## B ENEFIT 

## -C OST 

## D ETERMINATION 

## : C HOLINESTERASE 

## M ONITORING IN 

## A GRICULTURE 

## WAC 296-307-148 W ASHINGTON 

## S TATE 

## D EPARTMENT OF 

## L ABOR AND 

## I NDUSTRIES December 2, 2003

C

ONTENTS Executive Summary .............................................................................................................. ................1
Section 1: Background Information ............................................................................................. ......2
Previous Regulatory Activity................................................................................................... ..2
Cholinesterase-Inhibiting Pesticides..........................................................................................2

Cholinesterase Monitoring...................................................................................................... ...3
Summary of the Rule ............................................................................................................ .....4

Section 2: Probable Be nefits of the Rule ...................................................................................... ......5
Prevention of Serious Illness After Over-Exposure...................................................................5
Greater Certainty about Frequency of Pesticide Over-Exposure...............................................8
Prevention of Illness Through Compliance with the Worker Protection Standard....................8

Other Benefits ................................................................................................................. .........10

Section 3: Probable Costs of the Rule ......................................................................................... .....12
Number of Employees Affected ..............................................................................................14 Cost of Wages and Benefits..................................................................................................... 16 Recordkeeping Costs ............................................................................................................ ...17 Training Costs................................................................................................................. .........17 Baseline Testing Costs......................................................................................................... ....18 Periodic Testing Costs ......................................................................................................... ....19 Work Practice Investigation.................................................................................................... .19
Medical Removal Costs .......................................................................................................... .20
Notes on Calculations .......................................................................................................... ....22 Estimate of Total Industry Compliance Costs .........................................................................23

S ECTION 4: B ENEFIT -C OST D ETERMINATION ...................................................................................24 The Statutory Mandate.......................................................................................................... ...24 Comparison of Probable Benefits to Probable Costs ...............................................................25Benefit-Cost Determination Page 1 of 26 December 2, 2003



### E XECUTIVE 

### S UMMARY In this document, prepared in compliance with the Administrative Procedure Act (APA), the Department of Labor and Industries (L&I) ha s assessed both the proba ble benefits of the cholinesterase monitoring ru le and its probable costs. This assessment represents a unique challenge. Although the compliance cost s of the rule can be estimated in quantitative terms with some degree of confidence, the benefi ts are less susceptible to such quantitative analysis. L&I has identified a range of benefits, primar y among them being the protection of worker health and prevention of serious illness, as we ll as the increased knowledge and more reliable information that the monitoring and recordkeep ing provisions of the ru le would themselves generate. L&I has then balanced these benefits against the costs of the rule, estimat ed to be $858 thousand in the first year and $1.3 million beginning in the second year. 1 Table 1 includes this central estimate, as well as the high and low estimates for the same period. 2

Table 1: Estimated Compliance Costs

Central High Low

First Year $858,490 $1,159,349 $688,668

Second Year $1,274,487 $1,730,364 $1,096,165

After considering the statutory mandates of th e Washington Industrial Sa fety and Health Act (WISHA), the guidance provided by th e state Supreme Court in the Rios et al v. L&I et al decision that prompted the rulemaking, and the be st available evidence in the rulemaking record, L&I has determined that the probable benefits of the rule outweigh its probable costs for each of the three scenarios. L&I made this determinatio n on a preliminary basis in its draft Benefit-Cost Determination, circulated for public comment ending October 31, 2003. The final determination, reflected by the document, is strengthened by th e reduction in estimated compliance costs based on the most current information.

1 Throughout this analysis, dollar values for future years are presented in current dollars, without adjustment or discounting.
2 A comparison with the numbers provided in the Review Draft of the Benefit-Cost Determination provided for public comment will reveal that the current numbers, par ticularly for the second year and beyond, are noticeably lower; the bulk of the change is the result of more reliabl e figures for laboratory analysis, as discussed on page 19.Benefit-Cost Determination Page 2 of 26 December 2, 2003



### S ECTION 

### 1: B ACKGROUND 

### I NFORMATION This analysis evaluates the probable benefits a nd probable costs of the cholinesterase-monitoring rule (WAC 296-307-148), as required by the Admini strative Procedure Act 3

. In the context of this analysis and unless clearly used otherwise, ìpestici deî refers to toxicity category I or II organophosphate or N-methyl-carbama te cholinesterase-inhibiting pesticides and ìhandlerî refers to any employee who is a pesticide handler as defined in the agriculture Worker Protection Standard 4 and who is handling covered pesticides. Previous Regulatory Activity In 1993, after evaluating the feasibility and benefi ts of cholinesterase monitoring, coupled with the protections then being adopt ed as part of the pesticide Worker Protection Standard, the Washington State Department of Labor & I ndustries (L&I) recomme nded cholinesterase monitoring in agricu lture (WAC 296-307-14520). The reco mmendation included baseline and periodic red blood cell (RBC) and plasma c holinesterase testing for workers handling organophosphate or N-methyl-carbamate pesticides for 30 or more hours in any 30-day period. In 1997, L&I was asked to implement mandatory cho linesterase monitoring. L&I declined to do so, based on a consideration of available L&I resources and agency pr iorities. L&I did not, however, decide that a rule was not warranted. L&Iís decision not to pursue rulemaking at the time led to legal action to require L&I to act . In 2002, the Supreme Co urt of the State of Washington in Rios 5 upheld the 1993 decision to adopt a recommendation, but required L&I to initiate rulemaking in response to the 1997 request. To assist in the development of a rule proposal, L&I formed an advisory group consisting of agriculture worker representa tives, growers, other government agencies, and scientific community representatives. L& I also conducted public data-gathe ring meetings around the state. Both the public meetings and the grower a ssociations participating on the advisory group included representatives of small businesse s that would be affected by the rule.
Because no benefit-cost determination was included with the original proposal, L&I decided to provide a review draft of this document for additional public co mment after the comment period on the rule itself had ended. Those comments we re considered, responded to as part of the public record, and reflected in this final benefit-cost determination as appropriate. Cholinesterase-Inhibiting Pesticides Organophosphate and N-methyl-carbamate pestic ides inhibit the activity of the enzyme acetylcholinesterase (AChE). AChE aids in re gulation of the nervous system by removing the neurotransmitter acetylcholine fr om neuronal junctions and target receptor sites (for example, a muscle or gland). Exposure to these pesticides can lead to an accumu lation of acetylcholine, which in turn could result in the over-stimulati on of an individualís nervous system. Common symptoms of such cholinergic poisoning incl ude increased sweating, bl urred vision, diarrhea, tremors and malaise. Severe exposures may re sult in pulmonary edema, respiratory distress, seizures, loss of consciousness, and death. Organophosphate and N-methyl-carbamate pesticid es share a common mechanism of toxicity. Both bind with AChE and prevent destruction of acetylcholine. The major difference between

3 RCW 34.05.328(1)(c)
4 WAC 296-307-107 et seq , also known as Chapter 296-307, Part I
5 Juan Rios and Juan Farias v. Washington Department of Labor & Industries, et al ., 145 Wn.2d 483, 39 P.3d 961 (2002).Benefit-Cost Determination Page 3 of 26 December 2, 2003
organophosphate and N-methyl-carbamate pesticides is that the phosphate bond persists for days and may become permanent, while the carbamate bond may last for as little as 30 minutes to 24 hours. In general, regeneration (replacement) of permanently bound AChE is measured at the rate that AChE is synthesized in the bl ood stream (approximately 1 percent per day.) While inhibition of AChE by organophosphate pesticid es lasts much longer than the effects of Nmethyl-carbamate pesticides, the physiologic consequences are the same. Overlapping exposures to the two categories of pesticides can result in an a ccumulation of toxic effects. Symptoms of poisoning are often self-limited, w ith normal function returning when exposure is eliminated, as bound AChE regenerates and ne w enzyme is synthesized in the body. Cholinesterase Monitoring Accepted methods of cholinesterase monitoring involve measuring the activity of both red blood cell (RBC) and plasma cholinesterase. Both enzy mes have been shown to act as surrogates for AChE activity in the nervous system. RBC cho linesterase is the same AChE found in the nervous system and is thought to better reflec t effects on nervous system AChE than plasma cholinesterase. However, because plasma tes ting can provide useful additional information, monitoring both RBC and plasma cholinesterase enzymes provides a more complete clinical picture of exposure to covered pesticides. Exposure to cholinesterase-inhibiting pesticides also can be evaluated by direct measurement of pesticide in the blood or by measur ing pesticide metabolites in the urine. Both methods present problems that make them less desirable monito ring methods. Urine metabolites begin being secreted in the urine almost im mediately and may disappear with in 48-72 hours. Detection of pesticides in the blood requires sp ecific laboratory assays for each pesticide, thus requiring many different analytical methods. In addition, while both methods detect pesticide exposure, neither provides information on workerís physiologic res ponse. Given the limitations of other methods, measurement of blood cholinesterase levels provi des the most practical and efficient method for monitoring cholinesterase activ ity and identifying possible overexposures. However, the limitations of this method require that certa in practical consider ations be addressed. Blood cholinesterase measurement is subject to in tra- and interpersonal va riability. Because of expected intrapersonal variability, the rule do es not require a respons e until a meaningful reduction has been identified. Because of in ter-personal variability, there is no ìnormalî cholinesterase level. This means that eff ective monitoring depends upon a periodic comparison of an individualís cholinestera se levels to a personal baseline value established for that individual prior to exposure. Several laboratory methods for meas uring cholinesterase activity levels are available. Of these, the electrometric and colorimetric methods are most often used. Both methods are effective for RBC and plasma cholinesterase testing. Because these methods use different systems to report results it is difficult to compare tests between methodologies. Even though conversion equations exist to compare different reporting systems, thes e equations are not always reliable. For this reason, the rule requires that medical providers send samples to a laboratory approved by L&I, which will analyze each individualís baseline and periodic tests, using a consistent method.
The rule is part of the Agricu lture Standard adopted under WISHA 6 and, as such, applies to all agricultural activity in the state wh ere covered pesticides are used.

