222

the suggestions to narrow the scope of the proposal, one state and one academic insti tution wanted 2223

EPA to keep a central repository of SDSs for agricultural employers to access. Another suggestion was to 2224

require employers to keep the SDS only while the associated pesticide product remains on the 2225

establishment. Farmworker advocacy organiza tions, public health organizations, and one academic 2226

institution recommended expanding the proposed requirement to a full Hazard Communication (HC) 2227

Standard as required by the Washington State HC for all hazardous chemicals, which requires employers 2228

to dev elop a written Hazard Communication program, maintain availability and access to SDSs, provide 2229

information and training on hazards in the workplace, translate certain documents upon request, and 2230

keep and provide access to exposure records for at least 30 y ears. The academic institution explained 2231

that employers could be more committed to having a more effective hazard communication program if 2232

they had to put in writing. Furthermore, a written program would also serve as verification of 2233Page 51 of 176 compliance for enforc ement staff. One suggestion from a farmworker advocacy organization was to 2234

form a safety committee in each workplace to review and provide SDSs and other materials to workers. 2235

The safety committee would include farmworkers, thus offering them an opportun ity to be leaders at 2236

the work site. 2237

Many farmworker advocacy organizations, farmworkers, citizens and one academic institution 2238

suggested EPA require that SDSs be available in the workers’ native language and provided examples of 2239

similar requirements. Fir st, one farmworker advocacy organization cited the Migrant and Seasonal 2240

Agricultural Worker Protection Act (29 U.S.C. 1801, et seq .) , administered by the DOL, which requires 2241

written information on the terms of employment to be provided in English, Spanish or other language 2242

common to workers . One farmworker advocacy organization noted that employers are required by the 2243

Department of Labor to provide to workers in a language they understand information on wages and 2244

working conditions, and that vital health i nformation such as pesticide application records should 2245

therefore be treated the same way. Along the same lines, one academic institution explained it is an 2246

environmental justice issue not to make the information available in their native language. 2247

Furth ermore, one state regulatory agency thought it worthless to provide any information only in 2248

English. 2249

Many farmworker advocacy organizations, unions, citizens, academics, public health and 2250

organizations commenters argued there is a minimal burden to transl ating SDSs. According to a 2251

farmworker advocacy organization, the translation cost would be small compared to the benefits of a 2252

more informed workforce and safer workplace. As one union pointed out, the burden to translate SDSs 2253

would not be on the farmers , but on pesticide manufacturers who have the resources to do so 2254

efficiently. Many gave the Washington state requirement as an example that it is feasible. In 2255

Washington state, agricultural employers are required to provide translated documents if reques ted. 2256

Farmworker advocacy organizations asserted that it would be easy to translate SDSs because of the 2257

standard format required by OSHA’s adoption of the Globally Harmonized System of Classification and 2258

Labeling of Chemicals. To address the complexity of i nformation in SDSs, however, one academic 2259

institution suggested they be rewritten at the reading level of pesticide handlers. There was also 2260

opposition to mandatory translation of SDSs. One pesticide manufacturer organization was against 2261

translating the SDS because of cost and the many languages used by agricultural workers. 2262

EPA Response. After reviewing the comments, EPA has decided on an approach that will provide 2263

workers and handlers with more information about the potential health effects associated with the 2264

pesticides to which they may be exposed without overly burdening agricultural employers. Obtaining 2265

the SDSs for products used on the establishment should not be overly burdensome to employers; SDSs 2266

are available from pesticide dealers and the I nt ernet. An EPA

- managed repository of the SDSs of all WPS 2267

pesticides would not significantly improve access and would be a significant burden for EPA because of 2268

the number of pesticides used in agriculture. Stakeholders such as grower organizations are free to 2269

voluntarily develop SDS repositories with assistance from members. Voluntary programs of this sort 2270

would involve limited subsets of all WPS

- scope pesticide products and could possibly be accomplished 2271

within a short period in comparison to a national, fu ll

- scale repository program. 2272

EPA disagrees with commenters’ request to adopt a full hazard communication proposal as 2273

req uired by the Washington State HC for all hazardous chemicals. The full set of the WPS requirements 2274

in the final rule provide protection s similar to those provided to workers in other industries under 2275

OSHA’s Hazard Communication Standard, while recognizing differences between agriculture and other 2276

industries. As discussed in the Agency’s 1992 proposed rule on the Worker Protection Standard ; Hazard 2277

Information (Ref. 18), in response to numerous concerns about potential overlap or conflict between 2278Page 52 of 176 EPA’s July 1988 propos ed WPS ( Ref. 18 ) and OSHA’s August 1988 proposed Hazard Communications 2279

Standard ( Ref. 19 ), EPA committed to work with OSHA to minimize confusion and avoid duplication 2280

between the two agencies’ requirements. Rather than require agricultural establishments that may not 2281

routinely use the same pesticides to develop and maintain a written Hazard Communication Standard 2282

plan listing al l chemicals that will be used in the workplace, EPA’s approach, in both the 1992 proposed 2283

rule on Hazard Information ( Ref. 20) and this final rule, has been to identify generally applicable 2284

requirements, tailored to fit the context of pesticide use in agri cultural production that serve a purpose 2285

similar to the Hazard Communication Standard requirements in other industries. These requirements 2286

include pesticide safety training, display of basic pesticide safety information, notification or posting of 2287

treated areas, and access to information about pesticides used in the workplace at a central location. 2288

EPA notes that the WPS does not exempt employers with 10 or fewer employees, unlike OSHA’s Hazard 2289

Communication Standard , and that the cost of a developing and i mplementing a full hazard 2290

communication program specific to each establishment could be burdensome to small agricultural 2291

establishments. 2292

Lastly, although EPA is not requiring that SDSs be translated at this time, EPA encourages and 2293

supports employers to display this information in such a way that workers and handlers can understand, 2294

including translation. EPA is open to conferring with stakeholders on the need for translation and 2295

identifying content to be translated, if necessary. EPA notes that some pes ticide manufacturers already 2296

make pesticide product SDSs available in Spanish and EPA encourages employers to display Spanish SDSs 2297

where available and appropriate

. 2298

Comments on other forms of hazard communications materials . Many farmworker advoca cy 2299

organizations, public health organizations, unions, academics, citizens and a couple of state regulatory 2300

agencies suggested EPA develop and provide crop sheets, booklets, or other types of materials that 2301

describe the health effects of pesticides, either in lieu of or in addition to the SDS. These commenters 2302

identified a need for a pictorial booklet that was culturally appropriate and designed for low

- literacy 2303

audiences on the health effects from exposure to pesticides, based on the information in SDSs. One 2304

state suggested that a small booklet with basic pesticide exposure symptoms by classes of chemicals or 2305

modes of action, described in layman’s terms would be more helpful to workers than SDSs . Many 2306

commenters cited a study in Oregon as support for crop she ets, and gave experiences of California and 2307

Texas as examples that crop sheets are feasible. The Oregon study claimed to have shown reductions in 2308

pesticide exposure of farmworkers who received enhanced pesticide safety training in their native 2309

languages. The enhanced training included a crop booklet in the workers’ native language with short 2310

and long term health effects of pesticides used in the nursery industry. A couple of farmworker 2311

advocacy organizations described an increase in interest and engagemen t by farmworkers when shown 2312

sample crop sheets during pesticide safety training. 2313

Commenters gave EPA suggestions. For example, EPA should develop and provide electronic 2314

templates for crop sheets, and provide them at training and under PlexiGlas ® boxes at field 2315

decontamination sites. 2316

Several commenters agreed with EPA’s decision not to require crop sheets. One pesticide 2317

manufacturer organization and one commodity association opposed the development of crop sheets, 2318

mostly because the benefits do not j ustify the cost. 2319

EPA Response. EPA does not agree with commenters’ request to require crop sheets or similar 2320

materials because, in EPA’s judgment, the benefits of such a requirement would not justify the 2321

substantial costs associated with creating, updati ng, translating and distributing materials for every 2322

crop, growing region, and WPS

- scope pesticide product. As noted in the proposal for this rule, crop 2323Page 53 of 176 sheets and other types of material have been developed in the past, with very limited success. For 2324

exam ple, one state’s crop sheet program proved to be expensive and labor intensive, and the crop 2325

sheets were left as litter in the fields, unused. 2326

SDSs already contain information about the potential health effects (acute, delayed, and 2327

chronic) associated wit h use of pesticide products and will be readily available in a uniform format, 2328

including provide hazard information in words and in pictograms

. Pesticide safety training and the 2329

pesticide information display provide workers and handlers with information on the symptoms that may 2330

be associated with exposure to the specific pesticides they may have had contact with . If workers or 2331

handlers need information about the specific effects of a pesticide with which they have worked, they 2332

can consult the SDS. 2333

Comment s on inconsistencies in information between labels and SDSs

. A pesticide manufacturer 2334

organization opposed any requirement by EPA to provide SDSs to worker and handlers upon request. 2335

This commenter expressed concern about the confusion that may be caused b y inconsistencies between 2336

pesticide labels and SDSs. OSHA requires manufacturers to use GHS terms and chemical classification 2337

criteria on SDSs whereas EPA does not require their use on pesticide product labels. As a result, SDSs 2338

and pesticide product label s could have different hazard statements, pictograms and signal words. 2339

EPA Response . EPA has not finalized the proposed requirement for the employer to make 2340

available pesticide product labeling upon request. Instead, the final rule requires the employer to 2341

display only pesticide application information and SDSs for pesticide products used on the 2342

establishment. The SDS provides succinct information about the known health hazards of the product 2343

that typically is not presented as part of the product label or labeling. Such information can be 2344

invaluable to medical professionals for the diagnosis and treatment of certain pesticide

- related illnesses 2345

and injuries. Because EPA is not requiring the employer to display the labeling, EPA does not expect 2346

issues with a perception of conflict between labeling and SDSs. The persons who wear PPE and have 2347

access to the label are pesticide handlers who receive more thorough training than workers. If pesticide 2348

handlers encounter conflicting information on labeling and SDSs, s uch as the PPE identified, they should 2349

know they must follow the instructions on the pesticide labeling, as they are trained to do. For 2350

information on OSHA’s adoption of the Globally Harmonized System of Classification and Labeling of 2351

Chemicals for SDSs an d the pesticide product labeling, see EPA’s Pesticide Registration (PR) Notice 2012

- 2352

1, Material Safety Data Sheets as Pesticide Labeling ( http://www2.epa.gov/sites/production/files/2014

- 2353

04/documents/pr2012

- 1.pdf ). 2354

C. Pesticide Application Information

– Con tent of Pesticide Application Information 2355

1. Current rule and proposal. In the existing WPS, the agricultural employer must record and 2356

display the following information about each pesticide application: The location and description of the 2357

area to be treat ed, the product name, EPA registration number and active ingredient(s) of the pesticide 2358

product, time and date the pesticide is to be applied, and REI for the pesticide. 2359

EPA proposed to require the agricultural employer to record and make available, in a ddition to 2360

the information required in the existing regulation: The specific crop or site treated, the start and end 2361

dates and times of the application, and the end date and duration of the REI. 2362

2. Final rule. EPA has finalized the proposed requirements f or the contents of pesticide 2363

application information, with one change. The final rule requires agricultural employers to record and 2364

display the following pesticide application information: Product name, EPA registration number, and 2365

active ingredient(s) of the pesticide product applied; the crop or site treated and the location and 2366

description of the treated area; the date(s) and times the application started and ended; and the 2367

duration of the REI. The final rule does not require the employer to record the e nd date of the REI. The 2368Page 54 of 176 final regulatory text for this requirement is available at 40 CFR 170.311(b)(1)(ii)

- (v). 2369

The agricultural employer must record and display the information about the crop or site 2370

treated and the location of the treated area. EPA en courages employers to display the information in 2371

such a way that workers and handlers can understand and distinguish each treated area from all other 2372

areas on the establishment; in some cases, a map or diagram may be appropriate. 2373

EPA encourages and supports the display of application information so it is most useful to 2374

workers and handlers on the establishment. One such option is to separate the information about 2375

treated areas, so those areas where an REI is in effect are distinct from those where the REI has expired, 2376

allowing the viewer to more quickly identify areas where entry is restricted. Similarly, maps highlighting 2377

areas where an REI is in effect and those where the REI has expired could also present the information in 2378

a use r friendly, pictorial manner. EPA also sees an opportunity for employers to provide information of 2379

this nature through texting and other electronic means to their employees, and encourages such 2380

communication, in addition to the requirement for maintaining this information as part of the central 2381

display. 2382

3. Comments and responses. 2383

Comments. Many farmworker advocacy organizations, a few state regulatory agencies, a farm 2384

bureau, an academic institution, a grower organization, a union and others supported the proposed 2385

expansion of the content requirement for pesticide application information re cords. According to these 2386

commenters, it would be a small burden to require additional application information, such as crops 2387

treated, that could help workers proactively avoid exposure to pesticides. Many farmworker advocacy 2388

organizations insisted that th e additional information would have been helpful to state regulatory 2389

agency investigations and for the ability of workers and their families to keep themselves safe. A few 2390

state regulatory agencies agreed that the additional information is essential for e nforcement, and one 2391

remarked that their state already required this information. According to a public health organization, 2392

the agricultural employer already has the information so there would be no additional burden. The 2393

information would assist workers in proactively avoiding exposure as well as health care providers when 2394

evaluating and determining treatment for non

- emergency exposure. One state regulatory agency asked 2395

EPA to parallel the information required by USDA to avoid confusion for the applicato r, agricultural 2396

employer and state enforcement personnel, while another suggested that more information be required 2397

in addition to the information proposed to assist state pesticide regulatory personnel in determining 2398

compliance. Along the same lines, a u nion wanted EPA to add all of the ingredients and the Chemical 2399

Access Service registry number to the records. Lastly, many commenters including citizens, farmworker 2400

advocacy organizations and unions also wanted the pesticide application information writte n, and/or 2401

orally communicated, to workers in their native language. A few states, two farmworker advocacy 2402

organizations and other commenters suggested various combinations of records limited to three or 2403

fewer pieces of information. 2404

Several farm bureaus, a pesticide retail association, one grower organization and several states 2405

opposed any changes. These commenters asserted that the content required by the existing regulation 2406

is already too burdensome and amply fulfills the need. Many of these same commen ters opposed EPA’s 2407

proposed expansion of the content of records stating that EPA had not justified it with quantifiable 2408

benefits. These commenters suggested that EPA’s expansion of content was merely for additional 2409

enforcement actions, with little to no be nefit to the health and safety of workers. Furthermore, another 2410

grower organization pointed out that workers will receive oral and posted notification before entering a 2411

treated area. One grower organization argued that only a record of the active ingredi ent is needed for 2412

medical treatment. Lastly, these commenters maintained that recordkeeping of general use pesticide 2413Page 55 of 176 applications is not required by law, the proposed requirement is duplicative of state and federal 2414

requirements, and commercial applicators already keep records. 2415

EPA Response . EPA agrees with the comments that adding more information to application 2416

records is a small burden compared to the benefits of determining compliance and giving workers and 2417

handlers information to verify the location o f treated areas. The crop or site treated, start and end times 2418

and date(s) of the application, and duration of the REI are important for protecting worker and handlers 2419

and useful for determining compliance, for health care provider evaluations and treatmen t options, and 2420

for workers and handlers to take preventative protection against exposure. Although workers and 2421

handlers will see warning signs and/or be notified orally of treated areas, the application

- specific 2422

information will not be available to them u nder those specific provisions. The final rule requires that 2423

certain application

- specific information for the treated area for which the workers will be conducting 2424

early

- entry tasks must be communicated orally to early

- entry workers in a manner they can u nderstand. 2425

Workers and handlers will be able to see the application information at the central display while the REI 2426

is in effect and for 30 days thereafter (or until workers and handlers are no longer on the establishment, 2427

if that is less than 30 days), and by requesting a copy during the two year recordkeeping period. Being 2428

able to see and review the information allows for a better informed workforce which, in conjunction 2429

with the other provisions, helps workers and handlers take preventative measures ag ainst exposure. 2430

Workers and handlers who know what they have been exposed to and when, and are aware of the 2431

potential symptoms and treatment

, are more likely to recognize when they need medical care, and are 2432

better equipped to provide their relevant histo ries to health care providers who have to choose a 2433

treatment option. 2434

Agricultural employers, compliance officers, workers, handlers and others will be able to 2435

calculate the end date and time of the REI by having the end date and time of the application and the 2436

duration of the REI included in the pesticide application information. The combined information will also 2437

help workers and handlers identify the areas where an REI is in effect. EPA did not propose requiring 2438

more information because the proposed co ntent of application records fits the needs of stakeholders to 2439

determine compliance and to give workers and handlers the ability to discern which area had been 2440

treated. An arbitrary limit of only three or fewer pieces of information may not achieve the sa me 2441

benefits. 2442

EPA is not requiring agricultural employers to translate or interpret the pesticide application 2443

information into the native language of workers. Although the translated information would provide 2444

significant benefits, the burden of translatio n would be significantly higher than providing the 2445

information in English, and it is not clear that the benefits would be so much greater than the 2446

requirement to provide the information in English. EPA anticipates that the new requirement allowing 2447

designat ed representatives access to the application

- specific information will help convey that 2448

information to workers and handlers who do not understand English. Also, it appears that some SDSs 2449

are already being provided in Spanish, and perhaps other languages, as well as English, which may 2450

benefit many employees. Lastly, the lack of a requirement does not preclude voluntary translations and 2451

interpretations by farmworker advocacy organizations or agricultural employers. 2452

The WPS requires agricultural employers t o maintain records because those records provide 2453

information that is important for the protection of their employees. While a significant number of 2454

agricultural employers may also be certified as private pesticide applicators, their status as private 2455

appl icators does not exempt them from the WPS recordkeeping required of agricultural employers. The 2456

WPS does not require private applicators to maintain records on account of their status as private 2457

applicators. 2458Page 56 of 176 The risks of concern under the WPS include bo th RUPs and non

- RUPs, while certification 2459

requirements at the federal level, including recordkeeping, only apply to those using RUPs. Neither the 2460

USDA application record requirements for private applicators of RUPs, nor state application record 2461

requirement s for commercial applicators fully cover the information needed under the WPS for the 2462

protection of workers and handlers. The USDA required information does not include the active 2463

ingredients, duration of the REI or the start and end dates and times of ap plications, nor does it apply to 2464

applications of non

- RUP pesticides. Commercial applicators would have to record the information 2465

required by the state pesticide regulatory agency, which must at a minimum include the kinds, amounts, 2466

uses, dates and places o f RUP applications. 40 CFR 171.7(b)(1)(iii)(E). Also, state pesticide regulatory 2467

agencies may or may not require records of non

- RUP applications. Therefore, it is unlikely that all states’ 2468

commercial applicator RUP application records will match exactly th e record requirements of the WPS. 2469

Because the records required to be maintained by USDA and the states do not include all of the 2470

information needed for protection of workers and handlers, it is appropriate to require such 2471

recordkeeping through the WPS. 2472

D. Pesticide Application and Hazard Information

– When Information Must Be Made Available 2473

1. Current rule and proposal. In the existing rule, the agricultural employer must record and 2474

display the pesticide application information before the application takes place, if workers or handlers 2475

are present on the establishment before the application begins. Otherwise, the informa tion must be 2476

recorded and displayed at the beginning of any worker’s or handler’s first work period. If the employer 2477

posts warning signs for a treated area, the pesticide application information must be displayed at the 2478

same time as, or earlier than, the w arning signs. The information must remain on display when workers 2479

are on the establishment and from the time of the application until 30 days after the REI expires or until 2480

30 days after the application end date if the REI is 0 hours (or in the rare instan ce where a label might 2481

not have an REI). 2482

EPA proposed to eliminate the central display requirement and require the agricultural 2483

employer to provide the pesticide application information, the SDS and labeling upon request from a 2484

worker, handler or authori zed (now “designated”) representative during normal work hours, no later 2485

than the end of the day. 2486

2. Final rule. The final rule keeps the central display requirement and requires the agricultural 2487

employer to display the pesticide application information and the SDS (pesticide application and hazard 2488

information) at the central display no later than 24 hours after the application is complete. Also, the 2489

employer must display the pesticide application and hazard information for a treated area before any 2490

worke r is permitted to enter that treated area, and for thirty days after the R EI has expired. If workers 2491

will be in the area, they must be notified of the application before it starts, by posted signs or orally, and 2492

warned not to enter the area. The applicatio n information and SDS must remain posted for 30 days from 2493

the expiration date of the REI or from the application end date if the REI is 0 hours (or in the rare 2494

instance where a label might not have an REI). EPA did not finalize the proposed requirement for the 2495

agricultural employer to make available the pesticide application information and SDS no later than the 2496

end of the day of the application. Instead, the agricultural employer must provide the pesticide 2497

application information and hazard information wit hin 15 days of a written or oral request from a 2498

worker or handler, or a written request from a designated representative. This new requirement is in 2499

addition to the requirement to make exposure information promptly available to treating medical 2500

personnel. The final rule eliminates the existing requirement to display the application information 2501

before or at the same time a warning sign is posted at a treated area. The final regulatory text for this 2502

requirement is available at 40 CFR 170.311(b)(5) and 40 CF R 170.309(l). 2503Page 57 of 176 3. Comments and responses. 2504

Comments. Many farmworker advocacy organizations, citizens, a state regulatory agency and 2505

public health organizations requested that EPA keep the existing requirement to make information 2506

available before the appli cation so workers and handlers would be able to connect symptoms to an 2507

application if the exposure occurred during the application. While many farmworker advocacy groups 2508

supported the display of information before an application, some expressed concern abo ut the accuracy 2509

of the pesticide application information displayed when the application changed from what was planned 2510

and the displayed information was not updated. 2511

On the other hand, many comments from a pesticide manufacturer association, several farm 2512

b ureaus, and many state regulatory agencies, commodity organizations and applicator organizations 2513

requested more time for the agricultural employer to post the information at the central display. They 2514

also requested an enforceable time period for posting t he information and providing it to designated 2515

representatives, workers, and handlers. Several farm bureaus, an academic institution, and one 2516

pesticide manufacturer organization requested that EPA require employers to make the information 2517

available after t he application. An academic institution noted that it is difficult for agricultural 2518

employers

, who often hire commercial applicators

, to get the information by the end of the day. Several 2519

farm bureaus, many commodity organizations and a pesticide applica tor association wrote about the 2520

complications of providing accurate and timely information when application plans are changed because 2521

of the weather, the unexpected presence of people in the area, or other unforeseen events. Along with 2522

multiple fields at any one establishment and multiple customers over many establishments, these 2523

changes make it difficult for applicators to keep agricultural employers informed of up to date 2524

information. According to a commodity organization and a grower, sometimes records are not 2525

complete until the following day, or need to be verified and corrected. Also, more time helps with 2526

scheduling other field activities around pesticide applications and avoids confusion when posting 2527

multiple schedule changes. Several commodity org anizations pointed out that there are applications 2528

that take place at night and overnight, making it difficult to decide what “the end of the work day” was, 2529

particularly when nobody is present for applications such as smoke or automatic fog. 2530

EPA Respons e . EPA agrees with the commenters that it is important to provide workers and 2531

handlers with accurate information about pesticide applications. Displaying the information after the 2532

application is completed benefits workers and handlers because they can be c onfident the information 2533

is correct, and the employer no longer has to change the information when application plans change. 2534

Under the final rule, EPA expects all displays of pesticide application information will contain accurate 2535

information. The final ru le retains the requirement for workers to receive oral notification, or to see 2536

posted warning signs, or both before an application begins, informing them to stay out of an area before 2537

an application begins. Also, the final rule assists with compliance and enforcement by giving specific 2538

time periods for displaying information at the central location and providing information at the request 2539

of workers, handlers or designated representatives. 2540

E. Pesticide Application and Hazard Information

– Retention of Rec ords 2541

1. Current rule and proposal. The existing WPS requires employers to maintain pesticide 2542

application information at the central display from the time of application until 30 days after the REI 2543

expires. There is no requirement for the employer to retai n the pesticide application information in any 2544

form after that time. 2545

EPA proposed to require employers to retain, for each application of a WPS

- covered pesticide, 2546

the pesticide application information, labeling and SDS, for two years from the date of the end of the REI 2547

for each product applied. 2548Page 58 of 176 2. Final rule. The final rule requires agricultural employers to retain the pesticide application 2549

information and the SDS for the product used (pesticide application and hazard information) for two 2550

years from the date of expiration of the REI applicable to the application conducted. EPA has not 2551

included the proposed requirement for the employer to retain the pesticide labeling in the final rule. 2552

The final regulatory text for this requirement is available at 40 CFR 170.311(b)(6). 2553

3. Comments and responses. 2554

Comments

- timing . EPA received many comments supporting a two

- year recordkeeping 2555

requirement from some state pesticide regulatory agencies, several grower organizations, a few 2556

academic institutions, and a pest icide safety educator association. One of the grower associations 2557

supported EPA’s assertion that two years was sufficient for employees to access records and states to 2558

investigate complaints. An academic institution supported a two

- year recordkeeping requ irement, 2559

stating it would improve the state’s ability to follow

- up on referrals it makes on reported cases of 2560

pesticide exposure. One state pesticide regulatory agency commented that it did not have a need for 2561

the information after one year, but that two years was not much more of a burden. A state regulatory 2562

agency and a grower organization commented that the records should be kept for two years from the 2563

date of application, rather than from when the REI expires. Many commenters requested EPA to require 2564

records to be kept for longer than two years. There was support by an agricultural association and an 2565

applicator for a four

- year recordkeeping period if the minimum age requirement for early entry workers 2566

and handlers was 16 years old. The commenters rea soned that a four

- year requirement would mean 2567

that records would remain available for two years after they turned 18 years old, in the event of a 2568

lawsuit One academic institution and a farmworker advocate endorsed a five

- year requirement to 2569

coincide with the statute of limitations for civil violations as was suggested by EPA. Several farmworker 2570

advocates supported keeping records for seven years, because illnesses may take longer than two years 2571

to develop. These commenters also claimed that seven years w as feasible because it is a requirement in 2572

Washington. An academic association and many farmworker advocates supported a recordkeeping 2573

period of at least 30 years, which is consistent with OSHA’s requirement, in order to help with the 2574

diagnosis of chronic health effects that could be related to pesticide exposure. 2575

Many commenters, including farm bureaus, grower associations, the SBA Office of Advocacy, a 2576

few state pesticide regulatory agencies, a pesticide manufacturer and several agricultural organizat ions 2577

opposed a two

- year recordkeeping requirement. Some commenters opposed any recordkeeping 2578

because they asserted that EPA could not show quantifiable benefits. These commenters argued it 2579

would be a paperwork exercise without health and safety benefits d riven based on the needs of 2580

enforcement. Some other commenters shared these concerns and said that the proposed approach 2581

should be replaced with a minimal, non

- intrusive requirement such as a one

- year time period. One 2582

commenter suggested requiring employe rs to keep records only during the harvest season (crop year). 2583

A grower organization argued that last year’s records have no bearing on worker protection in real time. 2584

Several grower associations thought two years did not make sense, partly because the p lants would no 2585

longer be there. A state regulatory agency recommended limiting recordkeeping to only when the 2586

pesticide product is on the establishment, either in use or available for use. One agricultural association 2587

was concerned that an increase in do cumentation and recordkeeping would force state regulatory 2588

agencies to divert scarce resources from compliance and enforcement to the auditing of records. 2589

EPA Response . EPA has concluded that a two

- year record

- keeping requirement would be helpful 2590

for health diagnoses and investigation purposes. EPA considered requiring the retention of records for 2591

five years and asked state pesticide regulatory agencies about their need s for access to pesticide 2592

application records. These enforcement agencies informed EPA that they rarely need to rely on records 2593Page 59 of 176 beyond the two

- year timeframe. EPA agrees with the commenters who pointed out that two years 2594

allows a reasonable amount of time for follow up by state inspectors because it can take some time for 2595

incidents or cases of potential pesticide exposures to come to the attention of state pesticide regulatory 2596

agencies. In addition, a two year time frame allows time for workers and handler s to obtain the 2597

information if they develop an illness, which they may not associate with pesticide exposure when 2598

symptoms first develop. EPA decided not to extend the recordkeeping period longer than two years to 2599

find a balance between having the records available for a reasonable amount of time and minimizing the 2600

burden on agricultural employers. 2601

Comments

– format of records . A grower organization asserted that agricultural employers 2602

generally keep two sets of records: one at the central location and o ne on file, and therefore would 2603

need to keep both updated. Some commenters, including state pesticide regulatory agencies, applicator 2604

organizations and a farm bureau urged EPA to allow records to be kept electronically to facilitate 2605

compliance and minimiz e costs. The SBA Office of Advocacy commented that it would be difficult and 2606

time

- consuming for small businesses to obtain, print and file SDSs and labeling. They acknowledged, 2607

however, that if EPA allowed electronic recordkeeping it would help alleviat e the burden. A farm 2608

bureau stated that keeping all SDSs and labeling on hand in paper form for two years could take a lot of 2609

storage space and would be difficult to keep up to date , because labels are updated often and 2610

sometimes products are discontinue d. 2611

EPA Response

– format of records . EPA notes that this recordkeeping requirement does not 2612

necessarily impose a duplicative burden on agricultural employers to obtain pesticide application 2613

information and SDSs twice

– once to satisfy the central display requirement and once to satisfy the 2614

recordkeeping requirement. Agricultural employers may satisfy this recordkeeping requirement by the 2615

removal of the pesticide application information and SDS from the central display 31 days from the 2616

expiration of the REI (or from the end of the pesticide application if there is no REI) and retaining those 2617

records for two years from the date of application. EPA recognizes that some employers may choose to 2618

maintain electronic copies of pesticide application records and the product SDS to satisfy both the 2619

central display and recordkeeping requirements . The WPS does not specify that records must be kept on 2620

paper, so an employer can maintain records electronically as long as the employer satisfies all related 2621

requireme nts of the WPS for both provisions

, including keeping the pesticide application and hazard 2622

information display accessible to workers and handlers, and being able to quickly access and provide the 2623

required materials in the event of a pesticide emergency. 2624

V III. Information Exchange Between Handler and Agricultural Employers 2625

1. Current rule and proposal . The existing WPS requires handler and agricultural employers to 2626

exchange information about pesticide applications. When handlers are employed by an employer other 2627

than the agricultural employer, the existing WPS requires the agricultural employer to provide the 2628

handler employer with information about treated areas on the agricultural establishment the handler 2629

may be in (or may walk within one

- quarter mile of) , including specific location and description of any 2630

such areas and restrictions on entering those areas. The existing WPS requires handler employers to 2631

provide agricultural employers with the following information prior to making a pesticide application o n 2632

the agricultural establishment: 2633

• Location and description of the area to be treated. 2634

• Time and date of application. 2635

• Product name, active ingredient(s), and EPA registration number for the product. 2636

• REI for pesticide(s) applied. 2637

• Whether p osted notification, oral notification, or both are required. 2638Page 60 of 176 • Any other product

- specific requirements on the product labeling concerning protection of 2639

workers or other persons during or after application. 2640

The agricultural employer must display informat ion about the applications for workers and 2641

handlers employed by the establishment at the central location. The existing WPS requires handler 2642

employers to inform agricultural employers before the application takes place if there will be changes to 2643

scheduled pesticide applications, such as changes to scheduled pesticide application times, locations, 2644

and subsequent REIs. 2645

In addition to maintaining the current requirements, EPA proposed to require the agricultural 2646

employer to also provide to the handler emplo yer information about the location of “entry

- restricted 2647

areas” on the establishment. EPA also proposed to require the handler employer to communicate to the 2648

agricultural employer the start and end times of pesticide applications and the end date of the REI . EPA 2649

also proposed to relax existing WPS requirements by requiring handler employers to provide 2650

information about any changes to pesticide application plans to the agricultural employer within two 2651

hours of the end of the application rather than before the application. Changes to the estimated 2652

application end time of less than one hour would not require notification. 2653

Finally, in the proposal, EPA unintentionally omitted the provision in the existing WPS that the 2654

agricultural employer need not provide info rmation to the handler employer about treated areas if the 2655

handler will not be in or walk within one

- quarter mile of those treated areas. 2656

2. Final Rule. Information exchange from agricultural employer to handler employer. The final 2657

rule requires the agri cultural employer to notify the handler employer of any treated areas where an REI 2658

is in effect and any restrictions on entering those areas. EPA has not included in the final rule a 2659

requirement for the agricultural employer to communicate to the handler e mployer information about 2660

the location of “entry

- restricted areas” on the establishment because of the changes to the requirement 2661

concerning entry

- restricted areas, as discussed in Unit IX.B. EPA has also revised the final rule to correct 2662

the unintentional omission of the existing rule’s exception that the agricultural employer need not 2663

provide information to the commercial handler employer about treated areas if the handler will not be 2664

in, or walk within one

- quarter mile of those areas. The final regulator y text for these requirements is 2665

available at 40 CFR 170.309(k). 2666

Information exchange from handler employer to agricultural employer. EPA has finalized the 2667

proposal to expand and clarify the information the pesticide handler employer must provide to the 2668

agricultural employer with minor modifications. The final rule does not require the handler employer to 2669

convey the end date of the REI to the agricultural employer. The final regulatory text for these 2670

requirements is available at 40 CFR 170.313(i). 2671

Timing of exchange of information from handler employer to agricultural employer . EPA has 2672

modified the final rule to specify two situations where the handler employer must notify the agricultural 2673

employer of changes to the application information before the appl ication takes place. Changes to the 2674

date(s) and start and estimated end times of application or to the product name, EPA registration 2675

number, and active ingredient(s), must be communicated to the agricultural employer prior to the 2676

application. Updates to any of the other information handler employers are required to exchange must 2677

be provided to the agricultural employer within two hours after completing the application. The final 2678

regulatory text for these requirements is available at 40 CFR 170.313(j). 2679

3 . Comments and responses. 2680

Comments . Many states and a few farmworker advocacy organizations expressed general 2681

support for the proposal to expand the information to be exchanged. These commenters agreed the 2682

additional information would help agricultural employers protect workers, and reduce pesticide

- related 2683Page 61 of 176 illnesses and exposure from drift during applications. Many farm bureaus, states, applicators and 2684

applicator associations and an agricultural organization generally disagreed with the proposed 2685

expansion. Some of these commenters argued t hat the proposed requirements are unrealistic and 2686

impractical given the dynamics and unpredictable factors involved in a farming operation, such as pest 2687

infestations and weather changes. In addition, they argued that the proposal would require multiple 2688

par ties to exchange information, resulting in the potential for miscommunication. Some commenters 2689

also opposed the proposed expansion of information exchange because EPA did not provide 2690

documented justification. Crop consultants, an applicator association and a farm bureau indicated the 2691

proposal is unnecessary because close coordination of information already exists between applicators, 2692

handlers, crop consultants, and growers. Furthermore, they stated that not only are handlers already 2693

required to keep workers out of areas during applications, applications are often scheduled to take place 2694

when workers are absent. A few states, farm bureaus and a crop consultant opposed EPA’s proposal to 2695

add to the information the agricultural employer is required to give the h andler employer. One crop 2696

consultant indicated the information is already on purchase orders or sales agreements between 2697

growers and commercial handlers or their employers. One state requested that EPA omit the application 2698

start time because it is not used to calculate the REI. 2699

EPA’s proposal on the timing to provide notice of a change in application plans elicited many 2700

comments. Many commenters indicated that requiring handler employers to provide information about 2701

any changes to pesticide application pl ans to the agricultural employer within two hours of the end of 2702

the application would be impractical or impossible, and said that such a change would be an 2703

unreasonable burden. One state and several farmworker advocacy organizations endorsed the 2704

requireme nt because of the ease of providing the information in the timeframe by relying on existing 2705

electronic capabilities. One farmworker advocacy organization urged EPA to require that changes be 2706

communicated before the start of the application in order to enab le employers to be able to keep 2707

workers out of the treated area. 2708

To prevent confusion about scheduled and actual start and end times and to avoid 2709

miscommunication, one state suggested that EPA require the handler employer to inform the 2710

agricultural emplo yer of changes at any time on the application day. Two aerial applicators explained 2711

that a two

- hour window for notification of change sounds reasonable on paper, but not in practice. 2712

During long workdays of the busy season, applicators would have to make p hone calls in the middle of 2713

the night and send text messages, usually from the airplane during or in between applications. Also, it 2714

can take more than one day to complete an application because of factors such as the weather, a 2715

change in wind direction, or verifying the presence of bystanders. These situations could require the 2716

handler to give several updates to multiple parties, resulting in a greater chance for errors and 2717

noncompliance. 2718

One commenter requested that EPA require notification of a change w ithin 24 hours from the 2719

end of the actual application, while another advised EPA to require notification if the actual application 2720

completion time is two or more hours later than the scheduled application time. Several farm bureaus, a 2721

pesticide applicator and a crop consultant organization advised EPA to require that changes in 2722

application plans be communicated: Before the scheduled date and times, if the application is going to 2723

be made earlier than expected, or before the end of the REI as scheduled, if th e application is made later 2724

than expected. One aerial applicator stated that if an REI is greater than 24 hours, EPA should require an 2725

information update before the scheduled REI expires or within 24 hours of the scheduled application 2726

time. Another aerial applicator recommended the handler employer and handler give the agricultural 2727

employer a window of estimated start and completion date(s) and time(s). In this situation, the handler 2728Page 62 of 176 would not make the application outside of that window without the approval of the agricultural 2729

employer, who in turn must keep workers out of the area during that time, unless notified of a change in 2730

the application start and completion date(s) and time(s). 2731

Many commenters noted the absence of the existing provision that the agricultural employer 2732

need not provide information to the commercial handler employer if the handler will not be in or walk 2733

within one

- quarter mile of an area that may be treated with a pesticide or under an REI, and noted this 2734

could result in the need to provide excessive, unnecessary information. 2735

EPA Response. The information exchange requirements ensure that agricultural employers and 2736

handler employers have the information they need to comply with the requirements for notifying 2737

workers and handlers of r isks associated with pesticide applications and treated areas (i.e., agricultural 2738

employers are required to notify workers of treated areas and display pesticide application and hazard 2739

information at the central location on the establishment for workers an d handlers to see, and handler 2740

employers must inform their handler employees of treated areas on the agricultural establishment near 2741

where they work). 2742

EPA has been convinced not to adopt the proposed change to expand the information required 2743

to be commun icated by the agricultural employer to the handler employer to include information about 2744

the location of “entry

- restricted areas” on the establishment. Requiring employers to exchange this 2745

information would not be practical given other changes in the rule related to the “entry

- restricted 2746

areas” (replaced by “application exclusion zones” in the final rule) that make the tracking of such areas 2747

infeasible. EPA also agrees that it is not necessary for the handler employer to calculate the end time of 2748

the REI fo r each application and include it in the information conveyed to the agricultural employer. The 2749

requirement to provide this piece of information has been deleted from the final rule. 2750

Most of the other information required to be exchanged by the final rule is already required to 2751

be exchanged by the existing rule, and therefore EPA does not agree that this requirement presents a 2752

substantially increased or unreasonable burden. Agricultural and handler employers are currently 2753

required to exchange information s o agricultural employers may provide notification of application and 2754

treated areas under an REI to workers and handlers. Without this information transfer, accurate and 2755

timely notification would be difficult to achieve, exposing workers and handlers to pot ential exposure to 2756

pesticides. It is critical that the agricultural employer know the start times of applications in order to be 2757

able to notify workers and handlers (when they are on the establishment) so they may avoid treated 2758

areas. EPA recognizes that e xchange of the expanded information may already occur on some 2759

establishments and expects those entities to experience less burden than in situations where such 2760

coordination has not already developed. 2761

EPA recognizes that much of the information required m ay be available on sales agreements 2762

and purchase orders between commercial pesticide handlers and agricultural employers, which will 2763

reduce the burden for employers to gather it; however, without inclusion of the information exchange 2764

requirements in the WP S there is no assurance of timely exchange of all of the necessary information. 2765

EPA considered the range of options suggested for the timing of the information exchange. EPA 2766

found it confusing that many commenters indicated that the proposal requiring ha ndler employers to 2767

provide information about any changes to pesticide application plans to the agricultural employer within 2768

two hours of the end of the application would be impractical or impossible, because the proposal was 2769

actually granting a relaxation of the existing requirements that the handler employer must provide 2770

complete and accurate the information to the agricultural employer before the application takes place 2771

in all cases. The burden of providing updated information within two hours after the a pplication is 2772Page 63 of 176 significantly less than the burden of assuring that the application will be completed without change as 2773

originally communicated. 2774

That so many commenters did not acknowledge that the proposal was granting a relaxation of 2775

the current requiremen ts for some situations indicates widespread misunderstanding of the current 2776

rule’s requirements. Therefore, EPA will focus its outreach efforts during rule implementation to ensure 2777

that the regulated community is aware of the rule’s requirements in this ar ea, and that they understand 2778

the importance of the information exchange requirement in protecting workers and handlers. 2779

However, the comments convinced EPA that the proposed changes regarding information 2780

exchanges between the handler and agricultural employer are important and necessary to 2781

accommodate the unique situations involved in agricultural pesticide applications and to provide the 2782

needed flexibility for the information exchange between the handler and agricultural employers. 2783

Several of the recommendations for notification of application changes from the commercial pesticide 2784

handler employer to the agricultural emplo yer can be accommodated under the final rule. For example, 2785

the applicator and agricultural employer can agree on a window of the estimated start and end times, 2786

with the understanding that the application would be made during that period, unless the two 2787

com municate and agree to a different timeframe. This would allow the agricultural employer to notify 2788

workers of the treatment, keep them from the area, and create and post the application information, 2789

satisfying the requirement. 2790

EPA did not identify any sug gestions from commenters apart from those that would be covered 2791

by the final rule that would meet the needs for agricultural employers to provide employees notification 2792

of the application and inform them of treated areas under an REI, and to record and dis play the 2793

pesticide application information. Agricultural employers must have information about the start time of 2794

the application before it begins to ensure they have the ability to notify workers of the application 2795

before it commences. Agricultural employe rs must have the end time of the application to notify 2796

workers that although the application has ended, entry to the treated area remains prohibited because 2797

an REI is in effect. Without these details being provided prior to the application, agricultural em ployers 2798

are not able to fulfill their responsibilities to protect workers. Therefore, EPA has retained the provision 2799

of the existing WPS that requires the handler employer to notify the agricultural employer of changes to 2800

the application information regar ding timing and the product applied before the application takes place. 2801

In regard to changes other than timing and the product applied, EPA has adopted the proposal to allow 2802

the handler employer to provide updated information to the agricultural employer within two hours 2803

after completing the application. The final regulatory text for this requirement is available at 40 CFR 2804

170.313(j). 2805

EPA notes that the method for notification of changes to application information should be 2806

agreed upon between the handler employer and the agricultural employer to ensure receipt, and can be 2807

accomplished through electronic media, telephone, or other means. The agricultural employer must 2808

receive the information in sufficient time to record and display the information for work ers and 2809

handlers. 2810

Finally, EPA acknowledges that many commenters noted that the proposal omitted the 2811

provision at § 170.120(b)(3)(i) of the existing WPS that said that the agricultural employer need not 2812

provide information to the handler employer about t reated areas on the establishment if the handler 2813

will not be in or walk within one

- quarter mile of those treated areas. EPA acknowledges this was an 2814

inadvertent omission, and therefore EPA has included that provision in the final rule. 2815

IX. Drift

- Related Re quirements 2816

The requirements discussed in this section are intended to decrease the number of incidents in 2817Page 64 of 176 which workers and other persons are exposed to pesticides through unintentional contact during 2818

application. Drift is the off

- site movement through t he air of pesticide droplets or particles originating 2819

from pesticides applied as liquids or dry materials. Workers errantly in the area being treated may be 2820

directly exposed to pesticides during application. In addition, bystanders (both workers and non

2821

wo rkers) located outside a treated area may be exposed when pesticide droplets or particles move 2822

outside the area being treated through the air during and/or immediately after the pesticide application. 2823

As used here, the term “drift” includes both of these m odes of exposure, but does not include off

- site 2824

movement of pesticide

- imbedded soil

- borne particles by wind or vapor drift through volatilization of 2825

applied pesticide, although these are often categorized as “drift” in other contexts. EPA has developed 2826

met hodologies for assessing the risks to bystanders from exposure to pesticides from drift and also from 2827

volatilization, and addresses risks of concern and other issues via the registration review process. The 2828

purpose of the requirements discussed in this sec tion is to prevent workers and other persons from 2829

being exposed to pesticides by unintentional contact during application. The term “drift” is used as 2830

shorthand in this section to refer to unintentional exposure from both direct exposures to workers in 2831

the area being treated and drift exposures to workers and bystanders. 2832

A. Overarching Performance Standard 2833

1. Current rule and proposal. The existing WPS includes two related requirements that prohibit a 2834

pesticide from being applied in a way that contacts wo rkers or other persons. Agricultural products 2835

subject to the WPS must have this statement on the label: “Do not apply this product in a way that will 2836

contact workers or other persons, either directly or through drift. Only protected handlers may be in the 2837

area during application.” 40 CFR 156.206(a). Also, the existing WPS requires the handler employer and 2838

the handler to assure that no pesticide is applied so as to contact, either directly or through drift, any 2839

worker or other person, other than an appropria tely trained and equipped handler. These requirements 2840

prohibit application in a way that contacts workers or other persons both on and off the agricultural 2841

establishment where the pesticide is being applied. 2842

EPA did not propose any changes to the label st atement. EPA proposed several minor wording 2843

changes to the WPS requirement for the handler employer and the handler, but the impact of the 2844

proposed requirement would be the same as under the existing WPS. 2845

2. Final rule. EPA has finalized the proposed chan ges to the requirement for the handler 2846

employer and handler with a minor change. The final rule changes the language from the proposed 2847

“handler located on the establishment” to “handler involved in the application.” As with the existing 2848

rule, the final rul e prohibits contact to workers and other persons regardless of whether or not they are 2849

on the agricultural establishment. The final regulatory text for this requirement is available at 40 CFR 2850

170.505(a). There are no changes to the label statement at 40 CF R 156.206(a). 2851

3. Comments and responses. 2852

Comments. Many commenters, including states and their organizations, grower associations, 2853

farm bureaus, pesticide applicators and their organizations and pesticide manufacturer associations, 2854

stated that the exist ing two requirements adequately protect workers and bystanders from exposure 2855

during applications. These commenters opposed the other drift

- related requirements that EPA proposed 2856

(entry

- restricted areas for farms and forests and the requirement to suspend a pplications under certain 2857

conditions) as unnecessary, asserting the proposed requirements do not provide any additional 2858

protection. 2859

Many respondents from states and their organizations, grower associations, farm bureaus, 2860

pesticide applicators and their or ganizations and pesticide manufacturer associations commented that 2861

EPA’s risk assessments and pesticide labels include conservative protections for applicators, handlers, 2862Page 65 of 176 workers and bystanders. Some of these commenters argued that the existing restriction s on the labels, 2863

including REIs and pesticide

- specific buffers, provide sufficient protection to workers and bystanders. 2864

A farm bureau commented that the potential for drift is affected by many situational factors, so 2865

it is better to rely on applicator tr aining programs, state regulation of localized drift problems and 2866

pesticide

- specific label statements where appropriate. 2867

Many commenters, including farmworker advocacy organizations and a university, stated that 2868

EPA should require agricultural employers t o inform their neighbors when they are going to make a 2869

pesticide application so workers and others can stay out of the area during the application. 2870

Many respondents from all commenter types commented on incidents where workers or 2871

bystanders reported being contacted by pesticides that were being applied. Some of these incidents 2872

involve workers in the areas where pesticides were applied and other incidents involve workers or 2873

bystanders being exposed to pesticides that drifted off the target site. Many of the commenters cited 2874

three broad studies that looked at data from SENSOR

- Pesticides and California’s Pesticide Illness 2875

Surveillance Program (Refs. 10, 11 and 12). A grower organization pointed out that the study of drift 2876

incidents from 11 states (Ref. 12) f ound that, of the drift events with information on violations of 2877

pesticide regulations, a majority had one or more FIFRA violations that may have contributed to the drift 2878

exposure and suggested that better adherence to and enforcement of existing regulator y requirements 2879

could decrease the number of drift exposures. The study found that applicator carelessness contributed 2880

to almost half of the events where contributing factors were identified and noted that “applicators 2881

should be alert and careful, especial ly when close to non

- target areas such as adjacent fields, houses, 2882

and roads” and that applicators “should use all available drift management measures and equipment to 2883

reduce drift exposure.” Other commenters, including farmworkers, farmworker advocates, public 2884

health organizations, a university and a state department of health, cited specific incidents of exposure 2885

from drift to workers in the area being treated , or by being sprayed directly. Some applicator, retailer 2886

and pesticide manufacturer association s cited state data showing that there has been a decrease in drift 2887

complaints over time, dropping from an average of 333 complaints per year nationwide (from 1996 2888

through 1998) to an average of 247 complaints per year (from 2002 through 2004). Some grower and 2889

pesticide manufacturer associations cited an analysis by one of these commenters of incidents in 2890

California in one year, which showed that there were over 2.4 million pesticide applications and 76 cases 2891

of worker exposure to drift. These commenters cl aimed that none of the 76 cases of drift would have 2892

been prevented by implementing the proposed entry

- restricted areas. 2893

EPA R esponse. EPA disagrees with the assertion that the “do not contact” requirements, along 2894

with the other protections on pesticide labels, are by themselves sufficient to protect workers and 2895

bystanders from being directly contacted by pesticides that are applied. First, many commenters cited 2896

incidents where people were directly exposed to pesticide applications, even if there was disa greement 2897

about how regularly these types of incidents happen. Second, EPA’s risk assessments and registration 2898

decisions are based on the premise that the WPS protections effectively prevent people (workers and 2899

bystanders) from being sprayed directly (Ref. 13) . In other words, incidents where workers or 2900

bystanders are sprayed directly result in people being exposed to pesticides in a way that is not 2901

considered in EPA’s risk assessments or registration decisions. These types of incidents are misuse 2902

violations but they continue to occur, as described in the following sections. Therefore, there is a need 2903

to supplement the existing WPS protections to reduce exposures to workers and other persons from 2904

being directly sprayed with pesticides. 2905

EPA agrees with the f arm bureau commenter that there are many factors that can cause 2906

exposure to drift and there is no one solution that can prevent all drift incidents. It will take a 2907Page 66 of 176 comprehensive approach, including additional regulatory requirements, education, outreach, and some 2908

common

- sense voluntary measures to further reduce the number of people who are directly exposed to 2909

pesticide spray/applications. The additional regulatory requirements include revised requirements for 2910

entry restrictions during pesticide applicatio ns and for handlers to suspend applications in certain 2911

circumstances. Common

- sense voluntary measures include improving communications about when a 2912

pesticide application will take place by a grower talking to his/her neighbors to let them know when 2913

pestici des are being applied so the neighbors can keep workers and others away from the boundary of 2914

adjacent establishments during that time, and by participating in voluntary communication programs 2915

such as Spray Safe ( http://www.spraysafe.org/ ) and Drift Watch ( https://driftwatch.org/ ). 2916

In response to the comments that EPA should require agricultural establishments to inform their 2917

neighbors about pesticide applications , EPA notes that i t did not propose such a requirement . Because 2918

of the potentially far

- reaching impact a broad notification requirement could have on all agricultural 2919

establishments that apply pesticides, EPA believes that such a change would warrant public notice and 2920

comment before being added to the WPS , a nd therefore has n o t included it in the final rule . EPA 2921

intends to include notice to neighbors among information about good management practices during 2922

outreach for implementation of the final rule. 2923

It is also worth noting that EPA is working to assess a nd mitigate any product

- specific risks from 2924

exposure to pesticides from drift and from volatilization within the registration review process. Also, 2925

EPA has proposed changes to the pesticide applicator certification regulations to include more training 2926

and a requirement for applicators using certain higher risk application methods, such as aerial 2927

application and fumigation , to obtain a specialized certification . (80 FR 51355, August 24, 2015) This 2928

should improve the competency of applicators and decrease the incidents caused by applicator 2929

carelessness. EPA agrees that rigorous enforcement of existing and new WPS provisions and label 2930

requirements are necessary and has committed to a robust outreach, communication and training effort 2931

to communicate the new rule requirements to state, tribal and regional staff as well as the affected WPS 2932

stakeholders and will work closely with our state and tribal partners to enforce the WPS in the future. In 2933

2014, EPA launched its voluntary drift reduction technology progra m ( http://www2.epa.gov/reducing

2934

pesticide

- drift ), which is intended to encourage the development and use of validated low drift 2935

technologies. 2936

EPA has not reviewed the 76 drift cases from Californ ia that were mentioned by several 2937

commenters in detail. However, it is possible that at least some of them would be prevented by the 2938

final rule requirement for the handler to suspend application because that requirement extends beyond 2939

the boundaries of th e establishment, as explained in U nit VII.C. 2940

B. Entry Restrictions to Protect Workers and Other Persons During Application 2941

1. Current rule and proposal. The existing WPS establishes entry

- restricted areas adjacent to 2942

treated areas that apply during pestic ide application for nurseries and greenhouses only. The existing 2943

rule requires that the agricultural employer must not allow or direct any person, other than an 2944

appropriately trained and equipped handler, to enter or remain in the entry

- restricted area dur ing a 2945

pesticide application in a nursery or greenhouse. The size of the entry

- restricted area depends on the 2946

type of product applied and the application method. The entry restrictions for greenhouses also include 2947

ventilation requirements. The existing entr y restriction requirement applies only within the boundaries 2948

of the agricultural establishment. The existing provisions at 40 CFR 170.110 regarding entering entry

