I. Decontamination 1. When decontamination would be required. The Agency proposed that water, soap, and single-use towels be available during any work activity where there is potential worker contact with concentrated or diluted pesticides or with surfaces that have been treated with pesticides. The amount of pesticide residue which reaches the skin and the frequency of removal are the primary determinants of farm worker exposure. Research has indicated that 98-99 percent of fieldworker exposure to pesticides residues is dermal (Ref. 77). The rate of dermal absorption varies by area of the body, type of pesticide and type of solvent used in the pesticide formulation (Refs. A9,A20). Hence removing pesticides from the skin before they are absorbed could lead to considerable reduction in field worker exposure. An expert providing a summary and analysis of testimony submitted for OSHA's Field Sanitation Standard made the following observations: Studies using radioactive pesticide solutions have shown that as much as 8 to 20 percent is absorbed in the first hour; absorption then slows so 50 to 70 percent is still on the skin after 5 hours. These data suggest that the absorption rate is 6 to 10 percent per hour. Assuming that workers wash their hands at least every 4 hours, and that washing removes the residual pesticides, 24 to 40 percent of the exposure would be absorbed; thus their exposure and subsequent illness could be reduced 60 to 76 percent; if they washed every 2.5 hours the expected reduction in exposure would be 75 to 85 percent (Ref. A34). Field workers usually are not exposed to pesticides in solution; they are exposed to the residues on plants. Dry residues are not absorbed through the skin as readily as pesticides in solution, thus the expected reduction in pesticide exposure might be even higher. Having decontamination water available in the field would contribute substantially to the prevention of pesticide-related illness among agricultural workers because: (1) it would allow the removal of unabsorbed residue from the skin; (2) it would allow immediate decontamination in case of a spill, the first and most important step in the first aid for pesticide poisonings; (3) it would reduce dermatitis and would prevent the increased absorption which occurs when the skin is damaged; and (4) it would foster washing before eating, drinking, or smoking which would reduce the risk from ingestion of residues from contaminated hands. For pesticide handlers and early-entry workers, decontamination provisions would be required at all times since these activities have the greatest risk of exposure. For persons working in treated areas after the REI has expired, the Agency proposed to limit the requirement to activities in areas that have been treated during the current growing season. The Agency believed that these decontamination provisions would reduce the incidence of eye injuries and skin irritation in workers and reduce the risk of chronic health effects from continuing occupational exposure to pesticides. Many comments were received on the length of the "growing season" in forests which may range from "decades" to 25 to 60 to 100 years or longer. They questioned the need for water during an entire crop cycle; they stated that a definite time should be specified. The Agency agrees that forestry, with a perennial crop, differs from sectors of agriculture that plant crops annually. EPA also recognizes that some pesticide use might have taken place long before hand labor tasks are undertaken. On the other hand, the Agency believes that there is a need for decontamination water in the forests and fields after the end of the REI. The proposal required water to be in the fields if pesticides were used any time during the growing season. EPA agrees with those comments that suggested that this requirement might be excessive and it sought to determine what might be a reasonable time during which water should be available for decontamination. Knaak et al. (Ref. A14) investigated a series of pesticide poisoning incidents that occurred after the expiration of an REI; the median time from application in these incidents was 29 days. The Agency has studied more recent data regarding the incidence of multiple-case systemic illnesses of agricultural field workers from exposure to residues of organophosphates in California. Among the 44 incidents for which data were provided, the mean length of time from application to poisoning was 20 days, with a median of 16 days. The range was from less than 1 day to 66 days, although this latter figure was an outlier and did not appear to be well substantiated. Excluding parathion (no longer registered for most crops) and this outlier, the longest period between application and reentry poisoning was 39 days. The Agency believes that poisoning incidents that occur more than 30 days beyond the restricted- entry interval probably stem from a miscalculation in establishing the restricted-entry interval that is listed on the label. As part of the Pesticide Hazard Assessment Project funded by EPA in 1985, Popendorf (Ref. 76) developed a computer model under realistic field conditions to estimate what might be the most appropriate REI's for some selected pesticides. The predicted residue hazards persisted for one of the pesticides studied for 30 days after the REI had expired. The Agency is seeking to corroborate and to refine this model. In the meantime, the Agency believes it should institute a safety factor into the Worker Protection Standards to compensate partially for this variability. In response to the comments, the Agency has modified the language in the final rule to require decontamination water for workers entering a treated area for which an REI is in effect and for 30 days after the expiration of the REI. 2. Water quality. The Occupational Safety and Health Administration's Field Sanitation Standard (29 CFR 1928.110) requires potable water in the fields for hand laborers for drinking and washing. The Agency proposed to require potable water for decontamination. Even though EPA's proposed requirement is intended to provide water only for washing, in practice the water also may be used by workers for drinking. In addition, only potable water can be defined in such a way that noncompliance can be ascertained clearly. There were many comments about the proposed rule's reference to potable water. Those supporting the requirement for potable water said that OSHA requirements for field sanitation already require potable water in the fields. Comments from representatives of the forestry industry pointed out that potable water might not be available to forestry workers working in areas with no vehicular access. There were several comments indicating that drinking water, required under OSHA requirements, would be sufficient for eye, hand and face decontamination, and that irrigation water or streams could be used for emergency whole body decontamination. Many of those opposing the requirement for potable water stated that farm wells are not required to meet the Safe Drinking Water Act requirements, so it is unreasonable to expect water supplied from a farm to meet this standard for quality. In their comments on the draft final rule, under FIFRA section 25(a), the United States Department of Agriculture stated that the decontamination provisions of the draft final rule would be unreasonably burdensome to employers because of the requirement for potable water for handwashing purposes. They stated that the standard for potable water is higher than necessary for washing purposes and that clean water should be sufficient, and would be readily available from farm and irrigation wells whereas potable water may not be. They believe that changing the decontamination provisions to permit the use of clean water would greatly reduce the burden and expense to farm employers without significantly reducing worker protection. They suggested that an appropriate standard might be the regional or local standard for water safe for swimming. As stated in the NPRM, the Agency proposed the standard of "potable" for the quality of water for two primary reasons: (1) "OSHA's Field Sanitation Standard (29 CFR 1928.110) requires potable water in the fields for hand laborers, intended not only for washing but also for drinking purposes. Even though EPA's proposed requirement was intended to provide water only for washing, in practice the water may be used by workers for drinking as well." (2) "[O]nly `potable' water can be defined in such a way that noncompliance can be clearly ascertained." At the time of the proposal, EPA believed that since OSHA uses the potable water standard for its Field Sanitation Standard, it would be easier for employers to comply with one water standard than with two. However, EPA was reminded by commenters that approximately 89 percent of agricultural establishments are not currently covered by OSHA's Field Sanitation Standard and that EPA should be responsive to the burden to employers on those establishments. EPA has been persuaded by the comments that a standard of "potable" may impose a substantial burden to agricultural employers without a concomitant benefit to workers. EPA believes the goal of this requirement should be to ensure that workers and handlers will be provided with water that will not cause illness or injury when it contacts the skin or eyes and will not cause illness or injury if they should happen to swallow it. Thus, the Agency has been persuaded to eliminate the requirement for "potable" water and instead has required the provision of water that meets the stated performance standards. This will permit employers to equip decontamination sites with water which is used for drinking on the agricultural establishment, but which may not meet the standard of potability in the Notice of Proposed Rulemaking. In reexamining the options, EPA considered establishing the quality standard of "clean" water defined as water safe for swimming. However, the Agency was unable to ascertain how agricultural employers would be able to apply such a standard. In adopting a standard of water quality different from a potability standard, EPA remains concerned that in practice, some workers may drink the water, especially if no alternative source of drinking water were available in the field. Moreover, the Agency has concluded that water must be of a quality safe for drinking because (1) workers and handlers may accidentally swallow water in the process of washing/flushing their faces or eyes, and (2) workers and handlers may mistake wash water for drinking water. EPA believes that placarding water to indicate that it is not for drinking purposes would be a difficult and unwieldy requirement given the range of languages and degree of illiteracy among workers. EPA concurs with OSHA's stance in the preamble to Field Sanitation (29 CFR Part 1928) that they "would like to eliminate the use of signs in several languages to identify different classes of water quality in the same workplace and the errors that occur