6 ìSafety Standards for Agriculture,î Chapter 296-307 of the Washington Administrative Code (WAC).Benefit-Cost Determination Page 4 of 26 December 2, 2003
Summary of the Rule The final rule includes the following provisions: 1. The employer will be required to keep records of all employee handling of covered pesticides, and retain those records for seven years. 2. Cholinesterase monitoring (RBC and plas ma cholinesterase) will be required for employees who handle covered pesticides for 50 or more hours in any consecutive 30- day period beginning January 15, 2004, and for 30 or more hours in any consecutive 30-day period beginning January 15, 2005. 3. Employers will be required to ensure that em ployees requiring medical monitoring will receive training that includes at a minimum:

• The human health hazards associated with exposure to organophos phate and N-methylcarbamate pesticides

• The purpose and requirements of cholinesterase monitoring. 4. Employers will identify a medical provider to provide (at no cost to the employee, and at a reasonable time and place) baseline and periodic t esting, interpretation of test results, and recommendations resulting from those test results 5. Employees may choose to declin e cholinesterase testing after receiving training and consulting with the medical provider. 6. Pre-exposure baseline testi ng will be conducted annually. 7. Employers whose employees who handle only N-methyl-carbamate pesticides will be exempt from the requirement to offer tho se employees cholinesterase testing. 8. Hours spent mixing and loading using closed systems (as described in WAC 296-307- 13045(4)(d)) will not be counted as exposure hours for the purposes of periodic monitoring beyond the baseline. 9. Periodic testing will be required within 3 days of meeting the designated exposure thresholds or at least every 30 days while exposure is expected to exceed thresholds. 10. Cholinesterase depressions will requi re the following employer actions:

• A depression of 20% or more from the empl oyeeís personal baseline will require the employer to conduct a work practice investigation

• An RBC cholinesterase depression of 30% or more from the personal baseline or a plasma cholinesterase depression of 40% or more from the personal baseline will require the employee to be temporarily removed from organophosphate and N-methyl-carbamate exposure and the employer to conduc t a work practice investigation.

• An employee removed from exposure will not be allowed to return to handling covered pesticides or participate in other exposure-prone activities until his or her cholinesterase levels are within 20 percent of the personal baseline. 11. Medical removal protection until return to norma l duties (not to exceed 3 months) will be made available to employees removed from handling due to cholinesterase depression. 12. The employer must maintain (or contract with the provider to maintain) monitoring and related medical records for 7 years.
13. The thresholds in the rule will be evaluated by L&I (in consultation with both a scientific panel and a stakeholder advisory group) before the 30-h our threshold takes effect, and again before the third year of the ruleís existence. L&I will pr opose changes to the rule if appropriate based on this evaluation.Benefit-Cost Determination Page 5 of 26 December 2, 2003 

### Section 2: Probable Benefits of the Rule
The rule is expected to provide a number of benefits, and some quantitative information is available for certain benefits ñ such as the numbe r of workers likely to be identified and treated for cholinesterase depression as a result of the ru le. However, available information about most of these benefits makes it impracticable to qua ntify them with a high level of confidence.

In some cases ñ such as the value of increased knowledge and the preeminent value of protecting worker health ñ the benefits are essentially qualitative. 7 In other cases ñ such as the number of pesticide poisonings prevented ñ the benefits presumab ly can be quantified when more precise statistical information is availabl e. Indeed, the development of su ch information is itself one of the ruleís benefits. In still ot her cases ñ such as the degree to which the presence of medical monitoring and medical removal protection prompt s better enforcement of existing work rules and use of personal protective equipment ñ the in formation provided by the rule is not likely to provide quantitative certainty.
In all these cases, however, L&I must take the probable benefits into account, even when they cannot readily be quantified with info rmation presently in the record.
Prevention of Serious Illn ess After Over-Exposure L&I has estimated that medical monitoring will identify cholinesterase depressions requiring medical removal in between 1.2 and 4.8 percent of pa rticipating employees, with a central estimate of 3 percent. If 85 pe rcent of eligible employees part icipate in the medical monitoring, the central estimate suggests that the rule will identify 37 employees with depressed cholinesterase levels in the first year , and 95 beginning in the second year. Some testimony in the record has suggested that the percentage of employ ees identified could be as high as 25 percent, which would mean 310 empl oyees would be identified in the first year and 795 in the second year. However, L&I has concl uded that this estimate is unrealistically high. Similarly, the record contains te stimony arguing that the appropria te removal rate would be less than one percent ñ a one percen t rate would mean 12 employees in the first year and 32 employees in the second year. Again, L&I has concluded that the appr opriate lower bound is 1.2 percent and that the available evidence suggests it is unrealisti c to expect a removal rate approaching zero percent. Employees removed from exposure before serious illness occurs will be likely to experience a number of benefits, the most obvi ous of which is avoidance of se rious illness and the resulting effects on both economic productivity and social interaction. The t oxic effects of cholinesteraseinhibiting pesticides are well documented. 8, 9 In addition to the well- documented and widely accepted short-term health effects of overexposure to covered pesticides, the record also suggests that avoiding ongoing over-exposures may reduce th e risk of permanent harm to the nervous

7 The department recognizes that methods exist to assi gn quantitative meaning to ev en inherently qualitative benefits, such as the value of life, although such methods are based on a variety of methodologies and assumptions; however, the Administrative Procedure Act explicitly re ferences both ìquantitativeî and ìqualitativeî analysis, making the use of such statistical tools unnecessary.
8 Krieger, R.I. (2001). Handbook of Pesticide Toxicology. Academic Press, In c., New York, NY.
9 Lessenger, J.E. & Reese, R.E (2000). The Pathophysiology of Acytelcholinesterase Inhibiting Pesticides. Journal of Agromedicine. Vol. 7(2), 5-19.Benefit-Cost Determination Page 6 of 26 December 2, 2003

system. 10 Indeed, in 1992 the EPA concluded that acute poisonings could lead to ìsystemic illnessesî that may exist ìfor months or years after the initial exposure.î 11
The rule would prevent short, intermediate, and long-term adverse effects from chronic exposure. The rule would result in reporting of currently undiagnosed chronic exposure that is likely to be untreated and could result in a pest icide poisoning. Severa l long-term effects of acute and chronic exposure to cholinesterase-i nhibiting pesticides have been identified. Intermediate syndrome occurs following acute exposures, with potenti al symptoms including severe muscle weakness and respiratory paralysi s. Intermediate syndr ome is a collection of symptoms that generally occur 24-96 hours after exposure to ChE-inhibitors and prior to the development of Organophosphate-induced delaye d neuropathy (OPIDN). OPIDN results in weakness or paralysis of the extremities. The effects of OPDIN can last for months to years. 12, 13 Research has strengthened the relationship between exposure to cholinesterase-inhibiting compounds and central nervous system health effects including impairments in concentration, memory, language, and personality. 14, 15 Although some information in the record suggests that OPIDN is not likely to occur for pesticides licen sed for use in the state, the department has concluded that the risk remains real (especially in the event th at personal protective equipment (PPE) or engineering controls are used inconsistently ove r an extended period of time. It is difficult to identify illnesses resulting from chronic exposure using traditional methods. The EPA concluded in its own rulemaking related to pesticides that ìmany incidents of acute and allergic pesticide effects on agricultural workers and pesticide handlers are not diagnosed as such by a physician.î 16 In reviewing the data available on the subject in 1992, the EPA made the following observation:
There is considerable uncertainty about the num ber of such incidents. The available studies which address this issue often suffer from a number of limitations, including reliance on recall of workers that may be affected by the questions asked, samples that are small or that may not be representative, etc. Nonetheless, the Agency believes that, with all their weaknesses with respect to this objective, existing studies, taken together, are rem arkably consistent with a conclusion that undiagnosed cases of pesticide poisoni ng incidents among the agricultural work force subject to the WPS are likely to be significan tly more numerous than those that are diagnosed. 17

