*** EO12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review***

March 31, 2015 Page 1 of 9 

## EPA’s Responses to a Summary of USDA’s Comments on the Draft Notice of

Proposed Rulemaking & Economic Analysis

EO12866_Rin2070

‐ AJ20_PesticideCertApp_NPRM_EPA Responses to USDA_NPRM&EA_2015

‐ 03

‐ 31.docx

Summary of Comments on the Draft Notice of Proposed Rulemaking (NPRM) 1

1. USDA Comment : USDA included line edits to the text of the NPRM. 2

EPA Response : EPA has reviewed the comments embedded in the Notice of Proposed 3

Rulemaking (NPRM). Where appropriate, EPA has incorporated USDA’s suggested changes. A 4

copy of the NPRM showing all changes made to the documents sent to USDA for review are 5

included have been provided to USDA.. 6

7

2. USDA Comment : USDA raised concerns that the certification rule impinges on sovereign immunity 8

and requested information on what statutory provision requires development and implementation of 9

Government Agency Plans or federal agency certification plans. USDA also inquired about the specific 10

statutory authority that would allow EPA to codify the existing policy related to federal agency 11

certification programs. 12

EPA Response : The Federal Insecticide, Fungicide and Rodenticide Act requires the certification 13

of applicators of Restricted Use Pesticides (RUPs), regardless of where in the United States the 14

RUPs are used or by whom. 7 U.S.C. 136a(d) and 136i. EPA may either approve a plan submitted 15

by a state (under FIFRA, “state” means a State, the District of Columbia, the Commonwealth of 16

Puerto Rico, the Virgin Islands, Guam, the Trust Territory of the Pacific Islands, and American 17

Samoa, 7 U.S.C. 136(aa)) that meets the requirements established in FIFRA and under EPA’s 18

regulations, 7 U.S.C. 136i(a)(2) or EPA may administer a plan directly in states where no 19

certification plan is in effect. 7 U.S.C. 136i(a)(1). Thus, the purpose of the 40 CFR 171 is to 20

provide mechanisms to enable would

‐ be users of RUPs to obtain the certifications necessary for 21

them to comply with the requirements of FIFRA. 22

In developing the existing regulations at 40 CFR 171, EPA noted that employees of 23

federal agencies might apply RUPs in multiple state jurisdictions, and might therefore need to 24

obtain certifications from multiple states. At EPA’s discretion and as an accommodation to 25

federal agencies, EPA included in the existing regulation a provision that allows federal agency 26

employees to be certified under a single federal agency plan. Further, recognizing that a single 27

federal government

‐ wide plan would not meet the needs of the various agencies, EPA 28

developed a policy that allowed each federal agency to develop its own plan for certifying 29

pesticide applicators. Both the government agency plan option and subsequent policy related 30

to federal agency certification require federal employees to satisfy any additional requirements 31

for each state in which they use RUPs because any state that has jurisdiction to administer its 32

own certification program has jurisdiction over anyone applying RUPs within the state. 33

34

3. USDA Comment : USDA noted many places in which states are already doing what EPA is proposing in 35

this action. 36

EPA Response : EPA recognizes that states have taken various actions in most areas in which EPA 37

is proposing to change the rule. However, action at the individual state level only affects the 38

certification program within that state. EPA is proposing changes that would improve the 39

certification program and competency of RUP applicators nationally. EPA did consider the 40

actions taken by states when developing the changes proposed in this rulemaking. 41

42*** EO12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review***

March 31, 2015 Page 2 of 9 4. USDA Comment : USDA asked whether independent databases (e.g., Agrian, CDMS) have data on the 43

relative usage of RUPs vs. general use or unclassified pesticides. 44

EPA Response : Data on RUP usage is hard to gather because the decision on whether to restrict 45

a product is made at the product level, while most usage data is available at the active 46

ingredient level. Some data is available relative to usage of active ingredients that may have 47

products that are RUPs in agriculture. However, similar data is not available outside of 48

agriculture. EPA is not aware of data from Agrian or CDMS that would provide information on 49

the relative usage of RUPs versus general use or unclassified pesticides across all application 50

sites. 51

5. USDA Comment : USDA questioned EPA’s assertion that most of the estimated 800,000 farms that 52

might be impacted by the proposed rule are unlikely to apply RUPs. 53

EPA Response : EPA changed “most” to “about half.” According to the 2007 Census of 54