when water supplies are confused." The Agency believes that defining decontamination/eyeflush water, in part, as water that "will not cause illness or injury if swallowed" will allow enforcement officials to ascertain noncompliance. EPA expects that the water used for drinking purposes on the agricultural or handler establishment will usually be the source of water for washing and eyeflushing. EPA notes that those establishments currently complying with the requirement for providing potable handwashing water to workers under OSHA's Field Sanitation Standard would also be in compliance with the EPA requirement for decontamination water if the same water were used. It is important to note, however, that EPA is not exercising any statutory authority in this rulemaking to address the general sanitation hazards addressed by the OSHA Field Sanitation Standard. The Agency recognizes the difficulty in providing decontamination sites for employees working in areas with no vehicular access and is modifying the decontamination requirements for activities performed more than 1/4 mile from the nearest place of vehicular access. For these remote work sites, the required decontamination site may be located at the nearest place of vehicular access, instead of within 1/4 mile of each worker or handler. Workers and handlers may use clean water from springs, streams, lakes, or other sources for routine and emergency decontamination at the remote work site, if such water is more accessible than the water located at the decontamination site at the nearest place of vehicular access. The Agency has concluded that, in such circumstances, the risks from the use of water of uncertain quality are likely to be less than the risks from delay in removing pesticides or pesticide residues from the skin or eyes. 3. Water temperature. The Agency proposed that water be provided at a temperature that will not injure the eyes. The Agency also considered two other options: first, no temperature requirement, which would be consistent with the OSHA Field Sanitation Standard; second, requiring the water to be within a specific temperature range, such as not greater than 100 or less than 40 degrees F. Comment was solicited on the water temperature. Several comments indicated that more guidance is needed on the temperature of the water and that a temperature range should be specified. The United States Department of Agriculture (Ref. C189) stated that the temperature of water carried in a bottle will be the ambient temperature. Others commented that the availability of water was far more important than its temperature. The Agency agrees that the availability of the water is more important than its temperature, but extreme temperatures not only may injure the eyes, they may discourage workers from using the water, rendering the provision ineffective. Water in a closed bottle left sitting in the sun in a hot climate can exceed the temperature of the ambient air. The Agency requires that the water be at a temperature that will not injure the eyes or skin. 4. Exception for short-term exposure. The Agency considered the option of an exception from the decontamination requirements for workers exposed to pesticides for less than three hours, or some other time interval. Of the few comments that addressed this topic, only the American Farm Bureau Federation (Ref. C96) proposed an exemption for short term exposure; all others specifically opposed it. The United States Department of Agriculture stated that an accident could happen at any time and there should be no exception to the decontamination provisions for short term exposure (Ref. C189). The California Department of Food and Agriculture (Ref. C248) stated, "There is no reason that water, soap and towels should not be available at all times. . . . [A] three hour cut off would not be protective since workers could go from one field to another and spend less than three hours in each." The Agency has not provided an exemption to decontamination requirements for short term exposure. 5. Water quantity. The NPRM proposed that water must be made available in sufficient quantities for normal hand and face washing by all workers using the water, and for emergency whole-body decontamination when accidental exposure to undiluted pesticides is possible, as in the case of handlers and early-entry workers. The Agency considered requiring minimum volumes of water and a replenishment requirement based on the type of work activity. The Agency proposed to require "an adequate supply" of water, allowing flexibility according to the particular circumstances. Any available supply of running water will meet the quantity requirement. It is anticipated that most greenhouses, many nurseries, and some farms and forests will have running water available. The Agency solicited comment on the proposed quantity. The Oklahoma Department of Agriculture (Ref. C17) said that "adequate supply" is ambiguous and the Association of American Pesticide Control Officials (Ref. C319) said that "sufficient amounts" needs definition. California Department of Food and Agriculture (Ref. C248) says it requires 10 gallons of water for 1 employee and 20 gallons for two or more where pesticides in toxicity categories I and II are mixed or loaded. The Agency will not modify the language of this provision; the Agency has drafted the requirement to be consistent with the language used by OSHA. 6. Water location. The Agency proposed that the water be reasonably accessible from each worker's place of work. The Agency considered requiring a specific maximum distance from each worker within which the decontamination site must be located; this is the approach taken in the OSHA Field Sanitation Standard. "Accessibility" will vary by establishment. The Agency intended that decontamination sites be as near to workers as is practicable but the site for workers may not be placed in a pesticide-treated area or an area under an REI. The Agency solicited comment on its proposal for the location of the decontamination site. The Association of American Pesticide Control Officials (Ref. C319) commented that "reasonably accessible" needs definition. The Farmworker Justice Fund, Migrant Labor Action Program, Rural Opportunities Inc. and Mr.Cox (Refs. C126,C157,C168,C241) suggested that decontamination sites should be no more than 1/4 mile from workers. Others noted that the restricted entry area is where contamination may occur, and that decontamination sites should be made available there, and that water in a tank is protected in a treatment area. The Agency believes that the language of this requirement should be consistent with the language of the OSHA Field Sanitation Standard requiring that the decontamination site must be reasonably accessible, not to exceed 1/4 mile or approximately a 5-minute walk from each worker's place of work. As a result, the rule has been revised to include a specific distance requirement of 1/4 mile. For agricultural workers, the decontamination site must not be in an area under an REI. For early-entry activities, the decontamination site may be in the restricted-entry area where the employees are working. For application activities, the decontamination site may be in the area being treated if the soap, single-use towels, and clean change of clothing are in enclosed containers and the water is running tap water or is enclosed in a container. 7. Eye flushing. The Agency proposed that an eye flush dispenser be provided during handling and early-entry situations involving a product which is a potentially severe eye irritant, i.e., toxicity category I or II for eye irritation, signified to the user by a requirement for protective eyewear on the labeling. The dispenser would be immediately available for emergency use, e.g., it would be carried by the handler or on the handler's vehicle. The Agency solicited comment on whether the dispenser needs to be available during all activities or only certain ones, whether each worker should carry a dispenser, and whether carrying a one pint dispenser on one's person represents a health hazard from possible heat-induced illness because of the extra weight. There were many comments on emergency eye flushing. Strong support for mixers and loaders having eye flush dispensers came from the National Council of Agricultural Employers, several orchards, and the California Department of Food and Agriculture as well as farm worker groups. Several labor advocates stated that eye flush equipment should be available to all workers. Farm organizations and grower groups wrote that not all workers need to carry eye wash dispensers -- only handlers have such a need. Again, language such as "otherwise immediately accessible" was thought to be vague. The Oregon Health Division (Ref. C172) sent a copy of an OSHA Field Directive that cautions about the possibility of contamination of eyewash water by acanthamoebae. Some comments suggested that if pesticide is a hazard to eyes, it is best if each person carries a dispenser, but if that is not possible, a full pint for each 2 or 3 persons should be made available. Several persons commented that eye wash containers carried by workers may be contaminated by pesticides. The Agency is concerned that the language of the proposed rule may have led to some misconception about what water may be used for flushing the eyes in case of emergency. The decontamination water that must be provided for routine washing and emergency whole-body cleansing must not cause illness or injury when it contacts the eyes. Therefore, the Agency has added "emergency eyeflushing" as one of the basic functions to be met by that water. EPA wants to make clear that while special eyewash dispensers may be used, any source of water that meets the standards for decontamination in the final rulemaking is acceptable for flushing the eyes. In appropriate instances, the language of the rule has been altered to change the requirement from "eyeflush dispenser" to "eyeflush water." In addition, these requirements have been combined in this final rulemaking to avoid confusion. In response to comments about workers and handlers who need more immediate access to eyeflush equipment, the Agency requires that the emergency eyeflush water shall be carried by the handler or early-entry worker, or shall be on the vehicle or aircraft which the handler or early-entry worker is using, or shall be otherwise immediately accessible. Again, EPA wants to make clear that this water does not necessarily have to be in a dispenser. Any nearby source of adequate amounts of water meeting the definition of decontamination water satisfies this requirement. The Agency is persuaded of the importance of protecting against bacterial and other types of contamination of the water used for washing and eyeflushing. Therefore the final Rule will require employers to assure that "at all times when the water is available" to workers and handlers, it will remain of a quality and temperature that will not cause illness or injury when it contacts the skin or eyes or if it is swallowed. The agricultural employer and handler employer will be responsible for making sure that the water is replaced and the container is cleaned often enough to prevent bacterial or other contamination that could cause illness or injury to employees using the water for washing or eyeflushing. In most circumstances this would mean replacing water in containers at least daily and regular cleaning of those containers. 