10 Such risks are suggested by references in the record to articles such as the following: Ray, David and Richards, P.G., ìThe Potential for Toxic Effects of Chronic, Low-Dose Exposure to Organophosphates,î 120 Toxicological Letters 343-351 (2001); Peiris-John, Roshini, et al , ìEffects of Occupational Exposure to Organophosphate Pesticides on Nerve and Neuromuscular Function,î 44 J. Occupational Environmental Medication 4 (2002); Jamal, Goran, et al , ìLow Level Exposures to Organophosphorus Esters May Cause Neurotoxicity,î 181-182 Toxicology 23-33 (2002).
11 Regulatory Impact Analysis of Worker Protection Standard for Agricultural Pesticides ̧ Biological and Economic Analysis Division, Office of Pesticide Programs, United States Environmental Protection Agency, August 1992, pp. V-28-29.
12 Environmental Protection Agency (1999). Recognition and Management of Pesticide Poisonings, 5th ed. Environmental Protection Agency, Washington D.C.
13 Keifer, M.C. & Mahurn, R.K. (1997). Chronic Neurological Effects of Pesticide Overexposure. Occupational Medicine: State of the Art Reviews. Hanley 7 Belfus, Inc. Philadelphia, PA.
14 Ibid.
15 Savage, E.P., Thomas, K.J., Mounce, L.M., Heaton, R.K., Lewis, J.A., & Burcar, P.J. (1988). Chronic Neurological Sequelae of Acute Organophosphate Pesticide Poisoning. Archives of Environmental Health. Vol. 43(1). 38-45.
16 Ibid , p. V-17.
17 Ibid, p. V-17, emphasis added.Benefit-Cost Determination Page 7 of 26 December 2, 2003
After discussing the expected bene fits of its own rulemaking, the EPA declined to estimate how many such cases were occurring and might be a voided by compliance with the rule, observing only that ìthe Agency believes the nu mber is very likely to be large.î 18
These problems in identifying cases of occupatio nal disease have long been recognized as a limitation in using workers compensation, Bureau of Labor Statistics, and other data sources to indicate the extent of such illness. 19
Pesticide poisoning is commonly under-diagnosed and under-reported. 20, 21 Cholinergic poisoning has clinical symptoms that are common to a variety of medical conditions. In general, mild cholinergic poisoning mimics symptoms of the common cold or environmental allergies. A Washington state study found that more than 11 pe rcent of agricultural pesticide handlers had ChE depressions levels at the end of the appl ication season consistent with proposed work practice evaluation trigger levels . Even after eliminating the less reliable measurements for plasma cholinesterase, the study found 5.6 percen t with depressions th at would trigger an investigation of work practices under the rule and 1.85 percent with depressions that would trigger medical removal under the rule (this in spite of reported use of various forms of PPE). 22 A 2001 focus group study conducted by the Washi ngton State Department of Health (DOH) found that 75% of the participating farm worker s reported experiencing sy mptoms of pesticide illness, although it is unknown from the study how many of these were handlers. These included headache, eye irritation, difficulty breathing, and nausea. However, most did not seek medical care for these conditions. 23 These results, now availabl e from DOH in summary form, 24 support the conclusion that a large number of pesticide illnesses in farm workers are never identified. Although this analysis and the many studies that preceded it may each be individually challenged in certain respects, the EPAís conclusion of more than a decade ago remains true today: Taken together, existing studies and analyses ñ as well as anecdotal information ñ are consistent in their suggestion that pesticide illnesses in agriculture continue to be under-repo rted to a significant degree. Given this background, and an awareness of the inherent limitations of training and use of personal protective equipment in protecting empl oyees, it remains reasonable to assume that there is some meaningful group of employees in Washington agricu lture who not only are becoming ill because of organophosphate and N-met hyl-carbamate exposures, but also are doing so without knowing it. The three percent central estimate of depre ssed cholinesterase levels used by L&I is a reasonable estimate of these exposures , based on the best available information.

18 Ibid, p. V-33.
19 See, for example, Pollack, Earl S. and Deborah Ge llerman Keimig, et al, Counting Injuries and Illnesses in the Workplace: Proposals for a Better System ̧ National Research Council, National Academy Press, 1987, pp. 5, 80- 100; and An Interim Report to Congress on Occupational Diseases, United States Department of Labor, 1980, pp. 1,3
20 Environmental Protection Agency (1999). Recognition and Management of Pesticide Poisonings, 5th ed. Environmental Protection Agency, Washington D.C.
21 Washington State Department of Health. Pesticide Incident Report Data. Pesticide Incident Reporting and Tracking Review Panel.
22 Karr, C., Keifer, M., & Miller M. & Ka ufman, J. (1998). ìFie ld Based Monitoring of Agricultural Workers for Overexposure to Cholinesterase-inhibiting Pesticides: Evaluation of an Experimental Program.î Journal of Agromedicine, Vol. 5(4) 1998.
23 Vanderslice, J, Baum, L., Bardin, J, Bonnar-Prado, J, & Hanks C. (2001). Learning from Listening: Results of Farmworker Focus Groups About Pes ticides and Health Care. Washington State Department of Health (unpublished)
24 Summary Results of Yakima Farmworker Focus Groups about Pesticides and Health Care , Washington State Department of Health, September 22, 2003.Benefit-Cost Determination Page 8 of 26 December 2, 2003
The California experience confirms that monitoring can effectively combat serious poisonings. Results from a 1999 survey of California phys icians providing cholinesterase-monitoring services indicate that the program is effectiv e in identifying and removing workers from overexposure. 25 Of the 101 physicians who responded to the 1999 survey, 68% reported that they had recommended that employees be removed fr om exposure to cholinesterase inhibiting pesticides due to falling below trigger thres hold for ChE levels. The physician respondents indicated that medical monitoring was effectiv e in preventing illness. The survey results establish that when monitoring detects ChE i nhibition, workers can be removed from exposure before becoming clinically ill and work plac e deficiencies can then be corrected. The rule also will prevent such illnesses by identifying depressions even before removal is necessary. The resulting investig ation of work practices should result in a correction of any identifed problems without either medical re moval or medical treatment being required.
Greater Certainty about Frequency of Pesticide Over-Exposure

One of the clear and obvious bene fits of the rule is that the relative uncertainty regarding the number of employees being poisoned can be ad dressed by a comprehensive medical monitoring rule. After just a year or two of tests have been conducted, the ru le will provide relatively clear answers to the question ìhow ma ny pesticide handlers are experien cing depressed cholinesterase levels?î If the level is dramatically higher that L&I now believes, further rulemaking may be appropriate. If the level is dramatically lower, the rule and its requirements can be adjusted to reflect that information. In this way, one of the clear benefits of the rule is increased certainty about the degree to which pesticide handlers ar e being poisoned by covered pesticides. This benefit will accrue to employees, employers a nd L&I alike. In addition to the immediate benefits of information, more reliable data wi ll allow greater precision in future discussions about the degree of pesticide poisoning and cholines terase depression. This, in turn, will inform future activities by researchers and policy-ma kers attempting to better understand the relationships between pesticide use and illness. In addition to the benefits within Washington wor kplaces that would result from greater certainty regarding these issues, the record suggests that th ere will be at least some modest benefits in other jurisdictions as a result of the medical monitoring requirements in the rule, coupled with effective data capture and analysis that is not available elsewhere in the country. The rule also will enable the development of a database allowing the scientific review of historic monitoring and cholinesterase de pression data, as well as the tr acking of popluations of exposed workers, including those suffering from significant cholinesterase depression. This, in turn, will allow greater certainty about th e long-term effects of over-ex posure and of cholinesterase depression.
Prevention of Illness Through Greater Compliance with Pesticide Worker Protection Standard Traditionally, monitoring requirements supplem ent other regulatory provisions. Medical monitoring is one way to determine whether ap propriate work practices are being used and personal protective equipment (PPE) is being provi ded and worn. The EPA estimated that full compliance with the Worker Protection Standard (WPS) would prevent 80 percent of the acute pesticide poisoning cases among pesticide handlers. 26 However, this result ñ which protects