Agriculture, almost 860,000 small farms (gross revenue < $750,000) use pesticides. Including 55

large farms (revenue > $750,000), there are almost 920,000 farms that use pesticides. EPA data 56

show about 480,000 private applicators and some, particularly large farms, may have more than 57

one certified applicator. Using this information, EPA estimated about 400,000 private 58

applicators on the 860,000 small farms, meaning just under half of the small farms would be 59

affected by the proposed rule. 60

6. USDA Comment : Isn’t a person who passes the core exam for commercial applicators to qualify as a 61

noncertified applicator (using RUPs under the direct supervision of a certified applicator) actually 62

considered a certified applicator? Who can administer training or exam for noncertified applicators? 63

EPA Response : No, taking the core exam for commercial applicators alone would not qualify 64

anyone as certified to apply RUPs without direct supervision by a certified applicator. The core 65

exam for commercial applicators is one element of commercial applicator certification; the 66

person seeking certification as a commercial applicator must pass the core exam and an exam in 67

at least one category in which he or she intends to apply RUPs. Passing the core exam for 68

commercial applicators is also not sufficient to certify a person as a private applicator. To 69

become certified as a private applicator under the proposal, a person must either pass the exam 70

for private applicators, which covers content from the commercial core exam plus information 71

on pesticide use in agriculture, or must attend a training covering content outlined in the 72

proposed rule. Therefore, passing the core exam for commercial applicators alone is not 73

sufficient to qualify a person as either a private or commercial applicator. 74

EPA is proposing to allow noncertified applicators to be trained by certified applicators, 75

persons designated by the state as a trainer of applicators, or persons who have completed a 76

train

‐ the

‐ trainer program under the Worker Protection Standard (WPS). EPA is also proposing 77

that each certifying authority may designate who can train noncertified applicators, giving each 78

certifying authority discretion to adopt requirements more stringent than what is included in 79

EPA’s proposed regulations related to the qualifications of persons as noncertified applicators. 80

Whether the training for a noncertified applicator conducted in one jurisdiction could be carried 81

over into another jurisdiction would depend on the relationship between the two jurisdictions. 82

For example, in some cases training conducted in state A would not be valid in state B if state B 83

does not permit anyone who is not a certified applicator to use RUPs (i.e., no RUP use under the 84

direct supervision of a certified applicator). 85*** EO12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review***

March 31, 2015 Page 3 of 9 Unlike EPA’s proposal to allow a variety of persons to conduct training for noncertified 86

applicators, only the certifying authority that administers exams for applicator certification 87

would be permitted to administer the core exam for noncertified applicators. 88

89

7. USDA Comment : How does the minimum age for commercial, private, and noncertified applicators 90

affect family farms? Compare this proposal with the immediate family exemption in the Worker 91

Protection Standard (WPS). 92

EPA Response : There is no “family farm” provision in the Certification rule. FIFRA requires all 93

persons using RUPs to be certified, whether using them on their own property or using them 94

commercially. Any minimum age requirement would apply to any person using an RUP, 95

regardless of the circumstances or location of the use. RUPs pose elevated risks to the health of 96

the applicator, the target site, bystanders, and the environment whether used on a family farm 97

or in a commercial setting. 98

The WPS has a provision that exempts the owner of a farm or any of his or her 99

immediate family members (as defined by the rule) from many provisions of the WPS, including 100

the proposed minimum age provision; employees on “family farms” who are not immediate 101

family members of the owner are covered by all applicable provisions of the WPS. The WPS is 102

designed to protect agricultural workers and handlers from occupational pesticide risk. No 103

parallel exemption exits for the Certification rule because its intended protections are broader 104

and the Certification rule deals with pesticides that EPA has determined need to be applied only 105

by qualified persons in order to avoid unreasonable adverse effects to human health and the 106

environment. 107

108

8. USDA Comment : USDA expressed concerns that states that require private applicators to pass an 109

exam violate FIFRA’s prohibition against requiring private applicators to take an exam. 110