2949

restricted areas during application are different than the existing provisions at 40 CFR 170. 112 regarding 2950

entry into treated areas after the application of a pesticide and before the REI specified on the pesticide 2951

labeling has expired. 2952Page 67 of 176 EPA proposed to establish entry

- restricted areas during pesticide applications on farms and in 2953

forests, while slightly modifying the requirement for entry

- restricted areas for nurseries and 2954

greenhouses. EPA proposed two types of entry restrictions: One for enclosed space production, which 2955

would apply to greenhouses and other types of indoor production operations ( e.g., mushroom houses, 2956

hoop houses, polyhouses), and one for outdoor production, which would apply to farms, forests and 2957

nurseries. In addition, EPA proposed to define the entry

- restricted area as the area from which workers 2958

or other persons must be exclud ed during and after the pesticide application. 2959

2. Final rule. In regard to enclosed space production ( e.g. , greenhouses, mushroom houses, 2960

hoop houses), EPA has finalized the requirements for entry restrictions during pesticide applications 2961

with several minor changes. For the most part, the final rule incorporates the existing entry restriction 2962

and ventilation requirements for greenhouses as the requirements for enclosed space production. The 2963

final rule deletes the term “entry

- restricted area” and adjusts the descriptions of the application types 2964

to be consistent with the changes to the description of applicatio n exclusion zones for outdoor 2965

production. In addition, EPA changed the definition of “enclosed space production” to clarify that it 2966

applies only to areas with non

- porous covering, so structures with a covering made of fencing or fabric 2967

to provide shade on plants (no walls) such as shade houses, are not considered enclosed spaces under 2968

the final rule. See the discussion of definitions in Unit XVIII.C. of this document for more information 2969

about the changes to this definition. 2970

In regard to outdoor productio n (e.g., farms, forests, nurseries, shade houses), the final rule 2971

differs substantially from EPA’s proposed requirements. The final rule makes the following changes from 2972

the proposal: 2973

• Replacing the phrase “entry

- restricted area” with “application exclus ion zone” to make it more 2974

distinct from the requirements regarding REIs. The final regulatory text for this requirement is available 2975

at 40 CFR 170.405(a). 2976

• Revising the corresponding definition to clarify that the application exclusion zone exists only 2977

d uring (not after) a pesticide application. The final regulatory text for this definition is available at 40 2978

CFR 170.305. 2979

• Revising the corresponding definition and regulatory description of an application exclusion 2980

zone so it is a specified distance from the application equipment rather than from the edge of the 2981

treated area, and clarifying that the application exclusion zone moves with the application equipment. 2982

The final regulatory text for this requirement is available at 40 CFR 170.405(a)(1). 2983

• Revis ing some of the application methods in the description of the application exclusion zone 2984

to reflect current application methods and to differentiate the distances based on the spray droplet size 2985

rather than pressure. The final regulatory text for this requ irement is available at 40 CFR 170.405(a)(1). 2986

• Adding a provision to the regulatory text to clarify that any labeling restrictions supersede the 2987

requirements of the WPS, including those related to application exclusion zones. This was discussed in 2988

the p reamble of the proposed rule (Ref. 2 at 15490) but was inadvertently left out of the proposed 2989

regulatory text. The final regulatory text for this requirement is available at 40 CFR 170.303(c) and 2990

170.317(a). 2991

3. Comments and responses. 2992

Comments

– supporti ng the proposal or more stringent measures. Many commenters, including 2993

farmworkers, farmworker advocacy organizations, public health organizations, state pesticide regulatory 2994

agencies and a university, generally supported the proposed requirement for entry

- restricted areas. The 2995

commenters stated that the proposed change should provide modest improvements in protecting 2996

workers from pesticide drift during application if there is enough training and education of applicators. 2997Page 68 of 176 One farmworker advocacy organizatio n described an incident where workers were in a field topping 2998

tobacco at the same time a plant growth regulator with a 24

- hour REI was being applied to the adjacent 2999

row. The workers were close enough to have to move out of the path of the tractor. However, because 3000

the treated area was defined to be only the rows being treated, this was permissible under the existing 3001

WPS. Many commenters provided other examples of incidents where workers were unintentionally 3002

exposed directly to the pesticide spray. A few far mworker advocacy organizations commented that 3003

many workers say that they have felt the spray of pesticides from fields close to where they work. A 3004

farmworker advocacy organization commented that in 2012, about 20% of farmworkers surveyed by the 3005

organizatio n in New Mexico reported that pesticides were applied to the fields at the same time that 3006

they were working. Another farmworker advocacy organization stated that about half of the child 3007

tobacco workers interviewed by the organization in 2013 reported that they saw tractors spraying 3008

pesticides in the fields in or adjacent to the ones where they were working. 3009

Many commenters, including farmworker advocacy organizations, public health organizations, 3010

state departments of health and universities argued that EP A should revise the approach for entry 3011

restrictions to protect workers on neighboring property and to increase the length of the entry

3012

restricted area. The recommended distances ranged from 60 to 200 feet for ground application and 300 3013

feet to a mile or mo re for aerial application. Many of these commenters also stated that EPA should 3014

protect workers the day after the application, claiming that pesticide would be volatilizing off the field. 3015

EPA addressed similar suggestions in its response to “Pesticides in the Air

– Kids at Risk: Petition to 3016

Protect Children from Pesticide Drift (2009)” by describing EPA’s current methodologies for assessing 3017

the risks to bystanders from exposure to pesticides from drift and from volatilization and how EPA will 3018

address risks of concern via the registration review process (Ref. 13). 3019

Comments

– opposing the proposal. Many states and their organizations, grower organizations, 3020

farm bureaus, applicators and their organizations, agricultural producer organizations

, pesticide 3021

manufacturer organizations , and the SBA Office of Advocacy opposed the proposed requirement to 3022

apply the entry

- restricted areas to farms and forests. Most of these commenters argued that the 3023

approach is too complicated because it establishes ano ther area to be controlled that varies by 3024

application type, may include persons other than those employed by the agricultural establishment and 3025

may be different than label restrictions. Some states and their organizations commented that the 3026

requirement to keep individuals out of varying widths of areas surrounding treated areas would be 3027

difficult for an agricultural employer to implement and even more difficult for a state to enforce. 3028

Several state agencies and a farm bureau commented that the tables descr ibing the entry

- restricted 3029

area are too complex to communicate and implement. Another state agency opposed the term “entry

3030

restricted area” because it is not clear and recommended calling it exactly what it is, a restricted area. A 3031

state pesticide regula tory agency in the Midwest commented that they have not documented an 3032

incident of worker exposure from drift and suggested that the incident data from California should not 3033

be the basis of a national requirement. 3034

Most of these commenters asserted that the proposed requirement to apply entry

- restricted 3035

areas to farms and forests would present some logistical issues that could effectively shut down parts of 3036

the establishment. For example, many ground and aerial pesticide applications occur along rural roads 3037

or near access points to the agricultural establishment. These roads and access points would be within 3038

the proposed entry

- restricted areas. On larger fields, pesticide applications could take several hours to 3039

complete. Commenters claimed that prohibiting w orkers from using these roads or gaining access to 3040

buildings on agricultural establishments such as farms or nurseries for long periods of time would be 3041

impractical, could cause the establishment to shut down during applications and could have an adverse 3042Page 69 of 176 e conomic impact. Many commenters, including state pesticide regulatory agencies and their 3043

organizations and grower organizations, opposed the proposal stating that work in nearby fields or 3044

forest blocks would be impossible during pesticide applications. M any of the commenters stated that 3045

EPA did not account for the cost of stopping business during some pesticide applications. Several 3046

commenters, including state pesticide regulatory agencies, grower organizations, applicators and their 3047

organizations, and a pesticide manufacturer organization, commented that the entry

- restricted area 3048

should account for the wind direction because any exposure would only occur downwind. 3049

A farm bureau commented that a buffer seems reasonable if workers are near a sprayer maki ng 3050

an application and suggested that the buffer should be from the sprayer, not the edge of the field. A 3051

grower organization argued that the proposed entry

- restricted area requirement is not necessary 3052

because they already move workers away from areas being sprayed to avoid contact from overspray and 3053

fumes. Several applicator organizations commented that aerial applicators often apply pesticides to 3054

large farms and forests where workers are seldom present. 3055

Some of the comments appear to reflect a misunderst anding of the proposal, i.e., that the 3056

entry

- restricted areas would be “buffer zones” that would remain in effect after the application was 3057

complete. As an example, one grower organization opposed the “worker buffers” because they could 3058

take a lot of area out of cultivation on smaller farms, farms with widely varied crop maturities and farms 3059

that are not laid out in large blocks that could not space crops to accommodate this restriction. Instead 3060

of arbitrary buffers, this commenter argued to keep the stand ard as it is

- do not apply where workers 3061

are present and do not allow spray (or drift) to contact workers. Another commenter asked EPA to 3062

revise the entry

- restricted area to require workers to not be present when the application is occurring. 3063

A farm bur eau commented that there is little reason for the expanded entry

- restricted areas to exist 3064

once the pesticide has been applied. A state regulatory agency claimed that the proposed entry

3065

restricted area would significantly impact agricultural practices and increase pest pressure due to 3066

untreated areas. A grower organization and a farm bureau commented that the proposed entry

3067

restricted area could cause concerns among neighbors of farms by encouraging the impression that 3068

similar “buffer zones” are necessary between areas receiving pesticide applications and adjacent public 3069

areas. 3070

The SBA Office of Advocacy recommended that EPA remove the proposed entry

- restricted areas 3071

for farms for many of the reasons cited in this and the previous section: current regula tions already 3072

provide protections, EPA’s risk assessments include protections on the label, the requirement could be 3073

confusing, and the proposed requirement could block roads which would disrupt operations on the 3074

agricultural establishment. 3075

Comments on ap plication types and distances . Some commenters addressed the specific 3076

application methods and the distances of 100 feet and 25 feet in the proposed entry

- restricted areas. 3077

Some commenters, including states and their organizations, grower organizations, ag ricultural 3078

organizations and pesticide manufacturer organizations commented that the distances of 25 to 100 feet 3079

are not supported by drift reduction technologies, applicator standard operating procedures or incident 3080

data. A pesticide manufacturer organiz ation commented that fumigants should be excluded from the 3081

entry

- restriction area requirements because they are addressed individually with more detailed 3082

restrictions. A state regulatory agency commented that the label should take precedence if it has 3083

buf fers for human exposure. A state commented that the table of application methods and distances is 3084

flawed because it does not account for all application scenarios and does not logically apply distances. 3085

For example, tower

- type sprayers are generally at t he height of the tree canopy and spray horizontally 3086

into trees at a pressure under 150 psi. The proposed entry

- restricted area for these would be 0 feet, 3087Page 70 of 176 although the state commented that there should be a buffer because of the height of the application. 3088

The state also pointed out that some chemigation systems may require a 100

- foot entry

- restricted area. 3089

This state and a grower organization pointed out that the distances do not account for canopy cover, 3090

which can affect how far a spray droplet travels. 3091

EPA Response . Based on the comments, EPA has made some changes in the final rule from the 3092

proposed requirement to extend entry

- restricted areas to farms and forests. However, experiences such 3093

as those of workers having to move to get out of the way of t he tractor that was applying pesticide 3094

(described previously) and workers being directly sprayed confirm EPA’s position that additional 3095

protections are necessary during pesticide applications on farms and in forests. The existing WPS 3096

prohibits a farm or fo rest agricultural employer from allowing or directing any worker to enter or remain 3097

in a treated area, which is defined to include areas being treated. The existing regulations require oral 3098

notifications before pesticide applications to include the locatio n and description of the treated area, 3099

the time during which entry is restricted and instructions not to enter the treated area until the REI has 3100

expired. The existing regulations require handler employers to ensure that pesticides are applied in a 3101

manner that will not contact a worker either directly or through drift. Inasmuch as these requirements

– 3102

clearly intended to prevent direct exposure of workers during pesticide applications

– have proven 3103

insufficient for that purpose, additional measures are need ed. 3104

EPA has changed the final rule in several ways to address some of the concerns expressed in the 3105

comments about the logistical problems with the proposal. First, in the final rule EPA replaced the term 3106

“entry

- restricted area” with “application exclusi on zone,” which more clearly associates this restriction 3107

with the period during the pesticide application. This new term is also less likely to be confused with the 3108

term “restricted

- entry interval.” Second, EPA revised the requirements for the application exclusion 3109

zone so that it is not based on the “treated area,” but instead a specified distance from the application 3110

equipment as suggested by one of the farm bureau commenters. The application exclusion zone is 3111

essentially a horizontal circle surrounding t he application equipment that moves with the application 3112

equipment. For example, if a pesticide is applied aerially, the border of the application exclusion zone is 3113

a horizontal circle that extends 100 feet from the place on the ground directly below the a ircraft, and 3114

moves with the aircraft as the application proceeds. Third, EPA simplified the requirement for 3115

application exclusion zones for outdoor production by deleting the table and simplifying the description 3116

of the application exclusion zone. 3117

Because the application exclusion zone is based on the location of the application equipment, 3118

rather than the location of the treated area, the application exclusion zone could extend beyond the 3119

boundary of the agricultural establishment. However, in 40 CFR 170.4 05(a)(2), the final rule limits the 3120

requirement for the agricultural employer to keep workers and other persons out of the treated area or 3121

the application exclusion zone during application to areas that are within the boundaries of the 3122

agricultural establi shment, as proposed. The existing entry

- restricted area requirement for nurseries is 3123

also limited to areas that are within the boundaries of the agricultural establishment. EPA retained the 3124

existing and proposed limitation because this requirement applies to the agricultural employer. The 3125

agricultural employer can control what happens on the agricultural establishment but could have 3126

difficulty limiting access to roads or fields that are beyond his property. 3127

Limiting the application zone to the area close st to the application equipment eliminates the 3128

concerns expressed by many commenters, including the SBA Office of Advocacy, about shutting down 3129

roads or closing off buildings for the entire time the field or other area is being treated or preventing 3130

work i n nearby fields. The approach in the final rule does not account for wind direction, although the 3131

final rule specifies a much smaller area that agricultural employers must keep workers and other people 3132Page 71 of 176 from than the existing WPS and the proposed approach. The approach in the final rule will be easy to 3133

comply with for growers that already move workers away from areas to be sprayed to avoid contact. 3134

Unfortunately, not all growers do this as shown by the example of the workers in the tobacco field who 3135

had t o move out of the way of the sprayer. Similarly, if workers are not present, it will be easy for 3136

agricultural employers to keep them out of the application exclusion zone during the application. 3137

The comments reflected a general lack of understanding that the proposed entry

- restricted 3138

areas would exist only during application, and many comments anticipated conflicts between no

- spray 3139

buffers on some pesticide labels and the proposed entry

- restricted area and expressed concern about 3140

areas needing to be taken out of production to stay 25 feet or 100 feet away from the adjacent field. 3141

However, these are two different types of requirements. If a label specifies a “no

- spray” buffer, 3142

pesticide cannot be applied in that area at any time. Under the final rule, a pes ticide can be applied in an 3143

application exclusion zone, and the requirement for agricultural employers is to keep workers and other 3144

people out of this zone during the pesticide application. These two types of requirements are distinct, 3145

and as a result shou ld not be problematic to implement. Further, the application exclusion zone only 3146

applies (and the proposed entry

- restricted area would have applied) only during the pesticide 3147

application and does not exist once the application is over. 3148

EPA reassessed t he application methods and distances in the proposed requirements for entry

3149

restricted areas for outdoor production and made some changes in the description of application 3150

exclusion zones in the final rule in § 170.405(a)(1). The final rule maintains the proposed distances of 3151

100 feet and 25 feet but revises the application methods associated with each distance. 3152

The application methods that have an application exclusion zone of 100 feet are the ones where 3153

pesticide is expected to move a longer distance fr om where they are applied. The changes include: 3154

• Adding air blast applications, to more accurately and more broadly describe current 3155

application methods. 3156

• Deleting pesticides applied as an aerosol because it is unnecessary. 3157

• Including pesticides app lied as a spray using a spray quality (droplet spectrum) of smaller than 3158

medium (volume median diameter less than 294 microns). The volume median diameter refers to the 3159

midpoint droplet size or mean, where half of the volume of spray is in droplets smalle r, and half of the 3160

volume is in droplets larger than the mean. EPA chose to establish this criteria based on the spray 3161

quality rather than just the pressure because the drop size depends on a number of variables, including 3162

the pressure, the nozzle type, l iquid properties, and the spray angle. Focusing on the spray quality, 3163

rather than pressure, is also consistent with EPA’s voluntary Drift Reduction Technology program and 3164

current models of drift used in EPA’s risk assessments. 3165

The application methods th at have an application exclusion zone of 25 feet are the ones where 3166

pesticide is expected to move a shorter distance from where they are applied. The changes include: 3167

• Replacing several of the proposed criteria with pesticides applied as a spray using a spray 3168

quality (droplet spectrum) of medium or larger (volume median diameter of 294 microns or larger). 3169

• Eliminating the criterion based on the product label requiring a respirator because it is 3170

intended to apply to enclosed spaces like greenhouses and was accidentally included in the proposed 3171

criteria for outdoor production. 3172

• Eliminating the proposed requirement for the spray to be applied downward, so tower

- type 3173

sprayers would be subject to an application exclusion zone of 25 feet or 100 feet, depen ding on the 3174

spray droplet spectrum. 3175

The corresponding changes to application methods were made to the Table

– Entry Restrictions 3176

During Enclosed Space Production Pesticide Applications at 40 CFR 170.405(b)(4) for consistency. 3177Page 72 of 176 EPA acknowledges that some pesticide labels will have restrictions that apply during 3178

applications that are different than the application exclusion zones. For example, the restrictions on soil 3179

fumigant labels are more restrictive than the application exclusion zone of 100 feet spec ified in § 3180

170.405(a)(1)(i)(D). In situations like this, pesticide users must follow the product

- specific instructions 3181

on the labeling. As stated in §§ 170.303(c) and 170.317(a), when 40 CFR Part 170 is referenced on a 3182

pesticide label, pesticide users mus t comply with all of the requirements in 40 CFR Part 170, except 3183

those that are inconsistent with product

- specific instructions on the pesticide product labeling. 3184

Although the size of the application exclusion zone does not vary based on the amount or ty pe 3185

of canopy cover, EPA believes that the changes from the proposed rule will provide appropriate 3186

application exclusion zones in almost all use situations. While additional refinements to account for 3187

canopy cover might offer some advantages, those advanta ges would be offset by the additional 3188

complexity they would add to the rule. 3189

C. Suspend Application 3190

1. Current rule and proposal . As discussed in Unit IX.A., the existing WPS requires handler 3191

employers and handlers to assure that no pesticide is applied so as to contact, either directly or through 3192

drift, any worker or other person, other than an appropriately trained and equipped handler. However, 3193

the existing WPS does not include an explicit requirement for handlers to stop or suspend application. 3194

EPA pr oposed to add a provision to require a handler performing a pesticide application to immediately 3195

stop or suspend the pesticide application if any worker or other person, other than an appropriately 3196

trained and equipped handler, is in the treated area or th e entry

- restricted area. Based on the 3197

description of entry

- restricted areas in the proposed rule, the requirement for handlers to stop or 3198

suspend application in certain circumstances would apply only within the boundaries of the agricultural 3199

establishment. 3200

2. Final rule. In the final rule, EPA has made several changes to the proposed requirement to 3201

suspend applications. First, EPA revised the language to require a handler to “immediately suspend a 3202

pesticide application” rather than to “immediately stop or suspend a pesticide application” to clarify 3203

that the application must be suspended but can be restarted once workers or other persons are out of 3204

the zone. Second, EPA changed the area that is covered by the requirement to suspend application in 3205

two ways. E PA replaced “entry

- restricted area” with “application exclusion zone,” decreasing the size of 3206

the area that is covered by the requirement. See Unit IX.B. Also, EPA removed the treated area from the 3207

requirement. For outdoor production, the area covered by t he requirement is much smaller than the 3208

area that would have been covered by the proposed rule, which would have been the treated area plus 3209

up to 100 feet beyond the edge of the treated area. Third, the application exclusion zone can extend 3210

beyond the boun daries of the agricultural establishment for the purposes of this requirement, i.e., the 3211

handler must suspend application if any person other than another handler involved in the application is 3212

in the application exclusion zone, regardless of whether the a pplication exclusion zone extends off of 3213

the employer’s property. 3214

The final rule requires the handler performing the application to suspend application if people 3215

who should not be present are in the application exclusion zone (which ranges up to 100 feet from the 3216

application equipment for outdoor production) or in the area identified for exclusion for enclosed space 3217

production (which ranges from 25 feet to the entire enclosed space plus any adjacent structure that 3218

cannot be sealed off)

. The final regulato ry text for this requirement is available at 40 CFR 170.505(b). 3219

3. Comments and responses. 3220

Comments . Many commenters, including farmworkers, farmworker advocacy organizations, 3221

public health organizations, academics, a public health agency and state pest icide regulatory agencies 3222Page 73 of 176 generally supported the proposed requirement for applicators to stop or suspend pesticide applications 3223

under certain conditions. A farmworker advocacy organization supported the proposed requirement, 3224

stating that current rules do not provide meaningful guidance on how applicators can prevent human 3225

exposure during applications. Many commenters from farmworker advocacy organizations, public 3226

health organizations, public health agencies and universities supported the proposed requireme nt but 3227

urged EPA to extend the protections to workers at neighboring establishments. Many of these 3228

commenters provided information suggesting that workers may be more likely to be affected by drift 3229

from a different establishment. For example, commenters ci ted a Washington Department of Health 3230

report that documented 43 workers in Washington being affected by drift from another farm while only 3231

13 workers reported being affected by drift from the farm where they were working in 2010

- 2011. In 3232

comments arguing a gainst the need for entry

- restricted areas, several applicator organizations provided 3233

examples supporting the requirement to suspend applications, stating that it is standard operating 3234

procedure for aerial applicators to temporarily avoid making passes adj acent to roads or other areas if 3235

workers happen to be passing by in vehicles or on foot. 3236

Three comments from Washington

– the state pesticide regulatory agency, the state farm 3237

bureau and a grower organization

– pointed out that the Washington drift incide nt cited in the 3238

preamble of the proposed rule would not have been prevented by the proposed requirement for 3239

applicators to cease or suspend pesticide application if workers or other people were in the entry

3240

restricted area. This is because the workers wer e on a neighboring farm and under the proposal, the 3241

entry

- restricted area would stop at the border of the establishment where the pesticide is being applied. 3242

Many states and their organizations, grower organizations, farm bureaus, applicator 3243

organization s, agricultural producer organizations and pesticide manufacturer organizations opposed 3244

the proposed requirement for handlers to stop or suspend pesticide applications in certain 3245

circumstances. Most of these commenters argued that the provision is unnecess ary because it would 3246

not offer any protections or prevent contact from pesticide applications beyond the existing “do not 3247

contact” requirement. Some commenters raised logistical concerns: Applicators may not be aware that 3248

a person has entered a treated are a or entry

- restricted area in many situations, such as in a forest or an 3249

orchard in full leaf, in a very large field, or if there are restricted sight lines or rolling hills; the proposed 3250

requirement would impose unwarranted expectations for pilots, who wo uld have to be fully aware of 3251

boundaries 100 feet on all sides of the target area while traveling at 150 mph; as proposed, an 3252

applicator would have to stop if a person is in an entry

- restricted area even if it is not possible for that 3253

person to encounter p esticides because of wind conditions. Many commenters, including state 3254

pesticide regulatory agencies and their organizations, a grower organization, a farm bureau, a pesticide 3255

manufacturer organization and applicator organizations, asked how an applicator would know if a 3256

person in the entry

- restricted area is an appropriately trained and equipped handler, who could legally 3257

be in the entry

- restricted area during application. 3258

A few grower organizations and farm bureaus commented that there is a difference b etween 3259

stopping and suspending an application and asked whether this would require applicators to cease 3260

application altogether or suspend the application until a person is no longer in the area. 3261

EPA Response . As stated in the proposal, EPA has identified a need to supplement the “do not 3262

contact” performance standard because exposure to drift or direct spray events still happen despite the 3263

“do not contact” requirement, and EPA’s risk assessments and registration decisions presume that no 3264

workers or other pe rsons are being sprayed directly. Therefore, the final rule includes an explicit 3265

requirement for handlers to suspend pesticide applications under certain conditions, which mandates 3266

applicators to take specified actions to prevent exposing people to pestici de during applications. 3267Page 74 of 176 However, EPA revised the final rule in response to several points made by commenters. First, 3268

the final rule requires a handler to “immediately suspend a pesticide application” rather than to 3269

“immediately stop or suspend a pesticide application.” This change was made to clarify that the 3270

application must be suspended immediately if workers or persons other than handlers are in the 3271

specified areas but can be restarted once workers or other persons are out of the specified area. 3272

EPA wa s persuaded by the commenters who raised logistical concerns about the proposed 3273

requirement, which were related to the handler not being able to see the person or a person entering 3274

an edge of a large area that is not near the application equipment. EPA rev ised the requirement in the 3275

final rule to decrease the size of the area that the handler must monitor for workers or persons other 3276

than handlers by removing the treated area from the area covered by this requirement and by changing 3277

the “application exclusi on zone” so it is measured from the application equipment rather than from the 3278

edge of the treated area. In the final rule, the handler performing the application must suspend 3279

application if any of the identified people are in the application exclusion zon e (which ranges up to 100 3280

feet from the application equipment) rather than if any of the people are in the entire treated area plus 3281

that distance (up to 100 feet) from the edge of the treated area. EPA acknowledges that there will be 3282

situations where the handler (applicator) legitimately cannot see a person 100 feet away, such as in a 3283

dense orchard or a forest. During the review of incident cases for the benefit analysis, there were 3284

several cases where a person in an orchard was exposed to pesticides appl ied aerially. EPA assessed 3285

those cases as not preventable by WPS because this requirement would not change the fact that the 3286

applicator could not see the person in the orchard. When EPA updates the WPS Inspector Guidance, we 3287

will discuss mitigating circu mstances such as the inability of an applicator to see the worker or person in 3288

the application exclusion zone, as well as information about how this requirement can be enforced. 3289

In response to the questions regarding how an applicator would know if a pers on in the entry

3290

restricted area is an appropriately trained and equipped handler who could legally be in the entry

3291

restricted area during application, the answer is that if the applicator is not certain, he or she must 3292

suspend application. EPA presumes th at the only trained handlers present in or around the treated area 3293

and wearing the PPE appropriate for the pesticide being applied would be handlers who are 3294

participating in the application, and further presumes that each handler should be aware of all oth er 3295

appropriately trained and equipped handlers participating in that same application. EPA notes the idea 3296

that an appropriately trained and equipped handler is in the existing WPS at §170.110(a) and 3297

§170.210(a) so agricultural employers, handler employers and handlers should know how to identify an 3298

appropriately trained and equipped handler after 20 years of experience with the WPS. 3299

EPA was also persuaded by the comments and incident information about workers at 3300

neighboring establishments being directly c ontacted by drift and acknowledges that the Washington 3301

State drift incident cited in the preamble of the proposed rule would not have been prevented by the 3302

proposed entry

- restricted area, which would have been limited by the boundaries of the agricultural 3303

establishment. The incidents cited by commenters show that workers are directly exposed to pesticide 3304

applications from neighboring establishments as well as from the establishment where they are 3305

working. To reduce the number of incidents where workers are exposed to drift from neighboring 3306

establishments, the final rule extends the application exclusion zone beyond the boundaries of the 3307

agricultural establishment for this requirement, thus requiring applicators to immediately suspend 3308

applications if people o ther than a properly trained and equipped handler are in the application 3309

exclusion zone. 3310

EPA has decided to extend the application exclusion zone beyond the boundaries of the 3311

agricultural establishment for the requirement to suspend applications for sever al reasons. First, this 3312Page 75 of 176 addresses more of the worker drift cases, where workers are within 100 feet of the agricultural 3313

establishment to protect more workers. Out of 17 incidents identified in the comments, only one would 3314

have been prevented if the applica tion exclusion zone was limited to the boundaries of the agricultural 3315

establishment as provided in the proposed rule. The requirement in the final rule would have prevented 3316

at least four of the incidents reported in the comments, and possibly as many as 12 , depending on the 3317

actual distances between the workers and application equipment, which were not specified in the 3318

comments. Second, the existing requirement that the handler must assure the pesticide is applied in a 3319

way that does not contact workers or ot her persons already extends beyond the boundary of the 3320

agricultural establishment. The new, explicit requirement to suspend application if people other than 3321

handlers are in the application exclusion zone is intended to supplement the existing “do not conta ct” 3322

requirement by giving the applicator specific criteria for suspending application. These specific criteria 3323

should be equally useful to applicators attempting to comply with the existing “do not contact” 3324

requirement beyond the boundaries of the agricult ural establishment. Third, the application exclusion 3325

zone would extend a maximum of 100 feet beyond the boundary of an agricultural establishment only 3326

for the length of time it takes for the equipment applying the pesticide to pass by, so this should not 3327

s hut down roads or access points to the establishment for long periods of time. To reiterate a point 3328

made in Unit IX.B., the final rule does not hold agricultural employers responsible for keeping workers 3329

and other persons out of portions of the application exclusion zone that extend beyond the boundaries 3330

of the agricultural establishment. On the other hand, this provision in § 170.505(b) of the final rule 3331

imposes a requirement on the handler applying the pesticide to immediately suspend the application if 3332

w orkers or persons other than handlers involved in the application are in the application exclusion zone, 3333

whether on the establishment or beyond the boundaries of the establishment. 3334

3335

X. Establish Minimum Age for Handling Pesticides and Working in a Treated Area while an REI is in 3336

Effect 3337

A. Current Rule and Proposal

. 3338

The existing regulation does not establish any age restriction for handlers or early

- entry work. EPA 3339

proposed to prohibit persons younger than 16 years of age from handling pesticides, with an exception 3340

for handlers working on an establishment o wned by an immediate family member. EPA requested 3341

comment on an alternative option of prohibiting any person under 18 years old from handling 3342

pesticides. 3343

The existing WPS establishes conditions for when a worker may enter into a treated area under 3344

an REI. The conditions are related to the type of work performed (often referred to as “early

- entry” 3345

tasks) and the length of time the worker may be in the treated area. However, the existing WPS 3346

establishes no minimum age for workers entering a treated area unde r an REI to perform early

- entry 3347

tasks. EPA proposed to prohibit any worker under 16 years old from entering a treated area under an 3348

REI to perform early entry tasks, with an exemption from this prohibition for persons covered by the 3349

immediate family exempt ion. EPA requested comment on an alternative option of prohibiting any 3350

person under 18 years old from entering treated areas during the REI to perform early entry tasks. 3351

B. Final Rule

. 3352

The final rule prohibits persons younger than 18 years old from handling pesticides. EPA has 3353

retained the proposed exemption for handlers working on an establishment owned by an immediate 3354

family member. The final regulatory text for the prohibition is available at 40 CFR 170.309(c) and 3355

170.313(c). The final regul atory text for the exemption is available at 40 CFR 170.601(a)(1)(i). 3356Page 76 of 176 The final rule prohibits persons younger than 18 years old from entering treated areas during 3357

the REI to perform early entry tasks, and retains the proposed exemption for persons working on an 3358

establishment owned by an immediate family member. The final regulatory text for this prohibition is 3359

available at 40 CFR 170.309(c) and 170.605(a). The final regulatory text for the exemption is available at 3360

40 CFR 170.601(a)(1)(xii). 3361

C. Comm ents and Responses. 3362

Comments . Many commenters requested that EPA establish a minimum age of 18 for handlers 3363

and early

- entry workers. Commenters cited several reasons for their request. First, many commenters 3364

noted that adolescents’ bodies are still develo ping and they may be more susceptible to the effects of 3365

pesticide exposure. Second, commenters noted that adolescents are less mature and their judgment is 3366

not as well developed as that of adults. This immaturity may mean that adolescents may be less 3367

consi stently aware of risks associated with handling pesticides or entering a treated area while an REI is 3368

in effect, that they may not adequately protect themselves or other workers from known risks, and that 3369

spills, splashes, and improper handling practices m ay be more likely. In addition, some of these 3370

commenters noted that adolescents may lack the judgment or confidence to refuse to perform a task 3371

that places them at risk if asked by an adult in authority. A few commenters submitted studies related to 3372

develo pment of maturity and decision

- making skills in adolescents in support of this assertion. Third, 3373

commenters asserted that restricting handling activities to persons at least 18 years old could result in 3374

higher potential economic benefit from avoiding expos ure and any potentially related chronic effects to 3375

children, because they have a longer potential life span. Fourth, because information on the potential 3376

chronic effects of pesticide exposure on developing systems is not known, commenters recommended 3377

that EPA prohibit adolescents from handling pesticides and entering treated areas while an REI is in 3378

effect as a precaution until it can be shown that they would not suffer adverse chronic effects from 3379

potential exposure. Finally, a few commenters noted that pe rsons under 18 years old are protected in 3380

other industries by OSHA and should receive similar protections under the WPS, and that some states 3381

have already prohibited handling of pesticides in agriculture by anyone under 18 years old. 3382

Some commenters expre ssed support for a minimum age of 16. States primarily supported 3383

EPA’s proposal to establish a minimum age of 16, noting that establishing a minimum age of 18 would 3384

require them to change their state laws. Other commenters supporting the proposed minimum a ge of 3385

16 noted that this requirement would align with DOL’s restriction on handling pesticides in toxicity 3386

categories I and II in agriculture. 3387

A few commenters supporting establishing a minimum age of either 16 or 18 noted that a 3388

specific minimum age req uirement would be easy to remember and enforce. 3389

A few commenters suggested establishing a higher minimum age (either 20 or 21) for handlers 3390

and early entry workers, or only for people using RUPs

. 3391

A few commenters opposed establishing any minimum age. The se commenters asserted that 3392

EPA should not take any action because the DOL’s hazardous occupations orders under the Fair Labor 3393

Standards Act (FLSA) already prohibit adolescents under 16 years old from handling pesticides in toxicity 3394

categories I and II in agriculture with limited exceptions. Some commenters also asserted that 3395

establishing any minimum age for pesticide handlers is a matter that should be handled by the states, 3396

not EPA. A few commenters suggested that rather than EPA setting a minimum age, th e WPS 3397

requirements should be aligned with each state’s laws and regulations related to minimum age. 3398

Some commenters requested that EPA eliminate the exception from any minimum age 3399

requirement for members of the owner’s immediate family. Commenters assert that adolescents’ 3400

developmental status does not differ if they are an employee on a farm owned by an immediate family 3401Page 77 of 176 member or by someone unrelated to them. Other commenters supported EPA’s proposal or requested 3402

that EPA establish a higher minimum age onl y if EPA also retains the exception for members of the 3403

owner’s immediate family. 3404

EPA Response . Based on the comments received and an evaluation of existing literature related 3405

to adolescents’ development of maturity and judgment, EPA has decided that the b enefits of further 3406

reductions in adolescent pesticide exposures justify their cost; the final rule generally prohibits persons 3407

under 18 years old from handling pesticides or entering a treated area while an REI is in effect. EPA 3408

recognizes that adolescents ’ bodies and judgment are still developing. While studies have not 3409

demonstrated a clear cut off point at which adolescents are fully developed, literature indicates that 3410

their development may continue until they reach their early to mid

- 20s. EPA also agree s that research 3411

has shown that adolescents may take more risks, be less aware of the potential consequences of their 3412

actions on themselves and others, and be less likely to protect themselves from known risks. In addition, 3413

EPA recognizes that adolescents m ay not feel empowered to question or refuse tasks assigned to them 3414

that would put them at risk. All of this information supports establishing a higher minimum age than 3415

proposed in order to allow those handling pesticides to develop more fully before puttin g themselves, 3416

others, and the environment at risk, and to allow those performing early

- entry activities to develop 3417

more fully in order to adequately protect themselves from the risks of entering a treated area while an 3418

REI is in effect. EPA agrees that est ablishing a consistent minimum age for handlers and early

- entry 3419

workers would be easy to remember and enforce. The final rule will reduce the potential for misuse by 3420

adolescent handlers who may less consistently exercise good judgment when handling agricul tural 3421

pesticides. 3422

EPA notes commenters’ assertions that avoiding pesticide exposure in adolescents could result 3423

in higher potential economic benefit because of adolescents’ longer potential lifespans. EPA agrees that 3424

it is appropriate to take reasonable p recautions to protect adolescents from pesticide exposures, both 3425

because of the potential impact of pesticides on further development and because adolescents may not 3426

properly appreciate (and take appropriate steps to avoid) the risks of potential pesticide exposure. 3427

While statistical associations have been observed in studies that estimate the relation between pesticide 3428

exposure and chronic health outcomes such as cancer, the causal nature of these associations has not 3429

yet been determined; thus quantifying the magnitude of the chronic health risk reduction expected as a 3430

result of pesticide exposure reduction is not possible. However, based on what is known about the 3431

potential for biologically active chemicals generally to disrupt developmental processes, it is reasonable 3432

to have heightened concern for adolescents under the age of 18 in situations where they face 3433

particularly high pesticide exposures. Prohibiting adolescents under the age of 18 from handling 3434

agricultural pesticides will protect them from any p otential risks of pesticide use through handling 3435

activities, ensuring that adolescents do not suffer unreasonable adverse effects from handling 3436

agricultural pesticides. Prohibiting adolescents under 18 years old from entering a treated area while an 3437

REI is in effect will protect them by delaying their entry into treated areas until residues are at a level 3438

that should not cause unreasonable adverse effects. 3439

EPA recognizes that DOL prohibits persons under 18 years old from engaging in hazardous tasks 3440

in othe r industries, and that some states have taken action to prohibit certain adolescents from handling 3441

pesticides in agriculture (state minimum ages for pesticide handlers, where established, range from 16 3442

years old to 18 years old). These examples of protecti ons for adolescents in other industries or by states 3443

indicate a recognition that different standards for certain adolescents and adults are appropriate. 3444

EPA disagrees with commenters’ request to establish a minimum age higher than 18. While 3445

research show s that brains continue to develop until people are in their early to mid

- 20s, the minimum 3446Page 78 of 176 age to engage in many hazardous activities has been established as 18 years old. For the reasons 3447

outlined above, in addition to the lack of recognition in other indus tries that people must be at least 20 3448

or 21 to conduct certain risky occupational tasks, EPA disagrees with commenters’ requests to establish 3449

a minimum age higher than 18 years old. In addition, EPA notes that limitations on the use of RUPs falls 3450

under a different regulation, the Certification of Pesticide Applicators rule. Persons using restricted use 3451

pesticides in agriculture could be covered by both the WPS and the Certification of Pesticide Applicators 3452

rule. EPA has proposed establishing a minimum age for all users of RUPs under that rule (80 FR 51355

, 3453

August 24, 2015 ). 3454

EPA also disagrees with commenters’ assertions that EPA should defer to the states or the FLSA 3455

and not establish any age

- related restrictions on pesticide handling or early

- entry activ ities. EPA has the 3456

responsibility under FIFRA to regulate the use of pesticides to avoid unreasonable adverse effects, apart 3457

from any requirements established by other federal or state laws. The DOL’s actions under the FLSA 3458

limiting the use of certain pest icides to persons at least 16 years old do not preclude EPA from taking 3459

actions to ensure that human health and the environment are protected from unreasonable adverse 3460

effects. While DOL’s hazardous occupations order prohibiting those under 16 years old fr om handling 3461

certain pesticides satisfies the purposes of the FLSA, those purposes are distinct from those of FIFRA. 3462

EPA has concluded that because, as discussed previously, adolescents’ bodies, maturity, and judgment 3463

are still developing, the handling of a gricultural pesticides and entry into a treated area while an REI is in 3464

effect by persons under 18 years old presents an unreasonable likelihood of adverse effects. Therefore, 3465

the final rule generally limits pesticide handling and early

- entry activities to persons who are at least 18 3466

years old. 3467

EPA agrees that adolescents’ developmental status does not differ if they are employees on a 3468

farm owned by an immediate family or by someone unrelated to them. However, EPA recognizes that 3469

imposing a minimum age fo r handling agricultural pesticides or performing early

- entry tasks on owners 3470

or members of their immediate families could significantly disrupt some immediate family

- owned farms. 3471

Given the high social cost of imposing a minimum age requirement on f arms own ed by members of the 3472

same immediate family , EPA has finalized the proposed exemption to this requirement. See Unit XVII.A. 3473

3474

XI. Restrictions on Worker Entry into Treated Areas 3475

A. Requirements for Entry During an REI 3476

1. Current rule and proposal. The exist ing WPS establishes specific exceptions to the general 3477

prohibition against sending workers into a treated area while an REI is in effect. Workers who enter 3478

pesticide

- treated areas during an REI (known as “early

- entry workers”) without adequate protection 3479

m ay face an elevated risk from pesticide exposure. Under the existing rule, the employer must: Ensure 3480

that the worker has read or been informed of the human health hazards on the product labeling; 3481

provide instruction on how to put on, use, and remove PPE; s tress the importance of washing after 3482

removing the PPE; and instruct the worker on how to prevent, recognize, and treat heat

- related illness. 3483

The employer must also implement measures to prevent heat related illness when workers must wear 3484

PPE. 3485

In additio n to these existing requirements, EPA proposed to require employers to inform 3486

workers sent into a treated area while the REI is in effect of the specific exception under which they 3487

would enter, to describe the tasks permitted and any limitations required u nder that exception, and to 3488

identify the PPE required by the labeling. EPA also proposed to require the employer to create a record 3489

of the oral notification provided to early

- entry workers, to obtain the signature of each early

- entry 3490

worker acknowledging t he oral notification prior to the early entry, and to maintain the record for 2 3491Page 79 of 176 years. 3492

2. Final Rule. EPA has finalized the proposed requirements for the employer to inform the 3493

worker of the type of exception which permits the entry into the area under an REI, to describe the tasks 3494

that the worker may perform and other limitations under the exception, and to identify the PPE that 3495

must be worn. However, EPA has decided not to require employers to create or maintain records of the 3496

oral notification. The fina l regulatory text for this requirement is available at 40 CFR 170.605. 3497

3. Comments and responses. 3498

Comments on oral notification . Comments on the proposal to inform workers of the early

- entry 3499

exception and to explain the PPE were largely supportive, recognizing the reasonable nature of the 3500

proposed information. Commenters in support of the proposal included a pesticide manufacturer 3501

organization and farmworker advocacy organizations. One public health organization supported the 3502

proposal, but recommende d that the requirement be modeled after OSHA’s confined space regulations, 3503

to include: Specific training for early entry, a requirement for workers to be provided respirators and 3504

other necessary PPE, written emergency rescue procedures and resources in cas e of an overexposure or 3505

other mishap, on

- site monitoring of the worker from outside the entry zone, and recordkeeping of each 3506

entry. 3507

Several agricultural producer organizations and pesticide manufacturer organizations supported 3508

the proposal, but expressed concern for the requirement for employers to manage heat stress. 3509

EPA Response . EPA has decided not to amend the final rule based on OSHA’s confined space 3510

regulations. OSHA’s definition of a confined space is one in which there is limited or restricted m eans for 3511

entry or exit. These characteristics exacerbate any hazard to the employee, in that the employee could 3512

be overcome by a toxic atmosphere or by physical engulfment, such as in a grain storage bin, and be 3513

unable to quickly exit. EPA recognizes a sim ilar potential for pesticide handlers making fumigant 3514

applications in greenhouses to be overcome by the fumigant. The WPS provides protections for such 3515

scenarios by requiring PPE, including respirators where required by the label, and continuous monitoring 3516

by a handler outside of the treatment area. The handler entering the greenhouse would have specific 3517

instructions on the labeled hazards. The monitoring handler must have access to the PPE required by the 3518

product labeling in case they would need to enter t he greenhouse for rescue of the applicator. However, 3519

except for the use of fumigants, which have specific label requirements because of their increased 3520

potential for inhalation risk, the more common scenario of a worker entering a treated area on a farm, 3521

f orest, or in a nursery during the REI would not pose such risks from a toxic atmosphere. It is unlikely 3522

that there would be an environment that could concentrate the pesticide and produce a potentially life

3523

threatening environment. The predominant componen t of exposure during work in a treated area 3524

where an REI is in effect is dermal, with rare exceptions. Specific information about the entry must 3525

include the human health hazards on the pesticide labeling, explanation of the required PPE and the 3526

proper way to wear and remove PPE, description of the tasks that may be performed and any limitations 3527

on the time permitted in the area. Workers directed to enter a treated area during the REI must have 3528

had the pesticide safety training so they may protect themselves . Employers must provide the PPE 3529

required by the product label for early entry to minimize exposure. Employers must provide early

- entry 3530

workers with the decontamination supplies appropriate for pesticide handlers. 3531

EPA agrees with commenters that heat str ess can be a problem for workers in warm, humid 3532

climes and when employees must wear PPE. EPA notes that requirements related to heat stress for 3533

early

- entry workers are already included in the existing rule at 40 CFR170.112(c)(6)(x) and 170.112(c)(7)

, 3534

and E PA did not receive comments to indicate this requirement has posed a problem for employers in 3535

the past so EPA has retained in the final rule the requirement for employers to take appropriate 3536Page 80 of 176 measures to prevent heat

- related illness

. 3537

Comments in oppositio n to the early

- entry exceptions . A number of farmworker advocacy 3538

organizations voiced opposition, in general, to most or all of the early

- entry exceptions in the existing 3539

rule, suggesting that workers should not be required to enter treated areas under an REI, due to risk of 3540

exposure. 3541

EPA Response . In deciding whether to allow workers to enter treated areas prior to the 3542

expiration of the REI, EPA considered the risk to the workers and the benefits from the early

- entry 3543

activities. In each case, EPA determi ned that the potential risks to properly trained and equipped early

3544

entry workers are reasonable in comparison to the significant economic impacts from delaying 3545

necessary activities, provided that the required limitations to each exception are observed. 3546

Comments on recordkeeping of oral notification . Several farmworker advocacy organizations 3547

supported the recordkeeping requirement, stating that the “proposed changes will ensure early entry 3548

workers are adequately informed about the risks of the work they a re asked to do.” In contrast, several 3549

states and their organizations expressed concern for the recordkeeping requirement, stating that it is 3550

not practical and would result in technical violations, such as failures to obtain the necessary signatures, 3551

withou t enhancing worker protection. The SBA Office of Advocacy also commented that the 3552

recordkeeping and retention schedule would present a burden to small businesses. 3553

EPA Response . EPA was convinced by the rationale provided by the states and the SBA Office of 3554

Advocacy that the requirement for records of notification to early

- entry workers was too burdensome 3555

for agriculture, while adding little or no protections for the workers. Th ere is typically some urgency to 3556

the need for entry into a treated area while the REI is in effect; the added burden to create records 3557

during this time could be unreasonable as it would not necessarily increase protection of early

- entry 3558

workers. 3559

Comments on the use of the signal word to differentiate between handler and worker entry

. 3560

One academic suggested that handlers, having higher risk from pesticide exposure because they are in 3561

close contact with the pesticide, should have separate re

- entry intervals from workers. 3562

EPA Response . EPA agrees that handlers may experience higher rates of exposure to pesticides 3563

as a result of their direct contact with the concentrated form of pesticides as they mix, load, and apply. 3564

As a result, handlers making applicati on are often required to wear PPE for protection. In contrast, 3565

workers are most likely to have only dermal contact with the dried pesticides on the plants (although 3566

EPA’s risk assessments also account for possibility pesticide may contact their eyes) owing to the risk 3567

management measures EPA imposes during the pesticide registration process; these include application 3568

rates, application methods, and REIs based on degradation of the pesticide. Accordingly, the only 3569

workers who should need to wear PPE are ear ly

- entry workers. 3570

Comments on worker entry restrictions after applications. The commenter questions why EPA 3571

has established new REI requirements at § 170.107 of the proposed rule (in this final rule, the provisions 3572

appear at § 170.407(a) and (b)). 3573

EPA R esponse . The REI requirements identified in § 170.407 are similar to those in the existing 3574

rule at § 170.112. The additional content of the requirement informs the reader that, in addition to the 3575

requirement that the employer must not allow or direct any w orker to enter or remain in the treated 3576

area before the REI has expired, all treated area warning signs must be removed or covered before such 3577

entry is permitted, except for early entry under § 170.303. This clarifies the responsibility of the 3578

employer to ensure the posted information does not conflict with oral information. 3579

Comment on heat related requirements. A commenter agreed with the requirement for 3580

protections of workers entering a treated area during an REI, but expressed concern for heat effects t o 3581Page 81 of 176 workers in PPE. The commenter went on to state that incidence of heat stress is dependent on the 3582

individual worker and their sensitivity to heat, and suggested that EPA acknowledge this subjectivity to 3583

avoid legal jeopardy for employers. 3584

A state regula tory agency commented on the requirement for PPE, stating that is it reasonable 3585

to require the employer to provide the PPE, but the worker or handler may choose not to wear the PPE. 3586

This commenter stated that the rule should also hold the employee respons ible for wearing PPE. 3587

EPA Response . EPA agrees with commenters that heat stress can be a problem for workers in 3588

warm, humid climes and when employees must wear PPE. EPA notes that requirements related to heat 3589

stress for early entry workers are already inc luded in the existing rule at 40 CFR 170.112(c)(6)(x) and 3590

170.112(c)(7)

, and EPA did not receive comments to indicate this requirement has posed a problem for 3591

employers in the past so EPA has retained in the final rule the requirement for employers to take 3592

appropriate measures to prevent heat

- related illness. 3593

EPA disagrees with the comment that the rule should hold the worker responsible to wear PPE. 3594

The employer must ensure that the worker or handler wears the required PPE, and because the 3595

employer is ma king the pesticide use decision, the employer is responsible to ensure the required PPE is 3596

worn. 3597

Comment on information for workers . A farm bureau representative agree d that workers should 3598

have appropriate information to protect themselves, but question ed why the worker would need to 3599

know what pesticide was used or which exception applied. 3600

EPA Response . Should a pesticide exposure occur, response time may be critical if the employee 3601

is made ill. Informing the worker of the pesticide they may be exposed t o may motivate the worker to 3602

take appropriate precautions, and could be critical information should the worker later require medical 3603

attention. Knowing the nature of the REI exception will help the worker understand the scope of the 3604

tasks permitted under t he exception, and empower the worker to question work assignments that go 3605

beyond the scope of the particular exception. 3606

B. Clarify Conditions of the “No Contact” Exception 3607

1. Current rule and proposal . The existing WPS allows workers to enter areas while an REI is in 3608

effect for activities that do not result in contact with any treated surfaces. In the proposal, EPA sought to 3609

clarify the “no contact” requirement of the exception by explaining that perfo rming tasks while wearing 3610

PPE does not qualify as “no contact.” The proposal offered three examples of acceptable “no contact” 3611

activities. 3612

2. Final rule . EPA has finalized the proposed clarification. The final rule adds to the exception the 3613

following lan guage: “This exception does not allow workers to perform any activities that involve 3614

contact with treated surfaces even if workers are wearing personal protective equipment.” The final 3615

regulatory text for this requirement is available at 40 CFR 170.603(a)( 1). 3616

3. Comments and responses

. 3617

Comments . One farm bureau stated that workers are prevented from having contact with 3618

pesticides and their residues through the medium of PPE. 3619

EPA Response . Although PPE

– when properly fitted, worn, removed, cleaned and ma intained

– 3620

can provide significant protection against pesticide exposures, it does not eliminate exposure. The 3621

variation in exposure reduction offered by various types of PPE can be seen in EPA’s “Exposure 3622

Surrogate Reference Table” (http://www.epa.gov/opp 00001/science/handler

- exposure

- table.pdf). Use 3623

of PPE for activities involving contact with pesticide

- treated surfaces does not reduce risks to the same 3624

level as no

- contact activities. EPA has finalized the “no contact” exception as proposed because the PP E 3625Page 82 of 176 appropriate for early entry into treated areas under this exception is appropriate only for activities that 3626

do not involve contact with treated surfaces. 3627

Comments on the exception . One commenter stated that the exception cannot be considered 3628

to be “no contact” because the worker may be exposed from contaminated air or dust, and if they must 3629

dismount and repair the equipment they would be exposed to treated surfaces. The same commenter 3630

stated that restricting entry until 4 hours after the REI does not p revent harmful levels of exposure 3631

because pesticides continue to volatilize after application. 3632

EPA Response. EPA believes that the commenter may have misunderstood the extent of the no

3633

contact exemption. The no

- contact exception does not presume that the re is no risk of exposure ; in 3634

recognition of those risks, early entry is only permitted subject to the protections required by § 170.605 3635

(e.g., early

- entry PPE, meeting the minimum age of at least 18 year s old , access to decontamination 3636

supplies)