8. Other requirements. For efficient pesticide removal, the surfactant qualities of soap are necessary during washing. The Agency also proposed to require single-use drying materials, such as paper towels, which would lessen the likelihood of washed hands being re- contaminated by workers wiping them on clothing. A change of clean clothing, such as a "one size fits all" coverall, would be required at each decontamination site for handlers to use if their clothing became saturated by a spill, by spray, or from residues. The only comment on this topic strongly supported the availability of water, soap and towels. The Agency has not modified these requirements. 9. Other Federal and State regulations related to the proposed decontamination requirements. The OSHA Field Sanitation Standard includes requirements for water for hand washing, and some States have requirements that differ slightly from the OSHA standard. Although these general sanitation requirements would provide for adequate pesticide decontamination under some circumstances, they do not cover all agricultural workers. There was a request for consistency with OSHA's Field Sanitation Standards among the comments received on this topic. EPA has employed the regulatory wording in OSHA's standard, whenever possible. EPA intends that meeting the decontamination requirements of the final rule will also meet OSHA's requirements. J. Cholinesterase Monitoring EPA proposed that commercial pesticide handlers who are exposed to toxicity category I or II organophosphate pesticides for 3 consecutive days or for any 6 days in a 21-day period be monitored for cholinesterase inhibition. The Agency explicitly solicited comments on: (1) the types of workers to be monitored and, in particular, whether the requirement should be extended to private handlers; (2) the length of exposure (whether a more sensitive "trigger" with fewer days exposure would be more appropriate); and (3) the difficulties, costs and advantages of day-based and symptom- based triggers. 1. Types of workers to be monitored--(a) Handlers. Some respondents felt that only commercial handlers had sufficient exposure to warrant monitoring. Many other respondents argued that both commercial and private pesticide handlers may have sufficient exposures to warrant cholinesterase monitoring. A group representing farm workers in Oregon, SALUD (Ref. C195) noted that they were aware of situations where organophosphorus pesticides were applied 10 months of the year by spray rig operators who would be excluded from monitoring as private applicators. Evergreen Legal Services (Ref. C98) described situations where private applicators worked all day for several days in succession applying pesticides with tractor rigs and backpack sprayers using high pressure upward directed spray on fruit trees. Other comments opposed the inclusion of private handlers on the basis that private handlers receive less exposure than commercial handlers (Refs. C166,C180). Some comments suggested that private handlers may have a greater need to be monitored than commercial handlers. Texas Rural Legal Aid, Inc. (Ref. C147) stated, [E]xperience has shown that private applicators are often untrained, unprotected, and even unable to read the labels or warnings on the chemical containers. This group of workers has had many of the most serious injuries we have seen. The Oregon Department of Human Resources (Ref. C172) commented: Many agricultural operations which utilize pesticides in these categories include non-licensed applicators working under supervision of a private applicator. These applicators frequently have less training and are at greater risk of exposure. The Association of American Pesticide Control Officials (Ref. C319) wrote: "There is a much greater concern for private handlers that infrequently use "dangerous" pesticides who are in many cases untrained, do not have or use the proper PPE, do not recognize the potential hazard and probably apply these pesticides under conditions of greater exposure." Other comments stated that any employee who handles pesticides should be monitored. Other comments suggested that cholinesterase monitoring be an option rather than a requirement. The Pennsylvania Farmers' Association (Ref. C331) wrote: "We believe the decision of whether or not to test for cholinesterase levels should be left up to the individual private handler based on their knowledge of their exposure." The Association of American Pesticide Control Officials (Ref. C319) stated: "If the employer determined that they wanted to implement, on a voluntary basis, a cholinesterase program, it would, in all probability, be more successful." Some comments opposed expanding the monitoring to private handlers because of the cost. The North Carolina Farm Bureau Federation (Ref. C180) stated: "A medical monitoring program for small farms would be a tremendous financial burden." On the other hand, some growers stated that they have cholinesterase monitoring programs for their workers. (b) Agricultural workers. Several comments supported the inclusion of all agricultural workers in a medical monitoring requirement. Rural Opportunities, Inc. (Ref. C168) stated: . . . this part [cholinesterase monitoring] of the regulation affords no protection for early re-entry workers, other farmworkers, and family members. We would encourage the expansion of this requirement to cover at least a sampling of early re-entry workers at the beginning and end of the employment period. The Maryland Division of Labor and Industry (Ref. C80) commented: All workers exposed to organophosphates should be monitored for cholinesterase inhibition. The risk to these workers is so high that measures must be taken. The United Church of Christ Commission for Racial Justice (Ref. C310) questioned the exclusion of workers and asked "What is the cost-benefit analysis which led EPA to propose testing only handlers?" Other comments opposed the inclusion of agricultural workers in a medical monitoring program. The California Department of Food and Agriculture (Ref. C248) stated: "It is unnecessary and impractical for fieldworkers to undergo cholinesterase monitoring." The Northwest Food Processing Organization (Ref. C240) wrote: [We are] opposed to expanding the current proposal for cholinesterase monitoring to growers and workers who are not handling, applying, mixing, or loading. Monitoring can only be justified for those individuals who are applying the substance or who, through the course of handling or mixing, have opportunity to come into contact with the cholinesterase inhibitor. The National Farm Workers Health Group (Ref. C179) would like to see testing of workers who have been poisoned: [Part 170] does not address testing of workers after a poisoning episode in the fields involving cholinesterase inhibiting pesticides. Since field workers do not have baseline values for comparison, repeat testing is necessary to determine if cholinesterase inhibition has occurred. A single laboratory value in this situation is not adequate to make such a determination. The lack of such testing has been a serious problem in cases in California. We are proposing a mandatory testing procedure when such poisonings occur. 2. Which pesticides should be monitored. The Agency solicited comments on which organophosphorus pesticides should be covered by the monitoring program. The National Agricultural Chemicals Association (Ref. C311) stated: "NACA finds little scientific justification for further restricting the scope of pesticide coverage to a smaller subset of compounds unless California experience (which the Agency references) clearly indicates a relative absence of adverse findings with, for example, Category II compounds." Chemlawn (Ref. C170) which provides cholinesterase monitoring for their workers, reminded the Agency that pesticides containing organophosphorus compounds marked "DANGER" or "WARNING" because of irritant effects rather than their potential to cause cholinesterase inhibition need not be covered. The Occupational Health Legal Rights Foundation (Ref. C156) commented: "We agree . . that cholinesterase monitoring should cover all Toxicity I and II organophosphates . . . not just Toxicity I . . . " Industrial Hygiene New England, Inc. (Ref. C340) stated: [A] more meaningful response to the proposal could be made if more data were available. A list of pesticide products associated with the need for cholinesterase monitoring, with the `top 5 or 10' incident-causing pesticides identified, would be of substantial help. The National Farm Workers Health Group (Ref. C179) advocates that all organophosphate pesticides be included in a monitoring program and states: "[W]orker poisonings with class III and IV organophosphate pesticides, including malathion, have been reported in the medical literature." Several respondents felt that carbamate pesticides also should be included in a cholinesterase monitoring program. A few respondents questioned why biological monitoring was targeted at organophosphate pesticides. One said there should be more comprehensive health monitoring for agricultural workers. 3. Exposure trigger. The Agency also solicited comment on the length of exposure that should occur before an employee must be monitored and whether monitoring should be based on symptoms. The majority of respondents supported the Agency's proposed "trigger" of 3 consecutive days or any 6 days of exposure in a 21-day period. The California Department of Food and Agriculture (Ref. C248), which has several years experience with a statewide monitoring program, advised: A day-based trigger is best and easiest to compute, although the proposed 21-day period may be difficult to track. If symptoms appear, it is time to monitor the entire work force. One comment stated that a trigger based on hours (rather than days) of exposure would be a more rational way of including the highly exposed. Some comments suggested using a 30-day trigger instead of a 21-day one. One respondent recommended a shorter than 21-day trigger. A few reviewers stated that the Agency had given no rationale for the trigger chosen. One comment pointed out problems in using a symptom-based trigger; symptoms of cholinesterase inhibition are often difficult to distinguish from other illnesses. A symptom-based trigger is not sufficiently defined for use as a regulatory tool and could be confusing to both the employer and the supervising physician as to its applicability. One comment suggested that determining the ideal trigger would have to wait until more data were available. That would come only when the monitoring program had been implemented and evaluated. Some comments suggested eliminating a trigger and requiring the testing on a preset schedule (Refs. C129, C299). Driscoll Citrus Service, Inc. (Ref. C253) stated: . . . we are testing cholinesterase at the start of our application season to establish a base from which to evaluate any future problem. The local county health doctor feels this plus maybe once more in the middle of the season would be adequate. 