25 California Environmental Protection Agency (1999). Results of a Survey regarding Certification and Training for Physicians Providing Medical Supervision for California Pe sticide Mixer/Loader/Applicators. California Office of Environmental Health Hazard Assessment.
26 Regulatory Impact Analysis, EPA, p. V-31.Benefit-Cost Determination Page 9 of 26 December 2, 2003
workers even before the low-level depressions described above occur ñ can be achieved only if the requirements of the standard are followed on the job site. A National Academy of Science analysis of the issue stated ìThe major criticism of the 1992 WPSÖhas been lack of compliance.î 27 The analysis goes on to say: The current system has a number of problems. First, it is generally more difficult to monitor activities on a large farm than a factory or other circumscribed area. Second, most enforcement efforts are responses to complain ts, so enforcement activities do not give a quantitative indication of general compliance. Third, the agencies responsible for compliance reporting can have political conflicts of interest. Fourth, it is di fficult for workers and even medical personnel to diagnose pesticide poisonings (EPA 1998). 28
The analysis also identified as one important goal to increase benefits and decrease risks by increasing ìÖthe ability and motivation of agri cultural workers to lessen their exposure to potentially harmful chemicals and refine worke r-protection regulations and enforce compliance with them.î 29
California has had a cholinesterase-monitoring program in place for agricultural pesticide handlers since 1974. 30 California program staff have iden tified several benefits of routine cholinesterase monitoring. Monitoring can iden tify workers with small but significant ChE depressions, triggering a review of work practices and empl oyersí safety programs to find the source of exposure and make necessary correctio ns. Physicians may remove workers with depressed ChE levels from further exposure, thereby preventing illness. Participation in a cholinesterase monitoring increases worker and employer awareness of the toxicity of chemicals handled. By reducing over-exposure to cholines terase-inhibiting pesticides, cholinesterase monitoring may protect workers from de veloping possible long-term effects. 31
Comments from stakeholders ( both supporters and opponents of th e rule) confirm the importance of enforcing the use of PPE among the workfo rce in order to avoi d poisoning. Although it cannot be readily quantified, one of the benefits of the rule will be increased compliance with the existing WPS requirements by employers and employ ees. This would occur both in relation to specific instances of over-exposure (and resultin g depression) and as a result of greater awareness of the need to ensure workplace safety rules are followed. Employers and their employees will benefit from increased worker productivity when workers are healthy. In addition to th e debilitating effects of the im mediate symptoms of poisoning by covered pesticides, the record includes suggestions that worker productivity will benefit from reduced long-term exposure as well. 32 The benefits to workers from the identification of problems with the applicati on of existing PPE, work prac tice and engineering control requirements will not be limited to those pest icide handlers who suffer pesticide poisonings identified by the rule, but also will benefit other workers, in cluding those who may be handling pesticides below the ruleís thresholds and thos e workers who may not be handling pesticides at all but may be exposed as a result of br eakdowns in workplace health protection.

27 National Academy of Science (2000), The Future Role of Pesticides in US Agriculture . p. 131.
28 Ibid.
29 Ibid. p. 4.
30 Ames, R.G., Brown, S.K., Mengle, D.C., Kahn, E., Stra tton, J.W., & Jackson, R.J. (1989) ìProtecting Agricultural Applicators From Over-Exposure to Cholin esterase-Inhibiting Pesticides: Perspectives from the California Program,î Journal of Occupational Medicine vol. 39, 85-92.
31 Ibid

. 32 See, for example, Burton, W., et al., ìThe Role of Health Risk Factors and Disease on Worker Productivity,î Journal of Occupational Environmental Medicine 10 (1999); and Moses, Marion, ìPesticide-Related Health Problems and Farmworkers,î 37 American Associational Occupational Health Nurses 3 (1989).Benefit-Cost Determination Page 10 of 26 December 2, 2003
Other Benefits Identification of Existing, But Undi agnosed, Workers Compensation Claims . Currently, without a proper diagnosis, a poisoned worker misses work and is not paid for me dical costs or lost wages from undiagnosed pesticide poisoning. After the rule takes effect, these pesticide handlers are likely to be ëbrought intoí the workers compensation system as a result of the ongoing monitoring program. The rule wi ll therefore help to accomplish an important goal of the workers compensation system by compensating workers for occupationally caused illnesses, in accordance with existing legal mandates found in the Industrial Insurance Act. 33,34

Identification of the Need to Improve WPS Requirements. In addition to identifying problems with the application or enforcement of existing re quirements, the rule will enable L&I and other agencies, as well as employers and employees, to identify any existing PPE, work practice and engineering control requirements that are not sufficient to pr otect pesticide handlers from dangerous exposures.

Protection of Worker and Family Health . Protection of worker health, even from uncertain risks, is itself a preeminent benefit under WISHA. 35 By decreasing the risk of uncontrolled exposures to workers due to inappropriate PPE or inadequate decontamination the rule will also decrease unintended exposures to workersí families, includ ing children. Evidence suggests children may have a higher sensitivity to health effects from pesticides. In any case, the rule should at least make sure that workers are better informed a bout those exposures, which remain a meaningful issue in the homes of agricultural workers. 36
Economic and Social Impacts on Handlers and Their Families. Pesticide poisoning has impacts beyond the physical symptoms and illnesses that may be suffered by handlers. Missed work generally means missed or lowered paychecks fo r handlers, since many of these workers do not have sick-leave benefits. This can in turn resu lt in additional financial stress on their families. Likewise, the symptoms of chronic overexposure to pesticides can add stress to families as well as to workers. The diminished ability to perform family and social roles that result from illness ñ or fear of illness ñ canno t readily be quantified but are real in their impacts on the lives of workers and their families. Incentives for Closed Systems. The rule has an incentive effect for employers to increase the use of closed systems for pesticide mixing/application. The benefit from an increased use of closed systems would be a reduction of accidental splash /spill exposures and medical removals partly or wholly due to these types of exposures.

Evaluation of Relative Pesticide Toxicities. Linking depressed cholin esterase levels with the specific pesticides could allow hea lth and safety experts to identify the more toxic or absorbable covered pesticides that are causing these depressions. This could lead to pesticide substitution

33 Title 51, Revised Code of Washington.
34 It can be suggested that this ìbenefitî is offset by the ìcostî to employers and others of paying for workers compensation claims that are o ccuring but that go unreported. Clearly, the benefit of fulfilling the legislative intent of Title 51 RCW exceeds the costs of pa ying for claims that should be reported but are currently un recognized. The question of such ìtransfersî comes up in other contexts as well ñ for example, it could be argued that the costs to employers of complying with the rule by paying doctors, laboratories and workers are offset by the benefit to the doctors, laboratories and workers of receiving those paym ents. However, the depart ment does not consider it appropriate to consider the be nefit to such recipients of mandated complian ce costs as offsetting the costs of the rule.
35 This is discussed in greater detail in the analysis beginning on page 23.
36 Thompson, Beti, PhD, et al, ìPesticide Take-Home Pathway among Children of Agricultural Workers,î Journal of Occupational Environmental Medicine , January 2003, pp. 42-52.Benefit-Cost Determination Page 11 of 26 December 2, 2003
and possibly restricting the use of these pesticid es, resulting ultimately in fewer adverse health effects.

Increased Farm Worker Access to the Healthcare System. An incidental bene fit of the rule will be an increase in farmworker access to the he althcare system by establishing a relationship with a medical provider. This relationship should increase the likelihood th at workers will report potential pesticide exposures and pe sticide-related illnesses to their doctors, even if the pesticides involves are not covered by the rule . While it is not the intent or the purpose of the rule, other medical problems of farm workers could be di scovered incidentally to the initial medical consultation of the pesticide handler and the health care provider. Greater Awareness by Other Work ers of Potential Exposures. Medical monitoring will make additional information available, both in the workplace and in the scientific and medical community, that will allow former workers to become aware of the possibility of prior exposures and that will allow the iden tification of exposures and pot ential exposures by job task.