. The n o

- contact exception is limited to persons working in a treated area during the REI only if 3637

they will not contact, or be contacted by, pesticide residues from plants

, from the soil or planting 3638

medium, water with residues, such as water from a drainage ditch , or pesticides that remain suspended 3639

in the air after application. 3640

These conditions may be met by a worker performing tasks in a treated area after sprays, dusts, 3641

and vapors have settled out of the air, and the worker is: 3642

1. wearing footwear and is walking in aisles or on roads or paths through the treated area where 3643

plants or other treated surfaces cannot brush against the worker and cannot drop or drip 3644

pesticide on the worker, or 3645

2. in an open

- cab vehicle in a treated area where plants cannot brush against, or drop or drip 3646

pesticides onto the worker, or 3647

3. in a treated area after an application that is incorporated or injected into the soil and the worker 3648

is not disrupting the soil surface, or 3649

4. in an enclosed cab on a truck, tractor, or other vehicle. 3650

Under the exception the worker may not enter the treated area if the pesticide is suspended in 3651

the air, and may not contact any treated surfaces. 3652

C. Limit “Agricultural Emergency” Exception 3653

1. Current rule and proposal . The existing WPS permits entry into a treated area during an REI 3654

when a state, tribal, or federal agency having jurisdiction declares the existence of conditions that could 3655

cause an agricultural emergency. EPA proposed that only agricultural emergency determinations by EPA, 3656

state and tr ibal pesticide regulatory agencies, and state departments of agriculture, could authorize 3657

early entry under the agricultural emergency exception. 3658

In addition, EPA proposed to limit the time a worker may be in the treated area under the 3659

agricultural emerg ency exception when the label of the product used to treat the area requires both 3660

oral and written notification (“double notification”). Under the existing rule, there is no time limit; EPA 3661

proposed to establish allowing workers to be in a treated area und er this exception for a maximum of 4 3662

hours in any 24 hour period. 3663

2. Final rule . EPA has finalized the proposal, with one change. The final rule does not include EPA 3664

as an agency with authorization to declare the existence of conditions that could cause an agricultural 3665

emergency because EPA decided that States and Tribes are best situated to decide what conditions in 3666

their respective jurisdictions could constitute an agricultural emergency. The final regulatory text for this 3667

requirement is available at 40 CFR 170.603(c). 3668

3. Comments and responses

. 3669

Comments on restricting the declaration of an agricultural emergency . One state supported the 3670Page 83 of 176 proposal, but recommended broadening the declaration of an agricultural emergency to include the 3671

state governor. An other state found the proposal satisfactory. One grower organization opposed the 3672

proposal, stating that pre

- approval to enter the treated area would be cumbersome and unnecessary if 3673

the criteria are clearly defined and documented. Another grower organizati on and a farm bureau from 3674

the same state expressed concern that this change would seriously impact growers’ ability to enter a 3675

treated area to manage fires, fix broken irrigation and chemigation pipes, and address other problems 3676

that could pose risks to ad jacent public areas and cause crop loss. These commenters recommended 3677

that EPA develop guidance to instruct relevant municipal agencies such as local fire departments to 3678

declare agricultural emergencies. 3679

One department of agriculture stated that any entr y into a treated area during the REI should be 3680

subject to the early

- entry restrictions. This commenter stated that workers entering the area during an 3681

agricultural emergency exception should wear the PPE required by the labeling. 3682

Commenters also suggeste d that there is a need for entities other than EPA, state departments 3683

of agriculture and the state pesticide regulatory agencies to declare agricultural emergencies. In the 3684

examples provided by commenters, fires and broken irrigation or chemigation pipes c ould pose risks to 3685

the public and the crop. 3686

Two farm bureaus suggested that they did not receive specific information about the changes to 3687

the agricultural emergency exception and could not characterize its potential impact on producers . They 3688

recommend ed that EPA consult with state departments of agriculture and stakeholders to evaluate the 3689

impact and how the change would enhance worker safety. 3690

EPA Response . As described in the preamble to the proposed rule, EPA noted that entities other 3691

than the state p esticide regulatory agencies, state departments of agriculture, and EPA might not have 3692

the background and technical expertise to assess the benefits and risks to workers from the entry while 3693

the REI is in effect, and might not understand the statutory requ irement to consider both risks and 3694

benefits when establishing conditions for early

- entry workers. EPA decided not to include state 3695

governors as an entity authorized to declare an agricultural emergency because it is not necessary; a 3696

state governor could di rect the state department of agriculture or pesticide regulatory agency to 3697

determine whether conditions that could result in an agricultural emergency exist. 3698

The need for pre

- approval for conditions that may result in an agricultural emergency is a 3699

requir ement in the existing rule. EPA has responded to the concern of the grower organization through 3700

its Interpretive Guidance Workgroup on the existing WPS, which clarified that state pesticide regulatory 3701

agencies may establish guidance or regulations describi ng the circumstances that could constitute an 3702

agricultural emergency and for which entry into areas under an REI is permitted. If a grower determines 3703

that such conditions exist at a site, then workers may enter the area while the REI is in effect under the 3704

agricultural emergency exception, consistent with applicable restrictions. 3705

EPA has decided not to expand the declaring agencies to include municipal agencies such as 3706

local fire departments, but will work with state pesticide regulatory agencies and depar tments of 3707

agriculture to support the identification of circumstances that could constitute an agricultural 3708

emergency in their jurisdictions. EPA recommends that these entities identify, in their states, local 3709

conditions that could constitute such emergenci es. Through state regulation or by policy, these agencies 3710

may pre

- approve entry when such conditions occur. 3711

EPA agrees with the department of agriculture that entry into a treated area during the REI must 3712

be subject to the early entry restrictions, and t hat workers must wear the PPE described on the label 3713

during their work periods. 3714

Regarding the two responses suggesting that EPA consult with state regulatory agencies and 3715Page 84 of 176 stakeholders, EPA believes the comment opportunity associated with publication of t he proposed 3716

changes to the WPS addresse d that need. 3717

D. Codify “Limited Contact” and “Irrigation” Exceptions 3718

1. Current rule and proposal. EPA established exceptions from the REI for certain limited contact 3719

and irrigation activities as administrative exc eptions in 1995. Although these are noted in the existing 3720

rule at 40 CFR 170.112(e)(7), the terms and conditions of these exceptions are not included in the 3721

existing rule. These exceptions permit entry into a treated area under an REI for certain non

- hand labor 3722

activities, including irrigation. The existing exception for irrigation requires , among other things, that the 3723

need for early entry be unforeseen. 3724

EPA proposed to incorporate the terms and conditions for these exceptions into the final rule, 3725

and to eliminate the requirement for the need for irrigation to be unforeseen. 3726

2. Final rule . EPA has finalized the rule as proposed. The final regulatory text for this 3727

requirement is available at 40 CFR 170.603(d). 3728

3. Comments and responses

. 3729

Comments in su pport of the exceptions . Two farm bureaus and a state department of 3730

agriculture specifically supported the codification of the limited contact and irrigation exceptions. 3731

Comments in opposition to the exceptions . Two farmworker advocacy organizations expr essed 3732

concern for codifying these exceptions, stating that improvements in training and establishment of an 3733

age restriction cannot adequately mitigate the risks. In addition, two such organizations oppose d the 3734

relaxing of the early reentry restriction for irrigators, allowing early reentry even if the need for 3735

irrigation could have been foreseen before the pesticide application. They note that i rrigators are at high 3736

risk of pesticide poisoning because they tend to work long hours and because t hey also often work alone 3737

with no coworker to assist in calling for help in case of pesticide or heat illness. 3738

These commenter s also noted that the rule requires that contact be limited to the feet, lower 3739

legs, hands, and forearms. They cited a California study of exposure to irrigators that indicated that 3740

nearly 33% of exposure occurred to torso and arms after the REI had expired. One farmworker 3741

advocacy organization urged EPA to prohibit early entry for all pesticide applications, given the high risks 3742

fo r applicators. They state d that early entry should be only for true agricultural emergencies. Concerns 3743

were also raised for the need for irrigation that is for e seeable, with comments suggesting that the 3744

employer needs to be aware of the risks and should c onsider managing the timetable for irrigation so 3745

workers can enter before the pesticide treatment. 3746

EPA R esponse . EPA agrees that there is risk to workers from early entry, but believes that the 3747

new requirements of annual training and notification of the e arly entry that highlights the pesticides and 3748

risks from exposure

, combined with the existing PPE requirements and activity limitations, will 3749

adequately protect workers in early

- entry situations , including the limited contact and irrigation 3750

exceptions . Awa reness of the limitations of the exception, for example, the number of hours and type of 3751

work the worker may perform, and requirements for PPE that are required, will help the worker 3752

recognize risks and takes steps to minimize them

. EPA’s general prohibit ion against early entry is 3753

expected to limit worker exposure during the REI. In granting the exception for irrigation, EPA has 3754

weighed the risk from exposure against the benefits of early entry irrigation and finds justification for 3755

the exception. 3756

E. Elimi nate the Option for an Exception Requiring Agency Approval 3757

1. Current rule and proposal . Under the existing rule, an applicant may request approval from 3758

EPA for an exception to the prohibition on worker entry into a treated area during the REI for a speci fic 3759

need. EPA proposed to eliminate the process for requesting an exception from the rule. 3760Page 85 of 176 2. Final rule. EPA is finalizing the proposal to eliminate the provision for exceptions requiring 3761

Agency approval. 3762

3. Comments and responses. 3763

Comment. One grower opposed the elimination of the provision, citing the evolution of farming 3764

practices and the potential for conflict between new practices and the rule. The commenter stated that 3765

there is no administrative burden to the EPA, except to evaluate request s if they are submitted. 3766

EPA Response . EPA included the administrative exception process into the WPS in 1992 in 3767

recognition that the general prohibition on routine early entry might significantly affect various 3768

agricultural entities or practices in ways that might only become apparent as the 1992 WPS was put into 3769

effect. EPA created a small number of exceptions during the 1990s, but none since 1997. The effects of 3770

reentry intervals on agricultural entities and practices are now sufficiently well understoo d that the 3771

administrative exception process is no longer needed in the WPS. As explained in the preamble to the 3772

proposed rule, EPA finds the pesticide re

- evaluation process a more appropriate venue than the WPS for 3773

considering the economic impacts of REIs on particular agricultural entities and practices. Under EPA’s 3774

registration review process, applicants may request alternative REIs for specific needs for their crop. This 3775

process takes into account the potential increased risk to workers and the benefits to the production of 3776

the crop. In cases where EPA finds that the revision of an REI is warranted, the product label will be 3777

amended to specify the REI for that particular use. 3778

3779

XII. Display of Pesticide Safety Information 3780

A. Pesticide Safety Information Content 3781

1. Current rule and proposal. The existing rule requires employers to display a pesticide safety 3782

poster containing the following information: 3783

• Avoid getting on your skin or into your body any pesticides that may be on plants and soil, in 3784

irrigat ion water, or drifting from nearby applications. 3785

• Wash before eating, drinking, using chewing gum or tobacco, or using the toilet. 3786

• Wear work clothing that protects the body from pesticide residues (long

- sleeved shirts, long 3787

pants, shoes and socks, and a hat or scarf). 3788

• Wash/shower with soap and water, shampoo hair, and put on clean clothes after work. 3789

• Wash work clothes separately from other clothes before wearing them again. 3790

• Wash immediately in the nearest clean water if pesticides are spilled or sprayed on the body. 3791

As soon as possible, shower, shampoo, and change into clean clothes. 3792

• Follow directions about keeping out of treated or restricted areas. 3793

• There are federal rules to protect workers and handlers, including a requirement for safe ty 3794

training. 3795

The existing rule also requires the employer to provide contact information for the nearest 3796

emergency medical care facility and to promptly update the safety information poster when any of the 3797

required contact information changes. 3798

EPA propo sed changing the term for what employers must display from “pesticide safety 3799

poster” to “pesticide safety information.” EPA proposed retaining the existing content requirements of 3800

the existing rule, with one exception. EPA proposed removing the item regard ing federal rules to allow 3801

the other information to be more prominent. EPA proposed retaining the requirement to display the 3802

contact information for the medical facility and amending the language from “nearest emergency 3803

medical care facility” to “a nearby operating medical facility.” Finally, EPA proposed requiring the 3804Page 86 of 176 employer to provide on the display the name, address, and telephone number of the state or tribal 3805

pesticide regulatory agency. 3806

2. Final rule. EPA has finalized the proposed requirements for content, and has added a point to 3807

the proposed display requirements that advises workers and handlers to seek medical attention as soon 3808

as possible if they believe they have been made ill from pesticides. EPA has also amended one of the 3809

existing required p oints to clarify that if pesticides are spilled or sprayed on the body, workers and 3810

handlers should rinse immediately in the nearest clean water if more readily available than the 3811

decontamination supplies, and should wash with soap and water as soon as pos sible. The final rule 3812

refers to the requirement as “pesticide safety information” and allows display of the information in any 3813

format that meets the requirements of the rule, rather than only as a pesticide safety poster. EPA has 3814

included a requirement in the final rule for the employer to update the pesticide information display 3815

within 24 hours of notice of any changes to the medical facility or pesticide regulatory agency contact 3816

information. Finally, EPA has provided an option in the regulatory text that allows employers to comply 3817

by following the requirements at 40 CFR 170.311(a)(1)

- (4) before they are fully implemented. The final 3818

regulatory text for these requirements is available at 40 CFR 170.311(a)(1)

- (4). 3819

The final rule delays implementation of th e changes to the required pesticide safety information 3820

until two years after the rule is made final, in order to allow time for model pesticide safety information 3821

display materials to be developed and distributed. 3822

3. Comments and responses. 3823

Comments. Fa rmworker advocacy groups and public health organizations supported the 3824

emergency medical care change and inclusion of the state or tribal agency responsible for enforcement. 3825

However, they urged implementation sooner than the proposed two years from the eff ective date of 3826

the final rule. One commenter reported that a recent survey they conducted indicated that 25% of 3827

respondents did not complain about pesticide

- related health problems or pesticide applications to the 3828

fields while they were working because the y did not know to whom to complain and 62% feared losing 3829

their jobs if they were to complain. 3830

In general, agricultural producer organizations, states and a pesticide registrant organization did 3831

not object to the proposed changes for providing emergency me dical information but several 3832

commenters were concerned about spurious reporting of alleged violations resulting from inclusion of 3833

the state or tribal regulatory agency in the pesticide safety information. Commenters suggested that 3834

EPA should carefully mon itor any reports of alleged violations and work with state and tribal agencies to 3835

monitor whether such reports are well

- founded and whether the information is being used by others as 3836

a means of pursuing agendas unrelated to worker protection. Several comme nters interpreted the 3837

proposal as requiring injured workers to contact state or tribal agencies responsible for enforcement for 3838

emergency medical attention. Several commenters requested that EPA state and clarify the purpose for 3839

posting the regulatory agen cy contact information (i.e., for worker protection). One state requested that 3840

EPA be less prescriptive of which agency contact information is provided because in some states, the 3841

lead agency for pesticide enforcement may have counterpart agencies that als o enforce pesticide

3842

related issues and jointly enforce the WPS. 3843

A grower organization pointed out that the nearest operating medical facility might change 3844

depending on the time of day and wondered if the employer would need to list hours of operation and 3845

addresses of all emergency medical care facilities in the area where the employer operates. 3846

One grower organization objected to including the regulatory contact information as part of the 3847

pesticide safety information display. One state argued that addin g the regulatory agency contact 3848Page 87 of 176 information to the poster would be redundant, because it is already available from many different 3849

sources, and impractical to implement at the state or employer level. 3850

One commenter suggested the safety poster should alway s be in a standardized format and 3851

requested that EPA not allow the information to be displayed in several different formats. 3852

Several commenters suggested that in addition to requiring the pesticide safety information 3853

display to contain information on the nearest medical facility, EPA should also require the display to 3854

include instructions for workers and handlers to notify their employer as well in the event of a medical 3855

emergency. 3856

EPA Response. EPA has concluded that there was general support for the proposed requirement 3857

regarding the content of the safety information display, including the proposal to add contact 3858

information for the pesticide regulatory agency. EPA has delayed implementation of the final 3859

requirements for two years after publication of the final rule to allow time for display material to be 3860

updated, printed and distributed. However, EPA encourages employers to implement the new 3861

requirements prior to that date by allowing employer s the option to use either the existing or the new 3862

safety information content prior to the implementation date. 3863

In response to concerns about the placement of the medical facility information and the 3864

inclusion of regulatory agency information in the displ ay, EPA has revised the regulatory text to clarify 3865

that the contact information about the medical facility must be clearly identified as the emergency 3866

medical contact information on the display. Further, the regulatory text separates the requirements to 3867

di splay the contact information for the medical facility and the contact information for the regulatory 3868

agency information. Displaying the regulatory agency information is important for the ability of workers 3869

and handlers to report possible violations, and i n those states where it is already required, it does not 3870

appear to have generated spurious reporting of alleged violations. EPA appreciates that some states 3871

may already require employers to make such medical and regulatory information available and where 3872

s tate requirements meet or exceed the federal requirement, they do not need to be duplicated. 3873

However, EPA has added this requirement to the WPS to ensure the information is available to workers 3874

and handlers in all states. 3875

EPA will work with states during and after implementation of the WPS to identify issues, 3876

including any problems with implementation of the revised pesticide safety information display 3877

requirements. EPA does not anticipate any systematic monitoring of reports of alleged violations, either 3878

to determine whether such reports are well

- founded or whether the information is being used by others 3879

as a means of pursuing agendas unrelated to worker protection. If issues of abuse arise, EPA would 3880

anticipate working with the pertinent state or tribal regulatory agency as needed. 3881

EPA disagrees with the request that the pesticide safety poster specify the purpose for providing 3882

contact information for the regulatory agency. Workers and handlers will receive training on the 3883

employer’s responsibility to pr ovide pesticide safety information and on how to report suspected 3884

pesticide use violations to the s tate or t ribal agency responsible for pesticide enforcement (i.e., call the 3885

number on the pesticide safety information display). EPA believes including this information in the 3886

training for workers and handlers, rather than explaining on the display the rationale for including the 3887

regulatory contact information

, balances the need to provide workers and handlers with contact 3888

information and the concerns of some stakeholders that providing this information will result in 3889

spurious and unnecessary calls to regulatory agencies. 3890

EPA has not amended the final regulatory requirements in response to comments requesting 3891

that the regulation be less prescriptive in requiri ng the display to include contact information for the 3892

pesticide regulatory agency. The regulatory language does not specify that only a single agency 3893Page 88 of 176 responsible for enforcement of the WPS must be included on the display; rather, it requires “[t] he name, 3894

a ddress and telephone number of the State or Tribal pesticide regulatory agency .” 40 CFR 3895

170.311(a)(3)(x). EPA interprets this requirement to be flexible enough to allow the inclusion of 3896

information for multiple agencies when multiple agencies in the state are responsible for WPS

- related 3897

regulatory activities. 3898

EPA disagrees with commenters who asserted that it is unnecessary to include the regulatory 3899

agency contact information as part of the pesticide safety information display. While this information 3900

may be available from multiple sources within the state, it may not be readily accessible to workers and 3901

handlers. Workers and handlers receive training on reporting suspected violations and need to know 3902

where and how to find the contact information in order t o do so. Including the regulatory agency 3903

contact information in a standard location, i.e., as part of the pesticide safety information display, 3904

ensures that workers and handlers will know where to look for this information if and when they need 3905

it. 3906

EPA is finalizing the proposed requirement to identify a nearby operating emergency medical 3907

care facility to simplify the requirement in situations where the nearest operating emergency medical 3908

facility varies with the location of workers and handlers. 3909

EPA disa grees with the comment requesting that the information be displayed in a standardized 3910

format. As long as the information is provided in a way that workers and handlers can understand, EPA 3911

sees no need to mandate a specific format. 3912

EPA disagrees with the r equests to include in the pesticide safety information display 3913

instructions for workers and handlers to notify their employer in the event of a medical emergency. 3914

Workers and handlers may notify their employer, and many may do so to request transportation for 3915

medical treatment or to report the incident. However, EPA has chosen not to include instructions to 3916

contact the employer as part of the safety display because in the event of an emergency, the most 3917

critical information for a worker or handler is the lo cation of the nearest medical facility. EPA does not 3918

want to give workers and handlers the impression that they must delay seeking treatment to inform 3919

their employers that an incident has occurred. 3920

B. Location of Pesticide Safety Information Display 3921

1. Cu rrent rule and proposal. The existing rule requires agricultural and handler employers to 3922

display the pesticide safety poster at a central location on the establishment. EPA proposed to require 3923

that agricultural employers display the pesticide safety infor mation at locations where decontamination 3924

supplies must be provided, in addition to the existing requirement to display it at a central location. 3925

2. Final rule. In the final rule, EPA has amended the proposal to require that in addition to 3926

displaying pes ticide safety information at a central location, employers must also display it at permanent 3927

decontamination supply locations and where decontamination supplies are provided in quantities to 3928

meet the needs of 11 or more workers or handlers. The final regul atory text for this requirement is 3929

available at 40 CFR 170.311(a)(5). 3930

3. Comments and responses

. 3931

Comments . Farmworker advocacy organizations and public health organizations supported 3932

requiring display of pesticide safety information where decontamination supplies are provided for easy 3933

access to safety information for farm workers and families at strategic locations. They asserted that this 3934

would improve the ability of farmworkers and their families to stay healthy. They maintained that due to 3935

language bar riers, immigration status, and fear of retaliation, farmworkers are often reluctant to ask 3936

their employers for information. Three individual farmworkers also commented on the proposed rule 3937

and echoed concerns expressed by farmworker advocacy groups and pub lic health organizations. The 3938Page 89 of 176 commenters requested clear information in Spanish and English at a central location with easy access 3939

that includes telephone numbers, places to go for help, and hospitals in the area. They stated that it was 3940

important that emp loyers give farmworkers the necessary information about the pesticide application 3941

without workers having to ask for information. About half of the grower organizations commenting had 3942

no objection to the additional mandate on employers and agreed that the a dditional reminders at 3943

decontamination sites have potential benefits. One farmworker advocacy organization recommended 3944

that EPA also require pesticide safety information to be displayed near where workers enter treated 3945

areas to remind workers to avoid comi ng into contact with pesticides before exposures occur. 3946

Some grower organizations asserted that the proposed requirement would pose a significant 3947

burden. One commenter stated that duplicating the pesticide safety information at multiple sites 3948

throughout a n agricultural organization did not equate to a better training program and believed this 3949

requirement would likely result in additional fines for noncompliance without raising safety awareness. 3950

To support the claim of additional burden without commensurate benefit, a commenter asserted that if 3951

a person views the same information in the same location repeatedly, he or she will soon disregard the 3952

information. Some grower organizations pointed out that workers are bused in for a day in the field and 3953

irrigators are sent to different areas by phone; none of these congregate at a central location. 3954

Some grower organizations and a state supported only retaining the requirement to display 3955

pesticide information at the central display. A few grower organizations reco mmended that EPA allow 3956

for the pesticide safety information to be displayed either at a central location on the establishment or 3957

at decontamination sites. One grower organization recommended that EPA require that only emergency 3958

contact information, rather than the proposed pesticide safety information, be posted at 3959

decontamination sites. 3960

One grower organization raised concerns with the requirement for the pesticide safety 3961

information display to be accessible when it is required to be posted, noting that i t would be impractical 3962

and troublesome for workers to have 24

- hour access to vehicles and equipment where pesticide safety 3963

information would be required to be displayed. 3964

Many states opposed displaying the pesticide safety information at all decontaminatio n sites. 3965

Because of the mobile nature of many decontamination sites, such as the back of a pickup truck, many 3966

noted the proposed requirement would be burdensome. One indicated that it would be difficult for a 3967

grower owning fields across multiple counties t o keep the pesticide safety information accurate. States 3968

generally supported displaying the pesticide safety information at permanent decontamination sites and 3969

base of operation mix/load sites. Several states asked for clarification about what types of 3970

dec ontamination sites would be required to display the pesticide safety information. States suggested 3971

that permanent or fixed decontamination locations, such as portable toilet facilities and plumbed wash 3972

sites would be more appropriate locations for displayi ng the pesticide safety information than portable 3973

decontamination kits commonly carried by irrigation workers and others. 3974

Other states mentioned the lack of protection from the weather of the pesticide safety 3975

information at OSHA

- required restroom facilit ies and the lack of access to this information when the 3976

vehicles carrying decontamination supplies are locked up at night. Two states recommended different 3977

sizes for the pesticide safety information. One state suggested that pesticide safety information di splays 3978

be no larger than 11 x 17 inches and laminated to withstand at least one year’s worth of weather 3979

conditions for use at decontamination sites; this state also recommended resizing the existing pesticide 3980

safety information to 8.5 x 11 inches or less a nd made of durable card stock or plastic for the agricultural 3981

workers to take home. Another state recommended the safety sign be available in different sizes to 3982

accommodate displaying it at various sites. 3983Page 90 of 176 One state recommended providing different pesticid e safety information displays for workers 3984

and handlers, with information more specifically targeted to each audience. The commenter 3985

recommended that a handler safety display include primary instructions on how to remove pesticide

3986

contaminated clothing, how to properly wash off pesticide residues in the eyes and skin, and what to do 3987

after these two processes are complete. Some states asserted that the poster is mainly targeted to 3988

workers. 3989

EPA Response. EPA agrees with the commenters who supported requiring safety information 3990

displays at a central location and anywhere decontamination supplies must be provided because the 3991

information is a useful reminder of the hygienic safety principles from their training. However, EPA was 3992

persuaded by arguments that the b urden to display the information at mobile decontamination sites 3993

could be substantial, based on concerns for their ability to display the information so that it could be 3994

easily seen by workers, such as by posting it on a vertical surface. The final rule r equires employers to 3995

display the information at the central display and all permanent sites, including a lavatory or bathroom, 3996

where decontamination supplies are provided to meet the requirements of the rule. However, for other 3997

locations where decontaminat ion supplies must be provided (certain non

- permanent sites) , the 3998

pesticide information display is required only when the supplies are provided for 11 or more workers or 3999

handlers. This aligns with OSHA’s field sanitation standard that requires toilet facili ties for 11 or more 4000

workers. EPA notes that employers may use these portable toilet facilities or permanent wash sites to 4001

display the information, as recommended by some states. 4002

EPA disagrees that with the request to require pesticide safety information t o be displayed near 4003

where workers enter treated areas. The final regulation, requiring the poster to be displayed at a central 4004

location, at permanent decontamination sites, and at sites where decontamination supplies are being 4005

provided for 11 or more emplo yees, balances the burden on employers to post and maintain the display 4006

with the need to provide workers and handlers with pesticide safety information where supplies for 4007

addressing potential exposure are available. Workers and handlers receive training on the importance of 4008

preventing exposure. Requiring the pesticide safety information to be displayed at each entrance to 4009

treated areas would substantially increase the burden on employers to post and maintain the 4010

information that would not be outweighed by b enefits to workers. 4011

EPA does not agree with the contention that requiring the pesticide safety information display 4012

at multiple locations would result in fines for noncompliance without greatly benefiting the employee. 4013

The pesticide safety information disp lay reinforces the hygienic training principles from the safety 4014

training, and when coupled with access to decontamination supplies, offers a hands

- on opportunity for 4015

workers and handlers to adopt these practices. Additionally, information about medical fac ilities 4016

available to workers and handlers where they may be exposed to pesticides may help them take steps to 4017

respond to an emergency. 4018

EPA disagrees with requests to require display of the pesticide safety information only at the 4019

central display or to offer the option to display it at either a central display or decontamination sites. 4020

Posting at decontamination sites is beneficial because the information would be readily available in an 4021

emergency, because EPA assumes many emergencies may involve some de contamination efforts. 4022

Having the display at the central location allows workers and handlers access to information such as the 4023

emergency medical assistance and regulatory agency contact numbers at the same place they can find 4024

information about pesticides recently applied on the establishment. 4025

EPA disagrees with the request to require only emergency contact information, rather than the 4026

proposed pesticide safety information, to be posted at decontamination sites because the pesticide 4027

safety information prov ides helpful information to workers and handlers about washing after potential 4028Page 91 of 176 exposure. Requiring this information at the site where supplies for decontamination are provided 4029

reminds workers and handlers about these hygienic practices at the point where t hey can take action. 4030

In response to concern that requiring the pesticide safety information to be accessible could be 4031

impractical and troublesome, and might result in employers having to ensure that workers have 24

- hour 4032

access to vehicles and equipment wh ere pesticide safety information would be required to be displayed, 4033

EPA notes that the pesticide safety information must be displayed only “ if workers or handlers are on 4034

the establishment and within the last 30 days a pesticide product has been used or a r estricted

- entry 4035

interval for such pesticide has been in effect on the establishment.” 40 CFR 171.309(h). At times when 4036

no workers or handlers are on the establishment, the employer would not need to provide or ensure 4037

access to locations where the pesticide safety information is displayed. Further, the final rule 4038

requirement limits the locations where pesticide information must be displayed to the central location, 4039

permanent decontamination sites, and sites where decontamination supplies are being provided f or 11 4040

or more employees. 4041

EPA appreciates the comments regarding display size and options for lamination. The final rule 4042

does not establish a specific size for the information or require it to be laminated. However, the final 4043

rule requires the information to be legible at all times while it is displayed, and EPA expects that 4044

employers will opt for the optimal size and protection from the elements for their specific needs. 4045

Because the final rule limits the type of decontamination sites covered by this requir ement and includes 4046

flexibility for identifying the regulatory agency and a nearby operating emergency medical care facility, it 4047

is possible but unlikely that some growers with larger establishments may need to provide different 4048

specific contact information about the regulatory agency and/or the medical facility, depending on the 4049

area where workers or handlers are working. 4050

Commenters suggested the information be available in English and Spanish. EPA notes that the 4051

requirement is for the information to be p rovided in a manner that the workers and handlers can 4052

understand, which may include making it available in English and Spanish, or in other languages as 4053

appropriate. 4054

EPA plans to develop and make available to agricultural and handler employers posters be aring 4055

the pesticide safety information, in a bilingual and pictorial format and with space for employers to add 4056

the required regulatory agency and medical facility information. As discussed in the proposed rule, the 4057

information does not have to be displaye d as a poster as long as the display includes the required 4058

information and meets the requirements of the section. 4059

EPA disagrees with the commenter’s request to provide different pesticide safety information 4060

displays for workers and handlers. The pesticide safety information display reminds workers and 4061

handlers about basic pesticide safety and hygienic principles that apply to both audiences. Developing 4062

and maintaining separate pesticide safety information displays for workers and handlers could result in 4063

a significantly higher burden on employers without providing substantial additional benefit to workers 4064

and handlers. 4065

4066

XIII. Decontamination 4067

A. Clarify the Quantity of Water Required for Decontamination 4068

1. Current rule and proposal . The existing rule requir es employers to provide “enough water for 4069

routine washing and emergency eye flush” when workers are performing activities in areas where a 4070

pesticide was applied and the REI has expired. For early

- entry workers, the existing WPS requires 4071

employers to provid e “a sufficient amount of water” for decontamination. The existing WPS requires 4072

employers to provide handlers with “enough water for routine washing, for emergency eye flushing and 4073Page 92 of 176 for washing the entire body in case of an emergency.” EPA proposed to requi re specific quantities of 4074

water for workers, early

- entry workers and handlers based on its 1993 guidance, “How to Comply with 4075

the Worker Protection Standard for Agricultural Pesticides; What Employers Need to Know.” In the 4076

guidance, EPA recommended one gal lon of water per worker for routine decontamination, three gallons 4077

of water for early

- entry workers for decontamination and three gallons of water per handler for routine 4078

handwashing and potential emergency decontamination. 4079

EPA requested comment on the p roposed quantities of water and the use of waterless cleansing 4080

agents in place of soap, water, and single

- use towels. EPA also requested information on the efficacy of 4081

waterless cleansing agents for removing pesticide residues. 4082

2. Final rule . EPA has fina lized the proposed decontamination water requirements. EPA has also 4083

clarified that employers must make the required quantities of water and other decontamination 4084

supplies available at the beginning of the work period. The final rule does not allow waterle ss cleansing 4085

agents to be used in place of water, soap, and single

- use towels. The final regulatory text for these 4086

requirements is available at 40 CFR 170.411(b), 170.509(b) and 170.605(h). 4087

3. Comments and responses. 4088

Comments . A majority of commenters s upported the proposal to require one gallon of water 4089

per worker for routine decontamination, three gallons of water for early

- entry workers for 4090

decontamination and three gallons of water per handler for routine washing and emergency 4091

decontamination

, but ma ny requested clarification of the time frame associated with the supply

. T hey 4092

wondered if the prescribed amounts were the maximum quantity per site or per number of workers, the 4093

minimum amount at the beginning of the day or at all times during the work per iod. Of the 14 s tate 4094

pesticide regulatory agencies that commented, six supported the codification of the guidance to require 4095

that employers provide 1 gallon of water per worker for decontamination and 3 gallons of water per 4096

handler for routine washing and emergency decontamination. Eight agencies requested clarification of 4097

these quantities; they recommended that the quantity be indicated as the maximum per site or per 4098

number of workers; they also questioned whether the quantity was to be available at the be ginning of 4099

the day, throughout the day, or at the end of the day. A state department of agriculture pointed out that 4100

requiring a change of clothing for workers will place a large burden on employers. Eight public health 4101

agencies and academics commented on the proposed specific quantities for workers and handlers. Two 4102

of the commenters recommended following the requirements in American National Standards Institute 4103

( ANSI ) Z358.1

- 2009 while one recommended that EPA follow the OSHA requirements (29 CFR 1928.110 ) 4104

and the California field sanitation standards. One commenter did not believe water could remove oil

4105

based pesticide products and would therefore not be effective for decontamination of oil

- based 4106

pesticide products. Eight farmworker advocacy organization s expressed support for the proposed 4107

quantities of water but urged EPA opt for the stronger protections offered by OSHA and ANSI for 4108

workers and handlers. Of the seven growers and grower organizations, four were generally supportive 4109

but requested clarifica tion of the time period in which the gallons per worker or handler would be 4110

required. Two grower organizations urged coordination with the OSHA requirements or adoption of the 4111

OSHA requirements. Only one grower organization believed that it was a mistake t o specify quantities of 4112

water for workers and handlers. Of the five farm bureaus that commented, four did not support the 4113

proposed quantities of water; these four supported maintaining the existing rule requirements. Some of 4114

the reasons the commenters incl uded: a large number of workers would mean an impractical amount of 4115

water; the existing language on a “sufficient” amount of water adequately addresses this problem; and a 4116

“specific amount of water may re

- direct compliance from actions that are clearly foc used on worker 4117

safety to merely technical considerations.” One farm bureau understood the proposal to be clarification 4118Page 93 of 176 and codification of existing compliance expectations. A pesticide manufacturer organization 4119

commented that the quantities were reasonabl e but prescriptive. This commenter requested 4120

clarification about the time period for the water requirements; as an example, the commenter 4121

wondered whether the water for handlers would be required at the beginning of the day or at all times. 4122

An agricultural organization was supportive and agreed with EPA that it is important to have proper 4123

decontamination supplies available. Two other organizations recommended that EPA incorporate the 4124

ANSI/OSHA standards. 4125

Two farmworker advocacy organizations, one public he alth organization, one farm bureau, one 4126

pesticide manufacturing organization and one grower organization commented on whether waterless 4127

cleansing agents should be used in place of soap, water, and single

- use towels to remove pesticide 4128

residues. Two comment ers did not support replacing soap and water with the waterless cleansing 4129

agents; they stated that alcohol

- and chemical

- based waterless cleansing agents were designed to kill 4130

bacteria and not remove pesticide residues. Waterless wipes designed to remove d irt and grime were 4131

also not an acceptable substitute for soap and plenty of clean water. The remaining commenters were in 4132

favor of using the waterless cleansing agents. One commenter felt it would be reasonable for routine 4133

worker decontamination but not pr actical for handler decontamination. Two commenters requested 4134

that EPA evaluate the use of such agents, but did not provide any data on the efficacy of these agents to 4135

assist in the evaluation. Only one commenter argued for use of the waterless cleansing a gent if it was a 4136

neutralizer. This particular commenter provided a reference indicating that Reactive Skin 4137

Decontamination Lotion (RSDL©) would be effective against organophosphates. 4138

EPA Response . EPA notes that the proposed quantities of water for decont amination are 4139

intended for agricultural settings that are not subject to the field standards of OSHA and ANSI . The WPS 4140

requirements are meant to be protective, flexible and not overly burdensome in agricultural settings 4141

where OSHA’s field sanitations do no t apply. In the final rule EPA is requiring a minimum of 1 gallon of 4142

water per worker and a minimum of 3 gallons of water per handler. Based on comments, EPA has 4143

clarified that the specified amount of supplies be available at the beginning of the work peri od and that 4144

they are to be calculated per worker and per handler. The final rule does not require the replenishment 4145

of used supplies until the beginning of the next work period. As for the comment that water would not 4146

remove oil

- based pesticide products, t hat is why the rule requires soap be provided with the 4147

decontamination supplies. The use of soap and water as a first response measure in the field should 4148

help remove enough of these pesticides to provide some immediate removal and protection from 4149

exposur e before accessing more effective decontamination measures that may be more protective. EPA 4150

acknowledges the proposed requirement for a change of clothing for workers was inadvertently 4151

included in the proposed regulatory text and that was a mistake so it h as been removed in the final rule. 4152

The information supplied by commenters was insufficient to convince EPA to replace water, 4153

soap, and single

- use towels with a waterless cleansing agent. The reference provided for one waterless 4154

cleansing agent was usefu l but not a practical solution because it appeared it would only be effective 4155

against organophosphate pesticides, so this particular agent would be of limited use. Workers and 4156

handlers are likely to encounter more than one family of pesticides in their wo rk, so water and soap 4157

would still be necessary for other pesticides. Therefore, EPA is requiring in the final rule that the 4158

employer supply water, soap, and single use towels in quantities sufficient to meet the worker’s and 4159

handler’s needs. Hand sanitizin g gels and liquids or wet towelettes do not meet the requirement for 4160

soap. Wet towelettes do not meet the requirement for single

- use towels. 4161

B. Eliminate the Substitution of Natural Waters for Decontamination Supplies 4162Page 94 of 176 1. Current rule and proposal . For sit es where worker or handler activities are farther than one

4163

quarter mile from the nearest vehicular access, the existing rule permits employers to allow workers and 4164

handlers to use clean water from springs, streams, lakes or other sources (“natural waters” for the 4165

purposes of this section) for decontamination, if such water is more accessible than the employer

4166

provided water. The employer must ensure any water used for decontamination, including natural 4167

waters, is of a quality and temperature that will not c ause illness or injury. EPA proposed to eliminate 4168

the provision that allows employers to permit workers and handlers to substitute natural waters for the 4169

required decontamination supplies at remote sites. For remote sites, the proposal would have 4170

maintaine d the existing requirement for employers to provide all decontamination supplies (soap, 4171

single

- use towels, clean change of clothing and water) at the nearest point of vehicular access. However, 4172

the existing regulation does not permit substitution of waters from natural sources for the 4173

decontamination water at the point of nearest vehicular access, and EPA’s proposed change 4174

mischaracterized the existing requirements. 4175

2. Final rule . In the final rule, EPA has removed from the regulatory text the provision th at allows 4176

employers to permit workers and handlers to use clean water from springs, streams, lakes or other 4177

sources if that water is more accessible in remote locations where the decontamination supplies are 4178

farther than one

- quarter mile from where workers and handlers are working. EPA is taking this approach 4179

to remove confusion about the employer’s responsibilities. The employer must always provide the 4180

decontamination supplies in quantities outlined in the regulation. When workers or handlers are 4181

performin g tasks at remote sites more than one

- quarter mile from the nearest point of vehicular access, 4182

employers must provide all required decontamination supplies (soap, single

- use towels, and water, plus 4183

clean change of clothing if required) at the nearest point of vehicular access. Under the final rule, 4184

employers are required to make the decontamination supplies available as close as possible to the 4185

remote site (as determined by how close a vehicle can get) and employers do not have to check or 4186

confirm that wate r from springs, streams, lakes or other sources at remote sites meets the standard of 4187

being of a quality and temperature that will not cause illness or injury. EPA has amended the training 4188

requirements to cover the proper use of natural waters at remote si tes by workers and handlers. EPA 4189

believes that workers and handlers in these remote areas should primarily rely on the decontamination 4190

water that is provided by the employer for routine washing and emergency decontamination because 4191

the quality of the natur al waters at the remote site is unknown. In case of an overexposure, such as a 4192

spill, contact from drift, or direct spray, workers and handlers should always use the emergency 4193

decontamination supplies if they are more readily available. However, training w ill emphasize that 4194

workers or handlers should rinse immediately using the nearest source of clean water to mitigate the 4195

exposure, and to use the nearest source of clean water, including springs, streams, lakes or other 4196

sources, if more readily available th an the decontamination supplies. Workers and handlers will be 4197

advised through training that as soon as possible they should decontaminate thoroughly with the soap, 4198

water and towels provided by the employer and, if available, change into clean clothes. EPA plans to 4199

modify training materials to incorporate this information. The final regulatory text for worker and 4200

handler decontamination is available at 40 CFR 170.411(d), 170.509(c), and 170.605(h)

- (j). 4201

3. Comments and responses. 4202

Comments . Many commenters supported not using natural waters to replace the required 4203

decontamination supplies. Several commenters also supported the need for employees to access the 4204

nearest clean water in case of an emergency or significant exposure. Seven state pesticide regulator y 4205

agencies commented on the proposal. Two of the agencies said they would support the proposal if use 4206

of the natural waters were allowed for emergency decontamination. Five agencies supported the 4207Page 95 of 176 proposal but commented that the term “natural waters” was co nfusing; they suggested replacing the 4208

term with “water of a quality and temperature that will not cause further injury.” One agency felt the 4209

proposal complicated matters without a clear benefit. Three public health organizations and academics 4210

supported the proposal. One suggested that the use of natural waters for decontamination should be 4211

managed without letting the pesticides enter public waters. Another commenter suggested that in a 4212

true emergency, it was important to use whatever water was available. T wo farmworker advocacy 4213

organizations supported the proposal to eliminate the exemption allowing employers to use natural 4214

bodies of water in place of the required decontamination supplies. The y suggested that the actual 4215

cleanliness of the natural bodies of water was unknown and expressed concern that the quality of the 4216

natural waters might be questionable and not the best choice for decontamination. Of the four growers 4217

and grower organizations t hat commented, three did not support the proposal. One commenter said 4218

the use of natural waters should be reserved for true emergency situations; for immediate 4219

decontamination, the employee should use whatever water is available. Three farm bureaus 4220

commen ting on this proposal did not support the proposal and urged EPA to discard it. One farm bureau 4221

suggested that employees be allowed to use natural water bodies to supplement needs in the event of 4222

an emergency. Finally, one farm bureau commenter stated that large scale planting activities can place 4223

workers more than one

- quarter mile from vehicular access, and retaining the existing requirement is 4224

more reasonable than expecting workers to carry washing water with them. 4225

EPA Response. EPA maintains its positio n that the employer

- provided decontamination supplies, 4226

provided within one

- quarter mile of the workers and handlers

– or in remote areas, at the nearest point 4227

of vehicular access to worker and handler work sites

– are the appropriate supplies for routine w ashing 4228

and emergency decontamination. The employer must ensure this water meets the minimum criteria for 4229

quality. However, EPA agrees with commenters that prompt washing in clean water is an important step 4230

in reducing overexposure, for example, from a spil l, contact from drift, or direct spray. EPA has identified 4231

acute incidents that would have been mitigated if the exposed worker or handler had decontaminated 4232

promptly. EPA is concerned that the existing requirements for employers to ensure the quality of n atural 4233

waters prior to their use and for employers to specifically permit the use of natural waters will prevent 4234

workers and handlers from using these waters to decontaminate in case of an emergency. Ensuring the 4235

quality of all natural waters on their esta blishment could be burdensome for employers, and as a result 4236

they might not evaluate the quality or permit the use of natural waters. 4237

To ensure that workers and handlers needing emergency decontamination can use water that is 4238

more accessible than the dec ontamination water provided by the employer, the rule permits the use of 4239

natural waters for emergency decontamination by not prohibiting the use of such waters by workers 4240

and handlers. The employer is not required to predetermine that the quality of such w ater meets the 4241

criteria for the rule since it is not provided as the water for decontamination supplies, but is merely 4242

available for their employees to access in an emergency situation. The employer is still required to 4243

supply separate water for decontami nation and to assure that the quality of the supplied water meets 4244

the criteria of the rule. Workers and handlers seeking to mitigate an emergency exposure will be 4245

informed in their training to use the nearest clean water to immediately rinse off if such w ater is more 4246

readily available than the employer

- provided decontamination supplies, and then go to where the 4247

employer

- provided supplies are to fully decontaminate. EPA believes the benefits of using natural clean 4248

waters to decontaminate immediately in an e mergency pesticide exposure situation outweighs the 4249

potential risks of making workers or handlers wait until they can use supplied decontamination water 4250

that has been evaluated for quality but may be less available to immediately address the exposure. 4251Page 96 of 176 Alth ough the quality of the natural waters is unknown, EPA thinks that washing in natural waters in any 4252

agricultural area is unlikely to pose risks comparable to a significant direct pesticide exposure. 4253

C. Requirements for Ocular Decontamination in Case of Ex posed Pesticide Handlers 4254

1. Current rule and proposal . The existing rule requires employers to provide “enough” water to 4255

handlers for routine and emergency washing and emergency eye flushing. For handlers who use 4256

products that require eye protection, empl oyers must provide each handler with at least one pint of 4257

water that they can carry for use in the event of an ocular pesticide exposure. EPA proposed to require 4258

employers to provide clean, running water at permanent (i.e., plumbed and not portable) mixing and 4259

loading sites for handlers to use in the event of an ocular pesticide exposure when using a pesticide with 4260

labeling that requires eye protection. 4261

2 . Final rule . Under the final rule, employers must provide water for ocular decontamination 4262

either thro ugh a system capable of delivering 0.4 gallons/minute for at least 15 minutes or from six 4263

gallons of water able to flow gently for about 15 minutes. This water must be available at all mixing and 4264

loading sites where handlers are mixing or loading a product that requires eye protection or when 4265

closed systems, operating under pressure, are in use. The final rule amends the existing requirement for 4266

employers to provide at least one pint of water per handler in portable containers that are immediately 4267

available to handlers applying the pesticide, rather than to all handlers mixing, loading and applying 4268

pesticides, if the pesticide labeling requires protective eyewear. The final regulatory text for these 4269

requirements is available at 40 CFR 170.509(i). 4270

The term “potable” in the preamble and regulatory text for the proposed rule was a 4271

typographical error and has been corrected to “portable” in the final rule. 4272

3. Comments and responses. 4273

Comments . There was general support for this proposal. Nine state pesticide regulatory 4274

agencies supported the proposal but several requested definitions or clarifications and some supported 4275

the proposal conditionally only if EPA allowed for certain types of water tanks. O ne pesticide 4276

manufacturing organization stated the proposal was reasonable with certain understandings such as if 4277

the water does not have to be potable, employers would be allowed 12 months to provide the eye 4278

decontamination station, it was required only for permanent mixing/loading sites which already had 4279

running water, and no recordkeeping of the water flows would be required. All four public health 4280

organizations and academics that commented supported the proposal, saying it was “reasonable.” 4281

However, they urged the adoption of the other ANSI requirements which i ncluded an emergency 4282

eyewash and shower equipment capable of delivering 20 gallons per minute for 15 minutes. Seven 4283

farmworker advocacy organizations commented they supported the requirement for ocular 4284

decontamination of exposed handlers. All five farm b ureaus commenting on the proposal generally 4285

supported it. Four of the farm bureaus urged EPA to ensure that the “availability of potable water for 4286

decontamination requirements apply only to permanent mixing and loading facilities.” 4287

Many commenters from a cross all groups urged EPA to adopt or coordinate with ANSI standard 4288

Z358.1

- 2009 and/or the OSHA requirements, 29 CFR 1928.110, as several states have done. Another 4289

commenter felt the proposal was reasonable but EPA should follow the ANSI guidelines becaus e running 4290

water was not enough for ocular decontamination. The commenter noted that a faucet cannot be 4291

turned on in one second or less, operated hands

- free, or allow the injured person to hold eyes open and 4292

have automatically tepid water flow. They said AN SI should be followed because it requires portable 4293

gravity

- fed eyewashes and portable pressurized eyewash/drench hose units and both keep the fluid 4294

uncontaminated and portable. 4295Page 97 of 176 Several commenters from across multiple groups requested a definition of “perm anent mixing 4296

and loading site” and “a system capable,” and some state pesticide agencies suggested EPA use 4297

“plumbed mixing and loading site” instead of “permanent mixing and loading site.” Two grower 4298

organizations pointed out that permanent mixing and loa ding water sources are clean but not 4299

necessarily potable; many remote locations without permanent plumbing have no potable water 4300

because nursery and tree farm locations use ponds or reservoirs as their source of water. 4301

Several commenters from state pesticide regulatory agencies, grower organizations and farm 4302

bureaus questioned whether the final rule included “nurse rigs,” “nurse tanks” and “gravity

- fed tanks” 4303

or similar types of water storage tanks, and many said they supported the proposal based on the final 4304

rule permitting the inclusion of such sources as allowable sources of the water for eyeflush since many 4305

permanent mixing and loading sites did not have running water but instead relied on these other types 4306

of water sources. The commenters explain ed that much of the mixing and loading is done in the field 4307

rather than at site with running water so it was important to be able to use this water for eyeflush to 4308

minimize burden. One commenter pointed out that recharging a simple eyewash deluge station f or 4309

occasional use with 6 gallons of water, the proposed requirement, would not result in a significant 4310

expenditure or additional labor. Other commenters wondered if the water for decontamination needed 4311

to be potable. 4312

EPA Response . The OSHA standard at 29 CFR 1910.151(c) specifies that “... where the eyes or 4313

body of any person may be exposed to injurious corrosive materials, suitable facilities for quick 4314

drenching or flushing of the eye s and body shall be provided ...” The ANSI standard provides 4315

specifications for two types of eyewash stations, plumbed and gravity

- fed. The specifications describe a 4316

system with a precise rate of flow (0.4 gallons/minute for 15 minutes), that can activate in 1 second or 4317

less and does not require the user to control the flow of wat er. While the OSHA and ANSI standards are 4318

very protective, EPA believes that it would be very costly and burdensome for employers to provide 4319

eyewash systems that meet the OHSA and ANSI standards given the remote sites often encountered 4320

with mixing/loading sites and agricultural operations and settings. The final rule requirements provide 4321

handlers with mitigation appropriate to pesticide exposure in agricultural settings at significantly lower 4322

costs than the ANSI standards. 4323

Based on the comments, EPA realiz ed that there might have been some confusion regarding the 4324

nature of permanent mixing and loading sites, the plumbing associated with both permanent and non

4325

permanent mixing and loading sites, and the quality of the water required. EPA proposed to require 4326

eyewash systems only for permanent mixing and loading sites since EPA believed it was common for 4327

most “permanent” mix/load sites to have running water and therefore it would be relatively easy to 4328

provide eyewash systems that could meet the desired flow rat e and standard. EPA received comments 4329

indicating that was not the case. Therefore, in the final rule, EPA decided to apply the requirements for 4330

eyewash systems to all mixing and loading sites where pesticides whose labeling requires protective 4331

eyewear are handled because the risk to handlers who mix and load these products is the same, 4332

regardless of whether they perform the mixing/loading tasks at a permanent site or a mobile site. 4333

Additionally, rather than specify that eyeflush water must be running wate r and what types of water 4334

tanks or eye wash systems would comply with the requirement, EPA opted for flexibility. The final rule 4335

allows employers to provide either at least 6 gallons of water in containers suitable for providing a 4336

gentle eye flush for abou t 15 minutes, or a system capable of delivering gently running water at a rate of 4337

0.4 gallons per minute for at least 15 minutes to satisfy the requirement. EPA did not propose 4338

recordkeeping of the water flows and there is no such requirement in the final rule. One emergency 4339

eyewash system is required at each mixing/loading site where a handler is mixing or loading a product 4340Page 98 of 176 whose labeling requires protective eyewear for handlers, regardless of how many handlers are mixing or 4341

loading at that site. Lastly, t he final rule retains the existing requirement for water to be of “a quality 4342

and temperature that will not cause illness or injury.” EPA did not propose to require “potable water” 4343

for the eyeflush water as some commenters indicated, and there is no require ment in the final rule for 4344

eyeflush water to be potable water, although the employer must ensure that it is of a quality and 4345

temperature that will not cause illness or injury when it contacts the skin or eyes or if it is swallowed. 4346

D. Showers for Handler Decontamination 4347

1. Current rule and proposal . The existing rule establishes specific requirements for routine and 4348

emergency handler decontamination supplies, but these requirements do not include shower facilities. 4349

EPA considered but did not propose a req uirement for handler employers to provide shower facilities. 4350

2. Final rule . EPA has not included in the final rule a requirement for employers to provide 4351

shower facilities for handlers. 4352

3. Comments and responses. 4353

Comments. Many commenters from growers a nd grower organizations, farm bureaus and 4354

agricultural organizations supported the proposal’s omission of a provision requiring shower facilities for 4355

handlers. They cited prohibitive costs and burden, and noted the provision would not necessarily 4356

guarante e use, and therefore would not guarantee any reduction in take

- home or handler exposure. 4357

One state pesticide regulatory agency detailed its experiences after 10

- 15 years of shower use in 4358

agricultural settings in the state and noted that their inspections r evealed that showers were “largely 4359

unused.” Several commenters from public health organizations, academia and farmworker advocacy 4360

organizations requested that EPA require employers to provide shower facilities for handlers, and said 4361

such facilities are imp ortant for emergency eyewash and decontamination. Those supporting a 4362

requirement for shower facilities indicated that handlers would use them if they were provided, 4363

especially with better training about the importance of using showers and reducing take

- hom e pesticide 4364

exposure. Worker advocacy organizations also thought showers should be provided for workers. 4365