4. Recordkeeping. Many comments, both those for and against a cholinesterase monitoring requirement, expressed concern about the recordkeeping that would be necessary to implement a cholinesterase monitoring program. Several comments pointed out that it would be difficult to track migrant workers. Some commenters expressed concern that the trigger would create a "record-keeping nightmare" for growers who would have to record every day on which an organophosphate pesticide in toxicity category I or II was handled. One aviation firm stated that keeping records on organophosphorus pesticides used for two years would be a hardship and expense and that if this regulation was going to be imposed, a simple form should be developed by the Agency that would be approved for keeping such information. Some groups wanted the record keeping requirement extended. The National Farm Workers Health Group (Ref. C179) stated: This section [cholinesterase monitoring] is . . . deficient in its recordkeeping provisions. Medical monitoring and exposure records should be maintained by both commercial and private handlers for 30 years. These critical records are essential not only for monitoring acute exposure situations, but also for epidemiological studies of effects of chronic exposure. The section provides no rights for workers or their representatives to have access to their medical monitoring and exposure records. 5. Cholinesterase monitoring guidelines. The NPRM states that the technical issues associated with cholinesterase monitoring would be addressed in guidelines that would be available to State Agencies, physicians, and laboratories responsible for conducting the tests. Given the importance of these guidelines, several groups insisted that public review be granted as well as review by the Agency's Scientific Advisory Panel to assure that guidelines met standards for good laboratory and good medical practice. The National Farm Workers Health Group (Ref. C179) submitted guidelines that they would like to see in the final rule. Several comments emphasized the importance of establishing a baseline when workers are not exposed. 6. Costs and who should bear them. Concern was expressed over how much this part of the regulation would cost and who would pay the costs. A number of comments predicted financial disaster and that costs would cause many commercial applicators to go out of business or would be "prohibitive", and "catastrophic" for the smaller businesses. Florida Citrus Mutual (Ref. C88) stated: "The costs associated with implementing such a [cholinesterase monitoring] program seem unreasonably burdensome." The North Carolina Department of Agriculture (Ref. C58) commented: "We feel that the Agency has grossly underestimated the magnitude of the resources required to meet such prescribed monitoring." Two comments included estimates that monitoring would cost $70 per test or $200 to $400 per employee over the growing season exclusive of the costs of record keeping and additional physician fees. Others noted that lost work time and cost of transporting workers to a physician office where the test could be performed would be an "incredible burden to growers." In some remote rural areas, the testing would necessitate long-distance travel to the nearest qualified physician. One comment warned that the expense of the test and the time off work probably would result in this regulation being ignored. Another suggested a cost- benefit analysis be done to determine whether private applicators should be covered. A comment from one organization stated that the reduced medical disability costs among workers would easily outweigh the costs of implementing a monitoring program. Several respondents wanted to see a clearer statement of who pays the costs associated with cholinesterase monitoring and some wanted the wording changed so it was clear that the employer pays for the monitoring of employees. The Yakima Valley Workers Clinic (Ref. C249) stated that workers will refuse cholinesterase testing because of the cost if they must pay for the testing. The Clemson University College of Agricultural Sciences (Ref. C358) commented: The Public Health System should become involved in the cholinesterase testing program by conducting current, applicable research, providing guidelines concerning the frequency of the tests, and performing the tests at no cost to the farmer or worker. Federal and state funds should be made available for this. The Oklahoma Department of Agriculture (Ref. C12) stated: "EPA should recognize that "the cost of doing business" is ultimately paid by consumers, not the company." Comments from worker representatives expressed concern about what happens when an employee is removed from handling pesticides because of lowered cholinesterase. Some stated alternative employment should be provided; others asked whether the employer would have to make up lost wages that might result from changed work. Still others wanted to be sure that workers would be compensated when they were removed from handling pesticides because of cholinesterase inhibition. 7. Deficiencies in cholinesterase testing methods. Numerous comments expressed concerns regarding the validity and the reliability of cholinesterase testing methods, the availability of qualified laboratories to support a cholinesterase monitoring program, the sufficiency of most physicians' knowledge about the toxicity of pesticides, and the ability to interpret the results of cholinesterase tests properly. The Virginia Department of Forestry (Ref. C36) remarked: [Y]ou list four deficiencies of cholinesterase monitoring as a regulatory tool. The four you have listed makes the situation unworkable even for a farm situation where the workers or handlers stay on the same farm. Add to the problem list you cite, the operational and logistical problem of the contract tree planters and private forest ownership patterns in the above scenario. (a) Standardization needed. A number of concerns were expressed about the validity of the cholinesterase test. It was felt that results were too variable to serve as a reliable indicator of pesticide exposure and that cholinesterase levels could be influenced by lifestyle or medical conditions. The Yakima Valley Farm Workers Clinic (Ref. C249) stated: "Cholinesterase testing (CE) needs standardization. . . . Limitations of CE testing need to be publicized." The North Carolina Department of Agriculture (Ref. C58) commented: [W]e are alarmed to see the agency considering such implementation [cholinesterase monitoring] in light of its own admission, that there are few laboratories capable of performing and interpreting such results. We commend EPA for its belief that the industry will rise to the challenge, however, we feel that the need must be met before the requirement is in place. The Work Group on Pesticide Health and Safety (Ref. C297) stated: Cholinesterase testing should be standardized among all laboratories involved in this process. At the current time, tests from individual labs can reveal different findings resulting in a high degree of false positives and negatives and negating the purpose of cholinesterase monitoring. A national standard is needed. The New England Fruit Growers' Council on the Environment (Ref. C143) stated: [W]e have learned that the standard deviation for an individual's plasma cholinesterase level is . . . about 20% from baseline. The accepted range of plasma cholinesterase levels (between individuals) is . . . about 40%. Red cell range and deviation are similarly wide. The Maryland Division of Labor and Industry (Ref. C80) suggests: "The disagreements among professionals about levels, baselines and frequency of testing will never be resolved without the proper statistical base. This could be the forum for creating the data base." (b) Physician knowledge. Some comments stated there should be some kind of certification program for physicians or questioned the mandatory use of physicians. Chemlawn (Ref. C170) suggested that the rule not require that a physician interpret test results, but that any test found to be below normal be referred to a physician. It felt this was common industrial hygiene practice that they follow in their cholinesterase monitoring program. Others agreed that the requirement to have a physician supervise all testing was an unnecessary expense. The Association of American Pesticide Control Officials (Ref. C319) commented: Employer responsibilities require the employer to contract with a physician. Is either a verbal or written contract acceptable. . . . Who determines whether the physician uses the EPA guidelines or equivalent? . . . Employers are required to follow the physicians's recommendations. . . . Are these recommendations enforceable? If they are enforceable, how will the enforcement agency know they have been issued? Who is responsible to provide the enforcer with this information? . . . In some areas of the country, it may be necessary for handlers to use an entire work day to travel to the physicians, have a cholinesterase test and such other observations the physician deems necessary. (c) Laboratories. Other comments focused on the possible problems with laboratories. Some stated that in many rural areas, qualified laboratories with appropriate quality control procedures would not be available. Standards or certification for laboratories and procedures for monitoring or assuring accurate and timely processing of test results were concerns for several reviewers. Chemlawn (Ref. C170) suggested that labs should be eligible only if they were licensed by the Clinical Laboratories Improvement Act and that licensing included cholinesterase testing. The Association of American Pesticide Control Officials (Ref. C319) commented: Laboratory results in rural areas may not be received for two or three days or more. If a significant depression is being experienced, then the owner/handler/physician will not know this and the handler will continue to have exposure. (d) Public reaction. Some of the comments indicated concerns about reaction to mandatory cholinesterase testings. The New England Fruit Growers' Council on the Environment (Ref. C143) stated: "We fear that required cholinesterase testing without thorough public and media education about this very normal range and deviation will open the door to more of the sort of sensationalistic journalism and other uninformed attacks from which the fruit industry already smarts." Foothills Nursery (Ref. C215) commented: "[We] fear that someone who gets AIDS will blame the blood test for giving it to him." 8. Need for testing. Many comments