EPA Response : FIFRA allows states to regulate the sale or use of any registered pesticide, but 111

only if and to the extent the regulation does not permit any sale or use prohibited by FIFRA and 112

not impose or continue in effect any requirements for labeling or packaging in addition to or 113

different from those required under FIFRA. 7 USC 136v. Therefore it is permitted under FIFRA 114

for a state to enact a law under its own inherent police powers to require private applicators to 115

take a written examination as a precondition for certification. 116

117

9. USDA Comment : USDA requests that EPA make allowances to the proposed minimum age 118

requirement for youth training programs where persons who do not meet the minimum age work under 119

the direct supervision of a certified applicator and for educational programs for youth in high school. 120

EPA Response : EPA recognizes USDA’s interest in youth training and educational programs. EPA 121

is requesting comment on USDA’s suggestion; however, EPA did not revise the proposal related 122

to establishing a minimum age for users of RUPs to allow an exception to the age requirement 123

for participants in these programs. The proposal establishes a minimum age to protect the 124

health of adolescents as well as to ensure that RUPs are handled by persons who have 125

developed judgement and maturity in order to handle these higher

‐ risk products in a manner 126

that would not cause unreasonable adverse effects on human health or the environment. 127

Participants in such programs have several other options to learn about proper use and 128

handling of pesticides without access to RUPs. For example, they can practice using application 129

equipment with a non

‐ pesticide liquid (e.g., colored water). Alternatively, they can have hands

‐ 130

on experience with pesticide application, such as mixing and loading pesticides, calculating the 131

amount of pesticide needed, calibrating equipment, and making applications, with non

‐ RUP 132

pesticides. 133*** EO12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review***

March 31, 2015 Page 4 of 9 See also EPA’s response to Comment 1 of USDA’s Comments on the Proposed Rule. 134

135

10. USDA Comment : Regarding the proposed elimination of the option for limited certification for 136

persons who cannot read and are seeking private applicator certification: the WPS requires pesticide 137

training to be offered in the language commonly spoken by the worker. How does the implementation 138

of this provision coordinate with the WPS? Would a requirement limiting certification of private 139

applicators to those who speak English affect how much they charge for their services? 140

EPA Response : The Worker Protection Standard (WPS) is designed to protect agricultural 141

workers and handlers from occupational risks associated with pesticides. The Certification rule 142

establishes competency standards for persons to be certified to use RUPs

– both private 143

applicators (farmers) and commercial applicators (for

‐ hire and government)

– and outlines how 144

certification programs can be administered. These separate regulations address different 145

populations who bear significantly different responsibilities and who face

– and contribute to

– 146

significantly different levels of risk. There is some overlap between the WPS and the 147

Certification rule, e.g., a person covered as a handler under the WPS could be using an RUP 148

under the direct supervision of a certified applicator and therefore covered by the training 149

requirement of both rules. The WPS requirements related to training (e.g., training must be 150

provided in a manner the worker or handler understands) do not apply to applicators seeking 151

certification under this rule. There is no requirement in the certification rule, current or 152

proposed, that requires persons seeking private applicator certification receive instruction in a 153

manner they understand. 154

A private applicator must be competent to use an RUP in a manner that will not cause 155

unreasonable adverse effects to human health or the environment. A critical element of safe 156

pesticide use is reading, understanding, and following the pesticide labeling. EPA specifies that 157

the private applicator must be competent to read, understand and follow the labeling, but 158

leaves it to the certifying authority to determine competency

– whether through a training 159

program, written exam, combination, or other mechanism. States also have discretion about the 160

language in which training or exams are offered, but EPA’s registration eligibility decisions for 161

RUPs are contingent upon the presumption that the applicator can read and follow pesticide 162

labeling. EPA requires labeling to be available in English and permits registrants to make labeling 163

available in other languages at their discretion. 164

The proposed change to eliminate the option for limited certification for persons who 165

cannot read should not impact the amount that private applicators charge to make applications. 166