Commenters from both groups generally agreed that better training and adequate information on 4366

reducing take

- home exposure, as suggested by EPA, is nee ded. Several commenters from across both 4367

groups said improved training would be a better, more reliable approach to addressing how to reduce 4368

take home exposure. 4369

EPA Response. EPA agrees that the potential cost and burden of providing showers for handlers 4370

as described in the proposal, combined with the lack of confidence that most handlers would routinely 4371

use showers if provided, led to the conclusion that a shower requirement would be unlikely to reduce 4372

risks to an extent commensurate with the costs. EPA also believes that the additional training being 4373

required for handlers, combined with clarified decontamination provisions such as the provision of at 4374

least 3 gallons of water per handler for routine and emergency washing, will reduce take

- home 4375

exposure wi thout requiring shower facilities. EPA also believes the new requirements for eyewash 4376

systems will address concerns raised about the need for shower facilities to provide for eyewash in 4377

ocular exposure emergencies. 4378

XIV. Emergency Assistance 4379

A. Current ru le and proposal . The existing WPS requires employers of workers or handlers, 4380

including those handlers employed by the agricultural establishment or those working for a pesticide 4381

handling establishment, to provide prompt transportation to an emergency medic al facility to 4382

employees who have been poisoned or injured by exposure to pesticides used on the establishment. 4383

Emergency medical assistance under the existing rule consists of the prompt provision of transportation 4384

to an emergency medical facility for the worker or handler and the provision of obtainable information 4385Page 99 of 176 about the exposure, including information about the product(s) that may have been used, to emergency 4386

medical personnel or the exposed employee. 4387

EPA proposed to require agricultural and handle r employers to provide emergency medical 4388

assistance within 30 minutes after learning that an employee may have been poisoned or injured by 4389

exposure to pesticides as a result of his or her employment, replacing the current standard of “prompt.” 4390

The proposed change was intended to ensure that the potentially injured party would be on route to a 4391

medical facility within 30 minutes. 4392

EPA also proposed that the employer provide a copy of the pesticide label, or specific 4393

information from the label, along with the SDS and circumstances of the pesticide use and potential 4394

exposure, to employees potentially injured by exposure to pesticides and to treating medical personnel. 4395

B. Final rule. EPA has retained the existing requirement for providing transportation and 4396

information promptly. The final rule clarifies that these requirements apply only to current or recently 4397

employed workers, and that emergency assistance must be provided if there is reason to believe that a 4398

worker or handler has been potentially exposed to pesticides or shows symptoms of pesticide exposure. 4399

EPA has amended the requirement for the information that the employer must provide related 4400

to emergency assistance. The final rule requires the employer to provide to treating medical personnel 4401

a copy of the SDS, product name, EPA registration number and active ingredient for each pesticide 4402

product to which the person may have been exposed, as well as the circumstances of applic ation or use 4403

of the pesticide on the agricultural establishment and the circumstances that could have resulted in 4404

exposure to the pesticide. This is a slight change to the existing rule which makes the information 4405

available to the worker or handler. In th is final rule, the worker or handler has access to the information 4406

through the hazard communications requirement. This provision deals specifically with meeting the 4407

needs for medical assistance, and requires that the information be provided to the medical personnel. 4408

EPA has clarified in the final rule that the provision of the emergency assistance requirement for 4409

transportation and information applies only to currently employed workers seeking emergency medical 4410

assistance or recently employed workers withi n 72 hours after their employment for acute exposures 4411

occurring on the agricultural establishment. 4412

Readiness is among the most important factors in an employer’s ability to promptly carry out 4413

the emergency assistance requirements. EPA strongly encourages employers to develop an emergency 4414

response plan and to address in such a plan details related to the emergency medical assistance 4415

requirements of the WPS. EPA also encourages employers to periodically test, evaluate and, if 4416

necessary, update the plan. EPA will develop a sample plan to help employers prepare for possible 4417

pesticide

- related emergencies. Employers can also find additional information concerning the 4418

development and implementation of an emergency preparedness program at the U.S. Department of 4419

Hom eland Security’s web site, http://www.ready.gov/business/

. 4420

Although EPA believes that it is important for employers to develop emergency response plans, 4421

EPA has not made this a requirement of the final rule. E PA recognizes that pesticide exposure is just one 4422

of many hazards that should be addressed in an emergency response plan, and that EPA has very little 4423

information about the extent of emergency planning in the agricultural community. Accordingly, EPA 4424

has de cided that it would be unwise to address this issue in the WPS without the benefit of a more 4425

robust dialogue with all stakeholders

. 4426

The final regulatory text for these requirements is available at 40 CFR 170.309(f) and 170.313(k). 4427

C. Comments and respon ses. 4428

Comments. Many private citizens and farmworker advocacy organizations, some pesticide state 4429

regulatory agencies and several public health organizations supported the proposal to require 4430Page 100 of 176 agricultural employers and handler employers to provide emergency medical assistance within 30 4431

minutes after learning that an employee may have been poisoned or injured by exposure to pesticides 4432

as a result of his or her employment, replacing the current standard of “prompt.” They stated that the 4433

clarification of time f or the provision of transportation and information would improve the safety of 4434

farmworkers. 4435

M any farmworker advocacy organizations, academic institutions

, public health organizations 4436

and another organization expressed concern that the proposed emergency response time of 30 minutes 4437

is too long and recommended that it should be further reduced. Commenters reasoned that pesticide 4438

poisoning can be fatal or result in long

- term effects if not quickly treated. 4439

On t he other hand, many commenters, mostly growers and farm bureaus, and some states and 4440

agricultural producer organizations expressed opposition to the proposal and favored retaining “prompt 4441

“ to allow more flexibility due to geographical constraints. The SBA Office of Advocacy stated that small 4442

farms that are farther away from medical facilities would not be able to obtain emergency 4443

transportation within the timeframe. Those with few employees and limited transportation options 4444

would be overburdened in attemp ting to comply with a 30 minute timeframe. Commenters 4445

representing many states, several agricultural industries, many growers and farm bureaus, and the SBA 4446

Office of Advocacy recommended that emergency response requirements should apply only to current 4447

em ployees seeking emergency medical assistance for acute incidents. 4448

Additional comments from states and their organizations recommended that the agriculture 4449

emergency requirement address only acute exposures to current employees of the establishment. They 4450

r aised concerns for the potential for former employees or those with exposures in the past to request 4451

emergency assistance. One commenter stated that allowing any person who was ever employed by the 4452

establishment the ability to demand emergency assistance c ould cause problems with compliance and 4453

enforcement. Some of these organizations, including grower organizations claimed that the current 4454

definition for “poison or injured” is vague and could cause agricultural employers to be required to 4455

provide emergency assistance for minor health issues that may not be pesticide related. They also 4456

requested clarification of the term “emergency medical facility.” 4457

The grower and agricultural industry commenters expressed concern with the “proposed 4458

provisions and interpr eted the proposal as requiring injured workers to contact state lead pesticide 4459

agencies responsible for enforcement for emergency medical attention. They stated that the proper 4460

reaction to an incident remains the responsibility of the employer who can best respond to the needs of 4461

their employees in a timely fashion. Commenters also recommended that the requirement allow, similar 4462

to OSHA, trained first aid providers on the establishment to provide care, which could enable more 4463

timely treatment. 4464

Commenters noted that requiring the employer to provide the label to employees potentially 4465

injured by exposure to pesticides and to treating medical personnel could lead to further exposure, if 4466

the employee takes an open container of pesticides bearing the label. Further, commenters suggested 4467

that the information outlined in the proposal could be obtained from sources other than the label. 4468

EPA Response. EPA was convinced by the concerns raised by members of the agricultural 4469

community that geographical constraints, in some cases, would make the 30 minute response 4470

timeframe for transportation difficult or impossible to meet. Agricultural establishments can be very 4471

large and are often distant from population centers. Remote locations, including those in forestry, are 4472

common; and the distance to an emergency medical facility or to an ambulance service can be 4473

significant. 4474Page 101 of 176 The final rule requires employers to comply with the emergency assistance requirements by 4475

promptly making transportation available to an emergency m edical facility for potentially injured 4476

employees and providing the SDS, specific product information, and information about the exposure to 4477

the treating medical personnel. Because the information about the pesticide may be critical to 4478

effectively manage t he illness, EPA decided to focus the requirement to ensure that treating medical 4479

personnel receive the information. The agricultural employer must provide that information in a way 4480

that is reasonably expected to be accessible to the treating medical perso nnel. The requirement does 4481

not preclude the employer providing the information to injured employees and does not prevent injured 4482

employees from requesting this information. This requirement will allow continued flexibility for 4483

employers and encourage time ly medical treatment for potentially injured employees. 4484

In deciding to retain the requirement for prompt provision of transportation, EPA also took into 4485

consideration OSHA’s standard for the provision of transportation to persons in construction, which 4486

r equires “Proper equipment for prompt transportation of the injured person to a physician or hospital.” 4487

29 CFR 1926.50(e). 4488

EPA agrees with the recommendation to clarify that the requirement applies only to current or 4489

recently employed workers seeking emerg ency medical assistance for acute exposures occurred at the 4490

agricultural establishment, and has revised the final rule accordingly. The final regulation also addresses 4491

the comment regarding the vagueness of “poisoned or injured person” and clarifies that e mergency 4492

assistance must be provided to “a worker or handler that has been potentially exposed to pesticides or 4493

shows symptoms of pesticide exposure as a result of his or her employment

. ” In response to the 4494

requests for language clarifications, EPA notes t hat a hospital, clinic, or infirmary offering emergency 4495

health services qualifies as an emergency medical facility for purposes of the WPS. EPA notes that for 4496

some cases of suspected pesticide injury, the attention of a trained first aid provider can mitig ate the 4497

injury. Such treatment would not negate the obligations of the employer to provide transportation 4498

promptly to an injured employee, or to provide information about the pesticide and exposure to 4499

medical personnel, but is encouraged. Allowing a compet ent first aid provider to administer timely 4500

treatment to an injured employee could offset complications from longer exposures. 4501

EPA agrees with comments that a requirement to provide the label in the event of an 4502

emergency could be burdensome and place emp loyees at risk for additional exposure if the label is 4503

attached to an open container of pesticides. EPA has not included the proposed requirement to provide 4504

the label or information from the label; rather, the final rule requires the employer to provide t he 4505

necessary information, but does not specify the source of the information. EPA has removed from the 4506

list of specific pieces of information the employer must provide information about antidote, first aid, 4507

and recommended treatment because the SDS contain s this information. EPA notes that the 4508

information about the product and the SDS will be available as part of the pesticide application and 4509

hazard information. 4510

Finally, the employer must provide information about the pesticide and the exposure to the 4511

tre ating medical personnel. 4512

XV. Personal Protective Equipment 4513

A . Respirators: Fit Testing, Training and Medical Evaluation 4514

1. Current rule and proposal . The existing regulation requires handler employers to ensure that 4515

each handler’s respirator fits correct ly. However, the existing rule does not provide specific details on 4516

ensuring that a respirator fits properly, nor does it require employers to conduct medical evaluations of 4517

the handler’s fitness for respirator use, provide training on the proper use of re spirators, or retain fit 4518

test records. 4519Page 102 of 176 EPA proposed to require handler employers to comply with the respirator fit testing, training, 4520

and medical evaluation requirements set by OSHA at 29 CFR 1910.134 whenever a respirator other than 4521

a dust or mist filter ing mask is required by the labeling. EPA did not propose any new requirements for 4522

filtering facepiece respirators (OSHA’s term for dust or mist filtering masks). The OSHA standard includes 4523

a specific standard for fitting a user for respirator use, trainin g on recognizing when the respirator seal 4524

may be broken, and what steps to take to properly use and maintain respirators. OSHA also requires 4525

respirator users to be medically evaluated to ensure the respirator use does not cause undue stress on 4526

their bodies . EPA proposed to require that employers comply with the OSHA requirements for fit 4527

testing, training, and medical evaluation by cross

- referencing 29 CFR 1910.134, in order to avoid 4528

creating a duplicative regulation and to ensure that if technology advances lead OSHA to amend its 4529

standard, the change would automatically apply to pesticide uses subject to the WPS as well. EPA also 4530

proposed to require handler employers to maintain records of the fit test, training, and medical 4531

evaluation for two years. 4532

2. Fin al rule. EPA has retained the proposed elements in the final rule, with some changes and 4533

clarifications. Specifically, the final rule cross references and requires compliance with the OSHA 4534

standards for fit testing, training, and medical evaluation when a respirator is required by the labeling. 4535

The final rule expands from the proposal the types of respirators covered by the requirement to include 4536

filtering facepiece respirators. The final rule also adds an additional item to the list of conditions that 4537

wo uld trigger replacement of the gas

- or vapor

- removing canisters or cartridges. 4538

In the final rule, EPA has retained the proposed requirement for handler employers to maintain 4539

records of the fit testing, medical evaluation, and training. The final rule clar ifies that the required 4540

training is limited to the care and use of respirators, 29 CFR 1910.134(k)(1)(i)

- (vi), and does not include 4541

the training on the general requirements (i.e., 29 CFR 1930.134(k)(1)(vii)). 4542

The final regulatory text for these requireme nts is available at 40 CFR 170.507(b)(10 ) and 4543

170.507(d)(7)

. 4544

3. Comments and responses. 4545

Comments

– support. EPA received many comments in favor of requiring handler employers to 4546

comply with the respirator fit testing, training, and medical evaluation requirements established in the 4547

OSHA standard. Many farmworker advocacy organizations and some PPE manufacturer s asserted that 4548

EPA should also apply the proposed standards for fit testing, training, and medical monitoring to users of 4549

filtering facepiece respirators in addition to the other respirator types (e.g., tight fitting elastomeric 4550

facepieces). Commenters su ggested that filtering facepiece respirators are widely used and covered by 4551

OSHA’s respirator requirements, and that their exclusion would result in inadequate protection for 4552

many pesticide handlers. One state department of agriculture expressed support fo r the adoption of 4553

OSHA respiratory standards with the exception of the recordkeeping requirement. 4554

EPA Response. In the final rule, EPA has required that employers comply with the respirator fit 4555

testing, training, and medical evaluation requirements describ ed in the proposed rule when the use of 4556

respirators is required by the labeling. The final rule also expands its coverage to include filtering 4557

facepiece respirators (referred to as dust/mist filtering respirators in the proposal). EPA included 4558

filtering fa cepiece respirators in the final rule to ensure that handlers required to use any type of 4559

respirator are adequately protected. Filtering facepiece respirators need to be fit tested and used 4560

properly to provide the intended protection. In addition, this wil l ensure that respirators used under the 4561

WPS provide the same level of protection as comparable respirators used under OSHA’s respiratory 4562

protection requirements. EPA does not believe that the recordkeeping requirement for employers 4563

impose unnecessary burd en in comparison with the benefits. 4564Page 103 of 176 Comments

- adopt full OSHA respiratory protection program. Many farmworker advocacy 4565

organizations stated that EPA should require compliance with all elements of 29 CFR 1910.134, rather 4566

than the proposal to just include fit testing, training, and medical evaluation. Specifically, they urged EPA 4567

to adopt OSHA’s requirements for employers to develop a respiratory protection program (29 CFR 4568

1910.134(c)) and conduct a workplace hazard evaluation (29 CFR 1910.134(d)(1)(iii)). 4569

EPA Response. EPA acknowledges that, if the final rule were to require handler employers to 4570

comply with the OSHA requirement to adopt a worksite

- specific respiratory protection program, such a 4571

requirement would address in detail the selection, cleaning, s toring, repair and replacement of 4572

respirators, as well as worksite

- specific procedures when respirator use is required. EPA has decided not 4573

to expand the final rule to include the OSHA requirement to adopt a worksite

- specific respiratory 4574

protection program because specific respirator requirements are described on EPA

- approved, product

4575

specific pesticide labeling. These product

- specific respirator requirements are based on the acute 4576

inhalation toxicity of the end

- use product or a comprehensive risk assessmen t informed by incident 4577

data, or on extensive pesticide active ingredient toxicology data, exposure science and epidemiology 4578

data (if available), or on both. Therefore, requiring a general worksite

- specific respiratory protection 4579

program would duplicate the analysis underlying product

- specific respirator requirements included on 4580

pesticide labeling. In addition, the WPS includes requirements for providing, inspecting, cleaning and 4581

maintaining PPE. 4582

However, in consideration of the commenters who asked that EPA require compliance with all 4583

elements of OSHA requirements at 29 CFR 1910.134, the Agency re

- evaluated other elements of that 4584

regulation. As part of that re

- evaluation, EPA identified an inconsistency between the Agency’s proposal 4585

and OSHA’s requirements c oncerning a change schedule for the replacement of the gas

- or vapor

4586

removing canisters or cartridges. Specifically, OSHA requirements address change schedules that utilize 4587

NIOSH end

- of

- service

- life indicator designations (29 CFR 1910.134(d)(3)(iii)(B)(2))

. T o ensure respirator 4588

protections are of greater consistency across industries, EPA has added the OSHA requirement that 4589

triggers the replacement of the gas

- or vapor

- removing canisters or cartridges to the list of conditions in 4590

the final rule at §170.507( d)(7) through an incorporation by reference. 4591

Comments

- oppose. Nearly all commenters expressed support for a general requirement 4592

related to proper respirator care and use, such as appears in the existing rule. However, many pesticide 4593

manufacturers and th eir associations, state farm bureaus and agricultural producer organizations 4594

questioned the feasibility of the proposed requirement for medical evaluations because locating 4595

qualified physicians practicing in rural areas would be difficult. Other farm burea us and the SBA Office of 4596

Advocacy noted that the OSHA standard applies to general industries, shipyards, marine terminals, 4597

longshoring and construction, and it would not likely be easily adopted in agricultural settings. 4598

EPA Response. EPA acknowledges th a t implementing respirator fit testing, training, and medical 4599

evaluation in agriculture will place additional burden on agricultural employers. However, the proper fit 4600

and use of respirators is essential in order to realize the protections respirators are intended to provide. 4601

EPA’s pesticide risk assessment process relies on NIOSH protection factors (i.e., respirators used 4602

according to OSHA’s standards) when deciding whether handler inhalation exposure can be mitigated by 4603

respirator use. If the handler inha lation exposure can be mitigated by a particular type of respirator, EPA 4604

may require the use of that respirator on the pesticide label, among other risk mitigation measures. 4605

Without the protection provided by the respirators identified on the label, use of those pesticides would 4606

cause unreasonable adverse effects on the pesticide user, i.e., the handler. 4607

EPA is aware of several states, including California, Oregon and Washington, that have 4608

successfully incorporated all aspects of the OSHA standard for res pirators in agriculture, demonstrating 4609Page 104 of 176 the feasibility of applying OSHA’s requirements in agriculture. North Carolina has incorporated many 4610

innovative ways to facilitate the medical evaluation and fit testing process, and helped farmers 4611

(including handler employers) locate reputable sources for online services for fit testing and medical 4612

evaluation, and sources for NIOSH

- approved respirators, filters, and cartridges. EPA plans to work with 4613

stakeholders such as state regulatory agencies, universities, and ot hers to provide outreach assistance 4614

such as training programs and written materials and to encourage the dissemination of information 4615

about fit testing and medical evaluation resources. 4616

Comments

- access to medical evaluation for respirator users. Many c ommenters, including 4617

growers and their associations, states and their associations, pesticide applicators and the pesticide 4618

industry, raised the issue of medical evaluation/clearance for respirator users, particularly for rural 4619

farmers. 4620

EPA Response. EPA notes that many handler employers may be able to rely on online services 4621

where medical evaluations can be performed by relying on medical questionnaires. The employee would 4622

complete the medical questionnaire, which would be provided to the licensed medical professional for 4623

review. If the employee is cleared by the review, he or she is approved to wear a respirator. If the 4624

employee is not cleared through the review of the questionnaire, the employer may send the employee 4625

for further medical review or the emp loyer may identify a different employee to handle the pesticide. 4626

EPA acknowledges the new respirator requirements will be a change for handlers and handler 4627

employers, and EPA plans to work with stakeholders on outreach assistance addressing changes in 4628

res pirator requirements and the impacts on pesticide labeling. Since WPS enforcement is primarily a 4629

state issue, various state agencies will have to be involved and communicate on appropriate training and 4630

enforcement issues. 4631

Comments

- alternative medical cle arance for respirator use. Several organizations suggested 4632

that an alternative to the medical evaluation requirement would be for EPA or CDC

- NIOSH to develop an 4633

agricultural respirator use medical screening questionnaire for potential respirator users, an d then 4634

respirator users could voluntarily comply. 4635

EPA Response. The final rule cross references and requires compliance with the OSHA standards 4636

for fit testing, training, and medical evaluation when a respirator is required by the labeling. By 4637

referencin g existing work by OSHA, EPA is leveraging existing health infrastructure (the medical 4638

evaluation forms available for industry), which provides a consistent solution for general industry and 4639

agriculture. The medical evaluation is important for assuring th at a respirator will prevent, rather than 4640

cause, adverse effects. OSHA has a medical evaluation questionnaire that is available on its web site, 4641

and EPA will include this information in compliance assistance materials. 4642

Comments

- use of respirators in a griculture versus industry. One farmer alliance drew a 4643

distinction between the use of respirators in a life threatening situations in industry versus the 4644

incidental use of respirators in agriculture, and proposed a chemical

- specific pathway to respirator 4645

requirements based on acute toxicity. Similarly, one grower group and several state farm bureaus 4646

provided a perspective that the need for respirators is infrequent in agriculture and that mixer/loaders 4647

can take themselves out of harm’s way easier than pers ons in an industrial environment regulated by 4648

OSHA requirements. 4649

EPA Response. EPA notes that respirator requirements are established through the pesticide 4650

registration process, and the respirator requirements on pesticide labeling reflect the toxicity ( acute, 4651

systemic, etc.) of its ingredients. When a respirator is required on pesticide labeling, EPA has conducted 4652

a scenario

- specific assessment for the occupational handler based on the active ingredient, the pesticide 4653

formulation, and registered applicat ion rate. The final rule ensures that respirators used under the WPS 4654Page 105 of 176 provide the same level of protection as comparable respirators used under OSHA’s respiratory 4655

protection requirements. 4656

Comments

- respiratory protection during tank cleaning. One trade as sociation identified 4657

several situations and recommendations regarding handler respiratory protection. Specifically, the 4658

comment noted that Immediately Dangerous to Life and Health (IDLH) precautions associated with 4659

OSHA’s respirator regulations must be fol lowed during pesticide tank or vessel cleaning. 4660

EPA Response. Pesticide product labeling identifies required respiratory protection for handlers 4661

involved in mixing, loading, and applying a pesticide, or other activities associated with pesticide 4662

handling (e.g., cleaning up a spill or repairing contaminated equipment). EPA recognizes that there are 4663

other federal, state, or local regulations that may impact appropriate respirator use for confined space 4664

work. 4665

Comments

- medical records. One state d epartment of a griculture expressed concern about the 4666

records for medical evaluation being covered by the confidentiality provisions of the Health Insurance 4667

Portability and Accountability Act (HIPAA), which would cause problems for state compliance officers. 4668

EPA Res ponse. To the extent that the results of a medical evaluation to determine fitness to use 4669

respirators would be considered medical records protected from disclosure under HIPAA, state 4670

inspectors may obtain access with the handler’s authorization pursuant t o 45 CFR 164.508, or without 4671

the need for authorization pursuant to 45 CFR 164.512, particularly §§ 164.512(d) and 4672

164.512(f)(1)(ii)(C). 4673

Comments

- definition of “licensed health care professional.” Several agricultural industry 4674

associations offered suppo rt for use and proper fit testing of respirators and requested a definition of 4675

“licensed health care professional.” 4676

EPA Response. The final rule requires “a medical evaluation by a physician or other licensed 4677

health care professional that conforms to the provisions of 29 CFR 1910.134 ...” OSHA’s regulations at 4678

29 CFR 1910.134(b) defines “Physician or other licensed health care professional” as an individual whose 4679

legally permitted scope of practice (i.e., license, registration, or certification) allows h im or her to 4680

independently provide, or be delegated the responsibility to provide, some or all of the health care 4681

services required by 29 CFR 1910.134(e). 4682

Comments

- cost estimation. Many commenters, including growers and their associations, 4683

states and their associations, pesticide applicators and the pesticide industry, commented on EPA’s cost 4684

estimation relating to respirator fit testing, training, and medical evaluation for respir ator users. Many 4685

of the comments pertained to concern over access to adequate medical evaluation for potential 4686

respirator users in rural areas of the U.S. 4687

EPA Response. EPA has reviewed and revised its cost estimates for fit testing, training and 4688

medical evaluation. The cost estimate assumes that farms would designate one handler to be fit tested 4689

so the incremental costs for the filtering facepiece respirators reflects the need to fit test and train on 4690

multiple types of respirators. The increased costs al so reflects the cost of the on

- line medical evaluation, 4691

which replaces the estimated time of a medical technician reviewing the evaluation, and the cost of the 4692

employer’s time to arrange (if off

- site) or oversee (if on

- farm) the evaluation and fit test, wh ich was 4693

previously omitted. EPA has also updated wages, price of materials and services such as the cost of the 4694

medical evaluation and the fit test materials. Details of the revised estimate are available in the 4695

Economic Analysis for this final rule. 4696

Comm ents

- respirator selection. Many commenters, including growers and their associations, 4697

states and their associations, pesticide applicators and the pesticide industry, raised issues pertaining to 4698Page 106 of 176 user safety and respirator selection, including 1) the type s of respirators available for users, and 2) the 4699

need to address heat stress as part of the overall respirator requirement. 4700

EPA Response. EPA recognizes that some handlers may not be able to use a tight

- fitting 4701

respirator. Tight fitting respirators inclu de filtering facepiece respirators, full and half face elastomeric 4702

respirators and tight fitting powered air purifying respirators (PAPR). EPA notes that the purpose of the 4703

medical evaluation is to ensure handlers are able to tolerate the physical burden c aused by the use of 4704

respirators. Many medical conditions, such as cardiovascular diseases and the reduced pulmonary 4705

function caused by smoking, could impede the ability of the handler to wear a respirator without 4706

adverse health impacts. The medical evaluat ion should identify these potential issues and disqualify the 4707

handler from using a tight

- fitting respirator. However, for these handlers, loose

- fitting PAPRs are an 4708

option for respiratory protection because they do not require medical evaluations or fit te sting. 4709

EPA concurs that heat stress is an important element of worker protection and that heat stress, 4710

PPE and health and wellness should be included in training on respirator use in agricultural settings (i.e., 4711

outdoors). EPA anticipates that heat stre ss management will be included in its outreach assistance 4712

between issuance of the final rule and the compliance date. 4713

Comments

- OSHA’s jurisdiction in agriculture. Some commenters, including a farm bureau, 4714

raised concerns that EPA’s reference to OSHA’s regulations could give OSHA legal grounds to pursue 4715

oversight of certain small farming operations, contrary to provisions of existing law. 4716

EPA Response. EPA does not believe that including in the WPS a requirement that employers 4717

must perform respirator fit testing, training, and medical evaluation in accordance with OSHA’s 4718

requirements by cross

- reference to 29 CFR 1910.134 affects the scope of OSHA’s jurisdiction. Today’s 4719

final rule changes only the FIFRA WPS, which is implemented and enforced by EPA, s t ates and t ribes, 4720

and not by OSHA. 4721

Comments

- respirator cartridge changeout. One farmworker advocacy organization 4722

recommended that employers should be required to analyze work areas and processes in order to 4723

develop change schedules for filter cartridges to ensure filters are changed before their end of service 4724

life via one of the available tools available from OSHA and online advisors. 4725

EPA Response. EPA acknowledges the utility in analyzing both work areas and/or similar job 4726

tasks to help evaluate pote ntial risk concerns. In the final rule, there are several provisions that trigger 4727

replacement of filtering facepiece respirator and gas/vapor

- removing canisters and cartridges. In 4728

addition to the provisions in the proposed rule, the final rule requires re placement when the maximum 4729

use time is reached, as determined by a change schedule conforming to the provisions of 29 CFR 4730

1910.134(d)(3)(iii)(B)(2). 4731

Comments

- respirator designation on pesticide labeling. One PPE manufacturer recommended 4732

that EPA should take immediate action to update the pesticide labels to specify the current NIOSH

4733

approved respirators under 42 CFR 84 because of confusion in EPA and stakeholder materials on 4734

occupational handler respirator requirements. 4735

EPA Response. EPA is aware that s ome labels do not have the correct respirator designation. 4736

The correct language is in EPA’s pesticide labeling guidance (the Label Review Manual) but has not been 4737

incorporated onto all pesticide labels. As part of the WPS roll

- out, EPA plans to work inte rnally and with 4738

stakeholders to raise awareness and understanding of the correct respirator designations in the Label 4739

Review Manual to facilitate the adoption of the correct respirator designations on labels. 4740

Comments

- respirator filter selection informat ion. One PPE manufacturer identified a concern 4741

about appropriate selection information for N

- , R

- and P

- series filters for filtering facepiece respirators; 4742Page 107 of 176 specifically, that the selection criteria for the different series filters should be added to the r egulatory 4743

text. 4744

EPA Response. Respirator selection depends on the pesticide product being applied, and the 4745

user must comply with the respirator or replacement filter specifications in the pesticide product’s 4746

labelling. It would be impractical to includ e in the WPS, or keep up to date, respirator selection 4747

information for each pesticide product. 4748

Comments

– greenhouse respirator use. One state farm bureau urged EPA to consult with 4749

respirator fitters and greenhouse plant growers in their expressed concern over 1) inadequate 4750

information for fit testing requirements for greenhouse workers and 2) the burdensome nature of 4751

meeting OSHA stan dards for respirators. 4752

EPA Response. EPA acknowledges that implementing respirator fit testing, training, and medical 4753

evaluation in agriculture will place additional burden on agricultural employers. However, the proper fit 4754

and use of respirators is essen tial in order to realize the protections respirators are intended to provide. 4755

EPA recognizes the need to provide information on fit testing and medical evaluations to all sectors of 4756

the agricultural industry subject to the WPS including greenhouses. As par t of the WPS roll

- out, EPA 4757

plans to work with stakeholders to provide needed outreach assistance addressing changes in respirator 4758

requirements and the impacts on pesticide labeling. 4759

B . Chemical

- Resistant PPE 4760

1. Current rule and proposal . The definition fo r “chemical resistant” in the existing WPS is a 4761

“material that allows no measurable movement of the pesticide being used through the material during 4762

use.” Prior to the proposed rule, EPA received many comments from stakeholders suggesting that there 4763

was no way for agricultural employers, handlers, early

- entry workers, pesticide educators and inspection 4764

personnel to ensure the PPE being used was “chemical resistant.” EPA proposed requiring employers to 4765

provide PPE defined by its manufacturer as chemical resi stant. 4766

2. Final rule . EPA has rejected the proposed change. The final rule retains the existing definition 4767

of chemical resistance. The final regulatory text for this requirement is available at in 40 CFR 4768

170.507(b)(1). 4769

3. Comments and responses. 4770

Comm ents

– definition of chemical resistant. Some commenters, including two state pesticide 4771

regulatory agencies, a university agricultural center, a farm bureau, a grower organization and a 4772

farmworker advocate, supported the idea of PPE manufacturers defining chemical resistant in principle, 4773

stating that this should clarify terminology and make it easier for agricultural employers to comply with 4774

PPE requirements. However, many commenters opposed EPA’s proposed approach and questioned its 4775

feasibility. Specific ally, some state pesticide regulatory agencies and their organizations questioned 4776

whether manufacturers can reliably designate PPE as chemical resistant in a permanent manner that 4777

would be easy for enforcement personnel to check during inspections. Many c ommenters of all types, 4778

including state pesticide regulatory agencies, grower organizations, farmworker advocates, pesticide 4779

manufacturers and PPE manufacturers raised concerns about assessing chemical resistance for the wide 4780

range of pesticide formulation s and active ingredients. Some of the commenters stated that it is 4781

unreasonable to expect PPE manufacturers to test their PPE against all pesticide formulations and active 4782

ingredients. Other commenters suggested that the PPE manufacturers would have to i dentify the 4783

specific chemicals to which the PPE is resistant. Some commenters asserted that establishing a standard 4784

of chemical resistance is meaningless without defining permeation or test procedures. A few other 4785

commenters pointed out that there are test methods and standard test substances available that EPA 4786

could use. One PPE manufacturer asserted that the existing definition was purposefully worded to 4787Page 108 of 176 ensure worker protection and that EPA’s proposal over

- simplifies a very complex and critical issue. 4788

EPA Response . EPA recognizes the many comments highlighting the challenging issues involved 4789

with having PPE being defined as chemical resistant by the equipment manufacturer, who does not 4790

know the ingredients in every pesticide product. EPA agrees with co mmenters that the proposed 4791

approach would create more problems than it would resolve. Therefore, the final rule retains the 4792

existing chemical resistant definition. 4793

Comments

– other suggestions regarding chemical resistant or waterproof PPE . Some 4794

comment ers, including grower organizations, a pesticide manufacturer organization and a university, 4795

urged EPA to reassess the situations where chemical resistant PPE is required by pesticide labels. In 4796

general, the commenters questioned whether certain PPE, such as footwear and hats, needs to be 4797

chemical resistant or if it is sufficient for the PPE to be waterproof. A few of these commenters pointed 4798

out that revising the requirement from requiring that PPE be chemical resistant to being waterproof 4799

goes beyond ch anging the WPS and would also involve revising the Label Review Manual and the 4800

pesticide labels that specify chemical resistant PPE. 4801

EPA Response . EPA agrees that changing the label requirement for a certain piece of PPE from 4802

being chemical resistant to being waterproof involves more than updating the WPS regulation. EPA is 4803

currently reviewing the PPE statements in the Label Review Manual for accuracy and assessing whether 4804

pesticide labels include the most current and accurate PPE descriptions, based on other discussions with 4805

state regulatory agencies and other stakeholders. EPA will consider the comments on chemical 4806

resistance and waterproofness in the context of that effort. In addition, EPA realizes that its outreach 4807

associated with the WPS revision is a good opportunity to clarify confusion about what PPE is required, 4808

and therefore plans to develop guidance and outreach material on PPE where appropriate. 4809

C . Contaminated PPE 4810

1. Current rule and proposal . The existing WPS requires employers to ensure that PPE is cleaned 4811

before each day of reuse. If the article cannot be properly cleaned, the employer must dispose of it in 4812

accordance with applicable Federal, State, and local regulations. EPA proposed to add a requirement for 4813

employers to render unusable contaminated PPE that cannot be properly cleaned before it is disposed. 4814

2. Final rule. In the final rule, the employer must ensure that contaminated PPE is made 4815

unusable as apparel or disposed of in such a way that it is unavailable for further use. EPA has also 4816

included in the final rule a requirement for the person who cleans, disposes, or otherwise handles the 4817

contaminated PPE to wear the gloves required for mixing and loading the pesticide that contaminated 4818

the PPE. The final regulatory text for this requirement is available at 40 CFR 170.507(d)(2). 4819

3. Comments and responses. 4820

Comments . Prior to the proposed rulemaking, state pesticide regulatory agencies expressed 4821

concern that unless proper measures are taken, contaminated PPE might be reused either as PPE or 4822

simply as a garment, placing the person wearing it at risk from pesticide exposure. Many organizations, 4823

including farmworker advocacy organizations, universities, public health organizations, a state 4824

department of public health, as well as indiv iduals through two mass comment campaigns, expressed 4825

general support for the proposal to ensure that contaminated PPE be rendered unusable if it cannot be 4826

cleaned properly before it is disposed of. In support of the proposal, several commenters noted that 4827

rendering contaminated garments unusable would prevent adverse health effects. A state noted that 4828

the proposal was an effective method to reduce the potential for access to contaminated PPE. One 4829

grower organization noted that the potential for exposure exi sts when individuals cut or render 4830

contaminated PPE unusable, and suggested a requirement to seal the contaminated PPE in a disposal 4831

container and to dispose of the container in an appropriate manner. 4832Page 109 of 176 In contrast, a state and some grower organizations sta ted that the current requirement is 4833

adequate and EPA should not adopt the proposal. Some farm bureaus opposed the proposal and 4834

thought the concern for individuals gaining access to contaminated PPE was well meaning yet 4835

hypothetical. Some of these commenter s suggested it could lead to confusing violation scenarios, 4836

specifically from the interpretation of “render unusable.” 4837

Some states requested that EPA delete the provisions requiring contaminated PPE and 4838

contaminated glove liners to be disposed of in acco rdance with federal, state, or local regulations. They 4839

noted that if such regulations exist, the WPS does not add regulatory authority and adds another 4840

potential technical violation to the WPS. Further, they noted that states and localities can address 4841

dis posal regulations as appropriate. 4842

EPA Response . The final rule clarifies that the requirement is to make the PPE “unusable as 4843

apparel.” EPA agrees that access to contaminated PPE might be prevented by sealing it in a container 4844

and entrusting it to a waste disposal system that effectively prevents diversion of waste, and that such 4845

an approach would reduce pesticide exposure to the person handling the contaminated article relative 4846

to many methods of rendering the PPE unusable. EPA has included in the final r ule a provision allowing 4847

the PPE to be “made unavailable for further use” as an alternative to the proposed requirement to 4848

render the contaminated PPE unusable. To reduce the potential exposure to a person handling 4849

contaminated PPE, the final rule requires that a person must wear gloves while handling PPE covered by 4850

40 CFR 170.507(d)(2). 4851

EPA disagrees with comments from farm bureaus suggesting that there is little likelihood of 4852

persons accessing contaminated PPE. As mentioned in the preamble to the propose d rulemaking, state 4853

pesticide regulatory agencies have raised concerns for the potential reuse of contaminated PPE to EPA. 4854

EPA relies on state pesticide regulatory agencies to raise issues with implementation of the existing WPS 4855

that arise when they conduc t inspections of WPS establishments. EPA has chosen to amend the existing 4856

rule in response to the input provided by the states. 4857

EPA disagrees with states’ request to delete provisions requiring contaminated PPE to be 4858

disposed of in accordance with federa l, state, or local regulations. Although the WPS reference to 4859

federal, state, and local waste disposal regulations is somewhat duplicative, violations of those 4860

regulations can hardly be dismissed as “technical” violations, regardless of whether they are p rosecuted 4861

under FIFRA or other authorities. However, the primary reasons for inclusion of these provisions in the 4862

WPS are to make clear that the WPS does not supersede federal, state, and local waste disposal 4863

regulations, and to remind employers of their responsibility to be aware of and comply with relevant 4864

disposal regulations. 4865

4866

XVI. Decision not to Require Monitoring of Handler Exposure to Cholinesterase

- Inhibiting Pesticides 4867

A. Current rule and proposal. 4868

The existing WPS does not have a r equirement to monitor cholinesterase (ChE) levels in workers 4869

or handlers. In the proposal, EPA invited comment on whether to require routine ChE monitoring of 4870

handlers. However, because EPA’s initial judgement was that the benefits of routine ChE monitorin g 4871

would not justify the cost, EPA did not propose to add a requirement for routine monitoring of ChE 4872

inhibition in handlers. 4873

B. Final rule. 4874

The final rule does not include a requirement for routine ChE monitoring for handlers. 4875

C. Comments and responses. 4876Page 110 of 176 Comments

- general. In response to the proposal, several grower organizations, farm bureaus, 4877

crop consultants and their organizations, and states and their organizations expressed support for EPA’s 4878

decision not to require a mandatory routine ChE monitoring program as part of the WPS. Several 4879

commenters stated that the most effective approach to prevent handler exposure to any pesticide 4880

product is to address the potential for exposure in advance of use, rather than after exposure has taken 4881

place. Many of these commenters agree d with EPA’s assessment in the proposal that EPA’s worker risk 4882

assessments and mitigation measures are sufficient to provide the necessary protection from pesticide 4883

exposure during handling. One commenter also suggested that requiring ChE monitoring may ad d to 4884

confusion and provide a false sense of safety to workers, health care providers, and regulators because 4885

it only measures exposure. These commenters suggested that the best approach that can be taken to 4886

mitigate exposure would be to address it through product

- specific risk assessments supporting the 4887

registration of pesticide products, robust handler training on specific pesticides, and effective 4888

enforcement of label requirements. 4889

In addition, some of the commenters objected that ChE monitoring is an in vasive process, and 4890

that routine ChE monitoring would be extremely time

- consuming and costly and would provide 4891

information of questionable value. One commenter stated that a proper ChE monitoring program would 4892

require that a baseline be established for emp loyees, and that it would be highly unlikely that a baseline 4893

could be obtained for many workers because of previous exposure to organophosphate insecticides, 4894

while another commenter suggested that exposure to other common materials can change the levels of 4895

ChE, especially in serum level measurements, making it difficult to establish a baseline. Another 4896

commenter added that the timing of meals, stress, physical activity, and changes in body mass can cause 4897

ChE levels to fluctuate within an individual, and tha t the baseline value should be taken on the day of 4898

handling a ChE

- inhibiting pesticide prior to exposure due to this intra

- individual variability. The 4899

commenter suggested that baselines established every 1 to 2 years, as currently recommended by 4900

Washington State and California, respectively, would not provide meaningful information concerning 4901

the degree of exposure due to these daily fluctuations. 4902

Conversely, several commenters, including some members of Congress, the California 4903

Department of Public Healt h, Washington State’s Department of Health and Department of Labor and 4904

Industries, several public health organizations, academics, and farmworker advocacy organizations 4905

supported the idea of adopting a routine ChE monitoring program as part of this rulemak ing, particularly 4906

for handlers who use ChE

- inhibiting pesticides like organophosphates and N

- methyl

- carbamate 4907

pesticides. Many of these commenters cited the existing ChE monitoring programs in California and 4908

Washington State in their arguments for why ChE monitoring should be expanded nationally. 4909

Some commenters stated that California and Washington have longstanding medical monitoring 4910

programs with proven track records in reducing exposure to, and illnesses from, highly neurotoxic 4911

chemicals. These comment ers stated that the successful implementation of these monitoring programs 4912

has helped health professionals understand the effects of these classes of pesticides and prevent 4913

poisoning by identifying overexposure. Two commenters stated that Washington’s prog ram is effective 4914

and protects workers as reflected by worksite field evaluations of action level ChE depressions, which 4915

have identified multiple pesticide WPS violations that are believed to contribute to worker exposure. A 4916

couple of commenters stated that the benefits realized by the state programs, which would expand 4917

nationally if monitoring were to be required, include: 4918

• Greater certainty about the frequency of pesticide overexposure. 4919

• Avoidance of serious pesticide illness. 4920

• Improved compliance wi th the WPS. 4921Page 111 of 176 • Identification of any existing PPE, work practice, and engineering control requirements that 4922

are not sufficient to protect pesticide handlers from exposure. 4923

• Greater awareness of chemical and exposure hazards. 4924

Some commenters cited Washin gton State’s data that shows that the percentage of 4925

overexposed participating handlers who required remedial action fell from 20% when the program 4926

started in 2004 to 6% in 2013, for a reduction of 70%. These commenters stated that Washington’s 4927

Department o f Labor and Industries found that ChE monitoring helped identify the causes of 4928

overexposure, which allowed for those causes to be corrected by alerting employers and handlers to 4929

unsafe work practices, conditions, or equipment. Additionally, a couple of com menters stated that the 4930

percentages of handlers who actually reached the removal level from handling ChE

- inhibiting pesticides 4931

remained consistently low after the implementation of the ChE monitoring program, with the 4932

percentages being 3.8% in 2004, 0% in 2010 and 2011, 2.3% in 2012, and 4% in 2013. These commenters 4933

believed that the sharp decline in the number of handlers needing remedial action, along with the 4934

consistently low percentage of handlers who exceeded 20% below their baseline (i.e., those who r each 4935

the evaluation level in the state programs), shows that the program has been effective in reducing 4936

exposure to OPs and carbamates, and that monitoring should be implemented nationally so that all 4937

workers receive similar benefits. 4938

Some commenters in support of requiring ChE monitoring also discussed the costs associated 4939

with ChE monitoring. They stated that the cost of implementation should not deter EPA from requiring 4940

medical monitoring on a national level. A few commenters stated that EPA’s estimate that the cost of 4941

ChE monitoring would average $53 per year per agricultural establishment was a small cost when 4942

contrasted with the 70% reduction in overexposure according to Washington State’s data. A couple of 4943

commenters also stated that monitoring in C alifornia and Washington has led to substantially fewer 4944

pesticide poisonings and reduced use of these highly toxic pesticides, and can, in turn, reduce long

- term 4945

medical costs to farmworkers and the agricultural economy. Some commenters stated that EPA’s 4946

a nalysis did not include an estimation of the medical expenses that were saved, the lost wages 4947

prevented, and the pesticide

- related illnesses avoided as a result of early detection and intervention. As 4948

a result, the commenters believed that the benefits of a national ChE monitoring program would more 4949

than justify the costs given the severe effects of overexposure to ChE

- inhibiting pesticides. 4950

Other commenters supporting ChE monitoring stated that employees who handle ChE

- inhibiting 4951

chemicals in non

- agricult ural sectors routinely receive the protection of medical monitoring. For 4952

example, some commenters stated that OSHA requires medical monitoring for workers who handle a 4953

wide range of toxic substances. They also stated that USDA requires monitoring of its em ployees who 4954

may be exposed to organophosphate or carbamate pesticides. These commenters stated that these 4955

safeguards should be provided for all workers who handle these pesticides, and therefore should be 4956

included in the final rule. 4957

EPA Response. After r eviewing the comments, EPA continues to believe that the expected 4958

benefits of a routine ChE monitoring program for handlers are not sufficient to justify the costs. As 4959

stated in the proposed rule, EPA believes that Washington State’s efforts have identifie d the primary 4960

reasons for ChE inhibition among pesticide handlers. In many cases, ChE depression was caused by 4961

handlers not following basic safety and hygiene procedures, e.g., not wearing the label

- required PPE and 4962

failing to wash before meals or bathroom breaks. Additionally, several handlers who did wear 4963

respirators as required by labeling had beards, which compromised the seal between the face and the 4964

respirator and reduced the protection intended to be afforded by the PPE. EPA believes that requiring 4965

e xpanded and more frequent handler training, in combination with requirements for fit testing and 4966Page 112 of 176 training on proper respirator use for handlers, addresses the primary reasons for overexposure to ChE

4967

inhibiting pesticides. 4968

The revised labeling with increas ed protections and new mitigation measures resulting from the 4969

reregistration of organophosphates and carbamates will also result in lowered handler exposure. 4970

Reregistration has resulted in some uses of the most acutely toxic organophosphates being phased o ut. 4971

For the remaining uses, EPA has imposed additional PPE requirements, requirements for closed

- system 4972

mixing and loading, and reductions to rates of application and number of annual applications permitted. 4973

As labels with updated PPE requirements for hand lers are seen and followed in the field, EPA expects to 4974

see reduced numbers of overexposures. Additionally, the organophosphates and carbamates that are 4975

still registered are being used less frequently and being replaced by pesticides with lower risks, also 4976

reducing the potential for overexposure. 4977

While EPA estimated the costs of a national, routine ChE monitoring program to be at least 4978

$15.2 million annually, or about $53 per agricultural establishment per year and $120 per commercial 4979

pesticide handling e stablishment per year, this estimate does not include the full costs that would be 4980

expected of a national ChE monitoring program. As stated in the proposed rule, a national, routine ChE 4981

monitoring program would likely include program components such as tra ining, recordkeeping, clinical 4982

testing, and field investigations, which were not included in the estimated costs because the initial $15.2 4983

million estimate appeared by itself to be disproportionately high in comparison to the expected 4984

benefits. Additionall y, the estimated costs do not include the states’ costs to build infrastructure to 4985

support ChE monitoring or to cover continued laboratory costs such as equipment maintenance and 4986

administrative support. If EPA were to calculate these additional costs, the estimated costs would be 4987

much higher than $15.2 million annually. Therefore, EPA stands by its assessment in the proposed rule 4988

that the cost of implementing a national, routine ChE monitoring program is not justified by its limited 4989

benefits. 4990

EPA believes that the increased handler protections being finalized in this rulemaking, combined 4991

with the product

- specific risk mitigation measures, will appropriately address the elevated potential for 4992

ChE inhibition in handlers. Moreover, the training and PPE elemen ts of the final rule will have the 4993

combined effect of providing important protective benefits to all pesticide handlers through increased 4994

knowledge of exposure risks and prevention strategies. This approach will lead to a reduction of 4995

pesticide exposures b ecause it prevents handler exposure before it occurs. 4996

Comments

– m onitoring h andler e xposure to c holinesterase i nhibiting c hemicals. Some 4997

commenters, including a state regulatory agency, a public health organization, and various farmworker 4998

advocate organizations disagreed with EPA’s proposed decision to not implement medical monitoring 4999

for cholinesterase inhibiting pesticides, and not ed that the concept of medical monitoring and the 5000

preventative measures that EPA is implementing in the final rule are not mutually exclusive. One health 5001

organization proposed the use of computerized Action Plans in conjunction with medical monitoring to 5002

p reemptively address worker exposure concerns. One farmworker advocate organization commented 5003

that the only way to know whether the cumulative exposure to organophosphate pesticides has 5004

depressed cholinesterase levels to dangerous levels in either handlers or workers is through monitoring. 5005

EPA Response. EPA acknowledges that monitoring employee exposures to organophosphate 5006

pesticides through cholinesterase monitoring has been successfully implemented in some states and 5007

may be a prudent occupational health practice in some occupational exposure situations. However, EPA 5008

stands by its assessment in the proposed rule that the cost of implementing a national, routine ChE 5009

monitoring program is not justified by its limited benefits. EPA believes that the increased handler 5010

protections being finalized in this rulemaking, combined with the product

- specific risk mitigation 5011Page 113 of 176 measures, will appropriately address the elevated potential for ChE inhibition in pesticide handlers. In 5012

addition to the training and new protection s in the rule, EPA also makes a regulatory decision on each 5013

active ingredient and use site as part of the comprehensive occupational exposure and risk assessment 5014

under the FIFRA registration process in order to address worker safety concerns. The findings of the risk 5015

assessment are addressed in the registration decision for each pesticide product, and are manifested on 5016

the pesticide product labeling (e.g. application rate, use site). EPA believes that the registration 5017

decisions informed by the chemical

- spec ific occupational risk assessment, in tandem with the training 5018

and PPE elements of the final rule

, will protect handlers from unreasonable adverse effects of 5019

cholinesterase

- inhibiting pesticides. 5020

Comments

– n ational c holinesterase m onitoring p rogram. One pesticide manufacturer 5021

organization commented on ChE monitoring programs noting that they not be used as a substitute for 5022

adherence to pesticide labelling and sound handler safety practices. This commenter also stated that 5023

the proposed enhancements of th e WPS include aspects pertaining to training, communications, and 5024

PPE that are important protective benefits for all pesticide handlers through increased knowledge of 5025

exposure risks and prevention strategies, ultimately leading to reductions in potential e xposure. 5026

EPA Response. EPA agrees that compliance with the requirements on pesticide labeling and 5027

sound handler practices are important to limiting potential exposure to pesticides. 5028

Comments

– c holinesterase i nhibition. One pesticide manufacturer organ ization commented on 5029

the difference in ChE inhibition between ChE

- inhibiting pesticides like organophosphates and N

- methyl

5030

carbamate pesticides. 5031

EPA Response. EPA thanks the commenter and agrees that there are toxicological differences 5032

between the nature of ChE

- inhibiting chemical classes. EPA makes regulatory decisions based on the 5033

human health and ecological risk assessments for each active ingredient and cumulative chemical class, 5034

if appropriate. The toxicological databases for both individual active in gredients and the cumulative risk 5035

assessments for the organophosphate and N

- methyl

- carbamate chemical classes reflect differences 5036

based on the toxicological data submitted to EPA. EPA also agrees that when medical monitoring occurs, 5037

there may be logistical differences in the biological sampling to account for toxicological differences 5038

between chemical classes. 5039

Comments

– overall protections

. One farmworker advocate commented that EPA doesn’t 5040

sufficiently test or understand the chemical pesticides on the market and that there may be adverse 5041

effects for women and children as opposed to the protections provided by occupational exposure limits 5042

like OSHA’s Permissible Exposure Limits (PELs) or NIOSH’s Recommended Exposure Limits (RELs) 5043

established for given ch emicals. 5044

EPA Response. Although the scientific community’s understanding of the biological and 5045

physiological effects of pesticides is always expanding, EPA believes that the range of studies currently 5046

required of applicants for pesticide registration prov ides an appropriate and reliable basis for 5047

determining whether a product meets FIFRA’s registration standard of no unreasonable adverse effects 5048

on man or the environment. EPA conducts a rigorous human health risk assessment based on a given 5049

active ingredie nt’s toxicological database, and exposure scenarios reflective of the site and method of 5050

each proposed use. For pesticide handlers, the exposure and risk assessment does not rely on 5051

occupational exposure limits (e.g. PELs or RELs), but rather a comprehensi ve scenario

- driven assessment 5052

based on the use pattern identified on the product labeling to determine what use limitations, 5053

directions, and precautions would be necessary in order to prevent unreasonable adverse effects to 5054

handlers, other persons and the environment. Additional information on the assessment of pesticide 5055Page 114 of 176 handler risks is available on the Agency website: http://www.epa.gov/pesticides/science/handler