questioned the need for a mandatory requirement for cholinesterase monitoring. The Chemical Producers and Distributors Association (Ref. C125) stated: EPA acknowledges that it will review the data collected under the cholinesterase monitoring program at the end of three years to determine if the program should be continued on a nationwide basis, modified or eliminated. If the need for a nationwide program is not now clearly demonstrated, the Agency should implement a test monitoring program in selected states, review the data collected and then make a decision on whether to proceed with a nationwide program. The New England Fruit Growers' Council on the Environment (Ref. C143) commented: The New Hampshire Fruit Growers' Association is in the midst of a voluntary cholinesterase study of applicators and field workers. To date not a single sample has suggested cholinesterase suppression. . . Driscoll Citrus Service, Inc. (Ref. C253) remarked: . . . not enough basic information is known about what things affect cholinesterase and what reduction can occur before symptoms occur. Rather than have everyone perform the tests I think the EPA should monitor sample crews applying spray and applying granules to determine the needed information before any rules are put into effect. Aerial applicators requested that they be exempted from the monitoring requirement and several cited their safety records (e.g., only 1 poisoning in 10 years) as evidence that such regulations were not needed for them. The National Agricultural Aviation Association (Ref. C165) pointed out that in some States regulations prohibit pilots from mixing and loading pesticides. It noted that with improvements in the technology of aerial application pilot exposure is less likely now and that costs would be burdensome because many firms are small, family-run businesses. The Association of American Pesticide Control Officials (Ref. C319) thought that EPA should consider eliminating this part of the rule because other portions of the worker protection rules, once implemented, would provide sufficient protection. It states: This requirement seems to ignore several issues: a) the proposed rules establish specified PPE requirements for commercial handlers which presumably will reduce exposure; b) applicators and their handlers, many of who are certified are more knowledgeable of organophosphate risks and the need to minimize exposure; c) employers of handlers recognize their personal liability for not protecting these handlers has significantly increased in the last few years; and d) industry and associations of users have increased their communications with applicators and handlers on how to protect themselves and their employees. 9. Other concerns. A number of respondents wanted more explicit statements on how notification of the person being tested would operate. Several groups wanted the rule to state explicitly that the physician would notify workers of the test results, not just the employer. The National Farm Workers Health Group (Ref. C179) commented: "This section provides no rights for workers or their representatives to have access to their medical monitoring and exposure records." Some of the aviation firms felt that cholinesterase test results would be considered confidential medical information that could only be revealed to an employer if the pesticide handlers signed an authorization to the physician to release the results to the employer. Some comments suggested that any diagnosed poisoning or significant cholinesterase depression should be reported automatically to State or federal authorities. The National Farm Workers Health Group (Ref. C179) stated: "This section does not require physicians and employers to report known or suspected pesticide illnesses to enforcement officials. Timely reporting of illnesses is essential for adequate investigation, enforcement, and prevention." They also recommend a new section be added to requirements for physicians to state that the physician must: "Notify the employer and the FIFRA enforcement Agency within 24 hours after the physician knows, or has reasonable cause to believe, that a worker is suffering from pesticide poisoning or any disease or condition caused by a pesticide." 10. Alternatives. Several comments offered alternatives to the proposal for mandatory cholinesterase monitoring. The Association of American Pesticide Control Officials (Ref. C319) suggested: EPA should develop an alternative approach. . . . Cholinesterase testing should not be mandatory for commercial operations. . . . a system requiring owners or commercial handlers to report any "poisonings" to the federal or state pesticide enforcement agencies could be implemented.. . . Once the SLA [State Lead Agency] or EPA determined that the commercial operation was deficient in providing PPE, and other protective measures required by the rule and documentation of employee (handler) poisoning is verified, then a specific cholinesterase program would have to be implemented by the commercial operation. . . . An employer could have this mandatory requirement of cholinesterase testing suspended after one year. The physician would have to certify that the handlers are not experiencing cholinesterase depressions of any significance . . . The advantage of this proposal, according to AAPCO, is that it provides a strong economic incentive for employers to assure safe work practices to prevent poisonings. The Oregon Division of Health (Ref. C172) stated: [A] requirement for baseline cholinesterase tests for all handlers exposed at the specified level would at least provide a means of evaluating the severity of an acute exposure episode, or the extent of cholinesterase inhibition in a worker who becomes symptomatic from chronic exposure. This alternative would provide additional protection with less of an economic and recordkeeping impact than fully expanding the applicability of the monitoring requirement. Workers with exposures below the proposed trigger would also benefit from a baseline cholinesterase test. The fact that they handle these products less frequently may enhance the likelihood of an accidental exposure. The Agency is concerned about the number of comments that pointed out the actual or potential practical problems of cholinesterase monitoring, including the difficulty in finding knowledgeable physicians to set up monitoring programs and qualified laboratories to perform the analyses. California, the only State that currently requires cholinesterase monitoring for pesticide handlers, has a quality control program for laboratories. The comments pointed out that such a program would be needed nationwide if a monitoring program were to be a success. EPA is not prepared to establish such a program nationwide at this time. The Agency believes that despite the practical difficulties associated with a nationwide program, the monitoring of worker/handler exposure may be prudent occupational health practice and encourages employers wishing to operate such programs. To facilitate voluntary programs, the Agency has required that pesticides that contain cholinesterase inhibiting compounds be identified as such in the labeling of the product. The Agency also is interested in cooperating in research or evaluations that might be done on new or existing exposure monitoring programs. The Agency is concerned that even reliable blood-level cholinesterase monitoring often would not prevent pesticide poisoning incidents. Blood samples are taken at intervals -- weekly, biweekly, or often monthly -- during the exposure season. As a result, the handler may accumulate enough exposure between samples to become ill. In addition, the delay between sampling and the evaluation of the test results is such that most handlers will receive more exposure before the test results are known. Before such a monitoring system can indicate that handlers should be removed from further exposure to cholinesterase- inhibiting pesticides because their blood cholinesterase levels are dangerously low, the handlers already may have received enough additional exposure to precipitate acute poisoning. In general, EPA is troubled by the after-the-fact nature of available cholinesterase monitoring methods. The Agency would prefer to explore methods of monitoring exposures to cholinesterase-inhibiting and perhaps other pesticides which are more likely to be preventive. One promising approach involves immunoassay-based detection. Immunoassay techniques could provide rapid, simple, and cost-effective monitoring methods for exposure monitoring systems under field conditions. It is expected that inexpensive kits can be developed that will yield quantitative results in less than 30 minutes, thus enabling more frequent monitoring and rapid response if unacceptable exposure is indicated. This technology therefore could provide an effective means of signaling the pesticide handler when exposure is unacceptably high. EPA has determined that more research is required to develop immunoassay monitoring systems for pesticide handlers. However, the research data to date indicate that an immunoassay-based personal monitoring exposure system probably could be developed. Immunoassay devices use antibodies as receptors to sample the environment of the exposed persons. Specific antibodies to many pesticides of concern already have been developed and evaluated but specific antibodies for other priority compounds need to be identified. Ideally, a sampling system would be developed to incorporate all of the compounds of concern. The Agency encourages the rapid development of practical and reliable techniques of this kind and welcomes further information on on- going research and the opportunity to cooperate with developers on the necessary research. To support the goal of improving exposure monitoring technology, the Agency also intends to consider requiring the development of such detection methods for the registration or continued registration of selected pesticides. In conclusion, although a blood-level cholinesterase monitoring program may be prudent for some handlers, EPA has determined that imposing a nationwide requirement for such monitoring is not justified at this time. The Agency is not convinced that such a program would provide benefits commensurate with the costs entailed. The Agency intends to pursue the development of more effective exposure monitoring systems, such as the immunoassay-based system discussed above. EPA intends to reconsider the need for and the appropriate form of exposure monitoring for pesticide handlers after there has been an opportunity to implement the new Worker Protection Standards through revisions to labeling. This will give the Agency the opportunity to evaluate more thoroughly on-going research in this area and the results of new or existing exposure monitoring programs. The Agency would expect to issue a proposed rule in this area in about 3 years. K. Emergency Assistance 1. Provide information on location of nearest medical care facility. Although the Agency believes that precautions such as entry restrictions, use of personal protective equipment, decontamination procedures, and training will decrease the frequency of acute pesticide poisoning or injury incidents, medical emergencies involving agricultural workers and handlers may still arise. In such cases, prompt medical treatment is necessary to mitigate the extent of the injury or poisoning. EPA proposed that all workers be informed of the name, address, and telephone number of the nearest physician, clinic, or hospital equipped to provide medical care in a pesticide poisoning or injury emergency. This information would be required to be displayed in a prominent location on the agricultural establishment at all times. 