By FIFRA’s definition, a private applicator can only make applications for producing an 167

agricultural commodity to his or her own property, the property of his or her employer, or on 168

the property of another only if applied without compensation other than trading of personal 169

services between producers of agricultural commodities. Private applicators cannot charge to 170

apply pesticides as a service

– that would make them commercial applicators. Private 171

applicators may earn wages to apply RUPs to the land of their employers. EPA does not 172

anticipate that the wages of private applicators making RUP applications on their employers’ 173

property would be affected by this proposal. Private applicators will not be able to charge more 174

to make applications to others’ (non

‐ employers’) property because such applications cannot be 175

made for compensation. 176

177

11. USDA Comment : USDA noted that both the proposed rule and current regulation only list 10 178

categories of certification for commercial applicators, while EPA says that there are 11. 179

EPA Response : EPA has clarified the preamble to note that there are 10 numbered federal 180

categories of certification. EPA and other certifying authorities may sometimes refer to 11 181*** EO12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review***

March 31, 2015 Page 5 of 9 categories of certification if the two subcategories under agricultural pest control are counted as 182

individual categories. Considering these categories as separate brings the total number of 183

categories to 11. 184

185

12. USDA Comment : USDA asked whether the proposed rule would incorporate reciprocity, such that an 186

applicator taking an exam in one jurisdiction would not have to retake the same exam in a second 187

jurisdiction to be certified in the second jurisdiction. Is EPA developing a standardized, nation

‐ wide 188

exam system? 189

EPA Response : While EPA is not proposing mandatory reciprocity between jurisdictions, EPA is 190

proposing new requirements that promote reciprocity. States have raised differences in 191

administration of both exams and recertification programs, as well as the recertification period, 192

as barriers to issuing reciprocal certifications. However, the proposed exam security standards 193

(i.e., photo identification and proctored, closed

‐ book exams), and minimum standards and 194

length for recertification should facilitate more reciprocity between states where they have the 195

same/a similar category. Further, EPA is proposing to require state certification plans to outline 196

whether, and under what circumstances, the state would recognize a certification issued by 197

another jurisdiction. 198

EPA is also not proposing to develop a standardized, nation

‐ wide exam system. EPA is 199

committing to support development of certification exams and training materials for federal 200

categories that can be used directly or adapted and used by states, tribes, and federal agencies. 201

These resources will be available for use by any entity administering a certification program, but 202

not required. 203

204

205

Summary of Comments on the Economic Analysis 206

13. USDA Comment : USDA included line edits to the text of the Economic Analysis. 207

EPA Response : EPA has reviewed the comments embedded in the Economic Analysis (EA). 208

Where appropriate, EPA has incorporated USDA’s suggested changes. A copy of the EA showing 209

all changes made to the documents sent to USDA for review are included have been provided to 210

USDA. 211

212

14. USDA Comment: Did EPA consult youth

‐ training programs? USDA would appreciate the impact of 213

its impact/non

‐ impact of this proposal on youth training programs for pesticide applications. 214

EPA Response: EPA did not consult any youth

‐ training programs in the development of this 215

proposal. EPA considered the impact of the proposal on those who may use RUPs as certified 216

applicators or noncertified applicators working under the direct supervision of certified 217

applicators. EPA has amended the NPRM to request comment on the impact of the minimum 218

age proposals on youth

‐ training programs specifically. 219

220

15. USDA Comment: Which groups representing noncertified applicators and growers were approached 221

for feedback? Were they asked specifically regarding each proposed change in this proposed rule? 222

What feedback was received? 223

EPA Response: EPA had formal and informal meetings with stakeholders related to this 224

potential rulemaking. Formal engagement included meetings held as part of the National 225

Assessment of the Worker Safety Program, the Small Business Advocacy Review Panel and the 226

Pesticide Program Dialogue Committee Worker Safety Regulations Workgroup. The feedback 227

from these groups is included in the docket. EPA also met with other groups informally. EPA did 228

not meet with any groups that represent only noncertified applicators. 229*** EO12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review***