5056

exposure

- dat a.html

. 5057

XVII. Exemptions and Exceptions 5058

A. Immediate Family 5059

1. Current rule and proposal . The WPS currently exempts the owners of agricultural 5060

establishments from requirements to provide certain WPS protections to themselves and their 5061

immediate family mem bers. Owners are required to comply with all applicable provisions of the WPS for 5062

any worker or handler employed on the establishment who is not a member of the owner’s immediate 5063

family. The definition of “immediate family” in the existing rule includes only the owner’s spouse, 5064

children, stepchildren, foster children, parents, stepparents, foster parents, brothers, and sisters. EPA 5065

proposed to expand the definition of “immediate family” to add father

- in

- law, mother

- in

- law, sons

- in

5066

law, daughters

- in

- law, g randparents, grandchildren, brothers

- in

- law, and sisters

- in

- law. 5067

Note, too, that the WPS definitions of workers and handlers depend upon them being employed 5068

for compensation. Therefore, any person performing worker or handler tasks who does not receive a 5069

wage, salary or other compensation is not a worker or handler protected by the WPS, regardless of 5070

familial relationship to the owner. 5071

EPA requested comment on but did not propose changes narrowing the immediate family 5072

exemption in two ways: (1) Limiting i t only to those immediate family members of an owner of an 5073

agricultural establishment who are at least 16 years old, and (2) eliminating the exemptions from 5074

requirements regarding emergency assistance for workers and handlers and regarding handler 5075

monitori ng during fumigant application. 5076

As part of the proposal to establish a minimum age for pesticide handlers and early

- entry 5077

workers, EPA proposed to add an exemption from the minimum age requirements to the immediate 5078

family exemption. 5079

2. Final rule . EPA ha s finalized the definition of “immediate family” as limited to the owner’s 5080

spouse, parents, stepparents, foster parents, father

- in

- law, mother

- in

- law, children, stepchildren, foster 5081

children, sons

- in

- law, daughters

- in

- law, grandparents, grandchildren, brot hers, sisters, brothers

- in

- law, 5082

sisters

- in

- law, aunts, uncles, nieces, nephews, and first cousins. “First cousin” means the child of a 5083

parent’s sibling, i.e., the child of an aunt or uncle. The final regulatory text for this definition is available 5084

at 40 C FR 170.305. 5085

EPA has amended the exemption from certain provisions of the WPS for owners and members 5086

of their immediate families to include exemptions from the minimum age requirements for handlers and 5087

early

- entry workers. The final regulatory text for thi s exemption is available at 40 CFR 170.601(a)(1)(i) 5088

and 170.601(a)(1)(xii). 5089

EPA has clarified the final regulatory text related to the exemption from certain provisions of the 5090

WPS for owners and members of their immediate families. The exemption in the fi nal rule will apply to 5091

owners and members of their immediate family on any agricultural establishment where a majority of 5092

the establishment is owned by one or more members of the same immediate family. The final 5093

regulatory text for this exemption is availa ble at 40 CFR 170.601(a)(1). 5094

EPA has not included in the final rule any of the other changes to the owner and immediate 5095

family exemption considered in the proposal. 5096

3. Comments and responses. 5097

Comments . Many commenters expressed general support for the proposed expansion to the 5098

definition of immediate family and the inclusion of an exemption from the minimum age requirement. 5099

Some commenters asserted that the definition provides greater clarity about who qualifies under the 5100Page 115 of 176 immediate family exemption and will assist both the regulated community and state regulatory agencies 5101

in ensuring compliance with the proposed rule. One commenter noted that the proposed immediate 5102

family exemption may not affect California employers or workers because California’s rules are more 5103

prohibitive. Another commenter contended that the immediate family exemption does not undermine 5104

the intent or protections of those the WPS is intended to protect but did not provide a specific rationale 5105

for this assertion. 5106

Several commenters req uested that EPA expand the definition to include cousins. Many 5107

commenters , including the SBA Office of Advocacy, requested that EPA expand the definition further to 5108

include aunts, uncles, nieces, nephews, and cousins. One commenter requested that EPA expan d the 5109

definition to include nieces, nephews, and extended family. Commenters requesting further expansion 5110

of the definition noted that an expansion of the family members considered immediate family under the 5111

WPS would better reflect the reality of the fami ly farm in America. Commenters also requested that 5112

EPA further expand the definition and exemption to recognize varying ownership patterns used to 5113

assure the continued operation of the farm and the involvement of siblings and their heirs. One 5114

commenter su ggested that EPA align the exemption with USDA’s interpretation of farm ownership by 5115

family members, which considers a “family farm” to be one where a majority of the farm is owned by 5116

family members, rather than retaining EPA’s interpretation of the exempt ion as applying only on 5117

establishments that are wholly owned by one or more members of the same immediate family

. 5118

One commenter suggested that immediate family be determined by shared DNA, to be 5119

evaluated by the enforcement agency on a case

- by

- case basis. Another commenter urged EPA to include 5120

close

- held corporate entities as family, if all workers are either parents or children of stock or share 5121

owners. A third commenter requested that EPA amend the definition and exception to require that the 5122

exemption wo uld apply when the employee has an immediate family relationship with one of the 5123

owners. One commenter suggested deleting from the definition foster children. 5124

A few commenters requested that EPA delete the definition of immediate family and eliminate 5125

the exemption. These commenters noted that risks from pesticide exposure are the same for family and 5126

non

- family members, so all persons need the same level of protection regardless of their familial 5127

relationship to the owner. Other commenters requested that EP A eliminate the exemption for 5128

immediate family members under 16 or 18 years old to provide WPS protections to all children working 5129

with or around pesticides. One such commenter cited the number of injuries to working and non

5130

working youth on farms in the U .S. 5131

EPA Response

. EPA has further expand ed the definition of immediate family to also include 5132

aunts, uncles, nieces, nephews, and first cousins (i.e., child of a parent’s sibl ing, child of an aunt or 5133

uncle) and is retaining the exemption in the WPS. EPA b elieves that the proposed definition of 5134

“immediate family” represents an appropriate accommodation to the social costs of the WPS to farm 5135

owners and members of their immediate families relative to FIFRA’s requirement to prevent 5136

unreasonable adverse effects

. 5137

EPA considered commenters’ requests to expand or contract the definition of “immediate 5138

family.” Commenters suggested that a definition that includes cousins, or cousins, aunts, uncles, nieces 5139

and nephews would better reflect the actual patterns of family

- based farm ownership in the United 5140

States. EPA agrees with commenters’ suggestions that farm ownership may extend beyond relationships 5141

covered by EPA’s existing or proposed definition. To accommodate the reality of family

- based farm 5142

ownership patter ns in the U.S., EPA agrees with commenters’ requests to expand the definition to 5143

include aunts, uncles, nieces, nephews, and cousins. For clarity, EPA has chosen to include in the 5144Page 116 of 176 definition “first cousins.” A “first cousin” is defined as the child of a pa rent’s sibling, i.e., the child of an 5145

aunt or uncle. 5146

EPA has clarified the applicability of the exemption in the final rule in response to comments. 5147

The exemption in the final rule applies to the owners and their immediate family members on any 5148

agricultur al establishment where a majority of the establishment is owned by one or more members of 5149

the same immediate family. A “majority of the establishment” means that more than 50 percent of the 5150

equity in the establishment is owned by one or more members of the same immediate family as defined 5151

in the WPS. 5152

EPA agrees that the risks associated with pesticide exposure do not vary based on a person’s 5153

relationship to the owner of the establishment. However, EPA recognizes that family

- owned farms need 5154

flexibility an d is relying on representations by family farm and small business advocates that those 5155

family members (including children) working on an establishment covered by the immediate family 5156

exception would be adequately prepared and supervised by family members. Although owners and their 5157

immediate family members are exempted from certain provisions of the WPS (e.g., providing pesticide 5158

safety training and specific decontamination supplies for immediate family members), they are 5159

obligated to follow the pesticide la beling and other WPS provisions that are established to protect 5160

workers and handlers from risks associated with specific pesticides. For these reasons, EPA has chosen 5161

not to eliminate the definition of immediate family or the exemption from certain portion s of the rule 5162

for the establishment owner and members of his or her immediate family. 5163

Although owners of establishments and members of their immediate family are exempt from 5164

some of the provisions of the rule, EPA expects that they will voluntarily follow the provisions from 5165

which they are exempt, or achieve equivalent risk mitigations through other means. EPA encourages 5166

owners and family members to carefully study the WPS requirements and assure themselves that they 5167

are not placing each other at risk of u nreasonable adverse effects. 5168

B. Crop Advisors and Employees 5169

1. Current rule and proposal . The existing rule exempts employers from complying with certain 5170

handler requirements when the employee performs crop advising tasks in a treated area under an REI 5171

a nd is a certified or licensed crop advisor or directly supervised by a certified or licensed crop advisor. A 5172

certified or licensed crop advisor is one who has fulfilled the requirements of a program acknowledged 5173

as appropriate in writing by EPA or a state or tribal agency responsible for pesticide enforcement. The 5174

existing rule allows a certified or licensed crop advisor to make specific determinations regarding the 5175

appropriate PPE, decontamination and safe method of conduct for themselves and those working under 5176

their direct supervision. A person employed by a commercial pesticide handling establishment 5177

performing crop advising tasks after expiration of an REI is not subject to any provisions of the WPS. The 5178

rule also exempts employers from complying with w orker requirements such as providing 5179

decontamination supplies and emergency assistance for certified or licensed crop advisors and for 5180

persons they directly supervise. 5181

EPA proposed to eliminate the exemptions for employees directly supervised by certified or 5182

licensed crop advisors. EPA also proposed to eliminate the exemption from the worker decontamination 5183

and emergency assistance provisions for certified or licensed crop advisors employed as workers on 5184

agricultural establishments. 5185

2. Final Rule . EPA h as eliminated both exemptions as proposed. However, EPA has included in 5186

the final rule added flexibility in the PPE requirements for crop advisors and their employees. 5187

Specifically, EPA has added language to the final regulation that allows crop advisors a nd their 5188

employees who perform crop advising tasks while an REI is in effect to substitute the label

- required 5189Page 117 of 176 handler PPE with either the label

- required PPE for early

- entry activities or a standard set of crop advisor 5190

PPE. The standard set of PPE for crop advising tasks included in the final rule consists of coveralls, shoes 5191

plus socks, chemical

- resistant gloves made of any waterproof material and eye protection if the labeling 5192

of the pesticide product applied requires protective eyewear for handlers. The f inal regulatory text for 5193

this requirement is available at 40 CFR 170.601(b) and 170.607(g). 5194

3. Comments and responses. 5195

Comments in support of eliminating the exemption. Comments from several state regulatory 5196

agencies, a farmworker advocacy organization an d an independent crop consultant support EPA’s 5197

proposal to eliminate the exemption currently in place for employees working under the direct 5198

supervision of a certified or licensed crop advisor. The state regulatory agencies and farmworker 5199

advocates stated that crop advisor employees should be provided protections consistent with other 5200

agricultural employees. An independent crop consultant discussed the changing nature of the business 5201

and noted: 5202

“I don't even allow my own son to undertake certain tasks wit hout some sort of accredited training. 5203

When something is going to unravel in this field, there is nothing a 'direct supervisor' can do to 5204

prevent something terrible from potentially happening. I've seen it happen too often. DO NOT PUT A 5205

WORKERS SAFETY IN T HE HANDS OF A DIRECT SUPERVISOR. ” 5206

EPA Response . EPA agrees that allowing workers to conduct crop advising tasks under direct 5207

supervision but without the same basic protections provided for other agricultural employees would 5208

establish a lesser standard of protection for similar types of work. 5209

Comments in opposition to eliminating the exemption . Crop consultant associations, several 5210

state regulatory agencies, state farm bureaus, and one academic institutions objected to eliminating the 5211

exemption currently i n place for employees working under the direct supervision of a certified or 5212

licensed crop advisor. They asserted that certified and licensed crop advisors often exceed the minimum 5213

safety training requirements when educating their employees and those emplo yees are aware of the 5214

risks associated with their work. Some crop consultant associations noted that they are not aware of any 5215

case of endangerment or harm that has occurred to any employee under the direct supervision of a 5216

certified or licensed crop advis or. 5217

The commenters also expressed concern that EPA underestimated the economic impact to crop 5218

advisors, and in turn to farmers, of eliminating this exemption, citing specifically the increased costs of 5219

additional PPE, the cost of work done by certified o r licensed crop advisors instead of by their 5220

employees, and the cost of increased management time. The commenters contended that these 5221

increased costs could discourage investment in integrated pest management (IPM) and result in 5222

increased pesticide use tha t might put persons performing crop advising tasks at increased risk of 5223

pesticide exposure. 5224

EPA Response. EPA has concluded that the burdens associated with eliminating the exemption 5225

for employees of crop advisors are justified by the additional protecti ons provided to persons 5226

performing crop advising tasks who are not certified or licensed crop advisors. EPA has retained the 5227

exemption to the WPS for certified or licensed crop advisors because these individuals are highly trained 5228

about pesticide risks and how to protect themselves. EPA eliminated the exemption for crop advisors’ 5229

employees because pest scouting tasks may result in substantial contact with a pesticide on treated 5230

surfaces in pesticide

- treated areas. The amount of contact with pesticides durin g scouting depends on 5231

variables such as the height and density of the crop, the nature of the activity, the surface that contains 5232

the pesticide residue, and whether residues are dry or wet. W hile EPA recognizes that the crop advising 5233

industry has implement ed a training program for employees, the program is not required and can vary 5234Page 118 of 176 in content and quality from employer to employer. Additionally, crop scouts and assistant crop advisors 5235

are generally entry

- level employees who may not feel empowered to ask an e mployer for PPE or other 5236

protections and may not understand the complex factors influencing risk well enough to take 5237

appropriate protective measures for themselves. 5238

The existing incident monitoring programs do not capture illness data specifically associa ted 5239

with crop advising tasks because cases are categorized under a general “field worker” label. However, 5240

EPA’s risk assessments indicate that people doing crop advising tasks during an REI are at risk of chronic, 5241

low

- level pesticide exposure over time. PP E requirements and availability of decontamination supplies 5242

during and after an REI are fundamental to mitigating risks of concern for persons performing crop 5243

advising tasks. 5244

EPA understands that IPM programs require post

- application entry and the timing is critical to 5245

efficacy. By retaining the exemption for certified or licensed crop advisors to conduct crop advising tasks 5246

during an REI and allowing flexibility for employers to substitute the label required PPE for handlers with 5247

either PPE for early

- entr y workers or a standard set of PPE, the increased costs noted in comments are 5248

reduced. Eliminating the exemption for a non

- certified crop advisor to forgo wearing PPE based on 5249

his/her employer’s recommendation seems misunderstood by those commenting on th e perceived 5250

impact. The WPS currently requires employers of non

- certified crop advisors to make PPE 5251

available. The final regulation requires that employees working under a certified crop advisor in a field 5252

during an REI use a standard set of PPE (consist ing of c overalls, shoes plus socks and chemical

- resistant 5253

gloves, and eye protection if the pesticide product labeling applied requires protective eyewear for 5254

handlers) or label

- required PPE. That is, the impact of the provision is that the non

- certified crop 5255

advisor may have to put on a pair of coveralls, gloves, and in some instances, eye protection. The 5256

benefit of this revision is to remove a potential externality and protect employees who may not be fully 5257

trained and may be unable to make appropriate judgments regarding personal risk. 5258

C. Closed Systems 5259

1. Current rule and proposal . The existing WPS permits exceptions to the label

- specified PPE 5260

when using a closed system for certain pesticide handling activities. The existing rule does not 5261

adequately describe the specific characteristics of an acceptable closed system. EPA proposed to 5262

establish specific design criteria and operating standards for closed systems based on California's 5263

existing standards outlined in the California Department of Pesticide Regulation’s (CDPR) 1998 Closed 5264

Systems Director’s Memo (http://www.cdpr.ca.gov/docs/whs/cac/cacwhs98

- 01.pdf ). 5265

2. Final Rule . EPA has modified the proposed approach regarding closed systems. Specifically, in 5266

the final rule EPA has adopted a broad definition, a performance

- based standard, and basic operating 5267

standards. The operating stan dards require the handler employer to ensure that written operating 5268

instructions for the closed system are available, that the handler receives training on use of the closed 5269

system, and that the system is maintained according to the written instructions. S pecific design criteria 5270

and recordkeeping requirements that EPA proposed are not included in the final rule. 5271

The final rule retains the existing requirements for PPE when a closed system is used: Labeling

5272

mandated PPE must be immediately available for us e in an emergency and handlers must use protective 5273

eyewear for closed systems that operate under pressure. 5274

The final regulatory text for the definition of closed systems is available at 40 CFR 170.305. The 5275

final regulatory text for the closed system excep tion is available at 40 CFR 170.607(d)(3). 5276

3. Comments and responses. 5277

Comments . Most comments that addressed closed systems supported the goal of encouraging 5278

their use as an engineering control through a WPS exception; however, very few individuals, stat es or 5279Page 119 of 176 organizations supported the proposal as written. Several farmworker advocacy organizations, public 5280

health organizations, universities, and private citizens suggested that EPA require closed systems for all 5281

Toxicity Category I pesticide products rathe r than continuing the voluntary system. 5282

Comments from states and grower and industry associations supported the existing voluntary, 5283

performance

- based system and objected to the proposed specific design criteria, noting a number of 5284

weaknesses in the criter ia. Specifically, they noted that the pressure requirements were too prescriptive 5285

and would not allow effective mixing, that the proposal did not address water soluble packaging or lock 5286

and load systems used for dry formulations, and that the complicated r equirements would be a 5287

deterrent to increased adoption of closed systems. A number of commenters also noted that the design 5288

standards are too restrictive to accommodate future innovation. States commented that assessing 5289

compliance with the design standard would require extensive inspector training and could result in 5290

technical violations without providing additional handler protection. Many commenters from the 5291

pesticide industry and grower associations also stated that EPA underestimated the costs of closed 5292

systems in the proposed rule partly because existing closed systems would need to be upgraded to meet 5293

the proposed standards. A number of commenters felt that EPA depended too heavily on CDPR’s 5294

evaluation of closed systems. 5295

EPA Response . EPA considered the comments submitted and was convinced that the 5296

prescriptive requirements in the proposal would be a disincentive to the voluntary adoption of closed 5297

systems. In response, EPA has finalized a closed system performance standard that will permit flexibili ty 5298

for the system while meeting the protection goals. 5299

In response to comments advocating that EPA require closed systems for all Toxicity Category I 5300

pesticides under the rulemaking, EPA reminds the commenters that worker risk assessments and the 5301

risk man agement processes establish the required protections that appear on product labels. EPA 5302

identifies the basic protections, often PPE, to protect handlers from risks of concern. If handler exposure 5303

during mixing and loading is above the established level of concern, and if PPE does not reduce exposure 5304

to below the level of concern, the pesticide label may require a closed system for mixing and loading. 5305

EPA has required the use of closed systems on some product labeling. 5306

EPA recognizes that the reduction in h andler PPE alone is not likely to be enough incentive for 5307

an employer to use closed systems. However, EPA is convinced that on larger establishments, the 5308

efficiency and comparative protection value of a closed system, combined with the reduction in PPE tha t 5309

must be worn by the handler, may induce users to adopt closed systems. Establishing requirements for 5310

such closed systems

– whether required or used voluntarily

– is necessary to protect handlers, who 5311

could be exposed to concentrated pesticides if they us e poorly designed or constructed closed systems. 5312

EPA agrees with the comments that a broad definition of “closed system” will encourage 5313

industry innovation better than the proposed prescriptive rule and will allow flexibility for employers to 5314

design syste ms specific to their needs. A broad performance standard, along with requirements 5315

concerning operating instructions, training and maintenance, will enable employers, handlers and 5316

regulatory personnel to determine whether a closed system qualifies for the e xemption. The operating 5317

standards will ensure that the closed systems are used as intended and are adequately maintained. 5318

EPA considered CDPR’s proposed rule in the development of the final closed systems standard 5319

because they are a nationally recognized expert in closed

- system regulation. California is the only state 5320

with specific closed system standards, and has required their use with certain chemicals since the 1970s. 5321

EPA notes that CDPR no longer supports use of the prescriptive

- based criteria upon wh ich EPA modeled 5322

the proposal outlined in the NRPM. In December 2014, CDPR published proposed regulations outlining a 5323

simplified, performance

- based criteria for closed system design. CDPR developed their revised closed 5324Page 120 of 176 systems standard and discussed the pro posal with representatives from groups that will be directly 5325

affected including agricultural producer organizations, manufacturers, applicators, and growers, as well 5326

as at CDPR’s Pesticide Registration and Evaluation Committee and the Agricultural Pest Con trol Advisory 5327

Committee and Pest Management Advisory Committee meetings. EPA’s final closed system 5328

requirements were developed using CDPR’s proposal as a model and do not conflict with CDPR’s 5329

proposed closed system requirements. 5330

Section 170.607(d)(2)(i) e stablishes a performance standard for closed systems. Specifically, a 5331

closed system must remove the pesticide from its original container and transfer the pesticide product 5332

through connecting hoses, pipes and couplings that are sufficiently tight to preve nt exposure of handlers 5333

to the pesticide product, except for the negligible escape associated with normal operation of the 5334

system. This closed system performance standard is based on the criteria for closed systems in section 5335

6746(f)(1) of CDPR’s proposed regulations with a few changes, partly to accommodate the different 5336

terminology in the two sets of regulations. Also, EPA adjusted the requirement to apply to transferring 5337

any pesticide product rather than a pesticide concentrate so the WPS criteria woul d apply to 5338

transferring liquid formulations and dry formulations whereas California’s proposed requirements would 5339

only apply to liquid formulations. Lastly, EPA added the phrase “except for the negligible escape 5340

associated with normal operation of the sys tem” to provide the flexibility intended in the proposed rule. 5341

The existing WPS describes a closed system as preventing the pesticide from contacting handlers or 5342

other persons, which is a very high standard because it does not allow any exposure. The phr ase 5343

“except for the negligible escape associated with normal operation of the system” is intended to 5344

account for the expected or predictable small release of pesticides from existing closed systems when 5345

hoses, pipes and couplings are disconnected. EPA rec ognizes that there will often be a small amount of 5346

material in the hoses, pipes and couplings to which the handler possibly could be exposed. EPA has not 5347

quantified the maximum amount of pesticide escape that is acceptable, but notes that it should be 5348

con sistent with the intent of a closed system, which is to prevent contact to the handlers or other 5349

persons. 5350

EPA also adjusted the final regulatory text for closed systems to address the comments about 5351

water soluble packaging. The regulatory text in the fin al rule was revised to state clearly that the closed 5352

system exception from PPE applies when intact, sealed water soluble packaging is loaded into a mixing 5353

tank or system. The regulation also clarifies that water soluble packaging is no longer a closed syst em if 5354

the integrity of the packaging is compromised. This language in the final rule incorporates EPA’s current 5355

position about water soluble packaging and closed systems, as established in the Interpretive Guidance 5356

on the WPS ( http://www.epa.gov/pesticide s/safety/workers/wpsinterpolicy.htm )

. 5357

While the final rule includes only a performance standard, EPA recognizes that it may be helpful 5358

to have guidance on how to construct a system to meet that standard. As part of California’s proposed 5359

rulemaking, CDPR a nd the University of California, Davis (UC Davis) developed plans for building a closed 5360

system to release along with the proposal. The “Overview of Closed Systems Components and User 5361

Designs” document includes lists of component parts (and costs) for three levels of systems (basic, 5362

medium and high). The design plans developed by CDPR and UC Davis will provide users with examples 5363

of representative closed systems components so they can identify or develop acceptable closed 5364

systems. 5365

The changes to replace th e proposed specific design standards with a broad performance 5366

standard in the final rule address commenters ’ concerns with cost estimates in the proposal, because 5367

employers will be able to continue using most existing closed systems with minimal adjustment s. In 5368

addition, EPA notes that the WPS does not require use of closed systems, so commenters who assumed 5369Page 121 of 176 many pesticide users would have to purchase expensive closed systems were incorrect. EPA adjusted 5370

the closed system cost estimates from the proposed r ule in several ways to reflect changes in the final 5371

rule. The cost estimate in the proposed rule assumed that some users of closed systems would purchase 5372

new systems while others would revert to using PPE. In light of the revised definition, the final cost 5373

estimate assumes that most users would simply purchase an adapter to connect their existing closed 5374

system to the pesticide container, which is the part that most likely needs to be added to convert 5375

existing mechanical transfer systems to be closed systems that meet EPA’s criteria. These changes and 5376

costs are based on the CDPR and UC Davis document “Overview of Closed Systems Components and 5377

User Designs,” which includes lists of component parts and their costs for three levels of systems. In 5378

addition, the c ost of developing operating instructions was added, assuming that most closed systems 5379

are custom

- made systems that would require the employer to develop operating instructions, while the 5380

costs of keeping records of maintenance was deleted. EPA reduced the estimated number of farms using 5381

closed systems based on information from the Agricultural Handler Exposure Task Force, which showed 5382

that the limited number of pesticide users who use closed systems are primarily larger establishments 5383

and commercial pestici de handling establishments. Therefore, the estimated costs of the closed system 5384

criteria decreased from the proposed rule to the final rule. 5385

Using closed systems is preferred to wearing PPE as an approach for managing chemical 5386

exposure in the “hierarchy of controls” established under standard industrial hygiene principles. 5387

Enclosing the chemical and substantially reducing the potential for exposure at the source reduces the 5388

potential for subsequent exposure to handlers, other people, and the environment. 5389

EPA estimates the cost of the final closed system requirements will be $ 2 .1 million annually. EPA 5390

estimates that cost per agricultural establishment will range from $5

- $30 per year, and the cost per 5391

commercial pesticide handling establishment will be abo ut $21 per year. EPA estimates that on family 5392

establishments, the cost would range from $1

- $30 per year. Many commenters from the pesticide 5393

industry and grower associations stated that EPA underestimated the costs of closed systems in the 5394

proposed rule par tly because existing closed systems would need to be upgraded to meet the proposed 5395

standards. The changes to replace the proposed specific design standards with a broad performance 5396

standard in the final rule address these comments, because employers will b e able to continue using 5397

most existing closed systems with minimal adjustments. For details refer to the Economic Analysis 5398

accompanying this rule (Ref. 1)

. In addition, EPA notes that the WPS does not require use of closed 5399

systems, so commenters who assume d many pesticide users would have to purchase expensive closed 5400

systems were incorrect. 5401

EPA adjusted the closed system cost estimates from the proposed rule in several ways to reflect 5402

changes in the final rule. The cost estimate in the proposed rule assume d that some users of closed 5403

systems would purchase new systems while others would revert to using PPE. In light of the revised 5404

definition, the final cost estimate assumes that most users would simply purchase an adapter to connect 5405

their existing closed sys tem to the pesticide container, which is the part that most likely needs to be 5406

added to convert existing mechanical transfer systems to be closed systems that meet EPA’s criteria. 5407

These changes and costs are based on the CDPR and UC Davis document “Overvie w of Closed Systems 5408

Components and User Designs,” which includes lists of component parts and their costs for three levels 5409

of systems. In addition, the cost of developing operating instructions was added, assuming that most 5410

closed systems are custom

- made s ystems that would require the employer to develop operating 5411

instructions, while the costs of keeping records of maintenance was deleted. EPA reduced the estimated 5412

number of farms using closed systems based on information from the Agricultural Handler Expos ure 5413

Task Force, which showed that the limited number of pesticide users who use closed systems are 5414Page 122 of 176 primarily larger establishments and commercial pesticide handling establishments. Therefore, the 5415

estimated costs of the closed system criteria decreased from the proposed rule to the final rule. 5416

D. Aerial Applications

- Eyewear Protection for Open Cockpits 5417

1. Current rule and proposal. Under the existing WPS, where labeling requires eye protection, 5418

the requirement may be satisfied by goggles, face shield, safety glasses with front, brow and temple 5419

protection, or a full face respirator. The existing WPS allows aerial applicators applying pesticides from 5420

open cockpit aircraft to substitute a visor for label

- required eye protection. Because the term “visor” can 5421

be used to refer to the brim of a cap that provides only shade and offers little eye protection from 5422

pesticide sprays, EPA proposed to clarify the requirement by removing the term. EPA proposed to allow 5423

aerial applicators to substitute a helmet with the face shield lowered for the label

- required eyewear, 5424

because this more clearly indicates EPA’s expectation of a clear visor that cover s and adequately 5425

protects the eyes. 5426

2. Final rule. In the final rule, EPA has removed the term “visor.” The final rule allows the 5427

substitution of a helmet with face shield lowered for labeled protective eyewear for aerial applicators in 5428

aircraft with op en cockpits. The final regulatory text for this requirement is available at 40 CFR 5429

170.607(f)(2). 5430

3. Comments and responses. 5431

Comments. There were very few comments addressing this proposal. One state suggested EPA 5432

consult with relevant aerial agencies re sponsible for overseeing the use of open cockpits for making 5433

pesticide applications to see if the proposal is feasible. One state regulatory agency supported the 5434

proposed changes along with a state academic institution and a farmworker advocacy organizatio n. 5435

Two farm bureau organizations said they had no objection the proposal, while another farm bureau 5436

organization and a commodity group said they deferred to or supported comments from aerial 5437

applicator associations. 5438

An aerial applicators association asse rted that aerial applications of pesticides using open 5439

cockpit aircraft are very rare and that EPA is solving a problem that does not exist. They objected to 5440

handlers operating open cockpit aircraft being required to wear the same PPE as handlers operating 5441

open cab ground equipment. They did not highlight any specific issue with the helmet and visor being 5442

lowered when protective eyewear are required, but generally objected to EPA proposing any rule that in 5443

any way impacted aviation safety and recommended de leting this and other provisions applicable to 5444

aerial applicators. 5445

EPA Response

. EPA acknowledges that while open cockpit aircraft may be rare, available 5446

exposure data indicate that even pilots in enclosed cab aircraft are exposed to the pesticides they apply. 5447

Ensuring that the eye is protected from pesticides is required by the product labeling. Helmets with face 5448

shields in the lowered position provide acceptable eye protection, but many items referred to as 5449

“visors” offer no eye protection from pesticid e sprays. EPA believes it is common for some aircraft pilots 5450

to wear helmets with face shields, so this practice should not present a hazard or safety issue for pilots. 5451

Additionally, EPA is unaware of any adverse problems that have arisen because of the e xisting WPS 5452

requirements related to aerial applicators and PPE; therefore EPA is retaining this provision as proposed 5453

and the other related provisions for aerial applicators and PPE as they were in the existing rule. 5454

E. Aerial Applications

– Use of Glove s 5455

1. Current rule and proposal . In the existing rule, aerial applicators have the option of whether 5456

to wear chemical resistant gloves to enter and exit the aircraft unless gloves are required by the product 5457

labeling. In the proposal, EPA inadvertently ins erted the regulatory language that existed prior to the 5458

2004 rule revision that required pilots to wear chemical resistant gloves. 5459Page 123 of 176 2. Final rule . The final rule retains the exception in the existing WPS that offers aerial applicators 5460

the option of wearin g chemical

- resistant gloves when entering and exiting the aircraft, except when the 5461

product labeling requires that chemical

- resistant gloves be worn when entering and exiting the aircraft. 5462

The final regulatory text for this requirement is available at 40 CFR 170.607(f)(1). 5463

3. Comments and responses. 5464

Comments . Several commenters, including aerial applicators, aerial applicator associations and 5465

agricultural industry noted this inadvertent error in the proposal and noted that they had learned it was 5466

an ove rsight, but they reiterated support for keeping the requirements the same as they are in the 5467

existing rule. The commenters also asserted the use of gloves presents a hazard to pilots who may fall 5468

when entering and exiting the aircraft when wearing gloves. They also suggested contamination from 5469

contact with the exterior of the aircraft is minimized due to advances in application techniques (e.g., 5470

GPS) that help pilots avoid flying through their spray. 5471

EPA Response . EPA agreed with commenters that said to k eep the existing requirements for 5472

gloves in cockpits without changes. The final rule retains the exception in the existing regulation that 5473

offers aerial applicators the option of wearing chemical

- resistant gloves when entering and exiting the 5474

aircraft, exc ept when the product labeling requires that chemical resistant gloves be worn entering and 5475

exiting the aircraft. 5476

F . Enclosed Cabs

– Changes to Exceptions to PPE Requirements when Applying Pesticides from Inside an 5477

Enclosed Cab 5478

1. Current rule and propos al. The existing WPS permits exceptions to the labeling

- specified PPE 5479

when handling tasks are performed from inside an enclosed cab that meets the specifications defined in 5480

the rule. These exceptions are based on the dermal protection provided by the encl osed cab, which 5481

prevents pesticides from contacting the body, and allow handlers to substitute a long

- sleeved shirt, long 5482

pants, shoes, and socks for the labeling

- specified PPE. The existing rule requires persons occupying an 5483

enclosed cab to use labeling

- required respiratory protection, except where the cab has been certified by 5484

the manufacturer to provide respiratory protection equivalent to the handler respiratory protection 5485

required by the pesticide labeling. 5486

EPA proposed to exempt handlers from all l abeling

- specified respiratory protection PPE 5487

requirements when applying pesticides from inside an enclosed cab. This would have allowed handlers 5488

to substitute a long

- sleeved shirt, long pants, shoes, and socks for the labeling

- specified PPE in all cases 5489

no matter what type of respiratory protection PPE was required by the labeling. 5490

2. Final rule. In the final rule, EPA requires h andlers in enclosed cabs to wear the labeling

5491

specified respiratory protection except when the only labeling

- specified respira tory protection is a 5492

filtering facepiece respirator (NIOSH approval number prefix TC

- 84A) or dust/mist filtering respirator. In 5493

the final rule, handlers in enclosed cabs may substitute a long

- sleeved shirt, long pants, shoes and socks 5494

for the labeling

- spe cified PPE for skin and eye protection. If a filtering facepiece respirator (NIOSH 5495

approval number prefix TC

- 84A) or dust/mist filtering respirator is required by the pesticide product 5496

labeling for applicators, then handlers do not need to wear the respira tor inside the enclosed cab 5497

provided that the enclosed cab has a properly functioning air ventilation system that is used and 5498

maintained in accordance with the manufacturer’s written operating instructions. If any other type of 5499

respirator is required by th e pesticide labeling for applicators, then the handler must wear the respirator 5500

inside the enclosed cab during handling activities. 5501

EPA has retained the other conditions of the existing WPS exception to PPE requirements for 5502

handlers using enclosed cabs. Specifically, all of the PPE required by the pesticide product labeling for 5503

applicators must be immediately available to handlers in an enclosed cab and be stored in a sealed 5504Page 124 of 176 container to prevent contamination. Handlers must wear the applicator PPE if the y exit the cab within a 5505

treated area during application or when a REI is in effect. Once PPE has been worn in a treated area, 5506

handlers must remove it before reentering the cab to prevent contamination of the cab. 5507

The final regulatory text for the enclose d cab exception is available at 40 CFR 170.607(e). 5508

3. Comments and responses. 5509

Comments . EPA did not receive any comments in opposition to the proposed changes to the 5510

enclosed cab exception. One grower noted that the enclosed cab exception is an excellent component 5511

of the proposal. Another commenter noted that respirator use is infrequent since the spraying 5512

operation takes place from inside an enclosed, climate

- controlled tractor cab. 5513

EPA Response . EPA considered the comments submitted but has retained the existing 5514

exceptions with minor changes. Although EPA considered a more expansive exception under its 5515

proposal, after reevaluation of the potential exposure risks for handlers and the protections afforded by 5516

enclosed cabs, EPA determined that enclosed cabs may not universally provide respiratory protection 5517

necessary to mitigate inhalation risks for any pesticide product that required respiratory protection 5518

greater than a filtering facepiece respirator (NIOSH approval number prefix TC

- 84A) or dust/mist 5519

f iltering respirator. EPA determined that enclosed cabs may not provide adequate protection from 5520

inhalation exposure hazards when the inhalation exposure risk arises from vapors or other non

5521

particulate inhalation hazards. Additionally, EPA has learned tha t there are no longer any enclosed cab 5522

manufacturers certifying cabs to provide respiratory protection and the American Society of Agricultural 5523

and Biological Engineers has withdrawn their enclosed cab standard. Based on this information, EPA has 5524

removed p rovisions under the enclosed cab exception that permit persons occupying an enclosed cab to 5525

eliminate certain labeling

- required respiratory protection PPE if the cab has been certified by the 5526

manufacturer to provide respiratory protection equivalent to the respiratory protection required by the 5527

pesticide labeling. 5528

X VIII . General Revisions 5529

A. Label vs. Labeling 5530

1. Current rule and proposal. FIFRA defines the label as “the written, printed, or graphic matter 5531

on, or attached to, the pesticide or device or an y of its containers or wrappers.” 7 U.S.C. 136(p)(1) For 5532

reasons of space and user convenience, detailed use instructions and precautions often appear in 5533

labeling provided with the pesticide product upon sale. As defined in FIFRA, “labeling” includes “all 5534

labels and all other written, printed, or graphic matter accompanying the pesticide or device at any 5535

time; or to which reference is made on the label or in literature accompanying the pesticide or device...” 5536

7 U.S.C. 136(p)(2). 5537

Labeling may include booklets distributed with the product when such documentation is too 5538

long to be included on the label that is securely attached to the container. For example, some products 5539

have labeling that is 60 or more pages long. FIFRA and EPA reg ulations require certain information to 5540

appear on the label

– on or attached to the pesticide container. Other information necessary to use the 5541

product safely, such as directions for use, may be included in a booklet distributed with, but not securely 5542

atta ched to, the container (40 CFR 156.10(i)(1)(ii)); this information could also be available on the 5543

Internet if the producer has decided to provide web

- distributed labeling for the product (Ref. 21). In 5544

either format, the information would be considered labe ling. Labeling sometimes includes enforceable 5545

references to other documents that do not physically accompany the container, such as the WPS. 5546

The existing rule discusses employers’ responsibilities related to pesticide labels and labeling in 5547

several place s. The existing rule requires agricultural and handler employers to ensure that pesticides 5548

are used in a manner consistent with the labeling. When the emergency assistance provisions of the 5549Page 125 of 176 WPS are triggered, the existing rule requires employers to provide information from the product 5550

labeling to affected workers, handlers, and/or treating medical personnel. Handlers must receive 5551

training on the format and meaning of information contained on pesticide labels and in labeling. Finally, 5552

employers must ensure t hat handlers have either read or have been informed in a manner they 5553

understand of all labeling requirements related to safe use of the pesticide, and that the handler has 5554

access to the product labeling during handling activities. 5555

Although the proposal re organized the rule, some of the requirements for the existing rule 5556

outlined in the previous paragraph remained essentially unchanged in the proposed rule, e.g., 5557

agricultural and handler employers’ responsibility to ensure that pesticides are used in a mann er 5558

consistent with the labeling. The proposal included a requirement for employers to maintain copies of 5559

the pesticide labeling for each pesticide used on the establishment for 2 years from the date of 5560

application. The proposal also would have required the employer to provide a copy of the label and the 5561

product’s SDS when the emergency assistance provisions are triggered, rather than to provide 5562

information from the pesticide labeling. 5563

2. Final rule . Where the proposed rule would have required the employer to provide a copy of 5564

the pesticide label, or specific information from the labeling, and the SDS under the emergency 5565

assistance provisions, the final rule only requires the employer to provide the SDS and specific 5566

information, which can be obtained from th e pesticide application and hazard information display, 5567

rather than the label or labeling. See Unit XIV. for other comments, EPA’s responses and the final 5568

regulatory text related to emergency assistance. The final rule eliminates the proposed requirement f or 5569

employers to maintain copies of the labeling, rather than the label, for each product bearing a WPS 5570

requirement on the labeling, and replaces it with a requirement for the employer to retain specific 5571

information about the product used and the applicatio n, as well as the SDS. See Unit VII. for other 5572

comments, EPA’s responses and the final regulatory text related to this requirement. 5573

For handler training requirements, EPA has amended the language in the final rule to delete the 5574

word “all” related to labeling. The final rule requires handlers to receive training on following the 5575

portions of the labeling applicable to the safe use of the pesticide and on the format and meaning of 5576

information contained on pesticide labels and in labeling applicable to the safe use of the pesticide . The 5577

final regulatory text for these provisions is available at 40 CFR 170.501(c)(3)(iii)

- (iv). 5578

For labeling and application

- specific information the employer must provide to the handler, EPA 5579

has amended the final rule to require the employer to provide the handler with information on all 5580

portions of the labeling applicable to the safe use of the pesticide , rath er than on all labeling 5581

requirements. The final regulatory text for this provision is available at 40 CFR 170.503(a). 5582

3. Comments and responses. 5583

Comments . Commenters raised issues with EPA’s use of the term “labeling” in the proposed 5584

rule. Commenters ra ised specific concerns with the use of the broader “labeling” in various 5585

requirements instead of limiting those requirements to just the label. These concerns arose in regard to 5586

agricultural and commercial pesticide handler employer duties, emergency assis tance, hazard 5587

communication, and handler training and establishment

- specific information. 5588

Some commenters generally disagreed with EPA’s use of “labeling” and requested that EPA use 5589

“label” instead throughout the rule. They asserted that labeling is too b road and that labeling includes 5590

materials not attached to the container, such as advertisements, brochures and pamphlets. 5591

Commenters assert that the broadness of “labeling” applied to requirements to provide or retain this 5592

information could result in a req uirement on employers to track down many ancillary pieces of 5593Page 126 of 176 information for a complete record, or to face a technical violation for failure to retain all elements of the 5594

labeling. 5595

Under the agricultural and commercial pesticide handler employer duties, a t 40 CFR 170.9(a) 5596

and 170.13(a) of the proposal, commenters said that EPA’s use of labeling was too broad. They asserted 5597

that employers’ liability should be only to comply with the WPS rather than with the label or all relevant 5598

labeling because making the employer responsible for complying with all labeling exceeds the scope and 5599

intent of the WPS. They also noted that certified applicators, those competent to use pesticides 5600

according to the labeling instructions and who make the actual applications, should be required to 5601

comply with the labeling, but that the agricultural employer should not. 5602

In regard to emergency assistance, commenters requested that EPA delete the reference to 5603

labeling and replace it with a requirement to provide the label and EPA regis tration number of the 5604

product. Commenters note that this requirement would be sufficient to provide appropriate information 5605

for emergencies. 5606

Commenters also requested that in the section on pesticide application and hazard information, 5607

EPA delete the req uirement for the employer to maintain copies of the labeling for all WPS

- labeled 5608

pesticides used on the establishment, and instead to require the employer to maintain a copy of the 5609

label and EPA

- registration number. Again, commenters noted that such a requ irement would likely 5610

result in technical violations without providing benefit to workers or handlers. 5611

In the sections on handler training and establishment

- specific information, commenters took 5612

issue with requirements to train handlers on all labeling and to ensure that for specific applications 5613

handlers have read the labeling or have been informed of all labeling requirements. Commenters noted 5614

that a requirement for handlers to be trained on all labeling requirements, rather than those pertinent 5615

to their specific tasks, would be overly broad and unnecessary. Commenters requested that EPA replace 5616

“labeling” with “label” in these sections. A commenter also requested that EPA distinguish between 5617

types of handlers and limit the requirement to provide access to labeling to handlers at mixing and 5618

loading sites, rather than impose the same requirement in regard to all handlers, including those making 5619

applications. 5620

EPA Response . EPA disagrees with commenters’ request to replace “labeling” with “label” 5621

throughout t he regulation because the broader term is appropriate in many provisions of the WPS. The 5622

FIFRA scheme for managing the risks of pesticide products rests primarily on mandatory use directions 5623

and precautionary statements approved by EPA in the registration process and communicated to users 5624

through labels and labeling. Although in the case of lower risk products intended for general consumer 5625

use, this information typically fits on the label, this is not the case for many agricultural and commercial

5626

use pestic ides. 5627

Labeling does not include advertisements, pamphlets or brochures unless they accompany the 5628

product when sold or are referenced on the labeling. For instance, EPA has indicated that documents 5629

such as marketing brochures used to sell the product and t o provide information to customers and is not 5630

labeling as defined by FIFRA section 2(p). 5631

( http://www.epa.gov/pesticides/regulating/labels/labels_faq/lr_faq_10.html ) If a document of this type 5632

does not accompany the product when sold and there is no referen ce to the bulletin on the product 5633

label, it is not “labeling.” Note though, that non

- labeling documentation related to a product must not 5634

have claims that differ from the product label. 7 U.S.C. 136j(a)(1)(B). 5635

Because mandatory use directions often appear in the labeling of agricultural pesticides, rather 5636

than the label, some provisions of the WPS appropriately use the word “labeling.” Where the word 5637

“labeling” appears in the WPS, employers are responsible for following or providing labeling as defined 5638Page 127 of 176 in FIFRA. This does not require employers to find, retain, or provide advertisements, pamphlets or 5639

marketing brochures that do not meet the definition of “labeling.” 5640

For example, it is appropriate that agricultural and handler employers’ duties under the fi nal 5641

rule include ensuring compliance with “labeling” rather than just the label . The existing regulation has 5642

the same requirement under general duties and prohibited actions. 40 CFR 170.7(a)(2). The labeling may 5643

include directions for use or other informat ion essential to the safe and effective application of the 5644

pesticide, or specific information related to WPS protections, such as the REI. For these reasons, EPA has 5645

decided not to replace “labeling” with “label” throughout the final rule as suggested by t he 5646

commenters. 5647

Furthermore, the obligation of certified applicators (or any other person applying a pesticide) to 5648

follow the labeling does not negate the obligation of agricultural and handler employers to comply with 5649

the labeling. Requirements related to the WPS are found both in the regulation (e.g., training, 5650

application

- specific information) and on specific product labeling (e.g., directions for use, REI, PPE). In 5651

addition, other non

- WPS elements of the labeling, such as application rates and maximum n umber of 5652

applications to a crop, are relevant to protecting workers and handlers from occupational exposure to 5653

pesticides. When employers choose to use a pesticide that references the WPS on the labeling on their 5654

establishment (either as the applicator or by directing another person to apply the pesticide on their 5655

behalf), they are obligated to ensure that all requirements of the labeling are followed, not only those 5656

related to the WPS, to ensure that workers and handlers are adequately protected. 5657

However , EPA agrees that certain WPS requirements could be limited to the information on the 5658

label or specific information from the label, and has specified “label” instead of “labeling” or specific 5659

information from the label where appropriate. For example, EPA a grees with commenters that 5660

employers need not provide all labeling in the event of the emergency. In the current rule, EPA lists 5661

specific information that must be provided to a potentially injured worker or handler, or to treating 5662

medical personnel: Produc t name, EPA registration number, active ingredients, antidote, and first aid 5663

and medical treatment information. Since all of this information is required on the label (40 CFR 5664

156.10(a)(1)), the final rule allows the employer to provide a copy of the label or this specific 5665

information from the label, in addition to providing a copy of the SDS, when emergency assistance is 5666

required. 5667

EPA also agrees with commenters’ request to eliminate the requirement for employers to 5668

maintain copies of the labeling for all pesticides with a WPS reference statement used on the 5669

establishment

. EPA agrees that if workers, handlers, or other persons need information on a specific 5670

product that was used on the establishment, such information can be obtained using the EPA 5671

registrat ion number and product name. In response to comments received, EPA has replaced the 5672

proposal with a requirement for the employer to retain only the EPA registration number , active 5673

ingredient(s), product name, and other application

- specific information for such products , in addition to 5674

the SDS

. 5675

Similarly, EPA agrees that if they are only using a product for a single type of application it may 5676

be unnecessary to require handler employers to ensure that handlers have been trained generally on, 5677

and for specific applications have read or been informed of, all labeling requirements. The labeling could 5678

include directions for use covering multiple application methods and multiple crop sites, which may be 5679

of no relevance to a particular handler. Although the final ru le continues to refer to “labeling” in this 5680

context, it now requires employers to ensure that for specific applications, handlers have read the 5681

portions of the labeling applicable to the safe use of the pesticide or have been informed in a manner 5682

they unde rstand of all portions of the labeling applicable to the safe use of the pesticide. Further, EPA 5683Page 128 of 176 has amended handler training to require that handlers are instructed on their duty to follow the 5684

portions of the labeling applicable to the safe use of the pes ticide, and on the format and meaning of 5685

information contained on pesticide labels and in labeling. 5686

EPA disagrees with commenters’ request to distinguish between applicators who are mixing and 5687

loading pesticides and handlers who are making pesticide appl ications for the requirement to ensure 5688

that handlers have access to the product labeling. Regardless of the handling task being conducted 5689

(mixing, loading or applying), the handler is working with a pesticide and needs to understand and 5690

follow the applicab le labeling instructions, for his or her own protection and the protection of others 5691

and the environment. A person making an application may have questions about the application rate, 5692

appropriate sites, handling precautions, practical treatment, or other i nformation that could be found 5693

on the pesticide labeling. Therefore, EPA has chosen to retain the requirement for the employer to 5694

ensure that all handlers have access to the applicable pesticide labeling at all times during handler 5695

activities. 5696

B. Regulatin g Other Persons 5697

1. Current rule and proposal. Some provisions in the existing WPS provide protections to 5698

persons other than workers and handlers (“other persons”). For example, an existing requirement on 5699

the label and in § 170.210(a) specifies that the a pplicator must apply the pesticide in a way that will not 5700

contact workers or other persons. The existing requirement for entry

- restricted areas on nurseries in § 5701

170.110 specifies that an agricultural employer must not allow or direct any person, other th an an 5702

appropriately trained and equipped handler, to enter or remain in the restricted area. The existing 5703

handler training content in § 170.230(c)(4) specifies that training must cover those requirements that 5704

handlers must follow, including the prohibitio n against applying pesticides in a manner that will cause 5705

contact with workers or other persons. The existing immediate family exemption in § 170.104(a)(2) 5706

states that the owner of the agricultural establishment must provide protections to other workers a nd 5707

other persons who are not part of his immediate family. The description of closed systems in § 5708

170.240(d)(4) of the existing rule describes closed systems as systems that enclose the pesticide to 5709

prevent it from contacting handlers or other persons. A lso, the scope and purpose in § 170.1 of the 5710

existing rule explains that the WPS is intended, in part, to reduce the risks of illness or injury resulting 5711

from the accidental exposure of workers and other persons to pesticides. 5712

The proposed rule included t hese same protections for persons other than workers and 5713

handlers and added several additional provisions that would affect “other persons.” The proposed 5714

requirement for a handler to cease or suspend application if a worker or other person is in the treat ed 5715

area or entry

- restricted area was intended to supplement the existing “do not contact” requirements, 5716

which already protect persons other than workers or handlers. In addition, EPA proposed to include 5717

“other persons involved in the use of a pesticide to which this part applies” in the proposed anti

5718

retaliation provision in § 170.15. 5719

2. Final rule . The final rule includes the protections and references to “other persons” that were 5720

proposed, except that EPA removed the reference to other persons from the definition of closed 5721

systems. The final rule’s prohibition against “other persons involved in the use of a pesticide” retaliating 5722

against workers or handlers in § 170.315 of the final rule is consistent with OSHA’s non

- retaliation 5723

provision. The other se ctions that provide protections to other persons continue existing requirements 5724

or supplement existing requirements and are discussed in detail in Unit IX. and Unit XVII.C. 5725

3. Comments and responses. 5726

Comments . Many commenters, including some grower organizations, states and their 5727

organizations, a retailer organization, a few commercial applicators and two agricultural industry 5728Page 129 of 176 organizations, opposed including protections for “other persons” in the WPS. These commenters 5729

argued that the proposal would extend the WPS to persons not currently covered and would result in an 5730

unwarranted expansion of scope beyond workers, handlers and employee/employer relationships. The 5731

grower, retailer, applicator and agricultural industry commenters stated that includin g “other persons” 5732

could create the potential for frivolous legal challenges by anti

- chemical activists seeking to prevent 5733

pesticide applications. Many of the states and a state organization commented that pesticide labels 5734

already protect other persons so it is unnecessary to include protections for them in the WPS. Some of 5735

the states and their organizations claimed that including other persons in the WPS would complicate the 5736

implementation and enforcement of the regulations. Most of the comments focused on the proposed 5737

entry

- restricted area requirements during pesticide applications in proposed § 170.105 and § 170.205, 5738

although a few commenters also opposed including “other persons” in proposed § 170.1 regarding 5739

scope and purpose, proposed §170.15 on proh ibited actions, the proposed § 170.201(c)(3)(1) training 5740

requirements for handlers, the immediate family exemption in proposed § 170.301(a)(2) and the 5741

exception from some PPE when using closed systems in proposed § 170.307(d)(2). 5742

EPA Response . EPA disagr ees with the comments on including protections for “other persons” 5743

in the WPS. EPA already protects “other persons” in addition to workers and handlers in the existing 5744

WPS, so there will not be major changes to implementing and enforcing the regulations w ith regard to 5745

protecting “other persons” under the revised rule. EPA is not aware of anti

- chemical activists using the 5746

current protections to prevent pesticide applications and the final rule does not appear significantly 5747

more likely to be used in that ma nner. EPA acknowledges that the labels of pesticides subject to WPS do 5748

include a statement protecting “other persons” from being contacted with pesticide either directly or 5749

through drift, because the worker protection label regulations in 40 CFR 156.200

– 156.212 require that 5750

statement. As explained in Unit IX, however, the existing requirements for an applicator to prevent 5751

pesticide contacting workers or other persons during application are insufficient because incidents 5752

where workers and other persons a re sprayed still occur. As explained in Unit Section XVII.B.1, nearly all 5753

of the regulatory sections that include “other persons” are in the existing WPS. An exception is that the 5754

anti

- retaliation provisions in §170.315 of the final rule (which was propo sed § 170.15) prohibits 5755

retaliatory actions by an agricultural employer, commercial pesticide handler employer, or other person 5756

involved in the use of a WPS

- covered pesticide, which is broader than the existing anti

- retaliation 5757

provision in § 170.7(b), whi ch cover agricultural employers and handler employers. The anti