2. Emergency transportation. In pesticide poisonings or injury emergencies, the victims may be unable to transport themselves to the nearest medical facility. EPA proposed that prompt transportation to an appropriate medical facility be made available to workers and handlers who suspect pesticide poisoning or injury, or when a pesticide exposure has occurred which might reasonably be expected to result in pesticide poisoning or injury. 3. Emergency information. In a suspected pesticide poisoning or injury, the most effective medical care can be provided only through a correct diagnosis and prompt administration of the appropriate antidote or treatment. A doctor must know the name of the product or active ingredient to which the worker or handler has been exposed in order to ascertain the appropriate treatment. EPA proposed that in an emergency, workers and handlers be provided, if available, the product name, registration number, active ingredient(s), and first aid or antidote information and any other information relating to the pesticide that might be useful in treatment for any agricultural pesticide product. This information is available to pesticide users from the label of the product; the requirement to provide information did not require that the user maintain records or keep pesticide labels or containers. There were not many comments on the emergency duties and responsibilities proposed for the revised regulation. Comments such as: "I am depressed that simple compassion and responsibility have to be legislated." "Emergency duties should be part of the law and there should be stiff fines for those who do not provide them." "These are provisions any responsible person would take." "Emergency care is a natural occurrence." "Certainly any farmer would be willing to transport a worker in the event of an emergency." "Requiring such would be frivolous." In contrast, one person wrote "by requiring the owner of a farm to provide transportation you are putting him in the ambulance business." Several comments wanted the Agency to specify who should pay for the treatment; others wanted the Agency to be more specific about who should transport the worker. In their comments on the draft final rule, under FIFRA section 25(a), the United States Department of Agriculture stated that EPA needed to clarify when the employer is responsible for making available to the worker prompt transportation to an appropriate emergency facility. USDA stated that they interpret this provision to be applicable only while the employee is on the employer's property. EPA agrees and has clarified in the rule that the agricultural employer must provide such transportation when a worker is on the employer's establishment, including in any labor camp located on the establishment. The Agency has similarly clarified in the final rule that the handler employer must provide emergency transportation when a handler is at the place of employment or at the handling site. The Agency found no other information among the few comments on this requirement to cause it to reconsider other aspects of the requirement; they remain in the final rule essentially as proposed. L. Other Comments 1. Relationship between OSHA's Hazard Communication Standard and EPA's Worker Protection Standards. The proposed revisions to the Worker Protection Standards (WPS) were published July 8, 1988. The following month, August 8, 1988, the Occupational Safety and Health Administration (OSHA) published a notice of proposed rulemaking which would modify its Hazard Communication Standard (HCS). In the preamble to these proposed modifications, OSHA states that the HCS would apply to workers who are exposed to pesticide residues after application. EPA received numerous comments that pointed to the potential overlap of some requirements of the WPS with those of the HCS. Some were concerned that the requirements of the two standards might duplicate each other or might be conflicting. A few were concerned about possible conflicts with similar State laws. All want to see EPA and OSHA resolve any potential conflict before their respective regulations are made final. Some respondents felt that OSHA should have responsibility for defining hazard communication in agriculture; more felt that EPA should have the responsibility where pesticides are used. Some asked that the access to labeling provisions of the WPS be deleted because of the OSHA regulation calling for access to Material Safety Data Sheets (MSDS). A State agency and a trade association suggested that EPA should require an MSDS instead of the label as a source of information for workers. Sugar growers claimed that they should be exempt from the WPS because they are covered by OSHA. EPA is committed to working with OSHA within the constraints of each Agency's statutes to minimize confusion and to avoid duplication between the requirements of each Agency. Section 4(b)(1) of the Occupational Safety and Health Act precludes OSHA from regulating working conditions or hazards with respect to which other Federal agencies exercise statutory authority to prescribe or to enforce standards or regulations affecting occupational safety or health (29 U.S.C. 653(4)(b)(1).) In part 170, however, EPA has exercised statutory authority only with regard to agricultural working conditions or hazards that are related to pesticides. The Occupational Safety and Health Act and its regulations may apply to other agricultural working conditions or hazards and to nonagricultural working conditions (e.g., office work) that may take place on agricultural establishments. Among the regulations which may be applicable to agricultural nonpesticide working conditions are the Hazard Communication Standard (29 CFR 1928.21) and the Field Sanitation Standard (29 CFR 1928.110). Since the OSHA Field Sanitation Standard addresses general sanitary hazards, rather than pesticide hazards, EPA believes its applicability is not affected by part 170. 2. Juvenile workers. Present part 170 contains no requirements uniquely applicable to children who may be exposed to pesticides by handling activities or by working in treated areas. In the NPRM, the Agency considered the risk of pesticide exposure to juvenile workers and concluded that the information available at that time did not provide an adequate basis for proposing special requirements based on age. Thus, it was proposed that juvenile workers receive the same protections as adults under the proposal. Only one comment expressed the idea that juvenile workers should be treated the same as adults. All other comments cited evidence or expressed the belief the children were in need of special protection from pesticides. The comments focused on differences either in toxicity to or exposure of children. Some of the comments cited studies which indicated that young animals are more vulnerable than adult animals to the toxic effects of chemicals, including pesticides, because of lower body weight, lack of certain enzymes for detoxification of chemicals, and rapidly dividing cells in growing children. The Agency was criticized also for not recognizing numerous studies linking early exposure of young animals to carcinogens to the likelihood of developing cancer later in life, and for not recognizing the data showing increased effects of pesticides on children with nutritional deficiencies, a condition that might be common in migrant worker families. One comment believed that the use of child labor in agriculture was under reported. Several comments pointed out that young children frequently accompany working parents to the fields because no day care is available. Some comments were concerned because migrant labor camps often are near sprayed fields, leading to exposure of children both at work and at home. In such labor camps, clothing hung out to dry and children's toys in yards may be contaminated from nearby applications. One pesticide registrant commented that "people living in labor camps should receive health information and warnings similar to those in the work area." Another comment noted that the proposed warning requirements would not benefit children in adjacent labor camps because required field posting is so infrequent. Based on the comments received, EPA believes that the significance of juvenile exposure to pesticides used in agriculture is unclear. The studies of which the Agency is aware indicate that children of certain ages may be affected more adversely by certain pesticides than adults are affected for various reasons. However, the situation is complex and few data are available concerning the amount of exposure received by children during particular agricultural activities. As a result of these uncertainties, the Agency is unable to identify appropriate regulatory measures to address these issues at this time. No comments proposed specific solutions. The Agency notes that some regulatory protection now exists for children in agriculture under the Fair Labor Standards Act (FLSA) which indirectly may serve to reduce exposure. Children under 10 years old are prohibited from working in agriculture. Whereas children ages 10 through 15 years old may be employed only under certain limited conditions related to age, school hours, parental consent, and size of farm. A permit from the Department of Labor is required for employment of children ages 10 and 11 years old; to obtain a permit, there must be proof that no pesticide has been used or evidence that any pesticides used "would not have an adverse effect on the health or well-being of children." In addition, children under the age of 16 years may not be employed in certain occupations defined as particularly hazardous such "handling or applying (including cleaning or decontaminating equipment, disposal or return of empty containers, or serving as a flagman for aircraft applying) agricultural chemicals classified [under FIFRA] as Category I of toxicity...or Category II of toxicity" (29 CFR 171.71). 3. Pregnant women. Several comments questioned the adequacy of the proposed REI's to protect pregnant women from pesticide exposure; others stated that special measures were needed for pregnant women, claiming that a large portion of farm laborers are women of child- bearing age who routinely work during pregnancy. The Agency believes that the health information learned in the pesticide safety training required by the final rule, such as basic hygiene and decontamination practices, as well as the general exposure reduction practices mandated by the standards, will serve to reduce the exposure of pregnant workers significantly. 