March 31, 2015 Page 6 of 9 While EPA did not ask any group specifically about each proposed change, EPA did 230

discuss potential areas of change generally. EPA is requesting specific feedback on each area of 231

proposed change during the public comment period. 232

233

16. USDA Comment: USDA requested a copy of the National Assessment of the Worker Safety Program. 234

EPA Response: EPA provided this document to USDA; it is also available at 235

http://www.epa.gov/pesticides/safety/2005/workersafety

‐ assessrpt.pdf

. 236

237

17. USDA Comment: EPA’s wage estimates seem to support BLS figures. But should NASS data be used, 238

or are BLS data based on NASS data? 239

EPA Response: For the cost analysis, EPA used national average wage rates from BLS that 240

specifically relate to pesticide applicators. NASS does not report wage rates specifically for 241

pesticide applicators working on farms nor does NASS report wages for commercial applicators 242

who work in the non

‐ agricultural sectors. In order to make the cost analysis consistent, EPA 243

used private and commercial applicators from a single source, BLS. 244

245

18. USDA Comment: Because a number of states have developed certification requirements for soil 246

fumigants, it might be instructive to compare the costs incurred by those states and industry to EPA’s 247

estimates for states currently without training requirements for commercial and private applicators. 248

EPA Response: EPA will consider comparing the costs incurred by states and by industry related 249

to the new requirements on soil fumigant labeling with EPA’s estimated costs for adding a soil 250

fumigation category. EPA has amended the NPRM to request feedback on the costs associated 251

with developing certification requirements for soil fumigants. However, EPA has not revised the 252

EA for this proposed rule with this information. EPA will consider all available information 253

before issuing a final rule. 254

255

19. USDA Comment: USDA requested a cost analysis on family farms. 256

EPA Response: As EPA understands USDA’s concerns, USDA is requesting a cost analysis on 257

family farms to determine the impact that the proposal would have on these entities. The only 258

area of the rule in which USDA has requested EPA to consider different treatment of family 259

farms is related to the proposals to establish a minimum age to be a certified applicator or to 260

use RUPs under the direct supervision of a certified applicator. EPA has prepared a cost analysis 261

on family farms related to the minimum age provisions. See Private Age

‐ 03: Minimum Age of 262

18; Minimum Age of 16 for Family Members for Certified Private Applicators and Private Age

‐ 06: 263

Minimum Age of 18; Minimum Age of 16 for Family Members for Noncertified Applicators in 264

Appendix A to the EA for the detailed cost analysis for family members working on their farms. 265

266

20. USDA Comment: The assumption that private applicators of RUPs can be as young as 14 would be in 267

contrary to the Fair Labor Standard Act, its regulations and state laws for acutely toxic pesticides. As EPA 268

stated in the draft FRN, “The Fair Labor Standard Act’s child labor provisions, which are administered by 269

the Department of Labor, permit children to work at younger ages in agricultural employment than in 270

non

‐ agricultural employment. Children under 16 years old are prohibited from doing hazardous tasks in 271

agriculture, including handling or applying acutely toxic pesticides.” 272

EPA Response: The Fair Labor Standards Act has a parental exemption for youth employed in 273

agriculture. This exemption permits a youth under the age of 16 to perform any work if he or 274

she is employed “by his parent or by a person standing in the place of his parent on a farm 275

owned or operated by such parent or person.” 29 U.S.C. 213(c)(2). 276*** EO12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review***

March 31, 2015 Page 7 of 9 Based on this statutory exemption from the FLSA’s minimum age for hazardous work in 277

agriculture, EPA included an assumption that private applicators could be as young as 14 years 278

old although it might result in an overestimation of the costs. 279

280

21. USDA Comment: Are the costs for changing state laws included in the estimated costs of Admin

‐ 02: 281

Revise State Regulations and Update Plans? 282

EPA Response: Yes, Admin

‐ 02 includes these costs. The estimation includes the staff time to 283

change state laws and to update certification plans. 284

285

22. USDA Comment: How was $3,000 arrived at as the estimation for federal agencies to change their 286

certification plans (Admin

‐ 02)? 287

EPA Response: The cost to federal agencies was estimated based on the time needed to update 288

the certification plans. The costs to states includes updating certification plans and working 289

through legislative and/or regulatory change in order to have the legal authorities in place to 290

submit a revised certification plan for EPA approval. EPA is not aware of any federal agencies 291

that would need to effectuate regulatory or legislative changes in order to update their 292

certification plans. 293

294

23. USDA Comment: USDA suggests that NASS data be used for calculating the wage rates for 295

commercial applicators, while EPA cites BLS data. Was the BLS data used derived from NASS? 296