- retaliation 5758

provisions in the proposed and final regulations are modeled on similar provisions in the DOL 5759

regulations to strengthen the protections. 5760

C . Definitions 5761

1. General 5762

i. Current r ule and proposal

. The existing WPS provides definitions for certain terms for use in 5763

the rule. In addition to the specific definitions for the twenty terms listed in 40 CFR 170.3, the WPS 5764

defines the terms “closed system,” “enclosed cab,” “entry

- restricted area,” “personal protective 5765

equipment,” and “use” in other sections of the rule where those terms are used. EPA proposed to revise 5766

certain existing definitions to provide greater clarity, to add several new definitions for terms used in the 5767

rule, includin g definitions for the terms that had previously been defined elsewhere, and to eliminate 5768

two unnecessary existing definitions for “greenhouse” and “forest

. ” 5769

ii. Final rule . In the final rule, EPA has adopted the revisions to the definitions as proposed 5770

except for the definitions of the terms “agricultural establishment,” “agricultural plant,” “authorized 5771

representative,” “closed system,” “commercial pesticide handler employ er,” “commercial production,” 5772

“employ,” “enclosed space production,” “entry

- restricted area,” “farm,” “forest operation,” “hand 5773Page 130 of 176 labor,” “immediate family,” ”labor contractor” “outdoor production,” ”nursery,” and “use.” In the final 5774

rule, EPA has deleted the definitions for the terms “greenhouse” and “forest” as proposed. EPA has also 5775

deleted the existing definitions for the terms “farm,” “forest operation,” and “nursery,” as well as the 5776

proposed definition for “commerci al production.” Additionally, in the final rule EPA has added a new 5777

definition for the term “application exclusion zone.” The discussions of the existing definitions and 5778

proposal, final rule, comments and EPA response for these terms are contained in Units X VIII

. C .2

– 5779

X VIII

. C .8. The final regulatory text for these definitions is available at 40 CFR 170.305. 5780

iii. Comments and responses. 5781

Comments

. EPA received comments on the proposed definitions of the terms “authorized 5782

representative,” “closed system,” “ enclosed space production,” “entry

- restricted area,” “hand labor,” 5783

“immediate family,” “outdoor production,” and “use”. EPA did not receive any substantive comments 5784

opposed to the other proposed revisions related to definitions. EPA received several gener al comments 5785

from state, grower and agricultural producer associations that supported developing improved 5786

definitions because it would reduce the likelihood of alternative interpretations, while improving 5787

compliance and enforceability. Many farmworker advoc acy organizations and public health 5788

organizations also supported EPA’s proposed revisions to improve definitions, commenting that it is 5789

important to have clear and understandable language in order to avoid ambiguity. 5790

During USDA’s FIFRA section 25 review of the final rule, USDA commented that the definition for 5791

“agricultural plant” depends on the definition for “commercial production,” and the definition for 5792

“commercial production” depends on the definition for “agricultural plant” (Ref. 1 5 ). USDA said sim ilar 5793

issues exist in the definitions of “agricultural establishment” and “farm,” “forest operation,” and 5794

“nursery.” USDA recommended resolving these circular dependencies. USDA also commented that the 5795

proposed definitions of “employ,” “labor contractor,” a nd “commercial pesticide handler employer” 5796

contained problematic language that could confusion as to who is ultimately responsible for providing 5797

the handler protections in Subpart F of the proposed rule. 5798

EPA Response

. EPA agrees that improved definition s will reduce the likelihood of ambiguity and 5799

alternative interpretations, while improving compliance and enforceability. EPA believes these proposed 5800

revisions to the definitions adopt more widely used and commonly accepted “plain English” language, 5801

and wi ll add clarity and consistency to the rule. The proposed revisions to the definitions will also help 5802

address regulatory or policy issues with the existing rule raised by state regulatory partners and other 5803

program stakeholders. 5804

In response to comments fr om USDA made during their FIFRA section 25 review of the final WPS 5805

rule, EPA agrees that the definitions for “agricultural plant” and “commercial production,” and the 5806

definitions for “agricultural establishment” and “farm,” “forest operation,” and “nursery” are circular 5807

(Ref. 1 5 ) . While EPA is not convinced that serious confusion would result, EPA has eliminated some 5808

definitions and revised others to address USDA’s concern. The terms “commercial production,” “farm,” 5809

“nursery,” and “forest operation” appear only in the definition section and are not used elsewhere in 5810

the regulation. Accordingly, EPA has deleted t hese definitions and merged their substantive content into 5811

the definitions of “agricultural establishment” and “agricultural plant.” EPA also agrees that the current 5812

definitions of labor contractor and commercial pesticide handler employer contain some pro blematic 5813

language that could result in potential confusion and/or conflict regarding agricultural employer and 5814

commercial pesticide handler employer duties under the rule. In the final rule, EPA has adopted revised 5815

definitions for “employ,” “labor contract or,” and “commercial pesticide handler employer” to address 5816

the potential confusion that could result from conflicting language in the existing proposed definitions. 5817

EPA believes the revised regulatory text clarifies that CPHEs are responsible for the hand lers they 5818Page 131 of 176 employ and agricultural employers would no longer be considered employers of CPHE handlers for the 5819

purposes of the WPS, without overlooking the fact that some handlers are hired by agricultural 5820

employers through labor contractors and not CPHEs. A copy of USDA’s comments and EPA’s responses 5821

is available in the docket for this rulemaking. (Ref. 15). 5822

2. Authorized Representative. 5823

i. Current rule and proposal

. The existing WPS does not contain a definition for “authorized 5824

representative

. ” EPA propo sed to add the term “authorized representative” to the rule and defined it as 5825

“a person designated by the worker or handler, orally or in writing, to request and obtain any 5826

information that the employer is required to provide upon request to the worker or handler.” 5827

ii. Final rule. The rule finalizes the proposed definition with changes . EPA has re titled the term 5828

“authorized representative” to “designated representative” to better describe the relationship between 5829

the representa tive and the worker or handler, and t he definition narrows the information that is 5830

required to be provided by the employer to the designated representative

. In the final rule, “ d esignated 5831

representative ” means “ a ny person s designated in writing by a worker or handler to exercise a right of 5832

access on behalf of the worker or handler to request and obtain a copy of the pesticide application and 5833

hazard information required by § 170.309(h) in accordance with § 170.311(b) of this part. ” 5834

iii. Comments and responses. 5835

Comments . EPA rece ived many comments from state s , growers, agricultural associations and 5836

pesticide manufacturer associations objecting to the definition of “authorized representative.” Most 5837

commenters objected to the proposed requirement for employers to make certain pestic ide information 5838

available to an “authorized representative” of their workers or handlers rather than the actual definition 5839

of authorized representative. Several farm bureau commenters and grower groups stated that oral 5840

designation of the representative cou ld result in abuse, and would be unenforceable. O ne comment 5841

from a farmworker advocacy organization stated that EPA should keep the definition for authorized 5842

representative and clarify the range of representatives that could legitimately be asked to receive 5843

information on behalf of a worker or handler (e.g., medical care provider, legal advocate, family 5844

member, etc.). 5845

EPA Response

. EPA has been convinced by comments that designation of the representative 5846

must be in written form to protect employers from fraudulent claims. A written request that identifies 5847

the worker or handler can be verified against employment records, and information about the dates of 5848

their employ can be used to narrow the information needed to be provided. The final rule require s 5849

employers to respond to written requests. 5850

EPA disagrees with the recommendation to limit the definition to certain persons that could be 5851

asked to request the information on behalf of the worker or handler . EPA believes that specifying classes 5852

of person s permitted to serve as designated representative would unnecessarily limit worker and 5853

handler access to needed information. The final rule requires employers to respond to such requests 5854

within 15 days. However, to ensure that medical personnel treating a worker or handler have timely 5855

access to information necessary for purposes of diagnosis or treatment, EPA has included a separate 5856

requirement for employers to promptly provide the information to treating medical personnel or those 5857

working under their direc tion

, at 170.311(b)(8)

. 5858

3. Closed System 5859

i. Current rule and proposal. The existing WPS defines the term “closed system” as “a system 5860

that encloses the pesticide to prevent it from contacting handlers or other persons.” EPA proposed to 5861

move the defini tion of closed system to the definition section of the rule and to redefine a closed 5862

system as “a system for mixing or loading pesticides that encloses the pesticide during removal of the 5863Page 132 of 176 pesticide from its original container and transfer, mixing, or loadi ng of the pesticide product, mixtures or 5864

dilutions, and any rinse solution, if applicable, into a new container or application equipment, in such a 5865

manner that prevents the pesticide and any pesticide mixture or use dilution from contacting handlers 5866

or oth er persons before, during and after the transfer, except for negligible release associated with 5867

normal operation of the system. ” 5868

ii. Final rule. In the final rule, EPA has defined “closed system” as “an engineering control used 5869

to protect handlers from pesticide exposure hazards when mixing and loading pesticides.” The final 5870

regulatory text for this definition is available at 40 CFR 170.305

. 5871

iii. Comments and responses. 5872

C omments . EPA did not receive any specific comments on the definition of closed system. 5873

However, EPA received a number of comments related to EPA’s proposal on closed systems that 5874

indicated the proposed requirements may be too prescriptive or limiting, coul d eliminate desired 5875

flexibility for growers, and could discourage innovation and the adoption of closed systems. 5876

EPA Response . EPA agreed with the comments that the proposed requirements related to 5877

closed systems may be too prescriptive or limiting, coul d eliminate desired flexibility for growers, and 5878

could discourage innovation and the adoption of closed systems. Although the comments did not 5879

specifically mention the closed system definition, EPA reconsidered the proposed definition of closed 5880

system in l ight of the overall comments on closed system requirements. EPA believes that a broader 5881

definition of “closed system” will encourage industry innovation better than the proposed prescriptive 5882

definition, and will retain flexibility for handler employers to design systems specific to their needs. In 5883

the final rule, EPA has adopted a new definition of closed system that more accurately defines the 5884

nature and intent of a closed system without inadvertently prescribing specific requirements and 5885

operational compo nents for such closed systems. 5886

4. Enclosed Space Production and Outdoor Production. 5887

i. Current rule and proposal. The existing WPS does not contain definitions for the terms 5888

“enclosed space production” or “outdoor production.” Instead, the existing WPS d efines the term 5889

“greenhouse” to describe the type of WPS

- covered agricultural establishments that produce agricultural 5890

plants inside enclosed structures. The existing rule uses the terms “f arm, ” “ forest ” and “ nurser y” for 5891

WPS

- covered agricultural establishments that produce agricultural plants outdoors. Greenhouse is 5892

defined in the existing WPS as “any operation engaged in the production of agricultural plants inside any 5893

structure or space that is enclosed with nonporo us covering and that is of sufficient size to permit 5894

worker entry. This term includes, but is not limited to, polyhouses, mushroom houses, rhubarb houses, 5895

and similar structures. It does not include such structures as malls, atriums, conservatories, arbore tums, 5896

or office buildings where agricultural plants are present primarily for aesthetic or climatic modification.” 5897

EPA proposed to delete the definition of “greenhouse” because it would no longer be necessary as a 5898

result of the proposed addition of a new d efinition for “enclosed space production.” EPA proposed to 5899

define enclosed space production as “production of an agricultural plant in a structure or space that is 5900

covered in whole or in part and that is large enough to permit a person to enter.” EPA also proposed to 5901

add a new definition for the term “outdoor production” and defined it as “production of an agricultural 5902

plant in an outside open space or area that is not enclosed or covered in any way.” 5903

ii. Final rule. In the final rule, EPA has deleted the definition of the term “greenhouse” as 5904

proposed, and has adopted the definitions for “enclosed space production” and “outdoor production” 5905

with modifications. The final rule defines “enclosed space production” as “production of an agricultural 5906

plant indoors or in a structure or space that is covered in whole or in part by any nonporous covering 5907

and that is large enough to permit a person to enter,” and defines “outdoor production” as “production 5908Page 133 of 176 of an agricultural plant in an outside area that is not enclose d or covered in any way that would obstruct 5909

the natural air flow.” The final regulatory text for these definitions is available at 40 CFR 170.305

. 5910

iii. Comments and responses. 5911

Comments . EPA received several comments from state s and their organizations op posing the 5912

definition of “enclosed space production” as written. A few other commenters also expressed concerns 5913

with the definition of “outdoor production.” A state association noted that the proposed definition 5914

could greatly expand areas covered under cer tain entry restrictions to include any covered area such as 5915

fields or groves with shade covers and/or screen houses. The commenter expressed concerns that entry 5916

restrictions currently applicable to greenhouses would be extended to these establishments, and is not 5917

aware of any need for such an extension of these restrictions. State s generally echoed these comments. 5918

One state requested clarification of whether the term “spaces covered in part” includes structures such 5919

as “hoop houses,” and another state noted that the proposed rule did not define or reference high 5920

tunnels and requested clarification of whether “high tunnels” are considered a greenhouse for the 5921

purposes of WPS (i.e., would “high tunnels” be considered a type of enclosed space production?). One 5922

state commented that the proposed definition expands areas covered under certain entry restrictions to 5923

include shade houses and screen houses and this would have a major impact in on the state’s nursery 5924

industry. Another state also expressed concerns that the proposed definition of enclosed space 5925

production would expand restrictions beyond greenhouses, and suggested that EPA add the phase 5926

“where the production of agricultural plants for research or commercial purposes occurs” to the 5927

definitions of enclosed space production and outdoor production so that only those operations engaged 5928

in the production of agricultural plants for commercial purposes would be covered by the WPS. Another 5929

state commented that the term “outdoor production” is too broad and by misin terpretation, could 5930

encompass a number of non

- farm activities. 5931

During USDA’s FIFRA section 25 review of the final rule, USDA commented that the inclusion of 5932

the term “natural forest” in the definition of “outdoor production” creates confusion since there is no 5933

explanation of what the term “natural forest” means and therefore the term is not needed (Ref. 1 5 )

. 5934

EPA Response

. EPA considered the comments submitted and agrees with the comments that 5935

said the proposed definition of “enclosed space pr oduction” could expand areas covered under certain 5936

entry restrictions to include any covered area such as fields or groves with porous shade covers and/or 5937

screen houses where such restrictions are not necessary. EPA noted the potential impact of the 5938

propos ed definition on the nursery industry as raised by commenters

. EPA also agrees that the proposed 5939

definition of “outdoor production” could lead to some outdoor production being considered enclosed 5940

space production because of the phrase “that is not enclosed or covered in any way.” EPA is convinced 5941

that the definition of enclosed space production and outdoor production should be revised so that 5942

operations that use non

- porous coverings in their plant production operations , such as screen houses 5943

and shade house s, are not covered by the entry restrictions deemed necessary for the protection of 5944

workers and handlers that are working with pesticides or in pesticide treated areas in enclosed space 5945

production operations. Therefore, EPA revised the definitions of enclo sed space production and outdoor 5946

production to clarify that enclosed space production only includes areas covered in whole or in part “by 5947

any nonporous covering,” rather than “any covering” as in the proposed definition; and that outdoor 5948

production will in clude areas that are covered only with coverings that are sufficiently porous that they 5949

do not obstruct the natural air flow typical of open fields or forests

. It is intended that these definitions 5950

of enclosed space production and outdoor production be com plementary, such that all production 5951

agriculture is either enclosed space production or outdoor production. 5952

EPA does not agree with the request to add the phrase “where the production of agricultural 5953Page 134 of 176 plants for research or commercial purposes occurs” to t he definitions of enclosed space production and 5954

outdoor production so that only those operations engaged in the production of agricultural plants for 5955

commercial purposes would be covered by the WPS. EPA believes other definitions and language in the 5956

rule a lready clearly limit the scope of the WPS to establishments where the production of agricultural 5957

plants for research or commercial purposes occurs, so the addition of such language to these definitions 5958

would be redundant and would not serve to further limi t the scope of the rule in any way not already 5959

accomplished through other means

. 5960

Some commenters requested clarification of whether structures such as “hoop houses,” and 5961

“high tunnels” are considered a type of enclosed space production. The term “greenhouse” in the WPS 5962

has resulted in enforcement problems, because of the extreme variability in the types of structures that 5963

might be considered greenhouses. This problem is compounded when considering the many 5964

greenhouse

- type structures (e.g., polyhou ses, mushroom houses, hoop houses, high tunnels and similar 5965

structures) that have come into use. This is why EPA has replaced the term greenhouse with enclosed 5966

space production. EPA believes the new terms correspond more accurately to the nature of the ris k that 5967

EPA is concerned about mitigating (i.e., use of pesticides in enclosed spaces that could affect pesticide 5968

inhalation exposure potential). Therefore, if a structure or space is covered in whole or in part by any 5969

nonporous covering and is large enough to permit a person to enter, then the structure or space would 5970

fall under the definition of enclosed space production in the final rule. EPA anticipates that most 5971

greenhouses, hoop houses, high tunnels and similar structures will fall within the definitio n of enclosed 5972

space production , but a final determination will be made on a case

- by

- case basis applying the 5973

parameters of the definition to each situation

. 5974

EPA agrees with USDA that the inclusion of the term “natural forest” in the definition of 5975

“outdoor production” creates confusion and is not needed. In response, EPA has revised the final 5976

definition of outdoor production accordingly (Ref. 1 5 )

. 5977

5. Entry

- Restricted Area and Application Exclusion Zone. 5978

i. Current rule and proposal. The existing WPS does n ot contain a definition for the term s “entry

5979

restricted area” or “application exclusion zone.” Under the existing rule, the term “entry

- restricted area” 5980

is used to refer to areas on an establishment from which workers and other persons must be excluded 5981

dur ing, and/or immediately after, an ongoing pesticide application to protect the workers or other 5982

persons from being contacted by the pesticide (either directly or through drift). EPA proposed to define 5983

the term “entry

- restricted area” as “the area from whic h workers or other persons must be excluded 5984

during and after the pesticide application.” 5985

ii. Final rule. In the final rule, EPA has added the term “application exclusion zone” instead of the 5986

proposed term “entry

- restricted area

. ” EPA has defined the term “application exclusion zone” as “ the 5987

area surrounding the application equipment which must be free of all persons, other than appropriately 5988

trained and equipped handlers, during pesticide applications.” The final regulatory text for this 5989

definition is avai lable at 40 CFR 170.305. 5990

iii. Comments and responses. 5991

Comments . EPA received several comments from state s regarding the term “entry

- restricted 5992

area.” One commenter said the term was linguistically awkward and said EPA should instead use the 5993

term “restric ted area buffer.” 5994

EPA Response

. EPA considered the comments submitted and agrees with the comments that the 5995

term “entry

- restricted area” was not clear and would be likely to cause confusion. I n the final rule, EPA 5996

has eliminated the use of that term and has therefore deleted the proposed definition. The final rule 5997

adopts the term “application exclusion zone” to refer to the area from which persons must be excluded 5998Page 135 of 176 during applications. See Unit IX. for EPA’s response to the comments on the WPS requirements related 5999

to entry

- restricted areas. 6000

6. Hand labor 6001

i. Current rule and proposal. The existing WPS defines hand labor as “any agricultural activity 6002

performed by hand or with hand tools that causes a worker to have substantial contact with surfaces 6003

(such as plants, plant parts, or soil) that may contain pesticide residues. These activities include, but are 6004

not limited to, harvesting, detasseling, thinning, weeding, topping, planting, sucker removal, pruning, 6005

disbudding, roguing, and packing produce into co ntainers in the field. Hand labor does not include 6006

operating, moving, or repairing irrigation or watering equipment or performing the tasks of crop 6007

advisors.” In the proposal, EPA intended to revise the definition by deleting the following sentence from 6008

th e existing definition, “These activities include, but are not limited to, harvesting, detasseling, thinning, 6009

weeding, topping, planting, sucker removal, pruning, disbudding, roguing, and packing produce into 6010

containers in the field.” In the proposed regula tory text for the definition of term “hand labor,” EPA 6011

inadvertently deleted the phrase “ except that hand labor does not include operating, moving, or 6012

repairing irrigation or watering equipment or performing crop advisor tasks” from the end of the 6013

definiti on. The erroneously proposed definition for the term “hand labor” was “ any agricultural activity 6014

performed by hand or with hand tools that cause a worker to have substantial contact with plants, plant 6015

parts, or soil and other surfaces that may contain pesticide residues .” 6016

ii

. Final rule. EPA has corrected the unintentional omission from the proposed definition of 6017

“hand labor.” The final rule defines “hand labor” as “ any agricultural activity performed by hand or with 6018

hand tools that cause a worker to h ave substantial contact with plants, plant parts, or soil and other 6019

surfaces that may contain pesticide residues, except that hand labor does not include operating, 6020

moving, or repairing irrigation or watering equipment or performing crop advisor tasks.” Th e final 6021

regulatory text for this definition is available at 40 CFR 170.305 for the final regulatory language for 6022

definitions. 6023

iii. Comments and responses. 6024

Comments . One commenter objected to the proposed change to the definition of hand labor 6025

that delete d the phrase “ except that hand labor does not include operating, moving, or repairing 6026

irrigation or watering equipment or performing crop advisor tasks” from the end of the definition. The 6027

commenter indicated that removing this exception from the definitio n of hand labor would make the 6028

irrigation exception for early entry unworkable and would disrupt irrigation operations. 6029

EPA Response . EPA agrees with the comment on the definition of “hand labor.” In the final

, rule 6030

EPA has deleted the sentence listing ha nd labor activities as proposed, but has retained the clause 6031

excluding “operating, moving, or repairing irrigation or watering equipment or performing crop advisor 6032

tasks” from being considered hand labor tasks 6033

7. Immediate Family. See Unit XVII.A. for a complete discussion of EPA’s consideration of the 6034

definition of “immediate family” in conjunction with the exemption from certain provisions of the WPS 6035

for owners and members of their immediate families. 6036

8. Use 6037

i. Existing definitions and proposal. The existing WPS provides a definition of the term “use” (as 6038

in “to use any registered pesticide in a manner inconsistent with its labeling”) for the purposes of the 6039

rule at 40 CFR 170.9, “Violations of this part.” For the purposes of the WPS, EPA has interpre ted the 6040

term “use” to cover a broad range of pesticide

- related activities that are listed at 40 CFR 170.9. EPA 6041

proposed to move the existing definition for “use” found at 40 CFR 170.9 into the definitions section of 6042

the rule. 6043Page 136 of 176 ii. Final rule. In the final rule, EPA has adopted the definition for “use” as proposed. The final 6044

regulatory text for this definition is available at 40 CFR 170.305

. 6045

iii. Comments and responses. 6046

Comments . EPA received several comments from state s , growers, agricultura l associations and 6047

pesticide manufacturer associations objecting to the proposed definition of “use.” Most commenters 6048

objected to the definition of use because they did not support inclusion of “arranging for application of 6049

the pesticide” as part of the de finition of “use.” Some commenters said they believed that this language 6050

would greatly expand the scope of the WPS and would be unreasonable and unnecessary. Some 6051

commenters noted that they could not see how “arranging for application of the pesticide” cou ld be 6052

considered use. During its review of the draft final rule under FIFRA section 25(a), USDA noted that the 6053

term “arranging for the application of the pesticide” as part of the definition of the term “use” could 6054

lead to persons that call on or answer th e telephone and “arrange” for pest management by scheduling 6055

the appointment on behalf of another to be covered by the rule and possibly have WPS responsibilities. 6056

EPA Response

. EPA disagrees with comments that say the proposed definition for the term 6057

“use ” could or will expand the scope of the WPS because this interpretation has been in the WPS since 6058

the rule first became effective. Moreover, EPA has not been made aware of any instances where this 6059

interpretation of “use” has resulted in an unreasonable or inappropriate outcome. EPA believes that 6060

“arranging for application of the pesticide” is appropriately part of the definition of “use” for the 6061

purposes of the WPS because in production agriculture, the individual who physically “uses” a pesticide 6062

almost al ways does so at the direction of another person who has substantially greater control over the 6063

circumstances of the use. Thus the WPS is designed so that when an agricultural or handler employer 6064

arranges for the application of a pesticide by a handler empl oyee , it triggers certain WPS duties that are 6065

properly the responsibility of the agricultural or handler employer. For instance, once the agricultural 6066

employer arranges for a pesticide application by a commercial p esticide handling establishment , the 6067

comme rcial pesticide handler employer must provide the agricultural employer with certain information 6068

about the intended application before the application takes place (so the employer will be able to fulfill 6069

WPS notification requirements and protect workers du ring application, etc.). In such circumstances, it is 6070

reasonable and appropriate that the handler employer should be held responsible for the pre

6071

application information exchange even though the application has not commenced and even though the 6072

handler emp loyer personally never physically “uses” the pesticide. 6073

EPA interprets “arranging for application of the pesticide” as used in § 170.9(a) and § 170.305 as 6074

a means of assuring that the entities (generally the agricultural employer or handler employer) with the 6075

most authority and control over WPS compliance would be legally responsible for WPS compliance. EPA 6076

does not interpret “arranging for application of the pesticide” as making subordinate persons who 6077

merely perform the clerical functions of arranging f or application of the pesticide liable for WPS 6078

compliance. Therefore, since EPA has not been made aware of any instances where the existing 6079

interpretation of the term use has resulted in any problems for growers, state s or the agricultural 6080

industry, EPA has moved the definition for the term “use” into the definitions section of the rule without 6081

any change from the proposal. 6082

D . Restructuring 40 CFR part 170 6083

1. Current rule and proposal. The existing WPS is organized into three subparts: “General 6084

Prov isions,” “Standard for Workers,” and “Standard for Handlers.” Content that applies to both workers 6085

and handlers is repeated creating redundancy throughout the rule. 6086

EPA discussed renaming the regulation “Requirements for Protection of Agricultural Worker s 6087

and Pesticide Handlers” in the preamble of the proposal and proposed reorganiz ing the rule into four 6088Page 137 of 176 subparts: “General Provisions,” “Requirements for Protection of Agricultural Workers,” “Requirements 6089

for Protection of Pesticide Handlers,” and “Exemptio ns and Exceptions.” EPA proposed creating t he 6090

“General Provisions” subpart to describe certain obligations for agricultural employers, handler 6091

employers, and those requirements that apply to both. The proposal included subparts “Requirements 6092

for Protection of Agricultural Workers” and “Requirements for Protection of Pesticide Handlers” to 6093

provide information that supplements the general duties and obligations for employers and to outline 6094

the content of the training and decontamination supplies that the empl oyer must provide for workers 6095

and handlers respectively. EPA proposed to consolidate most of the exceptions and exemptions into a 6096

separate subpart titled “Exemptions and Exceptions” to make them easier to find and reference. 6097

2. Final Rule

. In t he final ru le , EPA has retain ed the existing name of the regulation, “Worker 6098

Protection Standard,” and has adopted the proposed restructuring of the rule with minor modifications. 6099

EPA has determined that it is appropriate to allow one year for employers, trainers, and state 6100

and tribal regulators to prepare for the changes to the WPS

. See Unit X I X. In order t o allow the existing 6101

WPS to remain in effect for one year and to make available the revised regulatory language in advance 6102

of the implementation date, both the e xisting WPS and the revised WPS must appear in the Code of 6103

Federal Regulations. Thus the final rule provides that Subparts A, B and C of part 170 will remain in 6104

effect until one year after the effective date of this final rule. Subparts D, E, F and G of pa rt 170 contain 6105

the full text of the revised WPS; however, these subparts will not be implemented until one year after 6106

the effective date of this final rule. Some provisions of subparts D, E, F and G , such as pesticide safety 6107

training and the pesticide info rmation display, will not be implemented until two years after the 6108

effective date of this final rule. One year after the effective date of this final rule, subparts A, B and C will 6109

no longer be effective. At that time

, EPA intends to delete subparts A, B and C from part 170. 6110

In addition to finalizing the proposed structuring of the rule, EPA has added a new section 6111

providing a process for allowing states and tribes to request equivalency determinations from EPA for 6112

existing state or tribal laws or regulations that may provide protections equivalent to the WPS. EPA has 6113

added this to a retitled subpart: “Exemptions, Exceptions and Equivalency

. ” 6114

3. Comments and responses. 6115

Comments . EPA did not receive any comments opposed to the proposal to restruct ure the WPS. 6116

One commenter noted that the proposed restructuring of the rule increased the clarity of the rule and 6117

the relationship among the components. Another commenter asserted that there was no need to 6118

change the name of the regulation, and noted that if EPA was going to change the name of the rule, it 6119

should more accurately represent the full scope of the rule and the impacted establishments. 6120

EPA Response

. EPA agrees with the comment that it is unnecessary to change the name of the 6121

rule. “Worker Protection Standard ” and the abbreviation WPS are commonly used and associated with 6122

the rule. Upon further consideration, EPA agrees that the existing name of the rule is very widely 6123

recognized and that it will facilitate more effective communications on t he rule to retain the current 6124

name of the rule

. 6125

EPA also agrees with the commenter that the proposed restructuring of the rule increases the 6126

clarity of the rule and the relationship among the components. EPA is adopting the proposed 6127

restructuring of the W PS in the final rule with the minor modifications noted. EPA expects the revised 6128

part 170 will be easier to read and understand, thereby improving compliance by worker and handler 6129

employers

. 6130

4. Costs and benefits. EPA does not estimate any c osts associate d with the restructuring of the 6131

rule. The benefits of the restructuring will be increased clarity and understanding of the rule which 6132

should result in improved compliance and more consistent enforcement. 6133Page 138 of 176 E. Equivalency P rovisions 6134

1. Current rule and prop osal. The current WPS does not contain equivalency provisions that 6135

would permit EPA to potentially recognize, through a WPS

- established regulatory mechanism, state or 6136

tr ibal worker protection laws and/ or regulations that may provide equivalent or significantly greater 6137

protection in comparison to the provisions of the existing WPS, or provide equivalent protection at a 6138

significantly lower cost. EPA did not propose to add equivalency provisions to the rule because it did not 6139

receive information from states or tribes that such provisions were necessary , and had not been 6140

informed by growers that WPS requirements conflicted with existing state or tribal worker protection 6141

laws or regulations. 6142

2. Final rule. In the final rule, EPA has included a section on equivalency because of comments 6143

received that indicate provisions may be needed to address certain issues with the WPS potentially 6144

conflicting with existing state and tribal worker protection laws or regulations. EPA recognizes that some 6145

states and tri bes have existing worker protection provisions in their own laws and regulations that may 6146

be equivalent to the provisio ns of the existing WPS, tha t may provide significantly greater protection, or 6147

may provide equivalent protection at a significantly lower cost, and decided it would be more practical 6148

and efficient to establish a mechanism to evaluate specific state or tribal requirements and to make 6149

equivalency determinations rather than relying on other EPA enforcement mechanisms or policies to be 6150

able to a llow such determinations. The final regulatory text for this requirement is available at 40 CFR 6151

170.609. 6152

3. Comments and responses. 6153

Comments. Although EPA did not propose equivalency provisions, EPA received comments from 6154

the California Department of Pes ticide Regulation (CDPR) that indicated it would be beneficial if states 6155

could be granted ‘equivalency’ as was done for the current WPS. The CDPR comment refers to an 6156

independent enforcement discretion decision that was granted under the current WPS to re cognize 6157

CDPR’s requirement for the content of their field posting sign to be equivalent to the existing 6158

requirement at 40 CFR 170.120

. Comments from some other state pesticide regulatory agencies 6159

indicate there may be issues of equivalency between their regulations and the final WPS requirements. 6160

Although these commenters did not specifically raise the need for equivalency provision, they indicated 6161

a need for EPA to be aware of the issue and potentially identify soluti ons. 6162

EPA Response. Based on the comments received and EPA’s experience with the current WPS 6163

and requests from CDPR for equivalency on certain regulatory requirements, EPA agrees that there are 6164

potential situations where states or tribes may request EPA t o consider equivalency under the WPS for 6165

their laws or regulations. Therefore, EPA believes it is prudent to consider an equivalency process under 6166

the WPS, and feel s strongly that it is more efficient and advantageous to establish a mechanism for 6167

consideri ng equivalency in the WPS rule rather than relying on other mechanisms. EPA has provided a 6168

general equivalency process in the rule that is modeled on the provisions that were developed and 6169

implemented for substantially the same reason and purpose un d er the pesticide containment 6170

regulations in 40 CFR 165.97. ( 71 FR 47 330, August 16, 2006)

. 6171

F . Clarifications 6172

1. Scope and Purpose. In the final rule, EPA has clarified who the rule protects and that 6173

agricultural and commercial pesticide handler employers are responsible for carrying out the 6174

requirements of the rule. EPA has also clarified that handlers have responsibilities under the rule to 6175

protect workers and other persons during pesticide applications. Refer to 40 CFR 170.301 for the revised 6176

language. 6177

2. Applicability. In the final rule, EPA has clarified in 40 CFR 170.303(c) that users must comply 6178Page 139 of 176 with product labeling requirements where the labeling requirements differ from the rule, except as 6179

provided in 40 CFR 170.601, 170.603, and 170.607, where the WPS provides exc eptions to label

6180

required PPE and REIs. 6181

G. Anti

- retaliation Measures 6182

The purpose of the requirements discussed in this section are to protect a worker’s or handler’s 6183

right to pursue protections established by the WPS without fear of retaliation from thei r employer. 6184

Retaliation occurs when an employer takes an adverse action against a worker or handler because he or 6185

she engaged in an activity protected by the law. 6186

1. Current rule and proposal . The existing WPS includes three related requirements intend ed to 6187

protect workers and handlers from retaliation. The prohibited actions section of the existing WPS 6188

directly prohibits agricultural employers from taking “any retaliatory action for attempts to comply” 6189

with requirements of the rule but does not describ e what those actions include. The existing rule also 6190

requires employers to assure that worker s and handlers are informed, as part of their pesticide safety 6191

training, about the availability of pesticide specific information and that they have protection ag ainst 6192

retaliatory acts for attempting to comply with the rule. 6193

EPA proposed modifications to the anti

- retaliation provision to clarify the actions that are 6194

prohibited. The proposed rule also expanded the training to highlight the anti

- retaliation provisio ns of 6195

the WPS. 6196

2. Final rule

. The anti

- retaliation measures proposed have been modified in the final rule. EPA 6197

has modified the anti

- retaliation provision based on comments provided from DOL on how EPA could 6198

improve its retaliation provision by modeling it after language used in similar provisions in DOL 6199

regulations. Moreover, EPA note s that this rule does not preempt the general anti

- retaliation provision 6200

in the DOL

- administered Occupational Safety and Health Act, 29 U.S.C. 660(c). The final regulatory text 6201

for the anti

- retaliation provision is available at 40 CFR 170.315. The expanded training points intended 6202

to address protection from retaliation were finalized as proposed. The final regulatory text for the 6203

expanded training point s is available at 40 CFR 170.401

. 6204

3. Comments and responses. 6205

Comments

. Many commenters, including 71 Members of Congress , farmworker advocacy 6206

organizations, Unions, Legal Aid organizations and private citizens stated that the existing language in 6207

the WPS does not provide strong enough protections against retaliation for workers to feel safe asking 6208

for information about pesticide applications, protective equipment or other protections required under 6209

the WPS. Commenters noted that farmworkers are also afra id to report violations or file a complaint 6210

with the employer or state pesticide regulatory agency because they fear the loss of their jobs or other 6211

forms of retaliation. These commenters specifically asked EPA to adopt the same standard provided by 6212

OSHA f or employees to report unsafe working conditions and protect employee confidentiality. 6213

Many state regulatory agencies, grower associations, and farm bureaus opposed the anti

6214

retaliation measures as unnecessary, asserting the proposed requirements do not p rovide any additional 6215

protection. State regulatory agencies specifically objected to including “other persons” in the prohibited 6216

actions on the grounds that the definition is unclear and would result in overly burdensome 6217

investigations. Other state pesti cide regulatory agencies noted that retaliation investigations are 6218

beyond the scope of pesticide use inspections and inspector training. 6219

EPA Response . EPA understands the importance of establishing mechanisms for farmworkers to 6220

get hazard information abo ut their workplace, to request protections required under the WPS, or to file 6221

complaints about workplace practices with their employer or a regulatory agency without risk of 6222Page 140 of 176 retaliation. The Agency disagrees with commenters that assert anti

- retaliation pr ovisions provide no 6223

additional protections. 6224

EPA recognizes the value of allowing workers to maintain confidentiality when requesting 6225

information or filing complaints against employers and would refer anonymous tips or complaints about 6226

workplace safety to the appropriate state enforcement agency. How ever, unlike the OSH Act, FIFRA 6227

does not include a directive to ensure confidentiality for workers, handlers, or other complainants. The 6228

OSH Act specifically establishes a worker’s right to file a complaint with OSHA about safety or health 6229

hazards in thei r workplace and to request that their names not be revealed to their employer. EPA can, 6230

and typically does, protect tips, complaints, inspection reports, etc., as “enforcement confidential.” 6231

Although this is not an absolute protection, EPA typically cont inues to treat such information as 6232

confidential until an enforcement case is underway. In addition, a number of states have established 6233

laws or policies that direct inspection and enforcement personnel to maintain confidentiality of any 6234

farmworkers who fi les a complaint. 6235

EPA recognizes the potential burden on state pesticide regulatory agencies of investigating 6236

complaints and understands that proving retaliation claims is different than other pesticide use 6237

violations. If retaliation is suspected or report ed, EPA encourages state regulatory agencies to refer 6238

investigations to EPA, or cooperate in the investigation of retaliation claims with another appropriate 6239

regulatory agency. 6240

H . Comments Related to OSHA 6241

Comments . Many commenters suggested that EPA ensure that the WPS provides workers and 6242

handlers with protections comparable to those provided to workers in other hazardous occupations 6243

under OSHA. Commenters suggested that EPA increase requirements for safety training, 6244

decontamination, emergency assistance, PPE (respirator safety), medical monitoring, and information 6245

about chemicals being used in the workplace to match OSHA’s requirements. More specifically, many 6246

commenters suggested that EPA require annual training for workers and full pesticide safety train ing 6247

before workers and handlers are directed to work with pesticides or in pesticide

- treated areas. Some 6248

commenters suggested that EPA require an emergency shower within the work area for immediate 6249

emergency use where there is potential for the eyes or bod y of any person to contact pesticides and 6250

adopt OSHA standards related to eyewash stations. Further, they urged EPA to adopt OSHA 6251

requirements related to the timing of providing transportation to employees in the event of a known or 6252

suspected pesticide exp osure or injury. Many commenters expressed support for EPA’s adoption of 6253

OSHA’s standards for respiratory protection. Many commenters requested that EPA adopt medical 6254

monitoring for handlers exposed to cholinesterase

- inhibiting pesticides. Some commenters suggested 6255

that EPA require records to be retained for 30 years and employers to maintain a written hazard 6256

communication plan, as required under OSHA regulations. Some commenters requested that EPA adopt 6257

OSHA’s standards for confined spaces for early

- early entry workers. Many commenters suggested that 6258

EPA adopt OSHA’s anti

- retaliation provisions to allow workers and handlers to report suspected 6259

violations of the WPS without fear of losing their jobs. 6260

Many commenters raised general concerns that incorporatin g into the WPS by reference 6261

elements of OSHA’s regulations, i.e., some portions of the respirator standards at 29 CFR 1910.134, 6262

would constitute an expansion of OSHA’s jurisdiction. 6263

EPA Response . EPA appreciates the commenters’ suggestions about incorporat ing OSHA

6264

equivalent protections into the WPS. For comments and EPA’s responses related to specific areas of the 6265

proposal, please see the appropriate sections of this document. 6266Page 141 of 176 EPA h as addressed concerns about jurisdictional issues related to the incorporation by reference 6267

of some of OSHA’s respiratory protection standards in Unit XV.A. 6268

X I X . Implementation 6269

A. P roposal. EPA proposed to make the final rule effective 60 days after the date of publication 6270

in the Federal Register ; however, compliance w ith certain provisions, including the additional content of 6271

pesticide safety training and pesticide safety information, and new signs for posting, would not be 6272

required until 2 years after the effective date of the final rule. EPA proposed the 2

- year delay between 6273

effective date of the final rule and the implementation date to allow time for new training materials to 6274

be developed and made available, and to give employers, trainers, and other affected stakeholders time 6275

to make the necessary changes to their practices and operations to comply with the new training and 6276

pesticide safety information requirements. EPA also linked the implementation date for the revised 6277

pesticide safety training requirements for workers and handlers to the availability of new revis ed 6278

training materials that satisfy the new rule requirements. Under the proposal, if EPA announced the 6279

availability of such materials sooner than 18 months after the effective date of the final rule, then the 6280

new training requirements would go into effect 2 years after the effective date of the final rule. If EPA 6281

announced the availability of materials that comply with the requirements more than 18 months after 6282

the effective date of the final rule, then the new training requirements would not take effect un til 180 6283

days after the announcement of availability of complying training materials published in the Federal 6284

Register

. 6285

B. Final rule. EPA ha s included in the final rule a one

- year delay from the effective date of the 6286

final rule before employers must compl y with any of the new WPS requirements

. Thus, on [ in sert date 6287

one year and 60 days after the date of publication in the Federal Register ], employers will be required to 6288

comply with almost all of the new and revised WPS requirements

. However, employers will not be 6289

required to comply with ce rtain new WPS provisions until two years after the effective date of the final 6290

rule. This two year delay applies to the new requirements for pesticide safety training for workers and 6291

handlers, pesticide safety information and handlers to suspend applications when workers or other 6292

persons are in the application exclusion zone. As proposed, the final rule provides that compliance with 6293

certain new training requirements will not be required until the later of two years after th e effective 6294

date of the final rule, or 180 days after EPA publishes in the Federal Register a notice of availability of 6295

new revised training materials that satisfy the new rule requirements. 6296

The final regulatory text for these provisions is available at 40 CFR 170.2

, 170.311(a)( 3 ), 6297

170.401(c)(3), 170.501(c)(3) and 170.505(b). 6298

C . Comments and responses. 6299

Comments . Most comments that addressed implementation focused on three main areas: 1) 6300

T he need for better and more effective enforcement of the revised r ule once the new requirements are 6301

effective; 2) the need for appropriate supporting communication, education, training and compliance 6302

assistance materials to facilitate effective implementation; and 3) the need for additional time before 6303

the final rule bec omes effective to give regulators and the regulated community time to prepare for 6304

compliance with new requirements. 6305

Many comments from s tate s , pesticide safety educators, trainers

, grower associations and 6306

pesticide manufacturer associations pointed out a need for appropriate training and compliance 6307

assistance materials to support effective implementation. Commenters indicated that it was essential 6308

for EPA to have updated communications and compliance assistance materials, such as fact sheets and 6309

the “WPS H ow to Comply” manual, developed and available to all affected parties in order for the 6310

regulated community to be able to learn and understand new requirements. Several state s , grower 6311Page 142 of 176 associations and pesticide manufacturer associations commented that EPA s hould provide more time 6312

before the new rule requirements become effective so that regulators and the regulated community can 6313

more adequately prepare for compliance with new requirements. However, several farmworker 6314

advocacy organizations urged EPA to imple ment the proposed training requirements for workers and 6315

handlers sooner than the proposal of 2 years from the effective date of the final rule. 6316

EPA Response

. EPA considered the comments submitted and agrees that after publication of the 6317

final rule, some time is needed before the new WPS requirements are implemented. EPA understands 6318

that State, tribal and federal regulators need time to become familiar with the new regulation, provide 6319

training to pesticide inspectors, develop the capacity for enforcing the new rule requirements, establish 6320

appropriate WPS inspection and enforcement policies

, and conduct outreach to the regulated and 6321

protected communities. In addition, agricultural employers will need time to become familiar with the 6322

new requirements and impl ement any necessary changes. In the final rule, EPA has delayed the 6323

implementation of the new WPS requirements for one year so that EPA can work with state and tribal 6324

pesticide regulators and the regulated community to better prepare for compliance with ne w rule 6325

requirements. The existing rule will remain in effect and be enforced during this time, as provided in 40 6326

CFR 170.2

. 6327

EPA disagrees with comments that the compliance dates for the new worker and handler 6328

training requirements should be implemented s ooner than 2 years from the effective date of the final 6329

rule as outlined in the proposal. EPA believes that up to 18 months could be needed in order to develop 6330

and disseminate new, high quality, multi

- lingual worker and handler training materials in multim edia 6331

formats that comply with the new requirements. Additionally trainers will have to obtain the new 6332

training materials, become familiar with the new training content and ensure that they continue to meet 6333

any eligibility requirements to train. Therefore, EPA has decided to retain the proposed requirement to 6334

delay the new training requirements for 2 years from the effective date of the final rule (or 180 days 6335

after the announcement that training materials are available , whichever is later ) to allow adequate time 6336

for development and widespread distribution of the materials to trainers and employers. While EPA 6337

agrees that it is important for workers and handlers to have the new safety training information as soon 6338

as possible, time will be needed to create and distribute new training materials and to allow existing 6339

trainers to familiarize themselves with t hose new materials. In order to maximize compliance with the 6340

final rule, and in the interests of consistency and efficiency, EPA intends to develop and make av ailable 6341

suitable training materials. EPA intends to have new training materials developed and disseminated as 6342

soon as practical and will encourage employers to begin using the new materials as soon as they 6343

become available so that many workers and handler s will begin receiving the benefits of the new 6344

training before the required date. 6345

EPA is committed to a robust outreach, communications and training effort to communicate the 6346

new rule requirements to affected WPS stakeholders. To facilitate implementation , EPA plans to issue 6347

plain language “how to comply” fact sheets and guidance materials once the final rule is published. EPA 6348

plans to develop compliance assistance materials that are targeted to specific agricultural sectors and 6349

rule requirements such as r espirator requirements or the WPS exemptions and exceptions. EPA also 6350

intends to develop and disseminate new worker and handler training materials, conduct outreach to 6351

potentially affected parties, and provide assistance and resources to States and Tribes for WPS 6352

implementation. EPA plans to hold Pesticide Regulatory Education Program courses for State and Tribal 6353

pesticide program staff that will focus on WPS implementation, and Pesticide Inspector Residential 6354

Training courses for State and Tribal pesticide inspectors that will focus on WPS inspection 6355

requirements. 6356Page 143 of 176 XX. Economic Analysi s 6357

A. Cost Assessment and Related Topics 6358

1. Estimation of Costs 6359

Comment . EPA has underestimated the cost of the proposed rule. (Comments in 6360

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#0205, #1642, #1722, #1870, #2155, #2199, #2200, 6361

#2207, #2208, #220 9, #2225, #2238, #2239, #2242, #2252, #2258, #2269, #2282, #2293, #2303, #2304, 6362

#2310, #2319, #2376, #2385, #2432, #2491, #2492) 6363

EPA Response . EPA appreciates the comment, but without additional information is unable to 6364

determine how the estimated cost sh ould be modified. In some cases, it appears that commenters 6365

observed the reported $5 per worker and $60 per handler costs reported in the evaluation of the 6366

impacts on jobs and did not realize that these costs represent only the portion of the costs accrui ng for 6367

each employee; establishments will also bear certain costs less directly associated with the number of 6368

employees. For example, posting hazard information is required if workers are present, regardless of 6369

the number of workers on the establishment. In other cases, it appears that commenters confused the 6370

requirements for obtaining certification to use restricted use products with the handler training 6371

requirements under the Worker Protection Standard (WPS). 6372

Comment . EPA has underestimated the number of affected entities by 1) not counting contract 6373

labor; 2) failing to count diversified and livestock operations; 3) underestimating overall numbers of 6374

workers, including contract labor, by using outdated (2007 Census of Agriculture) data, rather than the 6375

most recent available (2012 Census of Agriculture); 4) failing to use current wage rates; 5) failing to 6376

account for the seasonality of farm worker employment. (Comments in regulations.gov, docket EPA

6377

HQ

- OPP

- 2011

- 0184; ID#2200, #2206, #2286, #2294, #2439, #2442) 6378

EPA response . EPA disagrees that there has been an underestimation of affected entities. 1) 6379

While the estimates of the numbers of entities and workers in EA for the proposed rule did not 6380

specifically include contract labor, EPA relied on employme nt figures in the 2007 Census of Agriculture. 6381

These figures include all employees, including those who are not engaged in hand labor activities nor 6382

handle pesticides, and counts a person multiple times if employed at multiple establishments. As a 6383

result, the number of affected workers was likely overestimated for the analysis of the proposed rule. 6384

For the EA for the final rule, EPA relied on the 2012 Census of Agriculture, which resulted in an estimate 6385

of almost two million workers. Relying on more deta iled surveys of farm labor, USDA estimates that 6386

there are just over one million workers, including 200,000 workers employed through contract services. 6387

This indicates that EPA has overestimated the number of workers, and probably the number of entities, 6388

th at are affected by the final rule. 2) Using a special tabulation of data from the 2007 Census of 6389

Agriculture, EPA specifically accounted for livestock operations (NAICS 112) that produce crops in the 6390

analysis of the proposed rule and used the information to estimate the number of livestock operations 6391

producing crops for analysis of the final rule. 3) For the final rule, EPA has used data from the 2012 6392

Census of Agriculture, which was not published prior to the publication of the proposed rule. 4) For the 6393

final rule, EPA has updated wages and prices to estimate costs using data from 2014. 5) The seasonality 6394

of farm worker employment leads to an overestimation of cost because EPA has assumed that all 6395

workers are present on a farm for the entire season. Th is means, for example, that EPA assumes farms 6396

are required to notify all workers of all pesticide applications when, due to seasonal employment, 6397

workers may not be present for most applications and notifications are not required. 6398

Comment . The National Cotton Council believes that EPA has significantly underestimated the 6399

costs to farmers that these additional regulations will impose. For example, EPA estimates a cost of 6400

$5/worker/year. The wages alone for a four

- hour training session

– even at the curren t federal 6401Page 144 of 176 minimum wage

– would be $29/worker and that does not include transportation or fees for the training. 6402

Additional costs to farmers would include signs and postings, recordkeeping, and additional trips for sign 6403

placement and maintenance. (Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1842) 6404

EPA Response . It appears that this commenter has confused the costs of obtaining certification 6405

to use restricted use products with pesticide safety training under the WPS. Safety training is typic ally 6406

conducted on

- site, often by the employer if he or she is a certified applicator, and under the revised set 6407

of topics, pesticide safety training will likely take 45 minutes to an hour. 6408

Comment . EPA has underestimated the costs of the revisions because some states have higher 6409

labor costs, especially Hawaii. Average cost per farm does not reflect establishments with large 6410

numbers of workers. (Comments in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2200, #2282, 6411

#2320) 6412

EPA Response . EPA acknowledge s that there is a great deal of variability across states and 6413

agricultural entities, but averages provide a powerful tool for calculating national

- level impacts and for 6414

providing basic information about the impacts of policy options and decisions. EPA use d variations in 6415

the number of workers across regions of the country to better understand the range of impacts to farms 6416

of different sizes. Although the average cost per farm may underestimate the cost to establishments 6417

with large numbers of workers, it al so overestimates the impacts to establishments with few workers. 6418

Comment . By averaging the number of employees so broadly EPA has significantly 6419

underestimated the total impact of compliance on growers of vegetable, fruit, and nuts, nurseries and 6420

greenhous es

– those that employ the vast majority of farmworkers that engage in hand labor activities. 6421

(Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2200) 6422

EPA Response . EPA disagrees. The analyses of both the proposed and final revisions include 6423

d iscussions of the impacts on individual establishments across a range of farm types and sizes, including 6424

different number of workers and handlers. This discussion is provided throughout Section 3.3 of the 6425

Economic Analysis of the final revisions; see, for example, Table 3.3

- 56 in Section 3.3.8. Also see Section 6426

3.5, Small Business Impacts. 6427

Comment . The US Census for Agriculture makes a distinction between hired farm labor and 6428

migrant labor. To get an accurate assessment of the impact on employers, contra ct labor must be 6429

included in the calculation. (Comments in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2209, 6430

#2296) 6431

EPA Response . EPA acknowledges that the Census of Agriculture does not account for contract 6432

labor. However, employment figures in th e Census of Agriculture include employees who do not engage 6433

in hand labor activities or handle pesticides and count persons multiple times if employed at multiple 6434

establishments. As a result, the number of affected workers is likely overestimated. For th e EA for the 6435

final rule, EPA estimates there to be almost two million workers, based on data from the Census, while 6436

USDA estimates that there are just over one million workers, including 200,000 workers employed 6437

through contract services, based on more ref ined data from farm labor reports ( Ref. 24 ). As a result, 6438

national and regional level impacts are likely overestimated. 6439

Comment . To try to better understand the details of the incremental cost increase claim, Bayer 6440

Crop Science and CropLife America exami ned the estimated burden of the ongoing WPS by looking up 6441

the most recently approved ICR, EPA No. 1759

- 06. The estimated annual burden to agricultural 6442

employers for the existing WPS is actually 1,827,493 hours at a cost of $92,729,052. The expanded WPS 6443

ICR proposal calls for 8,316,993 hours and $196,130,463, which appears to be a much higher dollar 6444

value than the incremental increase put forward in the economic analysis document. (Comments in 6445