4. Public exposure. Some comments expressed concern for protecting the public from agricultural pesticide uses; for example, in retail greenhouses, at "you-pick" farms, in parks and recreational areas, along roads and rights-of-way, and in schools. The Agency is obligated under FIFRA to concern itself with any exposure to pesticides, and it routinely considers public dietary (e.g., pesticide residues on food) and nondietary (e.g., home use products) exposure in registration and reregistration actions. The revisions to part 170, however, are intended to address only occupational exposures, although the public may enjoy some incidental benefits from these regulations as, for example, when warning signs are located adjacent to a public right-of-way. IV. LABELING STATEMENTS A. Background of Proposal The Agency noted in the NPRM that in order for part 170 to be enforceable under the misuse provision of FIFRA section 12(a)(2)(G), its requirements must be incorporated onto pesticide labels or labeling. Rather than require that the regulations be printed in their entirety on each product, EPA proposed that part 170 be incorporated by means of a reference statement. In addition to the reference statement, those requirements of part 170 that were product-specific, such as personal protective equipment and REI's, and product-specific information necessary for compliance with part 170, such as whether the product is a fumigant, would appear as statements on labeling. Requirements applicable to all products, such as providing decontamination water, would not appear as statements on labeling. Under the proposal, the required worker protection labeling statements would be consolidated for the convenience of registrants in a new subpart K of part 156, "Labeling Requirements for Pesticides and Devices." The Agency proposed specific regulatory text and labeling statements for part 156, and solicited comment on the labeling aspects of the Worker Protection Standards. The Agency also discussed how it would implement these labeling changes as part of its pesticide registration program. B. Reference Statement The comments were divided evenly in opposing or supporting the proposal to reference part 170 on the label rather than including the full text of all requirements in labeling. Most comments that opposed the proposal to reference part 170 were user groups. The reasons cited were: (1) the lack of availability of the regulations (specifically, the Code of Federal Regulations (CFR)); (2) the need for information at the use site; (3) the undermining of the "read the label" and the "label is the law" message that users have been trained to follow. The comments stated that noncompliance is more likely for requirements that are not on the label. One comment summarized the issue from the user's perspective as follows: "Directing the user to the CFR may be effective in helping a State official enforce those provisions. . . Ease of enforcement is important, but compliance is crucial. Simplicity and understandability are of prime importance in gaining compliance." Among comments that were neutral or that favored the proposal, primarily State agencies and pesticide registrants, most cited the need for enforceability without excess label clutter, agreeing with EPA's justification in the proposal. Several comments, while supporting the proposed approach, cited the problem of availability of the specific requirements of the regulation should it not be incorporated in pesticide labeling in its entirety and stressed the need for wide dissemination of the needed information. Two comments suggested that users should not be referred to part 170 but rather to Agency-generated guides, instructional materials, or popularized versions of the regulations. Several comments objected to the length of the proposed reference statement and suggested alternative statements. The Agency acknowledges the need for pesticide users to have access to full information about the legal requirements for use of a pesticide. It also notes that in many cases the quantity of information on pesticide labeling is considerable and confusion in understanding labeling statements may result in noncompliance as surely as difficulty in obtaining the information may result in noncompliance. The Agency intends to develop and to make available, through its outreach activities and with the assistance of the Cooperative Extension Service, State pesticide regulating agencies, and the traditional networks of communication with the agricultural community such as commodity organizations and industry associations, information to assist users in understanding and complying with part 170. EPA believes that such information will minimize the need for users to seek out the CFR in order to understand their duties. The Agency considered requiring registrants to distribute a copy of part 170 with each sale of agricultural pesticides, but concluded that such requirement would result in waste through duplication. However, the Agency encourages any efforts registrants choose to make to communicate part 170 requirements to users. The Agency has retained its approach of referencing part 170 in the final rule, but has changed the language in the reference statement for the purposes of brevity and clarity. Other changes have been made to part 156 in response to comments. The proposed wording of the labeling statements for REI's, posting, and protective clothing have been shortened. C. General Statements One comment suggested that the signal word be required to appear in Spanish for products in toxicity categories III and IV as well as on products in toxicity categories I and II. The Agency believes that for the most toxic products, where there is a significant risk of serious injury by accidental exposure, it is reasonable to require translation of a limited amount of critical information, such as the signal word, into Spanish because it is the primary language for many agricultural workers in the United States. Extending this translation requirement to additional products, information, or languages would add verbiage to already crowded product labels, without increasing the likelihood of avoiding additional pesticide poisonings. EPA permits a product to bear labeling in languages other than English, but it will not require translation as part of the final rule. One comment objected to requiring the identification of the product as an organophosphate, an N-methyl carbamate, or a fumigant. As discussed in the proposal, these pieces of technical information about a particular product are useful for operating voluntary cholinesterase monitoring programs or are necessary for users to follow certain requirements of part 170, i.e., the application and entry restrictions for nurseries and greenhouses. These statements do not add many additional words to labels. Another comment suggested that these statements should appear in a specific location rather than where the registrant chooses, and that registrants should be allowed to repeat the terms in as many places as desired to get the message across. The Agency agrees that it can be more precise about the location, and in the final rule has stated that these statements, if not part of the product name, must appear "close to the product name." One comment suggested that the statements regarding visual contact with handlers of highly toxic products belonged in part 170 rather than part 156. EPA agrees that the requirement concerning contact with handlers of highly toxic pesticides and with handlers of fumigants in greenhouses is not product-specific and has moved this requirement to part 170. D. Restricted Entry Statements Two comments supported the inclusion of restricted entry statements on labeling. Two comments requested that registrants be allowed the option of using the abbreviation "REI" to refer to an REI. EPA will permit the option to use the abbreviation "REI" but only if the adopted abbreviation has been defined previously in the labeling. One comment suggested that the requirement to reference the REI in the human hazard precautionary section of the label, if the REI appears in supplemental labeling rather than on the label, was not necessary. EPA agrees that the general reference on the label to part 170 restricted entry requirements will be sufficient, and it has deleted this requirement from the final rule. A number of other changes to restricted entry statements have been made in the final rule in response to comments. These changes have focused on risk mitigation measures such as the entry restrictions, notification about treated areas, use of personal protective equipment by handlers or workers entering treated areas prior to the expiration of an REI. Changes have been made in the criteria for determining the length of REI's and the relationship of REI's established through part 170 to existing product-specific and interim REI's. In addition, EPA has clarified that the REI's established through part 170 are not applicable to fumigants. Existing entry restrictions on fumigant product labeling will continue to apply unless modified on a case-by- case basis. The restricted entry statements are to be placed in the "Directions For Use" section of the pesticide labeling under the heading of "Agricultural Use Requirements" in order to consolidate most worker protection statements in one place. E. Notification Statements No comments were received in reference to the proposed notification statements. Several changes to the notification section have been made in the final rule. The wording of the statement was changed to "notify workers of the application by warning them orally and posting warning signs at entrances to treated areas" rather than merely "subject to posting" to distinguish the statement from other general requirements of part 170 which involve the display of written materials. The subsection related to location of the statement on the labeling has been modified to require that the notification statement be in the "Agricultural Use Requirements" section of the labeling with the other required worker protection statements. F. Personal Protective Equipment Statements No comments were received on the proposed personal protective equipment statements. In the final rule the Agency has made a number of changes to these sections which derive from specific risk mitigation measure decisions regarding personal protective equipment requirements, discussed in Unit III.H. of this document. These are reflected in changes to the table of minimum personal protective equipment requirements for handling activities (40 CFR 156.212(e)). Two differences between the proposed and the final rule related to personal protective equipment labeling statements should be noted. Wherever possible throughout the personal protective equipment