EPA Response: The BLS data cited in the EA was not derived from NASS. For the cost analysis, 297

EPA used national average wage rates from BLS that specifically relate to pesticide applicators. 298

NASS does not report wage rates specifically for pesticide applicators working on farms nor does 299

NASS report wages for commercial applicators who work in non

‐ agricultural sectors. For the 300

cost analysis to be consistent, EPA used a single source (BLS) for private (agricultural or farm) 301

and commercial applicator wages. 302

303

24. USDA Comment: In relation to the discussion of the Potential Impacts on Small Businesses (Section 304

5.7), which grower groups were consulted by EPA? Were they asked for their thoughts concerning each 305

proposed change in this Certification and Training proposed rule? 306

EPA Response: USDA’s comment here is related to EPA’s discussion of the thresholds used for 307

determining the “substantial” number of impacted entities, based on Wyatt 2008, “ Screening 308

Level Analysis of the Small Business Impacts of Revoking Carbofuran Tolerances .” For the 309

Worker Protection Standard and Certification rules, EPA convened a SBREFA panel meeting with 310

stakeholders, including applicator organizations. EPA has provided USDA with a copy of the 311

SBREFA Panel Report, which includes the topics discussed and the Small Entity Representatives 312

that participated in the discussion. 313

Again, EPA did not discuss each specific proposed change with stakeholders. EPA 314

expects all interested parties to provide feedback on the specific proposed changes during the 315

public comment period after the proposed rule is issued. 316

317

25. USDA Comment: “Could be substantial” is not a solid basis for promulgating new regulations. 318

Although the deaths are unfortunate, geese, blackbirds, grackles and gulls are not scarce species and 319

certainly far from extinction. 320

EPA Response: The deaths of birds and other ecological incidents due to RUP use are only part 321

of the justification for the proposed rulemaking. EPA is basing the cost and benefits of the rule 322

on acute health effects from RUP use. EPA presents ecological incidents to show that certified 323

applicators make mistakes that can lead to negative environmental consequences as well as to 324*** EO12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review***

March 31, 2015 Page 8 of 9 provide an overview of the type of incidents that can be caused by applicators who meet 325

current standards for competency. Note too that it is the fact that geese, blackbirds, grackles 326

and gulls are not scarce species that allows the mass mortality events that are most likely to be 327

noticed and reported. Uncommon, threatened or endangered birds face precisely the same 328

risks, yet their numbers dictate that their deaths are less likely to be observed. 329

330

26. USDA Comment: EPA cites a BLS occupational illness report and highlights carcinogens. Because this 331

proposed rule concerns RUP applicators, EPA should provide stronger evidence that the RUP applicator 332

population is more vulnerable to pesticides which are carcinogens instead of stating “some correlation” 333

may exist. 334

EPA Response: EPA used the BLS occupational illness report to highlight how occupational 335

illnesses, especially exposure to carcinogens, can be difficult to track. EPA is citing existing 336

information, rather than making assertions about the RUP applicator population. 337

338

27. USDA Comment: Because EPA wishes to add additional training categories for aerial, chemigation, 339

soil and non

‐ soil fumigants, a review of incident data for these four RUP uses would be instructive 340

compared to the numbers of applications a year without incidents. 341

EPA Response: EPA agrees that it would be helpful to have a complete count of how many and 342

what types of incidents occur for different application methods. Available data, however, do 343

not permit such an analysis. EPA has included in the incident review all available incidents 344

related to RUPs. Where possible, EPA has included the application method in the description of 345

incidents considered. Section 6.5.2 of the EA outlines factors that contribute to significant 346

underreporting of pesticide

‐ related human health incidents. In addition to underreporting of 347

incidents, some information, such as the application method, is not available for all incidents 348

reviewed. As discussed in the response to USDA’s summary comments, EPA has not and does 349

not plan to estimate the number of applications per year overall or by application method. 350