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1763, #2209) 6446Page 145 of 176 EP A Response . The Economic Analysis is the better source to understand the estimated 6447

incremental cost of the rule. Comparing ICRs confounds different changes as explained in Chapter 7 of 6448

the analysis of the proposed rule and in Chapter 4 of the analysis of the final rule. First, the ICRs capture 6449

the ‘paperwork’ burden associated with the rule at different points in time. Thus, there will be 6450

differences in key parameters such as the wage rates and the number of affected entities ( e.g. , farms 6451

and workers). In contrast, the Economic Analysis is an assessment of the impacts of changes to the rule, 6452

i.e. , with and without revisions to the WPS holding other parameters constant. Second, in developing 6453

the ICR to accompany the proposed (and final) rule revisions, EPA developed a more detailed accounting 6454

of the activities employers and employees and revised many estimates of the time needed to comply 6455

with the existing and new requirements. Finally, it should be noted that the ICR only captures the 6456

‘paperwork’ burde n associated with the rule as a whole. Impacts of a minimum age, for example, will 6457

not be captured through an evaluation of paperwork requirements. 6458

Comment . Costs associated with the record keeping provisions need further explanation. 6459

(Comment in regula tions.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#0153) 6460

EPA Response . Details on the activities associated with the record keeping requirements have 6461

been provided in Appendix A of the analysis of the proposed revisions and in Appendix B of the analysis 6462

of the fi nal revisions. 6463

2. Training Costs 6464

Comment . EPA has underestimated the time required for training. Videos used run 35 minutes 6465

for worker training and 50 minutes for handler training, respectively. Additional time beyond running 6466

the video is needed. (Comm ent in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2320) 6467

EPA Response . EPA acknowledges that training times may vary. However, using an average 6468

facilitates estimation of the national level impact and provides a concise measure of the impact per 6469

esta blishment. 6470

Comment

. This year we have spent 2092.37 hours training 4456 employees on the 6471

WPS/Pesticide function alone. If we use an average field wage of $11.00 per hour, that is $23,016.00 just 6472

on WPS/Pesticides. ( Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1871) 6473

EPA Response . EPA appreciates the information and notes that 2092 hours to train 4446 6474

employees implies an average of 28 minutes of training per employee. 6475

Comment . USDA suggested that more sensitivity analyses should be conducted around 6476

different training parameters such as the typical duration, the frequency at which workers are trained, 6477

and the frequency different types of trainers are used. (Comment in regulations.gov, docket EPA

- HQ

6478

OPP

- 2011

- 0184; ID#0153) 6479

EPA Respons e . EPA conducted some sensitivity analyses for the proposed rule. Because the 6480

baseline costs and costs under the alternative, proposed, and final requirements are influenced by the 6481

same parameters, the incremental costs are often not substantially differ ent. The number of affected 6482

entities and workers/handlers carries the largest influence on the estimates of the total cost. 6483

Comment . The cost of developing the new material, either by the Agency or private entities, is 6484

not included in the analysis but sh ould be considered. (Comments in regulations.gov, docket EPA

- HQ

6485

OPP

- 2011

- 0184; ID#0153, #2209) 6486

EPA Response . EPA plans to develop revised materials for safety training and the safety 6487

information display. This is part of EPA’s on

- going work. 6488

Comment . Th e proposed expanded content covers areas that are included in most food safety 6489

related training programs. The complexity and level of detail indicated in the proposed regulation would 6490Page 146 of 176 take much more than just an additional 15 minutes as suggested in the ru le. (Comment in 6491

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2452) 6492

EPA Response . EPA disagrees that the content is similar. The expanded content is primarily 6493

about informing workers how they can avoid inadvertently carrying pesticide residues home w ith them. 6494

EPA has pilot tested training using some of the material and has found that it can be covered in the 6495

suggested time frame. 6496

Comment . The cost of providing training in different languages other than English should be 6497

included in the estimates. Th e average 1.5 training sessions expected annually at a large WPS farm does 6498

not appear to include sessions in different languages. (Comment in regulations.gov, docket EPA

- HQ

6499

OPP

- 2011

- 0184; ID#0153) 6500

EPA Response . Establishments are not required to provide training in different languages, only 6501

in a manner that can be understood, which can include the use of imagery (posters or videos) as well as 6502

select translations. The estimated average of 1.5 training sessions per year under the final requirements 6503

is an a verage across all farms, considering different sizes of farms (according to the Small Business 6504

Administration definition, which is based on value of production and different numbers of workers). For 6505

example, a large farm (production value of at least $750 ,000/year) that employs an average of 50 6506

workers is anticipated to hold six to seven training sessions, on average, under the new requirements. 6507

This could include sessions in different languages, if the establishment found it convenient. 6508

Comment . EPA did not consider the costs for Train

- the

- Trainer programs. (Comment in 6509

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2209) 6510

EPA Response . EPA did not estimate the cost of expanding Train

- the

- Trainer programs . T he 6511

final rule retains certified applicators as qualified trainers and EPA does not anticipate that an expansion 6512

of Train

- the

- Trainer programs will be necessary

. 6513

Comment . The American Farm Bureau (AFB) raised several general concerns and applied them 6514

to the specific policy issue of Immediate Trainin g (elimination of the grace period between beginning 6515

field work and receiving pesticide safety training). (Comments in regulations.gov, docket EPA

- HQ

- OPP

6516

2011

- 0184; ID#2200, #2206, #2439, #2442) 6517

General Concerns 6518

1. Underestimation of the number of farms 6519

• Census reports of hired labor do not include contract labor 6520

• Concern that EPA limited farms to those that derive their predominant source of revenue 6521

from sales of fruits/nuts, vegetables, nurseries, and greenhouses 6522

• Use of 2007 Census data 6523

2. Underestimation of the number of workers 6524

• Census reports of hired labor do not include contract labor 6525

3. Underestimation of wage 6526

• Use of 2007 data 6527

• Use of national level data 6528

4. Farm structure 6529

• Use of average farm size (20 workers/large farm, 3.6 workers/small farm) 6530

• Assumpti on that all workers are present throughout the year (no seasonality of 6531

employment) 6532

6533

Specific Concerns with Immediate Training (example in Section 3.3.3 of Economic Analysis of Proposed 6534

Rule) 6535Page 147 of 176 Under current requirements, workers must be trained every five ye ars. EPA estimates that each 6536

worker spends 30 minutes in training at a wage rate of $13.43 per hour including benefits. EPA 6537

estimates that currently, 48.9 percent of workers need to be trained each year given the 6538

assumptions that all new employees will tak e the training (16 percent of the workforce) and 40 6539

percent of the returning workforce (84 percent of the workforce) will take full training each year . . . 6540

. EPA notes that small farms with fewer than ten workers are likely to hold 0.7 training sessions e ach 6541

year on average, small farms with more than ten workers hold an average of 2.2 training session per 6542

year, large farms with fewer than ten workers will hold 0.9 sessions per year, and large farms with 6543

more than ten workers hold 4.5 sessions per year. De spite these large differences, EPA’s calculations 6544

are based on one full training session each year. 6545

6546

Under the proposed new requirements, workers must be trained every year. EPA estimates that 6547

each worker will now spend 45 minutes in training . . . . EPA e stimates that in the first year of the 6548

new requirements 50.8 percent of workers need to be trained, and in each subsequent year 49.6 6549

percent will need to be trained, again given the assumptions that all new employees will take the 6550

training (16 percent of t he workforce) and 40 percent of the returning workforce (84 percent of the 6551

workforce) will take full training each year. EPA assumes that, on average, a WPS farm will need to 6552

conduct 1.5 full trainings each year on average, over all farms, since workers ma y be hired at 6553

different times during the year. 6554

6555

A. The amount of time a worker spends in training should also include travel time back and forth to 6556

the training facility in addition to the actual length of the training. A likely scenario is that 6557

workers will be called out of the field to complete the training, take some time to get seated and 6558

prepared for the session, complete the training, and then travel back to the field to continue 6559

work. 6560

B. EPA should use updated, regional wage data. 6561

C. The seasonal n ature of agricultural work and the fact that many workers are employed through 6562

labor contractors imply that the workers go through the WPS training several times. AFB 6563

expects that employers will train every worker, every year. 6564

D. The use of a simple avera ge of one training per year is misleading. 6565

EPA Response

. 6566

1. EPA acknowledges that the Census of Agriculture does not account for contract labor under 6567

reports of hired labor and this could lead to an underestimation of the number of entities affected by 6568

the rule. However, the Census reports of hired labor include many employees who are not covered by 6569

the WPS because they are not engaged in hand labor activities or in handling pesticides for crop 6570

production. Moreover, EPA estimated total costs over a ran ge of assumptions about the affected farms, 6571

nurseries, and greenhouses. EPA considered all farms regardless of the predominant source of revenue, 6572

even including farms who primary production is livestock. For the final rule, estimates were updated 6573

using d ata from the 2012 Census of Agriculture. 6574

2. Again, EPA acknowledges that the Census of Agriculture does not account for contract labor 6575

under reports of hired labor, but it does include many employees who are not covered by the WPS. EPA 6576

estimates costs ac ross a range of values for the number of workers. Our primary estimate is almost two 6577

million workers. This is in contrast to USDA’s estimate of just over one million workers, including 6578

200,000 workers engaged through labor contracts (ERS, 2014). EPA is confident we have not 6579

underestimated the number of workers in the cost estimation. 6580Page 148 of 176 3. EPA has updated wages, using data from 2014 as reported by the Bureau of Labor Statistics 6581

to estimate the cost of the final revisions to the WPS. Using national level d ata is appropriate for 6582

estimating total national costs. 6583

4. Relying on the average number of workers per farm and assuming they are present the entire 6584

year results in an overestimation of costs, both in total and per farm. EPA uses an average across farms 6585

accounting for all employees on the farm regardless of length of service. It is not the average workforce 6586

per farm across time. We assume these employees are all workers and are present the full season. 6587

However, many workers are present on a farm for a short period of time around harvest and certain 6588

requirements, like notification and posting of pesticide applications, are only required for those 6589

pesticide applications relevant for that period, not for applications when workers are not present. Thus, 6590

E PA is overestimating the cost of complying with such requirements by assuming that workers are 6591

present the entire season. Note that there are also exceptions for applications occurring on fields far 6592

removed from workers’ location. 6593

A. EPA sees no reason to include travel time as part of the scenario for pesticide safety training. 6594

Such a scenario would be highly inefficient; employers are highly likely to provide training prior to 6595

the work day, not interrupting it. This is especially true under the final r ule, which eliminates the 6596

“grace period” and requires each worker to be provided with safety training prior to entering a 6597

previously treated field. Finally, the requirement to provide safety training is not new. If it were a 6598

normal practice for an employ er to halt work for a training, this would be true in the baseline as well 6599

as under the new provision. Thus, the incremental difference in time is still only the additional time 6600

to cover a few additional training topic. 6601

B. EPA has updated wages, but is n ot using regional wage data. EPA acknowledges that there is a 6602

great deal of variability across states and across agricultural entities, but averages provide a 6603

powerful tool to understand the impacts of policy options. Although an average wage may 6604

underes timate costs in some states, it will overestimate costs in others. 6605

C. EPA agrees that, because workers may be engaged by multiple employers, workers may attend 6606

multiple WPS trainings each year. Since the Census surveys farms about the number of employees

, 6607

it will count such workers multiple times. Because EPA’s approach includes all employees 6608

enumerated in the Census, we essentially account for multiple trainings. Training records and 6609

documents may reduce repeated trainings, especially for workers engag ed through labor 6610

contractors. Finally, if employers are already training every worker every year, the impact of 6611

requiring annual training will be negligible. 6612

D. EPA reiterates that use of averages simplifies many of the calculations, particularly for nat ional 6613

level costs. However, in estimating the impacts on farms of different sizes and types, EPA considers 6614

that many farms will provide more than a single session while, currently, some farms may only be 6615

providing safety training every few years. 6616

Comment

. The Hawaiian Commercial and Sugar Company believes that the amount of time 6617

needed to cover the additional topics proposed to be added has been underestimated, and that both 6618

the additional time and additional expense of meeting the new training requiremen ts will be higher than 6619

EPA has estimated. It does not appear that EPA's estimate of $3 in additional annual training costs per 6620

agricultural establishment is remotely reasonable, particularly for establishments with large numbers of 6621

agricultural workers who must attend the training. (Comment in regulations.gov, docket EPA

- HQ

- OPP

6622

2011

- 0184; ID#2320) 6623

EPA Response . EPA is unclear as to the referenced estimate of $3 in additional annual training 6624

cost per establishment. EPA estimated that annual training would cost an additional $22 per 6625Page 149 of 176 establishment, on average, and that expanding the training content would cost an additional $11 per 6626

establishment per year, on average (Section 3.3.3 of the EA for the proposed revisions to the WPS). 6627

Based on data from the 2007 Census of Agriculture, the average establishment produced about 6628

$470,000 in annual value of production and employed six workers and handlers. All proposed revisions 6629

to the training requirements were estimated to cost about $240 for the average large farm, which 6630

produced about $2.4 million in annual value of production and employed 20 workers and handlers 6631

(Section 5.2.1 of the EA for the proposed revisions to the WPS). All final revisions to the training 6632

requirements are estimated to cost about $210 for th e average large farm, which, based on data from 6633

the 2012 Census, produces approximately $2.4 million in annual value of production and employs 18 6634

workers and handlers (Section 3.3.1 of the EA for the final revisions to the WPS). 6635

Comment . EPA asserts that tracking, maintaining, producing, and distributing training records 6636

both for internal and employee use will cost establishments $4.00 a year. We find this number to be a 6637

gross underestimate and plead with EPA to simplify the requirements for record keeping . (Comments in 6638

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1879, #2222, #2377) 6639

EPA Response . EPA appreciates the comment, but without additional information is unable to 6640

determine how the estimation should be modified. EPA notes that the cited cost of $4 to $5 per year is 6641

for worker training only and did not account for the increase in the number of training sessions arising 6642

from the annual training requirement. Considering the annual training requirement, EPA estimated 6643

recordkeeping costs associat ed with worker safety training to be $5 to $11 per year, on average. The 6644

final rule modifies the record keeping requirements somewhat, reducing some of the information that 6645

must be kept and specifying that agricultural employers only have to provide a cop y of the record to a 6646

worker or handler if he/she requests a copy. Details of EPA’s estimation, including the time required for 6647

record

- keeping are found in Appendix B of the Economic Analysis for the final rule. Considering the 6648

changes to the rule and new wage information, EPA is estimating that record

- keeping costs associated 6649

with worker and handler training may range from $5.60 to $14.20 per year. 6650

Comment . The estimated costs for creating worker and handler training records and retaining 6651

them for two or five years is not well explained in the EA. Costs of producing and retaining the record 6652

should be discussed. It is unclear how costs were derived. (Comment in regulations.gov, docket EPA

6653

HQ

- OPP

- 2011

- 0184; ID#0153) 6654

EPA Response . Details on the activitie s associated with the record keeping requirements have 6655

been provided in Appendix A of the analysis of the proposed revisions and in Appendix B of the analysis 6656

of the final revisions. 6657

3. Hazard Communication Costs 6658

Comment . The National Council of Agricultu ral Employers asked members about EPA’s 6659

estimated time to comply with the proposed hazard communication requirements and provide the 6660

Agency with the replies, three of which are relevant to the estimation of costs. (Comment in 6661

regulations.gov, docket EPA

- H Q

- OPP

- 2011

- 0184; ID#1871) 6662

1. Agency estimates employers will take 12 minutes to gather information and will do it an 6663

average of 20 times annually. Do employers think this is reasonable? 6664

Our Safety Supervisor spent 2 days (16 hours o r 960 min utes ) compiling all MSDS/SDS and labels 6665

for all locations. 6666

2. Agency assumes filing of record, label and SDS will take 1 minute per application (20 minutes 6667

per year total. Do employers think this is reasonable? 6668Page 150 of 176 Putting a MDSD/SDS or label in a book or binder may take 1 m in each if they are in a stack 6669

waiting for you and this is simply all that you are doing. That would never be a realistic 6670

assumption. 6671

3. Agency assumes a worker, handler or representative for a worker or handler makes a request 6672

for information on 25% of th e applications and it requires 6 minutes of the employer’s time to 6673

provide the information. Is 6 minutes enough to allow for discussion? Should it be recorded a 6674

request was made and by whom and why? 6675

Again this would assume you are doing nothing else but si tting and waiting for a request and you 6676

have the information in front of you. I think the request should be recorded and kept on file in 6677

case something comes from that request. That way you could prove compliance with the 6678

requirement. 6679

EPA Response . EPA ap preciates the effort taken by NCAE to solicit information. 6680

1. The reported time appears to be substantially more than estimated by EPA (4 hours per year, 6681

on average). However, without knowing the number of applications involved, EPA does not have 6682

sufficie nt information to revise its estimates. In fact, it would seem that this situation involves an 6683

employer much larger than average. Most farms do not have a dedicated safety supervisor. Further, it 6684

appears that the farm is already collecting SDS so no add itional effort would be required for the farm to 6685

gather the information to provide to workers. 6686

2. As EPA has detailed in the cost estimate (see Appendix B of the Economic Analysis of the final 6687

rule, Table B.2.b

- 1) , filing the documentation is only one fin al step. Gathering and recording the 6688

information is accounted for separately. The comment suggests that EPA’s estimate of filing the 6689

documents is reasonable. 6690

3. EPA appreciates that the comment suggests that the time to respond to an employee’s 6691

request for application information is underestimated in EPA’s analysis. For the final rule, EPA maintains 6692

the estimate of 6 minutes to honor a request from a worker on site for the hazard information since it is 6693

likely that the request can be easily clarified an d, in fact, the information should be readily available and 6694

easily provided to the employee. EPA revised the time needed to respond to a request from a former 6695

worker or through a designated representative to 20 minutes per request since it may be more dif ficult 6696

to identify the appropriate information for such a request and providing the information to the 6697

employee/representative is more complicated. 6698

4. Notification Costs 6699

Comment . WPS warning signs commonly used in horticultural growing operations are rep orted 6700

to cost around $6.00 each. Large operations may maintain 1000 or more signs. How did the Agency 6701

arrive at the conclusion that the cost to implement the warning sign change would be $0.25 per 6702

establishment? A requirement to change warning signs consti tutes significant cost burden. (Comment 6703

in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2287) 6704

EPA Response . EPA proposed a revision to the wording on the warning signs, but also proposed 6705

a transition period so that signs with the former wording could be used until replacement due to wear 6706

and tear, implying little cost to the grower. In the final rule, however, EPA is retaining current sign 6707

format, so no new signs are required. 6708

Comment . The time required to travel to sites should be added to the cost of posting pesticide 6709

safety posters. (Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1871) 6710

EPA Response . Since decontamination supplies must be provided at these sites, posting the 6711

safety poster could reasonably be combined with delivering decontamination supplies, so no additional 6712

travel time is needed to post a safety poster. 6713Page 151 of 176 Comment . Required information to be included on safety posters will mean posters must be 6714

replaced annually. (Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184 ; ID#1871) 6715

EPA Response . The required information is contact information for a nearby medical facility and 6716

for the state lead agency. This information is unlikely to change frequently. Further, updating contact 6717

information may not necessitate replacemen t of the entire displays. The information can be written, 6718

erased, and rewritten on some signs and updated information could taped over the old information. 6719

5. PPE Costs 6720

Comment . Current regulations require the handler employer to confirm that a respirato r is fit 6721

properly. The new regulations require fit test, training and medical evaluation conforming to OSHA 6722

requirements and recordkeeping. The baseline estimate for obtaining a fit test is not well described and 6723

it is unclear what assumptions were made fo r current practice. The incremental difference between the 6724

baseline and new requirements doubles the baseline cost but may understate the difference as it is 6725

unclear what current practice entails. Sensitivity analysis about the travel and wait time for med ical 6726

examinations and cost of follow

- up medical examinations could provide a range of likely values for the 6727

proposed alternative. The cost of travel, as well as time spent traveling should be included in the cost. 6728

Presenting a range, rather than a point es timate, incorporates some acknowledgement of uncertainty in 6729

these calculations. If the baseline is actually 'lower' than EPA is assuming, the benefits and costs of the 6730

new requirements will both be higher. (Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2 011

- 0184; 6731

ID#0153) 6732

EPA Response . EPA assumed very minimal procedures in the baseline for most situations. 6733

Appendix A of the analysis of the proposed revisions described these as the employer and handler 6734

checking the fit and going over the use instruction s for a total of 12 minutes (0.2 hours) each year. If 6735

anything, this probably understates the care employers take with the handlers in their employ. EPA also 6736

assumed that less than 1,000 handlers followed OSHA

- like procedures in the baseline because they are 6737

required to do so by the labels of soil fumigant products. Cost of travel was and is included in the 6738

estimation of costs under the proposed and final rule, for both obtaining a follow

- up medical 6739

examination, if necessary, and for the fit test, if con ducted off

- site. See Appendix B of the EA for the 6740

final rule, Table B.6.a

- 1 and B.6.a

- 2. 6741

Comment . The following are the costs for a fit test and medical evaluation: For a qualitative 6742

(smoke) fit test the cost is $12; For a quantitative computer fit test the cost is $24; Charges in the 6743

amount of $30.00 is paid to obtain the medical evaluation paperwork. The person obtaining the fit test 6744

and evaluation must then be signed off by a physician that they are physically able to use a respirator. 6745

Routine visits t o a medical provider start at $100 + per visit. Additional costs include employee wages 6746

and benefits, plus travel costs to a certifying physician. (Comment in regulations.gov, docket EPA

- HQ

6747

OPP

- 2011

- 0184; ID#1843) 6748

EPA Response . EPA appreciates the inform ation and has revised the scenario used to estimate 6749

the cost for the respirator medical evaluation, fit testing and training . We found similarly priced 6750

evaluation screens but note that it would generally not be necessary to visit a physician or clinic to 6751

complete the evaluation. EPA also assumes that most agricultural establishments will send handlers to a 6752

central location rather than purchase a test kit although fees may be somewhat higher than this 6753

comment reports, given other comments received. EPA in cludes the cost of the employee’s time, 6754

including travel, for the fit test as well as time for the employer to oversee the process. EPA estimates 6755

the total cost of complying with the respirator fit test requirements to be about $180 per handler, on 6756

averag e, who is tested. See Section 3.3.6 of the Economic Analysis for the final rule, including Appendix 6757

B.6 , Table B.6.a

- 1 , for details. 6758Page 152 of 176 Because there were many concerns raised for the respirator requirements, EPA plans to develop 6759

detailed information describ ing the specifics for employers and their handlers. 6760

Comment . Commenters believe the requirement for medical evaluation will be a significant cost 6761

on handler employers and difficult to carry out. EPA’s cost estimate of $54 per agricultural 6762

establishment i s unrealistically low. (Comments in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; 6763

ID#1842, #1848, #1871, #2385) 6764

EPA Response . As indicated by the previous comment and explained in Section 3.3.6 of the 6765

Economic Analysis for the final rule and Appendix B.6 , the medical evaluation for a handler to safely 6766

wear a respirator is not complicated. The evaluation is typically a questionnaire that can be completed, 6767

submitted, and reviewed on

- line. A visit to a physician is not necessary, unless the screening evalu ation 6768

indicates a more thorough physical examination is needed to ensure the handler can safely wear a 6769

respirator. EPA estimates the cost of the respirator

- related requirements to be about $150 for a 6770

handler, on average, but could be around $270 if a more thorough medical examination is warranted. 6771

Not every establishment will use products requiring a respirator every year, however, so the average 6772

cost across all agricultural establishments is substantially lower. 6773

Comment . The OSHA standard requires the use of respirators certified by the National Institute 6774

for Occupational Safety and Health (NIOSH). If EPA adopts the OSHA requirements then it needs to 6775

document the cost of purchasing certified respirators (Comment in regulations.gov, docket EPA

- HQ

6776

OPP

- 201 1

- 0184; ID#2385). 6777

EPA Response . The cost of respirators is not relevant to the requirement of proper fit 6778

established in the WPS. Specific respirator requirements are already mandated on product

- specific 6779

pesticide labeling. 6780

Comment . Requiring noncertified crop advisors to wear PPE when entering fields under a REI 6781

will weaken the producer’s ability to implement prevention

- based IPM programs, and pesticide use, 6782

including more toxic pesticides, will rise as a result. Independent crop consulting firms will have to 6783

reduce reliance on uncertified employees, doubling labor costs and increasing fees. Growers will reduce 6784

scouting and instead rely on more pesticides. (Comments in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 6785

0184; ID#2257, #2307 ) 6786

EPA Response . Comments appear to reflect a misunderstanding of the revision. PPE are 6787

required by the pesticide label for individuals entering a field under a Restricted Entry Interval (REI) 6788

immediately following a pesticide application. The existing W PS requires certified crop advisors to have 6789

PPE available for themselves and non

- certified crop advisors in their employ or under their supervision. 6790

However, the WPS exempts certified crop advisors and non

- certified crop advisors in their employ or 6791

under their supervision from wearing it if they judge the risks to be acceptable. The revision simply 6792

eliminates the exemption for a non

- certified crop advisor to forgo wearing PPE in a field under a REI, 6793

based on his/her employer’s recommendation. While the P PE specified in the existing WPS is the label

6794

specified PPE for handlers, the revised rule would relax this requirement to allow crop advisors and 6795

those in their employ or under their supervision to choose a reduced set of PPE. That is, the only impact 6796

of the provision is that the non

- certified crop advisor may have to put on available PPE (essentially 6797

coveralls and gloves) if they enter a field under a REI. 6798

Comment . The National Alliance of Independent Crop Consultants expressed concern that 6799

certified cr op advisors or the establishments on which they are employed would need to furnish 6800

additional PPE for employees if they are required to change or throw away PPE each day as disposable 6801

PPE is not as durable as normal work wear that can be carefully washed a nd reused. “For example Tyvek 6802

suits, which are the most common type of disposable PPE clothing, are extremely susceptible to rips and 6803Page 153 of 176 tears under normal levels of activity, especially the inseam. Due to the high temperatures and humidity 6804

inside a Tyvek sui t, employees often wear shorts under these suits, and a torn inseam then creates 6805

greater potential for exposure than had they been wearing long pants, the minimal PPE recommended 6806

by the NAICC’s position statement on Employees of Certified Agricultural Prof essionals.” (Comment in 6807

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2307) 6808

EPA Response . In the final rule, EPA provides three PPE options for noncertified crop advisors 6809

and employees entering areas during an REI that should minimize disruption in IP M practices. They may 6810

wear the handler PPE from the labeling, the PPE for early entry, or they may wear coveralls, shoes and 6811

socks, chemical resistant

- gloves, and eye protection (if the label requires eye protection). It is worth 6812

noting that the coverall s can be made of cloth and Tyvek suits are not required. 6813

Comment . Costs of retrofitting existing closed loading systems to meet the requirements of 6814

California’s Director’s memo are underestimated. CropLife America estimates that converting an 6815

existing sy stem to meet the proposed standard would cost $25,000 to $100,000. (Comment in 6816

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2209) 6817

EPA Response . Based on significant comments related to the closed system criteria in the 6818

proposal, EPA has revised the f inal rule to provide a closed system performance standard. CropLife did 6819

not provide a basis for the estimate of retrofitting costs. However, according to a study by Giles and 6820

Billings (2013), a simple closed system meeting the standard in the final rule would cost about $330. 6821

EPA estimates that retrofitting existing systems would likely mean purchasing an appropriate adapter to 6822

connect the pesticide container to a mixing tank or to the application equipment at a cost of about 6823

$150. See Section 3.3.6 of the Economic Analysis for the final rule. 6824

6. Cholinesterase Monitoring 6825

Comment . The Agency presented a simple cost analysis based on data collected in Washington 6826

in 2009. In comparison to Washington’s total agricultural production value, the costs assoc iated with 6827

the state’s cholinesterase inhibition monitoring program are exceedingly small. More importantly, this 6828

analysis does not include an estimation of the medical expenses that were saved, the lost wages 6829

prevented, and the pesticide

- related illnesse s avoided as a result of early detection and intervention. 6830

Washington State’s example shows that ChE monitoring program is not only cost effective but also 6831

enhances the health and safety of workers who directly handle pesticide products. (Comment in 6832

regu lations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2393) 6833

EPA Response . The comment’s description of the cost analysis omits the costs borne by the 6834

employer and handler in terms of the time required for the program. EPA acknowledges that the 6835

analysis did not a ttempt to quantify the benefits attributable to a monitoring program alone, primarily 6836

because of the difficulty in isolating the effect of one particular program in terms of preventing 6837

pesticide

- related illnesses. As discussed in the Economic Analysis of the Proposed Revisions to the WPS, 6838

Section 4.5.3, however, the benefits in terms of preventing pesticide

- related illnesses may be small. 6839

Instead of requiring medical monitoring

, EPA is instituting better practices, such as improved training in 6840

the use of PPE, which the Washington state program identified. These improved practices will be 6841

required for all handlers, not just those handling pesticides that may inhibit cholinesterase. 6842

7. Employment Impact Analysis 6843

Comment . Current WPS regulations have had th e unintended consequence of causing some 6844

famers to avoid hiring workers and complying with the related WPS training and recordkeeping 6845

requirements. This may be having a negative economic impact on the growth and competitiveness of 6846

small Iowa farms. (Comme nt in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2206) 6847Page 154 of 176 EPA Response . EPA has seen no studies suggesting that farmers forego hiring workers or 6848

handlers due to the cost of complying with the WPS. EPA estimates that the incremental cost of the 6849

revisio ns will add about $5.00 per year to the cost of a worker, which is unlikely to have sizeable 6850

consequences on farmers’ hiring decisions. See Section 3.3.4 of the Economic Analysis for the final rule. 6851

8. Small Business Impact Analysis 6852

Comment . Many small b usinesses believe that EPA’s anticipated impact of less than 0.1 percent 6853

is understated and recommend that EPA perform an additional sensitivity analysis related to small 6854

commercial entities before certifying the proposed action will not have a significant adverse economic 6855

impact on them. (Comments in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1843, #1870, 6856

#1871) 6857

EPA Response . EPA has performed a sensitivity analysis around the estimated costs to small 6858

businesses. The SBA defines a small agricultur al establishment as producing less than $750,000 in 6859

agricultural output. EPA examined the impact of the proposed and final rule changes on establishments 6860

throughout the size distribution, including on establishments producing less than $10,000 in agricult ural 6861

output. 6862

Comment . EPA finds that estimated costs would equal to almost two percent of smaller small 6863

entities’ revenues independent of other costs and economic circumstances that might be associated 6864

with this rulemaking or the specific industry. Based on this average, which is greater than one percent, 6865

EPA’s factual basis contained in the economic analysis does not provide adequate support for EPA’s 6866

certification that the rule will not have a significant economic impact on a substantial number of small 6867

entities. EPA should, therefore provide a full initial regulatory flexibility analysis, including regulatory 6868

alternatives to reduce the adverse economic effects on the smaller small entities. (Comment in 6869

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#18 48) 6870

EPA Response . EPA examined the estimated impacts of the revisions to the WPS in detail and 6871

the results are presented in both the Economic Analysis of the Proposed Revisions and of the Final 6872

Revisions. See Section 3.5 of the EA for the Final Revisions . EPA estimates that the smallest of farms, 6873

given 3.7 workers on average and relatively low pesticide use, may face incremental costs of about $86 6874

per year, but more likely costs of $30 to $50 per year given the seasonality of the labor they employ. 6875

Impa cts are compared to the value of agricultural production, but this measure understates the 6876

establishment’s total income. According to the 2012 Census of Agriculture, 92 percent of 6877

establishments producing less than $10,000 in agricultural production make less than 25 percent of their 6878

income from farming. Farm

- related income, which include s activities like agricultural services, land rent, 6879

and agrotourism, account for 35 percent more income for these establishments than does agricultural 6880

production. Furth er, EPA estimates that impacts of this magnitude or greater will be felt by those small

6881

small farms that primarily produce fruits, nuts, and vegetables and small

- small nurseries and 6882

greenhouses. These entities number about 12,000, comprising only six perc ent of all WPS farms. 6883

Comment . Small businesses are concerned with the use of national averages across all farm 6884

sizes. This is approach does not account for the seasonal nature of the workforce prevalent in most 6885

small entities. (Comment in regulations.go v, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1848) 6886

EPA Response . The Census of Agriculture reports the total number of persons employed by an 6887

establishment, regardless of the length of employment. Although the agricultural workforce is highly 6888

seasonal, EPA assumed that all workers on an establishment were present for the majority of the time. 6889

This assumption likely results in an overestimate of the cost of compliance, particularly compliance with 6890

the hazard communication and notification requirements because it as sumes that all workers are 6891

informed of all pesticide applications made on the establishment. 6892Page 155 of 176 Comment . EPA does not provide any cost adjustment for small agricultural entities nor provided 6893

any alternative methods of compliance. (Comments in regulations.go v, docket EPA

- HQ

- OPP

- 2011

- 0184; 6894

ID#2209) 6895

EPA Response . The Regulatory Flexibility Act (RFA) requires agencies to assess the impacts of 6896

regulations on small entities and to consider ways in which the burden can be reduced. Neither the RFA 6897

nor the Paperwor k Reduction Act requires agencies to provide alternative methods of compliance. 6898

Pursuant to the RFA, EPA assessed the impacts to small agricultural entities and considered several 6899

recommendations made by a panel of small business representatives in develo ping the proposal and 6900

final rule. Ultimately, EPA’s analysis indicates that there will not be a significant impact to a substantial 6901

number of small businesses. 6902

9. State Costs 6903

Comment . EPA’s economic analysis does not fully and accurately account for the costs to the 6904

FIFRA

- state lead agencies. These costs will be significant, especially during the first several years of 6905

implementation. (Comments in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1763, #1870, 6906

#1871, #1874, #2206, #2208, #2209, #2258, #22 82, #2293, #2313, #2432) 6907

EPA Response . The Economic Analysis of the final rule includes a discussion of the impacts on 6908

states. 6909

Comment . The Economic Analysis did not account for the increased cost of training sufficient 6910

trainers to comply with the propos ed requirement that worker safety training be conducted by trainers 6911

of certified applicators or by persons who have completed a Train

- the

- Trainer course. (Comments in 6912

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1870, #2293) 6913

EPA Response

. EPA did not estimate the cost of expanding Train

- the

- Trainer programs . T he 6914

final rule retains certified applicators as qualified trainers and EPA does not anticipate that an expansion 6915

of Train

- the

- Trainer programs will be necessary. 6916

10. ICR 6917

Comment . CropLife America and Bayer CropSciences raised several concerns over the burden 6918

and cost estimates of the proposed ICR. (Comments in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; 6919

ID#1763, #2209) 6920

• EPA used loaded wages (monetary compensation plus non

- monetary benefits such as paid leave 6921

and insurance) rather than fully loaded wages (monetary and non

- monetary compensation plus 6922

overhead for equipment and infrastructure). 6923

• EPA underestimated the number of greenhouses. 6924

• EPA should have used a minimum of five minutes for every record

- keeping activity. 6925

o set

- up costs to establish a record

- keeping system if one has not already been 6926

established 6927

o costs to develop internal record forms 6928

o printing costs for paper records 6929

o computer software/system costs for electronic records 6930

o stora ge costs 6931

o disposal costs of records with sensitive information 6932

o maintenance costs for records beyond the two

- year minimum for longer

- term 6933

employees 6934

• Added costs for Train

- the

- Trainer programs. 6935

6936

EPA Response

. 6937Page 156 of 176 • EPA agrees that it is appropriate to use the fully loaded wage rates for employers and for 6938

pesticide handlers, since these actors are using equipment and infrastructure that depreciates 6939

and must be replaced. However, EPA thinks it appropriate to use loaded wage rates for 6940

workers, since these employees typ ically are not using such equipment. Further, agricultural 6941

workers often do not receive non

- monetary benefits so any use of infrastructure is captured 6942

within the loading factor. 6943

• EPA disagrees that the number of greenhouses is underestimated. Publicly ava ilable data from 6944

the Census of Agriculture do not permit the identification of the number of farms that both use 6945

pesticides and hire labor nor does it report greenhouses separately from nurseries and 6946

floriculture production, which are all included under NA ICS code 1114. For ICR, both for the 6947

proposed and final rule, EPA estimated the number of farms, including greenhouses, that use 6948

pesticides and/or hire labor based on publicly available data from the 2012 Census of 6949

Agriculture and the information from the special tabulation of data from the 2007 Census. 6950

Please see Appendix A of the Economic Analysis of the Agricultural Worker Protection Standard 6951

revisions for details of the estimation procedure. EPA acknowledges that there are many more 6952

greenhouses in oper ation than are reported under NAICS code 11141 because U.S. farms 6953

typically produce a diverse array of crops and NAICS codes reflect only the primary source of 6954

revenue for an entity. However, since those greenhouses are reported as part of other entities 6955

listed under other NAICS codes, EPA is confident that this ICR accounts for the full burden of 6956

compliance with the WPS

. 6957

• EPA does not think a minimum of five minutes for each recordkeeping activity is warranted. EPA 6958

has frequently defined very limited acti vities to separate the gathering of information, which 6959

may vary by the type of information, from the filing and storing of the information, which is 6960

likely similar across types of information and takes very little time once the information is 6961

gathered. EP A also does not think it necessary to include set

- up costs, since agricultural 6962

establishments hiring labor will already have some recordkeeping system in place. The final rule 6963

does not require collection of sensitive information and since the rule does no t require 6964

maintenance of records beyond two years the ICR should not include such costs. 6965

• EPA did not include costs for train

- the trainer programs because most costs are covered by fees 6966

paid by those participating in the course. However, EPA acknowledges t he concerns raised by 6967

stakeholders about the availability of trainers as well as the skills necessary to provide pesticide 6968

safety training for agricultural workers. In the final rule, EPA is retaining the provision that 6969

worker safety training may be condu cted by certified applicators, so the cost of training 6970

additional trainers is no longer relevant. 6971

6972

Comment . EPA’s analysis must meet data quality guidelines of objectivity, utility, and integrity. 6973

While EPA’s FIFRA pesticide registration are based on ind ividual and cumulative risk assessment, the 6974

WPS analysis is not based on any risk assessments at all. OMB should not approve the WPS ICR because 6975

the ICR does not meet IQA guidelines and practical utility. (Comment in regulations.gov, docket EPA

6976

HQ

- OPP

- 201 1

- 0184; ID#0480) 6977

EPA Response . EPA’s analysis is based on the best and most appropriate data available and 6978

meets the Agency’s as well as OMB’s quality guidelines. The WPS analysis is not based on chemical

6979

specific risk assessments like pesticide registration decisions because it is not a chemical

- specific rule. 6980Page 157 of 176 Comment . The draft ICR does not account for the costs to the FIFRA

- state lead agencies. These 6981

costs will be significant, especially during the first several years of implementation. (Com ments in 6982

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1763 , # 2209) 6983

EPA Response . Neither the current WPS ICR nor the draft ICR includes a measure of the 6984

paperwork burden for state lead agencies charged with enforcement of the WPS. The ICR for the WPS 6985

has always focused on the burden to agricultural establishments, commercial pesticide handling 6986

establishments, workers, and handlers. In general, State reporting requirements are addressed in 6987

“EPA’s General Regulation for Assistance Programs ICR” (OMB nu mber 2030

- 0020; EPA No. 0938.18). 6988

Comment . Rule Familiarization is not a one

- time review. Material must be reviewed 6989

throughout the year. (Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1871) 6990

EPA Response . EPA agrees that an employer may re view WPS material multiple times in the 6991

year. The ICR estimates an annual average for a three

- year period (the time period covered by the ICR) 6992

that agricultural employers, as well as the operators of farms that do not hire labor, spend to familiarize 6993

them selves with the rule. The estimate is for the average time annually, estimated at 30 minutes, but 6994

does not specify the frequency of the rule reviews. The comment does not provide an estimate of the 6995

time spent per review of the material or the number of r eviews to inform whether the current estimate 6996

is low or high. If such information is provided, EPA can consider this information to incorporate it into 6997

future ICRs. 6998

11. Other 6999

Comment . Farmers’ ability to comply with immense quantities of regulations also differs from 7000

other businesses since farmers do not set the price on their commodities and they sell their 7001

commodities at a price determined by the market regardless of a farmer’s input costs. In some years, 7002

when crop prices or crop yields or both are low , farmers have limited funds to purchase large amounts 7003

of additional equipment or to pay an additional salary for someone to do additional EPA 7004

recordkeeping. Commodities prices such as corn and sugar are significantly below average which means 7005

farmers wil l have far fewer dollars to pay for additional EPA compliance costs. (Comment in 7006

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2443) 7007

EPA Response . EPA recognizes that farmers face risks associated with price variability and 7008

production variability. Ho wever, the revisions to the WPS do not entail investments in additional 7009

equipment, except for, perhaps, an additional fitting to complete a closed pesticide delivery system, and 7010

the recordkeeping requirements are unlikely to necessitate a dedicated employe e. In the final rule, EPA 7011

has eliminated some of the proposed recordkeeping requirements in order to focus those requirements 7012

on areas of importance. The required safety training records and application records are not wholly 7013

new; farmers already must ke ep employment records and often will maintain pesticide application 7014

records for reasons such as resistance management. 7015

Comment . The significant added cost burden imposed by these revisions could be reduced by 7016

focusing on the gaps in the implementation of the current WPS, rather than by adding layers of 7017

bureaucracy and prescription. (Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2311) 7018

EPA Response . EPA appreciates the comment, but without additional information is unable to 7019

address which gap s in the implementation of the existing WPS requirements the commenter identifies 7020

as significant problems. 7021

Comment . The proposed changes to the WPS fail to adequately acknowledge the adverse 7022

economic impact on small nursery, greenhouse, Christmas tree, an d floriculture operations, which were 7023

badly impacted by the economic downturn and the “great recession.” Many growers have gone out of 7024

business; the recently

- release Census of Agriculture suggests a nearly 25 percent decline in production 7025Page 158 of 176 of woody nursery crops. Many growers who survived have lost equity and are still vulnerable. In this 7026

environment, increased regulatory compliance costs are destabilizing and often untenable. (Comment 7027

in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2287) 7028

EPA Response

. EPA considered the impacts to all small entities, including nurseries and 7029

greenhouses. See Section 3.5 of the Economic Analysis of the final rule. 7030

Comment . An academic organization recommends that the WPS should protect the health of 7031

vulnerable populati ons without regard to cost

- benefit analysis, as is the case with health standards set 7032

under the Occupational Safety and Health Act (OSH Act) to protect workers from toxic substances and 7033

harmful physical agents, and dietary pesticide residue tolerances set under section 408 of the Federal 7034

Food, Drug and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act. (Comment in 7035

regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#1384) 7036

EPA Response . It is reasonable and appropriate to pay close attention to the anticipated costs 7037

and benefits of FIFRA regulation, and EPA does so in accordance with Executive Order 12866 and 7038

Executive Order 13563, among other applicable requirements. Unlike the certain regulatory standards 7039

of the OSH Act and FFDCA section 40 8, the FIFRA “unreasonable adverse effects” standard expressly 7040

requires that EPA take into account the economic, social, and environmental costs and benefits of the 7041

use of any pesticide. See FIFRA section 2(bb). 7042

Comment . EPA should perform a retrospectiv e analysis of the effects of the rule, including an 7043

analysis of the costs. (Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#0444) 7044

EPA Response . EPA will consider such an analysis at the appropriate time. 7045

Comment . EPA has promulgated extensive regulations establishing other data requirements for 7046

the regulation of pesticides under FIFRA. Subpart K of these regulations govern “Human exposure,” 7047

including “Applicator exposure” and “post

- application exposure.” Consequently, these EPA data 7048

requirement regulations apply to the WPS. (Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 7049

0184; ID#0480) 7050

EPA Response . EPA’s data requirements at 40 CFR part 158, subpart K, apply to pesticide 7051

registrants and specify the exposure data required to sup port a pesticide registration. Fulfillment of the 7052

data requirements enable EPA to conduct chemical

- specific risk assessments to inform chemical

- specific 7053

pesticide registration decisions. These requirements do not limit the Agency’s authority to consider 7054

other reliable information that may be pertinent to a pesticide registration, or to the WPS. 7055

Comment . While we appreciate the effort that went into the analysis, we suggest that the 7056

economic analysis section be subject to outside peer review to determine if the assumptions and 7057

uncertainties used by the agency adequately represent the real world and the current state

- of

- the

- art. 7058

(Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; ID#2310) 7059

EPA Response . Such a review is not a part of the regulatory r eview process. The analysis is 7060

subject to the OMB

- led inter

- agency review and review by the public. 7061

Comment . One individual asked (Comment in regulations.gov, docket EPA

- HQ

- OPP

- 2011

- 0184; 7062

ID#0136) 7063

1. What is the cost/benefit of implementing these new cha nges? 7064

2. Currently, what is the number and severity of any pesticide injuries for each of the last three 7065

years? 7066

3. In comparison to other work place injuries, where does the pesticide injuries stand? 7067

4. What will be the economic impact of these new regulat ions if implemented? 7068

EPA Response

. 7069Page 159 of 176 1. The cost/benefit ratio is not defined, given the inability to estimate a monetary value for many 7070

of the benefits anticipated. 7071

2. EPA provided the results of an analysis of incidents in Section 6.5 of the EA for the proposed rule 7072

and updated the analysis for the final rule, presenting the results in Section 4.5. 7073

3. EPA did not compare other kinds of work place illness or injury to the incidence of pesticide. 7074

EPA’s mandate under FIFRA is to protect human health, inclu ding the health of workers and 7075

handlers, and the environment from unreasonable adverse effects of pesticide exposure. 7076

4. EPA estimates the cost of compliance with the revised WPS to be about $60 to $67 million per 7077

year. EPA further estimates that the revi sions will result in fewer occupational incidents 7078

involving pesticides and will reduce day

- to

- day pesticide exposure to workers and handlers as 7079

well as reducing the amount of pesticide residues inadvertently carried home by workers and 7080

handlers. 7081

Comments i n Unit XX.A. 7082

ID#0136. Anonymous Public Comment 7083

ID#0153. US Dept. of Agriculture 7084

ID#0205. Idaho Farm Bureau Federation 7085

ID#0444. George Washington University Regulatory Studies Center 7086

ID#0480. Center for Regulatory Effectiveness 7087

ID#1384. Center for Gov ernmental Responsibility, Levin College of Law, University of Florida 7088

ID#1642. Texas Farm Bureau 7089

ID#1722. Elliot Gordon 7090

ID#1763. Bayer CropScience 7091

ID#1842. National Cotton Council 7092

ID#1843. Wyoming Dept. of Agriculture 7093

ID#1844. American College of Occ upational and Environmental Medicine 7094

ID#1848. U.S. Small Business Administration, Office of Advocacy 7095

ID#1870. National Association of State Depts. of Agriculture 7096

ID#1871. National Council of Agricultural Employers 7097

ID#1874. Maine Dept. of Agriculture, C onservation, and Forestry, Board of Pesticides Control 7098

ID#1879. Wilbur

- Ellis Company 7099

ID#2155. Minnesota Nursery and Landscaping Association 7100

ID#2238. Massachusetts Nursery and Landscaping Association 7101

ID#2199. USA Rice Federation 7102

ID#2200. American Farm Bureau Federation 7103

ID#2206. Iowa Farm Bureau Federation 7104

ID#2207. North Carolina Farm Bureau 7105

ID#2208. Pesticide Policy Coalition 7106

ID#2209. CropLife America 7107

ID#2222. North Carolina Dept. of Agriculture and Consumer Services 7108

ID#2225. Florida Nursery, Grow ers, and Landscape Association 7109

ID#2239. National Potato Council 7110

ID#2242. Utah Dept. of Agriculture and Food 7111

ID#2252. Ohio Farm Bureau 7112

ID#2257. Glades Crop Care, Inc. 7113

ID#2258. Georgia Dept. of Agriculture 7114Page 160 of 176 ID#2269. Western Growers 7115

ID#2282. Hawaii Farm Bureau 7116

ID#2286. Wyoming Ag

- Business Association, Wyoming Crop Improvement Association, Wyoming Wheat 7117

Growers 7118

ID#2287. AmericanHort, Society of American Florists, National Christmas Tree Association, and 7119

California Cut Flower Commission 7120

ID#2293. State o f Pennsylvania Dept. of Agriculture 7121

ID#2294. Pennsylvania Farm Bureau 7122

ID#2296. Georgia Farm Bureau 7123

ID#2303. Washington Friends of Farms & Forests 7124

ID#2304. Plains Cotton Growers, Inc 7125

ID#2307. National Alliance of Independent Crop Consultants 7126

ID#2310. Northwest Horticultural Council 7127

ID#2311. South Dakota Agri

- Business Association 7128

ID#2313. New Mexico Dept. of Agriculture 7129

ID#2319. Oregon Association of Nurseries 7130

ID#2320. Hawaiian Commercial and Sugar Company 7131

ID#2376. Kansas Dept of Agriculture 7132

ID#2377. African American Farmers of California, California Citrus Mutual, California Cotton Ginners 7133

Association, California Cotton Growers Association, California Fresh Fruit Association, Nisei 7134

Farmers League, Western Agricultural Processors Association 7135

ID#2385. Agricultural Retailers Association 7136

ID#2393. California Environmental Protection Agency 7137

ID#2432. Texas Dept. of Agriculture 7138

ID#2439. Michigan Farm Bureau 7139

ID#2442. MBG Marketing; Michigan Agricultural Cooperative Marketing Association; Michigan Apple 7140

Committee; Michigan Asparagus Growers, Inc.; Michigan Cherry Committee; Michigan Farm 7141

Bureau; Potato Growers of Michigan, Inc. 7142

ID#2443. Louisiana Farm Bureau Federation, Inc. 7143

ID#2452. Minor Crop Farmer Alliance 7144

ID#2491. National Agricultural Avia tion Association 7145

ID#2492. New York Farm Bureau 7146

B. Benefits 7147

Comment . Several commenters dispute EPA’s findings that there will be benefits from the 7148

changes to the WPS. These comments took several forms. Several commenters objected that EPA was 7149

unable to quantify benefits for specific proposals that are part of the changes to the WPS (1805, 1430, 7150

1012, 4529, 4543, 4531, 4533, 1369, 853, 697, 1809, 1436, 1809, 1436, 853, 4548, 4546). 7151

EPA Response . There are many changes to the WPS, and the changes work t ogether to increase 7152

safety. For example the better communication of hazards works together with better training to ensure 7153

that farmworkers and handlers know better how to protect themselves and their families. The changes 7154

also work together with pesticid e labels to ensure that pesticides can be used safely. For these reasons, 7155

the benefits of individual proposals could not be estimated. Because of the nature of pesticide 7156

exposure, the possible latency of effects, and the underreporting of pesticide incid ents, it is difficult to 7157

find precise estimates of the benefits of the WPS changes. The available evidence, however, is 7158

convincing to EPA that the rule changes will result in benefits sufficient to justify the costs. 7159Page 161 of 176 Comment . Commenters also objected t o the discussion of chronic disease reduction as a 7160

potential benefit of the rule, doubting that the WPS changes will result in reduced chronic illness (4461, 7161

4442); object ed to EPA estimating the value of reduced cancers, when the association between illne ss 7162

and exposure is speculative (576); and that the epidemiology literature cited only describes associations 7163

between pesticide exposure and illness, rather than causal relationships (4544, 1107, 4540). Some 7164

commenters objected that the epidemiology studie s cited were old, and many were based on exposure 7165

that happened prior to the registration of new, safer pesticides (1369, 348). 7166

EPA Response . EPA acknowledges that the pesticides registered for use are generally safer than 7167

in the past, and the Office of Pesticide Programs continually strives to strike an appropriate balance 7168

between pesticide effectiveness and safety. Despite continual efforts to improve safety, risks to 7169

farmworkers, handlers and their families remain. Studies of pesticide risks, such a s epidemiology 7170

studies, such as the Agricultural Health Study (AHS) are one of many lines of evidence that EPA used 7171

when considering the rule changes, and EPA utilized the best available peer

- reviewed scientific 7172

information to qualitatively describe the po tential chronic health effects of pesticide use. EPA has tried 7173

to be clear in the EA about uncertainties in assigning causality based on epidemiological studies and that 7174

the epidemiological results are suggestive, not conclusive, about links between speci fic pesticides. While 7175

many of the cited epidemiological studies have found associations with particular chemicals, they also 7176

provide valuable information about the potential impacts of chronic exposure in general. Evidence of 7177

elevated risk from a high

- qua lity cohort such as the AHS is a reasonable basis for taking preventative 7178

measures

. 7179

As a result of an extensive review of the epidemiologic evidence published in the peer

- reviewed 7180

literature, EPA concludes that there is strong evidence that pesticide exp osure contributes to adverse 7181

human health outcomes. The environmental epidemiology literature is growing rapidly, however, in 7182

terms of both quantity and quality of pesticide epidemiology studies. These illnesses were selected for 7183

discussion in the Economi c Analysis because they have been associated with pesticide exposures in 7184

studies that meet EPA’s data quality standards, and due to either the relative strength and plausibility of 7185

the hypothesized link, the number of studies available, or the relatively h igh prevalence of either the 7186

health outcome or a particular pesticide exposure. Overall, the totality of reported findings suggests 7187

long term health benefits from the rule, but, due to the state of scientific research and measures of 7188

chronic exposure at t his time, estimates of the quantitative benefits from the final rule are not possible. 7189