Decrease in Pesticide Use. Although the record sugge sts that pesticide use might be affected, L&I does not consider this potential shift to be eith er a cost or a benefit of the rule. The rule itself does not in any way restrict the use of covered pesticides, provided the monitoring requirements are met. Although there may be so me shift in use patterns, the record is inconclusive about whether such a shift would represent, on balance, a benefit or a cost. Therefore, L&I has treated the impact of any su ch shift as being an essentially neutral one.Benefit-Cost Determination Page 12 of 26 December 2, 2003 

### Section 3: Probable Costs of the Rule
Because data is available from an employer survey and other sources, it is possible to quantify the probable costs of the rule. For each set of employer costs resu lting from the rule, L&I calculated costs using the data from the survey and other sources (as noted in the text), which L&I believes represent the best available data. In developing these costs, L&I us ed a set of reasonable as sumptions to generate a most probable central value. In each case, alte rnative assumptions that would provide both a low and a high estimate are also provided. 37 These assumptions are desc ribed in detail below and summarized in Table 4 on page 23.
Employer Survey The department designed a survey instrument to help determine the probable compliance costs of the rule. The Washington State Department of Agriculture (WSD A) was consulted to determine the types of crops where use of covered pestic ides was most common in order to focus the survey on selectively targeted i ndustry sectors. The firms in each sector were identified from L&Iís workersí compensation database using a random sample in each of the affected industries. The industries targeted in the survey, with thei r associated standard industrial classification (SIC), are as follows:

• SIC 0134 All potatoes except yams.

• SIC 0139 Field crops: hay, alfalfa, hops, mint, etc.

• SIC 0171 All berry crops.

• SIC 0172 Grapes.

• SIC 0175 Deciduous fruit trees.

• SIC 0711 Only professional pes ticide applicators contacted.

• SIC 0721 Only soil fumigators in this SIC contacted.

• SIC 0811 Timber tracts, Christ mas tree growing, tree farms. The following sectors were among those not target ed in the survey because use of covered pesticides was expected to be minimal: 38

37 The analysis of the compliance costs contained in this CBA is similar to the methodology contained in the Small Business Economic Impact Statement (SBEIS) filed with th e proposed rule. The main difference is the statistical treatment of certain survey responses on how many empl oyees are handling covered pe sticides at the different exposure durations of 30-60 hours, 61-100 hours and over 100 hours. In the SBEIS, those firmsí responses of ënot knowní were coded as ënaí but were erroneously assigned a zero value in various calculations of averages and sums. The correction increases the average numb er of baseline and periodic testing costs for large firm orchardists. The impact on the commercial applicator sector is minute. This document also corrects an error in the SBEIS that overstated the rate of medical removal by applying the percentage to the number of tests, rather than to the number of employees as intended. These corrections, and several other minor adjustments to the statistical analysis, did not have a major effect on the calculation of the costs or on the comparison of small and larger businesses for potential disproportionate impact.
38 In addition to the SIC codes mentioned here Chapter 296-307 WAC also specifically applies to the following SIC codes, although use of the covered pesticides in these industrial sectors is likely to be either nonexistent or infrequent: 0133, 0173, 0179, 0181, 0182, 0191, 0211, 02 12, 0213, 0214, 0219, 0241, 0251, 0252, 0253, 0254, 0259, 0271, 0272, 0273, 0279, 0291, 0711, 0722, 0751, 0761, 0831, 0851.Benefit-Cost Determination Page 13 of 26 December 2, 2003

• SIC 0111 Wheat.

• SIC 0115 Corn.

• SIC 0119 Grains not el sewhere classified.

• SIC 0161 Vegetables. Due either to misclassification when the employerís original account was cr eated or to a change in crop composition after the acc ount was established, some firms in the above industries were included in the survey. Furthermore, some of those firms reported that they used covered pesticides at levels that w ould trigger monitoring by the ru le. Based on the information provided, their SICs were corrected, and they were included in the analysis. This survey data was organized into the following sectors for analysis:

• SIC 0721 (commercial applicators) was analyzed separately because of its unique characteristic of contra cting for other sectors.

• SIC 0175 (orchards) was analyzed separately because of its unique characteristics of being the heaviest user of pesticides in agriculture.

• SICs 0111, 0115, 0119, 0134, 0139, 0161, 0171, 0172, and 0811 (ëother growersí) were analyzed together as they were found to be less frequent users of pesticides than the orchard industry. Furthermore, due to the low number of respondents in these sectors, greater statistical reliability is achieved by aggregation. The Gilmore Group, based in Seattle, Washingto n, conducted a phone survey in February and March 2003 using lists of large and small ag ricultural businesses by SIC provided by the department. The Gilmore Group randomly select ed specified numbers of businesses in each subcategory.

The key questions asked of the survey participants were as follows:
1) Do you use pesticides in your business?
2) What are the 4 main crops grown by your bus iness and their associated acreages (growers only)?
3) In a typical growing season, how many handlers do you have that handle these pesticides?
4) What is the average hourly wage of these handlers?
5) Positive respondents to the question 3 were as ked for the number of handlers handling pesticides for each month of the year at the following levels of exposure durations:

• 30 to 60 hours

• 61 to 100 hours

• 101 or more hours
6) Do you currently conduct cholinesterase monitoring of your handlers that handle pesticides?
7) What were the results of the monitoring?
8) Are reassignment positions available for handler s removed from pesticide handling for up to 60 days?
9) How far is your business from the nearest medical clinic or facility that you use?Benefit-Cost Determination Page 14 of 26 December 2, 2003

10) To determine the probable firm response to th e proposed rule by changing work assignment or making other modifications to fall below the monitoring threshold, the su rvey asked the following question: If the rule requiring mandatory cholin esterase monitoring of handlers is eventually adopted, please select the response or a combina tion of the following responses for how you plan on complying with the rule. Please listen to all the choices before answering.
a. Discontinue the use of these pesticides altogether on my crops.
b. Have owners or family members apply the pesticides.
c. Contract with a professional pesticide appli cator and let them deal with the monitoring requirements.
d. Use regular handlers to handle the pesticides but have them handle the pesticides for time periods below the threshold that would trigger the medical monitoring requirement.
e. Use regular handlers over time periods above the threshold that would trigger the medical monitoring requirement and follow the medical monitoring requirements of the rule.

f. Other, please specify

___________

__________ Number of Employees Affected. One important assumption for both first and seco nd year costs involves the number of handlers affected by the medical monitoring requirements. A number of factors must be considered: First-year coverage. When the phone survey was designed and executed, the medical monitoring thresholds to be included in the proposed ru le had not been determined. Therefore data on monthly exposures in the following ra nges were queried in the survey:

• 30 to 60 hours;

• 61 to 100 hours;

• and over 100 hours. In addition, the survey responses allow for a cons ervative estimate for the number of employees who handle pesticides but never exceed the 30-hour threshold. The rule covers employees at 50 or more e xposure hours in the first year and 30 or more exposure hours during the second year. While the survey provides information directly applicable to the second year th reshold, the first year costs must be extrapolated from the survey results based on reasonable assumptions about th e number of employees who handle pesticides more than 50 but fewer than 60 hours. L&I used the available data to develop statistical models (one each for small businesses and the largest 10 percent of businesses). This allowed L&I to estimate the distribution in each industry sector in 10-hour increments, providing a central value for the 50 to 60 hour range. The low estimate was calculated at 75 percent of the central value, while the high estimate was calculated at 125 percen t of the central value. This assumption has no effect on costs from the second year forward. Inconsistent Survey Responses. Slightly fewer than 10 percent of the respondents gave inconsistent responses to the questions: ìIn a typical growing season, how many handlers do you have that handle these pesticides?î and ìNumbe r of employees handling pesticides 30-60 hours (61-100 or 100+) during (each) month.î For exampl e, if a firm reported a total of 2 handlers, but then later said that 2 handl ers worked at both the 30-60 an d 61-100 exposure levels in July, this would result in a total of 4 handlers in July, twice the to tal number of handlers the firmBenefit-Cost Determination Page 15 of 26 December 2, 2003
reported overall. In this example, L&I excluded the 2 users at the 30 to 60-hour interval, leaving 2 handlers at the 61 to 100 level as the most likely number. The alternative to this would be to discard the inconsistent data, wh ich is inappropriate given the co rrectible nature of the probable error and the effect discarding such data would ha ve on the ability to evaluate relative costs in the Commercial Applicator sector (where one of the three larger empl oyers responding to the survey gave inconsistent responses). Impact of reduced need for ìperiodic testingî. The rule provides reduced requirements when handlers are using only carbamates. It may also reduce requirements when handlers use closed systems to mix and load. In such cases, the ne ed for periodic testing (beyond the baseline) could be reduced or eliminated. However, L&I does not have reliable data on the degree to which either situation occurs, and even less ability to determine the degree to which it will occur when the rule is in place. Therefore, the current analysis assumes that all handling hours will be covered by the periodic testing requi rement, which is likely to overstate the cost of the rule to at least some degree. Impact in Shift of Pesticide Application Practices. Similarly, one of the questions on the survey asked about shifts in behavior or work assi gnment that would reduce the number of handlers affected by the medical monitoring requirements in the rule. Although such a shift was predicted by a meaningful number of respondents (see Table 2), this analysis does not reflect the resulting reduction in employer costs. Instead, it treats the co st of the shift as essentially identical to the cost of complying without any change in work assignments. The bene fit of reducing risk by distributing the exposures, suggested by some respondents, is reflected in the benefits section of this determination. This clearly overstates employer costs. Employers would not be likely to change unless they believed that the net cost of such a change woul d be lower than the cost of complying without such changes. However, no data is available to allow L&I to estimate the co st of the alternatives chosen by the respondents, making the conserva tive approach described above appropriate.