351

28. USDA Comment: Previously registered pesticides which contained dioxin impurities should not be 352

held up as an example since these are no longer used in the US. The remaining arsenical pesticides will 353

soon be canceled. If EPA believes that certain products contain unacceptable risk, EPA has the authority 354

to remove them from use. If they remain registered by EPA, then it should be assumed that they can be 355

used safely when applied as labeled. 356

EPA Response: EPA has removed the reference to dioxin and arsenical pesticides. EPA included 357

these examples to show how the international epidemiological community view the potential 358

long

‐ term health effects of pesticide exposure as important, EPA is not asserting that these are 359

potential exposures today. In registering a pesticide, EPA concludes that the product, when 360

applied as labeled, is safe. As new information about risks or exposure arise, EPA changes 361

labeling requirements. When a product is registered as “restricted use,” EPA assumes that the 362

person using the product has demonstrated competency to read and follow all labeling 363

instructions to ensure safe application. EPA is proposing changes to the certification regulation 364

to ensure that applicators continue to meet the standards of competency necessary to follow 365

the labeling of RUPs. 366

367

29. USDA Comment: Publications dated 2014 from the US Agricultural Health Study still highlight the 368

uncertainty of a causal relationship between currently registered pesticides and chronic illnesses despite 369

years of investigation. While USDA supports refinements to the certification rule, USDA asserts that 370

EPA's justification for increased regulation is not strongly backed by the current literature. For example, 371

in the Ag Health Study, the only statistically significant positive exposure response trend observed for 372*** EO12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review***

March 31, 2015 Page 9 of 9 Non

‐ Hodgkins lymphoma was for lindane and DDT. These two pesticides are now cancelled pesticides. 373

Other pesticides have only shown suggestive links or associations. Because epidemiological studies are 374

only suggestive, it is must still be proven that additional training will result in a reduction of the cited 375

chronic illnesses. 376

EPA Response: EPA agrees that the Agricultural Health Study outcomes have not established 377

any causal relationships between continued exposure to multiple pesticides and chronic health 378

effects. EPA is not asserting that additional training will result in a reduction of the cited chronic 379

illnesses. Rather, the EA notes that studies have only shown associations between pesticide 380

exposure and some chronic illnesses. 381

382

30. USDA Comment: USDA suggests that EPA use caution to base conclusions to mitigate risk based on 383

the outcomes from the National Agricultural Health Study because applicators were recruited in 1993

‐ 384

1997 after being exposed for a number of years to pesticides that EPA has since cancelled. USDA also 385

notes that the Worker Protection Standard, which went into effect in 1993, should have protected 386

pesticide applicators, among other workers. USDA recommends that EPA use studies of chronic illnesses 387

of RUP applicators who began applying RUPs after the WPS went into effect in 1993. 388

EPA Response: The certification rule has been in effect since 1974. While EPA may have 389

cancelled or further restricted the use of some pesticides that the applicators in the Agricultural 390

Health Study have been exposed to, the applicators in the study are certified applicators of RUPs 391

covered by the certification rule. Since individual product labeling requirements and applicator 392

competency as required by the certification rule work hand in hand to ensure RUPs can be used 393

safely, EPA believes it is appropriate to consider potential effects of RUP exposure since the 394

certification rule was implemented. However, for the quantified benefits of avoiding acute 395

health incidents, EPA has limited its consideration of data to 2009 and 2010. In addition, EPA 396

looked at cases involving high severity illnesses and fatalities in three different databases, 397

covering the years 2001 through 2014. 398

The WPS is designed to protect agricultural workers and handlers from occupational 399

risks associated with pesticides. The Certification rule establishes competency standards for 400

persons to be certified to use RUPs

– both private applicators (farmers) and commercial 401

applicators (for

‐ hire and government)

– and outlines how certification programs can be 402

administered. There is some overlap between the WPS and the Certification rule, e.g., a person 403

covered as a handler under the WPS could be using an RUP under the direct supervision of a 404

certified applicator and therefore covered by both rules. Implementation of the WPS did not 405

affect the competency required for applicators of RUPs

– they were held to the same standards 406

before and after the WPS was implemented. Therefore, EPA did not limit consideration of 407

studies to the period after the WPS was implemented. 408

409

31. USDA Comment: USDA made several comments requesting that EPA limit consideration of incidents 410

to those associated with RUPs. 411

EPA Response: EPA has adjusted the EA in response to USDA’s comments. See EPA’s response 412

to General Comment 4 of USDA’s Comments on the Proposed Rule for further detail. 413