Comment . Other commenters suggested that current protections from label requirements are 7190

sufficient, and that EPA has not pointed to an increase in exposures or health e ffects which would justify 7191

the rule (1430, 1416, 4541, 1107, 1416). 7192

EPA Response . EPA has concluded that additional protections to workers, handlers and their 7193

families are warranted to supplement current label requirements. The changes to WPS will work 7194

t ogether to ensure that the label requirements provide their intended protections , to improve pesticide 7195

safety. Because of the nature of pesticide exposure, the possible latency of effects, and the 7196

underreporting of pesticide incidents, it is difficult to identify reliable trends in pesticide incidents, or to 7197

find precise estimates of the benefits of the WPS changes. The available evidence, however, is 7198

convincing to EPA that the rule changes will result in benefits from reduced illness sufficient to justif y 7199

the costs. 7200

Comment . One comment suggested that the evidence for health risks is weak, because the 7201

agricultural population is healthier than the general population. The cohort in the Agricultural Health 7202

Study has a lower frequency of cancers than the general population. (576). 7203Page 162 of 176 EPA Response . Although the cohort in the Agricultural Health Study is healthier than the general 7204

population by some measures, such as heart disease, there are specific cancers where the cohort has 7205

higher incidence of cancer. 7206

Comment . One commenter wrote to say that despite the difficulty in quantifying benefits, the 7207

likely increase in health, safety and the environment justify the rule under the precautionary principle 7208

(2349). 7209

EPA Response

. The FIFRA regulatory scheme of pre

- m arket review of pesticide products is 7210

inherently precautionary, however, it is not identical to the Precautionary Principle. Instead, the FIFRA 7211

regulatory standard is intended to prevent unreasonable risk to man or the environment, taking into 7212

account the economic, social, and environmental costs and benefits of the use of any pesticide . EPA is 7213

confident that the adverse effects targeted by the revisions to the WPS are unreasonable when 7214

compared to the costs associated with those revisions to the rule. 7215

Co mment . Several commenters wrote to suggest additional literature that reports an 7216

association between pesticide exposure and health risks, information on sources of exposure to 7217

farmworkers, handlers and their families, and research that shows the importance of occupational 7218

health and safety programs for protecting workers (2437, 2250, 4435, 182, 4586, 2376, 2305, 1965, 7219

4464, 99, 2050, 79). 7220

EPA Response . EPA thanks the commenters for this information. 7221

Comment . Several commenters who either provide health care for farmworkers or represent 7222

organizations that do, discuss their experience with farmworkers made ill by pesticide exposure, or the 7223

difficulties that farmworkers face in receiving health care (2315, 99, 4576, 4401). 7224

EPA Response . Thank you for this information. The WPS changes should reduce the exposure to 7225

agricultural pesticides, which will reduce the need for expensive medical care. 7226

Comment . One commenter suggested that the demographic profile of farmworkers in Hawaii is 7227

diffe rent than on the mainland, and that the risks of exposure based on the experience of mainland 7228

agriculture do not reflect risks on Hawaii (4534). 7229

EPA Response

. The demographic profile of farmworkers affects some requirements, like 7230

providing training in a ma nner that can be understood, but is not a factor in the risks of pesticide 7231

exposure. The basic protective requirements of pesticide labels and the WPS do not depend on the 7232

demographics of the worker. 7233

Comment . One commenter was concerned that EPA is prim arily concerned with risks to 7234

farmworkers, handlers and their families, while ignoring the potential effect on other rural residents 7235

such as babies, children, pregnant women, and those who are already ill or disabled, along with those 7236

taking medication, wh ich the European Union defines as a “vulnerable group” (1886). 7237

EPA Response . Although the WPS focuses on protecting workers and handlers , some revisions 7238

may also reduce the potential for exposure to bystanders, i.e., people not employed by the 7239

establish ment making a pesticide application provide protection to bystanders. There is mention of 7240

bystanders in the introductory material and in Chapter 4 of the Economic Analysis. See Units IX and 7241

XVIII.B for an explanation about how the WPS protects bystanders from being sprayed, directly or 7242

through drift, and the protections in WPS for people other than workers and handlers. 7243

Comment . One commenter requested information on EPA’s estimate of under

- reporting of 7244

pesticide incidents. 7245

EPA Response

. There are few st udies available that quantify the extent of underreporting, even 7246

though the existence of pesticide incidents that are not reported in surveillance databases is widely 7247Page 163 of 176 acknowledged. The discussion of the basis for underreporting estimates is provided in Se ction 4.5.2 of 7248

the Economic Analysis. 7249

Comment . One commenter suggested that there is vast under

- reporting of pesticide

- related 7250

illness among farmworkers, partly due to fear of employer retaliation and the absence of a national 7251

pesticide incident reporting system. Without reporting and basic protections, farmworkers and their 7252

families are at risk for both acute illness and long

- term health conditions associated with these 7253

exposures and from take

- home exposures (4418). 7254

EPA Response

. EPA agrees that under

- rep orting of pesticide incidents is substantial, and the 7255

WPS changes are intended to reduce the risks to farmworkers and their families. 7256

Comment . A commenter provided incident data on pesticide exposure and illness from 7257

Michigan, citing specific examples that the commenter suggests would have been prevented by the 7258

changes to the WPS (87). 7259

EPA Response

. Thank you for this information. Many of these incidents are similar to ones that 7260

were included in EPA’s review of incidents in SENSOR

- Pesticides from 2008 to 2011. The additional 7261

protections in the WPS should help prevent incidents like many of these, for situations that are within 7262

the scope of the WPS. 7263

Comment . Commenters suggested that the number of incidents reported is low, and most are 7264

do not result in h igh severity illnesses. The commenters also said that the number of incidents is small 7265

when compared to the amount of pesticides applied nationally, and that most pesticides are applied 7266

without incident (4549, 4561). 7267

EPA Response: EPA acknowledges that th e vast majority of pesticides are applied without 7268

significant adverse effects. However, there are risks from pesticide exposure, and there is evidence that 7269

exposures occur among agricultural workers at levels that can cause adverse effects. There are few 7270

studies available that quantify the extent of incident underreporting, even though the existence of 7271

pesticide incidents that are not reported in surveillance databases is widely acknowledged. 7272

Comment . A commenter reports that there is strong evidence that tracking pesticide illnesses in 7273

a longitudinal fashion has probably significantly reduced pesticide risks in a number of settings, over 7274

study intervals spanning a decade or more. The commenter encourages EPA to develop an improved 7275

database of pesticide i llnesses, and encourage state

- level databases of pesticide illness similar to 7276

California. As part of that database, a definition of “pesticide illness” is necessary, and the commenter 7277

recommends the term be defined broadly, to capture known and suspected pesticide illnesses. One 7278

commenter further notes that EPA is required under Section 20 of FIFRA to develop a national pesticide 7279

incident reporting system (30, 4452). 7280

EPA Response. EPA does maintain a database of reported pesticide incidents, the Incident Data 7281

System (IDS). In addition to the IDS and NPIC, EPA looks at a variety of other databases for pesticide 7282

incident information, such as those maintained by the American Association of Poison Control Centers, 7283

the National Institute for Occupational Safe ty and Health’s Sentinel Event Notification System for 7284

Occupational Risks (SENSOR) and California’s Pesticide Incident Surveillance Program (PISP). Each of 7285

these databases has differences in scope, and there is significant overlap, but collectively, they p rovide a 7286

useful perspective on pesticide exposure incidents. Given the availability of these databases, it is not 7287

clear that developing another EPA database or requiring all states to develop pesticide surveillance 7288

databases would produce information that is so much more reliable as to justify their costs. Requiring 7289

employers to track and keep records of all pesticide illnesses on the farm or handler establishment 7290

would be at least as expensive, and EPA is concerned that employers would not have the skill and 7291Page 164 of 176 information to record incidents reliably. More information on reporting pesticide incidents to EPA can 7292

be found here: http://www2.epa.gov/pesticide

- incidents. 7293

Comment . Commenters suggest that data from the SENSOR website suggests that there is no 7294

diff erence between pesticide incidents for hispanics and non

- hispanics, therefore the demographics of 7295

the farmworker population does not require rule changes, and that there is no evidence of increasing 7296

trends in pesticide incidents (1024). 7297

EPA Response

. The demographic profile of farmworkers affects some requirements, like 7298

providing training in a manner that can be understood, but is not a factor in the risks of pesticide 7299

exposure. The basic protective requirements of pesticide labels and the WPS do not dep end on the 7300

demographics of the worker. 7301

Comment . A commenter provided some statistics on the numbers of pesticide incidents that 7302

occur, both in the US and nationally, and the number that are treated in health care facilities. The large 7303

scale manufacture and use of pesticides can lead to many potential incidents (1). 7304

EPA Response

. Thank you for this information. 7305

Comment . A commenter suggests that EPA has not been successful in preventing pesticide 7306

incidents to date, and that the available data suggest that farmworkers face a much greater risk of 7307

pes ticide poisoning that other workers, and that the risks of long

- term illnesses are substantial (4452). 7308

EPA Response

. EPA disagrees that we have not been successful in preventing agricultural 7309

pesticide incidents. As discussed in the preamble in Unit IV.B.2 , the number of incidents has dropped 7310

substantially in the years since WPS was first promulgated. However, we agree that more can be done 7311

and these revisions to the WPS are intended to further reduce the number of incidents. 7312

Comment . A commenter notes th at EPA is unable to put a value on prevented chronic illnesses 7313

from pesticide exposure, and does not believe that estimating the value of prevented illness from the 7314

break

- even analysis is realistic (425). 7315

EPA Response

. EPA agrees that it is very difficul t to quantify the extent to which these WPS 7316

revisions will reduce chronic illness, but nevertheless, it is reasonable to expect that the revised WPS will 7317

reduce chronic illness among agricultural workers and handlers, and thereby make an important 7318

contribu tion to the long

- term health of workers, handlers and their families. The break

- even analysis 7319

acknowledges that exposure and risk information is unavailable to fully quantify the changes in chronic 7320

illness from the rule, while providing a way for the publ ic to understand the importance of potential 7321

changes in risks from pesticide exposure. More information on the break

- even approach can be found 7322

in Section 7.5.2 of the EPA Guidelines for Preparing Economic Analyses, available here: 7323

http://yosemite.epa.gov/ee/epa/eerm.nsf/vwAN/EE

- 0568

- 50.pdf/$file/EE

- 0568

- 50.pdf

. 7324

Comment . One commenter recommended an additional review of data from SENSOR

- Pesticides, 7325

state level incident data, and toxicology data from registrations with respect to specific questions. After 7326

completing such a review, EPA will have sufficient data to support the rule changes. The questions 7327

included were: How many illnesses were attributable to labe l violations? How many are attributed to 7328

poor training? How many incidents or illness are attributed workers forgetting training in the fourth, 7329

third year, or second year after their initial training? How often are these standards enforced? How 7330

many violat ions are reported and for what? Is the EPA registration process not providing enough safety? 7331

What percentages are attributed to each type of incident and what proposed rule change would inhibit 7332

this type of incident? 7333

EPA Response

. EPA has updated the ana lysis for the final rule using the most recent data from 7334

SENSOR

- Pesticides. For that task, the information in SENSOR

- Pesticides was reviewed, and estimates of 7335

reduced incidents from the rule changes include only incidents where the WPS applies, and only 7336Page 165 of 176 i ncidents where there was sufficient information for EPA to determine that the incident could have been 7337

prevented by the rule changes. The remaining questions, such as the number of incidents attributed to 7338

workers forgetting training in specific years, are unanswerable without records of training for incident 7339

investigators. Other questions, such as those concerning enforcement actions and recorded violations 7340

are unlikely to change EPA’s conclusions that changes to the WPS are warranted, which were based on 7341

the evaluation of available incident data along with information on the effects of chronic pesticide 7342

exposure. 7343

Comment . A commenter believes that the estimates of under

- reporting of pesticide incidents 7344

are in error and ambiguous. If true, this would nega te much of the quantified benefits from the rule 7345

(2971). 7346

EPA Response

. EPA benefit estimates from prevented acute pesticide incidents are based on the 7347

best available data collected by pesticide surveillance databases. There are few studies available that 7348

quantify the extent of underreporting, even though the existence of pesticide incidents that are not 7349

reported in surveillance databases is widely acknowledged. The discussion of the basis for 7350

underreporting estimates is provided in Section 4.5.2 of the Ec onomic Analysis. 7351

Comment . In the preamble to the proposed rule, EPA states that “changes to the current WPS 7352

requirements are expected to lead to an overall reduction in incidents of unsafe pesticide exposure and 7353

to improve the occupational health of the nation’s agricultural workers and pesticide handlers.” Yet a 7354

full reading of the rule shows that in the overwhelming majority of instances, the agency can identify no 7355

discernible or identifiable benefits that will result from the burdens and regulatory r equirements it 7356

proposes to impose on employers. 7357

EPA Response

. There are many changes to the WPS, and the changes work together to increase 7358

safety. For example the better communication of hazards works together with better training to ensure 7359

that farmworke rs and handlers know better how to protect themselves and their families. The changes 7360

also work together with pesticide labels to ensure that pesticides can be used safely. Because changes 7361

are meant to work together, and because it is impractical to test each of the element of the WPS is 7362

isolation, EPA cannot quantify the benefits of individual proposals. Because of the nature of pesticide 7363

exposure, the possible latency of effects, and the underreporting of pesticide incidents, it is difficult to 7364

find pr ecise estimates of the benefits of the WPS changes. The available evidence, however, is 7365

convincing to EPA that the rule changes will result in benefits sufficient to justify the costs. 7366

Comment . This shortcoming is nowhere more glaring than in the agency ’s failure to use 7367

relevant, recent information from the Sentinel Event Notification System for Occupational Risks 7368

(SENSOR) Pesticide Program. SENSOR currently contains information from eleven states and has data 7369

for pesticide exposures for the years 1998

- 2006, during which time approximately 5,200 cases of 7370

individuals with acute occupational pesticide

- related illness were identified. 7371

We have incorporated below three tables derived from the SENSOR website. These three tables 7372

break out instances of acute occ upational pesticide

- related illness estimates by severity of exposure for 7373

three categories: overall (Table 1); for Hispanics (Table 2); and for non

- Hispanics (Table 3). What is 7374

remarkable about all of them is the consistency they show. Trend lines do not indicate a worsening of 7375

pesticide exposures, either in numbers or severity. Perhaps more importantly, they appear to show no 7376

evidence between the types and severity of exposures between Hispanics (the predominant 7377

demographic for agricultural workers) and others. This runs counter to the agency’s assumption that 7378

the demographics of this population calls for stricter, tighter requirements on agricultural employers. 7379

EPA Response

. The demographic profile of farmworkers affects some requirements, like 7380

providi ng training in a manner that can be understood, but is not a factor in the risks of pesticide 7381Page 166 of 176 exposure. The basic protective requirements of pesticide labels and the WPS do not depend on the 7382

demographics of the worker. EPA notes that the data cited by th e commenter includes exposure 7383

incidents to all kinds of pesticides, although the WPS is limited to agricultural pesticides. 7384

Comment

. Assuming reductions in chronic illnesses caused by pesticide exposures resulting from 7385

labelled directions implies that EPA’s risk assessment and regulatory decision making processes are 7386

flawed

. This is not the case. The benefits

– i.e. the reductions in acute and chronic disease that EPA 7387

proposes, are inappropriately and unscientifically determined. 7388

EPA Response

. EPA produces robust assessments of the potential occupational risks to 7389

agricultural workers, considering the totality of known or predicted pesticide toxicities in the human 7390

population (based upon animal studies); the type, timing and duration of exposure (based upon 7391

registrant supported label uses and application practices); and the relationship between hazard and 7392

exposure, based upon the nature of the quantitative relationship and science policy (uncertainty 7393

factors). As a result of our assessments, EPA i s able to adequately determine that anticipated pesticide 7394

exposure in the occupational population is acceptable when label practices are followed, i.e., 7395

anticipated exposure does not exceed that which would result in an adverse health effect under label 7396

pr escribed conditions. However, EPA neither states that pesticide exposure anticipated among 7397

agricultural workers is absent (EPA aims to prevent unreasonable risk)), nor does the Agency predict risk 7398

to human health in hypothesized instances in which the labe l directions are not followed. Despite the 7399

efforts of pesticide registrants, growers and other members of the agricultural community to ensure 7400

label conditions are followed in practice, given the magnitude and scope of pesticide use in the U.S., 7401

some inten tional or unintentional misuse of pesticides may be inevitable. 7402

Comment

. EPA admits that quantifying disease reduction is impossible. Their method to 7403

determine benefit makes it impossible to determine whether or not the revisions have been successful, 7404

and thereby determine if the cost was warranted. By using chronic disease as a metric for success, EPA 7405

has created an ever moving target and an endless requirement for revisions to the WPS without 7406

measurable performance metrics. 7407

EPA Response

. EPA acknowledges its current inability to determine the number of illnesses that 7408

will be reduced by changes to the WPS. For the analysis of the changes to the WPS, EPA follows 7409

guidelines from The Office of Management and Budget 1 which suggest using a threshol d or “breakeven” 7410

analysis when quantification of monetary benefits is not possible. 7411

Comment

. Again, EPA authors have left out important data on trends, data which demonstrate (i) 7412

ongoing reductions in acute poisoning, (ii) that agriculture workers are actually healthier relative than 7413

their non

- farm worker peers, and (iii) which demonstrate significant improvements in farm worker 7414

demographics since 1992. 7415

EPA Response

. EPA’s analysis for the final rule has been updated with the most recent SENSOR 7416

data. EPA’s evaluation of the available incident data and information on the effects of chronic pesticide 7417

exposure led the Agency to conclude the changes were warranted. Much of the information about the 7418

health of the farm population is from the Agricultural Health Study. While the Agricultural Health Study 7419

cohort of certified pesticide applicators and their families have lower rates of many diseases, such as heart 7420

disease, th an the general population, the cohort has higher risk than the general public of other chronic 7421

diseases. The primary purpose of the rule, however, is to protect farmworkers, pesticide handlers and 7422

1 OMB Circular A

- 4: https://www.whitehouse.gov/omb/circulars_a004_a

- 4/Page 167 of 176 their families. EPA has little information about how the health of current and former agricultural workers 7423

compares to the general population or farm owners. 7424

Comment . It is unclear how the recommended training and record keeping will result in a 7425

quantifiable and measurable reduction in acute incidents or chronic illness, and in particular how these 7426

reductions

– on which the cost of these improvements are based

– can or will be measured. Without 7427

this, EPA will be unable to make a future assessment as to whether these proposed revisions, if 7428

implemented, have been effective and the money well spent. 7429

EPA Response

. There are many changes to the WPS, and the changes work together to increase 7430

safety. For example the better communication of hazards works together with better training to ensure 7431

that farmworkers and handlers know better how to protect themselves and thei r families. The changes 7432

also work together with pesticide labels to ensure that pesticides can be used safely. For these reasons, 7433

the benefits of individual proposals could not be estimated. Because of the nature of pesticide exposure, 7434

the possible late ncy of effects, and the underreporting of pesticide incidents, it is difficult to find precise 7435

estimates of the benefits of the WPS changes. The available evidence, however, is convincing to EPA that 7436

the rule changes will produce benefits sufficient to ju stify the costs. 7437

Comment

. The costs of additional training should reflect reductions in acute illnesses only, and 7438

reference to reducing chronic illness be removed as it is not supported by the scientific evidence, or by 7439

the EPA risk assessments that h ave been conducted on all the pesticide products currently on the market. 7440

EPA Response

. Despite continual efforts to improve safety, risks to farmworkers, handlers and 7441

their families remain. Epidemiology studies of chronic health risks, such as the Agri cultural Health Study 7442

are one of many lines of evidence that EPA used when considering the rule changes. EPA utilized the best 7443

available peer

- reviewed scientific information to qualitatively describe the potential chronic health 7444

effects of pesticide use. EPA has tried to be clear in the EA about uncertainties in assigning causality 7445

based on epidemiological studies and that the epidemiological results are suggestive, not conclusive, 7446

about links between specific pesticides. While many of the cited epidemiol ogical studies have found 7447

associations with particular chemicals, they also provide valuable information about the potential impacts 7448

of chronic exposure in general. Information from such a high

- quality cohort such as the AHS should not 7449

be dismissed. 7450

Com ment

. CropLife America (CLA) rejects th e implicit statement that the EPA has failed in its 7451

mandate to protect farm workers. CLA instead contends that a thorough and accurate evaluation of the 7452

alleged unreasonable adverse effects, through analysis of morb idity and mortality data, discredits the 7453

Agency’s underlying assumption that current exposures under the WPS present unacceptable acute and 7454

chronic health effects. Analysis of the illness data for agricultural workers suggest that the current WPS 7455

and othe r changes in pesticide practices since 1992 have lowered the level of morbidity and mortality, 7456

such that the proposed revisions, with their additional imposed burdens and costs to American 7457

agricultural, are unlikely to yield additional reductions. CLA con tends that a “modernization” of the 7458

existing WPS and associated training to reflect the reality that exists today is not sufficient to continue 7459

this downward trend in morbidity and mortality associated with acute pesticide exposures. 7460

EPA Response

. EPA's pe sticide registration, reregistration, and registration review processes 7461

assess the specific risks associated with the particular uses of individual pesticides to ensure that people 7462

and the environment do not suffer unreasonable adverse effects. EPA implem ents any risk reduction 7463

and mitigation measures that result from the pesticide reregistration and registration review programs 7464Page 168 of 176 through individual pesticide product labeling. In doing so, EPA assumes that the labeling is followed. 7465

Despite improvements in l abels, however, incidents continue to occur and these incidents can be 7466

serious. Moreover, the fact that avoidable incidents occur strongly suggests that applicators do not 7467

always follow use directions precisely. Given that reported incidents are (a) unde rreported, and (b) 7468

likely only be reported where there is an immediately notable adverse effect, it is reasonable to infer 7469

that workers and handlers experience repeated exposures that do not, by themselves, rise to the level 7470

of an identifiable incident. E PA has reviewed epidemiological studies, which are a type of retrospective 7471

analysis, that focus on pesticide applicators to better understand the potential impacts associated with 7472

such chronic exposure. While many of the cited epidemiological studies have sought to establish 7473

associations with particular chemicals, it is also significant that they indicate elevated risks of certain 7474

chronic illnesses are associated with exposure to pesticides in general. This may be the result of 7475

cumulative or synergistic e ffects of different pesticides. Although EPA could require pesticide registrants 7476

to generate studies on the vast number of pesticide combinations and exposure scenarios, the costs of 7477

such studies appears prohibitive. 7478

In the analysis for the Final Rule, E PA used the most recent available incident data to estimate 7479

the reduction in illness from the rule, and concluded that the changes in the rule were warranted. EPA 7480

can regulate prescribed pesticide use (i.e., enforce the pesticide label; the label is the l aw), however, 7481

EPA cannot regulate human exposure (which reflects unintentional accidents, human error, off

- label or 7482

misuse) to pesticides. The break

- even analysis demonstrates that avoidance of a small number of 7483

possible cases of pesticide induced chronic disease outweighs the costs imposed by these commonsense 7484

enhancements to the WPS. EPA believes it is good public health practice to amend the WPS for these 7485

reasons. 7486

Comment

. However, we question EPA’s assumption that only 25% of acute poisonings are 7487

reported, and that those which are under reported are sufficiently severe to incur a cost. EPA’s stated 7488

reason for under report ing is given as “many symptoms of pesticide poisoning, such as fatigue, nausea, 7489

dizziness and diarrhea may be confused with other illnesses and may not be reported by the workers as 7490

related to their occupational exposure. ” But is this really under reportin g, or is this because these 7491

symptoms are, in fact, caused by things other than pesticide exposure? Or is the under reporting a 7492

reflection of the symptoms not being severe enough to lead a worker to seek treatment, or prevent him 7493

from going to work? Without more information on the reasons why 75% of pesticide related illness goes 7494

unreported, it is not reasonable to assume

– as the EPA does

- lost wages and medical costs. In other 7495

words, increasing the cost burden associated with acute poisonings, based on an assumption of under 7496

reporting alone, is illogical and untenable. 7497

EPA Response

. EPA benefit estimates from prevented acute pesticide incidents are based on the 7498

best available data collected by pesticide surveillance databases. There are few studies available that 7499

quantify the extent of underreporting, even though the existence of pesticide incidents that are not 7500

reported in s urveillance databases is widely acknowledged. The discussion of the basis for 7501

underreporting estimates is provided in Section 4.5.2 of the Economic Analysis. This section details 7502

reasons why experts in the field consider occupational pesticide incidents, especially agricultural 7503

pesticide incidents to be underreported. A number of steps are necessary before a pesticide incident is 7504

recorded; a breakdown in any one of which would cause an unreported pesticide illness. These include 7505

(1) workers must perceiv e that they have treatable symptoms; (2) workers must seek medical attention; 7506

(3) the physician must diagnose the symptoms as being pesticide related; and (4) the physician or the 7507

injured person must report the incident to the correct recordkeeping system, and the incident must be 7508Page 169 of 176 recorded as pesticide related. There is another step whereby exposure incidents are not reported to 7509

the SENSOR

- Pesticides database used in this analysis. If a record does not meet the criteria for inclusion 7510

in a surveillance da tabase, it means that an exposure will not be recorded, reported and available for 7511

review. This fifth step can exclude many potential cases that would be relevant to evaluating the 7512

changes to the WPS. The information presented in Section 4.5.2 of the Eco nomic Analysis of the final 7513

rule has lead EPA to conclude that the underreporting estimates are reasonable. 7514

Comment

. Information from a number of sources could assist in determining (i) the real 7515

magnitude of the problem to be addressed and (ii) the most appropriate training requirements in order 7516

to address it. Sources include California PISP data, NPDS, NIOSH SENSOR data and often provide detailed 7517

accounts of the circumstances under which the incidents took place, thus allowing for better 7518

tailoring of WPS training needs. EPA should examine the nature of pesticide related incidents and 7519

illnesses and their causes in greater detail before deciding possible solutions to put forward. EPA should 7520

reference its own data on real life exposures and reference doses as part of its analysis of the WPS. 7521

EPA Response

. For the analysis of the final rule EPA used the most recent available data from 7522

SENSOR

- Pesticides, and was careful to only include incidents that could be prevented by the changes to 7523

the WPS. EPA has relied on the best currently available information on p esticide incidents, and 7524

considers it, in combination with the epidemiology literature on the effects of pesticide exposure to be 7525

sufficient justification to support the WPS revisions. 7526

Comment . The break even analysis suggests that the benefits are limite d to very few cases and 7527

reduced cancer and illness rates will be too small to be measured. This also means it will not be possible 7528

to judge whether the revised WPS have worked or not. The causal evidence between exposure to 7529

pesticides and the chronic dise ases cited has not been demonstrated. In light of the extensive controlled 7530

and laboratory studies available for individual pesticides the Agency should not be including cancer rates 7531

in their benefit analyses, even for illustrative purposes. Of great conce rn is a tacit admission that the 7532

Office of Pesticide Programs has failed in its primary mission under the Federal Insecticide, Fungicide, 7533

and Rodenticide Act (FIFRA) to only register a pesticide the Agency determines that when used in 7534

accordance with the l abel it will not generally cause unreasonable adverse effects to handlers and 7535

workers. Specifically CLA supports efforts of the WPS to comply with the label. 7536

EPA Response . EPA does not use the breakeven analysis to estimate the number of incidents of 7537

chron ic illness that will be reduced because of the changes to the WPS. The breakeven analysis was 7538

used to show that only a very small reduction in the number of chronic illnesses would equal the cost of 7539

the WPS. 7540

EPA ’s Economic Analysis presented information from epidemiology studies on the potential for 7541

adverse chronic health effects from pesticide exposure. EPA relied on t hese studies due to the relative 7542

strength of the hypothesis (plausibility), and the quality and quantity of the ep idemiological research in 7543

the human population, as well as other scientific information. These data (peer

- reviewed, published 7544

epidemiology studies) were reviewed by EPA in accordance with our stated data quality practices, and 7545

reflected in the qualitative conclusions of the chronic health benefits section. 7546

EPA understands the limitations with epidemiological literature. EPA concurs that it would be 7547

imprudent to characterize any of the statistical associations referenced in the chronic benefits section of 7548

t he EPA economic analysis of the WPS rulemaking between a specific pesticide exposure and a specific 7549

chronic disease outcome as causal in nature. For this reason, EPA repeatedly stated in the document 7550

that it is premature to make this conclusion for any spe cific pesticide

- disease association. But the 7551Page 170 of 176 absence of a pesticide

- specific conclusion does not diminish the significance of the association between 7552

specific chronic health problems and elevated exposure to pesticides generally. 7553

EPA produces robust chemi cal

- specific assessments of the potential occupational risks to 7554

agricultural workers, considering the totality of known or predicted pesticide toxicities in the human 7555

population (based upon animal studies); the type, timing and duration of exposure (based upon 7556

registrant supported label uses and application practices); and the relationship between hazard and 7557

exposure, based upon the nature of the quantitative relationship and science policy (uncertainty 7558

factors). As a result of our assessments, EPA is able to adequately determine that anticipated pesticide 7559

exposure in the occupational population is acceptable when label practices are followed, i.e., 7560

anticipated exposure does not exceed that which would result in an adverse health effect under label 7561

prescribe d conditions. However, registration does not signify the absence of pesticide exposure or 7562

pesticide risk among agricultural workers (EPA aims to prevent unreasonable risk), and the Agency does 7563

not routinely predict the full extent of the risk to human heal th in hypothesized instances in which the 7564

label directions are not followed. If all users scrupulously followed label requirements and the best use 7565

practices regarding training, notification, and hygiene at all times, acute poisoning incidents among 7566

occupa tionally exposed persons should be low and would only include accidents. However, acute 7567

poisoning surveillance databases suggest otherwise, indicating that further improvements are possible. 7568

Further, while difficult to capture in a pesticide surveillanc e database, it is possible that an 7569

accumulation of acute exposures over time could lead to long

- term health effects that are outside the 7570

scope of the studies EPA requires in support of registration . EPA considers the results of both acute 7571

poisoning survei llance data and chronic disease epidemiology studies to offer valuable insight into the 7572

actual risk in “real world” circumstances. EPA does consider the epidemiological findings presented in 7573

the WPS EA to be an important part of the body of evidence that supports the suite of proposed 7574

regulatory amendments that, taken together, will provide protections that will lead to an overall 7575

reduction in the burden of disease among the exposed population. 7576

This conclusion is qualitatively supported by evaluating the studies in which use of any pesticide 7577

or any member of a large group of pesticides such as organophosphates or pyrethroids have been 7578

positively associated in the literature with chronic disease. Furthermore, review articles and/or meta

7579

analytic results ev aluating all pesticides have also observed significant relationships, potentially 7580

suggesting a generalized role for pesticide exposure in the agricultural environment as a risk factor for 7581

disease. 7582

Comment

. CLA proposes that costs associated with revision s to the WPS can only be 7583

meaningfully balanced by reductions in the incidence of acute poisonings and that reference to chronic 7584

disease should be excluded from the cost estimates. The causal role of pesticides in chronic disease is 7585

unfounded and reductions in chronic disease due to reductions in chronic exposure are therefore 7586

unlikely and un

- measurable. Referencing chronic disease in the preamble becomes unnecessary and 7587

should be removed, or at least rebalanced by (i) using a scientific literature review that includes 7588

toxicological data as well as epidemiology data, and (ii) which follows recommended best practice 7589

including the EPA Office of Pesticide Programs recommendations and guidelines such as their 2010 7590

document “Incorporation of Epidemiology and Hum an Incident Data into Human Health Risk 7591

Assessment”, http://www.regulations.gov/#!docketDetail;D=EPA

- HQ

- OPP

- 2009

- 0851, or the Weight of 7592

Evidence process EPA follows when incorporating other scientifically relevant information into a risk 7593

assessment. 7594

EPA R esponse

. EPA disagrees with the commenter’s characterizations of the evidence of chronic 7595

illnesses associated with general pesticide exposure, and disagrees with the contention that such 7596Page 171 of 176 evidence may not be used to support regulatory action. In the econo mic analysis and preamble of the 7597

proposed rule, EPA explained the possible risks from chronic pesticide exposure, and discussed the peer

7598

reviewed, scientific literature exploring possible associations between chronic pesticide exposure and 7599

illness. In this process, EPA was careful to identify the relevant studies, and describe the possible 7600

associations in line with EPA’s Principles of Scientific Integrity (http://www.epa.gov/osa/pdfs/epa

7601

principles

- of

- scientific

- integrity.pdf). Much effort was expended to ensure that the cited studies were 7602

presented in such a way that the public could clearly understand any uncertainties that necessarily 7603

remain in such a field. These works were all from peer

- reviewed journals, and meet EPA standards for 7604

peer reviewed work (http://www.epa.gov/peerreview/pdfs/peer_review_handbook_2012.pdf). The 7605

WPS analysis was careful to note the difficulty of moving from epidemiological results indicating an 7606

association to the determination of a causal link between specific pesticide expos ures and chronic 7607

health effects. Only a subset of possible associations in the literature were included. Several other 7608

associations have been measured in the literature, and the ones selected for discussion in the WPS 7609

analysis were chosen due to either t he relative strength and plausibility of the hypothesized link, the 7610

number of studies available, or the relatively high prevalence of either the health outcome or a 7611

particular pesticide exposure. Also important to EPA is the role of describing potential r isks in a way 7612

that can be understood by both scientists and the general public while being clear about scientific 7613

uncertainty. To that end, OPP follows the standards in the EPA Science Policy Council Risk 7614

Characterization Handbook (http://www.epa.gov/spc/ pdfs/rchandbk.pdf), which provides guidance on 7615

how to achieve the goals of “transparency, clarity, consistency, and reasonableness” when conveying 7616

the risk assessors’ judgement to the public. For this purpose, the Agency also follows the EPA and OMB 7617

data quality guidelines. These include the EPA Office of Environmental Information Guidelines for 7618

Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by 7619

the Environmental Protection Agency: 7620

( http://www.epa.gov/quality/informationguidelines/documents/EPA_InfoQualityGuidelines.pdf ) as well 7621

as the Office of Management and Budget Guidelines for ensuring and maximi zing the quality, objectivity, 7622

utility, and integrity of information disseminated by federal agencies 7623

(http://www.whitehouse.gov/omb/fedreg/reproducible2.pdf). 7624

Whether evaluating data, analyzing EPA policy, or presenting results to the public, peer revie w 7625

plays an important role at OPP, where we follow the guidance in the EPA Science Policy Council Peer 7626

Review Handbook (http://www.epa.gov/peerreview/pdfs/peer_review_handbook_2006.pdf), and abide 7627

by EPA's Principles of Scientific Integrity (http://www.epa. gov/osa/pdfs/epa

- principles

- of

- scientific

7628

integrity.pdf). 7629

Comment . However, the preamble narrative implying an estimated number of chronic illnesses 7630

are linked to various pesticide exposures is not supported by scientific data and is in conflict with the 7631

A gency’s registration and reregistration review programs. 7632

EPA Response

. EPA has tried to be clear in the Economic Analysis and preambles to the 7633

proposed and final rule about uncertainties in assigning causality based on epidemiological studies and 7634

that the epidemiological results are suggestive, not conclusive, about links bet ween specific pesticides. 7635

While many of the cited epidemiological studies have found associations with particular chemicals, they 7636

also provide valuable information about the potential impacts of chronic exposure in general. Evidence 7637

of elevated risk from a high

- quality cohort such as the AHS is a reasonable basis for taking preventative 7638

measures. 7639

As a result of an extensive review of the epidemiologic evidence published in the peer

- reviewed 7640

literature, EPA concludes that there is strong evidence that pes ticide exposure contributes to adverse 7641Page 172 of 176 human health outcomes. The environmental epidemiology literature is growing rapidly, however, in 7642

terms of both quantity and quality of pesticide epidemiology studies. These illnesses were selected for 7643

discussion in t he Economic Analysis because they have been associated with pesticide exposures in 7644

studies that meet EPA’s data quality standards, and due to either the relative strength and plausibility of 7645

the hypothesized link, the number of studies available, or the re latively high prevalence of either the 7646

health outcome or a particular pesticide exposure. Overall, the totality of reported findings suggests 7647

long term health benefits from the rule, but, due to the state of scientific research and measures of 7648

chronic exp osure at this time, estimates of the quantitative benefits from the final rule are not possible. 7649

Comment . EPA has embraced the arguments and objectives of farmworker organizations, while 7650

apparently overlooking the input from actual state co

- regulators; ba sed many arguments on outdated 7651

worker demographics; and made unfounded assumptions regarding worker exposures and chronic 7652

illnesses, without supporting scientific evidence. Had the Agency cited current literature, it would have 7653

acknowledged significantly i mproved farmworker demographics and safety since 1992; a steep and 7654

ongoing reduction in incidents of acute poisoning; and a lack of evidence of elevated levels of chronic 7655

illnesses among farmworkers. EPA cites a reduction in such illnesses and associated r isks under the 7656

estimated benefits to the Proposed Rule, but admits it is “not able to quantify the benefits expected to 7657

accrue from the proposed WPS changes that would reduce chronic exposure to pesticides.” The PPC is 7658

very concerned that the assumptions and rhetoric of the Preamble discredit the rigor of EPA’s pesticide 7659

registration and registration review processes; overlooks the many advances in new pesticide products 7660

and application technologies made since 1992; and dismisses the extensive worker

- prote ction 7661

stewardship programs of states, registrants, professional applicators and agricultural producers. 7662

EPA Response

. For the final rule, EPA has updated the data on pesticide incidents, and updated 7663

the information on farmworker demographics. 7664

Despite conti nual EPA efforts to improve safety, risks to farmworkers, handlers and their 7665

families remain. Studies of pesticide risks, such as epidemiology studies, such as the Agricultural Health 7666

Study (AHS) are one of many lines of evidence that EPA used when consid ering the rule changes, and 7667

EPA utilized the best available peer

- reviewed scientific information to qualitatively describe the 7668

potential chronic health effects of pesticide use. EPA has tried to be clear in the EA about uncertainties 7669

in assigning causalit y based on epidemiological studies and that the epidemiological results are 7670

suggestive, not conclusive, about links between specific pesticides. While many of the cited 7671

epidemiological studies have found associations with particular chemicals, they also pr ovide valuable 7672

information about the potential impacts of chronic exposure in general. Information from such a high

7673

quality cohort such as the AHS should not be dismissed. 7674

As a result of an extensive review of the epidemiologic evidence published in the peer

- reviewed 7675

literature, EPA concludes that there is strong evidence that pesticide exposure contributes to adverse 7676

human health outcomes. The environmental epidemiology literature is growing rapidly, however, in 7677

terms of both quantity and quality of pes ticide epidemiology studies. These illnesses were selected for 7678

discussion in the Economic Analysis because they have been associated with pesticide exposures in 7679

studies that meet EPA’s data quality standards, and due to either the relative strength and pl ausibility of 7680

the hypothesized link, the number of studies available, or the relatively high prevalence of either the 7681

health outcome or a particular pesticide exposure. Overall, the totality of reported findings suggests 7682

long term health benefits from the rule, but, due to the state of scientific research and measures of 7683

chronic exposure at this time, estimates of the quantitative benefits from the final rule are not possible. 7684

Comment . A business advocacy organization asserted that EPA's statements about t he WPS 7685

reducing chronic diseases, and about pesticide exposure being associated with chronic disease, are 7686Page 173 of 176 inaccurate, misleading, unreliable, biased, and not based on reproducible studies. This commenter 7687

asserted that the studies and data supporting the b reak

- even analysis in the EA, and therefore the 7688

proposed rule, violate EPA’s IQA Guidelines and EPA’s other data requirements for pesticides. 7689

The commenter argues that there is no scientifically supportable correlation between general 7690

pesticide exposure, as currently regulated, and chronic disease, and that any chronic disease concerns 7691

are adequately addressed during pesticide registrations. Consequently, the commenter contends that 7692

there is no rational basis for counting reduction of chronic disease as a benefit of the WPS, and thus no 7693

rational basis for the Agency’s Economic A nalysis. 7694

The commenter also argues that EPA’s assumption of an association between chronic human 7695

disease and general pesticide exposure is irreconcilable with EPA’s conclusions dur ing FIFRA 7696

registrations that individual pesticides do not pose any significant risk of human chronic disease. The 7697

commenter argues that any chronic disease concerns are adequately addressed during pesticide 7698

registrations, and that the Economic Analysis th erefore ignores or contradicts EPA’s previous 7699

determinations in individual pesticide registration decisions. 7700

The commenter further argues that the Economic Analysis is also inconsistent with OMB 7701

guidance because it does not include a Monte Carlo Analysis o f Uncertainty, as required by OMB Circular 7702

A

- 4. 7703

EPA Response

. The commenter’s view of the Information Quality Act (IQA) is mistaken. EPA has 7704

fully adhered to the IQA and to both OMB’s government

- wide guidance and EPA’s own information 7705

quality guideline s (IQGs). 7706

The proposed and final WPS are each an ordinary exercise of the Administrator’s rulemaking 7707

authority pursuant to FIFRA section 25(a), typical of similar exercises of authority. In exercising that 7708

authority here, the Agency reasonably relied on reliable, objective evidence, including the best available 7709

science, consistent with Executive Order 13563. The thorough consideration provided by the public 7710

comment process serves the purposes of the Guidelines, by providing an opportunity for correction o f 7711

any information that does not comply with the Guidelines. Thus EPA’s actions in regard to the WPS 7712

revision are fully in accord with both the spirit and the letter of the IQA. 7713

EPA disagrees with the commenter’s contention that evidence of the association between 7714

general pesticide exposure and chronic health risks does not meet adequate standards of quality 7715

required by the IQGs, and as a consequence the Cost

- Benefit Analysis also fails to meet the IQGs . To the 7716

contrary, the evidence supporting t his a ction includes reliable, objective, peer

- reviewed studies showing 7717

well

- documented associations between pesticide exposure and certain cancer and non

- cancer chronic 7718

health effects. 7719

S tudies of pesticide risks, including epidemiology studies such as the Agricultural Health Study

, 7720

are one of many lines of evidence that EPA used when considering the rule changes . EPA presented 7721

information from epidemiology studies on the potential for adv erse chronic health effects from 7722

pesticide exposure. EPA utilized the best available peer

- reviewed scientific information to qualitatively 7723

describe the potential chronic health effects of pesticide use. 7724

In this process, EPA was careful to identify the re levant studies, and describe the possible 7725

associations in line with EPA’s Principles of Scientific Integrity (http://www.epa.gov/osa/pdfs/epa

7726

principles

- of

- scientific

- integrity.pdf). Much effort was expended to ensure that the cited studies were 7727

presented in such a way that the public can clearly understand and evaluate any uncertainties that 7728

necessarily remain. The cited literature were all from peer

- reviewed journals, and meet EPA standards 7729

for peer reviewed work (http://www.epa.gov/peerreview/pdfs/peer _review_handbook_2012.pdf). The 7730

WPS analysis was careful to note the difficulty of moving from epidemiological results indicating an 7731Page 174 of 176 association to the determination of a causal link between specific pesticide exposures and chronic 7732

health effects. Only a subset of possible associations in the literature were included. 7733

These studies were identified due to the relative strength of the hypothesis (plausibility), and 7734

the quality and quantity of the epidemiological research in the human population, as well a s other 7735

scientific information. These data (the peer

- reviewed, published epidemiology studies) were reviewed 7736

by EPA in accordance with our stated data quality practices, and reflected in the qualitative conclusions 7737

of the chronic health benefits section. The illnesses were selected for discussion in the Economic 7738

Analysis because they have been associated with pesticide exposures in studies that meet EPA’s data 7739

quality standards, and due to either the relative strength and plausibility of the hypothesized 7740

a ssociation , the number of studies available, or the relatively high prevalence of either the health 7741

outcome or a particular pesticide exposure. Overall, the totality of reported findings suggests long term 7742

health benefits from the rule, but, due to the st ate of scientific research and measures of chronic 7743

exposure at this time, estimates of the quantitative benefits from the final rule are not possible. 7744

EPA understands the limitations with epidemiological literature and does not characterize the 7745

statistical association in referenced studies as causal in nature. This conclusion is qualitatively 7746

supported by evaluating the studies in which use of “any pesticide” or “any member of a large group of 7747

pesticides such as organophosphate or pyrethroid” have been pos itively associated in the literature with 7748

chronic disease. Furthermore, review articles and/or meta

- analytic results evaluating “all pesticides” 7749

have also observed significant relationships, potentially suggesting a generalized role for pesticide 7750

exposure in the agricultural environment as a risk factor for disease. 7751

EPA has tried to be clear in the EA about uncertainties in assigning causality based on 7752

epidemiological studies and that the epidemiological results are suggestive, not conclusive, about 7753

associa tions between disease and specific pesticides. The environmental epidemiology literature is 7754

growing rapidly, however, in terms of both quantity and quality of pesticide epidemiology studies. Also 7755

important to EPA is the role of describing potential risks in a way that can be understood by both 7756

scientists and the general public while being clear about scientific uncertainty. To that end, OPP follows 7757

the standards in the EPA Science Policy Council Risk Characterization Handbook 7758

(http://www.epa.gov/spc/pdfs/ rchandbk.pdf) which provides guidance on how to achieve the goals of 7759

“transparency, clarity, consistency, and reasonableness” when conveying the risk assessors’ judgement 7760

to the public. For this purpose, the Agency also follows the EPA and OMB data qualit y guidelines. These 7761

include the EPA Office of Environmental Information Guidelines for Ensuring and Maximizing the 7762

Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection 7763

Agency: 7764

(http://www.epa.gov/quality /informationguidelines/documents/EPA_InfoQualityGuidelines.pdf) as well 7765

as the Office of Management and Budget Guidelines for ensuring and maximizing the quality, objectivity, 7766

utility, and integrity of information disseminated by federal agencies 7767

(http://w ww.whitehouse.gov/omb/fedreg/reproducible2.pdf). 7768

EPA disagrees with the commenter’s contention that any chronic disease concerns are 7769

irreconcilable with the registrations of the individual pesticides and are adequately addressed during 7770

pesticide registrati ons

. First, EPA requires applicants for registration to submit a wide range of data to 7771

support the registration, typically including several types of chronic toxicity studies. While the studies 7772

EPA does require generally provide a sufficient basis for th e Agency to draw reasonable conclusions 7773

about the likelihood of the pesticide causing chronic adverse effects, they are not sufficient to rule out 7774

the possibility that the pesticide may contribute to chronic effects under certain conditions. Second, 7775

EPA d oes not ordinarily require registrants to test for chronic effects resulting from simultaneous or 7776Page 175 of 176 sequential exposure to multiple pesticides, with other environmental stressors that may be present in 7777

agricultural situations, or with genetically susceptible sub

- populations. Relatively little is known about 7778

the cumulative or synergistic effects of different pesticides, but such effects may be a factor in the 7779

elevated incidence of certain chronic illnesses observed in epidemiology studies of farm populations, 7780

like the Agricultural Health Study. In most cases, EPA’s registration decisions are not designed to protect 7781

agricultural workers against cumulative or synergistic effects of different pesticides unless they have a 7782

common mechanism of action. Thus, the W PS provisions work in concert with the individual labels to 7783

generally reduce and mitigate multiple pesticide exposures. Third, the fact that a pesticide is registered 7784

does not mean that it poses no chronic risk when used according to the label. The FIFRA registration 7785

criteria do not set a zero risk standard; instead, FIFRA only requires that a pesticide not generally cause 7786

unreasonable adverse effects, taking into account the economic, social, and environmental costs and 7787

benefits of its use. As a result, it is to be expected that registered pesticides will cause some measure of 7788

adverse effects including as chronic illnesses. These adverse effects would be greater in both frequency 7789

and severity without the general workplace practices , precautions, and hyg ienic measur es mandated by 7790

the WPS. 7791

EPA disagrees with the commenter’s contention that Circular A

- 4 requires a Monte Carlo 7792

a nalysis

. EPA notes that the annual costs associated with the WPS revisions are well below those for 7793

which Circular A

- 4 requires a formal quantitative analysis of uncertainty: “For rules that exceed the $1 7794

billion annual benefits or costs, a formal quantitative analysis of uncertainty is required. For rules with 7795

annual benefits or costs in the range from $100 million to $1 billion, ag encies should seek to match the 7796

more rigor of their approach with the magnitude of a rule’s consequences.” OMB Circular A

- 4, p. 41. 7797

The WPS EA was reasonable and appropriately rigorous for the magnitude of the rule’s consequences. 7798

In any case, a Monte C arlo simulation would not be an appropriate tool in this situation. EPA 7799

acknowledges that there are no estimates of reduction in exposure for the multitude of potential 7800

chemical combinations, nor estimates of a dose

- response curve between general pesticid e exposure and 7801

incidence of various chronic disease. The break

- even analysis itself is a tool for understanding the level 7802

of uncertainty by estimating the minimum number of cases of chronic illness that must be avoided to 7803

equal the cost of the rule. 7804

XXI. References 7805

The following is a listing of the documents that are specifically referenced in this document. 7806

1. EPA. Economic Analysis of the Agricultural Worker Protection Standard Revisions . Washington, 7807

D.C. 2015. 7808

2. EPA. Pesticides; Agricultural Worker Protection Standard Revisions; Proposed Rule. Federal 7809

Register ( 79 FR 15444, March 19, 2014) (FRL

- 9395

- 8). 7810

3. EPA. Final Report: Small Business Advocacy Review Panel on EPA Planned Revisions to Two 7811

Related Rules: Worker Protection Standard for Agri cultural Pesticides (RIN 2070

- AJ22); and Certification 7812

of Pesticide Applicators (RIN 2070

- AJ20). November 3, 2008. 7813

4. EPA. Response to Comments on Proposed Changes to the Worker Protection Standard. 2015. 7814

5. U.S. Senate. S. Rep. No. 92

- 883 (Part II), 92 nd Congress, 2nd Session at 43

- 46 (1972). U.S. 7815

Code Congressional and Administrative News 1972, p. 4063. 7816

6. DOL. 2011

- 2012 NAWS data

- public set. http://www.doleta.gov/agworker/naws.cfm#d

- files. 7817

Retrieved April 24 2015. 7818

7. USDA Economic Research Servi ce. Kandel, W. Profile of Hired Farmworkers, A 2008 Update. 7819

Economic Research Report No. 60. U.S. Department of Agriculture. Economic Research Service. 2008. 7820

8. EPA. Worker Protection Standard: A Summary of the Public's Comments and the Agency's 7821Page 176 of 176 Response. 1992. 7822

9. Burke, L., Hutchins, H. " A Study of Best Practices in Training Transfer and Proposed Model of 7823

Transfer." Human Resource Development Quarterly. Vol. 19 no. 2 , Summer 2008. 7824

10. Calvert, et al, 2008. “Acute pesticide poisoning among agricultural workers in the United 7825

States, 1998

- 2005.”American J Ind Med 51, no. 12: 883

- 898. December 2008. 7826

11. Kasner, et al . "Gender differences in acute pesticide

- related illne sses and injuries among 7827

farmworkers in the United States, 1998

- 2007. American J Ind Med 55, no. 7: 571

- 583. July 2012. 7828

http://onlinelibrary.wiley.com/doi/10.1002/ajim.22052/full. Retrieved April 24, 2015. 7829

12. Lee, S

- J, Mehler, L, Beckman, J, Diebolt

- Brow n, B, Prado, J, Lackovic, M, et al. “Acute Pesticide 7830

Illnesses Associated with Off

- Target Pesticide Drift from Agricultural Applications.” Environ Health 7831

Perspect 119:1162

- 1169. 2011. 7832

13. EPA. Response to “Pesticides in the Air

– Kids at Risk: Petition t o Protect Children from 7833

Pesticide Drift (2009)." 2014. 7834

14. EPA. Economic Analysis of the Proposed Agricultural Worker Protection Standard Revisions

. 7835

Washington, D.C. 2014. 7836

15. EPA. USDA Comments on the Draft Final Agricultural Worker Protection Standard Revision 7837

Rule and EPA Responses. 2015. 7838

16. EPA. Pesticides; Procedural Regulations for Registration Review; Final Rule. Federal Register 7839

(71 FR 45720, August 9, 2006) (FRL

- 8080

- 4). 7840

17. OSHA. Hazard Communication; Final Rule. Federal Register (77 FR 1757 4, March 26, 2012). 7841

18. EPA. Worker Protection Standards for Agricultural Pesticides; Proposed Rule. Federal 7842

Register (53 FR 25970, July 8, 1988) (FRL 3314

- 4). 7843

19. OSHA. Hazard Communications Standard; Proposed Rule. Federal Register (53 FR 29822, 7844

August 8, 1988). 7845

20. EPA. Worker Protection Standard; Hazard Information; Proposed Rule. Federal Register (57 7846

FR 38167, August 21, 1992) (FRL

- 3793

- 1). 7847

21. EPA. Pesticides; Final Guidance for Pesticide Registrants on Web

- Distributed Labeling; Notice 7848

of Availability. Federal Register (79 FR 18908, April 4, 2014) (FRL

- 9905

- 60). 7849

22. EPA. Pesticide Management and Disposal; Standards for Pesticide Containers and 7850

Containment; Final Rule. Federal Register (71 FR 47330, August 16, 2006) (FRL

- 8076

- 2). 7851

23. EPA. Information Collection Request Supporting Statement: Agricultural Worker Prot ection 7852

Standard Training and Notification (Final Rule)

. EPA ICR No. 2491.02 and OMB Control No. 2070

- 0190. 7853

2015. 7854

24. ERS. 2014. Farm Labor, Number and Geographical Distribution of Hired Farmworkers. 7855

Economic Research Service, U.S. Department of Agricult ure. Updated October 30. 7856

http://ers.usda.gov/topics/farm

- economy/farm

- labor/background.aspx#Numbers. 7857