Table 2: Reported Change in Pesticide Application Practices (Survey Response)*

Discontinue Owner or Family Use Professional Keep Hours No Change Pesticide Use Will Apply Applicator Below Threshold
Professional Applicators

Small Business 0% 52% 0% 62% 7%
Largest 10 Percent 0% 0% 0% 100% 33%

Orchardists

Small Business 0% 54% 0% 49% 5%
Largest 10 Percent 0% 4% 0% 61% 21%

Other Growers

Small Business 5% 5% 43% 33% 10%
Largest 10 Percent 8% 0% 8% 75% 17%

*Totals may exceed 100 percent because respondents were allowed to select more than one response. For example, one larger professional applicator indicated that it would make no change but would continue to keep hours below the threshold.Benefit-Cost Determination Page 16 of 26 December 2, 2003

Calculations of the number of handlers affected by the medical monitoring thresholds each month are discussed in ìnotes on calculationsî on page 22.
Cost of Wages and Benefits At several points, estimated wage costs are used. Estimated handler wages were calculated using employer responses to the survey to generate average wage estimates. Estimated wage costs for managers, supervisors, and administrative/clerical staff were used to develop costs of recordkeeping and training. In all cases, wage calculations have been adjusted to reflect the following additions to the basic wage. 39

• Federal Social Security/Medicare 7.65%

• State Unemployment Insurance 3.61%

• Federal Unemployment Insurance 0.80%

• State Workers Compensation 4.54%
Total Adjustment for Benefits 16.60%

Based on the information available and the nature of the employment relationships, the analysis assumes that there will be no additional benefit costs (for example, resulting from employerprovided medical insurance or pension benefits).

Table 3: Average Hourly Wage and Benefit Estimates Small Business Larger 10 Percent Professional Applicators $14.92 $14.21

Orchardists $10.13 $9.71
Other Growers $10.56 $11.83

Manager $34.80 Supervisor $23.20

Administrative/Clerical $13.92

39 The estimate was not adjusted to reflect slight variations in occupation rates or modifications based on employerspecific experience; the workersí comp ensation premium reflects only the empl oyer cost, and reflects an average estimated cost. The average employer pays somewhat le ss than the base rate, and a significant portion of the premium can be deducted from employeesí paychecks. The estimate has been increased 22 percent from the SBEIS to reflect proposed industrial insurance premium rates for orchards (although no decision had been made on those proposed rates at the time this analysis was prepared).Benefit-Cost Determination Page 17 of 26 December 2, 2003
Recordkeeping Costs. The central estimate for the recordkeeping cost per firm is the sum of three components: 1) initial recordkeeping setup costs, using materials generate d by L&I and estimated by L&I at 30 minutes of a field foremanís time per business;2) costs of recording the hours for pesticide handlers each month, estimated at 15 minutes perhandler month recorded; and 3) minimal costs for recordk eeping materials supplies. The assumptions for the central, high, and low estimates are as follows:

• In the central estimate, the wage for the fi eld foreman or other senior employee keeping records was estimated at $20 per hour, plus 16.60 percent in benefits.

• The low estimate assumes that a lower paid ad ministrative or clerical employee keeps the records at an estimated wage of $12 pe r hour, plus 16.60 percent in benefits.

• The high estimate assumes that the owner or a manager keeps the record s, with an estimated hourly wage of $30, plus 16.60 percent average cost of benefits (although some of these benefit costs would not necessarily be paid if the records were being kept by the business owner).
Training Costs. Training costs consist of the sum of four components: 1) the cost of the traine r setting up the training; 2) the cost of the traine r to conduct the training; 3) the cost of the handlerís time; and 4) costs for training materials. The analysis assumes that the field foreman (or equi valent) will be the traine r, and that he or she will spend one hour setting up the training and on e half hour conducting it. The employees will spend one-half hour each attendi ng the training (handler wages are based on responses to the survey and are reflected in Tabl e 3). Training material costs ar e estimated at $10 per employer.

• The central estimate assumes that at least half (5 0 percent) of these employees will return in the second year, based on consiste nt descriptions of these work ers in stakeholder and public meetings as being ìhighly valuedî and ìstableî members of the employerís workforce. This will reduce second year training costs accordingly (and would also mean that costs in future years would be somewhat lower than those in the second year). It also assumes that an employerís handlers can typica lly be trained as a group.

• The low estimate assumes that 75 percent of em ployees will be returni ng in the second year.

• The high estimate assumes that only 25 percent of employees will return in the second year.Benefit-Cost Determination Page 18 of 26 December 2, 2003
Baseline Testing Costs. The baseline testing costs are the sum of the following: 1) time spent in initial identification and selection of the medical provider; 2) clinical fees (including an initial fee for firs t clinic visit by each handl er, even if he or she subsequently declines testing); 3) laboratory analysis costs; 4) cost of handler wages; 5) mileage costs. The costs will also be affected by the employee pa rticipation rate and the number of employees who return to the employer in the second year. Employee Participation. A certain number of employees can be expected to decline participation in the medical monitoring after discussing it with the medical provider. Employees who do not participate will eliminate the labor atory costs and the costs of clinical evaluation of the test.

• The central estimate assumes that the employee participation rate will be 85 percent, based on consistent advice from stakeholders anticipating a relatively high non-participation rate.

• The low estimate assumes a 75 percen t employee participation rate.

• The high estimate assumes a 95 percent employee participation rate. Returning Employees. Many employees will return to the same employer in later years. Such employees will not repeat the initia l clinic visit in the second year (or in subsequent years).

• The central cost estimate assumes that 50 percen t of the employees who receive a baseline in

the first year will return to the same empl oyer (and medical provider) in the second year.

• The low estimate assumes that 75 percent of handlers will return in the second year.

• The high estimate assumes that only 25 percent of handlers will return in the second year.

Provider Costs . Medical provider costs ha ve been developed based on a determination of the time necessary to identify and sele ct a provider, as well as the pr oviderís clinical fees. Based on information from medical providers, the analysis includes an estimated $112 initial clinic fee for the first clinic visit for each employee, and an es timated $38 clinical evaluation fee for each test.

• The central estimate assumes one hour of a ma nagerís time would be necessary to identify and establish the relationship with a medical provider.

• The low estimate assumes that employers will be able to select from a meaningful number of medical providers identified and trained by L& I, reducing the managerís time in initial selection to 1⁄2 hour.

• The high estimate assumes that selection w ill take one hour of a managerís time.Benefit-Cost Determination Page 19 of 26 December 2, 2003
Laboratory Costs. Estimated initial baseline test cost s had been developed from data the department has collected from clinics and from employer responses to the survey. However, those numbers have been adjusted in this final analysis to reflect actual prices offered by the Public Health Laboratory (PHL) at the Washingt on Department of Health (which more than confirmed L&Iís earlier assumption that it would be able to es tablish a new benchmark rate using the first-year costs).

• The central estimate reflects costs quoted to L& I by the PHL of $27 for the first year and an

estimated $20 for the second year (based on the increase in volume) . In each year, a $10 clinical handling fee is also included in the analysis.

• The low estimate assumes that the second year laboratory analysis rate will be $18 (the rate

quoted by the PHL, which does not take into a ccount individual billing costs), with a $10 clinical handling fee.

• The high estimate assumes that laboratory analys is costs in the second year will increase to

the original estimate of $40). Wage and Travel Costs. Mileage (reimbursed at $.34 per m ile) and employee wages for all three estimates are based on responses to the employer survey.
Periodic Testing Costs. The periodic testing costs are the sum of the following: 1) clinical fees; 2) laboratory analysis costs; 3) cost of handler wages 4) mileage. The costs also will be affected by employee participation rates. Employee Participation. Employee participation assumptions are explained under the baseline testing, above. Employees who do not participate will eliminate the costs of periodic testing.