section, the Agency has taken the approach of specifying the exact wording of personal protective equipment labeling statements and specifying which products are subject to the statement. The goals of this approach are to reduce the burden on registrants in interpreting part 156 in the process of revising product labeling and to reduce the need for registrants to consult with EPA about personal protective equipment labeling language. Another difference between the proposed and the final rule is the way in which information about acceptable types of personal protective equipment is conveyed to users. Specific types of glove materials will be recommended on the labeling and specific types of respirators will be required on the pesticide labeling. Where protection of a certain body area is called for, e.g., eye protection, rather than list all acceptable kinds of personal protective equipment for protecting the eyes on the label, the labeling statement will list "protective eyewear" and users will refer to the standardized definition of acceptable kinds of personal protective equipment for eye protection in 40 CFR 170.240 (the section of the pesticide-handling subpart that covers personal protective equipment), in the EPA-prepared guidance brochure on protective eyewear, or in other new EPA training materials dealing with personal protective equipment. Through these definitions and through training programs, users should become accustomed to the criteria for acceptable types of personal protective equipment, and EPA believes this will reduce labeling verbiage related to personal protective equipment. G. Other Comments Several comments objected to "label clutter" from additional worker protection labeling statements. EPA has made every effort to minimize the additional labeling language necessitated by the revisions to part 170 and to eliminate excess verbiage. At the same time, EPA recognizes that use restrictions can be enforced only through labeling statements. EPA's approach therefore has been to put users on notice, via the labeling, of the regulations with which they must comply. Several comments stated that there was inconsistency between the use of signal words to express certain requirements in part 170 and the use of toxicity categories in part 156. Since part 156 applies only to registrants, who are familiar with the technical meaning of toxicity categories, users will not be affected by the use of this terminology in that part. For requirements in part 170 that are tied to the acute toxicity of the product, the user must make use of information to which he or she has access; the use of the signal word on the label rather than the toxicity category therefore is appropriate. One comment suggested requiring the identification of the toxicity category on product labels. Signal words are intended to convey the relative acute toxicity of products in a manner that users can understand easily. Since users may not be aware of the criteria on which toxicity categories are based, the Agency believed that the toxicity category would not be useful on labeling and that the signal word is sufficient. There were a number of requests that EPA specify the location and format of required labeling statements. In the final rule, EPA has specified the location, or alternative locations, for all required statements. A number of suggestions were made as to items that should appear in one or another location. The final rule specifies that certain statements must appear on the product label (as opposed to labeling), and that all other statements may appear either on the label or in labeling. The final rule requires that statements be consolidated to the extent possible for the convenience of the reader and that statements be at the beginning of the directions for use to emphasize their importance. Some comments suggested additional types of statements that should be required, all of which the Agency declines to require in this rulemaking. Labeling statements related to chronic health effects are specific to an active ingredient and will be required on a case-by-case basis when such effects are identified. Exemptions to requirements would contribute extensively to label clutter; the Agency believes that users will be motivated to learn of the exemptions in part 170 applicable to their situation. Medical symptoms and first aid information are included in general hazard information by other labeling regulations; all products in toxicity categories I, II, and III are required to bear a statement of practical treatment. One comment noted that the phrase "workers in pesticide-treated areas" was ambiguous, since certain requirements may affect workers who are not in a pesticide treated area at the time. The Agency agrees and has modified the wording appropriately. V. RELATIONSHIP TO STATE REGULATIONS A. National Minimum Standards Approach The Agency proposed to continue the national minimum standards approach to the protection of workers from pesticide exposure. Part 170 would act as a national minimum, with States permitted to set more stringent standards as necessary. This approach is consistent with the relationship established by FIFRA section 24 between the States and the Federal government with regard to pesticide regulation. There were comments both supporting and opposing this approach. Most comments focused on the Federal/State relationship established by FIFRA section 24, under which States are permitted to regulate pesticides in addition to Federal regulation, but they may not do so by altering labeling or packaging. A number of comments advocated that EPA preempt the States' authority to regulate more stringently. They cited the unequal impacts among farmers that would result if States introduced differing worker protection standards more stringent than EPA's. To date, few States have exercised State authority to regulate in this area. FIFRA establishes this State authority; EPA may not take it away by regulation. Another comment suggested that EPA adopt a program of State plan approval which would allow the label to provide either for the State or Federal requirements. EPA believes that it cannot establish such a requirement; requiring Agency approval to permit a State to regulate more stringently would conflict with State authority granted under FIFRA section 24. The final rule embodies the national minimum standards approach. States that choose to regulate more stringently will find a framework for expansion to more comprehensive requirements. For example, in the case of REI's, a State may increase an REI because of local climatic conditions, or may submit reentry data to EPA to show that a shorter REI is warranted for a particular pesticide used on particular crops or particular areas in that State, and EPA may modify the REI accordingly as provided for in part 156. B. Effect on Existing State Regulations In its proposal EPA identified two areas where some States had exercised authority to regulate worker protection in a manner that would lead to potential conflict, or confusion, between the State and Federal requirements. In these two areas, training and cholinesterase monitoring, the Agency proposed to permit State programs to continue in effect under certain conditions, even if their requirements differed in some respects from the Federal Worker Protection Standard. The proposed conditions were, in the case of training, that the State training requirements were "not inconsistent with" the training requirements of the Worker Protection Standard and in the case of cholinesterase monitoring, that the State requirements were "substantially equivalent to" the requirements in the Worker Protection Standard. In addition, a State could petition EPA for approval of "inconsistent" training requirements. Some aspects of a State program might not be clearly more or less restrictive than the Federal requirements, merely "different." To avoid confusion, EPA intended to allow variations in programs on the part of the States, as long as the scope and coverage did not place the program below the national minimum. Some comments stated that the proposed language of these sections appears to prohibit a State from creating more stringent or restrictive requirements, in violation of FIFRA section 24(a) which allows them to do so. The Agency did not intend this result; it agrees that proposed language appears to have this effect. In the final rule these sections have been deleted. The general test of permissible State regulation under FIFRA is whether the State requirements are as stringent as or more stringent than the Federal Worker Protection Standard. For example, a State program might enlarge the scope of persons to be trained, prescribe additional qualifications for trainers or require additional content in training programs, but the minimum EPA scope, qualifications, and content would remain applicable, and a training program must adhere to both State and Federal standards. To give another example, a State might require posting of treated areas following applications and specify certain words and symbols to appear on warning signs; the EPA- specified warning signs would still be required in addition to any other signs or symbol required by a State. Although some confusion because of similar State and Federal requirements is possible, States are free to consult with EPA on the relation between their existing or planned regulations and the Worker Protection Standard. C. State Regulations and Federal Labeling Among the labeling statements referencing the Worker Protection Standard and incorporating it into labeling proposed in the NPRM, a statement was included which referred to the possibility of additional State regulations that could apply to the use of the product. The purpose of the statement was to put users on notice of additional State regulations because such regulations usually would not appear on the product labeling. Under FIFRA section 24(b), States are prohibited from modifying labels to include their regulations. Two comments urged that, for the convenience of users, the Agency consider requiring State worker protection regulations applicable to the product appear on the product label. One comment limited the suggestion to situations where there is a State-REI longer than the Federal REI. Although this approach might facilitate user compliance in some cases, the problem is not national in scope; it is limited to users in those few States with worker protection regulations. EPA also believes that the burden on EPA and on registrants would be significant. Registrants would be responsible for identifying applicable State requirements and producing multiple, State-specific labelings. EPA in its review and approval of such labeling would be obliged to judge whether regulations it did not create are interpreted accurately and are stated accurately therein. The final rule contains language alerting users that a State may have more stringent requirements for worker protection, and does not incorporate State regulations into Federal labeling.