Provider Costs. An estimated $38 clinical evaluati on fee would apply for each test. Laboratory Costs. Estimated periodic test laboratory cost s are identical to those explained under baseline testing, above. Wage and Travel Costs. Mileage (reimbursed at $.34 per m ile) and employee wages for all three estimates are based on responses to the employer survey. Frequency of Monitoring. In all cases, the frequency of periodic monitoring is based on the monthly data reported by the employer survey. As discussed on page 16, it has not been adjusted to reflect the reported changes in behavior or work assignment by employers to reduce the number of handlers reachi ng the threshold level.
Work Practice Investigation. While the rule requires work practice investigat ions for handlers that have certain depressed cholinesterase levels found by pe riodic monitoring, this would not impose more than minimal costs on businesses. Employers are already required to be aware of hazardous conditions inBenefit-Cost Determination Page 20 of 26 December 2, 2003
their workplaces, and the monitoring results will actually provide them better information to meet their current obligations to identify and correct hazards. Therefore, the costs of the specific requirement to analyze work practices following an identified depression will be minimal and are not otherwise reflected here.

Medical Removal Costs.

The cost of medical removal is based on the ti me the employee is reassigned or removed from work completely, multiplied by the average wage and benefits. In order to calculate the cost of medical removal, it is necessary to estimate how frequently depressions requiring such removal will occur. It is also necessary to determine how frequently employees will be removed rather than reassigned to new duties. In additi on, it is necessary to de termine the ìcostî of reassignment (as opposed to removal from useful work). In each case, it is necessary to determine how long removal will last when it does occur. Frequency of Medical Removal. The California's Department of Pesticide Regulation found that 4.8 percent of workers tested had ChE values below the threshold level requiring removal. 40 The removal thresholds used in California at that time were 10% lower than those in the new Washington rule, so removal rates under the new rule might be slightly higher. 41 However, the group did not necessarily represent exposures addressed by this rule, particularly in the first year when the threshold for monitoring will be trigge red by 50 hours of covered activity, rather than 30. 42 In addition, the average California handler is likely to be exposed for more months, suggesting the Washington removal rate would be slightly lower based on lower cumulative exposures. The seven Washington growers and one Washington applicator who reported in the survey that they conduct voluntary ChE testing reported no depressed ChE levels . This could have provided a basis for an even lower estimate of removal fr equency. However, the details of this monitoring were not reported (number of handlers monito red, testing procedures and exposure durations triggering monitoring). Therefore, this informa tion, while suggestive, cannot be assumed to be representative of the populations monitored by the rule.

L&I reviewed this information and considered stakeholder comments about the differences between California and Washington application pa tterns, the increased use of closed systems, reductions in the use of the most hazardous pest icides, the more stringent worker protection requirements in place today compared to 1989, and the employer incentive to avoid the cost of removal created by the medical removal protection requirement itself. Based on these factors, L&I has concluded that the 4.8 percent removal rate represents the high end of the likely range and that the most likely outcome can be expected to be lower.

• The central estimate assumes a 3.0 percent removal rate.

40 Ames, et al , ìCholinesterase Activity Depression Among Ca lifornia Agricultural Pesticide Applicators,î American Journal of Industrial Medicine , 1989)
41 This expectation was confirmed by Ames unpublished analysis of removal rates under the more protective thresholds, which suggested a 7.5 percent removal rate.
42 It is not entirely clear what the eff ect of the higher hourly threshold would be on the average removal rate. While workers at a higher threshold obviously have a greater potential for exposure based on the level of pesticide use, it is also possible to argue that they are more likely to be higher skilled workers and may be more proficient in their work practices. Based on the data available, the department ha s reached no conclusion as to whether the average removal rate will be higher, lower or the same at the 50-hour thresh old as at the 30-hour threshold. For this reason, the same range of removal rates is used for the first year and for all subsequent years.Benefit-Cost Determination Page 21 of 26 December 2, 2003

• The low estimate assumes a 1.2 percent removal rate.

• The high estimate assumes a 4.8 percent removal rate.

Additional Medical Tests. In all scenarios, the analysis assumes that two additional periodic tests will be required before the em ployee is restored to full work status: one test to confirm the depression, and another test fo r return-to-work approval Wage Costs. Employee average wages are based on employer survey information, calculated against an estimated 55-hour work week, which is based on stakeholder information about the length of the work week during peak seasons. In addition, the employer survey provides an estimate of the availability of jobs in to which employees can be reassigned.

• For the central estimate, L&I assumes that wh en reassignment occurs another employee will

be assigned the duties of the pe sticide handler. The estimate also assumes the reported reassignment jobs have full value to the employer, so that the cost to the employer will be accurately reflected by an estimated $2 per hour in additional wages to pay another worker to take on the higher level duties normally performed by the pes ticide handler. The final analysis includes an additional $2 per hour in ad ditional wages to reflec t lost productivity due to training needs and related costs when replacement occurs.

• The central estimate also assumes that employees for whom reassignment jobs are not readily

available will be removed entirely, requiring employers to pay their wages and benefits without receiving any offsetting reduction in other costs.

• The low estimate makes the same assumptions about the cost of r eassignment but also

assumes that many employers who do not have reassignment jobs readily available will find reassignment jobs to avoid absorbing the complete cost of medical removal. Based on this assumption, and recognizing that such jobs are not likely to have full value to the employer, the low estimate reduces the cost of removing those employees by 25 percent.

• The high estimate assumes that the reported r eassignment jobs have only minimal value to

the employer and therefore calculates 75 per cent of the reassigned employeeís wages and benefits as a cost of compliance with the rule . It also assumes that employees for whom reassignment jobs are not readily av ailable will be removed entirely.

Duration of Removal. The only clear indication for the es timated length of time for a medical removal period that could be found in the medical literature is an average of 3.5 weeks. 43
In this study the results of data on 100 workers who had ongoing cholinesterase monitoring were evaluated. 44 Twenty-four workers were temporarily removed from exposure due to cholinesterase depression of great er than or equal to 40% for pl asma cholinesterase or greater than or equal to 30% for RBC cholinesterase. These work ers were returned to handling duties when their cholinesterase levels returned to wi thin 20% of the baseline. The shortest time an employee was removed from exposure was 1 day. The longest removal period was 119 days. Removing these outliers from the calculation, it is reasonable to expect a 22-day average removal period. This 22-day removal has been used for all scenarios. Table 4 on page 23 summarizes the various a ssumptions described in the preceding pages.

43 Lessenger and Fillmore, ìA Cholinesterase Testing Program for Pesticide Applicators,î Journal of Occupational Medicine , 1993.
44 The 24 percent does not reflect anticipated removal rate, because the sample was not representative; nonetheless, the data is useful in estimating the recovery period once a depression has occurred.Benefit-Cost Determination Page 22 of 26 December 2, 2003

Table 4: Summary of Parameters of High-Central-Low Estimates

High Central Low

Recordkeeper Wage $30 plus 16.60% $20 plus 16.60% $12 plus 16.60%

Trainer Wage $30 plus 16.60% $20 plus 16.60% $20 plus 16.60%

Handlers Returning in 2nd Year 25% 50% 75%

Handler Participation in Medical Tests 95% 85% 75%

Laboratory Costs (1st Year) $70 $55 $55

Laboratory Costs (2nd Year) $70 $60 $55

Manager Time to Select Provider 1 hour 1 hour 1⁄2 hour

Medical Removal Rate 4.8% 3.0% 1.2%

Medical Removal (w/o Reassignment) Wages plus 16.60% Wages plus 16.60% 75% of wages plus 16.60%

Medical Removal (with Reassignment) 75% of wa ges plus 16.60% $4 plus 16.60% $4 plus 16.60%

Handlers in 50- to 60-hour Group (1st Year) 125% of Centra l Estimate Estimated Distribution 75% of Central Estimate

Notes on Calculations Average number of employee months of pesticide handling above threshold. This was determined by aggregating the number of handlers monitored during any month of the year (see Table 5). For example, if a firm has six handlers expos ed at the 30-hour level in one month, then this results in 6 employee months of monitoring. If this happ ens in each of three months then this results in 18 employee months of exposure. This is calculated for 30-60 and 60+ levels of exposure for small and large firms and by sector. This statistic is used to calculate the number of periodic tests for average size fi rms and to estimate the number of medically removed handlers (the use of the 60+ data to esti mate exposures at the 50+ threshold in the first year is described in the footnote on page 13).

Table 5: Average Handler Months Above Monitoring Thresholds (Average per Employer with Employees Handl ing Covered Pesticides at Any Level)

First Year Second Year

Small Large Small Large Professional Applicators 2.91 17.81 4.10 22.00

Orchardists 0.97 6.99 4.08 18.96

Other Growers 0.32 1.24 0.68 3.33Benefit-Cost Determination Page 23 of 26 December 2, 2003
L&I does not have survey or other direct data showing pesticide handling on a monthly basis for those firms not expected to exceed the 30-hour th reshold (which is rele vant in estimating the record-keeping costs. However, the analysis assumes a monthly distribution similar to that found in the 30 to 60 hour range.
Estimates of Total Industry Compliance Costs The majority of these costs are the result of medical testing f ees, clinic evaluation fees, and doctors visits. There are two levels of exposure to covered pesticid es contained in the rule. In the first year, exposures of over 50 hours in a 30 -day period require the medical monitoring, and in the second and subsequent years, the threshol d is lowered to 30 hours. Costs were estimated for low, central and high scenarios (described in more detail in the attachments to this analysis). The appropriation of $378 thousand by the Wash ington State legislature in the 2003 regular session for laboratory-testing and medical fees w ould reduce the cost impact on industry and is in effect a shift in costs but not an overall reduct ion of actual costs; it is therefore not reflected in this analysis. The cost ranges fo r the first year and second years of the rule are in the following table. 45

Table 6: Estimated Compliance Costs

Central High Low

First Year $848,490 $1,159,349 $688,668

Second Year $1,274,487 $1,730,364 $1,096,165

The only qualitative cost suggested in the record related to the invasive nature of the medical test and the need to avoid imposing such a test on pes ticide handlers. However, since the test can be declined by the worker, the department has concl uded that its availability cannot accurately be considered a cost to the worker.

45 Throughout this analysis, dollar values for future years are presented in current dollars, without adjustment or discounting.Benefit-Cost Determination Page 24 of 26 December 2, 2003



### IV. B ENEFIT 

### -C OST 

### D ETERMINATION This assessment has been prepared by the Department of Labor and Industries (L&I) in compliance with the Administrative Procedure Ac t (APA), which requires that an agency adopting a ìsignifican t legislative ruleî 46 must ì[d]etermine that the probable benefits of the rule are greater than its probable costs, taking in to account both the qual itative and quantitative benefits and costs and the specific direct ives of the statute being implemented.î 47
To make the required determination, L&I has fi rst considered the crite ria for comparing the probable benefits to the probable costs.
The Statutory Mandate In this case, the statutory provision of the Washington Industrial Safety and Health Act (WISHA) being implemented requires L&I to adopt rules that ì[p]rovide for the promulgation of health and safety standards and the control of conditions in all work places concerning gases, vapors, dust, or other airborne pa rticles, toxic materials, or ha rmful physical agents which shall set a standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee ha s regular exposure to the hazard dealt with by such standard for the period of his working life; any such stan dards shall require where appropriate the use of protective devices or equipment and for monitoring or measuring any such gases, vapors, dust, or other airborne particles, toxic mate rials, or harmful physical agents.î 48
This provision, and the language in the federal Occupational Safety and Health Act (OSHA) on which is it based, have been addressed several tim es by state and federal courts. The case that prompted this rulemaking, Rios v. L&I , addresses the context in which the benefit-cost determination must be made. In Rios, the Washington Supreme Court reviewed the record and concluded by a 7-2 margin that
Because the Department had already invested its resource s in studying cholinesterase-inhibiting pesticides and because the report of its own team of technical experts had, in light of the most current research, deemed a monitoring program both necessary and doable, the Departmentís 1997 denial of the pesticide handlersí request was ëunreasoning and taken without regard to the attendi ng facts or circumstances.í Hillis, 131 Wn.2d at 383. Consequently, in failing to act on the request for rule making, the Department violated RCW 49.17.050(4), the requirement that the Department ëset a standard which mo st adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health.í 49

The Rios court stopped short of orde ring adoption of the rule, inst ead ordering L&I ìto initiate rulemaking on a mandatory cholinesterase m onitoring program for ag ricultural pesticide handlersî and remanded the issue to L&I ìfor further proceedings consistent with this opinion î 50 (emphasis added). In Rios , the court clearly did more than s imply direct L&I to consider the issue in the context of the formal rulemaking proce ss. It also identified the criteria on which the resulting decision must be based.

46 Defined in RCW 34.05.328(5).
47 RCW 34.05.328(1)(c).
48 RCW 49.17.050(4).
49 Juan Rios and Juan Farias v. Washington Department of Labor and Industries, et al , Washington State Supreme Court, Docket Number 70294-2.
50 Ibid.Benefit-Cost Determination Page 25 of 26 December 2, 2003

The courtís discussion of the statute indicates that L&I must give serious consideration to adopting a rule requir ing medical monitoring if L&Iís review of the rule making record concludes

• that a significant risk of pesticide poisoning exists,

• that a medical monitoring program is an appropr iate method to help reduce that risk, and

• that such a program is technologically and economically feasible. In light of the statutory mandate articulated by the Rios court, L&I must place a pre-eminent value on protection of worker health.

In the Cotton Dust case, the United States Supreme Court addressed the parallel Congressional determination:
Congress itself defined the basic relationship between costs and benefits, by placing the ìbenefitî of worker health above all other considerations save those making attainment of this ìbenefitî unachievable. Any standard based on a balancing of costs and benefits by the Secretary that strikes a different balance than that struck by Congress would be inconsistent with the command set forth in [the statute]. 51

The court went on to declare that ìcost-benefit an alysis is not required by the statute because feasibility analysis is.î 52 This formulation is simila r, if not equivalent, to the Rios court opinion that L&I is wrong to withhold action when a heal th rule would be ìboth necessary and doable.î Unlike federal OSHA, L&I must comply with a se parate statutory mandate to conduct such an analysis. However, it can be argued (and some have so argued in the record of this rulemaking) that the terms of the analys is have been predetermined by the legislative mandate.
Comparison of Probable Be nefits to Probable Costs L&I has concluded that there remains a significant risk to pesticide worker s. L&I has concluded that cholinesterase monitoring pr ovides additional and appropriate protection. Further, L&I has concluded that a cholinesterase-monitoring pr ogram is both technologically and economically feasible. Taken together, these co nclusions require that considerable weight must be given to the benefits discussed earli er in this document. In balancing the benefits against the costs, L&I has recognized that the limitations of the best available evidence prevent the use of a strictly mathematically model. The APA provides for this situation by explicitly requiring consider ation of ìqualitativeî as well as ìquantitativeî benefits and costs. In this case, the costs of empl oyer compliance with the rule can be estimated with some degree of confidence. That estimate, developed in itially for the Small Business Economic Impact Statement and adjusted slightly based on the ru lemaking record, begins on page 13 of this analysis. The central estimate indicates that the rule will cost roughly $858 thousand the first year and $1.27 million each year thereafter. 53 Against this probable cost, the department must weigh a variety of probable benefits, none of which can be quantified with any meaningful precision. Those benefits are discussed beginning on page 6 of this analysis.

51 American Textile Mfrs. Inst. v. Donovan, 452 U. S. 490, 506 n.25, 9 OSHA Cases 1913 (1981), 509.
52 Ibid.
53 The Legislature appropriated $378,000 to mitigate medical testing costs. However, that appropriation ñ which will reduce the cost of the rule for employers ñ does not reduce the overall cost of the rule and is therefore not reflected in this assessment of proba ble benefits and probable costs.Benefit-Cost Determination Page 26 of 26 December 2, 2003
As noted, one of the primary benefits of a mandato ry medical monitoring program is likely to be greater knowledge and certainty ab out the extent and effect of exposures to organophosphate and N-methyl carbamate pesticides. This benefit will largely be realized durin g the first two years of the ruleís existence. In comparing the benefits of such knowledge, as we ll as the other probable benefits of the rule, with the probable costs, L&I has determined that the value of greater certainty about the extent of over-exposure to covered pes ticides, and the result ing cholinesterase depressions, should be given considerable weight. And nothing short of a mandatory medical monitoring program is likely to provide anything approaching the cert ainty that would be provided by the rule.

With the information that will be made available fr om the first two yearís of the ruleís existence, L&I can evaluate the continued existence of the rule based on hard data and a more complete awareness of the ruleís benefits in the prevention of occ upational illness. If, as expected, the rule identifies a meaningful number of workers whose over-exposure to pesticides would not otherwise have come to light, the rule will be in place, or can be modified somewhat based on the information available. If, however, the da ta indicates that the expected over-exposures do not exist, L&I can take action to significantly modify, or even repeal, the rule. Because the rule explicitly includes such a review provision, any unexpected ìi mbalanceî of the benefits and the costs can be addressed.

Because of the benefits outlined earlier in this analysis, because of the statutory pre-eminence given to the protection of worker health, and because the rule pr ovides a mechanism to adjust its requirements if that becomes necessary based on new and better inform ation, L&I has concluded that the probable benefits of the rule outweigh its probable cost s, in each of the three cost scenarios discussed previously. L&I made this determination on a preliminary basis in its draft Benefit-Cost Determination, circulated for public comment ending October 31, 2003. The final determination, reflected by the document, is strengthened by the re duction in estimated compliance costs based on the most current information.